US Pharm. 2008;33(1):48.

Prison Sentences for Women Who Claimed ALS Cure
The FDA Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), or "Lou Gehrig's disease." Elizabeth Lerner, a.k.a. Elizabeth Cooperman, of Egg Harbor City, New Jersey, was sentenced last month for defrauding two patients with ALS and their families. She was also ordered to pay $35,390 in restitution to the victims of the scheme and a criminal fine of $7,500.

Lerner and her co-conspirator, Charlene C. DeMarco, were convicted in December 2006 of all charges contained in an 11-count federal indictment. DeMarco was sentenced in September 2007 to 57 months in prison, ordered to pay $32,190 in restitution to victims of the scam, and to pay a fine of $7,500.

Investigators found that from October 2002 until November 2004, Lerner and DeMarco defrauded patients with ALS and their families by claiming they could treat the disease with stem cell therapy, even though they knew they could not.

New OTC Contraceptive Warning
The FDA issued a final rule requiring that manufacturers of OTC stand-alone vaginal contraceptive and spermicidal products with the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception.

Following a 2003 clinical trial in Africa and Thailand that showed women using a contraceptive gel with N9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel, FDA proposed new warning statements. This and other studies have shown that use of products containing N9 cause vaginal and rectal irritation, which can heighten the chance of contracting HIV from an infected partner.

Pump Recall
Cardinal Health announced a voluntary, worldwide recall for its Alaris Pump module model 8100 (formerly known as Medley Pump module) as the result of misassembled occluder springs. This could lead to overinfusion, which could result in serious health consequences or death. The company notified customers of the recall for pumps that were shipped prior to September 27, 2007.

The pumps are used for delivering fluids, medications, blood and blood products, and there is no warning or notification of an overinfusion. Cardinal Health received one report of an injury and two reports of patient deaths associated with the use of the pump, however the deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this problem.

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