Life Science Compliance Update

April 03, 2013

Physician Payment Sunshine: ProPublica Database Leads with Disparaging Headlines

Doctor collaborates with industry to conduct lifesaving, breakthrough research.”  “Doctor educates colleagues about safety and clinical date to improve patient outcomes.”  “Physician speaks to peers about new trials that improve patient access to needed drugs.”  “Researchers meet to ensure the success of new clinical trial.”   

“Physician invents new medical device that improves cardiovascular health.”  “Industry and physicians collaborate to bring drug to market faster through new approval pathway.”  “Physicians attend education program mandated by FDA under REMS to better understand benefits and risk of drugs.” 

Of all these headlines, few, if any, are ever chosen by mainstream or local media to describe physician-industry relationships and collaboration that produce longer, healthier lives for all Americans.  In fact, the American Association for Cancer Research (AACR) recently released its second Annual Report on Cancer Survivorship, which showed that 18 million cancer survivors are expected by 2022.   

The headlines describing this report, however, failed to recognize that such increased survival rates are influenced significantly by the breakthrough drugs, therapies and treatments pharmaceutical manufacturers have researched, developed and discovered over the past few decades.  As Time Magazine noted, “advances in early detection and treatment are also contributing to helping people are live longer after diagnosis.” 

Consequently, news outlets are continuing their misleading headlines and stories regarding physician-industry collaboration over the last few weeks by relying on the recently updated payment data posted by ProPublica and its Dollars for Docs campaign.  This is particularly troublesome given that such news outlets will be able to significantly enhance the number of improper headlines once all payments are made public in March 2014 under the Physician Payment Sunshine Act.  Arnold & Porter, LLP recently hosted a webinar to discuss the final rule and its implications for all stakeholders. 

Charles Ornstein, who leads the Dollars for Docs campaign, told Medical, Marketing and Media in an interview that “companies’ strategies vary with respect to promotional speaking” in the latest update.  For example, “Forest Labs, which is the 20th-largest pharmaceutical company based on 2011 US sales, spent more money on physician speakers in the first three quarters of 2012 than any of its peers (many of which are much larger).” 

Ornstein recognized that trends are hard to determine given the different stages of brand lifecycles, which play a large role in terms of spending on speakers and marketing/sales.  Ornstein noted that he did not see much change in doctor’s willingness to speak with reporters about such payments.  Given the implementation of the Sunshine Act, Orenstein said that Dollars for Docs will still have a role, and provides unique aspects, such as linking to information about each drug on NIH websites.   

“Beyond that, on every payment page, [Pro Publica] has created a checklist that patient’s can print out and bring with them to their physician visits if they would like to ask questions about the payments or the drugs they are being prescribed.” 

Finally, Orenstein noted that ProPublica will be updating the database “from time to time,” and that it will be updated soon to include three new companies: Boehringer-Ingelheim, Sanofi-Aventis and Amgen.  The site will also offer historical value for payments reported prior to the Sunshine Act collection start date of August 1, 2013.  

Below is a summary of several articles, organized by State, that local and regional news organizations published after using the Dollar for Docs Database.  Most articles include a ProPublica badge and a Dollar for Docs function that lets readers search for doctor payments directly from the article. 


The reported that Louisiana doctors received $23 million from drug companies between 2009-2012, with more than 36,000 payments.  Doctors in northwest Louisiana raked in at least $4 million in payments from drug and medical device manufacturers since 2009.  While many support the move to make the medical industry more transparent, critics say the data lack context and in its current form do little more than scare patients. 

“Doctors and companies are automatically guilty until proven innocent if you’re looking at this,” said U.S. Rep. John Fleming, R-Minden, which is one of the many reasons he voted against the act.  Fleming, a licensed physician, said doctors may not stop at eliminating speaking engagements as guidelines increase and more documents are disclosed.  The disclosures when taken out of context can make doctors appear unethical, and some doctors may decide to stop participating in trials or anything involving these companies, Fleming said.  “Ultimately, it’s going to hinder innovation and research — research that benefits all of us,” Fleming said. 

Shreveport psychiatrist J. Gary Booker tops the region’s list of doctors receiving the most — $704,642 for research and meals.  Booker emailed the Times saying that the data and figures only told “half the story.”  “The studies pay well, but they are expensive to do,” Booker said.  Booker said he has performed nearly 100 clinical trials over the years, and the work he is doing could translate to long-term benefits for patients.  For example, he cited a recent study in which he worked to remove a plaque associated with Alzheimer’s disease from the brain. 

