Why Physician Leaders Can No Longer Ignore Health Policy

By John E. McDonough
January 24, 2019

For most physicians and physician leaders, health policy is an annoyance and distraction that happens “over there” in Washington DC, state capitals, and elsewhere.  The ways and means of politics and policy making are mysterious and not worth the bother.

In today’s U.S. health care system, that attitude makes less and less sense from institutional, professional, and personal points of view. Continue reading “Why Physician Leaders Can No Longer Ignore Health Policy”

Tort Reform and Health Care Costs

By Ajay K. Singh, MBBS, FRCP, MBA
August 31, 2017

The country gyrates and convolutes about whether Obamacare should be repealed and replaced, but the larger discussion should center on how to reduce health care costs.

One significant contributor to escalating health care costs is the impact of malpractice. An article published by Michelle Mello and colleagues in Health Affairs discusses the impact of medical malpractice on the US health care system. It estimates that in 2008, medical malpractice, including defensive medicine, cost $55.6 billion or about 2.4% of total health care spending.

Currently, having passed the House of Representatives, federal tort reform legislation is stuck in the US Senate . The nonpartisan Congressional Budget Office estimates that enacting federal tort reform would save approximately $14 billion over five years and $50 billion over 10 years. Some key features of the tort reform proposal languishing in Congress include a cap on non-economic damages, a three-year statute of limitations on medical liability suits from the date of injury, and a “fair-share” rule in which a defendant would be liable only for his or her share of responsibility for a medical injury.

One criticism of tort reform is whether it works, and in particular whether it could be implemented in the US. A recent article by Vishal Khetpal in Slate on reforming medical malpractice caught my eye.  The article makes two points:

  1. Tort reform that creates a no-fault compensation system has worked in several countries such as Sweden, Denmark and New Zealand.
  2. The US has implemented a system for patients harmed by the administration of a vaccine—the National Vaccine Injury Compensation Program. This system does seem to work.

The other criticism is that tort reform might reduce clinical quality and clinical outcomes. But the authors of an interesting article in the Journal of Public Economics disagree.

The President of the American Medical Association, Dr. David O. Barbe, MD, has been  quoted in Modern Healthcare by Mara Lee: “This legislation is an important step toward fixing that system—a step that reins in defensive medicine, reduces the growth of health care costs and strikes the correct balance by promoting speedier resolutions of disputes—while maintaining an injured patient’s access to just compensation.”

Ajay Singh, MBBS, FRCP headshotDr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.

*OPINIONS EXPRESSED BY OUR AUTHORS ARE VALUABLE TO US AT LEAN FORWARD, BUT DO NOT REPRESENT OFFICIAL POSITIONS OR STATEMENTS FROM HARVARD MEDICAL SCHOOL.

Doctors, Patients, and Guns

By Ajay K. Singh, MBBS, FRCP, MBA
Tuesday, Febraury 7, 2017

A few months back when I saw my primary care physician at one of the Brigham and Women’s Hospital practices, I noticed that there was a question on the pre-visit questionnaire asking about whether I owned a gun. I do not own a gun and never have and so had no problem in answering no to this question.

Recently, however, I noticed an article in Kaiser Health News discussing whether physicians should be allowed under the law to ask about their patients’ gun ownership. Really?

The article states: “Some states have imposed restrictions on gun-related information that patients must provide or that can be collected by providers and state officials. The most notable is Florida, which in 2011 passed the so-called ‘Docs vs. Glocks’ law that generally prohibited doctors from asking patients if they had a gun at home.

The law was found unconstitutional, then that decision was overturned by a divided three-judge panel of the 11th U.S. Circuit Court of Appeals in Atlanta. The full appeals court in turn vacated that decision and heard oral arguments last year, but has yet to rule. In the meantime, the Florida law has not gone into effect.”

So I dug into the literature a bit and came across a comprehensive article on the issue published back in August 2016 in the Annals of Internal Medicine by Wintemute and colleagues.

Some highlights:

  • In 2014, a total of 33,599 Americans died of gunshot wounds.
  • No federal or state statute prohibits physicians from asking about firearms when such information is relevant to the health of the patient or others.
  • When to ask? Firearm information would be directly relevant to the health of an individual patient and that patient’s close contacts under three general conditions:
  1. The first arises when a patient provides information or exhibits behavior suggesting an acutely increased risk for violence, such as explicit or implicit endorsement of suicidal or homicidal intent or ideation.
  2. The second involves patients who possess other individual-level risk factors for future violence. (A history of violence perpetration, patients hospitalized or treated in emergency departments for violent victimization, history of alcohol and/or drug abuse.)
  3. Third, questions about firearms would be relevant for patients in demographic groups that are at increased risk for firearm-related injury. Middle-aged and older white men are at high risk for firearm-related suicide (up to 5 times higher than black men of the same age), and young African-American men are 20 times as likely as young white men to die of firearm-related homicide. Children and adolescents may engage in risk behaviors with firearms because their judgment and cognitive skills are not fully developed.”

