September 29, 2007
Potential Research Opportunities and Information for Students
ACS ResearchLink is an innovative project, created by the American Constitution Society for Law and Policy (ACS), designed to bridge the gap between the research papers law students must write and the needs of public interest lawyers. According to the ACS website, public interest lawyers need legal scholarship to assist them in assessing the strength of specific novel theories, but have limited time and resources. Law students must write substantial research papers that satisfy their schools’ writing requirements, but frequently struggle for appropriate and interesting topics. ACS ResearchLink answers the question: Why not give students the option of creating relevant and timely scholarship that will simultaneously serve the public interest? The interactive database allows lawyers to submit paper topics that students can search for ideas. After papers are written and graded under faculty supervision, they will be posted in the online library (the library should have its first papers in 2008). There are many paper ideas currently posted in the database from a range of organizations that include the ACLU, Lambda Legal Defense and Education Fund, various legal aid societies, and more. [JJ]
September 28, 2007
FDA and Clinical Trials
I suppose it should not come as a surprise but the FDA apparently has not been sufficiently protecting the interest of individuals who participate in clinical trials. The New York Times reports:
The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. In a report released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.
Perhaps we need a human PETA organization . . . . . I say that 1-21-09 cannot get here fast enough!
Senators and SCHIP
The New York Times reports on the Senate's passage of the reauthorization of SCHIP. It states,
The Senate gave final approval on Thursday to a health insurance bill for 10 million children, clearing the measure for President Bush, who said he would veto it. The 67-29 vote followed a series of speeches by Republican senators supporting the bill and urging Mr. Bush to reconsider his veto threat. Senator Pat Roberts of Kansas, one of 18 Republicans who voted for the bill, said the White House had shown “little if any willingness to come to the negotiating table.”
Republican opponents of the bill, like Senators Judd Gregg of New Hampshire and John Cornyn of Texas, said it would be a big step toward socialized medicine, would shift people from private insurance to a public program and would allow coverage for illegal immigrants and children in high-income families. Senator Charles E. Grassley, Republican of Iowa, said it was “intellectually dishonest” to make such “outlandish accusations.” Mr. Bush has said the bill would move toward “government-run health care for every American.” Senator Bob Corker, Republican of Tennessee, said those fears were unfounded. “What will move our country toward socialized medicine is not this bill, which focuses on poor children, but the lack of action to allow people in need to have access to private affordable health care,” Mr. Corker said.
The bill would expand the State Children’s Health Insurance Program to cover nearly four million uninsured children, in addition to the 6.6 million already enrolled. It would provide $60 billion over the next five years, $35 billion more than the current spending and $30 billion more than the president proposed. Mr. Bush has not shown a willingness to compromise. But he may come under pressure so from Republican lawmakers who do not like being portrayed as hostile to children’s interests.
Democrats have selected Graeme Frost, 12, of Baltimore, to deliver their Saturday radio address. He will appeal to the president to sign the bill. . . . .
Should be an interesting weekend . . . Here is further coverage from NPR.
September 27, 2007
Pharmaceutical Regulation Pre-emption of State Law
Law.com has a brief overview of the Warner-Lambert v. Kent, 06-1498 case recently granted cert. by the United States Supreme Court. It states,
The Supreme Court said Tuesday it will decide a case that centers on whether federal regulation of pharmaceuticals pre-empts state law. The case involves a product liability lawsuit against Pfizer's Warner-Lambert unit.
A group of Michigan plaintiffs led by Kimberly Kent in April 2000 sued Warner-Lambert Co. over alleged injuries caused by its Rezulin diabetes drug. Rezulin was ordered off the market in March 2000 by the Food and Drug Administration after it was linked to nearly 400 deaths and hundreds of cases of liver failure.
A federal district court dismissed the suit in 2005, citing a Michigan law that shields FDA-approved pharmaceuticals from liability lawsuits. The case was brought under Michigan law but was moved to federal court because other states were also involved.
An exception in Michigan's law that allowed the suits to proceed if a pharmaceutical company misrepresents information presented to the FDA was pre-empted by federal laws governing the regulation of pharmaceuticals, the district court said.
The 2nd U.S. Circuit Court of Appeals, based in New York, reinstated the suit. The appeals court disagreed that the exception in Michigan's law for cases involving fraud against the FDA was pre-empted by federal law. That decision conflicted with other appeals court rulings in previous cases. Such conflicts in the federal appeals courts are one criterion the justices consider when deciding to take a case.
The Supreme Court's interest in weighing in on the federal pre-emption of state laws is rooted in a surge of product liability lawsuits in state courts, "particularly in the area of drugs and medical devices," said Paul Smith, an attorney at Jenner & Block.
