Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Wednesday, January 29, 2020

Cybernetic Opioid Pushers: EHR vendor Practice Fusion to Pay $145 Million to Resolve Criminal and Civil Investigations

Considering the devastating and deadly opioid problems in this country, this news release from DOJ describes particularly despicable behavior from an EHR vendor and pharmas.

These problems are likely more widespread, but this EHR company got caught.

The company admitted that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications, via "decision support" routines specifically designed by the drug company to increase drug company profits.

The DOJ reports that in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS (clinical decision support) alerts in ways aimed at increasing sales of the companies’ products.  Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself.  The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.

This story could certainly help explain why I could never get involved in EHR initiatives in pharma, despite having been at Merck in a science-support capacity, but seeking EHR involvement.  I had completed a Yale Medical Informatics postdoc and then faculty period authoring EHRs domestically and for a foreign country, and then had a period as a CMIO in Delaware. Yet, my many pharma applications over many years afterwards for EHR-related positions were mostly ignored.

The reason behind that shutout could likely be that I was known as being exceptionally honest, if only in part for my candid writing on EHR problems first on AOL 1999-2004, then at Drexel University and at this blog, at a time when the pundits and hyper-enthusiasts were pushing the technology uncritically and relentlessly.

Indeed, I would never have tolerated the types of conspiracy (DOJ's word) between EHR companies and pharma that are described in this DOJ release to help push drugs, any drugs - let alone opioids.

To make matters worse, this vendor is also described as cheating on the HHS EHR "certification" process.  The company is described as concealing from the certifying entity, known as an ONC-Authorized Certification Body (ATCB), that the EHR software did not comply with all of the applicable requirements for certification.

Apparently, no defendants were jailed.

I am posting the DOJ release in its entirety.  It is quite comprehensive, and I have nothing to add.

https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0
Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Monday, January 27, 2020

Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations

Practice Fusion Inc. Admits to Kickback Scheme Aimed at Increasing Opioid Prescriptions

Practice Fusion Inc. (Practice Fusion), a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software, the Department of Justice announced today.

As part of the criminal resolution, Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications.  Practice Fusion has executed a deferred prosecution agreement and agreed to pay over $26 million in criminal fines and forfeiture.  In separate civil settlements, Practice Fusion has agreed to pay a total of approximately $118.6 million to the federal government and states to resolve allegations that it accepted kickbacks from the opioid company and other pharmaceutical companies and also caused its users to submit false claims for federal incentive payments by misrepresenting the capabilities of its EHR software.

“Across the country, physicians rely on electronic health records software to provide vital patient data and unbiased medical information during critical encounters with patients,” said Principal Deputy Assistant Attorney General Ethan Davis of the Department of Justice’s Civil Division.  “Kickbacks from drug companies to software vendors that are designed to improperly influence the physician-patient relationship are unacceptable.  When a software vendor claims to be providing unbiased medical information – especially information relating to the prescription of opioids – we expect honesty and candor to the physicians making treatment decisions based on that information.”
The resolution announced today addresses allegations that Practice Fusion extracted unlawful kickbacks from pharmaceutical companies in exchange for implementing clinical decision support (CDS) alerts in its EHR software designed to increase prescriptions for their drug products. 

Specifically, in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS alerts in ways aimed at increasing sales of the companies’ products.  Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself.  The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.  In discussions with pharmaceutical companies, Practice Fusion touted the anticipated financial benefit to the pharmaceutical companies from increased sales of pharmaceutical products that would result from the CDS alerts.  Between 2014 and 2019, health care providers using Practice Fusion’s EHR software wrote numerous prescriptions after receiving CDS alerts that pharmaceutical companies participated in designing.

