The Wakefield Saga: 2004 All Over Again
By Anne Dachel
The stories are everywhere. They can’t say it enough. The events happening in Britain, the decision by the GMC and the Lancet retraction have settled the debate. THERE IS NO LINK BETWEEN VACCINES AND AUTISM. All the hysterical parents pointing to vaccinations need to find something else to blame for their child’s disability. Dr. Wakefield is at fault for convincing parents that vaccinations caused their child to become sick. If it weren’t for him, there never would have been a controversy.
It’s amazing the coverage this is getting, much of it on the opinion/editorial page.
New York Daily News Feb 6, 2010
Hippocrates would puke: Doctor hoaxed parents into denying kids vaccines
“British physician Dr. Andrew Wakefield has been branded a primary instigator of the mania that drove parents to avoid having their children undergo routine immunizations for fear that inoculations could produce autism.”
“As Alison Singer, president of the Autism Science Foundation, put it, ‘That study did a lot of harm. People became afraid of vaccinations. This is the Wakefield legacy: this unscientifically grounded fear of vaccinations that result in children dying from vaccine-preventable diseases.’
“Steadfastly defending both his integrity and his science - and backed by supporters who mutter about ‘show trials’ and ‘witch hunts’ - Wakefield has been shamed before the world. He deserves far worse.”
The Star-Ledger - NJ Feb 5, 2010
Autism and vaccines: Bogus study hurts research
“Now that a British medical journal has retracted a study linking autism and childhood vaccines for measles, mumps and rubella, the search for answers can explore other possible causes. But make no mistake: the article, first published in the Lancet in 1998, has done substantial damage.”
New York Times - Feb 5, 2010
A Welcome Retraction
“For a decade, many parents have worried that vaccines might somehow be causing autism in children. Repeated assurances from respected experts that there is no link have failed to quiet those fears. Now The Lancet, a prestigious British medical journal that published the paper that first gave wide credence to those fears, has retracted it, saying that the paper’s authors had made false claims about how the study was conducted.”
There’s a darker side to this. Measles is now the number one health threat facing our nation and any criticism of shots could cause parents not to vaccinate against this dread disease. Anyone daring to cite vaccines as the cause of autism is immediately labeled anti-vaccine. The potential result: Measles outbreaks all over the globe and ultimately, dead kids.
Fox News Feb 04, 2010 put out a truly disgusting opinion piece by Greg Gutfeld
“But although the study author has also been discredited, it doesn't matter. People who believe in junk science will continue to believe in junk science, because their egos won't allow any other option. And so they will continue preaching a dangerous and false belief that ends up killing kids — "they" being Jenny McCarthy, Jim Carrey and all the saps at the Huffington Post who, by their own earnest idiocy, misled the public into skipping vaccinations.”
Los Angeles Times Feb 5, 2010
The damage of the anti-vaccination movement
“After Wakefield's article appeared, vaccination levels plummeted in Britain and declined in the United States, and the diseases they prevented surged. Measles cases increased sevenfold in the U.S.
"‘One person's research set us back a decade, and we're just now recovering from that,’ Mark Sawyer, a pediatrician and infectious disease specialist at Radey Children's Hospital in San Diego, told me in an interview.
“But are we recovering? Anti-vaccination groups have popped up like toadstools after rain (there are more than 180 on the Web), while older ones such as the National Vaccine Information Center were reinvigorated. For the most part, these groups have had only a marginal effect on national vaccination rates, but they have encouraged localized boycotts of immunization. (In one Washington county, 27% of children had vaccination exemptions in 2006-07.) The result has been a resurgence of diseases gone so long that some doctors don't even recognize them. And children die because of it.”
CNN - Alison Singer - Feb 3, 2010 Time to regroup on autism (SEE VIDEO)
“The original Lancet publication had launched an era of anti-vaccine activism. At a news conference after the publication, Wakefield said there were "sufficient anxieties for a case to be made" to separate the three vaccines. Vaccination rates plummeted, and measles outbreaks swept across the United Kingdom. Hundreds of children were hospitalized, and several died. Across the country and around the world, parents became stricken with an unfounded fear of vaccination.
