Whistleblowers

July 12, 2018

FDA fails to police its elite MD-advisers’ ‘pay later’ deals with Big Pharma

The federal Food and Drug Administration has turned a blind eye to tens of millions of dollars paid by Big Pharma to doctors who play crucial roles in advising the nation’s prescription drug watchdog on the safety and effectiveness of medications sold for billions of dollars annually to the American public.

Science magazine deserves credit for its investigation of conflicts of interest it found by examining readily available public records on payments received by more than 100 physician advisers to the FDA over a four-year period.

Reporter Charles Piller and graphics editor Jia You took an important and different look at records, scrutinizing doctors disclosed drug company funding after their service on elite panels that assist FDA staff in the review and approval of products before they can go to market. Under fire by drug safety and other public advocates, and with intense peer pressure, doctors — grudgingly — have come to accept the notion that they should avoid conflicts of interest before sitting on such influential oversight groups.

November 27, 2017

Medicine needs to face up to sexism and sexual harassment in medical workplaces

by Patrick A. Malone

The profession of medicine gets mixed reviews in rolling back the centuries of chauvinism, arrogance, and boorish behavior of top (male) doctors. It’s now generally if grudgingly recognized that health care, though it may be a life-and-death practice, needn’t be a rude and obnoxious one. Nurses, many of them women but many men, too, shouldn’t be bullied and demeaned by doctors. It makes for mistakes and malpractice and bad patient outcomes, for one thing.

As health care leaders look around at mighty male leaders who are falling left and right in the entertainment, news and political industries, they may wish to look closely at their own talent and its treatment. Women doctors, for example, get a bad deal on a matter as basic as pay: They earn, on average, 20 percent less than men do, even within various specialties, data from 36,000 self-reporting MDs has found. Male vascular surgeons earn $89,000 more than their female counterparts, while male pediatric rheumatologists get about $45,000 more than their female peers do.

The American Medical Association has reported that only 12 percent of internal medicine, 1 percent of surgical, and 22 percent of obstetrics and gynecology department chairs at important, prestigious academic medical centers are women—figures that also are tough to reconcile because 83 percent of obstetrics and gynecology residents are women.

September 11, 2017

In hospitals, angry guys with guns (even with badges) are a bad idea

by Patrick A. Malone

Medicine and law enforcement can be a combustible combination, as a widely publicized incident in a Utah emergency room has reminded. The ugly incident has underscored the importance of hospitals keeping big, upset guys with guns cordoned off from caregivers, as well as the importance of front-line medical personnel knowing, respecting, and protecting patients’ privacy rights about their medical treatment.

Nurse Alex Wubbels became a heroine for firmly and politely telling Salt Lake detectives that the law forbade them from ordering blood extraction and testing on patient William Gray. The unconscious truck driver turned out to be a reserve cop in a nearby small town, and he had been involved in a crash connected to a high-speed chase by Salt Lake officers.

August 3, 2017

Money’s big for Big Pharma — in settlements, lobbying, and product prices

by Patrick A. Malone

Even 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.

July 25, 2017

Fame, reputation and a med school dean’s secret life

by Patrick A. Malone

Although 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:

April 18, 2017

Hospital safety and access are still big problems

by Patrick A. Malone

Hospitals can be risky, troubled, and even downright scary spots, as some recent news and other reports indicate:

Inspector general slams DC VA Medical Center

Almost 100,000 patients of the VA Medical Center in Washington, D.C., have been put at unnecessary risk because hospital staff and administrators, a government watchdog said, failed to “ensure that appropriate medical supplies and equipment were available to providers when needed; that recalled supplies or equipment were not used on patients; and that sterile supplies were stored appropriately.”

November 20, 2016

Quick tips for a safe and healthy Thanksgiving

by Patrick A. Malone

As 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.

October 25, 2016

Federal auditors assail $359 million in Medicare costs for chiropractic care

by Patrick A. Malone

Federal 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.

October 24, 2016

FDA lets medical device-makers report safety woes in lax, secretive ways

by Patrick A. Malone

Instead 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.

October 9, 2016

Big Pharma, undeterred, racks up a half-billion dollars in regulator penalties

by Patrick A. Malone

Big 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

Mylan, the controversial maker of the EpiPen, settled with the U.S. Department Justice and other federal agencies, agreeing to pay $465 million over claims it improperly classified and overcharged Medicaid and Medicare for its anti-allergy medication injection device. The government long had warned Mylan that it could not classify the EpiPen as a generic drug. Instead, officials said it should be deemed a brand-name product, meaning Mylan should have given the government a bigger rebate when it paid for EpiPens for the poor. The company, which I have written extensively about, admitted no wrong-doing, and said this settlement should help quell the public anger at the firm, which has sent the price of the EpiPens skyrocketing. Although the firm will pay almost a half-billion in federal penalties, officials estimated the revenue on EpiPens totaled almost $1.3 billion. And while the company has lowered its earnings guidance to cover the cost of this settlement and other of its responses to the public furor over EpiPens, the company’s stock rose after the settlement announcement by as much as $3 per share in after hours trading, closing at $39.35.