Saturday, November 27, 2004
The on-line version of Modern Healthcare (subscription required) reports that Seattle's Virginia Mason Medical Center posted on its web page an apology for a preventable medical error that resulted in patient's death. The hospital's statement, which may be viewed in its entirety here, begins:
Recently a preventable medical error occurred at Virginia Mason that we believe caused the death of one of our patients. We have offered our heartfelt apologies to the family of the patient and are doing everything we can to help them in this time of grief. But perhaps the only way we can make our apology real is to do everything we can to prevent medical errors in our system. Those efforts start with admitting that we make errors -- as in this case, owning up to errors, learning from them and fixing the systems that allow them to happen.
The MH article cites the Associated Press' report that "a technician mistakenly injected a 69-year-old woman with a toxic skin-cleaning antiseptic, rather than a harmless dye, during an operation two weeks ago. [Medical director of quality Robert] Caplan said both fluids were clear. The hospital has replaced the skin cleanser with an antiseptic-infused swab."
Friday, November 26, 2004
In the March/April 2004 issue of The Hastings Center Report, Carl Schneider and Angela Fagerlin wrote a piece entitled, "Enough: The Failure of the Living Will." For reasons best known to the Associated Press (slow news day?), Laura Meckler of the AP ran a story on this topic on Thanksgiving Day.
The criticisms of the living will are straightforward and well-known:
- "[E]nd-of-life medical questions often involve much more complicated medical and moral questions. Many living wills are so vague as to be useless."
- "People change their minds after they write their living wills but don't update them."
- "Many living wills never make it to the bedside, left in a file cabinet or safety deposit box."
- "And family and doctors often do a poor job of deciphering the patient's wishes even when they have the wills in hand."
- "Since 1990, hospitals have been required in most states to offer all patients the chance to fill out a living will. But despite the law and despite several high-profile end-of-life legal disputes, most people still don't have living wills."
On the other hand, "Naomi Naierman, president of the American Hospice Foundation, acknowledged there can be problems with living wills and other end-of-life plans. But doing nothing is far worse, she said.
"'You're only leaving a mess behind if you don't have directives for when you cannot speak on your own behalf,' said Naierman, whose organization promotes living wills. 'It's a terrible burden to leave with the family.'"
The article provides a lengthy vignette that is supposed to illustrate the limitations of living wills:
Jeanne and James Hanchett thought they were prepared. Both physicians, they had filled out living wills saying they did not want extraordinary treatments. Each had given the other legal power to make medical decisions.
While watching his beloved Pittsburgh Steelers play at Three Rivers Stadium, James Hanchett's head fell onto his wife shoulder. Mrs. Hanchett and bystanders tried to revive him. "There was no response at all," she said.
Paramedics arrived about 25 minutes after he suffered the heart attack and put a tube into his lungs to get them moving again. But Mrs. Hanchett, a semiretired pediatrician, knew it was too late.
At the emergency room, she told the doctor to stop resuscitation attempts. He refused, saying, "'If it were my mother or wife, I would want this to continue,'" Mrs. Hanchett recalled.
She said the doctor dismissed her when she told him that her husband had a living will and that she had power of attorney.
"So I turned on my heel and walked out. I didn't want to start screaming and yelling. I had to call our children," she said.
It was 29 hours before she succeeded in persuading doctors to remove the equipment.
"I'm a bit angry, mostly frustrated," she said, a year later. "We had done everything we thought we should do and it was ignored."
What this illustrates, however, is that if you call 911, you can expect the paramedics to do what they are trained and required by law to do: attempt to resuscitate. Living wills aren't designed to overcome this problem. That's what nonhospital DNR's are for.
As Schneiderman and Fagerlin suggest, the better answer may be the medical power of attorney. Personally, I usually recommend both the MPA and the living will, for a variety of reasons. There is no question that the living will hasn't, and often won't, solve subtle treatment problems. But is it better than nothing? I tend to agree with Naomi Naierman. And in tandem with an MPA, the living will can be better yet.
Thursday, November 25, 2004
On a bioethics listserv today, a colleague posted the following message:
>I would welcome the List's comments on the following scenario:
>A psychiatric patient is treated and released from a psych unit of a
>hospital. Nothing comes up during this stay that would lead treating
>staff to suspect that the patient has committed a crime or poses a
>danger to others. However, following the patient's discharge, several
>members of the health care staff read in the local paper a police
>profile of a person suspected in an armed robbery. These staff members
>believe the profile (which includes a police sketch) is of the psych
>patient released from the hospital. Aside from the legal issues raised
>by this case (which are governed by state law and HIPAA), the staff
>members want to know whether it is ethically permissible to notify the
>authorities of the identity of the suspect. For example, would it be
>permissible for the staff member to notify the authorities anonymously?
