Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

By Timo Minssen

In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.

In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).

Following an invitation for public comments on this document, the EMA received more than 1,000 submissions from stakeholders. Based on these comments the EMA recently proposed “Terms of Use” (TOU) and “Redaction Principles” for clinical trial data disclosure.

In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. Continue reading

“Sanitizing” Lethal Injection

Nadia N. Sawicki

Oklahoma’s botched execution of Clayton Lockett has brought increased attention to an issue that I have been concerned with for years – the increased “medicalization” of legally sanctioned executions, and, in particular, the role that medical professionals and the scientific community play in this process.

Until the 20th century, most executions were conducted publicly – execution was a communal ritual that served as a means of catharsis. But the American execution process has, over time, become less visible, and, as a consequence, subject to less public oversight. I believe that the movement of the capital punishment process “behind the curtain,” both literally and figuratively, should trouble death penalty opponents and supporters alike.

The standard lethal injection protocol used throughout the United States was developed in 1976 by Dr. Jay Chapman, Oklahoma’s state medical examiner, and Dr. Stanley Deutsch, chair of the Oklahoma Medical School anesthesiology department. Without testing or research, they settled on a three-drug protocol for executing prisoners – sodium thiopental, a short-acting barbiturate; pancuronium bromide, a paralytic; and potassium chloride, which stops the heart. Until recently, this was the combination used in every state.

Things began to change when Hospira, the U.S. pharmaceutical company that manufactured sodium thiopental, stopped making the drug in 2011. Since then, European manufacturers of sodium thiopental and pentobarbital have limited the production of these drugs, and the European Commission has restricted their export to the U.S. for execution purposes. And just last year, the U.S. Court of Appeals for the District of Columbia ruled in Cook v. FDA that the FDA lacks authority to permit importation of these drugs, which, when used for lethal injection, are considered “misbranded” under the FDCA. As a result, many states, including Oklahoma, have had to resort to other alternatives.

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New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

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Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

Progress is Possible in the Institutional Corruption of Healthcare

Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests).  For those who have been working long and hard on these issues, they are cause for hope.  The needle does move.

First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs.   My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money.  In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions.  (See their newfound commitment to opening up their clinical trial data too.)

The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions.  My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies.  Yet, something has caused Glaxo to change course.

Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries.  The counterfactual is that the NFL could have kept the money, of course.  But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf.  The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.

This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid.  Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies.  Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk?  If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.

 EDIT:  Corrected link to NFL story on NYT, and corrected amount from $100M to $30M.  Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.

Conflicts of Interests and the Goals of Translational Medicine

By Matthew L Baum

There are many ways to drive medicine forward. One is to work to remove economic, political, or geographic barriers to accessing care, and thus aid those whose suffering can be assuaged but is not being so. Another is to work to develop treatments for types of suffering poorly eased (or addressed) by current care. Both are important. Serious pursuit of the second strategy, however, requires the participation of industry; to translate bench science into benefits for real people will usually require manufacture of new medicines or devices, a function that universities and public institutions do not do but industry does well.

But for those students, like myself, currently training in MD-PhD programs in hopes of pursuing this goal of translational medicine, it is not at all clear what attitude we should take towards industry. On the one hand, the vision to move science from bench to bedside would seem best served by those clinician-scientists who do not see publication as the end result but are devoted to responsibly guiding their discoveries into the industrial setting and propelling them to patients. On the other hand, connections between industry and academia are often described categorically as “conflicts of interest” that must be disclosed and ideally divested. I will not attempt to comment here on the events that have led to a prima facie (pharma facie?) negative valence of academic-industrial connections; I was struck to hear, however, one of the panelists (an academic) on a recent panel discussion on translational medicine open with a slow and measured statement affirming her belief that collaborations between academics and industry can be a “good thing.” She then paused, as if to let the shock of the statement permeate the audience.

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Should we Trust the New Cholesterol Guidelines?