“Whereas anti-vaccine parent advocates cite personal anecdotes and state that they know with certainty that their child's autism came from vaccines because ‘they know their child,’ scientists talk about the ‘preponderance of evidence’ and ‘statistical significance.’ That is not the stuff from which good sound bites are made.
“Once you put a scary idea in someone's head, it is very hard to reassure them, even in the presence of compelling science. Anti-vaccine autism activists continue to view Wakefield as a hero willing to take on the establishment and fight for their children.”
For parents and other experts in the autism community, this may seem like a concerted effort to finally crush those who dare to point to vaccines as the trigger for autism. It also serves as a warning to any experts who might be interested in researching this topic. The medical community and the media will destroy you.
So why am I going through all this?
One reason: It isn’t going to matter.
Come on, we’ve heard it all before. This has an eerie feeling of déjà vu. The issue was also dead in 2004. I remember it like it was yesterday. The Institute of Medicine had focused all their cutting edge resources into the question of vaccines and autism and they found no connection.
Science Daily 2004: (HERE)
"The overwhelming evidence from several well-designed studies indicates that childhood vaccines are not associated with autism," said committee chair Marie McCormick, Sumner and Esther Feldberg Professor of Maternal and Child Health, Harvard School of Public Health, Boston. "We strongly support ongoing research to discover the cause or causes of this devastating disorder. Resources would be used most effectively if they were directed toward those avenues of inquiry that offer the greatest promise for answers. Without supporting evidence, the vaccine hypothesis does not hold such promise."
Washington Post 2004: (HERE)
“The Institute of Medicine, a highly influential adviser of the government on scientific matters, said yesterday there is no credible evidence that either the measles-mumps- rubella (MMR) vaccine or vaccines containing the preservative thimerosal cause autism.
“ ‘This is the nail in the coffin. The final bit of research we were looking for to finally discredit this link between the measles vaccine and autism,’ said Marie McCormick from the Harvard School of Public Health on ABC News.
“The Institute of Medicine committee has produced eight studies on vaccine safety at the request of the National Institutes of Health and the Centers for Disease Control and Prevention. This is the last one, and the committee will now disband.”
CBS News 2004: (HERE)
" ‘Don't misunderstand: The committee members are fully aware that this is a very horrible and devastating condition," said Dr. Marie McCormick, a Harvard professor of maternal and child health who led the IOM probe. ‘It's important to get to the root of what's happening.’
“But, ‘there seem to be lots of opportunities for research that would be more productive’ than continuing the vaccine hunt.”
For several years after the 2004 IOM Report, it was commonly cited as backup in news stories about the controversy. Doctors mechanically pointed to THE IOM REPORT as the final proof of no association.
In 2010, no one in the press denouncing Wakefield really knows what they’re talking about. He invited anyone to look at his paper and study what he found. No one does.
Back in 2004, no one in the media examined what was presented at the IOM Conference nor did they question what wasn’t included in the final report:
Scientist after scientist in 2004 revealed research that showed evidence of the great potential for vaccines to damage the physical health of children, including experts like David Baskin, M.D., Richard Deth, Ph.D., Boyd Haley, Ph.D., H, Vasken Aposhian, Ph.D., Jeffrey Bradstreet, M.D., F.A.A.P and Thomas Burbacher, PhD..
Parent after parent testified on medical evidence showing the mercury levels in their children or live measles virus found. The IOM panel remained unmoved.
What I’m seeing in the news in 2010 is merely an update of 2004. So take heart people. This too will fade away. It has to. All the doctors being covered in local news stories act like events in Britain are some victory for them. What exactly have they won? They can’t tell us a thing about the epidemic overwhelming one percent of children. In December 2009, U.S. health officials finally, grudgingly, had to admit that the autism rate is a true increase. This came after years of claiming that there weren’t really more kids with autism with the tired mantra of “better diagnosing” by doctors.
