Dan Olmsted - Autism's Dick Tracy
by Evelyn Pringle
According to officials in the nation's regulatory agencies, the main obstacle to proving or disproving a link between the autism epidemic and the mercury-based preservative, thimerosal, that was contained in childhood vaccines until a few years ago, and is still in flu vaccines, has been the inability to find a large enough group of people who have never been vaccinated to compare with people who have.
In fact, a few months ago, CDC officials claimed that such a study would be nearly impossible. On July 19, 2005, the CDC held a Media Briefing on the topic of vaccines and child health. On the issue of government research on autism, a reporter asked CDC Director, Dr Julie Gerberding: "are you putting any money into clinical studies rather than epidemiological studies, to verify or disprove the parents' claim about a particular channel, a particular mechanism by which a minority of genetically suspectable kids are supposed damaged?"
Gerberding replied: To do the study that you're suggesting, looking for an association between thimerosal and autism in a prospective sense is just about impossible to do right now because we don't have those vaccines in use in this country so we're not in a position where we can compare the children who have received them directly to the children who don't.
Dr Duane Alexander, of the National Institute of Health, agreed and said: It's really not possible ... in this country to do a prospective study now of thimerosal and vaccines in relationship to autism. Only a retrospective study which would be very difficult to do under the circumstances could be mounted with regard to the thimerosal question.
However, Dan Olmsted, investigative reporter for United Press International, and author of the Age of Autism series of reports, appears to have solved this problem when he came up with the idea of checking out the nation's Amish population where parents do not ordinarily vaccinate children.
First he looked to the Amish community in Pennsylvania and found a family doctor in Lancaster who had treated thousands of Amish patients over a quarter-century who said he has never seen an Amish person with autism, according to Age of Autism: A glimpse of the Amish on June 2, 2005.
Olmsted also interviewed Dick Warner, who has a water purification and natural health business and has been in Amish households all over the country. "I've been working with Amish people since 1980," Warner said.
"I have never seen an autistic Amish child -- not one," he told Olmsted. "I would know it. I have a strong medical background. I know what autistic people are like. I have friends who have autistic children," he added.
Olmsted did find one Amish woman in Lancaster County with an autistic child but as it turns out, the child was adopted from China and had been vaccinated. The woman knew of two other autistic children but here again, one of those had been vaccinated.
Next Olmsted visited a medical practice in Middleburg, Indiana, the heart of the Amish community, and asked whether the clinic treated Amish people with autism.
A staff member told Olmsted that she had never thought about it before, but in the five years that she had worked at the clinic she had never seen one autistic Amish.
On June 8, 2005, Olmsted reported on the autism rate in the Amish community around Middlefield, Ohio, which was 1 in 15,000, according to Dr Heng Wang, the medical director, at the DDC Clinic for Special Needs Children.
"So far," according to Age of Autism, "there is evidence of fewer than 10 Amish with autism; there should be several hundred if the disorder occurs among them at the same 166-1 prevalence as children born in the rest of the population."
In addition to the Amish, Olmsted recently discovered another large unvaccinated group. On December 7, 2005, Age of Autism reported that thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with Amish children, they have never been vaccinated and they don't have autism.
Homefirst has five offices in the Chicago area and a total of six doctors. "We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973.
Olmsted reports that the autism rate in Illinois public schools is 38 per 10,000, according to state Education Department data. In treating a population of 30,000 to 35,000 children, this would logically mean that Homefirst should have seen at least 120 autistic children over the years but the clinic has seen none.
It looks like the problem is finally solved. Thanks to autism's Dick Tracy, the government now has thousands of unvaccinated people to compare to people who were vaccinated.
evelyn.pringle@sbcglobal.net
December 22, 2005
December 21, 2005
Clevland Clinic: Ties to Industry Cloud a Clinic's Mission
Ties to Industry Cloud a Clinic's Mission
By REED ABELSON and STEPHANIE SAUL
December 17, 2005
Dr. Eric J. Topol, a cardiologist, has been perhaps the most public face of the prestigious Cleveland Clinic Foundation, a prominent medical center regarded as one of the nation's best.
Not shy in the media spotlight, Dr. Topol has cultivated the persona of a Naderesque crusader against drugs he deems dangerous, as well as their makers. Some of his most impassioned criticism has been aimed at Merck and its drug Vioxx, the painkiller the company withdrew from the market over questions about its safety. But he has also been outspoken recently about other drugs.
Now, Dr. Topol's bluntness - refreshing to his admirers, startlingly unscientific to his targets and his critics - has drawn a bright spotlight to his own conduct and that of the Cleveland Clinic. In the last month, he has been demoted and the clinic's image has been tarnished in what has become an unusually public dispute pitting him against the clinic's chief executive, Dr. Delos Cosgrove.
Dr. Topol, who retains the position of chairman of cardiovascular medicine at the clinic, suggested in a Webcast on Thursday (http://www.theheart.org) that his unabashed willingness to take on Merck was a principal reason for his removal this month as head of the clinic's medical college. In what Merck lawyers have suggested is a vendetta, he described the company's behavior as "appalling" in recent testimony in a Vioxx lawsuit.
But his demotion has drawn attention to the mounting tensions between the clinic's research mission and its deep ties to the businesses that finance that research. Both Dr. Topol and Dr. Cosgrove refused to comment for this article, but associates say Dr. Topol may decide to leave the clinic.
The dispute at the Cleveland Clinic goes far beyond a simple power struggle between strong-willed men who competed for the clinic's top job. Dr. Topol severed his ties to industry after being embarrassed last December by an article in Fortune magazine. But the continued controversy has focused attention on the many longstanding corporate ties at the clinic. Those business links involve not only staff doctors and researchers, but also Dr. Cosgrove and the clinic's board.
The Cleveland Clinic is emblematic of the way the drug and medical device industries and the investment community work closely with medical researchers and doctors to develop and promote new medicines and technologies. Almost inevitably, such relationships raise concerns about possible conflicts of interest that could lead doctors to favor some treatments over others or to bias the results of medical research.
"It's not just the Cleveland Clinic," said Les Funtleyder, a health care strategist at the investment company Miller Tabak & Company in New York. He says other high-profile academic medical centers also have numerous financial ties that raise the potential for conflicts of interest.
Dr. Jerome P. Kassirer, a former editor in chief for The New England Journal of Medicine, describes the potential conflicts at the clinic "as extremely serious ones" but notes that the Cleveland Clinic is "not unique at all."
It was Dr. Topol's criticism of Merck that indirectly brought the clinic's conflicts to the fore. After the drug was withdrawn in September 2004 by Merck, Dr. Topol, who in journal articles had questioned the drug's cardiovascular safety, criticized the company's conduct.
Dr. Topol soon found himself under attack. He was the subject of the Fortune magazine article, which contended he had a conflict of interest. A hedge fund that listed Dr. Topol on its advisory panel had been a short seller of Merck's stock before the Vioxx withdrawal. Dr. Topol said he had nothing to do with the fund's action, which was a financial bet that the share price would fall.
Dr. Topol also found himself under fire at the clinic, where he would later claim that the chairman of the trustees, Malachi Mixon, had been contacted by Merck's chief executive at the time, Raymond V. Gilmartin. In any event, the clinic investigated Dr. Topol's business dealings, according to people briefed on the inquiry. Dr. Topol suggested in his Webcast that the clinic's pique might be related to the relationship between Mr. Gilmartin and Mr. Mixon, who attended Harvard Business School together.
Mr. Mixon, in an interview, would not discuss any conversations he had with Mr. Gilmartin on the subject. A Merck spokeswoman, however, denied that Mr. Gilmartin had ever contacted the Cleveland Clinic.
After the Fortune article, Dr. Topol publicly announced that he would cut all ties to industry, which included relationships with Eli Lilly, deCode Genetics and the Medicines Company - despite the fact that many doctors at the clinic and elsewhere had similar consulting deals.
"I think there's a real problem in academics today," he told The New York Times in January. "There's a very close-knit relationship with industry, and it's too close when any individual can derive a profit from that relationship."
The Cleveland Clinic itself was at the time finishing a set of ethical guidelines in which physicians and researchers were encouraged to continue working with industry, but were told that their ties would require reviews.
When his contract came up for renewal at the clinic at the end of last year, the clinic put Dr. Topol on a form of probation, giving him a six-month contract rather than the usual yearlong agreement, according to associates. It was a largely symbolic move, but associates said it angered Dr. Topol, who in 15 years at the clinic had been responsible for establishing the clinic's medical school and elevating the reputation of its cardiovascular medicine unit.
On the Webcast, Dr. Topol said the conflict-of-interest committee, on which he served, had looked into the financial arrangements of other doctors, including Dr. Cosgrove, as well as the fact that clinic patients were being used in tests of medical devices made by companies in which the clinic had financial interests.
Some of the clinic's perceived conflicts begin at the very top. Mr. BR Mixon, for example, is chief executive of Invacare, a major health care supply company. The company not only conducts about $200,000 a year in business with the clinic, but several people with clinic ties are on the Invacare board.
They include Dr. Bernadine Healy, the former head of the Red Cross who is married to Dr. Floyd D. Loop, the cardiac surgeon who led the clinic until he retired last year and was replaced by Dr. Cosgrove. Dr. Healy, who could not be reached for comment, owns options for 41,570 shares of stock in Invacare, according to a securities filing from earlier this year.
Mr. Mixon, who would not address other issues in this article, said his company's business dealings with the clinic constituted "peanuts" in the context of his company's overall annual revenue of about $1.5 billion.
A clinic spokeswoman, Eileen Sheil, said the clinic would not respond to questions about Mr. Mixon's company or Invacare's other board members.
Nor would the clinic address questions involving a number of Dr. Cosgrove's financial arrangements, although Ms. Sheil said he had severed those ties. In a statement, the clinic said it had begun an independent review of conflicts, to be conducted by an outside group.
Dr. Cosgrove, a well-regarded cardiac surgeon, is intimately familiar with the role physicians play in industry. His inventions include the Cosgrove-Edwards heart device, marketed by Edwards Lifesciences. The devices are used at the Cleveland Clinic, although the clinic would not discuss how or whether patients are informed of Dr. Cosgrove's connection when they are used.
Dr. Cosgrove also spearheaded the clinic's entrepreneurial efforts through a venture capital fund.
In an article last January, The New York Times described various companies in which the clinic had a financial interest, including AtriCure, the maker of a heart device. The Wall Street Journal featured AtriCure in a front-page article about the Cleveland Clinic this week.
All of this attention threatens to tarnish the clinic's image as an institution conducting world-class medical research. "All of these pieces of information coming out bit by bit are potentially damaging to the clinic's reputation," said Dr. Mildred K. Cho, a medical ethicist at Stanford University.
The clinic says its board of trustees has appointed an independent group to review the clinic's conflicts. But, in the meantime, Dr. Topol has been removed from the conflict-of-interest committee, a position he held by virtue of his leadership role at the medical college.
The publicity may prompt change, said Dr. Kassirer, the former medical journal editor. "The only question is whether it will really embarrass anyone. The clinic is so powerful, it has so much clout."
By REED ABELSON and STEPHANIE SAUL
December 17, 2005
Dr. Eric J. Topol, a cardiologist, has been perhaps the most public face of the prestigious Cleveland Clinic Foundation, a prominent medical center regarded as one of the nation's best.
Not shy in the media spotlight, Dr. Topol has cultivated the persona of a Naderesque crusader against drugs he deems dangerous, as well as their makers. Some of his most impassioned criticism has been aimed at Merck and its drug Vioxx, the painkiller the company withdrew from the market over questions about its safety. But he has also been outspoken recently about other drugs.
Now, Dr. Topol's bluntness - refreshing to his admirers, startlingly unscientific to his targets and his critics - has drawn a bright spotlight to his own conduct and that of the Cleveland Clinic. In the last month, he has been demoted and the clinic's image has been tarnished in what has become an unusually public dispute pitting him against the clinic's chief executive, Dr. Delos Cosgrove.
Dr. Topol, who retains the position of chairman of cardiovascular medicine at the clinic, suggested in a Webcast on Thursday (http://www.theheart.org) that his unabashed willingness to take on Merck was a principal reason for his removal this month as head of the clinic's medical college. In what Merck lawyers have suggested is a vendetta, he described the company's behavior as "appalling" in recent testimony in a Vioxx lawsuit.
But his demotion has drawn attention to the mounting tensions between the clinic's research mission and its deep ties to the businesses that finance that research. Both Dr. Topol and Dr. Cosgrove refused to comment for this article, but associates say Dr. Topol may decide to leave the clinic.
The dispute at the Cleveland Clinic goes far beyond a simple power struggle between strong-willed men who competed for the clinic's top job. Dr. Topol severed his ties to industry after being embarrassed last December by an article in Fortune magazine. But the continued controversy has focused attention on the many longstanding corporate ties at the clinic. Those business links involve not only staff doctors and researchers, but also Dr. Cosgrove and the clinic's board.
The Cleveland Clinic is emblematic of the way the drug and medical device industries and the investment community work closely with medical researchers and doctors to develop and promote new medicines and technologies. Almost inevitably, such relationships raise concerns about possible conflicts of interest that could lead doctors to favor some treatments over others or to bias the results of medical research.
"It's not just the Cleveland Clinic," said Les Funtleyder, a health care strategist at the investment company Miller Tabak & Company in New York. He says other high-profile academic medical centers also have numerous financial ties that raise the potential for conflicts of interest.
Dr. Jerome P. Kassirer, a former editor in chief for The New England Journal of Medicine, describes the potential conflicts at the clinic "as extremely serious ones" but notes that the Cleveland Clinic is "not unique at all."
