Health Law

American Medical News (2/2, Sorrel) reports that some physicians are considering mediation as a way to "settle cases more efficiently," as "a typical lawsuit takes weeks or years, including trial and appeals." But "mediation can resolve a dispute in days or hours." American Medical News points out that "Chicago's Rush University Medical Center started a mediation program in 1995; since 2004, 95 percent of claims have been resolved through the process." Some "legal experts say mediation and other voluntary, early intervention programs are attracting interest -- among plaintiffs and defendants -- as an alternative to the court system, particularly as tort reform efforts face ongoing challenges and the patient safety movement gains ground." While "proponents tout mediation not only because it saves time and money, but primarily because it encourages open dialogue between both sides," some critics argue "that mediation and other voluntary methods are no silver bullet for resolving physicians' medical liability woes."

The Wall Street Journal (1/31, Dooren, Mundy) reported, "A Food and Drug Administration (FDA) panel recommended banning the painkiller Darvon [propoxyphene] and a related drug [Darvocet (propoxyphene napsylate and acetaminophen)], following a decades-long effort by critics who charged that the drugs' users often intentionally or unintentionally overdose on them." Public Citizen, a nonprofit consumer advocacy organization, had petitioned the FDA to withdraw Darvon. In its petition, the nonprofit "cited data from the Drug Abuse Warning Network implicating propoxyphene in 5.6 percent of drug-related deaths from 1981 to 1999." The organization "also said the network reported 2,110 accidental deaths related to propoxyphene over the same period."

        "In an analysis prepared for the hearing, the FDA's safety office said it had searched the agency's database of reported drug problems, but the result was 'insufficient' to allow reviewers to make a clear-cut recommendation," the AP (1/31) added. "The safety office found more than 3,000 reports of serious problems." If the agency "decides not to ban the drug, it may take other steps, such as requiring stiffer warnings, safety studies, or education efforts aimed at doctors and patients." Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, the companies responsible for marketing the drug, contend that it "is safe and effective when used as directed. In documents filed with the FDA, the companies said doctors need a range of options to treat pain, and noted that many other painkillers have become drugs of abuse." USA Today (1/30, Winter) On Deadline blog and AHN (1/31, Genova) also covered the story.

The Wall Street Journal (2/2, Favole, Mundy) reports that a Food and Drug Administration (FDA) advisory "panel is set to recommend whether the FDA should approve" prasugrel, "a competitor to Plavix [clopidogrel bisulfate]." A panel analysis reveals that "prasugrel is more effective than Plavix in preventing heart attacks." According to "documents released Friday, FDA reviewers suggested the agency should approve prasugrel but limit use in those who are over 75 or have a history of stroke."

        Eli "Lilly seemed to anticipate these concerns in its own documents," the AP (1/31, Perrone) added. Lilly "suggests not prescribing the drug for patients with a history of stroke or ongoing internal bleeding." The company "also recommends labeling that would caution doctors about prescribing the drug to patients who are older than 75 or who weigh less than 132 pounds."

        Bloomberg News (1/31, Larkin, Randall) reported that the FDA's "Division of Cardiovascular and Renal Products recommended that Effient [prasugrel] be marketed to prevent heart attacks. At the same time, it said too little proof existed to support the companies' request to claim a benefit against strokes or deaths." Also, "while some reviewers suggested limiting Effient use to one week to manage the risk of bleeding and prevent a possible association with cancer, there was no consensus in the agency report whether this was necessary."

        The FDA "review said a 'black box' warning -- the most serious warning a drug can carry -- might be suitable," the Indianapolis Star (1/31, Russell) noted. Forbes (1/31, LaMotta) and the Wall Street Journal (1/30, Goldstein) Health Blog also covered the story.

The Chicago Tribune (2/2, Japsen) reports that Takeda Pharmaceuticals North America Inc. announced on Friday that the Food and Drug Administration (FDA) approved Kapidex (dexlansoprazole) for the treatment of gastroesophageal reflux disease (GERD). "Although the FDA granted the approval of Kapidex, studies show it is not much more effective than Prevacid. In an eight-week trial, Kapidex 60-milligram dosage produced similarly effective overall healing rates when compared to Prevacid's 30 milligram dosage, according to Takeda."

