Health Law

The AP (2/28, Perrone) reports, "A marketing campaign for a GlaxoSmithKline prostate drug has drawn complaints from federal regulators, who said the space-themed advertisement is misleading." In an advertisement for Avodart [dutasteride] capsules, one actor recommends that another actor with frequent urination take the medication "adding that 'other medicines, they don't treat the cause, because they don't shrink the prostate.'" But, Food and Drug Administration (FDA) "regulators say that claim is false. In a letter to the company's US management, the FDA said Merck & Co. Inc.'s Proscar [finasteride] also reduces the size of the prostate, and has a similar indication." The FDA also takes "issue with the visuals used to promote the drug. At one point the ad shows a man holding a model of a planet which is quickly replaced with a much smaller planet, to demonstrate Avodart's prostate-shrinking power." The agency "says the visual exaggerates the drug's effect."

The Wall Street Journal (3/2, B3, Winslow) reports, "Astellas Pharma Inc.'s $1.1 billion hostile tender offer for...CV Therapeutics Inc. steps up the battle over a long-struggling heart drug that could be emerging as an important treatment for chronic chest pain called angina." CV Therapeutics' Ranexa (ranolazine) "initially was turned down by the U.S. Food and Drug Administration [FDA] earlier this decade, but was finally approved in 2006 with tough safety warnings about concerns it could heighten the risk of potentially dangerous irregular heartbeats." Ranexa "was approved to be marketed only for patients who failed to get sufficient relief from such standard medicines as beta blockers, calcium channel blockers, and nitrates." However, "CV Therapeutics' own research indicated the drug didn't trigger irregular heartbeats, and may actually prevent them. A three-year, 6,500 patient study begun before the FDA imposed strict safety warnings backed the company's view." The company's "study, reported in 2007, led to the FDA approval change in November that sparked Astellas' bid."

        Astellas Pharma takes bid for CV Therapeutics directly to shareholders. The Wall Street Journal (3/2, B3, Winslow) reports that last week, Astellas Pharma "said it is now taking [its $1.1 billion offer for CV Therapeutics] directly to shareholders." Astellas "said it preferred a friendly transaction, but said the refusal of CV Therapeutics to discuss the proposal left no alternative." The Tokyo-based company "said its offer provides shareholders 'with immediate cash value that exceeds what the company could reasonably expect to deliver on its own.'"

        CV Therapeutics told "its shareholders to take no action at this time," Bloomberg News (2/28, Mider, Olmos) added, while pointing out that the tender offer of $16 a share offered by Astellas is "the same price the board of...CV Therapeutics...rejected as too low on Feb. 20."

        In addition, "Astellas is suing CV Therapeutics and its directors over the company's recently amended stockholder's rights plan," according to the AP (2/28). "Astellas wants an injunction on the plan in the lawsuit, which was filed in Delaware." The AP noted that "the companies are already partners in selling Lexiscan [regadenoson], an agent used in patients who cannot exercise sufficiently for a coronary stress test."

The Wall Street Journal (3/2, Rockoff) reports, "New drugs are the lifeblood of pharmaceutical companies, but that hasn't stopped" Valeant Pharmaceuticals International "from cutting its budget for research and development in half." The drugmaker "is using the money for acquisitions and stock buybacks and to pay off debt." The company "has decided that research is so risky it is best left to small biotechnology companies -- which it can buy later if they succeed." While "cutting R&D is generally considered taboo in the pharmaceutical industry, which prides itself on innovation and figures it has to spend a lot on research because drug discovery is inherently unpredictable," Robert Ingram, Valeant's lead director, said that R&D "is a high-risk bet, and the fact is we fail more often that we succeed." Although "its position is extreme, Valeant isn't the only drugmaker abandoning the long-held wisdom that R&D is the source of growth for drug companies." Some "other executives changed their minds after years of high-profile failures."

According to the AP (2/27, Alonso-Zaldivar), President Obama "plans to repeal a Bush administration rule that has become a flash point in the debate over a doctor's right not to participate in abortions. The regulation, instituted in the last days of the Bush administration, strengthened job protections for doctors and nurses who refuse to provide a medical service because of moral qualms." An unnamed Health and Human Services official said the administration "will publish notice of its intentions early next week, opening a 30-day comment period for advocates on both sides, medical groups and the public." The AP notes that as a candidate, Obama "criticized the regulation."

