HealthLawProf Blog

Americans Want Health Reform

The New Republic's Jonathan Cohn reports on a new poll in the International Herald Tribune showing that four out of five Americans would like to see our health care system completely overhauled.  He writes,

 

. . . . On behalf of the International Herald Tribune and France 24 television, Harris Interactive surveyed people in the U.S., Britain, France, Germany, Italy, and Spain. The findings? Four out of five Americans say the system needs fundamental changes or a complete overhaul--the highest of all the countries surveyed.

Just to be clear, the number of dissatisfied people was pretty high in most of the countries. But in the other countries, it's more people calling for "fundamental changes" rather than a "complete rebuilding." And, having just spent some time in these countries, I suspect a lot of that is concern over long-term financing. They want to sustain what they have--and are worried that, given medical care's escalating costs, they will have trouble doing so in the future. It's a valid concern but, of course, one that only makes their systems look even better relative to ours, since they already spend far less than we do.

In any event, the citizens of one country actually did seem pretty satisfied with their health care system. That country is France. But this is hardly surprising. People who follow health care closely--like Ezra Klein, Victor Rodwin, and, yes, me--have been talking up the French system for a while. French national health insurance offers convenience, a high level of services, plus universal coverage--again, all at a significantly lower price tag than in the U.S. The system is far from perfect, but, overall, it seems like a far better deal than what we give our citizens.

                                      

Obama's First 100 Days: Health Care

Ezra Klein comments on Obama's speech discussing what he would do during his first 100 days in office.  He would focus on health care - as well as some other items obviously.  Ezra writes,

Speaking at a fundraiser in Denver last night, Obama was asked what he'd do in his first 100 days. The answer? After sitting down with the Joint Chiefs of Staff to figure out a strategy in Iraq, "[G]et our health care plan moving. We need a bill...by March or April to get going before the political season sets in." For those of us into the politics of this issue, that timetable is big news. Doing health care quickly is crucial. You can't lose your momentum. You can't get bogged down in the endless unknown events and unexpected crises of a presidency. You need a strategy and you need momentum and in order to preserve those things, you need to move. This is what Clinton failed to do in 1993. . . .

Global Warming as Public Health Threat

The Washington Post writes about the EPA's report on the impact of global warming and the various health risks it poses to individuals.  Andrew Revkin states,

The Bush administration, bowing to a court order, has released a fresh summary of federal and independent research pointing to large, and mainly harmful, impact of human-caused global warming in the United States. The report, released Thursday, is online at climatescience.gov, along with a new report updating the administration’s priorities for climate research.

Most of the findings, like the spread of warmth-loving pests and the inevitable loss of low-lying lands to rising seas, are not new. But the report included new projections of how the poor, elderly and communities with lagging public-health and public-works systems will face outsize health risks from warming.

Among the report’s new conclusions on health: “An increased frequency and severity of heat waves is expected, leading to more illness and death, particularly among the young, elderly, frail and poor.” It added that deaths from cold would decline, but said uncertainties on both projections made it impossible to characterize the overall risk.

It gave high odds (essentially a two out of three chance) that Lyme disease and West Nile virus would have expanded ranges because of warming. The report gave the same odds that some food- and water-borne diseases would also increase among susceptible populations, but said “major human epidemics” were unlikely as long as public-health systems remained effective. . . .

Obama's Health

Obama's doctor revealed today that Obama is in excellent health.  The New York Times reports,

Senator Barack Obama was in “excellent health” at the time of his last examination more than a year ago, according to a letter released today by his physician, and has no known medical problems that would affect his ability to serve as president. 

It is the first time Mr. Obama, 46, has publicly released information on his medical history or current health condition. The brief statement summarized the senator’s health for the last 21 years and was signed by Dr. David L. Scheiner , who has been Mr. Obama’s primary care physician for more than two decades.

Mr. Obama’s “family history is pertinent,” according to the doctor, who noted that the senator’s mother died from ovarian cancer and his grandfather died of prostate cancer. Mr. Obama’s smoking history – off and on for at least two decades – also was noted. . . .

The Wall Street Journal Health Blog wanted to know about the cigarettes . . . .

Barack Obama’s doctor just released a one-page letter describing the senator’s health as “excellent.” . . .  He exercises and eats well. His blood pressure is 90/60, his LDL cholesterol is 96 and his HDL is 68, says the letter by Dr. David Scheiner, who has treated Obama since 1987.   The letter does note that Obama’s history has included “intermittent” cigarette smoking. “He has quit this practice on several occasions and is currently using Nicorette gum with success,” says the letter. But it doesn’t say how much Obama smoked, or for how long. . . .

The letter concludes that Obama is in “overall good physical and mental health needed to maintain the resiliency required in the Office of President.” . . .

Vioxx Verdicts - Score Two for Merck

The New York Times reports on the latest two Vioxx verdicts and they aren't good for plaintiffs.  The Associated Press states,

Appeals courts in New Jersey and Texas have scrapped verdicts against the drug maker Merck stemming from some of the earliest trials involving its once-popular painkiller Vioxx.

A Texas court reversed a $26 million verdict against Merck from the first trial. The court found no evidence that the patient, Robert Ernst, suffered a fatal heart problem from a blood clot caused by Vioxx. He had been taking the now-withdrawn drug for eight months before being stricken in May 2001. His widow had won a $253 million verdict against Merck in 2005, but caps on punitive damages in Texas later cut that to about $26 million.

Also Thursday, a New Jersey appeals court voided $9 million of the $13.9 million awarded to John McDarby in 2006 by a jury in Atlantic City.  The panel found that New Jersey’s Product Liability Act was pre-empted by the federal Food, Drug and Cosmetic Act. Mr. McDarby survived his 2004 heart attack.

