Health Law

Measles outbreaks show legal challenges of balancing personal rights and public good

Posted on May 9, 2019



This post originally appeared on The Conversation on April 11, 2019.

The measles outbreaks continue to spread, with New York City declaring a public health emergency and requiring people in four ZIP codes to have their children vaccinated or face penalties, including a fine of US$1,000 and or imprisonment.

Since September 2018, 285 measles cases have been reported in Brooklyn and Queens, mainly in neighborhoods where ultra-Orthodox Jews have chosen to not have their children vaccinated.

The Centers for Disease Control and Prevention, said that from Jan. 1 to April 4, 2019, 465 individual cases of measles have been confirmed in 19 states. This is the second-highest number of cases since the CDC declared measles eliminated in 2000; in 2014, 667 cases occurred.

Cases have still been occurring each year, often brought into the United States from international travelers. Officials believe that to be the causeof the outbreak in Rockland County, New York, where 168 cases were reported as of April 8, 2019.

Rockland public health officials issued a ban that would keep unvaccinated children out of public places, but a judge overruled that on April 5. On April 9, county officials said they would appeal.

But there are limits to what health care providers, public health officialsand legislators can do. It is crucial to consider both the power – and the limits – of potential solutions that will provide education, medical care and protection for the public while still upholding principles of informed consent, parental decision-making and sustaining public trust.

As a professor who researches and teaches health law, public health law and medical ethics, I think it’s worth clarifying what states can or cannot legally do when responding to cases of communicable disease.

A right to refuse medical care

The law recognizes the right of an individual to refuse medical interventions. Health law has a strong history of recognizing bodily integrity: Adults can choose whether to accept or reject a proposed medical intervention, even in instances where public health authorities conclude a vaccine would benefit both the individual and society. The Supreme Court has recognized parents’ ability to direct the care and control of their children, including consenting or forgoing medical treatment for their child except in very specific circumstances.

In the 1905 Jacobson v. Massachusetts case, the Supreme Court upheld a state law delegating power to local health officials mandating that adults receive one smallpox vaccine in the midst of an epidemic or pay a fine (about $130 today). Under the concept of police power, states have a duty to enact laws that promote the health, safety and welfare of its residents. Public health authorities may offer vaccines as a method of prevention, but medical professionals, public health authorities and even courts may not legally compel a person to submit to a vaccine.

The Jacobson decision also set forth limits on police power, yet subsequent cases addressing vaccine mandates discarded these requirements, extending multiple vaccine mandates to school attendance for disease not in circulation and in the absence of an epidemic.

Deferring to respected scientific consensus as a means to justify forced medical interventions in the name of individual benefit and the public good has historically resulted in some of the most egregious constitutional and human rights atrocities in the U.S. The mass forcible sterilization during the eugenics movement is but one example.

The history of science and medicine further demonstrates the fallibility of commonly accepted medical knowledge, such as when Bayer introduced heroin as a safe, non-addictive substitute for morphine, or physicians prescribed Bendectin and thalidomide to relieve nausea, only to find these medications resulted in babies born with severe birth defects.

Public good, personal rights

The law is also quite clear that public health authorities and law enforcement may place restrictions on a person’s individual liberty – including religious liberty – in situations where a person’s actions pose a direct, immediate and compelling harm to others, such as using venomous snakes in religious worship or asserting a nonexistent “right” to use an illegal substance such as marijuana when operating a motor vehicle.

In public health law relating to communicable disease, this constitutes a very specific standard: A person must have a present disease, and this person’s actions must pose a direct threat to others.

For example, health officials may seek a quarantine order or civil commitment for a person with active tuberculosis who continues to frequent highly populated public spaces until the person is no longer contagious.

Even in such a case, health authorities can offer treatment and limit a person’s movement to prevent infecting others, but the law does not permit forcibly medicating a competent person against his will.

Accordingly, legal precedent does not support quarantining vast geographic areas of healthy persons who have not been exposed to the communicable illness, but would support tailored voluntary isolation and quarantine of persons who have been exposed to, or currently have, the illness.

What health officials can do to protect children

The CDC classifies vaccines as one of the top 10 public health achievements. The vast majority (about 98%) of parents across the U.S. as a whole comply with the state law mandated schedule of vaccines for their children.

