Neurontin and Lyrica are a Death Sentence for New Brain Synapses

A shocking study shows that these two drugs block the formation of new brain synapses1, drastically reducing the potential for rejuvenating brain plasticity – meaning that these drugs will cause brain decline that apparently robs one of the ability to rebuild. The study demonstrating this type of brain damage with these two drugs came out in 2009 but apparently the media has been very lax in getting any of this information to the public – most likely because they do not want to jeopardize their advertising income from this company.
But the patients are not the only ones not getting this information because the doctors are apparently clueless as well. I say that because first our Facebook group for these two drugs “Neurontin (Gabapentin) & Lyrica (Pregabalin) Should Be Illegal” is growing so quickly. Then this past Spring my brother working on some things in the backyard pulled a muscle in his back. I was shocked to learn that he had gone to the doctor for that and the doctor gave him a prescription for Neurontin!
When I asked when he had started having seizures that he would need an anti-seizure medication for he said, “What?!”
I had to explain to him that Neurontin is an anti-seizure medication and that the company had received two huge fines, totaling billions, from the FDA for prescribing it for anything else. And in 2010 they were even found guilty of RICO, yes racketeering, for encouraging doctors to prescribe this drug off label – for things it is not approved for-like pulling a muscle in your back! Then I shared with him the information in this study indicating the brain damage from the drug at which point he understandably decided not to take the drug.
Although I have included the full article on this below this is the link to the article which you need to follow to find the full research study if you want to take it to your doctor to educate him: https://www.wellnessresources.com/news/neurontin-and-lyrica-are-a-death-sentence-for-new-brain-synapses#ref1
Now my question is why on earth has the FDA not pulled these drugs from the market in light of this study? I ask that because before this study the worst I had seen in producing brain damage were the diet pills Fen-Phen and Redux which were pulled from the market due to the brain damage they produced … even though the media convinced the world those drugs were pulled because of the heart and lung damage. It was the brain damage the FDA was concerned about and had required studies from the maker to prove its safety. Something they had not yet done before Dr. Una Mc Cann at NIH put out a study showing the most horrific brain damage. Those drugs were pulled only days later.
Diet Pill article: http://articles.latimes.com/1997/aug/27/news/mn-26267

Neurontin and Lyrica are a Death Sentence for New Brain Synapses

October 15, 2009 | Byron J. Richards, Board Certified Clinical Nutritionist

Neurontin and Lyrica are a Death Sentence for New Brain Synapses

Neurontin and its newer more potent version, Lyrica, are widely used for off-label indications that are an outright flagrant danger to the public. These blockbuster drugs were approved for use even though the FDA had no idea what they actually did in the brain. A shocking new study shows that they block the formation of new brain synapses1, drastically reducing the potential for rejuvenating brain plasticity – meaning that these drugs will cause brain decline faster than any substance known to mankind.

The problem of these drugs is compounded by their flagrant illegal marketing. Neurontin was approved by the FDA for epilepsy back in 1994. The drug underwent massive illegal off-label promotion that cost Warner-Lambert 430 million dollars (the very first big fine for off-label promotion). The drug is now owned by Pfizer. Pfizer also owns Lyrica, a super-potent version of Neurontin. It has been approved by the FDA for various types of pain and fibromyalgia. Lyrica is one of four drugs which a subsidiary of Pfizer illegally marketed, resulting in a $2.3 billion settlement against Pfizer.

Even though the marketing of these drugs has been heavily fined, they continue to rack up billions in sales from the off-label uses. Doctors use them for all manner of nerve issues because they are good at suppressing symptoms. However, such uses can no longer be justified because the actual mechanism of the drugs is finally understood and they are creating a significant long-term reduction in nerve health.

The researchers in the above study try to downplay the serious nature of the drugs by saying “adult neurons don’t form many new synapses.” That is simply not true. The new science is showing that brain health during aging relies on the formation of new synapses. Even these researchers managed to question the common use of these medications in pregnant women. How is a fetus supposed to make new nerve cells when the mother is taking a drug that blocks them?

These are the kind of situations the FDA should be all over. As usual, the FDA is sitting around pondering a suicide warning for Lyrica while its off-label uses include bi-polar disorder and migraine headaches. The FDA is likely to twiddle its thumbs for the next decade on the brain damage issue. Consumer beware.

Referenced Studies

  1. ^ Neurontin and Lyrica are Highly Toxic to New Brain Synapses  Cell  Çagla Eroglu, Nicola J. Allen, Michael W. Susman, Nancy A. O’Rourke, Chan Young Park, Engin Özkan, Chandrani Chakraborty, Sara B. Mulinyawe, Douglas S. Annis, Andrew D. Huberman, Eric M. Green, Jack Lawler, Ricardo Dolmetsch, K. Christopher Garcia, Stephen

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ANTIDEPRESSANTS & ALZHEIMER’S: Glen Campbell’s Final Album “Adios”

