Doctors who had been heavily courted by Merck, the manufacturer of Vioxx, are now some of the drug’s most outspoken foes. In the ongoing Vioxx trial, doctors have come forward and testified that if they had been told of the potential risks the drug posed, they would never have prescribed the drug to their patients. One of the doctors, John Braun, took Vioxx for two years to treat neck pain, suffered a heart attack. Dr. Braun is now suing Merck. This is a classic man bites dog story and even more so considering it ran in the pro-pharmaceutical industry newspaper, the Wall St. Journal!
Drug Products
FDA Panel Recommends Tysabri
An FDA panel has recommended that the risky and controversial MS drug Tysabri be returned to the market. The panel argued that the decision to use the drug should be made by the doctor and the patient, in spite of evidence that the drug causes a deadly brain disease. If the FDA accepts the panel’s recommendation, it would be only the second time a drug was returned to the market after having been removed for safety reasons.
Ambien Sleep Driving
You’ve all seen the ads for the popular sleep aid Ambien. Yet, behind this popularity is a little known fact: the sudden rise in Ambien related impaired driver arrests. Some of those arrested state that they have no recollection of driving a vehicle prior to the arrest. In some state toxicology laboratories Ambien makes the top 10 list of drugs found in impaired drivers. And as a more people are taking the drug — 26.5 million prescriptions in this country last year — there are signs that Ambien-related driving arrests are on the rise.
Truth, Not Marketing, Goal of Scientific Research
According to Harold C. Sox, MD, scientific research should be directed at truth and objectivity rather than promoting the marketing initiatives of pharmaceutical companies. In an article published in the Annals of Internal Medicine, the doctor decries the use of fake scientific data to bolster sales of pharmaceutical drugs or medical devices. Sox further states that scientists have a duty not only to publish the truth but also to correct faulty data published in other journals.
Drug Trials Promised but Unseen by FDA
The FDA has reported that 2/3 of the drugs approved by the agency remain untested and unproven. When new drugs are approved for public use, they are supposed to report the results of clinical trials to the FDA. One drug approved in 1955 has still not complied with these tests. These studies are important in that they are intended to reveal if the drugs are working as intended and whether they are producing any side effects.
Drug Patch Latest to be Targeted by FDA Probe
In July 2005 it was the fentanyl patch used for chronic pain. The following November it was the Ortho Evra birth control patch after studies had shown women using the patch were exposed to 60% more estrogen than non-users. Now, the FDA is going to probe the entire drug patch industry for safety concerns.
Tequin Study Reveals Blood Sugar Problems
According to a Canadian study to be published March 30th in the New England Journal of Medicine, users of the antibiotic Tequin were 17 times more likely to receive emergency room treatment for hyperglycemia or high blood sugar. If untreated, the condition can be fatal. The antibiotic has been used to treat pneumonia, bronchitis, and gonorrhea.
Celebrex Increases Heart Attack Risk Two-Fold, According to Study
New Zealand’s Medical Research Institute has found that Celebrex users are nearly twice as likely to suffer a heart attack as those taking other arthritis drugs, commonly known as Cox-2 inhibitors. Last August, Pfizer, the manufacturer of Celebrex, put a “black box” warning on the drug yet Celebrex stayed on the market. The black box warning is the most severe of the labels placed on pharmaceutical drugs. Celebrex remains the only Cox-2 inhibitor still on the market today.
Carbon Monoxide Keeps the Meat Red
Have you ever noticed how you steaks or hamburger meat start to turn brown or gray soon after you open the wrapping? However, the meat industry has an answer that’s causing quite a stir among consumer advocates. They are treating the meat with carbon monoxide which keeps that fresh red color in the meat. Consumer advocates say this is a dangerous practice not because of the levels of carbon monoxide used but that this practice makes it harder for consumers to tell the freshness of meat. Debate will continue. . .
Kava Kava Feels Good but May Produce Harmful Consequences
The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to the islands in the South Pacific where it is commonly used to prepare a traditional beverage. Supplements containing the herbal ingredient kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. Liver-related risks associated with the use of kava have prompted regulatory agencies in other countries, including those in Germany, Switzerland, France, Canada, and the United Kingdom, to take action ranging from warning consumers about the potential risks of kava use to removing kava-containing products from the marketplace. Although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk.