Burr's bill would make vaccines risky
In response to
"Burr steps into the spotlight" (Oct. 22):
Every parent should be concerned by Sen. Richard Burr's fast-tracked drug development bill.
If the vaccine industry is accountable to absolutely no one, how can we ensure that
profit won't stand in the way of safety?
We cannot allow the pharmaceutical industry's fear tactics to steal a basic right of our children: the right to go to court after being harmed.
Burr's bill is a slap in the face to families who believe their autistic children were damaged by thimerosal in vaccines.
The threat to children from vaccines produced without accountability far exceeds the threat from bioterrorism. If our government won't protect them, who will?
Kelly and Matt Langston
November 7, 2005
Kelly from Walking With Alec
...ROCKS!
Another Chelation Success Story
http://www.wfsb.com/Global/story.asp?s=4069730
View the video by clicking the red camera icon next to "New hope for children with autism".
View the video by clicking the red camera icon next to "New hope for children with autism".
Children Who Have Recovered From Autism
As they do at the DAN conferences, on the first day they brought out several children who used to be autistic, and have recovered. It was quite inspirational. When ARI posts the video of the event I will be sure to let you know.
I had the honor of interviewing one of these kids. 16 year old Garrett. He gave a short speech at the conference. I will be posting that interview with the footage when it comes available.
I had the honor of interviewing one of these kids. 16 year old Garrett. He gave a short speech at the conference. I will be posting that interview with the footage when it comes available.
Autism survivors speak in L.B.
By Kevin Butler, Staff writer
LONG BEACH — Hundreds of people attending an autism conference on Friday heard from parents who say that various treatments greatly reduced, or eliminated, their autistic children's symptoms.
The three-day "Defeat Autism Now!" conference, organized by a San Diego think tank, The Autism Research Institute, featured parents saying their autistic children dramatically improved, thanks to dietary regimens, behavioral therapy and various medications.
Not all researchers believe that all the touted remedies have been scientifically demonstrated.
About 10 children whose parents say have recovered from the condition were interviewed on-stage in front of a large audience at The Westin Long Beach.
Stan Kurtz said he and his wife were devastated when they learned their young son Ethan had autism.
"It's life-changing," he said. "You lose your child. Â… and you have to rebuild. You have to see what's really going on."
Ethan, now 4 years old, didn't speak and often just stared out the window, Kurtz said.
Now his son's symptoms have largely gone away, thanks to a combination of drugs and dietary changes, said Kurtz, a Tarzana resident.
Kurtz on Friday asked his son to describe his favorite book, "Charlotte's Web."
Speaking of the main character, a
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pig called Wilbur, Ethan Kurtz smiled and said, "He was a baby, and then he grew up."
Cindy Goldenberg said until her son started a drug treatment when he was 3 years old, he wouldn't speak, make eye contact or play appropriately.
At around age 3, her son Garrett now 16 years old started receiving infusions of a protein used to treat immune deficiencies, she said. She said his symptoms were gone by the time he was 5 years old.
"I feel like I not only got a miracle, but I got a second chance," said Goldenberg, a Laguna Niguel resident.
Goldenberg, like some other parents at the conference, subscribes to the controversial theory that her child's condition was linked to a vaccine used to ward off measles, mumps and rubella.
The U.S. Centers for Disease Control and Prevention, however, has stated that "the weight of the evidence indicates that vaccines are not associated with autism."
November 2, 2005
An Update from David Kirby
Last Sunday at the Long Beach DAN! Conference, David Kirby spoke, updating the group on the latest on his book, Evidence Of Harm, and where the vaccine/autism story has come to date. Afterward was good enough to sit down with me and answer a few questions.
-----------------
Mr. Kirby announced that the paperback version of the book will be coming out in March, and will contain updates to the story since the book was published. St. Martin’s press has selected the book as one in a four-title collection for a book club series.
-----------------
The movie rights to Evidence Of Harm have been sold to Participant Productions with Nick Wechsler producing the project. The film is currently in development with plans to begin filming next year. Participant is a self-described socially conscious production company committed to bringing films to the screen that “Change the world one story at a time”. Among their current projects are North Country, with Charlize Theron, and the Good Night, and Good Luck, the story of Edward R. Murrow’s battle with Senator Joseph McCarthy, with George Clooney,
-----------------
Last week Mr. Kirby was invited by professors at NYU Law School to discuss the topic of thimerosal in vaccines at a project they are undertaking on medicine and human rights. Professor Mary Holland and her colleagues are viewing the thimerosal story in terms of potential human rights violations, with an eye toward presenting their findings to the United Nations.
-----------------
During his speech he touched on the current Bio defense bill, which will create a federal health department that would not be subject to the Freedom of Information Act, but would create public health policy. This department would have the power to order mandatory vaccinations of the general public, but its decision making process would not be open to public scrutiny.
Mr. Kirby points out that if FOIA revocation had been in place 5 years ago, we would know little about government action in regards to thimerosal and Evidence of Harm would not have been written.
-----------------
He also announced that Senator Joseph Leiberman would be introducing legislation to force the Center for Disease Control to open the Vaccine Safety Datalink to researchers, as the autism community as been asking. The CDC has restricted access to the VSD since Mark and David Geier discovered a link between thimerosal containing vaccines and autism using the VSD in 2004 in violation of federal law. Indeed the Lieberman legislation was introduced on Monday.
Mr. Kirby also told the crowd in attendance that has learned that the day that the Geiers last accessed the VSD, an order had been given by the CDC that as soon as they left the building, the data was to be removed from computer system. This order was carried out, and the following day the database was transported to the headquarters of the CDC and subsequently placed with a private company where it could not be accessed by FOIA.
-----------------
In addition he discussed the findings of the Burbacher study done by the National Institute of Health and published this spring. Burbacher's primate study expanded the understanding of how thimerosal behaves in the body in comparison to the way methyl mercury behaves in the body.
EPA safety limits for mercury are based on observations of the toxicity of ingested methyl mercury. It had previously been thought that because the ethyl mercury in thimerosal clears the blood stream in about the third of the time that methyl mercury does, and because ethyl mercury was a larger molecule, which made it more difficult for it to cross through the blood brain barrier, that ethyl mercury (the type in thimerosal) was the safer form of the two.
Burbacher's study confirmed that thimerosal did indeed clear the blood stream more quickly, and had more difficulty entering the brain, however it was discovered that once ethyl mercury was in the brain it oxidized and converted into inorganic mercury at a much higher rate than methyl mercury. From previous studies from Burbacher and NIH, we know that while organic mercury in the brain has a half-life of around 30 days, inorganic mercury in the brain has a half-life estimated at 20 years.
This of course would mean that the EPA, and all other government safety standards for methyl mercury would be woefully lacking in regard to thimerosal.
When the study was published in Environmental Health Perspectives, an NIH journal, the CDC issued a press release that stated that it showed that thimerosal cleared the blood faster than, and entered the brain less readily than methyl mercury, but made no mention of the fact that when the primates were sacrificed, the subjects given thimerosal had 4 times the inorganic mercury in the brain than the subjects who ingested methyl mercury.
The press picked up on the press release, printing that the mercury in vaccines was safer than the mercury in fish, when in fact the study had found that the opposite was true.
Burbacher was upset by this and demanded that the CDC issue another press release correcting the record. The CDC did so, but when the new press release was issued, it still made no mention of the finding that thimerosal was 4 times as toxic to the brain as mercury in fish.
Mr. Kirby has discovered that the CDC had hired a Triangle Park PR firm to issue the public statements and that the firm also represented several vaccine manufacturers.
-----------------
A few of Kirby’s detractors have written that he had previously been associated with Act Up, the AIDS activist group considered by many to be extreme in their tactics. I asked Mr. Kirby about his association with the controversial group, and he said that he had never been affiliated with Act Up.
Mr. Kirby told me that he had worked on David Dinkins campaign in his run for mayor in 1986 and during that time part of his responsibilities were to act as liaison to the AIDS support and awareness groups in the city. Act Up was one of those groups.
From 1990 to 1994, he worked for The American Foundation for Aids Research (AMFAR), a main stream AIDS research fund-raising organization for which Elizabeth Taylor acts as a spokesperson, where he again acted as liaison to other AIDS groups Act Up included.
During his tenure in both of these positions, he reports that he attended a few Act Up meetings as a representative of Dinkins campaign or AMFAR, but that he never did any work for them nor attended any of their demonstrations. He actually said that a few of their members had criticized him for being too mainstream in position.
Mr. Kirby reports that he did write one AIDS related article about a group of AIDS protesters that were arrested and not allowed access to their medications while in custody.
He had not heard of the accusation of his involvement with Act Up, and assumes that whoever started the rumor had confused Act Up with AMFAR.
-----------------
Mr. Kirby announced that the paperback version of the book will be coming out in March, and will contain updates to the story since the book was published. St. Martin’s press has selected the book as one in a four-title collection for a book club series.
-----------------
The movie rights to Evidence Of Harm have been sold to Participant Productions with Nick Wechsler producing the project. The film is currently in development with plans to begin filming next year. Participant is a self-described socially conscious production company committed to bringing films to the screen that “Change the world one story at a time”. Among their current projects are North Country, with Charlize Theron, and the Good Night, and Good Luck, the story of Edward R. Murrow’s battle with Senator Joseph McCarthy, with George Clooney,
-----------------
Last week Mr. Kirby was invited by professors at NYU Law School to discuss the topic of thimerosal in vaccines at a project they are undertaking on medicine and human rights. Professor Mary Holland and her colleagues are viewing the thimerosal story in terms of potential human rights violations, with an eye toward presenting their findings to the United Nations.
-----------------
During his speech he touched on the current Bio defense bill, which will create a federal health department that would not be subject to the Freedom of Information Act, but would create public health policy. This department would have the power to order mandatory vaccinations of the general public, but its decision making process would not be open to public scrutiny.
Mr. Kirby points out that if FOIA revocation had been in place 5 years ago, we would know little about government action in regards to thimerosal and Evidence of Harm would not have been written.
-----------------
He also announced that Senator Joseph Leiberman would be introducing legislation to force the Center for Disease Control to open the Vaccine Safety Datalink to researchers, as the autism community as been asking. The CDC has restricted access to the VSD since Mark and David Geier discovered a link between thimerosal containing vaccines and autism using the VSD in 2004 in violation of federal law. Indeed the Lieberman legislation was introduced on Monday.
Mr. Kirby also told the crowd in attendance that has learned that the day that the Geiers last accessed the VSD, an order had been given by the CDC that as soon as they left the building, the data was to be removed from computer system. This order was carried out, and the following day the database was transported to the headquarters of the CDC and subsequently placed with a private company where it could not be accessed by FOIA.
-----------------
In addition he discussed the findings of the Burbacher study done by the National Institute of Health and published this spring. Burbacher's primate study expanded the understanding of how thimerosal behaves in the body in comparison to the way methyl mercury behaves in the body.
EPA safety limits for mercury are based on observations of the toxicity of ingested methyl mercury. It had previously been thought that because the ethyl mercury in thimerosal clears the blood stream in about the third of the time that methyl mercury does, and because ethyl mercury was a larger molecule, which made it more difficult for it to cross through the blood brain barrier, that ethyl mercury (the type in thimerosal) was the safer form of the two.
Burbacher's study confirmed that thimerosal did indeed clear the blood stream more quickly, and had more difficulty entering the brain, however it was discovered that once ethyl mercury was in the brain it oxidized and converted into inorganic mercury at a much higher rate than methyl mercury. From previous studies from Burbacher and NIH, we know that while organic mercury in the brain has a half-life of around 30 days, inorganic mercury in the brain has a half-life estimated at 20 years.
This of course would mean that the EPA, and all other government safety standards for methyl mercury would be woefully lacking in regard to thimerosal.
When the study was published in Environmental Health Perspectives, an NIH journal, the CDC issued a press release that stated that it showed that thimerosal cleared the blood faster than, and entered the brain less readily than methyl mercury, but made no mention of the fact that when the primates were sacrificed, the subjects given thimerosal had 4 times the inorganic mercury in the brain than the subjects who ingested methyl mercury.
The press picked up on the press release, printing that the mercury in vaccines was safer than the mercury in fish, when in fact the study had found that the opposite was true.
Burbacher was upset by this and demanded that the CDC issue another press release correcting the record. The CDC did so, but when the new press release was issued, it still made no mention of the finding that thimerosal was 4 times as toxic to the brain as mercury in fish.
Mr. Kirby has discovered that the CDC had hired a Triangle Park PR firm to issue the public statements and that the firm also represented several vaccine manufacturers.
-----------------
A few of Kirby’s detractors have written that he had previously been associated with Act Up, the AIDS activist group considered by many to be extreme in their tactics. I asked Mr. Kirby about his association with the controversial group, and he said that he had never been affiliated with Act Up.
Mr. Kirby told me that he had worked on David Dinkins campaign in his run for mayor in 1986 and during that time part of his responsibilities were to act as liaison to the AIDS support and awareness groups in the city. Act Up was one of those groups.
From 1990 to 1994, he worked for The American Foundation for Aids Research (AMFAR), a main stream AIDS research fund-raising organization for which Elizabeth Taylor acts as a spokesperson, where he again acted as liaison to other AIDS groups Act Up included.
During his tenure in both of these positions, he reports that he attended a few Act Up meetings as a representative of Dinkins campaign or AMFAR, but that he never did any work for them nor attended any of their demonstrations. He actually said that a few of their members had criticized him for being too mainstream in position.
Mr. Kirby reports that he did write one AIDS related article about a group of AIDS protesters that were arrested and not allowed access to their medications while in custody.
He had not heard of the accusation of his involvement with Act Up, and assumes that whoever started the rumor had confused Act Up with AMFAR.
Safe Minds on Flu Vaccines
SafeMinds Issues Urgent Warning on Risk to Pregnant Women, Children,Infants of Exposure to Mercury from Flu Shots; As Bird Flu Plan is Unveiled
WASHINGTON, Nov. 2 /U.S. Newswire/ -- As the flu season approaches and the Bush administration begins sharing details of their plan to prevent a possible avian flu pandemic, much emphasis is being placed on the idea that flu shots should be readily available and administered to large portions of the population. But lost in these numerous media reports is the danger posed by mercury found in a majority of annually administered flu vaccine preparations.
"Consumers are not aware of the fact that flu shots still contain thimerosal, a mercury based preservative recently phased out of most childhood vaccines," said Lyn Redwood, president of SafeMinds, a non- profit organization dedicated to raising awareness and conducting research into mercury exposure. Most alarming to Redwood is the fact that pregnant mothers and infants are now targeted to receive the annual flu vaccine when they are exactly the populations known to be most vulnerable to exposure to mercury. "We know from study after study that mercury rapidly crosses the placenta, enters the fetal brain and interrupts critical stages of development," said Redwood.
