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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 10-06-2006

$1 billion would go toward developing bioterror remedies
The San Diego Union-Tribune, 10-6-06

Editor's Notes:

According to many experts, Project Bioshield—the program Congress created in 2004 to spur private sector research and development into countermeasures against potential bioterror attacks—has floundered in a sea of bureaucratic red tape.

Project BioShield was Congress' response to the anthrax attacks of 2001, which killed five people. The measure, passed two years ago, gave the government $5.6 billion for the procurement and stockpiling of treatments in case of another bioterrorist attack.

It was also supposed to create the incentive for the pharmaceutical industry to invest in the development of products that otherwise would not have a market—most people aren't going to buy an anthrax treatment until immediately after an anthrax attack.

Project BioShield was also supposed to allow companies to circumvent some regulatory requirements because the products cannot be tested on healthy humans. Biotech executives also contend the government was supposed to take risks, committing funds to buy drugs that seemed promising, not drugs that were proven safe and ready for production. The results have been lackluster at best.

The money wasn't big enough enticement to attract interest from Big Pharma. However, much smaller and often-unproven biotechnology companies, including Aethlon, Safe Life, Isis, Invitrogen and Hollis–Eden in San Diego wanted to meet the challenge.

"But HHS didn't put out enough procurements fast enough," Rapoport said. "During the last two years they've made only 10 or 12 procurements, mostly in the smallpox or anthrax area. They haven't spent all the money and this money wasn't supposed to last 10 years. You are supposed to spend it and then go back looking for more."

Congress wants to solve some of these problems with legislation that would make $1 billion of Project BioShield money available to biotech companies for research, long before they have a product ready for government procurement.

Last week, the House passed the measure commonly referred to as BARDA, which would create the Biomedical Advanced Research and Development Authority. It now is being considered by the Senate and is tentatively scheduled to be brought to the floor for a vote in November, according to the staff of Sen. Richard Burr, R–N.C., one of its sponsors.

Worries about mass casualties from bioterror attacks have so far–thankfully–proven unfounded, in part because it is still much easier for terrorists to buy and deploy guns or bombs than say, smallpox. But it would be much better to have a stockpile of products on hand in case terrorists make a quantum leap in sophistication, and that stockpile isn't going to develop without a better strategy from federal agencies. Stay tuned for additional developments.

[permanent link]

Pay Organ Donors, Experts Suggest
, 10-6-06

Editor's Notes:

Patients in need of organ donations routinely die on waiting lists for the relatively few organs other people have voluntarily donated—leading to a large and growing black market in organ sales. Thankfully, there is a solution: creating a regulated market with appropriate safeguards and compensation for prospective donors. In this article, a prominent American academic defends the concept in the British Medical Journal.

People should be paid for living organ donations, a US surgeon has said in an article in the British Medical Journal.

A regulated system for paying donors for organs such as kidneys would help solve the "desperate" need for organs, Professor Amy Friedman writes.

Prof Friedman, from Yale University School of Medicine, believes the system would prevent exploitation.

But British experts warned such a scheme would still exploit the most vulnerable members of society...

[Friedman argues that setting] up a regulated system of compensation for living donors is not against current medical practice, as other body parts such as eggs, semen and hair, are already on sale in the US and patients are also paid for participating in medical research, she argues.

"Bringing these activities out of the closet by introducing governmental supervision and funding will provide equity for the poor, who will get equal access to such transplant," she said.

She said any laws would have to be policed, probably by the government, with a balanced oversight board comprised of medical and transplant professionals, as well as representatives of patients, donors and social workers.

Critics who argue that a market for organ transplantation is de facto exploitive of the poor take the worst-case scenarios and assume that such scenarios prevail in all cases. Governments routinely allow individuals to risk their life and limbs in particularly dangerous occupations, such as service in the armed forces or coal mining, provided that appropriate safeguards are in place and fair remuneration is offered to volunteers. Organ donation seems to be a similar case.

[permanent link]



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