Health Law

The Wall Street Journal (2/24, B3, Winslow) reports, "A special committee of Genentech Inc.'s board stood firm against Roche Holding AG's hostile $86.50-a-share tender offer for the portion of the biotechnology company it doesn't already own, unanimously urging shareholders to reject the bid."

        "In a letter to shareholders, a committee of Genentech's directors said that Roche's offer of $86.50 a share substantially undervalued the company, given its track record of developing new biotechnology drugs," the New York Times (2/24, B9, Pollack) adds. "And the committee accused Roche of being 'consistently dismissive' of efforts to negotiate a deal." The rejection was not a surprise "because the same board committee had rejected an offer of $89 a share that Roche made last July for the 44 percent of Genentech it does not own."

        "Genentech said that throughout the eight-month impasse, Roche has failed to recognize that the biotechnology company's "unparalleled" research and "robust" product line will create more value for shareholders than the current $42.1 billion bid," Bloomberg News (2/24, Chase, Olmos) reports. The company "said it has 25 new potential therapies in development that 'have the potential to significantly advance the standard of care.' And 33 of Roche's 42 products in the final stage of testing needed for regulatory approval flow from collaborations," according to Genentech.

        For its part, "Roche has maintained that its pared-down offer for Genentech was justified by the general stock market downturn resulting from the global financial crisis," the San Francisco Chronicle (2/24, Tansey) points out. The AP (2/24), BBC News (2/24), AFP (2/24), the San Francisco Business Times (2/24, Leuty), MarketWatch (2/24, Chang), and TheStreet.com (2/24, Feuerstein) also cover the story.

The AP (2/24, Johnson) reports, "An attorney for the state of Alabama asked a jury Monday to order generic drug manufacturer Sandoz to pay as much as $170 million because the state claims its Medicaid program paid too much for prescription drugs for more than a decade." But, according to an attorney for the drugmaker, "the company reported accurate prices and Sandoz saved the Alabama agency millions by providing less-expensive generic drugs." Attorney Tabor Novak also claimed that "state officials did not understand the system used to determine prices and that generic drugs were much less expensive [than] brand name prescriptions." The state is seeking "$28.4 million in compensatory damages and as much as five times that amount in punitive damages." The company "is one of more than 70 prescription drug manufacturers...sued by Alabama Attorney General Troy King in 2005 over Medicaid drug prices dating back to 1991."

The release of stimulus funding for Medicaid was noted in several brief articles throughout the US. The Chicago Tribune /AP(2/24) reports, "Illinois could collect nearly $471 million from President Barack Obama's decision to release Medicaid money included in the federal stimulus package, providing a little relief to the pharmacies and hospitals waiting months to be paid for their services." Because Illinois' backlog of unpaid Medicaid bills and "many other expenses," the "$471 million increase from the federal government won't come close to solving the problem."

        The Hartford Courant (2/24, Hamilton) reports, "Connecticut can expect $274.6 million to start showing up in a special stimulus account as early as Wednesday. President Barack Obama, at a meeting with governors this morning, told them that they wouldn't have to wait long for Medicaid help to hit their states, saying special treasury accounts were being set up for use immediately." The funding "represents the first two quarters of help that was already promised in the recently signed economic stimulus bill. These special accounts will be run through the U.S. Department of Health and Human Services."

        The AP (2/24, Breen), the Iowa Independent (2/24, Waddington), the Cherry Hill Courier Post (2/24, Chebium), and the Tennessean (2/24, Theobald) also covered the story.

The Wall Street Journal (2/24, D2, Dooren) reports, "The Food and Drug Administration [FDA] said the epilepsy drug Zonegran [zonisamide] can cause a certain type of metabolic disorder that can increase the risk of kidney stones and bone diseases."

        The FDA "said recent data show patients taking the antiseizure pill Zonegran face higher risk of metabolic acidosis, which causes dangerously high levels of acid to accumulate in the blood," the AP (2/24) adds. Metabolic acidosis "can cause breathing difficulties, irregular heart rhythms, and fatigue. Left untreated, the condition can do long-term damage to the kidneys and bones and slow growth in children." The agency "advised physicians to monitor patient's blood serum levels while they are taking Zonegran, even if they don't have symptoms."

