Tag: FDA

FDA Approval of New Alzheimer’s Drug May Harm More Than It Helps

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This post is a part of our Bioethics in the News series

By Jennifer Carter-Johnson, PhD, JD

On June 7, 2021, the United States Food and Drug Administration (FDA) approved a controversial new Alzheimer’s Disease drug—aducanumab—to be sold by Biogen under the name Aduhelm. Alzheimer’s disease is estimated to currently be affecting over 6 million Americans plus their families, who must watch the mental decline of their loved ones and provide increasing levels of care as the disease progresses.

Controversy

Unfortunately, the approval of Aduhelm has generated a large amount of controversy because the FDA approval came despite the rejection of the studies of the drug’s efficacy by the FDA advisory committee. The opposition to the FDA’s approval has been so heated that three of the eleven-person advisory committee have resigned.

Detailed discussions of the science behind Alzheimer’s disease and the Aduhelm clinical studies can be found elsewhere. In summary, as Alzheimer’s disease progresses, protein plaques—amyloid and tau—build up in the patients’ brain. The progression of these plaques correlated with decreased mental acuity in patients. Therefore, drug candidates that target these plaques have been of interest to scientists for many years.

While the clinical data associated with Aduhelm supported a decrease in brain plaques in early-stage Alzheimer’s patients, the data did not show that decreasing plaques by the drug resulted in slowed progression of Alzheimer’s disease. In addition, the data showed that some patients have brain swelling as a result of the drug. Using this data, the FDA approved Aduhelm for broad use for all Alzheimer’s patients.

FDA Approval Process

Generally, to gain approval to sell a new drug, a company will complete a series of clinical trials to determine if a drug candidate is safe and effective for a given disease. Safety and efficacy are balanced against each other and consideration is given to the severity of the disease to determine if approval will be granted. As an example, a highly effective drug that is also highly toxic would not be approved as a simple headache remedy but may be approved as a treatment against a fast-growing, inoperable form of brain tumor. Conversely, an ineffective drug should never be approved no matter how safe it is—such are the wares of snake-oil salesmen of the past.

The FDA also has an Accelerated Approval pathway to allow drugs for diseases that have few treatments to proceed to market more quickly. It is under this accelerated path that the FDA approved Aduhelm. The accelerated pathway allows companies to use biomarker changes rather than disease improvement to show efficacy in the drug approval process. The FDA used the decrease in amyloid plaques as the biomarker for approval of the new Alzheimer’s drug—despite the fact that the clinical trial studies were submitted to show efficacy against disease progression. Moreover, the advisory committee was not informed of potential accelerated approval. Only after the clinical trial data was found unacceptable by the advisory committee did the FDA switch to the accelerated approval pathway. Perhaps most importantly, other drug candidates have been abandoned after amyloid plaque removal did not halt progression of the disease, so biomarkers may not be effective ways to judge the halt of Alzheimer’s progression.

The accelerated approval is, in effect, a contingent approval. Biogen will be allowed to sell Aduhelm, but it must gather data as to whether the drug is actually effective. If clinical data does not eventually support reduced disease progression, then the FDA can rescind the approval, and Biogen will no longer be able to sell the drug. The FDA’s approval of the Aduhelm may be harmful in the long run for several reasons.

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Image description: A close-up photo of an IV drip containing clear liquid. Image source: stux/Pixabay.

Trust in FDA

The move by the FDA to approve Aduhelm could lead to a decrease in trust in the agency. First, the controversial nature of its approval over the recommendations of the scientists who reviewed the data created a controversy that is playing out across the news media as people wonder why an ineffective drug has been approved.

In fairness, the accelerated approval process is contingent, but due to the way the accelerated approval was used scientists did not have the opportunity to weigh-in on the use of biomarkers in that approval. That way in which the accelerated approval process was tapped, only after the regular approval process seemed doomed to fail, may well erode trust that the FDA evenly applies its own rules. Additionally, it is very difficult to rescind these accelerated approvals, and if the drug approval is rescinded public perception will likely be highly negative. Finally, according to Biogen it may take up to nine years to gather the data to complete the required studies.

New Drug Development

Aduhelm is not the only drug candidate in its class in clinical trials for Alzheimer’s disease treatment. Other drug candidates that include patients who receive a placebo rather than the drug candidate are undergoing clinical trials. Since these studies tend to be double-blinded—neither the doctor nor the patient knows if the drug or the placebo has been administered—patients will likely drop out of these other studies in order to be assured of receiving some drug. Thus, Alzheimer’s drug development will be slowed, in favor of a drug that has no demonstrable efficacy. Additionally, these new drug manufacturers may also ask for similar approval, based on biomarkers that may not be indicative of clinical effectiveness.

False Hope

Patients and Alzheimer’s advocates pushed for approval of this drug. But a drug with contingent approval may give these patients and their families false hopes. We have seen in Right to Try legislation–legislation allowing patients to use un-approved drugs in the FDA approval pipeline–both a fundamental lack of understanding of the FDA approval process as well as the desperation of patients for whom there are no clear treatment options. I have argued before that Right to Try laws prey on the emotionally fragile. Here the FDA’s controversial accelerated approval may have the same result—patients clamoring for a drug that does not work.

In addition, the cost of the drug will be borne by insurance companies that may well decide not to cover the drug. While the drug is approved for all stages of Alzheimer’s, clinical studies were only aimed at early-stage disease. In effect, the FDA has shifted its responsibility as gatekeeper for effective drugs to insurance companies for whom profit is a driving force.

Drug Cost

The cost of Aduhelm in light of the lack of efficacy data presents its own problems. Biogen has indicated that the average yearly cost of Aduhelm will be $56,000, not including the cost of doctors, hospital or clinic visits, and supplies to receive the infusions, or the cost of brain scans to monitor for swelling and brain bleeds as side effects. This cost, like most drugs, will be passed on to consumers through direct payments, increased insurance premiums, and higher budget expenditures for Medicare and Medicaid. One study reported that if 500,000 people on Medicare are prescribed the drug, it would cost $29 billion per year with copays of over $11,000 per year.

Biogen defends its pricing of the drug. According to its own press release, Biogen “established the price of Aduhelm based on the overall value this treatment is expected to bring to patients, caregivers, and society.” This expected value seems high for a drug that may not work but admittedly reflects normal drug company calculations in a system where insurance covers most prescriptions and the uninsured either do without or rely on the generosity of the drug company.