In a statement, Merck’s general counsel, Bruce Kuhlik, said the company was gratified that the Texas 14th Court of Appeals found Vioxx did not cause Mr. Ernst’s death.  “In addition, the New Jersey court correctly reversed the awards of punitive damages and consumer fraud,” Mr. Kuhlik said. “We intend to seek further review of the portion of the award that remains standing after the New Jersey decision. We continue to believe Merck acted responsibly.”

Mr. McDarby’s lawyer, Ellen Relkin, said that while they were delighted with the affirmation of the $4.5 million compensatory part of the verdict, they would consider appealing the reversal of the $9 million in punitive damages.  Ms. Relkin said that “the most important legal finding” from the case is that court found that a drug maker could be found liable for contributory liability even in the case of a person with “underlying cardiac risk factors, such as diabetes, elevated cholesterol and advanced age.”

The New Jersey ruling also upheld a verdict in favor of Merck in the case of Thomas Cona, who survived a heart attack in June 2003. His case was heard simultaneously in Atlantic City with McDarby’s case.  Mr. Cona’s lawyer, W. Mark Lanier, called the ruling “unfortunate,” but said the New Jersey panel’s 126-page decision was well-reasoned.  Mr. Lanier, who also represented Mr. Ernst, complained that the Texas appellate panel’s ruling failed to interpret the evidence in the light most favorable to the jury verdict. . . . .   Mr. Lanier said he would appeal to the Texas Supreme Court if the appellate panel declines to reconsider the ruling.

All three cases were excluded from the settlement Merck reached in November in which it agreed to pay $4.85 billion to end thousands of other Vioxx lawsuits.  Thursday’s rulings give Merck 11 victories and 3 losses stemming from the trials that reached verdicts, with the damages now reduced in one of those losses. Retrials are pending in a few cases. . . .

Political Donations from Health Care Enterprises

The Wall Street Journal's Health Blog notes today that political contributions have started to flow toward the Democrats and away from the Republicans.  While this may partially be the result of the current lack of popularity of the President, it could mean that some sources are hoping to stop aggressive reform and benefit from some insurance reforms.  The Wall Street Journal's Jacob Goldstein writes,

From Jan. 1, 2007 through March of this year, people and political action committees in the health sector have contributed $42 million and to Democratic candidates for congress and the presidency, compared with $34.6 million to Republicans, Dow Jones Newswires reports. . . .  The figures come from the Center for Responsive Politics, a nonprofit group that tracks this kind of thing. They include gifts from people employed in the sector. The biggest donors are the American Dental Association, the American Hospital Association and PACs and people associated with Pfizer.

One obvious reason for the shift is the fact that the Democrats control Congress and will likely continue to do so after the November elections.  And on the presidential level, we’d point out that both Democratic candidates have called for a big expansion of health insurance coverage that would pour an additional $100 billion a year in federal funds into the health sector — plenty of new money to spend on health-care goods and services. John McCain’s health-care proposals, by contrast, wouldn’t put significantly more federal money into health.

Childhood Obesity - Some Positive News - It isn't getting worse

The New York Times reports on some good news on childhood obesity - a plateau.  Tara Parker-Pope writes,

Childhood obesity, rising for more than two decades, appears to have hit a plateau, a potentially significant milestone in the battle against excessive weight gain among children.  But the finding, based on survey data gathered from 1999 to 2006 by the federal Centers for Disease Control and Prevention and published in Wednesday’s issue of The Journal of the American Medical Association, was greeted with guarded optimism.

It is not clear if the lull in childhood weight gain is permanent or even if it is the result of public anti-obesity efforts to limit junk food and increase physical activity in schools. Doctors noted that even if the trend held up, 32 percent of American schoolchildren remained overweight or obese, representing an entire generation that will be saddled with weight-related health problems as it ages.  “After 25 years of extraordinarily bad news about childhood obesity, this study provides a glimmer of hope,” said Dr. David Ludwig, director of the childhood obesity program at Children’s Hospital in Boston. “But it’s much too soon to know whether this is a true plateau in prevalence or just a temporary lull.”

The data come from thousands of children who have taken part in the National Health and Nutrition Examination Surveys — compiled by the National Center for Health Statistics at the C.D.C. since the 1960s — and represent some of the most reliable statistics available on the health of American children.  The most recent data is based on two surveys — one in 2003 to 2004 and one in 2005 to 2006 — that included 8,165 children ages 2 to 19. In that group, about 16 percent of children and teenagers were obese, which is defined as having a body mass index at or above the 95th percentile on United States growth charts. For example, a 10-year-old girl who is 4-foot-7 would be considered obese if her weight reached 100 pounds. By comparison, about 5 percent of children and teenagers in the United States were obese in the 1960s and 1970s. As startling as those numbers are, the good news is that from a statistical standpoint, obesity rates have not increased since 1999. Estimates for the number of children who fall into the overweight or obese category also have remained stable at about 32 percent since 1999. Overweight is defined as at or above the 85th percentile. . . . 

The researchers did not give reasons for the leveling off of childhood obesity rates. One concern is that the lull could represent a natural plateau that would have occurred regardless of public health efforts. . . .

One worry is that as obesity rates stabilize, financing for childhood health efforts will wane. In Arkansas, the program was a success but a financial crunch prompted the state legislature recently to cut physical activity programs in seventh through 12th grade.

While the latest data suggest the obesity epidemic may have been contained, researchers say the real question is whether it is possible to reverse the obesity trend among American schoolchildren.  “We still lack anything resembling a national strategy to take this problem seriously,” said Dr. Ludwig, co-author of an editorial accompanying the obesity report. “The rates of obesity in children are so hugely high that without any further increases, the impact of this epidemic will be felt with increasing severity for many years to come.”

National Public Radio had further information on its Morning Edition Program as well as a discussion of the difficulties of determing a child's BMI. 

