Politics and Science

Posted on May 20, 2013 by Joanna Sax

On April 29, Scott Burris blogged about a new bill that would allow Congress to set the scientific agenda, which would replace the traditional peer review process. I echo his expressed concerns, but want to add more. The idea that politicians, and not scientists, could determine the advancement of science is, frankly, a disaster. In the past we have seen political leaders spar with scientists over many things – such as whether the earth is round, whether the earth is the center of the universe, etc. If scientists did not or could not answer those questions, we might think we are walking on a flat earth.

Even now, there is a strong interaction between politics and science. Evolution, a scientific theory with unequivocal consensus among the scientific community, still faces political opposition. Recently, I’ve been thinking and writing in this area, that is, the interaction of politics and science. Questions for scientific inquiry should be determined by scientists. How we allocate and manage our resources requires, as others have argued, experts in many areas, including economics, management, and public policy.

To look at the interaction of science and politics, I conducted an empirical analysis comparing the type of information communicated to the public versus the consensus in the scientific community to determine whether politics is playing a role in scientific inquiry. The study centers on the debate regarding the funding of embryonic stem cell research. If you are interested in this area, please check out a recent draft here. It’s an early draft and I welcome comments – you can email comments to me at jsax@cwsl.edu

More on NSF and NIH Funding

Posted on April 29, 2013 by Public Health Law Research

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been. It seems to reflect a terrible paradox: on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

4/25: Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

Posted on April 22, 2013 by abenedict

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.

Myriad (Gene Patent) Oral Argument and the “Lander Brief”

Posted on April 17, 2013 by glenncohen

First, and unrelated to this post, I wanted to say that like everyone here in Boston (and it seems throughout the U.S.) my heart goes out to the folks injured by Monday’s blast and their friends and family.

Now on to the substance. I have participated in a number of Supreme Court amicus briefs both in my life as a litigator and as an academic. In big name cases the Court is often inundated with them, and one can only hope that the brief is read, let alone put to good use. This is why I was incredibly happy and honored that the Supreme Court devoted a significant chunk of its oral argument time on Monday in the Association for Molecular Pathology v. Myriad Genetics, No. 12-398, the gene patent case, to discussing the brief I authored with Gideon Schor and Vern Noviel on behalf of Dr. Eric S. Lander. As Nature reported on the argument:

“The justices seemed to have been heavily influenced by a friend-of-the-court brief filed by Eric Lander, genomics whiz and founding director of the Broad Institute in Cambridge, Massachusetts. The brief argued against a lower court’s ruling that a snippet of DNA isolated from its chromosome does not occur in nature and is therefore patentable. To the contrary, wrote Lander, isolated DNA fragments do exist and are found circulating free in the blood. Indeed, a search of two public databases of DNA sequence data obtained from fetal DNA circulating in maternal blood revealed fragments that contained the BRCA1 and BRCA2 genes. “I think that raised a whole new ‘oops’,” said Robert Cook-Deegan, a policy researcher who has studied the case at Duke University in Durham, North Carolina. The justices never heard a proper response to Lander’s argument from Myriad’s attorney, who seemed to have either misunderstood the Lander brief or confused it with another when questioned.”

I reproduce some snippets from the actual transcript below the fold discussing our brief and its significance for how the Court rules.

Continue reading →

Join Us on April 19th for an Interdisciplinary Conference on New Directions in Health Policy and Law

Posted on April 4, 2013 by Wendy Parmet

Oral Arguments in FTC v. Actavis (SC pay for delay case)

Posted on March 28, 2013 by abenedict

By Adriana Benedict

As Jonathan Darrow notes below, on Monday, the Supreme Court heard oral arguments in Federal Trade Commission (FTC) v. Actavis, the “pay for delay” case questioning whether or not reverse payment settlements in Hatch-Waxman litigation should be presumptively anticompetitive, a question on which the Circuit Courts are divided. This particular case involves Solvay Chemicals Inc., whose patent on AndroGel cream, a synthetic testosterone formulation (set to expire in 2020) was challenged by three generic pharmaceutical companies that filed ANDA applications in 2003 for generic version of AndroGel (which is 1/6 the cost of the branded version). Following a 30-month stay triggered by Solvay’s subsequent infringement lawsuit, the FDA approved the generic version of Androgel in 2006, at which point the generic companies’ motion for summary judgment on the validity of Solvay’s patent was ready for decision. Instead of risking the judgment, the parties settled, with the generic companies agreeing to stay out of the market until 2015 in return for an estimated $186 – 252 million from Solvay over the course of six years. The FTC, expressing concern that consumers would ultimately bear the costs of delayed generic entry, unsuccessfully challenged this settlement as presumptively unlawful restraints of trade. The Eleventh Circuit affirmed the District Court’s decision in 2012, which rejected the FTC’s approach in favor of a “scope of the patent” test. Several months later, though, the Third Circuit reached the opposite verdict in a similar case, accepting the FTC’s position that reverse payment settlements are presumptively unlawful agreements not to compete. The Supreme Court granted cert to resolve this conflict.

