August 15, 2008

The FDA Wants to Stop You from Protecting Yourself Against Drug Companies

By Dr. Peter Breggin
Suing a drug company is your only way as an individual citizen of protecting yourself against drug company malfeasance. It’s the only way for you or your survivors to get justice or compensation if you have been injured or killed by drug company negligence. It should be a basic right under the law, and right now it is; but the FDA and the drug companies are on the verge of taking it away from you.

Without the right to sue pharmaceutical companies, not only will individuals fail to obtain justice, sealed company data about the harmful effects of drug will remain secret. That can become a public health problem when serious adverse reactions are hidden from view. The Wall Street Journal has released data indicating that GlaxoSmithKline (GSK) may have manipulated research in order to hide that its antidepressant Paxil was causing people to attempt suicide. In the weekend edition of June 14-15, 2008, the newspaper described how the drug manipulated its figure to disguise the frequency of Paxil-induced suicide attempts.

I had known for years about GSK manipulating its data and had attempted without success to get the FDA to acknowledge and to examine the problem. I originally discovered the shenanigans eight years ago when I was examining the secret files of GlaxoSmithKline (GSK) as a medical expert in a product liability suit against the company. California attorney Don Farber and my assistant Ian Goddard accompanied me.

The suit was brought by the family of a man named Lacuzong who had drowned himself and his two young children in a bathtub a few days after starting to take Paxil. He had no previous history of violence or suicidal thoughts.

As I went through the hundreds of boxes of materials packed into a large room in the GSK company headquarters, I came upon something remarkable. GSK had managed to hide that Paxil was causing an increased rate of suicide attempts compared to placebo. The company jacked up the number of suicide attempts in the placebo group, until it looked more dangerous to take placebo than to take Paxil. In reality, there were more suicide attempts among the patients taking Paxil.

I wrote a lengthy report charging the company with negligence in the development and marketing of Paxil and it was submitted to the court in 2001. Despite attorney Don Farber’s best attempts, the court refused to unseal the data, even though it disclosed a public health threat of suicidal behavior induced by an antidepressant drug that was being prescribed to millions of unsuspecting citizens. The case was settled for a substantial amount of money without GSK admitting any negligence, and the smoking-gun files were kept secret. Nonetheless, I wrote about my findings and even told the FDA about the manipulated data when I addressed the agency’s panel on two occasions at its 2004 hearings on antidepressant-induced suicide. I invited the FDA to make use of my knowledge about how GSK was fudging its research findings, but the agency ignored my offer and my written reports. This was not unusual. The FDA has always failed to utilize the otherwise unavailable information gathered by medical experts, and yet it will not carry out its own investigations.

A few years later I participated along with attorney Farber in another product liability suit against Paxil and GSK involving suicide. Again the case was settled to the satisfaction of the plaintiffs without GSK admitting any wrongdoing. But this time the new court made public my original Lacuzong report. As a result, in 2006 I was able to write three articles about my findings in the scientific journal, Ethical Human Psychology and Psychiatry, and I put the articles along with the original Lacuzong product liability report on my website, where they can still be found. The report and the articles describe many ways in which GSK managed to hide the truth that Paxil increases the risk of a person attempting suicide. This is the same information now released by TheWall Street Journal as a result of yet another expert’s product liability case report that drew in part upon my original data.

To this day, the FDA continues to act as if drug company data can be trusted, including GSK’s invalid manipulation of the Paxil suicide studies. The FDA has also ignored data that I discovered in product liability suits against Prozac and Eli Lilly. Eli Before Prozac went on the market, Lilly knew that patients taking their drug had a hugely increased rate of suicide attempts compared to similar or the same patients taking placebo. Even after the British medical journal BMJ released this data, the FDA has continued to ignore it.

In the meanwhile, I’ve continued to write about how GSK and Lilly have shamelessly distorted their research findings, and about how Paxil and Prozac cause mayhem, murder and suicide. The most vivid details involving dozens of cases can be found in my new book, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (2008).

Despite the flawed data, the FDA has finally warned that antidepressants like Paxil and Prozac (indeed, all of the newer antidepressants) cause suicidality. But the federal agency continues to serve drug company interests by limiting the risk to children, youth and young adults. That’s simply nonsense. There can be no parsing of the data in that manner. If a drug-induced suicide risk shows up in short-term, heavily manipulated clinical trials, it’s a serious signal that the drug will be a risk to a person of any age. And besides, the data itself is too flawed to make fine distinctions such as the age of the person at risk.

All of this critical information about drug safety, or the lack thereof, has come from product liability suits in which the courts have forced the drug companies to allow medical experts into their files to carry out an independent investigation. This November the U. S. Supreme Court will consider whether or not these suits should be permitted to continue. The drug companies and the FDA have joined together to argue that, once the FDA approves a drug, the manufacturer cannot be sued for its failures to disclose dangerous drug effects. This is called preemption. It should be called a political sleight of hand. It deprives the individual of his or her legal recourse, prevents physicians and scientists from learning the truth about harmful drug effects, and exposes the unwitting public to harm of potentially epidemic proportions.

Certainly drug companies have done a great deal to improve the health of people around the world. But they also have a bad record for hiding harmful and even lethal side effects of their products. If the Supreme Court supports preemption and hampers or stops product liability suits, it will be a bad day for people who use prescription drugs or prescription devices. That’s pretty much all of us. Everybody’s health will be put at risk when drug companies can no longer be monitored and scrutinized by product liability litigation.

Originally published on The Huffington Post