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Fabrazyme Lawyer Vitamin A Drug Shortage Lawsuit Blindness
Fabrazyme Lawyer Vitamin A Drug Shortage Lawsuit Blindness www.patentlawyersite.com http://youtu.be/bzs8CsJoL9I Drug Shortages in U.S. C. Allen Black, Jr., Ph.D., J.D. Who chooses survivors—those who get access during a shortage • M.D.s at FDA? No • Public Health Service Corp. at NIH? No • Trained Public Health Authorities? No • Doctors? No • Patients? No • Pharma M.B.A.s/CEOs untrained in medicine? YES Who will help Drug Shortage Patients • Call FDA? No access. Call NIH? No access. • Call Public Health Authorities? No access. • Call your doctor? No access. • Call inventors or scientists? No access. • Call pharma or pharma‐funded patient groups? • Call a lawyer. An unconflicted advocate gives patients an individual voice, opens access, and works to see that those causing the harms are ultimately held accountable. A New U.S. Healthcare Paradigm If a patient needs long‐term drug access, the patient (or child's parents) must stockpile needed medication to survive the inevitable shortages that have become epidemic. Stockpiling medication is a federal crime, but has become a crime of necessity for survival in the United States. If a patient does not have a stockpile, then the only chance for survival is to go to court. The Fabrazyme Dilution Case Overview • 1,500 U.S. Fabry Disease Patients • Genetic illness that results in the body being unable to breakdown fats. Patients are unable to make a specific enzymetermed agalsidase beta. • Fabry disease is lethal without treatment. Most patients dieof renal failure, heart attack and stroke by the time theyreach their 50s. The symptoms of the disease are severepain, loss of hearing, loss of eyesight, grave intestinaldisorders, and degenerative nerve loss. • From taxpayer funding under the Bayh‐Dole act, Mt. Sinai hospital patented Fabrazyme®, which replaces the defectiveenzyme in patients. Mt. Sinai licensed Fabrazyme® toGenzyme Corporation. • $250,000 per year for a patient administered IV every 2weeks for the rest of their life. Fabrazyme Shortage • Prior to June 2009 Genzyme contaminatedthe drug supply with a rodent virus whichdecreased output. • Genzyme also contaminated injectable vialswith glass, rubber, and steel particles. TheFDA fined Genzyme $175 million and implemented oversight over Genzyme for 7years under a consent decree. • Genzyme made $400 million per year before the shortage. Role of FDA and NIH? • Petitioned NIH (Nation Institutes of Health) for "March In" to allow other manufacturers to license patent. • • Bayh‐Dole Act bans non‐use or misuse of a patent funded the • U.S. taxpayers. Compulsory license system for non‐use. • Denied because NIH argued it would take too long to get another company up and running. Everything will be fine. • Genzyme told NIH it would provide a full supply by early 2011. Current Status • FDA declared shortage "over" in March 2012, • Some of my clients did not get doses until July • Shire refuses to market in US due to FDA animosity to Replagal. • U.S. Fabry patients must purchase Fabrazyme for the rest of their lives even after Genzyme caused them personal injury and killed family and friends. (Fabry is hereditary) • All patients have reported increased severe symptoms on low dose-- kidney disease, heart transplant, kidney transplant, multiple strokes, hearing loss, inability to work, loss of nervous function in legs, degenerative vascular disease, etc. The Aquasol (vitamin) A shortage Results Disappointing • Cattle vitamin A does not kill lawyers. • But, we have another source of vitamin that can be tested and, if appropriate, purified to be made safe for humans. • Will petition FDA to assist patients (hopefully won't wait years to reply) We've Been Here Before "It's imperative that we confront a serious threat to the health of our nation. And that threat is complacency -- a false sense of security, a false sense of calm that hides ... a serious epidemic." Dr. Kevin Fenton Director, CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention C. Allen Black, Jr., J.D., Ph.D., allenblack@patentlawyersite.com • Close family friend of drug shortage victim, • Ph.D., Immunology (mucosal sexually transmitted diseasevaccines) 1997 • Postdoctoral Fellow (HIV transmission/vaccines) 1998 • Assistant Professor Obstetrics and Gynecology 1999 • Law Degree/ Registered Patent Attorney 2003 • Adjunct Professor, Biotechnology Law, 2006‐present • Law Office of C. Allen Black, Jr., est. 2008 Fabrazyme Lawyer Vitamin A Drug Shortage Lawsuit Blindness http://youtu.be/bzs8CsJoL9I www.patentlawyersite.com (412) 908‐3268
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