        The FDA "warned of the side effect after reviewing data from two trials -- one in adults and one in children -- that found a persistent decrease in serum bicarbonate levels, a marker of the disease, along with hyperchloremia," MedPage Today (2/23, Fiore) explained. In the trial of adult patients, "the incidence of a persistent decrease in serum bicarbonate to less than 20 mEq/L ranged from 21 percent in patients treated with a 25 mg daily dose to 43 percent in patients treated with a 300 mg daily dose. The incidence of persistent abnormally low serum bicarbonate (less than 17 mEq/L) was two percent or less across all doses evaluated." In the trial of children, "the incidence of a persistent decrease was up to 90 percent and generally increased with higher doses. The incidence of persistent abnormally low serum bicarbonate was as high as 18 percent and appeared to increase with higher doses." Medscape (2/23, Hitt) also covered the story.

The Wall Street Journal (2/24, Favole) reports, "The Food and Drug Administration said it made a mistake in barring a leading cardiologist from an advisory panel meeting weighing a potential big-selling drug from Eli Lilly & Co." Ahead of the meeting, the company had "questioned the inclusion of Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in Los Angeles." Kaul "has written several papers critical of prasugrel," an anti-clotting drug. Without his presence, the panel voted 9-0 in favor of the drug, which will compete against Plavix. Janet Woodcock, who is head of the FDA's drug division, said, "At every step of the way there were errors by multiple parties."

The Los Angeles Times (2/24, Murphy) reports that "an estimated 1,200 Libby residents died or developed asbestos-related diseases from the asbestos fibers that permeated nearly every corner of the small town at the base of the Cabinet Mountains." Now, "prosecutors claim that W.R. Grace officials were secretly armed with studies that documented the dangers but insisted for decades that their product presented no health hazard." David Uhlmann, formerly the Justice Department's top environmental-crimes prosecutor and now a professor at the University of Michigan Law School said, "There's never been a prosecution in the United States where so many people have been sickened or killed as a result of environmental crime." The Baltimore Sun (2/24, Brown) also covers the story.

The Wall Street Journal (2/24, B3, Kamp) reports that "Medtronic, Inc. agreed to pay at least $1.03 billion to buy two closely held makers of replacement heart valves that don't require major surgery, taking the medical-device maker into a nascent market and fueling a rivalry with Edwards Lifesciences Corp." The two purchases, "for CoreValve, Inc. and Ventor Technologies, Ltd., could help Medtronic offset sluggish conditions in its biggest business -- implantable heart defibrillators -- and competitive pressure elsewhere." The devices the companies manufacture "are replacements for the aortic valve, which sends blood from the heart's main pumping chamber. The aortic valve can become narrow to the point at which it impedes blood flow, in which case patients may need a replacement."

        Minnesota's Star Tribune (2/24, Moore) notes that both companies "are developing new ways to replace heart valves in patients." Scott Ward, president of Medtronic's CardioVascular division, said, "Surgery to replace aortic valves is very successful; patients who have their valves replaced do quite well. ... But there are patients now who are not surgical candidates."

        The AP (2/24) explains that Corevalve's "technology has been implanted in 2,600 patients worldwide, though it has not yet been cleared for use by the Food and Drug Administration. Rather than performing open-heart surgery, the company's system allows a surgeon to insert a replacement heart valve through a small incision in the leg artery."

        The Financial Times (2/24, Arnold), Bloomberg News (2/24, Nussbaum), the Memphis Business Journal (2/24, Vomhof), and Modern Healthcare (2/24, Blesch) also cover the story.

Bloomberg News (2/24, Pettypiece) reports, "Pfizer Inc. Chief Executive Officer Jeffrey Kindler will create smaller business units to help manage the drugmaker after it grows by almost 50 percent as a result of the Wyeth acquisition." The plan "should keep Pfizer growing in spite of its size and dependence on a single product, Kindler said in an interview." Kindler "said Pfizer will rely on many products overseen by smaller units, giving the company less volatile swings in sales and earnings. For example, no research group will have more than 150 scientists, enabling quicker decisions, Kindler said." With smaller units, he "said integrating the Wyeth acquisition will be faster than when Pfizer digested its purchases of Warner-Lambert Co. and Pharmacia Corp." The Wall Street Journal (2/23, Goldstein) Health blog also covered the story.

