Life Extension Magazine June 2011
As We See It
The FDA’s Most Heinous Drug Approval
By William Faloon
When it comes to lethal FDA-approved drugs, I always felt that Life Extension® members had a better chance of surviving adverse reactions compared to the general public.
One reason is that members have their blood tested annually so they can detect many types of drug toxicities before permanent damage is inflicted. Another defense members have are the healthy lifestyles they follow, which confers protection against mechanisms by which prescription drugs kill, such as glutathione depletion and fatty acid metabolite imbalance.1-5
As it relates to the fraudulent drug you are going to read about, however, it would have been challenging for any of us to survive. This deadly drug was administered intravenously during complex surgical procedures where one’s life is completely at the mercy of others.
I am going to relate what may be the most atrocious cover-up of a toxic drug that a pharmaceutical company has ever perpetrated—a drug that the FDA should have never approved.
Why Some Surgery Patients Need These Kinds of Drugs
A common surgical complication is excessive bleeding. In patients at high risk of bleeding, intravenous drugs are administered ahead of time.
While lower-cost alternative drugs are available to reduce bleeding complications, pharmaceutical giant Bayer successfully penetrated the market with a drug called Trasylol® that costs about $1,000 per patient.
If you wonder how this kind of price gouging occurs, large drug companies aggressively promote expensive new drugs to doctors, in some cases paying cash kickbacks so that the more expensive drug is used in place of an alternative of equal efficacy.
In the case of Trasylol®, the results turned tragic.
The FDA’s Erroneous Approval of Trasylol®
Despite data showing that Trasylol® inflicted severe kidney damage in animals,6 the FDA approved it for human use in 1993.7 Low-cost alternative anti-bleeding drugs are less likely to produce this lethal side effect.
Soon, the same kidney side effects observed in animals were occurring in humans. One surgeon observed that the most common side effect seen in patients given Trasylol® was renal dysfunction. This surgeon then conducted a 20-patient study (not funded by Bayer) and found that 13 of 20 patients given Trasylol® had problems with kidney function after the surgical procedure.8
When the FDA approved Trasylol®, they did note that kidney toxicity was a problem. But Bayer lobbied the FDA hard, and by 1998, the FDA expanded approval of Trasylol® to cover all heart bypass patients.9
Sales of Trasylol® in 2005 hit $300 million, and Bayer envisioned a billion-dollar-per-year blockbuster.10 These kinds of profits provide an enormous war chest to lobby FDA officials to turn a blind eye, even while thousands of surgical patients were dying each year from kidney failure caused by Trasylol®.
Investigators were initially perplexed because kidney toxicity showed up in some studies, but not others. Critics maintain that Bayer never paid for studies large enough to determine the renal toxicity of Trasylol®.
The primary side effect mechanism of Trasylol® is that it causes excess blood clotting inside blood vessels (thrombosis).11 This made tissues throughout the body vulnerable to loss of blood flow, which is why patients given Trasylol® sometimes died from multiple organ failure—plus amputation of limbs.
Trasylol® Carnage Covered Up by Bayer
In 2006, a study was released showing that thousands of Americans were being killed each year by Trasylol®.11 The FDA responded by issuing an “advisory” alerting doctors to this potential problem, but did not plan to have a formal meeting about Trasylol® for eight months.12,13
Bayer was desperate to keep Trasylol® on the market, so they hired a respected Harvard professor to look at the records of nearly 70,000 patients treated with Trasylol®. The Harvard professor’s report did not please Bayer. It revealed that horrific numbers of Americans had died from Trasylol®. The Harvard professor wrote that patients on Trasylol® had an elevated risk of death and acute kidney failure.10
When the FDA finally held an advisory committee meeting to address the Trasylol® deaths, Bayer intentionally withheld the Harvard professor’s exhaustive study.14 Since the FDA did not know of Bayer’s negative study, it voted to keep Trasylol® on the market.
A week later, the Harvard professor went to the FDA to inform them that Bayer had hidden the study showing the lethal dangers of Trasylol®.15 The FDA’s response was to issue another warning to doctors.16 Bayer meanwhile continued to sell hundreds of millions of dollars worth of Trasylol® to unsuspecting surgical patients.
One Thousand Lives Lost Each Month Because of the FDA’s Delay in Removing Trasylol®
In 2007, the Canadian government terminated a study using Trasylol® because too many patients were dying.17 Germany responded to this study by banning Trasylol® altogether.18 The FDA’s initial response was to convince Bayer to suspend marketing of Trasylol® only temporarily.19,20
In 2008, amid a flurry of lawsuits, Bayer announced that it was removing the remaining supply of Trasylol® from the American market.21
Experts estimate that had the FDA taken action when the first report came out, 22,000 lives could have been saved—which equates to about 1,000 needless deaths each month the FDA failed to act.10
Bayer suspended two employees22 for failing to disclose the Harvard study to the FDA. As with other pharmaceutical companies that cover up the lethal dangers of their drugs, the FDA has taken no action against Bayer. Contrast FDA inaction against Bayer to FDA’s threats to imprison growers of cherries and walnuts for promoting the health benefits of their foods. 23,24