Kentucky Oral Health Coalition will host a regional meeting on oral health July 29 in Hazard

July 27, 2016: An updated graphic sent by Kentucky Voices for Health has been added.

The Kentucky Oral Health Coalition and its partners from across the state will host a regional oral health convening Friday, July 29 in Hazard to increase dental awareness and develop strategies to address the widespread dental access issues in Eastern Kentucky, says the Kentucky Rural Health Association.

This is the third of four regional meetings this year, welcoming local policymakers, health advocates, health professionals, educators and students.

Dr. Daria "Nikki" Stone, associate professor at the University of Kentucky College of Dentistry and director of the Ronald McDonald Care Mobile program in Hazard, will speak at the convening about the dental status of the Eastern Kentucky region.

A study on the oral health of Kentucky released this year indicates there is much to convene about. The good news is that the report found that more Kentuckians than ever had access to dental care because of Medicaid eligibility for dental insurance. Eastern Kentucky has 31 percent of the total Medicaid enrollment.

However, dental coverage for much of this population will be threatened if Gov. Matt Bevin's new Medicaid plan is approved because it will remove this benefit for all people covered by the 2014 expansion of Medicaid eligibility and require it to be earned back through a rewards program.

Initial graphic released by KVH

Kentucky Voices For Health put together a chart that shows what an individual on the new Medicaid plan would have to do to get dental (and vision) benefits. They have strongly opposed this proposed change.

Dental leaders have also opposed this change saying in a news release that the removal of these benefits, "interrupts enrollment of a vulnerable Medicaid population, at the expense of quality health for the population and under the guise of controlling state expenditures," noting that "adult dental expenditures comprise less than 2 percent of the cost drivers for the state share" of Medicaid.

Updated graphic, provided by KVH

The study also noted that despite more people having access, finding a dentist can still be a problem, especially in rural Kentucky where 24 Kentucky counties had fewer than 1.7 dentists per 10,000 population. It also found that even though children on Medicaid have dental insurance, more than half of them don't get any dental care.

In addition, the report found that Kentucky ranks 10th in the percentage of adults who haven't been to the dentist in the past year (39.7 percent); eighth in adults with permanent teeth extraction because of tooth decay or gum disease (50.3 percent); fifth in adults having six or more permanent teeth extracted (51.5 percent); and fifth in adults ages 65 and older who had all their natural teeth extracted (24.8 percent).

The convening will be at the University of Kentucky Center for Excellence in Rural Health in Hazard, from 10 a.m. to 3 p.m. It is free and open to the public, but registration is suggested. Click here to register.

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Cabinet says kinks are worked out of the state's new public benefit system, but Republican lawmaker calls for contract review

Health officials assured lawmakers on Thursday that they had worked through the issues that led to the  rocky rollout of the state's new public benefit system, but lawmakers pushed back with harsh criticism, with one Republican calling for the state attorney general's office to examine the contract with the company who built it, Deborah Yetter reports for The Courier-Journal.

"It seems like our most vulnerable populations are the ones who have paid for the shortcomings," Sen. Danny Carroll, R-Paducah, said of the system that caused "massive disruptions in public benefits such as Medicaid and food stamps earlier this year," Yetter writes. "Maybe that's something the attorney general should take a look at," he said.

Carroll, co-chairman of the joint Program Review and Investigations Committee, which held Thursday's hearing, suggested that Attorney General Andy Beshear look into whether the state could recoup some of the funds it paid Deloitte Consulting, the company that built the $100-million system known as Benefind, Yetter writes.

Benefind is meant to be a one-stop shop website for public benefits, like food stamps and Medicaid. It was initiated under former Gov. Steve Beshear. Its launch was delayed twice, once on Dec. 4, under Beshear and again on Dec. 28, under Gov. Matt Bevin. It went live on Feb. 29 and ended up causing a "massive disruption" in public benefits that has taken months to rectify. Kentucky paid Deloitte $3.5 million for the delays,  Kevin Wheatley reports for CN|2 Pure Politics.

Deloitte principal Kevin Pollari said the firm has "stepped up the best we can" to fix the problems, offering 120 employees to help train cabinet staff, providing staff to help the cabinet process the 50,000 backlogged cases that were disrupted during the launch, and implementing a rapid-response team for cases that required urgent attention, Wheatley reports.

"Some lawmakers said they had been inundated with complaints from people who lost health coverage, food stamps or other important public assistance," Yetter reports. In an earlier story, she wrote about one case:

  Good, affordable health insurance was essential for Harry Mudd when he retired in January.
  And he found it. Using Kynect, Kentucky's health insurance exchange, Mudd, 61, and his wife, Ginger Owen, bought a high-quality plan for about $560 a month, the additional cost offset by a tax subsidy under the federal Affordable Care Act.
  But after Kentucky launched benefind, a new public benefit system, their coverage was disrupted and the Louisville couple was startled to find that they had been enrolled in Medicaid – the public health plan for low-income and disabled Kentuckians. And they lost the $637 federal subsidy that helped pay for their private plan.
  Mudd and Owen, after repeated attempts, got Medicaid canceled. But they now must pay $1,200 a month for their private health coverage – more than double what they had budgeted – and despite multiple calls, lengthy waits on hold and complaints to various officials, they could not get the tax credit restored.

Rep. Jeff Taylor, D-Hopkinsville, wondered why state officials didn't have a contingency plan when they realized soon after the launch of Benefind that it was resulting in widespread problems.

Cabinet officials said the scope of the problems with Benefind weren't immediately apparent to the new administration, though they made it a priority once they realized it, Yetter reports.

Bernard "Deck" Decker, the cabinet's technology director, agreed, saying,"It probably took us a month and a half to get an idea of the magnitude of how bad this was. It was extremely bad."