Vaccines, like any other FDA-approved product such as a prescription drug or medical device, carry a set of risks and benefits. These calculations vary depending on the vaccine, its efficacy, safety, potential side effects, the severity of the illness the vaccine aims to protect against, and the individual to whom it is administered.

Vaccine science and practice similarly evolved with historical mistakes (the Cutter incident) and ongoing disputes about risks and benefits for individual vaccines like flu and anthrax.

To promote vaccination for children, health officials may offer educational campaigns and set up free clinics for parents to bring their children. State laws may also mandate vaccines as a condition for school attendance, or require excluding unvaccinated children during an active outbreak at their school.

However, if states offer a religious or nonmedical exemption, courts have been clear that health officials and school officials do not have discretion to require the child’s parent to identify with an organized religion or reject the sincerity of the parent’s beliefs because this violates the First Amendment.

Harm to community

Public health professionals worry that parents who forgo vaccination are placing their child and the community at risk. Some have advocated that the state should step in with coercive measures such as eliminating any nonmedical exemptions for all children or intervene by force, such as classifying parents’ decision as child neglect or seeking a court order to vaccinate the child.

In my opinion, these strategies rely on a distortion of legal precedent, dismiss longstanding authority of parents to make decisions for their children, and threaten to undermine an already fractured public trust.

Cases that uphold state intervention to protect a child by compelling medical treatment generally require that the child has an illness, the illness is severe and life-threatening, and the risks and benefits of intervening are assessed.

This requires medical professionals and health officials to maintain precision in distinguishing whether the parents are deciding to forgo recommended vaccines, or whether they are refusing medical care for a critically ill child. Indeed, a recent case in Chandler, Arizona, demonstrated how a climate of coercion and force may result in parental fear and refusal to constructively engage with state officials for even an ill child.

State public health officials have the duty to protect residents from illness and communicable disease, but these strategies must fall within appropriate legal parameters. Dismissing these legal boundaries or justifying unnecessary force not only undermines fundamental liberties, but in my view fuels parental and community distrust of health officials and sets back the ultimate goals of protecting the public.

This post originally appeared on The Conversation on April 11, 2019.

The measles outbreaks continue to spread, with New York City declaring a public health emergency and requiring people in four ZIP codes to have their children vaccinated or face penalties, including a fine of US$1,000 and or imprisonment.

Since September 2018, 285 measles cases have been reported in Brooklyn and Queens, mainly in neighborhoods where ultra-Orthodox Jews have chosen to not have their children vaccinated.

The Centers for Disease Control and Prevention, said that from Jan. 1 to April 4, 2019, 465 individual cases of measles have been confirmed in 19 states. This is the second-highest number of cases since the CDC declared measles eliminated in 2000; in 2014, 667 cases occurred.

Cases have still been occurring each year, often brought into the United States from international travelers. Officials believe that to be the causeof the outbreak in Rockland County, New York, where 168 cases were reported as of April 8, 2019.

Rockland public health officials issued a ban that would keep unvaccinated children out of public places, but a judge overruled that on April 5. On April 9, county officials said they would appeal.

But there are limits to what health care providers, public health officialsand legislators can do. It is crucial to consider both the power – and the limits – of potential solutions that will provide education, medical care and protection for the public while still upholding principles of informed consent, parental decision-making and sustaining public trust.

As a professor who researches and teaches health law, public health law and medical ethics, I think it’s worth clarifying what states can or cannot legally do when responding to cases of communicable disease.

A right to refuse medical care

The law recognizes the right of an individual to refuse medical interventions. Health law has a strong history of recognizing bodily integrity: Adults can choose whether to accept or reject a proposed medical intervention, even in instances where public health authorities conclude a vaccine would benefit both the individual and society. The Supreme Court has recognized parents’ ability to direct the care and control of their children, including consenting or forgoing medical treatment for their child except in very specific circumstances.

In the 1905 Jacobson v. Massachusetts case, the Supreme Court upheld a state law delegating power to local health officials mandating that adults receive one smallpox vaccine in the midst of an epidemic or pay a fine (about $130 today). Under the concept of police power, states have a duty to enact laws that promote the health, safety and welfare of its residents. Public health authorities may offer vaccines as a method of prevention, but medical professionals, public health authorities and even courts may not legally compel a person to submit to a vaccine.

The Jacobson decision also set forth limits on police power, yet subsequent cases addressing vaccine mandates discarded these requirements, extending multiple vaccine mandates to school attendance for disease not in circulation and in the absence of an epidemic.