It was Dr. Topol's criticism of Merck that indirectly brought the clinic's conflicts to the fore. After the drug was withdrawn in September 2004 by Merck, Dr. Topol, who in journal articles had questioned the drug's cardiovascular safety, criticized the company's conduct.
Dr. Topol soon found himself under attack. He was the subject of the Fortune magazine article, which contended he had a conflict of interest. A hedge fund that listed Dr. Topol on its advisory panel had been a short seller of Merck's stock before the Vioxx withdrawal. Dr. Topol said he had nothing to do with the fund's action, which was a financial bet that the share price would fall.
Dr. Topol also found himself under fire at the clinic, where he would later claim that the chairman of the trustees, Malachi Mixon, had been contacted by Merck's chief executive at the time, Raymond V. Gilmartin. In any event, the clinic investigated Dr. Topol's business dealings, according to people briefed on the inquiry. Dr. Topol suggested in his Webcast that the clinic's pique might be related to the relationship between Mr. Gilmartin and Mr. Mixon, who attended Harvard Business School together.
Mr. Mixon, in an interview, would not discuss any conversations he had with Mr. Gilmartin on the subject. A Merck spokeswoman, however, denied that Mr. Gilmartin had ever contacted the Cleveland Clinic.
After the Fortune article, Dr. Topol publicly announced that he would cut all ties to industry, which included relationships with Eli Lilly, deCode Genetics and the Medicines Company - despite the fact that many doctors at the clinic and elsewhere had similar consulting deals.
"I think there's a real problem in academics today," he told The New York Times in January. "There's a very close-knit relationship with industry, and it's too close when any individual can derive a profit from that relationship."
The Cleveland Clinic itself was at the time finishing a set of ethical guidelines in which physicians and researchers were encouraged to continue working with industry, but were told that their ties would require reviews.
When his contract came up for renewal at the clinic at the end of last year, the clinic put Dr. Topol on a form of probation, giving him a six-month contract rather than the usual yearlong agreement, according to associates. It was a largely symbolic move, but associates said it angered Dr. Topol, who in 15 years at the clinic had been responsible for establishing the clinic's medical school and elevating the reputation of its cardiovascular medicine unit.
On the Webcast, Dr. Topol said the conflict-of-interest committee, on which he served, had looked into the financial arrangements of other doctors, including Dr. Cosgrove, as well as the fact that clinic patients were being used in tests of medical devices made by companies in which the clinic had financial interests.
Some of the clinic's perceived conflicts begin at the very top. Mr. BR Mixon, for example, is chief executive of Invacare, a major health care supply company. The company not only conducts about $200,000 a year in business with the clinic, but several people with clinic ties are on the Invacare board.
They include Dr. Bernadine Healy, the former head of the Red Cross who is married to Dr. Floyd D. Loop, the cardiac surgeon who led the clinic until he retired last year and was replaced by Dr. Cosgrove. Dr. Healy, who could not be reached for comment, owns options for 41,570 shares of stock in Invacare, according to a securities filing from earlier this year.
Mr. Mixon, who would not address other issues in this article, said his company's business dealings with the clinic constituted "peanuts" in the context of his company's overall annual revenue of about $1.5 billion.
A clinic spokeswoman, Eileen Sheil, said the clinic would not respond to questions about Mr. Mixon's company or Invacare's other board members.
Nor would the clinic address questions involving a number of Dr. Cosgrove's financial arrangements, although Ms. Sheil said he had severed those ties. In a statement, the clinic said it had begun an independent review of conflicts, to be conducted by an outside group.
Dr. Cosgrove, a well-regarded cardiac surgeon, is intimately familiar with the role physicians play in industry. His inventions include the Cosgrove-Edwards heart device, marketed by Edwards Lifesciences. The devices are used at the Cleveland Clinic, although the clinic would not discuss how or whether patients are informed of Dr. Cosgrove's connection when they are used.
Dr. Cosgrove also spearheaded the clinic's entrepreneurial efforts through a venture capital fund.
In an article last January, The New York Times described various companies in which the clinic had a financial interest, including AtriCure, the maker of a heart device. The Wall Street Journal featured AtriCure in a front-page article about the Cleveland Clinic this week.
All of this attention threatens to tarnish the clinic's image as an institution conducting world-class medical research. "All of these pieces of information coming out bit by bit are potentially damaging to the clinic's reputation," said Dr. Mildred K. Cho, a medical ethicist at Stanford University.
The clinic says its board of trustees has appointed an independent group to review the clinic's conflicts. But, in the meantime, Dr. Topol has been removed from the conflict-of-interest committee, a position he held by virtue of his leadership role at the medical college.
The publicity may prompt change, said Dr. Kassirer, the former medical journal editor. "The only question is whether it will really embarrass anyone. The clinic is so powerful, it has so much clout."
Bill Gives Immunity to Pharma, Preempts State Laws Banning Thimerosal
From A-Champ:
Frist Gives Parents the Slip Again; Leadership in Congress Muscles Drug Company Liability Provision into Unrelated Defense Bill
Take Action!
Bill Gives Immunity to Pharma; Also Preempts State Laws Banning Thimerosal
ONE MORE PUSH - THE VOTE IS TOMORROW-WED. 12-21-05
Sen. Cantwell said on the floor of Senate today that people all over the country are watching - specifically referencing the drug company immunity provisions. Your response has been overwhelming - tell your friends and family to send a message
It will make a difference. Thank you.
In the middle of the night, Senator Frist used raw political muscle to impose sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report. The language constitutes an unprecedented wish-list of liability protections that will allow the industry to recklessly injure or kill Americans with contaminated drugs and vaccines and never be held accountable. This language offers more special interest immunity than any bill ever considered by either body of the Congress. You can read the provision by going here and downloading a pdf.
http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
The language also would allow preemption of state laws providing for safe vaccines, such as laws banning mercury in vaccines. If the President or his admininistration say so this law would allow the production of vaccines containing mercury even if your state has a law banning it. The people who backed this legislation have no respect for states like California, Iowa, Illinois, Delaware, Missouri and New York, whose citizens have sent a clear message: KEEP MERCURY OUT OF VACCINES.
Below is a list of the key provisions in this bill. If any of them bother you TAKE ACTION, send a letter, or fax or use A-CHAMP's email messaging system. Use our sample letter or write your own.
http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
You can find your Senator's contact information here:
http://capwiz.com/a-champ/dbq/officials/
We especially need our Republican parents and friends to write their Senators. Without the critical support of key Republican Senators the Eli Lilly Rider, immunity legislation that was enacted in 2002, would never have been repealed. (Thank you Senators Collins, Snowe and Chafee, among others).
Key Provisions of the immunity provisions in HR 2863 that will be considered by the Senate this week (Senate number is not assigned yet).
Take Action! http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
Six objectionable things that the new immunity legislation will do:
1) Allows use of Thimerosal in vaccines:
If the Secretary of Health and Human Services designates that a vaccine is a "covered countermeasure" thimerosal can be used in the vaccine, even if your state has banned Thimerosal. Any state legislation covering vaccines would be rendered ineffective and Federal law would preempt all state provisions.
2) Immunity for ALL Drugs and Vaccines:
The language could potentially apply to any drug, vaccine, or biological product that the Secretary of HHS deems a “covered countermeasure.” This list could include any commercial drug like Tylenol and is not limited in any way to drugs or vaccines meant to treat a pandemic like avian flu.
3) Immunity at ANY Time:
The immunity language depends on the Secretary making a declaration that a health condition is causing a public health emergency or that some health condition could become an emergency at some point in the future. There is nothing that limits this declaration to an actual health emergency or to an actual pandemic illness. This declaration could occur at any time for almost any reason.
4) Immunity for Harm Caused by a Manufacturer’s Bad Conduct:
The immunity applies no matter what the drug company did wrong. Even if a drug company operates a dirty facility in which a batch of vaccines is contaminated, and that vaccine kills thousands of Americans, the drug company is immune from liability.
5) Immunity for Anything but Assault or Murder:
The language explicitly protects drug companies who act recklessly or who are grossly negligent, and would allow a claim to go forward only where a drug company acted with such willful misconduct as to constitute criminal assault or murder. Anything less than criminal conduct is protected.
6) Immunity for Murder unless the Secretary or the Attorney General Say Otherwise:
Even if a drug company has acted with “willful misconduct” as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.
Take Action to Stop this Outrageous Legislation!
Frist Gives Parents the Slip Again; Leadership in Congress Muscles Drug Company Liability Provision into Unrelated Defense Bill
Take Action!
Bill Gives Immunity to Pharma; Also Preempts State Laws Banning Thimerosal
ONE MORE PUSH - THE VOTE IS TOMORROW-WED. 12-21-05
Sen. Cantwell said on the floor of Senate today that people all over the country are watching - specifically referencing the drug company immunity provisions. Your response has been overwhelming - tell your friends and family to send a message
It will make a difference. Thank you.
In the middle of the night, Senator Frist used raw political muscle to impose sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report. The language constitutes an unprecedented wish-list of liability protections that will allow the industry to recklessly injure or kill Americans with contaminated drugs and vaccines and never be held accountable. This language offers more special interest immunity than any bill ever considered by either body of the Congress. You can read the provision by going here and downloading a pdf.
http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
The language also would allow preemption of state laws providing for safe vaccines, such as laws banning mercury in vaccines. If the President or his admininistration say so this law would allow the production of vaccines containing mercury even if your state has a law banning it. The people who backed this legislation have no respect for states like California, Iowa, Illinois, Delaware, Missouri and New York, whose citizens have sent a clear message: KEEP MERCURY OUT OF VACCINES.
Below is a list of the key provisions in this bill. If any of them bother you TAKE ACTION, send a letter, or fax or use A-CHAMP's email messaging system. Use our sample letter or write your own.
http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
You can find your Senator's contact information here:
http://capwiz.com/a-champ/dbq/officials/
We especially need our Republican parents and friends to write their Senators. Without the critical support of key Republican Senators the Eli Lilly Rider, immunity legislation that was enacted in 2002, would never have been repealed. (Thank you Senators Collins, Snowe and Chafee, among others).
Key Provisions of the immunity provisions in HR 2863 that will be considered by the Senate this week (Senate number is not assigned yet).
Take Action! http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
Six objectionable things that the new immunity legislation will do:
1) Allows use of Thimerosal in vaccines:
If the Secretary of Health and Human Services designates that a vaccine is a "covered countermeasure" thimerosal can be used in the vaccine, even if your state has banned Thimerosal. Any state legislation covering vaccines would be rendered ineffective and Federal law would preempt all state provisions.
2) Immunity for ALL Drugs and Vaccines:
The language could potentially apply to any drug, vaccine, or biological product that the Secretary of HHS deems a “covered countermeasure.” This list could include any commercial drug like Tylenol and is not limited in any way to drugs or vaccines meant to treat a pandemic like avian flu.
3) Immunity at ANY Time:
The immunity language depends on the Secretary making a declaration that a health condition is causing a public health emergency or that some health condition could become an emergency at some point in the future. There is nothing that limits this declaration to an actual health emergency or to an actual pandemic illness. This declaration could occur at any time for almost any reason.
4) Immunity for Harm Caused by a Manufacturer’s Bad Conduct:
The immunity applies no matter what the drug company did wrong. Even if a drug company operates a dirty facility in which a batch of vaccines is contaminated, and that vaccine kills thousands of Americans, the drug company is immune from liability.
5) Immunity for Anything but Assault or Murder:
The language explicitly protects drug companies who act recklessly or who are grossly negligent, and would allow a claim to go forward only where a drug company acted with such willful misconduct as to constitute criminal assault or murder. Anything less than criminal conduct is protected.
6) Immunity for Murder unless the Secretary or the Attorney General Say Otherwise:
Even if a drug company has acted with “willful misconduct” as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.
Take Action to Stop this Outrageous Legislation!
December 19, 2005
The Age of Autism: The story so far Part 1 of 3
The Age of Autism: The story so far
by Dan Olmsted
Dec 18, 2005
Part 1 of 3. In February, we began this ongoing series of articles on the roots and rise of autism. Now, at the end of the year, here's a summary of our story so far:
-- Something happened among children born in the early 1930s to bring autism to the attention of Leo Kanner, the eminent and experienced Johns Hopkins University psychiatrist who first described the disorder in a landmark 1943 paper. At the same time, a Viennese pediatrician named Hans Asperger was noticing a remarkably similar, though somewhat less severe, syndrome that came to bear his name.
In our first column, "Donald T. and Fritz V.," we found it amazing that these first two patients -- Donald in the United States and Fritz in Austria -- were born within four months of each other in 1933. Yet these unique, impossible-to-miss children with Autism Spectrum Disorders had been around in similar numbers since the dawn of time?
Experts disagree, but our first and still-tentative conclusion is that's just plain unlikely. Scattered cases, sure. But 1 in 166, the current U.S. autism rate in children? We don't see it.
-- Instead, it appears more likely something happened around 1930 to set off the age of autism. Clearly, there are clues in the striking commonalities among the first U.S. families stricken with the disorder. They were college-educated; many had advanced degrees; four of the fathers in the first 11 families identified by Kanner were medical doctors -- psychiatrists, to be precise. There were professors, lawyers, scientists, engineers. One mother was also a doctor, and all of them were smart, accomplished women.
Some think that suggests a "geek effect," in which gummed-up genes finally find each other and generate offspring who aren't just brainy and distracted, they're downright autistic. Based on our own reporting, we don't buy that -- where were all the autistic offspring of geeks before 1931, the year the oldest child ever diagnosed by Kanner was born?
Coincidence or not, 1931 appears to be the first year in which U.S. vaccines contained a mercury preservative called thimerosal, and that yields an alternate hypothesis that could explain the decisive increase in cases that we think is probable. Some parents and a minority of scientists now believe thimerosal -- which is about half ethyl mercury by weight -- is behind most autism cases, perhaps triggering the disorder in a genetic subset of children who lack the ability to excrete it.
