Companies May Abandon Controversial Diabetes Drug
The makers of an experimental drug to help diabetics control blood sugar and cholesterol said Friday that they may abandon seeking approval from the U.S. Food and Drug Administration, the Associated Press reported.
Drug companies Bristol-Myers Squibb and Merck & Co. said the FDA, before considering approval, wanted additional safety data about Pargluva (muraglitazar) -- data the companies said could take up to five years to obtain, the AP reported.
The agency and some physicians who have examined data about muraglitazar obtained during clinical trials have concerns that the drug could be linked to heart problems, the wire service said.
Bristol-Myers Squibb released a statement Friday saying it was considering options including "conducting additional studies or terminating further development of muraglitazar."
Last week, both companies said the FDA had issued an "approvable" letter if the drug makers met certain conditions. It wasn't until Friday that the companies said the FDA wanted additional safety data information, the AP reported.
Members of the FDA's Endrocrinologic and Metabolic Drugs Advisory Committee voted 8-1 to recommend approval of the drug to treat type 2 diabetes, the wire service said. The full FDA usually follows the recommendations of its expert panels.
Last week, however, HealthDay reported that a group of prominent cardiologists warned that the FDA shouldn't approve Pargluva without additional studies, since the drug appeared to double the risk of death, heart attack, and stroke. The cardiologists' report was published Oct. 20 in the Journal of the American Medical Association.
Decision on Inhalable Insulin Postponed
The U.S. Food and Drug Administration has delayed its decision on approving the first inhalable form of insulin, the Associated Press reported Friday.
The agency said it wanted to review more data on the drug, which would be marketed under the name Exubera. Makers Pfizer, Sanofi-Aventis, and Nektar Therapeutics have hailed the drug as a convenient alternative to insulin injections.
Last month, an FDA expert panel voted 7-2 to recommend approval by the full agency, the AP reported.
In announcing the FDA delay on Friday, the developers said the agency wanted to review "additional technical chemistry data." The companies did not elaborate.
The expert panel that reviewed Exubera said the drug's potential benefits outweighed potential risks, including whether the drug's effects had been sufficiently studied in people with lung problems, the wire service said.
Record Number of Unmarried U.S. Women Give Birth
A record number of babies were born to unwed women in the United States last year, the government's National Center for Health Statistics (NCHS) announced Friday.
And contrary to a popular impression, it isn't mostly teenagers who are giving birth out of wedlock, an NCHS spokeswoman told the Associated Press.
Teens accounted for 24 percent of unwed births last year, down from 50 percent in 1970, spokeswoman Stephanie Ventura said. By contrast, significant increases in unmarried births have been seen among women ages 25 to 29, she said.
There were 1,470,152 babies born to unmarried U.S. women in 2004, which accounted for 35.7 percent of all births in the country, the NCHS said.
No Consensus on Tamiflu Hoarding
Even though businesses and individuals in the United States have been hoarding Tamiflu to protect against bird flu, there's confusion about whether that's the right thing to do, the Associated Press reported.
While some doctors' groups advise people not to stock up on Tamiflu, the U.S. Department of Health and Human Services, which includes the Centers for Disease Control and Prevention, hasn't offered an opinion. That's frustrated local public health officials who want to offer advice to people.
"A lot of people have asked the CDC to provide some guidance about this, with patients asking doctors for prescriptions," Dr. Craig Conover, medical director for the Illinois Department of Public Health, told the AP.
On Thursday, Swiss drug maker Roche said it was temporarily halting shipments of Tamiflu to private-sector recipients in the United States. The move is intended to prevent hoarding of the drug and to guarantee there's enough to treat conventional flu cases this winter.
The American Medical Association opposes personal stockpiling of Tamiflu and warns that misuse of the drug could result in the development of drug-resistant flu strains.
In related news, the United States has awarded Chiron Corp. $62.5 million to produce a vaccine against the HN51 strain of bird flu that has world health officials worried about a possible human pandemic.
In a prepared statement, HHS Secretary Mike Leavitt said the U.S. government planned to buy enough vaccine for 20 million people, and enough antirviral medication for another 20 million. The Chiron agreement follows last month's announcement of a $100 million contract to Sanofi Pasteur to produce additional bird flu vaccine.
It's not clear how many doses each company will produce since details are still being worked out, the AP reported.
Chiron had produced about half of the annual U.S. doses of regular human flu vaccine before contamination problems last year forced the company to suspend production at a British plant for several months. The closing caused widespread flu vaccine shortages in the United States last fall.
Tissue Products May be Tainted
The Canadian government has warned that an unknown number of skin graft and dental surgery patients in that country may have received tainted human tissue from a U.S. company that may have illegally obtained body parts from corpses in funeral homes.
Over the past year, about 300 of the company's tissue products made of processed human bone, skin and tendons have been imported into Canada, the Globe and Mail reported.
The company, Biomedical Tissue Services Ltd. of Fort Lee, N.J. is being investigated by the U.S. Food and Drug Administration. The FDA is trying to determine if human tissue used by the company met donor eligibility requirements or if the tissue donors were properly screened for infectious diseases such as HIV, hepatitis B and C, and syphilis.
Neither Health Canada or the FDA has received reports of adverse reactions caused by the tissue products. However, tissue processors that received material from Biomedical have issued a recall of tissue products, the Globe and Mail reported.
Cancer Drug May Boost Memory
An experimental cancer drug called bryostatin may aid in learning and memory and offer a possible treatment for Alzheimer's disease, according to a report in the journal Proceedings of the National Academy of Sciences.
The drug activates protein kinase-C, an important cellular messenger that also plays a role in learning and memory formation in the brain. U.S. researchers fed bryostatin to snails three days before they were put through a series of learning tasks. The drug seemed to promote the snails' long-term memories of the tasks, Newsday reported.
Health Tip: Winter Is Coming
Winter is fast approaching, and for many of us that means frosty mornings and snow-filled commutes. The U.S. Centers for Disease Control and Prevention suggest preparing a survival kit for your car.
Here's a list of items to include:
* Blanket.
* First-aid kit.
* Windshield scraper.
* Booster cables.
* Road map.
* Batteries and flashlight.
* Cell phone.
* Compass.
* Tool kit.
* Paper towels.
* Sand and salt to melt snow.
* Tow rope.
* Shovel.
* Dried foods and can opener.
* Canned, compressed air for tires.
Health Tip: When Sex Becomes Compulsive
Sex is a normal, healthy part of life, but it may become a problem when it interferes with your daily routine.
Here's a list of signs that your behavior may be sexually compulsive, provided by the Mayo Clinic:
* Having many sexual partners or extramarital affairs.
* Having sex with prostitutes and treating them as objects.
* Participating frequently in sexual chat rooms.
* Using sex to calm stress or depression.
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