Overprescribing Antibiotics

Slate.com's Zachary Meisel questions why doctors are still prescribing so many antibiotics.  He writes,

While working a busy night shift in the ER recently, I evaluated a 13-month-old girl. On her chart, the triage nurse had written: "Infant with fever and runny nose. Mother here for antibiotics." The baby was fussy but probably more tired than uncomfortable. Between her squirms, she cooed and smiled at me. Her anxious and upset mother, however, was in far worse shape, repeatedly sticking a rubber bulb syringe up her infant's nostrils in a futile attempt to suck out an endless stream of snot. The mom was also really mad: She had been waiting for more than three hours for a doctor to see her daughter. Now she wanted antibiotics: specifically, a prescription for bubble-gum-flavored amoxicillin.

By my assessment, the child was not acutely ill: She'd had a low-grade fever for two days, her mother said, and a mild cough, but she had clear lungs and appeared well-hydrated. Her eardrum may have had some fluid behind it but wasn't red or bulging. Just as the baby was trying to put my stethoscope in her mouth, paramedics pushed through the ambulance doors with a patient who was having an acute stroke. I had to decide right then if I was going to give this mother the antibiotics she wanted, even though I thought her daughter probably didn't need them. . . .

In the doctor's office or the ER, it's hard to tell the difference between bacterial and viral infections, and so doctors are tempted to prescribe antibiotics whenever they're unsure. That's especially true when doctors think that patients expect to take the medicine home, according to a recent study. Investigators interviewed patients with respiratory infections who went to the ER in 10 hospitals affiliated with medical schools, asking whether the patients expected to receive antibiotics and about whether they were satisfied with the care they received when they were discharged. The researchers also asked physicians why they prescribed antibiotics. The main conclusion was that doctors were significantly more likely to prescribe if they believed that patients expected them to—but did a lousy job predicting which patients those actually were. And the patients most satisfied with their care were the ones who left the ER with a better understanding of their condition, antibiotics or no antibiotics. The take-home message for doctors like me: Spend an extra five minutes talking to your patients about their medical problems, and you can send them away happy and without unnecessary medicine.

So once doctors absorb the result of this study and similar investigations, will they write fewer prescriptions? I bet not. To give out fewer antibiotics, the doctors will have to believe that their patients won't benefit from them. If you look closely at the ER study, 73 percent of the patients who received antibiotics for acute bronchitis had illnesses that were either deemed by their doctors to have likely been caused by a bacteria or to have origins that were in that gray toss-up area between a bacteria and a virus. If the doctors were right, and these were bacterial infections, they would, in fact, warrant antibiotics. Also, in many of these cases, the doctors gave other persuasive reasons for choosing antibiotics, including "ill appearance of the patient" and "concern about follow-up." . . . .

In the end, I did not prescribe antibiotics for the 13-month-old baby. Instead, I took the time to explain thoroughly why I didn't think she needed them (while my colleague took care of the stroke patient). But no matter what that study says, that mother left in a huff— highly dissatisfied, I can assure you. I'm not sure what I'll do the next time I see a similar case. Perhaps I will refuse to write the prescription again, notching another victory for public health. But, for all I know, something intangible will be different: Perhaps the kid just won't look right, or maybe the mother or father will seem too disorganized to be relied on to return if the kid worsens. And that may persuade me to send them home with a bottle of pink-bubble-gum-flavored amoxicillin. It's likely that the fussy kid and his parents won't sleep any better that night. But I will.

Malpractice Problem?

Ezra Klein has a few thoughts on what is causing the malpractice crisis - that would be malpractice . . . . He writes,

The medical malpractice problem is not, as some would have you believe, solely in the courts. It's on the operating tables. Take this study from the Harvard School of Public Health (as Maggie notes, "this is not a cabal representing lawyers who should be sitting on the bottom of the ocean. These researchers are interested in our health as a nation."), which found:

• “The great majority of patients who sustain a medical injury as a result of negligence do not sue.” Indeed, the New York Times reports, although “recent studies have found that one of every 100 hospital patients suffers negligent treatment, and that as many as 98,000 die each year as a result . . . only a small fraction of injured patients — perhaps 2 percent—press legal claims.)

• “Just 1.1 percent of all doctors accounted for 30 percent of all malpractice payments made between 1990 and 2002, while only 5.2 percent of doctors were responsible for 55 percent of all payouts.” A very small group of doctors are losing or settling malpractice lawsuits, but they are losing big.

• “Eighty percent of claims involved injuries that caused significant or major disability (39 percent and 15 percent, respectively) or death (26 percent).”

The problem isn't malpractice lawsuits, but the mistakes that lead to them. I'm sympathetic to doctors who don't want to be punished for human error, but I'm also sympathetic to patients who've been grievously injured because they trusted doctors to avoid major errors. In our system, such trust is all too frequently grievously misplaced. But trying to deal with this on the legal end, either by toughening the circumstances under which patients can sue or simply increasing disclosure and easing the path to restitution, is getting it exactly backwards. The suits aren't the problem, the mistakes are the problem. . . . .

McCain's Medical Records

I am not sure that a candidate's medical records need to be made public but if we are going to consider them, perhaps a little more time for examination would be helpful.  The Associated Press reports on  McCain's health,

Three-time melanoma survivor John McCain appears cancer-free, has a strong heart and is in otherwise general good health, according to eight years of medical records reviewed by The Associated Press. The Republican presidential nominee-in-waiting remains at risk for developing new skin cancers, and gets a thorough check by a Mayo Clinic dermatologist every few months. "I do not see any worrisome lesions," Dr. Suzanne Connolly concluded after McCain's most recent exam, on May 12.

The details of McCain's health are contained in 1,173 pages of medical documents spanning 2000 to 2008 that his campaign made available to the AP to make the case that he's healthy enough to serve as president, as well as to counter the notion that he's too old. The Arizona senator will turn 72 in August and would be the oldest elected first-term president. . . .

