Category Archives: International
Upcoming Conference: Issues and Case Studies in Clinical Trial Data Sharing
Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety
[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]
Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.”
Today Alta is presenting what she calls “more of an initial idea than an actual proposal,” and she notes that she’s very interested to hear responses to it, so comment away or contact her offline. She wants to integrate into the usual and longstanding “FDA speed versus safety” debate some concerns that should be of interest to industry. “In other words,” she said, “I’d like to be nice to the drug people.”
Alta begins with a brief history of the speed versus safety debate, which turns out to be quite cyclical. Before 1906, she asks us to recall, we had true snake oil: products with high toxicity and little or no efficacy. Often these products were nevertheless perceived as effective because they contained alcohol or other drugs, so made you feel better at least, but of course that’s part of what made these products so dangerous, especially for children.
And so with the Federal Food and Drugs Act of 1906, we get post-market remedies for misbranding, although they require proof of intent. And then in 1937 over 100 children die from elixir of sulfanilamide. And the following year we get the Food, Drug, and Cosmetic Act. But the FDCA targets only safety. (Although rightly Alta notes that it’s hard to see how regulators were truly only looking at safety and not also at some form of efficacy, since there is no such thing as safety in the abstract, only safety relative to purpose for which someone is taking the drug.) Continue reading
Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote
[Cross-Posted at Prawfsblawg]
The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.
Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.
I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.
I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.
4/25: Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies
by Adriana Benedict
Universities Allied for Essential Medicines (UAEM)
Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies
Thursday, April 25th, 3-5pm
Coffee and refreshments at 2:45pm; reception following the event
Harvard Medical School New Research Building – 77 Avenue Louis Pasteur
Seminar Room 1031
How do innovative medical technologies make their way to a global population, including patients in resource-limited settings? As centers of medical innovation, universities are well-placed to influence the global dissemination of the fruits of biomedical research and enhance access to advances in drug, vaccine, diagnostic and device technologies. In the past five years, several institutions in Boston and beyond have acknowledged this fact and taken bold steps to encourage the transfer of medical technologies to the developing world. Licensing provisions such as tiered, reduced and zero royalties for products sold in developing countries; march-in rights; agreements to agree; agreements not to patent or not to enforce patents in developing countries; and humanitarian licensing exceptions are just some of the strategies used to implement global access licensing of medical technologies. Others can be found in UAEM’s Global Access Licensing Framework, as well as the multi-institution Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.
In this Forum, technology transfer officials and academic research leaders from Harvard, MIT, Tufts, BU, Northeastern, Children’s Hospital and Partners Healthcare (MGH/BWH) will speak to their institutions’ philosophy and experience with global access licensing strategies. In an hour-long Q&A, the audience – including invited experts with significant experience in medical technology development – will contribute to the discussion. The Forum is open to the public; and researchers, entrepreneurs, university leaders and students are highly encouraged to attend.
UAEM is an international interdisciplinary student organization that works with universities to leverage academic research for global health. Since our founding in 2001, we have worked towards illuminating the poorly understood process that brings discoveries from the laboratory to widely accessible products and services meant to improve human health.
Registration through this link is appreciated, but not required.
This event is co-sponsored by grants from the Harvard Global Health Institute (HGHI), the HMS Division of Medical Sciences, and Harvard Law School Advocates for Human Rights.
Revisions to the Declaration of Helsinki
On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki. The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.”
You can see a side by side analysis of the proposed revisions and explanatory comments here. We’ll see what happens down the road, but a few things are worth noting:
- The working group responsible for the revisions explicitly acknowledges that it cannot literally be true that the well-being of the individual research subjects must take precedence over all other interests (new paragraph 8/old para. 6). Nonetheless, it retains that language for aspirational purposes – a strange choice, IMHO, which could conceivably lead to less respect for the Declaration as a whole.
- The revised Declaration would (in line with almost every other ethical body to consider the issue) add a new paragraph indicating that “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured” (new para. 15). The current version (old para. 14) states only that the protocol should include “provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.” The nature of the Declaration is such that it doesn’t provide much detail, but even this revised statement is a step in the right direction. Will US regulators ever take the hint?
- The revisions would take a harder stance toward research involving disadvantaged or vulnerable populations, permitting research with these groups only when it could not be carried out in a non-vulnerable population (new para. 20/old para. 17). I understand the sentiment…really I do. But this approach seems to unduly discount the real benefits that accrue to research participants and communities just by virtue of having the research done there. And if research is responsive to population/community needs and priorities AND the population/community stands to benefit from the research – two standards that remain in the revised Declaration – why do we need the third criterion that research couldn’t be conducted in an alternative population? Continue reading
Of Evergreening and Efficacy, Part III
This is the last in a three-part series (Part I, Part II) of posts I’ve written about the case between Novartis and the Union of India, in which the Supreme Court of India denied Novartis a patent for its anti-cancer drug Glivec. Today I’m continuing the discussion of the practical outcome of the case. What effect is the Glivec patent decision going to have on access to medicines in India and other developing countries?
