Goldacre on Pharma Research Credibility

fpasquale 11 Comments

By Frank Pasquale

Ben Goldacre is once again arguing that pharmaceutical “industry-funded trials are too common, can’t be trusted — and bring pills to market that likely don’t work.” The NY Times features his argument today. He has exhaustively compiled problematic practices that add up to a shocking claim: “the entire evidence base for medicine has been undermined by a casual lack of transparency.” For example, here’s one vignette from his most recent book:

In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation — searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators — they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.

When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.

I have not come across a convincing industry or FDA response to Goldacre’s work. (I don’t find this brief letter particularly compelling.). He offers several case studies like the reboxetine one. Isn’t it time to fund systematic reviews of the evidence of effectiveness on all drugs?

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Humane Transport of Research Animals

srivera 2 Comments

by Suzanne M. Rivera, Ph.D.

For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals.  Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines, urging them to continue transporting animals needed for research purposes.  A copy of the coalition joint letter is available here.

The letter initiative was organized by the National Association for Biomedical Research (NABR), and had the strong support of the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), the American Association for Laboratory Animal Science (AAALAS), and Research!America, to name a few.

The basic thrust of the letter can be summarized by this passage: “Your company’s commitment to transporting laboratory animals is crucial to finding treatments and cures for diseases afflicting millions of people worldwide. We ask that you continue transporting research animals, allowing lifesaving research around the world to progress.” Read More

Dave Purchase and Naloxone, Life Savers

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

Start with the sad news of the week. Dave Purchase died, aged 73. Dave was the father of needle exchange in the US, which as far as anyone can say started with Dave and a TV tray in disregard of Oregon’s drug paraphernalia law. Dave was a father figure to a whole generation (or two) of harm reduction advocates and providers. The Times obituary hits the key points in his life story, but not the calm moral force he brought to the movement. He was a man who did the right thing, modestly and steadily, and inspired others to do the same. He saved more lives than most people ever will, and had more friends. We’ll miss him.

On the good news front, Dave would have been happy to spread the word about the latest study on overdose programs using naloxone. Alex Walley and colleagues from Massachusetts reported this week in the British Medical Journal on the effects of the Massachusetts program. Between 2006 and 2009, six community overdose programs were launched to teach potential bystanders about how to recognize and respond to overdose, including with the use of nasal naloxone. Walley’s study reports that the deaths went down in places with the programs compared to places without, and that the reduction was significant in places that had a high level of implementation.

Meanwhile, the removal of legal and financing barriers to overdose programs continues to be a fairly hot item on state legislative agendas. How about every state getting on board? This would be a fine week for a series of “Dave Purchase Life Saver Acts.”

Commission Seeks Interns for Summer 2013

The Petrie-Flom Center Staff Leave a comment

The Presidential Commission for the Study of Bioethical Issues advises the President on bioethical issues that emerge from advances in biomedicine and related areas of science and technology. The Commission works with the goal of identifying and promoting policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner.

The Commission staff performs original, archival and literature-based research, as well as policy analysis to inform the deliberations of the Commission. In order to fulfill our mission, we are seeking unpaid Summer 2013 interns. Candidates must be college graduates and have a demonstrated interest in bioethics, health, ethics, or public policy issues. Anticipated work will include research, writing, meeting preparation, and other projects as needed. Applications will be accepted through close of business February 28 and applicants will be notified at the end March.  Summer interns must commit to at least 10 weeks.

Please send cover letter, resume, writing sample(s), and references with contact information to:

Esther Yoo
Committee and Staff Affairs
Presidential Commission for the Study of Bioethical Issues
1425 New York Avenue, NW C-100
Washington, DC 20005
Esther.Yoo@Bioethics.gov

Applications by email are preferred.

Petrie-Flom Interns’ Weekly Round-Up: 1/26-2/01

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

The Salience of Numbers: W-2s Now List Cost of Employer-Sponsored Health Insurance

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By: Katie Booth

Beginning in 2013, W-2s for firms who file at least 250 W-2 forms will list the amount of money that employers and employees spend on health insurance premiums. As the New York Times reports, “[t]o some, it will be a surprise, perhaps even a shock.” Many people insured through their employer have no idea how much health insurance actually costs. The W-2 provision will change this, providing a yearly reminder about how much employer compensation goes into health insurance rather than wages. This gives employees exactly one salient number about health care: the yearly cost of their employer-provided health insurance.

