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ASHINGTON — The National Institutes of Health received $7.5 billion in funding in 1990 — an amount that was seen as so paltry that Congress decided the country’s biomedical researchers needed help.

So lawmakers found a way to aid the NIH in a delicate ethical dance: They created a nonprofit that could turn to pharmaceutical manufacturers and soda companies to fund research into their fields, all while attempting to prevent the science from being compromised by the big-money interests picking up the tab.

Even as the NIH budget has climbed to $39 billion next year alone, such public-private partnerships have funded dozens of popular initiatives into specific areas like autoimmune diseases and cancer immunotherapy.

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But recent projects have put the NIH in the spotlight for the wrong reasons. The most controversial was a much-publicized partnership with alcohol manufacturers, which was canceled in June after the NIH concluded scientists had so thoroughly involved alcohol industry figures in planning as to render the science untrustworthy.

Now, the NIH is seeking to bounce back from the hit to its reputation — and to demonstrate that the failures of recent years are isolated incidents and not emblematic of a broader cultural problem. At the same time, some congressional aides have hinted at more aggressive oversight of the foundation through which the NIH takes on many of its partnerships.

NIH officials told STAT this week the agency is completing a plan to ensure better ethical compliance and better delineate the actual process for private-sector collaboration. The officials said the plan will be presented to an advisory committee in December.

Already, as STAT reported in April, the NIH proactively nixed a long-touted plan to accept roughly $200 million from pharmaceutical manufacturers to pursue research on pain and addiction treatment, with an explicit acknowledgement that involving companies being sued for their role in the crisis could taint the perception of the research.

NIH Director Francis Collins acknowledged the setbacks in an interview with STAT this week, but defended his staff’s efforts.

“If you see the major source of a partnership coming from an entity that has a strong investment in what the outcome of the research needs to be, that ought to be looked at very carefully,” said Collins, who has been director since 2009.

Referring to a failed partnership with the National Football League on concussion research, which STAT in 2016 reported carried more strings than originally disclosed, Collins added: “Obviously the NFL would like it if research showed that head injuries from football are not as damaging as some have thought. Certainly the beverage industry would like it if the outcome was that moderate alcohol intake was not bad for you, and might even be good for you.”

There is a clear throughline in the failed research partnerships, as former NIH officials, congressional staffers, and other experts in federal research told STAT: the low-profile Foundation for the National Institutes of Health.

The foundation, located down the road from the NIH’s campus in Bethesda, Md., is not technically a government entity, despite its congressional mandate. But in the last three decades it has facilitated hundreds of partnerships between the NIH and companies hoping to contribute to research, serving as an ethical clearinghouse between private donors and publicly funded researchers.

The FNIH often develops a scientific plan for research collaborations, in partnership with both private funders and the NIH, before soliciting contributions from the private sector and using the funds for science carried out by NIH staff or grantees. NIH scientists, per ethics requirements, are typically instructed to avoid contact with funders that could influence the direction of grant awards or scientific plans.

The vast majority of FNIH projects remain universally popular, including a recent collaboration in which the NIH put up $160 million, and 11 pharmaceutical companies another $5 million each, to aggressively research cancer immunotherapies. Another ongoing project, the Accelerating Medicines Partnership, funds research into Alzheimer’s, type 2 diabetes, rheumatoid arthritis, and lupus.

Some, however, are skeptical that the nonprofit can facilitate any partnerships without the potential for controversy.

“There’s a veneer of safety when money is given through FNIH,” said a former high-ranking NIH official. “Now it’s pretty clear FNIH has not provided much safety.”

Congress, too, is increasingly interested in the foundation: A House committee chastised FNIH in June, warning it and the parallel CDC Foundation to comply with transparency rules. (Crossfit Inc., the chain of high-intensity gyms that has publicly fought so-called “Big Soda” interests, took credit for the House committee language in a recent lobbying disclosure.)

Democratic aides, in an interview with STAT, suggested further oversight of FNIH was not out of the question, but declined to provide further detail.

Aides and outside groups alike also raised concerns that the composition of the FNIH board, which includes executives from Novartis, GSK, and Johnson & Johnson, is too corporate-friendly. It also includes the global head of the private equity firm BlackRock and president of the real estate company Beacon Capital Partners — and Jillian Sackler, a member of the family that benefited from sales of OxyContin.

That composition stands in contrast to FNIH’s congressional mandate, which required that board candidates be chosen from a list submitted by the National Academy of Sciences and specifies that a pediatric medicine and a biobehavioral expert should be included.

