January 15, 2005
Saturday Luke Blogging
January 14, 2005
"VD or Not VD" Article
While I am sure that many of you have all been following the recent work and surrounding controversy of C.A. Tripp, The Intimate World of Abraham Lincoln, the new book that claims that Abraham Lincoln may have been a bixexual,(I haven't read the book yet, only the reviews, which are quite positive), a new article on Dr. Koop's website examines recent findings by Dr. John J. Ross who concludes that William Shakespeare suffered from mercury poisoning due to treatment for syphllis. Dr. Ross states that the side effects of the treatment probably made it difficult for him to physically write, explaining his writing slowdown later in life, and that his suffering could also explain some of his attitudes toward women. Other scholars claim that Dr. Ross's theory is much ado about nothing and that no proof exists that Shakespeare suffered from a venereal disease. [bm].
FDA rejcts over-the-counter Mevacor
Today the FDA recommended against over-the-counter sales of Merck's cholesterol drug, Mevacor, stating that patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life. Even though the safety of Mevacor is well-established, advisers worried that the wrong people might take it if sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it. The vote on the advisory committee was 20-3.
The advisers expressed concerns due to studies that simulated over-the-counter sales, which indicated that 90 percent of people who took Mevacor did not satisfy the requirements of the label. Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.
Once again, Kevin Drum of the Washington Monthly finds a quote that reflects quite accurately the FDA's concern,. He quotes Michelle Cottle from the New Republic:
As a nation, Americans are apparently too stupid (or stubborn) to recognize that Big Macs and Big Gulps aren't the foundation of a healthy diet, but thanks to several gazillion dollars in direct-to-consumer drug advertising, we all consider ourselves experts in pharmacology.
....No matter what kind of qualifiers, disclaimers, and helpful tips Merck scrawls across Mevacor's box (or, more likely, crams onto a package insert printed in type so tiny it will make your eyes bleed), a fair number of self-medicating geniuses will think that the best way to prevent heart disease is to take two Mevacor for every six pieces of fried chicken they plan to eat that night. Don't laugh. It will happen and happen frequently.
Ethics Consultation: We've Seen the Future (Or Have We?)
In "When the Question is Life or Death" by Jim Ritter, the January 9 Chicago Sun-Times profiled the work of Dan Dugan, a full-time ethics consultant at Swedish Methodist Hospital. As reported in the article:
Hospitals are required to make ethics consultations available for difficult cases, such as whether to withdraw life support, what to do with a patient who refuses treatments on religious grounds or whether a doctor should reveal to parents their teenage daughter's request for birth control.
I confess to being a little surprised to read that consultations are required for difficult hospital cases -- is there an Illinois law on this? (Texas does have such a law. Section 166.046(a) of the Health & Safety Code requires an ethics consultation when there is a dispute between the attending physician and the patient (or surrogate) over the appropriateness of life-sustaining care.) Regardless, this article does a nice job of discussing the role of ethics consultation in modern medical dilemmas. It also cites an important 2003 article in JAMA (abstract) that described the results of a multicenter, prospective randomized clinical trial to determine the effects of ethics consultations on 'nonbeneficial' life-sustaining treatments in the intensive care setting. [tm]
January 13, 2005
CDC Reports on Racial Disparities in Health Care
The Centers for Disease Control and Prevention reports today that black Americans are far more likely than white Americans to die from strokes, diabetes and other diseases. The CDC report revealed that in 2002, the number of potential years of life lost due to strokes, diabetes and perinatal diseases was three times higher for black Americnas under 75 than for white Americans in same age group. The CDC report showed that the gap increased to approximately 11 times for AIDS and nine times for homicide.
For those of you interested in race and health care issues, Professor Vernellia Randall is one of the leading experts on this topic and her writings are a great resource. [bm]
Resident Hours: Lack of Sleep and Patient Safety
A new study appearing in the New England Journal of Medicine demonstrates once again that after staying up all night to care for patients, medical interns who drive home from the hospital at the end of a 30-hour shift become a threat to themselves and to the commuting public. The report found that interns more than doubled their risk of getting into a car accident after being on call for more than 32 consecutive hours with only two to three hours of sleep. The study is the latest in a long series of studies by researchers at Harvard Medical School and Brigham and Women's Hospital in Boston that aim to quantify the dangers of requiring doctors to work long shifts with little rest. The researchers say that working for more than 24 hours causes interns to make serious medical errors and poses a public safety hazard.
