HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, February 14, 2009

Looking for a Date on Valentine's Day

Well, here is a helpful new website for those searching for a good match and so appropriate since we just  Darwin's Birthday and Valentine's Day are so close -- GenePartner.  DailyBeast tells us about this new dating site and states,

. . . . Darwinian dating will soon be available though online dating sites that offer GenePartner, which cheek-swabs that potential matches can use to gauge long-term compatibility. The premise is based on the somewhat controversial science of histocompatibility, which suggests that potential mates can "sniff out" immuno-diversity in each other, which helps produce more satisfying sex and healthier offspring. The success of this Switzerland-based service seems like a long-shot, but cofounder Tamara Brown, a sweetly persuasive Amelie-lookalike with a PhD in molecular genetics who met her own husband in 2002 on uDate, insists it helps users "find someone who will be biologically compatible, which means high attraction, better sex life and, if you choose to have children, a high possibility of healthy pregnancies and healthier children."-

Wow - it sounds so romantic . . .

February 14, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, February 13, 2009

Designer Babies

You would think that after the recent rather negative publicity over the birth of octuplets that fertility clinics would be revisiting some of their policies and reconsidering some of their practices.  Perhaps they are but this brief article in the Wall Street Journal's Health Blog states that they continue to practice in ways that appear unsafe and also continue to expand their services in ways that are certainly troubling.  Jacob Goldstein writes,

A clinic called the Fertility Institutes says it will start allowing parents to select for gender and physical traits in their babies, the WSJ reports this morning. The technology for doing so is emerging from a procedure called pre-implantation genetic diagnosis, or PGD, which was developed to test embryos for life-threatening diseases.  “It’s technically feasible and it can be done,” Mark Hughes, a pioneer of the PGD process and director of a large fertility laboratory in Detroit, said of trait selection. But he added that “no legitimate lab would get into it and, if they did, they’d be ostracized.”

Meanwhile, the American Society for Reproductive Medicine this week highlighted its “concerns” about California octuplets case. “Physicians have known for many years the dangers of multiple pregnancy,” the group said in a statement. . . . The ASRM notes that the percentage of procedures resulting in triplets or more has fallen significantly in recent years, to about 2% for a common type of fertility treatment. But as this morning’s New York Times points out, nearly a third of in vitro births involve twins or more.

Nadya Suleman, the mother in the octuplets case, has said her doctor transferred six embryos, two of which divided. ASRM has voluntary guidelines that recommend against this sort of practice, but “it seems that the guidelines may not have been followed in Ms. Suleman’s case,” the ASRM statement noted.

February 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Cure for Common Cold

The New York Times reports on a breakthrough in the search for the cure for the common cold - results from the genomes of the various cold viruses.   The story states,

Curing the common cold, one of medicine’s most elusive goals, may now be in the realm of the possible. Researchers said Thursday that they had decoded the genomes of the 99 strains of common cold virus and developed a catalog of its vulnerabilities. “We are now quite certain that we see the Achilles’ heel, and that a very effective treatment for the common cold is at hand,” said Stephen B. Liggett, an asthma expert at the University of Maryland and co-author of the finding.

Besides alleviating the achy, sniffly misery familiar to everyone, a true cold-fighting drug could be a godsend for the 20 million people who suffer from asthma and the millions of others with chronic obstructive pulmonary disease. The common cold virus, a rhinovirus, is thought to set off half of all asthma attacks.

Even so, it might be difficult to kindle the interest of pharmaceutical companies. While the new findings are “an interesting piece of science,” said Dr. Glenn Tillotson, an expert on antiviral drugs at Viropharma in Exton, Pa., he noted that the typical cost of developing a new drug was now $700 million, “with interminable fights with financiers and regulators.” . . .The industry has also learned in recent years that turning a genetic discovery into a marketable drug is far harder than once thought. . . . 

Industry hurdles aside, perhaps the biggest reason the common cold has long defied treatment is that the rhinovirus has so many strains and presents a moving target for any drug or vaccine. This scientific link in this chain of problems may now have been broken by a research team headed by Dr. Liggett and Dr. Ann C. Palmenberg, a cold virologist at the University of Wisconsin. The researchers, who conducted the genetic decoding with the aid of Dr. Claire Fraser-Liggett at the University of Maryland, published their insights into the rhinovirus on Thursday in the online edition of Science. . . . 

