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Off-Label Prescribing – Where Lupron is the Rule, Not the Exception – and Doctors Never Have To Say They’re Sorry.

Posted on | February 8, 2017 | No Comments

Credit: U. Michigan Health Lab

Mike Magee

After a remarkably turbulent decade in the shadows of America’s Medical Industrial Complex – a span that has witnessed the creation of a manmade opioid epidemic, the treatment of thousands of 2 and 3 year old’s with Adderall, the placement of EpiPen’s out of the financial reach of Middle America after convincing most public schools that they were essential as portable defibrillators, the approval of an HHS secretary with a documented track record of insider trading reinforced by his own sponsored beneficial legislation while a Congressman – after all that, we are now poised to further liberalize the FDA in the name of “innovation”.

Unless one lives in an alternate reality where “alternate facts” prevail, there is no reason to further reward purveyors of off label marketing, physician profiled targeted sales, and sloppy prescribers. As Christina Jewett of Kaiser Health News has so well documented, this is the World of Lupron.

Lupron is the brand name for leuprorelin, an injectable blocker of gonadotropin releasing hormone. By interrupting the pulsed release of LH and FSH from the pituitary, the medication causes dramatic reductions of estradiol and testosterone. In adults, it’s most often used to treat prostate cancer and certain types of breast cancer, and sometimes is part of the therapy for endometriosis. Leuprorelin was first approved for use by the FDA for prostate cancer in 1985. Eight years later, it was approved for the treatment of precocious puberty in children, described as the onset of sexual characteristics “before age 8 in girls and before 9 in boys.” The cost for two years of treatment today can approach $40,000.

The FDA approving medical officer in 1993, Alexander Fleming, in retrospect later termed his approval “regrettable”. His regret was likely fueled by two factors. First, shortly after Lupron’s approval for the treatment of precocious puberty in 1993, doctors, with the blessing of manufacturers, began to treat children of “short stature” off-label with the drug. This is entirely legal in the U.S. The manufacturers are prohibited from marketing the product for unapproved uses, but they are allowed to provide doctors with information regarding off-label use if requested. The controlling company back then, TAP Pharmaceuticals,  apparently pushed the envelop a bit too hard leading to government fines for “fraudulent pricing and marketing practices” of $875 million in 2001.

Dr. Fleming’s second regret, related to the first, was that manufacturers had systematically downplayed complications and side effects of the drug. Most notable were the omissions of significant bone disorders and fractures. Over the past decade, more than 20,000 reports of Lupron side-effects have been registered with the FDA, 900 in children under 13. In 2003, a NEJM article raised the alarm that kids on the drug were losing bone density at an alarming rate. Then in 2009, an international body including pediatric endocrinologists questioned the safety of using the puberty delaying drug to add inches to children’s stature. A 2011 study at Children’s Hospital of Los Angeles echoed the concerns about osteoporosis. Still the practice continued. How was that possible?

An industry  2010 study, published in a non-peer reviewed journal by Dr. Peter A. Lee of Penn State, reported side-effects with the drug between 1991 and 2009, but no bone issues. A subsequent independent review of the NIH clinical research repository revealed omission of bone fractures and disorders under complications. Further investigation in the Medicare Open Payments database revealed that Lupron’s  now owner, AbbVie, paid Dr. Lee $157,066 from 2013 to 2015 to travel and promote Lupron to health professional groups. 2015 sales of Lupron netted $826 million for AbbVie.

For the Medical-Industrial Complex, which has systematically dismantled checks and balances, Lupron is the rule, not the exception. And too many doctors are cogs in the wheel, remarkably naive and susceptible to slick pitches and value laden inducements. Precocious puberty occurs in about 2000 American kids each year. And yet, doctors wrote 24,000 prescriptions for pediatric Lupron in 2015. America’s patients need the FDA to stand tall. Now is exactly the wrong time to go weak and wobbly on us.

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