March 6, 2009
Obama Will Issue New Executive Order on Stem Cells
The Washington Post is reporting that President Obama plans to sign a new executive order governing federal funding for stem cell research on Monday. Rob Stein writes,
President Obama is planning to sign an executive order on Monday rolling back restrictions on federal funding of human embryonic stem cell research, according to sources close to the issue. Although the exact wording of the order has not been revealed, the White House plans an 11 a.m. ceremony to sign the order repealing one of the most controversial steps taken by his predecessor, fulfilling one of Obama's eagerly anticipated campaign promises.
The move, long sought by scientists and patient advocates and opposed by religious groups, would enable the National Institutes of Health to consider requests from scientists to study hundreds of lines of cells that have been developed since the limitations were put in place -- lines that scientists and patient advocate say hold great hope for leading to cures for a host of major ailments.
Administration officials would not comment immediately other than to say "there will be a stem cell related event on Monday." But an email sent out yesterday from the White House stated that officials were planning a ceremony on Monday "on stem cells and restoring scientific integrity to the government process. At the event the president will sign an executive order related to stem cells." Sources close to the issue, asking not to be named because they were not authorized to discuss the plan, said the order would lift the restrictions on federal funding of human embryonic stem cells. . . . .
Obama's Health Summit
The Associated Press provides a quick summary of the health summit, stating,
President Barack Obama summoned allies, skeptics and health care figures of all stripes to the White House on Thursday to debate ideas for overhauling the nation's costly system and declared, "The status quo is the one option that is not on the table." The big Washington session — Obama called it a health care summit — and meetings to follow around the country show the new president's push for expanded health insurance will be more open and inclusive than the Clinton administration's failed attempt 15 years ago. . . .
The U.S. system is the world's costliest and leaves an estimated 48 million people uninsured. Although he wants coverage for all, the president suggested a willingness to compromise even if it means not fully meeting his goal. That, too, was a break from former President Bill Clinton's posture in the 1990s when he promised to veto any health-care measure that didn't give him what he sought. . . .
On Capitol Hill, Democratic leaders in both the House and Senate rallied behind him, saying Thursday that they hoped to have a health care reform measure passed by the end of the summer. . . .
The New York Times Opinionator blog provides some quick takes from the Health Summit.
Also, NPR's morning edition and the NewsHour had some good overviews of some of the conversations that took place and the open minds that many seem to have about the ability to make health reform a reality.
March 4, 2009
Wyeth v. Levine: No Preemption
In Wyeth v. Levine, the Supreme Court in a 6-3 vote held today that a drug manufacturer's compliance with federal (Food and Drug Administration) regulations did not preempt the ability of an injured plaintiff to sue that manufacturer in state court. According to the Washington Post,
The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers. In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont. . . . The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.
A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery _ precisely what happened to Levine. The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.
Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning." Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs. Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion. Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia. . . .
March 3, 2009
Opposition to Health Care Reform
Well, that didn't take long. Politico.com reports on the group - Conservatives for Patients Rights -- and their media offensive against government-run health care. Jonathan Martin writes,
Firing some of the first shots in the coming showdown over health care, a conservative group led by the former owner of the Hospital Corporation of America is beginning a multimillion-dollar campaign Tuesday in opposition to government-run coverage.
Conservatives for Patients Rights is going on TV, radio and the Web in the same week President Barack Obama hosts a health care summit at the White House. The group’s leader, Richard Scott, is hoping a pro-free-market message will rally the right to join the fray on what may be the most hard-fought policy battle in the first year of the new administration.
“If we have more government involvement we’re going to have dramatically worse health care,” said Scott, the wealthy health care executive who is overseeing the effort and seeding it with $5 million of his own cash. Scott, a major GOP donor, is pushing for four principles to any health care reform package: individual choice, competition between carriers, giving patients’ ownership over their own coverage and rewarding those who make healthy lifestyle choices. . . .
