Rep. Burton May Subpoena HHS Officials’ Financial Records On Vaccines

HHS officials' financial records may be subpoenaed by Rep. Dan Burton (R-Ind.) in an effort to disclose possible financial ties between pharmaceutical companies and government health agencies.

"I want to issue a subpoena for all financial records of the top decision makers of the HHS," House Government Reform Committee Chairman Burton declared at a committee hearing Dec. 12.

"I have had suspicions for a long time that a lot of the people that work at FDA and HHS have direct or indirect ties with pharmaceutical companies and they protect them. And that's really sad."

Burton has maintained a long-running interest in possible conflicts of interest in federal oversight of vaccines. In June 2000 he held a hearing on the 1999 withdrawal of Wyeth-Lederle's rotavirus vaccine RotaShield following reports of intussusception in vaccinated children (¹ (Also see "ACIP Chairman Ownership Of Merck Stock Challenged By Rep. Burton" - Pink Sheet, 19 Jun, 2000.), p. 28).

Burton expressed concern about the financial holdings of members of FDA's Vaccines & Related Biological Products Advisory Committee, which recommended approval of RotaShield, and CDC's Advisory Committee on Immunization Practices, which recommended RotaShield for routine use in newborns.

At least one top HHS official has close ties to a vaccine manufacturer: Merck exec Eve Slater, MD, has been tapped for assistant secretary for health (² (Also see "Merck Exec Taking Top Administration Health Slot: Slater For OASH" - Pink Sheet, 22 Oct, 2001.), p. 10).

The expansion of Burton's conflict of interest inquiry comes at a delicate time for oversight of the drug industry. Manufacturers are pressing for antitrust exemptions to aid in bioterrorism work and Public Citizen has challenged the legality of a pharma-HHS working group (³ (Also see "Vaccine Manufacturer Indemnification Delaying Kennedy-Frist Bioterror Bill" - Pink Sheet, 12 Nov, 2001.), p. 22). Senate Health Committee Chairman Edward Kennedy (D-Mass.) has indicated that he would view unfavorably an FDA commissioner nominee with strong industry connections.

The upcoming debate on user fee reauthorization may provide a vehicle for Burton to address his concerns on appropriate oversight of vaccine manufactures. Burton is planning several hearings on the issue next year. At the end of the next session, Burton will have to relinquish his chairmanship of the Government Reform Committee, having served for six years.

At the hearing, Rep. Ben Gilman (R-N.Y.) criticized the Department of Justice for not publishing some claims case decisions of the National Vaccine Injury Compensation Program.

DoJ Deputy Director-VICP Paul Harris replied that the department asks for unpublished decisions based on concerns that an "erroneous decision" by the special master may create an harmful precedent, but appeals are not "appropriate given the circumstances of each individual case."

"I am going to ask for a [General Accounting Office] audit" of the unpublished cases, Burton said. "I think most people would think that unseemly by the federal government" that claims cases go unpublished.

Reps. Burton and Henry Waxman (D-Calif.) intend to introduce legislation to reform the Vaccine Injury Compensation Program in the spring of 2002 (⁴ (Also see "Rx Import Controls Included In Tauzin/Dingell Bioterrorism Bill" - Pink Sheet, 10 Dec, 2001.), p. 13).

Burton also declared he will issue a subpoena for the "hot lot" number of Wyeth-Lederle's diptheria/tetanus/acellular pertussis vaccine Acel-Imune that adversely affected the son of one of the witnesses who testified before the committee.

Tara Dyer of Knoxville, Tenn., described how her son developed a seizure disorder after a vaccination with Acel-Imune in 1992.

Wyeth discontinued the product at the beginning of the year following manufacturing problems (⁵ (Also see "Wyeth-Ayerst Acel-Imune Discontinued; DTaP Vaccine Had Sales Of $71 Mil." - Pink Sheet, 29 Jan, 2001.), p. 17).

"I want to subpoena any records that the FDA has regarding Lederle and this hot lot. Get the hot lot number and then send the subpoena to the FDA regarding any correspondence between them and Lederle," Burton said.

"Why can't [the hot lot numbers] be made public?" the Indiana Republican asked. "Why were 200-300 people adversely impacted by that, other than maybe they didn't want that public because the pharmaceutical company would have a black eye and it might hurt sales and it might hurt business?"