Decker noted that the backlog of some 50,000 cases waiting to be processed has been cleared, hours-long wait times for calls have been cut to an average of 20 to 25 minutes, and state workers have reviewed and addressed some 200,000 letters (many wrongly sent) that were generated by the system that told consumers they were loosing benefits or demanding information already provided, Yetter writes.

Two health advocates agreed that many of the problems have been corrected, but said others persist, Yetter reports. Consumers are still getting letters with misinformation, still having difficulty accessing benefits, and still spending hours on the phone trying to get to a person with appropriate knowledge to help them, said Cara Stewart, a lawyer with the Kentucky Equal Justice Center.

Sen. Stephen West, R-Paris, defended the administration, saying the system has the potential to be more efficient and save the state money, despite current criticisms.

"I think you guys are to be commended," he told the officials. "There would have been a lot of second-guessing of Dwight D. Eisenhower when he stormed Normandy."

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Illinois Needs to Protect Consumers in Wake of Land of Lincoln Debacle

The liquidation of Land of Lincoln Health is just the first of mounting hurdles for Illinois consumers and small-business owners shopping for health insurance coverage in the Affordable Care Act marketplace.

Not only do Illinois consumers wait longer than others across the country to see annual rate increases, but they also have fewer resources to help navigate the marketplace. The state's budget morass means the two state agencies charged with protecting consumer interests and helping consumers connect with coverage options—the Department of Insurance and Get Covered Illinois—are underfunded and ill-prepared to serve the public.

Who will protect consumers' interests in the demise of Land of Lincoln? We keep hearing that the state's insurance department doesn't have the staff to provide information on rate increases to the public until Aug. 1 (even though the department received them from insurers in April). If regulators can't meet the requirements of the ACA in a timely manner, how will they manage the liquidation details for Land of Lincoln? Can consumers count on them to answer critical questions about their now-defunct Land of Lincoln plans?

Questions like: Should I keep paying my premiums to Land of Lincoln? (Yes, you should if you want to be eligible for the special enrollment period plan holders will be offered.) Will I be able to find another plan with my providers in the network at the same price point? What happens if I already met my deductible with Land of Lincoln? Will that carry over to the new plan? And, who will help me find a new plan? Because Get Covered grant funding to help consumers is gone, and insurance carriers reduced or eliminated broker commission for working with clients, Illinois consumers are left with fewer resources when faced with complex health insurance decisions.

We should all be watching how the Department of Insurance addresses the needs of Land of Lincoln policyholders. When Blue Cross & Blue Shield narrowed its networks offered in the marketplace, thousands migrated to Land of Lincoln because of its broader networks with academic medical centers like the University of Chicago. The loss of Land of Lincoln leaves consumers and small-business owners worrying about continuity of care—for themselves and their employees.

This development ensures one thing for the upcoming open enrollment season: Illinois consumers and small businesses will have even less choice, and fewer affordable options that cover a broader network of health care providers.

How the Department of Insurance responds to this crisis is important for all Illinois consumers. We only hope the Rauner administration redirects resources to make sure the Department of Insurance can do its job and do it well.


Barbara Otto and Michelle Thornton Health & Disability Advocates

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Reprinted with permission from Crain's Chicago Business

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Abort, Retry, Fail - Billionaire Bill Gates Opines, Sans Evidence, on ... the Efficacy of Hepatitis C Treatment?

If you needed advice about the technical characteristics of computer operating systems you probably would not go to your doctor for it.  So why would you seek the opinion of a software company mogul about the efficacy of pharmaceuticals?

Software Mogul Bill Gates on the Pricing and Efficacy of Antiviral Drugs for Hepatitis C 

Nonetheless, per Bloomberg, last week Bill Gates pontificated about drugs for the treatment of hepatitis C.  When apparently asked about the priorities of the Bill and Melinda Gates Foundation, Mr Gates said

market forces were working properly in hepatitis C, invoking Gilead Sciences Inc.’s treatments Sovaldi and Harvoni, which have been criticized by insurers and politicians as too expensive at $1,000 a pill or more for 12 weeks of treatment, before discounts and rebates.

While Gilead is the market leader, it’s now facing competition from Merck & Co. and AbbVie Inc., forcing prices lower.

'Curing hepatitis C, this is a phenomenal thing, and now you have multiple drug companies competing in terms of the quality and the price of that offering,' he said.

More broadly, Mr Gates defended the high prices of drugs in the US, partly because:

The drug companies are turning out miracles....

Not a Wonder Drug, According to the Clinical Research Evidence

Mr Gates, it seems, has not done a critical review of the data on the new antiviral treatments for hepatitis C.  In fact, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts here,  here, and here.)

Why Do Rich People Who Run Foundations Tout Expensive Drugs?


Yet there is something about hepatitis C and the newer treatments of it that seems to inspire rich people who run foundations to sound like marketers for Gilead, sans evidence to support their viewpoints.  About one year ago, former US President Bill Clinton, now a leader of the well-publicized Clinton Foundation and of the now apparently independent Clinton Health Access Initiative, said something similar, as we posted here:

Clinton pointed to new hepatitis C drugs, Sovaldi and Harvoni, which are sold by Gilead Sciences for more than $80,000 for a 12-week program of treatment. Those medications often cure a disease that can cause liver disease and eventually lead to transplants or death, which are expensive, too. But the sticker price on the drug has caused a backlash by payers and patients.

'Who wants to let somebody's liver rot? Nobody,' Clinton said. 'Who's got $80,000 to spend? Not many. And if you're a small businessperson and you're in a small pool [of employer-based insurers], are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them.'

So what is going on here?  In a general sense, it may be that people who have become very rich, and have held very high level executive positions, start to believe they are expert on everything, especially in a country increasingly dominated by market fundamentalism/ neoliberalism in which money is touted as the ultimate measure of everything important.  But more specifically, Mr Gates may also be spending too much time with the top brass of his foundation, who may be all too used to hawking expensive drugs.