FNIH maintains the mandate applied only to the board’s original composition and that, going forward, it was free to choose board members as it saw fit. David Wholley, who manages the FNIH’s research partnerships division, also expressed surprise that outside experts viewed FNIH as too close to industry.

“I’ve not heard that before,” Wholley said.

For Adriane Fugh-Berman, a Georgetown professor who studies pharmaceutical marketing and formerly worked at the National Institute of Child Health and Human Development, the missteps are an inevitable outcome when partnering with industry.

“NIH is well-intentioned and home to many ethical, honest scientists,” she said. “But scientists are not trained in persuasive techniques and are not privy to industry’s long-term marketing goals.”

Collins said FNIH “did its job beautifully” in setting up the trial on alcohol use, and voiced full support for its director, Maria Freire, and for Wholley.

Nothing about the setbacks with the NFL and alcohol collaborations reshaped Collins’s view of public-private partnerships, he said, cautioning against conflating two high-profile failures with the agency’s long track record of successfully accepting outside help.

The difference between successful and controversial projects may hinge on a simple question: whether or not the topic at hand is itself controversial. Private support for popular initiatives generates little or no pushback, especially compared to private support for research of controversial topics.

Ned Sharpless, the director of the National Cancer Institute, suggested as much in a recent interview.

“Think about it the other way,” he said. “If I were to say, ‘I really don’t want to accept private support for these efforts because we have some concerns about how we’re going to cure pancreatic cancer,’ it would give the sense that I’m tying one hand behind my back.”

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In some cases, NIH has accepted money from private-sector partners without FNIH’s help as the middleman. In the wake of the BP oil spill, for example, the oil company wrote NIH a check for $10 million to study the disaster’s health impacts.

Part of the increased exposure, FNIH officials have said, is the organization’s willingness to attempt higher-risk projects.

“Every time we consider something, we are looking at whether there’s any private benefit to anyone, and how does that balance against the public health benefit that we can create,” Wholley said in an interview. “The risk side of that equation goes way up when you’re talking about things like addiction, and it’s going to be a lot less if you’re creating a public-access database of genes that can be searched to see what causes type 2 diabetes.”

It’s a question of risk-reward, Wholley said — a calculus that he, Collins, and Capitol Hill aides said has not changed even as the NIH budget has increased by nearly $10 billion since 2013.

Wholley and a former NIH official said that FNIH itself planned to vote down a proposal to accept money from drug manufacturers on opioids research, before being beaten to the punch by an NIH advisory committee.

The broader question, another former NIH official said, was whether it was possible to construct ethical walls high enough that they can’t be scaled.

Often, it happens all too easily. Multiple sources confirmed an instance last year in which representatives from Wyeth Nutrition — a company acquired in 2012 by Nestle — asked to film a promotional video as part of a research collaboration with NIH, effectively using NIH’s logo to rubber-stamp a Nestle brand.

While a few NIH staffers didn’t reject the idea out of hand, Wyeth, eventually, was gently told no by NIH higher-ups and FNIH. There was no malice involved, said one official who recalled the incident, but it nonetheless demonstrated that ethical conflicts often come with the territory when accepting private funds.

Others opposed the practice outright.

“The fundamental problem,” a second former high-ranking NIH official said, “is that when someone gives you money, they’re not doing it out of altruism.”

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  • This is like looking where the light is better. The NIH decided to put “Alternative Medicine Research” on their Database years ago, and after 2 decades of Pseudo Science, there is no proof any of it works. Now the Complimentary and Alternative Industry, is using the fact that this crap appears on the NIH to advertise their products.
    The NIH lowered their standards for Science, leaving us all exposed to Fake Health Claims. At the same time the FTC has failed to regualte the marketing of this on social media, in Advertorials, or even legitimate news sites.

    Here in Post Science, Post Fact America, anything goes, as long as it is profitable.

    • Mavis, your comments reflect that you are unaware of how your government works. Most of the things you blame NIH for are the purview of other agencies such as FDA, CDC, AHRQ, HRSA, FTC, FCC, SAMHSA, HHS in general, DEA, and on and on. NIH does one thing – fund and conduct research – period. NIH does not set policy nor enforce the law. It does cut off funding for unsafe, or faltering studies. That’s it.

      NIDA has the lead for addictions research and has hundreds of studies in the field examining opioid use and abuse, the effectiveness of new treatment interventions, and the genetics and neurology of addiction as well. What NIDA or any NIH agency does NOT do is macro economic research into unemployment, eviction, bankruptcy, etc. It does fund several studies looking at things like how prescription opioids are used, but it is very unlikley that NIDA would see an epidemic rise in opioid abuse before CDC reported it.

