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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 02-07-2005

Novartis Weighs Cap on Prexige Use: Company May Seek Limits On FDA Approval, at First, To Study Effects on Heart
Wall Street Journal, 2-7-05

What do you do when you have a treatment with known benefits and some unknown risks? Novartis is asking itself this question as it considers applying for FDA “limited initial approval” for its new COX-2 painkiller. Limited approval would restrict the drugs use to a narrow group of patients until the drug builds up a proven safety track record.

Prexige is in the same class of drugs (COX-2 inhibitors) as the drug Vioxx, which was withdrawn from the market after it showed an increased risk for heart attacks and strokes. Will Prexige exhibit the same risk profile?

Novartis conducted its own 52-week study on Prexige in 18,000 patients with osteoarthritis. The study followed the number of gastrointestinal injuries in patients taking Prexige compared to ibuprofen and naproxen, two older and much cheaper painkillers that are known to cause potentially dangerous stomach disorders. The study found that Prexige was easier on the stomach, but Novartis didn’t have enough data to completely rule out any increased risk of heart attacks and stroke.

By asking the FDA for limited approval “only for pain sufferers with serious gastrointestinal problems who need a painkiller that won’t aggravate the stomach” Prexige would be allowed on market and could become a real boon for these patients. It could then accumulate safety data that Novartis could use to make the case for additional indications.

While this approach is no substitute for the development of personalized medicine, in this case it may be the best way for industry and the FDA to balance safety and risk without stifling medical progress.

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Power tools for the gene age ; New test can help doctors in prescribing medications
The San Francisco Chronicle, 2-7-05

Gene chips - small wafers of glass or nylon that are coated with DNA - are a technology that can be used to help doctors view the genetic profiles of their patients and prescribe medicines that match the profile.

“[Gene chips will soon allow doctors] to order a test to find out whether patients have unusual gene variations that predict whether they’ll suffer bad reactions to certain drugs. The diagnostic chip can reveal whether patients clear drugs from their systems too quickly or too slowly. Too fast and the normal dose is too low to do much good. Too slow, and the drug builds up in the bloodstream at potentially dangerous levels.”

The device, AmpliChip CYP450 “is the first diagnostic test approved by the Food and Drug Administration that belongs to the class of gene-scanning tools called DNA microarrays.”

Hopefully, AmpliChip is only the vanguard of many new gene tests that will allow doctors and their patients to turn drug therapy from guesswork into a true science.

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Internet pharmacies forced to open shop overseas; Concerned about Ottawa crackdown
The Globe and Mail, 2-7-05

As Canadian policymakers edge towards restricting Internet drug exports from their country into the U.S., Internet pharmacies are looking far and wide for ways around the ban.

And we do mean far and wide. One Internet pharmacy group imports drugs from over 30 countries to meet the demand for 10,000 prescriptions a week from American customers.

Still, Canadian exporters are concerned that eventually competitors from Europe, Asia, and Latin America will skip the middlemen and market their wares directly to Americans.

This raises questions about the safety of prescriptions purchased over the Internet - which is basically open to all comers. Purchasing drugs from directly from Canada is one thing, but widely expanding the pool of Internet imports to meet U.S. demand makes it impossible to effectively regulate the industry.

Are the Canadians likely to become the sole supplier for American drugs? Not at all. There just isn’t enough Canadian supply. The Canadian Health Minister has himself said that Canada’s Internet drug industry “is based on a false economy and on a price differential that was created for the benefit of Canadians and not for the consumption of Americans.” The real question is how long it will take Americans to recognize that fact.

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Health Group offers remedy to businesses; A coalition is moving into South Florida to increase healthcare quality and lower costs for large employers
The Miami Herald, 2-8-05

A group of South Florida’s largest employers has joined forces with a 21 year-old Orlando-based employer coalition to form the Florida Health Care Coalition, which will push for improved health care quality and lower costs for their employees and dependents.

Driving the merger are South Florida’s enormous health care costs, among the highest in the nation. “Studies of Medicare data by Dartmouth researchers show that the average senior in the region costs Medicare almost twice as much as a senior in Minneapolis. Private health plans report similar differences.”

According to some estimates, the Orlando-based coalition (formerly the Central Florida Health Care Coalition) saves its members $50 million every year in hospital costs alone. Orange County Public Schools, one of its members, has used its savings to hire 50 new teachers. The Coalition’s tactic is “to gather data on healthcare trends and prices, determine the best scientifically based standards for quality care and then work quietly with providers to make changes.”

Cost isn’t the only factor. The coalition is acutely aware that “discounts [don’t] heal patients.” Better health care does. For instance, hospital data for obstetricians at one Central Florida practice showed a spike in cesarean sections on Fridays - perhaps because doctors didn’t want to work weekends. The coalition brought the anomaly to the attention of the practice group and their C-section rates dropped.

Their solution is as simple as it is elegant. “When people know they are being watched, their behavior changes…So much of this is just common sense.”

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Why U.S., Canada Differ on Safety Of Attention-Deficit Drug
Wall Street Journal, 2-11-05

The problem with drug safety monitoring is that safety is an inherently slippery concept. A “safe” drug for a cancer patient may be poison to everyone else. Many patients with irritable bowel syndrome (IBS) demanded that GlaxoSmithKline and the FDA return Lotronex to the market after it was withdrawn due to a very rare but potentially fatal side effect in a small number of patients. For those patients, a small risk of catastrophic side effects was more than outweighed by the relief afforded by the drug.

Consider also the recent decision by Canadian regulators to remove the attention deficit drug Adderall XR from the Canadian market because of 20 reports of sudden deaths in patients taking the drug since its debut in 1994. (To date, over 38 million prescriptions have been written for Adderall in the U.S. and Canada.) The FDA, on the other hand, has decided to leave the drug on the market.

The FDA defended its decision not to remove the drug, saying that “although its database did have a dozen reports of sudden deaths in the U.S. of children and teens taking the drug, those cases may largely be explained by factors other than the medication. The 12 cases occurred between 1999 and 2003, when 30 million prescriptions were written in the U.S.”

Which agency made the right call? It is difficult to say because no one has been able to identify a causal link between the drug and adolescent deaths. Indeed, there may not be a link at all. Oftentimes, pharmaceutical regulators are at the mercy of statistical analysis that may only identify a very small anomaly without being able to explain it. Said one researcher commenting on the FDA position, “it is essentially invalid to make comparisons between drugs based on spontaneous reports…There’s no right or wrong because there’s no science.”

And more science is what we badly need. The FDA and industry need to work together throughout the entire life of a drug to identify genomic or physiologic biomarkers that clinicians can easily use to screen out patients at high risk for serious adverse events. Under the current system, a handful of tragic incidents can lead to the FDA depriving millions of patients access to critical medicines - which just compounds the tragedy.

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