HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, November 20, 2004

Reasonable Accommodation for a Dolphin?

Just for fun, a heartwarming story about a dolphin and an artificial fin designed by Bridgestone.  What will they think of next?

November 20, 2004 | Permalink | Comments (0)

Med-Mal Reform Developments in 8 States

The Kaiser  Daily Health Policy Report recently published its review of recent med-mal reform developments in eight states. Here are the leads:

  • Florida: More than half of rural physicians over the past year have limited medical services, and most cited increasing medical malpractice premiums as a "key reason" for limiting service, according to a 2003 study published Monday in the Archives of Internal Medicine, the St. Petersburg Times reports. . . . Voters on Nov. 2 passed Amendment 7, which will allow patients in the state to review records of medical errors committed by physicians in medical facilities. Voters also approved Amendment 8, which will allow the revocation of the licenses of physicians who lose three malpractice lawsuits. In addition, Florida voters passed Amendment 3, which allows plaintiffs in malpractice lawsuits to retain 70% of the first $250,000 in damages awarded and 90% of damages awarded in excess of that amount.
  • Georgia: About 59% of state residents believe it is "very important" to pass a bill to limit medical malpractice insurance premiums, and 25% said such a bill is "somewhat important," according to a Georgia Hospital Association survey released Monday, the Florida Times-Union reports.
  • Maryland: While Democratic state lawmakers support taxing HMOs to "help defray the costs" for the Medical Mutual Liability Insurance Society of Maryland -- the medical malpractice insurer that covers about 75% of the state's private practice physicians -- Gov. Robert Ehrlich (R) has "vowed" not to raise taxes and said the state should consider drawing from its general funds to help pay malpractice insurers, the Washington Times reports.
  • Missouri: Medical malpractice claims fell to "a record low" in 2003, and total payouts to plaintiffs in malpractice cases dropped about 21%, according to a report released last week by the state Department of Insurance, the St. Louis Post-Dispatch reports.
  • Nevada: Voters in the state last week approved Question 3, a medical liability reform measure on the Nov. 2 statewide ballot, by a 59% to 41% margin, but physicians in the state "now must wait and see" whether the measure will reduce malpractice insurance premiums in the state, the Las Vegas Sun reports (Kanigher, Las Vegas Sun, 11/5).
  • Utah: The Utah Supreme Court on Friday upheld the $250,000 state cap on noneconomic damages in malpractice lawsuits in a case that involved a six-year-old boy with brain damage, the Salt Lake Tribune reports. In the case, a Utah jury awarded $1,250,000 in noneconomic damages to the parents of the boy, who experienced severe brain damage when a physician failed to deliver him with forceps, in addition to $22,735 for medical costs and $1 million for future expenses.  (NOTE: the case is Judd v. Drezga, 11/5/2004.)
  • Virginia: Physicians at the Medical Society of Virginia annual meeting last weekend launched a "White Coats on Call" campaign to promote medical liability reform, the Washington Times reports. According to outgoing MSV President Mitchell Miller, as many as 100 physicians daily will visit Richmond throughout the next session of the state Legislature to highlight the increased costs of malpractice insurance in the state (McElhatton, Washington Times, 11/8).
  • Wyoming: Voters in the state last week passed Amendment C, a medical liability reform measure on the Nov. 2 statewide ballot, but rejected Amendment D, a companion measure, resulting in a "split" that supporters maintain could limit the ability of the state Legislature to address the issue of high malpractice insurance premiums, the AP/Billings Gazette reports (Bohrer, AP/Billings Gazette, 11/4).

November 20, 2004 | Permalink | Comments (0)

Politics of Abortion Snags Spending Bill.

