FDA cut off critic's access to drug database

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THE FDA AND DRUG SAFETY

 

FDA cut off critic's access to drug database

 

By Ronald Kotulak

Chicago Tribune staff reporter

 

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.

 

2005, Chicago Tribune

 

 

 

Laura

 

 

" To announce that there must be no criticism of the president, or

that we are to stand by the president right or wrong, is not only unpatriotic

and servile, but is morally treasonable to the American public. " -

Theodore Roosevelt, 7 May 1918