The new American Heart Association and American College of Cardiology guidelines on how patients should manage their cholesterol are likely to dramatically increase the sales of statins.  (E.g., check out the bump to Pfizer’s stock price.)  Yet, the new guidelines have become instantly controversial, with prominent cardiologists calling them into doubt.  In addition to the substantive scientific dispute, there are also questions about whether the guidelines panel may have suffered from biases, due to conflicting interests.  As PharmaLot reports:

Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medications. And among the half dozen who disclosed these relationships was one of the two panel co-chairs, which contradicts an Institute of Medicine suggestion about managing conflicts on such panels.  Each of the six panelists disclosed they worked as a consultant and received funding for personal research. And among the 10 expert reviewers, half listed consulting relationships.

I, of course, do not know the right answer about statins on the merits.  As a layperson, I must use proxies and heuristics to decide, and to some extent busy non-specialist physicians must do the same.  That is the whole point of the guidelines — so that each individual physician does not have to review the science himself or herself.  They are supposed to be able to simply rely on the guidelines, as the state of the art.  Yet, the conflicts of interests undermine our confidence in the AHA/ACC guidelines, making them less impactful on our prior beliefs.  (My own research has documented this sort of discounting, among both physicians and laypersons).  That sort of discounting is perfectly rational.

Some have argued that it is unrealistic to find experts who do not suffer from such conflicting interests.  But what if the AHA/ACC had just proceeded with the nine unconflicted panelists, and the five unconflicted reviewers?  Regardless of whether the panel reached the same outcome, it might have then better served the bona fide interests of the AHA and ACC, as well as the interests of public health.  If that panel did reach the same pro-statin outcome, which boosted Pfizer’s stock price, all the better.

Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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Report from Financial Conflicts of Interest conference now available for download

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University co-sponsored a conference exploring the issue of financial conflicts of interest at research universities in November 2012. The conference resulted in a final report, which is now available for download on the Petrie-Flom Center’s website. From the report:

In the latter 1990s, the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) and the now-named Government Accountability Office (GAO) sharply questioned the trustworthiness of research universities as stewards of federal research funds and overseers of the research, especially research that involved human subjects, when the institutions themselves increasingly had financial interests in research conducted by their faculty scientists. This was the first time the federal government had expressed concerns about institutional fCOIs in research universities and academic medical centers.

These concerns have only intensified in the ensuing years as research universities have been exhorted with increasing urgency to become ever more deeply engaged with industry in accelerating the translation of their faculties’ inventive research into tangible public benefits. Defining, let alone mitigating, institutional fCOIs in research universities becomes especially challenging as the institutions, in response to expanding and intensifying public expectations, progressively accrete missions that may themselves not be concordant.

This Symposium, organized by Professor David Korn and co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University, was intended to examine, clarify, and deepen our understanding of institutional fCOIs in the contemporary research university, and thereby help to identify effective measures that will ensure the continuing trustworthiness of these vital institutions.

For more, download the full report here.

Popular Distrust of Health Science: A Crowdsourced Solution

Benjamin Waterhouse's GraveEnjoying the fall foliage in Mt. Auburn Cemetery yesterday, I came across this marker for Benjamin Waterhouse.  In the overwrought language that is appropriate on a grave marker:  “In 1800 he introduced to the new world the blessing of vaccination.  Overcame popular prejudice and distrust by testing it on his own children and thus established a title to the gratitude of future generations.”

No less today, there seems to be plenty of popular distrust of elite science.  (And it doesn’t help that so much of contemporary science is infected by conflicts of interest.)  Self-experimentation does have a long venerable history, which has recently become more prominent in the quantified self movement.  (I’m not sure about experimenting on my kid though.)