HealthDay (1/30, Gardner) reported that some are claiming that "'bio-identical' hormones or 'bio-identical hormone replacement therapy'...do everything from helping menopausal women lose weight to preventing senility." But, according to the Food and Drug Administration (FDA) "these claims are 'unproven' and...the products are 'potentially dangerous.'" Furthermore, "bio-identical hormone replacement therapy -- or 'BHRT' -- is a 'marketing term not recognized by FDA,' the agency said." Companies that market these products claim that they "are identical to hormones produced by the body, and these 'all-natural' pills, creams, lotions, and gels don't carry the risks of menopausal hormone therapies approved by the FDA." However, "the FDA said it hasn't approved compounded 'BHRT' drugs and can't assure their safety or effectiveness."

The U.K. Times (2/2, Loughran) reports that GlaxoSmithKline "could shed about 6,000 employees globally as it faces competition from companies making cheaper, generic copies of its drugs and continuing pressure to shift away from developed economies to tap into the growth in emerging markets."

        "Glaxo, the world's second biggest drugs company behind Pfizer, employs about 100,000 people and, although yet to be confirmed, a proportion of the cuts are almost certain to be among its 18,000 staff at sites across the U.K., which would strike another blow to the battered [U.K.] economy," the U.K.'s Telegraph (2/1, Ruddick) noted.

        "News of the job losses are expected to be revealed when Glaxo reports its results on Thursday," the U.K.'s Guardian (2/2, Wachman, Wray) adds.

        A spokesperson "for the company could not confirm or deny the reports, saying simply that Glaxo 'was in the middle of a restructuring program,'" BBC News (2/1) reported. "The 'restructuring program,' designed to cut costs and boost profits, was announced in October 2007." At the end of last year, "Glaxo announced around 800 job cuts in the U.K."

        Jeremy Batstone-Carr, an analyst with Charles Stanley, said that "competition from generic rivals to the firm's key brands, such as bipolar and epilepsy treatment Lamictal [lamotrigine], and ongoing weakness for its under-fire diabetes drug Avandia [rosiglitazone maleate] could have hit sales," the Press Association (2/1) added. The U.K.'s Daily Mail (2/2, Barrow), AFP (2/1), the South Africa Times (2/2), the AP (2/1), Bloomberg News (2/1, Dobson), and MarketWatch (2/2, Hinton) also covered the story.

The Long Island edition of Newsday (2/2, Kitchen) reports that the New York Department of Labor says that "2,500 educational and health services jobs were added on Long Island in the 12-month period ended in December," even as the trade, transportation, and utilities sector lost 6,700 jobs in the same period and the professional and business-services sector shed 4,700 positions. The department also predicts continued growth in healthcare employment, seeing a 42 percent increase in demand for home health aides between 2006 and 2016, along with a 30.2 percent rise for medical assistants, a 19.8 percent higher demand for pharmacy technicians, a 16.3 percent greater demand for nursing aides and orderlies, and 13 percent growth in jobs for health information technicians.

USA Today (2/2, Schouten) reports, "Former Senate Majority leader Tom Daschle heads to Capitol Hill today to explain to his former colleagues how he made errors of more than $128,000 on his taxes, as he works to defend his nomination as the country's top health official." While "top Republicans expressed concern about the revelations Sunday, they did not say they were prepared to vote against Daschle." Commenting on the responses of some Republican Senators, Democratic spokeswoman Jenny Backus stated, "The indications are that people are sticking with him and that they are taking him at his word. ... He's made a mistake, and he regrets it."

        The AP (2/2, Daniel) adds that "nearly a quarter of a million dollars in fees" Daschle earned over the last two years speaking to healthcare industry leaders "was just a portion of the more than $5.2 million" Daschle "earned as he advised insurers and hospitals and worked in other industries." Backus argued that the payments "do not pose conflict for the healthcare reform Obama wants him to lead," noting that "he welcomed every opportunity to make his case to the American public at large, and the health industry in particular, that America can't afford to ignore the healthcare crisis any longer." The Politico (2/2, Vogel) and AFP (2/2) also cover the story.

Continuing coverage from last week, MedPage Today (1/30, Walker) reported on the Senate's passage of legislation authorizing the expansion of the State Children's Health Insurance Program, "paving the way for coverage for an additional 4.1 million kids. The bill, which was passed by the House earlier this month, would extend the life of the current SCHIP program to 2013. It had been set to expire at the end of March. The Senate version will now go back to the House, which is expected to adopt the Senate version. The final bill will be sent to President Obama, who is on record as supporting SCHIP expansion."

        House to vote on SCHIP bill. CQ (2/2, Armstrong) reports, "The Senate last week passed a $32.8 billion bill to reauthorize and expand the State Children's Health Insurance Program (SCHIP), sending the bill to the House, which plans to quickly clear it for President Obama." The legislation "would reauthorize the children's insurance program for four and a half years, covering 4.1 million previously uninsured children. Its $32.8 billion cost would be funded largely by an increase of 62 cents per pack in the federal tax on cigarettes, bringing the tax to $1 per pack." CQ notes that "several changes made to this year's bill kept some past" Republican "supporters from backing it. Among the most significant [changes] were the removal of a five-year waiting period to enter the SCHIP program for new legal immigrants, and looser citizenship and eligibility documentation requirements."

