Bayer Caught Deceiving the FDA

Americans are Injured and Killed by Drug

The next Vioxx scandal has now landed on the FDA's plate. A secret tip to the FDA forced Bayer to admit they had failed to disclose serious safety data. Bayer scientists recently testified before an FDA advisory panel investigating the company's heart-surgery drug, Trasylol. They failed to mention a new study Bayer commissioned for the drug, one that contained highly unfavorable results. On Friday September 29, 2006, the FDA, stung by the blatant deception, announced to the world that Bayer hid safety data during the FDA investigation. The FDA reported that the new data showed an “increased risk for death, kidney failure, congestive heart failure and stroke,” yet the FDA failed to pull the drug from the market.

As the crisis unfolds the FDA is doing virtually nothing to protect Americans from the drug (most don't even know when they get it). The FDA strategy is to attempt to protect itself from the soon to be unleashed attack on their ineptitude, as well as to protect Bayer as best they can from a flood of lawsuits. A recent Institute of Medicine report describes the FDA as having a dysfunctional organizational culture wherein the FDA and Big Pharma hide relevant safety data from the public. The FDA cannot be trusted and drug companies can be trusted even less.

Andrew von Eschenbach, temporary head of the FDA, is demonstrating a lack of leadership in crisis. If he pulls the drug off the market it will imply guilt that will be used in courts across the U.S. Von Eschenbach is known as a leader who wants even fewer safeguards on drugs. He is a man with a long and profitable Big Pharma friendship. He would rather help Bayer deflect lawsuits than take effective action to protect the safety of Americans. He is attempting to use the time-honored method called partial admission to escape taking responsibility. The FDA admits there might be a serious problem, but says the problem could be caused by something else. The idea is to stall for time, slow down the flood of inevitable lawsuits, and hope the crisis goes away. Von Eschenbach is up for Senate confirmation. So far he has had a free ride, as no Senators have asked tough questions on the real issues.

Yes, von Eschenbach is on a volcanic hot seat. Keep in mind that under von Eschenbach's leadership the FDA has asserted that no American citizen should be able to sue a drug company once the FDA approves a drug. If von Eschenbach had his way, Bayer would be immune from all lawsuits related to Trasylol. Explain that to the families of the Americans who have been killed and the thousands of Americans that need dialysis every year due to Trasylol-induced kidney failure. The FDA wants you to trust their competence to determine which drugs are safe, do you?

Trasylol

On September 30, 2006, the New York Times reported that the FDA learned of a secret Trasylol study due to a tip coming from a researcher involved, not from Bayer. Trasylol has been under scrutiny all year based on several reports of serious side effects, one published in the New England Journal of Medicine.

On September 21, 2006, an FDA advisory panel disagreed with the conclusions of the studies and stated that Trasylol was safe and effective. Bayer withheld from the FDA and the advisory panel that they had commissioned an independent study, that they possessed the results of the study, and that the results were highly unfavorable to the drug. Certainly, if the results had even been remotely positive, Bayer would have been waving the study in front of the advisory panel.

Trasylol is used to prevent excessive bleeding during coronary bypass surgery. There are less expensive drug options that do not contain the risks of Trasylol. Most patients do not know they are getting the drug as it is administered intravenously with other medications.

The new Bayer-sponsored study examined the hospital records of 67,000 patients. 37,000 had received less expensive drugs, while 30,000 received Trasylol. Trasylol users were clearly at greater risk for death and kidney failure, prompting the FDA alert. This supports the earlier New England Journal of Medicine report that warned of double the risk of kidney failure from the drug. That study concluded that we could save 250 million in drug costs and 1 billion in dialysis costs by preventing 10,000 – 11,000 cases of unnecessary kidney failure.

The FDA has moved at a snail's pace while sales of this dangerous medication were expected to triple in 2006. In 2005 one hundred and fifty thousand Americans were exposed to this drug. It is likely that significantly more Americans were exposed to it already this year, while the FDA failed to act in an expeditious or effective manner to protect the consumer public from serious drug harm. Bayer obviously stood to lose the profits of an emerging blockbuster drug if they disclosed the adverse safety information. When confronted on the deception Bayer issued a statement saying that the failure to disclose the information was “a mistake on the company's part.”

A Brief History of Bayer

During WWII the chief executive of Bayer, Fritz ter Meer, ran the Auschwitz concentration camps. He oversaw the use of slave labor to churn out war resources for the Nazis and was the ranking administrative official that oversaw the slaughter of millions of Jews. Following the war he and other executives were given “white collar crime” punishment, and were soon freed from jail by Rockefeller-backed interests that had actually made the war possible by supplying the Nazis with a special fuel additive needed to fly their planes. Within a decade of completion of WWII Fritz ter Meer was back at the helm of Bayer. I fully explain this sordid history in my book, Fight for Your Health: Exposing the FDA's Betrayal of America.

While many examples of Big Pharma disregard for life in the name of profit exist, two are worth mentioning. In 1982 Bayer sold an HIV-tainted blood product to hemophiliacs in the United States. When the FDA finally made them quit doing so, Bayer continued to sell the HIV-tainted blood product around the world, even producing more of it. All the while the FDA helped hide the problem from Congress and the American public. This scandal was detailed in a 2003 New York Times article. Bayer paid out over 600 million dollars in damages, while admitting no wrongdoing.

In another example, Bayer pushed to increase the dose of its cholesterol lowering drug, Baycol, so it could more effectively compete with other statin drugs. It did this even though it knew the higher dose was harmful to human health, information it withheld from the FDA. As Americans began dying from higher doses of Baycol, Bayer agreed to voluntarily pull the drug off the market. Bayer has paid out over 1 billion dollars in damages for Baycol-related lawsuits.

Who Is Responsible?

Bayer would like us to believe that the Trasylol cover-up is a mistake. Bayer has a history of disregard for human health in the name of profit. I believe it warrants a full Congressional inquiry. What did Bayer know exactly and when? Why did Bayer deceive the advisory panel and the FDA? Why has the FDA moved so slowly while hundreds of thousands of Americans were placed at risk? In the face of a crisis, why is the FDA playing a stalling game? Does the FDA have the right to let Americans die while it ponders, in a lackadaisical and inefficient manner, the safety of a dangerous drug? Is this how von Eschenbach plans to lead the FDA? Is the FDA hoping that Bayer will pull Trasylol like Merck pulled Vioxx? Why doesn't the FDA have the guts to take a hot-selling drug off the market?

It is high time drug companies who withhold safety data are held responsible for injuries and deaths that are associated with their drugs and products. It is unlikely drug company executives would hide safety data if they knew they would be criminally accountable.

The Trasylol example is a symptom of the disease that permeates the FDA, a disease that is bought and paid for by Big Pharma. Will Congressional leaders act or are their hands also too deep in the Big Pharma cookie jar? Yes, Congress is now on leave preparing for the coming elections. Big Pharma continues to be the leading source of Congressional lobbying money. After the elections there will be favors to repay. Americans on drugs should be running for cover.