Robert Marier, executive director of the Louisiana State Board of Medical Examiners, said doctors across the state are participating in cutting-edge research funded by these drugs, and protocols are in place to ensure doctors are behaving ethically.  “When you hear your doctor or any doctor is receiving funds from these companies, it can raise a red flag, but there are so much oversight from institutions, like medical centers, as well as the state and federal regulations,” Marier said.

At LSU Health Sciences Center in Shreveport, Dr. John Vanchiere collected at least $241,000 for research and speaking engagements from Merck and GlaxoSmithKline.  However, Vanchiere, chief of pediatric infectious diseases and vice chair for pediatric research, said the majority of that money went to LSU Health for a clinical trial — not into his pocket.  

“That’s why a lot of people are not happy with these disclosures, and these numbers can quickly be misinterpreted and taken out of context,” Vanchiere said—the final Sunshine rule may resolve this issue.  The trial, funded by Merck, is an effort to limit the number of required childhood immunizations while maintaining effectiveness in preventing disease.  Instead of a series of vaccines, as little as two could be required, he said. “These studies have the ability to impact patients’ lives,” Vanchiere said.  


The Portland Press Herald reported that payments to doctors in Maine between 2010 and 2012 dropped by 60%.  Money paid to doctors in Maine for research, usually clinical drug trials, increased by 40 percent from 2011 to 2012 ($450,390 to $788,755).  The database includes 927 total disclosures in Maine from 2009 to 2012.  Merck spent the most on research, followed closely by Pfizer. 

Eli Lilly spent the most money in Maine by far on speaking engagements, paying $571,572 for 37 appearances.  GlaxoSmithKline paid for 50 speaking engagements in Maine during that time and spent $256,262.   

In the top right of the article is a photograph of Dr. Jeffrey Barkin, who received $114,225 from drugmakers between 2009 and 2010.  Dr. Barkin maintained that he never felt his speaking engagements were a quid pro quo arrangement.  “I wasn’t writing more prescriptions for those drugs,” he said.   

Gordon Smith, executive director of the Maine Medical Association, noted that while companies used to reward doctors with perks, “those days are gone … largely because the American Medical Association updated its code of ethics and because of the increasing number of disclosures by the companies.” 

Below that picture, the Herald posts a snap shot of “Maine doctors paid the most by drug companies for speaking engagements from 2009-2012,” with a top 10 list.  Below, is a top 10 list for Maine doctors paid most by companies for research for the same period.  In addition to the top 10 lists, the Herald also provides a look at some of the most commonly known drugs associated with leading pharma companies, such as Eli Lilly, Pfizer, Merck, and GSK. 

Dr. Robert Weiss, an Auburn cardiologist, received $407,498, the highest total amount for research funds between 2009 and 2012.  Weiss, a nationally respected cardiologist, said he was often asked by drug companies to speak about a specific drug or course of treatment.  In most cases, he said, he agreed to the request because he had free rein to talk about both the benefits and drawbacks of the drugs. 

The Herald, however, included a discussion of companies having to review slides or asking doctors to speak from scripts—trying to suggest influence.  However, the Herald failed to recognize that such slides must be reviewed by the company to ensure compliance with FDA regulations and that such procedures are mandated by FDA.   

Already demonstrating the negative impact of increased transparency, Weiss said that some of his colleagues have stopped taking clinical research funds because of the increased scrutiny brought on by disclosure.  Weiss, who has been doing research for 30 years, said that almost all the money he has received from drug companies has gone to pay his 19 employees and cover stipends for patients who participate in the trials. 

There was some debate in the article about whether drug research is conducted properly or clinical trial data is accurate.  Weiss, however, pointed out that he has never been pressured to approve a drug, and most never even reach the market, which is part of the reason drugs cost so much.  

Barkin told the Press Herald that his speaking engagements were never specifically tied to certain drugs.  Rather, his talks were about educating other physicians on appropriate diagnoses for psychiatric disorders and about the overlap of physical disease with psychiatric disease and how that can sometimes lead to fragmented care.  

Scott MacGregor, communications director for Lilly USA, the domestic arm of Eli Lilly, said that employing experts to lead educational forums is a critical part of drug development.  He said payments are largely market-driven, depending on the development stage of a particular drug. 

The Herald claims that the most common payment, for travel and meals, represents about 60 percent of disclosures, “and it is given when a drug company pays physicians to listen to a presentation about a product.”  It is unclear how the Herald made this determination that all such travel/meals are for product education or promotion, rather than for investigator or research meetings. 


