What Is in That Briefcase?

The scene is a common one in many a doctor’s waiting room.

As patients wait anxiously for their turn, a well-dressed individual with a briefcase enters and takes a seat. This visitor, who may or may not have an appointment, is also there to see the doctor, but didn’t come to receive medical care. He is a salesman from a drug manufacturer, and his goal is to convince the doctor to prescribe and recommend his company’s products.

Unless he cuts the line and causes the patients a longer wait, his presence rarely causes discomfort among the others in the room. Patients want their doctors to have all available information about new medications and medical devices, and are usually delighted to get some free samples.

However, there is increasing evidence that what may be in that salesman’s briefcase isn’t merely freebies for the patients, but some serious incentives for the doctor, raising concerns about potential ethical conflicts in medicine.

 On Tuesday, the U.S. government released data detailing how drug and medical device companies paid doctors leading hospitals billions of dollars last year. The value of industry payments and other financial benefits — ranging from research grants to travel junkets — totaled nearly $3.5 billion in the five-month period from August through December 2013, according to the Centers for Medicare and Medicaid Services, which released the data.

The massive trove of information named companies and many of the recipients. Also listed were types of payments, with details down to travel destinations. According to an Associated Press analysis, some 546,000 clinicians and 1,360 teaching hospitals received benefits.

This new initiative, called Open Payments, is now required under President Barack Obama’s health care law. In future years, the information will cover a full 12 months and will be easier to search, officials said.

For consumer groups, the release is a step towards much-needed transparency. They see a built-in conflict of interest that can influence prescribing decisions, the use of high-tech tests and even types of surgeries performed. Supporters of Open Payments also argue that making these payments public will cause health-care providers to think twice before accepting money — helping reduce the chances of potential conflicts of interest.

An initial Associated Press analysis — which excluded research grants — found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.

For their part, doctors and industry spokespeople said the government rushed to release the data, and they raised questions about accuracy and lack of context. But even if the precise figures may turn out to be inaccurate, there is still very ample reason to be concerned.

The story of a medication called Risperdal is a classic example.

In November of last year, the Justice Department announced that global health care giant Johnson & Johnson and its subsidiaries would pay more than $2.2 billion to resolve criminal and civil liability arising from allegations related to Risperdal and two other medications.

The government charged that during a time period when Risperdal was approved only to treat schizophrenia, the company’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients. Though FDA repeatedly advised the company that marketing Risperdal as safe and effective for the elderly would be “misleading,” the salespeople continued to urge prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.

As part of this sales effort, the company paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives reportedly told doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

Under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding,” J&J and its subsidiary also paid millions of dollars in kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.

Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension” of their own sales force.

Sen. Charles Grassley (R-Iowa), who long championed for the disclosure provision in Congress says he hopes the data will become a resource for consumers over time.

“The patient who is prescribed a drug that might be beneficial, yet risky, will be able to learn whether the prescribing doctor accepted drug company money to study the risks,” Grassley said in a statement. “The information might not change the outcome, but it’s something a patient might like to know.”

We agree.