Life Science Compliance Update

April 04, 2017

JAMA Harps on PAOs


JAMA Internal Medicine recently published an article, “Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest.” The article focused on the nature of industry funding of patient advocacy organizations (PAOs) in the United States.

As the basis for the article, a survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies.

Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was $299 140 (interquartile range, $70 000-$1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was $50 000 (interquartile range, $15 000-$200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations’ conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors.

The study found that roughly two-thirds of a national sample of patient advocacy organizations (most of which were not for profit), reported receiving funding from for-profit companies. Twelve percent received the majority of their funding from industry; a median proportion of just under fifty percent of industry funding was derived from the pharmaceutical, device, and/or biotechnology sectors.

The authors of the study felt as though patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.


As noted above, the article found that most advocacy organizations receive money from industry. Therefore, the authors of the study concluded that increased transparency and robust conflict of interest policies and practices are needed to help the non-profit organizations maintain their independence.

However, as we have noted time and time again, conflict of interest policies and practices (along with transparency efforts) are not always the answer, and are not usually required to help non-profit (or even for-profit) organizations maintain their independence.

Additionally, the sample size for the study was only 5.6% of the 7865 PAOs identified in the United States. This is such a small sample size, and any results assumed from such a small sample size, nationally representative or not, should not be taken as an impetus for change. Transparency is confusing to the general population, who typically care about getting the healthcare they need, when they need it. Patience assistance organizations play a large role in helping those who need healthcare and other related items get what they need – they should not be targeted as the new “bad guy.”

March 06, 2017

ASCO Removes Restrictions on Researchers’ Conflict of Interest


The American Society of Clinical Oncology (ASCO) has removed all restrictions on author relationships previously in the 2013 Policy for Relationships with Companies statement, and all eligible manuscripts and abstracts otherwise will be considered for peer review, regardless of any financial relationships of authors. The decision was announced in the Journal of Clinical Oncology, the official journal of ASCO, in January 2017.

The 2013 policy restricted publication and presentation of research in certain ASCO forums, making abstracts and articles describing company-funded original research to be ineligible for consideration if the first, last, or corresponding author had been a company employee, investor, or paid speaker during the previous two years. ASCO felt that since they are a “leading source of cancer information worldwide,” and therefore, they “have a responsibility to ensure that important new information is disseminated to our members and the larger cancer community.”

The policy prompted researchers to voice their concerns of barring “ASCO members and highly qualified scientists from presenting their important original research to the oncology community in a setting where the work could be critically reviewed and discussed.” Following the outpour of such concerns, the restrictions were placed on hold and ASCO collected data for the following two years on the relationships of authors who submitted manuscripts or abstracts.

The collected data showed that potentially restricted submissions amounted to less than two percent of accepted journal articles, and roughly eleven percent of accepted meeting abstracts. The largest number of the abstracts related to developmental therapeutics and tumor biology, and a majority of them were accepted for poster presentation or publication. Turning to the remaining small number of abstracts accepted for oral presentation, ASCO examined the existing conflict of interest management strategies that the organization employs, such as slide review and live audit, when a heightened risk of bias is identified through disclosure.

Chief Medical Officer of ASCO, Richard L. Schilsky, MD, along with his ASCO colleagues, finally decided, “We have reached the conclusion that continued disclosure of commercial relationships, rigorous peer review, and management of potential conflicts of interest for all work submitted to ASCO best support our goals of trust and transparency and providing value to our members as a source for scientifically sound and unbiased original research.”

“ASCO continues to support universal and accessible disclosure of financial relationships with companies by authors, speakers, reviewers and participants in ASCO activities,” Schilsky and colleagues wrote. “ASCO welcomes further research and engagement with audiences on the most effective ways of communicating and managing disclosure information and on the impact of conflict of interest policies on scientific discourse.”

ASCO notes that it is important to point out that the ASCO policy continues to meet (or exceed) standards for accredited continuing medical education providers developed by the Accreditation Council for Continuing Medical Education Standards for Commercial Support as well as the standards for other interactions with companies described in the Council of Medical Specialty Societies Code for Interactions with Companies. Thus, eliminating author restrictions on submissions does not remove the prohibition on some company employees as speakers at ASCO meetings where accredited continuing medical education is offered.

June 22, 2016

JAMA Internal Medicine Bias – Now You See Me

Merlin the Magician would be proud of a recent study published in JAMA Internal Medicine attempting to prove that doctors who receive small gifts of food are more likely to prescribe a branded drug than generic drugs. The authors linked two national data sets in an attempt to quantity the association between industry payments and physician prescribing patterns.

The "researchers" utilized the most-prescribed brand-name drugs in four categories according to Medicare Part D information from 2013. They then cross-referenced those prescribing rates to the five months of data in the Open Payments database available for the year 2013. According to the authors, physicians who received only one meal promoting one of the four target drugs had higher rates of prescribing those medications.

The conclusion and relevance of the study in the abstract reads: Industry payments to physicians are associated with higher rates of prescribing brand-name statins. As the United States seeks to rein in the costs of prescription drugs and make them less expensive for patients, our findings are concerning.

However, once one digs a little deeper, it is clear that the investigation lauded by the press as evidence does not meet the scientific rigor that one would expect from a JAMA publication.

