HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, May 23, 2008

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.

May 23, 2008 | Permalink | Comments (1) | TrackBack (0)

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). . . .


May 23, 2008 | Permalink | Comments (0) | TrackBack (1)

Wednesday, May 21, 2008

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.

May 21, 2008 | Permalink | Comments (0) | TrackBack (0)

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. . . .

May 21, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, May 19, 2008

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.


May 19, 2008 | Permalink | Comments (0) | TrackBack (1)

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." . . .


May 19, 2008 | Permalink | Comments (0) | TrackBack (3)

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. . . .

May 19, 2008 | Permalink | Comments (0) | TrackBack (2)

Sunday, May 18, 2008

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. . . . .

May 18, 2008 | Permalink | Comments (0) | TrackBack (1)