The rhinovirus has a genome of about 7,000 chemical units, which encode the information to make the 10 proteins that do everything the virus needs to infect cells and make more viruses. By comparing the 99 genomes with one another, the researchers were able to arrange them in a family tree based on similarities in their genomes.That family tree shows that some regions of the rhinovirus genome are changing all the time but that others never change. The fact that the unchanging regions are so conserved over the course of evolutionary time means that they perform vital roles and that the virus cannot let them change without perishing. They are therefore ideal targets for drugs because, in principle, any of the 99 strains would succumb to the same drug. . . .

There are at present no effective treatments for the common cold. Frequent hand-washing is the best preventive, Dr. Miller said. Once a cold has started, she recommended washing out the nasal passages, warm drinks and rest.

February 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 12, 2009

New Medicaid Patients

Last nigiht the NewsHour had a sad story about the increasing number of people qualifying for Medicaid and another story on the high cost of COBRA.    Both are worth of a listen as we learn about the increasing number of unemployed people in our country.

February 12, 2009 | Permalink | Comments (0) | TrackBack (0)

No Vaccine/Autism Link

The New York Times reports on the recent federal rulings on the lack of a link between childhood vaccines and autism.  Donald McNeil writes,

In a blow to the movement arguing that vaccines trigger autism, three Federal judges ruled Thursday against all three families in three test cases, all of whom had sought compensation from the Federal vaccine-injury fund. Both sides in the debate have been awaiting decisions in these cases since hearings began in early 2007; more than 5,000 similar claims have been filed with the fund. These three decisions, each looking into a different theory as to how vaccines might have injured the children, are expected to guide the outcomes of all those claims.

The judges ruled that the families seeking compensation had not shown that their children’s autism was brought on by the presence of thimerosal, a mercury vaccine preservative, by the weakened measles virus used in the measles/mumps/rubella vaccine, or by a combination of the two.

For example, in a case pitting the family of Michelle Cedillo, a severely autistic child, against the Federal Department of Health and Human Services, the special master for the U.S. Court of Federal Claims ruled that the Cedillos had “failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contributed to causing either autism or gastrointestinal dysfunction.”

In his strongly worded decision, the special master, George L. Hastings Jr. ruled that the government’s expert witnesses were “far better qualified, far more experienced and far more persuasive” than the Cedillos. Although the Cedillos only had to show that the preponderance of the evidence was on their side, the judge ruled that it was “not a close case” because the evidence was “overwhelmingly contrary” to their argument. While expressing “deep sympathy and admiration” for the Cedillo family, he ruled that they were “misled by physicians who are guilty, in my view, of gross medical misjudgment.” . . .

Pediatricians and government agencies welcomed the rulings. “Hopefully, the determination by the special masters will help reassure parents that vaccines do not cause autism,” the Department of Health and Human Services said in a statement released Thursday. As the administrator of the Vaccine Injury Compensation Fund, the department was the respondent in all three cases. . . .

In contrast, J.B. Handley, the founder of Generation Rescue, a group that blames vaccines for autism and advocates treating children with wheat- and dairy-free diets, vitamins and chelation to remove mercury from their bodies, wrote on the blog Age of Autism that the decision not to compensate the Cedillos was “an incomprehensible injustice.”

The compensation fund was created because it is recognized that vaccines are not risk-free.In a small number of cases they can cause seizures, high fevers and other symptoms. Some vaccines no longer routinely used in the United States, such as oral polio vaccine and the smallpox vaccine, could even in very rare cases bring on life-threatening infections quite like those they were meant to protect against. The fund was created to compensate those victims, and comes from a tax on all vaccines. . . .

The Wall Street Journal's Health Blog has more here.

February 12, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 11, 2009

Anthem Blue Cross Settles Over Dropped Patients

The LA Times reports on the recent settlement reached between Anthem Blue Cross and the California Department of Insurance.  Lisa Girion writes,

Anthem Blue Cross, the state's largest for-profit health insurer, has agreed to pay a $1-million fine and offer new coverage -- no questions asked -- to 2,330 people it dropped after they submitted bills for expensive medical care.  As part of a deal that the California Department of Insurance is set to announce today, Anthem also will offer to reimburse those people for medical expenses that they paid out of pocket after they were dropped. The company, a subsidiary of Indianapolis-based WellPoint Inc., estimated that those reimbursements could reach $14 million.  In exchange, the state agreed to drop its prosecution of its accusation that the company broke state laws in the way it rescinded members in preferred provider organization (PPO) policies between 2004 and 2008.

