Direct to Consumer Genetic Testing and the Over-Production of Genetic Information

bernstein-gaia-lgCross Posted at HealthLawProf Blog

23andMe, the Internet genetic testing company, which offered genetic testing for health conditions and ancestry, has received extensive publicity in recent months. In November 2013, the FDA ordered 23andMe to stop marketing its health-related genetic test results to customers because their product is a “device”, which requires FDA approval. In its letter to 23andMe the FDA focused on the harms of consumers’ interpretation of genetic test results without the appropriate medical guidance.

And for sure, consumers’ independent interpretation of genetic results is potentially harmful. But, another important concern not addressed by the FDA is the need to regulate and constrain the production of genetic information in the first place – at the time that a consumer decides which tests to take. Direct to consumer genetic testing companies, like 23andMe, usually offers a battery of multiple tests that the consumer purchases without careful selection of what information is desirable to her. And, although genetic information can help improve and control health outcomes, not all genetic information is made equal and not all tests results are similarly desirable for all people. In my essay Direct to Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, I discuss the problem of indiscriminate production of genetic information and argue for the need for a medical gatekeeper not just for the interpretation of genetic test results but earlier on to guide consumers through the selection of tests.

The guidance of a medical practitioner (particularly a genetic counselor) at the test selection stage is important to avoid the production of genetic information that is unsuitable for the specific person who wants to undergo testing. First, some people may prefer not to know certain genetic information about themselves because there are no effective preventive measures, and they do not want to live with the knowledge that they are likely to incur a certain genetic disease. For example, currently, the most effective prevention for breast cancer is a mastectomy. Some women would welcome the information and the ability to prevent the disease. But, others may not view this as a preventive measure they can endure and would prefer not to undergo a genetic test for the breast cancer genetic mutations. Second, some genetic tests convey little information. Certain positive genetic test results indicate only a slightly higher probability of incurring the disease than the likelihood in the general population. Finally, some genetic tests may lack solid scientific validity, whether due to the state of the science or the effect of many mutations and environment factors that act in conjunction. For all these reasons, catering the selection of genetic information to the person testing can be as important as regulating the interpretation of the results stage.

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Health Law Outlook: Ending Philosophical Exemptions for Mandatory Vaccinations

April 16, 2014 by · Leave a Comment
Filed under: Health Law Outlook 

Adino BarbaritoBy Adino Barbarito

Adino (“A.J.”) Barbarito is a first year student at Seton Hall University School of Law who is interested in public health policy and litigation, as well as skeptical analysis and philosophy.  He plans to participate in the Ronald Riccio Moot Court Competition and to pursue studies in health law and litigation. This post is part of Volume VII, Issue 2 of Health Law Outlook, which is written and edited by student members of Seton Hall Law’s Health Law Forum.  Previous Health Law Outlook issues can be found here.

Mandatory vaccination, as a matter of public policy, is overwhelmingly accepted within the United States as a prerequisite for children seeking a public education. Vaccination continues to be upheld by the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts,1 and is considered established law. Unfortunately, exemptions to mandatory vaccination remain in effect in 48 states, based upon religious—and in some cases, philosophical—objections. While medical exemptions serve a legitimate interest, other opinion-based exemptions threaten the policy on which mandatory vaccinations are based. States that allow such exemptions should cease the practice. Furthermore, parents should pursue the possibility of tort liability against other parents who subject children to harmful diseases with their decision not to immunize their own children.

The Jacobson court recognized that the majority of the medical community, the citizens of the State, and the Massachusetts legislature all accepted that vaccines provide a necessary benefit. Since the state had a duty to protect its citizens’ welfare, it was within its rights to pass a law compelling them to be immunized, even if immunization was unattractive to a few:

. . . In every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.2

While no municipalities are currently under the threat of smallpox, they should still consider diseases like pertussis, polio, and measles—diseases that stand to threaten communities—as “great dangers.”3 Jacobson ruled that Massachusetts could compel its citizens to receive smallpox vaccinations, and that such compulsion was constitutionally justified under the police power afforded the states.4 In so ruling, the Supreme Court stated:

We are not prepared to hold that a minority, residing or remaining in any city or town where smallpox is prevalent, and enjoying the general protection afforded by an organized local government, may thus defy the will of its constituted authorities, acting in good faith for all, under the legislative sanction of the state.5

The Court was not prepared to let the whims of a minority refute laws that were designed for the protection of the people in good faith. The Court recognized that the mandatory smallpox vaccinations were for the benefit of the entire community, including those who may oppose them. Had the immunizations been designed to oppress the opposing minority, the Court may have decided differently.

