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California Approves Bill to Punish Doctors Who Spread False Information

https://www.doximity.com/articles/f1bb07d5-6b97-4cfd-b74b-23f49a29687f

Trying to strike a balance between free speech and public health, California’s Legislature on Monday approved a bill that would allow regulators to punish doctors for spreading false information about Covid-19 vaccinations and treatments.

The legislation, if signed by Gov. Gavin Newsom, would make the state the first to try to legislate a remedy to a problem that the American Medical Association, among other medical groups and experts, says has worsened the impact of the pandemic, resulting in thousands of unnecessary hospitalizations and deaths.

The law would designate spreading false or misleading medical information to patients as “unprofessional conduct,” subject to punishment by the agency that licenses doctors, the Medical Board of California. That could include suspending or revoking a doctor’s license to practice medicine in the state.

While the legislation has raised concerns over freedom of speech, the bill’s sponsors said the extensive harm caused by false information required holding incompetent or ill-intentioned doctors accountable.

“In order for a patient to give informed consent, they have to be well informed,” said State Senator Richard Pan, a Democrat from Sacramento and a co-author of the bill. A pediatrician himself and a prominent proponent of stronger vaccination requirements, he said the law was intended to address “the most egregious cases” of deliberately misleading patients.

California’s legislation reflects the growing political and regional divisions that have dogged the pandemic from the beginning. Other states have gone in the other direction, seeking to protect doctors from punishment by regulatory boards, including for advocating treatments involving hydroxychloroquine, ivermectin and other medications that the American Medical Association says remain unproven.

If enacted, the law could face a legal challenge. Governor Newsom, who has three weeks to sign the legislation, has not yet taken a public position on it.

While other nations have criminalized the spread of vaccine misinformation — and have higher vaccination rates — the response by states and the U.S. government has largely been limited to combating misconceptions with accurate information, said Michelle M. Mello, a professor of law and health policy at Stanford University.

She noted that even laws that cited a “compelling interest,” like public health and safety, to police disinformation ran the risk of having a chilling effect, a First Amendment standard for many courts.

“Initiatives like this will be challenged in court and will be hard to sustain,” she said in an interview. “That doesn’t mean it’s not a good idea.”

California’s response follows a warning last year by the national Federation of State Medical Boards that licensing boards should do more to discipline doctors who share false claims. The American Medical Association has also warned that spreading disinformation violates the code of ethics that licensed doctors agree to follow.

The measure was among a flurry of Covid-related bills proposed by a legislative working group that drew fierce opposition from lawmakers and voters. Some of the most contentious bills have stalled or died, including one that would have required all California schoolchildren to be vaccinated.

As the legislation moved through the Legislature, its sponsors narrowed its scope to deal directly with doctors’ direct interaction with patients. It does not address comments online or on television, though those have been the cause of some of the most impactful instances of Covid misinformation and disinformation.

“Inaccurate information spread by physicians can have pernicious influences on individuals with widespread negative impact, especially through the ubiquity of smartphones and other internet-connected devises on wrists, desktops and laptops reaching across thousands of miles to other individuals in an instant,” the Federation of State Medical Boards wrote in a report in April. “Physicians’ status and titles lend credence to their claims.”

The legislation would not require the suspension or revocation of a doctor’s license, leaving such determinations to the Medical Board of California. It is intended to make the dissemination of false information about Covid-19 subject to the same rules as other kinds of “unprofessional conduct” taken up by the board.

The legislation defines disinformation as falsehoods “deliberately disseminated with malicious intent or an intent to mislead.” Treading into the at times contentious debates over alternative, often unproven Covid treatments, the bill defines misinformation as spreading information “that is contradicted by contemporary scientific consensus contrary to the standard of care.”

It says doctors have “a duty to provide their patients with accurate, science-based information.” That would include the use of approved vaccines, which have been subject to fierce debates and political activism across the country, though there is broad agreement among medical professionals about their effectiveness.

A group called Physicians for Informed Consent opposed the legislation, saying it would silence doctors. The group filed a lawsuit this month to seek an injunction preventing the Medical Board of California from disciplining doctors based on accusations of disinformation. In its lawsuit, it called the legislation’s definition of misinformation “hopelessly vague.”

