Drug industry weathers horrid year and outlook appears rocky
December 31, 2004 12:02

The pharmaceutical industry endured a disastrous 2004, and the aftermath will linger into the new year.Regulators at the Food and Drug Administration were already expected to take a more cautious approach about new drug approvals in the wake of Merck & Co.'s... (Read Article)

Pfizer said the Food and Drug Administration has approved its new medication for pain caused by nerve damage from diabetes or shingles.

The drug giant says Lyrica is the first FDA-approved treatment for this type of pain, often described as burning, tingling, sharp, stabbing or pins and needles in the feet, legs, hands or arms. Pfizer said the types of pain that Lyrica treats are different from arthritis or musculoskeletal pain.

The company had also been promoting the drug for treating partial seizures in adults. But that is still under review.

Pfizer said the drug's most common side effects are dizziness, drowsiness, dry mouth, an abnormal build up of fluids in the ankle and legs, blurred vision, weight gain and difficulty with concentration.

Menopausal women, scared off traditional hormone therapy by studies showing the pills cause breast cancer and heart disease, are seizing on another approach: "bioidentical" hormones. A recent best-selling book gave a huge impetus to bioidentical hormones, saying... (Read Article)

I don't worry about the health effects because it's close to what the body produces," said Diane Schafer of Crown Point, Ind., a patient of BodyLogicMD, a Chicago medical practice that specializes in bioidentical hormone therapy. Schafer had been overweight, depressed and unable to sleep and had dangerously high cholesterol, but now she says she feels much better.

Joyce Kyce of La Grange Park, another devotee of BodyLogicMD, acknowledged that "every medication probably has some risks." But she added, "I feel [bioidentical hormone therapy] is safer."

In fact, a small study from the University of Oregon found that 71 percent of women believe these products have fewer or no risks compared with conventional hormones.

The only way to prove they're safer would be to randomly assign thousands of women to receive either conventional hormones or bioidenticals and then follow them for years to see how many in each group develop serious health problems. That would be prohibitively expensive.