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.
December 16, 2005
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.
Autism One Radio: Influenza and Bird Flu
Autism One Radio Schedule Dec 12 - 16 Influenza Vaccine & Bird Flu Dec 13
A Worldwide, Web-Based Radio Station for the Care, Treatment, and Recovery
of Children with Autism
http://www.autismone.org/radio
Monday, December 12th:
11:00 am - 11:30 ET Laura Cellini: Parent Activist
Tuesday, December 13th:
10:30 am - 11:30 ET Teri Small: Autism: Help, Hope, and Healing Guest:
Susan Owens, a member of the Defeat Autism Now! Think-Tank will discuss how
the sulfur system works, as well as the low oxalate diet.
Special: Part 1 of 2
12:00 pm - 1:00 ET Betsy Hicks: Path to Wellness Topic: Influenza
vaccine and Bird Flu issues. Guests: Dr. David Ayoub, Christina Blakey,
Anne Dachel, and Dr. Kenneth Stoller.
1:30 pm - 2:00 ET Chantal Sicile-Kira: The Real World of Autism with
Chantal Topic: "Growing up to be a successful adult with autism" Guest:
Judith H. Cohen, PhD, author of Succeeding with Autism: Hear my Voice.
Judith, a Professor of Education and attorney, tells the story of one of her
students, Michael, in the teacher education program she coordinated at
Adelphi University. Michael has autism, and Judith describes how he got to
the point of taking part in the teacher ed program, the strategies that
helped him, and where he is now. On Dec 20, Michael will be Chantal's
guest.
Wednesday, December 14th:
9:55 am - 10:25 ET Peta Cohen, MS, RD: Nutritional Approaches to
Treating Autism
11:30 am - 12:00 ET Seth D. Pearl, DC, CCN, CNS: The Health and
Wellness Hour with Dr. Seth Pearl Guest: Rebbecca Laber, OTR/L from Optimal
Kids. Topic: Eclectic approaches in occupational therapy for children with
special needs.
Thursday, December 15th:
1:00 pm - 1:45 ET Mary Coyle, D.I. Hom: Discussions on Bioenergetic
Therapies - A New Revolution in Healing. Topic: Discussions on the
Importance of Bioenergetic Protocol. Guest Anne Robertson and Mary discuss
many different bioenergetic therapies and the order to prioritize those,
especially prior to bio-chemical interventions.
Friday, December 16th:
1:00 pm - 1:30 ET Lisa Ackerman: Coffee Talk with Lisa Ackerman
2:00 pm - 2:30 ET Amy Lansky: There's Hope with Homeopathy
8:00 pm - 8:30 ET Valerie Herskowitz, MA CCC-SLP: Embracing the
Journey. Guest: Karen Simmons, founder of Autism TodayC. Karen is the author
of four books, including Little Rainman: Autism Through the Eyes of a Child
and Surrounded by Miracles, and is a co-author of an upcoming Chicken Soup
for Special Needs Community book. www.AutismToday.com.
A Worldwide, Web-Based Radio Station for the Care, Treatment, and Recovery
of Children with Autism
http://www.autismone.org/radio
Monday, December 12th:
11:00 am - 11:30 ET Laura Cellini: Parent Activist
Tuesday, December 13th:
10:30 am - 11:30 ET Teri Small: Autism: Help, Hope, and Healing Guest:
Susan Owens, a member of the Defeat Autism Now! Think-Tank will discuss how
the sulfur system works, as well as the low oxalate diet.
Special: Part 1 of 2
12:00 pm - 1:00 ET Betsy Hicks: Path to Wellness Topic: Influenza
vaccine and Bird Flu issues. Guests: Dr. David Ayoub, Christina Blakey,
Anne Dachel, and Dr. Kenneth Stoller.
1:30 pm - 2:00 ET Chantal Sicile-Kira: The Real World of Autism with
Chantal Topic: "Growing up to be a successful adult with autism" Guest:
Judith H. Cohen, PhD, author of Succeeding with Autism: Hear my Voice.
