HealthLawProf Blog

Looking for Health Care and Love in Canada

Cliff Schecter finds a different sort of advertisement for a mate and asks what it says about our health care system.  From his blog: 

Me: Writer, artist, teacher ... mother of two almost-grown sons ... vegetarian (but you don't have to be). Loves animals (two large dogs and three cats), gardening, house projects. The beach. Books. Travel. Financially solvent except for absurdly expensive health insurance premiums and medical costs.

You: Age 45 to about 57. Canadian citizen living in Vancouver, B.C., or willing to relocate there. Cancer patient or survivor. Open-minded. Bit of a risk taker. Warm hearted but not clinging. Bald OK.

It's not your typical posting of someone looking for a date. Granted, Jeanne Sather is looking for love and a best friend, according to this posting on her blog, assertivepatient.com. But what she was suggesting on the post was that she would like to marry a Canadian man so she could gain access to that country's publicly funded health-care system.  . . .

She estimates more than half of what she receives monthly in disability and child support goes toward her $800-a-month health insurance premium, and is still only a portion of what it costs to treat her disease. She said treating her cancer, which has now spread to her bones, is about $300,000 a year. She said she pays more than $20,000 of that out-of-pocket.

Potential Research Opportunities and Information for Students

ACS ResearchLink
http://researchlink.acslaw.org/

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]

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.

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").

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.

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:

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.

SCHIP Discussion

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)

Guests

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

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.

Health Insurance Lawsuits: Post-Claims Underwriting

Law.com reports on an increasing number of lawsuits against health insurers for post-claims unwriting (canceling policies on discovery of alleged inaccuracies in initial application) and discusses briefly an upcoming California case that could help clarify the law.

William Shernoff says he has been bringing lawsuits over canceled health insurance policies since the 1980s. Lately, however, that part of the Southern California plaintiff lawyer's practice has exploded: Last year, Shernoff filed about 70 lawsuits for people who have gotten stuck with hefty medical bills when an insurance company revoked their coverage by claiming they falsified or omitted important details on their applications. He's on pace to file about the same number this year.  So far, Shernoff says, litigation over the insurance companies' practice -- often referred to as post-claims underwriting -- hasn't led to any significant case law. . . . .

But next week, the Santa Ana, Calif.-based 4th District Court of Appeal will hear arguments in a closely watched case that challenges Blue Shield of California's practice of rescinding coverage based on inaccuracies in an application. If the challenge in Hailey v. California Physicians' Service, G035579, succeeds, plaintiff and defense lawyers say more cases may wind up in trial -- or lead to more lucrative settlements.

According to Michael Nutter, a Santa Ana solo representing the plaintiffs, Steven Hailey suffered a catastrophic car accident shortly after he and his wife enrolled in a health plan. When Blue Shield rescinded his policy, Hailey had to sign up with a new insurer and wait six months for surgery with a torn urethra and other injuries, Nutter said.

In court papers, attorneys for Blue Shield claim that Hailey lied on his application about his weight and concealed information about a recent hospital visit and a host of medical conditions.  More broadly, Blue Shield argues (.pdf) it can rescind coverage when someone's made a misrepresentation material to the company's decision to offer them a health plan.

Central to the case is California Health and Safety Code §1389.3: It suggests health care plans are responsible for resolving all reasonable questions about an application before entering into a contract, and generally prohibits post-claims underwriting. But it also expressly says it does "not limit a plan's remedies upon a showing of willful misrepresentation."

Plaintiff attorneys in the field contend (.pdf) that a showing of willful misrepresentation is required before yanking coverage; defense attorneys say the mention of willful misrepresentation does not amount to a prerequisite.  . . . If the 4th District requires a showing of willful misrepresentation, health insurers will likely find it harder to get cases thrown out early. "Even if the plaintiff's excuse was unbelievable, you might have some judges say, 'Well, let's have a jury deal with that,'" Pimstone said. Shernoff, of Claremont's Shernoff Bidart Darras, would jump at the chance to take other claims before a jury. In an amicus curiae brief filed in the Hailey case, Shernoff claims that Blue Shield has rescinded many members' coverage without investigating whether they intended to deceive the company.  "That means all the past decisions could have been in bad faith," he said, which could provide grounds for punitive damages.

Updates on SCHIP and Threatened Veto

The Government Executive.com website discusses recent visits from the new OMB Director Jim Nussle  to Congress concerning the SCHIP program and a vote to re-authorize it. 

President Bush has threatened to veto emerging State Children's Health Insurance Program legislation and appropriations bills that are $23 billion over his fiscal 2008 budget request. Even as he was starting meetings with key Democratic leaders and members of the Appropriations and Budget committees this week, Nussle, the former House Budget chairman, made it clear that he is not about to give ground on Bush's demands. . . .

