Filed under: Bioethics, Food and Drug Administration (FDA), Genetics
Cross 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.
Consent to Arbitration is Not a Health Care Decision: South Carolina Supreme Court Invalidates Nursing Home Arbitration Agreement Executed by Health Care Surrogate
Filed under: Bioethics, Elder Issues, Litigation and Liability
Nursing homes commonly include arbitration agreements in their admissions materials. These agreements require residents to bring any disputes against the facility to a professional arbitrator, as opposed to a court. Many advocates maintain that arbitration disadvantages nursing home residents, particularly in malpractice cases, and that their use in the admissions process takes advantage of a vulnerable population. Nonetheless, efforts to challenge such agreements have failed in light of the Supreme Court’s decision in AT&T Mobility LLC v. Concepcion, which held that the federal Arbitration Act (FAA) preempts state laws that “prohibit outright the arbitration of a particular type of claim.” Following Concepcion, the Supreme Court unanimously overturned a decision by the West Virginia Supreme Court that had found that nursing home arbitration agreements are inherently unconscionable, concluding that “a categorical rule prohibiting arbitration of a particular type of claim … is contrary to the terms and coverage of the FAA.”
Yet, as demonstrated by the South Carolina Supreme Court’s recent decision in Coleman v. Mariner Health Care, Inc., there is still one situation in which nursing home arbitration agreements are open to challenge: when the agreements are signed by a third party appointed to make health care decisions for the patient by operation of law.
Coleman involved a wrongful death suit brought by the surviving sister of a nursing home resident who had been admitted to the facility after already having lost decision-making capacity. The resident’s sister – the plaintiff in the wrongful death lawsuit – signed the admissions forms based on the authority granted to her under South Carolina’s Adult Health Care Consent Act. One of the forms the sister signed was an arbitration agreement.
Denying the nursing home’s motion to compel arbitration, the court concluded that the arbitration agreement was not valid because it exceeded the scope of the sister’s authority under the Adult Health Care Consent Act. According to the Court, the statute specifically limited surrogates’ authority to making health care decisions and associated financial arrangements. Because an agreement to arbitrate was not a health care or related financial decision, it exceeded the scope of the sister’s authority.
The dissent argued that the majority’s decision conflicted with Concepcion because it had the effect of treating a specific type of arbitration agreement – i.e., one entered into by a surrogate decision-maker – as inherently unenforceable. In response, the majority asserted that it was simply recognizing the legislature’s intent to limit the scope of surrogates’ decision-making authority to narrowly defined areas. It other words, the rationale for the majority’s decision was not that arbitration agreements entered into by surrogates are unenforceable because they are specifically disfavored; instead, it was that surrogates may not enter into any agreements that do not directly deal with “health care decisions” or the associated financial costs.
Of course, the majority’s narrow interpretation of the Adult Health Care Consent Act is not the only possible way to read the statute. If the surrogate has the authority to consent to an individual’s admission to a facility, it does not seem like much of a stretch to conclude that this authority implicitly includes all decisions reasonably related to the admission – including those related to how any subsequent disputes with the facility will be resolved. It is true that, in this case, the arbitration agreement was a “separate” document that “concerned neither health care nor payment,” but it could just as easily have been included as a term in the underlying contract for admission. It seems hyper-technical to say that the surrogate’s authority to consent to arbitration depends on whether the agreement is contained in the admissions agreement itself as opposed to a stand-alone document.
Yet, even if the court could have interpreted the scope of the surrogate’s authority more broadly, its decision remains consistent with Concepcion because it does not amount to “a categorical rule prohibiting arbitration of a particular type of claim.” Instead, the court was simply applying the general legal rule that arbitration agreements, like any agreements, must be entered into by an individual with the legal capacity to contract. At least in South Carolina, this means that nursing homes can no longer rely on arbitration agreements for residents who are admitted based on surrogate consent.
Filed under: Bioethics, Clinical Research, Drugs & Devices, Intellectual Property, Privacy, Transparency
We are very pleased to welcome Dana Darst, a Master of Science in Jurisprudence candidate in Health Law and Intellectual Property Law here at Seton Hall, to the blog today.
In recent years, biopharmaceutical research and development organizations have established partnerships with academic institutions and start-up biotechnology companies to drive external innovation, complementary to their own in-house advancements in life sciences. Companies such as Pfizer, Johnson & Johnson and Bayer have opened innovation centers of excellence globally, in start-up biotechnology- and academia-rich hubs such as Boston, San Francisco and Shanghai, as part of an effort to accelerate new product development and commercialization.
More recently, the industry has commenced driving innovation via sharing clinical study protocols and patient-level treatment information at the request of qualified external researchers. An objective of this undertaking is to enhance public health via data transparency. This may increase efficiencies by helping researchers avoid unnecessary use of resources for new studies, when relevant clinical outcomes data exists from previous studies. In addition, it may reduce risks for future research subjects.
