Tuesday, February 22, 2005


News About Pain Relieving Drugs

Energy Therapies

It turns out that highly touted, advertised and expensive pain relieving drugs, Vioxx, Celebrex and Bextra do more than relieve pain. An increased risk of heart attacks has been discovered.

According to Michael Smith, MD, of WebMD, most people on these drugs do not really need them.

This raises the question, Why are they prescribed? One major reason is that the marketing effort is very successful with the medical profession and with the public.

This gets my attention when I know that energy-therapies are highly effective for pain relief. And there are no side affects. This information is not likely to hit the news any time soon.

Below is a portion of an interview with FDA veteran, David Graham, posted on the AARP website:

Q. How serious are the heart risk problems with newer pain relievers like Vioxx, which is now off the market, Celebrex and Bextra?
Any individual patient’s absolute risk for developing a heart attack might be small, but if you have millions of people taking the drug, many thousands of people will get heart attacks. A recent clinical trial showed an almost fourfold increase in heart attack risk with high doses of Vioxx. We estimate 100,000 people had heart attacks due to Vioxx, with 30,000 to 40,000 dying. And the ones who didn’t die had their life expectancy shortened because they’ve had a first heart attack. This is a major safety problem.

Q. Why weren’t physicians and consumers more cautious about prescribing and taking these new drugs?
The direct-to-consumer advertising magnified the risk [by encouraging consumers to ask doctors for the drugs]. It is difficult for people to comprehend what these [risk-factor] statistics mean. If a person has diabetes, is a smoker or has high cholesterol or blood pressure, the risk is even higher. It is also difficult for the physicians, who rely on the drug companies for most of the information they get about the drugs. You would expect that people should be able to rely on the FDA for information about drugs. But in the case of Vioxx, the FDA let the American people down.
The Damage Control Begins

The spin has already begun on moderating the results of these studies. Why am I not suprised. The pharmacuetical companies have a lot of clout, and they see revenues losses in their future.

Here are comments of an FDA drug advisory panel on Friday:
The benefits of the popular prescription painkillers Vioxx, Bextra and Celebrex outweigh the potential increase in risk of heart problems, a panel of Food and Drug Administration advisers said Friday:

"The panel said all three drugs should stay on the market.

The advisers were unanimous in saying the drugs; known as Cox-2 inhibitors, pose risks of heart trouble.

But they didn’t all agree on whether the drugs should be sold.

Panel members voted 17 to 16 in favor of making Vioxx available. The painkiller is not currently on the market.

The vote was 17 to 13 in favor of continued sales of Bextra and 31 to 1 in favor of continued sales of Celebrex.

The FDA is not required to follow advisory committees' recommendations but usually does so.

The panelists suggested restrictions on the drugs such as placing a severe warning on them, including more patient information with the drugs, restricting which patients get the drugs and possibly banning direct-to-consumer advertising for the products." News article from KWTX.com
The Confusion Continues

Following are excerps from a Business Week article by John Carey:
..... Despite the hazards, the panel also concluded that some older NSAIDs could be just as dangerous as Celebrex -- and that all should stay on the market. The committee even decided that Vioxx, which may have caused thousands of deaths, is useful enough that it shouldn't be banned.

Is this Solomonic wisdom or simply more confusion? Both. The saga starkly illuminates larger underlying problems in drug regulation and use -- and the implications go far beyond painkillers. Here are some of the key insights and issues:

MEDICINES ARE NEVER HARMLESS "Clearly all drugs have risks. That is the price we pay for the benefits," says Dr. Alastair J.J. Wood, associate dean of the Vanderbilt University Medical Center and chair of the advisory meeting. That point has been often forgotten as new drugs appear on the market promising to make life better for tens of millions of Americans. And while the FDA is charged with ensuring that benefits exceed the risks, it's not easy to do. Even when done right, people will be hurt. "Drugs may have a positive risk balance but cause grievous harm," says Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation & Research.

A classic case: The agency yanked Lotronex, GlaxoSmithKline PLC's (GSK ) drug for irritable bowel syndrome, off the market in 2000 after five deaths -- only to allow limited use two years later when patients demanded it. The thorny question for the Cox-2 painkillers like Vioxx is whether reductions they may offer in stomach and intestinal bleeding, compared with older NSAIDs, outweigh their increased cardiovascular risks.
.....Is there a way out of this mess? Doctors need to better inform patients about risks and benefits, and ads should be more balanced. But part of the solution is getting out the message that regulators don't have all the answers. One benefit of the meeting, says FDA's Dr. John Jenkins, is that "it's good for the public to see how the science evolves and how challenging these decisions can be." Agency watchers also see an increased willingness by the FDA to acknowledge uncertainty by slapping black-box warnings on drugs even when risks aren't proven. "Putting concerns on labels treats physicians and consumers in a more adult fashion," says pediatrician Dr. Richard Gorman.

The next part of the solution is working harder to get answers. The FDA should require companies to collect information on patients receiving medicines and put far more effort into analyzing the data. Beyond that, new genetic technologies offer the promise of being able to identify individuals who will be most helped or hurt by any particular drug. Until then, the best advice comes from Wood. "Hopefully this will make people think about taking any drug," he says. All drugs are potent substances that must be used with respect and caution. The more we take that to heart, the safer we will be.
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