Mon Jan 1, 0001

Anthrax Vaccine (AVA/BioThrax) Malfeasance

AVIP Mandate

Anthrax Vaccine Immunization Program announced by SecDef William Cohen, December 1997. Vaccinations began March 1998. Goal: vaccinate all 2.4 million active-duty and reserve personnel. By 2000: ~500,000 had received at least one dose. Partially suspended 2000 (supply shortages), restarted in limited form 2002 after anthrax letter attacks.

BioPort / Emergent BioSolutions

Michigan Biologic Products Institute (state-owned) was sole AVA manufacturer. 1998: BioPort Corporation formed, acquired facility for ~$25 million. Co-founded by Fuad El-Hibri and Admiral William Crowe Jr. (former Chairman of Joint Chiefs, 1985-1989). Crowe received equity stake reportedly without financial investment.

Shortly after acquisition: BioPort received DoD contract modification worth ~$29 million to renovate facility. BioPort rebranded as Emergent BioSolutions (2004), continued as sole-source supplier.

GAO and congressional investigators noted revolving-door concerns re: Crowe.

Admiral William Crowe Jr.

Chairman of Joint Chiefs (1985-1989). Ambassador to UK (1994-1997). Founding investor and board member of BioPort (1998). Received equity at no personal cost. DoD was both the regulator mandating the vaccine and the sole customer. Died 2007.

FDA Approval Issues

AVA licensed by FDA in 1970 for protection against cutaneous (skin) anthrax from occupational exposure (mill workers handling animal hides). FDA had never specifically approved AVA for inhalation anthrax — the threat cited by DoD as military rationale.

2005: FDA issued Final Rule affirming licensure for anthrax “regardless of route of exposure” (70 FR 75180). This came after years of mandatory vaccinations. Federal courts found pre-2005 use constituted administration of an investigational product.

Manufacturing Deficiencies and Expired Batches

FDA inspections of Michigan facility in late 1990s found significant manufacturing deficiencies including potency failures. GAO-02-181 (October 2001): BioPort failed multiple FDA inspections between 1998 and 2001. Documented instances of BioPort seeking and receiving FDA permission to use non-compliant lots and to extend expiration dates on existing lots. Facility did not pass FDA inspection until 2001-2002.

Adverse Reactions

GAO-02-445 (April 2002) survey:

  • 85% reported localized reactions
  • 24% reported systemic reactions (joint pain, fatigue, memory loss)
  • Hundreds reported serious adverse events

~400+ Air National Guard and Reserve members transferred, retired, or resigned rather than take the vaccine.

Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003)

Judge Emmet Sullivan ruled December 2003: mandatory anthrax vaccination program was illegal. AVA used as investigational drug without informed consent, violating 10 U.S.C. 1107. Court issued injunction halting mandatory vaccinations.

After FDA’s 2005 Final Rule: D.C. Circuit in subsequent proceedings (Doe v. Rumsfeld, 341 F. Supp. 2d 1) allowed program to resume based on new FDA ruling.

2001 Anthrax Attacks

September-October 2001: anthrax letter attacks killed 5, infected 17. Dramatically increased demand for vaccine and strengthened BioPort’s commercial position at a time when company faced financial difficulties and FDA compliance problems.

FBI attributed attacks to Dr. Bruce Ivins, USAMRIID researcher who worked on anthrax vaccine development. Ivins died by suicide July 2008 before charges filed.

Sources

  • GAO-02-181 (October 2001)
  • GAO-02-445 (April 2002)
  • Doe v. Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003)
  • FDA Final Rule 70 FR 75180 (2005)
  • Congressional testimony, House Government Reform Committee (1999-2002)