The FDA is warning that a recently approved heart drug doubles your risk of death.
The drug in question is dronedarone. Its street name is Multaq. It was approved in July 2009 by the FDA. And doctors wrote over half a million prescriptions for it in 2010.
But it’s now clear that the drug causes severe liver injury. In some cases even acute liver failure. Late last year two patients were rushed to hospital for emergency liver transplants. Directly because of the drug.
Six Months of Drug Recalls and Warnings
A quick review of recent drug recalls and warnings shows that it’s six for six! In the last six months there have been at least six FDA recalls or warnings. These warnings all link pre-approved drugs to fatal or near-death side effects.
Terbutaline. Doctors use it to prevent women from giving birth too early. The FDA warns that the drug causes serious heart problems… and death. A further warning on Thursday, February 24 suggests the drug does nothing to ease pre-term labor.
Multaq. It’s used to treat heart conditions. The FDA issues a warning linking it to severe liver injury.
Darvocet. A popular painkiller. The FDA recalls the drug after it’s proven to cause fatal heart problems.
Meridia. A common diet pill. The FDA recalls it after linking it to heart attacks and stroke.
Accutane. A simple skin product used to treat acne. The FDA issues a warning linking it to birth defects and severe heart damage.
Depakote. It’s used to treat manic episodes of depression. The FDA issues a warning that it causes fatal pancreatitis in adults and children. The FDA further links it to birth defects and liver damage.
And this is just the most recent case of FDA-approved drugs causing serious damage. A quick review of 2010 shows that one drug or another was in the news almost every month. Why? Because they cause serious – and often life-threatening – side effects. (See Six Months of Drug Recalls and Warnings box.)
So why is the FDA approving so many drugs with such dangerous side effects? And how do
they get through the FDA’s review process in the first place? Join us as we investigate how and why Big Pharma sells you risky drugs.
So how is it that the FDA reviews a clinical drug trial and approves it for sale? Then some time later – and many millions of dollars’ worth of profits for the drug maker – turns around and withdraws it?
According to Dr. Marcia Angell, part of the problem comes from how the initial trials are generated.
Dr. Angell is currently a senior lecturer at Harvard Medical School. She also served as the Editor-in-Chief of the New England Journal of Medicine for over a decade. It was her job to judge such trials for publication in America’s oldest and most prestigious medical journal.
She says there’s a real problem with how drug trials are created and reviewed.
“There is growing evidence that financial conflicts of interest are compromising the integrity of clinical research,” says Dr. Angell.
She notes that the same drug companies – whose first priority is to make profits from their drugs – also sponsor most of the clinical trials that allow new drugs to be sold.
Her research shows that in the year 2000 alone, the drug makers spent almost $400 billion on grants for clinical trials. That compares to just $750 million spent by the US government.
Dr. Angell says some of that $400 billion goes to pay the clinical investigators who assess the safety and usefulness of these drugs. What Dr. Angell is saying – in simple language – is that the people who are doing the testing are paid to find the drugs useful and safe!
“Drug companies now control how and whether research is reported,” says Dr. Angell.
She notes that academic medical centers allow drug companies to design their own trials, analyze the data, write the papers, and review them before publication. They even decide whether to allow publication at all.
“Many clinical trials are never published because the results do not favor the sponsor’s product,” says Dr. Angell.
Sounds too incredible to be true?
You don’t have to take Dr. Angell’s expert opinion for it. The truth is available for all to see. Thanks to legal cases between individuals and drug makers that have since become public record.
About Dr. Angell
Marcia Angell, M.D., is currently a senior lecturer at Harvard Medical School. She graduated from Boston University School of Medicine in 1969. She went on to work for America’s oldest and most prestigious medical journal – The New England Journal of Medicine – for 20 years. She served as its Editor-in-Chief for over a decade. She was named one of America’s 25 Most Influential People by Time Magazine in 1997.
Case Study: Lacuzong Vs. Glaxo SmithKline
In late 1999 the family of Reynaldo Lacuzong took Glaxo SmithKline (GSK) to court.
Because one of its antidepressant drugs directly caused the deaths of several of their family members.
Prior to the case, Lacuzong was a machine operator. Records show he had no prior history of mental illness, violence, or suicidal tendencies. But he was suffering from mild depression. His doctor gave him a low dose of Paxil.
He reacted violently to the drug. In the first day he went from being depressed to hyperactive. The second day he developed akathisia. That’s another name for inner agitation. And it’s linked to violence, suicide, and psychosis.
On the third day, he drowned his two small children in a bathtub. And then killed himself.
