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By now, it's no surprise that medicine operates under the influence of industry. For decades, physicians and pharmaceutical companies have enjoyed cozy relationships. Though these links have led to the discovery of life-saving drugs and devices, they have also bred harmful conflicts of interest. Lawsuits in recent years revealed that doctors' relationships with industry can alter their prescribing practices and decision-making for the worse, and pharmaceutical companies have paid out billions of dollars in fines for fraudulent marketing practices.
These relationships have been mostly cloaked in secrecy and hidden from view — until today. This afternoon a government-run Open Payments website went live, detailing 4.4 million payments to more than 546,000 doctors and 1,360 teaching hospitals. In total, they show that industry paid doctors and hospitals at least $3.5 billion in only the last five months of 2013.
Here's what you need to know:
1) The Sunshine Act makes it possible to see which Big Pharma and medical device companies pay your doctor
The Sunshine law is part of the Affordable Care Act, passed by Congress in 2010. It mandates that every pharmaceutical and medical device company in the country annually disclose payments made to doctors and teaching hospitals for a range of activities — including promotional speaking, research grants, meals, and trips of at least $10 value. In addition, manufacturers and group purchasing organizations are required to report physician ownership or investment interests.
The companies had to provide details to the federal agency, the Centers for Medicare and Medicaid Services (CMS), about what they gave to whom and why, the amount and date of the payment, the name and address of the recipient, the associated physician ID number, the form of the payment (cash, services, stock options, etc.), and a few words about the context under which the payment was made.
Payments about medical doctors, osteopaths, chiropractors, podiatrists, dentists, and optometrists are had to be reported but not nurse practitioners and physician assistants since the law doesn't require reporting on payments to these groups.
CMS made this information public in an online, searchable database that launched on September 30.
2) The act was passed because payments by industry to health professionals can lead to bad medicine
The idea behind the database is simple: by shedding light on payments to medical professionals, the public can be informed about potential conflicts of interest. The sunshine is also meant to deter potentially harmful doctor-industry relations.
This type of remedy has been a long-time coming. Research for decades has shown that relations with industry — from industry-sponsored education to encounters with pharmaceutical-company sales representatives, and even drug samples provided by those companies — can bias a doctor's judgment in all sorts of ways. It can color the medical education they give to future doctors, cause them to inappropriately prescribe drugs, to push for the FDA approval of medicine, or for drugs to be included on their hospital formularies. Industry-funded studies are also four times more likely to lead to favorable and positive results than independent research.
The side-effects of this "Bad Pharma" behavior range from waste in the health system, to mistreatment of patients, and even avoidable patient death.
Sometimes the drugs aren't all right. (Photo by Philippe Huguen/AFP)
3)These relations are very common
Research has also shown that relationships between the medical profession and industry are common, according to the New England Journal of Medicine: a 2007 study showed that 94 percent of American physicians had some kind of tie with industry. 94 percent of American physicians had some kind of tie with industry
Of those, 83 percent took gifts, and nearly 30 percent received payments for professional services such as consulting or research participation.
"By 2001," the article authors wrote, "industry had become the major source of research and development funding, accounting for 55 to 60 percent of some $100 billion annually."
Of the doctors receiving this money, more than half were involved in educating future doctors, and 40 percent wrote medical practice guidelines. That means the very doctors who are supposed to be providing independent advice to the next generation of doctors or to committees who write guidelines that will steer their practice have interests that lie in places other than public health.
Doctors' financial relationships with industry
(Chart from Archives of Internal Medicine via Aaron Kesselheim)
4) The Sunshine data is incomplete and not necessarily representative
The new CMS database will only include payments made to doctors between August 1, 2013 and December 31, 2013, so it is by no means a complete picture of payments health professionals received. And while $3.5 billion in payments sounds like a lot, it's estimated that companies spend about $30 billion a year on marketing, so again, this is only a snapshot of what's actually going on between doctors and industry.
What's more, CMS says 40 percent of the 4.4 million records they collected are "de-identified" for now. This means that nearly half of the data on the database will not contain the name of the physician or teaching hospital that received a payment but only the name of the manufacturer because of unresolved concerns about the accuracy of the data. They promise this data will be fully identifiable by June 2015.