The
CDC's recently recommended exposure to mercury from flu vaccine comes despite the fact that one in every six women of childbearing already has blood levels of mercury high enough to harm their unborn children from environmental exposures. An EPA announcement came on the heels of a report, which found that the fetus actually accumulates mercury and typically has blood levels 70 percent higher than those found in the mother at the time of birth.
According to Mark Blaxill, director of SafeMinds, "Why on earth would the CDC on one hand recommend that pregnant mothers avoid environmental exposure to mercury from eating seafood, but on the other hand ignore the danger from mercury administered in vaccines when they know that an average flu vaccine exceeds EPA's safe level of daily mercury exposure in the average woman by four fold? By suggesting that a direct injection of ethyl mercury via a flu shot is harmless, and indeed by recommending that exposure, these policies defy not only sound medical practice but common sense."
"If you choose to be immunized against regular flu, you should know what benefits you're actually getting," continued Blaxill. "American consumers should make informed decisions about their health. Amidst rising fears over a theoretical avian flu pandemic, numerous health officials have tied the avian flu risk to the regular annual flu shot, but most people don't realize that the annual flu shot won't protect you against avian flu. In addition, pregnant women also should know that recent scientific studies show little support or benefit to them or to their fetus from a flu shot."
SafeMinds also expressed concern about the blanket protection from liability for vaccine manufacturers offered in Bush's flu pandemic plan.
"Any kind of blanket immunity will only take away incentives for producing safe products and inevitably, will set our country up for a bad outcome," continued Redwood. "Immunity from legal liability for injury will result in vaccines that are less safe, which in turn will cause declining public confidence in vaccines."
The claim that the threat of lawsuits has kept manufacturers from entering and staying in the vaccine business has long been touted as a reason for protecting the pharmeceutical industry. Language providing relief from liability for vaccine manufacturers has been introduced unsuccessfully over the past several years. Although supporters of these bills claimed that intervention is needed to address concerns over the vaccine supply, the past problems that occurred were a result of long overdue FDA enforcement actions concerning violations of good manufacturing practices and complacency on the part of the manufacturers for production and distribution of their products, not litigation.
As the avian flu scare becomes increasingly political, SafeMinds is urging consumers to take a critical view of the rising media hype. SafeMinds encourages doctors to educate themselves and their patients about the risks of mercury exposure before administering the flu vaccine and to recommend only mercury free vaccine products for their patients.
More information about SafeMinds (including neurodevelopmental disorders, autism and mercury exposure) may be found at http://www.safeminds.org or by calling Stephanie Morris at 202-628-7772.
WASHINGTON, Nov. 2 /U.S. Newswire/ -- As the flu season approaches and the Bush administration begins sharing details of their plan to prevent a possible avian flu pandemic, much emphasis is being placed on the idea that flu shots should be readily available and administered to large portions of the population. But lost in these numerous media reports is the danger posed by mercury found in a majority of annually administered flu vaccine preparations.
"Consumers are not aware of the fact that flu shots still contain thimerosal, a mercury based preservative recently phased out of most childhood vaccines," said Lyn Redwood, president of SafeMinds, a non- profit organization dedicated to raising awareness and conducting research into mercury exposure. Most alarming to Redwood is the fact that pregnant mothers and infants are now targeted to receive the annual flu vaccine when they are exactly the populations known to be most vulnerable to exposure to mercury. "We know from study after study that mercury rapidly crosses the placenta, enters the fetal brain and interrupts critical stages of development," said Redwood.
The
CDC's recently recommended exposure to mercury from flu vaccine comes despite the fact that one in every six women of childbearing already has blood levels of mercury high enough to harm their unborn children from environmental exposures. An EPA announcement came on the heels of a report, which found that the fetus actually accumulates mercury and typically has blood levels 70 percent higher than those found in the mother at the time of birth.
According to Mark Blaxill, director of SafeMinds, "Why on earth would the CDC on one hand recommend that pregnant mothers avoid environmental exposure to mercury from eating seafood, but on the other hand ignore the danger from mercury administered in vaccines when they know that an average flu vaccine exceeds EPA's safe level of daily mercury exposure in the average woman by four fold? By suggesting that a direct injection of ethyl mercury via a flu shot is harmless, and indeed by recommending that exposure, these policies defy not only sound medical practice but common sense."
"If you choose to be immunized against regular flu, you should know what benefits you're actually getting," continued Blaxill. "American consumers should make informed decisions about their health. Amidst rising fears over a theoretical avian flu pandemic, numerous health officials have tied the avian flu risk to the regular annual flu shot, but most people don't realize that the annual flu shot won't protect you against avian flu. In addition, pregnant women also should know that recent scientific studies show little support or benefit to them or to their fetus from a flu shot."
SafeMinds also expressed concern about the blanket protection from liability for vaccine manufacturers offered in Bush's flu pandemic plan.
"Any kind of blanket immunity will only take away incentives for producing safe products and inevitably, will set our country up for a bad outcome," continued Redwood. "Immunity from legal liability for injury will result in vaccines that are less safe, which in turn will cause declining public confidence in vaccines."
The claim that the threat of lawsuits has kept manufacturers from entering and staying in the vaccine business has long been touted as a reason for protecting the pharmeceutical industry. Language providing relief from liability for vaccine manufacturers has been introduced unsuccessfully over the past several years. Although supporters of these bills claimed that intervention is needed to address concerns over the vaccine supply, the past problems that occurred were a result of long overdue FDA enforcement actions concerning violations of good manufacturing practices and complacency on the part of the manufacturers for production and distribution of their products, not litigation.
As the avian flu scare becomes increasingly political, SafeMinds is urging consumers to take a critical view of the rising media hype. SafeMinds encourages doctors to educate themselves and their patients about the risks of mercury exposure before administering the flu vaccine and to recommend only mercury free vaccine products for their patients.
More information about SafeMinds (including neurodevelopmental disorders, autism and mercury exposure) may be found at http://www.safeminds.org or by calling Stephanie Morris at 202-628-7772.
November 1, 2005
The Age of Autism: The Amish Elephant
The Age of Autism: The Amish Elephant
By Dan Olmsted
UPI Senior Editor
Oct. 29, 2005 at 2:34PM
A specter is haunting the medical and journalism establishments of the United States: Where are the unvaccinated people with autism?
That is just about the only way to explain what now appears to be a collective resistance to considering that question. And like all unanswered questions, this raises another one: Why?
What is the problem with quickly and firmly establishing that the autism rate is about the same everywhere and for everybody in the United States, vaccinated or unvaccinated? Wouldn't that stop all the scientifically illiterate chatter by parents who believe vaccinations made their children autistic? Wouldn't it put to rest concerns that -- despite the removal of a mercury-containing preservative in most U.S. vaccines -- hundreds of millions of children in the developing world are possibly at risk if that preservative is in fact linked to autism?
Calling this issue The Amish Elephant reflects reporting earlier this year in Age of Autism that the largely unvaccinated Amish may have a relatively low rate of autism. That apparent dissimilarity is, in effect, a proverbial elephant in the living room -- studiously ignored by people who don't want to deal with it and don't believe they will have to.
Here are a few cases in point.
Earlier this month the National Consumers League conference in Washington held a session on communicating issues around vaccine safety. I was on the panel and talked about the Amish and autism. In the Q&A session that followed, the first question was for me.
"Is this a proper role for a journalist, or is this just a straw dog set up there with a preliminary answer? It not only showed up where you wrote it. It was all over the place. You did very, very well for UPI (at which point I said, 'Thank you -- please tell my bosses that!') but the question is, did you do very, very well for America?
"Is it appropriate for a journalist -- you weren't reporting, you were investigating. And I just wonder if you think it's an appropriate role for you to play."
My answer: "There's different roles for the press. That's certainly a reasonable question. That is investigative reporting. This idea is something that's already been discarded -- that there's any reason why you would want to look in an unvaccinated population.
"One of my favorite comments about journalism is that it's the wild card of American democracy. The First Amendment says we can do (in the sense of reporting about) whatever we want. So one of our privileges is to get an idea in our head and go look at it."
My questioner was not finished. "I wasn't questioning whether you have a First Amendment right to do it. I think this is more of a question of the ethics, of what value we are bringing to the debate."
My response: "That's probably not a good one for me to answer. Obviously I thought it was ethical."
At that point a fellow panelist, Dr. Louis Cooper, former president of the American Academy of Pediatrics and a staunch vaccine defender, spoke up. "I would jump in and say I thought it was ethical and I think it was useful," said Cooper, a courtly and unfailingly courteous Manhattan pediatrician.
"As you've learned, it was annoying to many people. I wasn't annoyed by it because I thought you kept the process and the debate and the discussion going forward. And we have to do that for one another."
That did not end the discussion. A few minutes later a public-health professor from -- where else? Harvard -- did her own version of Jeopardy!, offering the correct "answer" in the form of a question.
"This question is for Dan. Did you mention the outbreak of polio that happened in the Amish community in the Netherlands that caused widespread problems there, and also the fact that there'd been some context with respect to history in our country in trying to reach out to the Amish to actually encourage them to try to benefit from some of the vaccine technology to the extent that we could?
"So there's been a long history in this country of the CDC trying to reach out to them to the extent that they could. Also with respect to polio, I think what's really amazing is it's such a great story, this is such an exciting time, in the sense that we are very close to global eradication. What that means is we've gone from 1988 when we had 350,000 estimated paralytic polio cases in the world every year to roughly a thousand. It's very exciting that in fact we don't have the terror or the hysteria and all of the fear that surrounded disease.
"I just want to remind everyone that one thing that's very important in the context of reporting these stories is making sure that people do remember and also realize with infectious disease is these things can come back, and until they are eradicated they can come back and devastate us just as much as they did before, except now there are a lot more people.
"There's some related news that people might find interesting. A headline in the Washington Post today, 'Polio outbreak occurs among Amish families.' So I thought people might be interested in that."
At that point the moderator, Dr. Roger Bernier of the Centers for Disease Control, said time was getting short -- why was I not surprised? -- and asked for the next "question."
One thing I've noticed is the more that people want to lecture instead of learn, the more they speak in breathless run-on sentences that are hard to stop, slow down or even diagram. They leave one with the unspoken idea that dialogue -- opening the door to new information -- is somehow dangerous.
These exchanges reminded me of the response I got from Dr. Julie Gerberding, the CDC director, when I asked her this summer, verbatim: "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"
Her answer, verbatim:
--
In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.
But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.
I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.
I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.
So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.
We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.
--
The latest response to my pesky persistence comes not from academia or government but from my own profession. Last week the prestigious Columbia Journalism Review published an article whose main thrust -- with which I concur -- was that a vigorous debate over a possible link between vaccines and autism was being thwarted by the self-induced timidity of the press.
Some reporters told the author, Daniel Schulman, that they have basically given up on the story because the criticism -- some of it from their own editors -- was so fierce, and the story was so complicated.
Schulman described Age of Autism's efforts to come at the issue "sideways," looking for possible clues to the cause of the disorder in the natural history of autism. And he mentioned our reporting on the Amish:
"Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool. ... Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions."
Ouch. Being slammed by one's peers is never enjoyable, although reporters need to have thick skins and realize they dish this kind of thing out every day. (And those anonymous sources really are annoying, especially when I am happy to be quoted by name about everything.)
What's interesting about the reporters' "private" remarks is the degree of presumed expertise they suggest -- that looking at the Amish is misguided "since it may simply reflect genetic differences among an isolated gene pool." Really? Where did these guys get their doctorate in genetics, Harvard?
This assertion -- that the Amish gene pool could explain everything, based on no data that I'm aware of -- is the kind of self-interested speculation masquerading as expertise that has beset the autism-vaccines discussion for far too long. The term I learned for it long ago is "convenient reasoning," and it does not always have to be conscious.
The Amish have all kinds of standard genetic mental and developmental disorders -- from bipolar to retardation -- and a lot more genetic issues to boot from this supposedly protective "isolated gene pool." The doctors who actually know something about the Amish have never suggested to me that genes have anything to do with a low rate of autism. They seem perplexed.
In upcoming columns, we'll put that question to the right people -- geneticists -- and tell you what we find. It's called reporting.
By Dan Olmsted
UPI Senior Editor
Oct. 29, 2005 at 2:34PM
A specter is haunting the medical and journalism establishments of the United States: Where are the unvaccinated people with autism?
That is just about the only way to explain what now appears to be a collective resistance to considering that question. And like all unanswered questions, this raises another one: Why?
What is the problem with quickly and firmly establishing that the autism rate is about the same everywhere and for everybody in the United States, vaccinated or unvaccinated? Wouldn't that stop all the scientifically illiterate chatter by parents who believe vaccinations made their children autistic? Wouldn't it put to rest concerns that -- despite the removal of a mercury-containing preservative in most U.S. vaccines -- hundreds of millions of children in the developing world are possibly at risk if that preservative is in fact linked to autism?
Calling this issue The Amish Elephant reflects reporting earlier this year in Age of Autism that the largely unvaccinated Amish may have a relatively low rate of autism. That apparent dissimilarity is, in effect, a proverbial elephant in the living room -- studiously ignored by people who don't want to deal with it and don't believe they will have to.
Here are a few cases in point.
Earlier this month the National Consumers League conference in Washington held a session on communicating issues around vaccine safety. I was on the panel and talked about the Amish and autism. In the Q&A session that followed, the first question was for me.
"Is this a proper role for a journalist, or is this just a straw dog set up there with a preliminary answer? It not only showed up where you wrote it. It was all over the place. You did very, very well for UPI (at which point I said, 'Thank you -- please tell my bosses that!') but the question is, did you do very, very well for America?
"Is it appropriate for a journalist -- you weren't reporting, you were investigating. And I just wonder if you think it's an appropriate role for you to play."
My answer: "There's different roles for the press. That's certainly a reasonable question. That is investigative reporting. This idea is something that's already been discarded -- that there's any reason why you would want to look in an unvaccinated population.
"One of my favorite comments about journalism is that it's the wild card of American democracy. The First Amendment says we can do (in the sense of reporting about) whatever we want. So one of our privileges is to get an idea in our head and go look at it."
My questioner was not finished. "I wasn't questioning whether you have a First Amendment right to do it. I think this is more of a question of the ethics, of what value we are bringing to the debate."
My response: "That's probably not a good one for me to answer. Obviously I thought it was ethical."
At that point a fellow panelist, Dr. Louis Cooper, former president of the American Academy of Pediatrics and a staunch vaccine defender, spoke up. "I would jump in and say I thought it was ethical and I think it was useful," said Cooper, a courtly and unfailingly courteous Manhattan pediatrician.
