— Imagine a single pill that could lower not only cholesterol, but also blood pressure and the risk of heart disease and stroke, all at the same time.
That's what a new study is proposing: a "polypill" that could reduce cardiovascular disease by more than 80 percent. Could this be the "magic bullet" towards a cure?
A Provocative Proposal
The authors of the study, published today in the British Medical Journal, claim that such an intervention would have a "greater impact on prevention of disease in the Western world than any other known intervention." The study was written by researchers at Queen Mary's School of Medicine and Dentistry at the University of London.
The strategy is to combine many of the most well-known medicines into one cheap and safe pill. The ingredients of such a polypill would contain aspirin, a cholesterol-lowering statin, three blood pressure-lowering agents in half dose, and folic acid.
The drug would be targeted to people with vascular disease and those over the age of 55.
To come up with the components for their polypill, the researchers analyzed data from more than 750 trials with 400,000 participants. The goal was to simultaneously reduce four cardiovascular risk factors and find the best ingredients to achieve that.
Based on their results, the scientists estimated that such a pill would reduce heart disease and risk of stroke by more than 80 percent, while causing withdrawal symptoms in two per 100 people and fatal side effects in less than one in 10,000 users.
The implications for such a drug are enormous. Since many of the polypill's components are common, it could be made from generic drugs, likely making it easy to produce.
Patients who take multiple pills or forget to take all their pills would also probably prefer an all-in-one pill, if it could do the same job with few side effects.
The combination treatment would also have enormous potential for developing countries, where cardiovascular disease is on the rise and multiple drugs can be expensive and more difficult to deliver, medical experts said.
But some doctors and experts say not so fast.
"Both the concept and the likelihood that someone is likely to try this scare me to death," says Thomas Schwenk, chair of the Department of Family Medicine at the University of Michigan. "This almost sounds like an April Fool's Day article in the Journal of Irreproducible Science."
The main problem, according to critics of the polypill concept, is that the polypill challenges the idea of individualized medicines with its one-size-fits-all approach.
Some drugs, such as those used to control blood pressure, must often be catered specifically to the needs of each patient. A standard polypill, they argue, would not take into consideration such factors and could also make it difficult to deal with the individual and combined effects of each component.
"Patients differ in their need for, and tolerance of, medications. The one-size-fits-all mentality does not work when you are dealing with individual patients. In addition, while each therapy has benefit, it is not proven that the combination would be additive in its effect," said Richard L. Page, cardiology head at the University of Washington School of Medicine.
"This is a joke, right?" added David C. Miller, a physician at the Cabarrus Family Medicine clinic in Concord, N.C. "In medicine and most other branches of science, it is not permitted to say "If A is good and B is good, that proves that A + B will be good also."
Scott Grundy, director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center, said simplifying regimens by combining pills is a nice concept. "On the other hand, there is a problem with dosing. The polypill idea pretty much ignores the dosing question, which I think is a problem," Grundy said.
Some physicians also question the analytic approach taken by the researchers, and ask for more clinical trial data before making claims. Others fear that widespread use of a polypill would oversimplify medicine, undermining the doctor-patient relationship and promoting the idea of a "magic bullet" drug, making patients think they can just take a pill to take care of poor diet or unhealthy habits.
Richard Smalling, professor of cardiovascular medicine at University of Texas Medical School in Houston and Medical Director of Memorial Hermann Heart Center, says that while the polypill is a serious idea that merits exploring, "It might also give [patients] false hope that if they had chest pain, they could take the pill and their problem would magically go away, eliminating the need to see a doctor."
Long Road Ahead
The polypill faces a steep battle if it is to gain support in the United States, some experts said. "The barriers are many — the pharmaceutical industry, regulatory agencies, scientists with industry-friendly agendas etc.," said Curt Furberg, a pharmacologist and a professor at Wake Forest University.
Others noted potential legal implications from the use of such a drug, citing concerns that patients may sue if they suffer unexpected side effects.
Perhaps the biggest challenge to the polypill is one that physicians have struggled with for years. "Can you expect people to take the pill and still be committed to stop smoking, exercise, maintain an ideal weight, and avoid high fat intake?" Smalling asks.
Despite the criticism and the challenges, many experts still agree that the idea is not as crazy as some may think. They say there's a need for more discussion and debate within the academic community.
Combination drugs are not a new area of debate. The FDA has already approved a combination pill of the cholesterol-lowering pravastatin and aspirin, and others may be on the way. The editors in the British Medical Journal recommend widespread debate on the study's proposed paradigm.
"It will be controversial and create a lot of discussion which will lead to more people getting treated. It's all theoretical at this time, but most great things start that way," said Kevin J. Graham, director of preventive cardiology at the Minneapolis Heart Institute.