Monday Morning Recap: The Week (5.4.14-5.11.14) in Drug & Device Law & Policy

May 12, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. At HealthDay, Barbara Bronson Gray reports on research published in the latest issue of the Annals of Internal Medicine showing that the Women’s Health Initiative’s Estrogen Plus Progestin clinical trial, which cost the government $260 million, yielded a “net economic return [of] $37 billion, or $140 for every dollar spent on the trial.” Gray quotes Dr. Scott Ramsey as follows: “‘This is a classic example of the potential long-term impact of drugs. We’re lucky this study happened. There was controversy within the National Institutes of Health [the study's funders]; some people were really opposed to it. There is a role for big science, big studies like this, when there are big questions.’”

2. At Kaiser Health News, Roni Caryn Rabin reports on a study by the IMS Institute for Healthcare Informatics finding that “[t]he price of cancer drugs has doubled in the past decade, with the average brand-name cancer drug in the U.S. costing $10,000 for a month’s supply, up from $5,000 in 2003[.]” One reason for the increase is that “more patients are being treated by oncologists whose practices have been bought by hospitals, which may charge double or more for the same treatments . . . The report’s authors calculated prices for 10 common chemotherapy treatments and found hospitals charged 189 percent more on average — or nearly triple — what the same infusions would cost in an independent doctor’s office.”

3. A study by Nicholas Downing and colleagues published in this month’s Annals of Internal Medicine “found that, in the 15 months following publication of the NIH-funded landmark ACCORD-Lipid trial, articles in the news and biomedical literature were inconsistent in their description and interpretation of the trial’s results. Despite the conclusive overall finding that fenofibrate did not effectively lower cardiovascular risk, articles discussing the trial offered no clear consensus on the role of fenofibrate for patients with diabetes, with nearly 20% suggesting it was effective and 30% suggesting it was ineffective.  . . . authors with financial relationships with companies that manufacture and market fenofibrate were 3 times more likely to interpret the ACCORD-Lipid trial favorably and nearly twice as likely to recommend continued fenofibrate use.”

4. At the Boston Globe, Deborah Kotz reports on a article published last month in Drug Safety on a study assessing the utility of Twitter for tracking drug and device adverse events. The Drug Safety article provides a fascinating glimpse into the challenges of mining social media data. For example: “…consider the tweet ‘Humira never really worked for me. Orencia was good. Xeljanz was the best but ate a hole in my stomach. #RABlows.’ In this example with rheumatoid arthritis medicines, the first product could be reported as ineffective, but there is also a more serious event. The last product mentioned what could be an exaggeration: ‘ate a hole in my stomach.’ However, the medication guide for this product states ‘XELJANZ may cause serious side effects including: tears (perforation) in the stomach or intestines.’ The example illustrates that context is required to interpret the findings, a task that humans inherently perform better than machines.”

5. Finally, at the New York Times’ The UpShot, Brendan Nyhan describes a study he conducted “in which we found that parents with mixed or negative feelings toward vaccines actually became less likely to say they would vaccinate a future child after receiving information debunking the myth that vaccines cause autism. . . . other types of messages used by public health agencies — information about disease risks, a dramatic narrative and images of sick children — were also ineffective. . . . A more promising approach would require parents to consult with their health care provider . . . Parents name their children’s doctor as their most trusted source of vaccine information. That trust might allow doctors to do what evidence alone cannot: persuade parents to protect their children as well as yours and mine.”

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Monday Morning Recap: The Week (4.21.14-4.27.14) in Drug & Device Law & Policy

April 28, 2014 by · 2 Comments
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. On Tuesday of last week, Michael De La Merced, David Gelles, and Rachel Abrams of The New York Times’ DealBook reported that, on that day alone, “pharmaceutical companies announced $74 billion worth of potential deals, including an unorthodox $45.6 billion bid for Allergan, the maker of Botox, and a flurry of swaps and sales between Novartis of Switzerland and GlaxoSmithKline of Britain. More deals in the cash-rich industry are expected.” It will be very interesting to watch what happens with the “unorthodox” bid for Allergan.  The bidder, Valeant, is working with activist hedge fund manager Bill Ackman, and Allergan has adopted a poison pill defense.