        The Washington Post (2/28, A1, Stein), in a front-page, reported that the "move...triggered an immediate political storm" Friday. "The administration's plans, revealed quietly with a terse posting on a federal website, unleashed a flood of heated reaction, with supporters praising the proposal as a crucial victory for women's health and reproductive rights, and opponents condemning it as a devastating setback for freedom of religion." The Post adds, "Perhaps most tellingly, the move drew deep disappointment from some conservatives who have been hopeful about working with the administration to try to defuse the debate on abortion. ... 'This is going to be a political hit for the administration,' said Joel Hunter, senior pastor of the Northland Church in Longwood, Fla., whom Obama recently named to his Advisory Council on Faith-Based and Neighborhood Partnerships."

        The New York Times (2/28, A16, Stout) noted that the rule "prohibits recipients of federal money from discriminating against healthcare workers who refuse to perform or assist in abortions or sterilization procedures because of their 'religious beliefs or moral convictions.' Its supporters included the United States Conference of Catholic Bishops and the Catholic Health Association, which represents Catholic hospitals."

        According to the Washington Times (2/28, Lengell), "The 'provider conscience regulations' instituted by the Bush administration were intended to strengthen existing federal laws that prohibit institutions from discriminating against individuals who refuse to participate in abortions or provide a referral for one. The former administration also said the rule was needed to ensure that federal money doesn't flow to providers who violate those laws." Critics "said the Bush administration rule could be extended in its application to pharmacists who refuse to sell contraceptions or other medications and devices they morally oppose."

The Los Angeles Times (3/2, Rosenblatt) reported that last week, "Obama's push to expand healthcare coverage began in earnest, with the announcement of his plan to create a $634-billion fund to do just that." But, "the cost of covering the uninsured ultimately will depend on the number of people included, the specific benefits they receive, and the amount of financial help the taxpayers would provide." One "key plank in any plan offered by the Obama administration" would be allowing people to keep their current coverage. In addition, employer-sponsored coverage is expected to continue. And although "a mandate would represent a big expansion of government authority -- many believe it is the logical way to go," including "Democratic leaders in Congress." Still, lawmakers "would have to decide the amount of financial subsidies to help people pay for their coverage" before approving "such a mandate." Furthermore, "a mandate would also involve intense negotiations between the government and the insurance industry over the terms and details of coverage."

The AP (3/1) reported, "Terminally ill patients with less than six months to live will soon be able to ask their doctors to prescribe them lethal medication in Washington state." But, because the law does not require "physicians and pharmacists...to write or fill lethal prescriptions if they are opposed to the law," some people "could find their doctors conflicted or not willing to write them." Many physicians "are hesitant to talk publicly about where they stand on the issue," according to Dr. Tom Preston, a retired cardiologist and board member of Compassion & Choices. In fact, "there are a lot of doctors, who in principle, would approve or don't mind this, but for a lot of social or professional reasons, they don't want to be involved." Still, he noted that over time "more doctors who don't have a religious or philosophical opposition will be open to participating." Currently, "some Washington hospitals are opting out of participation, which precludes their doctors from participating on hospital property."

The Wall Street Journal (2/28, Burton) reported, "A plan to curb the number of beds available to" emergency department (ED) patients at the University of Chicago Medical Center "has spurred a divisive internal debate that is being closely watched by hospital physicians across the country." In a "Feb. 1 letter to the university's dean of medical education," Dr. Terry L. Vanden Hoek wrote that the plan "will make it more likely that only the poorest of the poor will be waiting prolonged hours for care." The dispute raises "critical questions facing hospitals that serve low-income populations: How many patients on Medicaid insurance, and older patients on Medicare, can a hospital afford to serve." A spokesman for the hospital stated last week that "a proposed reduction of 10 beds of the 31 in the [ED] was no longer part of the plan." Still, the hospital "continues to evaluate its allocation of beds, in part due to strains of a souring economy." In fact, "many emergency physicians across the country say limiting beds for [ED] patients could become a means of economizing that might spread to other hospitals."

In a front-page story, the New York Times (3/2, A1, Kolata) reports, "More than 95 million high-tech scans are done each year, and medical imaging...has ballooned into a $100-billion-a-year industry in the United States, with Medicare paying for $14 billion of that." Research has shown, however, "that as many as 20 to 50 percent of the procedures should never have been done because their results did not help diagnose ailments or treat patients." According to some medical experts, "bad scans...are part of a growing problem with medical imaging." And although "the differences in the images can be significant," insurers cover "the same for a scan done on a 10-year-old machine as one on the latest model." Meanwhile, a recent report from the Government Accountability Office showed that more physicians are referring "patients for imaging done by scanners they own and profit from." But, the report pointed out that currently the only national regulation for such "services delivered in physician offices" requires that "imaging services are...provided under at least general physician supervision."