Practice Fusion executed a deferred prosecution agreement with the U.S. Attorney’s Office for the District of Vermont based on its solicitation and receipt of kickbacks from a major opioid company to arrange for an increase in prescriptions of extended release opioids by healthcare providers who used Practice Fusion’s EHR software.  As detailed in the criminal Information made public today, Practice Fusion solicited a payment of nearly $1 million from the opioid company to create a CDS alert that would cause doctors to prescribe more extended release opioids.  That payment was financed by the opioid company’s marketing department, and the CDS was designed with input from the marketing department.  Practice Fusion and the opioid company entered the CDS sponsorship because they believed that the CDS would influence doctors’ prescriptions of extended release opioids.  In marketing the “pain” CDS alert, Practice Fusion touted that it would result in a favorable return on investment for the opioid company based on doctors prescribing more opioids.

“Practice Fusion’s conduct is abhorrent.  During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” said Christina E. Nolan, U.S. Attorney for the District of Vermont.  “The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.  This recovery is commensurate to the nature of Practice Fusion’s misconduct, represents the largest criminal fine in the history of this District, and requires Practice Fusion to admit to its wrongs.  It is another example of pioneering healthcare fraud enforcement by the talented Assistant U.S. Attorneys and staff of this U.S. Attorney’s Office, working with their partners in law enforcement.  We cannot — and will not — tolerate technology companies influencing patient treatment merely because a pharmaceutical company provided a kickback.”

The criminal Information charges Practice Fusion with two felony counts for violating the Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b)(1), and for conspiring with its opioid company client to violate the AKS, 18 U.S.C. § 371.  This case is the first ever criminal action against an EHR vendor and the unique Deferred Prosecution Agreement imposes stringent requirements on Practice Fusion to ensure acceptance of responsibility and transparency as to its underlying conduct, and to invest heavily in compliance overhauls and an independent oversight organization.  The Deferred Prosecution Agreement requires Practice Fusion to pay a criminal fine of $25,398,300 and forfeit criminal proceeds of nearly $1 million.  In addition, the company will cooperate in any ongoing investigations of the kickback arrangement and report any evidence of kickback violations by any other EHR vendors.  To ensure transparency and public awareness of the company’s activities while the nation continues to battle an epidemic of opioid addiction, the Deferred Prosecution Agreement requires Practice Fusion to make documents relating to its unlawful conduct available to the public through a website.  Additionally, the Deferred Prosecution Agreement mandates that Practice Fusion retain an independent oversight organization that is required to review and approve any sponsored CDS before Practice Fusion may implement the CDS, and create a comprehensive compliance program designed to ensure such abuses are not repeated.

The civil settlement with the United States resolves Practice Fusion’s civil liability arising from the submission of false claims to federal healthcare programs tainted by the kickback arrangement between Practice Fusion and the opioid company.  It also resolves allegations of kickbacks relating to thirteen other CDS arrangements where Practice Fusion agreed with pharmaceutical companies to implement CDS alerts intended to increase sales of their products.  The $118.6 million settlement amount includes approximately $113.4 million to the federal government and up to $5.2 million to states that opt to participate in separate state agreements.

“Prescription decisions should be based on accurate data regarding a patient’s medical needs, untainted by corrupt schemes and illegal kickbacks,” said U. S. Attorney David L. Anderson of the Northern District of California.  “In deciding what is best for patients, electronic health records software is an important tool for care providers.  It is critically important that technology companies do not cheat when certifying that software.”

In addition to the kickback allegations, the civil settlement with the United States resolves allegations relating to two intersecting Department of Health and Human Services (HHS) programs, one at the Office of the National Coordinator for Health Information Technology (ONC) that regulates the voluntary health IT certification program, and one at the Centers for Medicare & Medicaid Services that oversees EHR incentive programs.  Specifically, the United States alleged that Practice Fusion falsely obtained ONC certification for several versions of its EHR software by concealing from its certifying entity, known as an ONC-Authorized Certification Body, that the EHR software did not comply with all of the applicable requirements for certification.  ONC’s certification criteria were designed to promote enhanced functionality, utility, and security of health information technology, and access to patient medical information across the care continuum.  HHS implemented the certification criteria for EHR software in multiple stages, known as editions.  To be certified under the 2014 Edition certification criteria, EHR software was required to allow users to electronically create a set of standardized export summaries for all patients.  When Practice Fusion sought certification of this 2014 Edition criteria, Practice Fusion falsely represented to the certifying body that its software met this data portability requirement, when several versions of its software did not.  The civil settlement resolves allegations that, at the time these versions of Practice Fusion’s software were certified, its software was unable to permit a user to create a set of standardized export summaries.  Additionally, after obtaining certification of the 2014 Edition criteria, Practice Fusion disabled access to this feature altogether.  Instead, Practice Fusion required users to contact it separately to request export of this critical patient data.