Judith, a Professor of Education and attorney, tells the story of one of her
students, Michael, in the teacher education program she coordinated at
Adelphi University. Michael has autism, and Judith describes how he got to
the point of taking part in the teacher ed program, the strategies that
helped him, and where he is now. On Dec 20, Michael will be Chantal's
guest.
Wednesday, December 14th:
9:55 am - 10:25 ET Peta Cohen, MS, RD: Nutritional Approaches to
Treating Autism
11:30 am - 12:00 ET Seth D. Pearl, DC, CCN, CNS: The Health and
Wellness Hour with Dr. Seth Pearl Guest: Rebbecca Laber, OTR/L from Optimal
Kids. Topic: Eclectic approaches in occupational therapy for children with
special needs.
Thursday, December 15th:
1:00 pm - 1:45 ET Mary Coyle, D.I. Hom: Discussions on Bioenergetic
Therapies - A New Revolution in Healing. Topic: Discussions on the
Importance of Bioenergetic Protocol. Guest Anne Robertson and Mary discuss
many different bioenergetic therapies and the order to prioritize those,
especially prior to bio-chemical interventions.
Friday, December 16th:
1:00 pm - 1:30 ET Lisa Ackerman: Coffee Talk with Lisa Ackerman
2:00 pm - 2:30 ET Amy Lansky: There's Hope with Homeopathy
8:00 pm - 8:30 ET Valerie Herskowitz, MA CCC-SLP: Embracing the
Journey. Guest: Karen Simmons, founder of Autism TodayC. Karen is the author
of four books, including Little Rainman: Autism Through the Eyes of a Child
and Surrounded by Miracles, and is a co-author of an upcoming Chicken Soup
for Special Needs Community book. www.AutismToday.com.
Parents Want to Know About Every Pediatrician Error
(Hat tip: Schafer)
Parents Want to Know About Every Pediatrician Error
Same survey found they would be less likely to sue if told first.
By Amanda Gardner
ABC News
MONDAY, Dec. 5 (HealthDay News) — American parents want to know about medical errors involving their children, no matter how harmless or severe the mistake, new research suggests.
Parents also claim to be less likely to sue if they are told openly and honestly about an error, according to a study appearing in the December issue of Pediatrics.
"This is a very important study. Things aren't necessarily as well-studied in children as in adults, and our natural tendency is to assume that everything from adults applies to children, and that's not always true," said Dr. Marlene R. Miller, director of Quality and Safety Initiatives and an associate professor of pediatrics at Johns Hopkins Children's Center. "Among adults, we want more disclosure with more severe things. But parents of a small, vulnerable child want to know everything, regardless of the severity. That's a very key difference."
Medical errors have been a focus of attention lately, with a recent Institute of Medicine report estimating they are responsible for 100,000 deaths a year in the United States. According to the authors of this study, 42 percent of Americans say they have been affected by a medical error either personally or through a friend or relative.
Most of the information, however, applies to adults. Studies have shown that adults' desire to be informed of a medical error increases with the error's severity. It's been unclear whether parents felt the same way about errors affecting their children.
In this latest study, 499 parents of children presenting at a hospital emergency room answered a questionnaire outlining several different error scenarios. Participants were asked to rate the severity of the mistake, express preferences for disclosure and reporting, and to state how they expected to respond with or without that disclosure.
Virtually all (99 percent) of the parents wanted to be told of a mistake, while 39 percent wanted the error reported to a disciplinary body and 36 percent said they were less likely to pursue legal action if the error was disclosed by the doctor.
The finding that people were less likely to see legal recourse if the error was disclosed echoes previous studies in adults. "It's not so much the error that people get upset about —it's the anger at not being told," Miller said. "People can understand that medicine isn't black and white, that it's an art."
The desire to be told of a mistake did not differ by race/ethnicity, gender, age or insurance. However, the desire for an error to be reported to a disciplinary body increased with the severity of the error.