Conference negotiators are close to a deal on the Consolidated Appropriations Bill (H.R. 4818), an omnibus $388 billion spending package that is needed to keep the federal government running after midnight tonight.  One of the last issues to resolve is a rider that, according to the L.A. Times, "would make it easier for healthcare providers to refuse to provide abortions or abortion referrals."  Nine women senators (8 Democrats and Olympia Snowe (R-Me.)) wrote to Sen. Ted Stevens (R-Alaska), chairman of the Senate Appropriations Committee, voicing their opposition to the provision: "Should this provision become law, federal, state or local government may no longer require any institutional or individual healthcare provider to provide, pay for or refer abortion services. This will mean that medical providers in hospitals and clinics across the country will likely be victims of demonstrations and intimidation as this provision allows that they be forbidden from providing abortion care to women who need it, and also to deny women referrals to another provider."  (The full text of the senators' letter is on Sen. Diane Feinstein's web site (PDF).)

The paper also reports NARAL's opposition to the provision: "NARAL Pro-Choice America, an abortion rights group, also assailed the provision, contending that it would bar physicians at health maintenance organizations, for-profit hospitals and others from even talking to their patients about abortion. The group called the provision a 'backdoor gag rule.'"  (NARAL's press release is here.)

The provision itself is variously and confusingly described by parties for and against in a Washington Post article this morning: "Under the provision, sponsored by Rep. David Joseph Weldon (R-Fla.), state governments could lose federal funds if they were found to discriminate against any 'health care entity' that opts not to provide abortion services or referrals. Supporters of the change say it would protect Catholic hospitals and health insurers from 'harassment' by state officials. In a letter yesterday, the nine senators said it would expose abortion providers to more intimidation by antiabortion groups."

According to the ACLU web site, the "Federal Refusal Clause" -- which NARAL says has twice been inserted by the House into bills that have (until now) been rejected by the Senate -- is S.1397, which would amend 42 U.S.C. § 238n to read as follows [changes indicated in boldface]:

§ 238n. Abortion-related discrimination in governmental activities regarding training and licensing of physicians licensing, and practice of physicians and other health care entities

(a) In general
The Federal Government, and any State or local government that receives Federal financial assistance, may not subject any health care entity to discrimination on the basis that—
     (1) the entity refuses to undergo training in the performance of induced abortions, to require or provide such training, to perform such abortions to perform, provide coverage of, or pay for induced abortions, or to provide referrals for such training or such abortions;
     (2) the entity refuses to make arrangements for any of the activities specified in paragraph (1); or
     (3) the entity attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.

(b) Accreditation of postgraduate physician training programs
     (1) In general
In determining whether to grant a legal status to a health care entity (including a license or certificate), or to provide such entity with financial assistance, services or other benefits, the Federal Government, or any State or local government that receives Federal financial assistance, shall deem accredited any postgraduate physician training program that would be accredited but for the accrediting agency’s reliance upon an accreditation standards [1] that requires an entity to perform an induced abortion or require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training, regardless of whether such standard provides exceptions or exemptions. The government involved shall formulate such regulations or other mechanisms, or enter into such agreements with accrediting agencies, as are necessary to comply with this subsection.
     (2) Rules of construction
          (A) In general
With respect to subclauses (I) and (II) of section 292d (a)(2)(B)(i) of this title (relating to a program of insured loans for training in the health professions), the requirements in such subclauses regarding accredited internship or residency programs are subject to paragraph (1) of this subsection.
          (B) Exceptions
This section shall not—
               (i) prevent any health care entity from voluntarily electing to be trained, to train, or to arrange for training in the performance of, to perform, or to make referrals for induced abortions; or
               (ii) prevent an accrediting agency or a Federal, State or local government from establishing standards of medical competency applicable only to those individuals who have voluntarily elected to perform abortions.

(c) Definitions
For purposes of this section:
     (1) The term “financial assistance”, with respect to a government program, includes means governmental payments provided as reimbursement for carrying out health-related activities.
     (2) The term “health care entity” includes an individual physician or other health professional, a postgraduate physician training program, and a participant a participant in a program of training in the health professions , a hospital, a provider sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization or plan.
     (3) The term “postgraduate physician training program” includes a residency training program.

