|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 05-25-2005
Why Patients Fail to Take Their Medicines
Most U.S. health care spending is absorbed by a relatively small number of patients—for instance, about 25 percent of Medicare beneficiaries account for nearly 90 percent of the program’s expenditures.
Studies suggest that the most expensive patients have may multiple, chronic health conditions that are poorly controlled. For instance, this article notes that patients at high risk for heart disease—and who need medicines to control both high blood pressure and elevated lipid profiles—don’t take their medications as prescribed.
Reporting in the May 23 issue of the Archives of Internal Medicine, researchers at ValueMedics Research, in Arlington, Va., analyzed a managed-care organization's database, identifying more than 8,400 patients who'd been prescribed both anti-hypertensive and cholesterol-lowering medications. They then tracked each patient's adherence to the drug regimens for an average of almost 13 months.
Three months after starting their treatment regimen, just 44.7 percent of patients were still adhering to it, with that number dropping to just under 36 percent at both the six-month and one-year mark. [Ed: emphasis added.]
At the same time, the researchers found that between 25.3 percent and 29.6 percent of patients were taking one drug properly as prescribed, but failing to adhere to instructions for the second drug.
The study suggested additional protocols that doctors could follow to increase patient compliance. But it should also be noted that doctors aren’t paid for monitoring compliance—they’re paid for seeing patients.
Improving disease management for hard-to-treat patients means not only getting better data on patient compliance, but also moving away from the fee-for-service health care model that focuses payments on acute care (i.e., hospital and doctor’s office visits) rather than careful management of chronic illnesses.
CVS Will Try to Close One Gap Where Counterfeit Drugs Enter
Consumers usually assume that the drugs they take go right from the manufacturer to their local pharmacy. They don’t. They pass through many layers of wholesalers, large and small, who are regulated—often poorly—at the state level. Wholesalers profit on the differential between their initial purchase price and the final sale price to hospitals, pharmacy benefit managers, and pharmacies.
Lax state regulations and high profit margins on pharmaceuticals have lured criminals and counterfeiters into the wholesale market, with potentially deadly consequences for American patients. (For more information on how the wholesale drug market has become corrupted see the excellent book Dangerous Doses, by investigative reporter Katherine Eban.)
While lawmakers in Congress and in individual states are debating new regulations for wholesalers, pharmacy chains like CVS are moving to protect their customers by buying directly from the manufacturer or other trusted sources.
Lawmakers, drug makers and wholesalers have been grappling in recent months with what they say is a growing problem with counterfeits, on the rise due to a growing influence of organized crime and the ease of using the Internet to sell the drugs. Several states, most notably Florida, are working on "drug pedigree" legislation to track drugs from manufacturer to retailer. … CVS said that some of the legislative initiatives are "impractical," and that the company's action was a way to address patient safety.
CVS's decision is the latest industry effort to eliminate gaps allowing counterfeit drugs to get to consumers. Earlier this month, drug wholesaler Cardinal Health Inc., of Dublin, Ohio, said it will buy drugs only from manufacturers or other authorized sources. CVS is Cardinal's largest customer, accounting for 18% of Cardinal's revenue last year. A spokesman for Cardinal said its decision was unrelated to CVS's.
Drug manufacturers are also working on new technologies to deter theft and detect counterfeit drugs. In the meantime, consumers should seek out pharmacies like CVS that can verify the source of their medicines.
BOSTON SCIENTIFIC IN $25M VENTURE; STENT MAKER INVEST IN BRAIN-SCAN SYSTEM IN EFFORT TO DIVERSIFY
Depressive disorders affect about 19 million American adults today. Unfortunately, although many treatments are available, patients often have to try several medicines before they find an effective medication or dosage—prolonging suffering and adding to overall health care costs.
Boston Scientific, however, will help market a technology that could help doctors see how treatments for depression—and even Alzheimer’s—act in the brain, allowing them to find better treatments faster.
Boston Scientific Corp. yesterday said it will pay $25 million to Aspect Medical Systems Inc. of Newton for work on brain-monitoring devices that could help doctors select drugs to treat depression and Alzheimer's disease. … Aspect chief executive Nassib Chamoun said the devices could conceivably make it easier to detect and treat early signs of Alzheimer's, though treatment options are still limited to a few drugs like Pfizer's Aricept. Treating patients with depression might be a more lucrative market, Chamoun said, because the devices could help doctors determine how patients respond to various drugs. Data suggest they could also be used to predict which patients would be at risk of suicide brought on by antidepressants. "That is where the opportunity is, and why Boston Scientific is interested," Chamoun said.
Follow-up safety testing lags for FDA "fast-track" drugs, study finds
U.S. Representative Edward Markey (D-Massachusetts) claims that the FDA’s accelerated approval program is “broken and failing to ensure patient safety.” Accelerated approval is an FDA initiative designed to give drugs suffering from serious and life-threatening diseases quick access to promising drugs. In return for accelerated approval and market access, companies must agree to complete studies confirming the medicines’ safety and efficacy. Markey, however, has issued a report challenging the FDA’s management of the program.
The government's “fast track” system that makes new medications quickly available to treat the deadliest illnesses has become a route for companies to market drugs without fully proving their effectiveness or safety, either before or after they go on the market…companies have completed slightly more than half of the post-market clinical studies they pledged to conduct, the report found.
Dr. Scott Gottlieb, a former FDA official, took a dim view of Markey’s report on his website, www.FDAinsider.com:
…Rep Markey’s model is off. He includes in his analysis studies unrelated to the accelerated approval program, which overstates the findings of his paper.
The larger problem here is also one of math – not only Rep Markey’s analysis but also the FDA’s own statistical methods.
The biggest reason why companies are unable to complete post-market studies after drugs are approved through the accelerated pathway, is that all of these drugs treat life-threatening disorders (they have to in order to qualify for accelerated approval) and dying patients are unwilling to roll the dice on a placebo controlled trial – taking a chance they may get little more than a sugar pill – when the drugs are readily available on the market.
For these reasons, companies have a hard time enrolling these studies, or often need to conduct them overseas, in countries where the new drugs aren’t available yet.
Study Suggests Gene Tests Could Ease Use of Anti-Clotting Drug
Researchers announced this week the discovery of a gene that influences how patients metabolize the blood thinning drug Coumadin (warfarin), “which an estimated two million Americans take each day to help prevent blood clots because of problems like a heart attack, an abnormal heart rhythm, a stroke or major surgery.”
Establishing a proper dose of warfarin as patients start taking the drug is one of the peskiest problems in medical practice. In picking a first dose, doctors consider factors like the patient's age, sex and medical history. Then the doctors rely on costly blood tests that must be repeated frequently over a period of months to adjust the dose to ensure that the drug will work safely. Misjudgments in doses can critically affect the clotting mechanism, leading to potentially fatal bleeding.
Researchers “[analyzed] the genetic makeup of patients taking warfarin in clinics at the University of Washington in Seattle and Washington University in St. Louis and found that they fell into three dosing groups - low, intermediate and high.” The “genetic variations identified in the study correlated with the grouping, suggesting the findings hold promise for simplifying warfarin therapy” if a new genetic test could be developed that would help doctors prescribe the best possible dose quickly and easily.
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