The admission that there are environmental factors was done quietly. There was no alarm sounded. Legislators didn’t demand that the scientific/medical communities immediately focus on the triggers responsible for this epidemic. The press just accepted it. Autism still isn’t an official crisis by any means. The strongest language used by the Centers for Disease and Prevention regarding autism is “serious health care concern.”
I watched Dr. William Schaffner on CNN and I had to wonder what he was smiling about. He said, "There have been now about 20 studies that have looked at this question of vaccines and autism, different investigators, different populations...and they all have denied this link. The important thing is....we need to focus research ...to find out the real causes of autism.
“Science has an open mind. Most of the research today is looking at genetic predispositions as well as a whole array of environmental factors that can interact with the genetics. Vaccines ...have been looked at very very carefully...they're now out of the picture. We need to focus on other issues. That's where we need to put our research..."
The CNN newsman asked "Other issues? In what areas? What's the most promising?"
Schaffner responded, "A whole array of genetic predispositions.... As well as other environmental factors, whether they are chemicals in the environmental, things in our food perhaps. Could they interact with the genetics? ...There are a lot of people now who are focused now on finding what the real causes of autism are. ....Autism usually manifests itself largely in the second year of life and that's when vaccines are given and so you have that coincidence...doctors will provide reassurance.”
I’m sorry, but this doctor gleefully telling us that vaccines don’t cause autism, can’t tell us what does. I’d hardly find that reassuring. IF IT’S NOT THE VACCINES, WHAT IS IT? What’s attacking our children at never-before-seen rates? Why can’t you name a single prospective culprit in the environment that we need to look at?
(I’d also like to ask CNN and every other news source out there why they think that putting a parent up against a doctor is fair and balanced. Why couldn’t CNN talk to any of the experts on our side in addition to the parent shown?)
Finally, what convinces me most of all that this is a minor stumbling block for us in the autism community and that the controversy will continue as heated as ever, is the fact that none of us or our children are going away. Vilifying Andrew Wakefield isn’t going to stop us. Pretending that it does, is a joke.
Unless and until health officials can point to independently done studies disproving a link, the war will continue, unabated.
Where is research that we’ve demanded for years?
I personally promise to go quietly away if anyone can come up with an actual study comparing autism rates in vaccinated vs. unvaccinated populations of children and show me there is no difference.
I will never write another word on this topic if someone produces a study looking at regressive autism and can tell me what changed these children so suddenly that they lost learned skills. This is the research the former head of the National Institutes Health, Dr. Bernadine Healy, called for on CBS News in 2008.
I want to see a study showing us adults with autism just like we see in our children. I don’t want to hear about a study where researchers talked to possible autistic adults on the phone. I want to see the same signs of classic autism among adults that kids have.
If officials can’t produce these studies, no one, including Dr. Schaffner, has the right to say that vaccines “are out of the picture.”
--
Anne Dachel is Media Editor of Age of Autism.
Jake Crosby, I completely agree with you. It seems that autism-USA requires an organisation devoted to getting the truth out.
I recently saw a list of the biochemical abnormalities in the bodies of autistic kids. I would like to see a copy of that in the hands of every doctor in the United States, so that they wont be baffled and annoyed when they hear of parents seeking treatments.
I am one person who suspects that autism and or severe autism is now falling in the US, but we wont get the news(from the CDC) of that for many years- considering that only now are we getting the news of 1996 -born kids. In the meantime those individuals who tremble , knowing in their hearts that the public may one day focus on their keeping mercury in vaccines for so long, are desperate to convince the public to forget about this issue. Notice that the media articles largely focus on the safety and importance of the MMR rather than on Dr. Wakefield and his colleagues and their "misdeeds"
Posted by: Cherry Sperlin Misra | February 13, 2010 at 07:34 PM
The "Vaccine Nazis" have had a "successful witch hunt" and are now is seeking the love and support of fathers, mothers & their children everywhere.
Don't miss your next AAP well-baby visit.