The challenge is how to integrate this information into the medical system. "We rarely teach how to disclose," Miller said. "Any time you advocate a big change in behavior or practice, you probably need some training, what is appropriate, how do we do it, when do we do it. It's not as simple as it sounds."
A second study in the same issue of the journal found that using a preprinted, structured order form for medications significantly reduced medication errors among children in the emergency department.
The study authors had previously found that 10 percent of children who went to a pediatric emergency department experienced medication errors.
On different days, physicians were asked to use either regular, blank order sheets for prescriptions or the preprinted, formatted sheets. Drug errors were identified in 17 percent of the regular forms, and only 10 percent of the preprinted forms.
"This is a breath of air that, if you're an institution that can't afford computerized order entry, there are some very simple pen-and-paper solutions. If you have the right culture around the pen and paper, it's easy to do," Miller said.
A third study in the journal found that expensive computerized systems are not always the panacea they are held up to be, Miller pointed out. In fact, it found an increase in mortality after a computer order entry system was installed. Among 1,942 children admitted to a hospital for specialized care during the study period, the mortality rate went from 2.8 percent before the computer system was installed to 6.57 percent after the system was up and running.
The preprinted order forms, however, only addressed the prescribing phase of giving a medication, not the dispensing phase or administration phase. "The bulk of errors actually occur at administration, but it's a nice breath of air because some pen-and-paper, simple things that cost a couple of cents can work," Miller said.
Visit the National Patient Safety Foundation for more on medical mistakes.
Parents Want to Know About Every Pediatrician Error
Same survey found they would be less likely to sue if told first.
By Amanda Gardner
ABC News
MONDAY, Dec. 5 (HealthDay News) — American parents want to know about medical errors involving their children, no matter how harmless or severe the mistake, new research suggests.
Parents also claim to be less likely to sue if they are told openly and honestly about an error, according to a study appearing in the December issue of Pediatrics.
"This is a very important study. Things aren't necessarily as well-studied in children as in adults, and our natural tendency is to assume that everything from adults applies to children, and that's not always true," said Dr. Marlene R. Miller, director of Quality and Safety Initiatives and an associate professor of pediatrics at Johns Hopkins Children's Center. "Among adults, we want more disclosure with more severe things. But parents of a small, vulnerable child want to know everything, regardless of the severity. That's a very key difference."
Medical errors have been a focus of attention lately, with a recent Institute of Medicine report estimating they are responsible for 100,000 deaths a year in the United States. According to the authors of this study, 42 percent of Americans say they have been affected by a medical error either personally or through a friend or relative.
Most of the information, however, applies to adults. Studies have shown that adults' desire to be informed of a medical error increases with the error's severity. It's been unclear whether parents felt the same way about errors affecting their children.
In this latest study, 499 parents of children presenting at a hospital emergency room answered a questionnaire outlining several different error scenarios. Participants were asked to rate the severity of the mistake, express preferences for disclosure and reporting, and to state how they expected to respond with or without that disclosure.
Virtually all (99 percent) of the parents wanted to be told of a mistake, while 39 percent wanted the error reported to a disciplinary body and 36 percent said they were less likely to pursue legal action if the error was disclosed by the doctor.
The finding that people were less likely to see legal recourse if the error was disclosed echoes previous studies in adults. "It's not so much the error that people get upset about —it's the anger at not being told," Miller said. "People can understand that medicine isn't black and white, that it's an art."
The desire to be told of a mistake did not differ by race/ethnicity, gender, age or insurance. However, the desire for an error to be reported to a disciplinary body increased with the severity of the error.
The challenge is how to integrate this information into the medical system. "We rarely teach how to disclose," Miller said. "Any time you advocate a big change in behavior or practice, you probably need some training, what is appropriate, how do we do it, when do we do it. It's not as simple as it sounds."
A second study in the same issue of the journal found that using a preprinted, structured order form for medications significantly reduced medication errors among children in the emergency department.
