Barbara Garcia dumps a shoebox-full of pill bottles onto her bedspread.
“This one is for my heart,” she says, plucking a bottle from the pile. “This other one here is for migraines. And this is for depression.”
The list continues. The 57-year-old Omaha native takes 25 medications for ailments ranging from asthma to breast cancer. Although she receives Medicaid, the program doesn't cover all her prescribed drugs, leaving her to pay for the rest.
“I'm supposed to be on more,” she says. “But this month I could only afford about half of them.”
Garcia's situation is common. More than 43 million Americans are without health insurance, according to the Centers for Disease Control's National Center for Health Statistics. Last year, President Barack Obama signed the Patient Protection and Affordability Care Act to make it easier for the uninsured to access health care. To help lower costs and protect patients, the law requires doctors to disclose online any gifts or payments from pharmaceutical companies worth more than $10. Educational materials and drug samples — including rebates and discounts — are exempt from the requirement. The provision isn't effective until 2013, but some companies have already made payment records available on their websites.
Others, including Pfizer, Eli Lilly, AstraZeneca and Cephalon, have begun posting physician payments as a result of multimillion dollar settlements focusing on fraudulent marketing tactics, including offering kickbacks to healthcare professions who prescribe the companies' medication. ProPublica, a nonprofit investigative journalism organization, compiled a database of payments to U.S. doctors from eight pharmaceutical companies. Sixty of these doctors practice in Omaha. Specialties range from pulmonology to geriatrics, from internal medicine to critical care medicine. On the list, commonalities arise. Psychiatrists represent nine of the 60 doctors on the list; four practice pediatrics; and family practitioners and pain management specialists are each represented three times. Together, these Omaha doctors accepted more than $1.2 million from seven drug companies in 2009 and 2010. The annual amount each drug company paid to Nebraska physicians ranged from more than $22,000 to more than $935,000. Whether these payments cause conflicts of interest is hotly contested within the industry.
“That's the thing that's interesting about these relationships,” says Dr. Valerie Arkoosh, professor of medicine at the University of Pennsylvania. “I would tell you that every single physician would say that pharmaceutical marketing does not influence them, but it's been shown over and over again [through studies] that doctors are influenced, even if it's unconsciously, by the relationships they develop with the pharmaceutical representatives.”
Garcia sees a familiar name on the list of physicians.
“This is my doctor,” she says.
She points to Dr. Jacqueline Chanlatte, an internist and pain management specialist who received $34,840 from pharmaceutical giants Johnson & Johnson, GlaxoSmithKline and Eli Lilly for speaking fees, expert-led forums, consulting fees, meals and travel expenses during 2009 and 2010. She was also compensated for participating in health care professional programs. The Reader made several attempts, on the phone and in person, to speak with Chanlatte, but she declined comment.
In a small office near Westroads Mall, a handful of patients wait to be seen. Pain management specialist Dr. Jeffrey Edwards, who completed received his medical degree at Creighton University, forgoes the white coat and dons a casual sweater and slacks. In 2009 and 2010, Edwards accepted more than $108,000 from Johnson & Johnson, Eli Lilly and Pfizer. Like Chanlatte, he was compensated for speaking, business travel, meals, expert-led forums, consulting and participation in health care professional educational programs.
During a typical pharmaceutical-sponsored speaking forum, a doctor presents professional experiences highlighting a drug's use and effectiveness for treating patients, according to UK-based pharmaceutical company GlaxoSmithKline's website. Edwards says he participates in these events to educate and interact with peers.
“I'm a solo practitioner, so pharmaceutical talks are probably the No. 1 way that I can interact with my colleagues,” he says.
Edwards sits at a small table in the break area outside of his personal office. Inside, framed photographs of family members line his desk.
“Usual places that I meet up with my colleagues are meetings that are continuing medical education-driven or pharmaceutical-sponsored meetings. Those are really the only two ways I ever see my colleagues.”
He says drug company money helps offset his cost to attend the events.
“What we make in our office is partially everybody else's — the light company and the rent companies and the employees,” he says. “So when I'm gone, there still has to be some income of some sort to pay all those bills. Generally speaking, this isn't much of a make-money proposition as it is a lose-money proposition. I do it because I like that and it keeps me sharp.”
Arkoosh, a native of Omaha and an alumna of the University of Nebraska Medical Center, isn't persuaded. In addition to teaching, Arkoosh is president of the National Physicians Alliance, a nonprofit group of approximately 20,000 doctors aiming to restore the emphasis on service, integrity and advocacy within the profession. The group provides opportunities for health care professionals to become active in their communities to “provide high-quality, low-cost health care for all.”
“If you were away from your office that much, you're not, in some ways, practicing that much anymore,” she says. “It's a choice that individual has made as to where and how to spend their time and from which sources they're going to derive their income.”
Edwards doesn't believe drug companies should have to publish payments to doctors.
“I don't get why the doctors and the pharmaceutical companies were singled out,” he says. “The politicians and the lobbyists still do what they feel like. I'm in private, personal practice. What I get is published for all the world to know. I don't think that's fair, unless everybody's is.”
