Articles Posted in Conflicts of Interest

seqcore_slider_img_resizedAlthough doctors and hospitals report potentially sunnier news by the day about novel cancer treatments, it’s also worth keeping in mind that difficult obstacles like data misinterpretation still must be worked out to avoid endangering patients. The therapies themselves as well as cancer care overall can be crushing in their costs. And some experts also are raising questions about Big Pharma and the independence of advocacy groups that patients and families often turn to when diagnosed with different cancers.

Let’s start with the ray of optimism that the Washington Post reported for patients with advanced lung cancer. It kills more than 160,000 Americans annually, and isn’t diagnosed often until it reaches late stages. Lung cancer, the Post says, retains its stigma because of its proven link to smoking. Both smokers—and nonsmokers who also may develop the disease for many other complex reasons—are blamed for causing their own illness.

Oncologists have begun to look at this cancer not as one but many different disease, and the paper says immunotherapy may improve outcomes for a slice of late-stage patients, halting the disease’s spread and without the significant side-effects of current chemo or radiation treatments. In immunotherapy, patients’ cancers are tested to determine which drugs may best target and destroy tumors by unleashing the bodies’ own disease-fighting (immunity) systems.

elexAlthough many Americans remain saddened or exultant  by the results of the  presidential vote, the November ballot produced key health-related results worth a quick post-mortem:

Just some quick updates on some topics that the blog has followed in recent days:

Big Soda, Big Pharma spending big to battle ballot measures

SouthDakota-StateSeal.svgSouth Dakotans will need their state lawmakers’ help now to pry open physicians’ iron grip on secret decisions about which doctors get to practice in hospitals and why. That’s because the state’s Supreme Court ruled this vital information must be kept confidential, even if releasing it would serve a wider good of disclosing possible criminal or fraudulent conduct.

The high court ducked its potential role in helping more than 30 patients who claim they were mangled in excruciating, needless surgeries performed by Allen Sossan, an osteopath with an easily discovered criminal past and a checkered medical practice record in the area around Yankton, S.D. I’ve written about this case before.

Several South Dakota hospitals gave Sossan practice privileges after his credentials were reviewed by physician committees, which, since have fought mightily to keep secret what they knew and when they knew it about him. Sossan since has been indicted for providing false information to medical licensing authorities. The convicted burglar and check kiter apparently has fled the country and may be back in his native Iran.

aarpThey keep burgeoning, even though evidence-based research indicates they’re not working. They’re unfair to employees. They intrude on workers’ privacy.  And so AARP, the largest advocacy group for older Americans, is  suing a federal agency to try to curb workplace wellness programs.

AARP says in its suit that the Equal Employment Opportunity Commission, which oversees many workplace practices, must recognize that employer wellness programs are discriminatory, and they violate workers’ rights to keep private their personal health information.

Believing the programs help reduce ever-rising medical costs by encouraging healthier behaviors, employers are offering increasing incentives to get their employees into wellness programs. Some pay as much as 30 percent of workers’ annual health insurance premiums. The New York Times, citing Kaiser Family Foundation data, said  those yearly premiums for an individual average run $6,435. That means a worker could lose as much as $2,000 by declining to join a company wellness program.

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.

death-certificate-state-by-state-default-750_50California regulators have reversed themselves and decided to require hospitals to report outbreaks of “superbug” cases, rare infections that also can prove deadly. At the same time, officials in the Golden State haven’t moved to increase the information disclosed on death certificates−data that advocates suggest would give the public clearer outlines of just how severe a problem hospital-acquired infections have become.

Kudos to the Los Angeles Times, which delved in a recent front-page investigation into the dearth of information disclosed on death certificates, especially about hospital-acquired infections. The paper detailed how a Los Angeles area patient had contracted, while hospitalized, a rare carbapenem-resistant enterobacteriaceae or CRE infection. This superbug resists treatment with an array of antibiotics, eventually killing half those it afflicts. Its outbreaks are a huge concern for public health authorities.

But, The Los Angeles Times said, hospitals had cried “poor me” to the state, saying it required extensive resources to monitor and report CRE outbreaks. The death certificate for the patient with the CRE infection, the newspaper said, listed a perforated ulcer as her cause of death. Her family was outraged because they had urged Torrance Memorial Medical Center to report a CRE outbreak to the state.

SupremeCourtSealSouth Dakota’s highest court has been asked to reject hospitals’ attempts to keep secret why a doctor, who also is a convicted burglar with a checkered medical past that could have easily been uncovered, passed a peer review that permitted him to perform brutal, excruciating, and unnecessary spinal surgeries on dozens of patients.

A lower court rejected the sweeping claims by the hospitals that the reviews can never be disclosed. The judge said that indications of crimes or fraud, as raised by evidence-based malpractice lawsuits, are sufficient reason to breach confidentiality protections shielding vital insights into how hospitals judge physician performance and permit doctors to practice in their institutions.

More than 30 patients have sued surgeon Allen Sossan. He is a convicted felon, who had changed his name, and who apparently has fled to Iran. Patients assert he caused them great pain and maimed them with unnecessary, complex back procedures. Further, patients have sued more than a dozen doctors who reviewed his credentials and granted him privileges at Avera Sacred Heart and Lewis & Clark Specialty Hospital, both in Yankton, S.D.

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

Raw_cane_sugar_lightWe’ve seen this playbook before, and it’s never pretty how wealthy industries can distort scientific research and harm the public health for decades. Think tobacco and cancer, oil and climate change, football and brain injury. Now: sugar.

Big Sugar secretly paid influential experts, steered and reviewed their inquiry, and, as a result, American health policy at a critical point in the 1960s–and since–has emphasized the role of fats and downplayed sugar’s harms in the rising incidence of heart disease, researchers have found.

This influence-peddling involved then-prominent (now dead) Harvard nutrition experts and the highly respected New England Journal of Medicine (NEJM). The prevailing ethics then differed. Authors were not required by medical journals to disclose conflicts of interest, as they are supposed to now.

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