Beyond issues specific to the transition period, the Supreme Court was considering challenges to Section 3(d) of its patent act, which prohibits patents for a new form of an existing drug without a change in therapeutic efficacy. It is designed to prevent evergreening, a term used to label practices where a small change is made to an existing product and claimed as a new invention. When Section 3(d) was enacted in 2005, it was unique to India—there was no analogous provision in any other country.
Novartis had at one point tried to argue that Section 3(d) was unconstitutional under the Indian constitution and non-compliant with TRIPS, but those arguments were rejected by the High Court at Madras in 2007. Novartis did not appeal those decisions. The High Court rejected the TRIPS claim because in India private plaintiffs may not challenge a national law based on its compatibility with an international agreement. However, the court also referred to the Doha Declaration, which affirms that “the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” This means that WTO members can set their own standards for patent protection within the bounds of TRIPS. Section 3(d) establishes a higher standard for an inventive step, which means that drugs patentable in other countries won’t necessarily be patentable in India.
Of Evergreening and Efficacy, Part II
I wrote earlier this month about the case between Novartis and the Union of India, in which the Supreme Court of India affirmed denying a patent for Novartis’ anti-cancer drug Glivec. Adriana Benedict added an insightful post about the case last week.
In my last post, I talked about the theory behind the decision and what it means for a drug to be therapeutically efficacious. Today and tomorrow, I thought it would be interesting to focus on the practical outcome of the case. In other words, what does this case mean for the access to medicines more generally, both in India and around the world?
Judging by recent public comments, this will be a landmark case. On the Novartis website, where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novaris spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”
Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.
Twitter Round-Up (3/31-4/6)
By Casey Thomson
This week’s slightly belated round-up concerns palliative care across cultures, the threat and problems of over-prescribing, and Big Pharma’s failure to create prices with the patient in mind. Read on for more from this week’s round-up.
- Alex Smith (@AlexSmithMD) retweeted a piece on the lessons learned by Dr. Vvjeyanthi “V.J.” Periyakoil on how to approach palliative care for patients from a variety of backgrounds in ways that both extend life and fulfill the desires of the patient (in particular, reducing pain). (4/3)
- Alex Smith (@AlexSmithMD) also retweeted an opinion piece in the NYT about the growing trend towards self- and over-medication, and the problems of overextending definitions of medical ‘conditions.’ As the piece’s author summarized: “The D.S.M. would do well to recognize that a broken heart is not a medical condition, and that medication is ill-suited to repair some tears.” (4/3)
- Daniel Goldberg (@prof_goldberg) retweeted a link on two new wrongful death lawsuits against the NFL, which claim that the NFL withheld knowledge of the risks associated with concussions from players, that have been added to the string of other brain injury lawsuits filed against the league. (4/3)
- Daniel Goldberg (@prof_goldberg) additionally retweeted a blog post on the striking results of a new study comparing male and female mortality amongst counties in the United States. While male mortality increased in only 34% of counties from 1992-1996 to 2002-2006, female mortality increased in 42.8%. This brings up questions concerning the cause of this demographic and largely geographic inequality, and what such a differential could mean on the health of dependents (children). (4/3)
- Daniel Goldberg (@prof_goldberg) posted another article that put the recent New York “True Cost” campaign in historical context. The article called the campaign a “modern manifestation of…anxieties about the ‘contagion’ of working class and poor communities,” comparing it to the World War II-era venereal disease campaigns and the case of Typhoid Mary as all moralizing weapons aiming to instill shame rather than promote actual solutions to public health concerns. (4/4)
- Arthur Caplan (@ArthurCaplan) linked to his own discussion of the problem with Novartis and India, noting that emphasis has been wrongly placed on patents when the concern should be on pharma’s hesitancy to create a pricing strategy that can provide medications for those who cannot afford huge prices. This unwillingness to do so, he claims, is violating a moral obligation. (4/4)
If Novartis’s “improved” version of Glivec is not more therapeutically efficacious, why is the Novartis decision such a big deal?
By Adriana Benedict
Last week, Ryan Abbot blogged here about the Novartis case decided last Monday by the Supreme Court of India. Since then, there have been a broad range of reactions to the case, but many of them appear to have left a lurking elephant in the room.