Nussle lambasted the outlines of SCHIP legislation Democrats hope to send to Bush's desk by the end of the month as "veto-bait" and a "political strategy" to paint the administration as insensitive to low-income children more than a serious effort to renew the program.

"What they're doing is choosing political strategy over kids ... they can't get their work done, so they're going to send up something that they know is veto bait," Nussle said. "Everyone knows that; it's been as telegraphed as just about anything around here."  From a philosophical standpoint, Nussle rejected the proposed expansion of SCHIP and efforts to finance it through a cigarette tax increase.

"I think it will end up basically being the first big tax increase on the part of the Congress, and the president's been clear on that. So here we have another situation where we had an opportunity to improve a program that had unsustainable growth, and that was serving people outside of its ... original intent, and actually causing, potentially causing, people who were already under private insurance to potentially shift to government-run insurance, and that seems to be counter to everyone's intent," Nussle said. "So we'll have to look at it. But at this point in time, it looks more like a political strategy in search of a potential solution."

Democrats Monday answered Bush's veto threats by pointing to his 2004 campaign, saying he promised to enroll more children eligible for health insurance.  In a floor speech, Senate Majority Leader Harry Reid, D-Nev., pointed to the bipartisan support for the Senate bill and said the Senate "will not be intimidated by the president's veto threats."  A spokesman for House Speaker Nancy Pelosi, D-Calif., noted that all but three Republicans supported the proposed cigarette tax increase in the House version as part of a GOP motion to recommit, and that the majority of the bill's $272 billion, 10-year cost was financed by Medicare spending cuts.  "We will get a bipartisan bill to the president that insures millions more children, that is fully paid for and does not increase the deficit. For the sake of America's children, we hope the president will sign it," said Pelosi spokesman Nadeam Elshami.

The stalemate over SCHIP mirrors that over fiscal 2008 appropriations, as none of the 12 annual spending bills are likely to make it to Bush's desk in time for the end of the fiscal year on Sept. 30. That means an interim continuing resolution will be necessary to fund government operations, as will a short-term extension of the expiring SCHIP.

The Washington Post reports further that it isn't just the Democrats in Congress who favor this bill.  In today's paper, it states,

Republicans reacted angrily yesterday to President Bush's promise to veto a bill that would renew and expand the popular State Children's Health Insurance Program, raising the likelihood of significant GOP defections when the package comes to a vote next week.

"I'm disappointed by the president's comments," said Sen. Charles E. Grassley (R-Iowa), who urged Bush, in an early-morning telephone conversation yesterday, to support the emerging bipartisan compromise. "Drawing lines in the sand at this stage isn't constructive. . . . I wish he would engage Congress in a bill that he could sign instead of threatening a veto."

New Source of Life-Saving Stem Cells

Forget those old debates over embryonic stem cells -- Daily Kos points to an interesting article concerning a new scientific discovery conerning stem cells.  The Globe and Mail reports,

Men have a source of potentially life-saving stem cells between their legs.

A team of American researchers has found a way to easily identify stem cells in the testicles of adult mice that can be coaxed to turn into brain cells, muscle cells, heart cells, blood cells and even blood vessels.

One day, they say, male patients may be able to turn to their own testicles as a source of stem cells to repair an ailing heart or kidney or to fix the brain damage caused by Alzheimer's or Parkinson's disease.

The procedure would involve removing a small piece of testicle - about the same amount used for a biopsy. "We don't need a lot of material," says Marco Seandel, the lead author of a paper to be published today in the journal Nature and a stem cell researcher at the Howard Hughes Medical Institute in Maryland.

His team's work - and that of a German team also experimenting with stem cells extracted from testicles - is part of a growing international effort to look beyond the embryo for cells that can give rise to all human body parts and systems.

I have to agree with the editors at DailyKos who write, "Rarely has any medical breaththrough offered so many potential benefits to the population, while also providing such bounty to late night commedians."

Plenty of Flu Vaccine

After several years of shortages, this year there is plenty of flu vaccine for everyone.  Time Magazine reports the CDCs effort to encourage individuals to take advantage of the new supply: 

The ample supplies have the government urging vaccinations not just for people at highest risk of dying from influenza, but for anyone who wants to avoid a week of aching misery.

"Flu is a formidable foe," Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, said Wednesday. "It is not an illness we should be complacent about."

But new CDC data show only a fraction of people who need flu shots the most get them, including just one in five babies and toddlers. And there's wide geographic variation, with Rhode Island reporting the most high-risk adults vaccinated and Nevada the fewest.

Shots aren't the only option. Wednesday, the government ruled that it's safe for younger kids than ever before to try a nasal-spray vaccine called FluMist. Once only an option for people ages 5 to 49, FluMist now can be used by children as young as 2.

