June 11, 2007

Drug Approval: Diabetes is NOT Advanced Cancer

A friend of mine took a wonderful drug last year. It gave him at least 3 heart attacks and put him into intensive care for more than a month. Another friend took a terrible drug. It raised his risk of dying of a heart attack.

Why is one drug that guarantees a heart attack good, and the other that only raises the risk of one bad?

Because of what the drug was prescribed for. The first drug was wonderful because it was given to treat Stage IV melanoma a, cancer which usually kills the patient within six months of diagnosis. There is currently no other drug treatment that works for State 4 melanoma at all. My friend is still alive and in what looks like good health 18 months after treatment with the drug that gave him his heart attacks. Because of the damage the drug did to his body, he knows he is not likely to live to be 80, but he may live to be 50, and for someone who was given 6 months to live almost two years ago, that is good enough.

The second drug was terrible because it was given to treat the high blood sugars caused by Type 2 Diabetes. Type 2 Diabetes can be fatal, but a diabetes diagnosis is not a crisis. It usually takes anywhere from 10 to 30 years of exposure to elevated blood sugars before diabetes kills its victims. If the patient can their blood sugars down into the normal range, they can live as long as anyone else. And many people do.

Unlike the case with the cancer drug, there are safe existing drug treatments available to patients with diabetes that work well and do not have the cardiac risk presented by the terrible drug. There is even a well-documented non-drug treatment for Type 2 diabetes, cutting the carbohydrates way down and adding exercise, that for many people works even better than the terrible drug and has no side effects. The only reason to take a new drug for Type 2 Diabetes is if it is safer and more effective than existing treatments. Any drug that worsens health in any way is not a good drug for this disease, because there are drugs that improve it already available.

Patients can tolerate side effects, even dreadful side effects, if a new drug may save their lives in a situation where they are otherwise facing certain death. It makes sense for the drug regulators to hurry a drug into production if it looks like it may provide even a few extra months to someone who is has no other options.

But the criteria for approving a drug intended to save a life where there is no successful treatment should be very different from those used to approve a drug for a chronic but not immediately life-threatening condition. Especially since drugs for chronic conditions are meant to be taken every day, week after week, year after year, so that over time the potential for side effects becomes much, much higher.


There needs to be different criteria for approving a drug intended to treat a fatal condition for which there are no effective treatments than there are for approving a drug meant to treat a chronic survivable, condition like arthritis or diabetes which may last for decades.

If there IS an effective treatment for a chronic condition, the drug company must be forced to prove that a new drug is both more effective and as safe as the existing drug.

The current FDA drug approval process does not ask that drug companies prove their drug is better in controlling symptoms than drugs already on the market. It only requires that the drug perform better than a sugar pill. It does not ask drug companies to show that their drug is safer than existing, effective treatments.

As a result, we are seeing new treatments brought to market, like Avandia, Vioxx, and Januvia that are not any more effective than existing treatments, but which have much higher risk profiles--or, as in the case of Januvia, risk profiles that are unknown because no research has been done to identify the subtle, but possibly serious, long-term side effects caused by inhibiting the action of an enzyme used throughout the body.


Once a new drug is approved for a condition where an existing, effective drug exists, it should be prescribed only after patients have tried the known, proven drugs for this condition.

The FDA should institute rigorous follow up tracking of the drug. Each new patient put on a drug should be required to file a report after three months of taking the drug listing any side effects they have experienced with the drug. Doctors should be required by law to perform any test that the drug prescribing information suggests.

The current aftermarket tracking system current system makes it so time consuming to report a side effect that doctors rarely do it, and few patients even know that they can report a side effect. That is why it takes five or more years for serious side effects to surface, though thousands of patients have been experiencing them all along.

After the drug has been on the market for a year, the FDA should require investigation of any side effect that is reported by a significant number of patients. The side effect tracking should continue until the drug is five years old.

By forcing patients to report side effects of brand new drugs, the FDA would be giving patients the message, "This drug is new, its effects are unknown, and yes, you are a guinea pig." If patients know this and are willing to take the risk the new drug represents, fine. But they won't be, as is the case now, taking new drugs in the naive belief that their dangers are already understood.


Finally, drug companies must be prevented from promoting new drugs by claiming they do things that are not proven by high qualify research that has been carefully examined. The makers of Avandia and Actos should have been prohibited, by law, from claiming that their drugs rejuvenated beta cells. The makers of Byetta and Januvia should face the same prohibition, until that effect has been conclusively proven by research.

Most of the most dangerous drugs have been promoted by well-financed drug company campaigns that told doctors that their drugs did highly desirable things they turned out not to do. Doctors, alas, do not have time to investigate the research on which such claims are made. If drug companies were prevented from marketing their drugs to doctors with these inflated claims, doctors would be a lot less likely to prescribe new drugs until they were better understood.