Wednesday, March 22, 2006
The New Yorker has a moving story about how a woman Alice Stewart Trillin, dealt with disagreement between her doctors on her treatment. The article begins, "Jerome Groopman has written in this magazine about the dilemma a doctor
faces when giving medical advice that strongly contradicts the
diagnosis of another doctor, and about the difficulty of waiting rather
than taking swift action in the face of a dire medical situation. He
recalled an admonition he heard as a medical student: "Don't just do
something—stand there." But what about a patient who has to bet his
life on one doctor's best guess against another's, and stands there,
waiting to see which way the possibly loaded dice will roll? "
Erza Klein notes the increased mention of health insurance as a means of attracting a date, a mate and even true love. For example, Slate.com cites the following ads: "1) A woman's ad asks, "Do you make at least $75,000 a year and have health insurance?" 2) A man's ad says he "can supply all the little things like health insurance and the big things like a nice place to live." 3) Another man's ad says, "If you are able to add someone to your health insurance as a 'spousal equivalent' have I got a deal for you."
Although quite funny at first glance, it is rather sad that access to health insurance is being used in this manner. Yet another reason to re-think our health care system . . . [bm]
Tuesday, March 21, 2006
The Health Care blog has a great post discussing Paul Ginsberg's recent article concerning price transparency in health care. He concludes,
. . . . The need for consumers to compare prices of providers and treatment alternatives is increasing and has the potential to improve the value equation in health care. But we need to be realistic about the magnitude of the potential for improvement from making consumers more effective shoppers for health care. Whatever the gains from increased shopping activity, rising health care costs will, nevertheless, price more consumers out of the market for health insurance and burden governments struggling to pay for health care from a revenue base that is not growing as fast as their financing commitment. For those who have health insurance, their health plan will be a key agent in facilitating their obtaining better value. Government needs to take care not to interfere with this relationship and should focus instead on the needs of those without insurance
Just for fun - if you are thinking about retiring or just moving to a different location as a means to improve your health - you may want to check out the findyourspot.com website. You do need to register. It provides a comprehensive survey of questions and then provides you with a list of places where you would be happy living. I apparently should be in Medford, Oregon. [bm]
Monday's NY Times had a very good piece on the correlation patent issue about which the Court will hear oral argument today ("Justices Reach Out to Consider Patent Case"). My earlier post is here Take this with the proverbial grain of NaCl, but according to the article, "Both sides say the case, which involves a blood test for a vitamin deficiency, could have a wide-ranging impact on the development of diagnostics, perhaps threatening many of the underlying patents for genetic and other medical tests." [tm]
Yesterday's Wall Street Journal reported (paid subscription required) that three bioethicists -- Nancy King (UNC), Robert Nelson (UPenn), and Ken Kipnis (Hawaii) -- have written an open letter expressing their concerns to the 31 institutions conducting clinical trials of a blood substitute for seriously bleeding emergency department patients. The Office of Human Research Protection has already announced that it is looking into the research, as has the SEC (see Newsday story). The Wall Street Journal's March 10 article on this study is here. [tm]
Monday, March 20, 2006
Ever since the FDA approved RU-486, the abortion pill, it has been mired in a variety of controversies. Recent challenges have been made to its safety because several women allegedly have died due to the drug. Thoughts of an Average Woman has some of the recent studies and write-ups. [bm]
Reuters reports that a number of Bush administration officials, including Interior Secretary Gail Norton, Agriculture Sectretary Mike Johanns, and Secretary of Health and Human Services Michael Leavitt, have indicated that "it was "increasingly likely" that bird flu would be detected in the United States as early as this year but added it would not mean the start of a human pandemic." Today, these officals also disclosed "a plan to increase monitoring of migratory birds that are likely to bring the bird flu virus to U.S. shores."
For all things concerning bird flu and other public health issues, see effect measure. [bm]
It's not exactly health law, but an article in The Boston Globe caught my eye anyway, maybe because I spend a substantial part of every school year with MSIII's who rotate through Pediatrics and with fourth-years getting ready to leave school and start their residencies. The article ("Learning the Patient's View: Harvard Alters Doctors' Training" [requires free registration]) describes the biggest changes in the medical school's curriculum in 20 years:
The biggest shift will occur in the third year, which is the first time that students leave the classroom to see patients. At present, students go from hospital to hospital for one- to three-month stints, a practice that gives them few opportunities to get to know patients or senior doctors.