McClatchy (2/1, Adams) reported, "In the waning days of the Bush administration, the Food and Drug Administration finalized new guidelines to make it easier for drug manufacturers to promote 'off-label' prescription drug uses, which can be deadly for patients." The Department of Veterans Affairs criticized the guidelinesm and "Congressional leaders from both parties criticized the guideline when it was proposed last year. Sen. Charles Grassley...said he had serious concerns about the proposal, which he said would deem appropriate something that 'the FDA once considered evidence of unlawful marketing. ... A legislative fix may be in order."

The Washington Post (2/2, B1, Kunkle) profiles a Virginia family with two autistic children and their plight in trying to get insurance coverage for therapy. "The national debate over the explosion in autism cases has arrived in Richmond this year, and the legislation is one of the few bills to draw attention in a session consumed by fixing a $2.9 billion hole in the budget. The measure, which brought about 200 demonstrators to the Capitol grounds last month, has been backed by Democrats and Republicans." However, "private businesses, already facing the worst economy in generations, have lined up against another government-ordered mandate that would drive up healthcare premiums. Every increase causes some companies, especially small businesses, to consider dropping their policies and leaving employees without coverage, they say."

In the Wall Street Journal (1/30) Health Blog, Jacob Goldstein wrote that paying "doctors for every procedure" that they perform provides "an incentive for unnecessary treatments," while "there's no incentive for doctors to prevent complications." Now, lawmakers are considering "paying a single, bundled fee for and 'episode of care' such as a hip implant." In fact, "Tom Daschle, the man Obama's picked to lead the health reform push, is a backer of episode-based payments." Similarly, "Max Baucus, a key senator in...health reform" favors such payments as well. The Centers for Medicare and Medicaid services (CMS) is now "piloting a program that pays a lump-sum to split by the hospital and physicians." In addition to Medicare, "several experiments are looking at different ways of bundling payments." For instance, "UnitedHealth plans to test bundled payments for oncologists."

American Medical News (2/2, Dolan) reports, "A lot of practices make the mistake of adopting an 18-wheeler of an electronic medical record (EMR) system when they aren't even ready to drive a sedan," according to Shahid N. Shah, CEO of Netspective. In fact, Shah noted that 30 percent "of practices that adopt an EMR...de-install it later." Instead, practices should either automate "one process at a time," or choose to adopt "a so-called lightweight EMR" that has "limited functionality." Although "most experts agree that some level of automation is better than none," where to begin varies for each practice.

American Medical News (2/2, Sorrel) reports, "A pair of settlements with the Federal Trade Commission (FTC) highlight some of the risks and obstacles involved when physician practices engage in collective negotiations with health insurers." The agreements, however, "also signal an increased effort by the commission to educate physicians on how they can collaborate legitimately...without running afoul of antitrust laws," experts noted. The settlements resolved allegations that "two multispecialty physician independent practice associations engaged in illegal price-fixing when they negotiated payer contracts on behalf of their members without any evidence of risk sharing or other cooperative clinical activities." The FTC claimed that the two groups threatened "not to deal with various insurers unless the firms agreed to doctors' demands for higher rates on fee-for-service contracts." But, the agency stated "that the settlements do not prevent doctor groups from negotiating jointly with insurers in one of two ways: through financial integration with risk-sharing contracts or through clinical integration with the goal of setting uniform quality measures."

Life Sciences Law

The Washington Post (1/31, A7, Stephens) reports that the U.S. Court of Appeals for the 2nd Circuit in New York Friday "revived two lawsuits brought against Pfizer by Nigerian families who say the giant drugmaker used their children in an illegal test of an experimental antibiotic." The Post notes that the actions had been dismissed by a lower court judge "who said they should have been brought in Nigeria," adding that the move is being seen as "a precedent affecting other American companies accused of wrongdoing overseas. The lawsuits seek unspecified damages on behalf of the families, who say Pfizer violated international law by testing the drug, known as Trovan (trovafloxacin), on perilously ill children without their knowledge. Eleven children died during the 1996 clinical trial, carried out during a record meningitis epidemic. ... Pfizer also is the target of criminal and civil legal actions in Nigeria, where authorities are seeking damages of more than $8 billion." UPI (1/31) also covered the story.

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