In a recent letter to Surgeon General Vivek H. Murthy, James L. Madara, chief executive of the American Medical Association, said disinformation swirling around vaccines had contributed to ignorance among the public that had worsened the pandemic’s impact.

“The most unfortunate result of this has been significant vaccine hesitancy and refusal among certain communities and within certain demographics, ultimately resulting in continued higher rates of severe illness, hospitalization and death due to Covid-19 in these populations — outcomes largely preventable with vaccination,” he wrote.

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Can’t help but notice.. NACDS ( National Assoc of Chain Drug Stores) that represents some 50%-60% of all community pharmacies, nor AMCP (Academy of Managed Care Pharmacy) which represents all the PBM/mail order pharmacies are not aligning with this statement. I am not waiting for a similar statement supporting those pts dealing with subjective diseases and have a medically necessary medications – often a controlled substance. I guess that the SCOTUS ruling (9-0 vote) https://www.scotusblog.com/case-files/cases/ruan-v-united-states/  Which basically told the DEA that they could not use objective criteria in judging prescribers treating pts dealing with SUBJECTIVE DISEASE. Is this a “wink & nod” to all the pharmacists employed by these chains… that denial of care – refusing to fill controlled meds… they are perfectly okay with.

AMA, APhA, ASHP, NCPA Statement on State Laws Impacting Patient Access to Medically Necessary Medications

https://www.ashp.org/news/2022/09/08/statement-on-state-laws-impacting-patient-access-to-medically-necessary-medications

The American Medical Association (AMA), American Pharmacists Association (APhA), American Society of Health-System Pharmacists (ASHP), and National Community Pharmacists Association (NCPA) are concerned about state laws that limit patients’ access to medically necessary medications and impede physicians and pharmacists from using their professional judgment.

Following the U.S. Supreme Court Dobbs v. Jackson Women’s Health Organization decision, physicians, pharmacists, and other health care professionals face a confusing legal landscape due to state laws’ lack of clarity, confusing language, and unknown implementation by regulatory and enforcement bodies. This includes many questions about how broadly state laws will be interpreted and the impact of these actions on physicians’ and pharmacists’ ability to serve the needs of their patients. Physicians and pharmacists need clear guidance from state boards of medicine and pharmacy, agencies, and policymakers to support the prescribing and dispensing of medically necessary medications that may be affected by this new legal and regulatory paradigm. Without such guidance, we are deeply concerned that our patients will lose access to care and suffer irreparable harm.

In the wake of the Dobbs decision, over half of U.S. states have severely restricted or are expected to soon restrict access to abortion services, including medications that induce abortions. In many states, these laws prohibit prescribing and dispensing an “abortion-inducing drug,” or contain other comparable terms. This language is vague, and it is unclear whether it prohibits certain medications only when prescribed to induce abortion or whether a medication is prohibited entirely if it has the potential to induce abortion regardless of the condition for which it was prescribed. Namely, methotrexate can be used off-label for the termination of intrauterine pregnancy and is also approved and used off-label for numerous indications such as cancer and ectopic pregnancy along with being commonly prescribed as the first-line treatment of inflammatory diseases such as arthritis. Similarly, mifepristone is indicated for the termination of pregnancy but is also prescribed in a medical emergency to treat ectopic pregnancy, preeclampsia, and other emergent medical presentations during labor and delivery and for the medical management of a miscarriage.

Our members and our patients report that this uncertainty is disrupting care. Patients who rely on these medications for reasons unrelated to pregnancy termination report new challenges in accessing these and other medications, and it is placing our patients’ health at risk. Many health care professionals, including physicians and pharmacists, are uncertain of their legal liability related to prescribing and/or dispensing these medications regardless of whether they are being used for an abortion or another indication. We are aware of the following examples that highlight reactionary steps taken by various stakeholders stemming from a lack of clarity in state policy and resulting in patients experiencing delays or denials in accessing medications for medically necessary purposes:

• At some health systems and hospitals, we have heard reports of legal counsel, tasked with minimizing legal exposure for their institution and employees, prioritizing caution over access and advising against providing certain medications.
• Some organizations have removed emergency contraceptives (which are not abortifacients) from kits used to care for victims of sexual assault—compounding the trauma these victims experience—because the legal risk is too unclear.
• Some pharmacies are implementing policies requiring pharmacists to reject prescriptions unless new, burdensome administrative processes are met, such as confirming a female patient’s diagnosis with the prescriber for every potential abortifacient regardless of whether the medication has multiple uses.