Former Pharmaceutical and Biotechnology Executives Running Supposedly Charitable Foundations

In particular, the current CEO of the Gates Foundation is Dr Susan Desmond-Hellmann.  When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I suggested that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  During her previous service as President of Drug Development at Genentech, Dr Desmond-Hellmann had defended the then sky high pricing of bevacizumab.  Of course, Dr Desmond-Hellmann, as a top executive, personally profited from such pricing.  In her last year at Genentech while the company was still independent, her total compensation was over $8,000,000.  As we discussed in 2014, while she was at UCSF, questions arose about her committment to public health when it was revealed she and her husband had large stock holdings in the tobacco company Altria.  Yet she continued to dismiss the importance of her many apparent conflicts of interest.

Also, in 2011, prior to the hiring of Dr Desmond-Hellmann, as we discussed here, a PLoS Medicine article by Stuckler et al(3) suggested a revolving door between the leadership of the Gates Foundation and of pharmaceutical and biotechnology companies,

Members of personnel also move between the Foundation and pharmaceutical companies. For example, in April 2010, a former Merck senior vice president, Richard Henriques, became the chief financial officer of the Gates Foundation. At least two other members of the Gates Foundation leadership have transferred from the leadership of GlaxoSmithKline to sit on the Foundation’s board of directors, including Kate James, the chief communications officer, and Tachi Yamada, until February 2011, the head of the Foundation’s global health program. Similar patterns were observed with the other foundations studied.

Foundations Promoting the Biotechnology and Pharmaceutical Agenda

Dr Desmond-Helmann has continued to use her bully pulpit at the Gates Foundation to promote high-tech medicine that uses the newest, most expensive drugs.  For example, in an interview in December, 2015 in the Washington Post, she promoted "precision public health" which would emphasize the supposed "innovation, that speed, that ability to use big data" characteristic of precision medicine brought to public health.  However, "precision medicine" has so far not been proven to fulfill its promise to benefit patients.

In addition, in May, 2016, a Wall Street Journal article noted that she has led the Gates Foundation to invest in commercial biotechnology firms,

Dr. Desmond-Hellmann cited a $52 million investment by the foundation in CureVac, a German biopharmaceutical company, as the type of partnership that could produce new tools against epidemics. CureVac is developing vaccine technologies based on messenger RNA that would instruct the body to produce its own defenses against infections. The funding, which the foundation announced in 2015, is for construction of a manufacturing facility; the foundation said it would provide additional funding to develop vaccines for several infectious diseases.

Are these investments the best way to provide better global health care?  An aside in the Bloomberg article suggests they may be more about making money.

The foundation reported in May that it had received an unexpected boost to its endowment when a stake in a small biotechnology firm, Anacor Pharmaceuticals Inc., sold for $86.7 million -- about 17 times the fund’s original investment. While the foundation had invested in Anacor to encourage the company’s work in neglected diseases, Anacor shares took off after its toenail fungus drug was approved.

I am sure that toenail fungus is not a major public health problem anywhere, much less in the developing world.

The tragedy here is that the Gates Foundation, which appears to be the largest private foundation in the US (and the world), has a huge impact on global health, and yet its leadership is squandering its moral authority in the pursuit of the pharmaceutical/ biotechnology agenda.  A review of a new book out about the foundation in November, 2015 in the Intercept noted that the book's author

spends much more time discussing whether the Gates Foundation is protecting the patents of pharmaceutical companies and whether it is making common cause with Monsanto to spread genetically modified crops in Africa

In January, 2016, the  Global Policy Forum put out a report that, per a Guardian article,  accused

organisations like the Bill and Melinda Gates Foundation, the Rockefeller Foundation and others are promoting solutions to global problems that may undermine the UN and other international organisations, says the report by the independent Global Policy Forum, which monitors the work of UN bodies and global policymaking.

Futhermore, the report asserted,

 Through their multiple channels of influence, the Rockefeller and Gates foundations have been very successful in promoting their market-based and bio-medical approaches towards global health challenges in the research and health policy community – and beyond.

More specifically, an article in the Independent accused the foundation of having a

ideological commitment to promote neoliberal economic policies and corporate globalisation

The report, per the Guardian, also accused the foundation of conflicts of interest,

The report also questions why the Gates foundation invests heavily in companies like Monsanto and Bayer. 'In addition to its grant-making activities, the Gates foundation has recently stepped up its support for the biotechnological industry directly.'

Also, similar to the PLoS Medicine article cited above(3)

'There is a revolving door between the Gates foundation and pharmaceutical corporations. Many of the foundation’s staff had held positions at pharmaceutical companies,' the report adds.

More dramatically, per the Independent,

the Gates Foundation 'often appears to be a massive, vertically integrated multinational corporation, controlling every step in a supply chain that reaches from its Seattle-based boardroom … to millions of end-users in the villages of African and south Asia.'

Furthermore, per the Intercept book review article, the larger problem is that the Gate Foundation and its CEO are largely unaccountable,

Bill and Melinda Gates answer to no electorate, board, or shareholders; they are accountable mainly to themselves. What’s more, the many millions of dollars the foundation has bestowed on nonprofits and news organizations has led to a natural reluctance on their part to criticize it. There’s even a name for it: the 'Bill Chill'  effect.

I would note parenthetically the foundation's board of trustees only includes Bill and Melinda Gates, Mr Gates' father, and Mr Warren Buffet.  Most large foundations have considerably larger boards of trustees, with at least some diversity in family membership and backgrounds.

In an interview with the Financial Times in March, 2016, Dr Desmond-Hellmann made a hash of addressing the accountability issue:

Accountability is another concern. To whom do these multibillion-dollar foundations answer?

