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02/22/2019 - 11:04pm
Timothy Leary (1920-1996) marqua de son empreinte l’évolution du mouvement progressiste et techno optimiste des années 70 à 90. Cet article fait partie de la série “Histoire du transhumanisme”.
02/22/2019 - 10:46am

The bill would have required you to give your DNA to the state and pay $250 for the privilege

02/22/2019 - 10:41am

Seeking to build a central identification platform, Kenya is storing the fingerprints, eyes, faces, voices, DNA, and location of its nearly 50-million population, and linking the data to everything from identity cards to access to education, health, and social services

02/22/2019 - 10:39am

The Chinese authorities turned to a Massachusetts company and a prominent Yale researcher as they built an enormous system of surveillance and control

02/22/2019 - 8:45am

Lawmakers could help some stay open. The decline of rural hospitals has been a slow-moving train wreck. It’s now accelerating

02/22/2019 - 8:25am

After a high profile set of scandals, the prominent cancer research hospital, New York’s Memorial Sloan Kettering made an unprecedented move to limit their executives capacity to engage with private industry while employed with Sloan Kettering. Part of a larger set of reforms, Sloan Kettering now has policies that curb or limit serving on corporate boards while employed at Sloan or from accepting certain forms of compensation such as stock or equity. These reforms were bold statements from a preeminent academic medical center about the need to ensure that financial conflicts aren’t compromising patient care or the work of the institution.

Yet, are these laudable reforms enough?

In order to understand what this is and why it matters, it helps to have some context. In late 2008, a joint investigation between ProPublica and the New York Times revealed significant relationships between Sloan executives and for-profit entities. In particular, José Baselga, then Chief Medical Officer of the institution was found to have had numerous financial conflicts of interest but had failed to report them in dozens of articles in high-ranking journals.

Such journals require that authors self-disclose financial conflicts of interest and thus, Baselga’s failure to disclose financial conflicts constituted a major breach and inspired a small PR nightmare for Sloan Kettering. In some instances, Baselga wrote about research areas and specific interventions where he had significant financial ties, without revealing those interests.

Potential Loopholes Around Memorial Sloan Kettering’s Crackdown on Conflicts

The move by Sloan Kettering is an important and useful one. Yet, questions emerge about it. For example, would the policy barring Sloan executives from sitting on boards of for-profit companies resolve larger revolving door relationships between executive staff and firms and startups? A lot of research has shown that there is a revolving door between academic medicine, global pharmaceutical companies, venture capital firms, and biotechnology startups.

Policies barring simultaneous board membership and employment at Sloan cannot get at the possibility that executives will simply be promised a lucrative position at any point once they resign from Sloan Kettering. It also doesn’t stop an executive with powerful financial ties at a company, resigning from a company, joining Sloan, but still acting to advance the “interests” of their former company. Relatedly, there are questions about delayed compensation. Many “creative solutions” emerged when institutions instituted a financial maximum that clinicians or researchers can make from outside for-profit entities.

Could people get around these Sloan Kettering regulations by refraining from board memberships while tenured at Memorial Sloan Kettering, but provide informal advisory services and a promise of potential stock equity in the event of that startup undergoes a lucrative acquisition or IPO? In other words, would it not be easy to be an “uncompensated” advisor and be given (as a form of “compensation”) a promise of stock only in the event of a lucrative exit? Certainly, such exits could be lucrative enough to warrant resigning from one’s position. There is a similar question in the case of conflicts of disclosure about whether authors may begin to start to “wait” to receive compensation from pharma companies until after they publish a paper, in order to avoid having to disclose such compensation.

Banning board membership may not get at arrangements whereby executive staff may still advocate for a company bereft of board memberships, and be provided a delegate kind of compensation. Non-board level advocacy on behalf of a company could include key introductions, working for the Venture Capital (VC) firms that are investing in a high-profile startup space and having compensation from the VC rather than the company directly.

A Good First Step

The move by Memorial Sloan Kettering is an important one, and constitutes a high visibility statement about the need to keep at bay the increasing financialization of science and medicine. Yet, the next generation of reforms must take into consideration the reality of these “revolving door” relationships and all of the creative ways to sidestep policies.

 

Mark Dennis Robinson is a 2018-2019 Petrie-Flom Center Student Fellow.

 

Image: José Baselga, former Chief Medical Officer of Memorial Sloane Kettering, in a 2013 file photo, via Wikimedia Commons. 

 

The post Memorial Sloan Kettering Stops Executives From Corporate Engagements: Is it Enough? appeared first on Bill of Health.

02/22/2019 - 7:25am

A major two-day conference in Rome will critically examine brain death: "Brain Death: A Medicolegal Construct: Scientific & Philosophical Evidence."

Brain Death Is Not Death: Clinical Experience...