Tomorrow, I’m heading to NYC to make a pitch to the Robert Wood Johnson Foundation’s Pioneer Fund, for major funding to launch a new project that would create a platform for robust, randomized experiments of lifestyle interventions (think: migraine management, diets, exercise regimens, nutritional supplements) for which there is virtually no FDA oversight and thus no regulatory imperative for rigorous scientific investigations.  Nonetheless, these lifestyle factors are the primary drivers of health and healthcare costs.  By crowdsourcing these sorts of experiments in an sound ethical framework robust against institutional corruption, I hope to develop gold-standard scientific knowledge with huge samples, but also build public engagement, public understanding, and public trust of health science.

The crowd uses Wikipedia to organize knowledge, and Indiegogo to invest in new health devices.  The crowd needs a platform to create knowledge too, especially through randomized interventions, which have the potential to actually change behaviors for the better and eliminate the confounding factors that undermine observational studies.

So, wish me luck in NYC tomorrow:   http://bit.ly/pioneerpitch

Call for Papers on “Buying and Selling Health Care”

The Journal of Law, Medicine & Ethics plans to publish a symposium issue in Winter 2014 exploring ethical, legal, and clinical issues triggered by the increasing commercialization of health care in the United States. The symposium will address a variety of dynamics present in this quintessentially American medical marketplace, with a particular focus on how commercialism impacts practitioners, patients, and policy makers at all levels.

Papers from any perspective or disciplinary background and concerning any aspect of the “buying and selling of health care” are welcome.

Deadlines and submission instructions below the fold.

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Art Caplan: Heiress’ gifts to medical workers raise thorny ethical issues

Art Caplan has a new opinion piece at MSNBC.com discussing the ethical issues raised by heiress Huguette Clark’s sometimes enormous gifts to the medical workers who cared for her while she lived in a New York hospital for over 20 years — despite being in good health.

[...] Clark’s favorite private duty nurse, Hadassah Peri, received more than $31 million in gifts during 20 years of service, including enough money to buy five homes, jewelry and other luxuries. Clark gave lavishly to Peri’s husband and children, too.

Other caregivers also got gifts, although not in those amounts. Still others got nothing. Was it ethical for those who got gifts to accept them?

Clark’s personal staff members were not the only ones with an eye on her fortune. The hospital where she lived pushed hard to get Clark to make a substantial gift, using their development staff to try to pry a promise from her, the book reports.

In 2004, Dedman and Newell write, hospital officials threatened Clark with having to move from her beloved room if she did not make a contribution of $125 million to forestall the sale of the building.

So what is the ethical deal?

Read the full article here.

Anonymity is Not Privacy (and Why it Matters)

Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods.  This is the central claim of my newest article (SSRN draft available here).

Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.

  • The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate.  It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
  • The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so.   They did not know that anonymity in voting was not just a right, but also a requirement.
  • The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University.  When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.

These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated.  But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Continue reading

Bei Bei Shuai First Degree Murder Charges Dropped

Less than an hour ago, Indianapolis prosecutor, Mr. Terry Curry agreed to drop first degree murder charges against Bei Bei Shuai in an agreement that required her to plead to a misdemeanor.  The case was a month away from trial in what would have been the first prosecution of a pregnant woman in Indiana for attempting suicide.  Ms. Shaui ate several packets of rat poison in a desperate attempt to end her life after being abandoned by her boyfriend.  After being saved by friends and doctors, prosecutors filed first degree murder charges against Shuai, because her baby died.

Bei Bei Shuai’s case highlights the turn to criminal prosecution in fetal protection cases as a terrible national phenomenon.  Shuai was spared the horrible fate experienced by poor women, many of color, across the U.S., including Regina McKnight, Paula Hale, Melissa Rowland, and others. In a forthcoming article to be published in the California Law Review, I argue that these prosecutions represent the new constitutional battlefronts as they burden pregnant women’s due process interests while also imposing the type of cruel and unusual punishment disallowed by the Eighth Amendment. I have argued in prior works found here and here that such prosecutions often involve racial profiling and create hierarchies among women’s pregnancies.  Indeed, most often the pregnant women targeted for threatening harm to their fetuses are so poor that they lack adequate legal representation, relying on overworked public defenders who make valiant efforts, but lack the economic wherewithal to  properly aid in these cases.   Shuai’s case was different in that she had Linda Pence, a valiant, private attorney, who spent over two years providing excellent pro-bono legal aid.

