Petrie-Flom Interns’ Weekly Round-Up: 5/4-5/10

[Ed. Note: This will be the last intern round-up of the academic year, to resume in the Fall.  Thanks, Hyeongsu and Kathy!]

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 4/20-4/26

By Hyeongsu Park and Kathy Wang

  • Harvard University announced on Wednesday that it would shut down its primate research center over the next two years. The facility has been cited for animal welfare violations, but the university said that it was closing the research center due to a tough economic climate.
  • After a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, a New York Times article discusses a broader issue that follows: whether birth-control pills should require a doctor’s prescription. Various groups, gynecologists, and politicians are sharply divided on this issue. The author discusses procedural hurdles and safety issues around making the morning-after pills over-the-counter drugs.
  • Utah recently became the first state to explicitly permit general prisoners (not death-row inmates) to donate their organs if they die while incarcerated. The New York Times introduces discussions among various academic and health professionals regarding the law allowing prisoners to become organ donors.
  • After Colorado voters approved a measure in November legalizing small amounts of marijuana for recreational use, Colorado legislators will discuss taxes on marijuana and the plan to use the tax revenues this week. The legislators are considering excise and sales taxes on marijuana of up to 30 percent combined. The goal is to set taxes high enough to finance the administration of new laws, but not so high that customers are driven back to the black market.
  • A group of Texas optometrists is lobbying the State Legislature for more power to negotiate contracts with health insurance companies, and the measure they support could hit consumers’ wallets.
  • British antitrust authorities accused the pharmaceutical giant GlaxoSmithKline of paying three rivals to delay the introduction of a generic version of antidepressant drug.
  • A Pennsylvania judge on Tuesday threw out three of seven murder charges against Dr. Kermit Gosnell, who was charged with killing viable fetuses while performing abortions.

Petrie-Flom Interns’ Weekly Round-Up: 3/29-4/5

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 3/16-3/22

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 3/2-3/8

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 1/19-1/25

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 1/12-1/18

By Hyeongsu Park and Kathy Wang

  • After an estimated 500,000 patients in the United States have received all-metal hip replacements that are failing early in many cases, the Food and Drug Administration is proposing rules that will require manufacturers to produce clinical data to support their devices’ safety and effectiveness.
  • A study published in Science identified people from online searches of DNA sequences, age, and a state. The result raises concerns about the difficulty of protecting the privacy of volunteers involved in medical research.
  • The Obama administration says it will give states more time to comply with the new health care law after finding that many states lag in setting up insurance exchanges.
  • The Department of Health and Human Services (HHS) announced $1.5 billion in new grants Thursday for states to continue building their insurance exchanges under the Affordable Care Act. California, Delaware, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oregon and Vermont received funding.
  • Pharmacies around New York City struggled to meet the demand for flu vaccinations on Sunday, a day after Gov. Andrew M. Cuomo declared a public health state of emergency in response to a drastic increase in the number of flu cases this year.
  • A new type of flu vaccine that requires less manufacturing steps and shorter production time won regulatory approval on Wednesday, and its manufacturer said that limited supplies are expected to be available this winter.
  • Quebec is slowly moving towards legal euthanasia. A committee of legal experts has delivered a 400-page report to the provincial government which argues that it should allow “medical assistance to die” when a patient is close to death and is suffering from unbearable physical or psychological pain.

Petrie-Flom Interns’ Weekly Round-Up: 1/5-1/11

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 12/29-1/4

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 12/22-12/28

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 12/1-12/7

By Hyeongsu Park and Kathy Wang

Petrie-Flom Interns’ Weekly Round-Up: 11/10-11/16

By Hyeongsu Park and Kathy Wang

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 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: 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.

Continue reading

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. Continue reading