What the Supreme Court did not do in Jacobson was prevent states from enacting statutes exempting certain individuals from vaccination. Forty-eight states have enacted statutes exempting individuals from vaccination for religious reasons. In addition, nineteen states have statutes which also exempt individuals from vaccination for “philosophical” reasons. While philosophical reasons vary by state, the most common exemptions allow a very broad array of reasons that can be deemed “philosophical.” As a result, a parent in most of these states can simply choose a “philosophical exemption” without stating any actual reason.6 Obviously no child should be compelled to receive vaccinations if she or she is predisposed to health risks as a result. It is recklessly irresponsible, however, for states to allow exemptions for any reason aside from health risks, when those exemptions create a public health danger and subject all unvaccinated children to easily preventable diseases.

It is well established that a parent may not forego lifesaving medical treatment while substituting prayer or other religious means of treatment.7 Courts have time and again recognized the fact that religion is no substitute for proper medical care, and that even a fervent belief in the power of prayer to heal does not excuse the parents and caretakers of children from their proper duty of care. Parents and guardians are required to submit to the expertise of medical professionals when a child is in imminent danger. It follows that, since we do not allow parents to substitute prayer for medicine, we should likewise not allow parents to substitute their religious beliefs for the proven vaccines that would prevent their child’s death.

In a series of cases leading directly back to the Jacobson holding, courts have established that there is no constitutional guarantee of religious exemption, and the Supreme Court, through their refusal to hear cases challenging compulsory vaccination, seems to believe the matter settled with Jacobson. The most current cases in vaccination address, and dismiss, free exercise claims when it comes to mandatory immunizations for children entering public school.8 With no constitutional hurdle, then, religious and philosophical exemptions rely solely on the discretion of the states, only two of which have refused to allow them.

The matter then becomes one of state policy. Unfortunately, states presently have little reason to compel vaccination against religious or philosophical arguments when the will of its voters does not reflect a desire for such compulsion. No state wants to enact a statute that defies most citizens’ expectations of free speech and free exercise without a particularly persuasive argument. Almost certainly, religious and anti-vaccination groups will oppose such a statute. It is a politically risky endeavor, which politicians would be loath to pursue without a strong public push in that direction. So how do concerned parents achieve such a push? Read more

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Monday Morning Recap: The Week (4.7.14-4.13.14) in Drug & Device Law & Policy

April 14, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. First up, the Washington Post analyzed data released this week on Medicare payments to doctors and  found “that the cost of drugs administered by doctors accounts for a growing piece of Medicare’s spending and varies widely from region to region in the United States, raising questions about whether some physicians may be misusing the pharmaceuticals. Most of the 4,000 doctors who received at least $1 million from Medicare in 2012 billed mainly for giving patients injections, infusions and other drug treatments, those records show.”

2. Eric Palmer at Fierce Pharma writes: “In case anyone missed the latest forecast, drug prices were up last year and are going to continue to grow, perhaps at double-digit rates in some cases. The outlook comes from the second pharmacy benefits management report to be released in three days, this one from CVS Caremark ($CVS) following Express Scripts’ ($ESRX) missive on Tuesday.” Palmer notes that although specialty drugs accounted for 1% of prescriptions in the United States, they “accounted for more than a quarter of total drug spending.”

3. Also making the news this week, new findings from a study by the Cochrane Collaboration that anti-influenza drugs Tamiflu and Relenza may not work as well as previously believed and may even do more harm than good.  In an article at Bloomberg News, Oliver Staley quotes one of the authors of the study who said: “’There’s no credible way these drugs could prevent a pandemic’ . . . Money spent on stockpiling ‘has been thrown down the drain.’”