The study authors had previously found that 10 percent of children who went to a pediatric emergency department experienced medication errors.
On different days, physicians were asked to use either regular, blank order sheets for prescriptions or the preprinted, formatted sheets. Drug errors were identified in 17 percent of the regular forms, and only 10 percent of the preprinted forms.
"This is a breath of air that, if you're an institution that can't afford computerized order entry, there are some very simple pen-and-paper solutions. If you have the right culture around the pen and paper, it's easy to do," Miller said.
A third study in the journal found that expensive computerized systems are not always the panacea they are held up to be, Miller pointed out. In fact, it found an increase in mortality after a computer order entry system was installed. Among 1,942 children admitted to a hospital for specialized care during the study period, the mortality rate went from 2.8 percent before the computer system was installed to 6.57 percent after the system was up and running.
The preprinted order forms, however, only addressed the prescribing phase of giving a medication, not the dispensing phase or administration phase. "The bulk of errors actually occur at administration, but it's a nice breath of air because some pen-and-paper, simple things that cost a couple of cents can work," Miller said.
Visit the National Patient Safety Foundation for more on medical mistakes.
Louis Conte is Really Angry With Dr. Sanghavi
He sent this to me:
UPDATE: Mark Blaxil and Teresa Conrick are angry with Dr. Sanghavi too:
A Modest Proposal: Plutonium in Vaccines Now! Mercury is for wimps!
It occurred to me tonight that I should say something about Dr. Darshak Sanghavi's“Secret Truth” story (or propaganda piece) as I mixed the juice supplement cocktail that I prepare for my two autistic sons every day. I usually do not have time for creative writing as trying to recover two of my triplet sons from autism is kind of a full time job.
I have been a little worried that some members of the “mainstream” medical establishment were perhaps insensitive to our concerns about mercury in vaccines having played a role in the autism epidemic. I was a little worried that perhaps I was misunderstanding these people. I was a little worried that maybe I was short changing their genuine human concern for their patients. I was worried that perhaps, just maybe, I was casting them as monsters when they really were not.
Well, I can stop worrying now.
Dr. Sanghavi’s piece in the Boston Globe was one of the most offensive pieces of writing that I have ever seen in my adult life. This doctor visited a Utah family trying to recover their two children from autism and described them as much humanity as one might describe livestock. These parents related how their children had descended into autism after vaccination. Dr. Sanghavi noted that these parents were just falling prey to the erroneous causal connection” between vaccination and regressive autism. Sanghavi expressed that he found their efforts at treatment sort of useless and made no connection between the treatments and the improvements the children seemed to make. However, he stated his that he liked them and that he though they were “well intentioned.”
Dr. Sanghavi seemed to indicate that these parents were desperate fools and that their doctors (you know those people) were “quacks.”
Nice guy.
However, I did not fully understand this doctor’s real purpose until later in the propaganda. It seems he has possession of “secret knowledge” that the rest of us “herd animals” – Dr. Sanghavi means that expression quite literally – do not have. The “secret knowledge” is this: Our children were poisoned with mercury vaccines for decades because the principles of the public health establishment required it. The personal rights and health of our children meant nothing. The “secret” is that individual liberty means nothing. Personal freedom, it seems to Dr. Sanghavi , is “a dangerous thing.” The reason that childhood vaccines are required by public health officials is because of the concept of “herd immunity.” According to Dr. Sanghavi, we are simply a “herd.” If a few members of the herd get sick from vaccines, well that is just good public health policy.
That is Dr. Sanghavi ’s “secret truth.” Charming fellow.
With the gentle spirit of Dr. Sanghavi in mind, I now call on the ghost of Jonathan Swift and make the following Modest Proposal regarding vaccinating American children.
Take out all the mercury and aluminum now. The new vaccine preservative dujuor shall be plutonium.
Mercury is for wimps anyway.
Why go with the second most deadly substance on earth, when you can inject human infants and toddlers with the most deadly substance on earth? I will “bet the house” that plutonium kills bacteria way better than that old mercury based thimerisol ever could. Why make them autistic when you can make them glow?