Because FDA approval is contingent, the FDA can remove the drug from the market if the required data do not show efficacy. However, the money paid for the failed treatment regime will not be refunded. Patients are paying to take this risk.

In the end, the FDA’s approval of Aduhelm will impact the way the agency is perceived, and the way other companies approach the drug approval process. Neither of these changes will be for the better.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law at the Michigan State University College of Law.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Monday, July 5, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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“Ask your doctor” – or just check Instagram?

This post is a part of our Bioethics in the News seriesBioethics in the News logo

By Robyn Bluhm, PhD

A couple of months ago, Kim Kardashian posted – and then quickly deleted – and then reposted – an Instagram advertisement promoting a morning sickness drug.

If this story sounds familiar, it may be because she did the same thing, for a different drug by the same manufacturer, in 2015. For the first post, the FDA issued a warning to the drug’s manufacturer, saying that the drug did not include information, e.g., about risks, required for pharmaceutical advertisements. Kardashian then posted a revised version that included the information missing in her initial post.

Direct-to-consumer (DTC) marketing of pharmaceuticals is not new. DTC marketing has been permitted in the U.S. by the FDA since the early 1980s, though it became much more common after 1997, when a number of restrictions on ad content were lifted. Since then, the use of these ads has greatly increased; in 2016 pharmaceutical companies spent $5.6 billion on ads, a 9% increase from the previous year.

Kim Kardashian Instagram post
Image description: Kim Kardashian’s Instagram post from June 20, 2018, showing a photograph of Kardashian holding a bottle of Bonjesta. Image source: @kimkardashian/Instagram.

Celebrity endorsements are also not new; they date back to the 18th century when Josiah Wedgwood used the patronage of the British royal family and other aristocrats to distinguish his china from competitors’. According to Megan Smith-Mady, one of the earliest uses of celebrity endorsement for pharmaceuticals had Mickey Mantel promoting an arthritis drug on TV talk shows. (YouTube actually shows him doing a commercial about athlete’s foot in 1976, though it’s best not to click on that link.) Smith-Mady also notes that the FDA responded quickly to this campaign, worried that viewers might not recognize that he was getting paid to promote the drug.

Since then, the relationship between celebrities and health care marketing has become more common – and more complicated. There have been many instances of celebrities appearing in commercials for medications (prescription or otherwise), and also of endorsing various medical devices and services related to health care.

Given all of this, Kardashian’s Instagram post is nothing new. Or is it? There is also reason to think that the use of social media in advertising for medical products may raise new ethical issues. For one thing, most countries do not permit DTC marketing of pharmaceuticals; in fact, Kardashian’s post includes a note saying that it is “for U.S. residents only.” Using social media is a way of getting around advertising bans.

Another thing to consider is the potential to target a younger market than can be reached with, for example, television or magazine ads. Not only do popular TV and film celebrities tend to have a strong social media presence and lots of followers, but celebrities whose fame is built entirely on social media platforms are becoming more common. One study found that respondents aged 13-24 were more likely to say that they would buy a brand or a product recommended by a YouTube star than by a traditional star. And while digital stars don’t (yet?) have the fame of “traditional” celebrities, top YouTube stars have Q scores (a rating of the familiarity and appeal of a celebrity) that are comparable to some traditional stars. Another study suggests that more children and teens consider social media celebrities to be role models more than they are influenced by musicians and actors.

Finally, I want to go back to the concern raised about Mickey Mantel’s talk show appearances – that it wasn’t clear that he was getting paid for his comments. In one sense, that worry now seems quaint; I think we are much more skeptical now about celebrity endorsements. And, in fact, some of Kardashian’s followers were less than impressed by her advertisement.

In another sense, though, new forms of online media do seem to complicate the relationships among information, marketing, medicine, and entertainment. Consider this: I first learned about the Instagram post via Bioethics.net, a site run by an academic bioethics journal. It linked to an article by Art Caplan, a well-known bioethicist (and one whose relationship with the media has been subject to attention). Caplan’s article appeared in LeapsMag, a new online publication focusing on news in the life sciences. On its “about” page, the publication hastens to describe itself as “an editorially-independent online magazine,” though you have to scroll down to find out that the reason it seems to be protesting its independence too much is that it was created by Bayer and is “the first magazine for mainstream readers created by a pharmaceutical company.”

But wait – there’s more. In looking online for information about Bayer and Leaps, I also found out that the company is currently feuding online with the makers of a new Netflix documentary, The Bleeding Edge. The movie documents problems in the medical device industry, and Bayer’s Essure contraceptive device is one of the central cases discussed (Bayer actually decided, for purely business reasons, to stop marketing the device the week before the documentary premiered. It’s worth noting, too, that Bayer released a “fact check” on the movie the day The Bleeding Edge premiered on Netflix, based on its April screening at a film festival.) And this feud is being covered by Variety, which started as a trade magazine for the entertainment industry, but now has a website and a Twitter following that vastly outstrips its print circulation.

What do I make of all this? I’m honestly not sure. I recognize that there are important differences between a documentary film and an Instagram post, even if both are reaching audiences through new online media. And I also recognize that there are arguments both for and against DTC marketing of pharmaceuticals. But it seems clear that the way that we get information about health and medicine is changing. Pharmaceutical companies are definitely paying attention to online media, so bioethicists should be, too.

Robyn Bluhm photoRobyn Bluhm, PhD, is an Associate Professor in the Department of Philosophy and Lyman Briggs College at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, September 6, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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More Bioethics in the News from Dr. Bluhm: Antibiotics: No Clear Course; To Floss or Not to Floss? That’s not the question

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Medicine’s Collusion with False Hopes: Rights to try, false hope, and the spine of the profession

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Marleen Eijkholt, JD, PhD

Imagine your loved one is dying. You have heard about an intervention out there, somewhere, that could help—you think. Not trying this intervention for and on your loved one would seem insane, as who knows, there could be a chance for a cure. Without trying it, your loved one’s death is certain. But by trying it—who knows—this intervention might be the miracle for your beloved. Why not try?

Though death ultimately takes all, most of us resist a final exit for both our loved ones and ourselves. Pursuits to forestall death can take the shape of family’s quests for experimental treatments, like in the Charlie Gard case, or they can come by insisting on a “full code” for a terminally ill loved one who is on their deathbed. This rescue impulse (by unbridled hope) encourages health care professionals as well to marshal all available resources in attempts to circumvent the inevitable.