  • Overall, I believe the efforts by NIH to correct the course of their partnership funding policies are sincere and will be effective.
    But I really like the caption photo juxtaposing NIH buildings with beer bottles!

  • This issue appears to be a HUGE problem when considering psychiatric drugs – check out the following articles:

    Lancee, M., et al. (2017). Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs. Translational Psychiatry, 7, e1232.

    Roest, A. M., et al. (2015). Reporting bias in clinical trials investigating the efficacy of second-generation antidepressants in the treatment of anxiety disorders: a report of 2 meta-analyses. Jama Psychiatry, 72(5), 500-510.

    Turner, E. H., et al. (2008). Selective publication of antidepressant trials and its influence on apparent efficacy. New England Journal of Medicine, 358(3), 252-260.

    Zubenko, G. S., Sommer, B. R., & Cohen, B. M. (2018). On the Marketing and Use of Pharmacogenetic Tests for Psychiatric Treatment. JAMA psychiatry.

    • Those psychiatric medications are widely prescribed at low income clinics, prisons, and foster homes. They are prescribed after short visits with professionals. Some states allow psychologists, social workers, or Nurse Practitioners to prescribe with no follow up. Currently there are Court Cases regarding the psychiatric drugging of children at our border.

      These drugs were also advertised as alternatives for chronic pain and addiction. The psychologists conflated the two disorders a few years ago in their DSMV 5. The hysteria over the Opiate Epidemic, weaponized the marketing of these drugs. They are widely prescribed by the VA also, often for Arthritis and other painful conditions. They took away opiates and replaced them with anti psychotics, and the little “research’ they did did not mention the psychiatric medication, they attributed any perceived benefits, to Mindfulness, and alternative medicine.
      Assortments of these drugs are give to people with various disorders, from situational depression to insomnia. They adverse events, hospitalizations, long term outcomes,
      liver damage, and overdoses are not counted. Pharma made sure there was no way to track these negative outcomes. Emergency Rooms, count these overdoses as opiate overdoses. There is no reporting requirement, for these drugs.
      ERs are not required to report the number of overdoses directly related to these drugs. This is anecdotal, but I know of people with numerous re admissions, due to treatments for chronic pain, or addiction, and other problems. These situations have only grown overt the years, yet remain uncounted. I suspect that studying or even counting the adverse events, could result in serious litigation, by well funded pharma lawyers.

      We have the best system money can buy! The NIH has promoted a lot of pseudo science on its database too. They include a number of “Studies” on Acupuncture, Psychological Interventions, Mindfulness, and other alternative woo. Each of these “Studies” are based on limited cohorts, biassed research methods and limited question “Surveys.” These are then used to advertise these alternative methods, with catchy deceptive headlines. We are seeing the end of Science. The only science that is done, is by the comanies themselves or the academic institutions, they fund.

    • @kdn:
      These are serious publications, but maybe the problem with psychiatric medicines is the low quality of the science (resulting in poor understanding and mis-applied knowledge) rather than the type of neurological research that NIH decides to fund or not to fund.

  • The alcohol study was such an egregious example of conflict of interest, and published accounts of the ham-handed way NIAAA’s director used threats and intimidation to dampen criticisms, show that the foundation is a) out of control, and b) the problem of conflict is clearly more systemic at NIH than Collins thinks.

  • Once again these industry partnerships have failed us. The NIH should have anticipated the Opiate Epidemic, or at least made sure that news coverage was factual. They took Industry funds, and looked the other way. The US has some major health problems, due to these Industry partnerships. Public health should not be a marketing scheme used to advertise products which are making American sicker. We live in dangerous times, where am industry can cause countless deaths, and our government agencies are not allowed to mention it. They can only do the “research” that is driven by an industry, and are required to not mention any negative effects. The NIH has become a marketing tool for the profiteers.

    • It is unclear how you think the NIH (NIDA) should have “anticipated” the opioid epidemic. There is no cure for addiction. None. Zero. Nada. There are treatments to help people move to opioid maintenance so they can function without the side effects of illicit opioids. There are drugs that make you sick or that dampen the high of opioids in order to help you abstain from use, but tons of research has shown that relapse to use is the norm. Other research shows that it takes 5 years of abstinence before the odds of relapse are minimized. Few addicts achieve that feat, even with the help of long-term recovery house participation.

