Failed TB Vaccines Raise Questions and Mistrust

Oxford University researchers have been creating and testing the MVA85A vaccine, meant to serve as a booster to the Tuberculosis (“TB”) vaccine. In the course of the research, it was discovered that the researchers falsely portrayed pre-clinical results of the booster in order to gain funding for clinical trials. The researchers misrepresented information in both applications for funding and in information given to parents whose children would receive the booster. They claimed that the booster was both safe and more effective at protecting against TB than the regular vaccine alone. The researchers also falsely claimed that the booster had been safely tested in multiple animal studies, which had never occurred. In fact, researchers at Stellenbosch University in South Africa later performed an animal study and the results did not support use of the booster as a way of increasing the effectiveness of the TB vaccine.

The misrepresentations made by the Oxford University researchers have raised questions about the safeguards in place for pre-clinical research. Unlike the extensive requirements for clinical trials, pre-clinical trials do not have to be registered with appropriate authorities, which increases the likelihood that errors and omissions go unnoticed.  Many believe that a registry should be established for pre-clinical trials to provide proper oversight and ensure that unsafe drugs do not reach the marketplace.

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Opinion: House Approves Bill that Defies Basic Standards of Medical Ethics

by Michael S. Dauber

On May 4th, 2017, the Republicans in the U.S. House of Representatives voted to pass the American Health Care Act, an Act that, if enacted into law, would repeal and replace many central elements of the Affordable Care Act, commonly known as Obamacare. The measure has received widespread criticism from many Democrats and from professional medical associations such as the American Medical Association and the American Cancer Society. Many people have questioned various parameters of the bill. This article questions it from an ethical perspective, and in particular, the potential consequences of abandoning health care protections designed under Obamacare to ensure that the most vulnerable people in society receive the care that they need.

The American Health Care Act would strip away protections that have facilitated access to care for pregnant women, patients with disabilities, patients that cannot otherwise afford health care, and patients with pre-existing conditions. While any attempt to discriminate against the sick and needy is unjustifiably wrong, the Act appears to directly target members of groups that are defined as most vulnerable and in most need of protection under most formulations of ethical practice.

For example, the Act would allow states to opt out of Obamacare requirements that prohibit insurers from charging patients with pre-existing conditions higher premiums for health insurance. It further classifies pregnant women, women who have had C-sections, and victims of domestic violence and sexual assault as patients with pre-existing conditions. It also targets elderly patients by allowing insurers to charge elderly patients up to five times as much as members of younger age brackets. Currently, under Obamacare, insurers cannot charge the elderly more than three times the amount they charge younger patients. The Act also includes plans to gradually eliminate $880 billion in Medicaid funding over the next ten years, funds that could have otherwise been utilized to extend coverage to low-income families.

In short, the Act specifically targets some of the most vulnerable members of society who might suffer immensely without health care and who may not be able to afford to pay the costs that many insurers may demand, or may be unable to pay for other essential expenses after paying their insurance premiums. Ahead of the vote in the House of Representatives, Senator Bernie Sanders called the Act “an abomination” and, in a CNN interview with Anderson Cooper, Sanders said, “thousands of Americans would die because they would no longer have access to health care.” Proponents of the Act argue that it is engineered to reduce the burdens of health care cost on the government and on insurers. Yet, the overall effect will be a higher cost for patients. Many patients will suffer and will lose their access to care because of circumstances beyond their control.

In this regard, the Act conflicts with basic principles of contemporary bioethics.  For instance, the Belmont Report (1979), as a blueprint for ethics in human subject research, stresses the importance of respect for the “dignity of persons” while ensuring protections in accordance with justice. The Belmont Report, though focused on ethics in human subject research, has become a defining document in the history of medical ethics, establishing a system in which patients must be respected and special protections must be given to members of vulnerable populations. If a patient falls into a protected class, health care providers have an ethical obligation to ensure that the patient receives the care he or she needs and that the patient is not denied care solely on the basis of disability, economic status, or prejudice against specific medical conditions.

There is an apparent conceptual link between commitment to protecting vulnerable populations in the clinical and research context and commitment to ensuring that vulnerable populations have access to care. The American Health Care Act has not yet become law. It must first obtain approval in the Senate and be signed by the President. Most recently, the Senate decided to modify the bill before voting on it and, as a result, the bill must be sent back to the House for a second vote. As the Senate prepares its own version of the bill, government officials should recognize that a policy that effectively precludes access to health care for members of vulnerable populations is unethical by virtually every principle of medical ethics.

Surrogates and Commissioning Parents Fight Over Abortion Clause in Surrogacy Contracts

A recent dispute between Melissa Cook, a California surrogate, and a commissioning father has brought to light the complexities of having abortion decision clauses in surrogacy contracts. Specifically, the enforceability of such clauses comes into question when surrogates and parents disagree on who should make decisions regarding abortion.