Without access to medications proven to be safe and effective, our patients’ health is at risk. As physicians and pharmacists, we view patient wellbeing as paramount and are deeply troubled that continuity of care is being disrupted. We call on state policymakers to ensure through guidance, law, or regulation that patient care is not disrupted and that physicians and pharmacists shall be free to continue to practice medicine and pharmacy without fear of professional sanction or liability. We strongly urge state medical and pharmacy boards, agencies, and policymakers to act to help ensure that our patients retain continuity of care and that our members clearly understand their legal and licensing obligations.

About ASHP
ASHP is the collective voice of pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings spanning the full spectrum of medication use. The organization’s more than 60,000 members include pharmacists, student pharmacists, and pharmacy technicians. For 80 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, ashp.org, or its consumer website, SafeMedication.com.

About AMA
The American Medical Association is the physician’s powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises, and, driving the future of medicine to tackle the biggest challenges in health care. For more information, visit ama-assn.org.

About APhA
APhA is the only organization advancing the entire pharmacy profession. Our expert staff and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital leadership to help pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians find success and satisfaction in their work and advocate for changes that benefit them, their patients, and their communities. For more information, please visit www.pharmacist.com.

About NCPA
Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing nearly 19,400 pharmacies that employ 215,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America’s most accessible health care providers. To learn more, visit www.ncpa.org.

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Patients see their pharmacists as more dependable than their doctors, data shows

https://www.legalreader.com/data-shows-patients-trust-pharmacists-more-than-doctors/

A recent study found that more than half of Hispanic patients 50 years of age and older (61%), and 59% of African Americans the same ages view pharmacists as “supportive partners compared to doctors, particularly due to the pharmacists’ guidance when it comes to health and wellness.” CulturIntelTM published its “How to Leverage Doctors and Pharmacists in Marketing Plans to Yield Better Health Outcomes Study” on the trust matter after weeding through over one million online public domain conversations posted in the one-year span between April 2021 and April 2022. These conversations included “1.6 million public domain digital conversations about doctors and 84,000 public domain digital conversations about pharmacists,” the company reported.

While trust is an important factor in the relationship between any provider and a patient, pharmacies have gotten somewhat of a bad rap lately with all of the litigation being filed against these chains over claims they’ve helped to fuel the opioid epidemic. So, it’s interesting that the majority of minority patients in the stated age bracket continue to view pharmacists as trustworthy, and this begs that question – why?

The study reported that 67% of African American and Hispanic patients 50 years of age and older “collectively have a more positive sentiment toward pharmacists than doctors. The sentiment for both pharmacists and doctors are driven by a combination of soft skills like friendliness and support, as well as hard skills like effectiveness and expertise.”

And, while bias in the healthcare field continues to be a relevant issue, it seems pharmacists are not viewed this way.

“Interestingly enough, among Hispanic and Black people, pharmacists do not seem to suffer from the perception that they are being ‘biased,’ or that as pharmacists they are showing an unfair prejudice towards diverse communities,” said Caroline Brethanoux, chief strategy officer, CIEN+ and CulturIntel. “On the other hand, doctors are deemed biased in their interactions with diverse patients due to their personal experiences and historical injustice in the healthcare system. Within these communities, pharmacists could potentially become a gateway to foster more trust towards the healthcare system and drive better health outcomes as a result.”

The study found that “across all segments, 37% of the conversations in which patients are discussing doctors online are mostly driven by negativity compared to 22% of negative discussions about pharmacists.”

