Looking at the Evidence for New Drugs

Recent headlines about Vytorin, a drug prescribed to millions of patients to help lower cholesterol levels, raise questions about FDA drug approvals and benefits to patients. After years on the market, studies revealed Vytorin does not prevent heart attacks or strokes, as it was intended to do.

The Vytorin results follow on the heels of other drugs that had been prescribed for patients, were later found to be harmful, and were pulled off the market. The abrupt withdrawals of Vioxx, Rezulin, Baycol and others left doctors and patients reeling.

Why were these drugs approved by the Food and Drug Administration (FDA) to begin with if they didn’t work, or were dangerous?

Unfortunately, the FDA may approve a drug without knowing that problems exist. Its own approval process for reviewing new drugs does not require manufacturers to reveal everything they know. Recent cases have shown that negative drug study results have sometimes been withheld by manufacturers seeking approval for new drugs.

Knowing it’s possible a drug can be prescribed that may harm us, or simply won’t be helpful, means we need to be that much more cautious when we are given a new prescription.

To be clear, I’m not talking about a drug’s known side effects or contra-indications. Your doctor should be aware of those, and they will be documented in the drug’s literature. But there may be problems your doctor is not aware of because the manufacturer has not made them available to professionals or the public.

If your doctor prescribes a drug that’s new to you, ask her how long it has been available. If the drug is generic, or has a generic version, then it will already have a well-documented track record.

If the drug is too new to have a generic version, then make sure it has at least a two or three year history to draw from. You can do an Internet search to see if anyone has raised questions about its safety or effectiveness.

If the drug is newer than two or three years, then ask your doctor to help you weigh the pros and cons, knowing that it’s possible neither of you will know about possible negative outcomes.

Does all this sound a bit paranoid? Perhaps. But knowing the FDA isn’t holding manufacturers accountable means we patients need to be smarter to stay safe.