How effective is your medicine? If you are like most of us, you have no idea. What’s worse, neither does your doctor.

FDA approval is a little misleading. Although the law requires that all medicines be proven “safe and effective,” no one has really defined effective.

The agency demands that the drug under review perform a specified task–lower blood pressure or cholesterol, for example—better than a sugar pill. That doesn’t tell you whether the medicine does anything more meaningful, such as prevent a heart attack or help you live longer.

When people buy a new car, they expect it to work every time they turn it on. If it doesn’t get them to their destination without a breakdown, they will be back at the dealer the next day demanding it be repaired under warranty.

Drugs, on the other hand, do not come with warranties. If people applied the same criteria to their medicine as they did to other consumer products, they would be surprised at how poorly drugs performed.

Treatments for nail fungus are pricey. A prescription nail lacquer called Penlac costs almost $200 per bottle. It must be applied every day for almost a year. One pharmacist estimated that this could take as many as six bottles, for a price tag of over $1,000. Insurance companies don’t always cover the cost.

For this investment, you would anticipate extraordinary success. A TV which cost that much should work every time for years.

Penlac, on the other hand, provides a complete cure of nail fungus from 5 to 8.5 percent of the time. According to the company’s own data, only 10 people out of 119 achieved a complete cure of their nail fungus using Penlac daily for 48 weeks.

Compared to nail fungus, hypertension, diabetes and heart disease seem a lot more serious. Patients are told that taking their medicine is critical to preventing bad consequences such as heart attacks, strokes and early death.

People with high cholesterol read that Lipitor lowers the risk of a heart attack by 36 percent. But according to the company: “That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

In other words, if 100 people took Lipitor and another 100 people took an inactive placebo, there would be one less heart attack among those on Lipitor after about three years. If you had to pay $120 a month for three years, you might want a better than 1 in 100 chance the drug would really protect you from a heart attack.
Earlier this year, a large study to find out how well diabetes drugs prevent the complications of the disease was stopped because patients were not benefiting. The drugs were lowering blood sugar just as they were supposed to, but patients under the most intensive treatment were more likely to die. Doctors had expected that these patients would be more likely to survive.

People with heart disease and diabetes need to take their medicine, of course. But shouldn’t we all know more about the effectiveness of our medicines? For a fascinating analysis of this controversial issue, we recommend a new book by Nortin Hadler, MD: Worried Sick: A Prescription For Health in an Overtreated America (UNC Press).

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  1. Caren L.

    Thank you for helping out with this excellent info. “If you would convince a man that he does wrong, do right. Men will believe what they see.” by Henry David Thoreau.

  2. merv s.,D.C.

    as a retired D.C. I would like to comment that I believe our health is depended on what we eat- but I have never heard of M.D. ask this question on their first visit- his only concern appears to treat the symptom. not the cause. I am 87 and take no drugs, but would if all alternative methods failed,

  3. wrj

    Restasis for dry eyes also a joke. Must use six months before you know if it works. ( It doesn’t.) Constant barrage of adverts from the company and Caremark in concert. One vial per application but doc says use it twice. Shame on FDA.

  4. Suzanne

    Many of the medications used to treat my daughter’s juvenile rheumatoid arthritis come with black box warnings or are not approved by the FDA for use in children. How can a parent decide if a benefit outweighs the serious risk, when the information from the studies is so complicated? It is easy to see how many children had adverse events, but good luck figuring out how many got better.

  5. Barbara S.

    After estrogen-positive breast cancer, an aromatase inhibitor such as Femara is often prescribed. At $200 per month, it replaces Tamoxifen, the older favorite for reducing estrogen levels, which costs about $25 per month. Careful reading of the enclosed information indicates that the “better” new drug is only very marginally better.
    Is it worth it? It was not to me, because of side effects seldom discussed. It caused painful joints and muscle misery that made it very difficult to sleep. These ended at once when I stopped taking Femara. Yet, most oncologists now favor the new drug and believe it’s better for their patients, probably because the sales reps push it so hard and docs don’t always have time to read the fine print.

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