Envisioning 2.0

Consumer-Driven Healthcare

New research published today on Health Affairs’ Website indicates that employers are increasingly embracing new “consumer driven” health plans. These forms of insurance place more financial burdens on patients by asking them to pay more for their care. Health Savings Accounts (HSA) are currently one of the most talked-about form of consumer driven insurance.

The study also indicates that one key criticism of consumer driven plans may hold water. Opponents of HSAs have suggested that wealthier and healthier people will populate these plans, while traditional insurance plans are left with sicker patients. Interestingly, (according to the Washington Post) the study shows that early enrollees in HSAs “tend to have higher incomes and be in somewhat better health than their counterparts in traditional plans.”

With consumer driven plans becoming more popular, people will be motivated to try and find information on the cost of medical care. Today, the Washington Post reports that a number of online services are attempting to fulfill this need. However, these Internet resources are currently less than stellar.
Is FDA Pulling Back On Non-inferiority Antibiotic Trials?

Today, the Wall Street Journal reports that the Food and Drug Administration rejected Replidyne’s application for its new antibiotic faropenem medoxomil.

What’s most interesting about this event is that the FDA may require the company to conduct “superiority” clinical trials in order to increase the odds that its medication will be approved. Previously antibiotics had been approved based on non-inferiority trials. In these studies the company conducting a trial need only show that their new drug is equivalent to an older one. Now, the FDA may require makers of new antibiotics to demonstrate that their medication is better than placebo. However, some have suggested that conducting superiority trials for antibiotic medications is unethical because it is wrong to give a patient a placebo for a bacterial infection.

For more information on the FDA’s emerging stance on non-inferiority trials, please see my interview with John Powers, MD.

This entry was posted on October 24, 2006 at 9:38 am and is filed under Health Policy. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.