Sunday, November 30, 2003
Texas Doctors’ Group Settles FTC Price-Fixing Charges
Do religious groups have to follow laws they don't believe in?
20 Questions for Senior Judge Richard Arnold.
Keillor on Twain.
It's the birthday of Mark Twain, born Samuel Langhorne Clemens, in Florida, Missouri (1835). He wrote Life on the Mississippi (1883), The Adventures of Huckleberry Finn (1884), and his own favorite, The Personal Recollections of Joan of Arc (1891). He was cynical and irreverent, but he had a tender spot for cats. There were always kittens in the house, and he gave them names like "Sin" and "Sour Mash." "Mamma has morals," said his daughter Suzy, "and Papa has cats." Twain swore constantly and without shame. His streams of profanity alarmed his wife. One day he cut himself shaving, and she heard a string of oaths from the bathroom. She resolved to move him to repentance, and she repeated back to him all the bad words he had just said. He smiled at her and shook his head. "You have the words, Livy," he said, "but you'll never learn the tune."
After Twain published The Adventures of Huckleberry Finn, he had a great deal of cash on his hands, which he invested in a typesetting machine that was very complicated and demanded more and more investment. In the end, it didn't work. He had to declare bankruptcy, and he decided to go on a worldwide lecture tour, the proceeds of which he would use to pay back all of his creditors. His visits to Africa and Asia convinced him that a God who allowed Christians to believe that they were better than savages was a God he wanted no part of.
Mark Twain said, "It is better to keep your mouth shut and appear stupid than to open it and remove all doubt." And he said, "Good friends, good books and a sleepy conscience: this is the ideal life."
Thanksgiving poem, on the rocks, with a twist.
More reactions to the Medicare reform bill.
- "But although some economists on the left and right might wring their hands, younger workers don't seem to be complaining. According to polls, members of the post-boomer generation are actually more enthusiastic than their elders about this new legislation. Their feeling is partly due to a desire to see their parents and grandparents save money on drugs, which ultimately redounds to their own benefit. And a lot of these younger adults — like members of Congress who voted for the bill — probably haven't quite focused on who will pay for the program or how." (A $400 Billion Purchase, All on Credit, John Tierney)
- "[Retirees] express disappointment but little surprise because, they say, they never had high hopes. They say they feel they were sold out, by Republicans and AARP, which endorsed a Medicare bill drafted mainly by Republicans. But the Democrats, they say, did not fight hard enough for a better drug benefit." (Florida Elderly Feel Let Down by Drug Benefit, Robert Pear)
Friday, November 28, 2003
US Congress OKs nanotech bill.
Organ retrieval practices tightened up in UK.
As many as 20,000 brains were illegally removed and kept by doctors without the consent of parents in the 1970s 80s and 90s at Alder Hey children's hospital in Liverpool while thymus glands were given to a pharmaceutical company in exchange for cash.
The harrowing events at Alder Hey led to some parents having to conduct up to four funerals as organs from their children were returned at different times.
Ideology and science (II)
The moralizers are trying to muck with U.S. science again. A flurry of activity over the past few weeks has followed the effort of a right-wing religious group to call into question almost 200 National Institutes of Health (NIH) grants focusing on behavioral and social aspects of issues such as sexuality, HIV/AIDS transmission, and drug abuse . . . This incident could have been written off as noise by a fringe group had it not come almost on the heels of the near-passage in the House of Representatives last July of what came to be known as the "Toomey Amendment," after its author Rep. Patrick Toomey (R-PA). By a vote of 212 to 210, the House just missed defunding four NIH research grants on sexual behavior that had already been through rigorous scientific peer review and approval by NIH Institute National Advisory Councils . . . .
We are not concerned that Congress wishes to exert oversight over the U.S. research agenda and research priorities. That is their job, and we want our representatives to do it well. We also believe that the scientific community should be fully accountable to the public, because much science is publicly funded and the public is the ultimate beneficiary of our work. By nature, science is an open enterprise that invites examination and criticism--and more often than not, it is actually strengthened by public scrutiny. Oversight bolsters public confidence in the scientific enterprise and provides incentives for scientists to interact with the public, explain the importance of their research, and spread an ethic of intellectual curiosity and critical thinking that helps make our society more innovative and dynamic.
On occasions like the present one, however, healthy scrutiny gives way to irresponsible attack. The recent assaults on science were not directed at broad research questions or national research priorities. Instead, they were aimed at imposing ideology and religious doctrine on the awarding of individual research grants, intervening in and thereby subverting the scientific peer review system that has served both science and national needs so well.
