|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 11-02-2005
Researchers Aim to Stretch Flu-Vaccine Supply
One popular business cliché holds that the Chinese word for crisis contains two characters: one signaling danger, the other opportunity. Whether the etymology holds up, the moral is true: in times of crisis, people often invent new methods or tactics that were unused until then.
Whether or not avian flu actually turns out to be a crisis, it is still forcing policymakers and researchers to rethink decades of assumptions about how best to thwart emerging diseases and other biological threats. This article chronicles how some researchers are reconsidering the traditional delivery of vaccines through a shot-in-the-arm.
In fact, scientists suspect that it may be possible to activate a powerful immune response with “much small doses administered just beneath the skin, where the cells that serve as the body’s barrier to outside invaders can quickly mount an immune response.”
As the nation prepares for a possible flu pandemic by improving domestic vaccine-manufacturing capabilities and monitoring emerging flu strains, researchers are also stepping up efforts to stretch the supply of vaccines and make them more effective. They are questioning entrenched practices like the traditional shot in the arm. And while less well-publicized than the development of new vaccines, such research is helping scientists better understand the human immune system -- and prepare for a potentially devastating public-health crisis.
The information researchers are gathering could be used to stretch the supply of vaccines for avian flu and other mutations, and to develop programs to protect patients against deadly threats such as smallpox and bioterrorism agents. "The primary aim is treatment of the standard flu, but if something worse were to hit, this could be adapted quickly," says Robert Frenck Jr., lead investigator for the dose-sparing study and a professor of pediatrics at the UCLA Center for Vaccine Research in Torrance, Calif. The idea that flu shots have to be delivered into the muscle is "just medical dogma, and we're trying to change it," Dr. Frenck adds.
There is plenty of other dogma that ought to be rethought as well: for instance pricing and regulatory policies that make vaccines less attractive products to the companies—big and small—that are doing cutting-edge medical research. Stretching supplies, of course is one thing, but it won’t do you any good if the industry isn’t producing the medicines we need.
Bird flu plan targets unknown: Bush maps assault on disease peril that hasn’t yet emerged
The President has delivered a bold and far-reaching plan to ward off mass casualties in the event of a bird flu pandemic.
His proposals include lawsuit protection for vaccinemakers, in addition to $2.8 billion for corporate research into ways of making vaccines more quickly after a new strain emerges. Bush also would spend billions to build national stockpiles of an experimental vaccine and antiviral drugs that might help treat the disease. White House aides said it's unclear when the antiviral supplies would be ready, though they hope the vaccine stockpile will be completed by 2009.
The administration and congressional leaders have stepped up preparedness measures recently as a strain of bird flu has spread through Asia and Europe. The deadly virus cannot yet spread from person to person, but experts say it could mutate to acquire that ability, which could spark a pandemic.
Bush stressed in a speech at the National Institutes of Health in Bethesda, Md., that no one knows when a pandemic might start or how many lives would be lost. But he echoed the opinion of many scientists that such an outbreak is all but inevitable.
"Our country has been given fair warning of this danger to our homeland--and time to prepare," Bush said. "It's my responsibility as president to take measures now to protect the American people from the possibility that human-to-human transmission may occur."
No plan is, of course, perfect. Stockpiling medicines and vaccines could easily backfire if the new genetic strain of avian flu turns out to be resistant to them. But the President is on stronger ground in funding research for new vaccine technologies, which will improve our capacity to produce new vaccines quickly. He should also be commended for addressing liability concerns, which have jeopardized the very survival of the vaccine industry in recent decades.
Ruling in Merck’s favor was an easy choice for jury
While it would be foolish to speculate on future Vioxx trials (there are thousands of cases pending across the country), the recent outcome in New Jersey was the result of a jury that took its duties seriously and studied the facts carefully.
Legal experts said the form of the jury questionnaire, more than any other single factor, could go a long way toward determining the outcome of the Vioxx litigation Merck faces in New Jersey. "The fact that the jury found there was no failure to warn has an implication for all Vioxx cases, regardless of how long the plaintiff took Vioxx or his or her pre-existing condition," said Victor Schwartz, a Washington, D.C., lawyer and general counsel of the Tort Reform Association.
Schwartz, a lobbyist for big businesses seeking tighter restrictions on product-liability lawsuits, said New Jersey law helps Merck because juries must first find what amounts to misconduct - Merck knew or should have known it was selling a faulty product - before considering whether Vioxx caused a plaintiff's injury. And as Kent Jarrell, a Merck spokesman, pointed out, the facts about the company's conduct in the Humeston case will be repeated in all future Vioxx trials in the state.
