Who is Already Reporting Payments to Physicians
November 8, 2012
Although the Sunshine Act has yet to be implemented, some pharmaceutical companies are already disclosing payments made to physicians, and the numbers may surprise you.
The Physicians Payment Sunshine Act was passed in March of 2010, and its provisions state that pharmaceutical and medical manufacturers must begin reporting all of their payments to doctors by March of 2013. While the bureaucrats sort out the rules and regulations that will govern the reporting that must be done, and work out the details of how to get that information to the public easily, you’ll notice that many companies are already reporting details of payments that they have been making to physicians.
In fact, you’ll notice that you can look up payments made to individual doctors here on our website.
Why is this information available? While each of the companies in question will tell you that they are “voluntarily” reporting doctor payments on their own websites, the truth is actually a bit different: almost all of them are reporting those payments because they are required to do so as a result of a legal settlement with the United States Department of Justice.
In fact, each company was faced with serious charges of Healthcare Fraud. The charges ranged from promoting drugs for off-label uses to giving doctors kickbacks for implanting medical devices. Each company agreed to pay a substantial fine, and agreed to corporate integrity measures that included forced reporting of payments to doctors. Each of the companies entered into these settlements to avoid trials and the possibility of still worse penalties: the Federal government warned them that it could strike them from the list of approved Medicare/Medicaid providers.
It is no accident that disclosure of payments made to doctors was a condition of settlement, whether paid as “consultants,” as recipients of “honoraria,” or simply as beneficiaries of lavish resort vacations. Such large payments to doctors were uniformly for one of two things: assisting in the promotion of drugs for off-label use, or kickbacks for using the company’s product directly.
Here is a non-inclusive list of companies that are “voluntarily” disclosing their doctor payments (usually on obscure corners of their company websites). We’ve conveniently assembled the payments into a single database for you to search by doctor’s name. But here’s the truth about why these companies have “volunteered” to tell you who they are paying, and when they agreed to start disclosing.
2007
Company: Zimmer
What they do: Manufacturer of joint replacement products
Settlement: Agreed to pay $169.5 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Kickbacks to orthopedic surgeons for using their joint replacement products.
Company: DePuy (a subsidiary of Johnson & Johnson)
What they do: Manufacturer joint replacement products
Settlement: Agreed to pay $84.7 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Kickbacks to orthopedic surgeons for using their joint replacement products.
Company: Stryker
What they do: Manufacturer joint replacement products
Settlement: Agreed to a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Kickbacks to orthopedic surgeons for using their joint replacement products.
2008
Company: Cephalon
What they do: Pharmaceuticals
Settlement: Agreed to pay $425 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Actiq, Provigil and Gabitril.
Example criminal activity: According to the DOJ settlement press release, Actiq, a powerful and addictive opiate, was approved only for use in “opioid-tolerant cancer patients.” However, “between 2001 and 2006, Cephalon allegedly promoted the drug for non-cancer patients to use for such maladies as migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressings or radiation therapy.” Cephalon’s illegal promotion of the drug was allegedly accomplished by training its sales force to ignore the FDA restrictions, promote to physicians other than oncologists, including general practitioners, and to promote this drug for many uses other than breakthrough cancer pain. In addition, the company funded continuing medical education programs, through millions of dollars in grants, to promote off-label uses of its drugs in violation of the FDA’s requirements.
2009
Company: Eli Lilly
What they do: Pharmaceuticals
Settlement: Agreed to pay $1.415 billion, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Zyprexa.
Example criminal activity: According to the justice department’s information, Eli Lilly’s off-label promotion of Zyprexia targeted the elderly, particularly in nursing homes, as candidates for unapproved treatment with this powerful anti-psychotic drug.
“When pharmaceutical companies ignore the government’s process for protecting the public, they undermine the integrity of the doctor-patient relationship and place innocent people in harm’s way,” said acting U.S. Attorney for the Eastern District of Pennsylvania, Laurie Magid. “Off-label marketing created unnecessary risks for patients. People have an absolute right to their doctor’s medical expertise, and to know that their health care provider’s judgment has not been clouded by misinformation from a company trying to build its bottom line.”
Company: Pfizer
What they do: Pharmaceuticals
Settlement: Agreed to pay $2.3 billion, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Bextra, Geodon, Zyvox and Lyrica.
Example criminal activity: Among other things, Pfizer promoted the sale of Bextra for several uses and dosages that the FDA had specifically declined to approve because they were considered unsafe. The settlement included a criminal fine of $1.195 billion – to that date, the largest criminal fine ever imposed in the United States for any matter.