The moral judges who are doing this don't like the fact that HIV is spread through sexual contact, and they believe that drug addicts have made bad personal choices that have led to addiction. Is their disapproval of these behaviors a justification for stifling research on the diseases that result? Do they suppose that some form of national denial will make these problems go away? Regardless of personal feelings about the etiology of these illnesses, we need to understand their causes and transmission patterns if we are ever to get a handle on some of society's most pervasive public health problems.
WSJ.com - Remaking Medicare
Ideology and science (I)
Advocates for infertile couples have raised alarms over draft documents released by President Bush's Council on Bioethics that recommend sweeping changes in the way assisted reproduction is regulated in the U.S.Here is the Palm Beach paper's reaction in an editorial entitled, "Find a Cure for Ideology":
The draft recommendations, quietly posted to the council's Web site last month, call on the federal government to track and monitor embryos created for fertility purposes. They call for far-reaching legislation that would curtail embryo research and some common business practices. One proposal called for banning the sale of human eggs and sperm, a common practice in the U.S., though transcripts of the council's October meeting indicate that proposal has been withdrawn.
"The recommendations and legislation could change the face of reproductive medicine in this country," said Pamela Madsen, executive director of the American Infertility Association, an advocacy group in New York.
A final report from the ethics panel, formed by President Bush in 2001 following the divisive stem-cell debate, won't be released until next year. Council staff said the drafts are discussion documents and subject to change.
But critics and even some members of the 17-person council said the drafts signaled an ongoing effort by conservative members of the council to create new protections for human embryos created in fertility laboratories.
President Bush's Council on Bioethics is reviving attempts to ban therapeutic cloning for research -- and this time, patients suffering from debilitating diseases and scientists seeking cures for them wouldn't be the only potential victims. In its latest inappropriate invocation of ideology, the president is using his panel to urge Congress to assign legal rights to human embryos. Not only would such unnecessary legislation disrupt research toward cures for Parkinson's, diabetes and other widespread diseases, the action would make it harder for infertile couples to conceive.The draft recommendations come in a staff working paper entitled "Biotechnology and Public Policy: Biotechnologies Touching the Beginnings of Human Life/Defending the Dignity of Human Procreation."
Referring to the embryos as "children-to-be," the panel's draft recommendations -- reported in The Wall Street Journal -- call for the federal government to track the creation, use and disposition of embryos. The panel suggests a ban on using an 11-day-old or older embryo for research, restrictions on surrogate mothers and limits on the reason a woman could get pregnant by in vitro fertilization. Would enforcement require parents to declare that they plan to "produce a live-born child"? How does such a requirement fit the panel's claim that it wants to protect women "against certain exploitative and degrading practices"?
According to a study by the Rand Corp. and the Society of Assisted Reproductive Technology, nearly 90 percent of the 396,526 embryos in storage throughout the United States as of April 2002 were designated for future family-building by the patients who created them. Fewer than 3 percent -- 11,000 -- are available for donation for research. Those that are were designated, correctly, by the parents, not the government.
Two years ago, President Bush approved spending federal money on embryonic stem-cell research but set limits on the study. The cell lines he approved for federally financed research were initially grown on mouse cells -- which, a medical ethics panel formed by Johns Hopkins University said this month, could expose humans to an animal virus their immune systems could not fight. Safer stem-cell lines, the panel said, now exist but aren't eligible for federal financing. The president would rather allow ideological debates to halt progress.
Twenty-five years after the birth of the first "test-tube baby," Congress should not let the president and his advisers distract from the quest for life-saving discoveries.
The Seattle Times: Big Pharm Big Winner in Medicare Sweepstakes.
With the closely held GOP legislation approaching 1,000 pages, it will take time to fully understand all that was included and what the cost will be.Amen, brother. Ever read a session law? It's an interesting exercise. This is what got delivered to House members and Senators just before the Thanksgiving recess: (1) text of the legislation (678 pp.), (2) the joint explanatory statement of the Conferees (403 pp.), (3) a summary of the Medicare conference agreement, (4) a summary of the regulatory and contracting reform conference agreement, (5) a table of Congressional Budget Office estimates for major provisions of H.R. 1 and S. 1 (the competing versions of the Medicare reform bill), and (6) the CBO's 68-page analysis of both bills as of June 27 (i.e., before the conference committee started whacking at the bills to forge their compromise). It will take days, if not weeks, to track these changes back through existing provisions to make sense of the whole thing, and just as long, if not longer, to get a solid estimate of costs and savings from the bipartisan CBO.
