Nov. 11, 2005 – Fear of a looming flu pandemic has goaded Congress and the White House to ramp up the countryâ€™s capacity to deal with the threat. But watchdog groups and healthcare advocates warn that instead of preparing and protecting the public, recent federal initiatives would fail to resolve shortages of medical resources, encourage corporate profiteering and flout drug-safety regulations.
The initial federal responses include the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, introduced by Senator Richard Burr (R-North Carolina), and the Bush administrationâ€™s $7 billion national pandemic flu strategy, rolled out earlier this month.
In addition to providing for flu treatment and vaccination, both plans aim to remove regulatory and legal checks on the drug industry, purportedly to foster investment in medical research and development. The White House plan and Burrâ€™s bill both aim to protect companies from lawsuits rising out of any adverse health effects from drugs or vaccines.
The biodefense bill would also enhance exclusive patent rights for manufacturers and, to coordinate research efforts, create a new administrative agency that would be exempt from the Freedom of Information Act and other mechanisms for public oversight.
The privileges served up to pharmaceutical companies tie into growing anxieties over the H5N1 avian-flu strain, which some fear will soon mutate into a highly contagious form and ignite a global outbreak. The Centers for Disease Control has estimated that an especially lethal pandemic could kill up to 2 million people in the United States alone.
Critics say that business-friendly pandemic strategies could disrupt that balance by promoting a cure worse than the disease.
Dean Mason, president of the Sabin Vaccine Institute, an organization that promotes vaccine research, said that while Washingtonâ€™s attention to the pandemic threat is promising, the current plans leave open controversial health and safety questions.
"The more proactive you are," Mason told The NewStandard, "the more immediate you are [in] the response, the more youâ€™ve had to waive what normally are considered essential safeguards. So finding that balanceâ€¦ is the challenge."
But critics say that business-friendly pandemic strategies could disrupt that balance by promoting a cure worse than the disease.
Some in the scientific community argue that given the severe shortage of medical resources needed to deal with a pandemic, the government must yield somewhat to industry demands, even if companies are leveraging scarcity for financial gain.
The Department of Health and Human Services reports that as of October, the U.S. stockpile of antiviral flu treatment consisted mainly of 2.3 million 10-dose courses of the drug oseltamivir â€”not enough to treat even 1 percent of Americans â€“ with plans to acquire another 2 million courses by the end of the year.
The administration is aiming to stockpile roughly 80 million courses to cover about one-quarter of the population, divided between state and federal supplies. But the Swiss company Hoffmann-La Roche, which exclusively produces oseltamivir as Tamiflu,,has indicated it could provide only 13 million treatment courses in 2006, followed by 70 million in 2007.
Sen. Burrâ€™s biodefense bill, according to critics, would encourage pharmaceutical giants to horde the market without making supplies accessible enough to poor and vulnerable populations.
Health authorities have further warned that if a pandemic hits, the vaccine industry â€“ now dominated by just four corporations â€“ would only be capable of meeting only about 10 to 15 percent of the countryâ€™s estimated needs.
Public health groups say profit-minded drug companies have avoided the vaccine market because yearly fluctuations in consumer demand make it a financially risky environment. Another deterrent, according to pro-business lawmakers, is the threat of lawsuits from consumers claiming injuries from vaccines and drugs. The actual economic impact of litigation is unclear, however, because the government already protects companies by compensating victims through the federal Vaccine Injury Compensation Program.
Joseph Oppong, a professor of geography at the University of North Texas specializing in global epidemics, said that as long as vaccine production is tied to a market-based system, "we have no choice" but to satisfy drug company demands in order to meet public health needs.
"Hopefully, these manufacturers are not just simply interested in profit-maximizing," he told TNS. "Unfortunately, thatâ€™s what the American system is all about."
While advocacy groups acknowledge the need to prepare for a pandemic, they say proposals like the Biodefense Act give too much to the pharmaceuticals industry and demand too little in return.
Limitations on supply would strike poor populations in developing countries the hardest.
Barbara Loe Fischer, president of the patientsâ€™ advocacy organization National Vaccine Information Center (NVIC), said that although her group generally supports preparedness efforts like the stockpiling of drugs, the proposals to protect companies from lawsuits do more harm than good. The waiver in the Burr bill would go even farther than existing liability shield laws, she said, because it would essentially apply to any drug administered in response to a major disease outbreak.