McCain's most recent exams show a range of health issues common in aging: He frequently has precancerous skin lesions removed, and in February had an early stage squamous cell carcinoma, an easily cured skin cancer, removed. He had benign colon growths called polyps taken out during a routine colonoscopy in March.

The Vietnam veteran has degenerative arthritis from war injuries that might mean a future joint replacement. His blood pressure and weight were healthy, and his cholesterol good but not optimal _ and he switched medication from the controversial Vytorin that made headlines this past winter to a proven standby, simvastatin.

His likely Democratic rival, Barack Obama, will be 47 in August. Obama, lean and agile and a frequent basketball player, says he has quit smoking. Neither he nor Democratic opponent Hillary Rodham Clinton has released health records. . . . .

This time, the AP examined the documents over several hours Thursday in a conference room of a resort just outside of Phoenix and a few miles from the posh Mayo Clinic in Scottsdale, where McCain receives most of his medical care under a pseudonym _ which the AP was asked not to disclose. Coincidentally, the release came the same week that McCain's close friend, Sen. Edward M. Kennedy, revealed that he had a cancerous brain tumor. . . .

Ezra Klein notes the access was a little shaky and states,

The "viewing" of John McCain's medical records is an absurd farce. A dozen or so reporters hand-chosen by the McCain campaign are getting a few hours of access to 400 pages of doctor scribbles and medication names. They will have no idea what any of it means. The organization that brought an MD to the medical record viewing in 2000 hasn't been allowed back in.  . . . .
 

As it is, I think health history is a basically illegitimate issue in campaigns. If it were up to me, the chief doctor of the White House Medical Unit would sit down and evaluate each the medical records of both nominees and give them a physical. If there was anything related to the job that should be disclosed, it would be disclosed. If not, not. But insofar as we are going to have medical records be part of the campaign process, they shouldn't be open for a limited viewing by certain reporters on the Friday before Memorial Day. Do it right, or don't do it.

Medicare Cuts . . .

EmaxHealth reports on the Democrats new proposal for the Medicare budget.  The story states,

Senate Finance Committee Chair Max Baucus (D-Mont.) on Wednesday said he will move forward with a Medicare package developed by Democrats that likely will be opposed by Republicans and the Bush administration, CQ Today reports. Baucus said he is retreating from crafting a bipartisan Medicare package that would delay for 18 months a 10.6% cut to physician fees (Armstrong [1], CQ Today, 5/21). Although both parties want to halt the cut, which is scheduled to go into effect on July 1, they have been unable to agree on offsets to pay for the bill, among other issues (Armstrong [2], CQ Today, 5/21). 

Baucus said, "It seems clear to me that we're not going to get an agreement in time to meet the deadlines, so I'm going to move forward with a bill that I think has the right policies and priorities for the Medicare program." He also said, "Frankly, the White House is a stone wall. And it makes it very difficult for the Republicans to negotiate," adding, "They just don't want any reductions to any of the (Medicare Advantage) plans."

Baucus and fellow Democrats on the committee have proposed cuts to Medicare Advantage to offset the legislation, including cutting indirect medical education payments to insurers and capping payments to private MA plans. Sen. Kent Conrad (D-N.D.) said capping MA plan payments at 130% of traditional Medicare costs would save $6 billion over five years. Democrats also want to add some other provisions to the measure, including a small increase in the physician fee rate, an electronic prescribing initiative and preventive care programs (Armstrong [1], CQ Today, 5/21). The measure would cost $18.2 billion over five years, according to Conrad.

Medicare legislation drafted by Republicans would cost $14.9 billion over five years, Conrad said (Armstrong [2], CQ Today, 5/21). According to CQ Today, "Republicans will almost certainly block Baucus' proposal to force a compromise after the Memorial Day recess." The compromise package "would likely be a pared down measure," CQ Today reports. Committee ranking member Chuck Grassley (R-Iowa) said, "Before this process is over, I'm confident that we're going to have a bipartisan package that passes the Senate," adding, "There are differences, but there aren't big differences" (Armstrong [1], CQ Today, 5/21). . . .

 

Best Wishes for Senator Kennedy

While many tributes have been written today demonstrating the huge impact that Senator Kennedy has had on all our lives, the Wall Street Journal Health Blog notes his importance to a large number of health law initiatives.  Jacob Goldstein writes,

Nowhere has his role as power broker been more apparent than in health care. A genetic nondiscrimination bill that remained stalled in Congress for a more than a decade finally moved ahead earlier this year with Kennedy’s help and was signed into law today by President Bush, the Associated Press reports.

His deal-making skills were essential in adding prescription drug benefits to Medicare, and he was a key force in the State Children’s Health Insurance Program (SCHIP) and the Americans With Disabilities Act of 1990. He was a central player in crafting last year’s big FDA reform bill.  If Kennedy, who chairs the Senate Committee on Health, Education, Labor & Pensions, is unable to return to work in the near future, it’s unclear what will happen to the health-related issues he’s been working on.  Kennedy’s the sponsor of a bill that would give the FDA power to regulate cigarettes. That effort, described in this WSJ story, could falter without Kennedy’s backing.

And, as Politico notes today, one of Kennedy’s top priorities for the summer was to negotiate a compromise over conflicting versions of a mental health parity bill passed by the House and Senate. In those negotiations, he would have been sitting across the table from Patrick Kennedy, a Rhode Island Democrat who is the senator’s son.

New Currency?

The New York Times reports today on the change that may be occuring to our currency - no its not new faces but new sizes, colors and textures.  David Stout writes,

In a decision that could radically change the size, the color and even the feel of American money, a federal appeals court ruled on Tuesday that the United States discriminates against the blind and those with limited vision because its paper currency is all the same size regardless of a bill’s value.

The ruling is sure to please blind people and those whose sight is weakening with illness or age. Unless overturned on appeal, it also holds the potential to send manufacturers of vending machines back to the drawing boards, open new fashion frontiers for wallet makers and cause the term “greenback” to become increasingly quaint.

