Soldiers win latest anthrax vaccination battle
The US Department of Defense suspended its military anthrax vaccination program for the second time in a year after a federal judge ruled that the Food and Drug Administration (FDA) skirted its own procedures by approving the vaccine. The Pentagon halted the inoculations indefinitely, but noted that the ruling does not question the vaccine's safety or efficacy.
The situation unfolded just one week before the US government announced an $877.5 million contract to California-based VaxGen, Inc. to develop and manufacture 75 million doses of a new anthrax vaccine.
The FDA in December 2003 approved the first-generation vaccine, developed in the 1950s, without the requisite period for public comment, District Judge Emmet G. Sullivan ruled on 27 October.
Since 1998, more than a million soldiers have been vaccinated—and hundreds disciplined for their refusal—amid lingering questions about the vaccine's efficacy against inhalation anthrax and widespread complaints of long- and short-term side effects. In March 2003, six soldiers sued the government, saying they were being forced to take an experimental drug in violation of federal law. Sullivan agreed, and ruled to halt the program (Nat. Med. 10, 112; 2004), but reversed his decision just eight days later. —BD
Generics manufacturer withdraws AIDS drugs
The Indian generic drug company Ranbaxy in November pulled its AIDS drugs from the market after discovering that its documentation of tests comparing the drugs to brand-name versions was flawed.
The company—the world's largest generics manufacturer by sales—says it is conducting new studies on the seven recalled drugs, and says the first tests will be complete by December. In August, the World Health Organization dropped three of Ranbaxy's AIDS drugs from its list of approved medicines because the laboratories testing them were deemed substandard (Nat. Med. 10, 885; 2004).
The move is a setback for plans to provide millions of AIDS patients in the developing world with affordable drugs. US-funded AIDS relief programs have insisted on distributing more expensive brand-name drugs, arguing that generics may be unsafe. —AK
FDA set to overhaul drug safety, marketing
The US Food and Drug Administration (FDA) on 5 November announced a plan to revamp how it monitors the safety of marketed drugs.
The agency has asked the Washington, DC–based Institute of Medicine to review its drug safety system and its relationship with drug companies. The FDA also plans to appoint a director for the Office of Drug Safety, develop guidelines for both drug companies and regulators on detecting drug risks, and create a way for researchers to resolve internal disagreements.
The announcement comes in the wake of criticism over the agency's handling of safety data for antidepressants and for Merck's antiarthritis drug, Vioxx (Nat. Med. 10, 1149; 2004). In both cases, a congressional committee accused the FDA of ignoring the safety concerns voiced by its own scientists.
In a separate initiative, the FDA and its European equivalent, the European Medicines Agency (EMEA), have signed a confidentiality agreement allowing them to exchange information about drug approval. Beginning in January 2005, the two agencies—which approve the vast majority of the world's drugs—can exchange data from new drug applications and post-approval studies and the results of manufacturing plant inspections. —AK
Spain loosens reins on stem cell research
The Spanish government on 29 October passed a law easing restrictions on embryonic stem cell research.
The government intends to dedicate €100 million over four years to stem cell research, including establishing a regenerative medicine institute in Catalonia and a stem cell bank in Granada. The health ministry is also set to create a commission to evaluate stem cell–based research proposals.
Spain in 2003 legalized stem cell research on stored embryos originally obtained for in vitro fertilization, but did not create a mechanism to authorize specific projects. The new legislation stipulates that researchers must specify which embryos they will use, obtain consent from couples who donated the embryos and make publicly available any cell lines developed from the embryos.
Some previous restrictions—such as the prohibition on using embryos stored for less than five years—will continue to hold. But the new legislation eased limits on the number of embryos that could be created for fertility treatment. The ruling came one week after the United Nations member states chose to delay the vote on an international consensus on cloning for the third year in a row. —AK
Malaria drugs in short supply
Skyrocketing demand for the Chinese herbal drug artemisinin, adopted as a first-line malaria treatment by nearly 40 countries over the past three years, has led to a supply shortage projected to last through March 2005, the World Health Organization (WHO) announced in November.
The WHO in 2001 commissioned Swiss drug giant Novartis to provide an artemisinin-lumefantrine cocktail to the poorest malaria-endemic countries at cost. But just over half of the 4.5 million treatment courses ordered through March will now be available, the WHO says. Novartis officials say they are conferring with Chinese suppliers to address the shortages. Meanwhile, the WHO is advising African health ministries to procure more second-line quinine-based drugs.
The WHO first endorsed the artemisinin treatment in 2001, but in January 2004, an international group of scholars criticized the WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria for continuing to fund treatment schemes that rely on conventional chloroquine-based drugs (Lancet 363, 237; 2004). The agencies strengthened their endorsement of the newer, but more expensive, treatment course; 18 countries have switched to the artemisinin-based combination therapies this year, and global demand for 2005 has been projected at 60 million 12-dose treatments.
Artemisinin is extracted from wormwood, cultivated only in China and Vietnam. Drug companies have been hesitant to develop artemisinin-based therapies that—as derivatives of a plant—are difficult to patent. —BD
News briefs written by Alla Katsnelson and Bruce Diamond
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News In Brief. Nat Med 10, 1269 (2004). https://doi.org/10.1038/nm1204-1269
Nature Medicine (2005)