Attempt to Discredit Whistle-Blower Alleged

November 24, 2004

http://www.washingtonpost.com/ac2/wp-dyn/A8715-2004Nov23?language=printer

washingtonpost.com

Group Says His FDA Colleagues Made Calls

By Marc Kaufman

Washington Post Staff Writer

Wednesday, November 24, 2004; Page A19

Managers at the Food and Drug Administration last month anonymously called a

group that protects whistle-blowers in an attempt to discredit an outspoken

agency safety officer who was challenging the FDA's drug safety policies,

the legal director of the whistle-blower group said yesterday.

Tom Devine of the nonprofit Government Accountability Project (GAP) said the

anonymous callers did not identify themselves but he is " 100 percent

positive " they were managers at the FDA because of their phone numbers and

other identifying information. He said he initially took the callers'

concerns seriously but later came to see the calls as an effort to smear the

whistle-blower, Associate Director J. Graham of the Office of Drug

Safety.

Last week, Graham, a 20-year FDA veteran, said at a Senate hearing that FDA

policies have left the American public " virtually defenseless " against the

kind of safety problems that led to the abrupt withdrawal in September of

the popular arthritis drug Vioxx.

He named five other prescription medications that he said pose serious

safety risks that are not being adequately addressed by the FDA.

Although the FDA initially sharply criticized Graham's testimony -- one top

official called him " irresponsible " and a practitioner of " junk science " --

the agency yesterday tightened the restrictions on one of the five drugs

Graham had criticized, the acne medication Accutane.

In a statement regarding the GAP allegations, the FDA said yesterday that it

" acknowledges the right of its employees to raise their concerns to

oversight groups. "

The agency said that it had no prior knowledge of any employee's contact

with the whistle-blower group and that it is working to improve a process

for ensuring that internal differences of scientific opinion are fully

incorporated into its decision-making. " The agency promotes vigorous debate

of the tough scientific questions it confronts every day, " the statement

said.

The allegation that the FDA used deceptive practices against Graham came two

days after the Government Accountability Project agreed to take him on as a

client.

Devine said Graham had asked five weeks ago for advice about overcoming his

supervisors' opposition to the publication of his critical findings about

Vioxx. The anonymous calls followed several weeks later, Devine said.

" The calls came under the guise of being anonymous whistle-blowers, " Devine

said. " They were clearly working together and shared allegations -- mostly

that Dr. Graham's research was unreliable and that there were serious

questions of possible scientific misconduct with his study. They said Graham

wouldn't address their concerns, and that he was a demagogue and a bully. "

Devine said that after several conversations, he persuaded the callers to

provide documents to support their accusations, and Devine then challenged

Graham based on what was provided.

" It became clear to me that Dr. Graham could reasonably explain any

questions about the research, and that the callers were trying to smear

him, " Devine said. " After that, I called their bluff for more information

and that was the end of it. It was all a red herring, and it made me believe

Dr. Graham far more. "

Devine said that, under his organization's rules, he could not identify the

callers because they initially contacted GAP as whistle-blowers themselves.

But he said he is certain they were supervisors at the FDA because of the

details of the arguments they made and the phone numbers from which they

called. In addition, he said that, after identifying the callers to his

satisfaction, he referred to them by name during subsequent phone

conversations. He said the callers were surprised by his identifications but

did not tell him he was wrong.

The allegations follow weeks of bruising criticism of the FDA, which has

been accused of being lax on drug safety and was sharply assailed in

Congress over its oversight of the British plant that was supposed to

produce half of this winter's U.S. supply of flu vaccine. The plant was

closed by British health officials because of contamination problems.

The criticism on drug safety issues has led to calls for the creation of a

more independent Office of Drug Safety within the FDA, or perhaps outside of

it.

Currently, the office is overseen by the Center for Drug Evaluation and

Research, which also supervises the Office of New Drugs. To critics of the

current setup, the much larger and better-financed Office of New Drugs

dominates the safety office, in part because drug reviewers involved in

approving a new drug for marketing also play a role in deciding whether the

drugs should be withdrawn when safety issues crop up.

In his Senate testimony, Graham said a more independent drug safety office

is essential. His position was supported this week by the editors of the

Journal of the American Medical Association.

" The drug approval process must be decoupled from the post-marketing safety

and surveillance system, " the editorial said. " It is unreasonable to expect

that the same agency that was responsible for approval of drug licensing and

labeling would also be committed to actively seek evidence to prove itself

wrong. "

The FDA and drug industry officials have generally opposed a more

independent safety office, saying it is unnecessary and would serve to

de-emphasize the benefits of medications. But the FDA recently asked the

congressionally chartered Institute of Medicine to review its drug safety

procedures, and top officials said the agency will consider whatever

recommendations the institute makes.

Although the drug safety issue involves a number of medications, companies,

patients and officials, it has increasingly revolved in recent days around

Graham's personality and positions. He has been at the center of the Vioxx

controversy and has touched off more heated words and debate with his

congressional criticisms of five other drugs, but his impact on drug safety

issues goes well beyond those.

During his 20 years in the Office of Drug Safety, he fought passionately to

bring about the recall of the diabetes drug Rezulin, the diet pills Fen-Phen

and Redux, the cholesterol-lowering drug Baycol, the heartburn remedy

Propulsid, and the antihistamine Seldane.

Graham, 50, was trained as a physician at s Hopkins and Yale

universities and has spent his entire career at the FDA's drug safety

office. A deeply religious Roman Catholic, he has said that his faith serves

as a spur to his work. Some see him as a crusading hero, while others

believe he unfairly fixates on certain drugs and fails to take into account

the patients who are helped by those medications.

His influence has been enormous. In his congressional testimony, Graham said

that, in the course of his career, he had recommended that 12 drugs be taken

off the market, and that 10 of them were subsequently removed.

The news that Graham had sought whistle-blower assistance and protection --

and that FDA managers had sought to undermine his credibility -- was first

reported yesterday in the online edition of BMJ, formerly known as the

British Medical Journal.

In that account, Devine said the FDA was " employing a classic law of

whistleblower reprisal -- the smokescreen syndrome -- which shifts the

spotlight from the message to the messenger. The agency attempted to

discredit Dr. Graham rather than provide any scientific evidence

contradicting his conclusions. "

Graham could not be reached yesterday for comment.

One of the two drugs whose recall Graham has unsuccessfully sought is

Accutane, which was approved to treat severe acne but, critics say, is

widely prescribed for milder cases. The drug's distribution is restricted to

prevent its use by pregnant women because Accutane can cause fetuses to die

or develop birth defects. Nonetheless, some women have been getting pregnant

while taking the drug.

Under an expanded monitoring program announced by the FDA yesterday,

manufacturers will have to keep records of which doctors prescribe the drug,

which pharmacies distribute it and which patients take it. Doctors and

pharmacies will also have to inform women about the drug's risks, and

pharmacists will have to see a signed proof that the patient is not pregnant

before they dispense the drug, the FDA said.

In its news release, the agency said the changes stemmed from the

recommendations of an advisory panel in February.

November 24, 2004