Articles Posted in Whistleblowers

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.

michlawblogA Michigan lawyer may write about the untruthful testimony of an “expert” medical witness because his online blog post and his comments are protected speech under the First Amendment, officials from the Michigan Bar have decided. That’s good news for the lawyer, who had his law license challenged by the witness─a psychiatrist who also happens to be a member of Michigan’s lawyer licensing board. She had demanded that either his post about her or his license be pulled. Now neither will happen.

The case still leaves a lingering odor around that board, the doctor who served as a so-called Independent Medical Examiner (IME), and the process in which she sought sanctions against a legal professional, instead of receiving public condemnation when she got caught, on videotape, fabricating statements about a severely injured plaintiff.

Hired guns

michblogIn protecting its citizens, Michigan already is taking a deserved drubbing for its shameful government  negligence in allowing the lead pollution of Flint‘s drinking water. Officials now need to get their act together to stop a different kind of public policy embarrassment: Expert medical witnesses who abandon any pretext of objectivity and instead work hard to help insurance companies cheat injured people.

This legal controversy is developing in the Detroit suburbs.  It ought to deeply trouble anyone concerned with the First Amendment, and the civil justice system and its fair application of the law in cases of vulnerable litigants who have suffered medical injuries.

On its face, this looks like a doctor versus lawyer dispute. It’s more than that.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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