Posted by: cmo | February 12, 2010 at 12:58 PM
What Michael Framson said. Altho I would say that I see this as not so much a result of corporate 'personhood', as it is a result of Congress having given special priviledges to one particular group of corporations--vaccine makers.
I think you can't hold large organizations of people responsible. This will never stop until individuals are held accountable. Not by fines, but by prison sentences.
Posted by: Robin Nemeth | February 12, 2010 at 07:36 AM
Father of three home birthed, breast fed, UNVACCINATED, home schooled kids in a country full of facsists. Life is good!
The birth of our daughter cost $25 dollars.
We let the seven year old cut the cord. Happiest day of my life ;)
http://www.youtube.com/watch?v=2kqyS-HwPdw
Posted by: Andrew | February 12, 2010 at 06:54 AM
(I’d also like to ask CNN and every other news source out there why they think that putting a parent up against a doctor is fair and balanced. Why couldn’t CNN talk to any of the experts on our side in addition to the parent shown?
In order to understand the "Media", you have to understand that they have never been objective or nuetral.
Posted by: StephM | February 12, 2010 at 04:15 AM
It's always interesting to re-read the article Drug Test by Daniel Schulman for the Columbia Journalism Review. I can no longer find it at the CJR web site, but it's at Ginger Taylor's site. Hard to believe that this article was written five years ago. The story is about how taboo is the topic of a possible link between thimerosal in vaccines and autism.
"A reporter for a major media outlet, who did not want to be identified for fear of retribution, told me that covering the thimerosal controversy had been nearly 'career-ending' and described butting heads with superiors who believed that the reporter's coverage - in treating the issue as a two-sided debate - legitimized a crackpot theory and risked influencing parents to stop vaccinating their children or to seek out experimental treatments for their autistic sons and daughters. The reporter has decided against pursuing stories on thimerosal, at least for the time being. 'For some reason giving any sort of credence to the side that says there's a legitimate question here - I don't know how it becomes this untouchable story, I mean that's what we do, so I don't understand why this story is more touchy than any story I've ever done.'"
http://adventuresinautism.blogspot.com/2005/10/columbia-journalism-review-on.html
Posted by: Twyla | February 12, 2010 at 02:43 AM
Notice what the NY Times is saying today and what they said SIX YEARS about Andrew Wakefield. They told us almost the same thing in 2004 that they're telling us in 2010. It didn't make a difference then and it won't today.
2010 Editorial - A Welcome Retraction - NYTimes.com
http://www.nytimes.com/2010/02/06/opinion/06sat3.html
"For a decade, many parents have worried that vaccines might somehow be causing autism in children. Repeated assurances from respected experts that there is no link have failed to quiet those fears. Now The Lancet, a prestigious British medical journal that published the paper that first gave wide credence to those fears, has retracted it, saying that the paper's authors had made false claims about how the study was conducted."
". . . What was not known at the time was that Dr. Wakefield had filed for a patent on a single measles vaccine that would benefit if the triple vaccine failed and that he was receiving payments from a lawyer planning to sue manufacturers of the triple vaccine."
".. . What is indisputable is that vaccines protect children from dangerous diseases. We hope that The Lancet's belated retraction will finally lay this damaging myth about autism and vaccines to rest."
2004 Researchers Retract a Study Linking Autism To Vaccination
http://www.nytimes.com/2004/03/04/world/researchers-retract-a-study-linking-autism-to-vaccination.html?scp=1&sq=wakefield+mmr&st=nyt
"Ten of the 13 scientists who produced a 1998 study linking a childhood vaccine to several cases of autism retracted their conclusion yesterday."
"...The study came under fierce criticism last month when the editor of the Lancet said that the lead author of the report, Dr. Andrew Wakefield had failed to reveal that he had a conflict of interest when he conducted the research. At the time, the journal editors said, Dr. Wakefield was also gathering information for lawyers representing parents who suspected their children had developed autism because of the vaccine."