“Imagine waking up one day and all your medical decisions are made by a central national board,” Scott says in the radio ad. “Bureaucrats decide the treatments you receive, the drugs you take, even the doctors you see.” He goes on to raise the prospect of “national boards” and “waiting lists” as in the nationalized systems of Great Britain and Canada. “That’s what some in Washington mean by reform,” Scott says in the spot.
Some on the left have already formed their own group, Health Care for America Now, a coalition to push for guaranteed health care for all Americans. The group has a $35 million budget this year and is planning on spending half of that on advertising in addition to holding grass-roots events in Washington, and in the districts of key members of Congress. . . .
Obama already has sought to rebut criticism that he wants a government takeover of health care by outlining eight principles of any overhaul, including letting patients stick with their own doctors and health care plans, reducing insurance premiums and guaranteeing that Americans will have a choice of health plans and physicians. Beyond that, the Obama administration has signaled that it will push back hard on conservatives who try to label Obama’s efforts as “socialized medicine” or a massive government takeover of day-to-day health decisions. In his radio address Saturday, Obama said he’s ready for a fight against anyone who tries to block his efforts to remake health care and other programs. . . .
Ethical Conflicts/Need for Disclosure at Harvard Medical School
Harvard Medical School students want more information about their professors - specifically who might be providing their professors money that may influence their classroom teaching and research. It is interesting that this article appears in the New York Times on the same day the Supreme Court considers when judges and justices should recuse themselves due to potential conflicts of interest. The Times reports,
In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects. Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.
“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.” Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes. . . .
The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money. . . .
Further, the potential embarrassments — a Senate investigation of several medical professors, the F grade, a new state law effective July 1 requiring Massachusetts doctors to disclose corporate gifts over $50 — are only now adding to pressure for change. The dean, Dr. Jeffrey S. Flier, who says he wants Harvard to catch up with the best practices at other leading medical schools, recently announced a 19-member committee to re-examine his school’s conflict-of-interest policies. The group, which includes three students, is to meet in private on Thursday. Advising the group will be Dr. David Korn, a former dean of the Stanford Medical School who started work at Harvard about four months ago as vice provost for research. Last year he helped the Association of American Medical Colleges draft a model conflict-of-interest policy for medical schools.
The Harvard students have already secured a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school. (One Harvard professor’s disclosure in class listed 47 company affiliations.) . . .
The rules, though, do not require them to report specific amounts received for speaking or consulting, other than broad indications like “more than $30,000.” Some faculty who conduct research have limits of $30,000 in stock and $20,000 a year in fees. But there are no limits on companies’ making outright gifts to faculty — free meals, tickets, trips or the like. . . .
A smaller rival faction among Harvard’s 750 medical students has circulated a petition signed by about 100 people that calls for “continued interaction between medicine and industry at Harvard Medical School.” A leader of the group, Vijay Yanamadala, 22, said, “To say that because these industry sources are inherently biased, physicians should never listen to them, is wrong.”
Encouraging them is Dr. Thomas P. Stossel, a Harvard Medical professor who has served on advisory boards for Merck, Biogen Idec and Dyax, and has written widely on academic-industry ties. “I think if you look at it with intellectual honesty, you see industry interaction has produced far more good than harm,” Dr. Stossel said. “Harvard absolutely could get more from industry but I think they’re very skittish. There’s a huge opportunity we ought to mine.”
Brian Fuchs, 26, a second-year student from Queens, credited drug companies with great medical discoveries. “It’s not a problem,” he said, pointing out a classroom window to a 12-story building nearby. “In fact, Merck is right there.” . . .
Dr. Glimcher says industry money is not only appropriate but necessary. “Without the support of the private sector, we would not have been able to develop what I call our ‘bone team’ in our lab,” she said at a recent student and faculty forum to discuss industry relationships. Merck is counting on her team to help come up with a successor to Fosamax, the formerly $3 billion-a-year bone drug that went generic last year. But Dr. Marcia Angell, a faculty member and former editor in chief of The New England Journal of Medicine, is among the professors who argue that industry profit motives do not correspond to the scientific aims of academic medicine and that much of the financing needs to be not only disclosed, but banned. Too many medical schools, she says, have struck a “Faustian bargain” with pharmaceutical companies. “If a school like Harvard can’t behave itself,” Dr. Angell said, “who can?”
