Back in October 2010, an investigative journalist shop with the help of funding from the Pew Charitable Trust known as ProPublica started publishing stories in local news papers around the country as the “Dollars for Docs” campaign. The campaign itself created a database that aggregated the payments that pharmaceutical companies had made to physicians and voluntarily or under legal obligations, made public. Concerns about such relationships grew as pharmaceutical manufactures were settling federal lawsuits alleging that they paid kickbacks and encouraged doctors to prescribe medications for unapproved uses.
In December of last year, we noted that ProPublica had not updated its payment data since 2011. However, just this week, ProPublica updated its website, and is helping several local news agencies produce articles and stories about payments.
The database will largely be irrelevant by next year, when the Centers for Medicare & Medicaid Services (CMS) will be posting payments from all applicable manufacturers to physicians and teaching hospitals pursuant to the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act. Nevertheless, this recent update from ProPublica should signal to all stakeholders the future of media outlets and local news agencies making use of the public database in ways that may surprise some doctors, and in some cases, incorrectly report such payments.
Publishing the payments on a large scale is likely to have significant implications for physicians and the pharmaceutical industry. As a recent article the Newstelegram.com noted, some medical institutions with strict conflict of interest (COI) policies may place restrictions or penalties on physicians found to have violated such policies. For example, the article noted that since 2008, UMass Memorial Medical Center has prohibited anyone directly or indirectly involved with patient care — from accepting gifts, food, entertainment, travel and honorariums from manufacturers. “We want to ensure the integrity of all patient care, clinical research and business decisions,” said John T. Randolph, vice president and chief compliance officer at the medical center.
UMass allows consulting work if it doesn't involve marketing. Speaking before nonprofit organizations — for instance, the American Heart Association — is OK as long as no industry is involved in developing the agenda or approving speakers and educational materials. Speakers' bureaus are considered “a marketing tool of industry,” according to Mr. Randolph, and UMass physicians are prohibited from participating. UMass can't prohibit private appointees to the medical staff or faculty from involving themselves in these talks, but it can — and has, since last year — prohibited them from using their UMass credentials to bolster their credibility.
New ProPublica Data, Report
In its newest iteration of data, ProPublica announced that its database now contains more than $2 billion in payments to doctors, other medical providers and health care institutions that have been disclosed by 15 pharmaceutical companies since 2009. They noted that the combined 15 companies account for prescription drug sales of about 47 percent of the U.S. market in 2011. However, such reporting is likely incomplete because some companies only recently posted data, others report in only a few categories, and some report in payment ranges, not specific amounts.
ProPublica worked with the Daily News, Los Angeles and the Nashville Business Journal to report on Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals. ProPublica noted that during the last four years, Dr. Draud has earned more than $1 million for delivering promotional talks and consulting for seven drug companies. ProPublica said this made Dr. Draud the “best-paid speaker” in its database. He may have more payments because he has separately disclosed ties with at least four additional companies that haven't revealed how much they pay speakers.
Draud is not the only high earner: 21 other doctors have made more than $500,000 since 2009 giving talks and consulting for pharmaceutical manufactures, the database shows. And half of the top earners are from a single specialty: psychiatry. “It boggles my mind,” said Dr. James H. Scully Jr., chief executive of the American Psychiatric Association, referring to the “big money paid to some psychiatrists for what are billed as educational talks.”
Scully recognized that paid speaking “is perfectly legal, and if people want to work for drug companies, this is America.” Unfortunately, ProPublica uses his quote out of context, by maintaining that such payments are only for “marketing,” without acknowledging that a majority of such payments are for research and education—both of which advance patient care and improve patient outcomes—and in some cases is mandated by FDA under a REMS. In fact, ProPublica recognized that while a third of payments went to speakers, roughly half were for research; the rest was for consulting, educational materials, meals and travel.
Susan Chimonas, a research scholar at the Center on Medicine as a Profession at Columbia University, said many medical centers that regulate interactions between drug companies and their doctors would be “alarmed” by the high tallies in the updated Dollars for Docs. How do these folks have time to do their real jobs if they’re speaking so much?” Chimonas said. Hospital administrators, she predicted, would be “concerned not only about the conflict of interest, but also the conflict of commitment.”
