You Talkin’ to Me?

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?!”) Read More

Impact of the Sequester on Health Care: By the Numbers

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

Read More

Petrie-Flom Center to Work with NFL Players Association

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.

Read more from Harvard Law School:

Petrie-Flom Center will participate with HMS and University partners in 10-year project with NFL Players Association

[HLS Assistant Professor of Law I. Glenn Cohen, faculty co-director of the Center and] one of this year’s Fellows of the Radcliffe Institute for Advanced Study at Harvard University, will be a co-investigator on the 10-year project along with Holly Fernandez Lynch, the Center’s executive director.

The project, which will be known as the Harvard Integrated Program to Protect and Improve the Health of NFLPA Members, was announced on Jan. 28 by Harvard Medical School and the National Football League Players Association (NFLPA).

“Holly and I will be assuming leadership over one of the six aims of the project, the one that will address the ethical, legal and policy issues relevant to the health and health care of current future, and retired players,” said Cohen. “We will begin the 10-year project by conducting ‘listening tours’ in collaboration with the NFLPA, where we will get current and retired NFL players and their families to help us shape the agenda for our legal and ethical analysis. We will also be involving our students and colleagues at HLS and across the university in trying to wrestle with some of the thorniest legal and ethical issues involved, including: the appropriate role of players and teams in the management and employment and accreditation of team doctors and other medical staff, the privacy of players’ medical information and the ethical development of testing for injury, and liability and compensation for injured players. I feel privileged that the players will be entrusting us and the rest of the team with this vital responsibility.”

Cohen and Lynch will also serve as ethics consultants for the entire project, to help ensure that the clinical research is performed according to the appropriate ethical standards.

Said Harvard Law School Dean Martha Minow: “I am delighted and proud that the Petrie-Flom Center will be working with Harvard Medical School and others across the University on this extraordinary and much-needed project, and I am confident that together they will do something important for football, its players, and the country.”

For more information, see these selected news articles announcing the partnership:

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.”

Read More

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

[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.

Read More

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

[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 112th 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.

Read More

The Future of Biomedical Research Funding

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.