November 20, 2004 | Permalink | Comments (0)

More Nonprofits Sued Over Charity Care

Modern Healthcare reports that "Carolinas HealthCare System, Charlotte, N.C., and Wake Forest University Baptist Medical Center, Winston-Salem, N.C., were named in class-action lawsuits brought by uninsured patients who claim the providers charged them too much for care compared with what publicly and privately insured patients would have paid."  Although the suits are reportedly based on a breach-of-contract theory -- and thus may resemble class-action suits brought this summer by Richard Scruggs and attorneys working with him -- they are not listed on Scruggs' Not-For-Profit Hospital Class Action Litigation site.  Numerous "copycat" lawsuits have been filed since Scruggs' suits first started to appear, of which these may be two more.  (The Modern Healthcare site requires registration.)

November 20, 2004 | Permalink | Comments (0)

Friday, November 19, 2004

Kentucky Governor/Doctor - Problems with the Death Penalty

This is an interesting article about a dilemma that Governor Fletcher of Kentucky may face with respect to keeping his medical license and signing off on death warrants as the Governor of Kentucky.    Thanks for Professor Fred Harris for the article.

According to the Associated Press, Governor Fletcher, also a licensed Doctor, risks potentially losing his medical license.   The article states,
"When Gov. Ernie Fletcher signed a death warrant for a convicted killer this month, he may have done more than start the clock ticking on an execution. Some say Fletcher, a doctor, may have put his medical license at risk.

American Medical Association guidelines bar doctors from taking part, directly or indirectly, in executions. And Kentucky requires doctors to follow AMA ethical guidelines. . . .

A group of doctors is seeking an opinion from the Kentucky Board of Medical Licensure on whether Fletcher can sign death warrants without running the risk of having his medical license revoked. The board is not scheduled to take up the matter until at least January, and would not comment in the meantime."

The New York Times on Saturday November 20th, also has a further update discussing Governor Fletcher's potential problems fulfilling his Governorship duties as well as his duty to remain true to the guidelines controlling his medical license.

November 19, 2004 | Permalink | Comments (1)

Congressional Investigation of the Flu Vaccine Shortage

The following provides some informative links to recently released documents from Rep. Henry Waxman's office about what went wrong this year and in previous years with our flu vaccine supply. 

More than 1,000 pages of documents obtained by Rep. Henry Waxman (D-CA) reveal, in striking detail, "that despite being aware of major problems at the [Chiron] vaccine manufacturing facility as early as June 2003, [the Food and Drug Administration] missed repeated opportunities to correct them." (The Chiron facility was located in Liverpool, England,, but Chiron is a California company whose operations are regulated by the FDA.) Sixteen months later, British regulators shuttered the facility because of contamination problems and the United States was left with a massive flu vaccine shortage. The incident draws focus to bipartisan concerns about the impact of the Bush administration's personal and financial ties to the drug industry. Sen. Charles Grassley (R-IA) said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny. One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern."

Waxman staff summary of FDA docs at http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf

Washington Post story (Nov. 18th) quoting Grassley (above ) http://www.washingtonpost.com/ac2/wp-dyn/A58470-2004Nov17?language=printer

Highlights provided by the American Progress Fund in its Progress Report for

Nov. 18, 2004

. http://www.americanprogressaction.org/site/pp.asp?c=klLWJcP7H&b=83210

FDA VISITED PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION: In June 2003, the FDA inspected the plant and "found high levels of overall bacterial contamination." FDA inspectors, in some instances, "found records of bacteria concentrations that were more than a thousand times higher than inspected." The inspectors also "identified poor sanitary practices that could contaminate sterile parts of the production process." Significantly, the FDA found the company was not doing enough to correct the problems.

TOP OFFICIALS REJECT INSPECTORS' RECOMMENDATION FOR MANDATORY ACTION: The FDA team that visited the facility recommended official enforcement action

against the facility. That means issuing a warning letter to Chiron outlining the problems that must be fixed. If Chiron failed to fix the problems, the FDA could have initiated legal action against the company. Instead, FDA officials overruled the recommendation of inspectors and instead submitted a request for voluntary action by Chiron. 