Flu usually peaks in February, so a winter vaccination isn't too late. Still, Gerberding advised seeking vaccine early in case flu begins striking before the usual November.

Palliative Care

This week's Journal of the American Medical Association contains a brief article discussing the adoption of palliative care by hospitals.   The article provides a concise definition and overview of the history of palliative care.  It states in part,

Despite advances in medicine and medical technology, there is a growing population of aging patients with complex health problems who are poorly served by even the best intensive care units. To help these patients, who often have multiple chronic conditions or various complications of acute conditions, hospitals are turning to palliative care, which focuses on symptom management, communication, and other means to improve quality of life for patients and their families. 

^{Palliative care may be delivered in concert with curative or life-prolonging medical care and is not prognosis dependent. These features distinguish it from hospice care, which offers symptom management for patients who are facing a terminal illness and no longer wish to undergo life-prolonging treatments, as well as other kinds of support for these patients and their families.}

Between 2000 and 2005, the number of hospitals with palliative care programs grew by 96% from 632 to 1240, according to the Center to Advance Palliative Care, which analyzed data from the 2007 American Hospital Association Annual Survey of Hospitals.

The field of palliative and hospice care became formally recognized as a subspecialty by the American Board of Medical Specialties in 2006. A record 10 specialty groups—anesthesiology, emergency medicine, family medicine, obstetrics and gynecology, internal medicine, pediatrics, physical medicine and rehabilitation, psychiatry and neurology, radiology, and surgery—endorse hospice and palliative medicine as a subspecialty of their fields.

USC Law Prof and Schizophrenia

The LaTimes recently ran this amazing and inspirational story about Professor Elyn Saks discussing her new book concerning her Schizophrenia.  The article reports,

Saks has schizophrenia, a severe mental disorder often characterized by social isolation, disorganized speech, delusions and hallucinations. She has defied the prediction of a doctor who once said she would never lead an independent life. She has even flourished, thanks to a strict regimen of medication and talk therapy.

Now she wants to dash the myths surrounding an illness that affects 3 million Americans: Schizophrenics aren't all emotionally out of touch, shouting and swiping at gremlins, shut away in hospitals. Like her, some lead productive lives with good friends, loving spouses and precious emotional triumphs.

At 51, Saks says, the time has come to reveal her secret. The San Francisco speech was one of her first major public forays.

Like the story of fellow schizophrenic John Forbes Nash, the Nobel Prize-winning economist and mathematician whose life was portrayed in the book and film "A Beautiful Mind," Saks' life illustrates not only the stresses mental illness places on personal and professional relationships but also how they can be overcome. . . .

On Aug. 14, Saks' memoir, "The Center Cannot Hold: My Journey Through Madness," was published. The secret was out.

As she prepared to address the American Psychological Assn. convention, Saks fidgeted.

"I'm nervous," she said.

Her book had received positive reviews. But there were hints of negativity: One USC worker told Saks she would have never gone to dinner with her had she known of her schizophrenia, afraid that one of Saks' delusional episodes could occur at any time.

Saks was speaking to her first large audience since her memoir had been published. She was never comfortable with public speaking, and her hands shook visibly as she took the podium, introduced by her old friend Steve Behnke.

When she finished, a lone woman rose to her feet, followed by more audience members. Quickly, the entire crowd was standing. The applause was prolonged and emotional as listeners lined up to speak with her.

September 20th: Two Great Events

My apologies for not posting these events sooner.   If you are in New York or Chicago tomorrow, you have a wonderful opportunity to attend an interesting and educational health law event.

DePaul University College of Law, its Health Law Institute, Center for Intellectual Property Law & Information Tehcnology Center for Public Interest Law and International Human Rights Law Institute and Doctors without Borders, present "Intellectual Property and Access to Medicines in the Developing World."

The program runs from 3-5pm tomorrow at the DePaul Center Room 8805, One East Jackson Boulevard, Chicago.  More information is available here.

Brooklyn Law School and its Center for Health, Science and Public Policy and the ABA Antitrust Section Committee on Health Care and Pharmaceuticals present, "Balancing Competition and Goverment Allocation of Health Care Resources:  The Berger Commission Report."

The program runs from 9am-12:3pm, at Brooklyn Law School, Subotnick Center 250 Joralemon Street, Brooklyn, New York.  More information is available here.