I found a couple features of yesterday’s oral arguments particularly striking. First was Justice Breyer’s statement that he thought one of the four briefed scenarios in which a reverse payment settlement may rebut an anticompetitive presumption was “neutral”:

JUSTIC BREYER: [B]the person’s already in the market thinks that the next year or two or three years is worth $100 million a year, and the person who’s suing thinks it’s worth 30 million a year. And so he says, hey, I have a great idea, I’ll give him the 30 million and keep the 70. And — and that, I don’t see why that’s anticompetitive if that’s what’s going on.

Continue reading →

You Talkin’ to Me?

Posted on March 5, 2013 by Suzanne Rivera

by Suzanne M. Rivera, Ph.D.

The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and 2) avoiding the unjustified exclusion of any population ( whether out of bigotry, laziness or convenience).

Recruitment strategies invariably shape the selection of research subjects and the extent to which a pool of participants really represents a cross-section of society. Institutional Review Boards (IRBs) are charged with evaluating whether study recruitment plans and materials used to obtain informed consent are easily understood and free of misleading information. This is relatively straightforward when researchers, IRB members, and study subjects all speak the same language. But when studies are done in geographical areas that include numerous cultural and language communities, it can be quite tricky.

One of the barriers that prevents people from enrolling in (or even knowing about) studies is a lack of awareness and planning by researchers to address language differences. The human research protection regulations at 45 CFR Part 46.116 require that informed consent information must be provided to research participants (or their representatives) in language understandable to them. IRBs are supposed to be vigilant about this and require investigators to obtain translated Informed Consent Documents (ICDs) for use with non-English speaking research subjects. But researchers commonly balk at this expectation, saying it’s unreasonable. (A disproportionate number of objections have been raised to me thusly, “And what am I supposed to do if someone shows up speaking only Swahili?!”) Continue reading →

Impact of the Sequester on Health Care: By the Numbers

Posted on February 26, 2013 by kbooth

By: Katie Booth

The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care sector. Read on for sequestration by the numbers…

Medicare:

Medicare cut by 2% ($11 billion) (not set to begin until April 1st, 2013, unlike other sequestration cuts, which are set to begin on March 1, 2013)
Physicians’ payments cut by 2%
Hospital Medicare reimbursement cut by $5.8 billion
Hospitals could end up with especially large cuts under the sequester because other parts of healthcare system run on longer term contracts
Loss of almost 500,000 health care sector jobs in the first year of the sequester according to an American Medical Association and American Hospital Association study, including job losses for 40,000 practitioners such as physicians and dentists

FDA:

FDA cut by 8% ($318 million)
FDA public funding cut by $206 million
FDA industry user fees cut by $112 million (for an interesting discussion of user fee cuts and the sequester, see Patrick O’Leary’s Bill of Health blog post)
Cuts by department (assuming 8% across-the-board cuts): $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.5 million to Devices
Longer drug approval process is likely
Layoffs and furloughs likely
2,100 fewer food safety inspections

Continue reading →

Petrie-Flom Center to Work with NFL Players Association

Posted on January 30, 2013 by petrieflom

The Petrie-Flom Center at Harvard Law School is pleased to announce our involvement with the new “Harvard Integrated Program to Protect and Improve the Health of NFLPA Members.” The Program will be created through a $100 million grant to Harvard Medical School from the National Football League Players Association in order to launch a transformative 10-year initiative. The Petrie-Flom Center will work to address the critical ethical, legal, and policy issues relevant to the health of current, future, and retired players.

No Access to Medicines without Access to Research

Posted on January 29, 2013 by abenedict

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.”

Continue reading →

Guest Post on Animal Research: Animal Research Is an Ethical and Vital Tool to Fight Disease

Posted on January 14, 2013 by petrieflom

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir. We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research. Mr. Holder's post is below and Dr. Capaldo's post can be found here. As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Tom Holder

The Benefits

In the US alone there are over 95 million prescriptions every year for asthma medications, primarily inhalers. So what can over 25 million American asthma sufferers thank for making their lives manageable? The guinea pigs and frogs which allowed scientists to gain the underlying understanding about how chemical nerve transmitters helped to control the muscles in the airways, as well as create reliever inhalers with a long duration of action.

This is just one example of a long list of medical achievements made possible by animal research which include insulin (dogs and rabbits), polio vaccine (monkeys), anaesthetics (rabbits), blood transfusion (monkeys, dogs), antibiotics to cure tuberculosis (guinea pigs), asthma treatment (frogs and guinea pigs), meningitis vaccine (mice), deep brain stimulation (monkeys), penicillin (mice).

Herceptin, originally developed in mice, has had a significant impact on the survival rates for breast cancers. As a mouse antibody (now humanised) it would not have come about without the use of animal research. Mice, far and away the most common mammal used in scientific research, have also been used in conjunction with stem cell research to create a treatment for macular degeneration (one of the leading causes of blindness). This research, pioneered in mice, has now been used successfully to treat humans.

In a country where we eat 9 billion chickens and 150 million cattle, pigs and sheep every year, 25 million (approx.) animals (96% is estimated to be mice, rats, birds and fish) seems a small price to pay for medical progress.