Dr. Peter Breggin served as the medical expert in the case. He was authorized to examine all of GSK’s files from their sealed record room. That included GSK’s correspondence with the FDA… The worldwide clinical trials… And adverse drug reports for Paxil.
And what he found was “staggering.”
He says GSK simply withheld or manipulated the truth about Paxil. File after file showed the drug to be dangerous – even during its development and clinical trials.
Under the Microscope: Manipulating Data
Dr. Breggin found that during the U.S. clinical trials, patients treated with Paxil made 12 suicide attempts. How many attempts were recorded for people taking the placebo version? Just one!
One Paxil patient slashed his wrists and abdomen on the third day of treatment. He was withdrawn from the study.
But GSK’s 1991 report to the FDA omits this.
“To hide this data was extremely misleading,” says Dr. Breggin.
And that’s just the U.S. tests. He says there was further trickery in the worldwide tests.
Dr. Breggin found that two suicide attempts made by non-U.S. Paxil patients were omitted from the report. So too were two suicides.
Worse, two attempted suicides and two suicides were listed under the placebo group. But Dr. Breggin says these numbers were “fixed.”
Those patients weren’t actually taking the placebo. Instead… the incidents happened during the placebo “washout” period.
What that means is that those patients were being weaned off previous drug treatments. Before starting the placebo. Yet the researchers included these cases in the placebo study data.
Dr. Breggin believes it was to decrease the stark difference between the placebo and Paxil groups.
And he points to further manipulation…
The numbers in the final worldwide report were different from those submitted in the New Drug Application made to the FDA. The number of Paxil suicide attempts changed from 42 to 40. And the total number of placebo suicide attempts increased from four to six.
At the time of the Lacuzong case, GSK refused to allow Dr. Breggin to make public his findings.
But that changed in 2005. His report was filed as a part of another Paxil case. Because this case was filed in the public record, his report was made available to everyone.
You can check out that public report here.
So how did the FDA react to the findings?
They acknowledge Dr. Breggin’s findings about the dangers of Paxil, Prozac, and other antidepressants.
But they have not ordered any independent investigations into how dangerous these drugs are. Or how useful they may be. Instead… the FDA still uses GSK’s own findings!
However, the FDA now requires drug companies to place warnings on their drug labels about the negative effects of these drugs.
Among these warnings is an “increased suicidal feeling in children.”
Working with the FDA
The case of GSK and Paxil is not an isolated one. Researchers at the University of California San Francisco investigated how selective reporting is common in drug trials to gain favorable outcomes. The study was headed up by Lisa Bero and Peter Bacchetti. It was published in a 2008 edition of PLoS Medicine.
They found that up to one quarter of all drug trials submitted in support of New Drug Applications to the FDA remain unpublished for over five years.
They also looked at the publication status of all efficacy trials carried out in 2001. These trials supported 33 New Drug Applications that were later approved by the FDA.
They found that trials with favorable outcomes were usually published. But almost 50 percent of trials with unfavorable outcomes were not.
They note that those remaining negative results were further “fixed.”
Between the original application and the final submitted reports to the FDA, 25 percent of the figures inexplicably changed to favor the drug trial.
And the UCSF review found the discrepancies didn’t end there.
A further 10 percent of final trials submitted to the FDA changed between the FDA review and when the study results were finally published.
At one stage or another of the review-to-publication process, their figures inexplicably changed. And, as the researchers note, always to the benefit of the drug.
These figures – known as “outcomes” in clinical trials – were added or deleted. Their statistical significances were altered. And even the trial conclusions were changed.
So what’s the final result? These changes present the drugs in a better light in the medical literature that gets published. And, as the study points out, doctors use these findings to base their recommendations on.
“The information that is readily available in the scientific literature to health care professionals is incomplete and biased,” concludes Bacchetti.
So What’s the Answer?
The proof is pretty clear: drug trials are fixed to make you and your doctor put your faith in drugs. And it’s almost impossible to see which trial has been manipulated… and which hasn’t.
And that’s why it’s always better to put your faith in an all-natural and totally safe alternative. Whenever that’s a realistic option.
That’s why NHD brings you the very latest research on these natural cures. From the most credible sources.
And we’ll continue to do that… and keep you on top of the latest health warnings in mainstream medicine.
To your health,
NHD “Health Watch”
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About Dr. Breggin
Dr. Peter Breggin is a legend in the field of mental health. He was trained at Harvard Medical School, and went on to serve on the faculty. He’s also taught at John Hopkins University. During his career, he’s worked for the National Institute of Mental Health. He has helped patients deal with depression in private practice for almost 45 years.
Dr. Betram Karon – Professor of Psychology at Michigan State University – calls him “the conscience of psychiatry.”