TB Patient and Potential Suit against CDC

Over at Concurring Opinions, Professor Daniel Solove looks into whether the infamous TB patient may sue the CDC for release of his name.  Professor Solove thinks that he may have a case and provides this overview of Mr. Speaker's life and potential lawsuit,

The WSJ blog points to this interesting update about the TB patient who was quarantined for having a highly-resistant strain of TB. I blogged about the case here and here. According to the news story, times aren't very good from Andrew Speaker, the TB patient:

Speaker was released from National Jewish on July 26, his treatment successfully completed. He takes 11 pills every morning at 8 a.m., supervised by public health officials who drop by on their way to work -- a standard regimen he will follow for the next two years to make sure the TB has been fully eradicated. He's in excellent health and has gone back to his previous routines, unmasked and unquarantined.

But his personal injury law practice is floundering, and his life is far from normal. His existing clients have stuck with him, but there have been no new clients since the ordeal began. The perception that he's a selfish jerk who thought nothing of exposing others to a deadly disease lingers.

"The CDC told everyone that I only care about myself," he said. "They made statements they knew were wrong. They intentionally went after my family and our character." . . . .

Speaker is also being sued in Canada for $1.3 million by eight passengers on his flight from Prague to Montreal for potentially exposing them to TB plus pain and suffering. The brother of one passenger is also suing.

At the end of the article is this interesting tidbit:

Does Speaker have any plans to sue the CDC?

"They're a federal agency. They have immunity," he said in resignation. "It's easier to think this guy is a jerk than that a government agency got together to intentionally misinform the public. That's much harder to believe."

What?

According to the news reports, Speaker's name was disclosed by government medical officials (probably CDC officials trying to cover their behinds for screwing up so badly). Medical officials have legal and ethical duties to maintain confidentiality. There's also a potential Bivens action for a violation of the constitutional right to information privacy. See Whalen v. Roe, 429 U.S. 589 (1977). Most circuits recognize the constitutional right to information privacy, and it is violated by unjustified disclosures of personal information, especially medical data. For example, in Doe v. Borough of Barrington, 729 F. Supp. 376 (D.N.J. 1990), the court held that the police could be liable for disclosing to a person's neighbor that the person was HIV positive. There are many other cases on point.

The short of it is that Speaker does have a case against the CDC if he can prove that CDC officials leaked his name and/or other medical information. It is clearly established that government officials have a duty of confidentiality of medical data under the constitutional right to information privacy in most circuits, so any qualified immunity claims would not bar liability (qualified immunity applies if the constitutional violation is not clearly established). . . .

Hillary Clinton Health Care Reform Proposal

Senator Hillary Clinton announced her proposal for health care reform today.   Her website states,

Building on her proposals to rein in costs and to insist on value and quality, her American Health Choices Plan will secure, simplify and ensure choice in health coverage for all Americans. This Plan covers every American - finally addressing the needs of the 47 million uninsured and the tens of millions of workers with coverage who fear they could be one pink slip away from losing their health coverage - with no overall increase in health spending or taxes. For those with health insurance, the plan builds on the current system to give businesses and their employees greater choice of health plans - including keeping the one they have - while lowering cost and improving quality.

The website then provides some specifics about how her plan would work.  Ezra Klein has his review here.  Overall, he finds much to like about the plan.  He states,

Here's the thumbnail: Clinton's plan is of the "individual mandate" variety, in which universal coverage is achieved by mandating that every American purchase health care. In order to ensure that that's both possible and affordable, the Clinton plan creates a few new coverage options, reform the insurance industry, limits coverage costs to a percentage of income, and washes your car.

Okay, it doesn't wash your car. It does open the Federal Employee Health Benefits Program to everybody, ensuring that anyone can access the same menu of regulated private options that federal employees get. FEHBP is the program that already insures millions of current government employees, including the members of Congress, by offering a variety of regulated private options to choose from. Throwing the doors to that program wide open is the most basic and ubiquitous of coverage solutions.

More importantly, the plan also creates a new public insurance option, modeled off, but distinct from, Medicare. That's a big deal: The public insurer offers full coverage and is open to all Americans without restriction. Public insurance is what I feared her plan would avoid, and instead, she embraced it wholeheartedly. The concern with a plan like this (as with the Edwards plan), is that insurers will market coverage to the young and healthy and subtly tilt the public plan's risk pool towards the old and sick (the check is that governmental plans are, for reasons related to administration costs and care incentives, cheaper). At the end of the day, there's not much that can be done about that, unless you want to tax insurers with overly healthy pools, as they do in Germany. Come to think of it, that's exactly what they should do -- it was even in the 1994 bill.

And if you don't go through the newly expanded FEHBP or the public option, preferring to keep your current insurance, you'll still be dealing with a heavily-regulated and reformed insurance industry, which can no longer price discriminate based on preexisting conditions or demographic characteristics, refuse you coverage, or deny renewal of your policy -- including if you change your job. So if you like your current insurance but quit your cubicled existence at MegaCorp, your insurer can't drop you. All this matters because it keeps the private programs from having too much capacity to undercut the risk pools of the other options. It also destroys the elements of the insurance industry's business model that rely too explicitly on screwing you over. . . .