But lobbyists' financial records are published and available on the U.S. House of Representatives website and from organizations tracking political money, such as the Center for Responsive Politics, in accordance with the Lobbying Disclosure Act of 1995. These records show drug companies such as Pfizer and AstraZeneca spent millions of dollars lobbying Congress on health care issues, including the Physicians Payment Sunshine Provision. Pfizer, and its Wyeth subsidiary, spent $61.4 million lobbying in 2009, and another nearly $6.6 million in 2010, the year the provision was passed. GlaxoSmithKline spent more than $8.7 million in 2009 and about $5 million in 2010. The law's co-author, Sen. Chuck Grassley (R-Iowa), believes transparency will help eliminate the disparity between the money that physicians and medical researchers receive, and the amount they report from pharmaceutical companies.
“I’m interested in meaningful transparency,” Grassley said in an e-mail to The Reader.“Letting the sun shine in and making information public is basic to accountability. Public dollars and public confidence are at stake.”
Despite nine months working on the bill and vigorous debate following its introduction in 2007, Grassley joined 39 other Republicans and voted against the health care reform bill that included his provision. Later, he argued the bill would increase taxes and premiums while damaging Medicare.
Joseph S. Ross, assistant professor of medicine at the Yale School of Medicine, says transparency laws may help combat conflicts of interest, of which he's seen his fair share. In 2008, Ross and a team of colleagues discovered articles in top medical journals written by professional writers but published under physicians' names. The ghostwritten articles focused on Vioxx, a best-selling drug manufactured by Merck, and sometimes involved the company's own marketing department to produce favorable content for the articles. Ross says collaborations between physicians and the pharmaceutical industry can help develop medications, answer new questions and find better ways to treat patients. But he says the relationships become negative when the industry influences physicians.
“The idea of the industry’s influence on the way medicine is practiced is evident as soon as [the residents] start to step into the world,” Ross says in a telephone interview. “People used to tell stories about how Eli Lilly gave medical students their first stethoscope for free.”
Ross says physicians must decide whether they'll accept payments. “I don't know why a physician would argue 'I have to accept these payments because I'm losing money by leaving my clinic to do these talks,'” he says. “Everybody makes decisions about how they spend their time. Some people voluntarily do things they think are better for their community or society. That's their own choice.”
Dr. Ann Edmunds — an ear, nose and throat specialist — received $16,500 in speaking fees from GlaxoSmithKline in 2009. She, too, cites education as her reason for participating.
“You do it to educate people, not to make money,” she says in a phone interview. “If I agree to do a talk in the afternoon, I'm going to lose money because I won't be in the clinic seeing patients. If we receive compensation, it's to cover expenses.”
GlaxoSmithKline doesn't pay for travel or hotel rooms, says Mary Rhyne, director of U.S. Media Relations for GlaxoSmithKline. Nor does it compensate for attending speaker events, according to the company's website. The company does, however, pay for meals at speaker events “in accordance with state law,” whether held at restaurants, hospitals, hotels or other locations “conducive with scientific and educational communication.” The type of restaurants where industry-sponsored events are held vary, says Scott MacGregor, Eli Lilly spokesman. He says the company conforms to a code of ethics laid out by the industry group Pharmaceutical Research and Manufacturers of America (PhRMA). “These are not lavish dinners by any means,” he says. But in a Oct. 10 press release on interactions with health care professionals, PhRMA states its code prohibits sales representatives from “providing restaurant meals to health care professionals, but allows them to provide occasional meals in health care professionals' offices in conjunction with informational presentations.”
MacGregor says its sales representatives are not the ones leading or conducting speaker-events in restaurants; rather, a third-party provides educational, in-depth presentations. He references Section 2 of the PhRMA Code stating “it is appropriate for occasional meals to be offered as a business courtesy to the health care professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value.” MacGregor says the purpose of speaking events held in restaurants being to inform and educate health care professionals about treatment options, rather than selling them on drugs, makes all the difference to PhRMA. In addition to speaking at industry-sponsored events, doctors on the ProPublica list received payments for participating in expert-led forums. Pfizer offers information on its website regarding the forums.
“[Expert-led forums] provide a way for doctors to educate their peers on important topics. Pfizer's speakers are health care professionals who spend years building expertise in their fields,” the company's website states. All content presented must be “grounded in science and free from any misleading information.”Doctors are compensated “according to fair market value guidelines.”
Arkoosh says she was approached about 10 years ago to speak about an anesthetic at a drug company's expert-led forum.
“It's flattering to be asked and they're really nice to you and talk about how they only invite experts from the field, so it's deceptive in a way,” she says. She told the company she would be available, and received a set of presentation slides. She says she disagreed with how the slides presented information.
“[The company] said 'Thank-you very much,' but I was never invited to speak anywhere,” she says.
While some drug companies are publishing physician payments in preparation of the provision's March 2013 effective date, others have far different reasons. Those companies communicate, via their websites and written statements, that their transparency and physician payment disclosure are marks of honesty. But multimillion dollar fraud settlements paint a different picture.
On the company's website, Pfizer states “We report payments for a range of activities with physicians: We want patients to understand the way we work with health care professionals.”