For once, Dr Desmond-Hellmann’s confident responses falter. In reply to a suggestion that trans­parency is not the same thing as accountability — putting everything online means you can see what the foundation is doing, but does not mean that it is being held to account — she seems uncharacteristically stuck for words.

'The way that people can hold us accountable is to look at what we achieved as a foundation through our collaborations,' she says, quickly regaining her poise.

So even the foundation's CEO cannot say to whom, and how she is accountable.


Conclusions

So maybe Bill Gates' seemingly ill-informed apologia for the extremely high drug prices charged in the US, and his lack of understanding of the evidence about the efficacy, or lack thereof, of some of these high priced drugs is a small humorous story that indicates just the tip of the iceberg.  It appears that in our current market fundamentalist, neoliberal world, foundations may be more about promoting the commercial interests of their board members and officers than about improving the lot of humanity.  Yet for the most part they may succeed in obfuscating what they are doing through the haze of marketing and public relations.

True health care reform would first make transparent the web of institutional and individual conflicts of interest that seems to tie together nearly all big health care organizations, and open discussion of how to make health care organizations better serve health care rather than the narrow financial interest of their top leaders.

Graphic Interlude

A "blue screen of death"

 References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3.  Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020.  doi:10.1371/journal.pmed.1001020.  Link here.

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Two recent stories of EHR un-exceptionalism, and a connection to prior HC Renewal posts including my own experiences

The following stories recently appeared in the press about the "un-exceptionalism" (or, I might more accurately state, the negative exceptionalism) of today's EHR technology.

Regarding each organization mentioned, I have had personal experience that, in retrospect, aligns with views I expressed about the organizations years ago.

First:

EHR safety goes to court
By Lisa Schencker

June 25, 2016

http://www.modernhealthcare.com/article/20160625/MAGAZINE/306259982

One patient's blood pressure plummeted dangerously after he was allegedly discharged with the wrong medications. In another instance, a physician couldn't place a pharmacy order for a newborn to receive vitamin K, which is given to babies to prevent serious bleeding.

On several other occasions, patients weren't accurately tracked, creating potential problems getting drugs to them.

Each of these alleged mishaps occurred at PinnacleHealth, a three-hospital system based in Harrisburg, Pa. PinnacleHealth blames each of the mishaps on its electronic health records vendor, Siemens; Cerner Corp. purchased Siemens' health IT business in February 2015.

The relationship between healthcare system and vendor devolved into this dueling lawsuit:

The incidents came to light as part of a breach-of-contract lawsuit Cerner filed against PinnacleHealth last year after the system, which had used Siemens as a vendor for 20 years, sharply curtailed its relationship and entered into a contract with a competing EHR vendor, Epic Systems Corp. PinnacleHealth related the incidents in its counterclaim; the counterclaim was filed in March of this year in state court in Pennsylvania, where it is seeking damages for Cerner's alleged fraud and breach of contract.

(I am cited in the article with respect to hold harmless clause-related issues not relevant to this blog posting.)

Cerner Corp. purchased Siemens' HIT business in Feb. 2015.  Prior to that, Siemens was an independent vendor of an EHR suite known as Soarian, deployed at PinnacleHealth as early as 2008.

See for instance http://news.usa.siemens.biz/press-release/customer-solutions/soarian-plan-care-assists-clinicians-developing-and-deploying-goal-

Soarian Plan of Care Assists Clinicians in Developing and Deploying Goal-Oriented Plans of Care
Monday, February 25, 2008

Siemens (http://www.usa.siemens.com/healthcareit) today announced that PinnacleHealth, a 750-bed, non-profit hospital and healthcare system serving Central Pennsylvania, and CentraState Healthcare System, a 272-bed, non-profit medical facility located in Freehold, N.J., have each signed on to serve as beta sites for Soarian® Plan of Care, a solution designed to support inter-disciplinary care teams in defining and helping to manage patient problems, interventions and expected outcomes, to provide care in order to achieve desired outcomes and to generate new knowledge at the point of care.

Notwithstanding my warnings on this blog and elsewhere that hospitals should NEVER be "beta testing sites" for experimental HIT software used on live patients without informed consent, that the relationship devolved to dueling lawsuits involving safety is not a surprise to me.

Relating to my own experiences as posted previously on this blog:

On August 20, 2009 I posted "Why Siemens Healthcare Fails" (http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html).  In that post I noted regarding a job posting by Siemens for a "physician consultant" on HIT implementation:

... This [Siemens] job description might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants.

I would not want such a physician advising or supporting complex HIT projects at my organization.

I also recalled my own Siemens face time:

... I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite [as a result of my work in development of an extensive cardiology information system as CMIO at Christiana Care in Delaware from 1996-8]. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role.

I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.)

I'd informed my German hosts in 2000 that they'd better be very, very careful about acquisition of an American HIT company due to my experiences with a number of such companies, which I found highly political and highly ignorant of EHR quality issues.

Then, in my Feb. 2016 post "Plaintiff's Lawyers Are The Cause of EHR Problems?" (http://hcrenewal.blogspot.com/2016/02/himss-2016-presentation-plaintiffs.html) I recounted further experience with Siemens:

... an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs.  However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region "impractical" - and never followed up with me.  Pearls before....)