Although it wasn't fully understood at the time, organic mercury is a potent neurotoxin in even minute quantities; beginning in 1999 thimerosal was phased out of routine childhood immunizations, though federal health authorities say it is safe in that form, and they stand by its continued use in flu shots for pregnant women and toddlers.
An alternative to the "geek theory" is that those first 11 families back in the 1930s -- especially the ones with links to the medical world -- would have had had the information, income and access to take advantage of the latest health innovations and vaccinate themselves and their children.
A related hypothesis was proposed to us by Mark Blaxill, a director of the anti-mercury-in-medicine group SafeMinds. He suggested an association
between several more of those first 11 cases and ethyl-mercury-based fungicides that came on the market at the same time, patented by the same scientist who developed thimerosal.
Case 1 in Kanner's study -- Donald T., born in 1933 -- came from an area surrounded by a forest being replanted with seedlings by the Civilian Conservation Corps.
Case 2's father was a plant pathologist. Case 3's was a forestry professor at a Southern university. Case 4's was a mining engineer. Case 8's was a chemist-lawyer at the U.S. Patent Office. All of them might have come in contact with mercury or other toxic compounds.
Given this intriguing though by no means conclusive set of associations, it's possible those parents were not in fact passing on malignant mutations of the genes that made them doctors, forestry professors, plant pathologists, chemists. Rather, through their particular professions they might have exposed their children to something wholly new in commercial medical and agricultural products, something they did not know was devastatingly neurotoxic to developing brains.
That might make the age of autism, in effect, the age of organic mercury.
Not that it proves anything, but looking back recently through the groundbreaking book "Infantile Autism" by Bernard Rimland, something struck us that we hadn't noticed before. This 1964 work is widely credited with single-handedly debunking the idea that "refrigerator mothers" or aloof fathers caused autism.
Reviewing the rare descriptions of children with autistic-type behavior prior to Kanner's 1943 paper, Rimland noted a case that "sounds very much like autism." That child's father, Rimland said, "was a Ph.D."
A professor of chemistry.
That's the kind of detail that means nothing to the experts looking for incredibly complex gene interactions to explain autism, but it makes our layman's hair stand on end.
As we pressed to find more about those early cases, the trail led all the way back to Case 1 himself, and to a small town in Mississippi.
We'll go there next.
Dan Olmsted is a UPI Senior Editor
by Dan Olmsted
Dec 18, 2005
Part 1 of 3. In February, we began this ongoing series of articles on the roots and rise of autism. Now, at the end of the year, here's a summary of our story so far:
-- Something happened among children born in the early 1930s to bring autism to the attention of Leo Kanner, the eminent and experienced Johns Hopkins University psychiatrist who first described the disorder in a landmark 1943 paper. At the same time, a Viennese pediatrician named Hans Asperger was noticing a remarkably similar, though somewhat less severe, syndrome that came to bear his name.
In our first column, "Donald T. and Fritz V.," we found it amazing that these first two patients -- Donald in the United States and Fritz in Austria -- were born within four months of each other in 1933. Yet these unique, impossible-to-miss children with Autism Spectrum Disorders had been around in similar numbers since the dawn of time?
Experts disagree, but our first and still-tentative conclusion is that's just plain unlikely. Scattered cases, sure. But 1 in 166, the current U.S. autism rate in children? We don't see it.
-- Instead, it appears more likely something happened around 1930 to set off the age of autism. Clearly, there are clues in the striking commonalities among the first U.S. families stricken with the disorder. They were college-educated; many had advanced degrees; four of the fathers in the first 11 families identified by Kanner were medical doctors -- psychiatrists, to be precise. There were professors, lawyers, scientists, engineers. One mother was also a doctor, and all of them were smart, accomplished women.
Some think that suggests a "geek effect," in which gummed-up genes finally find each other and generate offspring who aren't just brainy and distracted, they're downright autistic. Based on our own reporting, we don't buy that -- where were all the autistic offspring of geeks before 1931, the year the oldest child ever diagnosed by Kanner was born?
Coincidence or not, 1931 appears to be the first year in which U.S. vaccines contained a mercury preservative called thimerosal, and that yields an alternate hypothesis that could explain the decisive increase in cases that we think is probable. Some parents and a minority of scientists now believe thimerosal -- which is about half ethyl mercury by weight -- is behind most autism cases, perhaps triggering the disorder in a genetic subset of children who lack the ability to excrete it.
Although it wasn't fully understood at the time, organic mercury is a potent neurotoxin in even minute quantities; beginning in 1999 thimerosal was phased out of routine childhood immunizations, though federal health authorities say it is safe in that form, and they stand by its continued use in flu shots for pregnant women and toddlers.
An alternative to the "geek theory" is that those first 11 families back in the 1930s -- especially the ones with links to the medical world -- would have had had the information, income and access to take advantage of the latest health innovations and vaccinate themselves and their children.
A related hypothesis was proposed to us by Mark Blaxill, a director of the anti-mercury-in-medicine group SafeMinds. He suggested an association
between several more of those first 11 cases and ethyl-mercury-based fungicides that came on the market at the same time, patented by the same scientist who developed thimerosal.
Case 1 in Kanner's study -- Donald T., born in 1933 -- came from an area surrounded by a forest being replanted with seedlings by the Civilian Conservation Corps.
Case 2's father was a plant pathologist. Case 3's was a forestry professor at a Southern university. Case 4's was a mining engineer. Case 8's was a chemist-lawyer at the U.S. Patent Office. All of them might have come in contact with mercury or other toxic compounds.
Given this intriguing though by no means conclusive set of associations, it's possible those parents were not in fact passing on malignant mutations of the genes that made them doctors, forestry professors, plant pathologists, chemists. Rather, through their particular professions they might have exposed their children to something wholly new in commercial medical and agricultural products, something they did not know was devastatingly neurotoxic to developing brains.
That might make the age of autism, in effect, the age of organic mercury.
Not that it proves anything, but looking back recently through the groundbreaking book "Infantile Autism" by Bernard Rimland, something struck us that we hadn't noticed before. This 1964 work is widely credited with single-handedly debunking the idea that "refrigerator mothers" or aloof fathers caused autism.
Reviewing the rare descriptions of children with autistic-type behavior prior to Kanner's 1943 paper, Rimland noted a case that "sounds very much like autism." That child's father, Rimland said, "was a Ph.D."
A professor of chemistry.
That's the kind of detail that means nothing to the experts looking for incredibly complex gene interactions to explain autism, but it makes our layman's hair stand on end.
As we pressed to find more about those early cases, the trail led all the way back to Case 1 himself, and to a small town in Mississippi.
We'll go there next.
Dan Olmsted is a UPI Senior Editor
December 17, 2005
Wade Looks At Environmental Mercury and Autism
Wade Rankin is again Injecting Sense into the mercury discussion with his review of the Texas study on mercury emissions and their correlation to special ed and autism rates.
December 16, 2005
Up To $16 Million In Drug Company Stock Investments Conflict 42 U.S. Senators Out of Vaccine Vote
Up To $16 Million In Drug Company Stock Investments Conflict 42 U.S. Senators Out of Vaccine Vote, Says FTCR
SANTA MONICA, Calif., Dec. 13 /U.S. Newswire/ -- Forty-two U.S. Senators hold stock in pharmaceutical companies even as they vote on legislation to benefit the drug industry, according to an analysis released today by the nonprofit, nonpartisan Foundation for Taxpayer and Consumer Rights (FTCR). The Senate is expected to vote this week on an eleventh-hour amendment to immunize vaccine makers for dangerous drugs. Senators should not participate in votes from which they will financially benefit, said FTCR.
FTCR's analysis of Senate personal financial disclosures reveals that 42 senators -- 27 Republicans and 15 Democrats -- held pharmaceutical stock worth between $8.1 and $16 million in 2004. Senators earned an additional $2.5 to $7.2 million in capital gains and dividends, and two senators' spouses also earned salaries from pharmaceuticals. View the analysis at: http://www.consumerwatchdog.org/resources/SenPharma.pdf.
"Senators can't ethically support a giveaway deal for the pharmaceutical industry when their own financial interests match those of the drug companies," said Carmen Balber, consumer advocate with FTCR. "A financial interest in the outcome of legislation should conflict any politician out of the vote."
The GOP-backed amendment would grant immunity to drug companies for any vaccine or product, classified by the Bush Administration as necessary to respond to a public health threat, when patients are harmed by dangerous drugs. The amendment is so broad that any product considered a "countermeasure," not just vaccines, could be protected.
Senate Majority Leader Frist aims to make the provision an amendment to a conference report that cannot be altered. Frist's blind trust included stock in drug companies Abbott Laboratories and Johnson & Johnson through 2004, each worth $15,000 to $50,000 when the trust was created.
In July, Rep. F. James Sensenbrenner (news, bio, voting record) (R-Wis.) recused himself from a vote on medical malpractice legislation that would have benefited the pharmaceutical industry because his millions in drug company stock create the appearance of a conflict of interest.
"It's time the U.S. Senate met the Sensenbrenner standard," said Balber.
The pharmaceutical industry was the largest industry donor to Frist's National Republican Senatorial Committee, and the industry has given 64 percent to 74 percent of its federal contributions to Republicans every year for the last decade according to the Center for Responsive Politics.
Congressional leaders tried to provide liability protection for the makers of the vaccine additive Thimerosal in 2002 with an amendment to Homeland Security legislation based on legislation Frist carried. Frist denied involvement, but public backlash forced the Senate to remove the immunity provision.
FTCR filed an ethics complaint with the Senate Select Ethics Committee last April charging Frist with a conflict of interest for promoting medical malpractice liability limits while retaining stock worth millions in the hospital corporation, HCA. HCA owns the nation's fourth largest malpractice insurer. Read the complaint at: http://www.consumerwatchdog.org/malpractice/pr/?postId=1882.
FTCR called for an SEC investigation this summer when Sen. Frist ordered the well-timed sale of his HCA stock. The Justice Department and SEC are investigating the Senator's stock sale for insider trading. Read the SEC letter at: http://www.consumerwatchdog.org/resources/Frist_SEC.pdf.
SANTA MONICA, Calif., Dec. 13 /U.S. Newswire/ -- Forty-two U.S. Senators hold stock in pharmaceutical companies even as they vote on legislation to benefit the drug industry, according to an analysis released today by the nonprofit, nonpartisan Foundation for Taxpayer and Consumer Rights (FTCR). The Senate is expected to vote this week on an eleventh-hour amendment to immunize vaccine makers for dangerous drugs. Senators should not participate in votes from which they will financially benefit, said FTCR.
FTCR's analysis of Senate personal financial disclosures reveals that 42 senators -- 27 Republicans and 15 Democrats -- held pharmaceutical stock worth between $8.1 and $16 million in 2004. Senators earned an additional $2.5 to $7.2 million in capital gains and dividends, and two senators' spouses also earned salaries from pharmaceuticals. View the analysis at: http://www.consumerwatchdog.org/resources/SenPharma.pdf.
"Senators can't ethically support a giveaway deal for the pharmaceutical industry when their own financial interests match those of the drug companies," said Carmen Balber, consumer advocate with FTCR. "A financial interest in the outcome of legislation should conflict any politician out of the vote."
The GOP-backed amendment would grant immunity to drug companies for any vaccine or product, classified by the Bush Administration as necessary to respond to a public health threat, when patients are harmed by dangerous drugs. The amendment is so broad that any product considered a "countermeasure," not just vaccines, could be protected.
Senate Majority Leader Frist aims to make the provision an amendment to a conference report that cannot be altered. Frist's blind trust included stock in drug companies Abbott Laboratories and Johnson & Johnson through 2004, each worth $15,000 to $50,000 when the trust was created.
In July, Rep. F. James Sensenbrenner (news, bio, voting record) (R-Wis.) recused himself from a vote on medical malpractice legislation that would have benefited the pharmaceutical industry because his millions in drug company stock create the appearance of a conflict of interest.
"It's time the U.S. Senate met the Sensenbrenner standard," said Balber.
The pharmaceutical industry was the largest industry donor to Frist's National Republican Senatorial Committee, and the industry has given 64 percent to 74 percent of its federal contributions to Republicans every year for the last decade according to the Center for Responsive Politics.
Congressional leaders tried to provide liability protection for the makers of the vaccine additive Thimerosal in 2002 with an amendment to Homeland Security legislation based on legislation Frist carried. Frist denied involvement, but public backlash forced the Senate to remove the immunity provision.
FTCR filed an ethics complaint with the Senate Select Ethics Committee last April charging Frist with a conflict of interest for promoting medical malpractice liability limits while retaining stock worth millions in the hospital corporation, HCA. HCA owns the nation's fourth largest malpractice insurer. Read the complaint at: http://www.consumerwatchdog.org/malpractice/pr/?postId=1882.
FTCR called for an SEC investigation this summer when Sen. Frist ordered the well-timed sale of his HCA stock. The Justice Department and SEC are investigating the Senator's stock sale for insider trading. Read the SEC letter at: http://www.consumerwatchdog.org/resources/Frist_SEC.pdf.
December 15, 2005
The Age of Autism: Question of the year
The Age of Autism: Question of the year
By DAN OLMSTED
UPI Senior Editor
This was the year Big Media pitted parents against experts over whether vaccines cause autism -- and decided the experts are right. But they may have forgotten to ask an embarrassingly obvious question.
In its new issue on medicine in 2005, Time weighs in: "The idea that childhood vaccinations might lead to autism has gained currency among some concerned parents, fueled by unsubstantiated reports on the Internet. .. Most scientists are convinced that the shots are safe."