Continue reading →

Guest Post on Animal Research: Inadequate laws don’t – but research alternatives will – protect animals in labs

Posted on January 14, 2013 by petrieflom

[Ed. Note: A few weeks ago, we had a post comparing the protections offered to humans and animals used in research, and it prompted quite a stir. We thought the issues merited more discussion from both sides, and therefore solicited blog posts from two divergent perspectives: Theodora Capaldo, President of the New England Anti-Vivisection Society and Tom Holder, founder of Speaking of Research. Dr. Capaldo's post is below and Mr. Holder's post can be found here. As always, we welcome discussion via the comment thread, but request that your comments be respectful and focused on the topic rather than the speaker.]

By Theodora Capaldo

When the New England Anti-Vivisection Society (NEAVS) launched Project R&R: Release & Restitution for Chimpanzees in U.S. Laboratories in 2006, 1,300 chimpanzees languished in U.S. laboratories. The campaign was a focused effort to end invasive and harmful research on the first non-human species in the U.S. Today, more and more chimpanzees are being transferred to sanctuary as momentum for the ethical and scientific cases against using them in biomedical research continues to grow. Though the Great Ape Protection and Cost Savings Act was one of many bills to not pass in the 112^th Congress, policy is taking shape that reflects an end to holding and using chimpanzees in US labs. This month an NIH-convened council is expected to release its report on current and future chimpanzee use in NIH-supported research. The report will address how the NIH will realize its commitment to follow the Institute of Medicine (IOM) of the National Academy of Sciences’ recommendations from an expert paneled and lengthy assessment of the need for chimpanzees. The IOM report could not find any area of current biomedical research where the use of chimpanzees is critical and concluded that any possible future use must meet strict criteria. As to future need, the IOM noted that it could not conclude whether there would or would not be such future need.

Given the weight of scientific evidence, legislative and government support, and public opinion, chimpanzees who have been subjected to years of trauma, confinement, and research will one day soon have the chance to live the remainder of their lives in sanctuaries. They will be “released” and provided the “restitution” that only a sanctuary of high standards is capable of providing. The plight of chimpanzees in US labs highlights the suffering of all animals in laboratories. The scientific arguments highlight that even a species as closely related to humans as chimpanzees is a poor, limited, and even dangerous model by which to study human health and the inferiority of all animal research compared to modern methods. Chimpanzees are a keystone species by which myriad issues regarding the use of animals in research can be measured. Survivors in sanctuary bear witness to the degree of harm and suffering caused to them and are another indictment of the lack of effective laws and enforcement of those laws for animals in labs.

In short, there are no effective laws protecting animals in laboratories. The Animal Welfare Act (AWA), the only U.S. federal law governing animals’ “welfare,” provides minimal protections for less than 10% of animals used in laboratories. It excludes rats, mice, birds, fish, reptiles, amphibians, and farmed animals in research.

Continue reading →

The Future of Biomedical Research Funding

Posted on December 11, 2012 by Patrick O'Leary

By Patrick O’Leary

As I’ve written about previously on this blog, the consequences for the FDA of budget sequestration under the Budget Control Act of 2011 could be fairly severe (as well as raise some interesting legal questions). In a recent Online First piece for the Journal of the American Medical Association (JAMA), Hamilton Moses and E. Ray Dorsey note that sequestration would also have a serious impact–to the tune of $2.5 billion–on the National Institutes of Health (NIH), the primary source of public funding for biomedical research in the United States.

While Doctors Moses and Dorsey acknowledge that the immediate consequences of such a cut would primarily affect young researchers and new applicants for funding, “exacerbat[ing] tensions between large infrastructure projects . . . and small investigator-initiated grants, which historically have been the primary source of new clinical insights,” they also argue that sequestration presents an opportunity to reevaluate our emphasis on publicly funded biomedical research. In their telling, sequestration would be just the most recent step in a nearly decade-long trend of reducing federal funding, a trend that “presents an opportunity to reshape biomedical research.” Moses and Dorsey call for new private sources of research support, ranging from specialized financial instruments like Biomedical Research Bonds to an increased role for public charities and private foundations. The future of biomedical research, they argue, will be built on the private sector, not the federal government.

The challenges of shifting the burden of funding research to the private sector are many, of course. One particularly challenging question is whether private funds could effectively replace NIH’s significant role in funding “basic” research. Bhaven N. Sampat’s new article “Mission-Oriented Biomedical Research at the NIH” in Research Policy provides some context for the scale of the problem. Citing a 2010 study by Dr. Dorsey himself, Sampat notes that although NIH funding accounts for only about a third of U.S. biomedical research funding, “there is a sharp division of labor, with NIH funding concentrated further upstream, on ‘basic’ research than private sector funding” from private sector pharmaceutical, biotechnology, and medical device firms. Although the role of private foundations has grown in recent years, Sampat notes that NIH funding continues to exceed all such funding “by a factor of six . . . .” Assuming we continue to value basic research, the capacity and willingness of private actors to fund such research thus remains a major question mark.

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