Bei Bei Shuai’s release from murder charges also represents another victory for Advocates for Pregnant Women, the leading organization advocating on behalf of indigent pregnant women.

The Tylenol Debate: Can Hospitals be Sued for Excessive Markups on Medications and Devices?

By Alex Stein

Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the same price at Amazon); $77 for a box of sterile gauze pads (Amazon’s prices vary between $6 and $11); $18 for a single diabetes test strip (sold for 54 cents by Amazon); $108 for antibacterial Bacitracin ointment (Amazon’s prices vary between $2.50 and $6.50); and so forth. Charges for stay, scans, surgeries, canes, and wheelchairs skyrocket as well.

The American Hospitals Association (AHA) rejects Brill’s analysis. According to AHA, the chargemaster aggregates the hospital’s overall costs on delivering quality care to patients: “In order to take medications in a hospital, even over-the-counter medicines, they must be prescribed by a doctor (a little bit of cost for the doctor), that order gets transmitted to the pharmacy (a little more cost), the order gets filled by a pharmacist or pharmacy tech who retrieves just one Tylenol pill and individually packages that one pill (still more cost), the pill gets transported from the pharmacy to the nursing unit where the patient resides (a little more cost), then the pill is retrieved by a registered nurse who personally gives the pill to the patient and then must document the administration of that pill in the patient medication administration record (a little more cost). All of this process to give a patient a single dose of Tylenol in a hospital bed [must also be] in compliance with all pertaining regulations (a little more cost).”

This post will not try to resolve the Tylenol Debate. Nor will it say anything about the government as a plausible substitute for the eccentric chargemaster. Instead, I will raise a legal question: Can patients sue hospitals for excessive markups on medications and devices?

My answer to this question is a qualified YES. Entrepreneurial and business aspects of running a hospital fall under states’ consumer protection laws (Brookins v. Mote, 292 P.3d 347 (Mont. 2012)). Those aspects certainly include billing (Jaramillo v. Morris, 750 P.2d 1301, 1304 (Wash. App. 1988); Ambach v. French, 216 P.3d 405 (Wash. 2009)). The key question here is whether an excessive markup on medications and devices amounts to deceit or an unfair trade practice. If it does, the hospital would be in violation of the relevant state consumer protection law. This might happen to hospitals whose billing practices—to which patients gave no informed consent—are particularly aggressive. Those hospitals might face class action suits and the prospect of paying treble damages. They also may be stripped of the special protections given to defendants in medical malpractice suits (that include shortened limitations and repose periods for filing suits, caps on damages, and charitable immunities). For my account of the competition between medical malpractice and consumer protection rules, click here.

Brill and other participants in the Tylenol Debate call on the government to start regulating hospital prices. My short advice to hospitals: get rid of unconscionable markups forthwith.

Financial Conflicts of Interest

By Joanna Sax

A recent article in the Journal of Law, Medicine & Ethics (Vol. 41:1, pp. 315-22) nicely describes the contours of Physician Payment Sunshine Act (PPSA) on pharmaceutical marketing.  Similar to other policies addressing financial conflicts of interest, the lion’s share of the PPSA focuses on disclosure.  That is, pharmaceutical companies will be required to disclose how much money they are “giving” to physicians.  A financial conflict of interest can arise when the gifts of money unduly influence a physician’s prescribing habits.

I’ve previously argued here, here and here that the system of disclosure is inadequate to properly address financial conflicts of interest.  Disclosure does only that; it discloses.  So now people know about it – that’s it.  Instead of a system that increases disclosure, I’ve proposed changes to the underlying environment to decrease or eliminate the possibility of a conflict of interest arising.