In the Washington Post (2/24, D2) Regulators column, Cindy Skrzycki writes, "The Bush administration shut off a source of information last fall about abuse and neglect in long-term care facilities that people suing nursing homes consider crucial to their cases." Under the rule, "state inspectors and Medicare and Medicaid contractors" were designated as "federal employees, a group usually shielded from providing evidence for either side in private litigation." The regulation "generally prohibits state health departments and contractors from participating in private lawsuits involving facilities that are in the federal assistance program without approval by the head of the Department of Health and Human Services." As a result, litigants must "go to greater lengths, including seeking court orders, to get inspection reports," and such requests "now are stalled between state and federal offices." According to the Bush administration, "the rule was...necessary to accommodate the hiring of new contractors to make Medicare payments to providers, perform audit and fraud reviews."

AFP (2/24) reports President Obama announced "a bipartisan summit next week for policymakers and legislators to discuss reforms to fix the nation's ailing healthcare system. ... The president also stressed that health issues are closely intertwined with the economic crisis. 'Over the long run, putting America on a sustainable fiscal course will require addressing health care,' he said."

        The Washington Post (2/24, A5, Montgomery, Goldstein) reports White House budget director Peter Orszag "delivered a forceful argument for keeping Washington's focus, for now, on slowing 'the growth rate in health-care costs,' calling it 'the single most important thing we can do to improve the long-term fiscal health of our nation. ... Let me be very clear: Healthcare reform is entitlement reform. The path of fiscal responsibility must run directly through health care,' Orszag said."

        The Hill (2/24, Young) notes Obama "continues to lack a point person on health reform and a secretary of Health and Human Services. ... In the meantime, Democratic lawmakers, led by Senate committee chairmen Edward Kennedy (Mass.) and Max Baucus (Mont.), have been developing health reform legislation for months -- thus far without active leadership from the White House."

Life Sciences Law

In a front-page story, the Washington Post (2/24, A1, Stein) reports, "A handful of biotech companies are racing to market a new generation of tests for Down syndrome" that "isolate and analyze tiny bits of genetic information from the fetus that circulate in a woman's bloodstream." Current "tests often produce confusing, ambiguous results, unnecessarily alarming couples or falsely reassuring them," and "the new tests are designed to offer more definitive results early in the pregnancy." But, the new tests are also "renewing questions about why regulators do not require such innovations to be proved reliable before being offered to the public." In addition, some "fear that the technology may prompt more couples to terminate pregnancies." The companies are aiming to have "their versions on the market within a year." In the meantime, advocates are pressuring "Congress to fund a law passed last year aimed at ensuring that couples get accurate information about genetic conditions and at providing support for women who decide to keep their affected children."

Bloomberg News (2/24, Kresge) reports, "Teva Pharmaceutical Industries Ltd., the world's largest maker of generic drugs, is seeking to deepen its range of branded products by buying rights to treatments for cancer and neurological and autoimmune disorders." John Boris, an analyst for Citigroup Global Markets, wrote in a note to clients at the end of last year that "branded-product sales will account for 35 percent of Teva's revenue by 2013, more than double the 16 percent in 2007." The company "is developing a strategy to add cancer medicines to its portfolio of branded products," Jon Congleton, general manager of Teva's US neuroscience unit said. Congelton told Bloomberg that its "internal research pipeline will also continue to focus on 'niche specialty disease categories' such as multiple sclerosis and amyotrophic lateral sclerosis, known as Lou Gehrig's disease."

In The Middle Seat travel column on the front of the Wall Street Journal (2/24, D1) Personal Journal section, Scott McCartney notes that some "hotels have resisted installing" automated external defibrillators (AED), "citing potential liability issues." McCartney explains that "hotels worry that if they have the devices, which cost about $1,200 to $2,000 each, they could be sued for failing to have enough units, failing to put them in the right places, or failing to replace batteries or maintain them properly." Hotel worker training is "another concern." But, "AED advocates and hotel-industry officials agree that rarely, if ever, have hotels been found liable for a death when an AED was present (though some cases may have been settled). Hotels don't face any greater liability risk than other public buildings that have AEDs." Advocates also point to "a 2004 study published in the New England Journal of Medicine [which] found that public access to AEDs doubled the chances of survival in cardiac-arrest cases." According to Michael Sayre, M.D., emergency-medicine physician at Ohio State University Medical Center, "You could imagine in the neighborhood of 10,000 people could be saved who today are dying" if AEDs were more widely available.

