For the past several years, pharmaceutical and medical device companies have been posting payments made to physicians. Some companies voluntarily chose to do so, while others posted payments because of legal actions. These payments are posted on company websites to allow the public to search the names of health care providers who have received payments for education, consulting, and other related services. Much of the publicity surrounding these payments precedes the requirement of all drug and device companies to report all payments to health care providers in 2013 under the Physician Payment Sunshine Act.
One media source, ProPublica, a non-profit, “independent” organization, decided to combine the databases from seven companies that have posted payments to health care providers (AstraZeneca, Cephalon, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, Merck and Pfizer). In doing so, ProPublica sought to carry out an analysis of the payments to reveal any pertinent findings that could be in the public’s interest. Helping them carry out this project, the Chicago Tribune, NPR, Boston Globe, PBS, and Consumer Reports all provided separate reporting on the combined company data collected.
From the combined database, ProPublica noted that the data only accounted for 36 percent of the U.S. market in 2009, thus excluding more than 70 companies operating in U.S. Thus, ProPublica noted that the data in the report is limited to this 36 percent of sales, and that these “data may not be wholly representative of the industry.”
Nevertheless, ProPublica took these disclosures, totaling $257.8 million to about 17,700 providers, and assembled them into a single, comprehensive database that allows patients to search for their physician. These payments however are not significant for the overwhelming majority of health care providers. In fact, the average of payments amounts to less than $15,000 per physician. That means that some physicians over the course of one or two years made a very small amount of income from speaking or consulting with industry.
Despite the relatively small amount of money for most physicians, the ProPublica project focused on the doctors that were paid the most by industry. In doing so, they found that 384 doctors and other health providers have received at least $100,000 from drug companies in 2009 and early 2010. This is roughly only 2.2% of the doctors who worked with industry; the rest probably made close to the $15,000 average. While the fact that they identified the top earners separately from the rest of the group is troublesome, ProPublica’s analysis of some doctors “blemished records” is more problematic.
There is no doubt that the report did a good job of “uncovering hundreds of doctors on company payrolls, who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.” It is clear from this result that companies may not have done an adequate job vetting candidates, and moving forward, companies will learn from the mistakes that ProPublica has uncovered.
What is problematic about ProPublica’s investigation of such physicians is by headlining their articles with extreme language, they have tarnished the reputations of tens of thousands of doctors who work with industry and have exemplary records. Not only did their headlines and other materials imply that all doctors speaking for industry have questionable reputations, but it led other news source to create sensational headlines (i.e. Doctors with questionable records earn lots; Troubled docs hired as experts). So where is the data behind this headline?
Of the 17,700 health care providers, ProPublica conducted a review of physician licensing records in the 15 most-populous states and 3 others. They found sanctions against more than 250 speakers, including some of the highest paid. Are 250 speakers, about 1.5%, representative of all 17, 700 speakers. Of course, it is still important for companies to conduct adequate background checks of speakers now and in the future. But a similar survey of any professional group -- politicians, lawyers, journalists or priests -- you would expect to see 1.4%, or more, accused of misconduct.
ProPublica found that more than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. At least 20 more have had two or more malpractice judgments or settlements. ProPublica found 88 Eli Lilly speakers who have been sanctioned and four more who had received FDA warnings. In interviews and written statements, only Johnson & Johnson and Cephalon acknowledged they routinely check state board websites for discipline against doctors.
The problem with just using the numbers is that it does not take into consideration the fact that court settlements, FDA warnings and other disciplinary actions often are highly subjective, and usually involve a disagreement that could go either way.
ProPublica also found that forty-five doctors who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies. These are all credentials, but none is comprehensive or perfect. Plus, this is a very limited and small population of speakers.
Overwhelmingly, companies follow the PhRMA Code on Interactions with Healthcare Professionals. Thus, company decisions regarding the selection of healthcare professionals are based on defined criteria including medical expertise, reputation, knowledge and experience in a particular therapeutic area, and communication skills. Consistent with the PhRMA Code, companies also may look to other qualifications such as specific experience with a medication, faculty or medical society affiliations, leadership positions, authorship in the relevant therapeutic area, speaking experience, and participation in clinical trials.