"In New Jersey, there is a presumption in the defendant's favor if the defendant properly gave information to the Food and Drug Administration," he said Friday. "Merck did exactly that. The evidence in this case shows exactly that. "We will demonstrate that in every trial that comes up in New Jersey, and that is a factor the plaintiffs will have to deal with."
Plaintiff’s lawyers with other cases pending will, of course, do their best to paint this case as an aberration. It may yet turn out to be a fluke. But as more evidence is scrutinized by the public, Merck’s defense may turn out to be stronger than it appears in trial lawyer soundbites.
Feuding Over Vaccines; Doctor’s Vexed by Parent’s Refusal
Plaintiff’s attorneys who sue corporations for a living are fond of saying that jurors must “send a message” to companies to get them to stop illegal or unethical behavior that costs lives. What kind of message would we have to send to the plaintiff’s bar to get the message across that their scare tactics against pediatric vaccines are killing children?
Plaintiff’s attorneys often cloak themselves in the mantle of “disinterested defenders” of the public weal whose activities are inevitably beneficial. They are often successful in this charade because mainstream media organizations rarely stop to challenge their claims or probe them more deeply. The impulse to side with the underdog in their struggle against monolithic corporations fits a public script that plays to the advantage of the plaintiff’s bar.
But it is a temptation that should be strenuously resisted. While corporate wrongdoing often has spectacular and immediate effects and front-page coverage, lawyers are hardly ever sanctioned in public and the indirect effects of lawsuit abuse are usually buried in abstract statistics about the cost of medical malpractice insurance or bankruptcies.
Some effects are more highly visible. During the last several years, for instance, attorneys have waged a legal campaign against vaccine manufacturers (racking up $200 million in company legal costs) alleging that a preservative formerly used in childhood vaccines (thimerosal) caused autism.
Despite repeated study by regulators and researchers in the U.S. and abroad, no evidence supporting this claim has ever come to light. But it has frightened many parents and led them to object to routine childhood vaccinations.
It's a situation Northern Virginia pediatrician James R. Baugh says he and his partners find themselves confronting with increasing regularity: A parent, usually a mother, refuses a scheduled immunization because she has read on the Internet that it could cause her baby to develop autism.
"My last patient just did it," said Baugh, who estimates he and his 11 partners each grapple with parents who refuse some or all immunizations about twice a month. Most recently, he said last week, the mother of a 2-month-old said she didn't want her daughter to receive the vaccine against measles, mumps and rubella or any other immunization federal health officials recommend to protect children from childhood diseases, some of them fatal.
Baugh said that in this case he did what he usually does when a parent refuses shots. He referred the woman to a Web site maintained by the Children's Hospital of Philadelphia, a source pediatricians regard as one of the most informative; reassured her that vaccines are safe; and reminded her that multiple studies by prestigious scientific groups have found no evidence that vaccines cause autism. Then he made a follow-up appointment, hoping the mother would change her mind. …
His equanimity in the face of what many pediatricians say are persistent myths that circulate on the Internet -- that mercury used as a preservative in childhood vaccines causes autism, that the dangers of immunizations far outweigh their benefits, and that there is a conspiracy by drug companies, doctors and vaccine makers to conceal the harm -- is not shared by other physicians. …
If this child, or any child, gets sick and dies as a result of not receiving needed vaccinations, who will the parents sue? The lawyers who launched the campaign? Or the pediatrician who didn’t browbeat them into getting the vaccination?
A Special Drug Just for You, At the End of a Long Pipeline
Personalized medicine—the quest to develop drugs and other medicines keyed to a patient’s unique DNA—is on its way. This article, however, shows both how far we’ve come in developing diagnostics to inform medical treatments, and how far we still have to go.
Scientists are finding numerous examples of variations in genes that help predict who will respond to a drug or who will suffer side effects. Most drug companies now routinely collect DNA samples from patients in clinical trials to look for such markers. In March, the F.D.A. issued guidelines to encourage drug companies to pursue personalized medicine, and the agency is adding information about genetic tests to the labels of a few drugs. …
But despite progress, many more years of work will be required before combinations of drugs and tests, sometimes called theranostics, could reach the market. ''I don't see any indication that there is a drug that will come to market in the next five years that will have a DNA-targeted market,'' said Dr. Gualberto Ruano, president of Genomas, a company working on genetic tests for drug use. For that to happen, Dr. Ruano said, the drug and the genetic test would have to be tested together in a clinical trial. ''What Phase 3 trial is ongoing now where they have selected the patients based on genetic markers?'' he asked.
One factor that is driving the evolution of these technologies, however, is the legal liability companies face over products like Vioxx. Some executives hope that targeted diagnostics will help to limit liability by predicting which drugs will help (or might harm) patients. This is a great strategy, in theory. But we won’t know whether it works until the technology matures.
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