About 199,000 records that were collected won't be published at all today. Of these, CMS says 190,000 are being withheld because they met the criteria for a delay in publication since they involved a new product or one that's under regulatory review by the Food and Drug Administration. The remaining 9,000 were not published because of ongoing disputes with industry about the accuracy of the data.
So this means that some payments to doctors and hospitals just won't show up, and the fact that you don't find a doctor or hospital listed doesn't mean they haven't been paid.
5) Doctors are worried about the accuracy of the data
The American Medical Association, along with dozens of health professional groups and medical societies, had asked the federal government to delay the launch of the database for six months. They wanted more time to review the data.
CMS didn't comply, which has been a sticking point for doctors, who also heavily lobbied against the Act along with industry."The CMS website had so many bugs in it"
AMA president Dr. Robert Wah tells Vox, "We are concerned that with this data release, patients may take the information out of context or more importantly that there will be inaccuracies within the data."
He says CMS provided doctors with too little time to correct the data (45 days) and that the website's user interface made it difficult to correct mistakes. Of the more than half a million doctors on the database, CMS says only about 26,000 registered on their Open Payments website to review their and 400 hospitals did so.
Dr. Aaron Carroll, assistant dean for research mentoring at Indiana University School of Medicine, was one of the few who got online to check his data, and he had one of those less-than-ideal experiences. When he logged into the CMS site, he found a pharma-sponsored lunch was ascribed to him that he actually didn't participate in. It then took him hours to dispute and correct the claim. "The website had so many bugs in it. Half the time I would click things, and no matter what I did, I was brought to an error screen. It was just a horrible," he says.
While the mistake was so minimal — a $15 meal — that even if it wasn't caught, it wouldn't harm his career, he worried about the reputations of his colleagues who might have bigger errors attributed to them that they only learn about with the launch of the site. "I don't know how easy it will be to correct or fight this stuff."
For now, users of the database must proceed with caution, keeping in mind data may be incorrect or that it may be misleading or unrepresentative.
6) Some of this data is already publicly available
Journals now require physicians to disclose their conflicts of interest, and so do some hospitals. Several states — such as Maine, Massachusetts, Minnesota, and Vermont — mandate the public reporting of financial relationships, too.
Legal settlements with the Office of Inspector General of the Department of Health and Human Services have also forced more than a dozen pharmaceutical companies to report their relations with physicians under "corporate integrity agreements," and several pharma companies and medical device manufacturers voluntarily report payments to doctors on their own websites.
Notably, ProPublica, the investigative news website, has been tracking publicly reported payments to doctors since 2010 on its easily searchable Dollars for Docs database.
Dollars for Docs
So this data about conflicts of interest exists elsewhere. But what's supposed to be different about the newly-launched database is that it is designed to be a central location for payment data building annually from 2013. There's also the possibility that CMS can audit reports and fine stakeholders for lying, which means it should theoretically be more accurate than other company-run databases.
7) Critics say disclosure isn't enough
Time will tell whether this turns out to be the comprehensive and user-friendly resource it is supposed to be, and CMS emphasizes that it's a work in progress.. But right now, many observers are skeptical. "Is the patient going to know that this information is out there, and know where to go find it?"
Dr. Marty Makary, associate professor of surgery at Johns Hopkins, pointed out that while there is already public disclosure of industry ties in many places, doctors still don't have to report their conflicts to patients during their everyday interactions. He wondered why this hasn't happened yet and whether patients will have the wherewithal to check databases for this information.
"Is the patient going to know that this information is out there, and know where to go find it?" he asks. "Those are real barriers to the world of patient-centered care."
There's also the question of whether and how this database will actually change behavior. Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, says, "I don't know that there's any good evidence yet on how these data are going to effect patients or physicians."
