Big Pharma Will Have to Reveal Doctor Payments

Few professions have been spared from the corrupting effects of today's intense focus on profits and the bottom line within corporate America. The medical profession has been one of the most notable casualties of this push, as top drugmakers have showered doctors with ethically questionable or illegal financial incentives to prescribe certain drugs. Research has found that these payoffs may influence doctor choices in ways that are not beneficial to patients -- for example, getting doctors to use drugs for risky off-label uses that have not been approved by the FDA. More commonly, these practices have been found to increase healthcare costs by incentivizing doctors to prescribe more expensive drugs that aren't any more effective than alternatives -- sticking Medicare and Medicaid with the tab.

Yet today brings some good news in the battle to curb the influence of drugmakers over doctors. According to the New York Times, new rules will soon go into effect that require drugmakers to reveal their payments to doctors. As the Times explains:

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

This new transparency will be good. But what is still missing are tougher rules that govern what payments Big Pharma can make to doctors in the first place. And without those rules, the integrity of the medical profession will remain at risk.

Doctors Took Kickbacks to Implant Pacemakers

This week's DOJ settlement with Medtronic confirms some of people's worst fears about both doctors and medical device companies. As the Justice Department reports:

The United States contends that Medtronic caused false claims to be submitted to Medicare and Medicaid by using two post-market studies and two device registries as vehicles to pay participating physicians illegal kickbacks to induce them to implant Medtronic pacemakers and defibrillators. . . . . 

“Patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,” said Tony West, Assistant Attorney General for the Civil Division. “Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.”

“Medicare and Medicaid beneficiaries depend on their physicians to make decisions based on sound medical judgment, especially when they are choosing which pacemaker or defibrillator to implant,” said B. Todd Jones, U.S. Attorney for the District of Minnesota.  “Medical device manufacturers must not be permitted to use improper payments to cloud that judgment.”

“Today’s settlement highlights one of the key purposes of the Anti-Kickback law – to ensure that the judgment exercised by health care providers in treating Medicare and Medicaid patients is not influenced by unlawful payments,” said Benjamin Wagner, U.S. Attorney for Eastern District of California.                       

“Patients trust that decisions to implant certain pacemakers or other medical devices are based on their own health interests and not influenced by kickbacks,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “Companies distorting medical decision-making through kickbacks can expect that OIG investigators and our law enforcement partners will actively investigate and prosecute such unlawful conduct.”

New Database Reveals Ties Between Doctors and Drug Companies

A new database, created by the nonprofit news group ProPublica, documents money received by doctors from drug companies, along with possible conflicts of interest. The site functions as a comprehensive, searchable tool that allows people to see if their doctors have received money from drug manufacturers.

The database brings greater transparency of drug manufacturers in their dealings with doctors and provides the public with a new tool to assess whether doctors are ensuring their patients' best interests.

Financial ties between doctors and drug companies have long been kept behind closed doors, obscuring conflicts of interest. These transactions are not explicitly illegal, and many may be a sincere attempt to promote a drug in the name of innovative medicine. However, as ProPublica notes, such exchanges of money between medical professionals and drug companies (private corporations who do not deal with patients on an individual basis) do “raise ethical issues.” In total, this database contains 17,700 medical providers who have received, in total, close to $289.1 million.

The data was compiled from only those drug companies that listed the information on their website. Therefore, it does not include all manufacturers, nor can every healthcare provider in the United States be found on the site. Just because a doctor isn’t found does not mean he/she has not received money from a drug manufacturer to promote a product. However, neither are health care providers found on the site to be deemed guilty of corruption; manufacturers do hold conferences, seminars, and other events in order to legitimately educate doctors about new drugs that may have beneficial uses outside of what they have been approved for by the FDA. Either way, the "Doctors for Dollars" database is essential for bringing transparency to these transactions, which in turn is essential to the public’s ability to make informed decisions about the drugs they are being prescribed. The only people transparency will harm are those looking to work behind a curtain; in the name of public interest, that curtain should be lifted.   

Many manufacturers, such as Pfizer (the maker of Viagra and Lipitor) and Johnson & Johnson (the company that promotes Concerta for ADHD), are required to disclose this information as a result of legal actions taken against them. However, many companies freely publicize this information for their consumers. ProPublica also provides numerous links to articles and resources for those looking to learn more about drug companies and the legalities of off-label use.

Information regarding the links between drug companies and doctors is becoming increasingly available; ProPublica is one admirable example of a trend that is, hopefully, on the upswing. The new healthcare reform act passed in 2010 requires all drug companies to report data about their payments to healthcare providers (this includes pharmacists and nurses, too) to the federal government by 2013. While we wait on this legislation to take effect, resources such as ProPublica should make doctors think twice before padding their bank accounts with quick money from a drug manufacturer in exchange for a few prescriptions.

Alarming Numbers Of Surgeons Failing To Disclose Financial Ties

Almost half of all surgeons who made at least $1 million in payments from orthopedic device companies did not publish the relationship in their scientific articles, according to a study released today in the Archives of Internal Medicine. The study, conducted by researchers at the New York-based Institute on Medicine as a Profession (IMAP), is the first ever to use company records to examine the information doctors disclose in medical journals

Increasing numbers of pharmaceutical companies and medical device companies (many as a result of integrity agreements stemming from past lawsuits) are disclosing the sums paid to consultants (i.e., doctors). These payments present a clear conflict-of-interest, of which all patients should be aware before accepting advice from the doctor in question. However, when compared to the information these surgeons provided about themselves in their medical journal articles, almost half “failed” to acknowledge that they had received such large sums.

“The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions,” says senior author David Rothman, the president of IMAP.

The five companies studied (Biomet, DePuy Orthopedics, Smith & Nephew, Stryker and Zimmer) paid consultants an astounding $248 million in 2007 for various services. While many of these constitute legitimate, ethical payments, many can become an issue when the doctor in question advocates for a certain product or procedure the company created while failing to disclose his or her close financial ties. Often, the moral dilemma is to agree with the company shelling out the money over sound, scientific inquiry and an unbiased view toward finding the most efficient and cheapest methods to cure patients.

Which makes the following piece from the press release particularly unnerving: “In no case did journal articles reveal how substantial the payments were to the authors. Almost all of articles were directly related to a device, like a hip implant, made by the company. This study focused on orthopedic surgeons but other studies suggest other medical specialists also fail to have their industry ties published.”

Alpharma Settles Charges of Paying Off Doctors

Alpharma paid out a $42 million multi-state settlement in July 2010 for it role in sponsoring Advisory Boards between 2000 and 2008 that allegedly enticed health care professionals, including physicians and nurses, to participate in the program through lavish kickbacks. According to Attorney General Tom Corbett, Alpharma allegedly offered and paid for training programs, research grants, consulting forums and speaker events in an effort to increase prescriptions of Kadian, a morphine used to mollify intense pain.