 Finally, Siemens seems to have ignored a well-qualified informatics internal expert on explicit EHR safety warnings, as in my Feb. 8, 2010 post "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare" (http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html):

• Siemens Medical's physician internal consultants (skilled anesthesiologists/informatics specialists), apparently in writing and including a remediation plan, opined that an IT system developed for critical care had numerous severe flaws, of sufficient seriousness that in their opinion the systems could harm or even kill patients if deployed;

• These were warnings of defects and flaws in IT in the worst possible medical environment, critical care with the sickest and most vulnerable of patients, not some ambulatory clinic or primary care office;

• Allegations were raised that the warnings were ignored, with at least one of the physicians, Dr. Malin, who was strongly concerned and vocal about the risks then being told his position was being eliminated. [It is not a surprise to note this rings alarm bells about the possibility of wrongful discharge based on retaliation and/or "greasing the skids" to eliminate potential whistleblowers or "non-team players" who could delay release of the software and affect revenue - ed.];

• The company possibly ignored the remediation plans of their own clinician/informatics experts;

• There were allegations of company misrepresentations about the new system to the FDA;

• There were allegations of decision making on these issues by non-clinician IT managers lacking healthcare or healthcare informatics expertise.

• A wrongful discharge complaint and then lawsuit were filed by Dr. Malin on the basis of violation of the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002 (SOX), 18 U.S.C. § 1514A ("Civil action to protect against retaliation in fraud cases - Whistleblower Protection for Employees of Publicly Traded Companies");

• The suit was dismissed on the apparent technicality that Siemens Medical in the U.S. is not subject to the provision in the SOX Act as is the publicly-traded corporate parent, Siemens AG; from document #4, pg 15:

... Health Services is a wholly-owned subsidiary of Siemens Med ... Siemens Med is a wholly-owned subsidiary of Siemens Corporation, which is indirectly owned, through two intervening layers, by Siemens AG, a German company that is publicly traded as defined by § 1514A of SOX ... Of these entities, only Siemens AG is a publicly-traded company. While both Health Services and Siemens Med are incorporated in Delaware and located in Malvern, Pennsylvania, they are separately incorporated entities.

• Siemens Medical in their response to the suit denied the most severe allegations regarding the IT defects, but this issue was not followed up upon due to the lawsuit's dismissal on SOX issues despite the obvious potential public hazards the allegations of IT defects could represent;

• In fact a US District Judge in the case, Peter J. Messitte, in the period after allowing Malin to prove the validity of SOX towards his case, opined that "No other discovery will be permitted, including but not limited to the alleged safety problems of Defendants’ product", document 4 above, Judge Messitte opinion, US District Court Maryland, pg. 25. [While perhaps understandable from a legal perspective, injured or dead patients don't really care about what legal precedents got them into the injured or dead state - ed.]

• Siemens Medical admitted in their responses to the suit that some of the software in question, actually put in use in hospitals, was in fact "beta" software, i.e., experimental (per Item 38 in 'Siemens Answer to Complaint' document).

There's that "beta-software" issue again.

So, the acquirer (Cerner) of a product of an American Siemens HIT subsidiary that appeared to have what I consider defective HIT talent management practices (as exemplified by the aforementioned JD); bizarre views about successful, high-quality EHR software (seen by their German counterparts a few years prior as exceptional); and that appears to have not been very happy about its own employee warning explicitly of beta ICU software being so bad it could kill patients is now embroiled in litigation regarding safety by a former customer.

None of this is surprising to me at all.  Incompetence can only go so far in healthcare before things blow up.

An unanswered question, of course, is whether patients were harmed or killed as a result of Siemens software, including its beta tests on unsuspecting patients.

---------------------------------

Here is a second story of EHR un-exceptionalism with a personal twist, this article in the Journal of the American Medical Informatics Association (JAMIA):

Comparison of accuracy of physical examination findings in initial progress notes between paper charts and a newly implemented electronic health record, June 28, 2016
http://jamia.oxfordjournals.org/content/early/2016/06/28/jamia.ocw067

Introduction There have been several concerns about the quality of documentation in electronic health records (EHRs) when compared to paper charts. This study compares the accuracy of physical examination findings documentation between the two in initial progress notes.

Methodology Initial progress notes from patients with 5 specific diagnoses with invariable physical findings admitted to Beaumont Hospital, Royal Oak [Michigan, near Detroit -ed.], between August 2011 and July 2013 were randomly selected for this study. A total of 500 progress notes were retrospectively reviewed. The paper chart arm consisted of progress notes completed prior to the transition to an EHR on July 1, 2012. The remaining charts were placed in the EHR arm. The primary endpoints were accuracy, inaccuracy, and omission of information. Secondary endpoints were time of initiation of progress note, word count, number of systems documented, and accuracy based on level of training.

Results The rate of inaccurate documentation was significantly higher in the EHRs compared to the paper charts (24.4% vs 4.4%). However, expected physical examination findings were more likely to be omitted in the paper notes compared to EHRs (41.2% vs 17.6%). Resident physicians had a smaller number of inaccuracies (5.3% vs 17.3%) and omissions (16.8% vs 33.9%) compared to attending physicians.

Conclusions During the initial phase of implementation of an EHR, inaccuracies were more common in progress notes in the EHR compared to the paper charts. Residents had a lower rate of inaccuracies and omissions compared to attending physicians. Further research is needed to identify training methods and incentives that can reduce inaccuracies in EHRs during initial implementation.

Apparently not covered in the article was the issue of patient harms that might have occurred (and could still occur) due to the "significantly higher rate of inaccurate documentation" in the EHR.   

"Beaumont Hospital" caught my eye, as I had interviewed for the CMIO role there in 2007 or early 2008.  My experiences are memorialized in an anonymized post at my Drexel informatics site which I reproduce in part here (the full essay is at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=an_expert_says):

Sure, the experts think you shouldn't ride a bicycle into the eye of a hurricane, but we have our own theory

A medical informaticist who formerly held a “Director of Informatics” role a number of years ago in a very large hospital system, and who left the role due to a toxic management environment and lack of authority commensurate with responsibility, was seeking applied Chief Medical Informatics Officer (CMIO) positions once again.  ... He makes the following observations after completing two full rounds of interviews at a prestigious hospital system similar in size to his erstwhile employer, in a very competitive environment, that recently experienced a decline in its clinical quality stats. The organization feels the quality stats themselves were inaccurate, in part due to lack of good healthcare IT.