The 2-to-1 decision, by a panel of the United States Court of Appeals for the District of Columbia Circuit, held that the Treasury Department had failed to demonstrate that it would be too burdensome to make bills of different sizes or add features that could be read by touch to distinguish monetary value.

“A large majority of other currency systems have accommodated the visually impaired, and the secretary does not explain why U.S. currency should be any different,” Judge Judith W. Rogers wrote for herself and Judge Thomas B. Griffith, referring to Treasury Secretary Henry M. Paulson Jr., the nominal defendant.

What happens next is not certain. The government could appeal to the full 13-member appeals court (one of whose judges, David S. Tatel, is blind), or it could seek quick review by the Supreme Court, a step it has 90 days to take. . . . 

The suit was brought under the Rehabilitation Act of 1973, which addresses discrimination in federal programs. The appeals court said Secretary Paulson had acknowledged that the present currency system made blind people “dependent on the kindness of others.” And, it said, their plight is not satisfactorily remedied by currency-reading devices, which can be expensive and quite cumbersome: one costs $270 and has trouble reading $20 bills.

The decision upheld a 2006 ruling by Judge James Robertson of the Federal District Court in Washington, to which the case will be returned for consideration of remedies unless the government succeeds on further appeal.  “Of the more than 180 countries that issue paper currency,” Judge Robertson wrote in his decision a year and a half ago, “only the United States prints bills that are identical in size and color in all their denominations.”

Judge Robertson rejected the government’s arguments that making bills identifiable by touch would create an undue financial burden: an estimated $178 million for new printing presses, for instance, and up to $50 million for new plates. Those costs are not significant, he said, given that the government spent more than $4 billion producing currency in the decade before his ruling. . . .

Protection for Human Rights . . . . Not a Priority for FDA

Well, looks like there could be a change in our notions about bioethics and the protection of human subjects -- The FDA announced, rather quietly, that the United States will not be participating in the Declaration of Helsinki starting next Fall.  Integrity in Science reports,

FDA Scraps Helsinki Declaration on Protecting Human Subjects

Drug companies got a green light last week to start using data from foreign clinical trials in new drug applications even if the trials only compare new products to placebos instead of best available treatments. The change marks a sharp departure from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the Food and Drug Administration's previous standard. The new rule, which goes into effect next October, was pushed by drug and device manufacturers, but opposed by numerous public interest, patient advocacy, and consumer groups. The Declaration of Helsinki "is the standard-bearer for international research ethics and enjoys particular respect in the developing world," said Peter Lurie, deputy director of Public Citizen's Health Research Group. Its rejection is "in line with other U.S. efforts to flout international mores."    

The new rule's substitute standard says foreign trials should follow good clinical practices (GCP) and include a review and approval by an independent ethics committee. A major difference between the Helsinki Declaration and GCP is the former's insistence on using existing treatments instead of placebos if they are available. The Helsinki Declaration had the effect of extending existing treatments to people in poor countries if they participated in clinical trials.

The change is likely to push more clinical trials abroad, where an estimated 35 percent of all trials submitted to the FDA in new drug applications now take place. Unlike trials conducted in the U.S., companies do not have to submit an investigative new drug application (IND) to the FDA before beginning research in foreign countries. The FDA estimates about 575 of the foreign trials submitted to the agency each year as part of new drug applications do not go through the IND process. The FDA rejected the notion that adopting the self-regulating GCP standard and eliminating references to the Helsinki Declaration "will hurt subjects in developing countries or result in less protection for subjects in foreign studies." GCP requires trial sponsors closely monitor trial behavior and report adverse events, the agency noted.

The blog, Firedoglake, has more and states,

Bush's FDA has just announced that it is going to scrap American participation in the Declaration of Helsinki -- the major international accord on ethical principles guiding physicians and other participants in medical research on human subjects. This isn't a decision involving mere medical bureaucracy -- it in fact clears the way for ethics-free drug testing, especially beyond American borders, and it means people will die, sometimes horribly.

The shift in policy now makes it possible for American drug companies to conduct tests on human subjects (most often in Third World nations) wherein victims of particular diseases can, in the course of testing, be administered pure placebos that do nothing to help them fight those diseases, while being told they're undergoing treatment. (The longstanding standards required such tests to administer the acknowledged standard treatment as the placebo.) . . . .

Over at PAL, Sonia Shah, the author of a book on the subject, also titled The Body Hunters, discussed the consequences of the FDA's decision at length:

With hardly a word in the mainstream press, the FDA has gutted the rules restraining drug companies from exploiting clinical trial subjects in developing countries.

With 80 percent of clinical trials failing to recruit sufficient numbers of test subjects on deadline, drug companies increasingly export their trials to developing countries, where sick, undertreated patients abound. It’s faster, it’s cheaper, and it’s easier to conduct the placebo-controlled trials that companies and the FDA prefer. There is precious little oversight of these trials.

Unlike for domestic trials, the FDA does not require advance notice before drug companies take their trials outside US borders. And with 90 percent of trials failing to gain FDA approval, a massive number of trials are conducted, fail, and then vanish with no agency review at all—and little public record, if any at all.

Until now, the FDA’s sole requirement for these overseas trials is that they adhere to the Declaration of Helsinki (or local rules, on the off-chance that they are more stringent). Signed by the United States and 34 other countries in 1975, the Declaration of Helsinki consists of several dozen pithy principles to govern ethical research on humans, and is widely considered the gold-standard in research ethics. Crafted and updated by the World Medical Association, a group representing dozens of national physicians’ organizations from around the globe, the Declaration of Helsinki (DOH) urges that participants’ voluntary informed consent be obtained, that independent committees to review and oversee trials be used, that investigators prioritize their subjects’ well-being, that research subjects be assured access to the best health interventions identified in trials, and that their societies enjoy a “reasonable likelihood” of benefiting from the results of trials.