How very sad and tragic that these medical disasters continue to destroy the lives of so many celebrities, as well as many more in the general society, and NO ONE seems to know that medications have done this to any of them! Glen Campbell is sadly only one example of so many more.
FIRST THE ARIZONA DUI
Years ago when Glen was arrested in Phoenix for drunk driving they let everyone know he was on the antidepressant Lexapro (You can find that in our database of thousands of cases at www.SSRIstories.NET). Most important to consider in his arrest is that all of these serotonergic antidepressants – SSRIs and SNRIs – produce overwhelming craving for alcohol – even in those who have never touched alcohol before. And for those who had alcohol problems previously, these antidepressants so often given as “treatment” in rehab, have been shown in medical studies to increase drinking by 45%!
Did anyone explain that to Glen Campbell back then? Of course not! That would cut into their profits. I am sure they did as most doctors were doing – increased his dose or just switch to a different brand of the same kind of drug.
See our Facebook group “Antidepressant-Induced Cravings for Alcohol” for more info on the alcohol cravings:
So in thinking the antidepressants were helping him he continued to use them as his various mental disorders worsened and changed from depression, to major depression, etc. He could have easily developed a Bipolar Disorder,  as so many do who take antidepressants since antidepressants induce Bipolar so rapidly, but if he did I missed that one while I was attempting to keep up with all the other tragedies caused by these drugs.
Now for years we have heard that Glen Campbell is suffering from Alzheimer’s. But what he and so few others remain completely unaware of is that these drugs which are designed to increase serotonin produce all the symptoms of Alzheimer’s while they slowly shut down every body system. The drugs affect memory sp strongly that Amnesia is a common side effect!
Alzheimer’s disease has long been known to be a condition of elevated serotonin levels. The gummy gooey glossy substance they know builds up in the brain is the same gummy gooey glossy substance they found built up on the heart valves of those who took the serotonergic diet pills Fen-Phen and Redux.
These diet pill heart valve issues wound up being one of the very largest patient damage suits in the history of the US due to that gummy gooey glossy gunk that built up on the heart valves preventing the valves from shutting properly.
And what was the cause of that gummy gooey glossy gunk? Wwll according to the Mayo Clinic study by Dr. Heidi Connolly it was elevated serotonin – exactly the action of the these diet pills which increase serotonin levels from two directions while antidepressants do so from one direction.
So does that risk remain a concern with antidepressants as well? Certainly it should although it should take longer to produce this adverse effect than the diet pills due to the antidepressants increasing serotonin via one direction, serotonin reuptake, rather than two directions as the diet pills did. 
 

But what about the brain?

While the drug maker got away with the massive brain damage … the drugs were actually pulled for causing brain damage, not heart damage. Most were left to believe the drugs were pulled due to the heart valve damage brought to light by Heidi Connolly’s research but that was clear back in June, months before the drugs were pulled. What was new was the research of Dr. Una McCann at NIH on the resulting brain damage from these serotonergic diet pills. Only two weeks before the drugs were pulled she published a study done for NIH indicating some of the worst brain damage I have ever seen. The catch was that when the FDA had issued a temporary approval for Redux the year before they were concerned there may be brain damage from these serotonergic diet drugs so they insisted that Wyeth do research to learn if that was indeed the case with Redux. But Wyeth had done NO research at all on brain damage associated with their drug by the time Una McCann’s research came out. This is the real reason why the drugs were pulled by the manufacturer.

 

The brain damage was clearly associated with the elevated levels of serotonin in my opinion and this is why antidepressants designed to increase serotonin can produce that same brain damage which I have no doubt is what has happened to Glen Campbell over the years.

 

ROBERT REDFORD’S FAMILY TOO?!

Is it just a coincidence that two of the states with the highest use of antidepressants, Florida and Utah, hold the two highest rates of Alzheimer’s?!!! Read this link to see how this same reaction affected Robert Redford’s Utah family very early on and could have ended the same way as Glen Campbell’s has…

ANTIDEPRESSANTS & MEMORY LOSS: Utah No. 2 in nation for Alzheimer’s

Please visit our Facebook group on that side effect of these drugs: “Antidepressant-Induced Alzheimer’s, Amnesia and Memory Loss” :

Glen Campbell IS NOT not dying of Alzheimer’s!

He is dying of antidepressant poisoning!

And if anyone knows how to reach him they could let him know that he does not need to die of Antidepressant-induced Alzheimer’s, but that does not mean it will not be a long road back with a long and gradual weaning process and then rebuilding from all the damage.

Go here to listen to him sing “Adios”…..

http://www.billboard.com/articles/columns/country/7783512/glen-campbell-adios-final-album-song-stream?utm_source=Microsoft&utm_campaign=Syndication&utm_medium=Glen+Campbell+Says+Goodbye+With+Title+Track+From+Final+Album+%27Adios%27

Article by his wife Kim: ‘Thank you, heavenly Father’: Faith, Alzheimer’s and my husband Glen Campbell: http://www.foxnews.com/opinion/2014/10/24/faith-alzheimer-and-my-husband-glen-campbell.html

You can search for Glen’s earlier Lexapro case in our database of thousands of cases: www.SSRIstories.NET

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STUDY: 75% OF THOSE TAKING ANTIPSYCHOTIC MEDS SHOW LOSS OF BRAIN MATTER!

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Our most recent post was on the extreme increase in the use of antipsychotic medications – especially in children: Since 1993 use in children (who have no choice in the decision) skyrocketed by 800%, in teens by 500%, and in adults by 200%. Now a new study just out demonstrates brain damage in 75% of those who take these drugs!!

THE IMPACT UPON SOCIETY

Think it does not affect you because you are not on them? Better think again because we will all pay to care for those suffering brain damage from these drugs in higher taxes, higher insurance rates, disability payments, etc. and in reduced productivity & creativity via the contributions these people could have made to our society had their brains remained intact and functioning.

SEROTONIN-INDUCED OXYGEN DEPRIVATION

PRODUCING CELL DEATH

Of course my first question would be, “How many of those patients tested had previously been on antidepressants BEFORE they were given antipsychotics to treat their antidepressant-induced psychosis which antidepressants are so prone to produce?” Why would I want to know that? Because antidepressants ALSO decrease the blood flow to the brain as will any other drug that increases serotonin. The main function of serotonin is constriction of smooth muscle tissue such as the veins & arteries that carry oxygen to the brain.

CORKSCREW BRAIN CELLS FROM ANTIDEPRESSANTS

As early as a decade ago in February of 2000 Jefferson Medical College in Philadelphia published research indicating that several serotonergic medications within only four days use caused a shriviling up of brain cells or taking on of abnormal corkscrew shapes. (What a nice technical way to express that these drugs literally screw up the brain!) The drugs featured in this research were all serotonergic – the antidepressants Prozac and Zoloft, and the diet drugs Redux and Meridia which have now been pulled from the market due to the brain damage produced by these drugs (see below for that explanation).

