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Letter Urging that the HHS Implement and Enforce the Code of Ethics for Government

March 22, 2000

Donna Shalala, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC

Dear Secretary Shalala:

It is urgent for you and other leaders in HHS — and all government agencies — to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service (175 72 Stat B12, 1958) which states that "Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department." In addition, the Code of Federal Regulations governing basic obligations of public service (5 CFR Subpart A section 2635b.101) states that government "employees shall disclose waste, fraud, abuse and corruption to appropriate authorities." These guidelines have not been followed by those FDA officials who have harassed FDA physicians in the context of the recent controversy concerning Rezulin.

Yesterday, Rezulin, the fourth drug of 39 new drugs approved in 1997 — under conditions which many FDA physicians describe as lowered safety standards — was taken off the market. Rezulin has caused at least 63 people to die of liver failure and has been responsible for hundreds of other cases of severe liver toxicity. The number of drugs already pulled off the market (Posicor, Duract, Raxar and Rezulin) from those approved in 1997 is twice as many as in any previous year of approval, that having happened once, wherein two of the 30 drugs approved in 1985 have been taken off the market. In no other year of drug approvals between 1970 and now, has more than one drug eventually had to be removed from the market. A fifth drug also approved in 1997, Trovan, an antibiotic now banned in Europe, has been banned in this country except for hospitalized and nursing home patients. A sixth drug, approved in 1996 — the weight reduction drug Redux — has also been banned because of often-fatal primary pulmonary hypertension and heart valve damage (see Table). In many of these cases, there was either opposition by FDA employees to the approval of these drugs (Redux and Rezulin), unsuccessful urging of stronger product warnings on approval (Duract) or inadequately-heeded opposition from several FDA advisory committee members (Posicor).

Rather than encouraging FDA physicians and other scientists to be vigilant and try to stop these disasters from occurring before approval or encouraging them to speak up to urge that if post-marketing dangers become apparent, drug withdrawal should occur, there have been several recent incidents in which FDA medical officers have been harassed because of their concerns about drug safety. Robert Misbin, MD. and Leo Lutwak, M.D., both medical officers in FDA's Metabolic-Endocrine Drug Division, have been summoned before an FDA Internal Affairs Committee because of their opposition to the continued marketing of Rezulin. Yesterday, the agency conceded that they were right.

The morale among FDA scientists in CDER (the Center for Drug Evaluation and Research) is lower than I have seen at any time in the last 29 years. A survey we did of FDA CDER medical officers in late 1998 found 27 instances in which the medical officer thought a drug should not be approved but it was, over their objection. These FDA doctors also cited 14 instances in which they were told not to present data at FDA advisory committee meetings which might adversely affect the chance of a drug being approved.

For many dedicated FDA scientists, the atmosphere has become poisoned and repressive. I strongly urge the widespread dissemination and discussion of the above Code of Ethics and obligations of public service and for sanctions to be brought against those agency personnel who are responsible for interfering with the duty of other employees to voice their concerns about serious problems with drug safety or other similar matters. Until this is done, the FDA will continue to make additional serious mistakes regarding drug safety and other issues, much to the detriment of the health of people in this country. I look forward to a prompt response to this letter.

Sincerely,

Sidney M. Wolfe, M.D.
Director
Public Citizen's Health Research Group

Table. Drugs Approved in the U.S. in 1996-1997 and Subsequently Withdrawn for Safety Reasons

Brand/Generic Name

Date Withdrawn

Date Approved

Reason

Comments

Rezulin/ troglitazone

3/00

1/97

Liver toxicity - The FDA has concluded that Rezulin use has "possibly or probably" resulted in 90 liver failures, including 63 deaths and 7 nonfatal organ transplants.

FDA Medical Officer opposed the drug's approval.

Raxar/grepafloxacin

10/99

11/97

Heart rhythm disturbances resulting in at least 7 deaths.

8th fluoroquinolone antibiotic approved.

QT prolongation (abnormal electrocardiogram) known before approval.

Duract/bromfenac

6/98

7/97

Liver toxicity resulting in at least 4 deaths and 8 transplants.

20th nonsteroidal anti-inflammatory drug (NSAID) approved.

Liver toxicity known before approval.

Posicor/mibefradil

6/98

6/97

Drug interactions causing fatal heart rhythm disturbances.

9th calcium channel blocker approved for high blood pressure.

Redux/dexfenfluramine

9/97

5/96

Hundreds of cases of primary pulmonary hypertension (PPH) and thousands of cases heart valve damage.

PPH known before approval.

Withdrawn except for hospitals and nursing homes

Trovan/trovafloxacin

6/99

12/97

Liver toxicity that resulted in 9 deaths or liver transplants

9th fluoroquinolone antibiotic approved since 1986.

Liver toxicity known before approval.

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