Tag Archives: free speech

Update: Florida Physician Gag Rule Overturned

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In a previous blog post, Politics and Limiting Physician Speech, I discussed the Florida Gag Rule intended to prevent physicians from discussing firearm safety with patients. At the time, I expressed outrage that “there are laws curtailing a physician’s free speech and efforts to dictate practice based on political philosophy.”

It looks my views have been vindicated.  NEJM report (full text): Physicians, Firearms, and Free Speech

An excerpt:

In February, the full U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited ruling in Wollschlaeger v. Governor, State of Florida, invalidating parts of Florida’s Firearm Owners’ Privacy Act (FOPA) and affirming that the First Amendment applies to the speech between physicians and patients. The decision ensures that physicians may continue to make efforts to protect their patients from gun-related injuries, many of which are fatal and which in aggregate account for approximately as many deaths annually as do motor vehicle accidents….

the majority affirmed that laws regulating physician speech must be designed to enhance rather than harm patient safety. The majority took this mandate seriously and required the state to show some meaningful evidence that the regulation was apt to serve the state’s interest in protecting patients.

The state could not do so for two reasons. First, the decision to keep a gun in the home substantially increases the risk of death for all household members, especially the risk of death by suicide, and particularly so when guns are stored loaded and unlocked, as they are in millions of homes where children live.3 Second, the majority of U.S. adults who live in homes with guns are unaware of the heightened risk posed by bringing guns into a home.4 Indeed, by providing accurate information about the risks created by easy access to firearms, as well as ways to modify that risk (e.g., by storing guns unloaded and locked up, separate from ammunition), a physician’s counseling can not only enhance a patient’s capacity for self-determination, but also save lives…

The fact is that most clinicians, including those who routinely encounter suicidal patients, rarely, if ever, provide firearm-safety counseling.5 This reticence predated the FOPA and has persisted since its passage..The court has done its duty. It’s now the physicians’ turn.

Related blog posts:

Capers Island

Can the FDA stop snake oil salesmen?

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A recent commentary (C Robertson, AS Kesselheim. NEJM 2016; 375: 2313-5) examines how the issue of “free speech” may undermine the FDA’s ability to regulate ineffective or dangerous medications. This has been discussed in a previous blog:

Can the FDA prohibit free speech?

In a previous case, Caronia had promoted sodium oxybate for a wide range of nonapproved uses; some of these uses “were likely to cause patients substantial harm.”

Yet, the 2nd Circuit court reversed a lower court in ruling that Caronia’s sale pitches were protected free speech.  This decision “subverted decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries.”

The authors hope that an upcoming case to the 1st circuit will uphold the FDAs ability to assure that patients are protected and that the use of drugs is driven by science and not marketing.  If manufacturers are allowed to promote a wide range of uses for drugs with narrow indications, there will not be an incentive to determine if these medications are safe and effective.

My take: If the principles of free speech are extended to promoting bogus claims about pharmaceuticals and medical devices, this would be a huge blow to medical science.

Acadia Natl Park

Acadia Natl Park

Politics and Limiting Physician Speech

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A concise review/commentary (WE Parmet et al. NEJM 2016; 374: 2304-7) of Wollschlaeger v Governor of Florida explains how attempts to support the gun lobby are likely imposing unconstitutional limits on the free speech of physicians as well as undermining good health policy.

This law “prohibits physicians from intentionally entering into a patient’s record information about firearm ownership that ‘is not relevant to the patient’s medical care or safety, or the safety of others’; prohibits physicians from asking patients (or for minors, patients’ parents) about firearm ownership unless they believe ‘in good faith’ that ‘information is relevant to patient’s medical care or safety.'”

There are good reasons for physicians to inquire about guns in the homes as there is definitive evidence that a gun in the home increases the risk of death, especially by suicide.  The odds, on average from studies, is a 3-fold risk in homes with guns, but even higher for children and adolescents.

The law is counter productive as well. “Studies to date, as limited as they are, suggest that gun owners so counseled are more likely to change storage practices than to remove guns from their homes.”

While the politics with firearms is heavily influenced by well-funded lobbyists, there are other areas in which there are laws regulating physician speech, including abortion and fracking.

My take: I think it is outrageous that there are laws curtailing a physician’s free speech and efforts to dictate practice based on political philosophy. I hope they will not be upheld.

Related blog post: Can the FDA prohibit free speech? | gutsandgrowth

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Can the FDA prohibit free speech?

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Maybe not (NEJM 2013; 368: 103-05).

While the FDA is responsible for overseeing the safety of pharmaceuticals and veracity of marketing, its authority does not extend to the practice of medicine.  This enables the widespread practice of using medications for “off-label” purposes.  Physicians can use approved drugs for nonapproved uses.  FDA regulations have restrained marketing of off-label uses of prescription medications by pharmaceutical representatives.

However, a recent appellate ruling in United States v. Caronia has stated “the government cannot prosecute pharmaceutical manufacturers…for speech promoting the lawful, off-label use of an FDA-approved drug.”  According to this perspective article, the ruling stemmed from the argument that refusing to “allow the free flow of information would result in …limitations, and side effects of the drug.”

At stake is whether the ability of the FDA to combat false or misleading speech.  In addition, limiting the FDA’s authority may lead to fewer studies documenting the effectiveness of medications for various indications.  If the medication is approved for one use and there are no constraints on marketing, there will be little incentive to complete additional studies.

Additonal references:

UNITED STATES V. CARONIA 09-5006-cr Unofficial Oral Argument …

United States v. Caronia – Reed Smith