"As you've learned, it was annoying to many people. I wasn't annoyed by it because I thought you kept the process and the debate and the discussion going forward. And we have to do that for one another."
That did not end the discussion. A few minutes later a public-health professor from -- where else? Harvard -- did her own version of Jeopardy!, offering the correct "answer" in the form of a question.
"This question is for Dan. Did you mention the outbreak of polio that happened in the Amish community in the Netherlands that caused widespread problems there, and also the fact that there'd been some context with respect to history in our country in trying to reach out to the Amish to actually encourage them to try to benefit from some of the vaccine technology to the extent that we could?
"So there's been a long history in this country of the CDC trying to reach out to them to the extent that they could. Also with respect to polio, I think what's really amazing is it's such a great story, this is such an exciting time, in the sense that we are very close to global eradication. What that means is we've gone from 1988 when we had 350,000 estimated paralytic polio cases in the world every year to roughly a thousand. It's very exciting that in fact we don't have the terror or the hysteria and all of the fear that surrounded disease.
"I just want to remind everyone that one thing that's very important in the context of reporting these stories is making sure that people do remember and also realize with infectious disease is these things can come back, and until they are eradicated they can come back and devastate us just as much as they did before, except now there are a lot more people.
"There's some related news that people might find interesting. A headline in the Washington Post today, 'Polio outbreak occurs among Amish families.' So I thought people might be interested in that."
At that point the moderator, Dr. Roger Bernier of the Centers for Disease Control, said time was getting short -- why was I not surprised? -- and asked for the next "question."
One thing I've noticed is the more that people want to lecture instead of learn, the more they speak in breathless run-on sentences that are hard to stop, slow down or even diagram. They leave one with the unspoken idea that dialogue -- opening the door to new information -- is somehow dangerous.
These exchanges reminded me of the response I got from Dr. Julie Gerberding, the CDC director, when I asked her this summer, verbatim: "Has the government ever looked at the autism rate in an unvaccinated U.S. population, and if not, why not?"
Her answer, verbatim:
--
In this country, we have very high levels of vaccination as you probably know, and I think this year we have record immunization levels among all of our children, so to (select an unvaccinated group) that on a population basis would be representative to look at incidence in that population compared to the other population would be something that could be done.
But as we're learning, just trying to look at autism in a community the size of Atlanta, it's very, very difficult to get an effective numerator and denominator to get a reliable diagnosis.
I think those kind of studies could be done and should be done. You'd have to adjust for the strong genetic component that also distinguishes, for example, people in Amish communities who may elect not to be immunized (and) also have genetic connectivity that would make them different from populations that are in other sectors of the United States. So drawing some conclusions from them would be very difficult.
I think with reference to the timing of all of this, good science does take time, and it's part of one of the messages I feel like I've learned from the feedback that we've gotten from parents groups this summer (in) struggling with developing a more robust and a faster research agenda, is let's speed this up. Let's look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can.
So we are committed to doing that, and as I mentioned, in terms of just measuring the frequency of autism in the population some pretty big steps have been taken. We're careful not to jump ahead of our data, but we think we will be able to provide more accurate information in the next year or so than we've been able to do up to this point. And I know that is our responsibility.
We've also benefited from some increased investments in these areas that have allowed us to do this, and so we thank Congress and we thank the administration for supporting those investments, not just at CDC but also at NIH and FDA.
--
The latest response to my pesky persistence comes not from academia or government but from my own profession. Last week the prestigious Columbia Journalism Review published an article whose main thrust -- with which I concur -- was that a vigorous debate over a possible link between vaccines and autism was being thwarted by the self-induced timidity of the press.
Some reporters told the author, Daniel Schulman, that they have basically given up on the story because the criticism -- some of it from their own editors -- was so fierce, and the story was so complicated.
Schulman described Age of Autism's efforts to come at the issue "sideways," looking for possible clues to the cause of the disorder in the natural history of autism. And he mentioned our reporting on the Amish:
"Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool. ... Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions."
Ouch. Being slammed by one's peers is never enjoyable, although reporters need to have thick skins and realize they dish this kind of thing out every day. (And those anonymous sources really are annoying, especially when I am happy to be quoted by name about everything.)
What's interesting about the reporters' "private" remarks is the degree of presumed expertise they suggest -- that looking at the Amish is misguided "since it may simply reflect genetic differences among an isolated gene pool." Really? Where did these guys get their doctorate in genetics, Harvard?
This assertion -- that the Amish gene pool could explain everything, based on no data that I'm aware of -- is the kind of self-interested speculation masquerading as expertise that has beset the autism-vaccines discussion for far too long. The term I learned for it long ago is "convenient reasoning," and it does not always have to be conscious.
The Amish have all kinds of standard genetic mental and developmental disorders -- from bipolar to retardation -- and a lot more genetic issues to boot from this supposedly protective "isolated gene pool." The doctors who actually know something about the Amish have never suggested to me that genes have anything to do with a low rate of autism. They seem perplexed.
In upcoming columns, we'll put that question to the right people -- geneticists -- and tell you what we find. It's called reporting.
October 30, 2005
Missing Man Found After Being Hit by a Van
Antwan Hester was found two days after he walked away from his family. They found him because he was in the street and a van hit him. Thank God, he is ok.
As a reminder, I initially posted his story to point out how autism is dangerous. I don't mean to offend anyone who looks at autism as an 'alternative cognition' and feels it should not be cured if it can be, but I feel a little silly demonstrating how autism puts people at risk. It seems self-evident.
I will continue to post these stories as they arise. At least until it gets too upsetting for me.
As a reminder, I initially posted his story to point out how autism is dangerous. I don't mean to offend anyone who looks at autism as an 'alternative cognition' and feels it should not be cured if it can be, but I feel a little silly demonstrating how autism puts people at risk. It seems self-evident.
I will continue to post these stories as they arise. At least until it gets too upsetting for me.
Missing man found in southern Raleigh
From Staff Reports
RALEIGH -- A missing man was located late Monday night after he was struck by a van on Tryon Road.
Antwan Hester of Henderson, who has autism, received minor injuries and is back at home in Henderson, said Phyllis Stephens, spokeswoman for the Wake County Sheriff's Office.
Hester had wandered off from his family Saturday night at the State Fair. Around 11 p.m. Monday, Hester was walking on Tryon Road when he was struck by a 1997 Dodge van driven by Joan Curtis Smith, 50, of Raleigh, said Jim Sughrue, spokesman for the Raleigh Police Department.
Authorities do not know where Hester spent the two days he was missing. Smith was not cited in the accident, Sughrue said.
October 29, 2005
DAN! Blogging
I am attending the Long Beach Dan Conference. It is about half way through the three days of Autism research and treatment discussions, and the thought that keeps coming back to me is, how in the world can mainstream medicine be ignoring the DAN movement and the biomedical treatment for autism when there is THIS MUCH information on what the metabolic dysfunction is and THIS MANY children who have their autistic symptoms abate as a result of treating the dysfunction??
I feel like have a decent understanding of autism doctors and researchers growing understanding of what is going on inside autistic children as compared to most laymen, but being here, I realize how much more information there is than I had imagined.
I am sitting in one of the Science Sessions for doctors right now listening to Richard Deth talk about methylation dysfunction and dopamine D4 receptors and lymphoblasts and protein activation and well… other minutia that I can barely track. (Synchronizing Neuronal Networks: How improved Methylation Helps Autism). I quit trying to understand the details about 10 minutes ago, so I thought the best use of my time would be offering you my thoughts on the broad strokes that I am hearing.
Heavy metals interrupt the process of methylation, preventing the body from producing glutathione, which leads to impaired to Neuronal Synchronization, which we describe as Autism. Some people have genetic risk factors (like MTHFR, Transcobalmin II, MS Reductaise, COMT, and UBE3A), which causes this methylation interruption to happen at much lower levels of metal exposure. And oh, by the way, Thimerosal is one of those substances that interrupt methylation, and for some people with these severe genetic predispositions it does so at VERY small amounts, even a few nano-molars.
What is neuronal synchronization? Nerves firing in synchrony. If you are looking at a pen, and one neuron is transmitting the color of the pen and another neuron is transmitting the shape of the pen, we see a black pen. If these two neurons are transmitting the information at different rates, and each of these pieces of information arrive at different times, will the brain be able to build a coherent picture of what is being observed? If not, how will the individual be able recognize that picture in their head as a pen?
“This seems to be the recurring theme at most of the sessions. You will hear a long presentation on vitamins and minerals, sulferation, GI dysbiosis, methylation, whatever… Then the presenter will say, and by the way, make sure your child stays away from toxins, especially mercury, as it will screw up the healing pathway and here’s how…”
I gotta ask the question, are any of those who have been criticizing the mercury trigger hypothesis even looked into the science behind it? I may not be able to understand the intricacies of methylation (my best biology 101 analogy is that is a really complex version of a process like the Kreb cycle with molecules attaching and flying off to create substances the body uses to function properly), but it is more than obvious how doses of thimerosal set off a chain reaction that results in information processing problems, especially in people who already have other genetic factors that threaten the methylation process.
So. Offit, Orac, Kevin, Skeptico, JP, and those of you so vehemently reject the thimerosal/autism connection, have you really looked into the research? Have you into methylation dysfunction, its causes and its consequences?
Honestly, until you can explain how mercury does not damage methylation dysfunction or explain how methylation dysfunction does not impair the central nervous system and produce autistic like behaviors, then I am not sure how you can speak with any authority on the lack of a correlation between thimerosal and autism.
Attend a DAN conference and then we can talk.
…and if any one wants to stop by and say hello, I am the one sitting in back with the laptop.
I feel like have a decent understanding of autism doctors and researchers growing understanding of what is going on inside autistic children as compared to most laymen, but being here, I realize how much more information there is than I had imagined.
I am sitting in one of the Science Sessions for doctors right now listening to Richard Deth talk about methylation dysfunction and dopamine D4 receptors and lymphoblasts and protein activation and well… other minutia that I can barely track. (Synchronizing Neuronal Networks: How improved Methylation Helps Autism). I quit trying to understand the details about 10 minutes ago, so I thought the best use of my time would be offering you my thoughts on the broad strokes that I am hearing.
Heavy metals interrupt the process of methylation, preventing the body from producing glutathione, which leads to impaired to Neuronal Synchronization, which we describe as Autism. Some people have genetic risk factors (like MTHFR, Transcobalmin II, MS Reductaise, COMT, and UBE3A), which causes this methylation interruption to happen at much lower levels of metal exposure. And oh, by the way, Thimerosal is one of those substances that interrupt methylation, and for some people with these severe genetic predispositions it does so at VERY small amounts, even a few nano-molars.
What is neuronal synchronization? Nerves firing in synchrony. If you are looking at a pen, and one neuron is transmitting the color of the pen and another neuron is transmitting the shape of the pen, we see a black pen. If these two neurons are transmitting the information at different rates, and each of these pieces of information arrive at different times, will the brain be able to build a coherent picture of what is being observed? If not, how will the individual be able recognize that picture in their head as a pen?
“This seems to be the recurring theme at most of the sessions. You will hear a long presentation on vitamins and minerals, sulferation, GI dysbiosis, methylation, whatever… Then the presenter will say, and by the way, make sure your child stays away from toxins, especially mercury, as it will screw up the healing pathway and here’s how…”
I gotta ask the question, are any of those who have been criticizing the mercury trigger hypothesis even looked into the science behind it? I may not be able to understand the intricacies of methylation (my best biology 101 analogy is that is a really complex version of a process like the Kreb cycle with molecules attaching and flying off to create substances the body uses to function properly), but it is more than obvious how doses of thimerosal set off a chain reaction that results in information processing problems, especially in people who already have other genetic factors that threaten the methylation process.
So. Offit, Orac, Kevin, Skeptico, JP, and those of you so vehemently reject the thimerosal/autism connection, have you really looked into the research? Have you into methylation dysfunction, its causes and its consequences?
Honestly, until you can explain how mercury does not damage methylation dysfunction or explain how methylation dysfunction does not impair the central nervous system and produce autistic like behaviors, then I am not sure how you can speak with any authority on the lack of a correlation between thimerosal and autism.
Attend a DAN conference and then we can talk.
…and if any one wants to stop by and say hello, I am the one sitting in back with the laptop.
October 27, 2005
Bloggeration Rescue
JB Handley and his wife Lisa, founders of Generation Rescue, have begun blogging. Their inaugural post is a description of the changes they would like to see in the way we look at the autism/mercury connection:
Welcome to the discussion JB and Lisa.
Old Paradigm: "Mercury may or may not be one of the causes of autism. Once you have autism, it is life long. Autism is genetic. Treatment is behavioral therapy with a psychologist or social worker. Prognosis for recovery is poor."This peace speaks to the heart of the mercury/autism discussion. Go read the whole thing.
New Paradigm: "Mercury causes mercury poisoning, which has been mislabeled as autism. Mercury poisoning can be resolved by removing the mercury. Mercury poisoning is an issue of toxicology. Treatment is the removal of mercury through a process called chelation. Prognosis for recovery is very good."
Welcome to the discussion JB and Lisa.
Columbia Journalism Review on the Thimerosal Contraversy
The Columbia Journalis Review is the Bi-monthly publication of the Columbia University Graduate School of Journalism. It is considered the American academic publication advancing the cause of professional journalism. This reprint from the November/December edition is not available on the CJR website. It is long, but it is good and is a MUST READ for any one following the unfolding Thimerosal story.
Update: Craig Westover has a good piece on this article. Read it in it's entirity first here, then check out his take.
Drug Test
By Daniel Schulman for the Columbia Journalism Review.
On May 18, 2004, the Institute of Medicine, a branch of the prestigious National Academies, delivered its eighth and final report on vaccine safety, seeking to end a scientific controversy that had built to a slow boil over the previous five years: whether a mercury-containing vaccine preservative called thimerosal was to blame for an alarming spike in autism cases among a generation of children. After three years of reviewing this and other immunization safety questions on behalf of the Centers for Disease Control and Prevention, the institute's fourteen-member panel rejected the thimerosal link, and, in a powerful policy statement, recommended that research funding in this area be shifted toward other, more promising lines of inquiry. Under headlines such as this one from The Washington Post, EXPERTS FIND NO VACCINE-AUTISM LINK; PANEL SAYS MORE RESEARCH ON POSSIBLE CONNECTION MAY NOT BE WORTHWHILE, the press dutifully reported the IOM's conclusions, perhaps as eager to lay the question to rest as the IOM panel itself.
For a time it appeared the controversy over thimerosal would end there. It didn't. Over the past seven months, it has gained traction again, leaving journalists in an awkward position. The thimerosal question - scientifically, politically, and emotionally complex - is proving to be a test for journalism, and the successes and failures are evident in the coverage.