The Wall Street Journal (2/24, B3, Burton) reports that Medtronic, Inc.'s Sprint Fidelis defibrillator leads, "pulled from the market in 2007, represent an 'increasing hazard' for more than 200,000 heart patients world-wide," according to "Minneapolis Heart Institute cardiologist Robert G. Hauser, who first spotted the fractures in the Sprint Fidelis leads in early 2007, and David L. Hayes, chairman of cardiology at the Mayo Clinic in Rochester," MN. The cardiologists say that the "potential danger from fractures and other failures increases as the implanted wires...age." The Journal adds, "It is estimated that about 150,000 Sprint Fidelis leads remain implanted in US patients."

        The New York Times (2/24, B9, Meier) explains that in a study published online in the journal HeartRhythm, "Dr. Hauser and Dr. Hayes reviewed the performance of all defibrillator leads implanted at their institutions from 2004 to 2008. Of about 3,000 leads implanted during that period, the Sprint Fidelis accounted for 848 leads, or about 28 percent of the total." According to the investigators, "during the period, the annual failure rate of the Sprint Fidelis was 3.75 percent compared with 0.6 percent for other leads." The researchers also found "that the failure rate was increasing," writing, "The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable." The Times adds that "Medtronic and heart experts said leads that are functioning should not be removed as a precaution, because of the risks involved in the removal procedure."

In its World Briefing section the New York Times (2/24, A8, Burns) reports, "A long-awaited report on Monday described the use of contaminated blood products in Britain's National Health Service in the 1970s and '80s, infecting thousands of hemophiliacs with HIV, hepatitis, and other conditions, as a 'horrific human tragedy' and 'the worst treatment disaster' in the 60-year history of the publicly financed health system." The privately-funded study was carried out "over two years," and eventually revealed that "more than 1,700 of the 5,000 people who underwent transfusions with the infected blood products died." More alarmingly, the report's authors say that the majority of the "products came from American suppliers that obtained blood from prison inmates and other 'skid row' donors."

        And, "long after alarms had been founded about the risks of obtaining paid-for blood donations from communities with an increased incidence of relevant infections...this practice continued," the AP (2/24, Katz) adds. Therefore, the authors say that "it is difficult to avoid the conclusion that commercial interests took precedence over public health concerns."

        The report also attributes the incident to the fact that "there was 'lethargic' progress towards national self-sufficiency in blood products in England and Wales, where it took 13 years compared to just five years in Ireland," according to the UK's Independent (2/23, Marsden). But "whether the lack of urgency over much of this period arose from over-hesitant scientific advice or from a sluggish response by Government is now difficult to assess," in part because of the "Department of Health's decision not to give evidence to the inquiry." Nonetheless, the "hemophilia community feels that their plight has never been fully acknowledged or addressed."

        In addition, "campaigners, who feel they have been rebuffed by the government at every turn, were left dissatisfied both with the report's inability to name the guilty men after all this time and with the government's non-committal response," the UK's Guardian (2/24, Boseley, Topping) adds.

        In the meantime, the UK's Telegraph (2/23) says the government should "address" the inquiry's proposal of improving "the existing level of compensation for the victims and those who have to look after them." A commentary in the UK's Times (2/24, Purves) calls for the government to make similar financial amends.

        According to the Scotsman (2/24, Peev), Lord Archer of Sandwell, who presented the findings, "said the victims should receive compensation because many were plunged into poverty after their illness forced them out of work," while they were simultaneously "faced with the burden of ever rising costs for medical expenses and home care." Notably, the "inquiry took written and oral evidence from hundreds of witnesses," revealing "how ignorant politicians and health practitioners were about viruses in the 1970s and 1980s." AFP (2/24), UPI (2/24), and the Voice of America (2/23) also covered the story.

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