Kevin Drum of the Washington Monthly comments, "It's unbelievable that this system has continued as long as it has and unbelievable that it continues to be defended. Do we really need studies to tell us that people who have been awake for 30 consecutive hours probably aren't making very good decisions? And that both patients and others are suffering from this?
Would you want your mother to be looked after by a trainee who's been on her feet for 30 hours? I wouldn't."
More studies are available for your review in the latest AmNews. [bm]
Bush Administration's CDC Provides Support for Same-Sex Marriage?
So far, the debate over same-sex marriage has focused primarily on "values" and "morality," but a recent report from the CDC may have given marriage-law reformers additional ammunition. According to a news release from the agency, the report (“Marital Status and Health: United States, 1999-2002”) "suggests that married adults are healthier than divorced, widowed or never married adults":
- Nearly 60 percent of adults are married, 10.4 percent are separated or divorced, 6.6 percent are widowed, 19 percent are never married and 5.7 percent are living with a partner. Marital status varies greatly among race/ethnic groups: approximately 61 percent of white adults, 58 percent of Hispanic adults, and 38 percent of black adults are married, according to the survey.
- Married adults are less likely than other adults to be in fair or poor health, and are less likely to suffer from health conditions such as headaches and serious psychological distress.
- Married adults are less likely to be limited in various activities, including work and other activities of daily living.
- Married adults are less likely to smoke, drink heavily or be physically inactive. However, married men are more likely to be overweight or obese than other men.
- Adults who live in cohabiting relationships are more likely to have health problems than married adults and more closely resemble divorced and separated adults.
- The association between marital status and health is most striking in the youngest age group although it persists throughout the age groups studied.
If married adults enjoy a level of health that is superior to that of their unmarried peers, aren't the states' opposite-sex marriage requirements more vulnerable than ever to legal challenge? [tm]
January 12, 2005
Regulation of Dietary Supplements Supported
The Institute of Medicine today called for tougher regulations to make sure the dietary supplement products than many Americans use are safe and do what they claim. The Institute's 327-page report expressed concern about the quality of dietary supplements, saying "there is little product reliability" and urged that dietary supplements as well as altnerative medical procedures such as acupuncture and herbal remedies, be required to meet the effectiveness standards mandated for conventional medical treatments. The report recommended that Congress enact legislation to require improved quality control of supplements and to provide incentives to study the efficacy of the products. [bm]
Medical Malpractice Reform Not Viewed as Urgent Priority
A new study by the Kaiser Family Foundation and the Harvard School of Public Health reports that most Americans are much more concerned about lowering the cost of of health care and insurance, followed closely by making Medicare more financially sound and increasing the number of Americans with insurance than reducing medical malpractice awards. In fact, reducing such awards ranked 11th on a list of 12 items.
Three out of five said malpractice lawsuits were a very important factor in causing higher health care costs, just below the 63 percent who mentioned high profits made by drug and insurance companies. Although Americans did not see urgency in reforming our judicial system, they did indicate that they would support legislation that required an independent specialist review a case before a lawsuit could be filed, and many supported caps on damages for pain and suffering.
UMich Receives NIH Grant to Improve Research Consents
The January 10 issue of The Michigan Daily reports that Susan Dorr Goold, the director of the University of Michigan's bioethics program and associate professor of medicine, has "received a grant for $1.5 million from the National Institutes of Health to create a program to teach researchers from any field how to better inform research candidates of what is expected of them before they consent to participate. The program seeks to thereby improve communication between researchers and participants."
“One of the things that we know nationally, even internationally, is people often don’t know what they are volunteering to do. They sign long consent forms that they may not read. Or if they do read them, they do not understand them,” said Goold. . . .
She said the motivation for the program did not derive from any specific incident at the University, but out of her desire to improve the already functioning process of informed consent.
Instead of the traditional semester-long course, Goold’s program will offer a series of scheduled conferences for researchers. The curriculum will use multiple teaching methods, including selected readings, lectures and small-group exercises where the researchers can practice obtaining consent from each other.
The class will culminate with a simulation in which researchers will attempt to obtain consent from a pretend participant, called a simulated patient instructor.
The researchers will then be assessed on their communication skills — whether they conveyed all of the relevant information and assured that the patient understood all facets of the experiment, said assistant Medical School Dean Casey White.
