
[1] Cohen, E. "Company denies drug to dying child", CNN Health (March 11, 2014).
Update: Chimerex has reversed its position and agreed to give the drug to Josh Hardy and 19 others with compromised immune systems as part of a pilot trial. 03/13/2014
Sign-up to receive recall notices, medical news, and litigation updates.
![]() Seven-year old cancer survivor Josh Hardy is in intensive care with a virus, heart failure and kidney failure. His parents have asked Chimerex, Inc., for an experimental antiviral drug, brincidofovir, that could help him fight the virus but Chimerex has denied their request. The denial has caused a national uproar, escalating to threats against the company's executives. Still, Chimerex is holding its ground. Chimerex claims that allowing one child to have the experimental drug wouldn't be fair because it could delay getting the drug on the market and available to everyone. Under a "compassionate use" provision, FDA allows someone with a serious or immediately life threatening disease who has tried and failed other available treatments to ask a drug company for an experimental drug before the drug has been FDA-approved. However, because companies are required to report any poor outcomes on their applications to market the drug, companies are reluctant to delay or jeopardize the approval progress. An outraged public has turned to the social media with Facebook pleas and angry tweets to @chimerix. [1] Cohen, E. "Company denies drug to dying child", CNN Health (March 11, 2014). Update: Chimerex has reversed its position and agreed to give the drug to Josh Hardy and 19 others with compromised immune systems as part of a pilot trial. 03/13/2014
0 Comments
On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. Gardasil® is a vaccine recommended for 11-12 year olds in order to prevent human papillomavirus (HPV), a virus that causes cervical cancer. If a person received a vaccine containing glass particles, mild reactions such as swelling at the injection site may occur. The effectiveness of the vaccine is not affected by this problem. The affected vials were distributed between August 20, 2013, and October 9, 2013.
[1] CDC, "Voluntary Recall of One Lot of Gardasil HPV Vaccine" (December 20, 2013). Last week Merck & Co., the manufacturer of Gardasil, recalled one lot of the vaccine because a limited number of the vials in the lot may contain glass particles. Gardasil is a vaccine that protects against the human papillomavirus (HPV), a sexually transmitted disease that causes about 70% of cervical cancer cases and 90% of genital warts cases. The affected vials were distributed between Aug. 20 - Oct. 9, 2013. If a patient received a vaccine containing glass, he or she may experience mild redness or swelling near the injection site.
[1] FDA Biologics Recall of GARDASIL [Dec. 19, 2013] |
Archives
May 2014
Categories
All
|