Under the new curriculum, students will stay in one hospital and follow some patients the entire year.
Senior doctors would be able to better spot students' strengths and weaknesses, and they will hold twice-monthly conferences in which students will discuss not only their patients' medical issues but also ethical dilemmas, family problems, and health insurance snafus.
Harvard will extend the first year by two weeks to give students an introduction to the profession. Students also will be required to take one-semester classes on the effect of social and economic conditions on disease, medical ethics and professionalism, and health policy. These changes, among others, will be phased in over the next three years, starting in August.
The changes aren't being embraced at all the teaching hospitals in the Harvard system, but if they help the next generation of doctors better understand and deal with patients' "ethical dilemmas, family problems, and health insurance snafus," this has to be progress, doesn't it? [tm]
Glenn McGee & Peter Levin's editorial in the current issue of the American Journal of Bioethics is posted on their bioethics blog for all to read. It paints a pretty damning picture of COI practices at the home of the leading cardiovascular practice group in the world and is well worth reading. One tidbit worth thinking about: Of its 87 board members, more than half are in business relationships with the Clinic . . . not exactly a group that inspires confidence in the institution's ability to police conflicts of interest. [tm]
This ought to be pretty simple: A doctor can prescribe an FDA-approved drug for an unapproved ("off-label") use but cannot prescribe an unapproved drug for an approved use. And he especially can't use the unapproved drug while claiming he is using (and billing for) the approved version. That's misbranding and fraud.
An Oregon doctor has learned this lesson the hard way. He was charged with administering an unapproved (and cheaper) form of botulism toxin to more than 800 patients at his "A Younger You" clinics while claiming he was administering Botox, which is approved. On Thursday, according to an article in The Oregonian, the physician pleaded guilty and accepted an 18-month prison sentence. [tm]
Two developments noted in today's issue of AIS's Report on Medicare Compliance (and summarized in AIS's Government News of the Week):
- A U.S. district court was right to dismiss the charges against Baptist Health System (BHS) in Alabama and the American Hospital Association (AHA), says the U.S. Court of Appeals for the Eleventh Circuit in a March 9 opinion. BHS and AHA were charged in a class-action suit with breach of contract by billing uninsured patients more for health care than insured patients, and for violating the Emergency Medical Treatment and Active Labor Act (EMTALA) by conditioning treatment on patients' ability to pay. The appeals court agreed that the breach-of-contract claims were barred because judgments had already been entered in state suits. And the EMTALA charges were dismissed because the patients did not file their suit within the two-year EMTALA statute of limitations, the court says.
- Kansas Attorney General Phill Kline (R) says he is examining the billing and collection practices of not-for-profit hospitals in the state to "protect uninsured and underinsured Kansans from exploitation." Kline began the inquiry after receiving complaints by consumers who alleged questionable business practices by facilities throughout the state, a March 9 statement says. Kline has met with other attorneys general from midwestern states and with representatives of hospitals in Kansas to express concerns the state officials have about the issue. Former attorney general Robert Stephan has been appointed special assistant attorney general to lead discussions with hospitals and establish best practices for billing and collections, the statement says.
The opinion in the 11th Circuit case, Kizzire v. Baptist Health System, Inc., is here. The grounds for the appellate court's decision are narrow but worth noting to the extent the decision continues an almost unbroken string of losses for plaintiffs trying to use the federal courts to impose a charity-care requirement on hospitals that are exempt from taxation under § 501(c)(3) of the Internal Revenue Code.
Attorney General Kline's press release (not easy to find - his office's Press page has a bad link to this document) is here.
