HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, January 24, 2005

Health Care According to Frist

The New England Journal of Medicine has an article written by Dr. William Frist, you may know him better as Senate Majority leader Frist.  Since everyone wants to know what the 109th Congress may do with regard to health care, the article may provide some insight.  I was rather surprised that Senator Frist seems to be a supporter of a mild form of universal health care.  Indeed there was much for me to agree with in his piece. [bm]

January 24, 2005 | Permalink | Comments (0)

Thoughts on the Vioxx Litigation

Vioxx1 In this week's New Yorker, James Surowiecki has a short article on the issues surrounding the tort system and its role in determining which drugs are on the market.  He uses the Merck/Vioxx upcoming litigation to express his concerns about the tort system.  He states,

"Questions about Vioxx’s potential risks have been common since its introduction, six years ago, especially after a 2000 trial suggested that the drug increased the risk of heart disease. Merck did not hide these data, and beginning in 2002 the drug’s label included a warning about the possible cardiovascular risks. Some critics, however, have suggested that the company soft-pedalled the dangers. Internal company documents show that Merck employees were debating the safety of the drug for years before the recall.

From a scientific perspective, this is hardly damning. The internal debates about the drug’s safety were just that—debates, with different scientists arguing for and against the drug. The simple fact that Vioxx might have risks wasn’t reason to recall it, since the drug also had an important benefit: it was less likely to cause the internal bleeding that aspirin and ibuprofen cause, and that kills thousands of people a year. And there’s no clear evidence that Merck kept selling Vioxx after it decided that the drug’s dangers outweighed its benefits. . . .

Obviously, there’s something wrong with a system that discourages the careful weighing of costs against benefits—we want companies to learn as much as they can about the downsides of their products. But companies like Merck, which spend hundreds of millions on ads targeting consumers, have themselves to blame, too. Instead of getting people to think about drugs in terms of costs and benefits, these ads encourage people to think of medicine in the same way they think of other consumer goods. It would be one thing if Merck had marketed Vioxx only to people who really needed it—people who couldn’t take ibuprofen or aspirin safely. Instead, the company marketed it aggressively to everyone, so that some twenty million Americans had Vioxx prescriptions. That’s why the potential damages against Merck are so vast. If juries have a hard time accepting a risk-benefit trade-off when it comes to drugs, it’s in part because the drug companies have convinced them that no such trade-off has to be made."

The entire article makes for an interesting read.  As our nation considers tort reform, the question becomes should we cap damages or should we engage with manufacturers and the public to educate them about the trade-offs and the science behind certain pharmaceutical products.  In addition, the FDA may want to strenghen some aspects of its review of these products and their ads. [bm]

January 24, 2005 | Permalink | Comments (0)

Sunday, January 23, 2005

Cuts in Medicaid Predicted

For those you following the budget deficit and President Bush's promise to cut that deficit in half - it looks like some of that savings will come from cuts in the Medicaid program.   According to a variety of anonymous jWashington D.C. sources, some of the President's proposals include providing states more flexibility to use federal Medicaid funds, but also to reduce doctor's reiumbursements, trim fraud, and to limit the program's growth on a per-patient basis.

January 23, 2005 | Permalink | Comments (0)

Medicare Drug Benefit Final Rules Issued

HHS announced that it posted the final rule implementing the Medicare pharmaceutical benefit in last Friday's Federal Register.  HHS' press release is here: (Nothwithstanding, the rinal rule is not in Friday's Federal Register, but when it does appear we'll post the cite.)  [tm]

January 23, 2005 | Permalink | Comments (0)

Estimating the Costs of New Drug Development: Is it really $802m? (Recent Additions to SSRN Database)

"Estimating the Costs of New Drug Development: Is it really $802m?," by Christophers Adams & Van V. Brantner (Bureau of Economics, FTC).  Abstract:

