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| Archive : Winter 2007 |
RADICAL VISION:
A cocktail of cardiovascular drugs // Recommended for everyone over 55 // No prescription necessary // No need for a doctor’s oversight // The brainchild of overly ambitious would-be pioneers, or truly
the world’s next wonder drug?
The Polypill [page 4]
 By Rachael Moeller Gorman |
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All the trials will also look for adverse effects of taking drug combinations. The potential for such problems was a major issue for the CDC group, which was concerned about the possibility of aspirin producing serious adverse effects, mostly because of hemorrhage. Statins can also trigger serious side effects, including rhabdomyolysis (muscle breakdown) and liver failure from hepatitis, but problems are exceedingly rare—in the United States, rhabdomyolysis occurs at a rate of one per 10 million prescriptions, and in 13 years the Food and Drug Administration has recorded only 30 cases of liver failure because of statins. Side effects of the blood pressure drugs include cough, changes in sexual function and adverse blood levels of potassium, glucose and uric acid.
“We’re not certain yet—because we haven’t had any randomized, controlled trials—of the real side effects of putting all five drugs together,” says Lawrence Green, co-chair of the CDC panel. “But side effects are a potentially ominous issue, particularly if you’re not going to monitor people taking the pill.”
Still, if the secondary prevention studies find that the Polypill is both safe and an improvement over taking each drug individually, researchers could then move on to trials for primary prevention. The CDC group saw great potential in treating people before they’ve had cardiovascular problems, and the members were open to using the Polypill as its inventors envision, as an over-the-counter, safe-for-everyone pill.
“Is there sufficient benefit to be derived for the one-third of the population who will benefit to put two-thirds of people on a regimen that won’t do anything for them?” asks Green. “I would say yes—one-third of the population benefiting with minimal risk to the other two-thirds is very substantial.”
In Wald’s best-case scenario, the Polypill should be available for general use within 10 years. Getting such a complex combination drug approved in the United States could be difficult—drug patent laws in other countries are more liberal (or, in some cases, nonexistent), and the rules for drug trials also favor quick approval. Pharmaceutical companies in India are already making versions of the Polypill for the Australian and New Zealand trials, and many proponents of the drug combination, including the World Heart Federation’s Valentin Fuster, think developing countries are where the Polypill may do the most good.
According to the World Health Organization, some 80% of worldwide cardiovascular deaths now occur in low- or middle-income countries, and by 2010 cardiovascular disease will be the leading cause of death in developing nations, thus overtaking communicable diseases. An inexpensive, widely available Polypill that requires few medical resources might be particularly helpful in those parts of the world.
In the United States, patents have already expired or will soon lapse on many of the drugs, making it easier to combine them into one pill, but the FDA will still require trials to determine whether the combined drugs are safe and at least as effective as taking them individually. And all of this assumes there will be drug companies interested in developing Polypill drugs from generic components that may not generate large profits. But if the drug eventually is taken by a significant fraction of the world’s population, the benefits could be huge.
Here’s how Wald and Law sum it up in their original paper: “The preventive strategy outlined is radical. But a formulation that prevented all cancer and was safe would undoubtedly be widely used, and one that prevented more than 80% of cardiovascular disease would be even more important, because such deaths are more common than cancer deaths. It is time to discard the view that risk factors need to be measured and treated individually if found to be ‘abnormal.’ Instead it should be recognized that in Western society the risk factors are high in us all, so everyone is at risk; that the diseases they cause are common and often fatal; and that there is much to gain and little to lose by the widespread use of these drugs.”
Now, with a spate of trials beginning, the team members are confident their Polypill is about to be validated. Someday soon, they believe, it could prevent thousands of needless deaths each
year.
 Dossier
1. “A Strategy to Reduce Cardiovascular Disease by More Than 80%,” by N. J. Wald and M. R. Law, British Medical Journal, June 28, 2003. In the paper that kicked off the controversy, Wald and Law make the kind of grandiose claims that staid scientific papers typically eschew.
2. “The Polymeal: A More Natural, Safer, and Probably Tastier (Than the Polypill) Strategy to Reduce Cardiovascular Disease by More Than 75%,” by Oscar Franco et al., British Medical Journal, December 18–25, 2004. With stern warnings against possible adverse effects of the Polymeal (garlic could ruin a romantic rendezvous, redundant cardiologists could be retrained as Polymeal chefs), this satirical yet scientific paper is an enjoyable read.
3. “The Polypill: At What Price Would It Become Cost Effective?” by Oscar Franco, Ewout Steyerberg and Chris de Laet, Journal of Epidemiology and Community Health, March 2006. Franco is back—this time calculating the maximum annual price at which the Polypill would be cost-effective as a primary prevention of cardiovascular disease. The finding: $389 to $528 per high-risk man aged 50 to 60 years.
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Illustrations by Christoph Niemann |
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