The article concludes: “Medical specialty societies recommend asking and counseling about firearms during routine patient care or as an element of risk assessment. Neither the law nor the Second Amendment prohibits such activities, and the First Amendment may protect them.

” Quae Sunt Quasi Quaedam Manifesta” (Latin for “Some things seemed obvious.”)

Ajay Singh, MBBS, FRCPDr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.

*OPINIONS EXPRESSED BY OUR AUTHORS ARE VALUABLE TO US AT LEAN FORWARD, BUT DO NOT REPRESENT OFFICIAL POSITIONS OR STATEMENTS FROM HARVARD MEDICAL SCHOOL.

Marketing Drugs in the US: Is It Free Speech?

One step forward, two steps back.

By Ajay K. Singh, MBBS, FRCP, MBA
January 3, 2017

The 1962 Drug Amendments Act put the last nail in coffin—or so it seemed—for drug manufacturers/pharma companies in making outlandish claims on the effectiveness of their drug in promoting and marketing it. The process generated confidence that drugs were being marketed only after being shown to be effective. This put an end to the “tonic” industry that marketed liver tonics and kidney tonics and the like without much, or any, evidence.

A Perspectives article in the New England Journal of Medicine by Christopher Robinson and Aaron Kesselheim, centers around the controversy about whether a drug can be promoted and marketed based on an “individual’s right to free speech.” It discusses the impact of recent court decisions on whether pharma companies and their representatives can promote or market their drug without an express indication approved by the FDA.

A 2012 decision by the U.S. Court of Appeals for the Second Circuit (which includes New York, Connecticut and Vermont) overturned an earlier decision. Tamara Frazier, writing in Pharmaceutical Compliance Monitor, nicely summarizes the details of the court case:

Alfred Caronia was a pharmaceuticals sales representative for Orphan Medical who, together with a physician in Orphan’s speaker program, promoted the drug Xyrem for off-label uses.  Xyrem, known as the date rape drug, is approved for treatment of narcolepsy.  Caronia and the physician were caught on tape promoting its use for treatment of insomnia, fibromyalgia, restless legs, Parkinson’s disease, and multiple sclerosis, and in unauthorized patient populations. Orphan and the physician pled guilty.  After a trial on the merits, Caronia was acquitted of misbranding, but convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a) (2) of the Federal Drug and Cosmetic Act (“FDCA”). On December 3, 2012, the Second Circuit Court of Appeals overturned Caronia’s conviction, citing his first amendment rights.  It declared, unequivocally, that the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

The fundamental issue is this: under the umbrella of free speech can someone—the company sales representative or the company itself—claim benefits for a drug that are not proven and not approved by the FDA?

Since the Caronia decision, the US Government has tended to succeed in litigation regarding off-label use drugs with one notable exception. In a 2015 case, Amarin Pharmaceuticals was able to ultimately prevail on off-label promotion of it’s fish oil-derived cardio drug Vascepa, despite not having obtained an approved indication from the FDA.

As discussed earlier, The Drug Amendments of 1962, passed unanimously by the Congress, “recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing—a milestone advance in medical history.” This built on the 1938 Federal Food, Drug, and Cosmetic Act, a law enacted in the aftermath of 100 deaths following treatment with sulfanilamide.

The courts re-interpreting the role of the FDA is unfortunate. Robinson and Kesselheim write, ” Rather than acceding to the views of two judges in one federal circuit, we hope that the FDA continues to stand on principle. The U.S. Constitution should not be misconstrued in such a way as to undermine the primary functions of federal regulation in this area: to protect patients and to create a high-quality market for drugs and devices that is driven by science rather than hype.”


Understanding Addiction, the first in a three-part, accredited opioid use disorder program, is open for enrollment. Each of these self-paced, online CME courses is produced by Harvard Medical School’s Global Academy, and is free of charge with funding from the National Institute of Drug Abuse. These courses are intended for nurses, nurse practitioners, physician assistants, physicians, and other health care providers collaborating to treat patients with substance use disorders.


Ajay Singh, MBBS, FRCPDr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.

*OPINIONS EXPRESSED BY OUR AUTHORS ARE VALUABLE TO US AT LEAN FORWARD, BUT DO NOT REPRESENT OFFICIAL POSITIONS OR STATEMENTS FROM HARVARD MEDICAL SCHOOL.