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).