BRAIN CELL DEATH? PERMANENT OR TEMPORARY?

The lead researcher in this study concluded: “We don’t know if results with four days of drug treatment are clinically significant,” Dr. Kalia says. “We don’t know if the cells are dying. That’s the key question. We need to do more studies to prove cell death. These effects may be transient and reversible. Or they may be permanent.” (Please see my comments below on the question of permanent damage or temporary.)

POPULAR DIET PILLS PULLED DUE TO BRAIN DAMAGE

Another piece of information few have is the fact that Fen-Phen & Redux were pulled from the market due to the massive brain damage they caused, not the heart valve damage or PPHN that so many assumed was the reason they were pulled from the market. Just two weeks before the removal of those drugs  from the market the National Institutes of Health (NIH) had finished an extensive study on Redux & brain damage which the manufacturer, Wyeth, was suppose to have completed as part of the drug’s approval a full year before.

The NIH study results demonstrated some of the most massive brain damage you could imagine! JAMA published the study August 27 1997, titled, “Brain serotonin neurotoxicity and primary pulmonary hypertension from fenfluramine and dexfenfluramine. A systematic review of the evidence.”

BRAIN SEROTONIN NEUROTOXICITY?!!

PLEASE note that term in discussing ANY drug that increases serotonin! Make the connection between elevated serotonin and neurotoxicity – brain damage!

Within a couple of weeks after pubication that NIH study the drugs were off the market! But tragically that left MANY patients in horrific cold turkey withdrawal which naturally resulted in many suicides, murder/suicides, and deep depression which most had never suffered from before taking these serotonergic diet pills. These cases went mostly unnoticed or recognized as related to the drugs or the cold turkey withdrawal from these drugs. At that point many of those patients ended up on antidepressants which helped to stop the withdrawal, but of course should be expected to continue the damage to the brain via the excess serotonin they too produce. This is an example of a dangerous senario all those on antidepressants need to be aware of – the potential abrupt withdrawal of the drugs they are taking being pulled with little to no warning.

IS THERE HOPE AFTER SUCH DAMAGE?

I have long contended that this brain damage does not have to be permanent. I do believe there is hope for recovery, but I think you have to work at it. Just stopping the drugs producing the damage is not enough. Please go to www.drugawareness.org/alternatives to see just how many options there are to restoring one’s health and brain function after the use of these drugs. You can even see brain scans before and after some of the treatments showing recovery.

I would also refer all to our website link to alternatives we have found to help and also to a special done by Dr. Sanjay Gupta from CNN, who, after interviewing with him I have much respect for as a brilliant and open minded scientist and good human being. The link to information on that special is located here: http://www.drugawareness.org/cnn-teen-in-coma-from-severe-brain-injury-recovers-with-alternatives/

Read the study on antipsychotics & brain damage, along with references here: www.sciencedirect.com/science/article/pii/S014976341200125X

Read article from Jefferson Medical College on corkscrew shaped brain cells here: http://www.antidepressantsfacts.com/Thomas-Jefferson-University-Hospital.htm

Read NIH study on Fen-Phen & Redux, Brain serotonin neurotoxicity and primary pulmonary hypertension from fenfluramine and dexfenfluramine. A systematic review of the evidence, here: http://www.ncbi.nlm.nih.gov/pubmed/9272900

 

Ann Blake-Tracy, Executive Director,

International Coalition for Drug Awareness

www.drugawareness.org & www.SSRIstories.com

Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the FullImpact of Antidepressants Upon Us & Our World” & Safe Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

BOOK:  Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. Find the book & the CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications. Available at www.drugawareness.org

BOOK TESTIMONIALS:

“VERY BOLD AND INFORMATIVE”

“PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME”

“THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS”

“WELL DOCUMENTED & SCIENTIFICALLY RESEARCHED”

“I was stunned at the amount of research Ann Blake-Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambian. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for Ann Blake-Tracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!

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Lies, Damned Lies, and Medical Science

Lies, Damned Lies, and Medical Science

The Atlantic

November 2010

Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science.

By David H. Freedman

IMAGE CREDIT: ROBYN TWOMEY/REDUX

IN 2001, RUMORS were circulating in Greek hospitals that surgery residents, eager to rack up scalpel time, were falsely diagnosing hapless Albanian immigrants with appendicitis. At the University of Ioannina medical school‟s teaching hospital, a newly minted doctor named  Athina Tatsioni was discussing the rumors with colleagues when a professor who had verheard asked her if she‟d like to try to prove whether they were true—he seemed to be almost daring  her. She accepted the challenge and, with the professor‟s and other colleagues‟ help, eventually produced a formal study showing that, for whatever reason, the appendices removed from patients with Albanian names in six Greek hospitals were more than three times as likely to be perfectly healthy as those removed from patients with Greek names. “It was hard to find a journal willing to publish it, but we did,” recalls Tatsioni. “I also discovered that I really liked research.” Good thing, because the study had actually been a sort of audition. The professor, it turned out, had been putting together a team of exceptionally brash and curious young clinicians and Ph.D.s to join him in tackling an unusual and controversial agenda.

Last spring, I sat in on one of the team‟s weekly meetings on the medical school‟s campus, which is plunked crazily across a series of sharp hills. The building in which we met, like most at the school, had the look of a barracks and was festooned with political graffiti. But the group convened in a spacious conference room that would have been at home at a Silicon Valley start-up. Sprawled around a large table were Tatsioni and eight other youngish Greek researchers and physicians who, in contrast to the pasty younger staff frequently seen in U.S. hospitals, looked like the casually glamorous cast of a television medical drama. The professor, a dapper and soft-spoken man named John Ioannidis, loosely presided.