2. This past week’s JAMA includes two studies on the treatment of stroke with intravenous tissue plasminogen activator (tPA), as well as a thought-provoking editorial by James Grotta discussing their implications. One of the studies tested the effects of an ambulance equipped with a computed tomography (CT) scanner and telemedicine and found that it reduced the time from alarm to tPA treatment by 25 minutes. Dr. Grotta writes: “Whatever benefits occur from interventions to achieve more rapid tPA treatment for patients with acute stroke need to be balanced against the costs to establish and maintain them, both to the payers who will pay for them and the hospital and EMS organizations that will implement and operate them. . . . One of the first needs for the out-of-hospital environment is to validate the ability of telemedicine on the CT-equipped ambulance to replace the physician to reduce personnel costs, which contribute substantially to maintaining such units in operation.”

3. At the LA Times, Chad Terhune reported that “University of California regents agreed to pay $10 million to [Robert Pedowitz,] the former chairman of UCLA’s orthopedic surgery department, who had alleged that the well-known medical school allowed doctors to take industry payments that may have compromised patient care. . . . ‘These are serious issues that patients should be worried about,’ Pedowitz said in an interview. ‘These problems exist in the broader medical system and they are not restricted to UCLA.’”

4. At Reuters, Esha Dey and Susan Kelly reported that “The U.S. Food and Drug Administration on Tuesday proposed speeding up medical device approvals for patients who have no other treatment options through a new program focused on earlier and more frequent interactions between companies and FDA staff.” On Twitter, Stanford Law’s Hank Greely commented on the FDA’s announcement, writing:FDA proposes that devices targeting an unmet need for severe conditions be expedited. I assumed they did!” Patti Zettler, a former FDA attorney, now a Fellow at Stanford Law, responded: “I imagine they informally expedited such devices before…at least I hope they did.”

5. It was a big week for the FDA–on Thursday the agency announced that it was proposing a new rule “that would extend the agency’s tobacco authority to cover additional tobacco products . . . including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority.”

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Industry Funding of CME Down, According to ACCME

kathleen m. boozangWhen we think about health care reform, we need to remember that we have been attempting reforms through many avenues of myriad parts of our health system.  The IRS revised Form 990 and schedule H in anticipation of the ACA; critics of conflicts of interest have been working on multiple fronts simultaneously.  One of the challenges about all of these changes is how we measure whether they have made any positive difference.

The Accreditation Council for Continuing Medical Education (ACCME), which is the accrediting entity for Continuing Medical Education (CME), just released its annual report, which was much less interesting than I had hoped, as it is mostly a financial statement for the year’s CME activities.  Nonetheless, it shows that industry grants to CME have declined from 50 to 30 percent of total CME income, which is attributed to the tremendous scrutiny CME has received over the years.  Importantly, industry has not lost interest in medical conferences, as ad revenue from exhibits rose 7.2 percent to $296 million.  You can read a summary of the report on Pharmalot or read the whole report.

While interesting, it’s hard to make out exactly what to conclude from this news about CME funding.  First, it could be a response to the economy, but that’s belied by the increase in exhibit funding.  And besides, pharma has historically been of the “you have to spend money to make money” mind.  So, perhaps industry is indeed responding to the criticism about funding CME.  Not mentioned is the possibility that CME sponsors have been turning away industry money, but that too is a possibility.

Some were concerned that if this happened, health professionals would be unable or unwilling to pay for their own CEUs.  The total income for 2011 CME appears to be in line with prior years (especially given a methodology change adopted in 2011).  While the number of physicians participating in CME was down slightly, that decline is consistent with a multi-year downward trend; the number of non-physician participants in CME is slightly up.  Finally, as noted by Pharmalot, “other income, which includes registration fees paid by participants, rose 4.4 percent [in 2011] to nearly $1.2 billion.”  While more than one year of experience will give a better picture, it seems fair to conclude so far that physicians are indeed willing to underwrite their own CME.