Where “right to try” creates false hope, I submit, however, that that the health care profession (HCP) has an obligation to avoid collaborating in, participating, propagating or augmenting false hope. By not speaking up against such requests, health care providers precipitate a harm, i.e., the false hope harm (FHH). As such, the HCP should show courage, and show spine to resist more broadly unreasonable “rights” to try.

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Image description: an illustration depicts a white whale above a sea of orange waves. The whale is in a net that is being held up by orange birds. The background is blue. Image source: Matthias Töpfer/Flickr Creative Commons

I call for an active stance from the HCP against populist legislative initiatives, such as the latest U.S. Senate’s “right to try” bill. In the same way, I call for an active stance against unrealistic patient and family requests for rights to try, including resuscitative efforts in terminally ill patients or other demands for non-beneficial treatments. My position thus supports the providers’ prudent approach in the tragic Charlie Gard case, as described at the end of this post. The FHH can best be countered by courageous advocacy from the profession.

Earlier last month, the U.S. Senate passed a “right to try” bill, and if the House approves this legislation, the bill would allow terminally ill individuals to access experimental drugs not yet available on the regular market. Once a drug has passed Phase I drug testing, an individual could petition the pharmaceutical company for access to that experimental drug. This bill also provides protection for pharmaceutical firms. The legislation restricts the FDA from using right-to-try-related adverse outcomes in determining a drug’s safety. Accordingly, the bill limits “penalizing” pharmaceutical companies for their “generosity” in offering access.

A discouraging stance against “right to try” legislation is tricky. It is telling that “right to try” legislation has been dubbed “feel good” legislation, and thirty-nine states already have such legislation, including Michigan. Although there are proponents of these laws, I contend that these laws are “rhetorical pleasers” more harmful than beneficial. Criticism directed at “right to try” legislation focuses on several concerns, including its potential to undermine the clinical trial system and the belief that ultimately such laws only serve the elite. Some critics address false harm arguments, although these concerns are mostly different from mine. Critics argue that the legislation creates false hope, because pharmaceutical companies are less than eager to share their innovative pharmaceuticals, and are afraid of right-to-try-associated risks and harms that might lead to scientific and drug development setbacks. Patients, therefore, most often are unable to obtain access to the medications, so their hope for a “miracle drug” is in fact unfulfilled. Without actionable pathways, patient access cannot be guaranteed. (Indeed, in Michigan, Bridge Magazine suggests that the legislation has failed to change the status quo, and no one has sought access.)

My proposal that the HCP should stand up against unreasonable rights to try comes from my belief that these laws create FHH instead of real benefit. “Right to try” legislation generates false hope as the sought after experimental interventions are unlikely to benefit the patient. Although the legislation requires the drug to have passed Phase I clinical trial safety testing, this measure does not amount to a guarantee that the medication offers benefit. A Phase I clinical trial is safety focused, conducted in a very controlled environment, and in fact many treatments fail to demonstrate benefit outside that controlled environment.

The federal legislation is therefore an even more troublesome example of “feel good” legislation, as it propagates and augments FHH. It endorses the idea that pursing experimental treatment is both feasible and reasonable. Equally, it supports the notion that as long as one has the means, one should have access to try. Most importantly, by limiting FDA oversight, it undermines safeguards and trust in the system, and creates more room for FHH, giving pharmaceutical companies nearly a free reign.

Standing up to false hope is painfully hard, especially in the face of persuasive, emotionally vivid stories. Who would want to deny anyone hope for a miracle? Charlie Gard’s parents wanted to try a new treatment for their son, but their providers refused access. While their son was tragically dying, they were helpless to avert the inevitable. They heard about a treatment in the U.S. and appealed for access. But the UK doctors refused to endorse their appeal and the Court eventually prevented Charlie Gard’s parents from taking their son to the U.S. for treatment. A compassionate intuition could be: provided Charlie did not feel pain, why would there be anything wrong with them pursing this treatment in the U.S.? His parents had sufficient funds to cover related costs, so their pursuit would not further tax the social system. Experts suggested that there was a zero percent chance of health benefits for Charlie, but who can really know zero percent if you haven’t tried? We can never exclude miracles, can we? Even though this drug was not past Phase I, it had shown marginal benefit in other kids with illness that were related to Charlie’s, so safety wasn’t hard to prove.

I propose that if providers would have allowed Charlie to leave for the U.S., their endorsement would have exploited vulnerable individuals; they would have collaborated in FHH. The providers took the right and courageous action. Not speaking out against FHH passively supports initiatives that are more harmful than beneficial, and speaking out requires an active positioning of individual providers—optimally supported by the larger body of HCPs. I submit that this should extend to participating in requests for non-beneficial treatment requests like resuscitative efforts on dying patients. The medical profession rests on elements of trust, guidance, expertise and collaboration. Absent health care providers’ courage to deny treatment, we are doomed to see a further erosion of that profession. Without provider action against “right to try,” under legislation or requests in the clinic, medicine is at risk of further drifting into consumerist medicine, where money, fear, and privilege turn health care (and providers) into hostages of patient demands.

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Marleen Eijkholt is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine. Dr. Eijkholt is also a Clinical Ethics Consultant at Spectrum Health System.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 5, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

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Thorny Questions After a French Clinical Trial Goes Wrong

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series

By Hannah Giunta, MPH, PhD

The problem of balancing access to new drugs with the conduct of rigorous clinical trials is not new. Indeed, readers might be interested in checking out a previous Bioethics in the News column that dealt with the right to try novel therapies. But, despite all the coverage, answers are hard to find. The public want access to new therapies that are safe and effective; but, both patients and professionals remain relatively uninformed of how and why the current process operates as it does. While we may rebalance the benefits and burdens of drug development, we can never provide early and widespread access without risk.