Using the biased headline of “Drug Money: How Pharmaceuticals Earn A Doctor’s Endorsement, KMOX news radio in St. Louis noted that hundreds of doctors received payments for speaking fees, travel and meals.  Without providing any context for such payments or the importance of physician-industry collaboration, the article dives into listing several high-paid physicians who work at Washington University in St. Louis.  Later, the article lists payments to several psychiatrists in St. Louis, pointing out that such physicians are paid the most across the country. 

KMOX News reached out to several of these physicians.  Joni Westerhouse, spokersperson for Wash. Univ. School of Medicine, explained that Dr. Jeffrey Gordon, does not see patients or prescribe drugs.  Dr. Brian Dieckgraefe does prescribe drugs, including those made by Pfizer, but, according to Westerhouse, fully discloses to patients his financial ties to the company before doing so. 

Nevertheless, the article fails to elaborate on the nature or context of payments, or even mention that such fees are almost always fair market value and go towards educating other doctors about new safety and clinical data, all of which improve patient outcomes and may even reduce healthcare costs. 

Susan Chimonas, a research scholar at the Columbia University Center on Medicine as a Profession who has been studying these relationships, expressed her concern with some interactions, but recognized that some relationships are “beneficial for physicians, and therefore, for their patients.”  Nevertheless, Chimonas—and the article—dedicate their comments on how such relationships are negative, and paint a picture of the old habits that companies used to engage in.  Those practices are long gone, prohibited under industry codes and strongly prohibited by corporate integrity agreements (CIAs) and other settlement documents between most of the companies and the federal government. 

The article pointed out that the Washington University School of Medicine first revised its conflict-of-interest guidelines in 2007.  The policy prohibits doctors from using promotional items such as pens and magnets in clinical areas and says “meals, sporting event tickets, golf outings, gift baskets, travel, and any other free goods or services” should not be accepted from industry vendors.  The changes also ensure speakers “have final editorial discretion as to lecture content and materials,” however, this must be balanced against FDA’s requirements.  

At the time of the change, four companies – Pfizer, Bristol-Myers Squib, AstraZeneca, and Sanofi-Aventis – refused to comply with Washington University’s new policy.  Dr. James P. Crane, executive vice chancellor for clinical affairs in the School of Medicine, then advised his faculty to cut ties with the companies.  Some of those companies later agreed to comply with the university’s requirements, according to Washington University School of Medicine spokesperson Joni Westerhouse.  


The, in York, Pennsylvania, reported 160 instances in which York-area physicians or medical facilities received payments from pharmaceutical companies.  Of those, 50 of the payments were for more than $1,000—are we really wasting our time being concerned with $1,000?  It probably costs most companies and government agencies over $1,000 to track and report such payments! 

Dr. Wanda Filer, a family medicine physician at Family First Health, was paid by Merck for traveling across the United States giving educational vaccine lectures to medical staff, she said.  “It wasn’t for prescribing anything, …It was for travel costs.”  Filer’s lectures were mostly about Gardisil, an HPV vaccine.  As a result of the lectures, she said, she helped incorporate new public health guidelines in practices nationwide, as “a lot of people were not up-to-date on their guidelines.”  She no longer speaks because she was elected to the board of directors of the American Academy of Family Physicians and didn't want a conflict of interest. 

Dr. Kevin McCullum, a cardiologist at Cardiac Diagnostic Associates, is listed at the top of the database for York doctors with an $84,615 payment from Merck for research.  But he said the money actually went to York Hospital, not his bank account.  Dr. McCullum said the U.S. government funds almost no research, so his clinical research on preventive drugs is paid by pharmaceutical companies because his team looks almost exclusively at new drugs.   

McCullum said he keeps the patient’s needs and the cost of medicine in mind when prescribing to patients, prescribing drugs that correlate to the individual's clinical condition and recommending cost-effective medicine when he can and takes the results of his research into account.  McCullum said he is doubtful about the possibility of these payments being used for unethical purposes -- like doctors partnering with a drug company and getting paid to promote its product.  

“First and foremost, I don't think it happens, … [a]nd I can assure you that here in the WellSpan Health system, that doesn’t go on.”  He said there are layers and layers of safeguards in place when it comes to clinical research, such as performing double-blind trials, where both patient and researcher are unaware if drugs or placebos are being administered.  “All (the safeguards in place) are acting as advocates to the patient,” he said.  “The cost is so high because there is so much work involved.” 


The reported that more than $97 million has been paid to physicians in Massachusetts by pharmaceutical companies between 2009 and 2012, including $1.5 million to Greater Lowell physicians.  Lowell General Hospital spokeswoman Angela Strunk said physicians employed by the hospital must disclose any relationships to pharmaceutical companies, according to their contracts.  Payments to Fitchburg, Leominster, Lancaster and Gardner-based physicians totaled $585,000, according to data released by pharmaceutical companies and collected by ProPublica.  

