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Making our medicine safer

When Merck, the makers of Vioxx, first learned that their drug could cause serious health problems including heart attack and stroke, they could have told doctors and their patients. They didn’t.

When GlaxoSmithKline, makers of the antidepressant Paxil, learned that it was linked to an increased risk of suicidal behavior in children, they could have sounded the alarm. They didn’t.

These companies had the opportunity to do the right thing by giving doctors and patients the information they needed to make safe and informed medical decisions. They consciously chose not to tell the public the full story.



Instead, they decided to gamble with the health of millions of Americans by keeping vital safety information from doctors and patients, and they continued to heavily promote the drugs in question. This may have helped them sell more medicine in the short term, but the consequences have been deadly ” according to an FDA whistleblower, Vioxx alone caused an estimated 140,000 heart attacks and strokes and 55,000 deaths.

While these are two of the highest profile cases of drug companies spinning the roulette wheel with our health, revelations of similar problems within the pharmaceutical industry have become too common. The bottom line is that the pharmaceutical industry has proven that it cannot and won’t police itself.



That job is supposed to be done by the federal U.S. Food and Drug Administration. Unfortunately, due to a combination of legal restrictions and a lack of political will from many within the FDA, America’s drug safety system is woefully inadequate.

The good news is that there is momentum and bi-partisan agreement in Washington that something needs to be done. Congress is currently considering several drug safety bills.

In fact, Colorado Sen. Wayne Allard will be reviewing the Kennedy-Enzi bill, S. 484, as a member of the Senate Committee on Health, Education, Labor and Pensions.



As he examines the multiple bills, Sen. Allard should consider the following five reforms when debating drug safety policy:

First, federal law currently requires that the FDA use an overwhelming percentage of the agency’s budget on the process of approving new drugs. This restriction leaves an anemic and insufficient pool of funding for reviewing and monitoring the safety of drugs. Congress needs to put an end to this restriction and insist that more money be spent on reviewing drug safety, not less.

Second, despite the fact that it monitors more than a trillion dollars worth of products, the FDA has shockingly few powers to actually regulate or penalize the companies it oversees. Congress needs to give the FDA stronger enforcement powers, including the ability to levy substantial fines on companies that fail to complete required drug safety tests or that conduct misleading advertising campaigns.

Third, the FDA relies on outside expert advisors who, too frequently, are on pharmaceutical industry payrolls or are otherwise financially tied to drug manufacturers. With these ties, advisors cannot be fully objective experts. The FDA must be required to recruit and hire truly independent advisors without conflicts of interest.

Fourth, current law allows drug manufacturers to heavily and aggressively market their medicines from the minute they hit store shelves, even before doctors, researchers, and patients know all the dangers that a drug might pose. Congress should enact a moratorium on marketing any new drug for the first three years it is on the market. This will give the FDA a longer window of time to monitor the real-world effects of a drug as it is used by a market far bigger and more diverse than the small groups studied in clinical trials.

Finally, Congress must empower and require the FDA to shine the light of day on clinical trial results for all drugs. Had doctors, patients, and researchers been given full access to all the Vioxx studies and seen the indications that the drug could cause serious health problems, the tragedy of the situation could have been dramatically curtailed.

As basic as these reforms are, they won’t come easily. They will meet stiff opposition from the pharmaceutical industry. Drug companies much prefer a system where they’re allowed to avoid real fines for misbehavior, tuck unfavorable results away from doctors and the public, and advertise to their hearts’ content. Their army of lobbyists (more than two full-time lobbyists for every member of the House and Senate) and massive war chest have already swung into action to bottle up or water down reform efforts underway.

Passing these reforms will require standing up to the pharmaceutical industry and their lobbyists, but it will also mean standing alongside a wide array of senior, health, labor, and consumer groups supporting change.

From the public’s perspective, these changes are appallingly overdue. A recent poll found that 80 percent of Americans were concerned about the ability of the Food and Drug Administration to make independent decisions that ensure patients have access to safe and effective medicine.

The Vioxx and Paxil tragedies demonstrate that our system of regulating prescription drugs is broken. By addressing these five problems immediately, Congress will restore public confidence in the FDA and protect the public from dangerous and potentially deadly prescription drugs.

Kirpal Singh is the staff attorney for the Colorado Public Interest Research Group or CoPIRG. E-mail comments about this column to editor@vaildaily.com.


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