During his campaign, President Trump repeatedly promised to eliminate red tape at the Federal Food and Drug Administration (FDA) and speed the approval process for potentially life-saving medications; although, just how he will attempt to accomplish these objectives remains unclear. But, many ethicists are alarmed that current regulations and requirements do not go far enough. Early phase trials are by their design risky propositions. A recent CNN article by Jen Christensen brings these concerns to the forefront. In the article, Christensen highlights the trepidations of several leading ethicists about the current clinical trial process, emphasizing the fact that clinical trial sponsors do not need to provide proof of efficacy in order to begin early phase trials even though the trials can have significant risks for participants. Christensen focuses on a 2016 French clinical trial where six healthy volunteers were gravely injured, and in one case even killed, during a phase 1 trial of a novel painkiller. Previous trials of similar compounds had shown the agents to be clinically ineffective, but the company was not required to show proof of possible clinical efficacy before launching the trial. Ethicists in Christensen’s article suggest that the solution is creating an independent advisory body within the FDA charged with evaluating preclinical evidence of efficacy. Is this a good idea? Possibly, if indeed there is sufficient scientific literature to review and that literature correlates to some degree with efficacy in humans. But, it will not change the necessary step of administering a drug to humans for the first time. No amount of animal testing can establish precisely what will happen in vivo. The very nature of experimentation necessitates a certain level of risk, and early access without risk is impossible.

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Image description: a person’s hands are shown holding a stethoscope. They are wearing a white doctor’s coat. Image source: Alex Proimos/Flickr Creative Commons

In the current system, the FDA focuses on the safety and toxicity of compounds in phase 1 trials before moving on to efficacy assessments in phase 2 and 3 trials. The thought seems to be that toxicity is the first bar to overcome, since efficacy matters little if subjects are harmed by the drug itself. The classic model for phase 1 trials is the dose escalation study where participants are randomly assigned to receive an ever increasing dose of an experimental agent until unacceptable toxicities develop. In the current case, 90 healthy volunteers were recruited for just such a trial. News of a problem was first publicized in January 2016 after one participant was declared brain dead and five others were hospitalized (Bichell, 2016). Medical findings at the time indicated that the previously healthy man who died suffered a massive stroke in his brainstem. Five other men who received an equally high dose of the experimental agent after the first man became symptomatic were also hospitalized. Four suffered headaches, altered consciousness, and short-term memory difficulties (Bichell, 2016).

The question of how the trial went wrong is an indictment and profound misunderstanding of the current system. The investigators gave extremely high levels of the drug in order to determine what dose would be toxic and at what dose the pain receptor in question would be 100% blocked by the agent (Bichell, 2016). In other words, they did it for rigorous scientific reasons in accordance with their approved protocol. The scientific purpose of a phase 1 trial is to establish the dosage level that is toxic. Agents in a phase 1 trial are not dosed as they would be in clinical practice. A second complaint leveled at investigators concerns the fact that similar agents tested in previous trials had failed to markedly reduce pain (Bichell, 2016). Again, these complaints belie a poor understanding of the drug development process. Small differences in chemical structure can make a large difference in pharmaceutical outcomes, and scientists never know when a compound will radically change medical practice. The nature of research means that many drugs will not be successful, but a few will be. A final complaint lodged against the trial investigators suggested that some neurotoxicity in animal studies should have forced scientists to re-evaluate their plan for a phase 1 trial. But, even the scientist lodging this complaint admits that these injuries have happened with other experimental agents (not this particular class of drugs), and those agents caused no problems in human subjects (Bichell, 2016). Of note, the sponsor has made changes regarding how they are notified of subject hospitalization due to concern that additional volunteers received a high dose after the first man was hospitalized.

So, how does what happened last year in France factor into current promises to speed access to new drugs? By scientific standards, the phase 1 trial in question did not fail. It established the outer limits of toxicity. The outcry over what happened in France highlights the differences between how scientists think and how most patients and health care professionals think. Most drugs in the development pipeline will never gain FDA approval. Scientists are concerned with insuring safety and efficacy through a rigorous scientific process that takes time. What is a promising drug today may be a complete flop tomorrow. Expanding access requires that we accept a different standard of evidence (i.e. retrospective clinical data, clinical dosing guidelines without scientifically established maximum doses, etc.). Accepting different standards may make a lot of sense, but it will not mean access without risk. Perhaps the most important step we should take is to test drugs in people who suffer from the disease in question and not healthy volunteers. At least then, the burdens will be borne by those who stand to benefit. Yet, any of these solutions will not change the fact that medical progress is not a straight line, and we are putting people at risk today for the sake of tomorrow.

Hannah Giunta photoHannah Giunta is an eighth year DO-PhD student at Michigan State University. She received her MPH in May 2015 and her philosophy PhD in May 2016. She is currently completing her medical school clerkships and plans to graduate in May 2017.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, March 9, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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HIV prevention: benefits, barriers, and ethical concerns

bbag-icon-decEthical Implications of HIV Pre-Exposure Prophylaxis (PrEP) for African American Women and Adolescent Girls

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Pre Exposure Prophylaxis (PrEP) is a new HIV prevention strategy approved by the Food and Drug Administration for use by uninfected, high-risk adult populations. PrEP’s potential as an HIV preventive strategy/biomedical method for adolescents is unknown. The presentation will present preliminary results from a study that examined benefits, barriers, and ethical concerns associated with Pre-exposure Prophylaxis (PrEP) utilization and clinical trial participation among African American adolescent girls. Study findings have the potential to generate evidence-based data to inform HIV research ethics practices and increase just and fair access to HIV scientific advances.

feb-17-bbagJoin us for Faith Fletcher’s lecture on Wednesday, February 17, 2016 from noon till 1 pm in person or online.

Faith E. Fletcher is an Assistant Professor in the Division of Community Health Sciences at the University of Illinois at Chicago (UIC). Prior to joining UIC faculty in 2013, Dr. Fletcher completed a National Cancer Institute R25T- funded postdoctoral fellowship in the Department of Behavioral Science at the University of Texas MD Anderson Cancer Center. The ultimate goal of her research program is to address HIV-related health inequities by understanding barriers that prevent African American women and adolescent girls from accessing innovative HIV preventive methods and treatment. Recent awards include joint funding through the Developmental Center for AIDS Research and Center for Clinical and Translational Science; Kaiser Permanente Burch Minority Leadership Fellowship; Building Interdisciplinary Careers in Women’s Health Research (BIRCWH K12) Fellowship; Visiting Professor in Minority Health through Northwestern Feinberg School of Medicine’s Program in Public Health; and an HIV Research Ethics Training Institute (RETI) Fellowship through Fordham University’s Center for Ethics Education. Dr. Fletcher received her foundation in bioethics and social justice through Tuskegee University’s National Center for Bioethics in Research and Health Care and Michigan State University’s Interdisciplinary Program in Bioethics, Humanities and Society. She completed her PhD in Health Behavior and Promotion from the University of South Carolina Arnold School of Public Health in 2011.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! View our archive of recorded lectures.