Accordingly, while ProPublica has highlighted the need for companies to be careful about speaker selection, the vast majority of speakers, including top-paid ones, have impressive resumes, clearly demonstrating their expertise as researchers or specialists. Companies engage these physicians as speakers “to provide other health care professionals with accurate and balanced information about the use, safety, benefits and risks of medicines.”
In a recent interview responding to the ProPublica stories, AstraZeneca US Compliance Officer Marie Martino noted that despite the exceptions that ProPublica found, “physicians have the expertise and credibility necessary to educate colleagues to ensure they have the information they need to make informed treatment decisions for their patients.” Moreover, “patients ultimately benefit when physicians are well informed and knowledgeable about medicines, treatment options, and standards of care.”
Physicians should be compensated travel and preparation as well as lecturing, and the time they spend away from their practices for providing such information to other health care providers about medicines. By law and the PhRMA Code, such compensation must be offered at a fair market value based on their qualifications, skill and time spent on the presentation. Additionally, many companies have a cap on how much each physician can earn each year.
Moreover, companies specifically prohibit paying physicians in exchange for prescribing medicines or as an incentive to promote products. In fact, such arrangements are illegal under Stark and anti-kickback laws. Companies also routinely require physicians to participate in extensive training on their medicines, policies, and the laws and regulations that apply to industry-sponsored presentations.
Impact of Speaking
Critics of industry-physician payments say that disclosure is not enough because it does not fully explain what the doctors do for the money — and what the companies get in return. Critics, such as ProPublica, assert that companies “wouldn't be spending this kind of money if they weren't getting returns from the perspective of increasing their brand in the market, letting doctors know about it, encouraging them to prescribe it.” They point to lawsuits against industry, which allege that getting doctors to increase prescribing of company products is exactly the objective of commercial speaking.
ProPublica tries to discredit these payments further by pointing to a Consumer Report survey, published in collaboration with the Doc for Dollars project, which found that 74 percent of respondents disapprove of doctors taking payments from drug companies in exchange for promoting specific drugs to other doctors, and that 77 percent would be “very concerned” (37 percent) or “somewhat concerned” (40 percent)-–about the quality of treatment or advice from a doctor who accepts such payments. However, the specific questions and raw data are not available to the public. This is significant, because the researchers who want an specific result can easily design questions that elicit the wanted answer. This is particularly important here, because the results of this survey contradict data from Research!America, which showed that 78% of respondents trusted their health care providers as sources for medical research information.
In response to the criticisms of industry-physician payments, numerous physicians defended such collaboration. Oklahoma pulmonologist James Seebass, the former chair of internal medicine at Oklahoma State University College of Osteopathic Medicine, noted that the talks he gives are important because “physicians and nurse practitioners had come 50 to 60 miles to hear him.”
Dr. Samuel Dagogo-Jack, chief of the division of endocrinology, diabetes and metabolism at the University of Tennessee Health Science Center, who also conducts research funded by the National Institutes of Health, has edited medical journals and continues to see patients, also defended such collaboration. He too pointed out that he brings “news of fresh diabetes treatments to non-specialist physicians,” which see the vast majority of cases, especially in rural areas. Interestingly, Dr. Dagogo-Jack noted that his earnings per hour are “barely more than minimum wage.”
St. Louis pain doctor Anthony Guarino, who speaks for several companies, recognized that a “big part of his job, is educating the generalists, family practitioners and internists about diseases like fibromyalgia, which causes chronic, widespread pain — and to let them know that a company has a drug that has an on-label indication for treating it.”
Additionally, Dr. Brent Forester, a geriatric psychiatrist at McLean, in Massachusetts, gave nearly 40 talks for Eli Lilly to colleagues about the antipsychotic Zyprexa and the antidepressant Cymbalta over dinners in restaurants and in doctors’ offices. Although he resigned from speakers bureaus to comply with new rules, he said he “never felt like a spokesperson for the company at all.” In fact, he asserted that his speaking for the company was “an opportunity to educate primary care doctors about the treatment of psychiatric conditions.”