David Kirby, a Brooklyn-based writer, jumpstarted the debate in April with the publication of his book, Evidence of Harm, which lays out a compelling case for a connection between thimerosal and autism. Then, in June, Robert Kennedy Jr. followed with a more pointed - some say over-the-top - article, co-published by Rolling Stone and Salon.com, that alleges what amounts to a government cover-up of the harmful properties of thimerosal in the interest of buffering vaccine manufacturers from a cascade of lawsuits and maintaining public confidence in the national immunization
program.
Still, the bulk of the scientific establishment denies the autism link, citing the conclusions of the IOM panel, and views believers as crackpots, conspiracy theorists, or zealots - a perspective many medical experts barely conceal in conversations with reporters. In an interview with Myron Levin of the Los Angeles Times after the publication of the IOM report, Dr. Stephen Cochi, the head of the CDC's national immunization program, dismissed supporters of the thimerosal theory as "junk scientists and charlatans." If so, then such universities as Harvard and Columbia, among others, employ charlatans - scientists who believe that a link between mercury exposure and autism is plausible. Even so, the perception that only distraught, activist parents and disreputable scientists back the thimerosal theory has seeped into the collective consciousness of the news media, which, in general, have been reluctant to cover the controversy.
Both sides in the debate make convincing arguments to support their cases, and in the cacophony of competing claims each is guilty of using data selectively. What is known is this: Since the late 1980s the number of children diagnosed with autism has increased sixty-fold, from one in every 10,000 in 1987 to one in every 166 in 2003. Much of this spike overlaps with a period when, due to recommendations by the CDC and the Food and Drug Administration, the number of suggested immunizations on the childhood vaccination schedule more than doubled, raising the doses of mercury that some children received to levels that far surpassed federal standards for mercury exposure. (The standards were based on methylmercury, the type emitted by coal-burning power plants. Ethylmercury, which makes up nearly half of thimerosal by weight, is a closely related compound.
To date, ethylmercury has received far less study, and scientists disagree on whether it's as harmful as methylmercury, though both are considered neurotoxins.) Until the late 1990s, health officials were unaware of the total amount of mercury children were receiving in their vaccinations. It's not unreasonable to ask how this went unnoticed, and unreported, for so long. The answer is simple: no one had ever done the arithmetic. When scientists did, the U.S. Public Health Service recommended that vaccine manufacturers phase out thimerosal from children's vaccines in 1999 as a precaution. It was careful to note, however, that "there are no data or evidence of any harm." As it stands, the preservative, which allowed drug manufacturers to supply vaccines in multidose vials (the thimerosal-free, single-dose versions are costlier), has been eliminated from most immunizations, excluding some flu and tetanus shots. During 1999 and 2000, the thimerosal link was quietly under study by the CDC, and, as shown in internal memos and meeting minutes, health officials were deeply concerned about what they might find.
Thimerosal activists point to this history: In June 2000, the CDC convened a closed meeting at the Simpsonwood Convention Center in Norcross, Georgia, to discuss, among other things, preliminary findings on thimerosal. In addition to the health officials, researchers, and vaccine experts in attendance were representatives from GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur, the vaccine manufacturers who had the most to lose if an autism link were proven. During one session of the two-day meeting, the CDC epidemiologist Thomas Verstraeten presented the results of an analysis of the CDC's Vaccine Safety Datalink, a database that contains the vaccination histories of more than seven million Americans. His study, at least at that stage, appeared to support a connection between thimerosal and neurodevelopmental disorders, showing what Verstraeten described as "statistically significant relationships between exposures and outcomes." The presentation caused one physician in attendance to remark, "the medical legal findings in this study, causal or not, are horrendous." Attendees were instructed that what they'd heard that day was to be considered "embargoed."
Known as the Simpsonwood transcripts, the minutes of this meeting are widely available on the Internet thanks to a Freedom of Information Act request by the autism advocacy group SafeMinds. Some advocates of the thimerosal theory point to Simpsonwood as proof that the government buried evidence of an autism link. In the minds of some supporters of the theory, the perception of conspiracy was heightened when Verstraeten's study, published three years later, no longer indicated an association between thimerosal and neurological maladies, including autism. Adding to their suspicion is the fact that in the study, published in the journal Pediatrics, Verstraeten was listed as a CDC researcher, when in fact he had been hired away by GlaxoSmithKline two years earlier. (Nor did they find it any less suspicious when a midnight rider turned up in a 2002 bill creating the Department of Homeland Security that sought to protect vaccine manufactures from thimerosal-related lawsuits. The measure was eventually removed.)
But Simpsonwood is not a smoking gun. Nor are other documents that purport to be, including the transcript of a private session of the Institute of Medicine's Immunization Safety Review Committee from 2001, in which the committee's chairwoman, Dr. Marie McCormick, referring to the vaccine-thimerosal issue, says that the CDC "wants us to declare, well, these things are pretty safe on a population basis." It is a statement that indicates to some that the IOM had already decided where it was going to come down on thimerosal. If transcripts of both meetings are not damning, the comments of some attendees are striking, particularly when they are quick to note the legal ramifications should a connection be established. As McCormick makes plain during the 2001 meeting, attendees were aware of the conclusion that the CDC wanted them to reach, but that isn't proof that the institute manipulated data to reach that end, as some allege.
When the IOM panel released its final report in 2004, it had analyzed more than 200 studies and based its conclusions largely on five recent epidemiological papers that appeared to debunk the autism connection, including Verstraeten's and one from Denmark that shows autism cases rising after thimerosal was removed from that country's vaccine supply. Excluded was much of the biological research that supports a link, which the IOM deemed speculative.
Those are the facts, though they are interpreted in radically different ways by each side. Even the question of whether the nation is currently experiencing an autism epidemic is subject to debate. Detractors posit that the increase in cases is a red herring, that the numbers reflect changes in how autism is diagnosed and reported. As for the IOM report - the nail in the coffin for the autism link as far as many scientists are concerned - believers hold that the studies that the panel relied on were flawed. For example, as David Kirby reports in Evidence of Harm, the
researchers on the Danish study examined autism cases both before and after 1992, when thimerosal was removed, but used two different data sets in doing so, tallying inpatient cases through 1994 and adding outpatient cases to their count thereafter, a factor that could explain the increase they observed. According to Kirby, even the study's authors conceded, in their own words, that they "may have spuriously increased the apparent number of autism cases." Verstraeten, for his part, seemed to grow tired of how his findings were being interpreted by both sides. In an April 2004 letter to Pediatrics, he wrote that his study "does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come." He went on to call allegations of a potential conflict of interest an "insult," saying that he remained on the study only in an advisory capacity after he went to work for Glaxo. "Did the CDC water down the original results? It did not."
Steeped in controversy and intrigue, the thimerosal debate has all the makings of a compelling news story, yet it has been approached with caution by the news media, which, more often than not, don't portray it as a legitimate scientific debate. "I'm putting my faith . . . in the Institute of Medicine," ABC's medical editor, Dr. Timothy Johnson, told viewers during a segment on thimerosal in July. At the conclusion of an NBC report on the debate last winter, the science correspondent Robert Bazell was careful to note that "if we stop vaccinating our children, we run the risk of having these horrible diseases come back . . . . And the evidence right now is that vaccines do not cause autism."
There is a very real fear that taking the thimerosal theory seriously will prompt antivaccine blowback. Myron Levin, the Los Angeles Times reporter, said that some journalists have been cowed by the notion that "by the mere act of covering this, they will instill panic in the vaccination-getting public, or feed mindless phobias that cause people to refuse to let their kids get shots." That concern is reflected in the coverage and has implications for how deeply the story is reported. "I think many news organizations have held back and given the story short shrift," Levin said.
On June 25, The New York Times addressed the thimerosal controversy in a front-page article, the product of five months of reporting by Gardiner Harris and Anahad O'Connor. Appearing less than two weeks after Robert Kennedy's piece, which would later have a list of corrections and clarifications appended to it, the Times article had been eagerly awaited by proponents of the thimerosal link, some of whom had been communicating regularly with the Times reporters over the previous months. Believing that the heft of the paper's reputation would help to propel their cause into the mainstream, they expected a proper airing of both sides of the question - that, after all, was the impression O'Connor gave at least one of his sources, the mother of an autistic child and a member of an autism advocacy organization, when he approached her in late January. "I'm thinking of a 2,000-word story, essentially saying that an array of studies over the years (the Institute of Medicine report, I would think, being the most prominent) were intended to settle the issue of autism and vaccines once and for all," he wrote in an e-mail. "Yet it seems that the question is still very much open . . . and evidence for the case against vaccines has been mounting, despite many researchers' insistence that the issue is dead. I think, for now at least, I'd like to just present the evidence on both sides and let
the readers decide."
The result was much more one-sided. Headlined ON AUTISM'S CAUSE, IT'S PARENTS VS. RESEARCH, the story cast the thimerosal connection as a fringe theory, without scientific merit, held aloft by angry, desperate parents. The notion that supporters of the theory were disregarding irrefutable scientific findings was an underlying theme, drilled home several times. "It's really terrifying, the scientific illiteracy that supports these suspicions," Dr. Marie McCormick told the Times. Readers were left with little option but to believe that the case against thimerosal was scientifically unsound.
The piece did note the work of Mark and David Geier, a father-son research team who believe that mercury exposure is linked to autism. The Geiers's research has been a lightning rod for criticism, and their methodology has been called into question by some in the scientific community. But before the reporters even discussed the Geiers's science, they had already painted the researchers as eccentric outsiders: "He and his son live and work in a two-story house in suburban Maryland. Past the kitchen and down the stairs is a room with cast-off, unplugged laboratory equipment, wall-to-wall carpeting and faux wood paneling that Dr. Geier calls 'a world-class lab - every bit as good as anything at N.I.H.'" Omitted from the story was the work of Dr. Mady Hornig, a Columbia University epidemiologist; Richard Deth, a Northeastern University pharmacologist; Jill James, a professor of pediatrics at the University of Arkansas; and others whose work suggests that thimerosal may cause neurodevelopmental disorders in a subset of susceptible children (those who are not able to eliminate mercury from the body in the ways that most people do). The story alluded to Boyd Haley, chairman of the department of chemistry at the University of Kentucky and an ally of thimerosal activists, in the same sentence as a Louisiana physician who believes "that God spoke to her through an 87-year-old priest and told her that vaccines caused autism" - leaving Haley, it would seem, guilty by association of lunacy. Several reporters I spoke with who have covered the thimerosal controversy described the Times story as a smear. One called it a "hit piece."
The Times's O'Connor told me he had looked at the research linking thimerosal with autism, including the work of Hornig, Deth, and James, but ultimately found the epidemiological studies cited by the IOM more persuasive. "The larger scientific community has rejected a link between thimerosal and autism," he said. "You do have some scientists who are convinced that there's a link, but then you have the American Academy of Pediatrics, the World Health Organization - it's not a stretch to say that the scientific community has rejected this link."
The article prompted a massive reader response. One organization, known as A-Champ (Advocates for Children's Health Affected by Mercury Poisoning), organized an e-mail campaign directed at top editors at the Times, as well as the public editor, Byron Calame. O'Connor personally received dozens of e-mails and letters. "There were a couple that were threatening. There were some that were pretty harsh and others saying that I was part of the conspiracy. A lot of people responded saying there must be some link between the Times and the pharmaceutical industry."
Responding to the complaints of one group, Calame wrote: "I have carefully reviewed your e-mail and spent several hours with the editors and reporters who prepared the article . . . . This has left me convinced that the article isn't intellectually dishonest. Nor are the omissions staggering. Nor is there a pervasive editorial bias. I find the article fair and accurate."
As it turned out, the story had angered members of the epidemiology department at Columbia's Mailman School of Public Health, including the department's chair, Dr. Ezra Susser. Since some of their work, including that of Dr. W. Ian Lipkin, a highly regarded neurologist, and Mady Hornig, explored the connection between environmental mercury exposure and autism, including exposure through thimerosal-carrying vaccines, they felt that they had been lumped into the category of scientific illiterates. Responding to the article in a June 28 letter to the Times (never published), signed by Susser, Lipkin, Hornig, and the epidemiologist Michaeline Bresnahan, the researchers wrote that "scientists pursuing research on mercury and autism are caricaturized as immune to the 'correct' interpretation of existing studies. Researchers rejecting a link are depicted as the sole voices of reason . . . . Whether mercury in any form (or any of several factors recently introduced to our environment) has anything to do with autism can and should be resolved with rigorous studies and respectful discourse, not moral indictments and denunciations."
Journalists agree that the thimerosal story is one of the most explosive they've ever encountered. In addition to the vitriolic response Anahad O'Connor drew from readers, he also said he received a number of e-mails praising him and Harris from fellow reporters who had been interested in covering the thimerosal controversy, but had "gotten scared away from really tackling the subject . . . they were afraid of getting hate mail."
Some reporters who have portrayed this as an ongoing scientific controversy have been discouraged by colleagues and their superiors from pursuing the story. A reporter for a major media outlet, who did not want to be identified for fear of retribution, told me that covering the thimerosal controversy had been nearly "career-ending" and described butting heads with superiors who believed that the reporter's coverage - in treating the issue as a two-sided debate - legitimized a crackpot theory and risked influencing parents to stop vaccinating their children or to seek out experimental treatments for their autistic sons and daughters. The reporter has decided against pursuing stories on thimerosal, at least for the time being. "For some reason giving any sort of credence to the side that says there's a legitimate question here - I don't know how it becomes this untouchable story, I mean that's what we do, so I don't understand why this story is more touchy than any story I've ever done."
Pursuing this story is unattractive for other reasons, too. The issue is exceedingly complex and easily oversimplified. "It took me two and a half years and four hundred pages to tell this story, and I'm sure I made some mistakes," David Kirby told me, adding that the complexity convinced him to write a book.
The fact that the bulk of the public health establishment dismisses the thimerosal theory is also daunting, particularly for science reporters who rely on the same pool of medical experts and health officials regularly. "They depend on these people in this symbiotic relationship that they have," said Steve Wilson, an investigative reporter for the local ABC affiliate in Detroit, WXYZ, whose three-part series on thimerosal won an Emmy. "They've come to trust them and respect them and to believe when they tell them, 'Look, you're barking up the wrong tree here; these parents are just looking for somebody to blame.'"
Some of the most enterprising journalistic contributions to the thimerosal debate have come from the once prestigious, now flagging news wire United Press International, which is owned, along with the Washington Times, by the Reverend Sun Myung Moon's Unification Church. On my desk, UPI senior editor Dan Olmsted's "Age of Autism" series, which he began late last winter, occupies a file that at this writing is more than an inch thick and growing. He averages two columns a week on the topic. Aside from the Washington Times, though, not a single U.S. paper that Olmsted knows of has run any part of the series. It has, however, been widely disseminated on the Internet.