CulturIntel explained, “People are concerned about doctors being rude and disrespectful, but also incompetent and ineffective, suggesting a lack of trust in their abilities and their knowledge. Additionally, there are complaints about doctors’ biased behavior, especially among African Americans and Hispanic conversations which are not discussed for pharmacists,”

This is especially interesting because, in the opioid cases filed against pharmacies, many defendants have countered that doctors should be held accountable for suspicious orders. The pharmacies contend they are only fulfilling patients’ needs by filling the orders given to them that were written by physicians. Whether patients believe that their doctors are writing inappropriate prescriptions is something that hasn’t gotten a ton of attention, but it’s a curious question, nevertheless, given the trust patients put in their pharmacists and their apparent distrust of doctors.

Sources:

Study: Pharmacists May Overcome Trust Barriers Among Diverse Patients

Chicago-area counties sue pharmacy chains for allegedly feeding opioid crisis

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‘The Government Needed a Scapegoat’: 75-Year-Old Man Charged With Opioid Conspiracy Cleared

https://reason.com/2022/09/07/the-government-needed-a-scapegoat-75-year-old-man-charged-with-opioid-conspiracy-cleared/

A small blow against Drug Enforcement Administration (DEA) overreach. James Barclay was an accounts receivable manager for the wholesale pharmaceutical distributor Miami-Luken. The feds said doing his job made him a drug dealer worthy of criminal prosecution.

“I was indicted because the DEA failed to do their job, and the government needed a scapegoat after the publicity of the opioid problems in West Virginia,” he wrote in an August 25 letter to Judge Matthew W. McFarland of the U.S. District Court for the Southern District of Ohio.

Barclay, now 75, retired from Miami-Luken in 2015. Four years later, he was charged with conspiracy to distribute a controlled substance.

The DEA and federal prosecutors said Barclay was guilty of conspiring with his employer to illegally distribute opioid pills in Indiana, Ohio, Tennessee, and West Virginia. Miami-Luken was accused of distributing oxycodone and hydrocodone pills to doctors and pharmacies “not for a legitimate medical purpose.” And Barclay—whose job involved assisting with filling out compliance paperwork and responding to DEA inquiries—was charged with failing to “maintain effective controls against diversion of controlled substances” and to “report suspicious orders to the DEA.” Essentially, the government said Barclay should have known some doctors were writing illegitimate prescriptions or that patients were abusing them and then acted to stop it.

But Barclay says he never had the authority to stop an order from shipping, label an order as suspicious, or report anything to the DEA. “Plus, for some half dozen times I requested guidance from the DEA on controlled drug issues, the DEA’s only response was ‘We can’t tell you how to run your business, it’s a business decision,’ if they responded at all,” he stated.

For years, Barclay has been fighting to clear his name—and it finally paid off. In August, the U.S. District Court for the Southern District of Ohio granted a motion to dismiss the charges against Barclay and vacate his previously entered guilty plea (made under the threat of 20 years in prison if he went to court and no prison time if he pleaded out).

The decision came after federal prosecutors moved on August 2 to “dismiss the Indictment against all remaining defendants in this case, without prejudice,” under the stipulation that they agree not to bring lawsuits against the prosecutors, the DEA, or other law enforcement agencies involved in the investigation and prosecution. It’s unclear what made the government give up on the charges, but turnover at the U.S. Attorney for the Southern District of Ohio’s office seemed to play a role, with new U.S. Attorney Kenneth Parker rejecting charges brought by his predecessor. Judge McFarland has now dismissed the charges against all defendants (one of whom died during the case).

While this story has a happy ending, Barclay still had several years of his life stolen over a desperately overzealous attempt at drug law enforcement. “I had a mugshot taken, I was fingerprinted, I was put into a holding cell, and then I was shackled like the criminals seen on TV and escorted to the courtroom,” wrote Barclay in his letter.  “This case has affected our entire family” and “taken over our lives for the last three years.”

“Never in my 75 years, as an Army veteran and a law-abiding citizen, did I ever think that this could happen in our country,” he added.