The Indianapolis Star (2/27, Groppe) reported, "Two of Indiana's largest employers -- Eli Lilly and Co. and WellPoint -- would help foot the bill for President Barack Obama's plan to reform healthcare this year, and neither is happy about it. As part of his $3.6 trillion budget outline delivered to Congress on Thursday, Obama proposed cutting what the government pays health insurers for Medicare coverage, and what it pays drugmakers for medicines for the poor." The administration has said that any "savings would go toward expanding healthcare coverage to all Americans and other reforms." But WellPoint spokeswoman Cheryl Leamon stated that while the company "applauds Obama's plan to reform healthcare," it believes that "a significant portion of his proposed savings will come at the expense of high-quality, high-value healthcare coverage for millions of America's seniors.'" However, AARP spokesman James Dau "said the proposal would encourage higher-quality care at lower prices."

Life Sciences Law

The Washington Post (3/2, A5, Stein) reports that two teams of scientists "have developed what appears to be a safer way to create a promising alternative to embryonic stem cells, boosting hopes that such cells could sidestep the moral and political quagmire that has hindered the development of a new generation of cures." The work that is being detailed in two Nature papers is expected "to have a massive impact on this field." It also "comes at a politically sensitive moment" -- the scientific community is "anxiously waiting for President Obama to follow through on his promise to lift restrictions on federal funding for research on human embryonic stem cells." Some who oppose "such a move immediately pointed to the work as the latest evidence" that an alternative is plausible, making the issue a moot point.

        For years, scientists have scrambled to develop ways to generate "stem cell treatments without using embryos," BBC News (3/1) added. "In 2007, teams in Japan and the US managed to genetically modify skin cells to be pluripotent." These induced pluripotent stem cells (iPS) were to become "a new source of stem cells for use in research." But "the technique used viruses to genetically modify the cells." This "Trojan horse" method, according to AFP (3/2), essentially "modifies their DNA in such a way that they cannot be given to patients without boosting the risk of cancer." Now, researchers have found a way to circumvent that problem.

        In fact, "the teams in Edinburgh and Toronto had been working separately on iPS cells, until Andras Nagy from Toronto had a chance meeting with Keisuke Kaji, head of the Edinburgh group," the UK's Financial Times (3/2, Cookson) points out. "They found that each had independently solved half the problem." Dr. Kaji's team "discovered how to deliver the four crucial reprogramming genes without using a virus," while Dr. Nagy and his lab mates at the Mount Sinai Hospital were "able to remove all trace of the added genes from the new iPS cells, which avoids disrupting the cells' own genetic machinery."

        They were able to do so by using "a snippet of DNA from, of all things, a cabbage looper moth, which delivers the genes needed to reprogram cells into stem cells," the Canadian Press (3/2) reports. More specifically, the "team used a jumping gene, a mobile piece of DNA also known as a transposon," the Globe and Mail (3/1, McIlroy) added. Apparently, "in moths, corn, and other species, these genes hop from chromosome to chromosome, inserting themselves randomly into the genome." During the current experiment, the team "inserted the four reprogramming genes into a jumping gene from a moth," and later "put the jumping gene and its cargo into a skin cell." Eventually, the "jumping gene cut and pasted the stem cell genes into a chromosome in the skin cell. The scientists were then able to coax the skin cell back to its embryonic state, giving it the superhero-like ability to turn into many types of cells."

        The Toronto Star (3/1, Ogilvie, Hall), the UK's Press Association (3/2) and Guardian (3/1, Sample), Scotsman (3/2, Howie), CTV (3/1), and Japan's Yomiuri Shimbun (3/2) also covered the story.

In the Wall Street Journal (2/27) Health Blog, Jacob Goldstein wrote, "Court documents suggest AstraZeneca told U.S. sales reps to say the antipsychotic drug didn't cause diabetes, even though a company doctor had previously said that the drug could be linked to the disease in some patients."