One of the researchers, a biostatistician named Georgia Salanti, fired up a laptop and projector and started to take the group through a study she and a few colleagues were completing that asked this question: were drug companies manipulating published research to make their drugs look good? Salanti ticked off data that seemed to indicate they were, but the other team members almost immediately started interrupting. One noted that Salanti‟s study didn‟t address the fact that drug-company research wasn‟t measuring critically important “hard” outcomes for patients such as survival versus death, and instead tended to measure “softer” outcomes, such as self-reported symptoms (“my chest doesn‟t hurt as much today”). Another pointed out that Salanti‟s study ignored the fact that when drug-company data seemed to show patients‟ health improving, the data often failed to show that the drug was responsible, or that the improvement was more than marginal.

Salanti remained poised, as if the grilling were par for the course, and gamely acknowledged that the suggestions were all good—but a single study can‟t prove everything, she said. Just as I was getting the sense that the data in drug studies were endlessly malleable, Ioannidis, who had mostly been listening, delivered what felt like a coup de grâce: wasn‟t it possible, he asked, that drug companies were carefully selecting the topics of their studies—for example, comparing their new drugs against those already known to be inferior to others on the market—so that they
were ahead of the game even before the data juggling began? “Maybe sometimes it‟s the questions that are biased, not the answers,” he said, flashing a friendly smile. Everyone nodded. Though the results of drug studies often make newspaper headlines, you have to wonder whether they prove anything at all. Indeed, given the breadth of the potential problems raised at the meeting, can any medical-research studies be trusted?

That question has been central to Ioannidis‟s career. He‟s what‟s known as a meta-researcher, and he‟s become one of the world‟s foremost experts on the credibility of medical research. He and his team have shown, again and again, and in many different ways, that much of what biomedical researchers conclude in published studies—conclusions that doctors keep in mind when they prescribe antibiotics or blood-pressure medication, or when they advise us to consume more fiber or less meat, or when they recommend surgery for heart disease or back pain—is misleading, exaggerated, and often flat-out wrong. He charges that as much as 90 percent of the published medical information that doctors rely on is flawed. His work has been widely accepted by the medical community; it has been published in the field‟s top journals, where it is heavily cited; and he is a big draw at conferences. Given this exposure, and the fact that his work broadly targets everyone else‟s work in medicine, as well as everything that physicians do and all the health advice we get, Ioannidis may be one of the most influential scientists alive. Yet for all his influence, he worries that the field of medical research is so pervasively flawed, and so riddled with conflicts of interest, that it might be chronically resistant to change—or even to publicly admitting that there‟s a problem.

THE CITY OF IOANNINA is a big college town a short drive from the ruins of a 20,000-seat amphitheater and a Zeusian sanctuary built at the site of the Dodona oracle. The oracle was said to have issued pronouncements to priests through the rustling of a sacred oak tree. Today, a different oak tree at the site provides visitors with a chance to try their own hands at extracting a prophecy. “I take all the researchers who visit me here, and almost every single one of them asks the tree the same question,” Ioannidis tells me, as we contemplate the tree the day after the team‟s meeting. “„Will my research grant be approved?‟” He chuckles, but Ioannidis (pronounced yo-NEE-dees) tends to laugh not so much in mirth as to soften the sting of his attack. And sure enough, he goes on to suggest that an obsession with winning funding has gone a long way toward weakening the reliability of medical research.

He first stumbled on the sorts of problems plaguing the field, he explains, as a young physician-researcher in the early 1990s at Harvard. At the time, he was interested in diagnosing rare diseases, for which a lack of case data can leave doctors with little to go on other than intuition and rules of thumb. But he noticed that doctors seemed to proceed in much the same manner even when it came to cancer, heart disease, and other common ailments. Where were the hard data that would back up their treatment decisions? There was plenty of published research, but
much of it was remarkably unscientific, based largely on observations of a small number of cases. A new “evidence-based medicine” movement was just starting to gather force, and Ioannidis decided to throw himself into it, working first with prominent researchers at Tufts University and then taking positions at Johns Hopkins University and the National Institutes of Health. He was unusually well armed: he had been a math prodigy of near-celebrity status in
high school in Greece, and had followed his parents, who were both physician-researchers, into medicine. Now he‟d have a chance to combine math and medicine by applying rigorous statistical analysis to what seemed a surprisingly sloppy field. “I assumed that everything we physicians did was basically right, but now I was going to help verify it,” he says. “All we‟d have to do was systematically review the evidence, trust what it told us, and then everything
would be perfect.”

It didn’t turn out that way. In poring over medical journals, he was struck by how many findings of all types were refuted by later findings. Of course, medical-science “never minds” are hardly secret. And they sometimes make headlines, as when in recent years large studies or growing consensuses of researchers concluded that mammograms, colonoscopies, and PSA tests are far less useful cancer-detection tools than we had been told; or when widely prescribed antidepressants such as Prozac, Zoloft, and Paxil were revealed to be no more effective than a placebo for most cases of depression; or when we learned that staying out of the sun entirely can actually increase cancer risks; or when we were told that the advice to drink lots of water during intense exercise was potentially fatal; or when, last April, we were informed that taking fish oil, exercising, and doing puzzles doesn’t really help fend off Alzheimer‟s disease, as long claimed. Peer-reviewed studies have come to opposite conclusions on whether using cell phones can cause brain cancer, whether sleeping more than eight hours a night is healthful or dangerous, whether taking aspirin every day is more likely to save your life or cut it short, and whether routine angioplasty works better than pills to unclog heart arteries.

But beyond the headlines, Ioannidis was shocked at the range and reach of the reversals he was seeing in everyday medical research. “Randomized controlled trials,” which compare how one group responds to a treatment against how an identical group fares without the treatment, had long been considered nearly unshakable evidence, but they, too, ended up being wrong some of the time. “I realized even our gold-standard research had a lot of problems,” he says. Baffled, he started looking for the specific ways in which studies were going wrong. And before long he
discovered that the range of errors being committed was astonishing: from what questions researchers posed, to how they set up the studies, to which patients they recruited for the studies, to which measurements they took, to how they analyzed the data, to how they presented their results, to how particular studies came to be published in medical journals.

