FDA’s ‘safe and effective’ drug approvals

[+OverSword]

From the article:

The Food and Drug Administration must bless any new drugs as “safe and effective” before they wind up in pharmacy aisles or prescribed to patients. But the ways in which the agency arrives at those approvals “vary widely in their thoroughness,” according to an analysis by researchers at Yale University’s School of Medicine.

“Not all FDA approvals are created equally,” said Nicholas Downing, lead author of the study, which examined nearly 200 new drug approvals between 2005 and 2012.

Researchers found broad differences in the data it took to get a thumbs up from FDA. For instance, the agency required that many new drugs prove themselves in large, high-quality clinical trials. But about a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations. Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.

According to the Yale analysis, publicly available documents summarizing the FDA’s rationale for approving each drug showed the disparity in the quality of information and outcomes the agency required for each application.

“There was a lack of uniformity in the level of evidence the FDA used,” Joseph Ross, assistant professor of internal medicine at Yale and a senior author of the study, said in announcing the findings.

read the rest here

[Rafterman]

That's a very smart approach - the last thing we need is a one size fits all approval process.

Well done FDA!

[+OverSword]

Yes, especially for those drugs that we need to rush to the market in order to maximize our profits, because lord knows nothing is more important than making money. Not even people.

[Rafterman]

Yes, especially for those drugs that we need to rush to the market in order to maximize our profits, because lord knows nothing is more important than making money. Not even people.

Not seeing your statement supported by the study. What I am seeing is this:

The Yale study, funded by the Pew Charitable Trusts and published Tuesday in the Journal of the American Medical Association, acknowledges that the FDA has valid reasons for its varied requirements.

“Such regulatory flexibility allows for a customized approach to approval,” it states, “including the ability to rapidly approve potentially effective therapies for life-threatening diseases, such as certain cancers, or those diseases for which there is no existing effective treatment, such as orphan diseases.”

Funny, I always thought the rub from the anti-FDA crowd was that the regulatory process was too arduous and folks were dying due to their cautiousness. Other countries have much less stringent approval processes.

[praetorian-legio XIII]

The FDA is just another government agency up for sale to the highest bidder. How anyone has any faith in that organization baffles me. They don't give a **** if something is safe or not.

Aspertame, an undeniable cancenogenic, is just one of many many toxic substances that the FDA allows on the market. And the story of how it was "passed" is a classic story of corporate greed and corruption involving not only the businesses themselves but spineless greedy high ranking politicians

as well.

[Rafterman]

The FDA is just another government agency up for sale to the highest bidder. How anyone has any faith in that organization baffles me. They don't give a **** if something is safe or not.

Aspertame, an undeniable cancenogenic, is just one of many many toxic substances that the FDA allows on the market. And the story of how it was "passed" is a classic story of corporate greed and corruption involving not only the businesses themselves but spineless greedy high ranking politicians

as well.

It would be so refreshing for at least one discussion around here to not devolve into conspiratorial nonsense.

Fine, you don't like the FDA. Is the European Food Safety Organization more to your liking - you know, they ban lots of **** over there that we don't ban here in the US so they must be good, right? Didn't you guys love the this organization just a couple of weeks ago because it banned "yoga mats" in your bread?

http://www.cbsnews.c...ean-regulators/

How about independent scientists:

http://www.scienceba...uth-vs-fiction/

Aspartame is a highly studied food additive with decades of research showing that it is safe for human consumption. As expected, the research is complex making it possible to cherry pick and misinterpret individual studies in order to fear monger. But the totality of research, reviewed by many independent agencies and expert panels, supports the safety of aspartame.

A conspiracy to hide the risks of aspartame, however, remains a popular internet urban legend that will likely not disappear anytime soon.

Edited March 7, 2014 by Rafterman

[praetorian-legio XIII]

http://www.mercola.com/article/aspartame/hidden_dangers.htm

Like the author of the article you posted states "if you believe everything you read on the internet....."

For every article for aspertame theres one against. So I'll leave it at this, Rafterman. I will avoid that chemical the best I can for as long as I live. Maybe your belief that aspertame is harmless is correct in which case enjoy your artificial sweetener to your hearts content. Regardless of the example I cited, I seriously have a hard time trusting the FDA.

[+OverSword]

Rafterman, so the revolving door between the leadership slots at the FDA and other government agencies and the top slots at the companies which they police is just another one of thos whacky conspiracy theories like the the truther movement huh? ok.