Health Affairs has published a provocative piece that casts doubt on widespread fears that the U.S. faces a physician shortage:
Variations in End-of-Life Care Sow Doubt About Need For More Physicians
In the March/April Health Affairs, Dartmouth's David Goodman and colleagues question the belief that the United States faces an impending physician shortage. As evidence, Goodman and colleagues offer a threefold variation in the amount of physician care given to patients at different academic medical centers in the last six months of life. They write that this variation is related to regional differences in physician supply, rather than any effects on the well-being of the patient. They assert that we should use our resources on replicating the efficient care offered by interdisciplinary practices such as the Mayo Clinic, rather than training more physicians who will only generate increased costs for the health system. (emphasis added)
Of perhaps greater interest than the conclusions about a supposed physician shortage is the authors' analysis of end-of-life resource allocation (measured in terms of physician labor). [tm]
Sunday, March 19, 2006
Michael Crichton has an op-ed in today's N.Y. Times criticizing the Patent Office's approach to "correlation patents." It may seem like an obscure topic, but it's on the Supreme Court's docket this term and has major implications for bioscience research and medical practice.
The Supreme Court case -- Laboratory Corporation of America Holdings, dba LabCorp v. Metabolite Laboratories, Inc. (U.S., No. 04-607) -- will be argued Tuesday. Here's the question presented: "Whether a patent instructing a party to 'correlate test results' can validly claim a monopoly over a basic scientific relationship used in medical treatment such that a doctor infringes the patent by looking at a test result and thinking about that relationship." Sound weird? Or (as Crichton suggests) Kafkaesque? Read on . . . .
Here's Duke Law School's synopsis of the case:
Metabolite sued LabCorp for patent infringement. In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids and specifically sought to protect the scientific connection between homocysteine levels and vitamin deficiency. B vitamins help metabolize homocysteine, which is an amino acid. UPI's patent describes a two-step process of testing for homocystine (an amino acid), and then correlating the level with the B vitamin levels in the body. UPI licensed Metabolite, which sublicensed Laboratory Corporation of America Holdings (LabCorp), to use the patent. From 1992-1998, LabCorp paid LabCorp paid Metabolite a royalty every time it supplied a doctor with a homocysteine test. After 1998, LabCorp began using a test developed by another company and Metabolite sued LabCorp for patent infringement.
After a trial, a jury found that the patent was valid and that LabCorp had willfully infringed Metabolite's patent, justifying enhanced damages. The United States Court of Appeals for the Federal Circuit affirmed. The Supreme Court granted certiorari only to resolve the question of whether the patent was valid since it involves detecting a natural correlation between homocysteine and vitamin B, and “laws of nature, natural phenomena, and abstract ideas” are not patentable.
Right. So if laws of nature, natural phenomena, and abstract ideas are not patentable, how is it that a company can get damages when a doc looks at another company's test results and thinks about the relationship between homocysteine levels and vitamin B deficiency? Good question.
Crichton, great populizer that he is, puts the question even more vividly:
Although Metabolite does not have a monopoly on test methods — other companies make homocysteine tests, too — they assert licensing rights on the correlation of elevated homocysteine with vitamin deficiency. A company called LabCorp used a different test but published an article mentioning the patented fact. Metabolite sued on a number of grounds, and has won in court so far.
But what the Supreme Court will focus on is the nature of the claimed correlation. On the one hand, courts have repeatedly held that basic bodily processes and "products of nature" are not patentable. That's why no one owns gravity, or the speed of light. But at the same time, courts have granted so-called correlation patents for many years. Powerful forces are arrayed on both sides of the issue.
"Powerful forces," indeed, judging from the list of amici who have filed briefs in this case, including the AMA, AARP, IBM, American Express and the US of A (plus the Intellectual Property Owners Association, People's Medical Society, American Clinical Laboratory Association, American Heart Association, Financial Services Industry, Patients Not Patents, Association of the Bar of the City of New York, Computer & Communications Industry, Affymetrix, Public Patent Foundation, Franklin Pierce Law Center, American Intellectual Property Law Association, Boston Patent Law Association, Perlegen Sciences, Mohr, Davidow Ventures, and the Federal Circuit Bar Association).
As usual, the Medill School of Journalism's Supreme Court website provides the most detailed and intelligible discussion of the case:
It is well established in patent law that the laws of nature, including the body’s biological processes, cannot be claimed or owned.