We recently reported that Massachusetts posted its annual payments for 2011, showing a 3% decrease. 

Partners HealthCare, the parent organization of Massachusetts General and Brigham and Women’s hospitals in Boston, prohibited doctors from participating in promotional drug company speakers bureaus as of January 2010, concerned that physicians could lose their objectivity.  

Dr. Andrew G. Kowal, an anesthesiologist at Lahey Hospital and Medical Center in Burlington, has earned $337,651 from Pfizer and Eli Lilly for speaking, consulting, meals and travel fees from 2009 to 2011.  In an interview with The Boston Globe, Kowal, a critic of the overuse of addictive opiates, said he talks about alternative treatments such as Pfizer’s Lyrica for fibromyalgia.  At the time, he vowed to continue speaking free of charge, but he has not collected any payments since 2011, according to ProPublica’s data.  

Lahey CEO Howard Grant told the newspaper last year Kowal did not violate hospital policy in speaking at Pfizer events because he discussed only fibromyalgia and not a specific drug.  The hospital’s consulting policy states physicians may accept compensation for providing consulting services under certain circumstances.

Lahey’s policy states that a physician is prohibited from participating in talks where the company has a contractual right to control what the doctor says, creates the presentation materials or approves content or controls the publicity related to the event.  

Physicians are also banned from participating in industry-sponsored speakers bureaus for which the doctor receives compensation to act as the company’s spokesperson to disseminate company-generated materials or to promote company products.  Doctors who serve as consultants for industry must submit a conflict-of-interest form that discloses the expected compensation.  

In another article covering the same area, the noted that Dr. Lawrence DuBuske, an allergy and immunology specialist earned more than $688,601 from pharmaceutical companies AstraZeneca, GlaxoSmithKline, Merck and Novartis between 2009-2012.  We noted several years ago that DuBuske had protested new policies banning relationships with industry and resigned from Brigham and Women’s Hospital in Boston.  DuBuske has courtesy privileges at Heywood Hospital in Gardner, which requires physicians to disclose any conflict of interest as it pertains to pharmaceutical companies, medical device companies or other organizations when appropriate. 

HealthAlliance Hospital in Fitchburg, which is partnered with the University of Massachusetts Medical School, has a compliance policy regarding business transactions or arrangements with persons of interest in order to mitigate conflict of interest, according to a hospital spokeswoman Mary Lourdes Burke.  Burke said none of the hospital’s physicians are part of the data collected by ProPublica.

March 02, 2012

Physician Payment Sunshine: USA Today Editorial Author Still Hiding in the Shadows vs. Stell bringing Sunlight to Sunshine

Now that the comment period for the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act) has closed, various news media have begun discussing and examining the potential impact this legislation and regulations will have on healthcare stakeholders.  

Unfortunately, these media have decided to focus on selling stories and headlines about “potential conflicts of interest,” instead of telling the true and balanced story behind physician-industry collaboration.  For example, a recent editorial from an unnamed author in USA Today, claimed—without providing any evidence (since none exists)—that “small-bore favors such as free samples, promotional trinkets, tickets to sporting events, and deli trays delivered to the office have evolved into practices that look more like outright bribes.” 

These kinds of claims are outright wrong and unethical.  They are nothing more than smoke and mirrors to promote an anti-industry agenda to support some peoples academic careers and livelihoods.  

The reality is, the kind of practices described above are practically non-existent, illegal, and banned by PhRMA and AdvaMed codes.  In fact, the USA Today article’s only mention of evidence of this activity came from a 2007 article.  And that article itself likely collected data from prior years.  So in its duty to report fair and balanced information, the USA Today failed by using old data and not even attempting to discuss the current state of industry.  

The article claims that while “the drug industry stopped paying for some restaurant meals and distributing trivial gifts such as mugs, pens and the like,” items like vacations thinly disguised as educational seminars and fees — kept flowing.  But this is absolutely incorrect.  ACCME and AMA rules ban such meetings for accredited educational programs, and while promotional programs may still exist, these have been restricted severely as well.  The “good old days,” as the author would like to believe still exist, are long gone. 

Consequently, the article then moves on to discuss the Physician Payment Sunshine Act, which requires pharmaceutical and medical device manufacturers to report and submit all payments they make over $10 to physicians and teaching hospitals.  The author’s viewpoint is that, “Physicians and medical schools are still fighting to limit the law's reach.” 

