FDA Cut Off Critic’s Access to Drug Safety Database – Chicago Tribune

Thu, 24 Feb 2005

The Chicago Tribune reports (below) about an eggregious example of the abuse of power by FDA officials who are retaliating against an independent scientist whose unique research project for detecting rare adverse drug reactions has uncovered potentially fatal side effects of 17 currently marketed drugs.

Dr. Charles Bennett, a Northwestern University researcher, has developed a proactive method for detecting adverse drug effects by examinning adverse drug reports submitted to FDA’s database and reports from reports by phamaceutical companies and independent groups of researchers thoughout the US and Canada. The project is called the Research on Adverse Drug Events and Reports (RADAR).

For example, Dr. Bennett discovered that the widely used anti-clotting drug, Plavix, can cause “a catastrophic collapse of the blood system.” He urged the FDA to issue Black Box warnings, but the FDA refused, but did add a less prominent warning.

Dr. Bennett published a paper in the journal Stroke (February) in which he compared the effectiveness of various systems for detecting adverse drug effects. The FDA system ranked at the very bottom:

“The study assessed how the FDA, Plavix’s manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent.”

The Tribune reports that The FDA retaliated against Dr. Bennett for publishing the results by cutting off his access to FDA’s post marketing surveillance database‹as if the agency were a private contractor. FDA’s Christine M. Bechtel wrote:

“While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your groups special status.”

FDA officials forget that they are public servants who have an appalling record on drug safety issues. Their failure to develop a viable tracking system for adverse drug effects has resulted in a health crisis due, largely to the agency’s failure to put safety as the top priority.

Dr. Bennett notes: “Half of the drugs prescribed today are being used in situations where we don’t have a good handle on whether they’re either safe or effective, and that’s a big problem,” Bennett said.

Whether it is because of a culture of arrogance, or incompetence, or bad faith, FDA policies keep physicians and the public in the dark about adverse‹even lethal‹drug effects.

See: In the Dark About Drugs, Los Angeles Times editorial, February 19, 2005

Contact: Vera Hassner Sharav
212-595-8974

CHICAGO TRIBUNE
FDA cut off critic’s access to drug database
By Ronald Kotulak
February 20, 2005

Over the last five years, a Northwestern University researcher has used information from the U.S. Food and Drug Administration–along with adverse drug reports from pharmaceutical companies and independent groups–to uncover potentially fatal side effects for 17 drugs.

One of those drugs is Plavix, an anti-clotting agent that has been given to more than 41 million patients worldwide since 1998. A group led by Dr. Charles Bennett reported in 2000 that in rare circumstances the drug can cause a catastrophic collapse of the blood system, leading the FDA to require the manufacturer to add a warning label.

Early last year, however, Bennett wrote another article giving the FDA a failing grade on post-marketing drug safety. Nine months later, the agency cut off his special access to its adverse drug reaction database.

Critics call the FDA’s action another misstep that reveals the agency’s shortcomings in monitoring drugs after they have been approved, thereby putting many patients at risk for adverse drug reactions.

One such patient was Marion Rao, an energetic 78-year-old from Manhattan who loved to travel. Last May she had a routine stent put in to open a blocked coronary artery. She also was prescribed Plavix.

What happened to her next was not routine. Rao went downhill. Bruises began appearing on her skin, a sign of internal bleeding.

“It was very difficult to see the doctor,” said Rao’s daughter, Joanne Perrotta. “They kept putting us off. When I did go see them, they made her see the nurse practitioner who looked at the blotches on her leg and said, `Oh it’s nothing.'”

When Rao was finally admitted to the hospital, her daughter recalled, the doctor on call said: “Plavix. It’s TTP.” That stands for thrombotic thrombocytopenic purpura, the scientific name for the meltdown of her blood system. Other doctors disagreed. Three weeks after receiving Plavix, Rao died.

All drugs have potential risks, but some risks only become apparent when thousands, even millions of patients, have used a drug. The problem is that the FDA does not have an effective system for monitoring complications from drugs after they’ve been approved, according to many authorities.

Reporting adverse reactions is voluntary, and most doctors don’t bother to document problems, often because the process is time-consuming, and they are wary that the records could be used in malpractice suits.

The FDA can ask pharmaceutical companies to conduct trials to determine the safety of a drug when questions arise, but there is little enforcement. And half of such trials sought by the agency have not even been started.

The result is a gross underreporting of adverse drug reactions. The FDA receives about 350,000 to 400,000 adverse drug reports each year, but this represents only 3 to 10 percent of the actual number, experts estimate. An estimated 100,000 people die annually from drug reactions.

The drug surveillance program operated by Bennett, of Northwestern’s Feinberg School of Medicine and the Jesse Brown VA Medical Center, is an effort to prevent some of the potentially deadly reactions. His program and several other independent ones are funded by the National Institutes of Health.

Called the Research on Adverse Drug Events and Reports (RADAR), Bennett’s project is a collaboration of researchers from around the U.S. and Canada who actively look for the most serious drug reactions, ones that cause organ failure or death.

Plavix’s side effects, for example, were uncovered after Bennett organized 20 blood banks nationwide to be on the watch for blood disorders that might be linked to drugs. The drug has proved beneficial to many patients, but it should contain a stronger warning of possible adverse reactions, Bennett contends.

Bennett originally asked the FDA to require a black box warning on the label, the agency’s strongest. The FDA, however, declined, saying that a regular cautionary note was sufficient since the life-threatening side effect was too rare to warrant a black box.

Though FDA officials have praised Bennett’s efforts to discover drug problems, he apparently raised the agency’s ire in a paper published in February in the journal Stroke. The study assessed how the FDA, Plavix’s manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent.

The FDA “did terrible. They flunked, and the drug companies didn’t do much better,” Bennett said. “The system is broken in many ways, and safety is on the bottom of their lists.”

Bruce Lambert of the University of Illinois at Chicago’s College of Pharmacy said restricting access to the FDA’s post-marketing surveillance reports is “a bad idea.”

“These reports should be wide open, especially to people like Dr. Bennett who are devoted to trying to understand adverse events,” he said.

In notifying Bennett of the cutoff, the FDA’s Christine M. Bechtel wrote: “While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your groups special status.”

Reacting to mounting criticism, the FDA on Tuesday said it will establish a new independent Drug Safety Oversight Board to monitor medicines once they’re on the market and alert doctors and patients to any risks. Critics quickly pointed out that the board would be advisory and would not have the power to withdraw a drug.

Another major problem facing the FDA is the lack of a system for tracking adverse drug events for the 50 percent of medications that are used off label. Once a drug is approved, physicians can prescribe it for conditions for which it was not originally approved, but the drugs are usually not tested for safety in such off-label uses.

“Half of the drugs prescribed today are being used in situations where we don’t have a good handle on whether they’re either safe or effective, and that’s a big problem,” Bennett said.

Copyright © 2005, Chicago Tribune

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