By Dr. Mercola
Pharmaceutical companies have kept the wool pulled over Americans' eyes for many years, and had many convinced that they were working fervently to develop safe medications that would cure and prevent virtually every disease plaguing the world.
But these modern-day messiahs are not the saints they would have you believe … not even close.
According to Dr. David Healy, who has had the opportunity to investigate the circumstances behind the approval of certain drugs at a level that very few others have been able to, drug companies frequently hide vital information about their drugs in order to get it on the market and keep it there.
The drug companies that manufacture some of the best-selling drugs in the world have committed some of the greatest crimes against human health, and all of them have at one point or another been found guilty of criminal activity—some have been nailed several times.
So much so that several pharmaceutical companies are on the Top Corporate Criminals list. Yet we entrust our health, our very lives, to these same corporate "personages" who cannot be put in jail for cutting lives short, and who view billion dollar fines as nothing more than the cost of doing business.
As recently as July 2, GlaxoSmithKline plead guilty to three counts of criminal misdemeanor and other civil liabilities relating to the prescription drugs Paxil, Wellbutrin and Avandia, and agreed to pay a total of $3 billion in fines.
In 2009 Pfizer was fined $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra and their antipsychotic drug Geodon.
Dr. Healy, a professor of psychiatry in North Wales and Great Britain is a former secretary of the British Association for Psychopharmacology and author of over 175 peer-reviewed articles, 200 other pieces, and 20 books, including Let Them Eat Prozac (one of my favorites), and Pharmageddon, another favorite.
His time is divided between an active psychiatry practice and research.
For example, he has studied the serotonin-uptake theory in depressed patients, and is adamant that there's no evidence indicating that depressed patients have something wrong with their serotonin system, which makes selective serotonin reuptake inhibitors (SSRI's) a dubious treatment for depression. It may even be part of the equation for why some people become suicidal on SSRI's, even if they've never had such tendencies before.
"We've got 30 to 40 years' worth of work, and no evidence has come to light that there's anything wrong with the serotonin system in people who were depressed," he says.
Profits Before Life—The Sad History of Antidepressant Drugs
Dr. Healy's conviction that SSRI's can make people actively suicidal was originally borne directly out of his own clinical experience. Since then, the research demonstrating this link has become quite clear, and this class of drugs now carry a "black box" warning. What's really infuriating though is the evidence that has since emerged showing that pharmaceutical companies knew about it, and hid it, and it wasn't until it became an obvious issue in clinical practice that a warning was finally issued. People literally lost their lives because these companies didn't want to risk sluggish sales.
"I got involved as an expert witness in some legal cases that involved these drugs," Dr. Healy explains. "When you get involved as an expert witness in legal cases, you get to go behind the scenes. You get to go into the company archives, and you get to see what the clinical trials really showed, and what the company personnel really thought about the issues.
Then it was clear that the trials also really showed those problems. It was clear that the companies knew there was a problem, and they were in the business of trying to hush the whole thing up.
... The regulators also clearly knew there was a problem, I would say from very early on. They may well have known there was a problem even before the drugs came to the market. They certainly knew there was a problem shortly after Prozac was launched and a great number of people complained about the fact that they had a problem on this drug.
When they looked at the data – the kinds of data that the FDA, for instance, would have been able to see when they held the first public meeting about whether SSRI drugs, Prozac in particular, could cause people to become suicidal – they had a lot of data that the rest of us didn't have. They had data on the other SSRIs that haven't yet been marketed.... I'm sure it was very clear to them then that the SSRIs can cause people to become suicidal."
Publicly, the FDA argued that putting a warning on the drug might deter people from treatment, so by doing the right thing, we might end up with a detrimental outcome. However, no one addressed the fact that not putting a warning on the drug might make more people use them, hence killing more people, more indiscriminately. This is exactly the situation we're dealing with now. Even with the warning, antidepressants are prescribed more or less willy-nilly, for everything from anxiety to pain, high blood pressure, and insomnia—minor ailments that in NO WAY warrant such a huge risk.
"[The information] the FDA had points very clearly not just to the fact that [SSRI] drugs can cause a problem, but that on balance, they harm more people than they help," Dr. Healy says. "How the FDA squared this, I'm not sure."
SSRI's Likely Harm More People than They Help
In addition to suicidal thoughts and behavior, there also seems to be an association between antidepressants and other violent behaviors, such as homicides and school shootings. Unfortunately, while suicide has become a well-established (yet oft-ignored) side effect, the data on other types of violence is, again, being hidden.
