In These Tough Times, Young Children Provide Health Care for Parents and Grandparents

Posted on by
Reply

Tim WelchBy Tim Welch

As the incidence of chronic conditions such as diabetes increases across the nation (in 2007, there were 1.6 million new cases of diabetes diagnosed in people aged 20 years or older), more Americans are requiring long-term medical care.  Couple that with an economic recession that has millions of workers unemployed, without income or insurance, and unable to pay expensive hospital bills, and you have a serious health care crisis.  A recent article published in The New York Times described how the pressures of this crisis are frequently falling on the shoulders of American children.  As parents and grandparents are increasingly unable to foot the bill for medical care, children aged 8-18 are assuming the caregiver role.

According to the article, children across the country are being asked to perform various tasks often becoming of professional nurses, including, but not limited to, "lifting frail bodies off beds or toilets, managing medication [including injections], washing, feeding, dressing, and talking with doctors." 

Continue reading →

Sen. Grassley Investigates Payment to Harvard Researchers by Drug Companies

Posted on by
Reply

JulieBergerBy Julie Burger

When allegations were made public that academic researchers who conduct clinical trials were failing to report funding they received from industry (including the drug companies which produced the drug being tested), I suggested some ways medical centers or the government could assure the disclosure of these relationships.  U.S. Sen. Charles Grassley (R, IA) has launched an investigation into whether researchers are failing to disclose payments from pharmaceutical companies.  He found evidence that prominent physicians at prestigious universities failed to disclose payments from drug companies–some payments were even received while the doctor was conducting trials on a drug made by the company paying the physician.  Now the U.S. Attorney for the District of Massachusetts and the Inspector General of the Department of Health and Human Services have issued a subpoena to a law firm that represents States in their claims of Medicaid fraud against manufacturers of antipsychotic drugs.  The subpoena asks for information about researchers and their connections with the drug companies.

Continue reading →

Deciding the Fate of Frozen Embryos

Posted on by
1

Lori Andrews by Lori Andrews

What do Nadya Suleman and Barack Obama have in common?  The mother of octuplets and the President whose Executive Order allows funding for embryonic stem cell research have raised questions about the fate of frozen human embryos.

Over half a million human embryos are frozen in in vitro fertilization clinics across the country.  After Glenda and Scott Lyons had a child through in vitro fertilization, they decided to donate their 14 excess embryos to two other couples.  This month's Good Housekeeping contains an in-depth report of the couple’s decision and the unique family tree that resulted, with seven biological siblings being raised in three different families. 

Continue reading →

Commentary in Nature Suggests Changes in Licensing Practices for Gene Patents

Posted on by
Reply

Jake Meyer by Jake Meyer

This week, the scientific journal, Nature published a commentary about gene patents.  In their article, “The Dangers of Diagnostic Monopolies,” Robert Cook-Deegan, Subhashini, Chandraskharan, and Misha Angrist, state that “patents have not caused irreparable harm in genetic diagnostics, but neither have they proven greatly advantageous.”  458 Nature 405-406 (26 March 2009).  The commentary recognizes that gene patents do cause a problem through the monopoly provided by a patent or exclusive license.  Exclusive licenses are difficult to invent around and the reality is that exclusive rights to testing for multiple common genes or variants associated with a disease ends up in the hands of one provider, even if they’ve only patented one or two of the genes.  The authors, concerned with the effect of exclusively licensed gene patents on the patient’s rights, propose that patient’s rights should have priority over patent rights when the patent holder interferes with the purpose of patent law – “to promote public good through advancing science and technology.”  The authors state that the rights of the patient should trump the rights of the patent holder if the patent holder does not permit:

Continue reading →

Minnesota Families Sue Minnesota Department of Health, Allege that Newborn Screening Violates Informed Consent for Genetic Testing

Posted on by
Reply

Tim WelchBy Tim Welch

A group of families is suing the Minnesota Department of Health (MDH) for violating a 2006 genetic privacy statute that includes an informed consent provision for collecting genetic information.  The plaintiffs allege that MDH has taken blood samples from their newborn babies without their consent, tested the blood for various disorders, kept the blood samples in storage instead of destroying them, and shared the samples with various private entities and hospitals.  The plaintiffs allege that Minnesota state law (Minn. Stat. §13.386) prohibits MDH from "collecting, storing, using, and disseminating blood and genetic information."  In collecting and testing these blood samples, MDH is complying with another Minnesota law (Minn. Stat. §144.125) that requires the mandatory testing of newborns (called "newborn screening") for certain genetic diseases.

Minnesota is not the only state to require the genetic testing of newborn babies for hereditary diseases.  In fact, all states require testing for phenylketonuria (PKU) and congenital hypothyroidism.  Testing for PKU is generally considered justified, since a newborn diagnosed with PKU must immediately follow a strict diet, or suffer irreparable brain damage.  The number of diseases tested for ranges across the country from 4 to 32.  States decide which diseases to test for based on several criteria, including benefit to the newborn, validity and reliability of the test results, and safety and effectiveness of treatment.

Continue reading →

New Technology for Administering Glucagon Could Assuage Schools’ Fears, Save Children’s Lives

Posted on by
2

Tim WelchBy Tim Welch

Many kids with diabetes are having serious problems at school when it comes to potential emergency situations.  One of the issues that children and adults with diabetes face is the risk of severe hypoglycemia.  Severe hypoglycemia occurs when the body's blood sugar level gets too low.  It is an extremely dangerous and life-threatening condition, in which the body begins to shut down.  Without immediate treatment, the hypoglycemic person will lose consciousness and stop breathing.  If left untreated, the condition will lead to coma, brain damage, and death.

