MAKER OF ANTHRAX VACCINE VIOLATED REGULATIONS, EXPERTS BELIEVE
LATEST: FDA PRESS OFFICE: SITE PROMOTING VACCINE PAID FOR BY COMPANY NOT NECESSARILY CONSIDERED PROMOTION
By John Byrne, RAW STORY Editor
Quietly lurking in the shadows of all three presidential debates has been the specter of terrorism. And as the fear of terrorism followed one debate to the next, so too did BioPort, the U.S. military’s sole provider of the anthrax vaccine.
Marred by the reports from hundreds of servicemembers who say they’ve been made ill by the vaccine since it was mandated 1998, three federal lawsuits about the vaccine’s safety and financial woes related to the government’s refusal to add the vaccine to its civilian defense stockpile, the has company launched an aggressive grass-roots marketing push.
To ensure that it nets the lucrative civilian contract, BioPort has systematically sought to elevate concern about the risk of anthrax exposure, successfully playing on local fears and paying “experts” thousands of dollars to produce reports that assert the threat of anthrax is immediate and grave.
It has also retained a medical professor to run a lobbying group while masking its own affiliation. The group has disseminated misleading information about adverse reactions to the vaccine, putting BioPort in apparent violation of federal regulations, RAW STORY has learned.
BioPort did not return repeated calls seeking comment. In the past, they have steadfastly defended their vaccine, which is their only financially significant product.
A press officer for the Food and Drug Administration said Monday that if BioPort paid a third-party to promote their vaccine, it might not be considered promotion, in apparent contradiction with the agency’s own federal regulations and industry experts. She said she would contact a relevant member of the FDA and provide further comment later today.
BioPort is battling a nascent rival company, VaxGen, to net the civilian contract. How the corporate war pans out could determine who will supply up to 75 million anthrax vaccine units – and whether troops continue be injected by a vaccine with a questionable safety record. VaxGen promises a cheaper and more effective next generation vaccine which has yet to win FDA approval.
But BioPort, saying they rely solely on their defense contract for research and development, state they don’t have the means to produce a new vaccine.
Yet the company has raised the price of the vaccine to the Defense Department by nearly a factor of ten; their original contract said the vaccine would be priced at under $3 per dose after 3.3 million doses. According to a 2001 company interview, the Pentagon now pays $22 per dose.
Their predicted price to the public?
“Somewhere in the neighborhood of between $70 to $100 per dose,” the company’s owner recently told a reporter.
COMPANY LOBBY LIKELY IN VIOLATION OF FEDERAL REGULATIONS
Like many companies, BioPort maintains a seemingly independent lobbying group. But unlike, say, the Recording Industry of America, whose financial backers are listed on their website, BioPort and their public relations firm have taken pains to mask their affiliation with the group.
Neither Bioport or their PR firm, Ruder Finn, are listed anywhere on the website of the group, the Partnership for Anthrax Vaccination Education.
The only member listed is George Washington University School of Public Health professor Muhiuddin Haider.
Haider, according to a listing of externally sponsored projects on the George Washington University website, is paid by BioPort. The “affiliated organization” is listed as Ruder Finn.
The site, which mentions the BioPort vaccine by name, provides misleading information about adverse effects of the vaccine, putting the company in likely violation of federal regulations.
Under a section titled “Myth vs. Fact about the Anthrax Vaccine,” the group asserts that it is a myth that the vaccine “has dangerous side effects including death.”
“Anthrax vaccine has never been determined by medical experts to have been the cause of any death,” the section states.
This contradicts facts presented by the Defense Department, which is a strong advocate of the vaccine.
Two 2003 military studies found that the vaccine was the probable cause of a reservist’s death. While Pentagon-paid physicians found the evidence was not conclusive because Specialist Rachel Lacy, 22, had also received other vaccines simultaneously, both panels asserted the vaccine was the probable cause of her death.
The Defense-issued press release was titled, “Panels Find Vaccines May Relate to Reservist’s Illness, Death.”
Additionally, the BioPort lobby fails to document any of the serious adverse reactions to the vaccine as mandated by federal regulations. According to the manufacturer’s own product package insert (view pdf file), the most common side effects reported to the government’s vaccine adverse effects reporting system were an allergic reaction in the skin, headaches, systemic joint pain and fatigue.
Not a single one of these effects are listed on the site.
