Articles Posted in Whistleblowers

pills-300x129Even as drug makers are settling or scrambling to resolve disputes with regulators over dubious ways they peddle products, Big Pharma is busting records for its spending to lobby lawmakers on skyrocketing prices, easing industry oversight, and other issues critical not only to the sector but also to tens of millions of consumers.

It’s distressing how news reports continue to show not only the flood of money in prescription drugs but also how medication makers put profit motives ahead of other concerns like the public interest.

Take for example the $280 million that Celgene has agreed to pay to settle fraud claims over its marketing of Thalomid and Revlimid for unapproved uses.

nucarmen-189x300Although smaller community hospitals may provide treatments that are as good and as safe, Americans flock to academic medical centers for specialized care and complex procedures. They’re lured to the big, pricey institutions by their stellar reputations, state-of-the-art facilities, and top-line specialists. These tall, shiny complexes, combining medical education, research and clinical care, also have deep roots in their communities and become political powerhouses in their own right.

Which is why many in the nation’s No. 2 city are abuzz over a Los Angeles Times investigation into the “secret life” of Carmen A. Puliafito, a Harvard-trained eye expert. Until 18 months ago, he had served for a decade as the $1 million-a-year dean of the University of Southern California’s Keck School of Medicine. As Keck’s top doc, the paper says, he “oversaw hundreds of medical students, thousands of professors and clinicians, and research grants totaling more than $200 million … [and] was a key fundraiser for USC, bringing in more than $1 billion in donations, by his estimation.”

The university—which is Los Angeles County’s largest employer, a haven for affluent offspring of West Coast elites, and long has craved global recognition—hired and backed Puliafito to boost the medical school’s  standing.  But during his tenure, the Los Angeles Times found, Puliafito also “kept company with a circle of criminals and drug users who said he used methamphetamine and other drugs with them.” As the paper describes it:

Thanksgiving-turkey-shared-via-creative-commons-by-Betty-Crocker-RecipesAs tens of millions of us set out to feast and give thanks, some thoughts about making the holiday safe and healthy:

Turn off the e-devices when driving

When driving to see friends and family, shut off the electronic devices, please, and forgo the apps on them, as long as you’re the one behind the wheel. The National Highway Traffic Administration says that, after a half century of declines, traffic fatalities in 2015 recorded their largest percentage leap in a half century—and in the first half of 2016, the figures are up 10.4 percent more over last year (17,775 road deaths). Officials say distracted driving is reaching deadly levels, especially as motorists tap devices and apps to send meaningless texts or take selfies. This already has proved fatal to innocent others, including  multiple-vehicle wrecks.  I deal in my practice with the tragic aftermath of the carnage that vehicles and negligent drivers can inflict. When you’re behind the wheel, you’re responsible for what can become a multi-ton missile. Be safe. If you’re under the influence—due to alcohol, marijuana, or prescription drugs— rely on a sober, designated driver.  Or take a taxi or tap Uber or Lyft. Or sleep on the couch or floor. We’ll be thankful you did.

spinal cordFederal auditors have found that 80 percent of Medicare spending in a recent year on chiropractic care−some $359 million−was medically unnecessary. The federal insurance program for senior citizens should not have thrown taxpayer dollars at chiropractors to treat strains, sprains, or joint conditions, the Department of Health and Human Services’ Office of Inspector General says.

Its auditors, reporting on 2013 claims, said Medicare should impose limits on how often seniors can receive chiropractic care, which they said became excessive after a dozen visits; after 30 sessions of treatment, the federal watchdogs said, patients were receiving unnecessary care.

The chiropractors’ association denounced the audit and the proposed curbs on their practitioners’ care. The acting director of the Centers for Medicare and Medicaid Services resisted the recommendations for caps on chiropractic treatment, noting the absence of cited evidence and differences in individual patients. The agency noted that it has tightened its rules on chiropractic claims, including requirements soon to take force that will require advance approval for certain kinds of this care.

prof-Madris-glasses-crop-2Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices−from heart valves to drug pumps−the federal Food and Drug Administration all too often has served as an industry lap cat offering late, lax oversight in reporting safety woes, a new report finds. The Minneapolis Star-Tribune and former agency official Madris Tomes (photo right) deserve credit for blowing the whistle on the gaping bureaucratic loophole that lets device makers report problems almost at their leisure, and to do so in a way that hides issues from public view.

