Selling drugs to healthy people could mean billions for the drug industry

Selling drugs to healthy peopleThe FDA just gave AstraZeneca its blessings to add 6.5 million healthy people to its rolls of patients taking Crestor, a statin drug, as a preventative even if they do not have high cholesterol. That means health insurance will pay $3.50 per pill for all these millions of people until at least 2016, when generics can be sold.

Drug companies are already making billions on cholesterol lowering drugs, even though some question their widespread use. Some wonder whether the hype about cholesterol is a myth and taking statins actually poses a health risk. In fact, in February, the British medical journal The Lancet published a study linking statin drugs to diabetes risk. Does it make any sense to use a medication as a preventative for people who don't currently have high cholesterol and risk exposing them to diabetes?

Diabetes is not the only potential disorder tied to taking statin drugs. The most common side effect of these drugs is muscle pain and weakness, but questions have also been raised about links to peripheral neuropathy and interference with the production of Co-Q10, which can lead to congestive heart failure. Statins also have been linked to cognitive problems, especially in elderly patients. Rodent studies have shown a link to cancer, but so far an increase in cancer rates in people have not been linked to statins.

Yet even as these studies mount, cholesterol lowering statins are taken by 40 million people, with double that amount already meeting the current cholesterol guidelines. Those guidelines have taken in more and more people every year. For example, 25 to 30 years ago, cholesterol lowering drugs were recommended for middle-aged men with cholesterol levels over 240 and other risk factors, such as smoking or being overweight. After a Cholesterol Consensus Conference in 1984, the levels were lowered to 200 and women were added to the mix. Just recently, they were lowered again to 180. Many times, these standards were expanded with advisory panels whose members are paid for their consulting by the drug industry.

The idea of prescribing statin drugs to healthy individuals as a preventative measure is "going overboard," Dr. Kirti Kalidas of the Center for Natural and Integrative Medicine told me in an interview. "I don't know how they can justify using it," he added. Dr. Kalidas believes life changes should be the first method of treatment, including changes in diet, weight reduction and exercise, before drugs are even prescribed. He also thinks people get a "bigger bang for their buck" by using fish oil rather than expensive prescription drugs.

The FDA used a study paid for by AstraZenaca, which sells Crestor, and conducted by Dr. Paul Ridker, a Harvard medical professor and cardiologist at Brigham and Women's Hospital in Boston, to make its recent decision about Crestor. He tried to sell the study idea to the National Institutes of Health and at least two other drug companies before AstraZenaca took the bait. The basis for the study is a blood test Ridker developed called high-sensitivity C-reactive protein, or CRP. He gets undisclosed royalties each time the test is used.

The study tests the level of inflammation in the body, but inflammation can be caused by problems not even related to heart disease, Dr. Kalidas explained. He thinks it's wrong to add statin drugs as the "first line of treatment," when the CRP test shows higher levels of inflammation.

The study showed that the risk of heart disease was cut in half, but in absolute terms there was a difference in the study groups of just 2 out of 1,000 people. Critics say 500 healthy people would need to stay on statin drugs for the rest of their lives to avoid one survivable heart attack. Is their exposure to other diseases worth the risk? Should billions be spent on drugs for healthy people that might better be used to treat other people who are sick?

As we are looking at ways to reduce the ever-growing health care bill, why is the FDA rushing to approve a drug that will need to be taken by healthy people for the rest of their lives? Don't we have better ways to spend our limited heath care dollars?

Lita Epstein has written more than 25 books, including The Complete Idiot's Guide to Social Security and Medicare and The Pocket Idiot's Guide to Medicare Part D.

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