This array suggested a bigger, underlying dysfunction, and Ioannidis thought he knew what it was. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it‟s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”

Perhaps only a minority of researchers were succumbing to this bias, but their distorted findings were having an outsize effect on published research. To get funding and tenured positions, and often merely to stay afloat, researchers have to get their work published in well-regarded journals, where rejection rates can climb above 90 percent. Not surprisingly, the studies that tend to make the grade are those with eye-catching findings. But while coming up with eye-catching theories is relatively easy, getting reality to bear them out is another matter. The great majority collapse under the weight of contradictory data when studied rigorously. Imagine, though, that five different research teams test an interesting theory that‟s making the rounds, and four of the groups correctly prove the idea false, while the one less cautious group incorrectly “proves” it true through some combination of error, fluke, and clever selection of data. Guess whose findings your doctor ends up reading about in the journal, and you end up hearing about on the evening news? Researchers can sometimes win attention by refuting a prominent finding, which can help to at least raise doubts about results, but in general it is far more rewarding to add a new insight or exciting-sounding twist to existing research than to retest its basic premises—after all, simply re-proving someone else‟s results is unlikely to get you published, and attempting to undermine the work of respected colleagues can have ugly professional repercussions.

In the late 1990s, Ioannidis set up a base at the University of Ioannina. He pulled together his team, which remains largely intact today, and started chipping away at the problem in a series of papers that pointed out specific ways certain studies were getting misleading results. Other meta-researchers were also starting to spotlight disturbingly high rates of error in the medical literature. But Ioannidis wanted to get the big picture across, and to do so with solid data, clear reasoning, and good statistical analysis. The project dragged on, until finally he retreated to the
tiny island of Sikinos in the Aegean Sea, where he drew inspiration from the relatively primitive surroundings and the intellectual traditions they recalled. “A pervasive theme of ancient Greek literature is that you need to pursue the truth, no matter what the truth might be,” he says. In 2005, he unleashed two papers that challenged the foundations of medical research.

He chose to publish one paper, fittingly, in the online journal PLoS Medicine, which is committed to running any methodologically sound article without regard to how “interesting” the results may be. In the paper, Ioannidis laid out a detailed mathematical proof that, assuming modest levels of researcher bias, typically imperfect research techniques, and the well-known tendency to focus on exciting rather than highly plausible theories, researchers will come up with wrong findings most of the time. Simply put, if you‟re attracted to ideas that have a good chance
of being wrong, and if you‟re motivated to prove them right, and if you have a little wiggle room in how you assemble the evidence, you‟ll probably succeed in proving wrong theories right. His model predicted, in different fields of medical research, rates of wrongness roughly corresponding to the observed rates at which findings were later convincingly refuted: 80 percent of non-randomized studies (by far the most common type) turn out to be wrong, as do 25 percent of supposedly gold-standard randomized trials, and as much as 10 percent of the platinum-standard large randomized trials. The article spelled out his belief that researchers were frequently manipulating data analyses, chasing career-advancing findings rather than good science, and even using the peer-review process—in which journals ask researchers to help decide which studies to publish—to suppress opposing views. “You can question some of the details of John‟s calculations, but it‟s hard to argue that the essential ideas aren‟t absolutely
correct,” says Doug Altman, an Oxford University researcher who directs the Centre for Statistics in Medicine.

Still, Ioannidis anticipated that the community might shrug off his findings: sure, a lot of dubious research makes it into journals, but we researchers and physicians know to ignore it and focus on the good stuff, so what‟s the big deal? The other paper headed off that claim. He zoomed in on 49 of the most highly regarded research findings in medicine over the previous 13 years, as judged by the science community‟s two standard measures: the papers had appeared in the journals most widely cited in research articles, and the 49 articles themselves were the most
widely cited articles in these journals. These were articles that helped lead to the widespread popularity of treatments such as the use of hormone-replacement therapy for menopausal women, vitamin E to reduce the risk of heart disease, coronary stents to ward off heart attacks, and daily low-dose aspirin to control blood pressure and prevent heart attacks and strokes. Ioannidis was putting his contentions to the test not against run-of-the-mill research, or even merely well-accepted research, but against the absolute tip of the research pyramid. Of the 49
articles, 45 claimed to have uncovered effective interventions. Thirty-four of these claims had been retested, and 14 of these, or 41 percent, had been convincingly shown to be wrong or significantly exaggerated. If between a third and a half of the most acclaimed research in medicine was proving untrustworthy, the scope and impact of the problem were undeniable. That article was published in the Journal of the American Medical Association.

DRIVING ME BACK to campus in his smallish SUV—after insisting, as he apparently does with all his visitors, on showing me a nearby lake and the six monasteries situated on an islet within it—Ioannidis apologized profusely for running a yellow light, explaining with a laugh that he didn‟t trust the truck behind him to stop. Considering his willingness, even eagerness, to slap the face of the medical-research community, Ioannidis comes off as thoughtful, upbeat, and deeply civil. He‟s a careful listener, and his frequent grin and semi-apologetic chuckle can make the sharp prodding of his arguments seem almost good-natured. He is as quick, if not quicker, to question his own motives and competence as anyone else‟s. A neat and compact 45-year-old with a trim mustache, he presents as a sort of dashing nerd—Giancarlo Giannini with a bit of Mr. Bean.

