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Teaching Hospital Update - December 7-11, 2009


Email Alert

By Leah Voigt*

December 11, 2009

Vaccinations Levels Expected to Hold Steady, According to Recent Study

Despite increased public discussion about the importance of being vaccinated against the flu, this year's seasonal influenza vaccination rate for adults will likely mirror last year's, according to a new study by RAND.

Under contract with flu vaccine manufacturer GlaxoSmithKline, RAND surveyed 5,679 adults online and over the telephone in mid-November, and found that 32% had received a seasonal flu vaccine--compared with 30% of adults who had been vaccinated by November 2008. Another 17% said that they intended to be vaccinated before this flu season was over. (A similar survey conducted this past March found that about 38% of adults received a vaccination during the 2008-2009 flu season.)

"It does not appear that the increased public discussion of the role of influenza vaccines has had a significant impact on the public's behavior," said Katherine Harris, a RAND senior economist and the study's lead author, in a news release. "Most of the results from our latest survey look much like those from last year."

Although fewer than half had received it, healthcare workers' 49% vaccination rate was the highest among populations specifically recommended for getting the vaccination. Another 12% said that they intended to get one.

Andis Robeznieks, Vaccination Levels Expected to Hold Steady, Modern Healthcare's Daily Dose (Dec. 9, 2009) (note: registration is required to view this content).

Things You Did Not Know Were in the Senate Health Bill

The "Patient Protection and Affordable Care Act"--better known as the Senate healthcare overhaul bill--is chock full of interesting but little-publicized provisions affecting consumers. Sure, the bill is mainly a blueprint for overhauling the insurance system. But, look closely and you will see a variety of items that would affect people from the cradle to old age--from breast pump use to retiree health benefits. It is a congressional tradition, adding pet interests that otherwise might not pass to a big bill that at least will be put up for a vote.

Yes, there is plenty of time to change the bill. But political analysts say a final overhaul bill would more likely look like this measure than the version already approved by the House because Senate Democrats barely could agree on sending it to the floor for debate. In short, there's not much political room for major changes.

Here are some examples of what lies in the 2,074-page bill:

Employers would be required to provide an unpaid "reasonable break time for nursing mothers" in the first year after giving birth. Women would be provided a private place, other than a bathroom, to use a breast pump. The provision exempts companies with fewer than fifty workers if the requirement would impose "an undue hardship," a determination left to the employer to make. This provision was inserted by Senator Jeff Merkley (D-OR) who in June introduced the Breastfeeding Promotion Act. Merkley is promoting breast feeding partly as a way to cut healthcare costs. He cites studies showing breast-fed children have a lower rate of disease and illness in their lifetime.

The Senate also wants to help with a provision allocating $400 million from 2010-2015 to help teens make the transition to adulthood. The money goes to states primarily to set up sex education programs. But the money can also be used for "adult preparation" programs that promote "positive self esteem, relationship dynamics, friendships, dating, romantic involvement, marriage and family interaction." In addition, the programs can teach financial literacy and other skills such as goal setting, decision-making, and stress management. About $10 million of funding would go to "innovative youth pregnancy prevention strategies" in areas of the country with high teen birth rates.

The Personal Responsibility Education for Adulthood Training funding was approved as an amendment in the Senate Finance Committee. Senator Olympia Snowe (R-MA) joined all the Democrats in passing it.

In addition to these measures, nonprofit hospitals would have to limit how much they charge low-income uninsured emergency patients to the lowest amount that they receive from insured patients for the same services. The provision in the Senate bill comes more than six years after consumer groups in California and Texas began highlighting how hospitals were charging uninsured patients several times more for the same services as insured patients.

A 2007 study published in the journal Health Affairs showed that many "uninsured and other 'self-pay' patients for hospital services" were often charged "2 1/2 times what most health insurers actually paid and more than three times the hospital's Medicare-allowable costs." The study also found the "gaps between rates charged to self-pay patients and those charged to other payers are much wider than they were in the mid-1980s." In response to the criticism, many hospitals have set up programs for the uninsured to apply for financial assistance and obtain discounted care. The Senate provision would require all hospitals to have such programs.

