|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 01-10-2006
Use of proven heart disease therapies has increased, but still suboptimal
Americans have access to a wide array of effective, affordable, and relatively safe treatments to ward off or minimize the effects of cardiovascular disease. The problem is that patients aren't using them consistently—leading to excess heart attacks and strokes, and driving up health care costs.
Between 1995 and 2002, the percentage of [coronary artery disease] patients using agents with a proven survival benefit increased each year. However, the [report in the journal Circulation] shows that many patients are still not using these drugs on a consistent basis. For example, just 71% of patients used aspirin consistently.
Part of the blame for poor patient-compliance lies with our fee-for-service reimbursement system, which pays providers for discrete procedures rather than for outcomes. Handing a pill to a patient is compensated; follow-up, to make sure they take it as prescribed, often isn't.
This isn't a plea for cookie-cutter medicine, where every provider would have to adhere to a single standard. It is a call for more consumer-oriented health care, where providers are rewarded for finding proactive ways to get and keep consumers in better health.
Insurers Offer Consumer-Friendly Health Statements
Knowledge is power. When it comes to health care, consumers need a lot more knowledge if they are to have any power. Insurers, in response to rising health care costs and growing use of Health Savings Accounts, are beginning to supply itemized, easy-to-read statements on the costs of benefits and on treatment alternatives that may save consumers money.
Mailed monthly or quarterly, the statements are embedded with tips on how to save money on health-care needs. Some statements flag brand-name drugs that individuals are taking, and then point out that they could save money by replacing those drugs with generics.
As more affluent Baby Boomers retire, they will demand more information on how to stay healthy and keep active (think: golf) without breaking the bank. Rather than being threatened by demographic changes, insurers and health care providers are in a unique position to provide that information and lock in market share, while also helping patients become more cost conscious.
Earlier Drug Testing on Humans Okd
Only 1 in every 5,000 compounds investigated by pharmaceutical companies will ever become a marketed drug. This is a horrible attrition rate, not least of all because some compounds fail—very expensively—in human clinical trials, and the costs of those failed projects must be recouped in the price of the miniscule number of drugs that actually reach market.
One way to streamline that process would be to get drugs into human testing earlier, so that researchers can evaluate whether they’re having the desired effect. This is exactly what the FDA is proposing in a new rule on “microdosing” in human subjects.
Concerned that too few new drugs are reaching the market and too much time is spent testing those that ultimately fail to win approval, the Food and Drug Administration announced rules Thursday for human testing that are intended to get effective drugs to the public more quickly, and possibly more cheaply.
Under the new guidelines, investigators will be allowed to give minute doses of experimental drugs to people earlier in the development process to see if the results are promising enough to warrant going forward with costly, full-scale clinical testing.
The FDA action was welcomed by scientific researchers and the drug industry. But some agency critics said they were concerned it could increase hazards for volunteers in clinical trials or facilitate the approval of drugs before their risks were understood. …
"Drug development is very, very high-risk, and the failure rate is still too high," said Dr. Raymond Woosley, president of the C-Path Institute, a nonprofit organization based at the University of Arizona that aims to speed the development of drugs without compromising safety. "This is an important step toward getting greater efficiency and more modern science into the drug development process."
Derek Lowe, author of the science blog In the Pipeline, describes the testing this way: “What they're doing here is making it easier to test limited numbers of people at smaller doses, just to see if you can narrow down your drug candidates with some realistic data. This "microdosing" approach has been tried in Europe for the last few years, and it's definitely time the agency laid out the rules for its application over here.”
'Vioxx like' drugs may still be best option for arthritis write scientists
This article complements our Spotlight article. Experts in the U.K. argue that, given the paucity of evidence on the cardiovascular risks surrounding older pain medicines, it would be a mistake to restrict access to all COX-2 inhibitors. In reality, pulling COX-2 drugs could expose patients to unknown risks from older medicines that have been poorly studied up to now.
In a Nature Reviews of Drug Discovery article this month the researchers from Imperial College London and Queen Mary, University of London examine the use of selective inhibitors of cyclo-oxygenase-2 (COX-2).
They argue that although this class of drugs, which includes Vioxx, has been associated with an increase in the risk of cardiovascular events such as heart attacks and strokes in some patients, the same may be true for traditional non-steroid anti-inflammatory drugs (NSAIDs). …
The researchers reviewed over one hundred papers on the subject and looked at the latest recommendations from organizations such as the American Federal Drugs Administration on the use of COX-2 inhibitors and NSAIDs. The researchers point out that the calls for the removal of COX-2 inhibitors, and a return to using NSAIDs, may cause additional problems. Although NSAIDs have been marketed for a number of years, they have never been required to meet the clinical trial standards now set for COX-2 inhibitors, meaning they may not be any safer.
The findings from this report highlight the truism that no drug is absolutely safe. However, we should remember that many of our daily activities—driving, walking, playing sports—also contain rare risks that we shoulder with aplomb. As our understanding of pain medicine advances, we’ll be able to use them more safely and effectively. In the meantime, we have no more reason to abandon them than we do to stop using Tylenol because of its side effects.
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