The Women's Health Activist
September/October 2013
By Wells Wilkinson FiDA highlight
On August 1, 2013, a new law
went into effect that’s intended to protect patients and improve the public perception of medicine and the health care
system. No, it’s not the new health care system, sometimes called “Obamacare.”
But it was enacted as part of health care reform. The Physician Payments Sunshine Act
(PPSA), originally proposed by Senators Chuck Grassley (R-IA) and Ed Kohl
(D-WI), is intended to disclose any conflicts of interest arising from drug and
device industries’ financial relationships with, or marketing to, physicians.
Lead legislative sponsor and
champion Sen. Grassley praised the final implementation of the PPSA, saying: “Disclosure
brings about accountability, and accountability will strengthen the credibility
of medical research, the marketing of ideas and, ultimately, the practice of
medicine.”1
The law creates the “Open
Payments Program,” which requires
the drug and device industry to record, and report to the federal government,
nearly every payment or gift to any doctor or teaching hospital. The
Federal government will make this information public in a searchable on-line database beginning on
September 30, 2014; the database will be updated by June 30th each year thereafter.
The Open Payments system’s
on-line information will be rich in details including the doctor’s name and
office address, the amount and date of the payment, and a description of what
the payment was for. It will also include any in-kind services, such as help
doing research or writing a manuscript. And, any specific drugs or devices
associated with this payment must also be reported and disclosed to the public.
Consumers will be able to
look up “Doctor Jones” at his or her office address and see all the payments
and nearly all of the gifts or meals their doctor’s received. Is your doctor a
high-paid consultant? Does he or she get paid to give promotional talks to other
doctors about a particular drug? If so, which drugs? Is your doctor
collaborating with any companies to research and develop new products?
Some of the interactions between doctors and the drug industry are
reasonable; some might argue they are
even necessary, given the chronic lack of Federal financial support to develop
new drugs or devices. But there
are many gifts that are clearly designed to influence providers to use
or recommend specific drugs or devices — and that’s not okay. Doctors should
make health care recommendations and decisions based on what’s best for the
patients and not the benefits they get from drug and device manufacturers.
Advocates have long sought
to make this information public due to concerns that the vast majority of these
financial relationships boil down to one thing — highly sophisticated forms of industry marketing.
Open Payments will also help consumers and the public see if their doctor has
accepted tickets to concerts or sporting events from a drug company. Is the
doctor letting one or more drug companies deliver lunch to their office staff?
Has he or she let a drug or device company pay for any travel or lodging and,
if so, where? Is the doctor going out to dinner at fancy restaurants on the
manufacturer’s dime, to learn about a particular drug or device product?
Transparency, so what?
If you see your doctor’s
name on the database, how can you be sure that his or her recommendations are
based on best practice, not other motives? If your doctor is getting concert
tickets, that’s clearly questionable. But what does it mean that your doctor is
paid to speak about a drug? Many patients may find some of these relationships
confusing, or even alarming. Patients will have to decide whether to discuss
payments or other gifts with their doctors — not an easy task for any patient
walking into their provider’s office.
Some kinds of gifts or payments — like tickets to entertainment events
— are prohibited by law in some states. Others — like gifts, dinners, and travel
expenses — are prohibited by internal policy
at some academic medical centers that want to protect their medical students
and patients from industry influence. But, most doctors have no external limits on the kinds
of gifts they can accept, and that’s where transparency may have an
effect. As Sen. Grassley states, “The lack of transparency regarding payments
made by the pharmaceutical and medical device community to physicians has
created a culture that this law should begin to change substantially.”2
Doctors may think twice
about accepting gifts if they know their name will appear in the Open Payments
online database. This public transparency may cause them to think twice
about accepting gifts, because they don’t want to explain to their patients or
the public why they accepted $5,000 in lunches over a year from
different drug companies, or received expensive travel to a conference held at
a fancy resort.
