|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 06-13-2005
How Safe Are Your Drugs? Not Enough, Some Say
There a ghost haunting the FDA: the ghost of thalidomide.
The FDA, politicians and the public are terrified by the 40-year-old specter of an apparently safe drug that caused birth defects in many patients who took it. As a result, the FDA places a premium on collecting as much information as possible regarding drugs before they are released, and much less effort on tracking the performance of drugs as they are actually used by doctors and patients.
But thalidomide doesn’t represent the central challenge facing the FDA today. Industry drug screening, often in early preclinical tests, is sophisticated enough to catch most serious common drug side effects. Consequently, the vast majority of prescription drugs used by Americans are remarkably safe. But no medicine is completely safe—and when millions of people take any medicine, some very tragic events will inevitably ensue. What are we to do, then,
…if a drug is good for some and bad for a few? That's the key question, says Dr. Jerry Avorn, professor at Harvard Medical School and author of the book "Powerful Medicines: the Benefits, Risks and Costs of Prescription Drugs..
Calls to increase premarket testing would probably not resolve this problem. It would just add to the costs and time involved in making new medicines, without necessarily making them any safer.
The FDA is on the right track, though: it is building more relationships with insurers and providers so it can access databases that follow individual patients and specific treatments. This is the best way to balance drug safety in large populations (which is generally good) with individual safety (where we need a lot more information).
WHO likely to miss “3 by 5” AIDS drug target
The biggest story of the week was the World Health Organization’s (WHO) admission that it is almost certain to fail to meet its “3 by 5” target – the plan to get 3 million HIV/AIDS sufferers onto antiretroviral treatment by the end of 2005. According to Jim Kim, director of the WHO's HIV/AIDS department:
"It is much slower than we thought," he told Reuters. "Three by the end of 2005 looks very unlikely." Kim could not say when the 3 million mark would be reached but was very hopeful it would be soon.
Left-leaning NGOs such as Action Aid immediately weighed in by claiming that the failure to meet the treatment targets was a result of a lack of ‘political will’. In fact, the failure of “3 by 5” was inevitable from the start, as it was an unrealistic target which incorrectly prioritized treatment over prevention.
Public health experts are virtually unanimous in concluding that prevention is of paramount importance in the fight against AIDS. The WHO’s “3 by 5” program, however, has lead to a skewing of resources away from prevention and towards the treatment of those who already suffer from the disease. As a result, new cases are piling up faster than they can be treated by dilapidated African healthcare systems. As such, the strategy of the “3 by 5” program is partly responsible for the increase in AIDS cases in Africa over the last few years.
G8, UN must act to get new AIDS drugs to poor – MSF
Unfortunately, many influential non-governmental organizations (NGOs) do not understand the incentives—i.e., profits—required for commercial outfits to risk billions of dollars on the research and development of new drugs. One NGO, Medicins Sans Frontiers – also known as Doctors without Borders – recently called for more developing countries to issue compulsory licenses in order “to head off a looming supply and cost crisis” of AIDS medicines. Worse, the NGO is calling on rich countries to compel their own drug companies to issue licenses to manufacture key medicines at firms located in developing countries.
Asking pharmaceutical companies to forgo profits at the whim of NGOs seems like the quickest and easiest way to end commercial research into the diseases of poverty completely. If you want to pay nothing for the next generation of AIDS drugs, nothing is what you’ll get.
Let’s hope saner heads prevail at the G8 this week and MSF’s bizarre proposals are roundly ignored.
43 ways to save the world
The Economist reports on the Gates Foundation’s recent decision to focus on developing 43 new technologies to combat disease in the poorest parts of the world. The proposals earmarked to receive some of Gates’ $450 million pot include innovative ways of delivering vaccines, improving nutrition and controlling insects. Some of the ideas on the table, for example, hope to find ways of creating needle-free vaccines that do not require refrigeration, and new ways of genetically or chemically controlling insects.
Certainly, such technologies would be a boon to mankind if they do make it into production. But, as The Economist notes, the fact that the product exists does not necessarily mean that it will necessarily reach those who need it:
How many of these ideas will translate into lives saved is, of course, impossible to say—and that is not only because of uncertainties about which of them will work. As the quest to deliver anti-retroviral drugs to poor people with AIDS shows, implementation is everything. Such drugs have been available for almost a decade, but only now are significant numbers of those who need them actually receiving them.
Diarrhea is one of the biggest killers of children under 5 in Africa today. Deaths can be easily prevented with cheap sachets of Oral Rehydration therapy. However, even simple technologies like these are not getting to those in need.
Perhaps, then, Mr. Gates’ grandiose scheme is missing the point: we need to create sustainable healthcare systems that get the basics right.
Gambia hails vaccination success
Despite the ongoing problems of delivering medicines to those in need in poor countries, well-organized vaccination programs can reap dividends. Perhaps the most successful program was Rotary International’s drive to eliminate polio in the 1980s.
Gambia can today report a more modest success – a vaccination program organized by the Global Alliance for Vaccines and Immunization (Gavi) has stopped the spread of Hib disease, which is a major cause of meningitis and pneumonia and kills nearly 500,000 people worldwide every year.
The study's author said it was remarkable that the disease was eradicated even though the doses were often given late, and almost a third of children did not receive the full course of vaccine.
Well done to all those involved.
South Africa falling behind in aids treatment, says WHO
The British medical journal The Lancet has singled out South Africa as being the biggest stumbling block towards meeting the aforementioned “3 by 5” target, a view tacitly echoed by the WHO itself:
"We are encouraged by the South African government's plans, but we think ... (it) could go much, much faster," [WHO HIV/AIDS director Jim Yong Kim] said during a telephone interview from Geneva.
The SA health minister later responded by arguing that the “3 by 5” target was set in Geneva without sufficient consultation with countries such as hers, and as such, failed to take into account the priorities and capabilities of each individual country.
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