The article notes that, “Doctors insist that industry payments lead to valuable innovations, not to conflicts of interest.”  And the author admits that this is “sometimes true.”  But instead of delving into the lifesaving breakthroughs, treatments, and technologies that have come from physician-industry collaboration, the article and author does what mainstream media do best: dramatize reality to sell papers and sensationalize news, leaving the hardworking physicians and patients to suffer from their publishing and editorial greed.  

The article references “investigations” that have “turned up evidence of payments that could compromise patient care, drive up medical costs and weaken drug safety.” 

We do not condone the past behaviors of companies, executives, or employees who have engaged in deceptive, immoral and unethical behaviors.  Those individuals and parties who have defrauded our government and harmed patients deserve to be prosecuted to the fullest extent the law allows.  These investigations, however, are rare instances, and involve a tremendously small amount of individuals.  

The overwhelming majority of individual physicians who are consulting, researching, and educating physicians are ethical physicians.  They would not deceive or harm patients for a pen or pizza or for that matter $10,000.  These physicians, as we have quoted many times, work with industry to advance medicine, to teach their peers, to interact and learn from other experts, and to ensure better patient care.  

However, USA Today could care less about the lifesaving treatments and medical devices that industry and physicians are creating every day.  The author sensationalizes and stigmatizes physician-industry collaboration without even considering or mentioning the value these relationships provide.  There is no mention of how American lifespan has increased tremendously, how cancer and heart disease death rates have dropped significantly, and how medicines and treatments are reducing the incidence and costs of chronic diseases such as diabetes, hypertension, and asthma.  

The only thing the author even says is the following: “some paid collaborations between doctors and industry yield important medical discoveries.”  Hardly a journalistic attempt considering the significant emphasis and research the author put on the opposing view.

Instead, the article focuses on the few cases where investigations have showed that the proper firewalls and safeguards were not used or in place, which allowed the “potential for conflict” to appear.  

Opposing View 

Lance K. Stell offered the opposing view to the above editorial.  Of course, USA Today gave Stell half as many words to respond to the “majority view” noted above. 

Dr. Stell, who teaches medical ethics at Davidson College and at Carolinas Medical Center, noted that, Supporters of the Physician Payments Sunshine Act fail to take into account how expensive sunshine" would be.  He recognized how, “Requiring drug and medical device manufacturers to publicly report virtually every payment they make to physicians, physician groups and teaching hospitals will end up costing far more than the $224 million estimated for just the first year of compliance.” 

As Stell noted, however, “The biggest cost will be the valuable, socially useful physician-industry collaborations that simply won't occur.” 

In 2007, the measure's original sponsors, Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., argued that shedding light on industry payments to physicians would be good for the system. The Pew Prescription Project, alarmed by findings that more than 90% of physicians receive payments of some kind from the pharmaceutical industry, opined that patients deserve to know whether their doctors are on the take. 

“Sunshine supporters always affirm that many financial relationships between medicine and industry are necessary and beneficial. However, the measure's title implies that such relationships need detoxification by exposure to "sunshine," the best disinfectant.”

Stell asserted that, “The new law stigmatizes payments and deters accepting them. But it's utopian to suppose that doctors will give their time and effort for free to do socially useful research and peer education.”  In fact, many physicians won't want to be enshrined in this hall of shame. 

Instead, Sunshine will just make physicians “require higher payments to provide what even "sunshine" supporters agree is valuable work. How much higher? That depends on how our most talented and innovative physicians price their time and how much compensation they'll charge for loss of anonymity and insinuations of corruption that a sunshine listing implies.” 

Ultimately, Stell noted that supporters of the Sunshine Act “foresee only benefit devoid of risk. But they've done no credible cost/benefit estimate. Reporting errors, misattribution and mistaken shaming will occur.” 

What is most problematic about this, as Stell points out, “the government candidly acknowledges that it has no empirical basis for estimating the frequency of improper payments, the likelihood that reporting will reduce them, or the likely effects on reducing the costs of medical care.” 


As CMS begins going through the hundreds of comments stakeholders submitted on the proposed Sunshine regulations, the media will continue to press on about the potential impact of publishing physician payments.  It is important to remember in reading articles about physician-industry collaboration that many of the articles and journalists covering these topics will only take the viewpoint that industry is bad and payments for collaboration are inherently wrong.  

We encourage readers to do their own research, to ask their own doctors and healthcare providers about the important value industry provides to them, whether through education, research, new products and treatments, and grants.  While transparency and sunshine is important for patients and consumers, it is also important to know the context of these relationships and payments.  Patients should be skeptical about reading articles that stigmatize a few bad apples to generalize an entire profession of healthcare providers who are overwhelming ethical and practice medicine to improve patient health and advance science. 


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