Olmsted, a former assistant national editor at USA Today, found his way into thimerosal through another medical side-effect story. It involved an antimalarial drug called Lariam, which was prescribed to Peace Corps volunteers, travelers to third-world countries, and more recently to U.S. troops stationed in Iraq and Afghanistan. As Olmsted and his UPI colleague Mark Benjamin (now a national correspondent at Salon.com) detailed in an investigation that spanned more than two years, starting in 2002, Lariam, which had been approved by the FDA and recommended by the CDC, also appeared strongly linked to psychosis, including homicidal and suicidal behavior. Partly because of their reporting, the effects of Lariam are now under study by the Pentagon. "If it hadn't been for Lariam, I don't think I would have ever thought twice about autism," Olmsted told me. "With Lariam, CDC officials said many times that there's absolutely no problem with side effects from this drug, it's extraordinarily safe. That's just not true."
Instead of wading directly into the thimerosal controversy, Olmsted approached it, as he puts it, "sideways." By this he means that after reading what had been written on autism and noticing a relative dearth of material about its origins, he set out to write a natural history of the disorder.
Eventually, Olmsted began thinking of ways to test the thimerosal theory. He wondered whether researchers had ever examined the prevalence of autism in an unvaccinated population, such as the Amish. That, it would seem, would be the most likely way to determine whether the vaccine link held water. If the number of autism cases among the unvaccinated mirrored the national average, then it would seem that thimerosal played no role. Olmsted found that though researchers had discussed such a study, none had ever been done. "That's an expensive study," he said, "but for a journalist all you have to do is get on the phone and start asking." After spending weeks searching for cases among the Amish of Lancaster County, Pennsylvania, he managed to find three children with autism, two of whom had been vaccinated, a rarity in that community. "The cases among the Amish that I've identified over the past several weeks appear to have at least one link - a link made of mercury," Olmsted wrote in a column on May 20, referring to the vaccinated children. "That's not something I expected to encounter." Looking at other large Amish populations in the Midwest, such as those in Middlefield, Ohio, and Goshen, Indiana, Olmsted found similarly low autism rates. He admits that his findings are not scientific. "I could be getting a completely wrong impression from what I'm finding, but it's interesting," Olmsted told me. Interesting enough to get the attention of members of Congress, including Representative Dave Weldon of Florida and Senator Joseph Lieberman of Connecticut; officials at the Department of Health and Human Services; and researchers, including Mady Hornig, the Columbia epidemiologist, who now hopes to devise a study looking at the Amish.
Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool (Hornig, however, said that a study on the Amish may still be valuable should the prevalence of autism in that community indeed be low, allowing researchers to study the genetics of people who are not susceptible to the disorder). Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions.
"I've just tried to find a way to get into this that adds something to the debate and is original," Olmsted said.
Among major newspapers, the Los Angeles Times's coverage of thimerosal stands out. It has taken the story seriously and devoted significant coverage to it, partly because through the summer and fall of 2004 a bill to ban thimerosal from all vaccines given to infants and pregnant women was making its way through the California legislature. Strongly opposed by the vaccine manufacturer Aventis Pasteur and the American Academy of Pediatrics, the measure was signed into law by Governor Arnold Schwarzenegger in late September of that year.
The reporter Myron Levin entered the fray in April 2004 with a piece that revealed that while the CDC would add flu shots to its list of suggested vaccines for children, it would not recommend that parents seek the available thimerosal-free version. He followed in August with a long feature on the attempts of parents who believed their children's autism was caused by mercury-containing shots to win compensation through a little known branch of federal claims court for the exorbitant costs of caring for their kids. (This "vaccine court," which pays out claims from a federal trust funded by revenue from a vaccine surcharge, was established during the mid-1980s as a means to protect drug companies from civil suits.) It was while covering this story, in which Levin captured both sides of the debate, as well as the devastating realities of raising a child with autism, that the CDC's Stephen Cochi referred to supporters of the thimerosal link as "junk scientists and charlatans."
Cochi's lack of diplomacy stunned Levin. "When government officials talk to reporters, they are usually beyond cautious and it can be really hard getting them to opine on anything," he told me. "To attack opponents in those terms shows the raw emotion that has infused this whole issue."
From his introduction to the thimerosal issue toward the end of 2003, Levin found it striking that a neurotoxin had ever been put into vaccines given to infants, even newborns. He wondered how health officials had failed for so long to consider the repercussions of injecting children with mercury-carrying vaccines.
As Levin reported last winter, the question of whether children were receiving too much mercury from their inoculations had been considered by Merck in the early 1990s. The front-page story - which reverberated through autism circles but drew little attention from the rest of the press - reported the contents of a leaked memo written by Dr. Maurice Hilleman, then the president of Merck's vaccine division. While public health officials had yet to recognize the total mercury load infants would receive from all of their suggested immunizations, Hilleman had done the math. "When viewed in this way, the mercury load appears rather large," he wrote in the 1991 memo, suggesting that thimerosal should probably be removed from vaccines administered to young children when possible. Levin kept the heat on Merck, reporting in March that the company had likely misled the public when it assured consumers in 1999 that its "infant vaccine line . . . is free of all preservatives." Merck had in fact continued supplying vaccines containing thimerosal until the fall of 2001.
Interestingly, this scoop had first been offered to The New York Times in February by a source who provided evidence to back up the claim. Gardiner Harris, then working on the story that turned out to be dismissive of the thimerosal debate that would run in June, blew off the tip, signing off his e-mailed response to the source, "I'll let Myron bite this apple."
Levin's reporting has drawn the ire of some in the pharmaceutical industry. Wyeth officials met with Levin and his editor in late July. "They have said there are problems with the tone, and that we seem to take too seriously an idea that they say is absurd and has been disproved by the IOM," Levin told me. (Douglas Petkus, a Wyeth spokesman who attended the meeting along with two lawyers who represent the firm, declined to discuss the particulars of the conversation.)
In late August, the Pittsburgh Post-Gazette reported the death of a five-year-old boy whose heart seized while he underwent an unproven autism treatment known as "chelation." Used for purging the body of heavy metals, particularly in cases of acute lead poisoning, it can prove damaging to internal organs by leeching certain necessary elements, such as calcium, from the system. While chelation has been embraced by some supporters of the thimerosal theory, who report that their children's conditions have improved as mercury was drawn from their bodies, the medical establishment has cautioned against it as a means of treating autism. To journalists, for whom the perils of covering thimerosal have been purely theoretical, this incident could only underscore the potential dangers of lending any credibility to the autism link.
The day the boy's death was reported, Craig Westover, a columnist at the St. Paul Pioneer Press, who writes frequently about thimerosal, received acid comments from readers on his blog. One reader, writing under the name Credenza, wrote, "They finally did it Mr. Westover, they killed a little boy trying to get that satanic mercury out of his little body. You have some blood on your hands. Like it or not you do. There has been no autism epidemic and thimerosal doesn't cause autism . . . . I hope the parents of this boy point the finger at you and scream murder."
"I really do try to walk a middle line on this," Westover told me that day, as he mulled his response to the reader. "You have to go out and investigate this and be able to come to some sort of conclusion. Not definitely that thimerosal does or does not cause autism, but you have to come to the question of whether this theory is plausible or not. Otherwise, I think you're doing a disservice to your reader." The evidence has led Westover to believe that a connection is possible. He realizes, moreover, that what he writes may influence others to believe the same.
To the reader who blamed him for the boy's death, Westover ultimately wrote, "That is the risk of a sin of commission, and one I considered long and hard before I wrote my first article on this topic . . . . I will stand on what I believe and accept the risk and the consequences if I am wrong."
Whether the thimerosal theory is proved right or wrong, there will be consequences - for the public health apparatus and vaccine manufacturers, for parents and their children, even for journalists. But with science left to be done and scientists eager to do it, it seems too soon for the press to shut the door on the debate.
Daniel Schulman is an assistant editor at CJR.
Update: Craig Westover has a good piece on this article. Read it in it's entirity first here, then check out his take.
Drug Test
By Daniel Schulman for the Columbia Journalism Review.
On May 18, 2004, the Institute of Medicine, a branch of the prestigious National Academies, delivered its eighth and final report on vaccine safety, seeking to end a scientific controversy that had built to a slow boil over the previous five years: whether a mercury-containing vaccine preservative called thimerosal was to blame for an alarming spike in autism cases among a generation of children. After three years of reviewing this and other immunization safety questions on behalf of the Centers for Disease Control and Prevention, the institute's fourteen-member panel rejected the thimerosal link, and, in a powerful policy statement, recommended that research funding in this area be shifted toward other, more promising lines of inquiry. Under headlines such as this one from The Washington Post, EXPERTS FIND NO VACCINE-AUTISM LINK; PANEL SAYS MORE RESEARCH ON POSSIBLE CONNECTION MAY NOT BE WORTHWHILE, the press dutifully reported the IOM's conclusions, perhaps as eager to lay the question to rest as the IOM panel itself.
For a time it appeared the controversy over thimerosal would end there. It didn't. Over the past seven months, it has gained traction again, leaving journalists in an awkward position. The thimerosal question - scientifically, politically, and emotionally complex - is proving to be a test for journalism, and the successes and failures are evident in the coverage.
David Kirby, a Brooklyn-based writer, jumpstarted the debate in April with the publication of his book, Evidence of Harm, which lays out a compelling case for a connection between thimerosal and autism. Then, in June, Robert Kennedy Jr. followed with a more pointed - some say over-the-top - article, co-published by Rolling Stone and Salon.com, that alleges what amounts to a government cover-up of the harmful properties of thimerosal in the interest of buffering vaccine manufacturers from a cascade of lawsuits and maintaining public confidence in the national immunization
program.
Still, the bulk of the scientific establishment denies the autism link, citing the conclusions of the IOM panel, and views believers as crackpots, conspiracy theorists, or zealots - a perspective many medical experts barely conceal in conversations with reporters. In an interview with Myron Levin of the Los Angeles Times after the publication of the IOM report, Dr. Stephen Cochi, the head of the CDC's national immunization program, dismissed supporters of the thimerosal theory as "junk scientists and charlatans." If so, then such universities as Harvard and Columbia, among others, employ charlatans - scientists who believe that a link between mercury exposure and autism is plausible. Even so, the perception that only distraught, activist parents and disreputable scientists back the thimerosal theory has seeped into the collective consciousness of the news media, which, in general, have been reluctant to cover the controversy.
Both sides in the debate make convincing arguments to support their cases, and in the cacophony of competing claims each is guilty of using data selectively. What is known is this: Since the late 1980s the number of children diagnosed with autism has increased sixty-fold, from one in every 10,000 in 1987 to one in every 166 in 2003. Much of this spike overlaps with a period when, due to recommendations by the CDC and the Food and Drug Administration, the number of suggested immunizations on the childhood vaccination schedule more than doubled, raising the doses of mercury that some children received to levels that far surpassed federal standards for mercury exposure. (The standards were based on methylmercury, the type emitted by coal-burning power plants. Ethylmercury, which makes up nearly half of thimerosal by weight, is a closely related compound.
To date, ethylmercury has received far less study, and scientists disagree on whether it's as harmful as methylmercury, though both are considered neurotoxins.) Until the late 1990s, health officials were unaware of the total amount of mercury children were receiving in their vaccinations. It's not unreasonable to ask how this went unnoticed, and unreported, for so long. The answer is simple: no one had ever done the arithmetic. When scientists did, the U.S. Public Health Service recommended that vaccine manufacturers phase out thimerosal from children's vaccines in 1999 as a precaution. It was careful to note, however, that "there are no data or evidence of any harm." As it stands, the preservative, which allowed drug manufacturers to supply vaccines in multidose vials (the thimerosal-free, single-dose versions are costlier), has been eliminated from most immunizations, excluding some flu and tetanus shots. During 1999 and 2000, the thimerosal link was quietly under study by the CDC, and, as shown in internal memos and meeting minutes, health officials were deeply concerned about what they might find.
Thimerosal activists point to this history: In June 2000, the CDC convened a closed meeting at the Simpsonwood Convention Center in Norcross, Georgia, to discuss, among other things, preliminary findings on thimerosal. In addition to the health officials, researchers, and vaccine experts in attendance were representatives from GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur, the vaccine manufacturers who had the most to lose if an autism link were proven. During one session of the two-day meeting, the CDC epidemiologist Thomas Verstraeten presented the results of an analysis of the CDC's Vaccine Safety Datalink, a database that contains the vaccination histories of more than seven million Americans. His study, at least at that stage, appeared to support a connection between thimerosal and neurodevelopmental disorders, showing what Verstraeten described as "statistically significant relationships between exposures and outcomes." The presentation caused one physician in attendance to remark, "the medical legal findings in this study, causal or not, are horrendous." Attendees were instructed that what they'd heard that day was to be considered "embargoed."
Known as the Simpsonwood transcripts, the minutes of this meeting are widely available on the Internet thanks to a Freedom of Information Act request by the autism advocacy group SafeMinds. Some advocates of the thimerosal theory point to Simpsonwood as proof that the government buried evidence of an autism link. In the minds of some supporters of the theory, the perception of conspiracy was heightened when Verstraeten's study, published three years later, no longer indicated an association between thimerosal and neurological maladies, including autism. Adding to their suspicion is the fact that in the study, published in the journal Pediatrics, Verstraeten was listed as a CDC researcher, when in fact he had been hired away by GlaxoSmithKline two years earlier. (Nor did they find it any less suspicious when a midnight rider turned up in a 2002 bill creating the Department of Homeland Security that sought to protect vaccine manufactures from thimerosal-related lawsuits. The measure was eventually removed.)
But Simpsonwood is not a smoking gun. Nor are other documents that purport to be, including the transcript of a private session of the Institute of Medicine's Immunization Safety Review Committee from 2001, in which the committee's chairwoman, Dr. Marie McCormick, referring to the vaccine-thimerosal issue, says that the CDC "wants us to declare, well, these things are pretty safe on a population basis." It is a statement that indicates to some that the IOM had already decided where it was going to come down on thimerosal. If transcripts of both meetings are not damning, the comments of some attendees are striking, particularly when they are quick to note the legal ramifications should a connection be established. As McCormick makes plain during the 2001 meeting, attendees were aware of the conclusion that the CDC wanted them to reach, but that isn't proof that the institute manipulated data to reach that end, as some allege.
When the IOM panel released its final report in 2004, it had analyzed more than 200 studies and based its conclusions largely on five recent epidemiological papers that appeared to debunk the autism connection, including Verstraeten's and one from Denmark that shows autism cases rising after thimerosal was removed from that country's vaccine supply. Excluded was much of the biological research that supports a link, which the IOM deemed speculative.