Why not more research into preventing cancer?

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Tom Tomlinson, PhD

Why are so much money and effort put into research aimed at curing cancer, and so little devoted to preventing it?

Three professors think they have at least part of the answer, as explained in a recent New York Times article (Why Preventing Cancer Is Not the Priority in Drug Development). They report that between 1971 and 2011, there were 12,000 research trials for drugs to treat patients with later stage cancer and a 90% chance of dying in five years; but only 6,000 for earlier stage patients with a 30% chance of dying. Even more starkly, 17,000 trials enrolled patients with recurrent cancers and low chances of survival, compared to 500 studying cancer prevention, where success would potentially yield much more benefit for more people (Budish, Roin and Williams).

In other words, the most money is being spent in pursuit of the least benefit for the fewest people. Why is this?

At great risk of over-simplifying, their answer is pretty simple: the commercialization lag. This is the time span between obtaining a patent for a new drug, and getting FDA approval to market it. The 20-year patent clock starts ticking when the patent is granted, but a company doesn’t begin to make money until the FDA allows sales. The shorter the commercialization lag, the more time available to amass a profit before your blockbuster goes generic.

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Image description: blue pills are spilling out of a pill bottle that is on its side. Image source: Flickr.

So how does this affect cancer drug development? If the measure of success (and FDA approval) is increased cancer survival, success can be determined most quickly in those already likely to die soon. Compared to a group of cancer patients with a 1-year life expectancy, it will take 10 times as long to detect success in a group with an average life expectancy of 10 years. This is why the commercialization lag adversely affects the profitability of research to prevent cancer or to treat it in its early stages, and so discourages such research.

Understandably, the authors of the report then discuss remedies that mitigate the effects of the commercialization lag—e.g., identifying “surrogate endpoints” that can be detected much sooner, are strongly associated with increased survival, and allow for earlier FDA approval.

I’m sure they would admit that there are other factors discouraging early-stage and preventive cancer research. Here are several that occurred to me, some of which have an ethical component.

1. Enrolling early stage patients in a trial of a new, as yet unproven cancer drug could be ethically treacherous, if there is already a standard treatment regimen supported by evidence. The cleanest design would assign some patients to the new drug and others to the standard of care, and this would be especially necessary if the surrogate end point also occurred among patients receiving conventional treatment. But this would mean that the proven treatment was being deliberately withheld from the experimental group, or delayed until the surrogate end point window closed. The interests—even the vital interests—of this group would be sacrificed for the advancement of medical knowledge. Of course, we would require that they give their informed consent to being exposed to that risk. But the quality of such consent would be highly suspect, given that it is so clearly at odds with their self-interest. These are the concerns that underlie the principle of “equipoise”—that the arms of an experiment should be roughly comparable in terms of their potential risks and benefits. (See Declaration of Helsinki, #30.)

This doesn’t mean that it is always ethically impossible to conduct research on early-stage cancer, just that it will probably be ethically more challenging to design such trials.

2. Another challenge is enrolling an adequate number of participants, especially for research on agents to prevent cancer. Studies of potential preventive drugs for cancers that occur later in life and at relatively low population rates will require large numbers to be enrolled for long periods of time to detect a statistically significant effect. If the study agent carries side effects, or burdens of compliance with the research regimen, it may discourage enrollment and encourage later drop outs.

We might address this problem by enrolling people already at high risk for cancer, which will reduce the numbers required to detect an effect. This strategy probably raises no special issues for people whose increased risk is outside their control, like women and men with one of the BRCA genetic variants carrying much higher risk of breast cancer.

But how about a study focusing on preventing lung cancer, which enrolls heavy smokers to more easily achieve scientific feasibility? Its feasibility in part depends on whether the subjects continue to smoke. And the goal of the study—to determine whether the new drug reduces the risk of smoking—may indirectly encourage participants to continue smoking. This would be due to the “therapeutic misconception,” the well-documented belief among many research participants that the experimental intervention offers a much higher likelihood of benefit than the evidence suggests (Lidz et al.).

3. And this example takes me to my last question. Would developing a whole armamentarium of drugs to prevent cancer be an unalloyed good? Of course, it’s almost certain that these drugs will carry their own side-effects and risks, as the pharmaceutical company TV ads constantly remind us; and these risks will be experienced by large numbers of people who never would have gotten cancer in any event. And for this reason, preventing cancer in this way could end up costing much more in total than treating it, as Louise Russell pointed out back at the dawn of time (Russell).

But even setting aside these complications, I would still worry about the effects that ready availability of such drugs would have on other approaches to preventing cancer, like behavior change and environmental clean-up.

If we could all just take our pills as directed, would we in the process be eroding our sense of our personal and political responsibility for the causes of cancer, and if so would that be too high a price? I’m not sure how to answer those questions. I hope you might have some ideas.

Tom Tomlinson, PhD,tomlinson is Director of the Center for Ethics and Humanities in the Life Sciences and a Professor in the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, February 4, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Jennifer Carter-Johnson, PhD, JD

Right to Try Laws Generally

Picture a mother with breast cancer hoping to see her daughters get married. Weep with parents as their nine year old son dies in their arms. Rally behind the newlywed couple fighting to experience just one anniversary. These are the people targeted by Right To Try (RTT) laws recently sweeping more than twenty states across the nation.

Based on model legislation put forth by the Goldwater Institute, RTT laws seek to allow terminally ill patients who have exhausted all approved drug therapies to access drugs that have not been approved for sale by the Food and Drug Administration (FDA). Proponents argue that the RTT laws empower terminally ill patients to attempt to try to save their own lives by allowing those patients access to drug candidates that have passed at least Phase 1 of FDA clinical trials.

FDA Clinical Trials Regulation

handful of pills
Image description: a hand is shown holding at least one dozen multi-colored pills. Image source: Flickr user Victor.

