Life Science Compliance Update

January 12, 2018

Media Has it Out for Pharma…Still

Media

Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta.

In October 2017, CNN published its first article on the subject, where it was noted that the company “aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” While PBA afflicts less than 1% of Americans, it is most commonly associated with patients who have multiple sclerosis (MS) or ALS.

Then, in December 2017, CNN published another article on the company, once again dinging them for payments made to physicians and alleging that physicians had criminal convictions in their history for illegal prescribing.

According to CNN, Nuedexta's financial success is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

Avanir Pharmaceuticals paid nearly 500 doctors to speak or consult on its drug, Nuedexta, between 2013 and 2016, according to government data. Through a review of the top prescribers and top paid physicians in this group, CNN identified a dozen who have been disciplined by state medical boards. These offenses included the harmful treatment of nursing home residents and "grossly negligent acts" involving the inappropriate prescribing of dangerous and addictive drugs -- resulting in probation, suspension, fines and revoked licenses.

Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

CNN noted that between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

In an emailed statement, the company said PBA is often "misunderstood" and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients -- a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts interviewed by CNN, including some of those paid by Avanir.

Avanir said it "vehemently oppose(s) any mischaracterization" of its interactions with physicians and other members of the medical community, explaining that these relationships are ethical and are used as a way to share important information and raise awareness of medical conditions and treatments that could help patients.

In response to the articles, the Pharmaceutical Research and Manufacturers of America, which represents drug makers across the country, said companies should strive to work with speakers who meet ethical and professional standards. "In the rare instance where there is an outlier," the group said on its website, "companies take corrective action."

This is one example of the way the media can use Open Payments to support cases against pharma companies. The ease with which Open Payments can be found highlights the need for companies to vet to whom they give money.

January 27, 2017

Politico Healthcare Briefing: What’s Next for Drug Costs?

Pro-healthcare-briefing-politics-and-prices-whats-next-for-drug-costs-230737.HEL.1247.POLITICS&PRICES.WEBELEMENTS.V13

Late last year, Politico Pro’s Health Care Team, along with CVS Health, held a conversation on the future of prescription drug costs, and how to reduce healthcare spending under a new administration. The briefing featured a panel of health care industry experts: Peter Bach, MD, Director of Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center; Jenny Bryant, Senior Vice President of Policy and Research at PhRMA; Ceci Connolly, President and CEO at the Alliance of Community Health Plans; and Chip Davis, President and CEO of the Generic Pharmaceutical Association (GPhA).

The panel discussion focused on the report, “Tackling High Drug Costs in the Trump Era,” and was followed by a discussion with Representative Jan. Schakowsky, concerning efforts on Capitol Hill to reform health care spending.

Panel Discussion

Dr. Bach argued that there was a “fundamental disconnect” between efforts to reduce costs of coverage and bring top treatments to patients. He expressed support for drug price negotiations under the Affordable Care Act, stating that such efforts have saved taxpayers over $10 billion. He also warned that if high-deductible health plans remain popular, tools will need to be developed to indicate to physicians when their prescribing patterns are negatively affecting their patients and have open conversations about the affordability of the drugs they are prescribing.

Ms. Bryant expressed hope that lawmakers can work together to reach an agreement to “move forward to advance pro-market and pro-science solutions.” She stated that drugs have the potential to avert more health care spending for a patient in the future than they cost in the present, and challenged the idea that rising pharmaceutical costs are to blame for increased health care spending. Ms. Bryant challenged the premise that the repeal of the Affordable Care Act (ACA) would be a “looming problem,” instead stating that price negotiations for pharmaceuticals under government programs would not be exclusive to the ACA. She noted that cost-sharing was actually counter-productive for the health care industry, and that the perceived value of a drug is extraordinarily personal, and it is nearly impossible to determine the “average value” for pharmaceuticals.

Ms. Connolly discussed her belief that the drug pricing debate is quickly fading as the new administration approaches, noting that many of President-Elect Trump’s larger ideas are taking focus away from the debate, and that the core of the drug pricing issue (the lack of transparency) should be more thoroughly addressed. Ms. Connolly declared that the debate no longer focuses on specialty drugs, but now also includes drugs for common ailments. She discussed reauthorization of the prescription drug user fee law as a potential vehicle to address pricing transparency, but that event transparency may not be enough to reign in health care spending. She requested that lawmakers focus on mandating transparency so that patients can make more informed decisions with their physicians about which drugs they are prescribed, and encourage affordable treatment options.

Mr. Davis cautioned lawmakers and others that a policy issue as complex as the drug pricing debate cannot be solved with a broad approach, and that by allowing complete transparency of the pharmaceutical industry could wind up forcing competition out of the industry. He encouraged lawmakers to include all aspects of the market in discussions surrounding transparency, and to not discount the opinions of the drug manufacturing industry.