FDA DELIVERS REPORT TO CHIRON NINE MONTHS LATE: Even when it recommends voluntary action, the FDA is "supposed to send the manufacturer the full inspection report to help the manufacturer understand what corrective actions are needed." The report wasn't sent to Chiron until a year later – June 2004 – nine months after it was supposed to have been sent. The biggest problem: by that time "manufacture of the 2004 vaccine supply was already well underway." Chiron requested a meeting with the FDA after the 2003 inspection, but the agency never granted the request.

FOR 16 MONTHS FDA DOESN'T INSPECT THE PLANT: For 16 months, the FDA failed to send inspectors to the plant to see if Chiron had fixed the problem. FDA Commissioner Lester Crawford "defended the decision not to send inspectors into the plant." Crawford claimed that occasional conference calls with the company were "a form of 're-inspection.'" (For more on the Chiron debacle, check out this column.)

CRAWFORD FALSELY CLAIMS THAT 2003 PROBLEMS WERE UNRELATED: At an Oct. 21 press conference, Lester Crawford claimed, "what happened in 2003 has no relevancy for 2004." That isn't true. When the FDA's own inspectors finally visited the facility last month – after it was shut down – they reported that at least three sources of contamination were "not corrected from [the] previous inspection of 2003."   

CRAWFORD SAID HE WOULD DO VIRTUALLY EVERYTHING THE SAME: The FDA's negligence has put the health of tens of millions of Americans at risk. But appearing before the House Reform Committee Crawford testified, "except for the late delivery of its full report, the FDA has done nothing wrong – and would do nothing differently if given the chance." Sound familiar?

November 19, 2004 | Permalink | Comments (0)

Thursday, November 18, 2004

DEA and the Treatment of Pain.

The DEA published its "Interim Policy Statement on Dispensing of Controlled Substances for the Treatment of Pain" in the Federal Register on Tuesday, November 16, 2004.  The link is here (PDF).

The DEA published a document on its website in August 2004 entitled "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel."  The DEA subsequently withdrew the document because it contained misstatements. This interim policy statement explains how some of the statements in the August 2004 document were erroneous. The DEA plans to address in a future Federal Register document the issue of dispensing controlled substances for the treatment of pain.

The three previous misstatements discussed in the interim policy statement involve the investigation of diversion behaviors, refills of Schedule II prescriptions, and reselling of controlled substances.  The DEA recommends that this interim policy statement be distributed to hospitals' outpatient pain management centers, emergency rooms, and other units of hospitals where controlled substances are ordered for the treatment of pain. It also recommends that an announcement of the interim policy statement should also be made in the next communication to the medical staff from the pharmacy department and generally as physicians in a variety of specialties prescribe controlled substances for the treatment of pain.   Thanks to Lew Lefko, of Haynes and Boone in Dallas, for bringing this notice to our attention.

November 18, 2004 | Permalink | Comments (2)

Tax-exempts and Political Activity.

On Friday, November 12, 2004, the IRS released a National Office Technical Advice Memorandum (TAM 2004-46-033) that addressed a payroll-deduction Politcal Action Committee arrangement established by a tax-exempt healthcare organization. According to the TAM, the entity "began an effort to make all . . . employees aware of their ability to participate in [the PAC] through payroll deduction.  During regularly scheduled meetings, department heads and the management . . . briefly discussed the Plan.  Managers were asked to develop a simple and efficient method of informing employees they had a right to participate . . . through payroll deduction. A video that featured [the Chairman of the Board of Trustees] explaining the impact of political input on the hospital industry was distributed to managers for use in communicating with employees.  Donation cards were made available to employees at the meetings and managers were encouraged to get a signed form from each employee, irrespective of the employee's decision to participate, in order to avoid duplicative efforts.  Employees were told that their participation in the Plan was strictly voluntary. The cards included an option to decline participation in the Plan."

The TAM concluded that the arrangement violates the political activity prohibition and triggers the § 4955 excise tax (10% tax on the amount of the political expenditures; and on the knowing agreement to make political expenditures, a 2-1/2% on the amount thereof).  A copy of this TAM is available on the AHLA website or the IRS website (PDF).