Moreover, the insert also reports rare severe reactions to the vaccine, including systemic disorders in the nervous system, skin, musculoskeletal system, connective tissue, and bones.
None of these are listed or alluded to on the site, either.
BioPort’s insert, which increased to six pages from two in 2002 to document additional adverse effects, also notes that the Pentagon’s own survey studies found systemic adverse reactions in five to 35 percent of those vaccinated.
This, too, is not mentioned on the lobby’s site.
Under Part 202 of the Food and Drug Administration’s federal regulations, pharmaceutical companies are required to disclose the “true statement of information relating to side effects, contraindications, and effectiveness,” including “each specific side effect and contraindication.”
Wayne Pilot, a former assistant commissioner at the FDA and former employee of the Pharmaceutical Manufacturer’s Association, who now practices law specializing in FDA regulation, confirmed that BioPort was responsible for regulatory infractions of its lobbies.
“The party which has the licenses is responsible for any claims that are made about the product including those which are made by third parties,” Pilot said Monday. “The licensee is responsible for correcting those statements that may be incorrect or misleading.”
Sarah Barak, the editor of the FDA Advertising and Promotion Manual, an independently-published industry guide, agrees.
“If you have information on a website that’s tantamount to promotion than you need to follow the rules of that area of promotion,” Barak said.
Pilot also asserted that BioPort is required to report any supportable claims made by the Defense Department about adverse effects.
“If the information is supportable,” he added, “that’s the company’s responsibility.”
Pilot also stressed that violating the regulations was not a minor infraction.
“Those regulations have the force and effect of law,” he said.
The BioPort lobby also states that it is a myth that miscarriages are linked to the vaccine. What it does not note is that a 2002 Navy study found that use of the anthrax vaccine in pregnant women may cause a higher incidence of birth defects.
The preliminary study, which was supposed to be disclosed in April 2002, was never released.
Out of nearly a hundred projects listed as externally sponsored at the university for 2004, Haider’s is the only affiliated with a public relations firm. Most are affiliated with foreign governments or specific medical centers.
SOWING FEAR AT THE DEBATES, FOR PROFIT
When the final presidential debate got under way in Tempe, Arizona, the firm sponsored a roundtable in Phoenix on terrorism preparation.
In a release for the event, BioPort noted “growing border security concerns with Mexico” and that Timothy McVeigh “concocted their deadly truck bomb in nearby Bullhead City, Arizona.”
“Many of the country’s terrorist-like patriot militia groups operate throughout the Southwest desert area,” the release added. “And even the relatively peaceful Scottsdale area was the scene of a July bombing at a local eatery.”
Arizona’s roundtable was only the most recent of the company’s panels. In fact, the company sponsored local roundtables at all three presidential debates, the vice presidential debate and at both parties’ national conventions.
While RAW STORY does not have independent knowledge of what transpired at these events, there is no indication from their press releases that they made any public mention of adverse effects.
Barak, who authored the FDA industry manual, said BioPort was obligated the report adverse effects if they were marketing the vaccine.
“If you have benefit claims then you must present the risk,” she said.
The Miami roundtable, BioPort stated in their release, ended on a “high note” when a county commissioner offered to propose legislation which would set aside a $5 million fund, under which “BioPort would hold and earn interest on the money given by the state” with the condition that vaccines would be “delivered immediately in the case of an outbreak or threat of [an] anthrax scare.”
In their announcement of a roundtable for the Republican convention, BioPort claimed that a biological terrorist attack on the U.S. before the election was high, citing unnamed ‘security analysts.’
In 2002, the company paid six bioterrorism “experts” $55,000 to produce a report which said the United States could experience other occurrences such as the 2001 anthrax mailings. The company’s president noted that Iraq, Iran, Libya and North Korea have weaponized anthrax or are working to obtain it.
This approach has paid dividends.
In June, BioPort successfully lobbied the U.S. Conference of Mayors – in a possible infraction of FDA regulations the requires a company to disclose all side effects in their lobbying efforts – to endorse a resolution supporting the inclusion of BioPort’s vaccine to the civilian defense stockpile.
Yet after years of pressure and an anthrax attack on Congress, the Department Health and Human Services has declined to add the vaccine to the stockpile. While they have not explicitly stated the reason is linked to the safety of the vaccine, many see the decision to be a tacit rebuke to BioPort.