... The FDA’s move against the DOH is more than a symbolic change. With drug companies rushing to countries where the domestic regulatory infrastructure is weak at best—India, where Pfizer and GlaxoSmithKline have set up global clinical trial hubs being perhaps the prime example—and the FDA turning a blind eye, the business of protecting impoverished, sick, undertreated patients from exploitative experimentation falls almost entirely upon local people convened by clinics and hospitals to sit on FDA-required ethics committees. Theirs is a nearly impossible job, much of it shrouded in secrecy. Some, from India and South Africa, spoke to me, anonymously. They told me of how their clinics and hospitals desperately need the income drug-industry trials bring in. Of how, often, their bosses sit on the committees with them, pressuring members to approve as many experimental protocols as come in. They are overworked, underpaid, and poorly trained—if trained at all—in the principles of research ethics. Even the most courageous among them find it difficult to challenge problematic experiments and interrupt the flow of industry dollars.

Yikes! 

VA and Women's Health Issues

McClatchy Newspapers reports on a new problem facing the Veteran's Administration - women's health issues.  Les Blumenthal writes,

Two nightmares haunt Robin Milonas.  While serving in Afghanistan in 2004 as an Army Reserve civil affairs officer, the former lieutenant colonel got lost in a minefield while leading a small convoy delivering school supplies to civilians. Even more troubling is the memory of a man who arrived at the main gate of Bagram Air Base carrying a young boy whose leg had been blown off by a land mine.

"I was an outgoing, energetic, determined good soldier who wanted to make the Army a career," said Milonas, of Puyallup, Wash., who just turned 50. "Now I am broken." Milonas is one of roughly 180,000 women who've been deployed to Afghanistan and Iraq. While they don't officially serve in combat, they have experienced life in a war zone where there are no front lines.  And as they return home, they're increasingly turning to an already overtaxed Department of Veterans Affairs for help. Last year, the VA treated more than 255,000 female veterans. The number is expected to double within five years.

            

VA officials say they're better prepared to handle female patients than they were several years ago. But they acknowledge "continual challenges" as they move to open the door to a man's world, where pap smears and mammograms could become as common as prostate exams. And where "military sexual trauma" would be treated as a serious and growing mental health problem, rather than as a subject to be avoided. . . .

"They aren't ready," said Sen. Patty Murray, D-Wash., said of VA officials. "Absent a proactive, concerted effort and knowing their limited resources, they (VA officials) are struggling with so much this might get lost."  Murray, perhaps the leading VA critic on Capitol Hill, has introduced legislation that requires studying how serving in Iraq and Afghanistan has affected the physical, mental and reproductive health of women, and how the VA is dealing with their problems.

The legislation also would require the VA to start caring for newborn children of female veterans who are receiving maternity care. Currently the VA doesn't cover newborn costs. In addition, it would require increased training for VA personnel dealing with military sexual trauma and post-traumatic stress disorder, or PTSD, in women.  The Senate Veterans Affairs Committee will hold a hearing on Murray's bill on  Wednesday.

The VA has begun a long-term study of 12,000 female veterans. Female veterans have faced a number of problems, ranging from clinics that don't have full-time obstetrician/gynecologists to uncomfortable group therapy sessions where men outnumber women and topics can include sexual assault and harassment.

Concern is mounting over the number of female veterans suffering from military sexual trauma, which can include rape, assault and harassment. According to the VA, nearly one in five female veterans seeking care has been diagnosed as a victim of military sexual trauma, though some believe the figure could be nearer to one in three. The character Melissa in the comic strip Doonesbury was a victim.  The VA now offers women-only group therapy sessions. In addition, female vets can request female counselors, and women-only entrances to clinics are being provided.  "A lot of women are reluctant to come into a hospital," said Jan Buchanan, a women's veterans program manager for the VA's Puget Sound Region. "It seems too military to them. They fear they might see their perpetrator." . . .

   

Medication Rates Among the Insured

The Associated Press reports on the new numbers of insured taking prescription medications.  Linda A. Johnson writes,

For the first time, it appears that more than half of all insured Americans are taking prescription medicines regularly for chronic health problems, a study shows. The most widely used drugs are those to lower high blood pressure and cholesterol - problems often linked to heart disease, obesity and diabetes. The numbers were gathered last year by Medco Health Solutions Inc., which manages prescription benefits for about one in five Americans.

Experts say the data reflect not just an aging population and worsening public health but better medicines for chronic conditions and more aggressive treatment by doctors. For example, more people now take blood pressure and cholesterol-lowering medicines because they need them, said Dr. Daniel W. Jones, president of the American Heart Association.

"Unless we do things to change the way we're managing health in this country ... things will get worse instead of getting better," predicted Jones, a heart specialist and dean of the University of Mississippi's medical school. . . .

The Power of the Apology

The New York Times reports today on the power of "I'm Sorry."  Kevin Sack writes,

In 40 years as a highly regarded cancer surgeon, Dr. Tapas K. Das Gupta had never made a mistake like this.  As with any doctor, there had been occasional errors in diagnosis or judgment. But never, he said, had he opened up a patient and removed the wrong sliver of tissue, in this case a segment of the eighth rib instead of the ninth.

Once an X-ray provided proof in black and white, Dr. Das Gupta, the 74-year-old chairman of surgical oncology at the University of Illinois Medical Center at Chicago, did something that normally would make hospital lawyers cringe: he acknowledged his mistake to his patient’s face, and told her he was deeply sorry.   “After all these years, I cannot give you any excuse whatsoever,” Dr. Das Gupta, now 76, said he told the woman and her husband. “It is just one of those things that occurred. I have to some extent harmed you.”