There you have it -- a more telling summary perhaps than Time intended. This was the year of "Parents vs. Research," as the equally estimable New York Times put it in a front-page headline in June.
But beneath this seemingly intractable fault line, the earth has been shifting. One major temblor: The April book "Evidence of Harm" by David Kirby, which painted those parents as armed not just with eyewitness accounts but their own critique of the experts' conflicts and flaws.
In our last column we summarized our take on the issue this way: If you're going to tell those parents it's time to shut up and leave the science to the scientists, where is the simple, straightforward study of autism in never-vaccinated U.S. children?
Given the sheer certitude of federal health authorities and mainstream medical groups such as the American Medical Association and the American Academy of Pediatrics, we were surprised we couldn't find comparisons between real-live American kids who've gotten vaccines, and those who haven't. Officials say such a study would be hard to do, in part because so many kids are vaccinated that you couldn't find a "control group" of kids who aren't.
We found tens, perhaps hundreds of thousands.
Our search started among the mostly unvaccinated Amish in Pennsylvania, Ohio and Indiana; moved on to homeschooling families who choose not to vaccinate for religious religions, and wound up in Chicago, where we reported on a medical practice with thousands of unvaccinated children. We didn't find much autism.
That "finding" -- we use quotes because we know it's not scientific -- has fallen on deaf ears, at least as far as the rest of the media is concerned. Time, the New York Times, the Washington Post -- no major newspaper or magazine has so much as paused to wonder whether never-vaccinated Americans have autism at anywhere near the rate of the rest of the population.
Two exceptions: Robert F. Kennedy Jr., in an article in Rolling Stone and on Salon.com, cited the Amish. And Daniel Schulman, in a groundbreaking piece in the Columbia Journalism Review, did the same thing while portraying the media as perhaps too willing to treat what the "experts" say as revealed truth.
While most journalists seem oblivious to the issue, it continues to resonate with those who suspect vaccines -- perhaps via the mercury-based preservative thimerosal -- triggered an autism epidemic:
-- "Those of you who have been following me over the years know that my mantra has always been that there are almost no vaccine safety or efficacy studies using never vaccinated children as controls," wrote Sandy Mintz at vaccinationnews.com. "It has long been my hope that I would somehow be able to make that point to the right person or persons, to appeal to someone who might have the ability to seriously address the problem."
Mintz got her chance at a congressional hearing in 2002.
"Hi. My name is Sandy Mintz. I am from Anchorage, Alaska. I am lucky enough not to have a child who has been injured by a vaccine. My question is, is NIH (National Institutes of Health) ever planning on doing a study using the only proper control group, that is, never vaccinated children?"
Dr. Steve Foote of NIH responded: "I am not aware of -- but note carefully what I said, that I am not aware of -- a proposed study to use a suitably constructed group of never vaccinated children. Now CDC would be more likely perhaps to be aware of such an opportunity."
Responded Dr. Melinda Wharton of the CDC: "The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult."
In her Web posting, Mintz disagreed:
"1) There are more than enough never vaccinated children in the states which allow philosophical exemptions to conduct a proper study.
"2) If children who have not been vaccinated are different in ways that prevent them from getting autism, wouldn't we want to know that?
"Well, wouldn't we?"
-- "There have never been any large, prospective, long-term studies comparing the long-term health of highly vaccinated individuals versus those who have never been vaccinated at all," Barbara Loe Fisher of the National Vaccine Information Center wrote in Mothering Magazine last year.
"Therefore, the background rates for ADHD, learning disabilities, autism, seizure disorders, asthma, diabetes, intestinal bowel disorders, rheumatoid arthritis, and other brain and immune-system dysfunction in a genetically diverse unvaccinated population remains unknown."
-- "Why hasn't the most obvious research been done -- that is, assess the incidence of autism in unvaccinated children?" wrote Illinois autism activist Dr. David Ayoub this fall.
-- Kennedy, in a white paper called "Tobacco Science and the Thimerosal Scandal," quotes University of Kentucky chemistry professor Boyd Haley as saying, "If the CDC were really interested in uncovering the truth, it would commission epidemiological studies of cohorts who escaped vaccination, most obviously the children of Jehovah's Witnesses, Christian Scientists or the Amish."
Instead, Kennedy said, the CDC has "worked furiously to quash such studies" and prevent access to its own vaccine safety database -- a charge the CDC denies. Kennedy said he asked an official at the Institute of Medicine -- which last year rejected a vaccines-autism link -- why it didn't encourage those studies rather than recommend research money be redirected.
"That's a great idea, no one has ever suggested it before," Kennedy quoted the official as saying. Kennedy commented: "That statement is incredible. ... The idea of finding an uncontaminated U.S. cohort is Science 101. ... In fact, Dr. Boyd Haley has repeatedly urged IOM and CDC to conduct such a study, including at two public and tape-recorded meetings."
All these people are saying the same thing: Given the stakes, where's the study? This winter the government wants all pregnant women and 6-to-23-month-olds to get flu shots, most of which contain thimerosal.
What's more, as we pointed out in our last column, tens of millions of children worldwide are being injected with thimerosal-containing vaccines every year, largely due to the reassurances of U.S. public health authorities and allied experts like the IOM.
Maybe 2006 will be the year journalists ask them about the autism rate in never-vaccinated American kids. That would be the question of the year.
--
E-mail: dolmsted@upi.com
By DAN OLMSTED
UPI Senior Editor
This was the year Big Media pitted parents against experts over whether vaccines cause autism -- and decided the experts are right. But they may have forgotten to ask an embarrassingly obvious question.
In its new issue on medicine in 2005, Time weighs in: "The idea that childhood vaccinations might lead to autism has gained currency among some concerned parents, fueled by unsubstantiated reports on the Internet. .. Most scientists are convinced that the shots are safe."
There you have it -- a more telling summary perhaps than Time intended. This was the year of "Parents vs. Research," as the equally estimable New York Times put it in a front-page headline in June.
But beneath this seemingly intractable fault line, the earth has been shifting. One major temblor: The April book "Evidence of Harm" by David Kirby, which painted those parents as armed not just with eyewitness accounts but their own critique of the experts' conflicts and flaws.
In our last column we summarized our take on the issue this way: If you're going to tell those parents it's time to shut up and leave the science to the scientists, where is the simple, straightforward study of autism in never-vaccinated U.S. children?
Given the sheer certitude of federal health authorities and mainstream medical groups such as the American Medical Association and the American Academy of Pediatrics, we were surprised we couldn't find comparisons between real-live American kids who've gotten vaccines, and those who haven't. Officials say such a study would be hard to do, in part because so many kids are vaccinated that you couldn't find a "control group" of kids who aren't.
We found tens, perhaps hundreds of thousands.
Our search started among the mostly unvaccinated Amish in Pennsylvania, Ohio and Indiana; moved on to homeschooling families who choose not to vaccinate for religious religions, and wound up in Chicago, where we reported on a medical practice with thousands of unvaccinated children. We didn't find much autism.
That "finding" -- we use quotes because we know it's not scientific -- has fallen on deaf ears, at least as far as the rest of the media is concerned. Time, the New York Times, the Washington Post -- no major newspaper or magazine has so much as paused to wonder whether never-vaccinated Americans have autism at anywhere near the rate of the rest of the population.
Two exceptions: Robert F. Kennedy Jr., in an article in Rolling Stone and on Salon.com, cited the Amish. And Daniel Schulman, in a groundbreaking piece in the Columbia Journalism Review, did the same thing while portraying the media as perhaps too willing to treat what the "experts" say as revealed truth.
While most journalists seem oblivious to the issue, it continues to resonate with those who suspect vaccines -- perhaps via the mercury-based preservative thimerosal -- triggered an autism epidemic:
-- "Those of you who have been following me over the years know that my mantra has always been that there are almost no vaccine safety or efficacy studies using never vaccinated children as controls," wrote Sandy Mintz at vaccinationnews.com. "It has long been my hope that I would somehow be able to make that point to the right person or persons, to appeal to someone who might have the ability to seriously address the problem."
Mintz got her chance at a congressional hearing in 2002.
"Hi. My name is Sandy Mintz. I am from Anchorage, Alaska. I am lucky enough not to have a child who has been injured by a vaccine. My question is, is NIH (National Institutes of Health) ever planning on doing a study using the only proper control group, that is, never vaccinated children?"
Dr. Steve Foote of NIH responded: "I am not aware of -- but note carefully what I said, that I am not aware of -- a proposed study to use a suitably constructed group of never vaccinated children. Now CDC would be more likely perhaps to be aware of such an opportunity."
Responded Dr. Melinda Wharton of the CDC: "The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult."
In her Web posting, Mintz disagreed:
"1) There are more than enough never vaccinated children in the states which allow philosophical exemptions to conduct a proper study.
"2) If children who have not been vaccinated are different in ways that prevent them from getting autism, wouldn't we want to know that?
"Well, wouldn't we?"
-- "There have never been any large, prospective, long-term studies comparing the long-term health of highly vaccinated individuals versus those who have never been vaccinated at all," Barbara Loe Fisher of the National Vaccine Information Center wrote in Mothering Magazine last year.
"Therefore, the background rates for ADHD, learning disabilities, autism, seizure disorders, asthma, diabetes, intestinal bowel disorders, rheumatoid arthritis, and other brain and immune-system dysfunction in a genetically diverse unvaccinated population remains unknown."
-- "Why hasn't the most obvious research been done -- that is, assess the incidence of autism in unvaccinated children?" wrote Illinois autism activist Dr. David Ayoub this fall.
-- Kennedy, in a white paper called "Tobacco Science and the Thimerosal Scandal," quotes University of Kentucky chemistry professor Boyd Haley as saying, "If the CDC were really interested in uncovering the truth, it would commission epidemiological studies of cohorts who escaped vaccination, most obviously the children of Jehovah's Witnesses, Christian Scientists or the Amish."
Instead, Kennedy said, the CDC has "worked furiously to quash such studies" and prevent access to its own vaccine safety database -- a charge the CDC denies. Kennedy said he asked an official at the Institute of Medicine -- which last year rejected a vaccines-autism link -- why it didn't encourage those studies rather than recommend research money be redirected.
"That's a great idea, no one has ever suggested it before," Kennedy quoted the official as saying. Kennedy commented: "That statement is incredible. ... The idea of finding an uncontaminated U.S. cohort is Science 101. ... In fact, Dr. Boyd Haley has repeatedly urged IOM and CDC to conduct such a study, including at two public and tape-recorded meetings."
All these people are saying the same thing: Given the stakes, where's the study? This winter the government wants all pregnant women and 6-to-23-month-olds to get flu shots, most of which contain thimerosal.
What's more, as we pointed out in our last column, tens of millions of children worldwide are being injected with thimerosal-containing vaccines every year, largely due to the reassurances of U.S. public health authorities and allied experts like the IOM.
Maybe 2006 will be the year journalists ask them about the autism rate in never-vaccinated American kids. That would be the question of the year.
--
E-mail: dolmsted@upi.com
December 13, 2005
Chicago Tribune: The Mercury Menace
TRIBUNE INVESTIGATION: THE MERCURY MENACE
U.S. safety net in tatters
Seafood shoppers are at risk for mercury exposure as regulators ignore their own experts, issue flawed warnings and set policies aiding industry
By Michael Hawthorne and Sam Roe
Chicago Tribune staff reporters
December 12, 2005
Shipped from Singapore, the swordfish entered the U.S. this year without being tested for the toxic metal mercury.
When a fillet from that fish reached a display case at a supermarket in suburban Des Plaines, it carried no government warning labels, even though federal officials know swordfish often is so contaminated that young children and pregnant women should never eat it.
And when the Tribune bought and tested this particular piece of fish, the results showed not just high amounts of mercury, but levels three times the legal limit.
This repeated neglect by the U.S. government--the lack of mercury testing, the failure to adequately warn consumers, the unwillingness to enforce its own rules--has unnecessarily put Americans at risk for decades, a Tribune investigation shows.
Year after year, the federal government has failed to fully disclose the hazards of mercury in fish to the public.
In some cases, regulators have ignored the advice of their own scientists who concluded that mercury was far more dangerous than what consumers were being told.
In other instances, regulators have made decisions that benefited the fishing industry at the expense of public health.
Even though mercury can cause learning disabilities in children and neurological problems in adults, regulators do not even bother to routinely check fish for the metal. This leaves consumers with little idea about which fish are most hazardous.
Although regulators have issued numerous warnings for fish caught recreationally, they have rarely done so for seafood sold in supermarkets, where most people buy their fish.
The U.S. government's only guide for consumers--a mercury warning posted on federal Web sites but not required in stores--is so flawed and misleading that people following the advice still could expose themselves to too much of the toxic metal.
The Food and Drug Administration, the agency responsible for the safety of commercial seafood, does not dispute recent studies showing that consumers might be harmed by relatively low levels of mercury. But the government's permissible mercury limit in fish has remained the same for 25 years.
That limit remains one of the weakest in the Western world. For example, fish sold in America is allowed to have twice as much mercury as seafood sold in Canada.
The American standard "reflects the science of the 1970s," said Kathryn Mahaffey, a top scientist at the U.S. Environmental Protection Agency and co-author of an agency report to Congress on mercury. "The science has changed, but the standard hasn't changed with the science."
In a series of interviews with the Tribune, the FDA defended its handling of the mercury issue, saying its decisions are based on the best scientific evidence available at the time.
"Am I pleased with the way our department has handled this issue? Yes," said David Acheson, the FDA's chief medical officer. "Outstanding job all around."
Acheson noted that the agency does not want to scare people away from eating fish because seafood is a low-fat source of protein and offers many other health benefits.