"We haven't had hearings about this issue," Dr. Healy says. "People haven't had access to the data. There's been no publications around it. This is one of the biggest problems on which there's a huge amount of data, but to which we've got little or no access."
Dr. Healy estimates that possibly 1,000 to 2,000 people taking an SSRI drug commits suicide each year in the US who would not have done so were they not on the drug. He also believes there's a comparable number of people who will commit a violent act against others as a result of the drug, who would not have done so otherwise. Then there's the issue of generational harm. Birth defects, miscarriages (as many as 20,000 per year), and voluntary abortions due to the baby being diagnosed with a birth defect are other devastating side effects that get little if any attention.
Why is that?
Why is so little attention given to the very serious nature of the side effects associated with these drugs? Why are antidepressants seemingly handed out like candy to cheer people up, as opposed to treat serious mental conditions?
A major part of the problem is the too-cozy-for-comfort relationship between drug companies and psychiatrists and other prescribers. Adding to that problem is the fact that drug companies are actively hiding and suppressing negative data on their drugs, so psychiatrists prescribe drugs without having the real facts.
Psychiatry is Committing "Professional Suicide"
Dr. Healy was recently featured in Time Magazine1, after giving a speech at the American Psychiatric Association's (APA) second largest annual meeting. The topic of the session was conflicts of interest in psychiatry. Maia Szalavitz writes:
"Arguing that his profession is "committing professional suicide" by failing to address its dangerously close relationship with the pharmaceutical industry, he likened psychiatry's attitude toward its faltering legitimacy to the Vatican's widely derided response to its child-sex-abuse scandal by priests — essentially that psychiatry is brushing off justifiable concerns as hype instead of dealing with the source of the problem.
Few experts believe that psychiatry's relationship with the drug industry is healthy. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
... "I'm going to argue that we need you to be biased. We want you to be biased by treatments that work," Healy told his colleagues. "I don't mind if you're my doctor and you've given talks for industry. My concern is not that you've been paid by industry, but that you've been fooled by industry. The key conflict is whether people are hiding data from you."
The article goes on to detail some the more unsavory aspects of conflicts of interest—the kind of suppression activities that lead to demolished careers, and worse. Dr. Healy has been personally targeted by drug companies for speaking out against various drugs and exposing wrongdoing. His presentation at the APA included a document obtained via a Freedom of Information Act request, which reveals Eli Lilly's plan for countering his public discourses on how drug companies hide drug data. One of these strategies includes planting people in the audience of his presentations to argue the industry's view.
What Clinical Trials Do and Do Not Show
According to Dr. Healy, in the clinical trials done to bring antidepressants to market it is virtually impossible to show that they have an overall positive effect. Part of the problem that few consider is the fact that clinical trials are not designed to answer some of the most important questions we have about any given drug, such as: Does this drug save lives?
"From what we know of the data that's there, the answer is no, they [antidepressants] don't save lives," Dr. Healy says. "Clinical trials also aren't designed to answer the question, "Will these drugs get people back to work?" From the data we have, we have no reason to think that these drugs will be more likely to get people back to work than placebo would, for instance.
In terms of what most people understand the word "work" to really mean, which is [in the vein of the questions] "Will my life be saved?" or "Will I be able to get back to being employed?" we have no evidence that these drugs "work." What we've got is clinical trials based on rating scales, where you can show that the drug does marginally better than placebo on these rating scales. But that's all we have."
Fortunately, there are other alternatives, which have been shown to have a more life-enhancing effect than antidepressants, such as niacin (vitamin B3). The renowned and recently deceased Canadian psychiatrist Dr. Abram Hoffer was a strong advocate of the use of niacin in psychiatric illness, specifically for schizophrenia, for which there don't seem to be many really good treatments.
What he discovered was that niacin deficiency is a major contributor to pellagra, the symptoms of which mimic depression.
He believed there's a subgroup of people who have an increased nutritional requirement for niacin, making them not merely deficient per se, but niacin dependent. When they don't get it on a regular basis, and typically in far higher doses than normal, they're predisposed to psychiatric illnesses. Dr. Healy believes there may be significant value in niacin supplementation, adding that one of the mechanisms of niacin is detoxification, especially lead. This makes sense, since it it's a potent vasodilator, which would increase supply to the filtering organs, thereby aiding in the excretion process.