For decades, malpractice lawyers and insurers have counseled doctors and hospitals to “deny and defend.” Many still warn clients that any admission of fault, or even expression of regret, is likely to invite litigation and imperil careers.  But with providers choking on malpractice costs and consumers demanding action against medical errors, a handful of prominent academic medical centers, like Johns Hopkins and Stanford, are trying a disarming approach.

By promptly disclosing medical errors and offering earnest apologies and fair compensation, they hope to restore integrity to dealings with patients, make it easier to learn from mistakes and dilute anger that often fuels lawsuits.  Malpractice lawyers say that what often transforms a reasonable patient into an indignant plaintiff is less an error than its concealment, and the victim’s concern that it will happen again.  Despite some projections that disclosure would prompt a flood of lawsuits, hospitals are reporting decreases in their caseloads and savings in legal costs. Malpractice premiums have declined in some instances, though market forces may be partly responsible.

At the University of Michigan Health System, one of the first to experiment with full disclosure, existing claims and lawsuits dropped to 83 in August 2007 from 262 in August 2001, said Richard C. Boothman, the medical center’s chief risk officer.  “Improving patient safety and patient communication is more likely to cure the malpractice crisis than defensiveness and denial,” Mr. Boothman said.

Mr. Boothman emphasized that he could not know whether the decline was due to disclosure or safer medicine, or both. But the hospital’s legal defense costs and the money it must set aside to pay claims have each been cut by two-thirds, he said. The time taken to dispose of cases has been halved.  The number of malpractice filings against the University of Illinois has dropped by half since it started its program just over two years ago, said Dr. Timothy B. McDonald, the hospital’s chief safety and risk officer. In the 37 cases where the hospital acknowledged a preventable error and apologized, only one patient has filed suit. Only six settlements have exceeded the hospital’s medical and related expenses.

In Dr. Das Gupta’s case in 2006, the patient retained a lawyer but decided not to sue, and, after a brief negotiation, accepted $74,000 from the hospital, said her lawyer, David J. Pritchard.  “She told me that the doctor was completely candid, completely honest, and so frank that she and her husband — usually the husband wants to pound the guy — that all the anger was gone,” Mr. Pritchard said. “His apology helped get the case settled for a lower amount of money.” . . . .

   

The Joint Commission, which accredits hospitals, and groups like the American Medical Association and the American Hospital Association have adopted standards encouraging disclosure. Guidelines vary, however, and can be vague. While many hospitals have written policies to satisfy accreditation requirements, only a few are pursuing them aggressively, industry officials said. . . .

The policies seem to work best at hospitals that are self-insured and that employ most or all of their staffs, limiting the number of parties at the table. Such is the case at the Veterans Health Administration, which pioneered the practice in the late 1980s at its hospital in Lexington, Ky., and now requires the disclosure of all adverse events, even those that are not obvious.

To give doctors comfort, 34 states have enacted laws making apologies for medical errors inadmissible in court, said Doug Wojcieszak, founder of The Sorry Works! Coalition, a group that advocates for disclosure. Four states have gone further and protected admissions of culpability. Seven require that patients be notified of serious unanticipated outcomes.

Before they became presidential rivals, Senators Hillary Rodham Clinton and Barack Obama, both Democrats, co-sponsored federal legislation in 2005 that would have made apologies inadmissible. The measure died in a committee under Republican control. Mrs. Clinton included the measure in her campaign platform but did not reintroduce it when the Democrats took power in 2007. Her Senate spokesman, Philippe Reines, declined to explain beyond saying that “there are many ways to pursue a proposal.”

The Bush administration plans a major crackdown on medical errors in October, when it starts rejecting Medicare claims for the added expense of treating preventable complications. But David M. Studdert, an authority on patient safety in the United States who teaches at the University of Melbourne in Australia, said the focus on disclosure reflected a lack of progress in reducing medical errors. . . . .

Olympic Dreams for Disabled Runner

The New York Times reports the good news that a disabled Olympian runner will be permitted to compete. Joshua Robinson and Alan Schwartz write,

     When an international court ruled Friday that a double-amputee sprinter from South Africa was eligible to compete in this summer’s Olympic Games in Beijing, the stage was set for disabled athletes to meet their own trailblazer.   

The watershed ruling made the runner, Oscar Pistorius, the first amputee to successfully challenge the notion that his carbon-fiber prosthetics gave him an unfair advantage and assured his right to race against able-bodied athletes in the Olympics, should he qualify. Previously barred from competing in such races by track and field’s world governing body, Pistorius will continue to stoke the debate over the competitive issues created by evolving technology in sports. . . .

In overturning a ban imposed by the International Association of Athletics Federations, track and field’s governing body, the court deemed that there was not enough evidence to prove that Pistorius’s flexible j-shaped blades, attached below his knees, gave him an advantage . . . .

“In the world of prosthetics, with so many variables, they need a stipulation for down the road, when we come to the day and age when bionics come to the fore,” Frasure said. “If they say it’s O.K. for all amputees to compete in the Olympics, they would be setting themselves up for even more controversy, more than Oscar dealt with, in the future.”

The I.A.A.F. thought it had made that stipulation when it barred Pistorius in January, despite clearing him to compete with able-bodied athletes last spring; he ran at international meets in Rome and Sheffield, England. . .  .

Pistorius was born without the fibula in his lower legs and with defects in his feet, and his legs were amputated below the knee when he was 11 months old. He went on to set Paralympic world records in the 100, 200, and 400 meters, but did not draw attention until he started competing with able-bodied athletes in South Africa in 2004.

So last November, the track and field governing body’s cooperation with Pistorius was uncharted territory. The I.A.A.F. sponsored three days of testing on Pistorius, who gave his consent, in Cologne, Germany, under the supervision of Peter Brüggemann, a professor at the German Sport University.

Brüggemann found that the Cheetah prosthetics were more efficient than a human ankle. He also found that they could return energy in maximum speed sprinting and that Pistorius was able to keep up with a few able-bodied sprinters while expending about 25 percent less energy.