Still, this much is known, as Washington Sen. Patty Murray put it, "The Senate has passed a bill that fundamentally changes the Medicare program while adding a meager 'drug benefit.' "What does seem pretty clear, however, is that, "in the final analysis, U.S. pharmaceutical companies will be better protected than elderly Americans in the overhaul of Medicare passed by Congress." Consider:
A bipartisan desire for a prescription drug benefit for the 40 million people on Medicare morphed into a legislative catch-all that tied enough disparate interests together to pass sweeping changes.
An initial impulse is to say that the bloated Medicare bill is better than nothing. That is not clear at all.
- "Private employers will receive $70 billion in tax-free subsidies to encourage continued drug coverage for retirees once the Medicare drug plan begins in 2006."
- "The new drug benefit will be administered by private companies and health plans with $12 billion in subsidies."
- "In the meantime, Medicare is specifically prohibited from using its buying power to negotiate discounts for bulk drug purchases or create any price structures for reimbursement."
- "Also, the government cannot have a preferred list of cost-effective drugs or specify a cheaper generic substitute for a costlier name brand. Medicare sets prices with doctors and hospitals but is prevented by law from doing the same thing with prescription medicine."
- "The final bill did not directly ban reimporting cheaper drugs from Canada, but requires Department of Health and Human Services approval, which has been refused."
And how did Medicare beneficiaries and rural providers -- the ostensible targets of this reform package -- make out?
- "The bill costs $400 billion over 10 years, and includes $25 billion in higher payments to rural hospitals and doctors. Other hospitals and doctors facing cuts under current law will receive higher payments or avoid future cuts."
- For two years, 2004 and 2005, Medicare beneficiaries can buy a discount card worth a savings of about 15 percent. Starting in 2006, the Medicare plan will collect a monthly $35 premium and charge a $250 deductible. Then insurance would pay 75 percent of drug costs up to $2,250. Then coverage stops until the retiree pays the next $2,850 out of pocket. Both the premium and gap in coverage are forecast to grow 78 percent in the first seven years of the plan. . . . Premiums and deductibles would be waived for seniors with incomes up to $12,123, and $6,000 in assets. Other seniors, especially with incomes over $80,000 a year, will find higher premiums."
Each piece could have been handled separately. A clean prescription bill was possible. So was more money for rural hospitals. But taken together, they provided political cover for a fundamental change in the 38-year-old government-run Medicare plan.For its part, Big Pharm's trade association, PhRMA, posted an announcement on its president, Alan Holmer's web page that was emphatically jubilant about the historic victory for seniors and disabled persons," not to mention Big Pharm, eh, Brother Holmer? Amen.
Democrats did not get the drug plan they wanted, and many conservative Republicans are simply appalled at the expense: "We are saddling future generations with enormous liabilities," said Sen. Don Nickles, R-Okla.
Narrow approval in the House and reluctant passage in the Senate are tell-tale signs not of triumphant compromise, but deep misgivings about what was accomplished. Only the nation's drug companies are absolutely sure.
Sunday, November 23, 2003
AHLA's Health Law Highlights: House Clears Bill Allowing FDA To Require Pediatric Drug Testing.
Saturday, November 22, 2003
House tentatively passes Medicare drug bill after lengthy vote.
Motorized wheelchairs: Medicare billing probe widens.
Tuesday, November 18, 2003
Medication errors almost doubled over the past year.
"The report data revealed that more than one-third of the medication errors reaching the patient involved a patient aged 65 or older," said Diane Cousins, R.Ph., vice president of the Center for the Advancement of Patient Safety (CAPS) at USP. "As the senior population continues to increase, USP is calling for hospitals to focus on reducing medication errors among seniors. Seniors and their families need to become more involved in their care."
Specifically with reference to the senior population, the 2002 MEDMARX data report revealed a number of significant findings, including:
"We are seeing a strong upsurge in the number of medication errors in the database," Cousins said. "This increase is a positive step toward identifying and eliminating medication errors and ensuring the safety and well-being of all hospital patients. By identifying medication error trends and problem areas, hospitals will be able to prevent future errors and reduce patient harm and injuries."
- A majority (55 percent) of fatal hospital medication errors reported involved seniors.
- When medication errors caused harm to seniors 9.6 percent were prescribing errors.
When harm occurred, wrong route (7 percent), such as a tube feeding given intravenously, and wrong administration technique (6.5 percent), such as not diluting concentrated medications, were the second and third most common errors among those aged 65 and over.
- Omission errors (43 percent), improper dose/quantity errors (18 percent), and unauthorized drug errors (11 percent) were the most common types of medication errors among seniors.