He has some further thoughts here as well. There is more to the plan so continue reading at Senator Clinton's website or Ezra Klein's.  Firedoglake also reviews Senator Clinton's plan here - not as positive a review (putting it mildly).  The Diane Rehm show has a brief overview of the various candidate proposals for health reform here.  Senator Edwards' also has a health care plan and he provides more details on how he plans to ensure that his plan becomes the law - remove coverage from those in Congress.

Genes and Privacy and Relationships

The New York Times ran a front page cover story concerning a young woman's decision about whether to have a mastectomy based on her family's history of breast cancer and the results of a genetic test.  It was a rather revealing story and revealed quite dramatically the changes that genetic information holds not just for medical decision making but also for our relationships with family members.  The article discusses the young woman's options on learning about her increased risk for breast cancer and the advice she receives from her relatives about whether to pursue surgery:

Parents who have fought cancer typically have no experience with the choices that confront their children, and guilt over being the biological source of the problem can color their advice. Siblings and cousins who carry the risk gene evangelize their own approach to managing it, while those who dodged its inheritance seem unqualified to judge.

Even as she searched for her own answer in the year after her DNA test, Deborah Lindner, medical resident, found herself navigating her family’s strong and divergent opinions on the imperfect options that lay before her.

Her father, who once feared he would lose his wife to cancer, encouraged the surgery. Her sister reminded her that cancer might be cured in a few years if she could wait.  Her aunt said she hated to see her niece embrace a course of action akin to “leechings of the Dark Ages.” A cousin declined even to take the DNA test.

But it was her mother’s blessing that Deborah most eagerly sought.  Mrs. Lindner, who had passed her defective gene to her daughter, wanted to will her more time. When she had her own breasts removed she had been married for 27 years and had raised two daughters. Now Mrs. Lindner couldn’t shake the fear that her daughter might trade too much in her quest for a cancer-free future. What if taking such a radical step made it harder for Deborah to find someone special and become a mother herself?

The Next Hurrah has a great post on the article and states,

The story is a sign of our changing relationship with our genetic inheritance -- not only the substance of the story, but the very fact that an entire family's genetic pedigree and relevant medical data, with their photos, was published as a front-page story in a major newspaper. Maybe it's the exhibitionism of the reality TV age dovetailing with the post-genome era: only one member of the pedigree declined to have his name and photo published. (Why didn't the NYT respect his wish for privacy and just leave him off the tree?) Not only do we know more than ever about our genetic makeup, we are sharing it.

Importantly, our ability to read (and publish) our genes is outpacing our philosophy of when to do so. Ultimately, the answer is simple: it's up to the individual. But those individuals will want to make an informed choice, and (as I've written many times) in a setting where about 3/4 of us believe in angels but only 1/4 believe in evolution, the infrastructure is not in place for people to be savvy consumers of genetic information. Add into the mix the self-interest of counseling companies, pharmaceutical companies, and insurance companies and you get a recipe for confusion and frustration. . . .

And who gets to read your DNA? Your employer? Your insurance company? The government? New York Gov. Eliot Spitzer has been trying to expand DNA databasing to anyone convicted of a misdemeanor, and some states apparently collect DNA from anyone arrested (whether or not they are convicted). Will your DNA become a bit of personal information like your social security number -- putatively private, but in reality requested every time you fill out a form, apply for credit, visit your dentist?

Below these pragmatic concerns there exists a deeper question about humanity and free will. How "proactively" do we want to try to control our future, and to what degree should we realize that we may be able to lightly weight the dice, but in the end we can only really control our own attitudes toward what may come? Arlo Guthrie decided not to be tested for the copy of the gene that led to his father, Woody, dying of Huntington's disease, for which there is still no treatment. He recently passed the age at which his father died, and is still going strong without any sign of illness -- he said, "I spent the day talking to my dad about it, as it were [...] I said, 'All right, there's progress. And if my kids live a day older than I get to be, we're moving in the right direction, anyway.' "

According to the The New York Times, companies are anxious to inform the public about the availability of such tests and have started rather aggressive advertising campaigns.  The Times published an article last week discussing the concerns that some have over the manner in which companies advertise the availability of genetic tests.  The Times reports,

Breast cancer runs in my family,” one woman says. She is followed in quick succession by other young and middle-aged women, who say in turn: “My mother.” “My grandmother.” “My dad’s sisters.”