>The staff member is not certain that the psych patient is the suspect,
>though the patient fits the fairly detailed profile to a tee.
>Anyone faced this sort of situation before? Thanks in advance for your
The first three responses, from bioethicists on the listserve with real name-recognition in the field, were that notifying the officials would be (1) permissible, (2) impermissible, and (3) mandatory.
Now, I don't offer this mini-colloquy as proof of anything, certainly not as proof that the field of bioethics lacks coherence. But these responses made me take a bit more seriously than I might have an editorial from Michael Cook in The Age (Melbourne), in which he takes on "Julian Savulescu, the Uehiro professor of applied ethics at Oxford, who recently returned home to tell Australian parents that they have a moral obligation to genetically modify their children. An obligation, mind you, not just a nice idea":
Savulescu insists that this isn't Nazi eugenics, because Nazi eugenics was "a state-imposed vision".
He's wrong, of course. Eugenics is eugenics is eugenics. Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating. He simply wants to achieve it through free-market, libertarian eugenics rather than through old-fashioned command economy eugenics. And as everyone in a globalised world realises, the libertarian approach has been far more effective at changing public preferences than Nazism or communism.
Savulescu is becoming a celebrity, but more for his brazen cheek in mentioning the unmentionable and trampling ancient taboos underfoot than for the depth of his arguments. His reasoning can accommodate any behaviour you want, as long as you make a freely chosen rational decision and accept the consequences. Stay tuned for further instalments.
Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating.But rather than bat the shuttlecock of human genetic engineering back and forth across an ethical net, I'd simply like to ask what credentials Savulescu possesses to give him such prominence in the Melbourne media. Isn't it a bit unfair to the rest of Australia's fruitcakes to invite him to give public lectures? They have loopy ideas too. Why isn't anyone interviewing them?
The answer, of course, is that Julian Savulescu works at Oxford and is a bioethicist. But do these two qualifications really guarantee his credibility as a minor guru when he pays us a visit?
Only if you still suffer from cultural cringe. Oxford, ancient Oxford, the Oxford of postcards and poetry, radiates 800 years of scholarship. Savulescu, however, works in a new Oxford, a competitive, funding-hungry Oxford. A Japanese benefactor offered the new Oxford a generous endowment to create the Uehiro chair in "applied ethics" - a code word for the philosophy of Peter Singer. Oxford took the Japanese shilling and hired one of Singer's most distinguished disciples, despite the fact that even among bioethicists Singer is regarded as weird and narrow.
So wipe the Oxford glaze off Savulescu's outrageous proposals. Pretend that he teaches at the University of Lincolnshire and Humberside. How sensible do they sound now?
Nor does working as a bioethicist make you a font of wisdom. In fact, it is becoming increasingly clear that calling yourself a bioethicist is not necessarily an advance on qualifications in astrology.
The word "bioethics" was invented by American academics as recently as 1970. The new field metastasised quickly, invading medicine, ecology and sociology as well as traditional philosophy. But unlike sharp-edged disciplines such as physics or mathematics, the goals, methods and boundaries of bioethics are as murky as the bottom of the Yarra.
A couple of weeks ago, for instance, an article in the world's leading medical journal, The Lancet, called bioethics a "bankrupt" discipline. Professor Roger Cooter, of University College London, wrote that "hardly wet behind the ears, bioethics seems destined for a short lifespan". He argues that some US bioethics centres have been funded by pharmaceutical companies; that it has a narrow and old-fashioned notion of ethics; and that bioethicists themselves can't even agree how it started or what it means. And Cooter is by no means alone in his assessment.
Not meaning to offer a comment on Savelscu's work, which I haven't read, I am struck by the responses on the bioethics listserve today. Evidence of bioethics' incoherence? Evidence of its rich and diverse underpinnings? Or . . . . ?
Wednesday, November 24, 2004
The Nov. 23 Kaiser Daily Health Policy Report reviewed med-mal-related developments in 8 states. Here are the leads:
- Arkansas: A 2003 state tort reform law (Act 649) has not led to reduced malpractice insurance premiums, according to a report by the Arkansas Insurance Department, the Arkansas Democrat-Gazette reports.