This paper replicates DiMasi et al (2003) drug development cost estimates using their published survey cost estimates along with information from a publicly available data set. The results suggest that the expected cost of developing the average drug is even higher than the DiMasi et al (2003) estimate of $802m (in 2000 dollars). The paper estimates the capitalized out-of-pocket cost per new drug to be between $839m and $868m (in 2000 dollars). The paper similarly estimates the expected cost of the average new drug with certain characteristics such as primary indication. It is shown that the expected cost of developing the average HIV/AIDS drug is $479m, while the expected cost of developing the average rheumatoid arthritis drug is twice that, at $936m. For one large pharmaceutical company the expected cost of developing an average drug is $521m, and for another large firm the cost is almost four times that number, coming in at $2,119m. The results support DiMasi et al's claim that the average cost to develop a new drug is over $800m while also suggesting that for some drugs the costs can be much higher or much lower. The results suggest that drug development costs can be influenced by numerous factors including regulatory policy as well as the pharmaceutical firm's own strategic decisions. The results further suggest that a great deal of care must be taken before using these numbers in public policy debates or interpreting them as a measure of actual drug development costs.

[tm - emphasis added]

January 23, 2005 | Permalink | Comments (0)

FTC Settlements with Pharm Companies

The FTC's Bureau of Competition recently posted summaries of its FY 2004 settlements with pharmaceutical companies.  Among the highlights:

1) 19 of the 22 agreements filed in FY 2004 involved agreements between brand and generic manufacturers, with the remainder occurring between two generic manufacturers;
2) 14 of these 19 agreements resolved patent infringement litigation between brand and generic manufacturers; and
3) no settlement included a payment from the brand to the generic manufacturer in exchange for the generic’s agreement not to market its product.


January 23, 2005 | Permalink | Comments (0)

Saturday, January 22, 2005

Shocking News: Vioxx and Celebrex Overprescribed!

A recent study by doctors at Stanford University and the University of Chicago found that both Vioxx and Celebrex, heavily marketed as "super-aspirin," had been prescribed for millions of patients who were not at risk for gastrointestinal bleeding, the main reason patients were told to switch from aspirin to COX-2 inhibitors.

With data from the National Center for Health Statistics, the study concluded that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs, and that those who were switched had to pay more for their drugs. According to the study, COX-2 inhibitors cost 10 to 15 times as much as the drugs they replaced.  The study may be found in the  January 24th issue of the Archives of Internal Medicine.

As you are all well aware, Merck recalled Vioxx last year because the drug has been linked to an increased risk of heart attacks and strokes.  More recently, studies have shown that Celebrex, manufactured by Pfizer, may pose similar risks to patieints. 

January 22, 2005 | Permalink | Comments (1)

Maternal Brain Death (Recent Addition to SSRN Database)

Maternal Brain Death, 30 Am. J. L. & Med. 453 (2004).  Abstract

Medical technology and sceintific knowledge enables health-care providers to maintain a brain-dead pregnant woman on life-support for the successful delivery of her fetus. However, the legality of such practice as well as its ethical implications remain unclear. The article examines the various aspects of this postmortem procedure. First, the permissibility of such an action is analyzed through discussion of other legal situations dealing with some similar aspects, namely abortion-law and Human tissue gift law. Following this, the major issues arising in this dilemma are being discussed. These issues include the moral and legal status of the fetus, on the one hand and of the dead, on the other hand; interest to life; pragmatical obstacles derived from the proposed procedure, the legal requirement of consent, physician-patient relationship and the status of next-of-kin in such situation. The article concludes with some practical guidelines for health-care providers, lawyers and other interested people at large.


January 22, 2005 | Permalink | Comments (0)

OTC Status of 'Morning After' Pill Again Before FDA

_1441898_pill_black300 As reported in the Wall Street Journal (subscription required), "Fierce arguments have gone on inside and outside the Food and Drug Administration, which may decide as soon as this week whether pharmacies can sell the emergency contraceptive, known as "Plan B" -- which prevents pregnancy when taken 72 hours after unprotected sex -- without a prescription to women age 16 and older."

The drug was turned down as an over-the-counter drug last spring:

"Some staff have expressed the concern that this decision is based on nonmedical implications of teen sexual behavior, or judgments about the propriety of this activity," said the memo by the FDA's acting drug chief, Dr. Steven Galson, who last spring rejected the first application for Plan B's sale over the counter. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."


