Physician Payment Sunshine Act: WSJ-Kaiser Editorial Discounts Value of Companies and Doctors Working Together to Find Cures

The average life span of Americans increased from 69.7 years in 1960 to approximately 80 years in 2007. This accomplishment could not have existed without physician-industry collaboration. Yet for Robert Pearl, Executive Director and CEO of the Permanente Medical Group of Kaiser Permanente, “Medical Conflicts of Interest Are Dangerous” and “for some patients, what their doctors don’t tell them could be hazardous to their health.”

The opinion piece published in the Wall Street Journal was written in response to the finalized regulations implementing the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act (ACA)—which in general, requires pharmaceutical and medical-device companies to disclose payments they make to doctors, hospitals and other health-care providers. The Centers for Medicare & Medicaid Services (CMS) will then post such payments on a public, searchable database and website, known as OpenPayments.

In an attempt to suggest that Kaiser is above all other institutions, Pearl notes that Kaiser adopted a policy to expressly prohibit these relationships nearly a decade ago as a way to preserve the “sanctity of the physician-patient relationship, and the trust of our patients.” Kaiser’s conflict-of-interest policy prohibits physicians from accepting anything of value from a vendor, serving on speakers’ bureaus, or being paid to “consult” with drug and device companies.

However, in response to Pearl’s opinion piece, Frederick W. Lewis, M.D., wrote that “Not all conflicts of interest are as clear as the examples given” by Pearl. Lewis recognized that although Kaiser physicians may not accept payments from medical-device companies, this doesn’t eliminate financial incentives for them. “For every dollar not spent by the Permanente Group on patient care, another dollar will be available to pay the physicians, creating an incentive to withhold care”; and most patients are “unaware whether a doctor they visit is incentivized to provide care or to withhold care.” Where is the Sunshine then for Kaiser?

In addition, William M. Glazer, M.D., an academic psychiatrist for over 30 years,
maintained that
Pearl’s “dismissal of value from industry-medical collaboration flies in the face of abundant economic and historical information. His vision for Kaiser is dingy and void of innovation. Physicians prevented from industry consulting must work dutifully in their cubicles seeing more patients, prescribing more generic products and thereby fattening Kaiser’s bottom line.”

Moreover, Glazer asserted that “Kaiser’s business model, like Wal-Mart’s or Targets, emphasizes volume and low-cost—meet the current medical standard and no more. Kaiser doesn’t perform expensive transplants and many other costly operations that mean a lot to afflicted patients but don’t fit the economic model.”

Nevertheless, Pearl asserts that the intent of the Sunshine Act is to “help reduce potential conflicts of interest for physicians or teaching hospitals that may have financial relationships with” drug and device companies, and that the Act helps “shed light on the magnitude of the problem.” Unfortunately, Pearl completely ignores the significant evidence and literature in existence, which shows that physician-industry relationships and collaboration have minimal if any harm to patients and do not create bias in various types of relationships (e.g., guidelines, continuing education (CE), and research).

In fact, even CMS acknowledged both in the proposed and final Sunshine rules that the agency has “no empirical basis for estimating the frequency of [conflicts of interest], the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the costs of medical care.” Moreover, Pearl ignores recent data, showing that State transparency or disclosure laws have no affect on the prescribing patterns of doctors.

Further, we have written extensively about overwhelming evidence, which shows that commercial support of CME does not influence or create any bias in such educational programs. See Cleveland Clinic; Medscape, and UCSF, all showing there is little if any bias in commercially supported CME.

Moreover, patients are not even aware of these relationships—in fact a recent survey from none other than Kaiser, shows that “42 percent of the public does not know the Affordable Care Act is still law of the land and is being implemented.” Thus, almost half of America does not even know the Sunshine Act exists, and it is highly unlikely that of the citizens who know the ACA is law, they even have a clue what the Sunshine Act is—particularly since most physicians don’t even know about the Sunshine Act, so how could they even tell their patients?

Additionally, only about one in 10 Americans report getting information about the reform law from federal agencies, such as the U.S. Department of Health & Human Services, so how will anyone even know when these payments are published and how to use the site? There is a high likelihood, however, that the Obama Administration will use funds to educate consumers about the Sunshine Act through its OpenPayments website.

Nevertheless, Pearl maintains that despite the Sunshine Act, potential conflicts of interest “will continue—and patients will continue to be at risk for potential harm—until physicians themselves stop participating in these relationships.” Under Pearl’s belief, no physician should ever communicate or even associate with industry—both violation’s of the U.S. Constitution’s First Amendment freedom of speech and right to associate.

Then, Pearl goes into a tirade about how pharma and device companies have “engaged in marketing and promotion strategy” and developed “consultative” relationships to “promote their products to colleagues.” He does not acknowledge any potential value in these relationships; Pearl just seeks to distort their view and paint only a negative picture. For example, Pearl does not acknowledge research, which has shown that practitioners who restrict access to sales reps are slower to adjust to negative news about a drug on the market.

Pearl also ignores the fact that without physician-industry collaboration or relationships, we would not have over 5,400 medicines in development globally, and more than 70% of therapies in the pipeline are potentially first-in-class and could offer patients new treatment options, and a notable number of potential therapies target diseases with limited treatment options such as ALS and rare diseases.

He also forgets to realize that because of physician-industry collaborations, the death rate from heart disease has dropped nearly 60% and deaths from stroke are down 70% since 1970. The death rate from cancer has dropped 16% since 1990 and the death rate from HIV/AIDS dropped more than 75% from its highest point in 1995. Instead, he suggests that such relationships with advance innovation “are really part of a thinly veiled promotional strategy designed to increase sales, particularly for expensive products with high profit margins.”

