Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

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Patrick Malone & Associates P.C. | DC Injury Lawyers

Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential professional conflicts of interest, notably the significant sums they get from Big Pharma and medical device makers.

ProPublica, the Pulitzer Prize-winning investigative organization, and the Los Angeles Times jointly scrutinized the experts’ required disclosures, finding they not only fall short. They may fail to give the public a fair view of the credibility of their findings. And, in California, they may be a unique rip-off of the state’s top university system. The “UCs” provide research faculty with costly facilities and other support, as well as sharing its global renown — in exchange for revenue the experts may earn outside the system.

In total, after examining records on tens of thousands of university scholars and NIH experts, ProPublica not only has made public its “Dollars for Profs” database, it also quotes federal watchdogs as estimating that with the NIH alone, conflicts of interest with agency grants amounts to $1 billion.

Different institutions set their own individual thresholds at which their faculty and staff must declare outside earnings, to be as transparent to the public as possible about ethical and other potential conflicts of interest, the news organizations reported.

The NIH level for “significant” financial ties that must be disclosed is $5,000 annually. As ProPublica explained how experts get to this sum — fast — and what it means:

“[These are] the financial relationships of researchers at universities, hospitals and nonprofit organizations. These outside interests range from stock holdings in companies that may benefit from the outcome of research to payments for royalties, consulting work and speaking engagements … The NIH requires disclosures of ‘significant’ financial conflicts — valued at more than $5,000 a year — because outside income from interested parties can potentially affect researchers’ objectivity and influence the design and findings of their taxpayer-subsidized work.”

Fewer than half of researchers who did declare to the agency put dollar sums to their potential financial conflicts, ProPublica reported. But the site also noted:

 “Most of the financial relationships with a value of $600,000 or more, the highest level of disclosure, resulted from researchers taking equity stakes in, or licensing patents and copyrights to, drug and biotech companies. The companies range from small, private startups to large pharmaceutical concerns such as Bristol-Myers Squibb, Eli Lilly and Co., and Novartis.”

That researchers not only get into these beneficial situations but also may hold board seats and have other authority may be further fuel for critics who argue that Big Pharma and medical device makers — while crying “poor me” about high research and development costs, which, they, in turn, use to justify sky high prices for their products — may reap huge benefits from taxpayer support for studies at universities, funded in or involving the NIH. As ProPublica reported:

“The NIH is the biggest public funder of biomedical research in the country, with more than 80% of its $39.2 billion budget going toward grants to fund work at universities and research institutions.”

The ProPublica report is laced with names of top schools like Harvard, Northwestern, and, of course, the UCs.

The Los Angeles Times picks up the criticism of profiting profs there, with a zing of Dr. Neal Hermanowicz, whom the newspaper reported “has led the movement disorders program at UC Irvine [shown above], where he earns more than $380,000 a year in salary and bonuses.” He has boosted his earnings with Big Pharma consulting, the news article said:

“Since 2014, 11 pharmaceutical companies have paid him a total of at least $588,000 in consulting and speaking fees and honorariums, according to federal data. For example, he has received more than $225,000 in speaking and consulting fees from San Diego-based Acadia Pharmaceuticals, manufacturer of a controversial drug for Parkinson’s-related psychosis. In 2017, he was the company’s highest-paid physician consultant in the U.S. That year, he prescribed the drug more than 180 times, costing patients or their insurers more than $445,000. Under University of California rules aimed at discouraging excessive moonlighting, Hermanowicz should have reported his outside income to UC Irvine. He also should have turned over more than $200,000 of it to the school from 2016 to 2018, according to UC Irvine policies. His academic department would then have decided how much to keep and how much to return to him. But that didn’t happen, because Hermanowicz did not report to UC Irvine any payments from pharmaceutical companies from 2014 to 2018, according to internal campus documents.

He declined to comment to the newspaper, which found he was not an outlier, as “A review of almost 90 UC system health faculty members, who had among the highest outside incomes at four medical schools, found that about two-thirds, including Hermanowicz, did not report all of the money as required,” the newspaper reported.

The conflict-reporting rules not only affect institutional finances, they play a key role in protecting the health, safety, and well-being of the public, the Los Angeles Times noted. That’s because they give institutions oversight of the outside work of esteemed faculty and staff, including how they may stake the hard-won credibility and reputation of a university while boosting their earnings:

“The failure to report outside income may conceal conflicts of interest affecting the objectivity of teaching and research. Under UC Irvine guidelines, for example, outside consulting should be ‘as separate from the research as possible’ to avoid conflicts. If a conflict interferes with academic duties, or the professor fails to report outside work, the university can intervene by limiting consulting or, in egregious cases, terminating employment. Hermanowicz has been a leading advocate for Acadia’s drug, pimavanserin. Approved in 2016, the drug, better known by its trade name Nuplazid, has been associated with more than 2,000 patient deaths and 10,000 other adverse events, according to Food and Drug Administration data — figures that one expert has called an ‘important warning signal.’ Besides serving as an investigator in its clinical trials, Hermanowicz has also published several studies that tout Nuplazid’s safety and efficacy while acknowledging his financial ties to the company. Nuplazid ‘got some attention in CNN recently with maybe an increasing risk of death, which I don’t think is valid,’ he told doctors and patients gathered in a hospital conference room in Burbank last year. ‘They didn’t really do a careful analysis. They just said people took this medication and then they died.’ Last year, an FDA analysis found no “new or unexpected” safety risks related to Nuplazid, which remains on the market. Acadia has maintained that the drug is safe for patients and that the multitude of adverse events reflects its patient population, which is mostly elderly and in an advanced stage of Parkinson’s disease.”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent medical care. This has become an ordeal due to the skyrocketing cost, complexity, and uncertainty of therapies and prescription medications, too many of which turn out to be dangerous drugs. Too many of us find ourselves out to sea way too often on health and medical matters, which almost seem to require Ph.D.s to even start to discuss. We fund with our hard-earned pay state and federal institutions to not only advance medical and other science but also to keep us from getting suffocated in industry fog about drugs and medical devices.

No one expects a vow of poverty from those who are brilliant enough to win tenure and advance medical science with their rigorous work, at top universities or the NIH. At the same time, it’s unacceptable for these intellectual elites to revel in the security, prestige, and support of taxpayers, universities, and the NIH while in extreme fashion enriching themselves and Big Pharma, medical device makers, and others. At minimum, if they want to live high on the hog, they should fess up to it — if it is ethical, meritorious, and justifiable. The rest of us can’t even begin to make decisions about good uses of our tax dollars with sound conflict declarations.

Stanton Glantz, a UC San Francisco professor whom the Los Angeles Times reported “researches the tobacco industry, sits on the conflict-of-interest committee for his campus and doesn’t do any paid outside consulting with pharmaceutical companies,” had some tough, smart words to say about the issue. As he told the newspaper:

“People who get in there [universities] and are trying to make money on the side: Why bother being a professor? If people are breaking the rules, they should be disciplined.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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