The humility and graciousness seem to serve him well in getting across a message that is not easy to digest or, for that matter, believe: that even highly regarded researchers at prestigious institutions sometimes churn out attention-grabbing findings rather than findings likely to be right. But Ioannidis points out that obviously questionable findings cram the pages of top medical journals, not to mention the morning headlines. Consider, he says, the endless stream of results from nutritional studies in which researchers follow thousands of people for some number
of years, tracking what they eat and what supplements they take, and how their health changes over the course of the study. “Then the researchers start asking, „What did vitamin E do? What did vitamin C or D or A do? What changed with calorie intake, or protein or fat intake? What happened to cholesterol levels? Who got what type of cancer?‟” he says. “They run everything through the mill, one at a time, and they start finding associations, and eventually conclude that vitamin X lowers the risk of cancer Y, or this food helps with the risk of that disease.” In a single
week this fall, Google‟s news page offered these headlines: “More Omega-3 Fats Didn‟t Aid Heart Patients”; “Fruits, Vegetables Cut Cancer Risk for Smokers”; “Soy May Ease Sleep Problems in Older Women”; and dozens of similar stories.

When a five-year study of 10,000 people finds that those who take more vitamin X are less likely to get cancer Y, you‟d think you have pretty good reason to take more vitamin X, and physicians routinely pass these recommendations on to patients. But these studies often sharply conflict with one another. Studies have gone back and forth on the cancer-preventing powers of vitamins A, D, and E; on the heart-health benefits of eating fat and carbs; and even on the question of whether being overweight is more likely to extend or shorten your life. How should we choose among these dueling, high-profile nutritional findings? Ioannidis suggests a simple approach:
ignore them all.

For starters, he explains, the odds are that in any large database of many nutritional and health factors, there will be a few apparent connections that are in fact merely flukes, not real health effects—it‟s a bit like combing through long, random strings of letters and claiming there‟s an important message in any words that happen to turn up. But even if a study managed to highlight a genuine health connection to some nutrient, you‟re unlikely to benefit much from taking more of it, because we consume thousands of nutrients that act together as a sort of network, and
changing intake of just one of them is bound to cause ripples throughout the network that are far too complex for these studies to detect, and that may be as likely to harm you as help you. Even if changing that one factor does bring on the claimed improvement, there‟s still a good chance that it won‟t do you much good in the long run, because these studies rarely go on long enough to track the decades-long course of disease and ultimately death. Instead, they track easily measurable health “markers” such as cholesterol levels, blood pressure, and blood-sugar levels, and meta-experts have shown that changes in these markers often don‟t correlate as well with long-term health as we have been led to believe.

On the relatively rare occasions when a study does go on long enough to track mortality, the findings frequently upend those of the shorter studies. (For example, though the vast majority of studies of overweight individuals link excess weight to ill health, the longest of them haven‟t convincingly shown that overweight people are likely to die sooner, and a few of them have seemingly demonstrated that moderately overweight people are likely to live longer.) And these problems are aside from ubiquitous measurement errors (for example, people habitually misreport their diets in studies), routine misanalysis (researchers rely on complex software capable of juggling results in ways they don‟t always understand), and the less common, but serious, problem of outright fraud (which has been revealed, in confidential surveys, to be much more widespread than scientists like to acknowledge).

If a study somehow avoids every one of these problems and finds a real connection to long-term changes in health, you‟re still not guaranteed to benefit, because studies report average results that typically represent a vast range of individual outcomes. Should you be among the lucky minority that stands to benefit, don‟t expect a noticeable improvement in your health, because studies usually detect only modest effects that merely tend to whittle your chances of succumbing to a particular disease from small to somewhat smaller. “The odds that anything useful will survive from any of these studies are poor,” says Ioannidis—dismissing in a breath a good chunk of the research into which we sink about $100 billion a year in the United States alone.

And so it goes for all medical studies, he says. Indeed, nutritional studies aren‟t the worst. Drug studies have the added corruptive force of financial conflict of interest. The exciting links between genes and various diseases and traits that are relentlessly hyped in the press for heralding miraculous around-the-corner treatments for everything from colon cancer to schizophrenia have in the past proved so vulnerable to error and distortion, Ioannidis has found, that in some cases you‟d have done about as well by throwing darts at a chart of the genome. (These studies seem to have improved somewhat in recent years, but whether they will hold up or be useful in treatment are still open questions.) Vioxx, Zelnorm, and Baycol were among the widely prescribed drugs found to be safe and effective in large randomized controlled trials before the drugs were yanked from the market as unsafe or not so effective, or both.

“Often the claims made by studies are so extravagant that you can immediately cross them out without needing to know much about the specific problems with the studies,” Ioannidis says. But of course it‟s that very extravagance of claim (one large randomized controlled trial even proved that secret prayer by unknown parties can save the lives of heart-surgery patients, while another proved that secret prayer can harm them) that helps gets these findings into journals and then into our treatments and lifestyles, especially when the claim builds on impressive-sounding evidence. “Even when the evidence shows that a particular research idea is wrong, if you have thousands of scientists who have invested their careers in it, they‟ll continue to publish papers on it,” he says. “It‟s like an epidemic, in the sense that they‟re infected with these wrong ideas, and they‟re spreading it to other researchers through journals.”

THOUGH SCIENTISTS AND science journalists are constantly talking up the value of the peer-review process, researchers admit among themselves that biased, erroneous, and even blatantly fraudulent studies easily slip through it. Nature, the grande dame of science journals, stated in a 2006 editorial, “Scientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.” What‟s more, the peer-review process often pressures researchers to shy away from striking out in genuinely new directions, and instead to build on the findings of their colleagues (that is, their potential reviewers) in ways that only seem like breakthroughs—as with the exciting-sounding gene linkages (autism genes identified!) and nutritional findings (olive oil lowers blood pressure!) that are really just dubious and conflicting variations on a theme.

Most journal editors don‟t even claim to protect against the problems that plague these studies. University and government research overseers rarely step in to directly enforce research quality, and when they do, the science community goes ballistic over the outside interference. The ultimate protection against research error and bias is supposed to come from the way scientists constantly retest each other‟s results—except they don‟t. Only the most prominent findings are likely to be put to the test, because there‟s likely to be publication payoff in firming up the proof, or contradicting it.