The FDA has a limited budget, he said, making it difficult to regularly inspect fish at ports or supermarkets for mercury contamination--or even to enforce the agency's own rules.
"Going out and using our resources to test individual fish, with the goal of protecting public health, is not a good use of our tax dollars," Acheson said. The agency is well aware, he said, that some species contain high levels of mercury and has tested enough of those fish to decide how best to protect the public.
But Acheson acknowledged more testing is needed for certain kinds of fish. The agency is taking 15 samples each of 29 species of fish this year to address the lack of information, he said.
The FDA's main strategy to protect consumers from mercury has been to issue warnings, though those advisories have been criticized as inadequate.
Last year, the FDA and the EPA jointly warned pregnant women, nursing mothers, women of childbearing age and young children not to eat shark, swordfish, king mackerel and tilefish because of high mercury levels. The warning also cautioned those groups to consume no more than 12 ounces of fish a week, including no more than 6 ounces of canned albacore tuna.
But a former senior EPA toxicologist said the advice fails to reflect the government's own calculations about how much fish--and what kinds of fish--people can safely eat each week.
The warning "was not based on science," said Deborah Rice, who helped develop the government's mercury exposure limit for the EPA and now works for the state of Maine.
Mercury's hazards have been known for centuries. In the 1800s, hatmakers using a compound of the silvery, liquid metal to shape wool hats developed trembling, twitching and other symptoms that people associated with madness. Hence, the term "mad as a hatter."
But the risks in seafood did not fully come to light until the 1950s, when a bizarre tragedy unfolded in the Japanese fishing village of Minamata. Residents noticed cats were stumbling about, sometimes collapsing into the bay and drowning. Locals called it the "cat dancing" disease.
People later learned that a nearby chemical plant had dumped tons of mercury into the bay, contaminating the fish and those who ate it, including the cats. Dozens of people died; some women gave birth to babies who were severely disabled and scores suffered a range of neurological problems.
The scientific world was slow to recognize the implications of the Minamata disaster for other people exposed to mercury at much lower levels. It was not until a decade later, in 1969, that the FDA set a guideline for the amount of mercury allowed in commercial fish.
The following year, testing led the FDA to order more than 12 million cans of tuna off store shelves and to urge all Americans to stop eating swordfish.
But the agency's crackdown on mercury would be short-lived.
AFTER COURT BATTLE, FDA EASES RULES
In the summer of 1977, in a rural Florida Panhandle courtroom, four swordfish went on trial.
On one side of the room was the FDA, which had seized the fish from a seafood warehouse in Panama City. FDA officials said the swordfish had mercury levels nearly twice the permissible limit and represented a health threat.
On the other side were lawyers for the nation's swordfish distributors, who had sued to block the government's seizure. The industry argued that mercury in swordfish came from natural, not man-made, sources and therefore could not be regulated under the nation's food-safety laws.
After a four-day trial featuring scientists who debated how much mercury it takes to cause neurological harm in children, a federal judge sided with the fishing industry. Though he ruled that the four swordfish were indeed contaminated by man-made pollution, he said Americans did not eat enough of the fish to be at risk.
More significantly, he dramatically weakened the rules on how much mercury would be acceptable in swordfish.
Pointing to a pair of studies presented at the trial, the judge increased the allowable amount of mercury from 0.5 to 1 part per million in fish tissue--a number slightly above the average level found in the four swordfish, court records show. Under this new standard, the four swordfish would be legal.
Although the judge and an appellate court that upheld his decision agreed the limit could change based on future research, the FDA backed off.
"They left us alone after that," recalled Charles Anderson, the fisherman whose company owned the swordfish on trial.
Instead of fighting for tougher standards, the FDA applied the court-ordered mercury limit to all seafood sold in America.
Announcing the change in the Federal Register in 1979, the FDA said new data showed that consumers were not exposing themselves to as much mercury as officials had estimated when they set the more stringent 0.5 guideline a decade earlier. The FDA said the new data came from a report by the National Marine Fisheries Service, an arm of the Commerce Department.
But the FDA highlighted one aspect of that report that had nothing to do with public health.
Relaxing the acceptable level of mercury in fish, the report said, would "provide a significant economic benefit to those industries most seriously affected" by the more stringent limit and "enhance the future development of a number of presently underutilized fisheries."
Moreover, the report said, a less restrictive rule "would significantly increase consumer confidence in seafood."
AS FISH SALES BOOM, TESTING STOPS
The report proved to be prophetic. With the relaxed rules in place, the seafood industry boomed. After decades of stagnant growth, fish consumption grew 20 percent from 1980 to 1990.
One reason was America's fitness craze. People were joining gyms, health food stores were popping up and doctors were recommending fish as a high-protein, heart-healthy food.
During these years, the FDA did virtually nothing to warn people of the mercury threat. Nor did the agency test any fish for mercury throughout the 1980s, according to FDA data.
The agency also conducted little basic research, such as studies to determine which fish have the most mercury or whether there were high-mercury "hot spots" in the oceans that fishing boats should avoid.
It took a sharply critical 1991 report from the National Academy of Sciences, the nation's leading scientific advisory body, to coax the FDA to resume significant testing of fish for mercury.
The agency promised several times during the 1990s to re-evaluate its mercury limit in fish. But the FDA never changed it, even though other government scientists were concluding the metal was far more harmful than previously thought.
Once again, an important calculation--this one aimed at determining how much mercury can be safely consumed--was at the center of a debate.
In 1997 the EPA, the agency responsible for monitoring recreationally caught fish, recommended a mercury-exposure limit in people based on the most recent scientific studies about the health risks.
The EPA took a far stricter approach than the FDA did in setting its safety standard for mercury, concluding that a person could safely ingest only 0.1 grams of mercury per kilogram of body weight each day. The FDA's equivalent was 0.4.
When the National Academy of Sciences weighed in again on the mercury issue by endorsing the EPA findings, the FDA responded in 2001 with a consumer warning, cautioning high-risk groups not to eat certain fish and to limit their consumption of all seafood.
But the FDA warning did not reflect the EPA's science on what constitutes acceptable exposure to mercury. Based on the FDA's own testing, many consumers following the agency's advisory still could absorb too much of the toxic metal.
For example, if a 161-pound woman--the average weight of U.S. females of childbearing age--ate 12 ounces of lobster in a week, she would expose herself, on average, to twice as much mercury as what the EPA considered acceptable. If she ate 12 ounces of orange roughy, or about two meals, she would be three times over the limit.
Under pressure from environmental groups and public health advocates, the FDA decided in 2002 to work with the EPA to issue a new warning that the FDA said would be based on the best available science.
After two years of meetings, the agencies released, with great fanfare, a rare joint public health warning, cautioning Americans about the risks of mercury in both commercial and recreationally caught fish.
But again, the warning was deeply flawed.
While it advised people to limit consumption of canned albacore tuna, it did not warn about other fish that, according to the government's own data, contained even more mercury, such as grouper, orange roughy and marlin.
More important, the warning still did not reflect the EPA's exposure limit. Many consumers following the advice would still expose themselves to too much mercury even by eating one meal of fish a week.
In interviews with the Tribune, Acheson, the FDA's chief medical officer, said the agency used the EPA limit as a guide but did not view it as a clear line between risk and no-risk.
He said the joint mercury warning, which is still used today, had to "strike an important balance between the benefits of eating fish and the risks of exposure to mercury. It's not as simple as `avoid fish because it has mercury in it.'"
Top EPA officials signed off on the joint warning even though it contradicted the agency's own science. Benjamin Grumbles, an EPA assistant administrator, said in an interview that the warning was not meant to be the "final say on the matter."
When asked if the joint mercury warning protects consumers, he said, "It's an important and protective step forward."
STATES STEP IN WHERE FEDS FAIL TO ACT
In recent years, the major government effort to crack down on mercury in fish has come not from the FDA, but from states.
Several states have issued more-restrictive advice about mercury in commercial seafood than the federal government.
Based on its own review of the FDA's data about mercury levels in fish, Washington state urges women of childbearing age and children 6 and younger to not eat fresh or frozen tuna at all, and to limit eating canned tuna based on how much they weigh.
Wisconsin and Minnesota recommend that at-risk groups limit consumption of halibut, tuna steak and canned albacore tuna to two meals a month. Minnesota also extends the warning to lobster.
In 2003, California successfully sued to get several supermarket chains to post mercury advisories throughout the state.
One of the firms, Safeway, began this fall to place warnings in its stores nationally, including Dominick's, a dominant grocery chain in the Chicago area. Two other chains, Jewel and Whole Foods Market, have begun posting versions of the warning in some stores.
The federal government has promised to take additional steps of its own. As recently as 2001, the FDA vowed in an agency policy handbook to take legal action to remove seafood from the market if it exceeded the federal mercury limit of 1 part per million. But it has not done so--and it has not even conducted enough tests to determine which fish are in violation.
In recent interviews, the FDA said it had no immediate plans to start routine testing of fish, improve warnings or re-evaluate its mercury limit. For now, agency officials said, they will continue to focus on educating consumers.
Many who have closely followed the issue said the FDA's outreach has been tepid at best. Michael Shannon, a pediatrician at Children's Hospital in Boston who sat on an FDA panel that advised the agency on its recent mercury warnings, questioned whether the government has effectively informed the public.
"I read the FDA Web sites," he said, "but you would be amazed at how few people in the American public do."
FDA and EPA officials defend their educational efforts. "We have done a very good job with outreach," the FDA's Acheson said.
The agencies said that in addition to posting information online, they are distributing 6 million mercury pamphlets to doctors, nurses and other health professionals in every state.
The central feature of the pamphlets: the same government warning that fails to adequately protect consumers.
U.S. safety net in tatters
Seafood shoppers are at risk for mercury exposure as regulators ignore their own experts, issue flawed warnings and set policies aiding industry
By Michael Hawthorne and Sam Roe
Chicago Tribune staff reporters
December 12, 2005
Shipped from Singapore, the swordfish entered the U.S. this year without being tested for the toxic metal mercury.
When a fillet from that fish reached a display case at a supermarket in suburban Des Plaines, it carried no government warning labels, even though federal officials know swordfish often is so contaminated that young children and pregnant women should never eat it.
And when the Tribune bought and tested this particular piece of fish, the results showed not just high amounts of mercury, but levels three times the legal limit.
This repeated neglect by the U.S. government--the lack of mercury testing, the failure to adequately warn consumers, the unwillingness to enforce its own rules--has unnecessarily put Americans at risk for decades, a Tribune investigation shows.
Year after year, the federal government has failed to fully disclose the hazards of mercury in fish to the public.
In some cases, regulators have ignored the advice of their own scientists who concluded that mercury was far more dangerous than what consumers were being told.
In other instances, regulators have made decisions that benefited the fishing industry at the expense of public health.
Even though mercury can cause learning disabilities in children and neurological problems in adults, regulators do not even bother to routinely check fish for the metal. This leaves consumers with little idea about which fish are most hazardous.
Although regulators have issued numerous warnings for fish caught recreationally, they have rarely done so for seafood sold in supermarkets, where most people buy their fish.
The U.S. government's only guide for consumers--a mercury warning posted on federal Web sites but not required in stores--is so flawed and misleading that people following the advice still could expose themselves to too much of the toxic metal.
The Food and Drug Administration, the agency responsible for the safety of commercial seafood, does not dispute recent studies showing that consumers might be harmed by relatively low levels of mercury. But the government's permissible mercury limit in fish has remained the same for 25 years.
That limit remains one of the weakest in the Western world. For example, fish sold in America is allowed to have twice as much mercury as seafood sold in Canada.
The American standard "reflects the science of the 1970s," said Kathryn Mahaffey, a top scientist at the U.S. Environmental Protection Agency and co-author of an agency report to Congress on mercury. "The science has changed, but the standard hasn't changed with the science."
In a series of interviews with the Tribune, the FDA defended its handling of the mercury issue, saying its decisions are based on the best scientific evidence available at the time.
"Am I pleased with the way our department has handled this issue? Yes," said David Acheson, the FDA's chief medical officer. "Outstanding job all around."
Acheson noted that the agency does not want to scare people away from eating fish because seafood is a low-fat source of protein and offers many other health benefits.
The FDA has a limited budget, he said, making it difficult to regularly inspect fish at ports or supermarkets for mercury contamination--or even to enforce the agency's own rules.
"Going out and using our resources to test individual fish, with the goal of protecting public health, is not a good use of our tax dollars," Acheson said. The agency is well aware, he said, that some species contain high levels of mercury and has tested enough of those fish to decide how best to protect the public.
But Acheson acknowledged more testing is needed for certain kinds of fish. The agency is taking 15 samples each of 29 species of fish this year to address the lack of information, he said.
The FDA's main strategy to protect consumers from mercury has been to issue warnings, though those advisories have been criticized as inadequate.
Last year, the FDA and the EPA jointly warned pregnant women, nursing mothers, women of childbearing age and young children not to eat shark, swordfish, king mackerel and tilefish because of high mercury levels. The warning also cautioned those groups to consume no more than 12 ounces of fish a week, including no more than 6 ounces of canned albacore tuna.
But a former senior EPA toxicologist said the advice fails to reflect the government's own calculations about how much fish--and what kinds of fish--people can safely eat each week.
The warning "was not based on science," said Deborah Rice, who helped develop the government's mercury exposure limit for the EPA and now works for the state of Maine.
Mercury's hazards have been known for centuries. In the 1800s, hatmakers using a compound of the silvery, liquid metal to shape wool hats developed trembling, twitching and other symptoms that people associated with madness. Hence, the term "mad as a hatter."
But the risks in seafood did not fully come to light until the 1950s, when a bizarre tragedy unfolded in the Japanese fishing village of Minamata. Residents noticed cats were stumbling about, sometimes collapsing into the bay and drowning. Locals called it the "cat dancing" disease.
