Petrie-Flom Interns’ Weekly Round-up: 10/27 – 11/02

By Hyeongsu Park and Kathy Wang

  • Uruguay’s Senate approved a bill that allows women to have abortions during the first trimester of pregnancy for any reason. Read the NY Times article about the topic here.
  • Another NY Times article reported on October 27 that the nationwide health insurance plans sponsored by the federal government, included as part of the Affordable Care Act, will be available to consumers in every state soon. The article can be found here.
  • On November 1, the U.S. Centers for Disease Control and Prevention (CDC) reported that 28 people have now died and 386 have been sickened in the ongoing fungal meningitis outbreak linked to contaminated steroid injections from a Massachusetts specialty pharmacy. Read the US News article about the outbreak here. Current case count for the multistate fungal meningitis outbreak, updated daily by the CDC, can be found here.
  • The British Medical Journal has announced that, beginning in January, it will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data on request.
  • Researchers at the NYU Langone Medical Center in New York City are worried that cells, tissues, mice, and rats used for medical research may have been lost as the Medical Center has been without power since Monday after superstorm Sandy struck. Read an NPR article about the story here.
  • The annual growth in spending on Medicaid slowed sharply last year as the economy began to improve, a survey by the Kaiser Family Foundation found. The slowdown is due not only to more measured enrollment growth but also to continued cost-cutting by states.
  • In response to the recent meningitis outbreak, Massachusetts adopted new regulations on Thursday to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the outbreak.

 

Petrie-Flom Interns’ Weekly Round-up: October 20 – October 26

  • The NY Times reported earlier this week on a split decision regarding a surrogacy case in New Jersey Supreme Court. The court’s decision held little clarity in interpreting who has parenthood claims to children conceived through surrogacy–the donors of the child’s genetic material or the adults who raise the child. Read the details and decision of the case here.
  • An opinion piece highlighted the growing trend and importance of nurses acting in the capacity of family doctors in order to promote access to health care. Clinics of nurse-practitioners have been important in allowing patients to save on health care costs, receive faster treatment and diagnosis, and connect more deeply to their healthcare providers.
  • In a time when the efficacy of mammograms still has not been firmly established, a new controversy has emerged as some state laws have mandated that clinics tell patients about dense breast tissue. The conflict emerges because there has been no conclusive evidence that dense breast tissue actually holds much significance. Critics are worried these laws will lead to a flurry of unnecessary tests and biopsies; however, there are many in the medical community that also support these laws, so opinion remains heavily divided.
  • Another article by the NY Times reported on a settlement of a nationwide class-action lawsuit that will allow patients with chronic conditions or disabilities to qualify for Medicare coverage of outpatient therapy, home care, and nursing homes. This has the potential to affect tens of thousands who are suffering from chronic disease and their families that have had to foot the often exorbitant financial bill.
  • On Thursday, a federal appeal court refused the appeal of Planned Parenthood in its attempt to obligate the the Women’s Health Program of Texas to fund its organization.
  • NPR reported on a very contentious issue in Massachusetts elections this year: the “Death With Dignity” ballot question, which, if voter-approved, would legalize physician-assisted suicide. In the US, only two states have already legalized this initiative. Critics on all sides fear the abuse of this provision and worry that it will send a damaging message on the value of life. On the other side, proponents argue for patients’ rights. Either way, the vote in Massachusetts, considered a pioneer in health care among the states, could set the stage for further national debates and decisions.

Petrie-Flom Interns’ Weekly Round-up: October 13 – October 19

By Hyeongsu Park and Kathy Wang

  • In England, a High Court judge ruled that a profoundly brain damaged 3-year-old boy in foster care should not be given life support when his condition deteriorates, despite the wishes of his birth mother.
  • The lower house of the Swiss parliament declined to tighten controls on assisted suicide, which has been allowed in Switzerland since 1941 on a conditional basis.
  • Health officials are warning that more people may be at risk from contaminated drugs made by the New England Compounding Center (NECC), a Massachusetts company linked to a growing meningitis outbreak. The FDA reported on October 15 that the company’s products used for open heart surgery and eye operations may have also caused other types of infection. The FDA’s reports regarding the meningitis outbreak can be found here.
  • Health organizations wrote a letter to the president of the World Bank, Jim Yong Kim, urging him to support developing countries that want to introduce universal healthcare coverage.
  • The Presidential Commission for the Study of Bioethical Issues released a report last week that set down principles for regulation and legislation in the whole genome sequencing field. The report pointed out that the regulatory safeguards are necessary in order to protect the patients’ privacy. The report is available online.