January 11, 2005
The Latest Health Care Stats
As reported by numerous news outlets, Health Affairs has published a report (abstract) indicating that the rate of growth in the health care sector has fallen off for the first time in years. Here's the summary from Kaiser's Health Policy Daily Report:
The "torrid pace of growth" in U.S. health care spending "cooled a bit" in 2003 -- in part because of state reductions in the Medicaid program and slower growth in prescription drug spending -- but the amount of spending, about $1.7 trillion, exceeded 15% of the gross domestic product for the first time, according to an annual CMS report published in the January/February issue of Health Affairs, the New York Times reports. The report found that total health care spending in 2003 increased by 7.7%, compared with a 9.3% increase in 2002 (Pear, New York Times, 1/11). Total health care spending in 2003 accounted for 15.3% of GDP and exceeded overall U.S. economic growth by three percentage points, the report found (Strahinich, Boston Herald, 1/11). According to federal officials, the slower growth in health care spending in 2003 resulted in large part because of one-time state changes in the Medicaid program and the expiration of mandated higher supplemental Medicare reimbursements to hospitals and nursing homes (Lueck, Wall Street Journal, 1/11). Medicaid in 2003 accounted for about one-third of the total $765 billion in public funds spent on health care, according to the report (Japsen, Chicago Tribune, 1/11). In 2003, spending on public health care programs for low-income residents increased by 6.6%, compared with 9.7% in 2002, the report found (Lipman, Atlanta Journal-Constitution, 1/11). Although most states prior to 2003 did not reduce funds for public health programs and used "state reserves, taxes and tobacco funds" to help cover the cost, 34 states in 2003 increased eligibility requirements and reduced benefits for such programs, the report said (Chicago Tribune, 1/11).
Beware Atkins Dieters!
Just when you thought it was safe to start your Atkins diet, a new study by the American Cancer Society reveals that eating red meat may increase the risk for certain types of cancer. In the study, [p]articipants recorded their meat intake in 1982 and again in 1992-93. Those with a high meat intake were about 30 to 40 percent more likely to develop lower colon or rectal cancer than those with a low intake." Unfortunately a related study also shows that eating lots of fruits and vegetables doesn't necessarily help prevent certain other types of cancer. The breast cancer study found no protective effect from fruits and vegetables in women questioned about diet and followed for an average of about five years. I guess I will just stick to eating chocolate. [bm]
Femal Vigra: What Happened?
The AmNews has a brief story on the drug Intrinsa and its failure to receive approval from the FDA. The FDA had concerns about the long-term safety of the drug.
"Worn on the abdomen, Intrinsa releases a small amount of natural testosterone in an attempt to compensate for a drop experienced by some women as they age. The 24-week randomized, double-blind, multicenter trial was limited to surgically menopausal women with hypoactive sexual desire disorder. Participants recorded an increase in satisfying sexual activity versus placebo. Still, the committee focused on the study's limits rather than the drug's efficacy.
"It needs to be studied on all women," said Leah Raye Mabry, MD, a family physician in San Antonio and an officer of the American Academy of Family Physicians. "This was targeted toward a special group of women. And there were concerns that the drug would be used off-label for groups not studied."
But off-label use of hormones to boost a woman's libido is common and has been going on for years. The problem is that there are no studies as to the long-term effects. "There was a concern it would end up like Viagra, and even if doctors were reluctant to prescribe, patients would be almost demanding that doctors give them a chance to try it," Dr. Mabry said."
It is unclear to me whether Instrinsa has more safety issues than many of the alleged male equivalents and it should be interesting to follow and see what drugs are developed and marketed to women for sexual disorders. In terms of full disclosure, my husband works for Procter and Gamble, the manufacturer of Instrinsa.[bm]
January 10, 2005
Judge Denies Pregnant Woman Divorce from her Batterer Husband
A judge in Washington state, who has subsequently retired, has denied a pregnant woman's request to divorce her husband who battered her throughout the course of their marriage and who is currently in federal prison awaiting trial on drug charges.
Shawnna Hughes' husband did not object when she asked for the divorce, and she is 7-months pregnant with a child that she alleges was not fathered by her husband. However, the Washington court held that the policy of the state is to delay a divorce if the wife is pregnant until the child is born and paternity can be established, thus protecting the support rights of the child.