I bet that a little radioactivity will kick the pants off measles or hepatitis.
What is that you say? We haven’t done any safety trials with plutonium? We didn’t do it with mercury either and Eli Lilly and those other companies got away with it. Besides, we will just tell people that “there is no direct link.” We will just tell people who report that their kids got sick after vaccines that it was all “just an erroneous causal connection.” We will just tell parents with suddenly radioactive kids that the symptoms just look like radiation sickness but are really some obscure genetic disorder that is suddenly on the rise. Or, we could say that there is no epidemic and that there were radioactive people laying around for centuries and no one ever thought to notice them. Then we will tell these parents that we do not know why their kids are sick. We will not spend one dime on researching medical interventions. We could just try blaming their mothers (everyone blames their mothers for their problems anyway) or their parenting styles. We could spread fear about decontamination treatments so that these kids could stay sick and so that their parents could stay hopeless because we would not want the cause of the disorder to ever be revealed. We could say there is no “evidence of harm.”
We could ridicule those who ask questions we do not like. We could label their research “junk science” and we could label them as “anti-vaccine nuts.” We could try wrecking the careers and reputations of those heroic enough to voice objection.
We could just poison an entire generation. We could just saddle society with a burden that will last decades and that will cost billions. Our political allies will cover our tracks with special protection legislation because we have paid them to do so.
Then, we will just walk away and hide safely behind our “secret truth.”
Do you think doing that would make us monsters?
UPDATE: Mark Blaxil and Teresa Conrick are angry with Dr. Sanghavi too:
Dear Dr. Sanghavi,
I just read your article, "The Secret Truth" in today's Boston Globe magazine. It is one of the most brazen pieces of propaganda yet written on the autism crisis. You were at least respectful of the Hansens. In all other respects, your essay was little more than propaganda for the National Immunization Program and more suited for a totalitarian dictatorship than America. I hope many people read it and think critically about the implications of your argument. More than ever, American citizens need to stand for an open society and against the coercive powers of the state. Your words should trouble us all.
You accuse parents of committing "classic errors." In turn, we would submit that many of our leading institutions are committing historic errors of medical negligence. You confuse the promotion and preservation of highly experimental (indeed radically interventionist) immunization strategies with the larger responsibility for the public health. In that confusion, you along with many of your colleagues are posing the wrong question. You want us all to be reassured about the safety of vaccines. As responsible parents and educated consumers of the policies and science that concern our families, we welcome safe health products and policies. But our interest is not to maximize our compliance or our consumption. Rather, our concern is the health of our children. And we find ourselves astonished that none of you are interested in asking the question that matters most.
Why are so many children sick?
The epidemic of autism and other neurological disorders is a crisis in our state and our country. The theory that these reported increases are somehow an artifact of a broader diagnostic concept and increased awareness is a spectacular yet testable hypothesis. You profess an admiration for Karl Popper; so am I (and as a Popper admirer, I question how much you really know about his philosophy). In any event, you might be interested to know that the "no epidemic" hypothesis has been tested and falsified at every turn. If you doubt this, I would be happy to educate you on the facts and the science of the issue.
I suggest to you that unless you begin with this question, you have little right to opine on any of the environmental hypotheses related to autism. You certainly cannot expect a rational person to support giving mercury, a known and potent neurotoxin, to infants in any form.
You resort to a number of transparent rhetorical devices. You demonize those who question the established order as dangerous and "anti-vaccine." That is incorrect. Autism parents generally support safe vaccination strategies. You resort to hysterical claims that immunization programs have almost been "derailed" in America. That is also incorrect. Vaccine compliance has never been higher. You claim a scientific consensus. That is an Orwellian assertion. The only consensus is among those who are uniformed or somehow interested by virtue of their scientific and/or medical specialty. A wide group of concerned scientists have deep concerns over the autism epidemic and its many potential environmental causes, but most of them have been cowed into silence by the brand of institutional intimidation of which your article is a prime example.