To understand why these laws are so troubling, it is important to put them in the context of the FDA regulation process. No chemical substance is completely safe – even drinking too much water can kill you. Cancer drugs are on the other end of the safety spectrum from water. Cancer drugs generally work because they kill cancer cells at a faster rate than they kill normal cells. The job of the FDA is to evaluate new drug candidates and approve one for sale when the proposed benefits of a drug outweigh its harms.

In order to make that determination, the FDA requires numerous studies culminating in a series of clinical trials using human patients. These clinical trials are divided into three basic phases with increasing numbers of patients enrolled in each. In a Phase 1 clinical trial, as few as twenty healthy patients are enrolled for a few months to determine a relatively safe dosage of the drug for use during further trials. Approximately seventy percent of drug candidates graduate from Phase 1 to Phase 2. It is not until Phase 2 that drug candidates begin to be assessed for effectiveness and side effects on a few hundred patients. Only about one third of the Phase 2 drug candidates show enough balance between effectiveness and side effects to move into Phase 3. Phase 3 trials involve large scale patient enrollment over several years to assess the true benefits and harms of a drug candidate. Of the drug candidates that enter Phase 3, only about twenty five percent are approved for marketing.

The drug approval pipeline is designed to screen large numbers of drugs to find the few that will be helpful in a given disease context. Of one hundred potential drug candidates, seventy will likely enter Phase 2; twenty three will pass into Phase 3 and about six will be approved for sale.

Impact of Right to Try on Patients and Society

Because most drug candidates enter Phase 2, a proposed cancer drug that kills normal cells too fast or causes side effects that kill a patient more quickly than the cancer will likely progress through at least Phase 2 trials before being dropped from the pipeline. That drug candidate would be available for use under the RTT Laws. In fact, a patient is far more likely to receive a drug candidate that will either do nothing to help the condition and/or have significant adverse side effects beyond the symptoms caused by the disease. Thus, patients who ask for drug candidates that have merely completed a Phase 1 trial very likely are banking on a false hope and may even have their lifespan decreased or their quality of life diminished.

black pills
Image description: A hand wearing a white latex glove is shown pouring large black pills from an unmarked bottle. Image source: Flickr user Health Gauge.

Other problems plague the patients invoking RTT laws. RTT laws allow companies to charge for the drugs, and small scale batches of drugs created for clinical trials are often highly expensive. RTT laws do not require insurance to cover those expenses, and many explicitly allow drug companies to go after the patient’s estate to recover costs. Thus, RTT laws are likely to primarily benefit those with resources to pay many thousands of dollars out of pocket. The poor will have no more access to drugs than before the law, and those with savings, life insurance policies, or retirement accounts will be tempted to drain those accounts for a false hope – likely leaving loved ones bereft of any financial buffer that had originally been planned.

Additionally, if a patient using an experimental drug has adverse side effects, he will further deplete his savings paying for care. Most RTT laws exempt insurance companies from paying for medical problems that arise while on an experimental drug. Public hospitals who cannot turn away those without insurance coverage may lead to a drain on the taxpayer. Because these laws protect both the drug company and the prescribing doctor from liability, the monetary and physical costs of any severe side effects will be borne by the patient alone.

Finally, there is the danger of the birth of a new snake oil market. Before the FDA regulated drugs for safety and efficacy, salesmen took advantage of customers to sell all sorts of tonics. We see similar problems in the practically unregulated supplement market today. The RTT laws hold the potential to underlie a new industry of drug candidates that have gone through Phase 1 to gain a sheen of FDA credence but that hold little chance of final approval.

More Reasonable Approach?

The access to drug candidates that have completed no more than a Phase 1 clinical trial is the worst form of false hope that threatens to cost those most vulnerable everything. In a nod to autonomy and the power of hope, perhaps a more reasonable approach would be to allow patients the right to try drug candidates that have entered into Phase 3 clinical trials. While many of the problems with cost, insurance and liability would remain, perhaps the most toxic and least effective drug candidates may have been screened from the pool of drug candidates.

j-carter-johnsonJennifer Carter-Johnson, PhD, JD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 5, 2015. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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The Joshua Hardy Case: Lessons Yet to Learn

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Hannah Giunta

Earlier this month, major news outlets reported the story of 7-year-old Josh Hardy, a current end-stage cancer patient at St. Jude Children’s Research Hospital. Hardy has faced and overcome cancer four times after first being diagnosed with rhabdoid tumors of his kidneys when he was only nine months old. After treatment for his kidney cancer, he relapsed, and cancer was again found first in his thalamus and then in his lung. In November 2013, Josh was diagnosed with myelodysplastic syndrome and required a bone marrow transplant. The weakening of his immune system caused him to come down with a particularly vicious case of adenovirus, and current antivirals have failed to control that infection. After approved drugs failed, Hardy’s doctors suggested that the experimental agent brincidofovir might offer the only viable chance at a cure. St. Jude previously hosted a clinical trial where patients who received the drug demonstrated a decrease in adenovirus-specific viral load. Hardy’s parents petitioned manufacturer Chimerix to provide the drug through a compassionate use protocol, but the company refused, saying that giving the drug to Josh and other critically ill patients would likely slow down the drug’s approval process. Chimerix officials also explained that the drug had not been proven effective in advanced adenovirus cases like Josh’s and that they did not have a current clinical trial in which they could enroll Josh. Public outcry over Chimerix’s refusal of the request, which included death threats directed at company executives, eventually pushed Chimerix to reconsider its decision and work with the FDA to start a new clinical trial in which Josh could enroll.

Although Josh Hardy’s case has been uneasily resolved, at least for the time being, public reaction reveals that larger questions are still unanswered. First and foremost, we continue to struggle with distinguishing our research system from our clinical care system in the U.S., and the resulting therapeutic misconception causes dashed dreams and animosity between drug developers and well-meaning, though misinformed, patient advocates. The truth is that the medication Josh is receiving out of compassion may make his life worse in the end, and failure to recognize this reality means false hope for families and insufficient attention paid to Josh’s quality of life. Secondly, there is a conflict between the needs of current patients like Josh and the needs of future patients who will benefit most from a fully approved medication. That conflict can only be meaningfully resolved when we have an honest discussion about what compromises we are willing to make. We cannot have both a drug development system that releases cutting edge medications meeting our stringent safety standards efficiently and one that makes unproven medications available on demand. The clinical trial system is not designed to release experimental agents for public consumption, even when that consumption occurs according to compassionate use protocols. Failing to get to the bottom of these conflicts leads to unnecessary heartache and public outrage.