Anne Dachel
Media
Posted by: Anne McElroy Dachel | February 12, 2010 at 01:17 AM
This is a saga.. to say the least. I can't believe Wakefield lied, and falsified his study; which in my opinion should have been recanted years ago!
Posted by: Mandy Heart | February 12, 2010 at 01:10 AM
"isn’t an admission of wrongdoing on part of Merck or the executives named in the suit, Rogers said."
Precisely the problem. This is criminal behavior wrapped up in corporate bottom line policy.
Corporate criminal behavior will not change until someone goes to jail.
Even when money appears to come out of their pockets in a settlement, its just the cost of doing business. It's only someone else's life and few billion dollars. It's the rights of corporate personhood without any responsibility.
Put a few of the bastards behind bars, or do what the Chinese did to their FDA director and execute a few. Merck's marketing scheme deliberately cloaked as science, constitutes malice and 55,000 people died. That's murder.
Posted by: michael framson | February 12, 2010 at 12:54 AM
Influencing the news is always a goal. It's very difficult with the media so biased though. I get most angry when some so-called reporter or writer tells me and other autism families that we are so desperate for a cause and a cure that we follow anyone who promises this, even if there is NO science behind it.
Really terrific article, Anne.
maurine
Posted by: Maurine Meleck | February 11, 2010 at 09:41 PM
I know, Jen, right? WTF? I have to let my friend, who is in his class, handle him, she asked me to stay out of it. But I couldn't help but share.
And Jake, I agree with you wholeheartedly about the media. I have often posted here that you have to get out there in your town and offer to be reporters' "go-to" on autism. Let them know they can call you with anything pertaining to the subject and they will! I had 2 tv reports on clarifying the Wakefield story last week, and they didn't even look for rebuttals. They know me and know I am studying this more than anyone else. I have also been asked to speak to the Pediatric Nurses' Association in town next week. Put yourself out there and things will happen. People need to hear our side on a grassroots level.
Posted by: kim | February 11, 2010 at 05:22 PM
6:00 am since 1980, at least. Happy Ground Hogs Day.
Be careful what you ask for in studies because you will get another "asked and answered." When they finally do a vaccinated/unvaccinated study, the results are already pre-determined. What we have to do is remove the "theys" in the equation and continue to do our own privately funded studies, keep helping affected children and teach others about our experiences. Only when there are no customers for the vaccine will they see it from our side.
Posted by: Cynthia Cournoyer | February 11, 2010 at 05:18 PM
I agree with Jake Crosby.
Posted by: Alison MacNeil | February 11, 2010 at 04:14 PM
Kim, WTF???!!! That CDC guy in public health sounds like a complete moron. It might even be constructive/instructive to take apart what he said and repeat the facts back and show people the difference. Guys like this need to be outed and be accountable to the facts, especially when it is a matter of public health. Similar to Offits ridiculous claim about children being able to withstand thousands (or whatever it was that he said) of vaccines at one time. Most of those guys are a complete joke and their stupid "safety" studies are a complete joke, too.
Posted by: jen | February 11, 2010 at 03:16 PM
Way to go Jen! My sentiments exactly.
And yes, how do we go about influencing the media just as pharma has?
Posted by: Kevin | February 11, 2010 at 02:33 PM
The one-size-fits-all vaccine promoters apparently continue to view vaccine safety concerns as a front-channel problem. Vaccine scares were sensationalized in the media, they think; turn the media around and parents will change their minds.
But as many here have pointed out, vaccine skepticism is a back channel phenomenon, at least in part, if not large part. Parents talking with other parents or listening to whatever selective voices they've chosen to trust. For example, a family on our floor has a spectrum kid, and they ard sure vaccines were involved; my wife's best friend has someone on her floor who believes the same thing; etc.
A front channel media assault is likely to have little impact on the slowly self-assembling momentum of back channel communication between people who trust each other. Case in point, I doubt all that many people keep up with AoA, yet somehow they get bashed for "stealing the debate" singlehandedly? Front channel thinking.