- Florida: Circuit Judge Janet Ferris on Nov. 15 temporarily barred the implementation of Amendment 8, which would allow the revocation of the medical licenses of physicians who lose three malpractice lawsuits, until the last day of the state legislative session, the AP/South Florida Sun-Sentinel reports (Royse, AP/South Florida Sun-Sentinel, 11/16). (Previously noted on this blawg.)
- Maryland: Gov. Robert Ehrlich (R) on Thursday said that he will present a revised malpractice insurance reform bill to Democratic legislative leaders this week that would not rely on the state general fund, the Washington Times reports.
- Georgia: Senate Republicans last week announced that in the 2005 legislative session they will press for an agenda that includes tort reform legislation, the Atlanta Journal-Constitution reports.
- Massachusetts: The state Board of Registration in Medicine last week released a report that found total malpractice jury awards and settlements in the state have fallen 8% over the past three years, from a peak of $129 million in 2001 to $119 million in 2003, the Boston Globe reports (Allen, Boston Globe, 11/16).
- Michigan: American Physicians Assurance, the state's largest medical malpractice insurer, has begun a contest for enrollees of the plan in an effort to reduce the number of malpractice lawsuits filed by patients, the Detroit News reports.
- Ohio: State representatives over the last two weeks have begun considering a measure that would limit noneconomic and punitive damage awards in medical malpractice lawsuits, CongressDaily reports.
- Oregon: The Oregon Medical Association is drafting a package of proposals to lower medical malpractice insurance rates that it plans to submit to the state Legislature, the Associated Press reports.
Tuesday, November 23, 2004
The Associated Press reports that a program currently underway at Temple University, and nine other universities, aims to increase the number of highly trained interpreters in America’s hospitals. A recent study found that, although hospitals receiving federal funding are required to provide interpretation services, fewer than ¼ of all hospitals had professional interpreters on staff.
In another small study, interpretation errors occurred on an average of 31 times during each of the 13 recorded doctor visits. About 22 percent of patients using untrained interpreters, such as family members or friends, had interpretation errors of potentially serious medical consequence, compared with 12 percent for those with a staff interpreter.
An interesting New York Times article (free registration required) reports on advances in medical data networks. The issue was addressed last week by a panel of experts, during a conference hosted by Rockefeller University.
According to the article, approximately 31 percent of the nation’s annual health care bill is attributable to administrative expenses. The implementation of a sophisticated data network would reduce both costs and the number of patient deaths caused by medical errors (it is estimated that 45,000 to 98,000 people die each year from medical errors attributed to misunderstood handwritten prescriptions and hospital charts or lost laboratory test results).
In addition to administrative and patient-safety benefits, a comprehensive database could provide the ability to assemble and distribute up-to-the-minute epidemiological studies. Of course, a network packed with so much patient information is sure to raise plenty of privacy concerns. The proposed data network is part of a 10-year plan being promoted by the National Institutes of Heath.
That's the title of a talk I frequently give around town. It's intended to be a humorous reminder that "brain death" isn't some sort of watered-down version of death; it's the real thing. All 50 states are more or less clear on this, except for New York and New Jersey, where it is possible for families to opt out of the neurological criteria for death and wait for cardiorespiratory death to occur.
It's also apparently not a clear concept in Utah, where physicians last month pronounced death on a 6-year-old cancer patient, Jesse Koochin. Even though their son's body had begun to decompose, his parents disagreed and obtained a preliminary injunction that required "life support" (a misnomer in these circumstances) to be continued until a court hearing could be held a few weeks later. The parents and hospital (Primary Children's Medical Center in Salt Lake City) reached an agreement under which the parents were allowed to take him home on a ventilator, where home hospice care would be provided, and the hospital would refrain from filing a death certificate.
Jesse's heart stopped last Friday and resuscitative attempts were unsuccessful. News articles and broadcasts routinely stated that November 19th is the date Jesse "succumbed" to cancer or is the date he died (see the Salt Lake Tribune article and the KSL-TV news broadcast that evening).
The Tribune article repeats an assertion that appears in a number of news stories about Jesse: "The murky question of what should be done when parents disagree with a doctor's determination of death remains. There are no laws saying doctors have to keep patients they believe are dead on life support." The AP story by Debbie Hummel ends on a similar note:
In Utah, there is no case law regarding whether doctors have to keep patients they believe are dead on life support. The law says a person is dead if physicians have determined "irreversible cessation of all functions of the entire brain, including the brain stem."