Petrie-Flom Interns’ Weekly Round-up: October 6 – October 12

By Kathy Wang and Hyeongsu Park
  • Despite protests, Rhode Island instituted a mandate for flu shots for all healthcare workers. This includes doctors, nurses, other employees, and volunteers at hospitals, nursing homes, and health-related organizations.
  • Earlier this week, the FDA announced it would be taking action against thousands of illegal Internet pharmacies. This initiative is targeted towards protecting consumers from potentially unapproved, dangerous drugs or medical products.
  • British pharmaceutical company GlaxoSmithKline released its findings on data for drug trials while also pledging to devote more resources towards the discovery of new medicines. This move towards transparency and collaboration is thought to be a response to critics suspicious of secretive pharmaceutical practices.
  • In the midst of a recent meningitis outbreak spread from the use of medical steroids that have left over 130 sickened, lawmakers have calling for increased regulation of the pharmacy industry. Despite this, pharmacies have resisted and argued that regulation will only worsen the industry.
  • After a US government advisory panel in January suggested that research using deliberately modified strands of the bird flu could possibly endanger the public, most research was halted. However, 9 months after this moratorium, the debate continues.
  • On Thursday, the Journal of the American Medical Association published on online guide to the major health care and health policy issues that are shaping discourse in the 2012 election. Included are diagrams and tables representing voter demographics, political views, and economic implications of the different policies.
  • When two stem-cell scientists were announced to share the 2012 Nobel Prize for Medicine this week, some began to question the ethical implications of this award. A Bioedge article probes some of these concerns and finds the scientists should be also honored with a “Nobel Prize for Ethics” for their upstanding handling of contentious bioethical issues.

**And a few more from the editors:

Attention Disorder or Not, Pills to Help in School

This Election, a Stark Choice in Health Care

Pepsi and Coke to Post Calories of Drinks Sold in Vending Machines

Before a Wave of Meningitis, Shots Were Tied to Risks

Oakland Sues U.S. to Prevent Closing of Marijuana Dispensary

Suit Is Filed Over Move to Regulate Circumcision

Redefining Medicine With Apps and iPads

The Ups and Downs of Electronic Medical Records

Petrie-Flom Interns’ Weekly Round-up: September 29 – October 5

By Hyeongsu Park and Kathy Wang

  • On October 1, under the Affordable Care Act, Medicare started fining hospitals that have too many patients readmitted within 30 days of their discharge because of complications. A Seattle Times article covers this news.
  • On September 28, the Food and Drug Administration launched a national campaign, called BeSafeRx, to alert the public to the danger of internet pharmacies. A USA Today article reports the news in detail.
  • The Montana Supreme Court held that state restrictions on medical marijuana access and sales do not violate patients’ rights to pursue health care under the state constitution, reversing a district court opinion that blocked enforcement of new regulations on medical marijuana.
  • Ethics & Health Law News introduces Nicolas Terry‘s article about the threats to health privacy posed by recent development in data collection and processing. Terry suggests incremental revision the Health Information Technology for Economic and Clinical Health (HITECH) Act and the Health Insurance Portability and Accountability Act (HIPAA) to regulate the collection and processing of health data. The article can be found here.
  • On September 25, the Ninth Circuit Court of Appeals ruled that parents whose children are harmed or killed by allegedly defective vaccines can’t sue the manufacturers for damages and must instead accept no-fault compensation from a national tribunal for vaccination injuries, upholding the dismissal of a suit brought by a couple whose baby son died after an immunization shot. A San Francisco Chronicle article about the news can be found here.
  • Last week, a national anti-tax activist Grover Norquist, in a letter to Georgia legislators, requested that they drop the hospital fee that raises money for the state’s Medicaid program. Norquist’s letter ignited a heated discussion over Georgia’s hospital tax. A Kaiser Health News article introduces the story.
  • According to a survey at the University of Calgary in Canada, 45 percent of respondents said that money is an acceptable incentive for organ donations from living donors, and 70 percent of them responded that cash is an acceptable enticement for people to donate their organs after death. Dr. Manns, a researcher on the survey, suggests the need to consider a system that compensates organ donors. A detailed story about the survey can be found here.

Petrie-Flom Interns’ Weekly Round-up: September 16-28

[Ed. Note: We have a few weekly round-ups available here at Bill of Health (from Yale’s Interdisciplinary Center for Bioethics, and from Nic Terry‘s list of what’s worth reading each week), but we’ll give you one more from our Petrie-Flom interns for good measure.  And this week – a bonus!  A two-week round-up…]

By Hyeongsu Park and Kathy Wang

  • On Thursday, September 20, the Appellate Court of Illinois ruled that pharmacists can refuse to dispense emergency contraceptives because of religious beliefs. The court’s opinion can be found here. (And Nadia Sawicki’s post here.)
  • An article published on guardian.co.uk introduces Ben Goldacre’s book Bad Pharma: How drug companies mislead doctors and harm patients. The book describes how drug manufacturers do not disclose full information about the drugs they produce to doctors and patients, resulting in potential harms to patients.
  • The Inter-American Court of Human Rights will decide within the next few months whether Costa Rica, the only country that forbids in vitro fertilization, has infringed basic rights with its ban.
  • Two Swedish women have donated their wombs to their daughters hoping that the daughters will be able to bear children. These are the world’s first mother-to-daughter uterus transplants.
  • A BioEdge blog introduces Tom Koch’s book Thieves of Virtue: When Bioethics Stole Medicine. The book unsparingly attacks the entire discipline of bioethics and questions its raison d’etre.
  • A recent Congress-mandated report by the National Research Council voiced concerns over the implications of a growing, aging population on the economy and federal policy. The Council and corresponding experts expressed their doubts over the sustainability of programs such as Medicare, Social Security, and Medicaid and urged for policy makers to find alternatives to these programs.

Read More

New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More