When Laws Go Too Far

The doctor-patient relationship is unique; almost sacred. Predicated on the Hippocratic Oath of "do no harm," physicians accept on themselves the responsibility for their patients' well-being. On the other side, patients entrust doctors to advise them on all decisions affecting their health. When government - whether state or federal - decides to intrude on this relationship, issuing mandates or laws, there needs to be more than a 'good reason' - there must be greater harm that can come from not interfering. Otherwise, a law may "[impair] the provision of medical care and may ultimately harm the patient," as noted by U.S. Disctrict Judge Marcia G. Cooke.

In a letter to the New England Journal of Medicine (NEJM), leaders of five professional physician's societies express concern over what they see to be a growing trend of state legislation intervening in the doctor-patient relationship. Among the legislation singled out, a New York law that was

enacted in 2010 and became effective in early 2011 [that] requires physicians and other health care practitioners to offer terminally ill patients "information and counseling regarding palliative care and end-of-life options appropriate to the patient, including . . . prognosis, risks and benefits of the various options; and the patient's legal rights to comprehensive pain and symptom management."

The authors note that end of life and palliative care is not a one-size-fits-all area of healthcare; instead, physicians can best determine what discussions are appropriate, and when. The law even imposes criminal penalties for 'willful violation.'

Another law singled out is the controversial Virginia legislation that originally required a woman to receive a transvaginal ultrasound - relatively invasive - before an abortion. While the bill was changed to require a transabdominal ultrasound instead, the authors maintain that the bill is still an unwarranted intrusion into the doctor-patient relationship.

Given the authors' apparently strong views on government interference in the doctor-patient relationship, it seems odd not to address recent developments at the federal level that are arguably more draconian - the Independent Payment Advisory Board (IPAB) established under the Affordable Care Act (ACA); the FDA's REMS policies; and Comparative Effectiveness Research (CER) used to establish a drug's effectiveness (and, eventually, reimbursement).

The Independent Payment Advisory Board

IPAB's goal is to reduce Medicare spending through 'efficiency improvements' such as reductions in reimbursements to physicians and drug companies. While IPAB is prohibited from changing benefits, they can effectively make reimbursement for a particular drug or medical device so low so as to discourage utilization. Effectively, this is rationing. And of course, it will be unelected bureaucrats making these calls - to the detriment of patients, who may have fewer cutting edge drugs and treatments available to them under Medicare. This is particularly troubling in emerging era of personalized medicine, when drugs or drug combinations may only be effective in discrete groups of patients.  One size-fits-all reimbursement is the last thing that patients and innovators need. Is this an intrusion? Without a doubt. 

FDA Risk Evaluation and Mitigation Strategies (REMS)

In order to assure itself that the benefits of a drug outweigh the risks, the FDA has the power to require risk evaluation and mitigation strategies (REMS) from drug manufacturers. Essentially, this means that when providers want to prescribe a certain drug that has a REMS requirement, the manufacturer has to impose certain preconditions - everything from a basic medication guide to including certain tests prior to prescribing it, or limiting the drug to specialist physicians.  Jumping through these hoops may lead to delays in patient access to some medications.  Effectively, this represents an intrusion on the practice of medicine, although the FDA doesn't like to frame it that way.

While ensuring that drugs are prescribed correctly is important, we can't overlook the danger that the FDA may prescribe more REMS to protect itself from the negative publicity and Congressional criticism that attends serious but rare drug side effects.  It's also worrisome that REMS seem to be expanding over time, with regulators increasingly looking over doctor's shoulders. The assumption is that physicians won't reach the same benefit-risk judgments that the agency makes, but they may have good reasons for doing so.     

Both patients' and pharmaceutical industry associations have expressed concern over the FDA's REMS program: pharmaceutical companies have noted that the FDA has no black-and-white criteria for determining when REMS will be required; meanwhile, the National Health Council, an association of health organizations, has called for a Government Accountability Office (GAO) review of the REMS process to determine if it is preventing new drugs from entering the market.

Increasingly, concerns about the abuse of prescription drugs (especially pain medicines and drugs for ADHD) have made it harder for some law-abiding physicians and patients to access drugs for legitimate uses.  Striking the right balance here is crucial, and bears careful watching

Comparative Effectiveness Research

With growing healthcare costs viewed as a substantial problem for state and federal budgets, comparative effectiveness research is increasingly being viewed as an attractive cost control strategy.  As President Obama once quipped, why pay for an expensive red pill when a cheap blue is available that does the same thing? Indeed, the 2009 American Recovery and Reinvestment Act (ARRA) allotted around $1 billion in funding for CER to "support research assessing the comparative effectiveness of health care treatments and strategies."

At the most basic level, CER studies compare two drugs to see which, on average, is more effective. The idea is that if a more expensive drug is as effective as a less expensive alternative, there is no reason to cover the more expensive variant. On the surface this logic may seem intuitive, but it misses a critical point - most people are not the average patient. A drug that looks to help the same 'average' patient may in fact be helping a different segment of the patient population that isn't being helped by another drug. While government sponsored CER can provide important information that markets may not produce (some comparative trials are so large as to be impractical for any single company) , and patients should certainly have better incentives to pursue the most cost effective strategies, it's no panacea - and runs counter to, again, the growing trend of more personalized treatment options.

Controversial social policy issues, like those mentioned in the NEJM article, often garner the most attention.  However, there are broader and potentially much more serious intrusions into the doctor-patient relationship waiting in the wings. 

After all, the more government pays for health care, the more it will want to tell doctors and patients what they're allowed to have - or what they have to go without. 

Related Entries:

keep in touch     Follow Us on Twitter  Facebook  Facebook

Our Research

Rhetoric and Reality—The Obamacare Evaluation Project: Cost
by Paul Howard, Yevgeniy Feyman, March 2013

Warning: mysql_connect(): Unknown MySQL server host 'tmiweb52.vwh.net' (2) in /home/medicalp/public_html/incs/reports_home.php on line 17
Unknown MySQL server host 'tmiweb52.vwh.net' (2)


American Council on Science and Health
in the Pipeline
Reason – Peter Suderman
WSJ Health Blog
The Hill’s Healthwatch
Forbes ScienceBiz
The Apothecary
Marginal Revolution
Megan McArdle
LifeSci VC
Critical Condition
In Vivo Blog
Pharma Strategy Blog
Drug Discovery Opinion