Brain Study Results Startling
http://pandagon.blogsome.com/Salon.com's Robert Burton has an interesting piece highlighting a recent study in the Archives of Neurology that a woman in a persistant vegetative state was "aware of herself and her surroundings." The article states,
In a recent article in the Archives of Neurology, a team of British and Belgian neuroscientists describe a clinically unconscious accident victim who can, on command, imagine herself playing tennis and walking around her house. By showing that her functional brain imaging studies (fMRI) are indistinguishable from those of healthy volunteers performing the same mental tasks, the researchers claim that the young woman's fMRI "confirmed beyond any doubt that she was consciously aware of herself and her surroundings, and was willfully following instructions given to her, despite her diagnosis of a vegetative state."
Their extraordinary conclusions are beyond provocative; they raise profound questions about the very notion of consciousness. What's more, they could throw thousands of families and doctors into utter turmoil. As with the Terri Schiavo controversy, patient advocacy groups, self-serving lawyers and politicians with personal agendas could use the study's stamp of certainty as a given.
Yet the study's conclusions are not beyond a doubt. There are plenty of questions about whether this young woman is conscious and capable of choice.
Amanda Marcotte at Pandagon responds to Burton's analysis of the study. She finds his concern that the Schiavo case and others involving PVS patients will be more problematic in the future. She writes,
Myth #1: The decision whether or not to terminate life support was about Schiavo’s specific condition.
Their extraordinary conclusions are beyond provocative; they raise profound questions about the very notion of consciousness. What’s more, they could throw thousands of families and doctors into utter turmoil. As with the Terri Schiavo controversy, patient advocacy groups, self-serving lawyers and politicians with personal agendas could use the study’s stamp of certainty as a given.
Burton doesn’t state that directly, but his statement here about how this study could “influence” the landscape invokes the anti-choice myth that this is about a very specific, unique circumstance in medicine, and it’s not really. The case was decided on two merits: Who has the final decision-making capabilities for the patient on life support and what were the patient’s wishes about the situation. The main relevance of her condition was whether or not she was far gone enough to put the decision to terminate in the family’s hands; but that fact wasn’t really up for dispute anymore. The real axis was whether or not
She clearly is not a supporter of Ms. Schiavo's parents. She has further thoughts on the study and Burton's analysis here (warning - some strong language). (I could not link directly to her post so you will need to scroll down a bit to find it. The Post is entitled, "Brain Flickers v. Who Decides").
September 26, 2007
UAW Strike Ends: What does it mean for Health Care
Emptywheel at the Next Hurrah ponders the question of what it will mean for health care in the United States when Unions begin to act as major purchaser of health care. Her commenters are not expecting much difference between GM and the Union in terms of bargaining power. She writes:
The UAW is about to become one of the country's biggest purchasers of health care.
Under the agreement, responsibility for the retiree health plan will shift to a Voluntary Employees' Beneficiary Association managed by the union. Details about how the VEBA will be funded have not been disclosed. But it is expected to involve a one-time payment of as much as $35 billion by GM, providing the union with money to invest and use to pay for retiree benefits while reducing the company's future expenses by billions of dollars. Creation of the retiree health trust is to be monitored by a judge and the Securities and Exchange Commission, according to GM's statement this morning.
At a Detroit news conference, UAW president Ronald A. Gettelfinger said the memorandum of understanding outlining the health fund would secure retiree health benefits for decades to come. . . . I'm especially intrigued by the possibilities of unions exerting a lot of sway in the health care industry. As the UAW becomes a bigger and bigger buyer, for example, they're going to be able to demand price reductions. Which means they might be able to offer affordable health care to unaffiliated workers who join the union.
SCHIP Passes House but Not by Veto-Proof Margin
ThinkProgress reports on the passage of the re-authorization for SCHIP in the House of Representatives. It states,
An overwhelming bipartisan majority in the House voted 265-159 tonight to pass the popular and successful Children’s Health Insurance Program Reauthorization Act. The support fell just short of the two-thirds majority needed to override Bush’s expected veto of the bill. Speaker Pelosi called on Bush to “dig deeply into his heart” before depriving millions of children of health insurance:
I’m reminded of the Bible tonight, and I speak with all of the sincerity and all of the hope to President Bush in the hope that he will change his mind. To dig deeply into his heart and think about the children in America who don’t have healthcare. Because if not, I think that the President is giving new meaning to the words, ’suffer, little children.’ Suffer, little children, if your parents can’t afford health insurance.
More about the run-up to the threatened Presidential veto here from the Kaiser Family Network.
September 25, 2007
Paying People to Lose Weight
The Associated Press reports on the idea that employers should pay employees to lose weight to save on health care costs. Apparently people do respond to such a financial stimulus. The AP states,
People will lose weight for money, even a little money, suggests a study that offers another option for employers looking for ways to cut health-care costs. The research published in the September issue of the Journal of Occupational and Environmental Medicine found that cash incentives can be a success even when the payout is as little as $7 for dropping just a few pounds in three months.
Unlike providing onsite fitness centers or improving offerings in the company cafeteria, cash rewards provide a company with a guaranteed return, the researchers said. "They really can't be a bad investment because you don't pay people unless they lose weight," said Eric A. Finkelstein, the study's lead author and a health economist at RTI International, a research institute based in nearby Research Triangle Park.