So opens a television commercial that is starting to run this week in New York and elsewhere in the Northeast. It urges women to consider being tested for certain genetic mutations that can sharply increase the risk of developing breast or ovarian cancer.   But the commercial, sponsored by Myriad Genetics, which sells the test, is stirring protests from some cancer and genetics specialists, and it has brought on an inquiry by Connecticut’s attorney general. Critics say that advertising such a complex screening test to the general population might create unnecessary anxiety among women and lead to overuse of the test, which costs $3,120.  “It really preys on the fears of our society, and one of those fears is getting breast cancer,” said Ellen T. Matloff, director of cancer genetic counseling at the Yale Cancer Center. . . . .

Myriad, which said it would cooperate with Mr. Blumenthal’s (Connecticut Attorney General)request, defends the commercial and other elements of what it calls a public awareness campaign. The company says that while its test has been given to about 200,000 women since 1996, only 3 percent of the women believed to harbor the harmful mutations that can be detected by the test have been identified so far. Therefore, the company says, there is a need for much more extensive testing.

Chemerinsky Update: Accepts Deanship

Professor Caron updates us again.

Chemerinsky Hiring/"Firing"/Protential Re-hiring: What Happened?

I don't know if any of you have been following (ok, how could you not be) the whole saga of the University of California-Irvine and its dean selection process that ended up in the press because they hired and then fired (or something close to fired) Professor Chemerinsky for reasons apparently related to his "controversial" political beliefs.  Now the LA Times reports that the law school may want to un-fire him.  Professor Paul Caron has a post detailing what both sides have said and some of the commentary and debate on the process. The AP Reports on the influence of politics in the decision and quotes a member of the county Board of Supervisors,

Making Chemerinsky the head of the law school "would be like appointing al-Qaida in charge of homeland security," Michael Antonovich, a longtime Republican member of the county Board of Supervisors, said in a voicemail left with The Associated Press.

Yikes - what an open-minded tolerant individual!  The Next Hurrah explains further some of the backgrounds of indiividuals involved in the Chemerinsky decision and provides some details on California politics. 

Blue Cross of California Meet Consumers

Blue Cross of California has decided to spend millions on dollars to lobby against health reform in California.  In response, a group called "It's OUR Healthcare" has set up a website, which contains personal stories, a blog and some utube videos.  The group states,

The state legislature is down to its final days of the session and Blue Cross alerted their list of insurance agent supporters that current reforms on the table are "unhealthy." (And the status quo isn't?)

If you're sick of groups like Blue Cross standing in the way of healthcare reform, then you'll love our new animated video released today at www.SickOfBlueCross.com/BrightSide. We're asking Californians to watch the video and sign our petition and tell Blue Cross: "Don't stand in the way of reform!"

Very creative!  In care you were not aware of what types of health care reform that are under consideration in California, if you visit the It's OUR Healthcare website, the right side of the page has a listing of recent articles detailing the California legislature's attempt at health care reform. 

New Orleans Nursing Home Owners Aquitted

TalkLeft has a brief story on the acquittal of the Manganos, the New Orleans nursing home owners who had been charged with negligent homicide in the deaths of patients at their nursing home.  The Washington Post provides some further background:

On Friday night, after four hours of deliberations, a jury acquitted the Manganos of negligent homicide, charges that could have put them in prison for life. The case raised broader questions about who, if anyone, deserves to be punished for the deaths in Katrina's deadly flooding.

Though numerous government agencies have been faulted for the disaster, the Manganos were the first and only people to be tried in a criminal court for any of the countless mistakes of planning that led to 1,800 deaths in the flooding that followed the storm late in the summer of 2005. . . . .

"I went back and forth for sure, but when it came down to it, the Manganos were not criminals," the juror, Kim Maxwell, 46, a secretary at a power plant, said later. "I just wanted to hug them." . . .

By all accounts, the Manganos' nursing home offered good care to its residents before the storm.

Mabel, the administrator, sometimes helped bathe and dress the residents; Sal, in charge of maintenance, stopped to spoon-feed those who could not feed themselves. Their son and daughter-in-law helped out.

Having been through Hurricane Betsy in 1965, the Manganos also believed that their nursing home had been built on a high spot and was less vulnerable to flooding.

The Manganos' fears for residents' safety during an evacuation were well-founded, too, according to expert witnesses who testified that nursing homes often suffer fatalities when evacuated.

The trial has been fraught with tears and bitterness, and the relatives of the dead and the Manganos have relived the tragedy.

"They killed 35 people," Joy Lewis, whose mother died in the flooding, said after closing arguments. She added that while she does not necessarily think the Manganos should go to jail, "they should pay" and the specific form would be up to God. "When they put their heads on their pillow at night," she said, "they'll pay."

NPR has additional coverage of the trial here and here.