Those are the facts, though they are interpreted in radically different ways by each side. Even the question of whether the nation is currently experiencing an autism epidemic is subject to debate. Detractors posit that the increase in cases is a red herring, that the numbers reflect changes in how autism is diagnosed and reported. As for the IOM report - the nail in the coffin for the autism link as far as many scientists are concerned - believers hold that the studies that the panel relied on were flawed. For example, as David Kirby reports in Evidence of Harm, the
researchers on the Danish study examined autism cases both before and after 1992, when thimerosal was removed, but used two different data sets in doing so, tallying inpatient cases through 1994 and adding outpatient cases to their count thereafter, a factor that could explain the increase they observed. According to Kirby, even the study's authors conceded, in their own words, that they "may have spuriously increased the apparent number of autism cases." Verstraeten, for his part, seemed to grow tired of how his findings were being interpreted by both sides. In an April 2004 letter to Pediatrics, he wrote that his study "does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come." He went on to call allegations of a potential conflict of interest an "insult," saying that he remained on the study only in an advisory capacity after he went to work for Glaxo. "Did the CDC water down the original results? It did not."
Steeped in controversy and intrigue, the thimerosal debate has all the makings of a compelling news story, yet it has been approached with caution by the news media, which, more often than not, don't portray it as a legitimate scientific debate. "I'm putting my faith . . . in the Institute of Medicine," ABC's medical editor, Dr. Timothy Johnson, told viewers during a segment on thimerosal in July. At the conclusion of an NBC report on the debate last winter, the science correspondent Robert Bazell was careful to note that "if we stop vaccinating our children, we run the risk of having these horrible diseases come back . . . . And the evidence right now is that vaccines do not cause autism."
There is a very real fear that taking the thimerosal theory seriously will prompt antivaccine blowback. Myron Levin, the Los Angeles Times reporter, said that some journalists have been cowed by the notion that "by the mere act of covering this, they will instill panic in the vaccination-getting public, or feed mindless phobias that cause people to refuse to let their kids get shots." That concern is reflected in the coverage and has implications for how deeply the story is reported. "I think many news organizations have held back and given the story short shrift," Levin said.
On June 25, The New York Times addressed the thimerosal controversy in a front-page article, the product of five months of reporting by Gardiner Harris and Anahad O'Connor. Appearing less than two weeks after Robert Kennedy's piece, which would later have a list of corrections and clarifications appended to it, the Times article had been eagerly awaited by proponents of the thimerosal link, some of whom had been communicating regularly with the Times reporters over the previous months. Believing that the heft of the paper's reputation would help to propel their cause into the mainstream, they expected a proper airing of both sides of the question - that, after all, was the impression O'Connor gave at least one of his sources, the mother of an autistic child and a member of an autism advocacy organization, when he approached her in late January. "I'm thinking of a 2,000-word story, essentially saying that an array of studies over the years (the Institute of Medicine report, I would think, being the most prominent) were intended to settle the issue of autism and vaccines once and for all," he wrote in an e-mail. "Yet it seems that the question is still very much open . . . and evidence for the case against vaccines has been mounting, despite many researchers' insistence that the issue is dead. I think, for now at least, I'd like to just present the evidence on both sides and let
the readers decide."
The result was much more one-sided. Headlined ON AUTISM'S CAUSE, IT'S PARENTS VS. RESEARCH, the story cast the thimerosal connection as a fringe theory, without scientific merit, held aloft by angry, desperate parents. The notion that supporters of the theory were disregarding irrefutable scientific findings was an underlying theme, drilled home several times. "It's really terrifying, the scientific illiteracy that supports these suspicions," Dr. Marie McCormick told the Times. Readers were left with little option but to believe that the case against thimerosal was scientifically unsound.
The piece did note the work of Mark and David Geier, a father-son research team who believe that mercury exposure is linked to autism. The Geiers's research has been a lightning rod for criticism, and their methodology has been called into question by some in the scientific community. But before the reporters even discussed the Geiers's science, they had already painted the researchers as eccentric outsiders: "He and his son live and work in a two-story house in suburban Maryland. Past the kitchen and down the stairs is a room with cast-off, unplugged laboratory equipment, wall-to-wall carpeting and faux wood paneling that Dr. Geier calls 'a world-class lab - every bit as good as anything at N.I.H.'" Omitted from the story was the work of Dr. Mady Hornig, a Columbia University epidemiologist; Richard Deth, a Northeastern University pharmacologist; Jill James, a professor of pediatrics at the University of Arkansas; and others whose work suggests that thimerosal may cause neurodevelopmental disorders in a subset of susceptible children (those who are not able to eliminate mercury from the body in the ways that most people do). The story alluded to Boyd Haley, chairman of the department of chemistry at the University of Kentucky and an ally of thimerosal activists, in the same sentence as a Louisiana physician who believes "that God spoke to her through an 87-year-old priest and told her that vaccines caused autism" - leaving Haley, it would seem, guilty by association of lunacy. Several reporters I spoke with who have covered the thimerosal controversy described the Times story as a smear. One called it a "hit piece."
The Times's O'Connor told me he had looked at the research linking thimerosal with autism, including the work of Hornig, Deth, and James, but ultimately found the epidemiological studies cited by the IOM more persuasive. "The larger scientific community has rejected a link between thimerosal and autism," he said. "You do have some scientists who are convinced that there's a link, but then you have the American Academy of Pediatrics, the World Health Organization - it's not a stretch to say that the scientific community has rejected this link."
The article prompted a massive reader response. One organization, known as A-Champ (Advocates for Children's Health Affected by Mercury Poisoning), organized an e-mail campaign directed at top editors at the Times, as well as the public editor, Byron Calame. O'Connor personally received dozens of e-mails and letters. "There were a couple that were threatening. There were some that were pretty harsh and others saying that I was part of the conspiracy. A lot of people responded saying there must be some link between the Times and the pharmaceutical industry."
Responding to the complaints of one group, Calame wrote: "I have carefully reviewed your e-mail and spent several hours with the editors and reporters who prepared the article . . . . This has left me convinced that the article isn't intellectually dishonest. Nor are the omissions staggering. Nor is there a pervasive editorial bias. I find the article fair and accurate."
As it turned out, the story had angered members of the epidemiology department at Columbia's Mailman School of Public Health, including the department's chair, Dr. Ezra Susser. Since some of their work, including that of Dr. W. Ian Lipkin, a highly regarded neurologist, and Mady Hornig, explored the connection between environmental mercury exposure and autism, including exposure through thimerosal-carrying vaccines, they felt that they had been lumped into the category of scientific illiterates. Responding to the article in a June 28 letter to the Times (never published), signed by Susser, Lipkin, Hornig, and the epidemiologist Michaeline Bresnahan, the researchers wrote that "scientists pursuing research on mercury and autism are caricaturized as immune to the 'correct' interpretation of existing studies. Researchers rejecting a link are depicted as the sole voices of reason . . . . Whether mercury in any form (or any of several factors recently introduced to our environment) has anything to do with autism can and should be resolved with rigorous studies and respectful discourse, not moral indictments and denunciations."
Journalists agree that the thimerosal story is one of the most explosive they've ever encountered. In addition to the vitriolic response Anahad O'Connor drew from readers, he also said he received a number of e-mails praising him and Harris from fellow reporters who had been interested in covering the thimerosal controversy, but had "gotten scared away from really tackling the subject . . . they were afraid of getting hate mail."
Some reporters who have portrayed this as an ongoing scientific controversy have been discouraged by colleagues and their superiors from pursuing the story. A reporter for a major media outlet, who did not want to be identified for fear of retribution, told me that covering the thimerosal controversy had been nearly "career-ending" and described butting heads with superiors who believed that the reporter's coverage - in treating the issue as a two-sided debate - legitimized a crackpot theory and risked influencing parents to stop vaccinating their children or to seek out experimental treatments for their autistic sons and daughters. The reporter has decided against pursuing stories on thimerosal, at least for the time being. "For some reason giving any sort of credence to the side that says there's a legitimate question here - I don't know how it becomes this untouchable story, I mean that's what we do, so I don't understand why this story is more touchy than any story I've ever done."
Pursuing this story is unattractive for other reasons, too. The issue is exceedingly complex and easily oversimplified. "It took me two and a half years and four hundred pages to tell this story, and I'm sure I made some mistakes," David Kirby told me, adding that the complexity convinced him to write a book.
The fact that the bulk of the public health establishment dismisses the thimerosal theory is also daunting, particularly for science reporters who rely on the same pool of medical experts and health officials regularly. "They depend on these people in this symbiotic relationship that they have," said Steve Wilson, an investigative reporter for the local ABC affiliate in Detroit, WXYZ, whose three-part series on thimerosal won an Emmy. "They've come to trust them and respect them and to believe when they tell them, 'Look, you're barking up the wrong tree here; these parents are just looking for somebody to blame.'"
Some of the most enterprising journalistic contributions to the thimerosal debate have come from the once prestigious, now flagging news wire United Press International, which is owned, along with the Washington Times, by the Reverend Sun Myung Moon's Unification Church. On my desk, UPI senior editor Dan Olmsted's "Age of Autism" series, which he began late last winter, occupies a file that at this writing is more than an inch thick and growing. He averages two columns a week on the topic. Aside from the Washington Times, though, not a single U.S. paper that Olmsted knows of has run any part of the series. It has, however, been widely disseminated on the Internet.
Olmsted, a former assistant national editor at USA Today, found his way into thimerosal through another medical side-effect story. It involved an antimalarial drug called Lariam, which was prescribed to Peace Corps volunteers, travelers to third-world countries, and more recently to U.S. troops stationed in Iraq and Afghanistan. As Olmsted and his UPI colleague Mark Benjamin (now a national correspondent at Salon.com) detailed in an investigation that spanned more than two years, starting in 2002, Lariam, which had been approved by the FDA and recommended by the CDC, also appeared strongly linked to psychosis, including homicidal and suicidal behavior. Partly because of their reporting, the effects of Lariam are now under study by the Pentagon. "If it hadn't been for Lariam, I don't think I would have ever thought twice about autism," Olmsted told me. "With Lariam, CDC officials said many times that there's absolutely no problem with side effects from this drug, it's extraordinarily safe. That's just not true."
Instead of wading directly into the thimerosal controversy, Olmsted approached it, as he puts it, "sideways." By this he means that after reading what had been written on autism and noticing a relative dearth of material about its origins, he set out to write a natural history of the disorder.
Eventually, Olmsted began thinking of ways to test the thimerosal theory. He wondered whether researchers had ever examined the prevalence of autism in an unvaccinated population, such as the Amish. That, it would seem, would be the most likely way to determine whether the vaccine link held water. If the number of autism cases among the unvaccinated mirrored the national average, then it would seem that thimerosal played no role. Olmsted found that though researchers had discussed such a study, none had ever been done. "That's an expensive study," he said, "but for a journalist all you have to do is get on the phone and start asking." After spending weeks searching for cases among the Amish of Lancaster County, Pennsylvania, he managed to find three children with autism, two of whom had been vaccinated, a rarity in that community. "The cases among the Amish that I've identified over the past several weeks appear to have at least one link - a link made of mercury," Olmsted wrote in a column on May 20, referring to the vaccinated children. "That's not something I expected to encounter." Looking at other large Amish populations in the Midwest, such as those in Middlefield, Ohio, and Goshen, Indiana, Olmsted found similarly low autism rates. He admits that his findings are not scientific. "I could be getting a completely wrong impression from what I'm finding, but it's interesting," Olmsted told me. Interesting enough to get the attention of members of Congress, including Representative Dave Weldon of Florida and Senator Joseph Lieberman of Connecticut; officials at the Department of Health and Human Services; and researchers, including Mady Hornig, the Columbia epidemiologist, who now hopes to devise a study looking at the Amish.
Privately, two reporters told me that, while intriguing, Olmsted's reporting on the Amish is misguided, since it may simply reflect genetic differences among an isolated gene pool (Hornig, however, said that a study on the Amish may still be valuable should the prevalence of autism in that community indeed be low, allowing researchers to study the genetics of people who are not susceptible to the disorder). Both reporters believed that Olmsted has made up his mind on the question and is reporting the facts that support his conclusions.
"I've just tried to find a way to get into this that adds something to the debate and is original," Olmsted said.
Among major newspapers, the Los Angeles Times's coverage of thimerosal stands out. It has taken the story seriously and devoted significant coverage to it, partly because through the summer and fall of 2004 a bill to ban thimerosal from all vaccines given to infants and pregnant women was making its way through the California legislature. Strongly opposed by the vaccine manufacturer Aventis Pasteur and the American Academy of Pediatrics, the measure was signed into law by Governor Arnold Schwarzenegger in late September of that year.
The reporter Myron Levin entered the fray in April 2004 with a piece that revealed that while the CDC would add flu shots to its list of suggested vaccines for children, it would not recommend that parents seek the available thimerosal-free version. He followed in August with a long feature on the attempts of parents who believed their children's autism was caused by mercury-containing shots to win compensation through a little known branch of federal claims court for the exorbitant costs of caring for their kids. (This "vaccine court," which pays out claims from a federal trust funded by revenue from a vaccine surcharge, was established during the mid-1980s as a means to protect drug companies from civil suits.) It was while covering this story, in which Levin captured both sides of the debate, as well as the devastating realities of raising a child with autism, that the CDC's Stephen Cochi referred to supporters of the thimerosal link as "junk scientists and charlatans."
Cochi's lack of diplomacy stunned Levin. "When government officials talk to reporters, they are usually beyond cautious and it can be really hard getting them to opine on anything," he told me. "To attack opponents in those terms shows the raw emotion that has infused this whole issue."
From his introduction to the thimerosal issue toward the end of 2003, Levin found it striking that a neurotoxin had ever been put into vaccines given to infants, even newborns. He wondered how health officials had failed for so long to consider the repercussions of injecting children with mercury-carrying vaccines.
As Levin reported last winter, the question of whether children were receiving too much mercury from their inoculations had been considered by Merck in the early 1990s. The front-page story - which reverberated through autism circles but drew little attention from the rest of the press - reported the contents of a leaked memo written by Dr. Maurice Hilleman, then the president of Merck's vaccine division. While public health officials had yet to recognize the total mercury load infants would receive from all of their suggested immunizations, Hilleman had done the math. "When viewed in this way, the mercury load appears rather large," he wrote in the 1991 memo, suggesting that thimerosal should probably be removed from vaccines administered to young children when possible. Levin kept the heat on Merck, reporting in March that the company had likely misled the public when it assured consumers in 1999 that its "infant vaccine line . . . is free of all preservatives." Merck had in fact continued supplying vaccines containing thimerosal until the fall of 2001.