By law, the paper says, makers are supposed to file safety incident reports with the FDA within 30 days of occurrence. But the agency not only fails to enforce that requirement, it has created a process of Orwellian double-speak, allowing “retrospective reporting.” Device makers in this process tell the agency about hundreds of thousands of safety incidents, sometimes years after they occurred. Further, the FDA allows the companies to detail the incidents, in some cases tens of thousands of them, in confidential reports. The only notice the public gets is via terse summaries, “marker reports,” of the much longer documents.

Tomes, since leaving the agency, has created a search engine, Device Events, that helps outsiders track agency information on medical devices’ performance. Using that tool, it still took Star-Tribune reporters almost a year to pry from the FDA information barely hinted at in marker reports.

drugpriceBig Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and tactics:

$465 million penalty, settlement for EpiPen maker

tarcevaFederal prosecutors have wrung $67 million in a settlement with two pharmaceutical companies accused of deceiving doctors to prescribe a drug that the firms knew would be ineffective in treating lung cancer patients. Genentech and OSI Pharmaceuticals pushed the drug Tarceva for non-small-cell lung cancer, “even though studies had shown that it worked for just those who had never smoked or had a certain gene mutation,” the Los Angeles Times says.

The paper and prosecutors described the sleazy promotion of Tarceva, which was disclosed in a lawsuit filed against Genentech by a former employee. He will receive a $10 million payment under federal whistleblower laws. His lawsuit asserted that the companies wrongly hawked Tarceva by:

Giving doctors illegal kickbacks disguised as fees for making speeches or serving on Genentech’s advisory boards. Sales representatives across the country were ‘instructed to spend lavishly’ on physicians, the case said, and given ‘an unlimited budget to wine and dine.’ Genentech also organized lunches or dinners for lung cancer patients where ‘patient ambassadors’ were paid fees to speak about how Tarceva could be used in ways never approved by regulators.

nihclincenterFederal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared that research concerns there had wrongly taken precedence over patient safety.

Initial reports about the NIH Clinical Center, as I wrote recently, had suggested that systemic changes were required at the venerated and sprawling facility, particularly after disturbing reports surfaced about neglect and unsanitary conditions in its pharmacy operations. Officials first spoke just of creating a new, external oversight body, and an office to monitor quality and safety concerns.

But, as the Washington Post since has reported, the NIH’s chief has decided to “replace the hospital’s longtime leadership with a new management team with experience in oversight and patient safety, similar to the top structure of most hospitals. He is recruiting for three new positions: a chief executive, a chief operating officer and a chief medical officer. … [He] wants all three to be physicians, and he wants them in place by the end of the year.”

It’s a short paragraph, fine-print tucked in a 10,000-word document on tobacco product regulations. But these 245 words (see Intended Use Regulations, ง 201.128) have lit up critics of the U.S. Food and Drug Administration. They say officials are trying to pull a fast one, seeking to relax labeling rules for drugs and medical devices. This could make it tougher to hold manufacturers accountable for their products’ harms. The proposed FDA rule change, critics say, relieves companies from providing “adequate labeling” for non-FDA-approved uses of their products that they know about. This applies to detailed explanations inserted with drugs or devices.

Although the change might give companies greater “free speech” in discussing their products and allow for more “off-label” uses, which doctors like, critics decry this alteration. They say the agency needs to get tougher on off-label uses and to force companies to be more rather than less transparent about them

I’ve written, for example, about the abominable practice by some physicians who write prescriptions for powerful anti-psychotic medications for tots; the drugs never have been tested in children. No one will defend this use, though it is increasing and may be a dangerous use of drugs to restrain difficult infants and toddlers. Medical device manufacturers have come under fire when their products were used off-label for unintended uses, resulting in one case in thousands of claims of patient harms.

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