We know that limiting drug
and device company gifts is good, because companies give out these gifts
precisely because they work in encouraging doctors to use their drugs
and devices. From big-ticket items (like expensive travel to an exotic
location) down to small items (like free lunches or pens), gifts impact
physician attitudes. Studies
show that even small gifts, like coffee mugs, can increase a doctor’s positive
feelings about a manufacturer and their products. Numerous studies show
that, when doctors accept a gift (large or small) they then have
feelings of obligation to the company that made the gift.3 Former drug industry
salespeople report being trained to use this feeling to influence doctor’s to
reciprocate and prescribe more of the company's products.4
Conversely, we know that limiting gifts can impact prescribing and make
doctors more likely to prescribe older, more
established (and more affordable) medications rather than the more
expensive brand-name drugs promoted by gifts and industry marketing.5 In fact, one medical school found exactly that: doctors
saw fewer salespeople once the institution banned industry from delivering free
lunches to doctors. There’s some speculation that doctors have already started
to reduce their interactions with drug company salespeople. A recent survey
shows about a 4 percent drop in 2012 in the number of physicians who said they
were willing to see drug industry salespeople.6
Perhaps most importantly, patients
are skeptical about these kinds of gifts. A recent study showed that, when patients know their doctor
receives gifts from the drug industry, they have less trust in their doctor
and the drugs they prescribe.7 The Open Payments database will reveal the full range of
financial relationships between doctors and industry. If the new program makes
doctors less interested in accepting gifts, and/or meeting with company
salespeople, it could have far-reaching impacts. Any effort to reduce the influence of profit-driven
industry marketing on doctors, leaving them free to select drugs and devices
based on science rather than marketing, is good for patient care — and
is likely be rewarded with greater patient trust. What more could any doctor
want?
Wells Wilkinson is a Staff
Attorney with Community Catalyst, a national, non-profit consumer advocacy
organization that works in partnership with national, state, and local
organizations, policymakers, and philanthropic foundations to ensure consumer
interests are represented in communities, courtrooms, statehouses and on
Capitol Hill. More information at: www.communitycatalyst.org.
References
1. Rep. Charles Grassley,
Press Release: Physician Payments Sunshine Act Regulations Released,”
Washington, DC: US House of Representatives, February 1, 2013. Available
online at: http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=44416;
last visited July 15, 2013.
2. Rep. Charles Grassley,
Press Release: Physician Payments Sunshine Act Regulations Released,”
Washington, DC: US House of Representatives, February 1, 2013. Available
online at: http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=44416;
last visited July 15, 2013.
3. Katz D, Caplan AL, Merz
JF. “All gifts large and small: toward an understanding of the ethics of
pharmaceutical industry gift-giving,” Am J Bioeth 2010; 10(10):11–17.
4. Fugh-Berman A, Ahari S,
“Following the script: how drug reps make friends and influence doctors,” PLoS
Med. 2007; 4(4):e150. doi:10.1371/journal.pmed.0040150
5. King M, Essick C, Bearman
P, et. al., “Medical school gift restriction policies and physician prescribing
of newly marketed psychotropic medications: difference-in-differences analysis,”
BMJ 2013; 346: f264, available at http://www.bmj.com/content/346/bmj.f264?view=long&pmid=23372175.
6. SK&A, Physician
Access -- U.S. Physicians’ Availability to See Drug and Device Sales Reps,
March 2013, available at http://engage.vevent.com/content/conf/docs/ec_1058/Physician_Access_1193785.pdf?__tkn__=1373054532_0c8a5a3098f85de093f319da3143fdb2a142b8d8410967000cc25d220989fb80&eid=1058&seid=429
registration required.
7. Green MJ, Masters R,
James B, et. al., “Do gifts from the pharmaceutical industry affect trust in
physicians?” Family Medicine 2012; 44(5):325-31, available at http://www.stfm.org/fmhub/fm2012/May/Michael325.pdf
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