People later learned that a nearby chemical plant had dumped tons of mercury into the bay, contaminating the fish and those who ate it, including the cats. Dozens of people died; some women gave birth to babies who were severely disabled and scores suffered a range of neurological problems.
The scientific world was slow to recognize the implications of the Minamata disaster for other people exposed to mercury at much lower levels. It was not until a decade later, in 1969, that the FDA set a guideline for the amount of mercury allowed in commercial fish.
The following year, testing led the FDA to order more than 12 million cans of tuna off store shelves and to urge all Americans to stop eating swordfish.
But the agency's crackdown on mercury would be short-lived.
AFTER COURT BATTLE, FDA EASES RULES
In the summer of 1977, in a rural Florida Panhandle courtroom, four swordfish went on trial.
On one side of the room was the FDA, which had seized the fish from a seafood warehouse in Panama City. FDA officials said the swordfish had mercury levels nearly twice the permissible limit and represented a health threat.
On the other side were lawyers for the nation's swordfish distributors, who had sued to block the government's seizure. The industry argued that mercury in swordfish came from natural, not man-made, sources and therefore could not be regulated under the nation's food-safety laws.
After a four-day trial featuring scientists who debated how much mercury it takes to cause neurological harm in children, a federal judge sided with the fishing industry. Though he ruled that the four swordfish were indeed contaminated by man-made pollution, he said Americans did not eat enough of the fish to be at risk.
More significantly, he dramatically weakened the rules on how much mercury would be acceptable in swordfish.
Pointing to a pair of studies presented at the trial, the judge increased the allowable amount of mercury from 0.5 to 1 part per million in fish tissue--a number slightly above the average level found in the four swordfish, court records show. Under this new standard, the four swordfish would be legal.
Although the judge and an appellate court that upheld his decision agreed the limit could change based on future research, the FDA backed off.
"They left us alone after that," recalled Charles Anderson, the fisherman whose company owned the swordfish on trial.
Instead of fighting for tougher standards, the FDA applied the court-ordered mercury limit to all seafood sold in America.
Announcing the change in the Federal Register in 1979, the FDA said new data showed that consumers were not exposing themselves to as much mercury as officials had estimated when they set the more stringent 0.5 guideline a decade earlier. The FDA said the new data came from a report by the National Marine Fisheries Service, an arm of the Commerce Department.
But the FDA highlighted one aspect of that report that had nothing to do with public health.
Relaxing the acceptable level of mercury in fish, the report said, would "provide a significant economic benefit to those industries most seriously affected" by the more stringent limit and "enhance the future development of a number of presently underutilized fisheries."
Moreover, the report said, a less restrictive rule "would significantly increase consumer confidence in seafood."
AS FISH SALES BOOM, TESTING STOPS
The report proved to be prophetic. With the relaxed rules in place, the seafood industry boomed. After decades of stagnant growth, fish consumption grew 20 percent from 1980 to 1990.
One reason was America's fitness craze. People were joining gyms, health food stores were popping up and doctors were recommending fish as a high-protein, heart-healthy food.
During these years, the FDA did virtually nothing to warn people of the mercury threat. Nor did the agency test any fish for mercury throughout the 1980s, according to FDA data.
The agency also conducted little basic research, such as studies to determine which fish have the most mercury or whether there were high-mercury "hot spots" in the oceans that fishing boats should avoid.
It took a sharply critical 1991 report from the National Academy of Sciences, the nation's leading scientific advisory body, to coax the FDA to resume significant testing of fish for mercury.
The agency promised several times during the 1990s to re-evaluate its mercury limit in fish. But the FDA never changed it, even though other government scientists were concluding the metal was far more harmful than previously thought.
Once again, an important calculation--this one aimed at determining how much mercury can be safely consumed--was at the center of a debate.
In 1997 the EPA, the agency responsible for monitoring recreationally caught fish, recommended a mercury-exposure limit in people based on the most recent scientific studies about the health risks.
The EPA took a far stricter approach than the FDA did in setting its safety standard for mercury, concluding that a person could safely ingest only 0.1 grams of mercury per kilogram of body weight each day. The FDA's equivalent was 0.4.
When the National Academy of Sciences weighed in again on the mercury issue by endorsing the EPA findings, the FDA responded in 2001 with a consumer warning, cautioning high-risk groups not to eat certain fish and to limit their consumption of all seafood.
But the FDA warning did not reflect the EPA's science on what constitutes acceptable exposure to mercury. Based on the FDA's own testing, many consumers following the agency's advisory still could absorb too much of the toxic metal.
For example, if a 161-pound woman--the average weight of U.S. females of childbearing age--ate 12 ounces of lobster in a week, she would expose herself, on average, to twice as much mercury as what the EPA considered acceptable. If she ate 12 ounces of orange roughy, or about two meals, she would be three times over the limit.
Under pressure from environmental groups and public health advocates, the FDA decided in 2002 to work with the EPA to issue a new warning that the FDA said would be based on the best available science.
After two years of meetings, the agencies released, with great fanfare, a rare joint public health warning, cautioning Americans about the risks of mercury in both commercial and recreationally caught fish.
But again, the warning was deeply flawed.
While it advised people to limit consumption of canned albacore tuna, it did not warn about other fish that, according to the government's own data, contained even more mercury, such as grouper, orange roughy and marlin.
More important, the warning still did not reflect the EPA's exposure limit. Many consumers following the advice would still expose themselves to too much mercury even by eating one meal of fish a week.
In interviews with the Tribune, Acheson, the FDA's chief medical officer, said the agency used the EPA limit as a guide but did not view it as a clear line between risk and no-risk.
He said the joint mercury warning, which is still used today, had to "strike an important balance between the benefits of eating fish and the risks of exposure to mercury. It's not as simple as `avoid fish because it has mercury in it.'"
Top EPA officials signed off on the joint warning even though it contradicted the agency's own science. Benjamin Grumbles, an EPA assistant administrator, said in an interview that the warning was not meant to be the "final say on the matter."
When asked if the joint mercury warning protects consumers, he said, "It's an important and protective step forward."
STATES STEP IN WHERE FEDS FAIL TO ACT
In recent years, the major government effort to crack down on mercury in fish has come not from the FDA, but from states.
Several states have issued more-restrictive advice about mercury in commercial seafood than the federal government.
Based on its own review of the FDA's data about mercury levels in fish, Washington state urges women of childbearing age and children 6 and younger to not eat fresh or frozen tuna at all, and to limit eating canned tuna based on how much they weigh.
Wisconsin and Minnesota recommend that at-risk groups limit consumption of halibut, tuna steak and canned albacore tuna to two meals a month. Minnesota also extends the warning to lobster.
In 2003, California successfully sued to get several supermarket chains to post mercury advisories throughout the state.
One of the firms, Safeway, began this fall to place warnings in its stores nationally, including Dominick's, a dominant grocery chain in the Chicago area. Two other chains, Jewel and Whole Foods Market, have begun posting versions of the warning in some stores.
The federal government has promised to take additional steps of its own. As recently as 2001, the FDA vowed in an agency policy handbook to take legal action to remove seafood from the market if it exceeded the federal mercury limit of 1 part per million. But it has not done so--and it has not even conducted enough tests to determine which fish are in violation.
In recent interviews, the FDA said it had no immediate plans to start routine testing of fish, improve warnings or re-evaluate its mercury limit. For now, agency officials said, they will continue to focus on educating consumers.
Many who have closely followed the issue said the FDA's outreach has been tepid at best. Michael Shannon, a pediatrician at Children's Hospital in Boston who sat on an FDA panel that advised the agency on its recent mercury warnings, questioned whether the government has effectively informed the public.
"I read the FDA Web sites," he said, "but you would be amazed at how few people in the American public do."
FDA and EPA officials defend their educational efforts. "We have done a very good job with outreach," the FDA's Acheson said.
The agencies said that in addition to posting information online, they are distributing 6 million mercury pamphlets to doctors, nurses and other health professionals in every state.
The central feature of the pamphlets: the same government warning that fails to adequately protect consumers.
Boyd Haley on Bio Chat
To get into BioChat goto www.drneubrander.com and click on the Chat/Forum tab and download the BioChat software.
Tuesday December 13, 9:00pm EST
Boyd E. Haley, Ph.D.
Boyd Haley, PhD, Chairman of the Department of Chemistry at the University of Kentucky from 1996-2005, Professor Haley is now devoting additional time to research. An NIH Postdoctoral Scholar in the Department of Physiology, Yale University Medical School from 1971 to 1974, in the past 17 years, Dr. Haley has emphasized studies on the biochemistry of Alzheimer's disease. His research in the biochemical aberrancies in Alzheimer's disease also led to his identifying mercury toxicity as a major factor in this disease. He was one of the first to propose that the organic-mercury preservative (Thimerosal) in infant vaccines was the most likely toxic agent involved in Gulf War Syndrome and autism related disorders. Dr. Haley has testified before numerous government agencies on the effects of mercury toxicity from dental amalgams and vaccines. His articles includeReduced Levels of Mercury in First Baby Haircuts of Autistic Children, which was published in the International Journal of Toxicology.
Tuesday December 13, 9:00pm EST
Boyd E. Haley, Ph.D.
Boyd Haley, PhD, Chairman of the Department of Chemistry at the University of Kentucky from 1996-2005, Professor Haley is now devoting additional time to research. An NIH Postdoctoral Scholar in the Department of Physiology, Yale University Medical School from 1971 to 1974, in the past 17 years, Dr. Haley has emphasized studies on the biochemistry of Alzheimer's disease. His research in the biochemical aberrancies in Alzheimer's disease also led to his identifying mercury toxicity as a major factor in this disease. He was one of the first to propose that the organic-mercury preservative (Thimerosal) in infant vaccines was the most likely toxic agent involved in Gulf War Syndrome and autism related disorders. Dr. Haley has testified before numerous government agencies on the effects of mercury toxicity from dental amalgams and vaccines. His articles includeReduced Levels of Mercury in First Baby Haircuts of Autistic Children, which was published in the International Journal of Toxicology.
Burr's Bill Loosing Steam
Burr's bill loses steam as critics gain traction
TIM FUNK
Sen. Richard Burr's freshman-year project -- a bill to speed development of new drugs and vaccines against pandemics and bioterrorist attacks -- was supposed to be on the fast track.
The Winston-Salem Republican introduced it Oct. 17. It was approved a day later, on a voice vote, by the Senate Health Committee. And Senate Majority Leader Bill Frist, R-Tenn., had hoped to give it a full Senate vote in early November.
But the upper chamber is close to adjourning for the year and Burr's ambitious bill has yet to resurface.
What's going on?
"He's been negotiating with Democrats ... for a long time," said Burr spokesman Doug Heye. "He'd like it to be a bipartisan bill."
Some have interpreted that to mean that Burr doesn't have enough votes and is busy changing the bill in order to get them.
While the N.C. senator negotiates, criticism of the legislation -- mostly from interest groups and bloggers -- appears to be getting louder.
For weeks, the main objection was that Burr's bill would shield drug companies from liability lawsuits. He has said some protection is necessary to entice profit-minded companies that have been reluctant to develop the new medicines.
Now the legislation is under fire from groups who say Burr would create a new federal outfit -- the Biomedical Advanced Research and Development Agency, or BARDA -- and then wrap it in secrecy.
As passed by the Senate committee, the bill would exempt BARDA from the Freedom of Information Act, which requires federal agencies to disclose records requested in writing. In the 40-year history of the law, no other federal agency has ever received such a blanket exclusion.
Among the groups speaking out: the Federation of American Scientists, the Reporters Committee for Freedom of the Press and the National Vaccine Information Center, a patients' advocacy group.
"It is an act of contempt for the public and for open government and hopefully will not be adopted," Steven Aftergood, head of the scientists' Project on Government Secrecy, told the Washington Post.
Burr spokesman Heye told the Observer that the bill's secrecy provisions will likely be fine-tuned.
"We've been working with some of those groups, to talk about the language (in the bill) and address their concerns," he said. "Nobody at BARDA will be able to classify information. In fact, they'll be putting out information every day."
Still, Heye said, the bill will retain some exemptions to FOIA: to protect companies' proprietary information and to keep would-be terrorists from finding out which threats the country isn't yet prepared to take on.
So when will Burr's re-written bill arrive on the Senate floor? This week? Next year?
Heye's answer is the same he's been giving since late October: "It will be voted on soon."
Reporter: Tim Funk: (202) 383-6057; tfunk@charlotteobserver.com
TIM FUNK
Sen. Richard Burr's freshman-year project -- a bill to speed development of new drugs and vaccines against pandemics and bioterrorist attacks -- was supposed to be on the fast track.
The Winston-Salem Republican introduced it Oct. 17. It was approved a day later, on a voice vote, by the Senate Health Committee. And Senate Majority Leader Bill Frist, R-Tenn., had hoped to give it a full Senate vote in early November.
But the upper chamber is close to adjourning for the year and Burr's ambitious bill has yet to resurface.
What's going on?
"He's been negotiating with Democrats ... for a long time," said Burr spokesman Doug Heye. "He'd like it to be a bipartisan bill."
Some have interpreted that to mean that Burr doesn't have enough votes and is busy changing the bill in order to get them.
While the N.C. senator negotiates, criticism of the legislation -- mostly from interest groups and bloggers -- appears to be getting louder.
For weeks, the main objection was that Burr's bill would shield drug companies from liability lawsuits. He has said some protection is necessary to entice profit-minded companies that have been reluctant to develop the new medicines.
Now the legislation is under fire from groups who say Burr would create a new federal outfit -- the Biomedical Advanced Research and Development Agency, or BARDA -- and then wrap it in secrecy.