January 22, 2005 | Permalink | Comments (0)

Friday, January 21, 2005

More on Single-Payer Health Insurance

When the topic is national, universal health care coverage, the go-to people and groups are the usual blue-state suspects: Physicians for a National Health Program, NOW, National Health Care for the Homeless Council, the Massachusetts Nurses Association, American Medical Students Association, Congress of California Seniors, and Sydney Wolfe of Public Citizen's Health Research Group, to name only a few.  But you have to figure the idea is starting to get some traction when it attracts the attention and support of an overflow crowd of rural docs in Colorado.  You can read about it in a recent article in The Denver Post.  Here's how it starts:

Rocky White is an unlikely radical.

A Nebraska-bred country boy, a Republican- voting, ranch-owning, small-town doctor, he hardly fits the profile of a wild-eyed revolutionary.

But White and a handful of cohorts are, in fact, trying to foment upheaval.

The revolution they are proposing: a national health-insurance program.

Nothing short of that will fix what White calls "our god-awful broken system."

White says he didn't jump to this conclusion.

He was pushed.

Pushed by the same forces that plague health care across the country: steep insurance premiums; soaring prescription-drug costs; 45 million Americans without health insurance; bureaucracy; and Medicare and Medicaid reimbursements that don't cover costs.

If anything, these problems are accentuated in rural, and overwhelmingly poor, parts of the country like the San Luis Valley in Colorado:

That is what drove White to join forces with Dr. Gladys Richardson, an unabashed liberal, a woman who could hardly be more different from White.

In August, they invited virtually every health care provider in the five-county valley to hear their pitch for national health insurance.

The response was so huge they had to move the evening meeting from White's office to the largest conference room in the largest hotel in Alamosa.

Dr. White does a nice, succinct job of describing the "health-care death spiral":

As White sees it, the spiral goes something like this: Health care costs go up; fewer people can afford insurance. More people without insurance "creates more people that have to be seen in hospitals and emergency rooms, and who are unable to afford their bills."

So hospitals charge more to insured patients. Then, insurance companies pass those increased costs on in the form of higher insurance rates. "And then ... more people are off the insurance rolls."

Draw a straight line from East L.A. to Boston, and it runs right through the San Luis Valley in Colorado.  It turns out patients, doctors, and hospitals in those places all may have more in common than they'd have ever guessed.  [tm]

January 21, 2005 | Permalink | Comments (0)

Law Firm Newsletters: Roundup

Law firms routinely post articles, newsletters, client alerts, etc. to their web sites.  Many are thinly-disguised teasers, telling just enough to interest clients (and potential clients) and giving a handy phone number that will connect the reader to a willing associate or partner who will gladly expound and expand on the published comments for no more than $500 per hour.  That said, they are occasionally a good source of information on developments deemed by health lawyers to be worthy of comment and fair warning.

That said, I offer herewith a quick overview of some of the more useful postings by these ready-to-please health lawyers, in no particular order of significance:

January 21, 2005 | Permalink | Comments (1)

Proposed Legislation to Limit Insurers' Antitrust Exemption

BNA reports that Democrats in Congress plan to pursue a very different legislative agenda when it comes to health issues than the President.  Recently, Sens. Patrick Leahy (D-Vt.) and Edward M. Kennedy (D-Mass.) indicated that they seek to reform  the medical malpractice insurance industry.   On January 13th, Leahy and Kennedy  circulated a "Dear Colleague" letter soliciting cosponsors for legislation that limits an insurance industry exemption from antitrust laws contained in the McCarran-Ferguson Act.   Both senators assert that the exemption enables malpractice carriers to collude to set higher premiums than true competition would achieve.  The proposed bill, less than two pages in length, contains the same language as unsuccessful legislation (S. 352) they offered in the previous Congress.

January 21, 2005 | Permalink | Comments (0)

Florida Business Proposal for Tort Reform - Most Radical?

Index0101_1 I have been following with interest the various tort reform measures that have been proposed around the country over the past few years.  I can honestly say that I believe the recent reform proposed by a Florida business group should win the award for the most radical changes to our legal system, not just our tort system.

