31 heart studies retracted in latest failure for much-hyped stem-cell therapies

anversaTreatments with “stem cells,” therapies that already were sliding into disrepute due to hyped claims and inappropriate use, took another big hit to their scientific credibility when two respected institutions announced they were retracting 31 published studies claiming stem cells could help patients with damaged hearts.

Harvard Medical School and Brigham and Women’s Hospital in Boston jointly denounced Piero Anversa, a once celebrated cardiologist who had worked at both institutions but left in 2015, for putting out false or fabricated data for dozens of studies he and colleagues published. The works — contrary to accepted science — purportedly showed that damaged heart muscle could be regenerated with stem cells, a type of cell that can transform itself into a variety of other cells.

The medical journals that have published Anversa’s studies must decide for themselves their course of action now with his work. The experts at Retraction Watch, a nonprofit that monitors science publishing and pulled papers as part of an effort to provide greater transparency to the scientific process, say it is rare for one researcher to have so many studies determined to be flawed and subject to removal from public view.

The two institutions have been subjected to growing professional condemnation for their slow response to other respected researchers’ work that built deep doubts about Anversa’s studies. His research not only made him a medical science star starting in 2001 but also helped to launch a wave of ambitious clinical and scientific investigations of stem cells in heart care.

Although Anversa kept churning out studies, many technical, that seemed to advance his idea that stem cells could help repair hearts, others hit a giant block ­─ they could not reproduce his results, despite repeated and rigorous efforts to do so. That can be the death knell for rigorous research. But Anversa faulted others for lacking the skill or techniques to match his own and his colleagues. And Harvard and Brigham and Women’s stood by him.

The well-known hospital, however, found itself answering to federal watchdogs, with Brigham and Women’s recently agreeing to pay $10 million to settle accusations that Uncle Sam’s money had been fraudulently spent on bogus research.

Before Harvard and the hospital backed away from Anversa, his research had led the National Institutes of Health to fund and conduct a clinical trial (under way but under increasing fire) of stem cells for heart repair, and other respected cardiology programs at places like the Cleveland Clinic, Cedars-Sinai Medical Center in Los Angeles, and Johns Hopkins in Baltimore jumped in with initiatives of their own. Anversa and others also started commercial enterprises to capitalize on heart stem cell care.

At the same time, skepticism has grown about this area of care, not only by experts at Stanford and the University of Washington in Seattle questioning Anversa’s work but also by doctors, yes, at Harvard and St. Louis University, where an assistant dean and colleagues raised doubts about the burgeoning business of direct-to-consumer clinics offering cardiac stem cell treatments.

Major heart research centers may have eased their earlier zeal for heart stem cell study and care, and experts quoted in news stories said that information, thus far, has not surfaced on patient harms attributable to Anversa’s retracted work — which, it also should be noted, some other researchers are supporting.

In my practice, I see the harms that patients suffer while seeking medical services and their struggles to access and afford safe, efficient, and excellent medical care, especially in a time when doctors and hospitals pursue their own professional, research, and profit-making agendas. Technology’s rise has put patients in the frustrating, confusing position of trying to decide which hot, new drug or treatment might best benefit them — and at what staggering cost or potential risk. Prominent institutions can’t seem to keep themselves out of negative stories and headlines in recent days, as they’ve been forced to fess up how they have put other interests ahead of the health and safety of their most important charges ─ their sick, injured, and trusting patients.

As for stem cells, their unique capacities to shift and regenerate may yet yield the enormous potential that medical scientists envision. They may, if nothing else push boundaries by boosting basic scientific research. But patients, as with all medical products and therapies, should be cautious and skeptical about stem cells, now to an nth degree. That’s because purported “treatment” with “stem cells,” materials often removed from bone marrow, has become medicine’s wild, wild west.

Companies have thrown up hundreds of web sites, advertising unproven and largely unregulated stem cell treatments. Providers, some operating out of strip malls, have taken to the airwaves to tout stem cell products and services with full-blown commercial broadcasts, while others have advertised heavily in print and wrapped some of the nation’s major newspapers with multi-page promotions.

Without rigorous evidence, claims are circulating freely that patients can benefit from “regenerative” therapies for a staggering array of conditions, including autism, aging, macular degeneration, Lou Gehrig’s disease, Parkinson’s, multiple sclerosis, lupus, and erectile dysfunction.

Patients are flocking to “clinics,” paying from $5,000 to as much as $50,000 a pop, to have fat, blood, and other tissues extracted from their bodies, processed and preserved in ways they likely don’t fully grasp, then re-introduced (injected) into areas of their bodies that give them pain or other problems.

Hype and bunk artists are working over patients and their finances, here and abroad. The results for patients have been scary and grim. The federal Food and Drug Administration has identified stem cell fraud as an area of major concern, and watchdogs have conducted periodic crackdowns on egregious violators.

But the feds, notably through the Health and Human Services department and Alex Azar, its powerful secretary, have signaled their latest focus may not be on cracking down on bogus stem cell study and treatment, instead, choosing to reopen bitter and divisive research arguments over fetal tissues, a related field. That’s a complicated matter, indeed, but federal officials needn’t make their watchdog roles an either-or proposition.

Americans clearly need and they should demand tough oversight and rigorous research on stem cells and their therapeutic uses. It’s an area where taxpayers are spending big money. In California, proponents pumped up taxpayers about how their financial support could transform health care and treatment of many diseases. Voters approved spending $3 billion on state-supported studies on stem cell-regenerative medicine, with modest results to date. Proponents want another $5 billion and skeptics abound.

Taxpayers and patients alike need confidence that novel therapies like stem cells provide benefits not harms – and those who skid beyond ethical bounds working with these materials, whether in fly-by-night storefront operations or elite medical schools and hospitals should suffer appropriate consequences if they engage in wrong doing and deception.

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