For example, one study used the state sunshine laws already implemented in Maine and West Virginia to see what effect they had on doctors' prescribing of cholesterol-lowering statins and selective serotonin reuptake inhibitors for some mood disorders. These classes of drugs have good generic alternatives but pharmaceutical companies heavily marketed the branded versions to doctors. The researchers found physicians continued to prescribe branded medications, and that the state laws had little impact on prescribing practices.
there's a lot of work on Conflict of interest left to be donE
"[Sunshine] is a long time coming, it's a welcome evolution," Kesselheim says. "But there's a lot of work left to be done. It's going to be important to use the data and figure out how to use the data in the right way to try to better educate physicians and patient."
Trudo Lemmens, a University of Toronto-based expert on pharmaceutical regulation, worries that mandatory disclosures could become "a cleansing ritual" for doctors with little actual impact on the profession or patients. "You get rid of your sins by confessing, then the problems with conflict of interest are washed away," he says.
"We've seen studies suggesting that when disclosure is introduced as a method by physicians telling their patients — 'I'm being paid by company x' — in a strange way it sometimes leads patients to have greater trust in the specialists."
Lemmens hopes people are aware of these pitfalls and that disclosure doesn't just replace more effective means of actually disinfecting industry-physician relationships.
Unintended consequences also include the potential that transparency could have the opposite of the desired effect among some highly-paid, entrepreneurial specialties — such as surgeons who work closely with medical device companies, says the director of Columbia University's Center for the Study of Society and Medicine David Rothman.
"These are the entrepreneurs," Rothman says. "They may take publication of income, their money, as a point of pride. It's possible sunshine will breed a kind of horse race and doctors will turn to a company and say 'hey all my colleagues are getting x, I'm only getting y. I want more.'"
8) Some worry the database will deter potentially beneficial industry ties
As the AMA said in a statement, "Just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately."
Dr. Thomas Stossel, known as Harvard's "pro-industry professor," says doctors' work with industry is "necessary and beneficial." He worries that the Sunshine Act could make it embarrassing and difficult for doctors to do work like developing medical devices or designing clinical trials, and that industry may start avoiding working with American doctors because of the time and investment disclosure will require.
"Some smaller companies may think this is too much trouble," he says. "They'll say 'we're not going to contract with American medical schools, we'll just do it in Croatia."
9) The money is already moving elsewhere
There are other limits to the Sunshine Act. Namely, conflicts of interest are a moving target. Payments to health professionals for marketing have been plummeting in recent years. It's possible that since this law was conceptualized and enacted, the target has already shifted and companies may now be required to disclose their least-troubling marketing practices.Companies such as GlaxoSmithKline have already reported that they'll be moving away from paying doctors to market their drugs
According to ProPublica, "Eli Lilly and Co.'s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012." During that time, Pfizer's payments decreased by 62 percent, from about $22 million to $8.3 million. Companies including GlaxoSmithKline have already reported that they'll be moving away from paying doctors to market their drugs soon, and instead train their own in-house physicians to do the job.
Kesselheim has run some of these analyses and also found payments to physicians are shrinking over time. "In the back of your mind, there's a concern that if you shed some light on one aspect of pharma marketing, that there will be ways, people will try to skirt or game the system to try to avoid the sunshine."
So if payments to doctors have been declining in recent years, the question now is where the money is being spent and what changes will need to be made to the Sunshine Act to reflect them .
10) We are entering a new era of transparency
No matter what happens today, it's important to note that this move is part of a new era of transparency in doctor-industry relations, however imperfect. Even the skeptics think this is a solid, if incomplete and overdue, step in the right direction.
Sen. Chuck Grassley, one of the authors of the Sunshine Law. (Photo by Bill Clark/CQ-Roll Call Group)
In recent years, companies have been putting more and more information that was previously hidden from view into the pubic domain.
This has included everything from payments to physicians to previously unpublished clinical trials data. There's already anecdotal evidence that suggests that many physicians — knowing the Sunshine Act was coming into effect — have stopped accepting gifts from industry. But the question remains whether and how people will access this data to improve the practice of medicine.
In a statement, Senator Charles Grassley — who co-wrote the law — says he is hopeful. "Transparency shouldn't stop doctors from receiving a payment if they want to. It should empower consumers to learn whether their doctors take payments and if so, why, and whether that matters to them."