As passed by the Senate committee, the bill would exempt BARDA from the Freedom of Information Act, which requires federal agencies to disclose records requested in writing. In the 40-year history of the law, no other federal agency has ever received such a blanket exclusion.
Among the groups speaking out: the Federation of American Scientists, the Reporters Committee for Freedom of the Press and the National Vaccine Information Center, a patients' advocacy group.
"It is an act of contempt for the public and for open government and hopefully will not be adopted," Steven Aftergood, head of the scientists' Project on Government Secrecy, told the Washington Post.
Burr spokesman Heye told the Observer that the bill's secrecy provisions will likely be fine-tuned.
"We've been working with some of those groups, to talk about the language (in the bill) and address their concerns," he said. "Nobody at BARDA will be able to classify information. In fact, they'll be putting out information every day."
Still, Heye said, the bill will retain some exemptions to FOIA: to protect companies' proprietary information and to keep would-be terrorists from finding out which threats the country isn't yet prepared to take on.
So when will Burr's re-written bill arrive on the Senate floor? This week? Next year?
Heye's answer is the same he's been giving since late October: "It will be voted on soon."
Reporter: Tim Funk: (202) 383-6057; tfunk@charlotteobserver.com
December 10, 2005
Doc Testifies Against Merck, Gets Fired
The doctor that figured out that something was wrong with Vioxx, tried (to no avail) to get Merck to run clinical trials on it in 2001, and testified to that effect during the trial, has been fired from his job as provost at the Cleveland Clinic 2 days after testifying. This despite the fact that he was a founding member of the clinic and has been responsible for bringing in a 40 million dollar increase in funds to the clinic.
"On Monday, the clinic's board will review Topol's removal from the leadership posts by chief executive officer Delos Cosgrove"
I am going to give Dr. Cosgrove a call and encourage him to give this "restructuring" decision a hard second look.
Here is his contact information in case any one wants to do the same.
Cosgrove, Delos, M.D.
Chief Executive Officer, Chairman of the Board of Governors, CCF
Phone: (216) 444-2300
Here is the link to the Cleveland Clinic's contact page:
http://www.clevelandclinic.org/contact/form.asp
This morning I sent them this email:
From Teresa Binstock:
Another honest doc put out to pasture. Several headlines precede the firing article.
* * * *
Lawyers Evaluate Censure of Merck.
Some legal experts said Merck & Co.'s defense against thousands of similar lawsuits would be hurt by an accusation that company scientists had downplayed the pain reliever's heart attack risk.
Los Angeles Times, California. 10 December 2005. [Registration Required]
* * * *
Vioxx Plaintiffs Seek Mistrial After Allegation on Merck Study.
Merck & Co. felt the first fallout from a top medical journal's allegation that key data were excised, as plaintiffs in a federal liability trial over the drug seized on the disclosure to call for a mistrial.
Wall Street Journal. 10 December 2005. [Subscription Required]
* * * *
Editor says he should've challenged Vioxx study.
The executive editor of the New England Journal of Medicine said yesterday that he should have been more aggressive in challenging research on the blockbuster pain pill Vioxx that appeared in the publication five years ago.
Boston Globe, Massachusetts. 10 December 2005.
* * * *
Vioxx witness fired from top posts
The medical school leader criticized Merck recently at a federal trial. He has often warned of the pain reliever.
By David Voreacos and Jef Feeley
BLOOMBERG NEWS
Dec. 10, 2005
A cardiologist who testified at a federal trial in Houston that Merck & Co. Inc.'s Vioxx pain reliever posed an "extraordinary risk" of causing heart attacks has been removed from two leadership positions at the Cleveland Clinic medical school.
Eric Topol, 51, criticized Merck in testimony Dec. 3 at the trial of a lawsuit by the widow of Richard "Dicky" Irvin, who blames her husband's fatal heart attack on Vioxx. Two days later, Topol was removed as provost and chief academic officer at the medical school. He remains chairman of the clinic's cardiovascular medicine department.
Federal jurors began deliberating Thursday on whether Merck, which has significant operations in the Philadelphia area, failed to warn of Vioxx's risks before pulling it off the market last year. The jury is to return today to resume deliberations.
In August, a Texas state jury ordered Merck to pay $253 million to the widow of a Vioxx user, an amount that will be reduced to $26 million under state law. Last month, a New Jersey jury ruled that Merck was not liable for the heart attack of an Idaho postal worker.
Topol's removal from the academic posts had "absolutely" nothing to do with his testimony or his views on Vioxx, said Eileen Sheil, a spokeswoman for the Ohio hospital system. "We've had a series of changes in the administration and the way things are structured. Dr. Topol is a key physician here at the clinic, and he's done a tremendous amount that has contributed to the success of the clinic."
Topol did not immediately return a phone call or e-mail seeking comment. He has been a professor at the Cleveland Clinic since 1991, and assumed the medical school posts in 2001.
Topol has been a central figure in the scientific debate over Vioxx - which generated $2.5 billion in annual sales before Merck withdrew it last year - saying it doubled the risk of heart attacks and strokes in long-term users.
Topol wrote a paper in 2001 highlighting the risks of Vioxx, concluding that patients experienced sharply higher rates of heart problems four to six weeks after starting the drug. Merck says Vioxx poses a risk only after 18 months of daily use.
Topol testified that he and his colleagues urged Merck to conduct clinical trials on the risks and that the company refused.
Topol told jurors in the Irvin case that Merck researchers visited him before he published his paper and said "we had gotten it wrong, and we'd be embarrassed if we published it."
In a videotaped deposition, he said former Merck chief executive officer Raymond Gilmartin called Malachi Mixon, chairman of the Cleveland Clinic's board, in October 2004 to question why Topol had targeted Vioxx.
As Topol recalled it, Gilmartin said: "What has Merck ever done to the Cleveland Clinic to warrant this?" Topol testified that the approach by Gilmartin "appalled" him.
In 2002, Topol helped found the medical school, which accepted its first students in 2004, Sheil said. On Monday, the clinic's board will review Topol's removal from the leadership posts by chief executive officer Delos Cosgrove, Sheil said.
Topol created the clinic's division of clinical research, and oversaw an increase in National Institutes of Health grants from $50 million in 2001 to $90 million in 2005, Sheil said.
Shares of Merck fell 55 cents to $29.13 in New York Stock Exchange trading.
"On Monday, the clinic's board will review Topol's removal from the leadership posts by chief executive officer Delos Cosgrove"
I am going to give Dr. Cosgrove a call and encourage him to give this "restructuring" decision a hard second look.
Here is his contact information in case any one wants to do the same.
Cosgrove, Delos, M.D.
Chief Executive Officer, Chairman of the Board of Governors, CCF
Phone: (216) 444-2300
Here is the link to the Cleveland Clinic's contact page:
http://www.clevelandclinic.org/contact/form.asp
This morning I sent them this email:
Dear Sirs,
I read the Bloomberg story today on Dr. Topol's firing and I was extremely disturbed by it. From where I sit, it seems like he may being punished for being an honest doctor and protecting patients because he spoke out against a powerful pharmaceutical company. I truly hope that this is not the case.
I understand this decision will be reviewed on Monday by Dr. Cosgrove. I hope that he takes a very hard second look at this decision as it is potentially a huge miscarriage of justice.
I have tried to reach Dr. Cosgrove this morning to share my thoughts over the phone, but there was no answer. I am assuming that the office is not staffed as it is a Saturday.
I will try to reach him again Monday morning.
Thank You,
Ginger Taylor, M.S.
From Teresa Binstock:
Another honest doc put out to pasture. Several headlines precede the firing article.
* * * *
Lawyers Evaluate Censure of Merck.
Some legal experts said Merck & Co.'s defense against thousands of similar lawsuits would be hurt by an accusation that company scientists had downplayed the pain reliever's heart attack risk.
Los Angeles Times, California. 10 December 2005. [Registration Required]
* * * *
Vioxx Plaintiffs Seek Mistrial After Allegation on Merck Study.
Merck & Co. felt the first fallout from a top medical journal's allegation that key data were excised, as plaintiffs in a federal liability trial over the drug seized on the disclosure to call for a mistrial.
Wall Street Journal. 10 December 2005. [Subscription Required]
* * * *
Editor says he should've challenged Vioxx study.
The executive editor of the New England Journal of Medicine said yesterday that he should have been more aggressive in challenging research on the blockbuster pain pill Vioxx that appeared in the publication five years ago.
Boston Globe, Massachusetts. 10 December 2005.
* * * *
Vioxx witness fired from top posts
The medical school leader criticized Merck recently at a federal trial. He has often warned of the pain reliever.
By David Voreacos and Jef Feeley
BLOOMBERG NEWS
Dec. 10, 2005
A cardiologist who testified at a federal trial in Houston that Merck & Co. Inc.'s Vioxx pain reliever posed an "extraordinary risk" of causing heart attacks has been removed from two leadership positions at the Cleveland Clinic medical school.
Eric Topol, 51, criticized Merck in testimony Dec. 3 at the trial of a lawsuit by the widow of Richard "Dicky" Irvin, who blames her husband's fatal heart attack on Vioxx. Two days later, Topol was removed as provost and chief academic officer at the medical school. He remains chairman of the clinic's cardiovascular medicine department.
Federal jurors began deliberating Thursday on whether Merck, which has significant operations in the Philadelphia area, failed to warn of Vioxx's risks before pulling it off the market last year. The jury is to return today to resume deliberations.
In August, a Texas state jury ordered Merck to pay $253 million to the widow of a Vioxx user, an amount that will be reduced to $26 million under state law. Last month, a New Jersey jury ruled that Merck was not liable for the heart attack of an Idaho postal worker.
Topol's removal from the academic posts had "absolutely" nothing to do with his testimony or his views on Vioxx, said Eileen Sheil, a spokeswoman for the Ohio hospital system. "We've had a series of changes in the administration and the way things are structured. Dr. Topol is a key physician here at the clinic, and he's done a tremendous amount that has contributed to the success of the clinic."
Topol did not immediately return a phone call or e-mail seeking comment. He has been a professor at the Cleveland Clinic since 1991, and assumed the medical school posts in 2001.
Topol has been a central figure in the scientific debate over Vioxx - which generated $2.5 billion in annual sales before Merck withdrew it last year - saying it doubled the risk of heart attacks and strokes in long-term users.
Topol wrote a paper in 2001 highlighting the risks of Vioxx, concluding that patients experienced sharply higher rates of heart problems four to six weeks after starting the drug. Merck says Vioxx poses a risk only after 18 months of daily use.
Topol testified that he and his colleagues urged Merck to conduct clinical trials on the risks and that the company refused.
Topol told jurors in the Irvin case that Merck researchers visited him before he published his paper and said "we had gotten it wrong, and we'd be embarrassed if we published it."
In a videotaped deposition, he said former Merck chief executive officer Raymond Gilmartin called Malachi Mixon, chairman of the Cleveland Clinic's board, in October 2004 to question why Topol had targeted Vioxx.
As Topol recalled it, Gilmartin said: "What has Merck ever done to the Cleveland Clinic to warrant this?" Topol testified that the approach by Gilmartin "appalled" him.
In 2002, Topol helped found the medical school, which accepted its first students in 2004, Sheil said. On Monday, the clinic's board will review Topol's removal from the leadership posts by chief executive officer Delos Cosgrove, Sheil said.
Topol created the clinic's division of clinical research, and oversaw an increase in National Institutes of Health grants from $50 million in 2001 to $90 million in 2005, Sheil said.
Shares of Merck fell 55 cents to $29.13 in New York Stock Exchange trading.
Dr. Deth Corrects Dr. Sanghavi
More reaction to, "The Secret Truth", by Darshak Sanghavi, MD
Dr. Sanghavi,I look forward to hearing the response from Dr. Sanghavi or seeing if he is willing to meet with Dr. Deth
I am a neuropharmacologist at Northeastern University doing research into the molecular cause(s) of autism. Having read your article in today's Globe, I would like to help you become more knowledgable about how thimerosal has contributed to the autism epidemic. While you dismiss parental concerns about the thimerosal connection as a sort of mis-guided blind faith, I can assure you that there is solid scientific evidence, both clinical and molecular, supporting a link between vaccine-related mercury exposure and autism. If you are going to assume the role of spokesperson for this issue, you also assume an obligation to understand all of the evidence.
I hope that you will afford me the chance to meet with you to update you on this recently obtained evidence, since it is impractical to do so in an email. However, let me just outline a few of the most important points here.
1. Thiol (sulfur) metabolism is widely recognized as the primary target of mercury (i.e. Thimerosal) neurotoxicity. (Would you not agree?)
2. Autistic children exhibit profound abnormalities in thiol metabolites (see attached study by Dr. Jill James).
3. Concentrations of thimerosal produced by vaccination inhibit methylation activity of the enzyme methionine synthase. (Article attached)
4. Autistic children exhibit impaired methylation activity (Dr. James study).
5. Thiol metabolism plays a key role in inflammation and oxidative stress (e.g. maintaining glutathione levels).
6. Autistic children exhibit neuroinflammation and oxidative stress (Vargas et al. Ann Neurol. 2005 Jan;57(1):67-81)
7. Mercury and other heavy metals cause neuroinflammation (e.g. activation of microglia).
8. Thimerosal causes significantly greater accumulation of inorganic mercury in the brain than does methylmercury. (Burbacher et al. Environ Health Perspect. 2005 Aug;113(8):1015-21)
Ergo, there is indeed substantial scientific evidence of a link between Thimerosal and autism.