How Outsourcing Clinical Trials Can Skew or Hide Unsavory Findings
Another significant problem that most people don't have a clue about is how outsourcing clinical trials to other countries can affect their believability. Even trials done in the US have been plagued with fraud, such as enlisting patients that don't actually exist. The matter of potential fraud increases with overseas trials, because the FDA does not have the ability to double-check the veracity of the data even if they wanted to (and even in US trials they rarely do).
"There's a trial recently that brought Abilify® to the market with an indication for maintenance treatment for bipolar disorder. This trial was run in approximately 30 U.S. clinical trial centers and two further clinical trial centers in Mexico. In the trial centers based in the United States, when you added all the patients together, you found that Abilify® didn't do any good.
It couldn't beat placebo as a maintenance treatment for patients who had bipolar disorder.
In the Mexican centers, however, it really did beat placebo. It wonderfully beat it. All of the patients down there who got Abilify® did well, and the patients who got placebo did poorly. When you added the two Mexican centers into the U.S. centers, overall you've got a marginal result, which showed that Abilify® was slightly better than placebo.
But this was caused by the Mexican patients. Now, clearly, the Mexican data looks very dodgy, very shaky. The FDA knew this was happening, but didn't in any way investigate the issues. They noted that it was odd, but they didn't investigate the issues, and they didn't stop the company, later, from publishing the trial without drawing any attention to the fact that, "Well, you know, our results don't look all that good when you leave the Mexican trial centers out of the picture."
Dr. Healy's Take on the Future of Medicine
Dr. Healy doesn't cast too much blame on the FDA though, stating that the agency always has been and probably always will be an agency that contributes to public health, "but does so by regulating the wording of adverts that the pharmaceutical companies put out." He points out that it's not really the FDA's job to evaluate the product or the practice of medicine, stressing that this responsibility really falls on doctors.
"Back 30 to 40 years ago, we were a lot safer not because the FDA were doing their job better, but because doctors were doing their job better," he says.
I think it's medicine that has lost its way. I think the FDA is still doing what it has always been doing, which is a very minimal job. I mean, most people out on the street want someone there to protect them from the risk that drugs or industry may pose. They're hoping that that's the FDA, when, in fact, that has never been FDA's brief. It's been the brief of doctors to do that, and we've been failing at that job more and more in recent years."
When asked what he thinks the solution is, Dr. Healy responds:
"I think my solution is this: the job of the doctors have been like the job of the pilot of a plane. Their job is to get you from Chicago to Houston alive—not to get you there 15 minutes earlier; it's to get you there alive...
Doctors seem to have forgotten this. If they can't get you there alive; if they can't be the people whose professional identity is linked to keeping you safe when you go on treatment, they're going to be replaced by cheaper prescribers – by pharmacists or nurses. Anyone can get you on the pill these days. It takes an expert to keep you safe. I think if doctors don't realize this, they're committing professional suicide."
How You Can Get More Informed, and Be Part of the Solution
Dr. Healy is a strong advocate for doing things to make a difference. And this was the impetus behind a brand new website called www.rxisk.org. His goal for this website is to create a people's movement for safer drugs.
"We want people to go in there and report any of the problems they may be having on the medicines that they're on. They can report this to FDA as well. But if they report to us, we're going to feed their reports through to FDA," Dr. Healy explains.
Potentially one of the most valuable features on the site will allow you to go through a series of questions that will help you determine whether ailments you're having are associated with any of the drugs you're taking. At the end, you will get a report that you can then bring with you to your prescribing doctor, to aid you in making a more comprehensive risk versus benefit analysis. The idea is to try and create better teamwork between you and your doctor. Furthermore, you will get feedback on potential problems with individual drugs long before you'd get it from the FDA.
I feel this could be an excellent tool for anyone currently taking any drug, as well as for anyone considering taking one. Forewarned is forearmed, as they say, and when it comes to drugs, you really need to do your due diligence, as the risks are all on you—not on your doctor, the FDA, or the pharmaceutical company.
Weighing the risks versus the benefits is crucial, but in order to do this, you need reliable, truthful information, and I believe www.rxisk.org can be a valuable resource that will only become more valuable with time, as people begin to use it and file their own reports on side effects. So please, bookmark it on your computer and refer to it whenever needed, and share it on your social networks. Together, as a community, we can help the movement for safer drugs.