Barclay’s story is part of a larger ploy by the DEA, federal prosecutors, and state attorneys general to hold all sorts of intermediaries responsible for people’s opioid addictions. The individuals and businesses caught in this drug war deluxe scheme have wildly varying degrees of culpability. They include pharmaceutical companies, distributors, medical practices, and pharmacies. Some have been obviously guilty of malfeasance, but others are being held responsible for not anointing themselves de facto drug cops.

For instance, Walgreens was recently found liable for San Francisco’s drug problems in a civil suit. It accused the pharmacy not of filling illegitimate prescriptions or otherwise illegally distributing opioid pills but of failing to divine which doctors had prescribed too liberally or which patients might abuse their prescriptions.

As Barclay’s case shows, even random employees of companies involved in opioid pill distribution can fall into the DEA’s crosshairs. (It’s about “holding accountable anyone and everyone with criminal responsibility for the diversion of drugs,” Benjamin Glassman, U.S. attorney for the Southern District of Ohio, said in 2019.)

The whole thing smacks of authorities frantically looking for folks to blame, scapegoating any entity who came near legal opioid pills in a bid to wring money, accolades, and good press out of their prosecution as the opioid crisis raged on unabated. All the while, drug war policies—like making prescription painkillers harder to get and intensifying the crackdown on people who used them—only fueled a massive market in illegal opioids, like heroin and fentanyl, that have proven more destructive and deadly.

William J. “Bill” Hughes, Barclay’s lawyer, told the Cincinnati Enquirer this was a test case for prosecuting pharmaceutical drug distributors.

However, he explained that the companies like Miami-Luken have no access to patients, prescriptions or the doctors who wrote them. They only ship drugs to entities registered with the DEA and the DEA can monitor all shipments between distributors and pharmacies in real-time. …

Hughes said the DEA had issued a letter to Miami-Luken and other companies like it saying the companies were responsible not only for knowing what their customers were doing, but what their customers’ customers were doing. And it had no basis in law, Hughes said.

The idea that an accounts receivable manager at a wholesale drug distributor should interfere with the relationship between doctors, patients, and pharmacies and make his own determinations about the legitimacy of prescriptions is just weird. Alas, it’s the world that federal authorities seemingly want us to live in.

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‘Healthcare is increasingly a fact-free zone for politicians’

https://www.beckershospitalreview.com/hospital-management-administration/healthcare-is-increasingly-a-fact-free-zone-for-politicians.html

The majority of Americans see healthcare costs as very important to their vote in the midterm elections, which are roughly two months away. Yet healthcare is becoming more of a black box to ballot-casters and political candidates, healthcare policy analyst Paul Keckley, PhD, contends. 

“Healthcare is increasingly a fact-free zone for politicians seeking votes,” Dr. Keckley, principal of The Keckley Group, wrote in his Sept. 6 edition of The Keckley Report. His take may be especially pertinent given aggressive spending on political ads ahead of the Nov. 8 midterms, which is set to reach nearly $9.7 billion by Election Day, according to the tracking firm AdImpact, topping the record $9 billion spent in the 2020 presidential election.

Dr. Keckley reasons that facts on healthcare are increasingly inessential to political campaigns and voters by pointing to the following: 

1. Incomprehension of the U.S. healthcare system is acceptable. “Voters do not understand the U.S. system of health. Understanding the U.S. health system is not a competency required of lawmakers who govern it nor employers and consumers who use and pay for it,” writes Dr. Keckley. 

2. Voters rely on personal experiences to define U.S. healthcare. The quality of providers, insurers and medications is largely a subjective assessment, which can challenge fact and make for a tricky translation on ballots for healthcare at the state and federal levels. When it comes to providers, “‘Good hospitals’ are those that accept an individual’s insurance and are accessible; affordability matters but all are expensive,” Dr. Keckley writes. “‘Good doctors’ are those that are accessible in person and affable; all are presumed competent.” 

3. Public trust in the medical system has fallen. In 2022, 38 percent of Americans said they have a great deal or quite a lot of trust in the medical system, down from 44 percent the year prior and 51 percent in 2020, according to Gallup’s longstanding index of confidence in institutions. This runs parallel to decreasing trust in the federal government, Congress, public education and number of other public institutions. When “trusted sources are less trusted,” as Dr. Keckley put it, facts are more likely seen as negotiable. 

