The 21st Century Cures Act: We Must Move from Euphoria to Vigilance

Families and caretakers of severe mental-illness victims are still jubilant, and justly so, a day after President Obama signed the 21st Century Cures Act into law. The $6.3 billion health care bill marked a historic triumph for America’s most helpless and marginalized sub-population and for Congressman Tim Murphy (R-PA), a statesman of mental-healthcare reform. Murphy, a Naval officer and a practicing psychologist, fought valiantly for four years for acceptance of his Helping Families in Mental Crisis Act, which is enfolded into the new law.

Murphy’s several allies in his crusade have amounted to a “Dream Team” of warriors for mental-health reform. Foremost among them have been E. Fuller Torrey, the prolific author and brilliant pioneering critic of our country’s responses to its mentally ill citizens, and Dj Jaffe, the “ultimate insider” activist and author of the forthcoming book, “Insane Consequences” (Prometheus Books, April 11, 2017) for which Fuller Torrey has written the Foreword.

The new law (whose provisions have been widely reported) has spread joy and hope throughout the “nation” of stricken families, to a degree probably unimaginable to outsiders. I can attest that their messages have amounted to a collective folk-poem of gratitude.

Yet now that the law is safely on the books, we must temper our euphoria with active vigilance. As one of my correspondents put it this morning, “We must all be watchdogs.”

The Achilles Heel in the new law—widely debated during its route to passage—is its easing of restraints on the pharmaceutical industry’s strong impulses toward excessive production and marketing of lucrative psychotropic and antipsychotic drugs.

I will defer a detailed analysis of this weakness to the masterful essay below, written by Adam Gaffney for this morning’s New Republic:

https://newrepublic.com/article/139328/congress-just-quietly-handed-drug-companies-dangerous-victory.

But I will underscore Gaffney’s piece with an excerpt from NO ONE CARES ABOUT CRAZY PEOPLE–one that provides a context for the need to press forward from the Cures Act toward new legislative oversight of Big Pharma:

“That the rising flow of riches in the pharmaceutical industry might bring trouble in its wake—trouble in the form of litigation—apparently did not trouble the giddy pharma-entrepreneurs of the Reagan years and beyond. (And as the years went on and litigation spread and court settlements and fines seemed to add zero after zero to their totals, it grew clear that the entrepreneurs didn’t really care. Their sales figures were adding even more zeros.) The international catastrophe of thalidomide should have been recognized for the dreadful omen that it was, but for some reason this did not happen. The German-made drug, introduced in Europe in 1957 as a completely safe antidote to morning sickness and soon a global phenomenon, caused multiple thousands of birth defects in children of women who trustingly bought it—such as flipper-like arms and the absence of toes, legs, and ears. Roughly half the cases were fatal. Some of the litigation continues today. (Thalidomide was never approved for sale in the United States, yet the makers sent samples to American doctors, who passed them along to their unsuspecting patients, with the inevitable results.)

“The first serious American-made hint of bad consequences arrived with clozapine, whose makers flirted with legal reprisal before voluntarily withdrawing their new atypical drug. But it was the debut of another “atypical” drug, Risperdal (risperidone), that introduced Big Pharma to Big Lawsuit.

“Risperdal went on the market in 1994, a product of Janssen, itself a subsidiary of the pharma giant Johnson & Johnson, the largest marketer of medications in the world. The drug was sold as a treatment for bipolar disorder and schizophrenia. Its makers assured the public of its safety based on three internal trials before submitting it to the FDA for review. Somehow, the trials failed to demonstrate that the drug could result in fever, muscle stiffening, irregular heartbeat, trembling, fainting—and the dangerous disorder tardive dyskinesia.

“These complaints caught the attention of consumer protection agencies in thirty-six states between 1993 and 2004. The state’s full catalog of complaints would have made a Gilded Age railroad baron recommend prayer and penitence. They included allegations that J&J payed kickbacks to the charmingly named Omnicare Inc., the largest nursing home pharmacy in America, to prescribe Risperdal to the generally clueless seniors—many of them suffering from dementia. (Risperdal’s packaging includes a “black box” warning with this language: “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.” Risperdal of course is an antipsychotic. Caveat emptor.) The kickbacks included money, offers of paid vacations for doctors’ trips, and “lucrative consulting agreements” to prescribe Risperdal to more patients. Johnson & Johnson decided to contest these charges and lost. Omnicare, for its part, agreed to pay $98 million to resolve claims that it accepted this booty and thus violated the False Claims Act.

“J&J later reached separate settlements with Texas in 2012 and Montana in 2014 for $158 million and $5.9 million, respectively. Settlements with other states added up to $181 million.

“The dollar amounts of these state trial costs and settlements might lead a reasonable observer to conclude that they taught Big Pharma a lesson it would not soon forget. The reasonable observer is invited to read on, preferably while seated or holding on to a firm object. Not long after the turn of this century, settlements and verdicts against drug companies began to roll out from federal court trials on a monetary scale that obliterated the state-level penalties and threatened to obliterate the very notion of “scale” itself.”