|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 09-15-2004
After two days of deliberations and testimony, an FDA advisory panel has recommended so-called "black box" labels on all antidepressants; the labels will warn patients and physicians about the risk "of increased suicidal tendencies in young people" taking these medications. The FDA usually follows the recommendations of its advisory committees.
The panel's recommendations are the result of a re-analysis of over 20 clinical trials that shows that 2% to 3% of adolescents who were treated with antidepressant drugs "displayed suicidal thoughts or behavior that could potentially be tied to the medications." There is no similar concern for adults, and none of the young people in the trials actually committed suicide.
Experts are divided on the wisdom of the warnings. Some are concerned that physicians may shy away from the drugs and note that increased supervision of patients during the first month of treatment would substantially lower any suicide risk. Others believe that the medications are over-prescribed and want to "raise the threshold for prescribing [antidepressants]" and hope that the black box labels will better inform the public about the risks involved. The FDA plans to pursue further research in this area, including pediatric trials of antidepressants that include "a comparison to a drug that works, rather than simply a placebo."
Will the new labeling requirement lead to better patient care? Only time will tell, since the data on antidepressants is open to conflicting interpretations, and suicide among adolescents has been trending downward since the mid-1990s. Ultimately, however, treatment decisions still rest where they should - with individual families and their physicians.
Medicare Web Site Points Out Less Costly Drugs
The Medicare website now offers a feature comparing the prices of similar drugs for five common illnesses. "The new price information covers 52 medications for high cholesterol, high blood pressure, allergies, arthritis and stomach ailments." The information is designed to help physicians and their patients choose the most cost-effective drugs for their illnesses.
Health and Human Services Secretary Tommy Thompson hopes that "the more Americans compare prices, the more market pressure will drive prices down. That's what [the Medicare web site] is all about." Indeed, and the more patients and doctors become savvy purchasers of medicines, the more manufacturers will compete on price and quality. This is one of the first, albeit small, tremors in the tectonic shift to consumer driven health care, and policymakers like Secretary Thompson and CMS Administrator Mark McClellan should continue to shake up the status quo by providing the public with better information – and more control – over their own health care.
Approximately 11 percent of Americans suffer from chronic kidney disease (CKD), which puts them at a greater risk for heart disease and adverse cardiovascular events. According to researchers, moderate CKD is associated with a "26% increase in MI [myocardial infarction or heart attacks], coronary death, or revascularization." The researchers analyzed data from three placebo-controlled trials that examined statin effects in patients with or at high risk of cardiovascular disease. Of these 19,700 subjects, approximately 4500 had moderate CKD at baseline.
"In both the moderate CKD and normal renal function groups, pravastatin therapy reduced the risk of the primary outcome [MI, coronary death, revascularization] by about 23%, the investigators state. In addition, pravastatin therapy was tied to a 14% reduction in the risk of all-cause mortality in the moderate CKD group." Statin drugs continue to show effectiveness across a wide range of ailments that increase the risk of heart disease: first for diabetes, now CKD. Hopefully, physicians will use these new studies to improve the standard of care for patients, leading to reduced mortality and more cost-effective treatments.
Technology Inc.: Company helps drug makers beat odds | Chemnavigator supports discovery, testing phases
Much of the cost of drug development can be attributed to promising starts that turn into dead ends late in the clinical testing process: drugs that looked promising in test tubes turn out to be useless or harmful in the human body.
In San Diego, an innovative company called Chemnavigator is using advanced computer modeling to help companies "beat the bad odds of drug development, first by helping them find potential compounds, then by allowing them to test the compounds on computer models." Drug companies spend $30 billion per year in "traditional" testing in which scientists hover over petri dishes in laboratories trying to see if chemical compounds bind with the target receptors that are the molecular pathways for disease. Chemnavigator's "software and databases of compounds allow customers to search through 13 million compounds catalogued in [their] library" to weed out the best candidates. Once a compound has been purchased, Chemnavigator can test the compounds against target proteins in computer models much the same way you test keys in a lock to see which one fits. Chemnavigator has also contracted with a German company with its own computer database of drug targets that can help determine if a drug has toxic properties before it is ever used in the human body. Increasingly, computer technologies like these will be used to speed up the drug development process, getting better drugs to market faster and less expensively.
