Bloomberg - Whistleblowers Help Congress Strengthen U.S. FDA (Update1)

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Whistleblowers Help Congress Strengthen U.S. FDA (Update1)

By Blum

Feb. 8 (Bloomberg) -- Scientists who have worked at the U.S. Food

and Drug Administration and criticized agency decisions are now

helping Congress fashion legislation to tighten product-safety

rules.

The scientists include Ross, who said in an interview that FDA

supervisors forced him to retract a recommendation that the

antibiotic Ketek, made by Sanofi-Aventis SA, was probably too

dangerous to be used for treating two common respiratory infections.

The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are

working with Congress on bills intended to create more stringent

drug safety rules. One change being proposed would create a new

office to monitor the safety record of drugs after they're on the

market. Next week, several of the critics may describe their

concerns at a congressional hearing on the FDA.

``I felt like if I didn't do something and people got hurt, I

wouldn't be able to stand it,'' said Ross, 48, who worked at the FDA

for a decade before resigning in November. ``I'm getting a chance to

say what the problems are, and I'm getting a chance to fix them.''

Legislation proposed by Senators Grassley, an Iowa

Republican; Kennedy, a Massachusetts Democrat; and other

lawmakers would give the FDA greater authority to restrict the use

of drugs with side effects and require the registration of drug-

company clinical trials.

Scientists' Clout

The proposal to create a separate group within the FDA with power to

monitor the safety of drugs after they are on the market was

inspired by the FDA whistleblowers, Grassley said. They told him the

scientists who oversee reports about drug side effects lack the

clout to alert doctors and the public about what they have

identified.

``Without the benefit of whistleblowers, would I even know that the

office of drug safety is under the thumb of the office of new drugs

and needs to be separated?'' Grassley said in an interview. He said

the critics have suggested that the approval group may not be

aggressive in recalling or restricting the use of drugs it allowed

onto the market.

The 12,000-employee FDA regulates products that account for more

than $1.5 trillion in annual sales, or more than a 10th of the U.S.

economy. Besides food and medicine safety, the agency writes and

enforces rules on cosmetics and medical devices such as heart

defibrillators.

Vioxx, Ketek

The FDA's oversight of drug safety has come under lawmakers'

scrutiny in the past three years after studies linked

antidepressants to suicide risk for children and painkillers to

elevated chances of heart attacks. Merck & Co., based in Whitehouse

Station, New Jersey, withdrew its top-selling pain drug Vioxx in

September, 2004 after a company study showed the drug's use was tied

to higher heart attack and stroke risks.

The FDA critics helping lawmakers include Graham, an FDA

medical officer who questioned the health risks of Vioxx years

before its withdrawal. Ross and Powers, former FDA medical

officers, raised challenges to the agency's oversight of Ketek, sold

by Paris-based Sanofi.

Another FDA employee talking to Congress is Hampshire, who

in 2003 identified safety problems with a Wyeth medicine for dogs,

ProHeart 6. She was forced from her veterinary medicine job to

another position after Wyeth said she had a possible conflict of

interest. She was later cleared of wrongdoing by the FDA. Wyeth

withdrew the drug in 2004.

FDA's Response

The FDA won't comment on the pending legislation or employees' role

in creating it, said spokeswoman Kathleen Quinn in an e-mail. The

agency supports ``employees' communicating their personal

opinions,'' without necessarily agreeing, she said.

The drug agency last week pledged to strengthen safety monitoring.

It is proposing a test program to examine side effects of new

medications after 18 months of sales. Drugmakers say new legislation

isn't needed.

``The U.S. drug safety surveillance system at the FDA is the best in

the world,'' said Alan Goldhammer, deputy vice president for

regulatory affairs for the Pharmaceutical Research and Manufacturers

of America, the industry's trade group in Washington.

Some of the FDA employees said they have responded to requests to

discuss their cases with Senate aides for Grassley and Kennedy, as

well as with Dodd, a Democrat from Connecticut, and

Enzi, a Republican from Wyoming. In the House, the critics

have talked with staff for Democratic Representatives Henry Waxman

of California and Ed Markey of Massachusetts.

Safety Review

Ross said some of his suggestions were shaped by the way the FDA

responded to his findings about Ketek when he was a medical team

leader. He wrote in a safety review that the drug's risks appeared

too great to allow approval for treatment of bronchitis and

sinusitis, two common respiratory infections.

``I was called into my division director and told to `soften my

review,''' Ross said. He changed the wording to be more ``neutral,''

he said. ``When I made scientific arguments, they were ignored when

there was an economic argument for the company.''

On Dec. 15, a panel of FDA advisers said the drug shouldn't be

routinely prescribed for the two conditions because of risks of

liver damage and death. The panel suggested keeping the drug on the

market only for treating pneumonia, a more severe illness. The FDA

hasn't acted on the recommendation.

Sanofi's chief medical officer, Doug Greene, said in a statement

issued after the FDA panel meeting that the company would discuss

the matter with the FDA. He said Sanofi considers patient safety its

``highest priority.''

Reviews Online

In a recent meeting with staff for Grassley and Dodd, Ross said he

suggested that all FDA staff reviews of medications be posted on the

agency's Web site. Powers said congressional aides have sent him

draft legislation for comment.

``Some FDA managers refuse to even admit there's a problem,'' said

Powers, who quit in October as the lead medical officer for

antimicrobial drug development and resistance initiatives. ``Its

kind of like alcoholism. You have to admit you have a problem before

you can do something about it.''

To contact the reporter on this story: Blum in Washington at

jblum4@... .