The Associated Industries of Florida, sent to the Florida legislature a massive (111-page) proposed revision to Florida's tort system which would abolish punitive damages, cap attorney fees and noneconomic damages in all tort cases and grant immunity from malpractice lawsuits to emergency room doctors.   Other provisions of the legislation would repeal the Sunshine in Litigation Act, which bars state court judges from sealing judgments that conceal public hazards, further cap damages in patient abuse and neglect lawsuits against nursing homes and allow jail time for those who duck jury duty.

The Republican-controlled Florida legislature have not yet expressed an opinion on the bill.  They are eager, however, to enact further tort reform.  In recent years, they have been successful in passing bills that cap damages for awards in medical malpractice cases.   The Academy of Florida Trial Lawyers and some Democratic legislators who oppose the tort measures view this legislative package as a signal that business and industry plan to attack the plaintiff bar again this session.

So, what do Florida doctors think about this proposed legislation?  They seem to have a completely different agenda.  The Florida Medical Association has promised its members to work to protect doctors' right to practice without malpractice insurance (mmm - interesting idea - I am sure that it will improve the quality of care that Florida residents receive), to maintain the wrongful death exemption, which prevents family members of single adults who die in an accident from filing lawsuits, to restrict attorney advertising, and to enact legislation that restricts who can serve as an expert witness in malpractice cases.  [bm]

January 21, 2005 | Permalink | Comments (0)

Thursday, January 20, 2005

Medicare to Cover Expensive ICDs

News The Centers for Medicare and Medicaid Services announced yesterday that it will expand its coverage for surgically implanted heart-shocking devices for people with weakened hearts.  The devices, called implantable cardioverter-defibrillators (ICDs) sense heart rhythm abnormalities and deliver shocks to the heart when potentially fatal flutters occur.

The Medicare decision is significant not only for its cost (estimated at more than $3 billion a year), but also because it demonstrates the government's willingness to use Medicare as a way to learn more about what works and what does not in medicine.  Officials report that to receive ICD coverage, Medicare requires that the patient permit the collection of ongoing information about his/her health.  The government plans to use such research to determine who best responds to the ICDs. 

The Washington Post reports that, "The plan is part of an evolving federal effort to prevent a replay of recent events in which physicians and patients were surprised to learn that some popular anti-inflammatory drugs and antidepressants have more side effects than previously recognized. Given the huge numbers of patients who receive drugs and medical devices through Medicare, officials said, long-term data collection by the program can be a powerful complement to the modest follow-up efforts made by manufacturers and the Food and Drug Administration."

The coverage decision coincides withthe  publication, in the New England Journal of Medicine, of results from a major study of ICDs sponsored by the National Institutes of Health.

It should be interesting to follow what happens with this decision.  Monitoring of the program will be required to ensure that patient participation in more than data collection research is not made a condition of receiving medical care.   In addition, I have heard from one cardiologist that some patients who have received a ICD shock have asked to have the ICD removed because, even though it saved their life, they have no wish to experience the shock again and would prefer to take their chances.  So, I wonder if Medicare will cover removal costs as well.  [bm]

January 20, 2005 | Permalink | Comments (0)

Wednesday, January 19, 2005

Bizarre Chemical Bombs

I am not quite sure what to think of this BBC article and I recognize that it
is a bit off topic, but I found it quite amazing (and amusing) how creative our military
can be.  The BBC article reports that the U.S. military investigated building
several different types of chemical bombs including the "gay bomb" which would
make enemy soldiers "sexually irresistable" to each other, and the halitotis bomb,
which would make soldiers obvious by their bad breath.  These specialized,
non-lethal chemical bombs were under consideration by the U.S. Air Force in
an effort to disrupt the enemy. 
The BBC obtained the U.S. Defense department records discussing plans for these
devices from the Sunshine Project, a  chemical and biological research monitoring
organization.  According to the BBC, "The plan for a so-called "love bomb"
envisaged an aphrodisiac chemical that would provoke widespread homosexual
behavior among troops . . .   My personal favorite project was the "Who? Me?
bomb which simulates flatulence in enemy ranks.  Apparently that bomb has
been under consideration since 1945 but was never developed due to the fact
that "people in many areas of the world do not find faecal ordour offensive, since
they smell it on a regular basis."  Plus, they didn't even consider individuals like
my young son for whom such noise and stink are quite amusing.  The good news
is that if any of these proposals had been developed, the government assures us 
that "It's important to point out that only those proposals which are deemed
appropriate, based on stringent human effects, legal, and international treaty
reviews are considered for development or acquisition."   Personally, I think that we
should develop the "why can't we all get along?" device and have no more
wars at all.  [bm]