Melissa Cook was carrying triplets and the commissioning father wanted her to abort one of the fetuses. Cook filed a lawsuit in Los Angeles Superior Court, claiming that state surrogacy laws violated due process and equal protection under the Constitution. As an alternative resolution, Melissa Cook wishes to carry all three fetuses to term, adopt the third child and also collect her surrogacy fee. This would require the court to deem Cook’s surrogacy contract unenforceable, allowing her to breach the contract and still keep her surrogacy fee in full.

Women who agree to become a gestational surrogate enter into legally binding contracts with commissioning parents. Included in the terms of these contracts is a clause that allows the parents to make decisions about abortion.   Doctors implant multiple embryos to increase the chances of fertilization but thereby also increase the likelihood of multiple gestations. Intending parents whose surrogate carries multiple fetuses sometimes request that the surrogate abort, or “selectively reduce,” one or more of the fetuses. The surrogacy contract ensures that, in situations where termination decisions must be made, all parties are on the same page. Some surrogacy agencies take steps to match surrogates with parents who share the same views on abortion to minimize the likelihood of a conflict.

Allowing surrogacy contracts to mandate that a woman abort a fetus creates many legal questions, including who is the true parent of the fetus and who should make decisions regarding abortion. As Elizabeth Reis, a professor at City University of New York explains, what makes these questions all the more difficult is the fact that after a surrogacy contract is signed “there is no way to know how [a surrogate will] feel when [she is] pregnant and ordered to reduce.”

In Cook’s case, the fetuses legally belong to the father. However, this does not necessarily mean that the father’s wishes will be honored. No court would force Cook to abort her pregnancy. Nevertheless, even if she does not abort, under California law, the commissioning father has the right to decide what happens to the child, including having the child adopted by a third party other than Cook. This creates an inherent tension in modern surrogacy contracts which can conflict with women’s right to privacy. Even though a surrogate has a constitutional right to undergo an abortion, or to choose not to, she has no constitutional right to receive payment under the terms of a surrogacy contract. It remains unclear how such recent disputes will be resolved by the courts or how they will change surrogacy regulation, but many lawyers believe that surrogacy contracts will become much more heavily regulated as a result.


STD? No Marriage License for You!

Oklahoma State Senator Anthony Sikes recently authored a bill that would not only require screening for sexually transmitted diseases (“STD”) as a prerequisite to obtaining a marriage license, it would deny the license altogether if one partner has been diagnosed with having an STD. If enacted, Senate Bill 733, the state Department of Health will be directed to require blood tests “for the discovery of syphilis and other communicable or infectious diseases” before a marriage license can issue. Furthermore, the law will require that, in order for a marriage license to issue, both partners must provide documentation from a physician stating that they are either not “infected” or, if they are “infected,” that the disease is not “communicable” to the other partner.

Although Fox23 News reports that Senator Anthony Sikes was “not available to comment,” the executive director of Tulsa Cares, a local nonprofit organization, has already pointed out that the proposed law will only increase fears about HIV without impacting the spread of the disease.  What’s more, the law will almost certainly face challenges under patient privacy laws and the American Disabilities Act.  While it remains to be seen whether the Bill will move forward in the Oklahoma State Legislature, it raises concerns about the politicization of serious public health issues.



HIPAA: The “Toothless Tiger”

When Congress passed the Health Insurance Portability and Accountability Act (“HIPAA”) in 1996, the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) was charged with enforcing regulations intended to protect the privacy of health information.  Although the premise of HIPAA was to allow a patient to safely assume that what was said in an examination room stayed in the examination room, a recent article in The Washington Post has revealed that the enforcement of HIPPA regulations is falling short.  For example, in 2014 alone, OCR received approximately 18,000 HIPPA complaints, but only brought 6 formal actions.  Moreover, the law does not allow patients a private right of action to sue an offending health care provider and OCR has admitted that repeat offenders are not tracked.

Solutions to protecting patient and consumer health care information, in large part, do not require legislative action.  For example, OCR could use the tools already at its disposal to levy punitive damages on repeat offenders, which would incentivize businesses to protect patient data.  Furthermore, in the long run, a “whistleblower” mechanism, such as a qui tam action under the False Claims Act, could incentivize HIPPA compliance, although such an action would involve Congressional approval.


Gitenstein Thought Leadership Conference




 A Spoonful of Sugar, Ethics and Practice:

Will It Help the Medicine Go Down?


Friday, October 24, 2014 | 8 a.m.-noon

David S. Mack Hofstra Student Center | Multipurpose Room East

More info | Register

Questions? Contact Melissa Kessler at