Deferring to respected scientific consensus as a means to justify forced medical interventions in the name of individual benefit and the public good has historically resulted in some of the most egregious constitutional and human rights atrocities in the U.S. The mass forcible sterilization during the eugenics movement is but one example.

The history of science and medicine further demonstrates the fallibility of commonly accepted medical knowledge, such as when Bayer introduced heroin as a safe, non-addictive substitute for morphine, or physicians prescribed Bendectin and thalidomide to relieve nausea, only to find these medications resulted in babies born with severe birth defects.

Public good, personal rights

The law is also quite clear that public health authorities and law enforcement may place restrictions on a person’s individual liberty – including religious liberty – in situations where a person’s actions pose a direct, immediate and compelling harm to others, such as using venomous snakes in religious worship or asserting a nonexistent “right” to use an illegal substance such as marijuana when operating a motor vehicle.

In public health law relating to communicable disease, this constitutes a very specific standard: A person must have a present disease, and this person’s actions must pose a direct threat to others.

For example, health officials may seek a quarantine order or civil commitment for a person with active tuberculosis who continues to frequent highly populated public spaces until the person is no longer contagious.

Even in such a case, health authorities can offer treatment and limit a person’s movement to prevent infecting others, but the law does not permit forcibly medicating a competent person against his will.

Accordingly, legal precedent does not support quarantining vast geographic areas of healthy persons who have not been exposed to the communicable illness, but would support tailored voluntary isolation and quarantine of persons who have been exposed to, or currently have, the illness.

What health officials can do to protect children

The CDC classifies vaccines as one of the top 10 public health achievements. The vast majority (about 98%) of parents across the U.S. as a whole comply with the state law mandated schedule of vaccines for their children.

Vaccines, like any other FDA-approved product such as a prescription drug or medical device, carry a set of risks and benefits. These calculations vary depending on the vaccine, its efficacy, safety, potential side effects, the severity of the illness the vaccine aims to protect against, and the individual to whom it is administered.

Vaccine science and practice similarly evolved with historical mistakes (the Cutter incident) and ongoing disputes about risks and benefits for individual vaccines like flu and anthrax.

To promote vaccination for children, health officials may offer educational campaigns and set up free clinics for parents to bring their children. State laws may also mandate vaccines as a condition for school attendance, or require excluding unvaccinated children during an active outbreak at their school.

However, if states offer a religious or nonmedical exemption, courts have been clear that health officials and school officials do not have discretion to require the child’s parent to identify with an organized religion or reject the sincerity of the parent’s beliefs because this violates the First Amendment.

Harm to community

Public health professionals worry that parents who forgo vaccination are placing their child and the community at risk. Some have advocated that the state should step in with coercive measures such as eliminating any nonmedical exemptions for all children or intervene by force, such as classifying parents’ decision as child neglect or seeking a court order to vaccinate the child.

In my opinion, these strategies rely on a distortion of legal precedent, dismiss longstanding authority of parents to make decisions for their children, and threaten to undermine an already fractured public trust.

Cases that uphold state intervention to protect a child by compelling medical treatment generally require that the child has an illness, the illness is severe and life-threatening, and the risks and benefits of intervening are assessed.

This requires medical professionals and health officials to maintain precision in distinguishing whether the parents are deciding to forgo recommended vaccines, or whether they are refusing medical care for a critically ill child. Indeed, a recent case in Chandler, Arizona, demonstrated how a climate of coercion and force may result in parental fear and refusal to constructively engage with state officials for even an ill child.

State public health officials have the duty to protect residents from illness and communicable disease, but these strategies must fall within appropriate legal parameters. Dismissing these legal boundaries or justifying unnecessary force not only undermines fundamental liberties, but in my view fuels parental and community distrust of health officials and sets back the ultimate goals of protecting the public.



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Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment

Posted on Mar 8, 2016

In November 2015, FDA published a startling report, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests, which enumerated serious concerns with the current framework it uses to oversee laboratory developed tests (LDTs). LDTs are tests used by physicians to diagnose disease, predict risk of disease, and guide critical therapy decisions. This report revealed grave shortcomings in test accuracy, reliability, and ability to provide clinically meaningful information to physicians and patients in a number different tests, ranging from tests to determine personalized oncology treatment, to fetal genetic tests, to tests to predict heart disease risk and pharmacogenetic response to statin therapy. The report listed that testing inaccuracies resulted in false positives, where patients were informed they had a condition they did not have, producing psychological distress and overtreatment. Other tests produced false negatives, where patient illnesses went undetected and the patient failed to receive appropriate and timely treatment.

