|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 05-10-2005
Test tells how much aspirin you need
Heart disease is one of America’s most deadly diseases, and low-dose aspirin therapy has become a popular treatment for preventing the platelet clotting that can cause heart attacks. But, as science advances, researchers have become aware that, like other drugs, different patients respond to aspirin very differently:
New research suggests that up to 27 percent of people taking aspirin may be resistant to it. Those most at risk for aspirin resistance include women, people over 65, diabetes patients and people taking less than 100 milligrams of aspirin. …More recently, doctors from Brigham and Women's Hospital in Boston reported that, for healthy women over 45, a low-dose aspirin (100 milligrams) every other day didn't seem to prevent heart attacks, although it did reduce their risk for stroke.
Thankfully, a quick and cheap blood test, called Verify Now, can tell patients whether low-dose aspirin is really helping them or just a placebo. Patients who are aspirin resistant can then talk to their doctors about taking a higher dose or switching to a different therapy.
US Medicare to help look for drug side effects
Health care insurers, like Kaiser Permanente, are already well-placed to help the FDA detect problems with drug adverse events, since they collect a wealth of data on patient treatment and outcomes.
In 2006, when Medicare starts offering a prescription-drug benefit, the program will probably become our largest single repository of information on prescription drug use and adverse events. Medicare Administrator Mark McClellan is determined to leverage that development for all it is worth.
The U.S. Medicare program will use data from its 43 million patients to aid quicker detection of dangerous side effects from medicines on the market, Administrator Mark McClellan said on Wednesday. …
"The goal isn't simply to learn more about the rates of rare but important side effects. It's also to get a better understanding of which kinds of patients experience these side effects, so that use of the drugs can be avoided in those patients, while targeting their use more effectively to patients who don't have such side effects and may truly benefit," he said. In addition to spotting side effects, the Medicare database may be useful for determining which patients benefit most from a therapy and for providing more evidence about "off-label" uses that are widespread but not approved by the Food and Drug Administration, McClellan said.
Medicare’s approach to this problem will be critical. If Medicare can leverage information resources to bring about more “personalized medicine,” matching the right treatment to the right patient, other insurers will probably follow suit—and every patient in America will benefit.
We can’t acknowledge progress in cancer treatment without recognizing that new treatments have often failed to live up to their original billing. In the late 1990s, for instance, a new class of cancer drugs were all the rage. These drugs, designed to starve tumors of access to the blood vessels they need to grow, seemed to be the “silver bullet” cancer researchers had been hoping to find for decades.
Initial studies showed lackluster results. Further study, however, has found that these drugs can substantially enhance the effectiveness of traditional chemotherapies:
…anti-angiogenesis therapy based on starving tumors to death by choking off their blood supply has reappeared on the cancer-care landscape, and this time more realistic expectations figure to keep it around. …
Now used in combination with chemotherapy, the new treatment is making inroads against some of the deadliest cancers. Researchers reported impressive results from Avastin, the field’s star drug, for mesothelioma, lung, breast, and ovarian cancer. …
There is another lesson to be learned here: medical progress, particularly in oncology, is an incremental journey where small gains build up over years and decades. Ultimately, the accumulation of moderate successes in clinical treatment can turn out to offer more hope than any single “silver bullet.”
U.S. FDA looking to improve drug safety monitoring.
Human biology, as scientists like to say, is conservative. What they mean by this is that the same biological pathway that one drug uses to kill cancer cells—or treat headaches, heartburn, or chronic depression—will probably affect one or more other bodily systems.
No drug is entirely safe for all patients, not even aspirin. There is really no way to know all of the potential effects of a drug before it goes on market, without bringing medical progress to a grinding halt.
The FDA tries to capture a better picture of drug risks through its Adverse Event Reporting System, or AERS (also known as Medwatch), which “collects voluntary reports of possible reactions from physicians, pharmacists and patients.” Given the sheer volume of potential problems, everyone recognizes that the voluntary system is in dire need of an overhaul.
Last year the FDA said it received about 400,000 reports and about three-fourths were related to drugs….About 40 percent are submitted online while the remaining 60 percent are split between mailed and faxed paper forms, the FDA said. Less than 1 percent are done by phone. …
Experts have estimated as few as 10 percent of potential side effects are reported. Several doctors said time pressures make it tough to download forms or use the MedWatch Web site.
The FDA is looking into automating the system, and getting more access to third-party databases. This will undoubtedly help, but Congress can speed up the process by getting more funding to the agency for state-of-the-art information-sharing technology, which can not only help identify adverse effects, but also can find new indications for treatments already in use.
Medicare's chief wants to reward doing right thing
Dr. Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services, understands the importance of linking financial rewards to better health-care outcomes, rather than just writing a government check every time a patient walks into a doctor’s office.
During a visit to MetroHealth Medical Center in Cleveland, McClellan
…praised MetroHealth’s efforts to control asthma and heart disease, and singled out the hospital’s effort to go paperless with its electronic records system. But he acknowledged [that] healthier patients and the improved efficiency of its records system can mean less income since providers are paid more to treat sick patients. That approach needs to change. When the government saves money by preventing illness, McClellan promised, “we will share in the gains with you….We’re going to spend more effort keeping people healthy rather than just pay the bills when something goes wrong.”
The devil, of course, is in the reimbursement details. After all, a more efficient hospital might need fewer labor-intensive staff, and more (cheaper) IT technology. In the long run, providers will have to learn how to be use every dollar more efficiently, and the process will undoubtedly require some painful choices. Still, McClellan is on target in his view that efficient providers should get more reimbursement for value-added services, not be penalized for them.
Fresh Lines of Attack in Fighting Cancer May Keep Tumors From Recurring
Last weekend, at the annual meeting of the American Society of Clinical Oncology, cancer researchers offered new hope for cancer patients, and even for cancer survivors, who often must live with the likelihood of a recurrence of the disease.
While advances in the early detection and treatment of tumors have led to lower death rates from diseases such as lung, breast and colon cancer, many tumors regrow and spread months or years after surgery. That is because the original tumor often sheds microscopic clusters of cells that survive the initial treatment.
Preventing recurrence is especially critical given the way cancer specialists increasingly view the concept of a cure for the disease…Find tumors early, take them out via a combination of surgery, radiation and drug treatment—and then prevent them from coming back.
Researchers are finding that many tools can reduce the chances of a cancer relapse. One study, for instance, found evidence that a restrictive, low-fat diet can lower the risk of recurring breast cancer. Another study suggested that colon cancer patients who took aspirin after surgery and chemotherapy had survival rates over 50% better than those who didn’t.
These strategies are becoming increasingly important as more Americans than ever before survive cancer. For instance, according to one researcher, “advances over the past several years have reduced the risk of death from breast cancer by 60% to 65% and…drugs like Herceptin may reduce the risk by as much as 80%.”
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