My research on financial conflicts of interest focuses on scientists at academic medical centers.  I’ve suggested that if academic scientists are in stressful situations, such as worrying about funding, they might be more likely to enter into a situation in which a conflict of interest might arise.  For this reason, if we change the underlying environment of our academic scientists such they are not living in a state of chronic stress, then they might make different decisions, which in turn should lead to fewer situations in which a conflict of interest might arise.

Private physicians operate in a different world than scientists at academic medical centers.  I’m curious if readers have suggestions to change the environment of private physicians such that they will be less likely to enter into situations in which a conflict of interest might arise.

Live Blogging from FDA in the 21st Century Conference, Panel 2: Preserving Public Trust and Demanding Accountability

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”

He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?

Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.

Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.

Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.

In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Continue reading

When Ethics Collide

[Posted on behalf of Nancy Dubler and Art Caplan]

Surprising that for a week there was constant news from Boston.  Minute by minute we heard details of carnage, searching, killing, lock down and capture.  Now, pretty much, silence.

The suspect, captured in a boat in a backyard in Watertown, is now both a prisoner and a patient.  That has proved, historically and most recently, to be a difficult dual status for physicians to address.  It is hard for those who want to interrogate him.  And hard for those who wish to initiate his arraignment and prosecution.  But they along with the rest of us must wait.

Prison and jail health care present an anomaly for medical caregivers.  The goals of medicine are to diagnose, cure and comfort.  The goals of the justice and correctional systems are to confine, try, sentence and punish.  These are not only mutually exclusive goals but, they make strange and strained bedfellows when the two must work together.

We know one can coopt the other.  American doctors who agreed that torture could continue, without killing the prisoner, during recent years when water-boarding was a clear part of the anti-terror arsenal, violated their oaths as physicians to attend only to the medical, physical and emotional needs of the patient…to do no harm.

In the same vein, on July 17, 2008, the AMA articulated its policy about executions clearly and unambiguously — “requiring physicians to participate in executions violates their oath to protect lives and erodes public confidence in the medical profession. A physician is a member of a profession dedicated to preserving life when there is hope of doing so. The use of a physician’s clinical skill and judgment for purposes other than promoting an individual’s health and welfare undermines a basic ethical foundation of medicine — first, do no harm”.  Yet physicians do participate in executions often using their respect for the criminal justice system as their rationale.

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Industry-Provided Meals, Gifts — Still Happening?

One of my primary areas of research is in conflicts of interest (COI). I generally focus on the financial relationships between physicians/researchers and the pharmaceutical industry. See Here Here and Here.

However, COI researchers and policy makers need to expand our scope to include other health care professionals who have relationships with other key health care industries, other than pharma and device companies. In this blog, I focus upon the relationships between discharge planners and long-term care providers (including home care, skilled nursing facilities and others). Long-term care is a growing part of health care expenditures, and represents an area where patients’ preferences and best-interests should be the primary obligations of discharge planning professionals — who are not biased due to industry marketing.

As I reflect back upon my almost two decades in health care, as a clinician, researcher and bioethicist, I am amazed at how pervasive marketing activities are in hospitals… other than seeing drug reps visiting doctors (in fact, this was banned in the hospital I worked). For example, during my first clinical internship, at a rural hospital near Atlanta, home care agency marketing reps were often bringing food and providing educational/marketing materials to the Case Management/Social Work office. We all hung out together. Same thing happened in NYC; although I was not directly involved in discharge planning, home care and post-acute care providers bestowed small gifts, food and other marketing materials – obviously, with the hope of building goodwill, and hoping that as a clinical social worker, I would indirectly influence referrals to their businesses. In addition to gifts and marketing, representatives from these health care companies were often ever-present in the inpatient units to help the Case Managers and other clinicians with the necessary paperwork, insurance reviews, and overall referral facilitation. From what I understand, this type of post-acute care industry “detailing” still occurs in American Hospitals with frequency.

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