From what the informaticist was able to gather, their leadership was displeased. Board members were seasoned executives from a heavy-manufacturing industry that is extremely dependent on information technology and concurrent supply chain data. These executives apparently recommended that the organization move quickly on implementing EHRs.

The organization is thus planning to implement EHRsfor thousands of physicians, most of whom are not employed by the hospital but are independent private practitioners, and likely to be skeptical or concerned about time impact and “grading” that could affect their livelihoods.  The hospital leaders also wanted to create integrated systems drawing on EHR data to automate quality reporting to regulatory agencies, as well as to support ongoing, funded clinical drug and device trials.

The informaticist was interviewed by the usual mix of clinician eager adopters, clinician skeptics, knowledgeable executives, skeptical executives who knew little about clinical IT, IT personnel who seemed overconfident given the enormity of the tasks at hand, and those who were clearly frightened by the prospect of being held accountable for a project of this magnitude. In the end, the informaticist did not get the position due to the organizational leaders being adamant the incumbent CMIO needed to also practice medicine.  The informaticisthad explained on the first round that he believed a leadership role in a project of such magnitude and challenge called for the highest levels of executive presence and freedom from distraction, thus he did not intend to practice medicine (he had not practiced in his former Director of Informatics role for the same reasons).

He’d thought this issue had been settled after the first round of interviews, leading to the invitation for round two. This line of questioning was revisited, however, in round two in a group interview setting. The group interview was attended by a number of people with whom he’d already discussed this issue via individual meetings in round one. This suggested his time was being wasted and was rather annoying, especially considering that the informaticist had flown cross-country not once but twiceto an organization not in consensus about a very basic hiring requirement ... It is not as if the organization had a doctor shortage, or that such a role would have ample free time where the incumbent would be idly sitting at their desk unless this time was absorbed seeing patients in the clinic. 

The stated reason for the organization’s wanting the CMIO to practice medicine was “to have credibility with the doctors.”  The informaticist explained that he’d found this not to be the case, that physicians being put “under the gun” of using EHR’swere generally more concerned that the CMIO had the executive authority to best represent their interests and understood medicine from training and practice at some point, not necessarily concurrently with the CMIO role.  Interestingly, there is no empirical research on this point, so the issue was the informaticist’sexperience vs. the hospital’s ‘second-guessing’ a seasoned expert.

Ironically, the informaticist was told during his interviews that a CMIO they'd hired a few years ago had left, in part due to being overextended.  He was also told that some of the clinical IT problems he'd solved as a CMIO in the past Director of Informatics position were problems this organization had not been able to solve during the same time frame.

... Regarding underestimation, this organization appeared to have little idea of the difficulties they were getting into

... The informaticist had observed another indication that this organization ‘didn't know what they didn't know.’  He was informed that the organization had selected their EHR vendor priorto seeking a medical informatics expert. This implies they really did not understand what a medical informatics specialist does and can do, which is far more than being a tactical "EHR implementation assistant." ... The informaticist had been there, and had done that in his past role. He found it unrewarding then and actually had decided not to take the risk again, rejecting the new position, even before the organization decided they wanted an (effectively) part-time CMIO who also saw patients.

It was clear this organization, who the informaticist tried to “take to school” based on hard-earned expertise and extensive references on social issues in health informatics (e.g. on this website), felt they were the experts on what was best regarding CMIO background.   This may have been a dysfunctionality satirist Scott Adams once described like this:

Ignoring the Advice of Experts Without Good Reason

Example: Sure, the experts think you shouldn't ride a bicycle into the eye of a hurricane, but I have my own theory.

As I recall, an informatics physician much younger than I and with less experience was hired.  I do not know his fate.  However, I believe that my expertise at that time in EHR issues, and my no-nonsense stance on EHR safety and excellent management, might have averted or minimized the "inaccuracy" problems.

Therefore, it is also no surprise to me that the organization now relates the EHRs were causing significant charting inaccuracies.  It would also not surprise me if close calls and harm occurred. They apparently rode their bicycle into that hurricane, and doing so will usually produce a less than optimal outcome.

In summary, two recent articles on EHR-related lawsuits and operational problems, in my own personal experience, have potentially relevant "backstories" that may help provide context.  Those backstories relate primarily to what I've called "HIT amateurism" (e.g., faulty expertise evaluation) as well as HIT mismanagement (e.g., ignoring explicit internal warnings of dangers.)  I believe my experiences, and that of other such as Dr. Malin, are symptomatic of widespread health IT industry dysfunction.

I also believe that if this industry is ever to learn from its mistakes, it will only occur in the courtroom.  Being that the defense side is usually fierce, however, I am not sanguine needed learning will occur any time in the near future.

-- SS

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Physicians go flatline on EHR enthusiasm

In a new study, physicians' enthusiasm levels for EHR's seem to resemble this EKG:

Do physicians really experience a satisfaction 'J-curve' with EHRs?
Max Green 
July 6, 2016 
http://www.beckershospitalreview.com/healthcare-information-technology/do-physicians-really-experience-a-satisfaction-j-curve-with-ehrs.html 

There's a school of thought about EHR adoption that suggests physicians experience an initial decrease in their positive perceptions of the technology, but over time those levels creep back up and ultimately surpass their pre-implementation perceptions. But does that J-curve actually exists for EHRs? A new study in the Journal of the American Medical Informatics Association says no. 

That "school of thought" must be from U.B.H. (Univ. of Blind Hyperenthusiasts) and O.U. (Ostrich University).

"[W]e did not find evidence for a J-curve pattern with respect to positive perceptions eventually exceeding baseline measures," the authors concluded. "Some measures followed a U-curve (returned to baseline), or flatlined, while most followed an L-curve (fell and remained below baseline)."

