April 7, 2006
Plan B: A Brief History
Majikthise, one of my favorite bloggers, has posted a history of emergency contraception. She states,
Scientifically validated emergency contraception (EC) didn't exist until 1974. Dr. Albert Yuzpe, a Canadian OB-GYN, developed and tested the first EC regimen in 1974. Planned Parenthood explains:
The ECP regimen first approved by the U.S. Food and Drug Administration (FDA) is called the Yuzpe Regimen, named for Canadian Professor A. Albert Yuzpe who, in 1974, published the first studies demonstrating the safety and efficacy of ECPs. The Yuzpe regimen consists of combined oral contraceptive pills that contain the hormones estrogen and progestin taken in two doses Our story begins in 1974 when emergency contraception was as innovative as rocket science.
The FDA declared the Yuzpe regimen safe and and effective in 1997 and approved an Yuzpe-based EC kit in 1998. Plan B got FDA approval in 1999.
The drug marketed under the name "Plan B" is a major advance on the Yuzpe regimen. Plan B is the first progestin-only emergency contraceptive pill on the US market.
As you know, the FDA denied over-the-counter status for Plan B in late 2003. She provides some updated history of where the controversy is now. [bm].
Harm v. Benefit
The blog, TigerHawk, has an interesting article on how the FDA and our regulatory system views the harms that drugs cause as compared to the benefits that those same drugs may achieve. The article is entitled, "The FDA, the Tysabri conundrum, and our cultural incapacity for single payor healthcare. The article quotes extensively from a piece in today's Wall Street Journal concerning the FDA and MS that requires a paid subcription. The blog writer states,
One of the biggest problems with our system for regulating pharmaceuticals is that we carefully measure all the harm a drug may have done, but do not weigh against it all the good it certainly can do. This asymmetry between sins of commission, which both the FDA and the tort system consider grave, and sins of omission, which neither take into account in any systematic way, means that it is very difficult to gain the approval of drugs that may do tremendous good for virtually all patients, but grievous harm to a tiny percentage of the people who take them. The risk to the tiny percentage overwhelms the benefits to the millions in the minds of risk averse bureaucrats, and the FDA prevents or delays the approval of the drug.
An example of this is the FDA's hanky-twisting over the multiple sclerosis drug Tysabri, which is orders of magnitude more effective against that nerve-killing disease than existing therapies. Unfortunately, Tysabri has been "linked" -- tenuously, at best -- with a rare brain infection in fewer than five patients out of the many thousands who have taken it. The FDA pressured Biogen and Elan to pull the drug last year, and it has not cleared the drug for relaunch notwithstanding the unanimous recommendation of a non-binding expert advisory panel. Why? Because it fears the quick death of one or two people more than it values the lifespans of hundreds of thousands of people.
GAO's Health-Related Reports, March 2006
The Government Accountability Office (formerly the General Accounting Office) is a wonderful source of information about how the government works (and a frequent source of story ideas for CBS' "60 Minutes"). And because most reports are the result of Congressional queries, they are some indication of what is on Congress' mind, as well. Here are the health-related reports released in March 2006:
- Health Information Technology: HHS is Continuing Efforts to Define a National Strategy. GAO-06-346T, March 15, 2006 (17 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-346T
- Health Professions Education Programs. GAO-06-55, February 28, 2006 (42 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-55
- Long-Term Care Insurance: Federal Program Compared Favorably with Other Products, and Analysis of Claims Trend Could Inform Future Decisions. GAO-06-401, March 31, 2006 (52 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-401
- Medicaid Integrity: Implementation of New Program Provides Opportunities for Federal Leadership to Combat Fraud and Abuse. GAO-06-578T, March 28, 2006 (15 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-578T
- Medicare Durable Medical Equipment: Class III Devices Do Not Warrant a Distinct Annual Payment Update. GAO-06-62, March 1, 2006 (19 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-62
- Medicare Payment: CMS Methodology Adequate to Estimate National Error Rate. GAO-06-300, March 24, 2006 (42 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-300
April 6, 2006
New Approach to Abortion Issue By Democrats
According to the Hill.Com, Senate democrats are pursuing a new strategy with regard to the abortion issue - to try to reduce the need for abortions through greater access to contraceptives. The article states,
The Prevention First Act is sponsored by Senate Minority Leader Harry Reid (Nev.), one of few congressional Democrats considered anti-abortion. The bill, which Reid introduced at the start of the Congress, has the support of Sen. Hillary Rodham Clinton (D-N.Y.), presumptive front-runner in the 2008 presidential primary and 21 other Democrats.