But a patent infringement lawsuit is testing the boundaries of that precedent, asking if a laboratory can patent the correlation between the level of an amino acid found in body tissues with the levels of vitamins in the body that make that amino acid.
Researchers at University Patents Inc. (UPI) in the early 1980s discovered a relationship between elevated levels of the amino acid homocysteine and the deficiency of two B vitamins, folate and cobalamin.
These vitamins help form homocysteine, and the researchers noted that unusually high homocysteine levels often signaled dangerously low levels of the important vitamins. Elevated homocysteine levels have been connected with a variety of health problems, including lupus, renal disease, arthritis and Alzheimer’s disease.
As early as 1969, researchers discovered that elevated homocysteine levels could signal increased risk of heart disease.
In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids. In claim 13 of that patent, UPI sought to license the scientific connection between homocysteine levels and vitamin deficiency, describing a two-step process of testing for the amino acid, and then correlating the level with the B vitamin levels in the body.
Laboratory Corporation of America Holdings (LabCorp) obtained a sub-license for the patent from Metabolite Laboratories, Inc., which was licensed by UPI’s successor. Beginning in 1992, LabCorp paid Metabolite a royalty every time it supplied a doctor with a homocysteine test. But after LabCorp began using another company’s testing method in 1998, Metabolite sued LabCorp for patent infringement.
The jury in the November 2001 trial awarded Metabolite almost $5 million in damages after finding LabCorp liable for breach of contract and patent infringement. The trial judge assessed an additional $1 million in damages in finding the infringement intentional, and issued a permanent injunction barring LabCorp from using other tests.
LabCorp appealed to the Court of Appeals for the Federal Circuit, arguing that for the “correlation” step of the patent to have any meaning, a doctor must confirm the vitamin deficiency through physical diagnosis–simply thinking about the relationship should not violate the patent.
A panel of the appeals court rejected the argument, holding that an infringement “only requires association of homocysteine levels with vitamin deficiencies.”
To Jonathan Franklin, who represents LabCorp, that decision amounts to regulating the thought processes of doctors who receive the test results and try to diagnose their patients’ illnesses.
“The lower courts said that every doctor who orders a homocysteine test, for any reason, infringes the patent,” Franklin said.
In Funk Bros. Seed Co. v. Kalo Inoculant Co. [link], the U.S. Supreme Court ruled in 1948 that a previously unknown natural phenomenon cannot be patented, but an invention resulting from the discovery that has a “new and useful” application may be patentable.
To LabCorp, claim 13 has no new and useful application, and the patent is akin to discovering that high cholesterol may be linked to Alzheimer’s disease, and claiming a monopoly on that connection–and in doing so collecting a royalty every time a doctor connects the two.
After LabCorp sought review from the U.S. Supreme Court, the Court asked the Solicitor General in February 2005 to file a brief expressing the government’s opinion on whether the patent is invalid because “laws of nature, natural phenomena and abstract ideas” are not patentable.
The Solicitor General recommended the Court deny LabCorp’s petition for a writ of certiorari, but argued that the natural phenomenon issue hadn’t been sufficiently raised in the lower courts. The Solicitor General did not go so far as to conclude that the patent is valid on its merits alone.
On Oct. 31, 2005, the Court accepted review of the case limited to the question of whether a patent instructing a party to “correlate test results can validly claim a monopoly over a basic scientific relationship used in medical treatment” such that a doctor infringes the patent by looking at a test result and thinking about that relationship.
LabCorp argues claim 13 is too vague and offers no instructions as to how one should correlate the homocysteine levels with vitamin deficiency.
“If the Court allows the Federal Circuit opinion to stand, anyone could obtain a patent on any scientific correlation–that there is a link between fact A and fact B–merely by drafting a patent claiming no more than ‘test for fact A and correlate with fact B,’” Franklin argues in LabCorp’s brief.
Glenn Beaton, who will represent Metabolite before the Court, counters that this example “grossly oversimplifies what the researchers did.”
“The researchers came up with a new way of testing for homocysteine,” Beaton said. “That example is an exaggeration because the correlation was not known previously.”
Beaton noted in his response that the appeals court had no problems deciphering the correlation step, adding that even LabCorp’s own employees testified they “understood the meaning of ‘correlating’” at trial.