The Problems (Not an Exhaustive List)

First, the media reports all focused on the propensity of physicians to prescribe brand-name drugs when cheaper alternatives were available, not at all taking into consideration weather the patient may actually be better off on the branded drugs. In their main argument around statin use, many patients tolerate one statin and not another.

Second, when looking at the table of financial payments types and their association with brand name prescribing rates for statins, (the only table with actual numbers) food payments which was the source of many media stories did not meet statistical significance of .05 or 5%. The confidence intervals on meals actually skewed toward fewer prescriptions with a range of -2.56 to +.42. We recommend that the authors and the JAMA internal medicine editors review the Wikipedia definition of statistical significance, to help them understand that drawing inferences on data that does not meet the null hypothesis may not be in the best interest of their journal. But then again, pharmascolds hold to the believe to never let facts get in the way of a good narrative. Unfortunately, their allies in the media hold that same view.

Third, if one looks closely at Figures 1 and 2, out of almost 2,500 physicians analyzed, only a handful are creating the upward slopes between the covariates. The relationship is non-existent for physicians who receive less than $2,000, and for those who receive above $2,000, there are a few data points. Overall, the actual change listed at the end of their article was less than .1% increased prescribing per $1,000 increase in the open payments database.

Fourth, all the media mentions that the study looked at three therapeutic areas, lipids, hypertension and depression, yet their paper only discusses statins.  The editing and peer review process takes many months.  The authors would have had ample time to know what was actually being published.  So where is the "study showing even small meals influencing physicians."

Fifth, we have made clear time and time again that the Open Payments data made available through the Affordable Care Act can be misused. Once again, we see opponents of marketing using the national registry as a stepping stone in their ultimate goal of eliminating any and all payments to physicians. As we have noted before, the data available through Open Payments has minimal pre-release vetting by the physicians, and can contain de-identified and disputed payments.

Sixth, some physicians may choose to attend industry events where information is provided about drugs they already prefer to prescribe. Such a choice would have little to no effect on their prescribing patterns. The authors of the study failed to take that into account.

The authors of the study recognized that there were several limitations, including equating five months of payment data to twelve months of prescription data. Comparing an entire year of prescribing patterns to five months of payment data should almost be considered malpractice: the five months of payment data is more than likely not representative of a full year.

Further, the study did not differentiate between new prescriptions and refills. By failing to take into account whether a prescription was a refill, the number of prescriptions written could very easily be inflated for each physician.


The media absolutely missed it on this one headlines included:

Wall Street Journal

Free Meals Influence Doctors' Drug Prescriptions, Study Suggests

"Doctors who received a single free meal from a drug company were more likely to prescribe the drug the company was promoting than doctors who received no such meals, according to a study."

New York Times

Drug Company Lunches Have Big Payoffs

A free lunch may be all it takes to persuade a doctor to prescribe a brand-name drug instead of a cheaper generic, a new study suggests.


Feed Me, Pharma: More Evidence That Industry Meals Are Linked to Costlier Prescribing

A study published online Monday in JAMA Internal Medicine found significant evidence that doctors who received meals tied to specific drugs prescribed a higher proportion of those products than their peers. And the more meals they received, the greater share of those drugs they tended to prescribe relative to other medications in the same category.

To ProPublica, perhaps you should take that course on statistics as well as the editors.

Several publications took a second look:

Bloomberg actually did a good job laying out the alternative scenario in an article titled: Maybe Pharmaceutical Reps Actually Aren't Bribing Doctors by Megan McArdle where she elegantly outlines how there are many more scenarios that the doctor being bribed as most the media coverage has focused on. In her analysis the physician may be doing this out learning new things about better drugs or perhaps he already writes the scripts.

Forbes in an editorial outlines how the choices of medications is important, and medical decisions are not made in a vacuum. The Way To Doctors' Prescription Pads Is Through Their Stomachs So, once again, the pharmaceutical industry is under attack for coercing physicians to prescribe its drugs. This time the temptation involves food ...

Industry Response

The Coalition for Healthcare Communications issued a statement in response to the "investigation," stating,

Nothing new here.  Information is power.  The more information prescribers obtain, the more they are likely to use a drug safely and effectively. Dinner meetings are regulated by the FDA to ensure that the information is consistent with the basic information about the drug and is not false or misleading in any way. The fact that the doctors have dinner as part of the process does not change the facts of the presentation in any way. Education informs effective prescribing.

 The Pharmaceutical Research and Manufacturers of America also responded, noting that:

This study cherry-picks physician prescribing data for a subset of medicines to advance a false narrative. Manufacturers routinely engage with physicians to share drug safety and efficacy information, new indications for approved medicines and potential side effects of medicines. As the study says, the exchange of this critical information could impact physicians' prescribing decisions in an effort to improve patient care.

Physicians' prescribing patterns are dynamic and based on individual patients' needs. According to a survey of physicians, 91 percent felt that a great deal of their prescribing was influenced by their clinical knowledge and experience. The survey also found that factors such as a patient's particular situation, including drug interactions, side effects and contraindications; articles in peer-reviewed medical journals; and clinical practice guidelines, affected prescribing decisions a great deal.

Normally, an editor and peer reviewers would have had the authors pull back on many of the assumptions made by this article. One has to hope that this lack of checks and balances does not also apply to their clinical articles. Unfortunately, this study will be added to the lexicon and quoted by many opinion papers and journal editorials as fact, adding to the vicious cycle. We encourage the American Medical Association to do a full review on how this paper passed publication.


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