Discussion with Representative Schakowsky

Representative Schakowsky expressed her belief that lawmakers should hold President-Elect Trump to his promises regarding health care and work together to pass legislation that discourages price increases and promotes transparency in drug pricing. She reminded attendees that Trump favored allowing Medicare to negotiate drugs and the re-importation of prescription drugs as two methods to combat rising drug prices and spending. She mentioned her legislation, the FAIR Drug Pricing Act, drafted with Senator Tammy Baldwin, which attempts to shed light on how drug prices are initially decided and influenced, and where profits are being spent.

August 10, 2016

Dollars for Doc’s Media Bomb – Examples of Expanding a Story on Hospitals

(Picture from ProPublica Dollars for Doctors)

The release in late June of the Open Payments data for 2015, received very little media coverage but earlier that week Dollars for Doctors dropped a media bomb on the open payments data from the previous year by tying in hospital privileges to open payments. Below are examples of some of the stories that were written.

National

Becker's Hospital CFO did a short bit on the six states where the highest number of physicians accept payments from industry, citing a ProPublica analysis. The article also briefly noted that the analysis revealed some differences based on hospital ownership: for profit hospitals rate was higher compared to other hospitals, included federally owned hospitals (which had the lowest rate).

NPR had a blurb, as part of their "All Things Considered" show, and an accompanying article that discussed the ProPublica analysis overall, picking on doctors affiliated with hospitals in the South and doctors at for-profit hospitals.

Southeast

USA Today picked on a small for-profit hospital on the outskirts of Memphis for their article on the ProPublica Analysis. Three reporters working for the USA Today Network – Tennessee wrote that St. Francis Hospital-Bartlett had the "highest rate of doctors who took payments from the pharmaceutical and medical device industry, out of more than 2,000 hospitals across the nation." The authors do note that there is nothing illegal about taking such compensation, just citing to the "studies" that physicians are more likely to prescribe certain medications than those without relationships. The same article can be found on the website of The Tennessean, part of the USA Today Network.

Mississippi Public Broadcasting wrote an article about how Mississippi doctors are among the top five list for receiving payments from pharmaceutical companies, according to the ProPublica analysis. The article also picks a bit on Louisiana, stating Mississippi and Lousiana tie for third place nationwide for the overall number of doctors receiving payments.

West Coast

Several California publications wrote about the analysis, including the Desert Sun. The article started out with a bold claim about Coachella Valley's hospitals and then gave a brief overview and noted that while this information has been public for quite some time, the recent ProPublica analysis is the first time the various open sources of payments have been used to look for variations between hospitals and doctors.

iNewsSource also covered the ProPublica analysis, explaining the wide variation across the country, with a bit of a focus on San Diego County.

An article on California Healthline covered the ProPublica report, with links to both of the above articles and noting that a hospital's owner is an important factor in whether a doctor meets with industry.

Northeast

An article published in the Boston Globe, stated, "Years after many big academic medical centers cracked down in industry perks, drug companies still regularly buy meals for doctors affiliated with smaller hospitals." This article was based on a new analysis, done by the Globe in coordination with ProPublica, which matched data on company payments to doctors with Medicare data on the primary hospitals physicians were affiliated with that year.

Another article, written for Philly.com, was written on the same analysis, and called out a local cancer center for having a high rate of physicians who work with industry players. The article, to its credit, did also note that some of the hospitals involved did question the data and provided valid reasons for doing so, for example, Crozer-Keystone Health System disputed the number of affiliated doctors attributed to it.

A New England Public Radio blurb focused on physicians in West Massachusetts, and included a graphic of which states have the highest concentration, according to the ProPublica analysis, of doctors who take payments from industry.

Midwest

The Springfield News-Leader published an article about the two largest health systems in Springfield and how one system forbids physicians from meeting with industry at lunch time and the other system, which does not have such a policy in place. The article then went through the policies and whether a meal is considered a "gift or down payment," and how systems also differ on free drug samples.

Indiana Public Media published a story, using the same graphic as was found in the New England Public Radio blurb above, also outlining the database and what it found for physicians in Indiana, noting "almost three out of four doctors in Indiana took a payment from a drug or device maker" in 2014.

Wyandotte Daily Online published an article on Kansas City-area hospitals and the large variations from system to system in how many doctors "accept money from drug and medical device companies." The article surmised that "much of the variation has to do with hospital policies governing such payments and how well they're enforced."

Conclusion, Part II

The media bomb is the most recent showing in a string of actions taken by ProPublica that they are trying to "black list" those working with industry. Few, if any, of the articles included any rationale or reasons why such industry coordination is not a good thing. As we have seen, ProPublica and others disagree that the way to future innovation and new medicines and devices is not through collaboration, but instead believes it is beneficial to put in place more restrictions, leading to less cooperation and coordination.

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