On January 30, 2014, Janssen Research and Development, LLC (a Johnson & Johnson subsidiary) and The Yale School of Medicine’s Open Data Access Project (YODA) announced a pioneering partnership model for sharing clinical trial data. Under their agreement, YODA will review all clinical trial data requests on Janssen’s behalf, as an independent third-party. In a press release, J&J’s Chief Medical Officer, Joanne Waldstreicher, MD, stated that their collaboration will “[e]nsure that each and every request for access to [their] pharmaceutical clinical data is reviewed objectively and independently.” She further stated that “[t]his represents a new standard for responsible, independent clinical data sharing.” Other biopharmaceutical companies sharing clinical trial data do so by reviewing data requests directly as they are received from qualified external researchers. Also, some have voluntarily adopted the Principles For Responsible Clinical Trial Data Sharing, jointly published by the Pharmaceutical Research Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA), and implemented on January 1, 2014.
Under the PhRMA-EFPIA guidelines, “Biopharmaceutical companies are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with the following Principles”: (1) Safeguarding the privacy of patients, (2) Respecting the integrity of national regulatory systems, and (3) Maintaining incentives for biomedical research. The guidelines provide a framework for life sciences companies to request patient-level data and study protocols. Additionally, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have proposed policies to increase transparency of clinical trial data. As Carl Coleman discussed here, both agencies have addressed the importance of patient and study de-identification.
So, what potential implications might clinical trial data sharing have on biopharmaceutical innovation? The Institute of Medicine (IOM) et al. recently published a report, Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements and Activities, as a framework for further discussion and public comment on how data from clinical trials might best be shared. It provides four guiding principles for consideration which include (1) respecting individual participants, (2) maximizing benefits to participants in clinical trials and to society, while minimizing harm, (3) increasing public trust in clinical trials, and (4) carrying out sharing of clinical trial data in a manner that enhances fairness.
The report does not provide conclusions or recommendations, which are expected to be developed and published approximately 17-months from the project’s start in August 2013. However, the IOM Committee, which includes a diverse group of representatives from government, charitable foundations, academia, healthcare institutions and private industry, has posed several potential implications of trial data sharing for consideration.
From a societal perspective, sharing clinical trial data could increase accuracy, reduce bias and provide a more comprehensive picture of a drug’s benefits and risks. In addition, data sharing could potentially improve efficiency and safety of the clinical research process. For example, it could reduce potential duplication of efforts and costs of future studies, and help to avoid unnecessary harm to patients. Furthermore, it may provide additional information to healthcare professionals and patients that can be utilized to make better informed decisions.
Alternatively, data sharing could lead to invasions of patient privacy or breaches of confidentiality, which may ultimately harm participants, either socially or economically. Moreover, it could reduce incentives for study sponsors to invest their limited resources (e.g. time, budget, FTEs) on additional trials, which could ultimately inhibit innovation. As the IOM Committee explains:
For example, data sharing might allow confidential commercial information (CCI) to be discerned from the data. Competitors might use shared data to seek regulatory approval of competing products in countries that do not recognize data exclusivity periods or that do not grant patents for certain types of research.
Sharing clinical study protocols and patient-level trial data could have benefits for society and healthcare, which outweigh the risks. The IOM is planning to include an analysis of risks and benefits in their final report. As academic, life sciences and start-up biotech entities increasingly share industry-driven trial data, a prudential approach should be taken to protect the confidentiality and intellectual property of all stakeholders involved. Specifically, data should be adequately redacted prior to disclosure to eliminate confidential information—as recommended by the EMA and U.S. FDA. Biopharmaceutical Innovation is driven by authors and inventors that rely on exclusive, protected rights granted for limited times. As the IOM committee works toward establishing guidelines, adherence to their guiding principles to address these protected rights will be vital.
To obtain additional information or provide public comments on the IOM project, visit their website at: http://www8.nationalacademies.org/cp/projectview.aspx?key=49578.
The Internet, Privacy, and Public Health: How Social Media and Big Data are Changing the Landscape of Surveillance and Research
Online social networks have potential to change the nature, speed, and scope of public health surveillance and research by offering a real-time stream of user-generated updates from millions of people around the world. In recent years, systems using informal data mined from social media sources have been credited with reducing the time it takes to detect an emerging outbreak, preventing governments from suppressing outbreak information, facilitating public health responses, and contributing to health risk behavior research in a quick and cost-efficient manner.
Despite the inherent public nature of social media, there are many ethical implications inherent in the systematic acquisition of personal information, especially that pertaining to health. Concerns surrounding social network data analysis include issues of privacy, data quality, public panic, autonomy, access, and informed consent. While online social network data analysis holds great promise, it is essential that this valuable data be systematically harnessed in compliance with the law and ethical principles to yield population-level health benefits.