The settlement follows Anthem's agreement last year to pay a $10-million fine to settle similar charges involving 1,770 members in HMO-type policies overseen by the Department of Managed Health Care, another state regulator.  In both cases, Anthem agreed to make substantial changes in the way it sells and manages individual insurance coverage in California. Those changes, which include simplifying coverage applications, are expected to reduce the number of people who lose coverage through rescission.

The Anthem deal is the latest in a two-year effort by regulators to crack down on health insurers for dropping sick members on dubious grounds. It brings the last state rescission investigation to a close.  But insurers Anthem, Blue Shield of California and Health Net Inc. all remain targets of individual and class-action lawsuits alleging that they gamed insurance laws to dump sick people and avoid the costs of their care. . . .

"I am pleased that through this settlement, we have guaranteed reimbursement and restoration of coverage for the more than 2,300 people whose healthcare insurance was terminated without their consent," state Insurance Commissioner Steve Poizner said about the Anthem deal. "The settlement is a significant step towards ending rescission practices that can devastate consumers already weakened in their battle against illness."

Leslie A. Margolin, president of Anthem Blue Cross Life, the unit involved in the deal, said she too was pleased.  Margolin said the company would be contacting consumers over the course of the next 90 days and sending them information on how to participate in this settlement.  "Under the terms of the settlement, Anthem Blue Cross Life will invite these consumers to purchase coverage on a go-forward basis, regardless of past or present medical conditions," she said. "Additionally, these consumers will be eligible to receive reimbursement of prior out-of-pocket medical expenses."

Under the deals with regulators, rescinded patients can accept new coverage without forfeiting any legal rights. But they must waive their right to sue insurers in order to make claims for out-of-pocket medical expenses.  Critics say medical expenses often are only the beginning of the losses. In some cases, they say, patients were unable to get care because they couldn't pay for it, causing health conditions to worsen. In others, mounting medical bills damaged their credit and led to financial calamity. . . .

Jerry Flanagan, a patient advocate with Consumer Watchdog in Santa Monica, said Anthem's $1-million fine was "an insult to the people of California, especially those who have lived under the financial destruction caused by rescission."  The fine, he said, pales in comparison to what Anthem must have saved by rescinding policies for years. Anthem has never said what costs it avoided through rescission. But Health Net, in documents produced for the Bates trial, said it avoided $35.5 million by canceling 1,600 policies.  "A low fine encourages the company to rescind more policies because the company saves far more money on the policies it does not get caught rescinding," Flanagan said.

Darrel Ng, a spokesman for Poizner, said the commissioner's top priorities were winning back coverage and medical reimbursements for rescinded patients. Another goal was to close the door on improper rescissions by persuading Anthem to agree to changes in the way it does business and the threshold it uses for dropping coverage.

February 11, 2009 | Permalink | Comments (0) | TrackBack (0)

Food Safety Hearings on C-Span

Well, it probably isn't the most exciting television but it could be extremely important.  Today at 10am, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations has a hearing scheduled to discuss the "Salmonella Outbreak: The Continued Failure to Protect the Food Supply."   C-Span will have coverage.   Christy at Firedoglake has a post about witnesses who are scheduled to appear. 

Meanwhile, the New York Times has a debate concerning whether the United States needs a "Department of Food" (combining the food-safety aspects of the Agriculture Department, the FDA and other agencies) to protect consumers from tainted food.   Here is a list of the individuals providing their ideas on this topic:  David A. Kessler, former F.D.A. commissioner; James E. McWilliams, history professor; Jaydee Hanson, food policy analyst; Ann Cooper, chef; Bill Marler, lawyer specializing in contaminated food cases; Caroline Smith DeWaal, Center for Science in the Public Interest.

February 11, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 10, 2009

The Passing of Ms. Englaro

Ms. Englaro passed away today, three days after doctors at a private clinic reduced her nutrition intake.  The New York Times reports,

Italy190 The woman at the center of a right-to-die battle gripping Italy died Monday in a private clinic, ending a case that divided the nation and ignited a debate among Italian leaders and the Vatican. . . .

IDr. Carlo Alberto Defanti, a neurologist who followed her case for years, said she had died suddenly of “unexpected” causes, according to the Corriere della Sera, the Italian newspaper. As recently as Monday morning, doctors said Ms. Englaro was in stable condition. A court is expected to decide Tuesday whether an autopsy will be conducted, Italian news media said.