4. Emily Cook and David Ivill of McDermott, Will & Emery reported on recent developments related to the 340B drug pricing program which requires pharmaceutical companies to give a discount to safety net health care providers. They write: “Entities participating in or contemplating participating in the 340B Program should remain alert to 340B Program developments in the coming months and should be prepared to implement changes to 340B Program operations as necessary to remain compliant with changing requirements.  All 340B stakeholders should carefully monitor the status of forthcoming proposed rules related to the 340B Program and be prepared to provide substantive comments to OPA during open comment periods.”

5. Finally, Ben Comer at the PharmExecBlog wrote a fascinating post (that quotes Seton Hall Law’s Dana Darst) on “Project DataSphere, the newest data transparency and collaboration project with buy-in from several top pharmas and academic medical institutions,” which currently contains data sets from the comparator arms of a number of late-stage oncology trials.  Among other things, Comer touches on the intriguing possibility that Project DataSphere will enable researchers to use “‘in silico’” comparator arms for new active trials”. He also discussed challenges associated with de-identification (a consultant to Project DataSphere has written “an informative de-identification strategy paper for organizations grappling with the legal implications of de-identification.”).  Comer concludes with a quote from Professor Peter Doshi who “says what’s often overlooked in the charge on pharma’s data vaults is the data that’s housed at FDA. ‘They singularly hold the most data across companies, across therapeutic areas, across time. EMA is releasing data, but why is FDA not similarly opening up its archives to the public?’ asks Doshi. ‘I think the status quo for them is a more comfortable place to be than a revolution in access to data.’”

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Massachusetts’ Ban on “Prescribing and Dispensing” Zohydro: The Arguments For and Against Preemption

Kate Greenwood_high res 2011 comp

Cross-Posted at Bill of Health

As Kurt Karst reported at FDA Law Blog, here, drug maker Zogenix has filed a Motion for Temporary Restraining Order and Preliminary Injunction challenging Massachusetts’ decision to “prohibit the prescribing and dispensing” of the company’s extended-release hydrocodone capsule, Zohydro ER. At a hearing on Tuesday, Judge Rya Zobel told the parties that she is likely to decide in the company’s favor. While Zogenix argues that Massachusetts’ action is unconstitutional for a number of reasons, including that it violates the dormant Commerce Clause and the Contracts Clause, Karst predicts that Judge Zobel will grant Zogenix’ motion on preemption grounds.

Zogenix argues in its Memorandum that “[t]he emergency declaration issued by Governor Patrick, and related order by the Commissioner of the Department of Public Health (DPH), purported to ban Zohydro™ ER based on safety concerns that squarely conflict with – and are therefore preempted by – FDA’s determination that Zohydro ER® is safe and effective and may be marketed and sold in the United States.”  Zogenix notes that the reason Massachusetts gave for banning Zohydro—that the drug lacks abuse-deterrence features—was expressly considered by the Food and Drug Administration during the course of the approval process.  FDA concluded that Zohydro’s benefits, in particular the fact that it contains no acetaminophen, outweighed the risks posed by its lack of such features.

Zogenix acknowledges that the Supreme Court’s decision in Wyeth v. Levine stands for the proposition that when the FDA approves the contents of a drug’s label, the agency merely establishes “a ‘floor’ upon which state tort requirements may build.” But, the company argues, “this is not a labeling case; it is a case about the safety and efficacy vel non of a drug already found to be safe and effective.”  If Massachusetts’ ban is upheld, Zogenix concludes, “Congress’s objectives to promote the public health through FDA drug approvals could be directly contravened by a potential flood of state policy disagreements.”

While Massachusetts has not yet filed papers in opposition to Zogenix motion, there are a number of strong counter arguments it could make.  First, while Zogenix emphasizes that the FDA “expressly” considered Zohydro’s lack of abuse-deterrence features, this is not an express preemption case. The federal Food, Drug, and Cosmetic Act does not expressly preempt the Massachusetts ban. Similarly, Zogenix uses the word “conflict” in its Memorandum, but this is not a case in which it would be impossible for the company to comply with both federal and state law. As the United States noted in an amicus brief submitted in the Supreme Court’s most recent FDA preemption case, Mutual Pharmaceutical v. Bartlett,

the FDCA makes FDA approval a prerequisite for, inter alia, “introduc[ing] or deliver[ing] for introduction into interstate commerce” any “new drug.” … That text does not expressly require that an approved drug be made available in any particular State or that the manufacturer be guaranteed the ability to make it so.