Combatting Urban Health Myths

The Washington Post reported on the Centers for Disease Control and Prevention completed some interesting research on myths surrounding the flu vaccine and how pervasive they are.  The Post states,

The federal Centers for Disease Control and Prevention recently issued a flier to combat myths about the flu vaccine. It recited various commonly held views and labeled them either "true" or "false." Among those identified as false were statements such as "The side effects are worse than the flu" and "Only older people need flu vaccine."

When University of Michigan social psychologist Norbert Schwarz had volunteers read the CDC flier, however, he found that within 30 minutes, older people misremembered 28 percent of the false statements as true. Three days later, they remembered 40 percent of the myths as factual.

Younger people did better at first, but three days later they made as many errors as older people did after 30 minutes. Most troubling was that people of all ages now felt that the source of their false beliefs was the respected CDC.

The psychological insights yielded by the research, which has been confirmed in a number of peer-reviewed laboratory experiments, have broad implications for public policy. The conventional response to myths and urban legends is to counter bad information with accurate information. But the new psychological studies show that denials and clarifications, for all their intuitive appeal, can paradoxically contribute to the resiliency of popular myths. . . .

Research on the difficulty of debunking myths has not been specifically tested on beliefs about Sept. 11 conspiracies or the Iraq war. But because the experiments illuminate basic properties of the human mind, psychologists such as Schwarz say the same phenomenon is probably implicated in the spread and persistence of a variety of political and social myths.

The research does not absolve those who are responsible for promoting myths in the first place. What the psychological studies highlight, however, is the potential paradox in trying to fight bad information with good information.

Schwarz's study was published this year in the journal Advances in Experimental Social Psychology, but the roots of the research go back decades. As early as 1945, psychologists Floyd Allport and Milton Lepkin found that the more often people heard false wartime rumors, the more likely they were to believe them.  The research is painting a broad new understanding of how the mind works. Contrary to the conventional notion that people absorb information in a deliberate manner, the studies show that the brain uses subconscious "rules of thumb" that can bias it into thinking that false information is true. Clever manipulators can take advantage of this tendency.

The experiments also highlight the difference between asking people whether they still believe a falsehood immediately after giving them the correct information, and asking them a few days later. Long-term memories matter most in public health campaigns or political ones, and they are the most susceptible to the bias of thinking that well-recalled false information is true.

The experiments do not show that denials are completely useless; if that were true, everyone would believe the myths. But the mind's bias does affect many people, especially those who want to believe the myth for their own reasons, or those who are only peripherally interested and are less likely to invest the time and effort needed to firmly grasp the facts.

The research also highlights the disturbing reality that once an idea has been implanted in people's minds, it can be difficult to dislodge. Denials inherently require repeating the bad information, which may be one reason they can paradoxically reinforce it.
Indeed, repetition seems to be a key culprit. Things that are repeated often become more accessible in memory, and one of the brain's subconscious rules of thumb is that easily recalled things are true.

Many easily remembered things, in fact, such as one's birthday or a pet's name, are indeed true. But someone trying to manipulate public opinion can take advantage of this aspect of brain functioning. In politics and elsewhere, this means that whoever makes the first assertion about something has a large advantage over everyone who denies it later. . . .

Hospital Errors

Shannon Brownlee writing at the Washington Monthly discusses the recent studies published in the Seprember 5th edition of Journal of the American Medical Association (JAMA) on reducing hospital errors.  She writes,

HOSPITAL ERROR....Two large studies, published today in the Journal of the American Medical Association, found that cutting the grueling work hours of doctors-in-training had little effect on reducing hospital errors and patient deaths. Surprised? So were the researchers who did the studies.

There are three possible explanations. One, most errors aren't caused by groggy, sleep-deprived, over-worked residents, so giving them more time off won't make any difference in the error rate. Two, the new regulations, which cut residents' typical workweek from 100 hours to 80, didn't reduce their hours enough to make a difference. I mean c'mon, 80 hours a week still doesn't leave much time for eating and sleeping and all those romantic couplings we see on television shows like "ER" and "Gray's Anatomy." Or, three, the number of mistakes made in hospitals is so large, any drop in the errors committed by residents was too small to be measured.

My vote goes to . . . well, let me just offer a couple of statistics. In its seminal 1999 report on the subject, To Err is Human, the Institute of Medicine estimated that as many as 98,000 American patients are killed each year by medical error. Hospitals are such complicated places, the ways that care givers can screw up are almost too numerous to count. A doctor can accidentally perforate a patient's colon during a colonoscopy, leading to infection. Surgeons leave devices or sponges inside wounds and stitch patients up. One intensive care unit that tracked near misses reported 1.7 errors per day per patient, about 30 percent of which could have been serious or fatal. . . . .

The two studies published today suggest why that might be the case. The studies included 318,000 veterans who were cared for at Veterans Administration Hospitals and another 8.5 million Medicare recipients. It turns out, error rates did go down at VA hospitals, but not at the other hospitals in the study.