Translation: doctors hate the technology in its present form.

The study is based on a prospective longitudinal survey of Ann Arbor-based University of Michigan Health System physicians over the course of two years, from when they dropped their homegrown CareWeb EHR, for Epic's. Although all physicians received training on the new system and the system "invested substantial resources developing customized content," according to the paper, the only significant increase over baseline perception after two years of the new EHR was for documenting while in the exam room with patients. 

Surely, that accomplishment is worth the investment of hundreds of millions of dollars ...

"Future research is warranted to determine if positive perceptions eventually surpass baseline, and what interventions can help physicians use EHRs more effectively," the authors concluded.

The answer is "likely not."

In fact, the results of the new study are not surprising considering the not-so-glowing reviews of EHRs forwarded on to HHS in Jan. 2015 by the list of medical societies below (see link to the letter at my Jan. 28, 2015 post "Meaningful Use Not So Meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

But, as the EHR pollyannas say, it'll all be better in ver. 2.0.

-- SS

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Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context

Tales of medical research misconduct seem increasingly prevalent in the media, and are getting increasing attention.    They often may present a simple narrative, like this recent story in the New York Times, "An NYU Study Gone Wrong, and a Top Researcher Dismissed."

The Narrative Arc

A Renowned Researcher

The researcher in question was one Dr Alexander Neumeister.  Oddly enough, the article provided very little information about his background, but made it clear he was at New York University, and was a "top researcher."

The Potentially Ground-Breaking Studies

The NY Times article noted that the studies were of "an experimental, mind-altering drug."  In particular,

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

The study was ground-breaking, in that

It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder, which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.

The drug was not identified, but the article noted that it was

a drug intended to produce some of marijuana's effects, made by Pfizer

and was thus like the drug in "a French trial," that caused six patients to be "hospitalized with severe neurologic problems."

The study was apparently a small short-term randomized controlled trial

Some participants took the drug over a seven-day period; others took a placebo pill. The N.Y.U. team performed scans on each person to see whether brain activation patterns correlated with symptom relief.

The study called for recruiting 50 people with a PTSD diagnosis, according to study documents.

Research Misconduct Discovered

Initially, apparently,

Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., said that people working with Dr. Neumeister had reported concerns about the lab’s compliance with research standards.

This led to

The federal inspection, from July 16 to Aug. 5 last year, found that the research team had failed to assess at least three subjects 24 hours after they had taken the experimental drug, contrary to study protocol, according to the F.D.A. letter. In several instances, the agency found, Dr. Neumeister had falsified documents by signing a fellow investigator’s name on reports. 'However, in fact, you or another study employee actually conducted these study procedures,' not the colleague, the F.D.A. concluded.

In summary

The violations 'jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,' the F.D.A. said in a letter

Note that the article did not explain why the FDA was called upon to investigate this problem.



Aggrieved Research Subjects

The article focused on one Ms Diane Ruffcorn, who "writes a popular Facebook blog on trauma,"

'I think their intent was good, and they were considerate to me,' said one of those subjects, Diane Ruffcorn, 40, of Seattle, who said she was sexually abused as a child. 'But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.'

After the trial, she was concerned because

Ms. Ruffcorn said she had several odd symptoms after the trial, including a hyper, wired sensation that occurred without the usual memories of abuse.  For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she had taken the drug or placebo.

However,

Earlier this month, after much persistence, she found out that she’d taken the placebo. 'It was a big relief,' she said.

Note that the article did not explain why Pfizer owned the data, and would not reveal it. 

The Researcher Punished

The researcher did not agree that things were so bad,

Georges Lederman, a lawyer for Dr. Neumeister, said there may have been protocol violations, 'but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were.' The issues could have been easily remedied, he said, and noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Note that the article did not explain why Pfizer was empowered to shut such a study down.

In any case,

Dr. Neumeister and N.Y.U. continue to disagree over the seriousness of the research violations, both sides said. But the university has tossed out all of the data as unreliable, and tracked down the study participants to check on their health, Dr. Marmar said.

And apparently Dr Neumeister quit, or was fired, although the article only said NYU "parted ways with a top researcher."

Summary

So, in summary, the story was that a prominent researcher was doing cutting edge research at a big university, but people onsite noted some problems, the government was called in to investigate, the investigation found problems, the research was stopped, and the researcher lost his job.  However, while the article mentioned that Pfizer sponsored the study, Pfizer had control of the study's data, and Pfizer had the power to shut the study down, the article did not comment on whether the involvement of Pfizer could have had any relationship to the narrative of alleged individual researcher misconduct.

Research Misconduct as a Problem with Bad Apples

Thus, in my humble opinion, this story followed the usual narrative arc of research misconduct stories: an individual scientist over-reaches, possibly in pursuit of fame and money, is discovered and punished, and things get back to normal.  The implication is that research misconduct is a bad-apple problem, although fueled by a hyper competitive research environment.  For example, last week the (UK) Times Higher Education Suppplement published an article entitled, "Is There a Problem with Research Integrity," that opened,

For many academics today, research is not about pushing intellectual boundaries. It is not about investigating a fascinating issue so much as it is about churning out publications, demonstrating impact and generating revenue in order to meet the performance targets upon which institutional reputation and individual careers depend.

The temptation to cut corners is immense. Tricks include getting your name on a paper that you contributed little towards, or “salami-slicing” the same research across several publications. More seriously, some researchers falsify – misrepresent – their data, or even fabricate them entirely. Some universities tacitly encourage such behaviour and the boundary between academic integrity and malpractice is becoming blurred.

The current case seems to be on of attempted falsification, misrepresentation of research data.