November 18, 2004 | Permalink | Comments (0)

Bills Address End-of-Life Care.

As reported in the Nov. 17 Bend (Ore.) Bugle, Sen. Ron Wyden (D. Ore.) has "introduced  two pieces of legislation Tuesday aimed at providing better care options for dying patients. . . .  The first Wyden bill, the Palliative Care Training Act, recognizes the need for a larger pool of health care professionals who know how to help terminally ill patients to have a better quality of life. The second bill, the Medicare Hospice Demonstration Act, seeks to test ways to improve the Medicare hospice benefit."  Neither bill is yet on Thomas or the senator's web page.  Wyden's press release on the bills is here.

November 18, 2004 | Permalink | Comments (0)

ADA Amendments from the National Council of Disability

On December 1, 2004, the National Council on Disability (NCD) will release its report Righting the ADA.  The report will contain NCD’s legislative proposal, entitled, “ADA Restoration Act.”   The NCD hopes that its proposal will restore the protections of the Americans with Disabilities Act that have been restricted by some of the recent ADA U.S. Supreme Court decisions.

If you cannot wait until December 1st, the NCD asks that you contact contact Mark Quigley or Julie Carroll at 202-272-2004 or 202-272-2074 TTY for further information. 

November 18, 2004 | Permalink | Comments (0)

Goody-Bye to the Employer-Sponsored Health Insurance Tax Deduction?

The Washington Post reports today on some of the President's plans for revising the tax code.   Although these are tentative, it does appear that some drastic changes are in store - including the elimination of the tax deduction for employer-sponsored health insurance.   The Post states,

"The Bush administration is eyeing an overhaul of the tax code that would drastically cut, if not eliminate, taxes on savings and investment, but it is unlikely to try to replace the existing tax code with a single flat income tax rate or a national sales tax, according to several sources familiar with ongoing tax deliberations.

During his reelection campaign, President Bush piqued interest among conservatives and liberals alike when he said replacing the income tax with a national sales tax was "an interesting idea." Just after the election he signaled that tax policy would be a centerpiece of his domestic agenda, reiterating his pledge to name a bipartisan panel to draft a fundamental tax reform proposal. That sent conservatives scurrying into either the flat tax or sales tax camp to muster political momentum.

But before the tax panel is even named, administration officials have begun dialing back expectations that they will move to scrap the current graduated income tax for another system.

Instead the administration plans to push major amendments that would shield interest, dividends and capitals gains from taxation, expand tax breaks for business investment and take other steps intended to simplify the system and encourage economic growth, according to several people who are advising the White House or are familiar with the deliberations.

The changes are meant to be revenue-neutral. To pay for them, the administration is considering eliminating the deduction of state and local taxes on federal income tax returns and scrapping the business tax deduction for employer-provided health insurance, the advisers said. "

I cannot believe that this would be acceptable to Congress but who knows . . . .  I don't seem to be able to predict anything in politics these days.

"To pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documentsTo pay for those large tax cuts, the administration is looking at eliminating both the deduction for state and local taxes, and the business tax deduction for employer-sponsored health insurance. That would raise nearly $926 billion over five years, according to White House and congressional documents."

November 18, 2004 | Permalink | Comments (0)

Wednesday, November 17, 2004

ERISA PREEMPTION

From the BNA Health Law Reporter:

TWO APPEALS COURTS REVERSE 'COMPLETE PREEMPTION' RULINGS, SEND STATE LAW CLAIMS WITH ERISA OVERTONES BACK TO STATE COURT

Recent federal appellate rulings denounce misuse of the "complete preemption" doctrine to remove state claims involving Employee Retirement Income Security Act plans. The Sixth Circuit holds that retirees' claims of fraudulent inducement to accept early retirement benefits cannot be recast as claims under ERISA's civil enforcement provision, Section 502, and thus must be remanded to state court. . .