More information for consumers about the cost of health care is a good thing, but making the cost of health insurance more salient may have some unintended consequences. Employees will be better able to compare the benefits of jobs with higher salaries but no health insurance to jobs with lower salaries and health insurance. This may lead employees to opt for lower salary jobs with health insurance, which could help decrease the number of employees who seek government-subsidized health insurance. The W-2 provision could, however, have the opposite effect. Now that employees can easily compare the cost of employer-sponsored insurance to government-subsidized insurance, employees eligible for government-subsidized health insurance may buy insurance through an exchange and then opt for a higher-paying job that does not offer insurance. Employers may be willing to pay the tax penalty, which is much less than the cost of insurance.

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Breaking News on Contraceptive Coverage Mandate

Holly Fernandez Lynch 1 Comment

News Release

FOR IMMEDIATE RELEASE
February 1, 2013		 Contact: HHS Press Office
(202) 690-6343

Administration issues Notice of Proposed Rulemaking on recommended preventive services policy

The Obama administration today issued proposed rules for public comment regarding contraceptive coverage with no cost sharing under the health care law. The proposed rules provide women with coverage for preventive care that includes contraceptive services with no co-pays, while also respecting the concerns of some religious organizations.

Today’s Notice of Proposed Rulemaking reflects public feedback received through the Advance Notice of Proposed Rulemaking issued in March 2012.  In addition, these proposed rules are open for public comment through April 8, 2013.

“Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,” said Health and Human Services Secretary Kathleen Sebelius.  “We will continue to work with faith-based organizations, women’s organizations, insurers and others to achieve these goals.”

The proposed rules lay out how non-profit religious organizations, such as non-profit religious hospitals or institutions of higher education, that object to contraception on religious grounds can receive an accommodation that provides their enrollees separate contraceptive coverage, and with no co-pays, but at no cost to the religious organization.

With respect to insured plans, including student health plans, these religious organizations would provide notice to their insurer.  The insurer would then notify enrollees that it is providing them with no-cost contraceptive coverage through separate individual health insurance policies.

With respect to self-insured plans, as well as student health plans, these religious organizations would provide notice to their third party administrator.  In turn, the third party administrator would work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies.

Insurers and third party administrators would work to ensure a seamless enrollment process. The proposed rules lay out how the costs of both the insurer and the third party administrator would be covered, without any charge to either the religious organization or the enrollees.

Additionally, the proposed rules simplify and clarify the definition of “religious employer” for purposes of the exemption from the contraceptive coverage requirement.  These employers, primarily houses of worship, can exclude contraception coverage from their health plans for their employees.

The proposed rules are available here: https://www.ofr.gov/inspection.aspx

A fact sheet on today’s proposed rules is available here:
https://cciio.cms.gov/resources/factsheets/womens-preven-02012013.html

For more information on women’s preventive services and the Affordable Care Act, visit: https://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html

Prosecuting Rape Victims, What Next?

Michele Goodwin Leave a comment
Representative Cathrynn Brown (Arizona)

By Michele Goodwin

In the wake of an election season peppered with references to rape by legislators vying for reelection or elevation to more prominent political positions: Representative Todd Akin’s woefully unscientific claim that “legitimate” rapes rarely result in pregnancy because women can “shut that whole thing down” or Richard Mourdock, Indiana state treasurer, reminding voters that when pregnancies result from rape “that it is something God intended to happen,” the deeply political intersections of criminal and health law became more visible.  Representative Joe Walsh (Ill), for example, claimed that “with modern technology and science, you can’t find one instance” where a woman’s life can be saved with an abortion.   Problematically, such comments to unwitting constituents parade as fact and stand contrary to vetted medical studies.   For example, a recent study found that “women were about 14 times more likely to die during or after giving birth to a live baby than to die from complications of an abortion.” An abstract of the study can be found here.

Months ago, I wrote that it would be a mistake to isolate these politically-charged comments to republicans or even male legislators; on inspection, recent personhood amendments and the passage of fetal protection laws expose bipartisan collaboration on laws that may be unconstitutional, undermine women’s reproductive health, and prioritize criminal law interventions over healthcare and rehabilitation. More of that work can be found here, here, and here.

Most recently, Representative Cathrynn Brown of New Mexico stepped into the political fray on rape, exposing once more the ways in which women’s reproduction can become hostage to political pandering.  Last week, Brown proposed House Bill 206, a law that would criminally punish rape victims who seek abortions.  According to Brown, obtaining an abortion after sexual victimization amounts to “tampering with evidence.” Rape victims could face felony charges and up to three years in prison for violating the law.

Likely, Brown’s rape bill will not gain sufficient political support for passage.  Nevertheless, recent political efforts to redefine rape, blame victims, and use the criminal law as a sword to regulate victims’ responses to rape deserve serious scrutiny and sustained critical engagement.