Posted by: Schoolteacher in NYC | February 11, 2010 at 02:01 PM
Does anyone feel like telling people to go ahead with those shots? I think, well, how many will it take? Let's get this over with. I feel like we are almost swimming upstream to tell people not to vaccinate. It sounds so callous. Unfortunately we need high numbers of autistics for anything to ever get done!! It is so sad but until they have lived it, few will listen and not much will be done I'm afraid. I apologize for being so brutal. Just very, very frustrated...
Posted by: Trace | February 11, 2010 at 01:52 PM
Anne, Thank you. I find this very encouraging.
They knocked down one of the guys who was doing more than his share of shoveling coal into the locomotive engine. But he'll get back up and do more than his share again. And there are others doing the same. Meanwhile the freight train is still moving down the tracks at breakneck speed. Best get out of the way if you're standing still or heading in the opposite direction.
Posted by: ObjectiveAutismDad | February 11, 2010 at 01:41 PM
well i suggest that they contact the parents that choose not to vaccinate during this time and see if there children have autism or not....then they can publish the results of that study....
Posted by: crystal winters | February 11, 2010 at 01:31 PM
RE: Dr. William Schaffner, keep in mind Vanderbilt University holds numerous vaccine related patents.
Posted by: Garbo | February 11, 2010 at 01:01 PM
"I personally promise to go quietly away if anyone can come up with an actual study comparing autism rates in vaccinated vs. unvaccinated populations of children and show me there is no difference."
Anne, even if no difference in rates, there could still be big differences in severity of autism symptoms. I don't think it would be a good idea to walk away quietly, not until both the rates and the severity are compared, honestly.
Posted by: Natasa | February 11, 2010 at 12:57 PM
"Under the settlement announced today, Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party."
Anyone wanna bet that the "independent third party" is a contract research organization with ties to Merck?
Posted by: Garbo | February 11, 2010 at 12:55 PM
A friend has a professor who is in public health with the CDC. We wanted to ask him how they could be promoting seasonal flu and H1N1 in pregnant women when the package insert says the effects are unknown and that the full set of both with boosters would expose mother and child to 100 mcg of thimerosal. This was part of his response:
"Thimerosol was just a preservative. Removing it from the vaccine has nothing to do with its sterility and/or effectiveness. The preservative just gave the vaccine a longer shelf life. Although there still has been no scientific data to support that Thimerosol was a problem, it has been removed from virtually all products now. In fact, the Lancet (journal), just yesterday retracted the article that made this such a big deal many years ago. They retracted the study and said it was bogus."
How do you fight this kind of ignorance from the CDC's own front line? Appalling.
Posted by: kim | February 11, 2010 at 12:17 PM
We need to stop bitching about the news and work on influencing it!
Posted by: Jake Crosby | February 11, 2010 at 12:17 PM
The SF Chronicle also had an editorial in the paper about the Lancet retraction. I am certain that the editor did not read the retracted study. I don't believe that any of the studies by big pharma, no matter how falsified they have been, have received such venom from any newspaper. The Wakefield et al. study is available online as we speak. The study invites further studies and does not cast anything in concrete as the editorial suggests. Besides we know why this campaign was launched at this time. It is used to discredit a study on primates that suggests that there is plenty wrong with mercury-containing vaccines.
Posted by: Birgit Calhoun | February 11, 2010 at 12:16 PM
I remember several months ago when the new Autism numbers were about to be released. Ginger Taylor and other bloggers were among the first to break the new numbers. Why did the bloggers beat the media to the story? Because the media and the CDC have an arrangement that they won't break certain stories until CDC clears them to do so. So, even though the media has agreed to serve as a publicity arm for the government in this fashion, some of them had the gumption to complain that the bloggers beat them to the story! An earlier post says it best, they have become the embedded media. True investigative reporting has been abandoned. They can complain about the bloggers but IMO they are just filling the void that the media left.
Posted by: AnaB | February 11, 2010 at 11:56 AM
Only a few short years ago,
the same newspapers were printing the glorious statements of finanacial wizard, Congressman Barney Frank, that the "American banking system was in fine shape" and there should be no need for future concern.
