Major issues with the anthrax vaccine include safety, conflicts of interest and the lobbying power of the drug developer. I don’t have all the answers, but will outline some of the concerns. Some of these are voiced by ardent vaccine opponents, such as NVIC; others sound more akin to “ conspiracy theorists .”
The anthrax vaccine was initially developed by the state of Michigan’s Biologic Products Institute (MBPI). In 1998, the MBPI plant was closed for “renovations” coincidentally following an FDA “ notice of intent to revoke licenses ”. MBPI was sold in 1998 to for-profit BioPort corporation, which became a subsidiary of Emergent BioSolutions.
The Corporate Research Project details the bailouts to BioPort to keep the company, the sole manufacturer of anthrax vaccine, viable following considerable regulatory and financial problems.
“BioPort had originally been awarded a $29.4 million DoD contract to supply 8.7 million doses of anthrax vaccine at the price of $4.36 each. But in 1999, the company got a $24.1 million bailout from the DoD. This included an increase in the price per dose from $4.36 to $10.64 and a reduction in the number of doses by about 30 percent. The Pentagon also agreed to advance BioPort $18.7 million to help it cover its debts. The new agreement increased the cost of the contract for the Pentagon to $49.8 million over the following five years. The government has reportedly spent more than $120 million of taxpayers’ money to keep the company afloat.”
Reporter Bob Evans further details BioPort’s financial mismanagement , quoting Congressman Walter Jones, R-N.C., “The message seems clear: If a company wants to make millions without providing a product or service, enter into a sole-source contract with the Department of Defense to produce vaccines…BioPort appears to have the government over a barrel.”
After September 11, 2001, Bioport quickly got its license back, although the FDA had previously found a number of quality control issues in the manufacturing process. Since then, Emergent BioSolutions has had a lucrative government monopoly and has been aggressive in protecting it. According to the Center for Responsive Politics, Emergent spent more than $3.2 million on lobbying in 2011 alone.
There have also been public relations and “educational” endeavors sponsored by Bioport, though not always advertised as such. The Partnership for Anthrax Vaccination Education, or P.A.V.E., had a website in support of the vaccine, operated by Muhiuddm Haider, a professor at George Washington University. One of PAVE’s regular speakers was Jerome Hauer, former assistant secretary of health and human services for emergency preparedness; there was no disclosure that he was being paid by BioPort.
The company and its allies in Congress ridiculed VaxGen and impugned the competence or motives of officials who supported the new vaccine. The lobbying effort damaged VaxGen’s credibility with members of Congress and the Bush administration.”
PharmAthene is another Emergent rival and has also had a rocky road, with it’s hopes for a 2008 contract dashed when Biomedical Advanced Research and Development Authority (BARDA) cancelled plans; and Emergent again vastly outspent its rival on lobbying.
Emergent had another reason to aggressively protect its contract. According to the Center for American Progress’ must read report, Getting Rich on Uncle Sucker , Emergent’s cost of production in 2009 was $46 million and profit $217 million—a markup of about 300%. Also, since the vaccine only has a four year shelf life, Emergent is guaranteed a steady income stream—on the order of $100 million/year—just to replenish the stock.
While Emergent won a grant worth up to $1.25 billion in late 2011 —and which was a sole-source contract—its future monopoly is not entirely guaranteed. BARDA is supporting development of next generation recombinant protein antigen (rPA)-based vaccines that will require fewer doses and hopefully have less side effects.
In 2004, President Bush signed Project Bioshield, which earmarked $5.6 billion for new drugs and vaccines to counter bioterrorism. At this point, we seem to have a multi-billion dollar vaccine which has never been shown to be efficacious against inhalational anthrax and was adopted by circumventing usual FDA procedures and despite numerous manufacturing quality issues and safety issues.
And that brings us to the proposed plan for testing the anthrax vaccine in children… Coming up next.
About the Author:Judy Stone , MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research , the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website . Follow on Twitter @drjudystone .
The views expressed are those of the author and are not necessarily those of Scientific American.