Health Highlights: Sept. 21, 2005

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Gives Conditional Approval to 2nd Silicone Breast Implant

The U.S. Food and Drug Administration said Wednesday that it has granted a second manufacturer of silicone gel-filled breast implants a "conditional approval," taking the company a step closer to returning the controversial implants to the market, the Associated Press reported.

The FDA told Inamed Corp., of Santa Barbara, Calif., that its implants can be approved under certain conditions, but the agency did not spell out those conditions.

In July, the agency gave a similar, conditional approval to manufacturer Mentor Corp., also of Santa Barbara, after an FDA advisory panel voted to recommend approval of the company''s application to sell the implants, the AP said.

But the panel at the time recommended against Inamed''s implants, citing safety concerns. The FDA said Wednesday that Inamed has subsequently provided additional information to address those concerns.

Silicone gel implants went on sale in 1962 in the United States. Thirty years later, the FDA banned all but those used for breast cancer reconstruction, amid fears that leaks might be responsible for autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue.

By 1998, more than 170,000 lawsuits had been filed against implant manufacturers by women claiming their silicone implants had caused immune system disorders and chronic diseases such as rheumatoid arthritis and systemic lupus. Four companies paid out millions of dollars in settlements to the women, and one of them, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle its claims.

However, studies by the Mayo Clinic, Harvard Medical School and the Institute of Medicine (IOM) panel from the National Academy of Sciences subsequently found no evidence that leaked silicone from gel implants caused systemic disease.

Proponents of silicone implants say they look and feel more natural than saline implants.

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FDA Rejects Liquid Cox-2 Painkiller

Pfizer Inc.''s application for an injectable liquid form of a cox-2 painkiller was rejected by the U.S. Food and Drug Administration, the Associated Press reported.

The FDA issued a "non-approvable" letter for the drug parecoxib sodium, which is marketed as Dynastat in the European Union and other parts of the world. The reasons behind the refusal were not disclosed, the AP reported.

Pfizer said it plans to meet with the FDA to discuss the rejection of the drug. The company contends that Dynastat, the only injectable cox-2 inhibitor, reduces the need to use opioids to control post-surgical pain.

Cox-2 inhibitors have been linked to increased risk of heart problems. Vioxx and Bextra have been removed from the market, and Celebrex now contains a warning label.

This is the second recent FDA rejection of a Pfizer application. Less than a week ago, the agency denied a Pfizer application for an osteoporosis drug, the AP reported.

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Personalized Drug Treatment Still Years Away: Report

Despite much hype, individually tailored drug treatments based on a person''s genes are still at least 15 to 20 years away, says a report by the Royal Society in Great Britain.

"Personalized medicines show promise but they have undoubtedly been over-hyped. With the human genome sequenced, some people are expecting personalized medicines within a few years, but the reality is still many years away," noted Royal Society working group chairman Sir David Weatherall.

"There are some examples around today, but the complex multiple causes of diseases mean it will be at least 15 to 20 years before a patient''s genetic make-up is a major factor in determining which drugs they are prescribed," he said.

The report said more funding and research are required to further the development of individually tailored drugs, BBC News reported.

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Asian Countries Agree on Plan to Fight Emerging Diseases

A strategy to counter bird flu and other emerging diseases has been approved by a group of 37 Asian countries at a regional meeting of the World Health Organization (WHO), Agence France-Presse reported.

The strategy has five key objectives to be subject to annual monitoring. These include: reducing the risk of emerging diseases; strengthening early detection of outbreaks; better early response to emerging diseases; improved preparedness for emerging diseases; and a sustainable technical collaboration between Asian-Pacific countries.

"It is very heartening that the nations of Asia have made this commitment, the WHO is anxious to make sure it is followed through on the ground. What we really needed was a pan-Asian, country-by-country commitment and that is what we got today," WHO spokesman Peter Cordingley told AFP

However, another WHO official said the strategy would not work without the support of wealthier nations. It will cost about $160 million to implement the strategy.

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HIV Drug Trial Halted Due to Liver Worries

Tests of a new HIV drug called aplaviroc have been halted after two patients suffered serious liver damage, GlaxoSmithKline announced Tuesday.

The compound is one of a new generation of drugs called CCR5 antagonists, which are being developed in order to treat HIV patients who''ve developed resistance to protease inhibitors like AZT, the Philadelphia Inquirer reported.

GlaxoSmithKline said it has stopped treatment of all 300 HIV patients taking part in the phase II clinical trial of aplaviroc. This trial was being conducted on patients in the United States, Canada and Europe who''ve never received HIV drugs. The two patients who suffered liver damage did not die and were not given liver transplants.

"We don''t know whether (the problems) were drug-related, but in the interest of safety we have notified the investigators to take all the patients off aplaviroc," GlaxoSmithKline spokesperson Rick Koenig told the Inquirer.

Although it halted this trial, GlaxoSmithKline is still testing aplaviroc in a phase III trial involving 40 patients who have previously received other HIV drugs.

Two other drug makers -- Pfizer Inc. and Schering-Plough Corp. -- are also developing CCR5 antagonist drugs and have not reported any liver damage problems, the Inquirer reported.

Last Updated: Sept. 21, 2005