Interestingly, this scoop had first been offered to The New York Times in February by a source who provided evidence to back up the claim. Gardiner Harris, then working on the story that turned out to be dismissive of the thimerosal debate that would run in June, blew off the tip, signing off his e-mailed response to the source, "I'll let Myron bite this apple."
Levin's reporting has drawn the ire of some in the pharmaceutical industry. Wyeth officials met with Levin and his editor in late July. "They have said there are problems with the tone, and that we seem to take too seriously an idea that they say is absurd and has been disproved by the IOM," Levin told me. (Douglas Petkus, a Wyeth spokesman who attended the meeting along with two lawyers who represent the firm, declined to discuss the particulars of the conversation.)
In late August, the Pittsburgh Post-Gazette reported the death of a five-year-old boy whose heart seized while he underwent an unproven autism treatment known as "chelation." Used for purging the body of heavy metals, particularly in cases of acute lead poisoning, it can prove damaging to internal organs by leeching certain necessary elements, such as calcium, from the system. While chelation has been embraced by some supporters of the thimerosal theory, who report that their children's conditions have improved as mercury was drawn from their bodies, the medical establishment has cautioned against it as a means of treating autism. To journalists, for whom the perils of covering thimerosal have been purely theoretical, this incident could only underscore the potential dangers of lending any credibility to the autism link.
The day the boy's death was reported, Craig Westover, a columnist at the St. Paul Pioneer Press, who writes frequently about thimerosal, received acid comments from readers on his blog. One reader, writing under the name Credenza, wrote, "They finally did it Mr. Westover, they killed a little boy trying to get that satanic mercury out of his little body. You have some blood on your hands. Like it or not you do. There has been no autism epidemic and thimerosal doesn't cause autism . . . . I hope the parents of this boy point the finger at you and scream murder."
"I really do try to walk a middle line on this," Westover told me that day, as he mulled his response to the reader. "You have to go out and investigate this and be able to come to some sort of conclusion. Not definitely that thimerosal does or does not cause autism, but you have to come to the question of whether this theory is plausible or not. Otherwise, I think you're doing a disservice to your reader." The evidence has led Westover to believe that a connection is possible. He realizes, moreover, that what he writes may influence others to believe the same.
To the reader who blamed him for the boy's death, Westover ultimately wrote, "That is the risk of a sin of commission, and one I considered long and hard before I wrote my first article on this topic . . . . I will stand on what I believe and accept the risk and the consequences if I am wrong."
Whether the thimerosal theory is proved right or wrong, there will be consequences - for the public health apparatus and vaccine manufacturers, for parents and their children, even for journalists. But with science left to be done and scientists eager to do it, it seems too soon for the press to shut the door on the debate.
Daniel Schulman is an assistant editor at CJR.
October 26, 2005
Vaccine bill to protect drug companies
Vaccine bill to protect drug companies
Sunday, October 23, 2005
Heidi Toth DAILY HERALD
Gary Facer of Orem summed up how most Americans, governmental entities and health professionals feel about a public health emergency.
"I hope it doesn't happen," he said.
But if at some point in the future it does, and Congress has passed the Bioshield II bill, and people are injured because of a government-mandated vaccine that is supposed to protect the American public from the outbreak, those people will not be able to sue the vaccine manufacturer.
The purpose of the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, said bill author Sen. Richard Burr, R-N.C., is to encourage pharmaceutical companies to be developing such vaccines. According to Burr's news release, the bill is a step
toward creating a partnership between the government and private corporations to "rapidly develop effective medical drugs and vaccines to protect the United States from deliberate, accidental and natural incidents involving biological pathogens."
The bill in a large part focuses on bioterrorism and biological, chemical and nuclear warfare, but Burr said in the release it also provides the resources necessary to deal with a naturally occurring epidemic. It absolves pharmaceutical companies from any liability from injured parties if the federal government declares a public health emergency and mandates the vaccine.
The bill's language and its precepts make Barbara Loe Fisher, president of the National Vaccine Information Center, uncomfortable. She said it takes away pharmaceutical companies' responsibility to consumers and gives too much power to the Secretary of Health and Human Services, who declares public health emergencies.
"Now this legislation is going to remove liability from the companies who produce these drugs and vaccines at government request and nobody is held accountable when a state of emergency is declared," she said.
Pharmaceutical companies already are protected from most lawsuits. In 1986 Congress created the National Vaccine Injury Compensation Program, which is a no-fault alternative to litigation, according to information from the U.S. Department of Health and Human Services. It was created after the number of lawsuits filed against vaccine producers spiked, and many companies opted to get out of vaccine production because of skyrocketing legal costs.
The measure could be a good thing, said Lance Madigan, spokesman for the Utah County Health Department. Protecting pharmaceutical companies from prohibitively expensive litigation is positive because it allows the companies to produce vaccines that in the large majority of cases protect the public. In many instances, diseases that could have caused a national crisis are controlled because of vaccines.
"There is always the possibility of adverse reactions" because of allergies or other factors, he said, adding those instances are rare and almost everyone benefits from getting immunized.
Under the bill, injured parties could still sue the vaccine company if they can prove criminal fraud or negligence, unless the vaccine is mandated by the government during a public health crisis, Fisher said. She is afraid that in the event of a national crisis, pharmaceutical companies will push an experimental drug through the
Food and Drug Administration, and it will be approved and distributed without going through the same rigorous process drugs should.
"We just feel that enough is enough," she said. "There has got to be some accountability somewhere for these vaccines and drugs."
Facer agreed someone should be accountable. But he questioned if it should be the pharmaceutical companies.
"If the government mandates it, they should also bear the burden of liability," he said.
Madigan said the FDA's process for approving a drug is thorough and a drug will not hit the market until it is considered safe for general consumption. Should there be a national health crisis, the approval process may be reduced, but it would be determined on a case-by-case basis, he said, with many factors taken into account.
"Obviously, if the disease is that infectious or that deadly, then they're probably going to be willing to have more risk," he said.
The Senate Committee on Health, Education, Labor and Pensions passed the bill Tuesday and now will go to the full Senate for a vote.
This story appeared in The Daily Herald on page A1.
Sunday, October 23, 2005
Heidi Toth DAILY HERALD
Gary Facer of Orem summed up how most Americans, governmental entities and health professionals feel about a public health emergency.
"I hope it doesn't happen," he said.
But if at some point in the future it does, and Congress has passed the Bioshield II bill, and people are injured because of a government-mandated vaccine that is supposed to protect the American public from the outbreak, those people will not be able to sue the vaccine manufacturer.
The purpose of the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, said bill author Sen. Richard Burr, R-N.C., is to encourage pharmaceutical companies to be developing such vaccines. According to Burr's news release, the bill is a step
toward creating a partnership between the government and private corporations to "rapidly develop effective medical drugs and vaccines to protect the United States from deliberate, accidental and natural incidents involving biological pathogens."
The bill in a large part focuses on bioterrorism and biological, chemical and nuclear warfare, but Burr said in the release it also provides the resources necessary to deal with a naturally occurring epidemic. It absolves pharmaceutical companies from any liability from injured parties if the federal government declares a public health emergency and mandates the vaccine.
The bill's language and its precepts make Barbara Loe Fisher, president of the National Vaccine Information Center, uncomfortable. She said it takes away pharmaceutical companies' responsibility to consumers and gives too much power to the Secretary of Health and Human Services, who declares public health emergencies.
"Now this legislation is going to remove liability from the companies who produce these drugs and vaccines at government request and nobody is held accountable when a state of emergency is declared," she said.
Pharmaceutical companies already are protected from most lawsuits. In 1986 Congress created the National Vaccine Injury Compensation Program, which is a no-fault alternative to litigation, according to information from the U.S. Department of Health and Human Services. It was created after the number of lawsuits filed against vaccine producers spiked, and many companies opted to get out of vaccine production because of skyrocketing legal costs.
The measure could be a good thing, said Lance Madigan, spokesman for the Utah County Health Department. Protecting pharmaceutical companies from prohibitively expensive litigation is positive because it allows the companies to produce vaccines that in the large majority of cases protect the public. In many instances, diseases that could have caused a national crisis are controlled because of vaccines.
"There is always the possibility of adverse reactions" because of allergies or other factors, he said, adding those instances are rare and almost everyone benefits from getting immunized.
Under the bill, injured parties could still sue the vaccine company if they can prove criminal fraud or negligence, unless the vaccine is mandated by the government during a public health crisis, Fisher said. She is afraid that in the event of a national crisis, pharmaceutical companies will push an experimental drug through the
Food and Drug Administration, and it will be approved and distributed without going through the same rigorous process drugs should.
"We just feel that enough is enough," she said. "There has got to be some accountability somewhere for these vaccines and drugs."
Facer agreed someone should be accountable. But he questioned if it should be the pharmaceutical companies.
"If the government mandates it, they should also bear the burden of liability," he said.
Madigan said the FDA's process for approving a drug is thorough and a drug will not hit the market until it is considered safe for general consumption. Should there be a national health crisis, the approval process may be reduced, but it would be determined on a case-by-case basis, he said, with many factors taken into account.
"Obviously, if the disease is that infectious or that deadly, then they're probably going to be willing to have more risk," he said.
The Senate Committee on Health, Education, Labor and Pensions passed the bill Tuesday and now will go to the full Senate for a vote.
This story appeared in The Daily Herald on page A1.
October 25, 2005
WaPo: Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine
A Shot of Fear
Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine
By Steven Woloshin, Lisa M. Schwartz and H. Gilbert Welch
Special to The Washington Post
Tuesday, October 25, 2005; Page HE01
Medical research often becomes news. But sometimes the news is made to appear more definitive and dramatic than the research warrants. This series dissects health news to highlight some common study interpretation problems we see as physician-researchers and show how the research community, medical journals and the media can do better.
For years, the public health community has used fear as one strategy to promote the flu vaccine. A vaccination poster distributed by the U.S. Centers for Disease Control and Prevention (CDC), for example, emphasizes that "36,000 Americans die of flu-related illnesses each year," implying that the vaccine could prevent many of these deaths.
What was an elderly person's chance of having a flu-like illness in a flu season?
Placebo group Vaccine group
Nursing Home
Study 1 (Russia) 13% 5%
Study 2 (U.S.) 15% 6%
Community
Study 3 (Netherlands) 4% 2%
Study 4 (Britain) 9% 5%
Study 5 (U.S.) 4% 2%
SOURCES: Lancet Online Cochrane Review 2005 and original journal articles
When it became aware of the vaccine shortage last October, the federal government changed course and tried to reassure Americans that going without a shot was no big deal. "We all need to take a deep breath. This is not an emergency," CDC director Julie Gerberding advised the public.
Instead of urging vaccination for everyone age 50 and older, as they had been doing, government officials recommended shots only for people 65 and older, and those in selected high risk groups. The public's response was predictable: People were upset and confused. Our local television news played a story in which a pharmacist was called "a murderer" when his vaccine supply ran out. Ironically, the crisis mentality led some to engage in behaviors that probably increased their risk. Frail elderly people, some with oxygen tanks, stood in long lines in the cold, waiting for the vaccine. Others crowded clinics and doctors' offices, increasing their chance of exposure to flu and other infectious agents.
With uncertainties about this year's vaccine supply, the CDC again recommended that highest-risk people get priority for flu shots, at least until late October. But last year's flu season may have left people confused about essential points: Just how risky is the flu? And just how effective is the vaccine? The answers to these questions may surprise readers.
How Risky Is the Flu?
First, a caveat: The risk calculations we analyze here describe typical flu seasons only. We don't consider here what the picture would be in the event of a deadly flu pandemic -- a worldwide outbreak of a new, highly virulent flu strain, the potential for which has recently drawn considerable media attention. No one really knows how likely such an outbreak is, but the risk profile would certainly change. A pandemic is a fundamentally different situation: The risk of death would be substantially higher, and untested strategies (including new treatments, quarantine and a new vaccine) would need to be implemented rapidly.
We deal here with what is known about typical flu seasons, based on data that form the basis for the federal government's flu-risk figures.
By choosing to highlight the annual number of flu deaths, the CDC employed an attention-grabbing tactic often used by public health and disease advocacy groups. It's a tactic readers should be inoculated against if they want a clear picture of the risks they face. (See "Research Basics: Understanding How Big a Risk Is," right.)
In fact, it is very difficult to know how many people die from any given disease because there is often much uncertainty in determining the cause of death. This is particularly true for the flu. That's because it shares symptoms with so many other diseases, and because people most likely to die a flu-related death are also at high risk for many other causes of death.
Flu deaths are probably undercounted because doctors do not routinely test for the flu, and because some deaths that should be attributed to the flu are given other diagnoses. For example, someone who dies from a heart attack because they are debilitated by the flu might not get counted as a flu death. Some overcounting of flu deaths also occurs: Clearly not all winter pneumonia deaths are caused by the flu.
According to the CDC, 90 percent of flu-related deaths occur among people age 65 years and older. Based on this information and the age distribution of the population, the chance of a flu-related death for people in that age group is about one in 1,000. Another way of saying this is that the chance of not dying from flu for those 65 and older is about 999 out of 1,000. (For context, the chance of a flu-related death is slightly lower than the chance of dying from a fall or other accident.)
For people younger than 65 (including children), the chance of a flu-related death is much smaller -- about one in 100,000. Of course, adults and children might be concerned about flu-related problems besides death, such as being hospitalized or just suffering with unpleasant symptoms (typically three to seven days of fever, muscle aches, headache, weakness, dry cough and runny nose). As you might guess, counting the number of flu-related hospitalizations or the number of people experiencing symptoms from the flu is even more difficult than counting flu deaths.
How Good Is the Vaccine?
Getting a shot does not guarantee you will not get sick from the flu or die from it. Recently, the Cochrane Collaboration, an international group that evaluates the evidence for various medical interventions, reviewed the medical literature on the effectiveness of the flu vaccine in preventing death.
Unfortunately, the evidence on how well the vaccine works to prevent death in the elderly is limited. Few of the existing studies are randomized trials -- considered the gold standard for medical evidence. Instead, most data are from observational studies -- studies in which scientists simply count up outcomes (here, the number of deaths that occur among people who did or did not get the vaccine).
But drawing conclusions about cause and effect from such observations is fraught with problems.
For example, a 2003 study published in the New England Journal of Medicine observed that the flu vaccine was associated with a 50 percent reduction in the overall death rate (that is, death from heart disease, stroke, cancer and all other causes combined). To attribute an effect of this magnitude solely to the flu vaccine is ludicrous: Flu-related deaths make up less than 2 percent of all deaths. If the claim were accurate, the vaccine's power would dwarf that of any other medical intervention. There is, however, a much more likely explanation: People who choose to get a flu shot are much healthier -- and therefore already at much lower risk of death -- than people who do not.