But Pfizer's disclosure is one of the stipulations outlined in a $2.3 billion fraud settlement, the largest in history, in which Pfizer pleaded guilty to felony FDA violations including the “illegal promotion of certain pharmaceutical companies,” according to a Sept. 2, 2009 Justice Department press release. As part of the settlement, the company is required to disclose physician payments. According to the settlement agreement, Pfizer promoted “off-label” uses for four of its drugs. This triggered false claims to government health care programs such as Medicare and Medicaid, which don't cover medication for non-FDA-approved uses.
AstraZeneca has a similar story. In October 2009, the company agreed to pay more than $520 million in a settlement relating to its anti-psychotic drug Seroquel. Like Pfizer, AstraZeneca was charged with promoting off-label uses to health care professionals, which allegedly resulted in several patient deaths. AstraZeneca was charged with offering kickbacks and engaging doctors to “give promotional speaker programs on unapproved uses for Seroquel,” as well as having “recruited doctors to serve as authors of articles ghostwritten by medical literature companies about studies the doctors in question did not conduct.” As part of the settlement agreement, AstraZeneca is required to publicly disclose all payments made to physicians.
Eli Lilly plead guilty to promoting off-label uses for its anti-psychotic drug Zyprexa in early 2009 and paid a $1.4 billion settlement. According to the plea agreement, sales reps were trained to promote Zyprexa to physicians to treat illnesses such as Alzheimer's and dementia, though the FDA had not approved those uses. The unapproved uses sparked false claims to Medicare and TRICARE, putting Eli Lilly in the hot seat for violating the False Claims Act. As part of its settlement, Eli Lilly must post on its website information regarding payments to doctors.
In 2008, Cephalon pleaded guilty and agreed to a $425 million settlement involving the company’s use of aggressive marketing tactics and wrongfully promoting its drugs for off-label uses. Actiq, a narcotic in a lollipop form used to treat cancer patients, was prescribed for migraines and sickle-cell pain, although the FDA didn't approve those uses. Cephalon, too, is required to post physician payments on their website.
Sphere of Influence
“Their [pharmaceutical companies'] success is in no way going to impact what I'm doing,” Edmunds says. “It's always been a question surrounding a potential conflict of interest, and I understand. But if you're doing it correctly, it's an unbiased discussion.”
Arkoosh, however, says the drug industry can influence physicians more than they realize. Seemingly small things like pens or notepads can have a big impact.
“Even if they're given a small gift, there's that sense of indebtedness to the person who gave it to them,” she says. “So maybe they'll think of that person and the company that they're from the next time they prescribe a certain drug.”
A 2009 study published in the Archives of Internal Medicine tested the influence theory. Researchers studied 352 medical students at the University of Miami (which allows gifts) and at the University of Pennsylvania medical school (which bans them). They found students who received gifts increasingly preferred drugs after using promotional clipboards and notepads advertising the drugs. Students who didn't receive gifts remained consistent with their drug preferences. Arkoosh says this influence affects patients in multiple ways.
“Pharmaceutical reps tend to encourage physicians to prescribe the newest drugs, which are never generic and that have been around for, usually, a relatively short period of time,” she says. “So the impact of that is that we may not have a complete understanding of the side affects or risks of a given drug because it hasn't been on the market that long, and that's going to be much more expensive for a patient than a drug that's available in a generic form.”
The University of Nebraska Medical Center allows its doctors to participate in industry-sponsored events and to receive compensation, as long as they tell the university, says Sheila Wrobel, the school's chief compliance officer.
“We have a policy of disclosure. Our policy does not prohibit the activity. It permits the activity with disclosure,” she says.
Wrobel believes potential conflicts of interest are controlled due to strict industry regulations and monitoring by the university.
“[We] assure the content is balanced and unbiased,” shel says. “And then we look at potential conflict of interest. And we set up management plans if there’s any appearance of conflict.”
Lois Colburn, UNMC's director of continuing medical education programs, says the industry's codes of conduct help limit potential conflict.
“The new  codes of conduct really cut back on a lot on what the industry may or may not do in terms of industry-sponsored speaker programs,” she says. “So the industry itself is regulated. The conduct of its sales staff and what it does in terms of marketing and other dimensions.”
But Ross says he believes industry-sponsored events are little more than marketing strategies.
“If a company is paying a speaker to come speak and they're putting out food for people to eat, I assume they're doing it because they think it's going to effectively promote the drug to the people who are attending,” he says.
In fact, doctors who are compensated for speaking at industry-sponsored events are ones who, according to Rhyne, “have contracts with GlaxoSmithKline to serve as promotional speakers.”
In the end, patients are most affected by potential conflicts of interest. They can impact the very lifeline of someone like Garcia, who relies heavily on medication for serious illnesses such as cancer. To her, it's about trust in knowing the shoebox full of medication is right for her and not a result of entangled relationships between doctors and drug companies. Although she believes Chanlatte is giving her the best possible care, she becomes angry when she sees the amount of money paid to doctors by pharmaceutical companies.
“I'm pissed off,” she says. “I had no idea this was going on.”