Providing patients with promising experimental therapy or ruining clinical trials?

Posted on: October 31, 2009  |   Author: Jessica
Filed Under: Bioethics, Drug & Device   |   Leave a Comment

Ninety percent of clinicians in a recent online survey believed that ignoring certain entry criteria for clinical trials was acceptable if the clinician believes that the patient will benefit from the trial. A number of clinicians described under what circumstances they would bend the rules. Downplaying a substance abuse history, altering medical records, and artificially improving an otherwise poor kidney function test are all examples of protocol violations that some clinicians found acceptable under the right circumstances.

All of the protocol violations were presumably made because the doctors felt that they were acting in the best interests of their individual patients. However, the purpose of clinical trials is not to improve the outcomes of individual patients, they are to determine the safety and effectiveness of an experimental drug or treatment. (To learn more about clinical trials see clinicaltrials.gov)

What does this mean for clinical trials? Do researchers need to focus on improving clinical trial designs so that clinicians do not feel conflicted between their commitment to their patient and the research? If so many clinicians seem willing to break protocol, can the results of the trials even be trusted?

The New York Times, October 29, 2009.

Obama Health Plan begins to unfold

Posted on: April 28, 2009  |   Author: Jessica
Filed Under: Access to Care, HMOs & Health Plans, Health Information, Public Health Policy   |   1 Comment

Take any course related to the delivery of healthcare (whether it is a health law class or a health care organizations course) and you will learn about the triangle of cost, access, and quality.  Any attempt to address one of these issues is going to impact the other two.

The Obama administration has made it a goal to reduce the number of uninsured Americans.  This will increase access to primary and preventive care for the previously uninsured- sounds great.  Except there are not enough primary care providers to go around.  There is a shortage of doctors and it is going to cost some money to increase the supply.

Here are some of the current proposals to alleviate the shortage:

  1. Increase Medicare payments to general practitioners.
  2. Increase enrollment in medical schools and residency training programs.
  3. Encourage greater use of nurse practioners and physician Assistants.
  4. Expand the National Health Services Corps.

All of these options will impact the access, cost, and quality to healthcare.  There are powerful stakeholders lobbying for and against all of these proposals.  Something needs to be done.  Even if Obama, like Clinton before him, fails to transform the healthcare delivery system in this country, there will still be a shortage of doctors.  The demand for general practioners is going to continue to increase as the baby-boomers age.

To read more see:

http://www.nytimes.com/2009/04/27/health/policy/27care.html?_r=1&hp

Second time’s the charm?

Posted on: March 3, 2009  |   Author: Jessica
Filed Under: Access to Care, Health Information, Medicaid, Medicare, Other, Public Health Policy   |   1 Comment

When President Obama nominated Senator Tom Daschle to be the secretary of health and human services it seemed like the time was ripe for some significant shifts in federal health policy.  Unfortunately, Senator Daschle had failed to pay some taxes, oops.  Now President Obama has nominated Gov. Kathleen Sebelius of Kansas for the position, and she has accepted the nomination.  She is a democrat from a republican state and has a history of bipartisanship.  Perhaps Gov. Sebeliu will be the one to help usher in health policy change.  Of course she must first make it past the pro-life lobbyists and gain senate confirmation.

To read more about the nomination:

http://www.nytimes.com/2009/03/01/us/politics/01cabinet.html?_r=1&hp

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