When it comes to reducing medical error, the VA health system has three things going for it that most other hospitals don't have. Numero uno, every VA hospital has a fully-functioning electronic medical records system.

This system not only helps physicians and nurses avoid many kinds of errors, like giving a patient the wrong drug, it also allows each hospital to track the treatment of every patient. Hospital safety officers can easily give physicians and nurses feedback on how they're doing when they implement any sort of error-reduction program. Other hospitals are left flailing along, hoping that they are making a dent when they initiate some new plan. VA doctors know -- and in real time.

And finally, VA hospitals do a better job of coordinating all the different people who have a hand in a patient's care. Veterans don't tend to fall through the cracks during hand-offs between one shift and the next, for instance. That's why my colleague Phil Longman's book about the Veterans Health Administration is titled Best Care Anywhere. It's also why a Democratic presidential candidate will probably be pointing to the VA in a speech later this month as one model for improving American health care.

MS Vaccine Passes Safety Hurdle

Science News Online reports on great news about the future development of a multiple sclerosis vaccine,

An experimental vaccine for people who have multiple sclerosis has proved safe, clearing a necessary first hurdle toward regulatory approval. The results of this initial trial also suggest that the vaccine can indeed quell the self-destructive immune reaction that many scientists believe causes the disease.

Despite this early promise, the researchers caution that the findings are based on data gathered from a small group over a limited time. The researchers used a technique called DNA vaccination, which introduces a gene into the body to elicit an immune response. But rather than rile the immune system against a foreign foe, the new multiple sclerosis (MS) vaccine seeks to induce immune tolerance of myelin basic protein, a component of myelin. A fatty material that protects nerves, myelin is degraded in MS, robbing patients of muscle control.

For the vaccine, researchers at Stanford University and Bayhill Therapeutics in Palo Alto, Calif., designed a DNA ring that encodes a slightly altered version of myelin basic protein. The changes replaced immune-stimulating parts of the protein with immune-suppressing ones.  Scientists gave 30 MS patients four injections over 9 weeks and then tracked their progress for a year. The study was made public this week and will appear in the October Archives of Neurology.  Periodic magnetic resonance imaging of the patients' brains showed that inflammation associated with the nerve damage of MS didn't worsen as a result of the vaccine. . . . .

"This is an important development in the field of MS therapy," says immunologist Gérald J. Prud'homme of the University of Toronto, who wasn't part of the study team. "This is the first demonstration of a beneficial effect of DNA vaccination in a clinical trial of autoimmune disease." The vaccine may inhibit myelin damage in several ways, Bar-Or says. For example, the vaccine's DNA apparently enters the nuclei of dendritic cells and other traffic cops that orchestrate immune reactions, he says. Because of the DNA's tweaked structure, the myelin basic protein that these cells then produce isn't seen as an enemy, and other immune cells decrease their responses against it. . . .

Meanwhile, the findings have cleared the way for a larger trial designed to assess whether the therapeutic vaccine can limit the nerve damage that marks MS. In that study, researchers have already given 290 patients a longer course of the vaccine than the safety study entailed. The team expects to release the results of the current study within the next year.

Human Genome Project Produces Results

McClatchy News reports on the latest and very exciting, developments resulting from the Human Genome Project

Four years ago, scientists triumphantly announced that they’d finished reading the entire human genome — the 3 billion "letters" of DNA that are the instruction manual for making a person.  Trouble was, they didn’t know how to make sense of the bewildering clutter of A's, C’s, G’s and T’s in the so-called "book of life." Now the genome project is beginning to bear fruit. A bumper crop of fresh discoveries connects specific bits of DNA to numerous diseases, including cancer, diabetes, blindness and AIDS.

New findings are being published almost weekly in scientific journals. Scientists say they're important steps toward future treatments or cures. "A whole series of studies is coming down the pike," Teri Manolio, a geneticist at the National Human Genome Research Institute in Bethesda, Md., told a genome conference in Boston this summer. "This is an unprecedented opportunity to apply genetics to disease."

The latest discovery is a report published in the journal Nature on Sunday declaring that two tiny changes in human DNA may add more than an inch to an individual’s height. An Aug. 2 paper in The New England Journal of Medicine identified other DNA variants that may predispose a person to a heart attack. Armed with such knowledge, doctors can recommend changes in lifestyle, such as losing weight and stopping smoking, that could save a patient’s life. . . .

The detection of a DNA variant related to a disease doesn’t mean that a cure is just around the corner. Some variants raise the risk of disease only slightly, and multiple genes are usually involved in complex diseases. The variant itself may not be to blame, but it shows the location along a strand of DNA where the trouble lies, helping resea