It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.
Some 5.4 million children in the United States have been diagnosed with attention-deficit hyperactivity disorder, or ADHD, with two-thirds of them taking psychiatric drugs. Sales of ADHD drugs reached $1.2 billion in 2010, a demand level so high that the U.S. is experiencing an ADHD drug shortage. But an increasingly vocal contingent of psychiatric experts is speaking up against diagnosing children with ADHD, arguing it is a non-existent condition drummed up by pharmaceutical companies to increase sales.
Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found. More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months. “Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.
The Neurological Devices Advisory Panel of the U.S. Food and Drug Administration (F.D.A.), recommended Friday that devices used to deliver shock treatment, also known as electroconvulsive therapy (ECT) remain in the most high-risk category (Class III), reserved for the most dangerous medical devices and not be downgraded to a lower risk category. In so doing, it recommended that the companies which manufacture ECT devices be required to prove that ECT is both effective and safe in order to remain in use. ECT has long been known to cause serious harm to patients, including extremely severe and permanent memory loss, inability to learn and remember new events, depression, suicide, cardiovascular complications, prolonged and dangerous seizures and even death.
Note from CCHR: Let’s see if we’ve got this straight…..last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. The company also paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes Other corporate violators included GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals. Criminal or civil illegalities included (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution. And after all that, the FDA is going to allow Big Pharma to launch into social media? Seriously?