Notice the use of the pronoun "you," emphasizing that research misconduct is about individual misconduct.  Similarly, tha THE article included commentaries by various individuals.  One was by a "research integrity expert," who began,

Having positive and preferably spectacular research findings is wonderful. It helps you to get a publication in a journal with a high impact factor, which will be cited often and may attract a lot of media attention. This is not only a pleasant ego boost but may also be instrumental in getting your next grant or strengthening your academic position. So, in an ever more competitive and metrics-driven scientific environment, it is tempting to make such results occur by any means necessary.

All this is true as far as it goes.  But in my humble opinion, the usual research misconduct narrative is vastly oversimplified, as is the case reported by the New York Times.

We have been writing for years about massive problems with manipulation of clinical research to increase the likelihood that the results would satisfy vested interests, and suppression of research whose results remain unsatisfactory after such manipulation.  The vested interests are most commonly pharmaceutical, biotechnology or device companies and those working with them.  Such suppression and manipulation may make treatments that do not work look efficacious, and treatments that are dangerous look safe, and may lead to excess costs, and worse, harms to patients.  This kind of research misconduct may be facilitated by individual researchers seeking fame and fortune, but is hardly an individual sport.

Focusing on individual research misconduct thus leaves the larger problem of vested interests dominating clinical research anechoic.

Looking carefully at the NYU/ Neumeister case as reported, and a little research on the web suggests that there may be more involved than just the conduct of one researcher.  But that could only be confirmed, or refuted, by investigation beyond what this humble blogger can do.

A Pharmaceutical Company Sponsored, Likely Pharmaceutical Company Designed, Phase II Drug Study Gone Wrong

The NY Times article acknowledged, almost parenthetically, that the study on which the article was focused was sponsored by Pfizer, although it first did so in the context of Dr Neumeister's lawyer arguing that the problems with the study were not that serious:

[he] noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Later, the article stated,

Pfizer said that N.Y.U. was responsible for conducting the trial,

but noted

the company had previously tested the same drug, known as an F.A.A.H. inhibitor, for osteoarthritic pain, without significant side effects. 'The safety profile we observed does not preclude future development of our compound,' a Pfizer spokesman said by email.

So this was not a case of a company funding a study merely to advance medical science.  The implication was that the company was testing its own compound in hopes of seeking approval from the US Food and Drug Administration. That must be why it was the FDA that investigated the research misconduct, particularly to the extent that the conduct of the research violated a "protocol" to which the FDA was apprently privy.

More evidence that the study was under the control of Pfizer, rather than of Dr Neumeister, could be inferred from the problems Ms Ruffcorn had in determining whether she had taken the drug or placebo.

For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she’d taken the drug or a placebo.

Note that the "data belonged to Pfizer," not to NYU or Dr Neumeister.

In fact, in perhaps the only critical look given to this story, in a post on Neuroskeptic, 

I believe the compound in question is PF-04457845.

I believe this because ClinicalTrials.gov lists a trial of PF-04457845 for PTSD, a trial which was recently terminated. NYU was one of the research sites. I also think that this trial is the fateful one, as it matches the NYT’s description of that study. Interestingly, ClinicalTrials.gov says that the trial was stopped 'based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845'.

So given that the study was a small randomized controlled trials of patients, not of healthy volunteers, it appeared to be a Pfizer sponsored, Pfizer designed, Pfizer controlled Phase II study being done in the hope of eventually marketing PF-04457845.

As noted in an article about agreements between academia and industry on the conduct of randomized controlled trials(1),

Many randomized clinical trials (RCTs) are designed and sponsored by for-profit companies. Companies typically contract academic investigators to identify, recruit, and manage patients. Clinical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results

It also appears that Pfizer was spending a more than tiny sum on this work.   A Politico article from 2014 revealed that Dr Neumeister at that time had a $1.7 million grant from Pfizer, presumably for this particular study.  Thus this drug trial was likely providing NYU with more than negligible monetary support, most likely including salary support for Dr Neumeister.

Dr Neumeister apparently has had some previous involvement with pharmaceutical companies, and with Pfizer specifically.  A search of the ProPublica Dollars for Docs 2009-13 database revealed that Dr Neumeister received consulting, travel funds and a more than $227,000 grant from Eli Lilly.  Dr Neumeister apparently is currently on the advisory board for Fiorello Pharmaceuticals.  In a 2015 article in the Journal of Clinical Psychiatry(2), Dr Neumeister acknowledged that he "has received consulting fees from Pfizer."

Conclusion

So it seems that in this case a study which may not have been conducted according to research standards was likely a pharmaceutical sponsored, designed, and controlled Phase II trial done as part of an effort to seek approval for a new drug.  Hence this case was not only about allegations of individual research misconduct, but about yet more problems with the implementation of commercially controlled human experiments designed to ultimately further marketing as well as science.  Yet none of the public discussion so far of this case was about whether Pfizer had any responsibilities to assure the quality of the research in which it was so involved, much less whether interactions between the company, the university which was being funded by the company, and the researcher employed by the university but whose salary was probably partially underwritten by the company might have affected how the study was implemented.

There may be many problems with individual misconduct affecting clinical research.  But failure to consider how this research is now mainly conducted within a commercial milieu seems to be missing the elephant in the room.  If we cannot plainly discuss research misconduct as part of the larger picture of health care dysfunction, we will not be able to do much about it.  True health care reform would help end the taboo on discussion about how powerful organizations and their wealthy and powerful leaders distort health care.  

ADDENDUM (11 July, 2016) - This post was re-published on the Naked Capitalism blog. 

References

1. Kasenda B, von Elm E, You JJ, Blumie A et al. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e1002046. doi:10.1371/journal.pmed.1002046. Link here.

2.  Mota N, Sumner JA, Lowe SR, Neumeister A et al. The rs1049353 Polymorphism in the CNR1 Gene Interacts With Childhood Abuse to Predict Posttraumatic Threat Symptoms. J Clin Psychiatr 2015; 76(12):e1622–e1623. Link here.

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