      NIDA is working on a clock-work orange intervention that might someday immediately change brain metabolism to reverse addiction. That might be a drug or a genetic modification or both. But the pace of science can move just so fast, and more cash will not pick up the pace proportionately.

      Finally, most of the Press and most Americans view the opioid overdose problem as a drug problem. In my opinion, and that of many colleagues, it is a problem with the US economy. Since the Great Recession, the middle class can no longer comfortably live beyond its means. Trump’s boast of 100% employment merely masks what amounts to indentured servitude. This sort of thing, coupled with automation continually eliminating jobs creates hopelessness, and THAT has triggered the use of fentanyl to commit suicide – as the MASH theme reminds, it’s painless.

    • Mr Hilton,
      The NIH chose to ignore the uptick in opiate prescriptions, back in 2000. They chose not to study the effects of marketing on public health. They also chose to ignore the factors leading up to the “Opiate Epidemic.” There was no objective research, on the increase in Musculo skelatlel injuries, or how the healthcare industry responded. Not much research was done on areas like the outcomes of spinal surgeries. Research like that could cut into industry profitability. No research was done on short term, limited employment as it led to more workplace injuries. The big box stores would have found that kind of research, inconvenient.

      Of course I agree with you that this is really The Epidemic Of Despair, since they choose to focus on prescription drugs by design, rather than look at Rates of alcohol deaths, and suicide. The media re framed the entire narrative. In one of the few areas where they made the “Overdose Deaths” public, it was really clear that 50% of the dead were older sick people, on multiple medications. They were aging blue collar workers, with nothing to look forward to. They were essentially older discarded workers with musculo skeletal injuries, for which there is no cure. They could not afford good healthcare, where their pain would be effectively treated. The rich can take time off, afford luxurious massages, and even hire help. Low income Americans still have to drive, chop firewood, raise their grandkids, and work part time, to survive.

      The NIH allowed pseudo science ‘research” to be included next the scientific research at about the same time they allowed opiates and other pharma products, to be marketed extensively. Maybe that is just a coincidence. A lot of the research exploits the causation, correlation debate.

      The “No Cure” narrative is another alternate fact used by the treatment industry to explain away the deaths after people spend their life savings for “treatment”. They are still cherry picking the facts. It is a fact that for some people there is no “Cure.” It is also a Fact that for others they can just give it up completely. It is a fact, that none of the “Research” was designed to target these groups, instead it conflated any drug usage with addiction. A few addicts are fine with a 12 Step program, but that was marketed to the public as if there was no need for MAT. The media turned it into a “Debate” instead of supplying Facts, Data And Statistics. Opiate Hysteria is good click-bait, and can be used to market other products.

      You are right this is an Economic Problem, and our media has been promoting the false narrative of an economic boom, and of course salaries are not going up. Walk into any national retailer or big box store, what do you think happens when those workers are injured? The industries re framed that too. Most of these employees can’t afford to take a few days off, when injured. They just keep working. Didja wonder why Amazon is so concerned with employee health? Amazon’s warehouse employees are getting injured at ridiculously high rates, so they need a counter narrative, one to discard injured workers.

      The NIH and other organizations had access to a lot of data. they were supposed to be protecting our health. They made the correlation between opiate prescriptions and public health. They chose not to study the effect of state prescription monitoring or even more draconian cuts to prescribing had on public health. One would think the most expensive area in healthcare would have gotten at least a little “research.” Especially with a greying workforce. Look at the available research for musculo skeletal back pain. Look at how there is no research at all on the rates of adverse incidents after back surgery. No government agency tracked the effectiveness of any of it.

      If you really wnat insight into that is going on here, look into billionaire Peter Thiels ideas on healthcare. He was 45s first choice, to run our healthcare system. It is a “Market” so if people want to believe something works, then it is their fault if they get taken. Most Americans have very little access to facts, most of the healthcare information they get is really marketing.

      They have been working on reverse addiction drugs for decades, they marketed one for alcohol. A magic pill is not going to “Cure” anything. It can’t fix the social and economic problems that lead to drug abuse in the first place. No one ever asks what are the Facts. They redefined “Addiction” back in 2015. That was directly related to the 2014 apex of opiate prescribing. This opened the door to all kinds of “Alternatives.” The Death Rate keeps rising, the only objective number we have access to. That might indicate that doing nothing while peddling imaginary cures, is not working.

      The British used Opium to invade China’s Markets, and the US prohibited the marketing of Patent Medicines, containing addictive drugs years ago. Nearly every contrived false narrative in the media, repeats the “We just did not know” story line. Plenty of us knew, the flags were raised in 2000!

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