Popular Menopause Treatment Comes Under Fire From Drug Company
The University of North Carolina English professor was 43 at the time, but she felt she was losing touch with reality. At times, she said, it was so bad she couldn’t even best nhl jerseys drive or read.
“You imagine somebody made a jigsaw puzzle on the table, and that jigsaw puzzle is you, and somebody comes along and jiggles dwyane wade jersey the table and the pieces break apart,” she said.
Her doctor had first prescribed an estrogen patch, but it didn’t help for long. In 2000, after hearing about “bio identical” hormone replacement therapy from a friend, she requested a measurement of her hormone levels from the Wisconsin based nfl jerseys cheap pharmacy Women’s Health America. Women’s Health then sent the results of a saliva test to her doctor,karl malone jersey 532, who wrote a prescription for progesterone cream, which Women’s Health custom made for her.
“Within two weeks,nhl jersey history, I knew that there was hope,” Danielewicz said. She now feels like she did before menopause and credits custom nhl jerseys her customized medication with saving her when manufactured drugs didn’t work as well.
Some pharmacists specialize in compounding drugs, a process in which drugs are custom mixed for a patient. Compounding is commonly done for patients who are allergic to a dye in a drug, for example, or when a drug manufacturer discontinues production of a drug.
Wyeth Pharmaceuticals, a global drug company that manufactures hormone replacements, wants the Food and Drug Administration to regulate competition from pharmacies that compound bio identical hormone replacement therapy also known as BHRT.
Wyeth’s drug Premarin, which is used to treat menopausal symptoms,nhl jersey history, is an estrogen derived from the urine of pregnant horses. BHRT, meanwhile, uses plant derived estrogens and is typically discount nfl jerseys formulated based on the hormonal reading taken from a woman’s saliva sample. Because of that matching process, advocates hail BHRT as a more appropriate way to replace hormones diminished in menopause.
The FDA has been taking comments on the issue since Oct. 6, 2005, when Wyeth filed a petition demanding that the government take action to stop compounding pharmacies from selling BHRT drugs, alleging illegal marketing and manufacturing.
The comment period ended on Tuesday, but no date has been set for the FDA to rule on the petition.
Wyeth’s petition also raised safety concerns,nhl jersey history, claiming there had been too little research and demarcus cousins jersey alleging that BHRT drugs were not accompanied by appropriate warning labels.
“These pharmacies’ failure to provide this legally required information demonstrates that allen iverson jersey they are simply trying to dupe an unsuspecting patient population,” Wyeth’s petition reads.
BHRT advocates said they were flabbergasted by the allegation that they were out to “dupe” the population. They point out that a person can only get BHRT with a doctor’s prescription.
And, nhl jerseys they say,nhl jersey size chart 335, when a doctor writes such a prescription for a customized dosage, wholesale nfl jerseys form, or combination of nhl jersey size chart medicines not commercially available it is a pharmacy’s responsibility to make or “compound” the drug.
The FDA regulates manufacturing, but not compounding.
Wyeth, however, alleged in its petition that with the growing market for BHRT drugs, compounding pharmacies had begun to veer toward wholesale manufacturing and therefore should be regulated as such.