The Evidence Gap: Quickly Vetted, Treatment is Offered to Patients

Posted on: October 28, 2008  |   Author: Lisa
Filed Under: Bioethics, Drug & Device, Medicare, Other   |   Leave a Comment

While the F.D.A. requires that new drugs be tested on hundreds or even thousands of patients prior to approval, medical devices may be fast-tracked and bypass evidence-based methods of approval.  Since physicians receive a higher rate of reimbursement from Medicare when adopting new procedures, newly-approved products may be accepted quickly into practice.  However, physicians are not required to disclose to patients that the effectiveness of new devices is not necessarily proven.  Even with such knowledge, patients may infer that devices approved by the F.D.A. are medically effective.

Opponents of fast-tracking favor long-term, proven results based on empirical evidence over the anecdotal evidence often cited to support unproven devices.

Due to increased concerns about the device-review process, the nonpartisan Government Accountability Office is releasing a report in November, 2008, on the effectiveness of the F.D.A.’s device-review process.

http://www.nytimes.com/2008/10/27/health/policy/27device.html?pagewanted=1&_r=1&ref=health

Sharing Your Personal Genetic Map with the World

Posted on: October 28, 2008  |   Author: Ali
Filed Under: Health Information, Technology   |   1 Comment

George Church is a Harvard Medical School genetics professor and he has published his entire genome online. Church hopes that others will follow suit. His goal is to further science by making DNA and identifying information available online to the general public. Church wants to “inspire a whole generation of ‘amateur geneticists’ to mine DNA sequences.”

The identifying information such as height, weight, ethnic background or fondness of a particular food will make it easier for science to advance. Current databases are void of this kind of information. Additionally, the database that is open to the general public will increase collaboration, a sort of “scientific Wikipedia.”

However, there are some dangers in making such personal information freely available. It could be difficult for these individuals to get health insurance and they could face discrimination.

Currently, there are 10 individuals whose genetic data was released on October 20th, 2008. These individuals are scientists who fully understand the risk and potential rewards from this project. Church hopes to recruit 100,000 volunteers to help with this project.

Article available at http://health.usnews.com/articles/health/2008/10/20/sharing-your-personal-genetic-map-with-the-world.html

Interested in George Church’s project go to www.personalgenomes.org/

Economic downturn forces tough prescription medication choices for patients

Posted on: October 23, 2008  |   Author: Phillip
Filed Under: Access to Care, Drug & Device, Elder Law, Medicare, Other   |   Leave a Comment

A tracking firm’s analysis between the months of January and August revealed a decrease in the number of prescriptions dispensed between the same period in 2007 and the first eight months of 2008, the first noted negative trend in the prescription drug industry in more than a decade. Faced with tighter home budgets, an increasing number of consumers are incorporating cuts in the amount of prescription medications they use as a part of overall expenditure reductions – drugs are a least priority after food and gasoline for many.

For some this involves extending the life of prescriptions – i.e., taking less than the recommended dosage to delay refilling the order, or even physically splitting pills; for others it involves foregoing the purchase of medication altogether. The problem is especially complicated for those on multiple medications for compound disorders – e.g., diabetes (where insulin cannot be sacrificed, but other medications might be perceived by diabetes patients as “less necessary” – for example cholesterol-reducing drugs). Those Medicare Part D beneficiaries encounter severe difficulties upon reaching the $2,510 “doughnut hole,” notably those whose medications cost thousands of dollars over the course of a few months. Many Medicare recipients find it all but impossible to meet the next approximately $3,000 in drug costs until coverage resumes at $5,726 without some form of subsidization.

The effects of this reduced consumption may be far-reaching according to some public health experts, as those with chronic disorders will experience a worsening of condition and require more costly treatment later. However, others note that “overprescription” has always been an issue within American medicine, driven in part by zealous pharmaceutical producers. Despite drug makers’ and doctors’ opinions that medications are one of the most crucial components in overall treatment of illness, however, patients and their families by this data indeed act according to their own perception of marginal benefits when times are hard. (New York Times, October 22, 2008)

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