While an interest as lofty as supporting infant children is involved here, this "policy" could not pass Constitutional muster, in my opinion. Faced with an Equal Protection challenge, the state cannot justify giving non-pregnant women enhanced rights over their pregnant counterparts. While the state will attempt to justify the disparity by invoking the right of the child, paternity can always be determined either during the pregnancy if necessary, or after the pregnancy with any necessary amendment to divorce settlement made in light of the paternity determination. Regardless, Washington state law presumes that a husband is the father of his wife's child during the marriage and 300 days thereafter, if a divorce is granted. With these facts in mind, it is difficult to see the logic underlying the policy.
According to a spokewoman for the Northwest Women's Law Center, the policy may incentivize a battering husband to impregnate his wife just to keep her hostage within the marriage. While this is rather hyperbolic, especially in light of the fact that a mother in Hughes situation will not be required to live with her husband, there are still some major problems with this decision.
The AMA News has an interesting story about the success of doctors with a variety of disabilities. The article makes clear what a difficult profession medicine is for those with disabilities. It states,
"Statistics on the number of physicians with a disability who are practicing medicine are scarce. A study published in the American Journal of Physical Medicine & Rehabilitation, based on data from 1996, estimated that 0.2% of medical school graduates have disabilities.
Most physicians who are practicing with a disability acquired that disability during their career. Despite the enactment of the American with Disabilities Act in 1990, which prohibits discrimination against a qualified applicant who has disabilities, few students with disabilities enter the profession. In part, this is because medical students must be able to perform the essential functions of being a doctor, and each school determines for itself what these criteria are." [bm]
Thank you Chris!
A very big thank you to my student Chris Kuhnhein for filling in for me while I was away. Thanks for the terrific posts! [bm]
Bush: Med-Mal Reform
or: "Picking the Low-Hanging Fruit"
The President's campaign to impose caps on noneconomic damages in tort cases elicits a negative reaction from only one group (the plaintiffs' bar), and that group is overwhelmingly behind Democratic candidates. For that reason alone, expect this to be the early "feel good" issue of the the 109th Congress, albeit an issue that the Senate's 44 Democrats can be expected to go to the mat to defeat. AHLA's "Health Law Highlights" provides these links:
In a January 5 speech at Gateway Center in Collinsville, Illinois, President Bush talked about the "need to fix a broken medical liability system" and urged Congress to pass "real" reform this year. According to Bush, "lawyers are filing baseless suits against hospitals and doctors" because they "know the medical liability system is tilted in their favor." In order to solve the problem of these "junk" lawsuits, Bush expressed his support for a cap on non-economic damages of $250,000. According to Senator Byron Dorgan (D-ND) the President's plan would also shield large drug companies from liability for their own negligence. "In its zeal to support the big drug companies, the Bush Administration is seriously overreaching with this proposal. It will not stand," Dorgan said.
To read the text of Bush's speech, go to http://www.whitehouse.gov/news/releases/2005/01/20050105-4.html
To read Sen. Dorgan's statement, go to http://dorgan.senate.gov/newsroom/record.cfm?id=230431
January 9, 2005
SCOTUS Grants Cert. in Biotech Patent Dispute
From Friday's Wall Street Journal (subscription required):
The Supreme Court also said Friday it will hear a biomedical patent dispute between Merck KGaA and Integra Life Sciences Holdings Corp.
By taking up the case, the justices will attempt to clarify under what circumstances one company may, citing a U.S. Food and Drug Administration exemption, use another company's patents when conducting certain types of biomedical research. The FDA exemption applies to preclinical research studies searching for new drug applications.
Merck KGaA -- not connected to the U.S. drug giant by the same name -- asserted it didn't have to pay Integra, of Plainsboro, N.J., for the use of patents in medical research it was funding for cancer treatments. But a federal jury awarded Integra $15 million in a patent-infringement lawsuit. A federal judge has since cut the judgment to $6.4 million.
The U.S. government filed a brief with the Supreme Court urging the justices to overturn the verdict and make it clear the FDA exemption applied to the medical research. (Merck v. Integra Lifesciences)
SCOTUSBlog adds: "Justices Stephen G. Breyer and Sandra Day O'Connor will not participate in the decision in the case; no reason was given."
The Federal Circuit's opinion in the case can be found here. [tm]