Find Dr. Keckley’s analysis in full here. 

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A Medical Student Realizes What It’s like to Be a Patient’s Loved One

https://www.doximity.com/articles/1ff6ff1c-5928-47d5-8fe7-6ffccf7f4afc

As I flew home two days before my mother’s hip replacement, I was quite confident. She was getting an anterior hip replacement, a fairly common orthopaedic procedure done by a well-known orthopaedic surgeon in my hometown. After an entire surgery rotation and half of an internal medicine rotation, I figured medicine had toughened me up quite a bit. After 3 a.m. wake ups, overnight call, and helping a team juggle a list of 20 patients, my job at home seemed like it would be quite straightforward: What could be so hard about waking up early, driving 30 minutes, and helping out my mother with basic tasks until neighbors could help pick up the slack?

The day of the operation, we pulled into the hospital parking lot well before the break of dawn. I was no stranger to waking up early, but this felt different. As a medical student, I would be rushing into the hospital at this time in my scrubs with a long mental checklist of tasks to complete before pre-rounding with my team at 6 a.m. When I stepped into the hospital before, my role was always defined. I quickly realized that all of my knowledge about what happens behind the scenes of a surgical team was not the least bit helpful to my usually gregarious mother who was now eerily quiet. My mother and I sat in silence in the waiting room, bathed in harsh yellow fluorescent light that seemed to give everything a tint of jaundice. I must have picked up and put down at least five different out-of-date magazines in the time we waited for my mother to be called back. I was relieved when the nurse finally came out and called out my mom’s name. When we walked back to the pre-op area, I finally saw a place that looked familiar. That comfort didn’t last long: I sat awkwardly like a lump in the corner as the anesthesiologist poked his head in and the incision site was marked and initialed. My feet felt wooden as my mom was wheeled down the hall and I was given vague directions to the patient waiting area.

I tried to curl up in the ugly wooden chairs and occupy myself by envisioning what was going on in the OR. The lack of information, however, felt overwhelming. Was the surgeon running late? Did the circulating nurse have all the tools ready?

I tried to picture my mom’s face where I had seen so many other patients lie on the operating table but I just couldn’t think about her in the same way. While I cared about all the patients I had seen on the wards, they still felt at least one step removed from me, since I was a member of their care team. During surgeries, once the drapes were aligned properly, patients’ faces disappeared and in that moment, they became no more than the body upon which the attending was operating. Cholecystectomy patients became Triangles of Calot, colostomy patients became their long winding tubes of intestine. Try as I might, I couldn’t picture my mother in the same light. I couldn’t focus on a single podcast that I had downloaded for the wait, and eventually fell asleep waiting for word from the OR on two chairs that I had put together into a makeshift bed.

Fortunately, my mother’s surgery went well and her recovery was relatively speedy. Still, caring for her immediately post-surgery was more difficult than I had expected. I had helped patients ambulate down the hallway during their stays, but I had never been awakened four times in a night in order to support my mother from her bed to the toilet. When before I could blithely write “PT/OT,” now I was experiencing just a small taste of many patients’ families’ daily lives.

On my flight back to school, I couldn’t help but think of all the dismissive comments that I had heard about “difficult families.” From the way nurses pre-warned our teams about certain rooms to walking in and immediately sensing hostility, I caught myself often being annoyed when patient families frequently questioned treatment plans or expressed frustration that their loved one had barely improved since the last visit. Didn’t they know we were doing the best we could? I found myself huffing. If only they understood how complex medicine is.

Well, I’m pretty sure that even if they did have the benefit of medical education, how could you ever blame families for their emotions running high? That feeling of powerlessness and uncertainty about the fate of a loved one, even for something medically “routine” like a common surgery, is enough to send anyone into a tailspin. I am now more amazed by how gracious and understanding most families are. As physicians, we have the privilege of doing things when patients are admitted. We get to prescribe medications, give transfusions. We get to be active participants in care. We should remember that families get to have the special agony of waiting.

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