Dr. Andrew Kowal, director of the pain clinic at Lahey Clinic and a critic of the overuse of opiates, gives dozens of talks, mostly about Lilly’s Cymbalta and Pfizer’s Lyrica for fibromyalgia and painful diabetic neuropathy. Dr, Kowal participates in speaking programs to help physicians in rural areas learn about ways to combat opiate addiction, which is “a big deal” in states like Arkansas. He asserted that if his educational speaking “can save one kid from getting hooked on opiates, then I’ve done my job.”
In the Chicago Tribune, Dr. Merle Diamond, president of the Diamond Headache Clinic on the North Side, who speaks for GSK, asserted that speaking for companies has always “been about helping physicians understand the treatments that are available for migraine.” In addition, Dr. David Guthman, a urologist who practices in Illinois and speaks for GSK about medications for enlarged prostates and bladder dysfunction, acknowledged that he “will not speak for a drug that I don't believe in wholeheartedly.” Dr. Guthman further noted that by speaking for companies, doctors are “helping health care by avoiding misuse of drugs.”
Experts or Not?
While some critics are asking why companies did not do background checks of speakers, the overwhelming majority of physicians were highly qualified. For example, as the Boston Globe reported, doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010. The money was mostly for talking to other physicians about the companies’ drugs and the diseases they treat, but also for consulting on research and marketing. In fact, Eli Lilly, gave 50 percent of its payments in 2009 to Harvard doctors and 33 percent during the first three months of this year.
It would seem then that critics have their own contradiction to deal with. On the one hand, they are concerned that the best experts should not be speaking, while conversely, they say in some instances, speakers are not qualified enough. For now, with less than 2% of speakers in this sample having questionable conduct, the evidence seems to show that companies are choosing the right experts.
ProPublica raised legitimate concerns about doctors who in the past have crossed ethical boundaries, some more severe than others. While this may suggest the possibility for future transgressions, ProPublica needed to better balance the rare exceptions these cases demonstrate, especially given that less than 2% had any form of misconduct.
Critics of industry speakers assert that such presentations are unethical because companies are the ones controlling the content, and therefore doctors are merely selling a product. What many neglect to realize is that federal law requires companies to train their speakers with the company’s content. Several news outlets did include interviews physicians on this issue.
As Dr. Om Ganda, a Harvard professor who sees patients at the Joslin Diabetes Center and speaks for AstraZeneca, Merck, and GlaxoSmithKline about diabetes drugs pointed out, the speakers must use company content and slides because the FDA must approve them. Specifically, companies control the content because FDA was finding that when doctors controlled the content, many times “the slides did not include enough safety information or information about competing drugs.’’
Moreover, as Diane Bieri, General Counsel and Executive Vice President of the Pharmaceutical Research and Manufacturers of America (PhRMA), noted in response to ProPublica’s articles, FDA holds “companies accountable for the presentations of their speakers; materials presented at these forums must be consistent with product labeling approved by the FDA.” She also pointed out that the PhRMA Code on Interactions with Healthcare Professionals, which was strengthened in 2008, “contains detailed provisions specific to the conduct and training of speakers. The Code also ensures that “companies have policies, procedures, and training in place to foster compliance with provisions governing speaker programs, including conducting periodic reviews to ensure speakers still meet the requisite qualifications.”
Despite these safeguards, critics still assert that industry presentations lead to overuse of medicines. This argument fails to consider research which has shown that many factors affect prescribing decisions, including a physician’s clinical knowledge and experience, a patient’s unique situation, peer-reviewed journals, continuing medical education, clinical practice guidelines and insurance coverage and formularies. Moreover, critics ignore the fact that “data from many peer-reviewed studies have shown that medicines used to treat many chronic conditions are far more likely to be underused than overused.”