March 2, 2009
Dignity and Control
Saturday's NewYorkTImes ran a moving story about Ms. Purdy who is facing some difficulty decisions as she considers how she best copes with her multiple schlerosis and her desire to have some say in her medical treatment at the end of her life. The article provides,
Multiple sclerosis came into Debbie Purdy’s life about the same time as her husband, a Cuban jazz violinist named Omar Puente. “He didn’t speak English, and I didn’t speak Spanish,” she recalled. “What we had was jazz, and a dictionary.” When she received her diagnosis, one of her first thoughts was: “How do you say ‘multiple sclerosis’ in Spanish?” . . .
But there may be a limit to the Purdy-Puente partnership, so close it feels almost symbiotic. The possibility exists that Ms. Purdy, 45, will get so sick that she no longer wants to live. Should that happen, she says, she plans to travel to an assisted suicide clinic in Switzerland and drink a lethal cocktail of drugs. As things now stand, she would have to go without her husband, she says, because helping someone die — even, say, by pushing a wheelchair onto the airplane — is illegal in Britain. It is her choice alone, Ms. Purdy said.
“Omar’s being prepared to go to jail because he loves me and respects my choices is the same reason I wouldn’t want him to go to jail: because I love him,” she said. “I’m not even prepared to let him be interviewed by the police.”
Ms. Purdy has taken her private struggle and turned herself into the latest public face of an anguished, longstanding debate about assisted suicide in Britain. She has sued the government in an effort to force officials to provide assurance that if Mr. Puente did help her die in Switzerland, he would not be prosecuted. Last week, her latest appeal failed when three Court of Appeal judges ruled that although they sympathized with Ms. Purdy, only Parliament could change the law. She is now considering whether to pursue the case further in the courts or to lobby for a new law.
Assisted suicide is legal in Switzerland. In recent years, about 90 Britons have killed themselves in the clinic, which is in Zurich. So far, no one back home has been prosecuted for helping them, but that does not mean it will not happen. “Many have faced police questioning and agonizing months waiting for the final decision not to prosecute,” said Ms. Purdy’s lawyer, Saimo Chahal. . . .
Mr. Puente, 47, who teaches and travels the world playing music, was away but spoke by telephone later. “Debbie was the woman I chose to be my wife,” he said. “I’ve seen the whole process, from when she was a very strong woman with a wonderful big bottom and strong legs, to using a walking stick to a wheelchair. She is still articulate and enthusiastic and full of life. She doesn’t want to die.” He does not want her to die either, and especially not alone. But, he added: “I love that woman and I don’t want her to suffer badly. Apart from everything else, she wants to control her life and make her own decisions.” . . .
But when you have a progressive disease, time moves in the wrong direction. If Ms. Purdy exhausts her options and cannot get the assurance she needs from the government, she is prepared to go to Switzerland alone, she said. But she would have to do it while she is still physically able, which would be long before she is ready to die, she said. She has worked out all the logistics, including how to get the $6,000 the trip would cost. That does not mean she will do it; she just wants the choice. “I don’t want to kill myself,” she said. “I don’t want to go to Switzerland and end my life early. But this is a security blanket.” She thinks often about what she can withstand. At what point does a life slip from manageable to untenable?
“When I was 20 and jumping out of airplanes, I thought being in a wheelchair would be unbearable,” Ms. Purdy said. “But it’s not. I thought asking people for help would be horrible and unbearable. “But what I consider dignity has changed, and what I consider unbearable and horrible has changed,” she said. “Having a stranger pick me up off my bathroom floor, that’s not undignified. What is undignified is having a stranger say that I have no control over my own life.”