Of the 192,477 medication errors documented by MEDMARX, the vast majority were corrected before causing harm to the patient. However, 3,213 errors, or 1.7 percent of the total, resulted in patient injury. Of this number, 514 errors required initial or prolonged hospitalization, 47 required interventions to sustain life, and 20 resulted in a patient's death. Compared with 2001 data, a smaller percentage of reported errors resulted in harm to the patient (1.7 percent in 2002 versus 2.4 percent in 2001).
The 2002 MEDMARX data report also found that incorrect administration technique continues to be responsible for the largest number of harmful medication errors (6.2 percent). This occurs when medications are either incorrectly prepared or administered, or both. Examples include not diluting concentrated medications, crushing sustained-released medications, wrong eye application of eye drops, and using incorrect IV tubes for medicine administration.
Health care facilities attributed medication errors to many reasons and often cited workplace distractions (43 percent), staffing issues such as shift changes and floating staff (36 percent), and workload increases (22 percent), as contributing factors. Although workplace distraction remains the leading factor contributing to medication errors, the data revealed a drop from 47 percent in 2001.
A limited number of high-alert medications continue to cause the most severe injury to patients when an error is committed. For example, three of the top medications frequently involved in harmful errors were insulin, heparin, and morphine. . . .
Sunday, November 16, 2003
More details on Medicare compromise in The Washington Post.
Maureen Dowd on organ donation.
"For Middle Class, Health Insurance Becomes a Luxury"
Medicare prescription drug benefit deal approved in principle by conferees.
Besides adding drug benefits to Medicare, the bill would inject competition and market forces into Medicare and establish a new mechanism to help hold down Medicare costs. It would also offer tens of billions of dollars in subsidies and other aid to employers to encourage them to continue providing health benefits, including drug coverage, to retirees.So scuttling this bill would require members to explain to the folks back home not just why the drug benefit got killed (and apparently "because we can't afford it" just isn't a good answer these days), but also why this or that favorite provision also had to be killed. Will this make the bill bulletproof? We'll see . . . .
Schiavo case is prompting experts to ask: Could it happen in my state?
Saturday, November 15, 2003
New play based on the trial of Carrie Buck.
Wednesday, November 12, 2003
False Claims Act recoveries at all-time record level.
Wednesday, November 05, 2003
SCOTUS' take on the Supreme Court's grant of certiorari in the Texas ERISA/HMO case.
Tuesday, November 04, 2003
HealthSouth's CEO Scrushy indicted on 85 counts this morning.
A Catholic priest and bioethicist takes on the Governor and legislature of Florida.
''For Christians, it is a blasphemy to keep people alive as if you were doing them a favor, to keep people alive in that condition as if it benefits them. It doesn't benefit them,'' O'Rourke argues. ``I know it is wrapped up in the pro-life, antiabortion activity, and while I am antiabortion, I also know there is eternal life and that we should not confuse or equate the antiabortion effort with the notion of withdrawing life support from dying people.
``They act as though the most important thing is to lead a long life and Christians who read the Gospel seriously believe that it is a good life you are pursuing, not a long life. But this notion of having a long life has become the watchword for these groups. Life is terminal. Life by definition is going to have an end.''
Monday, November 03, 2003
Human research then and now.
Our attitude is that in some ways his experiments from current standards... don't pass muster. . . But according to the standards of the day, doing experiments on prisoners was common. . . . There's no doubt that scientifically and medically he did pioneering and important work . . . At the same time, I think it's appropriate in acknowledging him to comment that some of the things that happened in the time were immoral. . . . Science has advanced and, in fact, ethics have advanced. . . . You have this problem that comes up all the time of holding people [to today's standards when evaluating their past actions] . . . There's been a shift in attitudes from the '50s to today in terms of research on prisoners and the rights of people to be informed . . . I think it's fine and appropriate to say to people [that] what we did then we've learned is wrong, and we are committed to doing better . . . I think that's owed the people. I think that's appropriate for the University to say.
U.N. to Consider Whether to Ban Cloning of Human Embryos
Supreme Court to Rule on ERISA Preemption Question in Suits Over Patients Denied Treatment.
This suit consolidates multiple district court actions and appeals for consideration of common issues. Ruby Calad, Walter Thorn, Juan Davila, and Gwen Roark sued their respective health maintenance organizations ("HMO's") for negligence under Texas state law: They alleged that although their doctors recommended treatment, the HMO's negligently refused to cover it. The HMO's removed to federal court, arguing that because each plaintiff received HMO coverage through his employer's ERISA plan, the claims arose under ERISA. The plaintiffs moved to remand.The Roarks' claims are the only ones held by the court to have been partially preempted under section 502 of ERISA (the complete preemption provision); thus the district court properly denied their motion to remand. After that, the district court ruled the remaining claims were preempted by section 514 of ERISA (the ordinary preemption provision of the federal law), which the Fifth Circuit affirmed on the bas sis of its earlier Corcoran case, which it found to be indistinguishable. More later . . .