The study involved about 200 overweight employees at several colleges in North Carolina. One group received no incentives while two other groups received $7 or $14 for each percentage point of weight lost. Participants didn't get any help. Employees who received the most incentives lost the most weight, an average of almost 5 pounds after three months. Those offered no incentives lost 2 pounds; those in the $7 group lost about 3 pounds.
Finkelstein and co-authors Laura Linnan and Deborah Tate, professors at the University of North Carolina at Chapel Hill's School of Public Health, are analyzing data from a follow-up study that observed about 1,000 participants for a year. . . .
SCHIP in Graphic Form
From Payson Schwin at the AFL-CIO weblog, a representative graph concerning the cost of SCHIP and the Iraq War:
September 24, 2007
Professor Outterson at Seton Hall Law School
For those of you in the New York, New Jersey area, Professor Kevin Outterson, Boston University School of Law and Merck Visiting Scholar, will be speaking tomorrow evening at 6pm at the Seton Hall Law School. His talk is entitled, "Putting Patients First: Access to HPV Vaccines for Low- and Middle-Income Populations."
The HPV vaccine holds the promise to help dramatically reduce cervical cancer but remains out-of-reach for numerous women across the world due to its costs. Professor Outterson will address the issue of access to the life-saving vaccine and examine ways in which pharmaceutical companies and governments can support both access and innovation. More about his presentation here. It should be a great talk and provides information on a topic that often gets overlooked in the excitement over a new vaccine.
Today's Diane Rehm show has an interesting discussion on the reauthorization of SCHIP. It provides some lively analysis of the debate over the expansion of the program and the President's threatened veto. Here is the write-up for the program:
A popular children's health insurance program expires September 30th. The House and Senate have worked out a deal to reauthorize it. Two experts, a journalist and a U.S. Senator will discuss the deal on the State Children's Health Insurance Program (SCHIP)
Robert Greenstein, founder and executive director of the Center on Budget and Policy Priorities
Jonathan Weisman, reporter, "The Washington Post"
Nina Owcharenko, Senior Policy Analyst in the Center for Health Policy Studies at the Heritage Foundation
Sen. Charles Grassley, (R-Iowa), ranking member of the Senate Finance Committee
September 23, 2007
Buying Nursing Homes: Profit v. Patient Care
The New York Times reports on private investors purchasing nursing homes. What has been the result of the change in ownership -- well - according to the Times research - not good.
Regulators say residents at these homes have suffered. At facilities owned by private investment firms, residents on average have fared more poorly than occupants of other homes in common problems like depression, loss of mobility and loss of ability to dress and bathe themselves, according to data collected by the Centers for Medicare and Medicaid Services.
The typical nursing home acquired by a large investment company before 2006 scored worse than national rates in 12 of 14 indicators that regulators use to track ailments of long-term residents. Those ailments include bedsores and easily preventable infections, as well as the need to be restrained. Before they were acquired by private investors, many of those homes scored at or above national averages in similar measurements.
In the past, residents’ families often responded to such declines in care by suing, and regulators levied heavy fines against nursing home chains where understaffing led to lapses in care. But private investment companies have made it very difficult for plaintiffs to succeed in court and for regulators to levy chainwide fines by creating complex corporate structures that obscure who controls their nursing homes. By contrast, publicly owned nursing home chains are essentially required to disclose who controls their facilities in securities filings and other regulatory documents.
The Byzantine structures established at homes owned by private investment firms also make it harder for regulators to know if one company is responsible for multiple centers. And the structures help managers bypass rules that require them to report when they, in effect, pay themselves from programs like Medicare and Medicaid. Investors in these homes say such structures are common in other businesses and have helped them revive an industry that was on the brink of widespread bankruptcy. “Lawyers were convincing nursing home residents to sue over almost anything,” said Arnold M. Whitman, a principal with the fund that bought Habana in 2002, Formation Properties I. Homes were closing because of ballooning litigation costs, he said. So investors like Mr. Whitman created corporate structures that insulated them from costly lawsuits, according to his company. “We should be recognized for supporting this industry when almost everyone else was running away,” Mr. Whitman said in an interview. . . .
The Times’s analysis of records collected by the Centers for Medicare and Medicaid Services reveals that at 60 percent of homes bought by large private equity groups from 2000 to 2006, managers have cut the number of clinical registered nurses, sometimes far below levels required by law. (At 19 percent of those homes, staffing has remained relatively constant, though often below national averages. At 21 percent, staffing rose significantly, though even those homes were typically below national averages.) During that period, staffing at many of the nation’s other homes has fallen much less or grown.
Nurses are often residents’ primary medical providers. In 2002, the Department of Health and Human Services said most nursing home residents needed at least 1.3 hours of care a day from a registered or licensed practical nurse. The average home was close to meeting that standard last year, according to data. But homes owned by large investment companies typically provided only one hour of care a day, according to The Times’s analysis of records collected by the Centers for Medicare and Medicaid Services.
TalkLeft has a great discussion about this takeover and what it means for individuals considering long-term care for their loved ones.