I’d like to attempt to provide some clarity to a question that seems to have created a lot of confusion surrounding the impact of the Novartis decision: If the older alpha crystalline form of imatinib mesylate (generic Glivec) is already available in India, and the newer beta crystalline form is not more therapeutically efficacious, then why does it matter whether or not Novartis can get a patent on the newer version of Glivec? The simple answer is that for the most part, it doesn’t really, in terms of the availability of generic Glivec. At most, it may make a difference for some Indian patients who will do better with the beta crystalline form. And it will make some difference for Novartis, which will now forego a potential market of these Indian patients who would prefer to take (and can afford to pay for) the beta crystalline version. But the alpha crystalline form of imatinib mesylate was already available in generic form in India, and it would have continued to be available in generic form in India regardless of the outcome of this case. So why all the commotion?
First, the Novartis decision means that Indian generic manufacturers can now produce the beta crystalline form of imatinib mesylate with impunity. This means that Novartis is likely to face competition in its production of the beta crystalline form, over which it would otherwise have held a global monopoly. Indian generic manufacturers may now produce and export the beta crystalline form to other countries, which means that many more cancer patients in developing countries will have access to it. Novartis’s markets in these countries may be disrupted through parallel importation of cheaper generics.
The Iraq War and Health Worker Brain Drain
I am writing my student fellowship paper under the broad topic of health worker “brain drain,” so I have been keeping an eye out for related news stories. Two stories that caught my eye in the past few weeks were about the health worker migration from civil war torn Syria and economic-crisis ridden Sudan. In Syria for example, half the doctors in Homs and all of the country’s nine psychiatrists have recently migrated. In Sudan, 1620 doctors left the country last year compared to 338 in 2008. In countries like these, especially Syria where medical personnel have been targets of violence, solutions to stem the migration or replenish the ranks seem particularly futile. Additionally, these countries’ self-inflicted wounds, including civil wars and poor administration, complicate matters. Not only do these internal struggles diminish the probable efficacy of potential solutions to the brain drain, but they also negate the perceived responsibility of the countries receiving these migrants, diminishing their will to help counteract the deleterious effects of the brain drain.
Civil war stricken countries like Syria present especially difficult cases for developed nation responsibility and intervention. But these news stories led me to think about brain drain and responsibility that results from war, specifically wars waged by developed nations in developing ones. A prime example is the recent war in Iraq. The Brookings Institute estimates that 20,000 of the 34,000 Iraqi doctors in the country in 2003 have migrated, and only 1525 had returned as of 2009. They also cite that 2000 Iraqi physicians have been murdered and 250 have been kidnapped over the same period. 50% of surveyed Iraqi doctors living both in Iraq and abroad said they had been threatened.[1] A recent article in Lancet describes that before 2003 the major problems facing the Iraqi healthcare system stemmed from drug shortages and poverty. These problems have been superseded by violence and failing infrastructure in the intervening years. The brain drain has likely been exacerbated by these new threats.
Reminder, Upcoming Conference on Universal Health Coverage in Low-Income Countries
A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.
AGENDA
http://peh.harvard.edu/events/2013/universal_coverage/agenda.html
REGISTRATION
No fee. Space limited. Registration required. Please register on our registration website.
REMINDER – Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions
A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard:
Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions
May 17, 2013, 8:00AM-5:00PM
Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor)
1585 Massachusetts Ave., Cambridge, MA
Our current agenda/objectives are below the fold, and will be updated with additional detail shortly. Please make sure to register as space is limited!
The Globalization of Health Care: Legal and Ethical Issues – Now Available from OUP
The edited volume stemming from the Petrie-Flom Center’s 2011 Annual Conference – The Globalization of Health Care: Legal and Ethical Issues, I. Glenn Cohen, ed. (Oxford University Press, 2013) – is now available for purchase through the publisher, Amazon, or other outlets. You can also download the introduction and front matter for free here.
The Globalization of Health Care: Legal and Ethical Issues is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas – medical tourism, medical migration (the physician “brain drain”), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented. The book features leading academics from across the world and different academic disciplines (law, philosophy, medicine, public health, government, business and geography) and outside academia to provide an international and interdisciplinary perspective.
TOC below the fold:
Twitter Round-Up (2/16-2/23)
By Casey Thomson
This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:
- Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
- Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
- Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
- Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
- Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
- Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
- Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
- Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
- Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)
A Fascinating Reproduction Story in the New York Times, Part I: Reproducing from an Israeli Prison
About 10 days ago, the New York Times had two fascinating stories about reproduction (on back-to-back days) I wanted to highlight and comment on. In this post I will take about the first concerning Palestinian prisoners in Israel who are smuggling sperm out of prison to get their wives pregnant. As the story reports:
“A Palestinian fertility doctor said Thursday that he was helping about 50 women conceive children using sperm smuggled out of Israeli prisons, that four of the women were now pregnant after in vitro fertilization, and that one delivered a boy last summer, named Muhannad. . . . Dr. Khaizaran said he decided to embark on his unusual fertility experiment because by the time inmates with long sentences are released, their wives are often too old to bear children, leading them to marry younger women. He said he received a fatwa, or legal ruling, from a Muslim cleric permitting the procedure, which he does free of charge. Neither the doctor nor several women interviewed would reveal details of how the sperm was smuggled out.”