Philosophers, researchers, and clinicians have struggled for years with how to prevent and ameliorate the impact of the therapeutic misconception. Defined as the failure to appropriately distinguish between the goals of research and the goals of clinical care, the therapeutic misconception leads to patients and family members believing that clinical trials are actually cutting edge treatment options, rather than legitimate experiments designed primarily to yield generalizable knowledge. In an effort to maintain hope for current patients, clinicians recruit participants with end-stage disease in order to push a research agenda forward while anecdotally hoping that somehow the experimental agent might benefit the enrollees. Unfortunately, previous reviews of pediatric cancer protocols suggest that substantial survival time is relatively rare. In fact, significant survival time was actually less common than drug-related toxicity (Kim et al. 2008). In Josh Hardy’s case, brincidofovir has only been shown to be effective in patients who did not have advanced adenovirus infection. Even then, the drug only demonstrated the ability to decrease viral load, and with Josh’s weakened immune system, his body may still not be able to clear the infection. Tissue damage is likely already significant after two months of illness. Most importantly, Josh has other significant co-morbidities and has had multiple cancer relapses. After Josh received his first dose of the drug, his own father admitted that his son faces a long road and is in bad shape overall (Cohen 2014). Seeing Josh weak, frail, and seemingly miserable in his hospital bed should leave us wondering whether this little boy has suffered enough. Perhaps, he might be better off if we focused solely on palliation and allowed the time he has left to be more comfortable and meaningful for him and his family.

The unique goals of medical research stem largely from a need to standardize clinical trials as much as possible to meet FDA standards. In order to show efficacy and safety, researchers use the gold standard double-blind, placebo-controlled clinical trial design. While this design helps researchers show aggregate differences in outcomes, it makes it less likely that individual patients will benefit from trial enrollment. In the trial earliest stages, participants are often randomly assigned to dosage groups, meaning that some participants may not even be receiving a therapeutic dose. In subsequent phases, participants are still randomly assigned to treatment arms of the trial, and if clinician-researchers don’t know what treatment a participant is receiving, it’s unlikely that they can provide individualized medical care for their patients. Living up to the FDA approval system’s high scientific requirements is a reality for Chimerix and other pharmaceutical companies, so distributing a drug in a less controlled situation presents a conflict. Maybe it is time to consider whether or not more novel trial designs or blended designs where patients receive an experimental intervention in a less controlled setting might help address this problem. Pediatric oncologists have recently expressed this opinion in a major research journal (Kearns and Morland 2014). Until we decide how rigorous our drug review standards need to be, we are forcing companies to confront a constant conflict between the human need for compassion and the larger social goal of developing new treatments.

Josh Hardy may or may not survive his current illness, although I hope and pray that he prevails. But, no matter the outcome, the Josh Hardy case should not be the end of our discussion. Josh’s story should push us toward a national conversation that asks the big questions. Most importantly, it requires us to reconsider the popular notion that research can serve two masters (i.e. the public and current patients) as well as the idea that length of life ought always to be our barometer for ultimate success in the face of terminal illness.

References:

Cohen, Elizabeth. “Josh Hardy’s father says son faces ‘long road to recovery.’” 15 Mar 2014. Last accessed on 3/17/2014 at http://www.ksl.com/?sid=29075987&nid=157.

Kearns P, Morland B. New drug development in childhood cancer. Curr Opin Pediatr. 2014 Feb;26(1):37-42. doi: 10.1097/MOP.0000000000000054. PubMed PMID: 24362409.

Kim A, Fox E, Warren K, Blaney SM, Berg SL, Adamson PC, Libucha M, Byrley E, Balis FM, Widemann BC. Characteristics and outcome of pediatric patients enrolled in phase I oncology trials. Oncologist. 2008 Jun;13(6):679-89. doi: 10.1634/theoncologist.2008-0046. PubMed PMID: 18586923.

Lupkin, Sydney. “Dying Boy to Get Unapproved Drug After Family’s Plea.” 12 Mar 2014. Last accessed on 16 Mar 2014 at http://abcnews.go.com/Health/dying-boy-unapproved-drug-familys-plea/story?id=22873957.

Lupkin, Sydney.  “Family Petitions For Unapproved Drug To Save Son.” 11 Mar 2014. Last accessed on 16 Mar 2014 at http://abcnews.go.com/Health/family-petitions-unapproved-drug-save-son/story?id=22851791&singlePage=true. 


hannah-giunta-100Hannah Giunta is a fifth year DO-PhD student pursuing a PhD in Philosophy and Bioethics.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, April 3, 2014. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

Welcome to FDA Enforcement

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Kayte Spector-Bagdady, J.D., M.Bioethics

 “This is me, my DNA. It helps make me who I am…I might have an increased risk of heart disease, arthritis, gallstones, hemochromatosis…hundreds of things about my health. Getting my 23andMe results, it really opened my eyes. The more you know about your DNA, the more you know about yourself. I do things a little differently now…”

On November 22, 2013, 23andMe (the leading direct-to-consumer (DTC) genetic testing company), received a “Warning Letter” from FDA—a first for the DTC genetic testing industry. In this letter, FDA requested that 23andMe discontinue marketing its personal genome service until further authorization and end its TV campaign excerpted above (now the YouTube video is marked “private”). 23andMe’s official FDA response might not be public, but on December 5, 2013, 23andMe did announce publicly that it was going to stop selling new customers its DTC health-related genetic test. Unlike, for example, an X-ray, “DTC” tests are those available directly to purchasers, like a pregnancy test. While there are many benefits to having certain diagnostic tests available directly to consumers without a trained intermediary, there are also concerns about giving laypersons medical information without specific guidance from a healthcare practitioner.

This is not the DTC genetic testing industry’s first tango with the U.S. federal government. In 2006 the Government Accountability Office (GAO) released a report on nutrigenetic testing which found that companies were selling $1,200/year vitamins (actually worth $35/year in a local drug store) to “fix” DNA. In 2010 a GAO investigator was advised by an industry representative that her BRCA mutation, associated with an increased risk of breast cancer, meant that she was “in the high risk of pretty much getting” the disease (GAO did not reveal company identities for either of its reports).

