|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 07-26-2004
Postmarketing Studies Becoming Essential to New Drug Development in the U.S.
Over the last five years (1998-2003), the FDA has requested postmarketing commitments for 73 percent of new drugs released in the U.S. Postmarketing studies, usually to study additional safety and efficacy issues, may help decrease the time required to move new medications from lab bench to market, decreasing the financial risks facing manufacturers and speeding the introduction of new treatment options for patients. "Given widely shared concerns about the cost and time needed to develop drugs, and increased attention focused on the safety of newly marketed medicines, PMCs may help streamline premarket approval of drugs while aiding postmarket identification of adverse drug events and other issues related to drug production and use."
Bioshield Too Little For Drug Industry; Companies Want More Protection From Financial Loss
The Bioshield legislation signed into law last week by the President was a good first step in government's campaign to protect the nation against bioterrorism. But observers have already weighed in on the shortcomings of the bill and are calling for further legislation. Perhaps the most serious defect in the legislation was its lack of liability protection for industry in the event that vaccines or other treatments have unforeseen side effects or aren't fully effective. After all, widespread testing to discover side effects is virtually impossible - short of an actual attack. One drug industry executive frankly remarked that "until the liability question is solved, we're not going to see big drug companies come to the table." Senators Lieberman, Hatch, and Kennedy have already begun writing new legislation (dubbed "Bioshield II") to address this and other loopholes in the law.
IRS issues final rules for HSAs
The IRS has issued its last rules for Health Savings Accounts for 2004. Now, there are few topics guaranteed to glaze eyes as quickly as arcane discussions of tax policy. Nonetheless, HSAs are so important that this bulletin from the Galen Institute is worth reading over a good cup of coffee. For instance, according to the latest IRS interpretation, individuals with family coverage can make annual contributions to the plan of up to $5,150, or the umbrella deductible, or the embedded deductible multiplied by the number of individuals covered by the plan. Translation: the IRS is allowing a higher annual contribution limit for family HSAs than would’ve been expected based on previous rulings. This is good news when it comes to making HSAs more family friendly. Kudos to the Galen Institute for helping readers decipher the jargon.
The National Cancer Institute and the Pancreatic Cancer Action Network are launching a free, web-based "map" that will track research, clinical trials, and treatment programs for pancreatic cancer. Although pancreatic cancer is relatively rare (striking just 32,000 Americans annually) it is also deadly - the five-year survival rate for patients after diagnosis is just 4%. Because the disease is often diagnosed in its latter stages every moment counts in finding available treatments. The map could help patients quickly find the best treatments available, and help researchers coordinate their own efforts. If the pancreatic cancer map proves effective, it may serve as a prototype "for tracking research, trials, and key doctors in other cancers, especially rare forms for which information is hard to come by."
Anesthesia, Without a Knockout Punch
Two decades ago, 1 in 10,000 patients would die from improperly administered anesthesia during surgery; today that risk is only 1 in 250,000. Indeed, the current anesthesia safety record is one of the great unsung victories of modern medical technology. In fact, anesthesia is so safe and effective that almost half of all surgeries are now done on an outpatient basis.
This quantum leap in safety has been accomplished largely thanks to improved technology that allows anesthesiologists to precisely monitor both the amount of carbon dioxide exhaled by patients during surgery (endtidal capnography) and oxygen saturation of the patient's blood (pulse oximetry). New drugs have also helped to alleviate the side-effects of anesthesia (such as nausea) and help regulate a patient's organ systems while sedated.
Often times, medical progress occurs in subtle ways that are unnoticed outside the medical community. This is one success story that should make anyone facing surgery feel a bit better about the process.
In the highly partisan debate over the recently enacted Medicare drug discount card program, observers have often been left with the impression that the perfect is, in fact, the blatant enemy of the good. Perhaps the program can be made less confusing. Perhaps the administration needs to find other ways to enroll more seniors. Nonetheless, the two-month old program is proving itself effective when subjected to independent analysis. A study sponsored by the Kaiser Family Foundation has found that the card offers seniors an average discount of nearly 25 percent over retail prices - and even more savings were found when seniors purchased their prescriptions via mail-order. This is good news by any measure - even during an election year.
Biotech Unsure On Kerry
As well they might be. The Kerry campaign has promised to spur medical innovation by supporting federal funding for stem cell research and other high tech cures. At the same time, he has promised to use Medicare's enormous purchasing power to "negotiate" with industry on drug discounts for seniors and to allow all Americans to purchase prescription drugs from countries with price controls, like Canada.
Both proposals would effectively set prices for prescription medications - but without actually calling them price controls. Perhaps Senator Kerry thinks that federal research could easily substitute for private sector biomedical innovation - or perhaps he thinks that price controls won't deter private investment. We look forward to hearing him develop his views on these issues.
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