But even for medicine‟s most influential studies, the evidence sometimes remains surprisingly narrow. Of those 45 super-cited studies that Ioannidis focused on, 11 had never been retested. Perhaps worse, Ioannidis found that even when a research error is outed, it typically persists for years or even decades. He looked at three prominent health studies from the 1980s and 1990s that were each later soundly refuted, and discovered that researchers continued to cite the original results as correct more often than as flawed—in one case for at least 12 years after the results were discredited.

Doctors may notice that their patients don‟t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence- based medicine, and contributing to Ioannidis‟s shockingly high estimate of the degree to which
medical knowledge is flawed. That we‟re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don‟t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.

Medical research is not especially plagued with wrongness. Other meta-research experts have confirmed that similar issues distort research in all fields of science, from physics to economics (where the highly regarded economists J. Bradford DeLong and Kevin Lang once showed how a remarkably consistent paucity of strong evidence in published economics studies made it unlikely that any of them were right). And needless to say, things only get worse when it comes to the pop expertise that endlessly spews at us from diet, relationship, investment, and parenting gurus and pundits. But we expect more of scientists, and especially of medical scientists, given that we believe we are staking our lives on their results. The public hardly recognizes how bad a bet this is. The medical community itself might still be largely oblivious to the scope of the problem, if Ioannidis hadn‟t forced a confrontation when he published his studies in 2005.

Ioannidis initially thought the community might come out fighting. Instead, it seemed relieved, as if it had been guiltily waiting for someone to blow the whistle, and eager to hear more. David Gorski, a surgeon and researcher at Detroit‟s Barbara Ann Karmanos Cancer Institute, noted in his prominent medical blog that when he presented Ioannidis‟s paper on highly cited research at a professional meeting, “not a single one of my surgical colleagues was the least bit surprised or disturbed by its findings.” Ioannidis offers a theory for the relatively calm reception. “I think that people didn‟t feel I was only trying to provoke them, because I showed that it was a community problem, instead of pointing fingers at individual examples of bad research,” he says. In a sense, he gave scientists an opportunity to cluck about the wrongness without having to acknowledge that they themselves succumb to it—it was something everyone else did.

To say that Ioannidis‟s work has been embraced would be an understatement. His PLoS Medicine paper is the most downloaded in the journal‟s history, and it‟s not even Ioannidis‟s most-cited work—that would be a paper he published in Nature Genetics on the problems with gene-link studies. Other researchers are eager to work with him: he has published papers with 1,328 different co-authors at 538 institutions in 43 countries, he says. Last year he received, by his estimate, invitations to speak at 1,000 conferences and institutions around the world, and he was accepting an average of about five invitations a month until a case last year of excessive-travel-induced vertigo led him to cut back. Even so, in the weeks before I visited him he had addressed an AIDS conference in San Francisco, the European Society for Clinical Investigation, Harvard‟s School of Public Health, and the medical schools at Stanford and Tufts.

The irony of his having achieved this sort of success by accusing the medical-research community of chasing after success is not lost on him, and he notes that it ought to raise the question of whether he himself might be pumping up his findings. “If I did a study and the results showed that in fact there wasn’t really much bias in research, would I be willing to publish it?” he asks. “That would create a real psychological conflict for me.” But his bigger worry, he says, is that while his fellow researchers seem to be getting the message, he hasn’t necessarily forced anyone to do a better job. He fears he won’t in the end have done much to improve anyone‟s health. “There may not be fierce objections to what I‟m saying,” he explains. “But it‟s difficult to change the way that everyday doctors, patients, and healthy people think and behave.”

AS HELTER-SKELTER as the University of Ioannina Medical School campus looks, the hospital abutting it looks reassuringly stolid. Athina Tatsioni has offered to take me on a tour of the facility, but we make it only as far as the entrance when she is greeted—accosted, really—by a worried-looking older woman. Tatsioni, normally a bit reserved, is warm and animated with the woman, and the two have a brief but intense conversation before embracing and saying goodbye. Tatsioni explains to me that the woman and her husband were patients of hers years ago; now the husband has been admitted to the hospital with abdominal pains, and Tatsioni has promised she’ll stop by his room later to say hello. Recalling the appendicitis story, I prod a bit, and she confesses she plans to do her own exam. She needs to be circumspect, though, so she won’t appear to be second-guessing the other doctors.

Tatsioni doesn’t so much fear that someone will carve out the man‟s healthy appendix. Rather, she’s concerned that, like many patients, he’ll end up with prescriptions for multiple drugs that will do little to help him, and may well harm him. “Usually what happens is that the doctor will ask for a suite of biochemical tests—liver fat, pancreas function, and so on,” she tells me. “The tests could turn up something, but they‟re probably irrelevant. Just having a good talk with the patient and getting a close history is much more likely to tell me what‟s wrong.” Of course, the doctors have all been trained to order these tests, she notes, and doing so is a lot quicker than a long bedside chat. They‟re also trained to ply the patient with whatever drugs might help whack any errant test numbers back into line. What they‟re not trained to do is to go back and look at the research papers that helped make these drugs the standard of care. “When you look the papers up, you often find the drugs didn‟t even work better than a placebo. And no one tested how they worked in combination with the other drugs,” she says. “Just taking the patient off everything can improve their health right away.” But not only is checking out the research another time-consuming task, patients often don’t even like it when they’re taken off their drugs, she explains; they find their prescriptions reassuring.

Later, Ioannidis tells me he makes a point of having several clinicians on his team. “Researchers and physicians often don‟t understand each other; they speak different languages,” he says. Knowing that some of his researchers are spending more than half their time seeing patients makes him feel the team is better positioned to bridge that gap; their experience informs the team‟s research with firsthand knowledge, and helps the team shape its papers in a way more likely to hit home with physicians. It‟s not that he envisions doctors making all their decisions based solely on solid evidence—there‟s simply too much complexity in patient treatment to pin down every situation with a great study. “Doctors need to rely on instinct and judgment to make choices,” he says. “But these choices should be as informed as possible by the evidence. And if the evidence isn‟t good, doctors should know that, too. And so should patients.”