Finally, Zogenix argues that it was Congress’ intent that the FDA promote the public health by approving drugs for sale.  One could as easily argue that it was Congress’ intent that the FDA do so without supplanting states’ authority to regulate the practice of medicine and against a backstop of states’ longstanding power to act as necessary to avert a public health emergency. The ban on prescribing and dispensing Zohydro was just one of a number of actions Massachusetts is taking as part of Governor Deval Patrick’s declaration that the “growing opioid addiction epidemic” in the state constitutes a public health emergency.

While Massachusetts can make a strong case against preemption, its case would be even stronger were Zohydro not a newly-approved drug.  In its amicus brief in Bartlett, the United States argues that a state law tort claim founded on an allegation that a drug had a “design defect” would not be preempted if it were based on “significant new evidence” that was not before the FDA when it approved the drug at issue. Even if Judge Zobel strikes down Massachusetts’ ban on Zohydro, then, there may be room for states to act with regard to other drugs under other circumstances.

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Monday Morning Recap: The Week (3.31.14-4.6.14) in Drug & Device Law & Policy

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. This week the New York Times published the seventh part  of Elisabeth Rosenthal’s gripping series Paying Till It Hurts, this one on the increasingly-costly drugs and devices relied on by Type I diabetics.

2. At The Atlantic, Clara Ritger summarizes “[a] new report from the Centers for Disease Control and Prevention find[ing] that states don’t offer many of the Health and Human Services Department’s recommended [tobacco cessation] treatments, and the services they do cover come with co-pays, limits on the duration of use, and other barriers to access for Medicaid patients.” Ritger explains that “[a]lthough more states increased the number of [tobacco cessation] treatments covered between 2008 and 2014, more states also added barriers to accessing those treatments. That trend can be attributed, in part, to the Affordable Care Act’s requirement that state Medicaid programs cover all FDA-approved tobacco cessation medications by January 2014. Not all states used to offer that benefit, so as some added it, they also added it with restrictions.”

3. The Philadelphia Inquirer ran a story about a campaign by Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Amy Reed, an anesthesiologist, to end the use of electric tissue-cutting morcellators in gynecologic surgery. ”Power morcellation, introduced in 1993, enables tissue removal through tiny abdominal incisions, but in rare cases it can also spread a hidden uterine cancer called leiomyosarcoma. Reed, a mother of six, has become the poster woman for that awful scenario. During a minimally invasive hysterectomy in October at Brigham and Women’s Hospital in Boston, the morcellator hurled uterine tumor fragments that were implanted in her abdominal cavity. She now has stage-four leiomyosarcoma, and the hospital acknowledges the procedure likely worsened her prognosis.”

4. Sachin Jain, Michael Rosenblatt, and Jon Duke published a piece in JAMA about a partnership between the Indiana University School of Medicine’s Regenstrief Institute and Merck to conduct research on electronic clinical data from the Indiana Network for Patient Care (INPC), a health information exchange. The authors write: “Neither industry nor academia can navigate this terrain alone—nor should they. Working together, governments, health plans, academic delivery systems, electronic medical record vendors, and private sector companies have the potential to analyze data to improve care and enhance the sophistication of this research.” That said, “[r]igorous controls on how the data are used and by whom, careful and considered alignment of interests, and focused investments in long-term capability-building are important starting points for this new and expanding frontier of collaboration.”

5. Finally, at the FCPA Professor Mike Koehler discusses the Foreign Corrupt Practices Act in light of the Supreme Court’s recent campaign finance decision, McCutcheon v. FEC.  He writes: “In the end, the double standard between the meaning of corruption as it relates to ‘foreign officials’ vs. U.S. ‘officials’ matters as it undermines the legitimacy and moral authority on which the U.S. government acts.”

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