Only five randomized trials have examined the effectiveness of the flu vaccine. In these studies, patients were randomly assigned -- a selection technique equivalent to the flip of a coin -- to get either a flu vaccine or a placebo injection. But none of these studies looked at whether the vaccine prevents death. Instead, the scientists measured who developed a flu-like illness. For a summary of the findings of these studies, see "How Well Does the Vaccine Work in the Elderly?" below.
In the absence of good randomized trial data, it is still possible to gauge the effectiveness of vaccination by looking at time trends in flu vaccine rates compared with flu-related deaths in the elderly. As more people get vaccinated, you would expect the flu-related death rate to decline -- if the vaccine is effective. But, as the graph below, titled "A Windening Gap," shows, despite a dramatic increase in vaccination among the elderly, deaths from the flu and pneumonia have hardly budged. (The calculations have taken into account the aging of the population.)
For younger adults, flu-related death is so rare that it has not been reliably studied: Doing so would require a trial of millions of people.
Of course, the flu shot may have benefits besides reducing the chance of death. Many may get flu shots simply to avoid getting sick. The Cochrane Collaboration identified more than 20 randomized trials addressing this question. The overall chance of developing "clinical" flu (we'll explain in a minute) was 19 percent in those chosen, again by chance, to receive the recommended flu vaccine vs. 23 percent in the control groups.
The careful reader may notice that these percentages are substantially higher than those reported for the elderly. (See "How Well Does the Vaccine Work in the Elderly?") This is because clinical flu is defined as a set of non-specific symptoms including fever, cough and muscle aches -- symptoms shared by many non-flu illnesses like the common cold. These non-flu illnesses may be especially common in younger adults because of their exposure to other people, particularly children. To try to isolate the effect of the vaccine, scientists sometimes use laboratory tests to confirm the activity of flu virus in the blood. Using this measure, the chance of flu in the vaccine group is 2 percent vs. 7 percent in the control group.
Studies have also measured another outcome: how vaccination affects days lost from work. On average, there are about 0.16 fewer days lost from work per person vaccinated. Another way of saying this is that about 5 percent of those vaccinated avoid missing about three days of work because of the flu. (That is, 0.16 days divided by the 5 percent who benefited from vaccination equals 3.2 days.) The other 95 percent vaccinated got no benefit.
Take-Home Messages
To promote vaccine use, many in the public health community have overstated the risk of flu-related death and the effectiveness of the vaccine in preventing it. While the flu vaccine may have some important benefit (less flu-related illness), we really do not know whether it reduces the risk of death. For younger individuals -- for whom the chance of flu-related death is extremely small -- any death-protection benefit can only be very modest (and it is unlikely we will ever reliably know whether it even exists). However, we do know that the vaccine reduces the risk of being sick and time lost from work. But because the effect is small, individuals will have to judge for themselves whether it's worth the bother.
We are not suggesting that Americans forgo flu vaccines. We simply want to help people make informed decisions.
For many people, getting the vaccine is a reasonable choice. And many may reasonably choose not to get it. (Consequently, the use of flu vaccination rates by Medicare and others to measure health care quality probably does not make sense.)
Regardless, public health officials should not exaggerate risks or benefits to promote vaccination. Exaggeration carries a price: Not only do some people get scared and engage in behaviors that increase their risk (like waiting in a crowded clinic for a flu shot). They may also grow cynical and end up ignoring health messages that really matter.
Steven Woloshin, Lisa Schwartz and Gilbert Welch are physician-researchers in the VA Outcomes Group in White River Junction, Vt., and faculty members at the Dartmouth Medical School. They conduct regular seminars on how to interpret medical studies. (Seehttp://www.vaoutcomes.org.) The views expressed do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.
To respond to this article, send e-mail to health@washpost.com.
Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine
By Steven Woloshin, Lisa M. Schwartz and H. Gilbert Welch
Special to The Washington Post
Tuesday, October 25, 2005; Page HE01
Medical research often becomes news. But sometimes the news is made to appear more definitive and dramatic than the research warrants. This series dissects health news to highlight some common study interpretation problems we see as physician-researchers and show how the research community, medical journals and the media can do better.
For years, the public health community has used fear as one strategy to promote the flu vaccine. A vaccination poster distributed by the U.S. Centers for Disease Control and Prevention (CDC), for example, emphasizes that "36,000 Americans die of flu-related illnesses each year," implying that the vaccine could prevent many of these deaths.
What was an elderly person's chance of having a flu-like illness in a flu season?
Placebo group Vaccine group
Nursing Home
Study 1 (Russia) 13% 5%
Study 2 (U.S.) 15% 6%
Community
Study 3 (Netherlands) 4% 2%
Study 4 (Britain) 9% 5%
Study 5 (U.S.) 4% 2%
SOURCES: Lancet Online Cochrane Review 2005 and original journal articles
When it became aware of the vaccine shortage last October, the federal government changed course and tried to reassure Americans that going without a shot was no big deal. "We all need to take a deep breath. This is not an emergency," CDC director Julie Gerberding advised the public.Instead of urging vaccination for everyone age 50 and older, as they had been doing, government officials recommended shots only for people 65 and older, and those in selected high risk groups. The public's response was predictable: People were upset and confused. Our local television news played a story in which a pharmacist was called "a murderer" when his vaccine supply ran out. Ironically, the crisis mentality led some to engage in behaviors that probably increased their risk. Frail elderly people, some with oxygen tanks, stood in long lines in the cold, waiting for the vaccine. Others crowded clinics and doctors' offices, increasing their chance of exposure to flu and other infectious agents.
With uncertainties about this year's vaccine supply, the CDC again recommended that highest-risk people get priority for flu shots, at least until late October. But last year's flu season may have left people confused about essential points: Just how risky is the flu? And just how effective is the vaccine? The answers to these questions may surprise readers.
How Risky Is the Flu?
First, a caveat: The risk calculations we analyze here describe typical flu seasons only. We don't consider here what the picture would be in the event of a deadly flu pandemic -- a worldwide outbreak of a new, highly virulent flu strain, the potential for which has recently drawn considerable media attention. No one really knows how likely such an outbreak is, but the risk profile would certainly change. A pandemic is a fundamentally different situation: The risk of death would be substantially higher, and untested strategies (including new treatments, quarantine and a new vaccine) would need to be implemented rapidly.
We deal here with what is known about typical flu seasons, based on data that form the basis for the federal government's flu-risk figures.
By choosing to highlight the annual number of flu deaths, the CDC employed an attention-grabbing tactic often used by public health and disease advocacy groups. It's a tactic readers should be inoculated against if they want a clear picture of the risks they face. (See "Research Basics: Understanding How Big a Risk Is," right.)
In fact, it is very difficult to know how many people die from any given disease because there is often much uncertainty in determining the cause of death. This is particularly true for the flu. That's because it shares symptoms with so many other diseases, and because people most likely to die a flu-related death are also at high risk for many other causes of death.
Flu deaths are probably undercounted because doctors do not routinely test for the flu, and because some deaths that should be attributed to the flu are given other diagnoses. For example, someone who dies from a heart attack because they are debilitated by the flu might not get counted as a flu death. Some overcounting of flu deaths also occurs: Clearly not all winter pneumonia deaths are caused by the flu.
According to the CDC, 90 percent of flu-related deaths occur among people age 65 years and older. Based on this information and the age distribution of the population, the chance of a flu-related death for people in that age group is about one in 1,000. Another way of saying this is that the chance of not dying from flu for those 65 and older is about 999 out of 1,000. (For context, the chance of a flu-related death is slightly lower than the chance of dying from a fall or other accident.)
For people younger than 65 (including children), the chance of a flu-related death is much smaller -- about one in 100,000. Of course, adults and children might be concerned about flu-related problems besides death, such as being hospitalized or just suffering with unpleasant symptoms (typically three to seven days of fever, muscle aches, headache, weakness, dry cough and runny nose). As you might guess, counting the number of flu-related hospitalizations or the number of people experiencing symptoms from the flu is even more difficult than counting flu deaths.
How Good Is the Vaccine?
Getting a shot does not guarantee you will not get sick from the flu or die from it. Recently, the Cochrane Collaboration, an international group that evaluates the evidence for various medical interventions, reviewed the medical literature on the effectiveness of the flu vaccine in preventing death.
Unfortunately, the evidence on how well the vaccine works to prevent death in the elderly is limited. Few of the existing studies are randomized trials -- considered the gold standard for medical evidence. Instead, most data are from observational studies -- studies in which scientists simply count up outcomes (here, the number of deaths that occur among people who did or did not get the vaccine).
But drawing conclusions about cause and effect from such observations is fraught with problems.
For example, a 2003 study published in the New England Journal of Medicine observed that the flu vaccine was associated with a 50 percent reduction in the overall death rate (that is, death from heart disease, stroke, cancer and all other causes combined). To attribute an effect of this magnitude solely to the flu vaccine is ludicrous: Flu-related deaths make up less than 2 percent of all deaths. If the claim were accurate, the vaccine's power would dwarf that of any other medical intervention. There is, however, a much more likely explanation: People who choose to get a flu shot are much healthier -- and therefore already at much lower risk of death -- than people who do not.
Only five randomized trials have examined the effectiveness of the flu vaccine. In these studies, patients were randomly assigned -- a selection technique equivalent to the flip of a coin -- to get either a flu vaccine or a placebo injection. But none of these studies looked at whether the vaccine prevents death. Instead, the scientists measured who developed a flu-like illness. For a summary of the findings of these studies, see "How Well Does the Vaccine Work in the Elderly?" below.
In the absence of good randomized trial data, it is still possible to gauge the effectiveness of vaccination by looking at time trends in flu vaccine rates compared with flu-related deaths in the elderly. As more people get vaccinated, you would expect the flu-related death rate to decline -- if the vaccine is effective. But, as the graph below, titled "A Windening Gap," shows, despite a dramatic increase in vaccination among the elderly, deaths from the flu and pneumonia have hardly budged. (The calculations have taken into account the aging of the population.)
For younger adults, flu-related death is so rare that it has not been reliably studied: Doing so would require a trial of millions of people.
Of course, the flu shot may have benefits besides reducing the chance of death. Many may get flu shots simply to avoid getting sick. The Cochrane Collaboration identified more than 20 randomized trials addressing this question. The overall chance of developing "clinical" flu (we'll explain in a minute) was 19 percent in those chosen, again by chance, to receive the recommended flu vaccine vs. 23 percent in the control groups.
The careful reader may notice that these percentages are substantially higher than those reported for the elderly. (See "How Well Does the Vaccine Work in the Elderly?") This is because clinical flu is defined as a set of non-specific symptoms including fever, cough and muscle aches -- symptoms shared by many non-flu illnesses like the common cold. These non-flu illnesses may be especially common in younger adults because of their exposure to other people, particularly children. To try to isolate the effect of the vaccine, scientists sometimes use laboratory tests to confirm the activity of flu virus in the blood. Using this measure, the chance of flu in the vaccine group is 2 percent vs. 7 percent in the control group.
Studies have also measured another outcome: how vaccination affects days lost from work. On average, there are about 0.16 fewer days lost from work per person vaccinated. Another way of saying this is that about 5 percent of those vaccinated avoid missing about three days of work because of the flu. (That is, 0.16 days divided by the 5 percent who benefited from vaccination equals 3.2 days.) The other 95 percent vaccinated got no benefit.
Take-Home Messages
To promote vaccine use, many in the public health community have overstated the risk of flu-related death and the effectiveness of the vaccine in preventing it. While the flu vaccine may have some important benefit (less flu-related illness), we really do not know whether it reduces the risk of death. For younger individuals -- for whom the chance of flu-related death is extremely small -- any death-protection benefit can only be very modest (and it is unlikely we will ever reliably know whether it even exists). However, we do know that the vaccine reduces the risk of being sick and time lost from work. But because the effect is small, individuals will have to judge for themselves whether it's worth the bother.
We are not suggesting that Americans forgo flu vaccines. We simply want to help people make informed decisions.
For many people, getting the vaccine is a reasonable choice. And many may reasonably choose not to get it. (Consequently, the use of flu vaccination rates by Medicare and others to measure health care quality probably does not make sense.)
Regardless, public health officials should not exaggerate risks or benefits to promote vaccination. Exaggeration carries a price: Not only do some people get scared and engage in behaviors that increase their risk (like waiting in a crowded clinic for a flu shot). They may also grow cynical and end up ignoring health messages that really matter.
Steven Woloshin, Lisa Schwartz and Gilbert Welch are physician-researchers in the VA Outcomes Group in White River Junction, Vt., and faculty members at the Dartmouth Medical School. They conduct regular seminars on how to interpret medical studies. (Seehttp://www.vaoutcomes.org.) The views expressed do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.
To respond to this article, send e-mail to health@washpost.com.
Cylert, ADHD Drug Withdrawn by FDA
FDA Withdraws Approval for ADD Drug
Mon Oct 24, 8:37 PM ET
WASHINGTON - The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.
The move means drug manufacturers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert. Abbott discontinued the drug earlier this year, but generic versions have remained available.
FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to alternative treatments, the agency said in a statement.
The lack of a recall drew fire from the consumer advocacy group Public Citizen.
"It is reckless and insensitive to the health and lives of children and adults using this drug for the FDA and the involved drug companies to fail to institute an immediate recall of these dangerous products," said Drs. Sidney Wolfe and Peter Lurie, who lead the organization's Health Research Group, in a letter to the FDA.
In a statement, the FDA said it has 13 reports of liver failure resulting in transplant or death among people who took the drug, which has been available for 30 years. There are additional reports of less serious problems.
Although that is a small number, it is well above what the normal rate of such problems among the general population, the FDA said.
"FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits," the agency statement says, noting that alternative treatments for ADD have come on the market since pemoline was introduced.
The drug acts as a stimulant to the central nervous system.
Mon Oct 24, 8:37 PM ET
WASHINGTON - The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.
The move means drug manufacturers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert. Abbott discontinued the drug earlier this year, but generic versions have remained available.
FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to alternative treatments, the agency said in a statement.
The lack of a recall drew fire from the consumer advocacy group Public Citizen.
"It is reckless and insensitive to the health and lives of children and adults using this drug for the FDA and the involved drug companies to fail to institute an immediate recall of these dangerous products," said Drs. Sidney Wolfe and Peter Lurie, who lead the organization's Health Research Group, in a letter to the FDA.
In a statement, the FDA said it has 13 reports of liver failure resulting in transplant or death among people who took the drug, which has been available for 30 years. There are additional reports of less serious problems.
Although that is a small number, it is well above what the normal rate of such problems among the general population, the FDA said.
"FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits," the agency statement says, noting that alternative treatments for ADD have come on the market since pemoline was introduced.
The drug acts as a stimulant to the central nervous system.
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