While ProPublica states that “Draud teaches continuing medical education courses, it is unclear from ProPublica’s database whether such CME courses are accredited by CME providers.
Fellow psychiatrists Rakesh Jain and Vladimir Maletic. Jain, of Lake Jackson, Texas, earned $582,049. Maletic, of Greer, S.C., made $527,850. Both also speak for other companies that keep their payments private. Jain told ProPublica that “he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him. “I am not a marketer, I am an educator,” Jain said. He said he is proud of his collaboration with Draud.
Changes Since 2010
In 2010, many universities and teaching hospitals were surprised to find that their faculty members were engaged in promotional speaking. ProPublica compared the faculty lists of institutions with conflict-of-interest policies barring such speaking with the database and found a number of physicians in violation. Both the pharmaceutical companies and academia tightened their policies.
Only a handful of doctors who were among the 20 highest-paid in 2010 have maintained their level of income from speaking, the new data show. Ten of the doctors dropped from making about $100,000 a year to less than $20,000 in 2012. Some doctors whose payments declined spoke about drugs the companies are no longer speaking. Others, like prominent cancer expert David Rizzieri at Duke University School of Medicine, faced new restrictions from their employers.
Rizzieri had been a speaker for Cephalon, GlaxoSmithKline and Novartis in 2010 and 2011. But after Duke restricted participation in speakers’ bureaus, his speaking pay dropped markedly in 2012, the new data show. All told, Rizzieri has received at least $567,300 in speaking and consulting payments since 2009. Dr. Ross McKinney Jr., director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke, said Duke physicians can deliver paid talks about diseases, but only if they use their own slides and presentation materials. “The general tone is a little bit more distant and less cozy than it used to be,” he said.
“I actually enjoy the aspect of educating my counterparts about developments in the field,” said Dr. Gustavo Alva, a California psychiatrist. Alva has received $663,751 speaking and consulting since 2009 for the companies in Dollars for Docs. He separately discloses speaking for other companies as well.
New Drugs, New Dollars
One thing ProPublica maintained is that payments for speaking is more of a reflection of market realities, not a changing use. For example, Forest Labs, which is much smaller than companies like Pfizer and Merck, spent $31 million on doctors during the first three quarters of 2012, dwarfing its rivals; nine doctors each made nearly $100,000 from Forest in that time alone, the data show. Pfizer - whose U.S. sales are five times greater than Forest’s - spent a fifth of Forest's total, paying out $6.2 million to promotional speakers during the same period. AstraZeneca, second to Pfizer in sales, spent $12.2 million.
Forest spokesman Frank Murdolo said in an email that the company spends more on speakers because it doesn’t use pricey direct-to-consumer TV marketing. It also has more new drugs than its competitors, Murdolo said. In contrast, GlaxoSmithKline spent $52.8 million on speakers in 2010. That fell to $24.1 million in 2011 and $7.6 million in the first three quarters of last year. Glaxo spokeswoman Mary Anne Rhyne wrote in an email that the company’s spending tracks with new drugs or new uses for existing products. “That activity has been relatively low in the past year, so spending for speaker programs has been lower, too,” she said.
AstraZeneca's spending on promotional speakers decreased from $31.6 million in 2010 to $17.6 million the following year and $12.2 million in the first three quarters of 2012.
"The decrease in spending is based on a variety of factors, including where our medicines are in their life cycles and brand budgets and strategies," Tony Jewell, a spokesman for AstraZeneca wrote.
Texas psychiatrist Jain “said he sees real value in the new brands because they give psychiatrists options if their patients are not responding to older drugs.” He said he has recently spoken on behalf of Forest's antidepressant Viibryd, Merck's antipsychotic Saphris, Lilly's ADHD drug Strattera, Pfizer's antipsychotic Geodon and its antidepressant Pristiq. Speaking for multiple companies should show that physicians’ loyalty cannot be purchased or influenced by one company alone, and that their expertise is sought by many.