Mary Agnes Carey et al., Seven Things You Didn't Know Were in the Senate Health Bill, Kaiser Health News, Henry J. Kaiser Fam. Fdn.
(Nov. 30, 2009).

Drug-Resistant H1N1 Cluster Seen in Vietnam

Researchers in Vietnam have reported a cluster of seven cases of pandemic H1N1 flu that were resistant to the antiviral drug oseltamivir (Tamiflu). The resistance appears to have originated in one patient and was transmitted to six others during a forty-two-hour train journey, according to researchers at the Oxford University Clinical Research Unit in Hanoi.

None of the patients was taking or had taken the drug before they came down with the flu, the researchers wrote in a letter published online in the New England Journal of Medicine.

"This shows that resistant 2009 H1N1 viruses are transmissible and can replicate and cause illness in healthy people in the absence of selective drug pressure," they said.

The resistance was blamed on a known resistance mutation, the so-called H275Y substitution in the virus' neuraminidase enzyme, according to the researchers. The mutation has been responsible for all cases of oseltamivir resistance seen in pandemic flu cases so far, but in most cases it has occurred in the wake of treatment with the drug.

The current cluster arose in July, when ten students socialized in the same railway car, the researchers reported. They had not known each other previously, had not had contact with anyone with suspected influenza in the week before the trip, had no symptoms during the journey, and had not been taking oseltamivir, the researchers found. Nonetheless, four of the students came down with a fever within twelve hours of arrival and two more developed fever within forty-eight hours. A traveler in a different rail car was also identified with the flu.

Reverse-transcriptase polymerase chain reaction testing of nasal swabs from all seven was positive for the H1N1 pandemic flu. The H275Y substitution was also found in diagnostic specimens taken before any of the patients had started oseltamivir, the investigators reported.

All seven were treated with oseltamivir at seventy-five milligrams daily and all recovered, the researchers said. No more cases were uncovered despite an extensive public health investigation. "On the other hand, not all contacts could be traced, the researchers said, "so ongoing transmission cannot be ruled out."

P. Horby et al., A Community Cluster of Oseltamivir-Resistant Cases of 2009 H1N1 Influenza, N ENGL. J MED.2009; DOI: 10.1056/NEJMc0910448.

Michael Smith, Drug Resistant H1N1 Cluster Seen in Vietnam, MedPage Today (Dec. 9, 2009).

Court Again Rejects Pharmacists' Bid to Challenge Merger of Pfizer, Wyeth

A challenge to the merger between Pfizer Inc. and Wyeth by a group of pharmacists failed for the second time, as the U.S. District Court for the Northern District of California on December 2, 2009, found that the plaintiffs again failed to establish a relevant market for their alleged antitrust injuries (Golden Gate Pharmacy Services Inc. v. Pfizer Inc., N.D. Cal., No. C-09-3854, 12/2/09).

In the case, filed in August, the plaintiffs alleged that because the companies compete in the manufacture, marketing, and sale of prescription drugs in the United States, the merger would violate both Clayton Act § 7 and Sherman Act § 1. Pfizer and Wyeth moved to dismiss based on the plaintiffs' alleged failure to sufficiently plead a relevant market for their antitrust injuries. The district court agreed to dismiss the complaint in October, but it afforded the plaintiffs the right to amend their complaint. Meanwhile, on October 15, 2009, Pfizer announced that the purchase of Wyeth was complete.

In the latest action, Judge Maxine M. Chesney said that the plaintiffs have amended the complaint to allege several different markets, the first of which is the product market for "[t]he manufacture and sale of all prescription pharmaceutical products." However, the court found this definition to be "similarly deficient" to that set forth in the initial complaint because the plaintiffs have again failed to allege that all prescription drugs are "reasonably interchangeable by consumers for the same purposes."