Meanwhile, the Third Circuit rules that a hospital's state law breach of contract action against a health plan for wrongly granting plan participants discounted rates cannot be maintained under Section 502 because the participants had not assigned their claims to it. Both courts stress that mere conflict preemption under ERISA Section 514 will not support removal. . . .

http://pubs.bna.com/ip/BNA/law2.nsf/is/a0a9z1t3p5

http://pubs.bna.com/ip/BNA/law2.nsf/is/a0a9z4w7e6

November 17, 2004 | Permalink | Comments (0)

Helpful Website

Balloonanimal_1 "The National Human Genome Research Institute, part of the National Institutes of Health, has launched a Policy and Legislation Database. The free, searchable database focuses on genetic testing and counseling, insurance and employment discrimination, newborn screening, privacy and confidentiality of genetic information, informed consent and commercialization and patenting. The site includes an interactive map of the United States that enables users to click on any state to view its legislation and laws. Users also can search the database by keyword, content type, topic and source. The database contains links to full-text copies of federal and state laws and statutes; federal legislative materials; and federal administrative and executive materials, including regulations, institutional policies and executive orders. Abstracts are also provided."
Thanks to Robert Ambrogi's LawSites blog and his post at

November 17, 2004 | Permalink | Comments (0)

Tuesday, November 16, 2004

Bioethics Class Visits NICU.

They're not law students, but the 13 members of Peter Singer's freshmen seminar, "Ethical Choices," nonetheless recently had an opportunity to view first-hand the excruciating choices typically debated in "Bioethics and Law" classes around the country.  As described in an article in the Nov. 15 Daily Princetonian, "Singer had brought his students to the ward to show them the living faces of a medical debate featured prominently in his scholarship and his seminar: whether it is ethical to end an infant's life when medical data predict she has a low chance of surviving."  Actually, Singer's claims go considerably beyond this statement, and the article eventually gets to the argument that has made Singer's views so controversial:

     Born 14 weeks premature, the 2-hour-old infant the class had come upon had a slim chance of surviving, let alone growing up without mental and physical impairments. Because of these defects, Singer argues the infant's parents should be able to decide whether to shut off her life-support machines and end her life. That claim, based on a belief that a young baby is not self-aware, has generated widespread controversy across the world. (emphasis added)

The class had the opportunity to get both sides of the argument from Singer and from the medical director of the NICU, Mark Hiatt:

   "We [at St. Peter's] don't want to do all this aggressive, heroic intervention unless there's a good possibility that this will be an intact, healthy child," he said. "[But] I could never do anything to terminate a [healthy] life. I became a doctor for the opposite reason."

    Hiatt said he would not allow a baby to die by any means except withdrawing care, called passive euthanasia.

    "As a society, I don't think we want our doctors to [perform active euthanasia, where the doctor directly ends someone's life]," he added. "I wouldn't do it. I couldn't do it. . . . I'm not an executioner."

    Not all students, however, accepted Hiatt's reasoning.

    In discussion on the bus ride home, class member Nic Poulos '08 called Hiatt's distinction between active and passive euthanasia "semantics."

    "He's enabling the child's death, period," Poulos said. "He didn't say, 'Yes, [my position is] based on guilt, but he did say, 'No, I couldn't do that.'"

    Singer played his usual Socratic role in the discussion, speaking up only to inject questions or ask for clarification. When pressed, he agreed with Poulos.

    "I don't think there's a distinction between deciding to withdraw life and deciding to actively end it," Singer said. "[Hiatt] also has an attitude that you should try to save every life you can, regardless of circumstances. In the case of the grad student [who asked Hiatt to withdraw care from his baby] . . . it's still a human life, but it's a life that's barely begun. I would have been prepared to agree with the parents."

This is a discussion I'd have been pleased to hear my law students develop, and the annual trip we take the PICU at Children's Medical Center Dallas often provides just such an opportunity. 

November 16, 2004 | Permalink | Comments (0)

Tired of all the Viagra Ads?

Viagra_hes_back03 He might not really be back.  . . . at least not if the Food and Drug Administration ("FDA") has its way.

CNNHealth reports that the FDA has requested that Pfizer Inc. pull two television advertisements for its Viagra impotence drug.  In a letter released on Monday, November 15th, the  FDA contends that the "wild thing" ads make unsubstantiated claims about a return of sexual desire and also fails to mention major side effects.

