The pharmaceutical industry has the most powerful lobby in Washington. There are more drug industry lobbyists in Washington than there are elected representatives in Congress.The fury over drug safety in the U.S. and the controversy over whether the FDA adequately protects the American public shows no signs of abating. The recall of Merck's Vioxx, suspected of causing heart attacks, is at the center of the latest outcry. Now, Bextra, Accutane, Crestor, Meridia and Serevent are among the drugs under renewed scrutiny.
A lawyer who specializes in pharmaceutical litigation and monitors the drug industry, Scott Hendler of HendlerLaw in Austin, Texas, and New York, has added his voice to those advising members of the public to advocate for themselves and their own families when it comes to the use of prescription and over-the-counter medications.
Hendler offers specific advice in a statement released by his office on Wednesday:
10 Things You Need to Know About Prescription Drugs and the Pharmaceutical Industry
1. Most of them do much more good than harm. They save millions of people everyday, substantially improve quality of life and help prolong life expectancy.
2. No drug is completely safe. All have potential side effects. Doctors prescribe a medication when they ascertain that the benefits of its use will exceed the potential risks. And doctors understand much less about the risks than people tend to think -- their primary sources of information about drugs are the drug companies themselves!
3. The FDA does not actually test any drugs. They only review the results of clinical trials conducted and submitted by the pharmaceutical company seeking approval for the drug.
4. The FDA's drug approval process is funded in large part by the drug companies themselves. User fees were introduced in the early 1990s to help expedite the drug approval process (reducing it from an average of 30 to 15 months). However it raises the question of who the FDA is truly serving -- the people of the United States or the pharmaceutical companies?
5. The long-term safety of drugs is not established before they are put on the market. And this is true despite the fact that so many drugs are used daily to treat chronic conditions such as high cholesterol, diabetes and Alzheimer's.
6. Drugs are frequently marketed and prescribed for medical problems they were not approved for and have never been proven to be effective (or safe) in treating. This practice is called "off-label" prescribing.
7. "Natural" products and herbal remedies are not always safe alternatives to prescription drugs. This industry is not regulated by the FDA; therefore while many of these products may be beneficial, few have been clinically tested for efficacy or safety, and drug interactions are unknown. Reports of adverse events from these products are now appearing regularly in the medical journals.
8. Only a small fraction of drugs represent any improvement over products already on the market -- although they are marketed as "breakthrough" drugs. The substantial premium being charged for these products is not a function of higher quality, but represents an attempt to maximize profits while patents are still in effect.
9. The pharmaceutical industry has the most powerful lobby in Washington. There are more drug industry lobbyists in Washington than there are elected representatives in Congress.
10. Although the pharmaceutical industry leads the public to believe that high prices are necessary to support research and development efforts, they actually spend more on marketing than on researching drugs. The truth is that the pharmaceutical industry is more profitable than any other industry -- by a considerable margin.
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