It is also important to point out that today recent prescribing trends do not reflect an undue influence of industry presentations. With 75 percent of all prescriptions being filled by generic drugs, any assertion that such presentations cause doctors to prescribe brand names is misguided. In fact, if anything, such presentations are helping patients because as Francine Kaufman, M.D., former President of the American Diabetes Association (ADA), pointed out, “pharmaceutical companies, along with patient advocacy organizations are helping narrow the gap between the standard of care and actual practice.”
Through new and innovative medicines, pharmaceutical companies are playing a key role in patient care, enabling patients to live longer, healthier, more productive lives. As such, “America’s biopharmaceutical research companies are committed to providing healthcare professionals with accurate, up-to-date information about new treatments and the benefits and risks of medicines.” As one commentator noted, “Doctors do need to learn about new drug products from somewhere,” and what better place than the manufacturer who made them.
The Dollars for Doc project from ProPublica deserves credit for accomplishing the goal of better transparency. However, the reporting of such results needed more balance. No one asserts that doctors and pharmaceutical companies are perfect. Indeed, both have made mistakes and rightfully paid for those mistakes. Are there bad journalists out there “struggling to find a way to survive in a rapidly changing information age, who sometimes decide to focus on something sensational and negative just to get a web hit?” Of course.
Nevertheless, these rare exceptions do not account for the vast majority of highly trained and respected professionals, which the article did not discuss (the other 98%). This overwhelming group of qualified experts and professionals who work with industry care about their patients enough to speak and attend these events. because “waiting for all the evidence, all the time, if no one is trying new options is a never ending black hole.”
Would you want your doctor to tell you there are no options because he never learned about them from industry, or would you rather him tell you that company X just came out with something new? Professionals who work with, teach, and learn in collaboration with industry provide those options to patients.
Those who assert that prohibiting such collaboration is a solution ignore the fact that consulting with industry to develop new treatments is considered part of an academic physician’s role. These presentations are an important tool for educating doctors. Doctors learn from other doctors. From each other, healthcare professionals learn about new medicines and gain additional knowledge on existing treatments. By participating in peer to peer discussions, both from certified CME and company promotions, by reviewing peer-reviewed journals, and through interactions with America’s biopharmaceutical research company representatives practicing physicians gain critical insights that benefit patient care.
In fact, it is precisely because industry sponsorship facilitates speaker programs that patients benefit because the interactions between healthcare professionals leads to an exchange of the latest regulated information about the benefits, risks and appropriate uses of medicines. The leaders of such programs, who have real-world clinical experience in specific therapeutic areas and direct interaction between biopharmaceutical companies and healthcare professionals, help improve patient care in various ways, such as disseminating information that will help address treatment gaps.
As ProPublica themselves recognized, industry speaker presentations “fill an educational gap, especially for geographically isolated primary care doctors charged with treating everything from lung conditions to migraines. For these doctors, poring over a stack of journal articles on the latest treatments may be unrealistic. A pharma-sponsored dinner may be their only exposure to new drugs that are safer and more effective.”
For the tens of millions of Americans who take drugs each day, created by the research based pharmaceutical industry, the role of the pharmaceutical industry is priceless. The companies that make the products that have improved the quality of health, reduced pain, and increased life spans “search daily to improve lives and work tirelessly to solve problems.” Do they need profits to succeed? Of course, but the more money they make, the more efficient and effective products they are able to discover, test, and produce. Profit is necessary to pay for new discoveries. The average research cost of each new product involves a $1 billion dollar, 7-10 year investment. Without “re-investment of some industry profits into education, academia, dissemination of knowledge, continuing education, we will never get sufficient information to most of those who need it.”
If all the critics out there want to end industry promotion of their products, do they expect companies to “just punch out the pills and put them on the street and say to doctors, “you figure it out?” Is that how you would want your doctor to learn about a product that he or she was going to prescribe you? Ultimately, when evaluating the articles from ProPublica, as Ronald P. Jordan, R.Ph., FAPhA, Dean of The University of Rhode Island College of Pharmacy, noted, it is important to consider the following question:
“Would you be happy to live the rest of your life only with the medicine that exists now and information we know today being used in your care?”
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