January 19, 2005 | Permalink | Comments (0)

Cancer is Nation's Top Killer

Yesterday the American Cancer Society released its annual statistical report which showed for the first time that in the year 2002, the most recent year for which data is available, 476,009 Americans under 85 died of cancer compared with 450,637 who died of heart disease.  This marks the first time that cancer has surpassed heart disease as the number one killer in America.  Health officials report that although deaths from both have fallen, the improvement has been more dramatic for heart disease.  The single biggest reason: fewer smokers.   Health officials expressed hope that many more deaths may be prevented because a third of all cancers are related to smoking, and another third are related to obesity, poor diets and lack of exercise — all factors that also contribute to heart disease.  Thus, if people only stopped smoking, ate right, and exercised more, they might be less likely to suffer from either cancer or heart disease.  The top killers were cancer, heart disease, injuries, lung disease and strokes.  [bm]

January 19, 2005 | Permalink | Comments (0)

Norma McCorvey (Roe) Ask SCOTUS to Overrule Roe v. Wade

Court_1 In 2003 the federal district court in Dallas rejected Norma McCorvey's request to overrule the case she famously brought more than 30 years ago, Roe. v. Wade.  In 2004 the Fifth Circuit Court of Appeals affirmed, with a strongly worded concurrence from Judge Edith Jones, who is widely reported to be on the very short short-list for any upcoming vacancy on the Supreme Court, arguing that Roe should indeed be consigned to the trash heap of history.  As reported by the AP this afternoon, Ms. McCorvey has asked the Supreme Court to reverse the lower courts and overrule Roe.

Even if five justices were prepared to overrule Roe today, is this the vehicle for them?  It's hard to see how Ms. McCorvey can overcome the objections that her FRCP 60(b) motion for relief from judgment is simply 30 years too late and the case is now moot.  Lyle Denniston has a link to the cert. petition over on SCOTUSBlog[tm]

January 19, 2005 | Permalink | Comments (0)

HHS Secretary Nominee Leavitt and Negotiating for Drug Prices

During his sentate confirmation hearing yesterday (which clearly is not receiving as much attention as Dr. Rice's), Michael Leavitt, President Bush's nominee for HHS Secretary discussed some of his views concerning Medicare and Medicaid.  CBS reports that in the hearing before the Senate Health, Education, Labor and Pensions Committee, Mr. Leavitt expressed opposition to the federal government negotiating drug prices on behalf of seniors in Medicare.  He further stated that he believed that the Medicaid program needed reforming.  Finally, he also focused on the importance of appointing a new commissioner for the FDA quickly.

  For further information, the full hearing is available on C-Span here.  [bm]

January 19, 2005 | Permalink | Comments (0)

FTC Announces Final Settlement in Price-Fixing Case

On Friday, Jan. 14, the FTC announced its final approval of a consent decree in a price-fixing case, White Sands Health Care System, LLC.  In essence, most of the health providers in the Alomogordo, including most of the physicians and all of the CRNAs, were charged with negotiating with managed care organizations and other third-party payors in a manner that amounted to price-fixing and concerted refusals to deal.  All of the pleadings and related documents in the case can be found here. [tm]

January 19, 2005 | Permalink | Comments (0)

Tuesday, January 18, 2005

CDC's Public Health Law Site Adds New Reading

As part of its on-going public-health eductional efforts, the CDC's Public Health Law Program website offers 26 readings in public health law.  This week they added No. 21, FDA v. Brown & Williamson Tobacco Corp. (U.S., 2000).  I think that, taken together, the CDC readings constitute a fine intro public-health-law curriculum.  Are there any readers who think CDC's missed something important, or has place its thumb too heavily on the scales in favor of one topic or another?  [tm]

January 18, 2005 | Permalink | Comments (0)