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Drug Shortage Death According to Widow
Janet Schubert, widow of Dr. William Schubert, sued Genzyme in state court claiming that the "indefensible" rationing of a vital enzyme replacement drug for Fabry disease led to her husband's death. Also named in the suit is the Mount Sinai School of Medicine, which holds the patent for the drug, Fabrazyme.
In the case, Janet Schubert says her husband was diagnosed with Fabry disease in 2005. Her husband needed the drug to treat the life-threatening condition. Dr. Schubert received Fabrazyme treatments about twice a month, his widow says, until a virus contamination in the drug's manufacturing facility triggered a shortage.
"Due to this shortage, Genzyme began arbitrarily rationing Fabrazyme toward the end of 2009," the complaint states. Although patients under the age of 18 continued to receive their treatment as scheduled, older patients received as much as a 70 percent reduction in dose. Genzyme's rationing scheme was undertaken despite their knowledge that less than a full dosage would not be effective and many patients would suffer catastrophic health deterioration and even death. Shortly after he began treatment with the reduced dose in late 2009, decedent's health condition began to decline due to the reduced and ineffective dosage. Dr. Schubert died on March 6, 2010."
The complaint states that "Defendants each grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals, and the public of the lethal risk presented due to inherent and customary manufacturing defects in the products...."
http://www.courthousenews.com/2012/03/07/44477.htm
No Access to Prostate Cancer Drug Abiraterone for Scottish Patients
Patients with advanced prostate cancer in Scotland will not get access to abiraterone, which can extend their lives by more than three months; the drug costs over $4,000 per month. It has already been provisionally rejected for use in England and Wales. The Scottish Medicines Consortium said the cost of the drug did not justify the health benefits. Although abiraterone is not a cure for prostate cancer, it can give some men extra time with their families. Some believe that pharmaceutical firms are over-charging and they should reduce their prices.
http://www.bbc.co.uk/news/uk-scotland-17332080
J&J CEO Weldon To Receive $143.5 Million in Retirement Pay
Weldon, who has been chief executive officer for about 10 years, said he would step down April 26, after a series of recalls over recent years. This has called into question the quality of some of the healthcare conglomerate's products. However, he will remain chairman of the board and has no plans to leave the company. The CEO has accumulated $95.1 million in various employee compensation programs and $48.4 million in pension benefits.
http://www.reuters.com/article/2012/03/15/johnsonjohnson-idUSL2E8EEFAG20120315
AstraZeneca Sues FDA Over Generic Seroquel
AstraZeneca is suing the FDA in an attempt to delay the market entry of generic versions of its top-selling antipsychotic Seroquel. The company is seeking an injunction barring the FDA from granting final marketing approval of generic forms of Seroquel. The FDA denied AstraZeneca's Citizen Petitions requesting it withhold approving any generic that did not carry the same warnings required for its branded version.
http://www.reuters.com/article/2012/03/13/astrazeneca-seroquel-idUSL5E8ED0FX20120313
Warner Chilcott and Subpotent Birth Control Pills?
In another problem for Warner Chilcott, they have disclosed that the FDA issued a subpoena for information on a wide array of sales and marketing activities and has issued a warning letter suggesting quality problems have existed for the past five years with the Ovcon birth control product. The FDA noted that they did not thoroughly investigate and identify the reason that certain lots of Ovcon failed stability testing going back to 2006, which can cause a problem with expiration dates. Meanwhile, the company continued to manufacture Ovcon 50 tablets, even though these may have been subpotent.
http://www.pharmalot.com/2012/03/warner-chilcott-and-subpotent-birth-control-pills/
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