Life Science Compliance Update

May 12, 2016

CNN Special Report on Prescription Addiction


We have been talking about the opioid addiction in America for several months now, from Congressional hearings, to new Centers for Disease Control (CDC) guidelines, to what solutions exist for patients and their loved ones. In response to the epidemic, CNN hosted a program entitled “Prescription Addiction,” hosted by Anderson Cooper and Dr. Sanjay Gupta.

The program featured guests including: addicts of opioids and heroin, family members of addicts who are no longer “themselves,” family members of addicts who have passed on due to their addictions, physicians, treatment center owners, and others, and was a question and answer session on the impact the epidemic has had on the country, and potential solutions.

Co-host Sanjay Gupta opened by calling the current opioid epidemic a “preventable” and “man made” epidemic. Dr. Leana S. Wen, the Baltimore City Health Commissioner, has been visible during many conversations on the epidemic, frequently speaks on the importance of doctors following guidelines and patients being involved in their medical care. During the special, she mentioned that patients should ask questions of their physicians, such as do I need this medication? What are the side effects? What are the alternatives available to me?

While many panelists and participants acknowledged that many doctors want to do the right thing, and do not go out of their way to perpetuate the epidemic, they focused on the idea that it is important that doctors review each individual patient and make a determination on whether or not to prescribe opioids based on individual situations, not general ideas.

Another reason behind the epidemic, and why America is disproportionately affected compared to the rest of the world, Dr. Wen believes, is that America is overprescribed. Patients are looking for a pill for every problem, and that culture needs to change before the opioid epidemic gets better. Dr. Wen as an emergency room physician tends to  over simplify serious problems as there are many aspects to the opioid academic often left out of these discussions such as access to rehabilitation, alternative therapies, and the work being done to develop opioid alternatives.

Dr. Gupta believes, and other physicians agreed, that the FDA is in a tricky spot when it comes to this particular situation. That while they do need to continue approving more drugs, so patients have more options, they also act slowly when it comes to safety precautions. For example, they just recently approved black box warnings for certain drug classes.

Dr. Mark Rosenberg of St. Joseph’s, an opioid free provider, spoke to the fact that certain patients seek St. Joseph’s out specifically because of that policy. Such patients have either typically had an opioid addiction themselves, or have been personally affected by someone who has.

One solution idea to help those who are in the throes of addiction is to follow in the footsteps of Gloucester, MA. Gloucester’s police department allows addicts to come to the station, turn themselves and their drugs in, and instead of being taken into jail or criminally prosecuted, are helped and brought to addiction treatment centers. It takes a strong person to admit their addiction, but having a support system – and not one that throws them into jail – is an important step on the road to recovery. While it is important for police departments to be on this page, the program (including take back programs) should be modified to include pharmacies as locations for taking back drugs.

Additionally, several participants suggested that legislation against pill mills is not only common sense, but needs to be done sooner rather than later. A major concern by panelists and participants alike is the fact that some physicians (a small minority) are effectively glorified drug dealers. They engage in egregious behavior (beyond mere negligence or bad judgment), such as posting signs around the office that they are “Cash Only” and provide prescriptions and drugs without actually caring for the patient and evaluating their individual situation. The rationale behind prescribing opioids should always be to relieve the pain and suffering of the patient in front of them, after evaluating the options available for that patient.

Narcan/Naloxone are prescriptions that can help reverse an overdose from heroin or OxyContin. The prescriptions come in an an injection or a nasal spray, and can be helpful if a friend or family member is present when one is suffering from a narcotic overdose. However, the prescriptions are limited and need to be used shortly after the overdose signs appear. Even still, they have such a potential to save lives. Areas like New York actually allow the drug to be bought over the counter, and cities like Baltimore allow for a standing prescription for anyone who feels they need it.

The physicians acknowledged that while the DEA may be monitoring how many prescriptions physicians are writing, that isn’t the end of the story. Warnings from the health department tend to have no effect on the physicians who are engaging in the egregious behavior outlined above.

In sum, it is likely that this conversation will continue, with stakeholders and others continuing to speak on the topic. It is clear that this epidemic is troublesome, and that a solution is necessary. It is a matter of time to determine what those solutions may be, and how effective they truly are.

June 16, 2015

Media Using Medicare Part D Data and Open Payments To Put a “Spotlight on Potential Conflicts”


In April, the Centers for Medicare and Medicaid Services (CMS) released over thirty Medicare Part D payment spreadsheets, containing millions of lines of data. Interested patients can download the document containing their doctor’s last name, and find out how often he or she prescribed particular drugs to Medicare patients.

We have speculated for some time now that the trove of Medicare data would be paired with Open Payments data, both by journalists and potentially the government. Modern Healthcare indeed recently published an article correlating the two, entitled “Drugmakers funnel payments to high-prescribing doctors.”

The article includes an interactive tool to search for physicians who prescribed $500,000 or more of a drug and received money from the drugmaker. One such entry is for a doctor who prescribed approximately $600,000 worth of a drug and received $24 from that drug’s manufacturer.

The article also includes a “spotlight on potential conflicts,” which parses out the ten highest-prescribing Medicare physicians who are listed in the general payments database in Open Payments as receiving at least $5,000 from drug companies in 2013.

The article’s takeaway is that “about 23% of the 400-plus providers who prescribed $1 million or more of one drug received money from the maker of the drug.” What is interesting—even taking into consideration the small meals or often vital consulting or education agreements deemed to be “funneling” of funds—is that 23 percent is quite a low figure if you consider that “[m]ore than 90% of physicians report having some type of business relationship with industry sources.” (Modern Healthcare).