Pistorius’s lawyers, however, argued that the results of the study did not provide enough evidence to make a decision, and they lodged an appeal in February. Jeffrey Kessler, a lawyer with the New York-based firm Dewey & LeBoeuf, who agreed to take the case on a pro bono basis, led Pistorius’s defense.

“The I.A.A.F. had not at all followed proper procedures in conducting any of its review,” Kessler said. “Many of its results were in many respects pre-ordained.”

To test how much mechanical energy a runner uses, researchers study forces on the ankle, knee and hip joints. They do this with video cameras to record the joints’ motions and plates along the running path that record the force on the joints. When the athlete’s foot, or prosthesis, touches a plate, it measures the forces in three directions: up and down, right and left, and front and back.

The measurements, combined with oxygen consumption, are a reliable indicator of the runner’s economy — and whether the prosthetics are providing an advantage, said Roger Enoka, a biomechanics researcher at the University of Colorado.

The researchers who examined Pistorius were instructed to study only his performance while running on a straightaway — when he was at his fastest. That approach was deemed unfair by the court. In its published opinion, the court censured the I.A.A.F. for its handling of the case, saying that from the outset, it had its mind made up.

“The manner in which the I.A.A.F. handled the situation of Mr. Pistorius in the period from July 2007 to January 2008 fell short of the high standards that the international sporting community is entitled to expect from a federation such as the I.A.A.F.,” the panel said.

Costs of Preventive Health and Health Reform

Erza Klein points out an interesting article by Neal Halfon discussing health reform and its costs.  He notes the power of preventive health and positive public health efforts and how small changes add up to quite a bit of savings not to mention better health for the entire population.  Ezra Klein writes,

Reading Neal Halfon's article on "The Primacy of Prevention" reminded me of a point that I don't make enough. Health reform, which is what we mainly talk about, is about economic security more than it's about health improvement. It's about ensuring people don't go bankrupt when they need care, and ensuring the country doesn't go bankrupt in 30 years beneath the burden of health costs.

Conversely, the real gains to be made in population-health (the term researchers use for the aggregate health of the country) will come from public-health efforts. That's a broad category. It can include everything from vaccinations to stripping lead from walls to encouraging better nutrition to making educational interventions. A better integrated health system would encourage this as it would make it far easier to reach the relevant populations, but it would not, on its own, radically change the health outcomes of anyone but the uninsured or severely underinsured, and it would not necessarily be reliant on individual medical care. Rather, it'll probably require broader policy changes that make it easier for whole populations to live healthier lives almost without meaning to. That means more walkable, bikable cities. It means less pollution and lead in the walls and water. It means more access to fresh, affordable, fruits and vegetables in poor and urban areas. It means food subsidies targeted towards healthy foods rather than foods with powerful interest groups. It means more anti-smoking programs. . . . .

Education Level and Death Rates

Newsweek post a blog about a recent PLoS study on death rates and the relationship of education level.  Sharon Begley reports,   

Last month I blogged about a study that underlined how we truly are Two Americas (though the idea never gained traction for John Edwards this primary season). That study found that, since the early 1980s, death rates in wealthy counties of the United States have fallen—but those in poorer ones have stagnated or risen, despite the huge strides in disease prevention and treatment. Those are just not reaching the poor. Now another study uses a different proxy for “haves” or “have-nots”—education—and reaches another shameful conclusion: the gap in death rates between Americans with less than a high school education and college graduates has soared since 1993, they will report tomorrow in the May 14 issue of PLoS One.

The scientists analyzed death certificates (which indicate the last year of schooling that the person completed, as well as cause of death) for blacks and whites between the ages of 25 and 64. The age cut-off was chosen because, for older generations, education is not as strong a proxy for socioeconomic status—class—as it is for younger ones.

The numbers are shocking. Among white men who did not graduate from high school, there were 837 deaths per 100,000 of them in 1993; that same year, only 285 white men with college degrees died per 100,000 in this age group. But it gets worse. In 2001, those respective rates were 931 and 213—the death rate for less-educated white men had risen, while that for college grads had fallen. Do the math: white men who did not graduate from high school were dying at a rate 2.9 times that of college grads in 1993—and at a rate 4.4 times higher in 2001. For black men, the comparable mortality rates were 2.1 times higher in 1993 and 3.4 times higher in 2001.

For white women who never graduated from high school, the death rate was 422 per 100,000 in 1993, and for white women with a college degree it was 165. In 2001? It rose to 553 per 100,000 in the first group, and dropped to 146 in the highly-educated group. Breaking that down, the death rate from cancer among white women with only 12 years of education rose 1.1 percent per year during the period studied; for heart disease and stroke, it rose 1.8 percent per year among these women. All three of these diseases have become more preventable and more treatable—but, apparently, only for some.

Conclusion: the widening death gap was due to sharp decreases in mortality from all causes—but especially in heart disease, cancer and stroke, all of which have benefited from new forms of prevention and treatment—among the most educated. The less educated have benefited hardly at all from medical progress.

Why are the death rates from the major causes of death falling among the educated but rising among the less educated? Think of lower educational attainment as a marker of social and economic class—which has become a big issue in the presidential campaign, as Clinton grabs the votes of those lower on the socioeconomic ladder and Obama gets the votes of the higher-ups. The have-nots are not only poorer; they also are less likely to have health insurance or stable employment, which means little to no preventive care, and lower health literacy. The last factor means less likelihood of knowing when some small symptom means big trouble, and greater difficulty navigating the medical system. Those with less education are also more likely to smoke, be obese, get little exercise, and suffer from high blood pressure due to the stress of unemployment.

“Risk factors are higher in less well-educated groups, and they have less access to preventive medicine and treatment,” says Ahmedin Jemal of the American Cancer Society, who led the study. . . .