Statutes provide guidance in cases where a patient has an advance medical directive or family members want to remove their loved one from life support. But they do not state what should happen when a family disagrees with a doctor's determination of death.
This doesn't strike me as an advance-directive problem, because there are simply no treatment options for a patient declared dead according to neurological criteria (unless a state legislatively abandons "brain death" or carves a hole in their statute to provide for conscientious objectors). In ordinary practice, if a family's disagreement with the diagnosis of death has to do with the competence of the neurologists, the accuracy of their exam, or the criteria they applied, a second opinion would be appropriate. Beyond that, however, the law is silent because once death occurs, the patient no longer presents a medical case. Correction: the law isn't entirely silent. Once death occurs, the state's laws on the handling and disposition of dead bodies, as well as the criminal laws against the abuse of a corpse, apply. Hospital policies, as well as the word choices and practices of health care providers, should reflect these realities. And local judges should be reluctant to sow confusion and prolong the suffering of families with decisions that are uninformed about the law.
Ronald Bayer and Amy Fairchild, both at Columbia, have published an article in Bioethics: "The Genesis of Public Health Ethics," 2004. 18(6):473-492. Their abstract has been posted on the SSRN website:
As bioethics emerged in the 1960s and 1970s and began to have enormous impacts on the practice of medicine and research - fuelled, by broad socio-political changes that gave rise to the struggle of women, African Americans, gay men and lesbians, and the antiauthoritarian impulse that characterised the New Left in democratic capitalist societies - little attention was given to the question of the ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed opposed to the ideological impulses of bioethics. Of what relevance is autonomy-focused bioethics for public health, with its mix of justifications including those that are either implicitly or explicitly paternalistic or that seek to impose strictures on individuals and communities in the name of collective welfare? To examine the deep divide between the central commitments of bioethics and the values that animate the practice of public health, we focus on a series of controversies implicating the concepts of privacy, liberty, and paternalism. Recognising the role of moral values in decision-making was a signal contribution of bioethics in its formative period. Over the past three decades a broad array of perspectives emerged under the rubric of bioethics but individualism remains central. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start when thinking about the balances required in defence of the public's health.
As reported in today's Wall Street Journal (subscription required), later this month Pfizer Inc. will face its first courtroom patent challenge against Lipitor, the cholesterol pill that is the biggest-selling drug in the world. Ranbaxy Laboratories Ltd., an Indian generic-drug company seeking to expand in the U.S. market, is trying to crack two patents that Pfizer says protect Lipitor through 2009 and 2011. If Ranbaxy shows that the patent protection shouldn't apply or that its copy of Lipitor doesn't infringe on Pfizer's patents, then it would be allowed to market a cheaper copycat version.
The battle over the Lipitor patents is emblematic of a much larger pattern:
After years of strong profits, generic-drug companies have hit a rough patch this year. Big buyers like wholesalers and national drugstore chains are driving harder bargains. And big pharmaceutical giants have found ways to put pressure on generics with their own generic products.
In the next five years, however, branded drugs with annual sales of $72.9 billion are expected to lose patent protection, according to analyst Gregory Gilbert of Merrill Lynch. Mounting concerns about prescription-drug costs will also fuel use of generics.
Industry critic Marcia Angell has assailed the use of patents by pharmaceutical companies to reap profits that far outstrip any reasonable return on their investment in drugs. An early version of her critique appeared as an editorial in the New England Journal of Medicine ("The Pharmaceutical Industry — To Whom is It Accountable?", NEJM. 2000;342:1902-1904 - requires subscription; letters to the editor are here). She expanded her critique in this year's The Truth About the Drug Companies: How They Deceive Us and What To Do About It; an abridged version appeared this summer as "The Truth About the Drug Companies," New York Review of Books, July 15, 2004.
The industry trade association, PhRMA, hasn't taken all of this lying down. In anticipation of the publication of Angell's book, it issued a 28-page refutation of her points.
The Associated Press reports on a new independent analysis by the Kaiser Family Foundation that shows that the Medicare Prescription Drug plan isn't saving everyone money. Although approximately 19 million people will benetif from the new Medicare drug benefit, 10 million others will pay the same or more for their medications.
"The biggest winners are low-income Americans who will receive government assistance that is projected to reduce their drug spending by 83 percent when the drug insurance program begins in 2006, said the Kaiser Family Foundation. The poorest of these people would spend an average of $90 for medicines, said the study by Kaiser, a health care think tank.