The bill would prohibit group health plans from excluding contraceptive drugs, devices and outpatient services if they cover the cost of other prescription drugs and outpatient services. It would also require the secretary of health and human services to disseminate information on emergency contraception to healthcare providers and require hospitals receiving federal money to provide emergency contraception to victims of sexual assault.
The bill would also mandate that federally funded programs provide information about contraceptives that is medically accurate and includes data on health benefits and failure rates.
When asked whether he would be able to get a vote on his bill soon, Reid said: “I hope so. I’ll do what I can.”
He added that bringing the issue to the floor is “on my mind.”
A Democratic leadership aide said that, while only a slim majority of voters favor abortion rights, an overwhelming majority support promoting the use of contraceptives and comprehensive sex education.
Thanks to Americablog for the cite.[bm]
Thanks to Americablog for the cite.[bm]
April 5, 2006
NPR.ORG has a great story on the latest Merck/Vioxx verdict. Click here to listen. Here is the brief write-up to the story:
A New Jersey state court jury has awarded $4.5 million in a lawsuit filed by men who had suffered heart attacks while taking Vioxx, made by Merck & Co. The trial involved two plaintiffs, John McDarby, 77, and Thomas Cona, 60.
In its split decision, the jury said Vioxx was responsible only for McDarby's heart attack, not Cona's. Cona said he had taken the drug for 22 months, but he could only produce prescriptions that proved seven months of use. He said he used samples the rest of the time.
The award of $4.5 million to McDarby is for compensatory damages. On Thursday, the jury will decide whether Merck should face punitive damages as well.
The jury also found that, under New Jersey consumer-fraud law, Merck misrepresented Vioxx's risks when it marketed the drug to physicians. Merck is accused of intentionally suppressing or omitting material information about Vioxx's risks in its marketing to doctors.
Merck faces a class-action lawsuit in a case brought by a New Jersey labor union that provides health benefits to its members.
New Health Quality Study Released
Not good news on the desire to improve patient safety and general health care quality, according to a recent study released from HealthGrades, a leading healthcare rankings company. A press release concerning HealthGrades annual report, states,"Patient safety incidents in American hopsitals grew from 1.18 million to 1.24 million aong the 40 million hospitalizations covered under the Medicare program and incidents varied widely from state to state and among the best and worst hospitals."
You should read the full report for the rest of the findings. None of which appear to be terribly uplifting. Thanks to the HealthyPolicy blog for this information. The HealthyPolicy blog also has further helpful comments. [bm]
Health Care Reform in the Bay State
The papers are all abuzz this morning about the passage of a near-universal coverage law in Massachusetts yesterday. Here are some links:
- Bloomberg News
- Wall Street Journal
- Boston Globe
- Health Care Conference Report
April 4, 2006
The Washington Post reports on an interesting new scientific development that may help with the organ donor shortage in the United States - a development that does not rely on embryonic stem cells. According to the Post,
Researchers said yesterday that they have grown complete urinary bladders in a laboratory and transplanted them into patients, improving their health and achieving a Holy Grail of medicine: the first cultivation of working replacements for failing solid organs in people.
The "neo-bladders," each one grown in a small laboratory container from a pinch of a patient's own cells, have been working in seven young patients for an average of almost four years, according to a report released yesterday by the British journal the Lancet. The organs have remained free of the many complications that bedevil the conventional practice of surgically constructing bladders from other tissues.
If ongoing studies continue apace, the researchers said, they hope someday to offer patients more than a dozen other homegrown organs, including blood-vessel complexes, partial kidneys and perhaps hearts.
"It was really uncharted territory in terms of how you do these things," said Anthony Atala of Wake Forest University School of Medicine in Winston-Salem, N.C., who led the work with Alan Retik at Children's Hospital and Harvard Medical School in Boston. "We're very pleased with how well they're functioning."