Rush for Medical Scans Raises Concerns on Cost
Patients in many parts of the U.S. can get quick access to some of the most sophisticated diagnostic tests in the world: magnetic resonance imaging, positron emission tomography, and computed tomography scans. In Massachusetts alone, there are 145 MRI scanners, perhaps as many as in the entire country of Canada.
So far, so good, if patients and doctors only used these services when they were really needed, and not as placebos meant to assuage a patient's vague fears or pad hospital bills. However, since health care in the U.S. is given to one party, prescribed by another party, and paid for by a third party, there are perverse incentives to over-consume or over-utilize health care.
No one disputes that these tests are powerful, and in many, cases, even cost effective. Still, the country may spend as much as $96 billion this year on these sophisticated tests, a 28 percent increase since 2000. As a result, "insurers and employers worry that the jump in imaging and advertising are leading to unnecessary scans as it becomes more convenient for doctors to refer patients to a [diagnostic] center and as more physicians install machines in their own offices." In Massachusetts, "insurers generally pay providers between $500 and $1,400 for an MRI scan", making them a lucrative option for those who own them.
The alliance between doctors and patients to splurge on expensive, but only marginally useful tests, drives up health care costs across the board. The solution? Patients need some skin in the game, and must become responsible for routine health care costs so they can ultimately decide if $1,000 in out-of-pocket costs for an MRI is money well spent or just an overpriced sugar-pill.
Scared parents keep young out of antidepressant trial
One potential side-effect of the recent furor over anti-depressant use among adolescents is that parents with severely depressed children will shy away from drug treatment due to the media’s recent focus on the small risk of suicidal tendencies associated with the drugs – about 2 or 3 percent. ("For every 100 children taking antidepressants in controlled clinical trials, two to three experienced increased suicidal tendencies.")
In fact, this may already be happening. Researchers are beginning a new study financed by the National Institute of Mental Health designed to test which schedule of treatments (anti-depressants, behavioral therapy, or both) can best prevent future suicide attempts among adolescents who have already attempted suicide once. However, the study is already having problems recruiting patients. "We're trying to increase the number who are treated [for depression], said one researcher working on the NIH study, and [the FDA black-box warning] is definitely not going to help."
Currently, only a fraction of patients who are diagnosed as clinically depressed receive any treatment at all. While antidepressants may not show much effect in children with mild or moderate depression, who often improve on their own over time, there is a real risk that parents of children with severe or persistent depression will exaggerate the perceived risks of antidepressant treatment versus the suicide risks associated with severe depression.
The challenge for clinicians is to disaggregate serious depression from transient episodes, and to monitor children aggressively when they receive any type of treatment (including antidepressants). Whether or not that message is making its way to parents through the media firestorm is another issue entirely.
MEDICINE; Patients who cut corners on drugs don't tell doctors; Rising costs are forcing many to reduce doses or skip them entirely. Physicians don't bring up the issue; often, neither do patients.
A new study has documented that when patients stop taking or skip doses of prescription drugs due to cost concerns, they often do not discuss the issue with their physicians – and physicians are not likely to ask if cost is a consideration when they issue prescriptions. The study also found that patients with expensive chronic conditions like asthma, diabetes, heart disease, and ulcers are most effected by non-compliance issues related to cost.
The study seems to highlight the issue of patient-physician communication, and physician education. There are many options for assisting low-income patients with prescription drug costs that patients and physicians may be unaware of; for instance, the Medicare website compares prices for similar drugs for the same illness and can help physicians identify less costly alternative treatments. Also, many pharmaceutical companies offer low-cost or free drugs to low-income patients. Drug discount cards are also available through the Medicare program, state and local government programs, and retailers.
|home spotlight commentary research events news about contact links archives|