Ms. Englaro had been in a persistent vegetative state since a car accident in 1992. Her father fought repeatedly in court for the right to remove the tube, saying it was his daughter’s wish not to be kept alive artificially. The Catholic Church was vehemently opposed to removing Ms. Englaro’s feeding tube, saying it was tantamount to euthanasia, which is illegal in Italy. . . .

On Friday, when Ms. Englaro’s feeding tube was to be withdrawn, Prime Minister Silvio Berlusconi’s cabinet introduced an emergency measure forbidding the removal. The decree circumvented a high court decision, and Mr. Berlusconi submitted it even though President Giorgio Napolitano had called it unconstitutional and damaging to the balance of powers in Italy. Mr. Napolitano said he would not sign the measure.  Instead, late Friday, the emergency measure was drafted into a bill, and the Senate was considering it Monday when Ms. Englaro’s death was announced.

Italy has no legislation on end-of-life issues and does not recognize living wills. Over the weekend, some Italians began using YouTube to post their own living wills.Members of Parliament are expected to decide Tuesday whether to continue debating the four-line bill, which states that “pending more comprehensive legislation” on such matters, “in no case” can feeding tubes be removed from patients unable to make the decision for themselves. . . .

February 10, 2009 | Permalink | Comments (0) | TrackBack (0)

Meet the New Farma . . .

The New York Times reports on the FDA's approval of  a new drug made from a goat that had been given a human gene.

Images Opening the barn door to a new era in farming and pharmaceuticals, the Food and Drug Administration on Friday approved the first drug produced by livestock that have been given a human gene. The drug, meant to prevent fatal blood clots in people with a rare condition, is a human protein extracted from the milk of genetically engineered goats.

At the same time, the F.D.A. also approved the goats used to make the drug, the first such animals cleared under guidelines the agency adopted only last month to regulate the use of transgenic animals in the nation’s drug and food supply.

Made by a company called GTC Biotherapeutics, the human anticlotting protein is produced by a herd of 200 bioengineered goats living under carefully controlled conditions on a farm in central Massachusetts.

Proponents say such “pharm animals” could become a means of producing biotechnology drugs at lower cost or in greater quantities than the existing methods — which include extracting proteins from donated human blood or growing them in large steel vats of genetically engineered cells.

The protein in the goat milk, antithrombin, is sometimes in short supply or unavailable for pharmaceutical use because of a shortage of human plasma donations. GTC Biotherapeutics said one of its goats can produce as much antithrombin in a year as can be derived from 90,000 blood donations. And if more drug is needed, the herd can be expanded. . . .

Turning animals into walking drug producers does not sit well with some environmental advocates and animal rights activists. “It is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures,” the Humane Society of the United States says in its position paper on the practice.

There are other concerns: that the animals could be harmed, that animal germs might contaminate the drug, that the milk or meat from genetically engineered drug-producing animals might enter the food supply or that the animals might escape and breed with others, spreading the gene, with unpredictable consequences.

But the F.D.A. approval could now encourage drug makers to consider this type of production.  The F.D.A.’s move “really takes away one of the biggest issues that have always been on the table, which is how do regulatory agencies view this kind of technology,” said Samir Singh, president of the American operations of Pharming, another company using such technology.. . . .

February 10, 2009 | Permalink | Comments (0) | TrackBack (0)

Monday, February 9, 2009

Italy's Divided Response to Eluana Englaro

Reuters has the latest news on the Italy's divided response to the request of the father of Eluana Englaro to disconnect her feeding tube.  Silvia Aloisi writes, 

Inspectors Monday visited an Italian clinic that has stopped feeding a comatose woman to check whether it was qualified to do so and let her die.  The conservative government, which wants the woman kept alive, has raised objections to the use of the facility as a place for 38-year-old Eluana Englaro, in a vegetative state since a 1992 car crash, to die.  "We must do everything to stop her death," Health Minister Maurizio Sacconi said. "This is clearly an illegal situation."

Doctors at the clinic in the northern city of Udine stopped feeding her Friday, in line with a ruling by Italy's top court that she could be allowed to die.   Prime Minister Silvio Berlusconi, backed by the Vatican, has been trying to block the implementation of the ruling, saying depriving Englaro of food amounts to euthanasia, which is illegal in Italy.  . . . .

The case has divided the mainly Catholic country, with daily demonstrations and sit-ins by those who favor letting her die and those who say it is tantamount to murder.  It has led to a constitutional crisis pitting Berlusconi against the head of state and sparked a debate about whether the Vatican, by siding openly with Berlusconi, was unduly interfering.  For the third day in succession, Pope Benedict indirectly referred to the case, telling the new Brazilian ambassador to the Vatican that "the sanctity of life must be safeguarded from conception to its natural end." . . .