        The documents were "released Friday in a legal dispute between the company and lawyers for thousands of people who sued the company because they said the drug caused diabetes and weight gain," the New York Times (2/28, B6, Wilson) added. In fact, in one 1997 email, an AstraZeneca official "praised Lisa Arventis, the company's Seroquel [quetiapine] project physician at the time, for minimizing the adverse findings in a 'cursed' study." The plaintiffs' attorneys claim "the documents show" the company "tried to hide the diabetes link for nearly a decade." One attorney argued that the company "not only failed to warn physicians and patients but marketed" the drug "in a way that represented there was no risk." Meanwhile, a company spokesman stated that "AstraZeneca had fully informed the Food and Drug Administration of all relevant data before and after the drug was approved in 1997." The company now faces "about 9,000 personal-injury lawsuits from more than 15,000 former users of Seroquel." UPI (3/1) also covered the story.

        Seroquel's efficacy as an antipsychotic questioned amid release of previously undisclosed data . The Wall Street Journal (2/28, Johnson, et. al) reported, "AstraZeneca PLC produced an analysis of studies showing that its antipsychotic drug Seroquel [quetiapine] was less effective than older-generation psychiatric drugs it was supposed to improve upon, new documents made public Friday in a federal court case show." The company "has marketed Seroquel as an effective treatment for schizophrenia and bipolar disorder" for "the past dozen years." In fact, "in some of its marketing material for the drug, AstraZeneca says that Seroquel works as well as -- and sometimes better than -- some other antipsychotics." But, "a newly unveiled analysis from 2000 of a dozen studies AstraZeneca conducted to test Seroquel's efficacy indicates that the drug was less effective than a half-century-old generic medicine called haloperidol." The company currently "faces more than 9,000 lawsuits from individuals who allege that they developed diabetes after taking Seroquel," and the drug's efficacy "isn't a key issue in these lawsuits." The "previously undisclosed data," however, "could affect sales of AstraZeneca's second-biggest selling drug."

The Wall Street Journal (2/28, Loftus) reported, "An unidentified whistleblower has filed a lawsuit against Amgen Inc. accusing the biotechnology company of illegal marketing of its blockbuster drugs Enbrel [etanercept]," a treatment for rheumatoid arthritis and psoriasis, "and Aranesp [darbepoetin alfa]," used to treat anemia. Among various defendants named in the case are "Wyeth, which co-markets Enbrel with Amgen...wholesale drug distributor AmerisourceBergen Corp., [and] online health-information provider WebMD Health Corp." The suit alleges that "the defendants violated federal and state false-claim laws, Medicare and Medicaid anti-kickback laws, and the US Food, Drug and Cosmetic Act 'by engaging in numerous unlawful activities in their marketing'" of the two drugs. Amgen is accused of marketing Aranesp to imply physicians "could profit more from prescribing Aranesp than competing drugs." Meanwhile, the suit claims "that both Aranesp and Enbrel were marketed for uses not approved by the Food and Drug Administration." In addition, "part of this so-called 'off-label' marketing was conducted on the online physician-education site Medscape, which is owned by WebMD."

Bloomberg News (2/28, Schneider) reported, "Johnson & Johnson, which has spent at least $68.7 million to resolve US lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the Ortho Evra [ethinyl estradiol and norelgestromin] birth control patch, agreed to settle similar claims in" in Ontario, British Columbia, and Quebec. Twenty-two "Canadian plaintiffs accused J&J's Janssen-Ortho unit of failing to properly warn patients and doctors that Evra increases risks of blood clots, strokes, and heart attacks compared to oral contraceptives." A judge in Ontario "will be asked to end the suit at a hearing March 23," according to an attorney for the Ontario plaintiffs.

Bloomberg News (2/28, Randall) reported, "US Congress is probing Eli Lilly & Co. after a critic's sudden removal from a government panel reviewing its anti-clotting drug prasugrel." The Food and Drug Administration (FDA) "acknowledged it was a 'mistake' to remove [cardiologist Sanjay] Kaul at Lilly's urging four days before the Feb. 3 hearing." The company "complained about research articles written by Kaul, director of a heart research laboratory at Cedars-Sinai Medical Center in Los Angeles, questioning prasugrel's safety and effectiveness. The FDA said it was concerned Kaul might be biased." According to David Moskowitz, an analyst with Caris & Co. in New York, "the controversy over Kaul's removal may prompt the FDA to give prasugrel its strictest warning to doctors, a boxed label, even after the advisory panel downplayed potential risks of bleeding and cancer." The agency "staff documents given to the panel, released before Kaul was dismissed, were unusually positive, 'raising a red flag,' and adding to suspicions when Kaul was dismissed."

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