In addition to failing to satisfy the data portability requirement, Practice Fusion’s software allegedly did not incorporate standardized vocabularies as required for certification.  The United States alleged that by fraudulently obtaining certification for its products, Practice Fusion knowingly caused eligible healthcare providers who used certain versions of its 2014 Edition EHR software to falsely attest to compliance with HHS requirements necessary to receive incentive payments from Medicare during the reporting periods for 2014 through 2016 and from Medicaid during the reporting periods for 2014 through 2017.

“As new technologies continue to develop and evolve, so too do new and innovative fraud schemes,” said Shimon R. Richmond, Assistant Inspector General for Investigations of the U.S. Department of Health and Human Services. “We will continue to be vigilant in detecting and investigating these schemes in order to protect the safety of patients in federal health programs and to ensure the appropriate use of electronic health records in providing their care.”

“Today's announcement shows that Practice Fusion exploited technology to profit at the expense of a vulnerable population – patients seeking medical advice," said Timothy M. Dunham, Special Agent in Charge of the FBI's Washington Field Office, Criminal Division.  "The FBI is committed to working with our partners to bring to justice the perpetrators of healthcare fraud in all its forms, especially one that fans the flames of the already rampant opioid epidemic.”

The U.S. Attorney’s Office for the District of Vermont handled the criminal investigation and resolution.  The civil investigation was jointly handled by the Civil Division’s Commercial Litigation Branch and the U.S. Attorneys’ Offices for the District of Vermont and the Northern District of California.  The investigation was supported by the HHS Office of Inspector General and multiple HHS agencies and components.  The FBI’s field office in Washington, DC, also provided significant investigative support.

Except for the conduct admitted in connection with the criminal resolution, the civil claims resolved by the settlement are allegations only, and there has been no determination of liability as to such civil claims.

Tuesday, March 20, 2018

Mrs. Smith Goes to Washington

Newly-appointed Minnesota Senator Tina Smith is off to an energetic start, challenging the powers-that-be in Washington, starting with Big Pharma.  She recently wrote to the CEOs of five drug companies, noting the gigantic tax windfalls reaped by their companies after the fall passage of the tax cut bill, and enquiring whether any of that money might enable them to reduce the skyrocketing prices of prescription drugs.


I am sure every one of the five CEOs privately gave a big horse laugh at the very thought. Each of them believes that their duty to the shareholders is precisely to exact the maximum possible amount from the public for their products, so lowering drug prices never entered their tiny minds. Instead, they announced stock buybacks and in some cases dividends, after the size of the windfall became apparent.  Senator Smith also enquired whether they had made increases to research and development investments after the tax changes, as well as asking about stock buybacks and monetary bonuses to company officials.

Tina Smith can’t possibly be so naïve as not to understand the actual priorities of the CEOs (her husband of many years is an investment manager). Nonetheless, her letters make an excellent point. Pharma’s frequently-invoked rationale for high drug prices – that they need to swell their profits to afford research – is utterly bogus. And every step that gets the public to understand that is valuable.

Although informed people do understand that, a lot of pretty intelligent members of the public who haven’t thought about it too deeply are still buying the falsehood, as I’ve found from talking to co-workers. So, thanks, Senator Smith!
 

Thursday, July 07, 2016

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.