2010
Company: Allergan
What they do: Pharmaceuticals
Settlement: Agreed to pay $600 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Botox®.
Example criminal activity: Allergan promoted many off-label uses for Botox, including use as a remedy for headache pain. According to the DOJ’s report, the off-label campaign was stunning and thorough:
“Allergan’s off-label marketing tactics also included calling on doctors who typically treat patients with off-label conditions. In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses. Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications.”1
Company: AstraZeneca
What they do: Pharmaceuticals
Settlement: Agreed to pay $520 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Seroquel.
Example criminal activity: According to the DOJ, AstraZeneca engaged in a campaign to promote the use of Seroquel, a strong anti-psychotic medication approved only to treat schizophrenia and bi-polar disorders, to doctors who do not typically treat these patients. Such physicians include those who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons. The illegal activities included improperly and unduly influencing the content of company-sponsored continuing medical education programs; engaging doctors to give promotional speaker programs on unapproved uses for Seroquel; conducting studies on unapproved uses of Seroquel. The company also recruited doctors to pretend to be authors of articles about studies the doctors in question did not conduct. These articles were ghostwritten by medical literature companies. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.
Company: Ortho-McNeil
What they do: Pharmaceuticals
Settlement: Agreed to pay $81 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Topamax.
Example criminal activity: The company aggressively promoted Topamax, an epilepsy medication, for use on psychiatric patients.3
Company: Novartis
What they do: Pharmaceuticals
Settlement: Agreed to pay $420 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
disclosure of payments to doctors.
Charges settled: Off-label promotion of Tileptal and kickbacks
Example criminal activity: The company aggressively promoted Tileptal, an epilepsy medication, for use on psychiatric patients. Additionally, they gave kickbacks to doctors for prescribing six medications: Trileptal, Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.4
Company: Wright Medical Technology
What they do: Manufacture artificial joints
Settlement: Agreed to pay $7.9 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Kickbacks to orthopedic surgeons who agreed to use their products
Complaint dismissed: After 2 years of compliance by Wright, the DOJ dismissed the criminal complaint.5
Company: Forest Pharmaceuticals
What they do: Pharmaceuticals
Settlement: Agreed to pay $300 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Guilty plea: Forest settled and pled guilty to sale of a drug, Levothroid, that was not approved by the FDA, as well as off-label marketing of Celexa and Lexapro, adult-approved anti-depressants, for pediatric use.
2011
Company: Merck Sharp & Dohme
What they do: Pharmaceuticals
Settlement: Agreed to pay $950 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Vioxx. This pain medication offered to arthritis patients was recalled in 2004 because of cardiovascular complications, including significantly increased risk of heart attack and stroke.
Guilty plea: As part of the settlement, Merck pled guilty to promoting Vioxx from 1999-2003 for the treatment of rheumatoid arthritis, an off-label use, and was sentenced to pay a criminal fine of $321,636,000.
Company: Medtronic, Inc.
What they do: Manufacture medical devices, including defibrillators and pacemakers
Settlement: Agreed to pay $23.5 million, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Kickbacks to surgeons who agreed to use their products
Example criminal activity: Doctors were paid $1,000 – $2,000 for each new Medtronic device they placed into their patients. Medtronics styled the kickbacks as part of post-market “studies” of the devices.
Company: GlaxoSmithKline
What they do: Pharmaceuticals
Settlement: Agreed to pay $3 billion, along with a 5-year Corporate Integrity Agreement requiring, among other things, disclosure of payments to doctors.
Charges settled: Off-label promotion of Paxil and Wellbutrin; withholding safety information on Avandia.
Example criminal activity: GSK was charged with hiring doctors and falsifying study results to promote the off-label use of Paxil for depressed children. The studies actually showed that Paxil increased the risk of suicide in young patients. GSK also promoted the anti-depressant Wellbutrin off-label as a weight-loss product, and paid physicians to falsely claim that Wellbutrin would increase sexual libido.
Company: Johnson & Johnson, Janssen Pharmaceuticals
What they do: Pharmaceuticals
Settlement: Settled a class-action with 36 states and the District of Columbia for $181 million; Federal charges are still pending.
Charges settled: Off-label marketing of anti-psychotic drugs for non-approved uses
Example criminal activity: The complaint charged that Janssen, a Johnson& Johnson subsidiary, promoted the powerful anti-psychotic, Risperdal, for non-approved uses including dementia, anger management and anxiety. Janssen allegedly rewarded doctors who prescribed and promoted Risperdal for unapproved uses with lucrative consulting agreements.