The FDA letter states, "FDA is not aware of substantial  evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra," said the letter from the FDA's Division of Drug Marketing, Advertising, and Communications.   According to the article, the FDA further provided that Pfizer should immediately cease using the offending ads and any similar promotions.  Pfizer has been asked to comply by November 24th. 

So, our Thanksgiving television watching may be less risqué, but  then again, Cialis and Levitra are still out there.   In any event, it does appear that health concerns have fallen victim to marketing ploys in this ad and I hope that the FDA wins.  Next, if they could do something about the many rather explicit enhancement and impotence ads that some of us receive through e-mail everyday - they would become a very popular government agency - but perhaps I ask for too much.

Thanks to Jim Tomasweski, research student extraordinaire, for this item.

November 16, 2004 | Permalink | Comments (0)

Monday, November 15, 2004

Soldiers and Mental Illness

Over the weekend, the LATimes reported that as many as one in six returning soldiers suffers from post traumatic stress disorder.   The LATimes story focuses on a recent study conducted by Walter Reed Army Institute of Research that found that "15.6% of Marines and 17.1% of soldiers surveyed after they returned from Iraq suffered major depression, generalized anxiety or post-traumatic stress disorder — a debilitating, sometimes lifelong change in the brain's chemistry that can include flashbacks, sleep disorders, panic attacks, violent outbursts, acute anxiety and emotional numbness."   Further the LATimes said that such results should come as no surprise to anyone with knowledge about the toll of wartime service.  It states,

"Combat stress disorders — named and renamed but strikingly alike — have ruined lives following every war in history. Homer's Achilles may have suffered from some form of it. Combat stress was documented in the late 19th century after the Franco-Prussian War. After the Civil War, doctors called the condition "nostalgia," or "soldiers heart." In World War I, soldiers were said to suffer shell shock; in World War II and Korea, combat fatigue or battle fatigue.  But it wasn't until 1985 that the American Psychiatric Assn. finally gave a name to the condition that had sent tens of thousands of Vietnam veterans into lives of homelessness, crime or despair." 

The LATimes concludes that unfortunately, even with all this knowledge, the Army failed to send the appropriate number of psychiatrists, psychologists and social workers to combat areas and Congress had allocated only $5 million in each of the next three years to deal with the soldiers' medical needs.   I know this isn't surprising given the apparent lack of planning that went into other aspects of the war in Iraq but it is rather sad that we fail to provide adequate treatment for serious mental illness in this country, especially when service to the country is somewhat responsible for the mental illness. 



November 15, 2004 | Permalink | Comments (0)

Florida's "Three Strikes" Law on Hold

As noted here on Nov. 13, Florida voters recently approved a constitutional amendment that would result in the loss of a medical license if a physician were found to have committed three acts of medical malpractice.  According to an Associated Press article filed this afternoon on the web page of the South Florida Sun-Sentinel, Circuit Judge Janet Ferris has enjoined the new law from going into effect until the legislature has an opportunity to enact legislation clarifying such questions as whether the "three strikes" rule applies retroactively.

November 15, 2004 | Permalink | Comments (1)

Forthcoming Publication by Norman Cantor

Zcantor Professor Norman L. Cantor, Professor of Law and Justice Nathan Jacobs Scholar at Rutgers University School of Law at Newark, has a new book "Making Medical Decisions for the Profoundly Mentally Disabled," that will be available from MIT Press in June 2005.  For those interested in the mentally ill and their treatment by the medical profession, this book appears to provide new proposals on how medical treatment decisions should be made on behalf of a mentally ill patient.

From publisher’s online catalog:

In this book, Norman Cantor analyzes the legal and moral status of people with profound mental disabilities -- those with extreme cognitive impairments that prevent their exercise of medical self-determination. He proposes a legal and moral framework for surrogate medical decision making on their behalf. The issues Cantor explores will be of interest to professionals in law, medicine, psychology, philosophy, and ethics, as well as to parents, guardians, and health care providers who face perplexing issues in the context of surrogate medical decision making.

