Quality Control at Wyeth

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From NVIC

Let it be recorded that if there are "vaccine shortages" in the future, it is because there are quality control problems at the plant. Quality control problems are not new for Wyeth or other vaccine manufacturers. Several years ago Lederle started all the publicity about "vaccine shortages" when the FDA cited the company for quality control problems (deficiencies) in the manufacture of DTaP vaccine. The company solution? Rather than fix the problem they immediately ceased production and sale of DTaP vaccine and left the country without a supply of DTaP, promting a "vaccine shortage" that was eventually falsely blamed on the threat of "lawsuits" by parents of vaccine injured children.

Another "vaccine shortage" was caused in 2001 by Wyeth underestimating the demand for Prevnar vaccine when it became the hottest selling new pharmaceutical in 2000, generating more than $460 million in sales after a company-led nationwide promotion campaign. The result was a "shortage" of Prevnar nationwide until the company could gear up production to meet the demand. Again, though, the generic blame for "vaccine shortages" was spun for Congress and the media as "threat of lawsuits." Looks like this company and other companies producing and marketing vaccines have a history of blaming their quality control problems on the public it profits from so handsomely.

http://biz.yahoo.com/rc/031106/health_wyeth_3.html

UPDATE - Wyeth halts shipments of Prevnar vaccine Thursday November 6, 10:47 am ET By Ransdell Pierson

NEW YORK, Nov 6 (Reuters) - Wyeth (NYSE:WYE - News) on Thursday said it has temporarily delayed shipping its blockbuster Prevnar vaccine against childhood pneumococcal infections because of the need to upgrade company quality-control processes.

Wyeth spokesman Doug Petkus declined to give further details, but said the company decided on its own to upgrade its quality-control systems for Prevnar and had not been asked to do so by the U.S. Food and Drug Administration (News - Websites) .

"The result of these changes will ensure that appropriate documentation is in order to assure that (the) manufactured product conforms to all quality assurance tests," the Madison, New Jersey-based drugmaker said in a release.

Wyeth said shipments of the vaccine, one of the company's fastest-growing products with annual sales of about $1 billion, should resume "shortly" and that the delivery delays should not create a shortage of the product.

Shares of Wyeth were down 34 cents to $42.70 in morning trade on the New York Stock Exchange (News - Websites) , amid a slight downturn for the drug sector.

Other large drugmakers, including Schering-Plough Corp. (NYSE:SGP - News) and Eli Lilly and Co., (NYSE:LLY - News) have been beset by quality-control problems at their plants that have sparked the ire of the FDA and held up approvals of the companies' new medicines.

Earlier this year, Wyeth was unable to produce enough Prevnar to salsify consumer demand, thereby crimping company earnings growth.

The shortages recently ended after Wyeth beefed up its Prevnar manufacturing capacity. Consequently, sales of the drug more than doubled in the third quarter of 2003.

Other newer Wyeth drugs have also enjoyed booming sales growth, including anti-depressant Effexor XR, arthritis treatment Enbrel and Protonix for ulcers.

But Wyeth, formerly known as American Home Products, posted a loss in the quarter due to a $2 billion charge for liabilities related to its two recalled "fen-phen" diet drugs.

Wyeth has taken $16.6 billion in charges since it withdrew the two drugs from the market in 1997 after they were linked to heart-valve damage and hundreds of cases of a deadly lung disorder. Thousands of the former diet-drug users are suing the company, claiming it failed to adequately warn them of the dangers.

Company earnings have also been hurt by plunging sales of Wyeth's two female hormone-replacement drugs, Prempro and Premarin, following a large federally-sponsored study that showed they increased the risk of heart attack, stroke and breast cancer.

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