IT makes for good medicine if doctors and patients know as much as they can about treatment options, including drug therapies.
Unfortunately, when it comes to prescription drugs, sometimes physicians and HMO executives know as much about a new drug as what they can glean from a white tablecloth lunch with the pharmaceutical rep.
Of course, there is the Food and Drug Administration, which is supposed to keep tabs on a new drug's effectiveness and side effects. But its lax enforcement of clinical drug trials has been borne out time and time again, most recently when the New England Journal of Medicine exposed a substantial increase in the risk of heart attacks associated with the oral diabetes drug Avandia. The Avandia disclosure - made outside the FDA's purview - follows other revelations about heretofore hidden potential side effects associated with popular, in-use prescription drugs Vioxx, Paxil and Zyprexa.
This month, the U.S. Senate woke up to the problem by passing a bill that empowers the FDA to better track the side effects of prescription drugs. But there is no guarantee that bill will make it out of Congress or see a presidential signature.
We need full disclosure here in California, where no one has to be reminded of the kind of business pharmaceutical companies generate.
Enter State Sen. Jack Scott, D-Pasadena, whose SB 606 will require drug manufacturers to release to the public the results of their drug studies. Scott's bill, which already cleared the state Senate Health Committee, is a good stop gap measure that could begin helping California consumers and physicians as early as Jan. 1. Under the bill, the clinical trial and the results - both good or bad - must be posted on the Internet. The public must have easy access to this site.
Today, patients consult the Internet for information about doctors, hospitals and drugs. But the clinical studies conducted by the drug manufacturers are unavailable - not even to doctors.
In the case of Vioxx, after the drug's manufacturer had found information of an increased risk of heart attack and stroke, it still was not ordered to make that information available to the public, testified Steve Blackledge of CALPIRG (California Public Interest Research Group, a consumer advocacy organization) at the hearing in Sacramento. In fact, Blackledge added, Merck continued to boast about the drug's effectiveness by putting out favorable press releases that did not mention the heart attack connection.
The recent firestorm over Avandia underscores the need for full disclosure of drug-maker clinical trials. Scott's bill can bring some daylight to the world of drug trials, drug benefits and side effects, both to patients and their physicians. The Senate, which is scheduled to vote on the bill today, should move it out of the upper house and onto the Assembly for fast approval. Gov. Arnold Schwarzenegger should make this part of his "health care reform" package by putting his signature on it.