You say, "personal freedom is a dangerous thing." I submit to you that the unchecked power of government is a far greater danger. Our Founding Fathers knew it. Our entire Constitution and civic culture is based on principles of limited government power. Yet today, these principles are under attack as never before: we go to war based on lies; we consume medical products based on tainted research; we have seen the integration of science and commerce on an unprecedented scale and then we bemoan the loss of confidence in scientific institutions that results. In the meantime, we stand by as we raise the sickest generation of children in our lifetime while our public health leadership refuses to face the reality of their suffering and lost potential. It is a bad time to be a parent in America.
Sincerely,
Mark F. Blaxill
Vice President, SafeMinds
Cambridge MA
Your coverage of vaccines and autism on 12/04/05, "The Secret Truth", was very disappointing. While it is important to discuss vaccines, especially with the increasing media coverage on a possible pandemic, this was a one-sided infomercial.
What I found interesting was the focus on autism research, and the attempt to paint the picture of anti-vaccine parents. What really seemed apparent, was a doctor trying desperately to ignore facts, research and data, especially on thimerosal. Instead the article gave the impression that Dr. Sanghavi was pro-unsafe vaccines, which is actually frightening.
What was also odd, was that Dr. Sanghavi had a very good article in your paper on May 25,2004 ("Lead may be even more dangerous than we thought"). He detailed his thoughts on exposure, discussed the politics and medical controversies, and emphasized how public pressure was instrumental in halting exposure of lead from the paint and gasoline industries. It was clear he thought lead to be a potent neurotoxin.
Public pressure is now vocalizing the need for safe vaccines. Like the families who were outraged about toxic lead, todays families are letting it be known that they expect what is injected into their children is safe. Thimerosal is 50% mercury, and investigating its role in autism does not make anyone anti-vaccine. If it were in a gallon of paint rather than a shot, Dr. Sanghavi would be condemning it. But because it is in the sacred, herd immunity vaccines, he is singing its praises.
Sincerely,
Teresa Conrick
Chicago
December 9, 2005
Used Gaming Systems Wanted
From Autism Cares:
‘Tis the season….To help a child with autism affected by the hurricanes!
Has your child asked for the newest Xbox, PSP, Gameboy or other video gaming system for Christmas? What will you do with the old one? We have a solution for you that will keep your closets uncluttered, and you can help a child in need!
After the presents have all been unwrapped, assembled, installed and the kids are playing, please pack up their old video game systems and any old games and send them to us! We will send them to children with autism who lost theirs in the hurricanes.
To participate, please email us at games4autismcares@adelphia.net and we’ll send you shipping instructions.
Have a Happy Holiday and remember us when the old system gets unplugged!
Sincerely,
Holly Bortfeld
AutismCares Care Package Coordinator
800-960-1844
http://www.autismcares.org
AutismCares is a coalition of National Autism Organizations who have come together to help families dealing with autism who are victims of the Gulf Region Hurricanes.
Please forward to everyone!
‘Tis the season….To help a child with autism affected by the hurricanes!
Has your child asked for the newest Xbox, PSP, Gameboy or other video gaming system for Christmas? What will you do with the old one? We have a solution for you that will keep your closets uncluttered, and you can help a child in need!
After the presents have all been unwrapped, assembled, installed and the kids are playing, please pack up their old video game systems and any old games and send them to us! We will send them to children with autism who lost theirs in the hurricanes.
To participate, please email us at games4autismcares@adelphia.net and we’ll send you shipping instructions.
Have a Happy Holiday and remember us when the old system gets unplugged!
Sincerely,
Holly Bortfeld
AutismCares Care Package Coordinator
800-960-1844
http://www.autismcares.org
AutismCares is a coalition of National Autism Organizations who have come together to help families dealing with autism who are victims of the Gulf Region Hurricanes.
Please forward to everyone!
Subscribe to:
Posts (Atom)