"Theyâ€™ve gone way, way overboard here in trying to use fear of pandemic fluâ€¦ to basically give a blank check to the pharmaceutical industry and protect them from all liability," she said. "And thereâ€™s nobody accountable."
Vera Sharav, president of the drug industry watchdog group Alliance for Human Research Protection, noted that the bill expands on emergency powers granted under the 2004 Project Bioshield laws, which permit the government to override the standard testing process for drugs. For example, the Department of Defense recently invoked Project Bioshield to relaunch a controversial anthrax immunization program without official formal approval of the vaccine â€“ even though a Government Accountability Office investigation found that among military personnel, anthrax-vaccine-related illnesses were far more prevalent than Pentagon officials had reported.
"If a vaccine is used without it first having been tested in controlled trials and shown to be safe and efficacious, then the public thatâ€™s being inoculated will be the guinea pigs," said Sharav.
Both activists and members of the scientific community have also raised concerns that the administrative body established in the biodefense bill â€“ the Biomedical Advanced Research and Development Agency â€“ would use its blanket exemption from oversight laws to keep the pharmaceutical development process out of public purview.
The bill does provide for limited government compensation for vaccine- and drug-related injuries. But Fischer said the provision could replicate the shortcomings of the Vaccine Injury Compensation Program, which has been criticized for blocking families from receiving larger awards or seeking further redress a court might deem more appropriate.
Fischer said that a system could be designed to provide "fair, just, expedited" compensation, but this would require "making some compromises that I donâ€™t think that this administration wants to make."
Holding the Rights to Health
On top of allaying fears of litigation, Sen. Burrâ€™s biodefense bill, according to critics, would encourage pharmaceutical giants to hoard the market without making supplies accessible enough to poor and vulnerable populations.
The legislation would primarily benefit drug manufacturers like Hoffmannâ€“La Roche, with its exclusive "right" to produce oseltamivir, and plans to sell it worldwide at about $14 to $18 per treatment. Brooke Baker, a policy analyst with the advocacy organization Health Global Access Project, said this monopoly threatens to hold the US and other countries hostage in a "house of cards" situation: "theyâ€™re controlling things totally, and they canâ€™t meet demand, and they wonâ€™t lower prices."
Roche has announced that it is negotiating with other manufacturers to outsource production under what it calls "equitable conditions." But as of November 7, out of roughly 150 offers from "third-party" producers to help manufacture the drug, Roche has initiated talks with only eight.
Limitations on supply would strike poor populations in developing countries the hardest, said Baker, but even in the US, people lacking private or public healthcare coverage could be priced out of a crucial treatment.
"Whatâ€™s crazy about our system right now," Baker said, "is the government provides direct subsidization, and then the companies still get to make a killing."
Beyond the Magic Bullet
Consumer advocates argue that instead of just subsidizing corporate profits, the government should focus on creating more sustainable methods for developing drugs and vaccines.
Simply expanding existing vaccination policies could boost overall demand, according to William Schaffner, a professor of preventative medicine at Vanderbilt University. He noted that if the government established a national immunization system for adults similar to pediatric vaccination programs, "you would reap the benefits of preventionâ€¦ plus, you would create a huge new market."
James Love, a patent law expert with the global policy think tank Consumer Project on Technology, recommends that the government offer a large "prize" for developing beneficial products, in exchange for control over the patent rights. Under this scenario, he said, "no one owns the product: it would be a generic, subject to competition," and federal authorities could leverage prices by managing the distribution of production and marketing licenses.
Some critics argue that for all the buzz in Washington about boosting the countryâ€™s pandemic defenses, officials have focused on coddling industry while overlooking the local healthcare systems that would be on the frontlines of the national response. The administration has dedicated less than 10 percent of its $7 billion package to the development of state and local emergency preparedness.
According to TomÃ¡s AragÃ³n, executive director of University of Californiaâ€“Berkeleyâ€™s Center for Infectious Disease Preparedness, the federal initiatives might help fill some supply gaps, but do little to ensure that healthcare workers and emergency responders â€“ who wrestle with capacity problems even during normal flu seasons â€“ can efficiently deliver these resources to their communities.
"Itâ€™s going to be shortsighted for us to be dependent onâ€¦ the magic bullet," he said, "when, if that fails, weâ€™re going to have to depend on good-old public-health infrastructure, which is really underfunded dramatically throughout the United States.