In addition to the interpretation of the correlating step, the Court’s decision is expected to clarify the issues surrounding patenting natural processes.
The Court may look to its 1981 opinion in Diamond v. Diehr [link] for direction. In Diehr the Court ruled that, while a mathematical formula is not patentable, a process for curing rubber that used the formula could be patented because the process involved a transformation to a “different state or thing.”
The Court may also rely on its 1978 decision in Parker v. Flook [link], in which it established that “the discovery of [a natural] phenomenon cannot support a patent unless there is some other inventive concept in its application.”
The question before the Court, then, is whether the correlation requirement of claim 13 is sufficiently inventive, as in Flook, or whether the process results in a “different state” to allow the monopoly of a natural phenomenon, as it held in Diehr.
In November Chief Justice John Roberts recused himself from the case. Roberts did not provide a reason, but he previously worked at Franklin’s law firm, Hogan & Hartson of Washington, D.C.
Noting that well-known and important medicine like drugs that treat AIDS were patented on the same correlation principle, Beaton says the precedent if Metabolite loses the case will lead to chaos in the scientific patent field.
“Thousands of correlation patents will be stripped, and there are huge investments in these patents,” Beaton said.
LabCorp, on the other hand, argues the precedent that will be set if it loses could lead to a “crippling liability” for sharing medical information.
“Medical professionals and others must be able to discuss such facts…without fear of liability,” Franklin said in the brief. “If the Federal Circuit’s decision is not reversed, the ultimate losers will be thousands of doctors and millions of their patients.”
In Sunday's N.Y. Times: "Nonprofit Hospitals Face Scrutiny Over Practices." Among those lining up to take their shot at the nonprofit hospital industry:
- the Senate Finance Committee's Charles Grassley
- Ways and Means Committee's Bill Thomas
- IRS Commissioner Mark W. Everson
- Kansas Attorney General Phil Kline
- Illinois Attorney General Lisa Madigan
- Minnesota Attorney General Mike Hatch
Not much new in this piece, but it's a good primer on some of the issues. [tm]
Saturday, March 18, 2006
The AP reports that the 6th Circuit has upheld Tennessee's pro-life license plate even though it does not offer the option of ordering a pro-choice license plate. According to the story,
Tennessee is the 13th state to offer "Choose Life" plates. The others are Alabama, Arkansas, Connecticut, Florida, Hawaii, Louisiana, Maryland, Mississippi, Montana, Ohio, Oklahoma and South Dakota. Most states donate proceeds to adoption groups, but Alabama, Hawaii, Maryland and Montana donate at least some of the money to anti-abortion groups.
Other courts around the country have ruled on the issuance of special license plates previously. In September 2005, a district judge ruled that Arizona could refuse to issue "choose life" plates [JURIST report]. In March 2004, the US Court of Appeals for the Fourth Circuit struck down anti-abortion plates [JURIST report] in South Carolina, while the US Court of Appeals for the Fifth Circuit in April 2004 upheld similar plates [JURIST report] against a challenge in Louisiana.
MIchael Kinsley of Slate.com has a thought-provoking article on whether United States is ready for single payer health care program outlined by Krugman and Wells. He prefers more modest reforms and says,
. . . Much of it isn't insurance at all but a subsidy. The value of the subsidy is the difference between what the individual pays and what the insurance would cost in the free market. If people were buying health care or insurance with their own money, they might or might not spend too much—whatever "too much" is—but no one else would need to care if they did.
A subsidy has to take from someone and give to someone else. Everybody can't subsidize everybody. Or, to put it another way, society cannot give the average citizen better health care than the average citizen would choose to buy on his or her own. And this is what people want. Krugman and Wells believe that the average citizen will be sated by whatever bonus comes out of single-payer efficiencies. In this day of $100,000-a-year pills, I doubt it.
