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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 07-06-2006

New AIDS Pill to Treat People in Poor Countries
The New York Times, 7-6-06

Editor's Notes:

The FDA has approved a new generic triple combination AIDS drug to be used as part of President Bush's initiative against AIDS in the Third World.

After a wave of initial criticism, the program has alleviated activist concerns that the president's program would be a financial boon for American drug companies and yet fall short of providing needed treatments for victims of the AIDS virus in the world's poorest nations. The program has used generic drugs while at the same time insisting that the drugs pass through an expedited FDA approval process.

At the time, many Bush administration critics feared the money would be reserved for expensive American and European brand–name drugs. But, defying those expectations, the program in May 2004 began buying generics and now pays for 24 generic formulations, including liquid solutions for infants. Also, the major Western companies dropped their prices for poor countries, sometimes as low as the prices of generics.

However, rather than subscribing to the World Health Organization's drug-approval process, the president's program requires separate F.D.A. approval, which has caused delays, even though the agency created a fast-track process and waived its large fees.

Critics should not, however, focus too much on the perceived shortcomings of the FDA process. In late 2004, the WHO withdrew seven generic drugs after key documents purporting to show their effectiveness were shown to be inadequate. The expedited FDA approval process ensures that these newly released drugs will reach poorer victims without the threat of sudden withdrawal.

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Doctors Group Declares War on Drug Ads
Orange County Register, 7-6-06

Editor's Notes:

The American Medical Association recently called on the FDA to enforce stricter regulations on direct to consumer drug advertising, which they insist causes patients to pressure doctors into prescribing unnecessary or expensive medicines. The AMA proposed a waiting period before direct to consumer advertising can begin during which doctors could investigate the drugs and their potential benefits and side–effects:

"Doctors just want to make sure they have a chance to get up to speed on new drugs before the patients are being urged to seek these medications because of heavy advertising," said Dr. Ron Davis, the association's president–elect. The ads can disrupt the patient–doctor relationship and contribute to rising health–care costs when patients insist on receiving new, more expensive drugs, said Davis, who works in the Henry Ford Health System in Detroit.

The drug industry's lobby, Pharmaceutical Research and Manufacturers of America, is opposed to a mandatory waiting period for drug ads. The lobby has voluntary guidelines encouraging drug companies to educate doctors and submit ads to the FDA for approval. In response to the medical association's ruling, the lobby released a statement that reads, in part: "Direct–to–consumer advertising provides doctors and patients with accurate, educational information about disease and treatment options."

Davis acknowledged that drug advertising can raise awareness and encourage communication between doctors and patients, but added that tighter regulations are necessary. "We hope that the FDA will step forward and show leadership in this area," Davis said. "If that doesn't happen then legislation may be needed to make it a requirement."

Although the AMA insisted that direct-to-consumer advertising increases pressure on doctors to prescribe unnecessary medicines, FDA studies have shown that although doctors report that patients ask more questions about heavily advertised drugs, doctors also believe that patient interest creates a better doctor patient relationship. Studies also show that over half of doctors did not feel at all pressured to prescribe the requested medicine and when the drug was prescribed it was the best option for treatment of the patient’s condition.

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Global Vaccine Initiative Hits Snag
Wall Street Journal, 7-7-06

Editor's Notes:

Political wrangling threatens to hold back a plan by G–8 governments to stimulate new vaccine production by pharmaceutical companies. This article provides a good look into the economic issues and political actors involved in the effort to create "advance purchase commitments" for vaccines where market incentives may be weak. These issues are expected to come to a head during the upcoming G–8 conference, where three new drug–finance plans are expected to be debated.

G-8 officials say that drug companies, although initially skeptical, have rallied behind the idea. "They're ready to give this a go," said the official familiar with the G–8 discussions.

The plan aims to address a problem in global drug markets: The countries that most need new treatments for diseases such as AIDS and tuberculosis are those that can least afford to pay for them. An Italian Finance Ministry paper concluded last year that poor financial prospects have made drug companies reluctant to develop vaccines aimed at diseases found mostly in developing nations.

Under the advance market commitment plan, the G–8 would guarantee a subsidy—valued at $800 million to $6 billion depending on the disease—for any company or companies that produce vaccines that meet agreed–upon safety–and–efficacy standards. Once the donors spend that initial subsidy, the pharmaceuticals companies would discount the vaccine sharply for developing–world customers.

"All of the technical work that can be done on an abstract level has been done," said Orin Levine, an epidemiologist who works on pneumococcus vaccines at Johns Hopkins University in Baltimore. "It's time to just commit, to take that step and move into the first stage, which is negotiating the first–ever advance market commitment for a vaccine."

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Fighting Diseases with Checkbooks
The New York Times, 7-8-06

Editor's Notes:

This recent New York Times article examines the benefits and potential pitfalls of medical research funded by private individuals. Warning against too much private discretion over research funds, the article argues that public or international research institutions can better determine fund allocation and research areas.

Wealthy individuals, through their philanthropies and the causes they support, like Michael R. Milken for prostate cancer and Michael J. Fox for Parkinson's disease, are a growing force behind medical research these days.

And with the largess comes concern about a potential overreliance on the generosity of the wealthy.

"To rely on a few philanthropic organizations, however rich and well intentioned they are, does present significant risks," said Nicolas de Torrente, executive director in the United States for Doctors Without Borders, which provides health care in developing countries.

The spotlight on the Bill and Melinda Gates Foundation, which experts say is already setting much of the world's agenda when it comes to fighting diseases in developing nations, has brought such concerns to light. The foundation was helped greatly last week when Warren E. Buffett said that he was giving the foundation $31 billion, most of his fortune. The gift will double the foundation's assets.

The world is fortunate that Mr. and Mrs. Gates are focused on health problems of the developing world, Mr. de Torrente said. But, he added, "What happens if they change their mind or de-emphasize something?"

He said there needed to be an institutionalized multinational system to assure such research takes place. The World Health Organization, at its meeting in May, took some initial steps to start planning such an effort.

Although the Times article advocates greater control of research and funding by international governmental organizations, it fails to note the downsides of these groups. Privately run funds can be more efficient and more determined, because they have to answer to their donors for the efficiency of their projects and administration. It is much harder to evaluate governmental groups like the WHO or the USAID, who tend to operate through opaque bureaucracies. A recent article by Roger Bate, sheds light on the problems of internationally run government groups. Bate castigates the World Bank’s efforts to eliminate malaria, which have been inefficient and unsuccessful—and have cost countless lives. Any private institution with that track record would have been subject to relentless media criticism, if not legal prosecution.

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