The signature component of last year’s Medicare law, the prescription drug benefit will vary widely in its impact on the 29 million older and disabled Americans that the Congressional Budget Office projects will enroll, the study said. The CBO said the average savings will be 37 percent in 2006."
In response, the federal Centers for Medicare and Medicaid Services sent a four-page rebuttal of the report, claiming that it is flawed and tends to "understate savings and exaggerate the number of people who would pay more."
Monday, November 22, 2004
As the Vioxx issue continues to concern many Americans, the December 1st issue of JAMA contains six articles concerning the conflicts of interest that exist in the current method of drug approval and the need for better postmarketing surveillance. In an editorial entitled, Postmarketing Surveillance--Lack of Vigilance, Lack of Trust, several JAMA editors called for the creation of a new and independent group, separate from the FDA, to monitor drug safety after a drug have been released on the market. They further call on Congress to provide the necessary funding for such an independent group.
If you are interested in learning more about what JAMA might be publishing in the future, you can register at JAMA's website to receive the table of contents of upcoming issues via e-mail.
The SCOTUSBLOG reports that the Acting Solicitor General Clement filed the Government's Reply Brief in Raich v. Ashcroft. Oral argument has been scheduled for November 30th with Acting SG Clement arguing for the government, and Professor Randy Barnett (Boston University School of Law) arguing on behalf of the respondents.
For those of you that are trying to decide on a textbook for a Spring Health Law course, you might want to check out the new Health Care Law and Ethics books by Hall, Bobinski and Orentlicher. Aspen Publishers has divided the longer text book into a three part set of shorter books that may be used for health law seminars and other health law classes that do not require the comprehensive coverage provided by the complete text. The three texts are: Bioethics and Public Health Law, Medical Liability and Treatment Relationships and The Law of Health Care Finance and Regulation. As you are well aware, the Health lLaw: Cases, Materials and Problems by Furrow, Greaney, Johnson, Jost and Schwartz has been published for a number of years in a series of shorter topical books. Now, you have more choices in textbooks and can even mix and match your health law text selections. Of course, there exist a variety of other health law texts on the market and I have tried a number of them in the quest to keep myself fresh and well-educated on a wide variety of health law topics and viewpoints. Best of luck with your selection!
Here's an item I meant to include last week, now back in my inbox today in the form of this helpful summary from AHLA's "Health Law Highlights":
In an initial decision announced November 16, an Administrative Law Judge (ALJ) upheld the Federal Trade Commission's (FTC's) complaint against a physicians' group alleging that the group conspired to fix prices in certain contracts its doctors entered into to provide medical services to the patients of health plans. According to the FTC, nearly all of North Texas Specialty Physicians' (NTSPs') participating physicians are parties to some non-risk contracts and that "[w]ith respect to these non-risk contracts, NTSP often has sought to negotiate for, and often has obtained, higher fees and other more advantageous terms than its individual physicians could obtain by negotiating individually with payors." In its decision, the ALJ stated that, "In this case, Complaint Counsel [FTC staff] has proven that Respondent [NTSP] engaged in horizontal price fixing through its negotiation, on behalf of its member physicians, of economic terms of non-risk contracts with health plan services for the provision of physician services."
The full text of the initial decision is here (PDF). As reported in Modern Healthcare, North Texas Specialty Physicians "has been the only IPA to challenge the FTC in the agency's three-year, industrywide investigation of physician price-fixing, which so far has resulted in 20 consent decrees with physician organizations." The other cases are summarized, beginning at page 7, in the FTC's publication, "FTC Antitrust Actions In Health Care Services and Products" (PDF).
Not surprisingly, the United Network for Organ Sharing "is asking hospitals to discourage patients from advertising for donors and, if possible, to refuse to perform transplants that arise from these campaigns" (Newsday, Nov. 19). As UNOS explained in its press release, "Most deceased organ donation takes place anonymously through the national organ distribution system. At times donors or donor families want to donate to a specific person they know, and we support that. But we strongly oppose public or private appeals that effectively put the needs of one candidate above all others and pose concerns of fairness. Transplant candidates rely on the public's trust in the fairness of the allocation system and support of that system through donation. Public appeals may jeopardize that trust."
The UNOS board was responding to news reports that "a Houston man, Todd Krampitz, bought a pair of billboards and gave a series of media interviews soliciting a liver donor. It worked: Someone died, and the person's family had heard about Krampitz and opted to donate directly to him.