Englaro's father battled his way through Italy's courts for 10 years to have her feeding tube disconnected, saying it was her wish not to be kept alive artificially.  Berlusconi issued an emergency decree of Friday ordering doctors to resume feeding the woman but it was rejected as unconstitutional by President Giorgio Napolitano.  Now the prime minister is pushing through parliament, where he has a large majority, a law that would ban withdrawing food from unconscious patients. The Senate looks set to pass the law Tuesday, while the lower house should vote the next day. 

Englaro's doctor, Carlo Alberto Defanti, said that besides the irreversible damage to her brain, she was in good physical condition and it could take two weeks with no food and water before her heart stopped.

February 9, 2009 | Permalink | Comments (0) | TrackBack (0)

Health Care Still Budget Priority

The Treatment, The New Rebulic's Health blog, reports that President Obama is still committed to health care.  Johnathan Cohn writes,

The Obama administration’s health care czar may be gone, but here is one hint that its commitment to pursuing major health care legislation in 2009 remains in place. On Sunday, a senior administration official told me that health care would be a “central focus” of Obama’s first budget proposal.

The official didn’t specify precisely what that meant: Would the administration be asking for funds to make sure every American has insurance, or just a portion? Would there be major reforms of the way medical care is delivered? But even with that ambiguity, the statement seems to signal that Obama still takes health care seriously and hopes to pass significant legislation in the next year.

Here's why. For the last month, the leaders of major liberal interest groups and some of Washington’s top health care experts have been nervous that Obama would not seek funding for major health care legislation when he unveiled his first annual budget proposal. The source of this anxiety was a rumor, circulating widely, that some Obama economic advisors were pushing him to put health care on the back burner--or at least to move very slowly on expanding insurance coverage--because of the huge cost and political risks inherent in any major reform effor

Those concerns intensified late last week, once former Senator Tom Daschle withdrew from the administration because of the controversies over his tax records and ties to the health care industry. Daschle, an outspoken champion of making health insurance a universal right and using government to reduce the cost of medical care, was supposed to spearhead the administration’s health care reform push. He was also close to Obama personally. . . .

Publicly, Senators Max Baucus and Ted Kennedy, who have been working together to craft health care legislation, sent Obama a letter urging him not to give up the cause. Privately, they signed onto another letter--along with Representatives Charles Rangel, Geoge Miller, Pete Stark, and Henry Waxman. That second letter, according to several Capitol Hill sources, urged Obama to include health care in his first budget. A similar letter was sent by the reform coalition “Divided We Fail,” which represents the American Association of Retired Persons, the Business Roundtable, the National Federation of Independent Businesses, and the Service Employees International Union. . . . They also say he believes it is important to make sure everybody (or almost everybody) has insurance, because it’s not possible to control costs while so many people lack health benefits. "I've been in meetings with him and it's clear this guy is committed to getting health care and getting coverage to everybody," says one high-ranking member of the administration. "There's no question in my mind."

And while these advisers acknowledged that the question of whether to deal with health care in the next budget had been under discussion, another senior official on Sunday indicated a decision had already been made: “Health care reform will be included--and indeed a central focus--of the budget,” this official said, while declining to offer more details. Another adviser subsequently confirmed that. (All of these sources asked not to be named.) . . . .

February 9, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 8, 2009

State-by-State Food Safety

The Minneapolis Star Tribune points out an additional problem with our current food safety program - the various standards applied by the 50 different states.  David Shaffer writes,

The system -- if it can be called that -- relies on 50 states and hundreds of local health agencies with widely varied expertise, funding and methods to detect pathogens loose in the food supply. The Minnesota investigators, based in the state health and agriculture departments, have cracked cases when other states have followed the wrong trail or didn't see one at all. . . .

The problem affects all Americans because an outbreak in one state, if undetected, can quickly erupt elsewhere. The salmonella outbreak first identified last year has sickened 575 people in 43 states; eight have died, including three in Minnesota. It has created a furor over the safety of the nation's food supply, and food companies have pulled back nearly 1,700 peanut products, one of the largest food recalls in history.  Dr. William Keene, an epidemiologist for the Oregon Public Health Division, is among those who believe "there really isn't a national system. There is an amalgam of state and local systems." . . .

Thanks to Scott Finch at Daily Kos for pointing out this article.

February 8, 2009 | Permalink | Comments (0) | TrackBack (0)