The respective district courts denied Calad, Davila, and Roark's remand motions and dismissed their claims under Fed.R.Civ.P. 12(b)(6), citing ERISA preemption. The district court granted Thorn's remand motion. Roark, Calad, and Davila appeal the refusal to remand and, in the alternative, the dismissal. Thorn's HMO appeals the remand. We affirm the judgments in Roark's and Thorn's cases and reverse with respect to Calad and Davila.
Sunday, November 02, 2003
Palm Beach editorialist weighs in on the Schiavo case.
"It is likely that no guardianship court," the judges said, "has ever received as much high-quality medical evidence in such a proceeding." The appeals court looked at the full-length videotapes of Ms. Schiavo, not the excerpts on TV news programs. The judges examined brain scans. The conclusion: Terri Schiavo is in a permanent vegetative state.Saving the best for last, Schultz concludes: "It should have ended there. The courts have spent years on Terri Schiavo's case and acknowledged the difficulty. The governor and Legislature spent two hours and proclaimed themselves saviors. So who's being reckless and uncaring?"
But as Judge Altenbernd noted in June: "Each of us, however, has our own family, our own loved ones, our own children... we understand why a parent who had raised and nurtured a child from conception would hold out hope that some level of cognitive function remained. If Mrs. Schiavo were our own daughter, we could not but hold to such a faith."
So the court sees Terri Schiavo as a person. The court knows the tragedy, of her condition, the family fight, the unpleasant decision. "It is a thankless task," Judge Altenbernd wrote, "and one to be taken with care, objectivity and a cautious legal standard designed to promote the value of life.
"But it is also a necessary function if all people are to be entitled to a personalized decision about life-prolonging procedures independent of the subjective and conflicting assessments of their friends and relatives... the law currently provides no better solution that adequately protects the interests of promoting the value of life."
Stem cells and President Bush.
(1) The series started with a column by syndicated Post columnist Michaeld Kinsley that appeared on October 24 (One Reason Not to Like Bush (washingtonpost.com)). In this piece, Kinsley argued that Bush's policy on federal funding was "unexpectedly restrictive" and was based upon two factual assumptions that turn out not to be true: (1) there are 60 viable stem cell lines available for stem cell research (turns out it's more like 10) and (2) there is hope for the process by which adult stem cells could be switched on to behave like pluripotential embryonic stem cells, a claim that has been authoritatively debunked by an article in the scientific journal Nature.
(2) The Bush administration replied with an Op-Ed in the Washington Post on October 30 by Jay Lefkowitz, who was chair of the White House Domestic Policy Council until last month. Lefkowitz asserted that the president "made the first-ever offer of federal aid to support the research" and responds to Kinsley's attack on the two bedrock assumptions that underlay the president's policies.
(3) Kinsley's reply ("Kabuki and Stem Cells") appeared on October 31. He yields no points to Lefkowitz, and his arguments on the merits of the stem-cell debate are worth reading. Of greater interest to some will be Kinsely's critique of Lefkowitz' response "as an illustration of modern Washington dishonesty":
I do not assert that Republicans are more dishonest than Democrats -- only that this document is a choice example of the state of the art.Kinsley then nicely skewers Lefkowitz' points, 1 by 1, 1-2-3.
The distinguishing feature of modern Washington dishonesty is that it is almost transparent, barely intended to deceive. It uses true-ish factoids to construct an implied assertion about reality that is not just false but preposterous. Modern Washington dishonesty is more like a kabuki ritual than a realistic, Western-style performance. The goal is not to persuade but merely to create an impression that there are two sides to the question without actually having to supply one of them.
Saturday, November 01, 2003
- The ACLU's brief on behalf of Michael Schiavo "as guardian of Terry Schiavo" against the Florida legislation can be found here (52 pp., PDF).
- Newsday, the L.A. Times, and others are reporting that Jay Wolfson, a University of South Florida professor and "expert on health care financing, has been appointed to independently investigate the case . . . . A judge on Friday named [him] as Terry Schiavo's guardian." Prof. Wolfson's web site is here.
- Today's Pittsburgh Post-Gazette has an excellent piece on the case, with useful observations from Alan Meisel, whom I think of as the Magister Ludi of "the right to die," and neurologist Ron Cranford.