For decades, Big Pharma and medical technology firms have made gifts and other payments to physicians as part of developing, testing and marketing their products, an expense long recognized as another cost of doing business.
On Tuesday, the federal government is set to release, for the first time, a more comprehensive database that will spotlight financial ties linking physicians to drugmakers or device-makers.
The searchable database will include hundreds of millions of dollars worth of legal but highly controversial payments for research, consulting, meals, travel, promotional speaking and gifts made from August to December 2013.
For patients, the database will allow them to see if their doctors or other medical providers have received money from any of the companies whose products they prescribe. Studies have shown that such payments or gifts, however small, alter prescribing patterns and influence how doctors practice medicine.
The Chicago-based American Medical Association, the nation's largest and most influential trade group representing doctors, said Thursday that it supports the idea of the database because it could help patients make more informed decisions about their medical care. But because the database has been fraught with "repeated shutdowns and other issues … the AMA feels the site is simply not ready for primetime," said Dr. Robert Wah, the association president.
"Patients deserve to have access to accurate information, and publishing inaccurate data can lead to misinterpretations, harm reputations and cause patients to question their trust in their physicians. It can also discourage research and care delivery improvements that benefit patients," Wah said.
Last month, the AMA urged the federal Centers for Medicare and Medicaid Services to delay release of the database for six more months. The association said doctors needed to review their payment data because of inaccuracies in the database. The agency granted a 12-day extension.
While physicians and industry groups have fought the release of the data, which they complain lack the proper context, they contend that their collaborations are crucial in encouraging research and development, along with training medical professionals how various drugs work to treat illnesses.
"Part of what we hope this data highlights is how important the interaction between industry and physicians is in advancing medical research and patient care," said John Murphy, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, or PhRMA, an industry trade group. "What we expect to see is a very high level of (research and development) funding, which, frankly, is the bread and butter of our industry and cannot be done by people other than physicians."
But some medical and policy experts question whether the relationships improperly influence doctors' decisions on patient care or unduly sway medical research.
"To deny that gift-giving does not change behavior is like denying that gravity exists," said Eric Campbell, a professor of medicine at Harvard Medical School. "It's absolutely, positively without merit and completely absurd to say it doesn't."
While physicians recognize that gifts and payments influence their colleagues, they tend to deny that they are personally susceptible, Campbell said. That's not to say that all payments to doctors from the drug and device industry are inappropriate, most agree.
Disclosure of the data is a new requirement under the federal Physician Payments Sunshine Act, a lesser-known provision in the 2010 Affordable Care Act. It mandates that pharmaceutical and medical device companies report payments of more than $10 to doctors.
Thousands of doctors and dozens of hospitals in Illinois have accepted payments through the years ranging from several hundred thousand dollars in speaking fees, travel and research grants, to a few bucks for a handful of drug-branded pens. That's based on data released by a limited subset of health care companies. Those companies began releasing such data about five years ago in the wake of separate legal settlements related to allegedly fraudulent marketing activities.
Illinois, with its high concentration of research facilities and biotechnology companies, finds itself near the center of the debate.
The state is home to 61 teaching hospitals, including major academic research centers in Chicago such as the University of Chicago Medicine, Northwestern Medicine, Rush University Medical Center, University of Illinois Health and Hospital System, and Cook County Health and Hospital System.
It also hosts the headquarters of several major health care companies, including Abbott Laboratories, AbbVie, Baxter International and Hospira, among others.
While many companies in the industry say they support the Sunshine Act, the trade groups that represent them have, for years, been fighting certain aspects of the disclosure called for under the act.
As a result, the database rollout was delayed several times, plagued by complaints of inaccuracies and technical problems.
Doctors, who were allowed to preview their own data ahead of the launch, complained about the database's lack of context and inaccurate data. That led the federal government to shut down the preview for 11 days before eventually deciding to withhold one-third of the records from the site for Tuesday's launch.
In recent weeks, the industry has ramped up the volume of its criticism of the government's handling of the data rollout.
This month, 64 health advocacy groups, including the American Diabetes Association, the American Heart Association and the National Health Council, asked the government to exclude certain indirect payments they make to doctors from the database.
The organizations said they receive donations from a variety of sources, including drugmakers and device-makers. They then pool the money and parcel it out directly to researchers.
Deconstructing those pools would create a "substantial administrative burden" for each group, and potentially put at risk future funding, the groups said in a letter.
Last week, with just a week to go before the data's scheduled release, three of the industry's biggest trade groups complained in a letter to Marilyn Tavenner, administrator of the Centers for Medicare and Medicaid Services, that the database, as presented, lacks "clear background information and context regarding such industry relationships." Such disclosures are necessary, the trade groups argued, in "ensuring patients do not form mistaken impressions that all payments to physicians are suspect."
The trade groups — PhRMA, BIO and AvaMed — also criticized the government for not explaining its rationale for withholding one-third of payment information submitted by the industry.
"It is not clear why this volume of data is being withheld," the letter said. "We are hopeful that this issue can be resolved expeditiously so that the data that is made available to the public is accurate, useful and complete."
Several companies, including North Chicago-based AbbVie, have released data about their financial relationships with physicians in the wake of various legal settlements related to allegations of fraudulent marketing activities.
AbbVie posted its first doctor-payment report to its website in March 2013. The disclosure followed a $1.6 billion settlement that its former parent, Abbott Laboratories, reached with federal and state regulators regarding its marketing of the anti-seizure drug Depakote for uses not approved by the Food and Drug Administration.
The company, which is required to post reports quarterly, made payments to 31,439 physicians in the first quarter of 2014, according to the most recent disclosure on its website.
Morry Smulevitz, an AbbVie spokesman, said its interactions with health care professionals are crucial to developing new and better therapies. The company said its financial relationships with physicians are primarily in research and development and medical education.
Those relationships are "guided by openness and transparency," Smulevitz said.
Abbott said in a statement that it views payments to physicians as an important tenet in "supporting programs aimed at increasing the understanding of scientific, clinical and healthcare issues that improve patient care."
Deerfield-based Baxter said partnerships with doctors are necessary to conduct medical research, clinical trials and physician education. It said it is "committed to acting with integrity in these interactions and in compliance with the transparency requirements" of the law.
Hospira declined to comment.
While Campbell, of Harvard, acknowledges that such relationships are necessary, particularly in research and development, he said the rationale behind some of the payments and gifts has little to do with medicine.
"Taking doctors to restaurants, buying them wine, having them play golf with drug reps — that's not research," Campbell said. "I'm not aware of a single medical device that was developed because you took a doctor out for drinks."