Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, October 5, 2013

Exposed! : Secret Medical Device Payments to Doctors




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.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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