Posted by: cmo | February 11, 2010 at 11:33 AM
well all these "newspapers" can suck it because it wasn't Andy Wakefield who caused doubt about vaccines, it was the f'g vaccines. Parents hear from other parents who know their kid was damaged by vaccines. There is an actual vaccine court (lame as it might be). "The problem is the problem," as Jim said.
Posted by: jen | February 11, 2010 at 10:21 AM
Some very interesting titles for some of the Lancet retraction articles.
I would suggest this one for the NY Times.
"Could Merck have a product, bigger, dumber and more expensive than Vioxx ???
Posted by: cmo | February 11, 2010 at 10:03 AM
How about this parallel narrative about Merck's future plan to keep itself honest? This is Merck talking.
"Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well “honest communication” with doctors.
“In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,” according to the amended code. “We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.”
Merck withdrew Vioxx in 2004 after a study showed it doubled the risk of heart attacks and strokes. The company won 11 of 16 Vioxx suits at trial before agreeing in 2007 to create a $4.85 billion settlement fund to resolve thousands of injury claims over the drug. Plaintiffs’ experts said Merck distorted the health risks of Vioxx in medical literature, advertisements and statements to doctors by sales representatives.
The settlement, which won preliminary approval from a New Jersey state judge yesterday, would resolve all so-called derivative lawsuits, which are for the benefit of the company rather than just shareholders. An approval hearing is scheduled for March 22 in Atlantic City, New Jersey.
Merck “believes this is the best and most appropriate way to resolve these suits and enable the company to put this matter behind it,” said Ron Rogers, a spokesman for Merck, based in Whitehouse Station, New Jersey.
The settlement, which covers federal and New Jersey state shareholder cases, isn’t an admission of wrongdoing on the part of Merck or the executives named in the suit, Rogers said. The company will be required to make corporate governance changes and “supplement existing policies and procedures,” he said.
In testimony videotaped in 2006 for the Vioxx trials, Harvard Medical School professor Jerome Avorn said Merck failed to conduct adequate studies of Vioxx’s risks before launching it in 1999 as an alternative to painkillers that caused more stomach bleeding. Merck also misled doctors about a 2000 study that showed Vioxx caused five times more heart attacks than another painkiller, naproxen, he said.
“There was a pattern of what I would characterize as systematic distortion that rose almost to the level of grotesque,” Avorn said in a tape played in federal court in New Orleans. “It was an embarrassment for me as a member of the medical profession that this was going on in presenting information to doctors in such a one-sided and lopsided way.”
One Merck study designed to show Vioxx was easier on the stomach than an older painkiller was actually a marketing tool to boost sales, according to a 2008 report in the Annals of Internal Medicine. The study, known as Advantage, was a trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale.
The study, which recruited 600 doctors, was crafted by Merck’s marketing department, according to researchers who reviewed 100 internal company memos and reports.
The Advantage study “was marketing masquerading as science,” the lead author of the Annals report, Kevin Hill of Harvard Medical School in Boston, said in a 2008 interview. “They went about this in a very analytic way, picking doctors who would be most influential, who will talk to other doctors and recommend Vioxx to them, and thus increase prescriptions in the area, planting the seeds of additional Vioxx use.”
Under the settlement announced today, Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party.
The chief medical officer would have an “executive voice” on product safety issues independent of Merck Research Laboratories. The appointee would serve as Merck’s “medical ambassador,” report to the chief executive officer and serve on the executive committee."
From PharmaGossip
Posted by: Carol | February 11, 2010 at 10:03 AM
Even when they knew that their lives would be ripped apart for it, Drs. Wakefield, Walker-Smith and Murch stood up for children's health.
Dr. Wakefield continues to. He's like a gastroenterological Rasputin from the point of view of Big Pharma. Without compassion or integrity themselves, industry, embedded medical authority and the embedded press can't figure out what drives Wakefield.