Teaching Children About People with Disabilities
Apparently teaching children about people with disabilities is something that a few parents are relunctant to do or perhaps overly uncomforable. CNN.com reports on the responses a British children's television program has had to a host was born with with one hand. Lateef Mugnin writes,
A children's show host who was born with one hand is facing criticism from parents over her disability. BBC spokeswoman Katya Mira said the corporation has received at least 25 "official" complaints recently about Cerrie Burnell, new host of two shows on the BBC-run CBeebies television network, which is aimed at children younger than 6.
The official complaints do not count the dozens of negative comments lodged in Internet chat rooms, Mira said. In one chat room, a father lamented that Burnell being on the show forced him to have conversations with his child about disabilities. However, there have also been messages of support for Burnell. "We have also received 99 appreciations of her," Mira said. . .
A BBC news release in January introducing Burnell made no mention of her disability, but a publicity photo showed the right sleeve of her sweater pulled up, showing her arm stops just below her elbow. The issue has spurred a debate in England among newspapers, columnists and bloggers. Burnell said she has heard the criticism and will not let it bother her.
'It can only be a good thing that parents are using me as a chance to talk disability with their children. It just goes to show how important it is to have positive, disabled role models on CBeebies and television in general," Burnell said. . . .
March 1, 2009
Governor Sebelius is Nominee for Secretary of HHS
The New York Times reports that Kansas Governor Kathleen Sebelius has accepted President Obama's invitation to be his nominee for Secretary of Health and Human Services. Peter Baker writes,
President Obama asked Gov. Kathleen Sebelius of Kansas on Saturday to become his nominee for secretary of health and human services, tapping a red state ally to help him push through his plan to remake the nation’s health care system. Ms. Sebelius accepted the president’s offer and will be introduced by Mr. Obama at the White House on Monday, said administration officials, who spoke on the condition of anonymity to avoid upstaging the formal announcement. The selection comes just days before Mr. Obama hosts a health care summit meeting at the White House. . .
In selecting Ms. Sebelius, Mr. Obama has decided to risk running headlong into the nation’s volatile abortion wars. Since Ms. Sebelius’s name emerged as a leading candidate for the health job, anti-abortion groups have assailed her record and vowed to fight her confirmation.
Ms. Sebelius is Mr. Obama’s second choice to run the health department, following former Senator Tom Daschle, who withdrew his nomination amid a furor over his failure to pay $128,000 in taxes until his selection. Unlike Mr. Daschle, who had negotiated a dual-hat arrangement in which he would also be White House health czar, Ms. Sebelius would serve only in the cabinet. It remained unclear who might take over the White House position.
Although her main assignment would be running a large and complicated department with 65,000 employees, a $700 billion budget and involvement in everything from food safety to bioterrorism, Ms. Sebelius, if confirmed by the Senate, would presumably also be a key figure in the battle to extend health care coverage to more than 40 million uninsured people. . . .
Despite a record of working with Republicans in some areas, health care was one where she often had trouble forging bipartisan agreement. She tried raising cigarette taxes to pay for health care for the poor but was rebuffed by a Republican Legislature. She promoted universal health care but never reached that goal. And she proposed consolidating health care programs, but lawmakers made sure she could not control the new independent authority.
Abortion may prove a lightning rod in her confirmation. Ms. Sebelius, a Catholic, has repeatedly vetoed abortion regulations on legal or policy grounds. “Personally, I believe abortion is wrong,” she wrote in one veto message before explaining that she did not think the bill would reduce late-term abortions.
Ms. Sebelius has defended her record by pointing to adoption initiatives and falling abortion rates in Kansas, but the archbishop of Kansas City last year said she should not receive communion until repudiating her support for abortion rights. . . .
MSNBC.com has a brief overview of some of the challenges facing the Governor Sebelius if she receives confirmation as HHS Secretary. More about Governor Sebelius can be found in the Washington Post story here.