Under the FD&C Act of 1976, FDA has the authority to regulate LDTs as medical devices, subject to registration, pre-market review, and adverse reporting to ensure the test’s analytic and clinical validity: that product is properly designed, manufactured consistently, and that the test is accurate at what it purports to predict. Up to this juncture, FDA has enforced these provisions with discretion and has not subjected certain LDTs to these regulatory requirements, so FDA has not assessed the analytic and clinical validity of certain tests that are currently on the market and relied upon by physicians. Indeed, FDA admitted concern that physicians and patients are using these LDTs without being aware that some are not FDA approved and that the FDA has not evaluated their analytic and clinical validity.

In 2014, FDA promulgated Draft Guidance Framework for Regulatory Oversight of Laboratory Developed Tests designed to phase in implementation of a more stringent regulatory approval process in the next several years. However, these classifications and requirements are not yet in place, and numerous faulty LDT tests are on the market being actively used and relied upon by physicians and patients.

Oncotype Dx and Prolaris, two LDTs recommended by the National Comprehensive Cancer Network and used by oncologists to aid in treatment protocol for breast and prostate cancer, respectively, were listed in FDA’s report. Both cancers are diseases of high visibility and frequency- almost certainly affecting someone we personally know. In the United States annually, 231,840 women are diagnosed with invasive breast cancer, and 220,800 men are diagnosed with prostate cancer. The aim of such tests lays at the heart of precision medicine– we want more effective strategies that account for individual variability that allows physicians to predict more accurately which treatment strategies for a particular disease will work.

Increasing the effectiveness of treatment, however, assumes that the oncologist’s testing tools are accurate.

Oncotype Dx, manufactured by Genomic Health, assesses 21 genes expressed in a patient’s tumor and a RNA based HER2 test, designed to detect whether the patient’s cancer is HER2 positive or negative. Genomic Health designed the HER2 RT-PCR portion of the test to provide physicians and patients personalized treatment based on this tumor profile with pharmacogenomic implications. Physicians likely believe in the test’s accuracy and reliability- both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) incorporate Oncotype Dx into their treatment guidelines, and the highly respected New England Journal of Medicine recently published a prospective validation of the HER2 RT-PCR component.

Despite the sterling support from the medical community, the HER2 RT-PCR component is not included in ASCO’s guidelines as a test to specifically decide whether certain drugs such as Herceptin, a drug commonly used to treat HER2 positive tumors, is indicated. FDA’s report evaluated evidence set forth by a group of independent pathologists who found discrepancies in test specificity and found the test produced false negatives, missing the diagnosis of patients with HER2 positive tumors and misinforming subsequent treatment decisions. Specificity of HER2 status is imperative to guiding appropriate treatment- patients whose tumor is HER2 positive may elect to add Herceptin to the treatment protocol based on its targeted indication for treating HER2 positive cases. Alternatively, potential overtreatment of patients with Herceptin is not only ineffective, but raises significant risks including cardiomyopathy, pulmonary toxicity, and death.

FDA’s report also profiled Prolaris, manufactured by Myriad Genetics, a prostate cancer biomarker test that examines 46 genes associated with the proliferation of prostate cancer cells and prognosticates the risk of cancer progression and survival rate. FDA assessed that there was insufficient evidence for Myriad Genetics’ marketing claims and questioned the test’s ability to meaningfully improve clinical outcomes, concluding that physicians relying on this test may over or undertreat patients accordingly. This is particular disconcerting because physicians do in practice rely on the result of this test, one study showing it impacted 65% of physicians’ treatment plans. The ramifications of overtreatment of prostate cancer are also considerable. Patients who elect to undergo a radical prostatectomy face a 70% risk of impotence, 25% risk of complete incontinence, and loss of fertility.

The accuracy and validity of such LDTs constitutes a critical key in both physicians’ clinical judgment and informed decision-making by patients when diagnosing illness and deciphering appropriate corresponding care. It is imperative that both physicians and patients be aware that these tests, as well as select other widely relied upon molecular diagnostic tests, are not currently FDA approved to ensure their accuracy and reliability despite any evidence set forth by the corporation offering the LDT and rely upon them with caution.

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