The profoundly mentally disabled are thought by some moral philosophers to lack the minimum cognitive ability for personhood. Countering this position, Cantor advances both theoretical and practical arguments for according full legal and moral status to profoundly disabled people. He also argues that the concept of intrinsic human dignity should have an integral role in shaping the bounds of surrogate decision making. Thus, he claims, while profoundly mentally disabled persons are not entitled to make their own medical decisions, respect for intrinsic human dignity dictates their right to have a conscientious surrogate make medical decisions on their behalf. Cantor discusses the criteria that bind such surrogates. He asserts, contrary to popular wisdom, that the best interests of the disabled person are not always the determinative standard: the interests of family or others can sometimes be considered. Surrogates may even, consistent with the intrinsic human dignity standard, sometimes authorize tissue donation or participation in nontherapeutic medical research by profoundly disabled persons. Intrinsic human dignity limits the occasions for such decisions and dictates close attention to the preferences and feelings of the profoundly disabled persons themselves. Cantor also analyzes the underlying philosophical rationale that makes these decision-making criteria consistent with law and morals.

November 15, 2004 | Permalink | Comments (0)

Congratulations to Jesse Goldner

Goldner 2004 has been a year of well-deserved recognition for Professor Jesse Goldner, professor at  the St. Louis University School of Law and founding member of the Center for Health Law Studies.  In June, he received the 2004 Jay Healey Distinguished Health Law Professor Award at the American Society of Law Medicine and Ethics (ASLM&E) Annual Health Law professor meeting.   More recently, St. Louis University School of Law announced that Professor Goldner has been appointed to the John D. Valentine Professorship.  Congratulations to Professor Goldner and a thank you for serving as such a wonderful role model.

November 15, 2004 | Permalink | Comments (0)

Sunday, November 14, 2004

Ancestry v. Race and Drug Safey and Efficacy

As recent studies show that drugs may have different safety and efficacy results depending on a person's race, the Wall Street Journal reports on other research that demonstrates that one's ancestry has a more important impact that one's race on whether a drug will benefit the individual.   A brief summary of the Wall Street Journal report follows:

Daily Policy Digest
Health Issues: Thursday, November 11, 2004

Studies claim that at least 29 medicines are safer for some racial groups than others, strongly suggesting that race is biologically real, reports the Wall Street Journal.

  • A drug for congestive heart failure had failed in two large clinical studies in the 1980s that included both blacks and whites; but in a trial enrolling only African Americans, the outcome was dramatically different.
  • Those receiving the drug BiDil did so much better than those receiving a placebo, announced manufacturer NitroMed, that it was ethically obliged to halt the trial and offer BiDil to all participants.

But new genetic data shows that racial categories are far too broad. For one thing, there is more variation within a race than between races. A white person and a black person may be more genetically similar, measured by the amount of DNA they have in common, than two blacks, says the Journal:

  • About 30 percent of white Americans have enough non-European ancestry -- more than 10 percent -- to make self-reported race an unreliable indicator of their generic make-up.
  • Many of these people might be good candidates for BiDil, but if their doctors see them as white they won’t receive it, notes Howard University biologist Charles Rotimi.

As a result, geneticists are inching away from the blunderbuss category of race and toward the more precise one of ancestry.

Ancestry reflects genetic variants fairly precisely, says the Journal. Thus, a smaller ethnic grouping, such as Cheyenne or Irish, reflects real genetic differences. But they get washed out when you use the larger category of race.

Francis Collins, director of the National Human Genome Institute, says that every attempt should be made to determine individual genetic profiles and stop using race, which is a very poor proxy for genetic variants that affect health.

Source: Sharon Begley, “Ancestry Trumps Race in Predicting Efficacy of Drug Treatments,” Wall Street Journal, October 29, 2004.

The WSJ text (subscription required)

For more on Health Care and Drugs, see http://www.ncpa.org/iss/hea/

November 14, 2004 | Permalink | Comments (1)