Advancements in information and communication technologies distort the boundaries between what is public and what is private. Users of online social networks often share identifiable information about themselves, including their full names, birthdates, email addresses, GPS coordinates, and job titles. By providing researchers with rich, ready-made data sets, social media is incentivizing researchers to develop innovative methods to search the Internet for health-related information. The mining and mapping of social networks have become a common practice, from market research to medical studies. However, it is important then to consider what obligations researchers and public health officials have in meeting their online subjects’ expectations of privacy.
The Code of Federal Regulations governing human subject research, 45 C.F.R. § 46.102, defines private information as individually identifiable information about behavior “that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.”
While mining publicly available data from open sources is within the letter of the law, it raises a number of ethical issues. Some might argue it seems unreasonable that a public posting on a public site can hold an expectation of privacy. However, privacy can conceptually be considered to be an individual’s right to determine what information one would like to share with others and the ability to control when others can access that information. While the practice of data mining is growing, many social media users are unaware of how public their data truly is.
Researchers must take into consideration the level of sensitivity of the information detected, such as stigmatized health conditions. Recent studies have shown that the Internet is used more often to get health information by patients with stigmatized conditions, such as mental disorders and sexually transmitted diseases. The misuse of such data collected from the Internet by researchers can lead to stigma, discrimination, and discomfort of the subject. With no national standard, researchers and bioethicists are left to grapple with the issue of determining what situations render it permissible to turn unsuspecting individuals into a research subjects without notification or informed consent. Historically, advancements in bioethics standards have been reactionary to human subject abuses. It is vital to resist this reactionary approach to the lack of oversight in internet research and take a proactive stance to develop acceptable standard operating procedures for the use of big data sets culled from online social network websites before foreseeable abuses occur.
Privacy concerns notwithstanding, the potential societal benefit of digital epidemiology remains clear. The use of social media has the capacity to transform disease surveillance and change how healthcare workers respond to public health emergencies. As public health threats become increasingly complex, trade-offs must be made to ensure the collective benefits of population health warrant infringement on individual rights, while balancing competing ethical, health, economic, and legal concerns. Public health researchers must work together with policy makers, medical professionals, and bioethicists to develop unambiguous ethical guidelines to answer to challenges stemming from today’s technological advances and changing communications structure.
For more on this topic, visit http://ieet.org/index.php/IEET/more/hanrahan20131205.
Filed under: Bioethics, Drugs & Devices, Food and Drug Administration (FDA)
This month marks the effective date of new joint Principles for Responsible Clinical Trial Data Sharing issued by the European Federation of Pharmaceutical Industries and Manufacturers (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The Principles commit the organizations’ members to “sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials” of approved medications.
The Principles were developed in response to growing concerns about the difficulty of evaluating manufacturers’ safety and efficacy claims without access to the underlying data from clinical trials. For example, last year, following an intensive campaign by scientists skeptical about the claimed benefits of the antiviral medication Tamiflu, the company Roche agreed to provide access to clinical study reports on all of its Tamiflu studies. Under the new Principles, companies will presumptively be expected to comply with similar requests in the future.
Yet, the Principles do not go nearly as far as some transparency advocates might have hoped. First, all requests for disclosure will be evaluated by scientific review boards made up of experts not employed by the company, who will be charged with assessing the “qualifications of the requestor and the legitimacy of the research purpose.” Second, in order to avoid “free-riding or degradation of incentives for companies to invest in biomedical research,” the statement provides that companies have the right “to refuse to share proprietary information with their competitors.”
In a draft rule circulated last summer, the European Medicines Agency proposed a more extensive system of data sharing under which de-identified research data would be published proactively, without the need for a request, as soon as a positive or negative decision on a marketing application has been made or the application has been withdrawn. The proposal would also allow for the sharing of documents containing personal information, but only if the requestor is a natural or legal person established in the European Union and agrees to enter into a data-sharing agreement containing limits on the use and disclosure of the data.
The US FDA has also entered into the discussion, although far more cautiously than its European counterpart. In 2013, it issued a request for public comments on a proposal to make available data that is not only “de-identified” but also “masked,” a term defined to mean “data with information removed that could link it to a specific product or application.” Strategies to mask data could include “making available certain data from a random sample or appropriately chosen subset of subjects, restricting the data fields made available or pooling data where possible from studies of multiple members of a product class, without identifying the specific product.”
As European and American regulators consider these proposals, it will be important to monitor how companies respond to requests for disclosure made pursuant to the voluntary EFPIA-PhRMA policy. If a voluntary disclosure system does not appear to be resulting in the free flow of scientific information, regulators may conclude that the only alternative is to implement a mandatory approach.