Furthermore, and more importantly:
Treatment of autistic children with regimens that:
1. Remove heavy metals (e.g. chelation)
2. Augment levels of glutathione (e.g. GSH or N-acetylcysteine)
3. Support methylation activity (e.g. methyl B12 (not just B12), folinic acid)
4. Reduce neuroinflammation (PPAR-acting agents)
....bring about clinical improvement in a large proportion of children with autism. If you or anyone else would like to understand the link between autism and Thimerosal, I suggest that you study autistic children. However, when the debate about thimerosal's role is put aside, it is the ability to provide improvement in the lives of autistic children that really matters.
I sincerely look forward to the opportunity to meet with you so that you can speak to this issue with a fully informed background. My contact information is provided below.
Richard Deth, Ph.D.
Professor of Pharmacology Northeastern University
Fruits and Veggies Limit Inflammatory Protein
(Hat tip: Binstock)
Fruits and Veggies Limit Inflammatory Protein (with recipe)
Janet Raloff
Over the past few years, many studies have linked an increased risk of
debilitating illness—such as heart disease or diabetes—with chronically
elevated blood concentrations of a protein typically associated with
inflammation. In many cases, people with the indicated illnesses didn't
even have a particularly level of inflammation. The good news: A new trial
finds that eating plenty of fruits and vegetables reduces concentrations
of the worrisome protein.
[fot] INFLAMATION QUENCHER? The fresh veggies in this, Janet's Carrot
Salad, are among those strongly associated with decreasing the body's
production of a protein known as CRP. Because this protein usually
connotes inflammation, the new findings suggest that carrots might offer a
dietary route to moderating potentially harmful, chronic inflammation.
Raloff
In the new trial, researchers recruited people to eat a low-produce diet
for a month and then increase that dietary component. The inflammation
marker—C-reactive protein (CRP)—was slightly elevated in the participants
while they ate few fruits and vegetables, says study leader Bernhard Watzl
of Germany's Federal Research Center for Nutrition, in Karlsruhe. He
points out that the recruits were not suffering from major infections but
that some were overweight. A host of studies has demonstrated that body
fat can trigger chronic inflammation (SN: 2/28/04, p. 139: Available to
subscribers at http://www.sciencenews.org/articles/20040228/bob9.asp).
Whatever the source of CRP, research has linked artery-clogging
atherosclerosis—and risk of heart attack—to excess blood concentrations of
the protein (SN: 4/20/02, p. 244: Available to subscribers at
http://www.sciencenews.org/articles/20020420/fob4.asp).
The study found that when the participants changed from a diet low in
produce to one high in such foods, they experienced a significant drop in
blood CRP. However, no statistically significant relationship emerged
between blood concentrations of any immune cell or of other components of
the immune system and the number of servings of fruits and vegetables
people had eaten.
Watzl says his team had actually been expecting to find that feeding
adults large quantities of fresh produce would rev up their immune
systems. The study was exploring the connections among diet, immune system
effects, and cancer risk. Earlier work by his team had suggested that
people eating little produce have weakened immune defenses against cancer.
The new findings, however, suggest a different potential explanation,
involving inflammation, for why people who eat the most fruits and
vegetables typically have the lowest incidence of cancers of the breast,
lung, and gastrointestinal tract.
Are carrots the answer?
Watzl's team recruited 63 healthy, nonsmoking men to take part in a
2-month study. All were around age 30, had similar body-mass indexes, and
reported no history of taking vitamin supplements.
During the study's first 4 weeks, the men were instructed to eat normally
except for their fruit and vegetable intake. The trial limited consumption
of these foods, or juices made from them, to just two servings per day.
One serving of solid food was 100 grams (3.5 ounces). A serving of juice
was 200 milliliters (6.8 ounces).
During the next 4 weeks, the volunteers were told to consume no fruits,
veggies, or juices except those provided by the researchers. The
participants were divided into three groups that received two, five, or
eight servings of these foods per day.
The most startling impact of getting eight servings of produce and juice
per day was a drop in blood CRP. In men going from two servings to eight
servings per day, CRP concentrations fell by one-third. No statistically
significant change occurred in men going from two to five servings.
"Our intervention study is the first to show that [blood] CRP
concentrations can be modulated by the consumption of vegetables and
fruits," the authors report in the November American Journal of Clinical
Nutrition.
The researchers attribute the CRP decrease in the eight-servings-per-day
group to increases in the men's consumption of foods rich in the
carotenoids alpha- and beta-carotene—plant pigments with antioxidant
properties. Although carotenoids impart color to a host of red, orange,
and yellow fruits and vegetables, alpha-carotene—at least in the German
diet—traces primarily to the consumption of carrots, Watzl notes. He says
his new data suggest that carrots may largely explain the CRP benefit.
Recruits may have been too well nourished
Several studies in recent years have shown that eating carotenoid-rich
foods, such as tomato juice or carrot juice, can stimulate the immune
system. To gauge that effect in the current study, the researchers
measured, at the beginning and end of each phase of the new trial, blood
concentrations of white blood cells and several immune-system chemicals.
However, concentrations of neither the cells nor chemicals varied
significantly during the trial.
Watzl concludes that the reason his team found no impact of the
high-produce diet on any of the men's immune systems is probably because
eating fruits and vegetables will stimulate the immune system only in
people whose diets are below some critical threshold in certain
plant-based compounds.
Alas, he notes, "our subjects were quite well nourished." Dietary history
data for the men showed most had been routinely consuming 350 milliliters
of fruit juice daily prior to taking part in the new study.
"In my opinion," Watzl says, "the reason that we didn't see major changes
in immune function is likely related to very high concentrations of
vitamins, like vitamin C, and carotenoids in the [recruits'] blood" when
they entered the study. In fact, the men's vitamin C concentrations didn't
notably drop in the lowest-fruits-and-veggies group until about 8 weeks
into the trial, he says, suggesting a person would have to eat a
low-produce diet far longer than that to seriously deplete his or her
stores of such nutrients.
Indeed, Watzl points out, a constant frustration to nutrition researchers
is that most people who volunteer to take part in their studies are "too
healthy or have too high an intake of certain nutrients" to reflect the
population generally, much less people who are poorly nourished.
"In this study," the nutritionist notes, "we did not really restrict the
intake of carotenoid-rich vegetables" severely: The lowest intake of
produce or juices was two servings per day. That's why Watzl's aim in his
next study is look at carotenoid impacts after "extended periods of
carotenoid depletion."
Janet's Carrot Salad
If carrots fight CRP, then this could be just the side dish to keep that
inflammation marker in check. So, we are again providing the recipe for
this year-round favorite in my household. The salad can be hot or not,
depending on whether you choose to add a dash of Tabasco sauce. Adults
tend to appreciate the unexpected kick far more than kids do.
I tend to be a little heavy-handed with the condiments, but for each pound
of peeled and grated carrots, mix in at least:
* 1/2 cup dried parsley
* 1/2 cup dried or fresh mint (mince fresh leaves and keep the stems out)
* 6 tbs. garlic powder (or to taste)
* 6 tbs. powdered cumin (or to taste)
* Salt and freshly ground black pepper (to taste)
Then blend in olive or canola oil (canola has less saturated fat), about
1/3 cup. Also add at least 1/4 cup of freshly squeezed lemon juice. Stir
thoroughly.
This salad tastes best when prepared an hour ahead of time and set out at
room temperature, so the flavors can meld. It keeps up to 5 days in the
refrigerator.
Fruits and Veggies Limit Inflammatory Protein (with recipe)
Janet Raloff
Over the past few years, many studies have linked an increased risk of
debilitating illness—such as heart disease or diabetes—with chronically
elevated blood concentrations of a protein typically associated with
inflammation. In many cases, people with the indicated illnesses didn't
even have a particularly level of inflammation. The good news: A new trial
finds that eating plenty of fruits and vegetables reduces concentrations
of the worrisome protein.
[fot] INFLAMATION QUENCHER? The fresh veggies in this, Janet's Carrot
Salad, are among those strongly associated with decreasing the body's
production of a protein known as CRP. Because this protein usually
connotes inflammation, the new findings suggest that carrots might offer a
dietary route to moderating potentially harmful, chronic inflammation.
Raloff
In the new trial, researchers recruited people to eat a low-produce diet
for a month and then increase that dietary component. The inflammation
marker—C-reactive protein (CRP)—was slightly elevated in the participants
while they ate few fruits and vegetables, says study leader Bernhard Watzl
of Germany's Federal Research Center for Nutrition, in Karlsruhe. He
points out that the recruits were not suffering from major infections but
that some were overweight. A host of studies has demonstrated that body
fat can trigger chronic inflammation (SN: 2/28/04, p. 139: Available to
subscribers at http://www.sciencenews.org/articles/20040228/bob9.asp).
Whatever the source of CRP, research has linked artery-clogging
atherosclerosis—and risk of heart attack—to excess blood concentrations of
the protein (SN: 4/20/02, p. 244: Available to subscribers at
http://www.sciencenews.org/articles/20020420/fob4.asp).
The study found that when the participants changed from a diet low in
produce to one high in such foods, they experienced a significant drop in
blood CRP. However, no statistically significant relationship emerged
between blood concentrations of any immune cell or of other components of
the immune system and the number of servings of fruits and vegetables
people had eaten.
Watzl says his team had actually been expecting to find that feeding
adults large quantities of fresh produce would rev up their immune
systems. The study was exploring the connections among diet, immune system
effects, and cancer risk. Earlier work by his team had suggested that
people eating little produce have weakened immune defenses against cancer.
The new findings, however, suggest a different potential explanation,
involving inflammation, for why people who eat the most fruits and
vegetables typically have the lowest incidence of cancers of the breast,
lung, and gastrointestinal tract.
Are carrots the answer?
Watzl's team recruited 63 healthy, nonsmoking men to take part in a
2-month study. All were around age 30, had similar body-mass indexes, and
reported no history of taking vitamin supplements.
During the study's first 4 weeks, the men were instructed to eat normally
except for their fruit and vegetable intake. The trial limited consumption
of these foods, or juices made from them, to just two servings per day.
One serving of solid food was 100 grams (3.5 ounces). A serving of juice
was 200 milliliters (6.8 ounces).
During the next 4 weeks, the volunteers were told to consume no fruits,
veggies, or juices except those provided by the researchers. The
participants were divided into three groups that received two, five, or
eight servings of these foods per day.
The most startling impact of getting eight servings of produce and juice
per day was a drop in blood CRP. In men going from two servings to eight
servings per day, CRP concentrations fell by one-third. No statistically
significant change occurred in men going from two to five servings.
"Our intervention study is the first to show that [blood] CRP
concentrations can be modulated by the consumption of vegetables and
fruits," the authors report in the November American Journal of Clinical
Nutrition.
The researchers attribute the CRP decrease in the eight-servings-per-day
group to increases in the men's consumption of foods rich in the
carotenoids alpha- and beta-carotene—plant pigments with antioxidant
properties. Although carotenoids impart color to a host of red, orange,
and yellow fruits and vegetables, alpha-carotene—at least in the German
diet—traces primarily to the consumption of carrots, Watzl notes. He says
his new data suggest that carrots may largely explain the CRP benefit.
Recruits may have been too well nourished
Several studies in recent years have shown that eating carotenoid-rich
foods, such as tomato juice or carrot juice, can stimulate the immune
system. To gauge that effect in the current study, the researchers
measured, at the beginning and end of each phase of the new trial, blood
concentrations of white blood cells and several immune-system chemicals.
However, concentrations of neither the cells nor chemicals varied
significantly during the trial.
Watzl concludes that the reason his team found no impact of the
high-produce diet on any of the men's immune systems is probably because
eating fruits and vegetables will stimulate the immune system only in
people whose diets are below some critical threshold in certain
plant-based compounds.
Alas, he notes, "our subjects were quite well nourished." Dietary history
data for the men showed most had been routinely consuming 350 milliliters
of fruit juice daily prior to taking part in the new study.
"In my opinion," Watzl says, "the reason that we didn't see major changes
in immune function is likely related to very high concentrations of
vitamins, like vitamin C, and carotenoids in the [recruits'] blood" when
they entered the study. In fact, the men's vitamin C concentrations didn't
notably drop in the lowest-fruits-and-veggies group until about 8 weeks
into the trial, he says, suggesting a person would have to eat a
low-produce diet far longer than that to seriously deplete his or her
stores of such nutrients.
Indeed, Watzl points out, a constant frustration to nutrition researchers
is that most people who volunteer to take part in their studies are "too
healthy or have too high an intake of certain nutrients" to reflect the
population generally, much less people who are poorly nourished.
"In this study," the nutritionist notes, "we did not really restrict the
intake of carotenoid-rich vegetables" severely: The lowest intake of
produce or juices was two servings per day. That's why Watzl's aim in his
next study is look at carotenoid impacts after "extended periods of
carotenoid depletion."
Janet's Carrot Salad
If carrots fight CRP, then this could be just the side dish to keep that
inflammation marker in check. So, we are again providing the recipe for
this year-round favorite in my household. The salad can be hot or not,
depending on whether you choose to add a dash of Tabasco sauce. Adults
tend to appreciate the unexpected kick far more than kids do.
I tend to be a little heavy-handed with the condiments, but for each pound
of peeled and grated carrots, mix in at least:
* 1/2 cup dried parsley
* 1/2 cup dried or fresh mint (mince fresh leaves and keep the stems out)
* 6 tbs. garlic powder (or to taste)
* 6 tbs. powdered cumin (or to taste)
* Salt and freshly ground black pepper (to taste)
Then blend in olive or canola oil (canola has less saturated fat), about
1/3 cup. Also add at least 1/4 cup of freshly squeezed lemon juice. Stir
thoroughly.
This salad tastes best when prepared an hour ahead of time and set out at
room temperature, so the flavors can meld. It keeps up to 5 days in the
refrigerator.
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