In fact, the question of whether the problems with medical research should be broadcast to the public is a sticky one in the meta-research community. Already feeling that they‟re fighting to keep patients from turning to alternative medical treatments such as homeopathy, or misdiagnosing themselves on the Internet, or simply neglecting medical treatment altogether, many researchers and physicians aren‟t eager to provide even more reason to be skeptical of
what doctors do—not to mention how public disenchantment with medicine could affect research funding. Ioannidis dismisses these concerns. “If we don‟t tell the public about these problems, then we‟re no better than nonscientists who falsely claim they can heal,” he says. “If the drugs don‟t work and we‟re not sure how to treat something, why should we claim differently? Some fear that there may be less funding because we stop claiming we can prove we have miraculous treatments. But if we can‟t really provide those miracles, how long will we be able to fool the
public anyway? The scientific enterprise is probably the most fantastic achievement in human history, but that doesn‟t mean we have a right to overstate what we‟re accomplishing.”

We could solve much of the wrongness problem, Ioannidis says, if the world simply stopped expecting scientists to be right. That‟s because being wrong in science is fine, and even necessary—as long as scientists recognize that they blew it, report their mistake openly instead of disguising it as a success, and then move on to the next thing, until they come up with the very occasional genuine breakthrough. But as long as careers remain contingent on producing a stream of research that‟s dressed up to seem more right than it is, scientists will keep delivering exactly that.

“Science is a noble endeavor, but it‟s also a low-yield endeavor,” he says. “I‟m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.”

This article available online at:

http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical
science/8269/

Copyright © 2010 by The Atlantic Monthly Group. All Rights Reserved.

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4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with the drug that
emerged during Food and Drug Administration testing, a former FDA scientist
tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of people who took
the drug have sued American Home Products of Madison, N.J., for health
problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent Sharyl Attkisson
reports the FDA’s key reviewer of fen-phen, Dr. Leo Lutwak, claims the
company knew about the problems long before the drug was pulled.

“I felt from the very beginning the drug companies were covering up. I felt
from the very beginning that these drugs were dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his research to make
it seem as if there was no way to predict fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of predicting some of
these side effects,” he said.

One of those who sued American Home Products was Patricia Buol, who developed
severe heart problems after taking fen-phen. She’s now in line for a life
saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is a
struggle,” said Buol. “But I just take one day at a time and do the best I
can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s. But the FDA
won’t let him testify. Now Lutwak says he’s planning to retire, making him
free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to work
within the system, it didn’t work. People died as a result of a dangerous
deadly drug being released,”he said.

Defendant American Home Products would not be interviewed, but has said in
the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request to answer the
allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the agency’s
current approach to drug regulation.

“I have some concerns that we may be losing sight of what the FDA is all
about,” said Kessler. “The question is, who’s the agency’s customers? Who’s
the agency partner?”

Consumer advocates say the FDA is constantly keeping damaging information
from the public.

“They view the drug industry in many ways as their customers, at least the
bosses do, as opposed to viewing the public as the customers they need to
protect from some of the excesses of the drug industry,” said Sidney Wolfe of
Public Citizen.

Concerns about the FDA also emerged during the controversy over the diabetes
drug Rezulin.

Kessler said the agency needs to realize the American consumer is its
customer.

American Home Products also makes such drugs as Caordarone, Sectral,
Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine and
phentermine, which work by suppressing the appetite of a person who is trying
to lose weight.

It was estimated that in 1996, 18 million Americans took the drugs.

But a report in the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary hypertension, a rare, almost
always fatal, disease. It was also linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new evidence about
significant side-effects,” asked the manufacturers to voluntarily withdraw
both medications, marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, complied.

However, the company continued to deny the drugs caused the alleged problems.
In November, 1998, Wyeth-Ayerst published a study that compared heart
function in people who had taken fen-phen and a group who hadn’t, and
concluded there was “no significant differences in cardiovascular clinical
outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News & World Report
revealed that Wyeth-Ayerst knew more than it told about the pulmonary
hypertension risks, a charge the company denied.

In September 1999, the Wall Street Journal reported that the FBI was
investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to $4.83 billion to
settle the more than 11,000 fen-phen lawsuits, one of the biggest product
liability settlements ever.

As part of the settlement agreement, the company admitted no wrongdoing.

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10/17/1999 – Fen-Phen Settlement on Shaky Ground

To our ICFDA Subscribers–

It was announced on Friday that American Home Products, maker of Redux
and Pondimin, is being sued by 11,000 plaintiffs. Now the majority
of those afflicted with heart and lung problems from the drug, 8,000
in all, say they are not interested in the proposed $3.75 billion
settlement offer.

Why should they be?

“I don’t know if there is an individual in the United States that would
qualify for $1.5 million under this settlement,” said Marc Bern, whose
New York City law firm represents 5,000 plaintiffs.

This case should serve as a warning to those companies now marketing
other SSRI medications which can have similar adverse effects in their
patient population. The users of these serotonergic medications
represent a much larger population than Fen-Phen users–now upwards
of 50 million individuals worldwide!

If this is the largest product liability suit to date, what might the
future bring?

For the full story, click on the link below.–Dr Ann Tracy, Executive
Director, ICFDA

Settlement on Shaky Ground
Thousands of Fen-Phen Users May Reject Offer

By Amy Westfeldt
The Associated Press

N E W A R K, N.J., Oct. 14 — Thousands of people suing American Home
Products Corp. for injuries allegedly suffered while taking the
fen-phen diet drug combination won’t participate in a proposed $3.75
billion settlement, threatening the resolution of one of the largest
product liability cases ever, lawyers say.

http://abcnews.go.com/sections/living/DailyNews/fenphen991014.html

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