Monday Morning Recap: The Week (10.6.14-10.12.14) in Drug & Device Law & Policy

October 13, 2014 by · Leave a Comment
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Picture3It’s Monday morning, time for what Ed Silverman calls a  “ritual cup of stimulation,” and time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. At USA Today, Peter Eisler and Christopher Schnaars report that “[t]wo years after contaminated drugs linked to a compounding pharmacy in Massachusetts killed 64 and sickened more than 750 with fungal meningitis, the industry still struggles with serious safety problems affecting thousands of patients … A regulatory crackdown by the U.S. Food and Drug Administration since the outbreak in October 2012 has led to an unprecedented spate of drug recalls by compounding pharmacies — and scores of citations for bad practices.

2. At the Food and Drug Administration’s FDAVoice blog, Jean Hu-Primmer discusses a new joint effort between FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the United States Critical Illness and Injury Trials Group (USCIITG) “to gather important information about medical countermeasures used during public health emergencies.” Among other things, the project will work to “address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making. … USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.”

3. At Bloomberg BNA’s Health Care blog, Alex Ruoff reports that “[n]early 60 health information technology groups and various industry associations are circulating a letter among member of Congress asking for legislation that clarifies the Food and Drug Administration’s authority to regulate health IT products. The letter was also sent to Health and Human Services Secretary Sylvia Mathews Burwell and called on lawmakers to pass legislation reflecting health IT oversight recommendations made earlier this year by three federal agencies, including the FDA and the Office of the National Coordinator for Health IT. The proposed legislation would ‘provide much needed statutory clarity and a stable foundation for continued innovation in health IT’ by establishing parameters, defined by the framework, for the FDA to oversee health IT products, the letter said.”

4. And at Bloomberg BNA’s Life Sciences Law & Industry Report, Nicole Ostrow summarizes the results of an analysis in the Annals of Internal Medicine that found that “[researchers] with financial ties to flu drug companies more often reported positive findings in their studies of the treatments… Christine Laine, editor in chief of the Annals and a senior vice president at the American College of Physicians in Philadelphia, said there’s a lot of confusion for doctors because of the conflicting findings among the studies of the flu medicines. Today’s results provide some insight into why the literature on this topic has been ‘inconsistent.’

5. Finally, I can’t recommend it yet, because I it hasn’t climbed to the top of the pile yet, but I am looking forward to reading this month’s Health Affairs, on Specialty Pharmaceutical Spending & Policy, cover to cover. (I did sneak a peak at the Narrative Matters piece, by Leana Wen, in which “[a] doctor who stutters confronts the stigma against patients—and providers—with disabilities.” It’s off the topic of drug and device law and policy, but of general interest and very thought-provoking.)


Monday Morning Recap: The Week (9.8.14-9.14.14) in Drug & Device Law & Policy

September 15, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3Well, once again it’s been two weeks since we last did a Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And there’s been a lot going on…

1. The September issue of The Milbank Quarterly contains an original empirical study by Genevieve Pham-Kanter analyzing the effects of the financial ties that members of the Food and Drug Administration’s advisory committees have with drug manufacturers.  Among her very interesting findings is the fact that while a committee member with ties to one manufacturer was more likely to recommend approval of that manufacturer’s drug, committee members with ties to multiple manufacturers did not show an overall bias in favor of approval. Aaron Carroll wrote about the study at the New York Times, here, and David Schlaes wrote about it here. Per Schlaes: “The take-home lesson to me is that experts are actually experts.  Those that are in demand by multiple companies for help in analyzing or developing their products are more likely to be the kind of experts the FDA is seeking and less likely to let their financial and other relationships with sponsors get in the way of their expertise.”

2. The contentious debate between the drug and device industry and the Department of Justice over where to draw the line between protected  speech, on the one hand, and punishable fraud, on the other, continues. In an article at FiercePharmaMarketing this week, Tracy Staton calls attention to a brief the government filed at the end of August. Staton writes: “In essence, the brief asks the court to determine that ‘speech that serves as a conduit for violations of the law’ isn’t protected by the First Amendment. PhRMA, of course, is asking for the opposite. It wants the court to decide that the law only prohibits ‘at most, false speech,’ which would give reps the chance to talk about off-label use of meds, as long as they’re telling the truth.”

3. This week also brought news that a supervisory pharmacist at the New England Compounding Center was arraigned and pled not guilty to a single count of mail fraud. Denise Lavoie of the AP reports: “Chin, a supervisory pharmacist, is accused of participating in a scheme to fraudulently cause one lot to be labeled as injectable, meaning it was sterile and fit for human use. The drug was shipped to Michigan Pain Specialists in Brighton, Michigan, and injected into patients. As a result, 217 patients contracted fungal meningitis, and 15 died. Chin is the first person to be charged criminally in the case, but prosecutors have said the prosecution is part of a larger criminal investigation of Chin and others.

4. At the New England Journal of Medicine, Rita Redberg argues that “[b]linded, randomized, controlled trials (RCTs), in which the proposed therapy is compared with a placebo or a ‘sham’ (nontherapeutic) intervention,”which are currently “rare for medical devices” need to become more common. Dr. Redberg recommends that “the risk associated with performing unnecessary procedures … be weighed against the risk of mistaking a placebo effect for therapeutic benefit and therefore subjecting thousands or millions of patients to a procedure that actually does them no good.”

5. Finally, at the New Yorker this week, Andrew Solomon discusses the “terrifying dilemma” confronting women with depression who must weigh a dizzying array of known and unknown risks when deciding whether to pursue treatment with antidepressant medication. Solomon writes:

The debate rages, and the choice is a difficult one: to be depressed during pregnancy, with troubling consequences, or to be on medication during pregnancy, with unclear ramifications. It is not helpful when the complexity of the decision is belittled. ‘Everyone’s happier with this idea that the medications are O.K.,’ [Roni Caryn] Rabin wrote, quoting an expert. Everyone is second most happy learning, as Rabin suggests, that the medications are poison but depression is fine—because clarity and simplicity make life easy. If the meds help more than they harm, you take them; if they harm more than they help, you don’t take them. The problem is that this is a highly nuanced question to which there is no consistent answer, and about which we know too little. That makes everyone excruciatingly uncomfortable.

In this article I wrote several years ago, I review some of the reasons for the dearth of information about the risk-benefit ratio of drugs when used during pregnancy and make recommendations for policy responses.


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

May 12, 2014 by · Leave a Comment
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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.”


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.”


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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