nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Friday, September 5, 2008

Politics has taught the healthcare community to be cowards

NYTimes says FDA should re-evaluate need for more definitive trials before approving drugs.

The New York Times (9/5, A26) editorializes, "The risks and benefits of" Vytorin (ezetimibe and simvastatin) "remain thoroughly muddled, despite a new analysis that purports to exonerate it from the worst safety concerns." Right "now, patients and doctors are best advised to use Vytorin only as a last resort." In a recently released analysis, "Vytorin did not seem to increase the risk of getting cancer, although there were hints that it might increase the risk of dying from cancer once you got it." Still, the editors of the New England Journal of Medicine "warn that the risk can't be dismissed until more data comes in." Although "experts...hope that the ongoing clinical trials will yield clearer results," those "trials may not be completed until 2012, at the earliest." The Food and Drug Administration (FDA) plans to "conduct its own analysis of the cancer risks." The Times argues that "the agency also needs to evaluate whether it should demand larger and more definitive clinical trials before approving certain drugs."

Doc D: Here’s the background story. The editor of the NEJM got his rear end kicked when he worked for the pharmaceutical companies. So, he wants to make sure that there’s no evidence of a problem with this medication. The problem is, he has no evidence for concern than his own professional scars. The data controverts another study of only 1000 people that there is an overall cancer increase.

We run across this issue repeatedly: risks of illness follow a pattern. A particular chemical or drug causes a particular reaction in humans that leads to a specific disease. There is no risk factor, or exposure that leads to cancer of all types in humans…none. Think about your knowledge of biology: are you aware of anything that causes problems in humans across the board? The study that related Vytorin to cancer included all types of cancer, and in fact was so small in number, that it has no value for real people like us. Also, a follow up study failed to substantiate even the “inclusive” increase in cancer that the Scandinavian study purported to demonstrate. Bottom line, if my doctor said Vytorin was the best drug for me, I would take it without hesitation.

Policy analyst says Republican focus shifting from healthcare to energy, defense policies.

Modern Healthcare (9/4, DoBias) reported, "The topic of healthcare reform has been crowded out of the Republican National Convention, replaced instead with a focus on energy and defense policies," according to Norman Ornstein, "a policy analyst with the American Enterprise Institute." Ornstein added that Sen. John McCain's (R-Ariz.) "marginal focus on healthcare" shows that he "may not fully be engaged in the topic." And, despite the "half dozen events this week [that] have courted advocates of free-market principles in the medical industry," Ornstein pointed out that "the Republican party's base is focused on many other things." And, while healthcare remains a top concern for Democrats, "the ground [Republicans] want to fight on is energy, not on health," Ornstein noted.

Doc D: According to the Census bureau, the number of uninsured Americans fell by 3 million in 2007. Remember when I said that 19th century Prime Minister Benjamin Disraeli said that the by the time an issue rises to the level of public concern the worst had already come and gone? The healthcare issue is an issue; it needs to be put into the mix with everything else…despite what Harry and Louise say in those commercials.

Doc D

Opinions are entirely my own. Quotations from AMA Morning Rounds (© U S News Custom Briefings)

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