In a severe hypoglycemic emergency, the person may not be capable of swallowing food or liquids and cannot eat food or drink beverages to raise their blood sugar.  But fortunately there is a life-saving treatment.  Glucagon, a hormone that causes the liver to release glucose into the blood stream, can be administered to help the person who is suffering from hypoglycemia.  It is crucial that glucagon be administered immediately in order to save the hypoglycemic person's life.  Administering glucagon is also relatively low-risk, since it is safe to inject even if the person with diabetes is not suffering from hypoglycemia, but some other condition with similar symptoms.

Continue reading →

New Database Seeks to Be the Google of Medical Research

Posted on by
Reply

Jake Meyer by Jake Meyer

Stephen Friend, a former senior vice president at Merck & Co., and Eric Schadt, the former executive scientific director of a subsidiary of Merck & Co.,  have announced plans to create an open-access online database of medical research called Sage, with the hopes of making it the "Google of biological science."  Sage was designed "to create open access, integrative bionetworks, evolved by contributor scientists, to accelerate the elimination of human disease."  According to Friend, "biology has mostly been archivists building up stacks of data," producing "linear data that set out . . . variations, rather then give us an understanding."  By establishing a forum where researchers can view and post data, Friend hopes to create a dynamic database of clinical, genetic, and other molecular data where researchers can collaborate and develop novel solutions to complex diseases.  It will take time for the project to develop into the global network of scientists Friend imagines; however, he hopes to start by addressing a few core diseases, including metabolic diseases, diabetes, and cancer.

Studies conducted by researchers at Merck's subsidiary, Rosetta, which resulted in at least nine papers published in peer reviewed journals in 2008, serve as the foundational research for Sage.  To help launch the project Merck is donating equipment and software, the pharmaceutical company Whitehouse Station is donating genomic information that doesn't relate to its drug discovery programs, and the Massachusetts General Hospital (affiliated with Harvard Medical School) is donating brain tissue samples.  A 3-5 year "incubation period" is planned for Sage during which it will operate in partnership with only a select few universities (potentially including University of Washington, Yale University, and University of California at San Francisco).  During this period, Sage's governing rules will be tweaked and a tool kit will be created for submission and review of the database.  The development model of Sage is similar to Facebook by making the website available only to select universities with minimal features before expanding to researchers at other universities, and eventually the public. 

Continue reading →

Wyeth v. Levine: The Supreme Court Gets It Right

Posted on by
1

Bruce PatsnerGUEST BLOGGER Bruce Patsner, M.D., J.D.

On March 4, 2009 the United States Supreme Court decided that pharmaceutical companies can be sued in state courts for damages either from use of a drug or a failure to warn about the drug’s potential side effects, even if the Food and Drug Administration (FDA) has approved both the product and its label.  One could not have asked for a more sympathetic plaintiff:  a concert pianist who lost her arm as the direct result of receiving an intravenous injection of an anti-nausea prescription drug (Phenergan) with known potential to rarely cause vascular necrosis, information which FDA deemed too unimportant to include in the approved product label.

The bitterly contested and much-anticipated decision in Wyeth v. Levine was the most important food and drug law case to be decided by the Court in the last decade.  At issue was the question of whether the federal government’s regulation of the safety and efficacy of drugs under the Food, Drug and Cosmetic Act preempts the field and prohibits finding the manufacturer liable under state laws.  The ruling represents a clear win for injured patients and possibly the final nail in the coffin of the recently-minted doctrine of implied federal preemption of state tort claims, at least in the area of food and drug law.  Coming on the heels of the Court’s 8-1 decision last year in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which forcefully affirmed the express statutory preemption provision for damages claims against manufacturers of certain types of prescription medical devices, the 6-3 vote in Wyeth v. Levine was a relief of sorts and surprising not only in outcome but also because the vote was not really even close.

Continue reading →

Embryo Stem Cell Research–Politics and Science are Still Entangled

Posted on by
Reply

Lori Andrews by Lori Andrews

On Monday, President Obama gave the green light for federal funding of embryo stem cell research. Stem cell research provides potential new treatments. Embryonic cells can develop into all the types of cells in the body. In the future, doctors might be able to repair damaged hearts by inserting new heart cells or help people walk with the use of embryonically-derived nerve cells.

Prior to Obama's actions, the existing Bush position reflected a pro-life religious belief that an eight-cell embryo is a person and stem cell research, which of necessity destroys the embryo, is murder. In August 2001, Bush addressed the nation and said that he would only allow federal funding for research on existing embryonic cell lines. Bush did not want to be a party to the termination of any further embryos, but he would allow research on cell lines where the embryos had been terminated in the past.

Continue reading →

Coerced Korean Egg Donor Loses Case

Posted on by
1

JulieBergerBy Julie Burger

Debate over embryonic stem cells heats up once again, between proponents claiming the technology will be a panacea to cure the world's ills and opponents contesting the hype and raising ethical and legal issues.  One such issue hit the Korean courts on February 18—the coercion of egg donors.  The saga began when Hwang Woo-Suk, a South Korean researcher, was hailed for his groundbreaking research after he reported in Science in 2004 that he had successfully cultivated human embryonic stem cells from cloned embryos.  One year later, he reported the creation of patient-specific stem cells.  Both articles were retracted after reports surfaced that much of Hwang's work had been fabricated.  As the story unraveled, more ethical and scientific violations were revealed.

Hwang submitted duplicative photographic images of cells to Science which he falsely claimed supported his creation of different cell lines in 2005.  He also manipulated the DNA testing of the cell lines to support his desired results.  Allegations abound that Hwang switched samples to cover up the falsification of data and potentially embezzled research funds.

Continue reading →