Most important to remember, however, is that the funding issue was merely a surrogate for the question of whether CME is biased either substantively or in subject matter coverage.  I don’t think we really knew the answer yesterday, any more than the ACCME report enlightens us about what the answer is today.  An annual report about CME in which I and others would really be interested would look at whether the subject matter of conferences has changed — are things being covered that weren’t before.  Is comparative cost-effectiveness being addressed in presentations that address alternative treatments?  Are real responses to racial health disparities being discussed?  Is education being delivered to audiences comprised of interdisciplinary healthcare teams rather than the homogenous audiences found at many academy and similar meetings?  Is CME delivery itself being studied to determine what learning methodologies are most effective?  In short, if we can conclude that industry is listening to its critics by redirecting its funding, can we also infer that changes are occurring in response to other critiques of CME, such as those posed by the IOM report entitled “Redesigning Continuing Education in the Health Professions” and Seton Hall Law’s Whitepaper entitled “Drug and Device Promotion: Charting a Course for Reform?”

Presumably, it is a good thing to have less industry funding of CME — although we only see the change in the United States, not elsewhere . But it doesn’t get to the heart of the matter, which is the need for significant reform of CME generally.  That’s the report I want to read.

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The NIH’s Amended Conflict of Interest Regulations: A New, Weaker Approach to Intellectual Property Interests?

August 24, 2011 by · Leave a Comment
Filed under: Conflicts of Interest 

kate-greenwood-kg-2010-1-cropped-compYesterday, at long last, the National Institutes of Health released the final revisions to its regulations governing financial conflicts of interest on the part of applicants for federal research funds.  And there is good news.  The rule’s sunshine provisions have not, as was feared, been “gutted.”  Grant recipients will have to make their investigators’ financial conflicts of interest publicly accessible.  While an institution will not have to post the details of each conflict on its website, as was provided in the proposed regulations, if it does not it will instead have to provide the information in writing to anyone who asks for it.  Academics, advocates, federal and state prosecutors, other regulators, and members of the news media will have the access they need.  For sure, prospective patients or research participants will be less likely to come across information about investigator conflicts, but, as Kathleen Boozang explains here, it is far from clear that they would find such information helpful.

Of potentially more significance than the weakened sunshine provisions, the final regulations diverge from the proposed regulations with regard to the treatment of intellectual property.  Under the prior regulations, investigators were required to inform their institutions about relevant intellectual property rights, including copyrights, patents, and royalties in excess of $10,000.  The proposed regulations modified the definition to require disclosure of copyrights, patents, and royalties (and agreements to share in royalties) regardless of amount.  Under the final regulations, investigators do not need to tell their institutions about their intellectual property rights and interests unless and until they are in “receipt of income related to such rights and interests.”

The preamble to the final regulations is somewhat confusing.  For example, while the final regulations define significant financial interest to exclude intellectual property rights and interests that do not produce income, the agency states in the preamble that it “would expect institutional policies to require disclosure upon the filing of a patent application or the receipt of income related to the intellectual property interest, whichever is earlier.”  The preamble also contradicts itself with regard to the applicability of the rule’s $5,000 threshold, stating at one point that the threshold “applies to licensed intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to licensed intellectual property rights,” while explaining (correctly, I think) at another point that “the $5,000 threshold would apply to equity interests and ‘payment for services,’ which would include salary but not royalties.”

The NIH’s explanation of its addition of the “receipt of income related to such rights and interests” qualifier to the definition of a significant intellectual property right or interest is especially confusing.  The agency writes that its intent was to exclude from the definition

“the rare cases when unlicensed intellectual property is held by the Investigator instead of flowing through the Institution,” because “it is difficult to determine the value of such interests.”  The agency’s point about valuation may be true, but that is an argument in favor of disclosure not against it.  With regard to equity interests, the final regulation requires investigators to disclose any equity interest in a non-publicly traded entity; the Food and Drug Administration similarly requires disclosure of equity interests “whose value cannot be readily determined through reference to public prices[.]“  The FDA also requires disclosure of any “[p]roprietary interest in the tested product,” without regard to value.

When an investigator has a proprietary interest in a product under study the potential exists for a serious conflict regardless of the interest’s current value or whether it is currently income-generating.  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy and others have recommended a near-total ban on serving as an investigator in that case.  Such a ban cannot, of course, be implemented unless investigators are required to tell their institutions about their proprietary interests.