The article targets the Open Payments data and prescribing habits of Dr. Vallerie McLaughlin, an expert in cardiovascular disease, and Director of the Pulmonary Hypertension Program at the University of Michigan. She prescribed $4.8 million of the pulmonary arterial hypertension (PAH) treatment, Tracleer, and received $40,000 in consulting, travel, and meal fees from the Tracleer’s manufacturer, Actellion. The article does provide some balance, including quotes from Dr. McLaughlin. “It's in the best interest of clinical-care delivery for biomedical companies to be advised by the knowledgeable, experienced experts,” McLaughlin states. “I have treated PAH patients and have been involved in clinical trials in PAH for 20 years.”

Unfortunately, however, the article and others like it may be a disincentive for experts such as Dr. McLaughlin, who work in a specialized and very important field, to educate their peers on their area of expertise. The article is unclear about who would be better qualified from an academic or professional standpoint to teach others about hypertension treatment. 

While there are certainly corrupt doctors who bill Medicare, the article’s implications that high prescribing doctors with payments in CMS’s Open Payments database are inherently unethical seems like the wrong approach. It not only has the potential to undermine the trust of patients in experts in a given specialty (which may lead to patients avoiding important treatments or not taking their medication), it also may silence doctors who should be educating their peers and patients on innovative new therapies. 

The article notes that CMS has "cautioned that payments to providers from drugmakers and biotechnology companies don't necessarily mean there is a conflict of interest." The agency states: “Information about financial relationships alone is not enough to decide whether they're beneficial or improper...[j]ust because there are financial ties doesn't mean that anyone is doing anything wrong. Transparency will shed light on the nature and extent of these financial relationships and will hopefully discourage the development of inappropriate relationships.”

With the second year of Open Payments data due out at the end of the month, articles that simply list the top paid doctors will continue to proliferate. However, the impact of industry-physician collaborations--which result in tangible patient benefits--should be similarly easy to communicate. 

June 11, 2015

AMSA Scorecard Provides Useful Conflicts of Interest Tool For Industry Compliance Professionals


AMSA Scorecard

Periodically since 2007, the American Medical Student Association (AMSA) has released a “Scorecard,” ranking medical schools on how strict their policies are regarding interactions between their students and faculty and the pharmaceutical and device industries. The AMSA Scorecard is decidedly anti-industry, but by consolidating all of the conflict of interest documents for schools around the country, the list is actually a very useful tool for compliance professionals who must be attentive to a wide range of university policies. 

This initial AMSA Scorecard graded medical schools simply on whether they had a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with the Pew Prescription Project, an initiative of the Pew Charitable Trusts, to develop an updated Scorecard, “which used a more rigorous and transparent methodology to assess the content of policies at medical schools throughout the country,” states AMSA. In 2014, the AMSA instituted “further changes to the scoring methodology that better assess the nuances of medical center and industry relationships.”  

Leading up to 2014, the "AMSA scorecard methodology working group reviewed the literature on conflicts of interest, including the recent recommendations published by the Pew Task Force on Medical Conflicts of Interest." As a result, AMSA changed the number of domains from 11 to 14 for medical schools, and 16 for teaching hospitals. AMSA focuses on conflict-of-interest policies directly related to industry marketing and education. While not addressed in the scorecard, "academic medical centers should also have robust policies to ensure the integrity of basic and clinical research," AMSA advises.

AMSA Scores

The domains AMSA rates are:

  1. Gifts from industry
  2. Meals from industry
  3. Industry-sponsored promotional speaking relationships
  4. Industry support of ACCME-accredited CME
  5. Attendance of industry-sponsored promotional events
  6. Industry-funded scholarships and awards
  7. Ghostwriting and honorary authorship
  8. Consulting and advising relationships
  9. Access of pharmaceutical sales representatives
  10. Access of medical device representatives
  11. Conflict of interest disclosure
  12. Existence of an adequate conflict-of-interest medical school curriculum
  13. Extension of COI policies to adjunct/courtesy faculty and affiliated hospitals/clinics
  14. Enforcement and sanctions of policies

For teaching hospitals, AMSA also scores on pharmaceutical samples and P&T committees. 

How Does AMSA score these domains?

Some of AMSA's decisions about "model" policies are worth noting (click on the image for a clearer view). 

AMSA Examples


On the topic of continuing medical education, hospitals get a “1” if they follow standards laid out by the Accreditation Council for Continuing Medical Education (ACCME). AMSA states: “Studies (of course they don't state what those studies are) have shown that industry funding of continuing medical education programs tends to bias topic choices and content in favor of the sponsors’ products and therapeutic areas.” Thus, to achieve a “model” policy ranking according to the AMSA scorecard, the policy would have to state “that industry funding is not accepted for the support of accredited CME courses except in certain clearly defined circumstances.”  Whatever AMSA defines them.

Other domains are similarly strict. For example, on the subject of pharmaceutical sales representatives, a “3” score would mean sales reps are not allowed any access to any faculty or trainees in academic medical centers or affiliated clinical entities. 

View AMSA's criteria for their various scores here


Leading institutions such as the Mayo Clinic, Cleveland Clinic, and Ohio State University’s Wexner Medical Center, just to name a few, are given B ratings by the AMSA. While the score itself is not of much help to compliance professionals, AMSA  has put together a comprehensive and helpful resource for anyone who has to monitor and keep track of a potentially long list of COI policies at various medical centers and teaching hospitals. As pharmaceutical and device manufacturers must track and report virtually all of their interactions with physicians and teaching hospitals in a public database under the Sunshine Act, the industry must remain mindful of academic policies and various issues related to their collaborations with the entities. 



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