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Politics : A US National Health Care System? -- Ignore unavailable to you. Want to Upgrade?

To: Peter Dierks who wrote (11299)	11/15/2009 3:58:55 PM
From: Peter Dierks	Respond to of 42652

Washington's Gift to European Biotech With a little help from Congress, Europe may take the lead in biologic drugs. NOVEMBER 13, 2009, 6:52 P.M. ET. By BENEDETTO DELLA VEDOVA European researchers are on the cusp of overtaking their American counterparts in biotechnology innovation, especially when it comes to the development of cutting-edge medicines known as "biologics." These medicines are grown in living cells and consist of molecules thousands of times bigger than those in conventional drugs. In 2004, European biotech firms had access to only 20% of the private equity financing that U.S. firms had. Today the European Union has just about as many dedicated biotechnology firms as the U.S., according to OECD figures. Yet just as the European biotech industry's substantial investments in research and development—about a third of revenues in recent years—is beginning to pay off, U.S. policy makers are considering legislation that would hamstring biotech research in their own country. This would provide a welcome boost to Europe's biopharmaceutical sector but hurt the U.S. industry and overall scientific progress. A bill currently before the U.S. Congress would allow drug companies to make knock-off versions of biologics much sooner than in Europe. To shepherd these advanced drugs from the research lab to a patient's bedside over the course of a decade can cost more than $1.2 billion. To encourage this sort of expensive R&D, companies are typically allowed to keep their research data private for a set amount of time. Only after this "data exclusivity period" has passed can copycat drug makers use an innovator's research data to make biosimilars. Firms manufacturing such knock-offs have of course much lower costs than the innovators because they don't have to spend billions on drug discovery and development. Without a significant exclusivity period, however, biotech companies won't have enough time to recoup the huge sums they have invested. Instead, they'd immediately have to compete with biosimilars, which are less expensive than the brand-name biologics but have much the same medicinal effect. A study released in September by Henry Grabowski, an economist at Duke University, pegs the ideal period for preserving innovation at 12 years. "If the data exclusivity period is too short," Mr. Grabowski argued, "biotech firms may elect to invest in lower-risk biosimilars rather than to pioneer innovative products." U.S law makers are considering a data exclusivity period of between five and seven years. This will make it nearly impossible for American biologic makers to be globally competitive. Firms in the EU enjoy 10 years of exclusivity with the option of an additional year if a biologic shows particular promise. The EU adopted this standard in 2003 to increase the competitiveness of the continent's pharmaceutical and biotech firms. And it has paid off, as the recent success of European firms illustrates. If the U.S. decides to handicap its drug makers, the task of creating the next generation of biologic drugs would fall primarily to Europe. This would mean more investment dollars, more jobs, and more research facilities on this side of the Atlantic. This would be a historic shift. For much of the past few decades, American biotech researchers have left the Europeans in the dust. If American lawmakers proceed with their plan to undermine the U.S. biotech industry, Europe may again take the lead. Mr. Della Vedova is a member of the Italian Chamber of Deputies and a former member of the European Parliament. online.wsj.com

To: Peter Dierks who wrote (11299)	10/17/2010 4:25:49 AM
From: Peter Dierks	Respond to of 42652

A Real Vaccine Scare Lawsuits, autism and the Supreme Court. OCTOBER 16, 2010. The Supreme Court waded into one of the great scare campaigns of the past decade this week, considering whether drug manufacturers may be sued for injuries allegedly caused by vaccines. The case will determine whether hundreds of lawsuits blaming vaccines for a child's autism may descend on state courts. In Bruesewitz v. Wyeth, the case was brought by the parents of Hannah Bruesewitz, who say her inoculation to prevent diphtheria, pertussis and tetanus in 1992 created seizures that left her disabled. The vaccine in question was discontinued and replaced in 1998, and the Bruesewitzs argue that Wyeth and the FDA were too slow to make the switch. At the center of the debate is the National Childhood Vaccine Injury Act, which Congress passed in 1986 to prevent vaccine manufacturers from being driven out of business by tort claims. Under that law, vaccine manufacturers could not be held liable for tort claims if the injury in question was "unavoidable, even though the vaccine was properly prepared and accompanied by proper directions and warnings." Congress also created a Vaccine Court within the Court of Federal Claims to manage injury allegations. It is operated as a no-fault system, and those who believe they were injured may receive compensation from a government-managed kitty funded by a tax on vaccine manufacturers. The Vaccine Court ruled that Hannah Bruesewitz's injuries had not been adequately shown to be caused by the vaccine, leading the family to file suit in Pennsylvania. The case was moved to federal district court, which ruled that the family's claim was pre-empted by federal law. The Third Circuit Court of Appeals agreed. While the Bruesewitz's vaccine claim is not autism related, its outcome will have legal implications for the efforts to link vaccinations to autism. Attempts to seek compensation for the diagnosis have persisted despite overwhelming scientific evidence that has found no connection. In February, the British medical journal The Lancet retracted a study that linked the measles-mumps-rubella vaccine to autism and contributed to a rash of parents fleeing the inoculation. In March, special masters in the Vaccine Court likewise ruled against parents claiming the vaccine was responsible for their children's autism. While the 1986 Vaccine Injury Act bars state tort lawsuits alleging defective design, two other kinds of lawsuits go forward all the time in pharmaceutical industry product liability cases. In the first version, plaintiffs may allege that the manufacturer failed to give adequate warnings about the dangers of the product. In the second, plaintiffs may claim that the vaccine itself was not manufactured properly. The Bruesewitz case is of particular interest because it falls into the bucket of so-called express pre-emption cases, in which a law explicitly bars state tort claims. In 2008's Riegel v. Medtronic, the Supreme Court ruled that federal law explicitly pre-empted state product liability for medical device claims. There, as here, the alternative remedy was favored by a horde of trial lawyers hoping for a new state tort jackpot. At oral argument on Tuesday, the Justices seemed to be dubious of plaintiff claims that the 1986 vaccine law left room for debate. Responding to the suggestion that Congress's intent was not to pre-empt all suits, Chief Justice John Roberts responded that "I would have thought the argument would go the other way: That because they set up a compensation scheme, that was a good sign that they didn't want to allow state law claims." Anthony Kennedy, often a swing vote, was skeptical that manufacturers could survive the assault from new tort claims. Vaccinating children against the many diseases that used to afflict them has been one of the most successful public health improvements in modern times. The Obama Administration, which filed an amicus brief in support of Wyeth in the case, has said it is appropriate to recognize pre-emption in cases where the statute makes the pre-emption explicit. That's a shot of good sense. online.wsj.com