Health Highlights: Nov. 29, 2004
FDA Interfered With Vioxx Article Publication: Report Stem Cells Used to Treat Incontinence in Women French AIDS Vaccine Shows Promise Couple Develops Botulism After Botox Shots Ailing Rehnquist to Miss Next Supreme Court Session
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Interfered With Vioxx Article Publication: Report
An official from the U.S. Food and Drug Administration took the unusual step of calling a medical journal's editor to question the legitimacy of an article critical of the now-defunct painkiller Vioxx, only days before the article was to run, USA Today reported Monday.
The article, written by Dr. David Graham of the FDA's Office of Drug Safety, was to have run in the British medical journal The Lancet. Graham alleges that the call to the journal by Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, was an attempt to block the article's publication, USA Today reported.
Galson said his call was an attempt only to point out that Graham's article had been submitted to the journal in violation of the FDA's clearance process, the newspaper reported, since agency superiors said they had not approved Graham's article. A statement by acting FDA Commissioner Lester Crawford said Galson contacted journal editor Richard Horton "out of respect for the scientific review process," USA Today said.
Graham's article cited an analysis of some 1.4 million Kaiser Permanente members showing that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, a competing painkiller. The article was to have been published on the journal's Web site on Nov. 17, but Graham told the newspaper he ultimately withdrew it for fear of losing his job.
Merck & Co., Inc., pulled Vioxx from the market in late September, citing its own data that users had an increased risk of heart attack and stroke.
Stem Cells Used to Treat Incontinence in Women
Austrian researchers say they have successfully used their female patients' own stem cells to treat urinary incontinence. The therapy is a potentially long-lasting one, with patients remaining continent one year after treatment, HealthDay reported.
Although the technique needs to be studied in more women and for longer periods of time, Dr. Joe Littlejohn, a clinical instructor of urology at Columbia University College of Physicians and Surgeons in New York City, called the results "very promising."
The small study was presented Nov. 29 at the Radiological Society of North America annual meeting in Chicago.
Stem cells are unspecialized cells that eventually grow into the myriad specific cells the body needs for specific functions.
Stress incontinence, the form of incontinence treated in the study, affects almost 15 million people worldwide, most of them women. Often the condition is a result of childbirth or aging. It occurs when problems with the urethra or the sphincter muscles that help open and close the urethra cause urine leakage.
French AIDS Vaccine Shows Promise
A French AIDS vaccine designed to treat the disease instead of prevent it has suppressed the virus for up to a year among a small number of patients, the San Francisco Chronicle reported Monday.
The vaccine was tested in Brazil among 18 volunteers already infected with the AIDS-causing HIV virus, none of whom had taken antiviral drugs. After four months, viral levels in the bloodstream dropped by an average of 80 percent, and after a year those levels fell by 90 percent, the newspaper reported.
Four of the patients tested with the vaccine had viral levels so low after one year that they could be compared to so-called "long-term non-progressors," a rare group of people infected with HIV who never seem to develop symptoms of AIDS, the Chronicle said.
While this vaccine wouldn't prevent people from getting the AIDS virus, scientists are investigating whether an annual dose would keep people healthy without them having to take toxic but effective antiviral drugs known as the AIDS "cocktail."
The lead investigators told the newspaper that the vaccine would cost less than a year's worth of the cocktail. Its only pronounced side effect, they said, was a swelling of the lymph nodes, which caused no pain and actually provided proof that the vaccine was working, the Chronicle report said.
Couple Develops Botulism After Botox Shots
A Palm Beach, Fla., couple has been hospitalized with symptoms of botulism following cosmetic treatment at a Fort Lauderdale clinic with a drug that was supposed to have been Botox, the Sun-Sentinel newspaper reported Monday.
The unidentified couple in their 50s were both on life support in critical condition over the weekend, the newspaper said. As of Monday, they were being treated at an unidentified New Jersey hospital following their transfer from a hospital in Palm Beach.
The couple had been given the cosmetic treatment at the Advanced Integrated Medical Center on Nov. 24, and the next day felt weak and had trouble breathing. The U.S. Centers for Disease Control and Prevention is investigating the incident, which the couple's doctor suspected may have been caused by a contaminated vial of Botox or some other drug used in their treatment, the newspaper said.
Allergan, Inc., which produces Botox, told the newspaper it is working with authorities in the investigation. Botox is derived from the same bacterium that causes botulism. Symptoms of the deadly disease include muscle weakness and trouble breathing and speaking.
Ailing Rehnquist to Miss Next Supreme Court Session
Chief Justice William H. Rehnquist, who missed the U.S. Supreme Court's November argument session while being treated for thyroid cancer, will be absent for the December session as well, the court has announced.
The New York Times reported that Kathleen Arberg, the court's public information officer, said Rehnquist was continuing to receive chemotherapy and radiation treatments as an outpatient and was meeting with his law clerks and court officials at his home. Arberg said she had no information on when the 80-year-old chief justice might return to the court.
Given the apparent seriousness of his illness, there has been widespread speculation that the chief justice will announce his retirement sometime this winter, the newspaper reported. Jan. 7 will mark his 33rd anniversary on the court.
The Supreme Court resumed Monday and began hearing arguments in a case that will decide whether patients in 11 states can legally use marijuana for medical reasons.
The court has to decide whether states have the power to allow the use of drugs that are banned by the federal government, the Associated Press reported.
Currently, the states of Alaska, Arizona, California, Colorado, Hawaii, Maine, Montana, Oregon, Nevada, Vermont, and Washington all have laws that allow the use of medical marijuana, which can't be sold, transported across state lines, or used for nonmedicinal purposes.
The Bush administration contends that such laws violate federal drug laws and that there is no medical value in marijuana.