The amended complaint also asserted that a relevant product market was "[t]he manufacture and sale of all brand name pharmaceutical products." The court said that this fails for the same reasons as the previous attempt, despite being more narrowly defined. Specifically, the judge said that the plaintiffs have again "fail[ed] to allege any facts to support a finding that all brand name prescription products, any more than generic prescription products, are reasonably interchangeable for the same purposes."

A third market alleged in the complaint was "[t]he innovation market for research and development of new prescription pharmaceutical products." The court, however, said that the plaintiffs have failed to identify any consumers who purchase such goods or services in such markets and that the products in development would, again, be reasonably interchangeable.

The plaintiffs also contended that several markets existed that were definable by reference to a specific disease or condition. Such a definition also failed, however, because such products were not alleged to be reasonably interchangeable.

The final market alleged by the plaintiffs was incorporated by reference to a complaint filed by the Federal Trade Commission (FTC) on
October 14, 2009, and included markets for "[t]he manufacture and sale of numerous animal health products"--namely, the twenty-one markets alleged in the FTC's complaint. As to this claim, the defendants did not challenge the identified markets but argued instead that the plaintiffs lack standing and that the claims are moot because they have divested all interest in their animal health divisions.

Chesney agreed with the defendants' assertions regarding lack of standing, finding that none of the plaintiffs have alleged that it is a customer who purchases products in any of the twenty-one specified markets, is a competitor with either defendant, or is a dismissed employee. She did not, however, agree with the argument that the claims are moot, pointing to a lack of evidence offered by the defendants proving that such divestiture took place.

Court Again Rejects Pharmacists' Bid To Challenge Merger of Pfizer, Wyeth, BNA'S HEALTH L. REP. (Dec. 10, 2009) (note: registration is required to view this content).

FDA Opposes Drug Reimportation Measure Previously Supported by President Obama

An expected vote on a healthcare reform bill amendment to allow U.S. pharmacies to import cheaper drugs from other countries was delayed Wednesday after a last-minute signal from the U.S. Food and Drug Administration (FDA) commissioner that the Obama Administration does not support the plan.

The amendment, sponsored by Senator Byron Dorgan (D-ND), would allow pharmacies and drug wholesalers to import FDA-approved drugs from Canada, Europe, Australia, New Zealand, and Japan. It would also allow individuals to purchase prescription drugs from FDA-inspected Canadian pharmacies.

The idea is popular with consumer groups, advocates for the elderly, and many rank-and-file Democrats. In fact, President Barack Obama was a co-sponsor of Dorgan's legislation when he was in the Senate. But the idea is just as unpopular with the pharmaceutical industry, which sells American drugs in foreign countries that control prices for much less money than it charges Americans for the identical drugs here.

"U.S. consumers are charged the highest prices in the world for FDA-approved prescription drugs, and that's just not fair," Dorgan said in a statement. "We've seen drug prices rise by 9% this year alone, and we need to get a handle on them."

According to a Congressional Budget Office (CBO) cost estimate from 2007--when Dorgan introduced the plan as a standalone bill--importation of prescription drugs would have saved the government itself more than $5 billion from 2009-2017 by allowing it to purchase cheaper drugs for Medicare and Medicaid recipients. In addition, the legislation would have increased federal revenues by about $5 billion by reducing the cost of private health insurance, which would end up increasing the share of employees' salary that can be taxed.

CBO only scores federal spending and savings, but Dorgan estimates that consumers would save about $100 billion over the next decade under his amendment. Just a day before Wednesday's planned vote, FDA Commissioner Margaret Hamburg sent letters to two senators laying out the administration's view on the amendment. In short, the FDA now thinks that allowing consumers to buy drugs from foreign countries would compromise the safety of the U.S. prescription drug supply, which she called "the safest in the world."

Among the commissioner's concerns is the fact that the imported drugs may not be safe and effective because they would not be subject to FDA's review process, and there are no guarantees that the drugs were made in a facility that complies with U.S. regulations.

Emily P. Walker, FDA Opposes Drug Reimportation Measure that Obama Once Supported, MedPage Today (Dec. 9, 2009).

*We would like to thank Leah Voigt, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI), for providing this week's update.

AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.

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