Here are some thoughts: First, there are a series of questions about the welfare of the children born from fathers in jail. My own work (see this and this and this and this) has argued that these kinds of Best Interests of the Resulting Child arguments often do not work, but certainly some others have (and will continue) to disagree me.
Second, there are some very interesting issues about rights to procreate of prisoners. There have been cases about rights to do sperm donation in jail in cases where there is no conjugal visits allowed. Here I think, especially for those facing life sentences or the death penalty, there is an interesting question of whether one has a right to produce a child for whom one will be a genetic parent and a legal parent but not a rearing parent in any meaningful way. Is a prohibition on allowing sperm donation to one’s wife while one is in jail a violation of one of the prisoner’s right to procreate? His wife? A woman with whom he has no pre-existing romantic relationship that wants to produce a child with him? And oh, by the way, what if the prisoner is a female and wants to gestate in prison?
Contrasting Views: Recent Publications on Access to Medicines
by Adriana Benedict
Last week, the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and World Trade Organization (WTO) released a trilateral study on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. According to the official summary of the book, the publication is aimed at policy makers and is divided into four parts:
I. Fundamentals: the background of health policy and medical technology, the work of the three organizations, the burden of disease that challenges health policy, and the factors shaping that policy. Much attention has been paid to diseases such as HIV/AIDS, malaria and tuberculosis, but noncommunicable diseases such as cancer, diabetes and heart diseases are a rising challenge.
II. The Policy Context: the international framework, linking health policy, intellectual property and trade, the contributions of economic analysis, and the use of traditional medical knowledge in research.
III. Innovation in Greater Detail: the evolution of research and development, alternative ways of promoting innovation for neglected diseases, the role of intellectual property rights, with examples.
IV. Access: how to ensure pharmaceuticals and other medical technology reach the people who need them: pricing policies, taxes and import duties, procurement, regulation, technology transfer, local production, patents, compulsory and voluntary licences, trade agreements, and competition policies, etc.
In her remarks at the launch of the publication, WHO Director-General Dr. Margaret Chan emphasized the importance of the public interest not only in public health, but also intellectual property and trade policy. Importantly, Dr. Chan noted that it “is worth considering” an extension of the TRIPS Agreement (WTO Agreement on Trade-Related Aspects of Intellectual Property) transition deadline (currently set to July 1, 2013) for least-developed countries (LDCs) to implement the agreement’s provisions.
In stark contrast, last week the Journal of Economic Perspectives released an empirical study by two Federal Reserve economists calling for the abolition of the patent system. Continue reading
Twitter Round-Up (1/27-2/7)
By Casey Thomson
Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:
- Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
- Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
- Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
- Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
- Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
- Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
- Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
- Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
- Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
- Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
- Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
- Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)
Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.
India Releases New Rules on Clinical Trial Injury
Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.” You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:
- “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.” Note that this doesn’t say anything about the injury being study-related.
- If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
- If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
- Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence. But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”. Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury. And I think US policy is woefully inadequate on this score. But the pendulum can also swing too far in the other direction. Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head's up re: publication of the new rules.]
No Access to Medicines without Access to Research
by Adriana Benedict
In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries. In recent years, open access issues have taken on an increasingly important role in global health discussions. In 2009, the Institute for Information Law and Policy, the Justice Action Center and Health Information for All 2015 made the case for a rights-based approach to the issue in a report called Access to Health Information under International Human Rights Law. In 2011, a medical student in the Right to Research Coalition explained 6 Reasons Open Access Matters to the Medical Community. And the 2012 WHO CEWG Report recommending a binding treaty on Research and Development to Meet the Needs of Developing Countries includes as one of its proposals “open approaches to research and development and innovation which include precompetitive research and development platforms, open source and open access schemes.”
In response to the increasing demand for open access to biomedical research, PLOS Medicine partnered with WHO to issue a call for papers “intended to culminate in an open-access collection of original research and commentary articles to coincide with the launch … [of] World Health Report 2012: No Health without Research.” However, the 2012 World Health Report was unexpectedly called off to be replaced by a 2013 report on “contributions to research to universal health coverage,” a far less politically polarizing topic. In its editorial response to the cancellation of the 2012 Report, PLOS Medicine noted that “The reasons for these delays and for the changes in scope of WHO’s flagship publication, are unclear,” not in the least because “Previous World Health Reports … have represented bold political statements.”