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Recommended Reading: Recent Legal Scholarship on Decision-Making about Health and Healthcare

July 20, 2011 by · Leave a Comment
Filed under: Recommended Reading 

kate-greenwood_high-res-2011-compIn Health Choices: Regulatory Design and Processing Modes of Health Decisions, Orly Lobel and On Amir briefly summarize a fascinating series of experiments they have conducted with the support of the Robert Wood Johnson Foundation that test individuals’ ability to make decisions about their health in the face of cognitive depletion or overload.  A longer version will be available in September, but the summary is well worth reading.  Lobel and Amir begin by reviewing a line of research demonstrating, perhaps unsurprisingly, that “psychological depletion caused by a prior task” — in one study it was eating radishes while resisting cookies–leads to a reduced ability to exercise “executive control” and “persist in demanding cognitive activities.”  As the authors note, applying this research to the context of health related decision-making is important because patients and providers alike are frequently asked to process information about relative risk and make reasoned, reasonable decisions under conditions of cognitive depletion or overload.

To test their hypothesis that “absent sufficient resources for executive functions individuals will take more risk in their [health-related] decisions,” Lobel and Amir conducted a lab experiment with approximately 700 participants and a web-based one with over 3000 participants, including 300 medical doctors.   The findings from their studies support the conclusion that depletion affects people’s ability to process risk, albeit not in entirely intuitive or predictable ways.  For example, when parents are cognitively depleted, they become more risk averse regarding vaccinating their children, but when policymakers are cognitively depleted, they become less risk averse regarding population-wide vaccination.  When consumers are in a state of attention and focus, a long list of potential side effects will deter them from using a new drug.  When cognitively overloaded, though, they paid “less attention to warning lists the longer they were.”  The implications of Lobel and Amir’s work are many, varied, and vast; I am looking forward to reading the full paper when it comes out in September.

I also highly recommend Christopher Tarver Robertson’s Biased Advice, which was published in the Emory Law Journal earlier this year.  Robertson conducted a series of experiments that built on the groundbreaking 2005 study by Daylian M. Cain, George Loewenstein & Don A. Moore evaluating the effect of a conflict of interest, and of disclosure of the conflict, on the quality of advice given by advisors regarding the number of coins in a jar and on the accuracy of advisees’ estimation of the number of coins in the jar.  Cain and his colleagues’ most surprising finding was that when a conflict existed, disclosing it caused the accuracy of advisees’ estimates to decline, in part because advisors gave more biased advice when their conflicts were disclosed than when they were not disclosed.

Among other questions, Robertson examined whether a more concrete disclosure about an advisor’s bias–that is, that “prior research has shown that advisors paid in this way tend to give advice that is $7.68 higher on average than the advice of advisors who are paid based on accuracy”–would aid advisees.  It did not, because advisees did not do what “one would hope and expect” and simply subtract $7.68 from the advisor’s estimate.  Rather, it appears that they “used the bias disclosure not as a mechanism of calibrating their reliance more precisely, but rather as a strengthened warning suggesting that the advice is altogether worthless.”

On the other hand, disclosing to advisees that an advisor was paid based on the accuracy of the advisee’s estimate–i.e. that the advisor’s financial interest aligned with that of the advisee–led advisees to rely more heavily on the expert’s advice and, as a result, to more accurately estimate the number of coins in the jar.  Disclosure of a conflict of interest is also likely to be valuable where advisees can seek out another advisor; a second, unconflicted, opinion dramatically increased the accuracy of advisees’ estimates.

Robertson’s research is important and interesting.  As he observes, one of the reasons that it is so difficult to rein in health care costs is that “[t]he health care industry is characterized by radically distributed decision making, with each patient deciding upon her own course of treatment within the range of treatments offered by providers and covered by public and private insurers.”  Improving individual decisions may be key to bending the cost curve.  Robertson’s research suggests that a disclosure mandate could help under certain circumstances, where, for example, there is “epistemic charlatanism” and a physician’s disclosure of a financial conflict of interest would lead a patient to reject the physician’s not-so-expert recommendations.  Robertson emphasizes, however, that disclosure does not improve layperson decision-making nearly as much as unbiased advice does.

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