Jain, Draud and Maletic also all serve on the advisory board and steering committee of the U.S. Psychiatric and Mental Health Congress, which will hold its annual convention in Las Vegas in September and October. Maletic is the 2013 program chairman. The convention receives financial support from several drug companies, and some of its presentations are sponsored by the firms. The congress is owned by North American Center for Continuing Medical Education, LLC, a for-profit New Jersey company that provides CME courses.
In response to written questions, Randy P. Robbin, president of the company, said members of the steering committee have “demonstrated experience and expertise in mental health and commitment to providing the highest quality education possible.”
The trio are paid for their work for the congress, but the money does not come from pharmaceutical sponsors, Robbin said. In CME courses, pharmaceutical companies don’t have a say in the educational content or speaker selection. Jain said in an interview that his talks for the company are reviewed for bias before and after he speaks. “I cannot present anything at the Psych Congress that hasn't been vetted repeatedly,” he said. “Pharma is not able to influence anything that I do at the Psych Congress."”
ProPublica and California
The Pasadena Star-News also collaborated with ProPublica, writing a story outlining the $242 million payments the state of California received between 2009 and 2012, which is the highest in the nation—hardly surprising given it is the largest state and population of prescribers. California was followed by Florida, Texas, New York, Massachusetts and Pennsylvania.
Of course the first sentence of the story gives readers no chance to objectively evaluate the article or physician-industry relationships: “Drug money runs deep in the Golden State.” Once again, the “journalists” at ProPublica and their affiliated news partners violate their own ethical principles of journalism and fail to present a balanced, objective point of view—forcing readers to believe that such relationships are guilty by association.
“Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,” said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar. “Now they must provide some educational content.”
Jeng was paid $80,500 by Pfizer last year for several speaking engagements. As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics. Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That’s why he agrees to speak.
“We (speakers) provide education when a new antibiotic does get released,” he said. “There needs to be education among doctors on how to use this new antibiotic.” Jeng said Pfizer is never mentioned by name at the events. Internal monitors attend the engagements to make sure, because of past litigation against the company. He also said he does not feel pressured to administer medications solely made by Pfizer.
“A lot of the lectures are in university settings. It's part of our job description,” he said. “We don’t take samples.”
Olive View is part of the Los Angeles County Department Health Services, and has its own policy on pharmaceutical influences, said hospital spokeswoman Azar Kattan.
“The Department of Health Services has a very formal process for selecting the drugs that we prescribe or use for our patients,” Kattan said. She said a committee establishes a list of drugs that can be used. If a physician wants to recommend a drug that is not on the list, he or she must receive permission from the committee.
“Part of the reason we have this process is we take potential conflict of interest very seriously, so we try to be very careful in how we select the drugs we use,” Kattan said. “If we identify noncompliance by a physician, we would investigate it and take appropriate action.”
At UCLA, faculty, staff, and trainees all can continue to be part of “Speakers' Bureaus” or similar programs sponsored by industry, but: “Faculty, staff, and trainees always should strive, however, to ensure that their talks or public presentations are free of any commercial influence,” according to UCLA guidelines. “In addition, they need to consider whether an industry-sponsored activity creates an appearance of impropriety and strive to avoid any activity that may create the appearance of a conflict of interest. Transparency and disclosure are an essential factor when participating in these programs.”
One doctor, Donald Tashkin, Medical Director of the Pulmonary Function Laboratory at the David Geffen School of Medicine at UCLA, however, was paid $181,670 last year by companies such as Merck, Novartis, Pfizer, AstraZeneca. But UCLA noted that his payments may be an exception to their guidelines.
“Dr. Tashkin, as an emeritus faculty member, is not subject to the same set of policies and reporting requirements as is a full-time, active faculty member,” said Dale Tate, spokesman for UCLA Health Sciences. “His reporting requirements depend on a number of variables including time spent at the David Geffen School of Medicine.”