"Normally, when people die their organs go to whomever is at the top of the waiting list, determined by many factors including who would obtain the greatest medical benefit from a transplant, who would die soonest without one, the locations of the patient and donor.
"'There's integrity to that. That process is public, it's transparent, it's accountable,' said Dr. Mark Fox, chairman of the network's ethics committee."
Sunday, November 21, 2004
Interested in reading mysteries or possibly even conspiracy theories, Jon Cohen of Slate reviews the new book, Vaccine A: The Covert Government Experiment That's Killing Our Soldiers - and Why GI's Are Only the First Victims, by Gary Matsumoto. Mr. Cohen doesn't find the book convincing in its argument that the government deliberately tampered with the anthrax vaccine given to soldiers during the first Gulf War but states that it does provide an overview of some of the problems with the vaccine and the quick decision to use it on those soldiers shipping out to Iraq in the early 1990s.
According to Mr. Cohen, in Vaccine A, Mr. Matsumoto alleges that the U.S. military's anthrax vaccine causes a constellation of autoimmune diseases and symptoms such as lupus, rashes, hair loss, and aching joints that fall under the rubric known as Gulf War Syndrome. Mr. Matsumoto argues that the problems result from the military secretly spiking the vaccine with squalene, "a fat naturally found in the body that, when injected as part of a vaccine, supercharges the immune system's ability to make antibodies." He further "accuses the Department of Defense of slipping this experimental vaccine past the Food and Drug Administration and involving unwitting troops in a human test" that he "equates with Nazi experimentation and the infamous Tuskegee syphilis study." Mr. Cohen contends that Matsumoto's book fails to answer the question of why the military would subject its soldiers to such an experimental and potentially dangerous vaccine. He also finds the book rather sloppily researched. If you have an interest in vaccines and vaccine contamination, Mr. Cohen recommends a different book on the polio vaccine and its early troubles. In his conclusion, he states,
"Vaccine accidents do happen, they do get covered up, and they deserve close scrutiny. One of the most famous vaccine accidents is the contamination of the first polio vaccines with a monkey virus, and a new book on the accident by Debbie Bookchin and Jim Schumacher, The Virus and the Vaccine, has many parallels with Vaccine A. But the research in this book is meticulous, and Bookchin and Schumacher's tone is so measured and thoughtful that my mind opens to their controversial thesis (that the monkey virus accidentally injected into people through polio vaccines causes human cancers). I'm not convinced that the monkey virus does, in fact, cause harm, but I am convinced that the question merits serious attention. Matsumoto, in contrast, with his sloppy errors, remote possibilities trumped up as facts, and outright dismissal of evidence that doesn't support his thesis, leaves me groaning."
As discussed here yesterday, the omnibus budget bill, H.R. 4818, contains an amendment to federal abortion law that has drawn the ire of 9 women senators and pro-choice advocacy groups. As expected, the Senate adjourned (at 12:31 a.m. this morning) having taken one record vote, to approve the bill, 65-30. The House had approved the spending bill (344-51) earlier in the day.
As reported by The Washington Post, "The abortion language remained in the spending bill, but late yesterday, Senate opponents agreed not to block its consideration after Senate Majority Leader Bill Frist (R-Tenn.) promised to schedule a vote in the near future on a bill drafted by Sen. Barbara Boxer (D-Calif.) to repeal the provision." Even if Sen. Boxer's bill passes in the Senate, no-one gives the repeal effort much of a chance in the more conservative House.
On Nov. 18, the FDA announced publication of "a final rule on current good tissue practice (GTP), the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls used to manufacture these products. With this final rule, FDA's efforts to establish a new, comprehensive, and risk-based approach to this promising and innovative field of medicine can be realized. The new approach will be fully implemented on May 25, 2005." The final rule is here and will be published in the Federal Register soon.
All tissue-related FDA documents are collected on this web page. The FDA describes its previous final rules this way: "[T]he agency has published two final rules and one interim final rule to implement aspects of the proposed approach. On January 19, 2001, we issued regulations to create a new, unified system for registering HCT/P establishments and for listing their HCT/Ps (registration final rule, 66 FR 5447). Part of the definition of 'human cells, tissues, or cellular or tissue-based products' became effective on January 21, 2004. On January 27, 2004 (69 FR 3823), we issued an interim final rule to except human dura mater and human heart valve allografts from the scope of that definition until all of the tissue rules became final. On May 25, 2004, we issued regulations requiring most cell and tissue donors to be tested and screened for relevant communicable diseases (donor-eligibility final rule, 69 FR 29786)."