Holly Fernandez Lynch - Bill of Health

Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

December 10, 2020December 10, 2020 Holly Fernandez Lynch Leave a comment

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

Medicine law concept. Gavel and stethoscope on book close up

Free Online Ethics Resources Available from the Perelman School of Medicine

April 2, 2020April 2, 2020 Holly Fernandez Lynch Leave a comment

By Holly Fernandez Lynch

One of the silver linings of the COVID-19 pandemic has been seeing communities come together to offer support in ways big and small. Individuals are organizing drives to collect personal protective equipment for health care workers, media outlets are making pandemic content available for free, and children’s book authors are hosting online story times to offer a brief respite for parents suddenly thrust into homeschooling.

In that same spirit, the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania is hoping to ease the burden for bioethics faculty and bioethics and health professions students who may be in search of online content as their learning experiences have moved out of the brick-and-mortar classroom. We’re offering a variety of recorded video content in clinical and research ethics at no charge through at least June 30 – with lectures from two Petrie-Flom alums, Holly Fernandez Lynch and Emily A. Largent, as well as other faculty experts.

What Should Academics Know About Lobbying Law?

January 29, 2020January 30, 2020 Holly Fernandez Lynch Leave a comment

This post was originally published on AM Rounds on January 14, 2020.

By Holly Fernandez Lynch, Alison Bateman-House, and Suzanne M. Rivera

Academics sometimes get a bad rap for being stuck in their ivory towers. But many academics realize that their expertise can be useful to policymakers and aim to make it widely available through a variety of avenues. We write op-eds, publish in policy-oriented journals, send letters to elected officials, write amicus briefs, submit comments on proposed regulations, serve on advisory committees, and offer testimony. At the current political moment, these types of public engagement and advocacy activities are particularly salient for academics doing work relevant to health and science policy, topics at the top of the national agenda.

In a recent article in Academic Medicine, we describe how academics can engage in advocacy without running afoul of legal restrictions on lobbying. Here are the top 10 things you need to know.

Image of two people shaking hands and exchanging money.

Payment, Lying, and Research Eligibility

February 4, 2019February 4, 2019 Holly Fernandez Lynch Leave a comment

Payment for research participation can raise ethical concerns and legal issues. But it can also raise scientific problems if it causes participants to lie about their eligibility or other things, like adverse events.

In our new study in JAMA Network Open, my colleagues and I wanted to see whether payment causes deception about study eligibility, and if so, whether more payment results in more deception. We found the answer to the first question was yes – but contrary to what one might expect, payment amount didn’t matter. Read More

Final Common Rule Revisions Just Published

January 18, 2017January 18, 2017 Holly Fernandez Lynch Leave a comment

By Holly Fernandez Lynch

This morning, the Federal Register posted for public inspection the final rule revising the Federal Policy for the Protection of Human Subjects (AKA “The Common Rule”). This has been a long, long road, beginning with an ANPRM in 2011 and a massive NPRM in 2015. The agencies clearly wanted to slide this in before the administration change on Friday, but substantial uncertainty remains.

I’ve copied the preamble’s articulation of key changes – and key proposals that have been dropped – below the fold. But I want to briefly address the “what now?” question. The incoming Trump administration will have its hands full with ACA “repeal and something,” so it’s hard to imagine this regulatory change will be high on the priority list, especially with some of the most worrisome proposals having been nixed already. But the Congressional Review Act provides Congress a streamlined process to eliminate new agency rules. Under the Act, agencies must notify Congress of new regulations, triggering a 60 legislative day review period in which Congress can pass a resolution of disapproval for presidential signature (or veto). So that’s a possibility here.

In addition, two bills have passed the House that could impact these regulations. First, the Midnight Rules Relief Act would amend the Congressional Review Act to allow Congress to disapprove multiple rules at once. In other words, Congress could pass a resolution of disapproval of ALL regulations that had been recently passed to get rid of them all in one fell swoop without individual consideration. Second, the REINS (Regulations from the Executive in Need of Scrutiny) Act, if passed, would require that “major” rules get a joint resolution of Congressional approval within 70 session days to take effect – “major” is defined as having an annual impact of $100M or more, a major increase in costs, or significant adverse effects on innovation.

Point being, don’t get too comfortable with the new rule just yet. Key changes – and things that are staying the same – are listed below (from the Fed. Reg. notice). And I’ll be presenting on these matters at Petrie-Flom’s upcoming conference, Health Law Year in P/Review, on Monday 1/23/17.

Religion or Women?

May 24, 2016May 24, 2016 Holly Fernandez Lynch Leave a comment

In response to the religious objections levied against the contraceptives coverage mandate at issue in Hobby Lobby, Zubik, and gobs of other cases, many have argued that this was really a matter of subjugating women – not about religion per se. Well, now we have a test case: Vermont’s governor just signed into law a requirement that public and private health insurance cover vasectomies without copays and deductibles. There won’t be the same arguments about abortifacients here, but many religious employers should object just the same, if they’re being consistent. Now let’s watch and see…

SCOTUS and More Surprises on Zubik

May 16, 2016May 16, 2016 Holly Fernandez Lynch Leave a comment

After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case. The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.

SCOTUS has pulled a few tricks out of its hat to avoid that possibility. First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire). The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept. Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.

So what does that mean? In my view, count it as a win for the government. Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now. Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden. And SCOTUS hasn’t said there is.

What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision. The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president. The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits. Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.

Some Commentary on How to Think About Secondary Research with Biospecimens

January 11, 2016January 11, 2016 Holly Fernandez Lynch Leave a comment

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when. One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers. This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens. How should we feel about this status quo, and the proposed change? My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement. There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out. But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise. She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission. Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity. Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem? And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists. Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

New Developments in the Guatemala STD Experiments Case

December 15, 2015December 15, 2015 Holly Fernandez Lynch Leave a comment

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards. They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative. We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential. Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles. The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed. But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

A Circuit Split on Contraceptives Coverage

September 18, 2015September 18, 2015 Holly Fernandez Lynch Leave a comment

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate. Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met. So far, so good. But that’s the end of my agreement.

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