“It’s not yet clear what they will report on the website,” said Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of Americ (PhRMA), in reference to the Sunshine Act database. “One of the concerns we still have is there will be masses of information and the companies feel it's very important that everybody understand the relationship between pharmaceutical companies and doctors,” she said. “The only way the companies do the research is to have physicians work on clinical trials. It's worrisome that things won't translate properly.”
But while medical schools and teaching hospitals welcome the disclosures, some say the information should be considered carefully by the public. “One of the most important pieces of disclosure is having context around transparency, which is the only way for true transparency,” said Heather Pierce, senior director of science policy at the Association of American Medical Colleges. A list of names and dollar amounts does not tell the public the whole story of why a doctor was paid by a pharmaceutical company, she said. “There is no additional information of where they are speaking, what they are speaking about and who they are speaking to,” Pierce said. “It’s an important distinction that a financial interest is not necessarily a conflict of interest.”
Northern Ohio and the News-Herald
ProPublica also teamed up with the News-Herald in Northern Ohio to show that since 2009 “Ohio physicians received $81.99 million from pharmaceutical companies, seventh highest in the nation.”
Janice Guhl Hammer, director of media relations and news services at University Hospitals of Cleveland, said UH has had policies in place for several years requiring doctors to report any relationships with companies for more than $5,000. Since the end of 2011, UH posted online a list of physicians who reported payments of $5,000 or more for speaking or consulting with outside companies, which could include payments from 2010 or 2011. Interestingly, the UH list includes a number of companies not a part of the ProPublica data, such as Bayer Corp. or Anacor Pharmaceuticals.
UH wanted patients to have as much information as possible so they could begin a “dialogue” with their doctors about any relationships they have with outside companies, said Cheryl Wahl, chief compliance officer for University Hospitals. “It could potentially bring bias into health care,” Wahl said. But UH has not had any issues of note with any physicians in recent years about a serious conflict of interests.
“There’s a lot of checks and balances in place to make sure it doesn't happen,” said Jennifer Elind, director of compliance for University Hospitals and the compliance officer for Case Western Reserve University. This includes an annual disclosure questionnaire that physicians complete. “From what we've seen, people want to do the right thing,” she said.
Additionally, while the UH does not forbid physicians from taking speaking engagements from pharmaceutical companies, the doctors do have to justify the engagement beforehand. The opportunity cannot just be for the doctor's own revenue, but it also must establish the physician's expertise in a field of medicine, Elind said.
Wahl said the hospital system has a hotline in place for people to call to report any problems they might have, which include concerns about physicians and outside companies.
Dr. Martha Sajatovic, who specializes in psychiatry, received the most research money of any UH doctor in the ProPublica data, including $274,800 from Merck and Pfizer for the period of 2010 through 2012. Elind and Wahl pointed out that the data does not specify how the money is used. While some of the funding likely went into Sajatovic’s salary, the bulk of the money was probably spent on the actual costs of performing the research.
Another large local hospital system, the Cleveland Clinic, requires staff physicians to regularly disclose and update potential conflicts of interest, according to statements of Integrity and Innovations on the Clinic's website. The potential areas of conflict are formally reviewed by one or more authorities within the Clinic.
“Cleveland Clinic policies and procedures also govern disclosure of interests to research subjects and the scientific community, as well as consulting, advisory and other financial relationships between staff physicians and healthcare companies,” the statement reads. A search of the Dollars for Docs database shows 79 disclosures of payments to the Cleveland Clinic from 2009 through 2012, the majority of which were for research. Amounts paid ranged from $400 to more than $3 million.
This effort is part of the "conflict of interest industry "which has been growing the last few years with the goal to discredit modern medicine, encourage the use of generic drugs, and alternative medicine which perhaps could reduce the cost of healthcare.
It is interesting to note that rather than report to the readers of the papers on one year of data, Propublica is adding all the years together to come up with a larger number which may give more interest to reporters but fails to put those payments in context. This could be described as a journalistic slight of hand. Big numbers alway impress the readers but do little to encourage innovation.