02/21/2019 - 10:15pm

By Jon Holmlund The World Health Organization (WHO) has empaneled an expert advisory committee to propose standards for governance and oversight of human gene editing. This group is to meet in Geneva on March 18 and 19 to review the state of the field, broadly, and formulate a plan for its work, over the ensuing …

Continue reading "The new WHO advisory panel on human gene editing"

02/21/2019 - 4:19pm

by Craig Klugman, Ph.D.

A teenager comes to a medical clinic and asks for an MMR vaccine. Although this particular vaccine is usually given at 12-15 months of age with a second dose at ages 4-6 years, this 16-year-old has never been vaccinated. His parents believe that vaccines cause autism* and are dangerous, therefore they have never vaccinated their children. In the age of the internet, the teen has done a lot of research and found that the science is conclusive: Vaccines are safe and beneficial (as long as you are not allergic to the ingredients).…

02/21/2019 - 2:55pm

Recent studies have highlighted the inherent susceptibility for medication errors by anesthesia providers in the perioperative environment. In a prospective survey at Massachusetts General Hospital, investigators identified a concerning potential error rate of 1 in 20 medication administrations, many of which resulted in patient harm.

To those of us who toil daily in the trenches of the operating room, this come as no surprise, for we are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels and administers the medications, independently and without secondary verification or use of technologic support. In one sense this may seem to be an advantage, for if there are fewer intermediaries, such as pharmacists or registered nurses, there are fewer humans to make a mistake. On the other hand, more intermediaries or additional verification might identify previously unrecognized errors.

Patients (and healthcare workers) would be surprised to learn that there are almost no laws or regulations pertaining to medication administration safety. I believe it is time for that to change. Although public health law has traditionally focused on the legal methods to prevent transmissible disease, over the past century this focus broadened to include prevention of chronic diseases, environmental hazards, and injuries. In fact, as early as 1958, Vickers characterized public health as “successive re-definings of the unacceptable.”

In an upcoming issue of the Journal of Patient Safety and Risk Management, I argue the case that harm from medication errors can be considered within the ambit of “public health”, and can be decreased using the public health law framework of increasingly stringent levels of paternalism, as described by Friedman. The least stringent (libertarian or apaternalistic) level, where the government allows a free market and relies on consumers to process relevant information, is the current level that exists in the U.S. (and throughout the world) today: patients need to figure out for themselves which hospitals have the safest medication administration procedures. This is essentially an impossible task, since hospitals generally do not keep close track of medication errors, and certainly do not make the results available to public if they do.

There are two main kinds of medication errors made by anesthesia providers. The first occurs when a medication syringe is accidentally prepared from the wrong drug vial. This can occur when drug vials look similar or are situated near each other in the anesthesia drug tray. The other main type of error occurs when the anesthesia provider administers a correctly filled syringe, but it was not the one that was intended, a process referred to as “syringe swap.” Without systematic mechanisms to prevent either of these two types of errors, patients have to rely on the anesthesia provider’s vigilance and mental focus to remain safe. Since human errors are inevitable and arguably normal, reliance only on vigilance will ultimately be unsuccessful; thus, more systematic safety methods are required to prevent these types of errors.

In the paper, I argue that there should exist regulations aimed at the prevention of vial and syringe swap errors, by mandating the availability of methods that circumvent the possibility of human error. This was accomplished by OSHA in 2000 with the Needlestick Safety and Prevention Act, created to confront the preventable problem of healthcare workers who contract serious viral illnesses by accidental needlesticks.

That Act requires healthcare employers to provide their employees with technologically advanced needles that are engineered to prevent accidental sticks during patient care. The Act forced healthcare employers to supply the needles to the employees at risk, without mandating their use; a clever solution to the infringement on the practice of medicine obstacle. Infection rates decreased because the needles were readily available, easy to use, and had no demonstrable disadvantages.

A similar regulation to decrease the incidence of medication errors would mandate the availability of pre-filled syringes, thus eliminating the possibility of vial swap. After all, what provider would go to the trouble of preparing their own syringe when one was immediately available? The prevention of syringe swap is admittedly more difficult, and will require the availability of technological equipment, such as barcoding, to confirm that the drug one intends to give is truly the correct one. Both of these medication safety advances are currently available but very few hospitals use them, primarily because of the increased cost, and the lack of knowledge of their availability. However, this is beginning to change, as hospitals that invest in these safety methods are beginning to publish their success.

Although gaps in legal and regulatory structure of medication administration by clinicians may indirectly allow patient harm, this gap can be filled by solutions based on the public health law framework that reveals the vulnerabilities of the current apaternalistic situation that exists in the U.S. today.

 

Ron Litman, D.O., M.L. is an anesthesiologist at the Children’s Hospital of Philadelphia and Professor of Anesthesiology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. He is the medical director of the Institute for Safe Medication Practices, and a current member of the FDA’s AADPAC.

The views and opinions expressed in this blog belong solely to the author, and do not necessarily reflect the opinions of the author’s employers or their affiliates.

 

The post Can Anesthesiologists Adopt a Public Health Law Framework to Improve Medication Safety? appeared first on Bill of Health.