Posted by: Gatogorra | February 11, 2010 at 09:48 AM
Unfortunately, it's going ot have to happen to these people's children the way it did to way too many of ours for them to realize we are right. And I love that they keep saying studies have proved that vaccines don't cause autism. What studies are they referring too? None of the studies that were done, were done correctly. Just so frustrating, but I will continue to tell my child's story. There are many that don't turn their backs and think I am crazy. And to them I feel that I am giving them the gift of knowledge and the truth.
Posted by: Jennifer | February 11, 2010 at 09:44 AM
Even a hot topic at momversation this week. So much confusion and now the majority of posters think everything is ok, rest easy and get those shots.
Posted by: Michele | February 11, 2010 at 09:33 AM
"IF IT’S NOT THE VACCINES, WHAT IS IT? What’s attacking our children at never-before-seen rates?"
TYLENOL.
http://www.birthdefects.org/research/ASD%20Report%202009.pdf
http://www.thorne.com/altmedrev/.fulltext/14/4/364.pdf
http://www.thorne.com/altmedrev/.fulltext/14/4/322.pdf
http://www.grc.nia.nih.gov/branches/rrb/dna/pubs/Becker%20and%20Schultz%202009.pdf
Posted by: Jen in TX | February 11, 2010 at 09:29 AM
Hyper-vax nut jobs must despise the Internet.
Not only has this not died down, it is more powerful than ever. Parents now realize that they do have a choice.
Many mainstream parents also question some of the more "borderline" recommended vax (i.e., HepB at birth, Rotavirus, chicken pox, flu shots).
Thank God for freedom, and for knowledge.
Posted by: Parent | February 11, 2010 at 09:10 AM
The only thing that will stop the biased media reports is a large body of solid, unassailable bench research proving the biological mechanisms of autism.
The vaxed/unvaxed study could show could show a 10,000% higher rate of autism in vaxed children, and the deniers would punt to arguments about genetic, educational and socio-economic differences in those who choose not to vax. ("Children of non-vaxers tend to be born to older, higher-educted parents (often mathematicians or engineers) who don't allow their children to watch television.")
I personally would like to know the results of the vaxed/unvaxed study, and such a study might help to change a few minds. But epidemiological studies, including vaxed/unvaxed, will not do it, IMO.
Posted by: MB | February 11, 2010 at 08:49 AM
Can't blame Dr. Wakefield for all the "coincidences" there are in heavily vaccinated populations.
CDC reports 1 in 6 children, of the most heavily vaccinated generation in our nation's history .. suffer chronic autoimmune disorders that were far less common in AlL previous, less vaccinated, generations.
Studies of another heavily vaccinated population... our military .. found they are at greater risk of developing Gullian-Barre Syndrome (GBS) and Amystrophic Lateral Sclerosis (ALS) than those with no military service.
AND THE BAND PLAYED ON......
Posted by: Bob Moffitt | February 11, 2010 at 08:33 AM
Schaffner and Wiznitzer always both have shit eating grins on their faces when on TV talking about no connection between vaccines and autism and how vaccines are oh so safe.
As a mom who's child regressed after the MMR and developed multiple and ongoing health issues I'd like to ask them, "What's so damn amusing fellows"?
Then I'd like to put those two and my 14 year old non verbal son alone in a room and let them experience what it looks like when he has a full blown meltdown. After several mintues of that experience I would open the door and see if those shit eating grins still remained on their faces. I doubt it.
Measles or the kind of autism my kid has. I'll take measles all day long.
Posted by: hate shit eating grin TV doctors | February 11, 2010 at 07:48 AM
Thank you, Anne for showing that the parallels of the 2004 IOM craziness is very much like what we are seeing now.
You are so correct that none of us are retreating and allowing the liars and the many conflict of interest characters slither off without the truth being shown, that their words and deeds do not have the best interest of anyone but themselves. The "anti-vaccine" plot that they try to paint instead of the reality of medical injury is criminal.
Posted by: Teresa Conrick | February 11, 2010 at 06:52 AM