Even though we don't do it, most Americans surely think we ought to guarantee decent health care to everyone. In fact, most would probably be uncomfortable saying it's OK to have anything less than equal health care for everybody. Should a poor child die because her family can't afford a medicine that an insured, middle-class parent can pick up at the drugstore? Current government programs don't protect poor people very well against the cost of becoming sick. They do much better at protecting sick people against the risk of becoming poor. People who can afford insurance ought to protect themselves against a catastrophic health expense. But subsidizing this insurance for them is not only unnecessary, it is futile and unfair. No one is better able to afford health care for people of average means or above than they are themselves.
Krugman and Wells say that private insurance is flawed by "adverse selection": Insurance companies will avoid riskier customers. Only a single payer (that is, an insurance monopoly) can insure everybody and spread the risk. But anyone is insurable at some price—a price that reflects the cost they are likely to impose on the insurer. Adverse selection is only a problem to the extent that insurance is not really insurance, but rather a subsidy.
If you're not as hopeful as Krugman and Wells about being able to avoid rationing, you face the question: Should people be allowed to opt out of rationing if they can afford it? That is, if the system (private or single-payer) won't pay for the $100,000 pill, should you be able to pay for it yourself? Fear that this would not be allowed helped to kill the Clinton health-care reform 13 years ago. But explicitly granting some people life and health while denying these things to others is hard, even though this disparity has existed throughout history and is probably unavoidable. In fact, a serious defect of single-payer is that it makes all sorts of unbearable trade-offs explicit government policy, rather than obscuring them in complexities.
The Times UK discusses the new book by Debora Spar called, "The Baby Business," and examines the unregulated market for eggs from young, smart women in the United States. The article reports,
“We are selling components of children,” Professor Spar said yesterday. “My whole argument is I would much rather we ’fess up to what we are doing and regulate it than push it under the carpet, as we have been doing with egg donation.”
As other countries tighten their rules, America’s loosely regulated market is becoming the world centre for egg donation. The Government’s Centres for Disease Control and Prevention has tracked a 40 per cent surge in the use of donor eggs, from 10,389 in 2000 to 14,323 in 2003, the latest year for which figures are available. Stem-cell research, still in its infancy, could add to demand for donor eggs.
Selling organs is illegal in America. But human eggs, like sperm, are not covered by the law. Nevertheless, fertility clinics insist that payments to donors are intended to compensate their time and effort rather than purchase the egg.
Thanks to the Huffington Post for this cite. [bm]
Thursday, March 16, 2006
I cannot believe that a doctor (or any human being) would actually do this to another individual. At first, the story read a little like some of those managed care horror stories that we used to hear about, but apparently this was not an effort to save money - just a case of some missing medical equipment.
According to a report on MSNBC, a jury in Hawaii found a doctor and a hospital negligent (the hospital for negligent credentialing) and awarded $5.6 million to the " family of a man who had the shaft of a screwdriver implanted into his spine by an orthopedic surgeon." Why would the surgeon do such a thing, you ask . . . well, apparently Dr. Robert Ricketson could not find the "two titanium rods he planned to attach to [the patient's] spine . . . during the operation at Hilo Medical Center." (Next time I undergo surgery, I plan to check for any common household tools that might be hidden in the operating room). Unfortunately for the doctor, the stainless steel (I believe this substance to be somewhat less strong than titanium) snapped several days later and the man had to undergo three more surgeries and then died two years later.
Dr. Ricketson's medical license had been suspended by both Texas and Oklahoma before he moved to Hawaii. Looks like someone failed to consult with the databank. [bm]
The New York Times reports today that President Bush has nominated the current acting FDA commissioner, Andrew von Eschenbach to become permanent head of the agency. He is currently also the director of the National Cancer Institute. For more information on him, see the very helpful write-up by the Kaiser Network Org. Citing to a recent LA Times story, it states as some of Von Eschbach's goals include: "As permanent commissioner, von Eschenbach likely would focus on streamlining FDA's process for approving new medications for hard-to-cure diseases like certain cancers. FDA also must "establish a framework for regulating emerging fields such as generic medicine."
However, according to a story aired this morning on National Public Radio, von Eschenbach may not ever be confirmed because Senators Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) have placed a hold on the confirmation vote due to the failure of the FDA to act on the nonprescription availability of Plan B (emergency contraceptive device). For more information and commentary, see the Washington Monthly discussion and read the full Kaiser Network Org article. [bm]