In fact, just a few years ago, nearly thirty DTC companies offered 400 discrete genetic tests—until Pathway Genomics announced in 2010 that it was going to start offering its previously web-based product in Walgreens across the country. This got the attention of FDA, which eventually sent 23 “Untitled Letters” (for a violation not quite as significant as those triggering a “Warning Letter”) stating that these products were in fact medical devices and had to receive FDA clearance or approval. Soon thereafter many DTC genetic testing companies either altered their model by requiring a physician order or collapsed entirely—leaving 23andMe to dominate the industry.

In 2007, 23andMe offered thirteen health reports for $999. As of December 2, 2013, 23andMe offered over 250 health reports for $99—including reports regarding a higher risk for Alzheimer’s Disease to whether your cilantro will taste soapy—all in a colorful box promising “Welcome to you.”

As of today, for the same $99, 23andMe is selling an analysis of your ancestral origins and lineage  and “raw genetic data” “without 23andMe’s interpretation” but have suspended their health-related genetic information service “to comply with [FDA’s] directive to discontinue new consumer access during our regulatory review process.”

FDA’s jurisdiction hinges on whether the 23andMe’s product can appropriately be considered a medical device under the Food, Drug, and Cosmetic Act. There has been a lot of interesting debate in the tweetisblogosphere regarding whether 23andMe is marketing their test as their terms of service state, for “research and educational use only,” or, as the TV adds promised, to tell you “hundreds of things about your health” so you can do things “a little differently.” But another possible consequence of 23andMe canceling their health analysis is the unintended encouragement of a new DTC genetic industry—one providing genetic medical information only.

Last year, Gene By Gene started the trend by offering consumers genomic sequencing only: a raw data file of As, Ts, Cs, and Gs without any interpretation. Think this. But, for the majority of consumers, raw sequence data services require a parallel offering of interpretation-only services to provide a marketable product.

FDA has stated that it’s not interested in regulating raw genomic data as a medical device, but entities that provide genomic interpretation (see, e.g., openSNP) can reveal more sensitive medical information about an individual’s propensity to develop disease and pharmacogenomic information about the efficacy of particular drugs given a particular genetic makeup—which places these services squarely within FDA’s area of interest. 23andMe has always offered customers their raw data as part of its package, but it’s the genetic risk and drug responses (i.e., analyzed information) that FDA cited as concerning in its letter.

But just as FDA begins to seriously grapple with the DTC genetic testing industry, open-source, web-based platforms that interpret genomic data free of charge are going to pose further challenges to the limits of FDA’s ability to regulate (potentially non-commercial) speech, and effectively utilize enforcement mechanisms made for tangible money-making products on information and open-sourced platforms.

The interpretation of FDA’s Warning Letter may be clear, but the future of DTC genetic testing might instead lie in how you interpret the letters “A, T, C, and G.”

(Still interested? Read more on the topic from me and my co-author Lizzy Pike here).

References:

Letter from Alberto Gutierrez, Dir., Office of In vitro Diagnostics and Radiological Health, Ctr. for Devices & Radiological Health, Food & Drug Admin., U.S. Dep’t of Health & Human Services, to Ann[e] Wojcicki, C.E.O., 23andMe, Inc. (Nov. 22, 2013).

U.S. Gov’t Accountability Office, GAO-06-977T, Nutrigenic Testing: Tests Purchased from Four Web Sites Misled Consumers, Testimony Before the S. Special Comm. on Aging (July 27, 2006).

U.S. Gov’t Accountability Office, Highlights of GAO-10-847T, Direct-to-Consumer Genetic Tests: Misleading Results are Further Complicated by Deceptive Marketing and Other Questionable Practices (July 22, 2010).

kayte-spector-bagdadyKayte Spector-Bagdady, J.D., M.Bioethics, is Associate Director at the Presidential Commission for the Study of Bioethical Issues where she managed the Commission’s reports on Privacy and Progress in Whole Genome Sequencing and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.*

Join the discussion! Your comments and responses to this commentary are welcomed. The author will not, unfortunately be able to respond to all comments, but will read input with interest. With your participation, we hope to create discussions rich with insights from diverse perspectives. You must provide your name and email address to leave a comment. Your email address will not be made public.

* The findings and conclusions in this blog are those of the author and do not necessarily represent the official position of the Presidential Commission for the Study of Bioethical Issues or the Department of Health and Human Services. Use of official trade names does not mean or imply official support or endorsement by the author.

Dr. Mark A. Largent, Associate Dean of Lyman Briggs College, joins Brownbag Webinar Series

bbag-iconReye’s Syndrome: A Medical Mystery and a Modern Dilemma

Event flyer: Largent Flyer

Throughout the 1970s and early 1980s, parents and physicians were terrified by the emergence of an apparently new ailment that left hundreds of children dead every year and hundreds more permanently damaged. Reye’s Syndrome, first described in the early 1960s, appeared as children were recovering from influenza and sometimes chickenpox, quickly throwing them into comas and frequently death. About half of the children diagnosed with Reye’s syndrome died and about half of the survivors were left with permanent brain or liver damage. Scientists and physicians raced to find the cause and develop treatments for Reye’s syndrome, and eventually epidemiological evidence emerged that it was caused or at least made more severe by aspirin. Since the early 1980’s, parents have been warned to avoid giving their children aspirin, especially when they suffered from a viral illness. But even before the FDA began labeling aspirin bottles, the number of Reye’s syndrome cases dropped dramatically, and it nearly disappeared before the before the Public Health Service could complete its study of the hypothesis that aspirin was to blame for the ailment. This talk will examine the history of Reye’s syndrome, the hunt to uncover its cause, and the debates that have emerged over last twenty years about the role of aspirin in Reye’s syndrome.

Oct-16-for-BlogJoin us for Dr. Largent’s lecture on Wednesday, October 16, 2013 from noon till 1 pm in person or online:

In person: The lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Mark Largent is an historian of science and medicine, Associate Dean of Lyman Briggs College at MSU, and an Associate Professor in James Madison College at MSU. His research and teaching focuses on the role of scientists and physicians in American public policy debates. His first book, Breeding Contempt: The History of Coerced Sterilization in the United States (Rutgers 2008) described the rise of compulsory sterilization laws in the US. Most recently, he published Vaccine: The Debate in Modern America (Johns Hopkins, 2012), which examined current debates about compulsory vaccination laws and the autism-vaccine controversy. He is currently writing a history of Reye’s syndrome.