Moreover, he uses outdated and old anecdotes and evidence in an attempt to find any credibility for his argument, maintaining that companies still invite doctors to “attend extravagant dinners and participate as “faculty” at conferences being held at resort destinations, with all expenses paid by the pharmaceutical or medical-device manufacturer.” These practices have been outlawed, banned, prohibited and non-existent for over five years now, and significant enforcement actions and federal settlements have all but made such activities a distant memory—for all except Pearl and his fellow pharmascolds.

In addition, he cites to social science research (without providing citations), of which there was never a measure on patient harm or negative patient outcomes, to suggest that “medical literature is full of examples of the pernicious impact that gifts and financial arrangements have on treatment decisions.” Yet, as noted above, even CMS does not know the extent potential conflicts have on health outcomes and no one has shown any evidence of negative impacts—rather, what we have seen is that more pharmascolds and conflict-mania has discouraged physicians from learning about new therapies and collaborating with industry to improve their knowledge and ultimately their patients’ outcomes.

Response to Pearl

A number of individuals responded to Pearl’s article, calling it “misleading [to] the general public” causing patients to think “that a physician who partakes in a medical-education event at which a modest meal is provided.” In his letter, to the WSJ, David M. Short correctly maintained that “the best physicians seek out information from every available resource”, including medical-device and pharmaceutical company representatives. They must take every aspect into account and determine the best treatment that has the best prognosis with the least adverse events.”

Short asserted that “Medical innovation can only advance if physicians are willing to participate in its advancement. Unfortunately, their participation takes time, thus they should be fairly compensated for their expertise and consultation.” As a patient, Short noted that he has “experienced a vast difference in medical knowledge between physicians who seek out information from every available resource versus those physicians who limit their continued medical education to medical journals they never read or who have had their ability to obtain knowledge stifled by their medical-group employer.”

Accordingly, Short noted that once “the Physician Payment Sunshine Act’s database is made public, I plan to use it to seek out the most up-to-date and open-minded physician.”

David Shaywitz, writing in The Atlantic, also criticized Pearl’s article, maintaining that Kaiser “has it backwards.” He noted that drug companies “would like to develop important new medicines that improve health and save lives. That’s what gets every industry researcher I know up in the morning, and what keeps them going through the many highs and lows that characterize the scientific process.”

Shaywitz recognized that while much early-stage research may occur in academic labs, “moving from research publication to validated drug is long, difficult, expensive, and very tricky — not least because many academic findings turn out not to be robust enough to support new drug development.”

Consequently, “To advance even a solid idea requires, ideally, close communication between industry and outside experts:

• university researchers, who often developed the science and understand it the best;
  
• practicing clinicians, who can describe where the medical needs are the greatest, and what properties an ideal therapeutic would have; and
  
• patients, of course, who understand better than anyone else what they need, and where existing approaches may fall short.
  

As he correctly maintains, “We should strive to cultivate, not demonize, these sorts of interactions.” Instead, Pearl and other pharmascolds call on the public to distrust “the physicians and university researchers who consult the most with industry, yet it’s often these experts who are the smartest scientists or the most experienced clinicians – that’s why companies seek them out.” Instead of viewing these relationships as conflicts, Shaywtiz maintains that innovation between industry and physicians represents “interdependence,” and “drug development is far too important, and far too difficult, for anyone to do by themselves.”

Shaywitz recognized that Pearl and others are “stigmatizing (and increasingly, seeking to exclude) experts who are arguably the most worthy of our admiration.” While industry and some physicians have been bad actors, so has academia, and Shaywitz argues that people “should be careful about generalizing from sensationalized examples to condemn everyone who works in pharma — or in universities, for that matter.”

And while Pearl assigns guilt to pharma and device companies for making large profits, Shaywitz recognizes that making high profits “is the means to the end of fulfilling” a critical mission—” the pursuit of new medicines.”

His article also recognizes how the importance of industry relationships and collaboration will actually grow in the future, despite repeated attempts to stigmatize these interactions because increasingly, physicians will be called upon to explain why certain therapies are necessary. Thus, physicians “will be highly motivated to think especially critically about their therapeutic choices, and are likely to discover many instances where a powerful new medicine turns out to provide the best, most economical option — when total costs are considered.”

On the same side of the coin, “Medical products companies will also be under tremendous pressure to deliver medicines capable of rigorously demonstrating value . To understand what would be worthy of use, drug companies will need to speak to clinicians; rather than stick their heads in the sand, Kaiser physicians should engage with medical product companies, participate in this dialog, and help increase the chances that they’ll be able to prescribe better medicines to patients in the future. Participating experts also deserve to be compensated for their time, as Kaiser can both well appreciate and precisely calculate.”

Shaywitz pointed out that “Emerging information technologies are likely to play increasingly important roles in both assessing and enhancing value . Not surprisingly, leading academic digital health initiatives — including both the Center for Assessment Technology and Continuous Health (CATCH) at MGH and MIT, which I co-founded, and the recently announced Center for Digital Health Innovation (CDHI), at UCSF, both explicitly seek to cultivate partnerships with industry, in particular the tech powerhouses of Cambridge and Silicon Valley.”

Thus, “to have even a fighting chance, stakeholders — pharma companies, university researchers, clinicians, and patients — need to work together, and collaborate as if our future health depends upon it. It probably does,” he concludes.

Moreover, Dr. Glazer maintained that his “30-year experience as an academic psychiatrist collaborating with the pharmaceutical industry belies Dr. Pearl’s insinuation that such activity constitutes “a thinly veiled” promotion to increase sales.” He concluded by noting that “as a patient suffering from a malignant disease, I want whatever it takes to help me live longer. I want doctors who can provide me with extraordinary interventions that include experimental or proprietary therapy. Those doctors collaborate with industry.”