Experts applauded the work as a coming of age for the long-struggling field of tissue engineering and as a possible way to bypass some of the controversy over embryonic stem cells.
Those versatile cells stir political trouble because obtaining them requires the destruction of human embryos. Although embryonic cells remain the most versatile biological building blocks, it now appears that at least some tissues, and even whole organs, can be generated without using the cells at all.
Should be interesting to see how this development continues and whether it can be used for other organs. [bm]
April 3, 2006
Final US News Rankings Available
US News and World Report has the latest rankings now available on its website here.
Plan B Article
William Saletan has an article in Slate.com concerning Plan B. The article is entitled, The Birds and the B's: Are Morning After Pills Abortion or Contraception?" He writes,
If you thought it was hard figuring out your views on abortion and birth control, get ready to wrap your mind around something in between.
Emergency contraception, also known as the "morning-after pill" and marketed in this country as "Plan B," is a drug that a woman can take after sex but before an embryo attaches to her womb. If you don't know much about this murky week in the reproductive process, it's time to learn. Lawmakers in many states are deciding right now whether EC will be easy or hard to get. Some say it causes abortions. Some say it only prevents them. And the dirty little secret is, nobody really knows.
He makes some good points about the importance of how Plan B is understood by consumers and others interested in the abortion debate. [bm]
Midwife Prosecuted for Infant's Death
Many of us teach some midwife cases in our Health Law courses, in connection with licensing or liability or some other subset of quality issues. An article in today's NY Times may therefore be of interest. It concerns the prosecution of a midwife in Indiana for lay midwifery, a felony punishable by up to 8 years in prison. [tm]
April 2, 2006
Latest from the Law Reviews
- Griffith, John R. Note. A public health and safety exception: finding a "position of trust" where none exists. (United States v. Snook, 366 F.3d 439, 7th Cir. 2004.) 13 Mo. Envtl. L. & Pol'y Rev. 54-66 (2005). [L][W]
- Nation, George A. III. Obscene contracts: the doctrine of unconscionability and hospital billing of the uninsured. 94 Ky. L.J. 101-137 (2005-2006). [L][W]
- 66 LOUISIANA LAW REVIEW, SPECIAL ISSUE, DECEMBER, 2005: Symposium: Proceedings of "The Genomics Revolution? Science, Law and Policy". 66 La. L. Rev. 1-143 (2005).
- Malinowski, Michael J., Bartha Maria Knoppers and Claude Bouchard. Introduction. 66 La. L. Rev. 1-7 (2005).
- McGinnis, J. Michael, M.D. Population health and the influence of medical and scientific advances. 66 La. L. Rev. 9-20 (2005).
- Knoppers, Bartha Maria. Overview of law and policy challenges. 66 La. L. Rev. 21-31 (2005).
- Yoon, Paula W. Risk prediction for common diseases. 66 La. L. Rev. 33-41 (2005).
- Malinowski, Michael J. Taking genomics to the biobank: access to human biological samples and medical information. 66 La. L. Rev. 43-67 (2005).
- Wells, Robert. Intellectual property/ownership issues. 66 La. L. Rev. 69-77 (2005).
- Greely, Henry T. Population participation and other factors that impact the compilation and the utility of resulting databases. 66 La. L. Rev. 79-90 (2005).
- Woodcock, Janet, M.D. FDA policy on pharmacognenomic data in drug development. 66 La. L. Rev. 91-102 (2005).
- Moe, Jeffrey L. Commercialization considerations for individualized diagnostic and drug therapies resulting from pharmacogenomics. 66 La. L. Rev. 103-116 (2005).
- Rothstein, Mark A. Liability issues in pharmacogenomics. 66 La. L. Rev. 117-124 (2005).
- Clayton, Ellen Wright, M.D. Implications for existing law/regulations. 66 La. L. Rev. 125-129 (2005).
- Ossorio, Pilar N. Race, genetic variation, and the Haplotype Mapping Project. 66 La. L. Rev. 131-143 (2005).
Lexis [L] and WestLaw [W] links are courtesy of the Marion Gould Gallagher Law Library at the University of Washington. [tm]