PDA

View Full Version : U.S. Issues FDA approved Big Pharma drugs without effectiveness data


KILLER_CLOWN
05-05-2011, 01:33 AM
(NaturalNews) Consumers constantly are told how complicated it is to get a new drug on the market. After all, researchers have to jump through all sorts of hoops to assure safety before new therapies are approved for the public, right?

It turns out they may be missing some of those hoops or not jumping through some of the most important ones.

In fact, huge red flags are being raised about how drugs are tested and approved in two new studies, including one just published in the May 4th issue of the Journal of the American Medical Association (JAMA).

A case in point: it turns out that only about half of the new prescription medications pushed onto the market over the last decade had the proper data together for the U.S. Food and Drug Administration - yet the FDA approved them anyhow.

The information in question is known specifically as comparative effectiveness data. And it is - or should be - a very big deal when it comes to deciding whether a drug should be approved and sold to the public.

According to the Institute of Medicine, comparative effectiveness data is defined as the "generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care."

In other words, how does a new drug stack up against other treatments - is it more beneficial, safer, or does it have more potential dangers?

Comparative effectiveness information on drugs is especially important when doctors are making decisions about whether to prescribe a med, and to whom, soon after a drug is approved. That's because when Big Pharma medications first hit the market, physicians are relying on what drug companies and the FDA tell them about a medication. It takes a while for real life reports to come in as people report reactions, side effects (including deaths related to a drug) to become clearer.

Also, there are usually not data from large head-to-head trials comparing multiple treatments available when a medication first hits the marketplace. "Comparative effectiveness is taking on an increasingly important role in U.S. health care, yet little is known about the availability of comparative efficacy data for drugs at the time of their approval in the United States," according to background information in the new JAMA study.

It's not like there's not money to come up with this information, either. In 2009, Congress allocated $1.1 billion of taxpayers' money to comparative effectiveness research.

For the JAMA study, researcher Nikolas H. Goldberg and colleagues from Brigham and Women's Hospital and Harvard Medical School, Boston, investigated the proportion of recently approved drugs that had comparative efficacy data available at the time they were authorized by the FDA to be sold in the U.S. They also examined the availability of this information over time and by therapeutic indication by checking out approval packages publicly available through the online database of drug products (dubbed new molecular entities, NMEs, for short) approved by FDA between 2000 and 2010.

The researchers found that only about half of 197 eligible approved NMEs between 2000 and 2010 had comparative efficacy data available at the time they were approved to be marketed.

Meanwhile, another recent study throws needed light on the limited data behind the safety and effectiveness of some Big Pharma drugs.

Research led jointly by Alexander Tsai of Harvard University and Nicholas Rosenlicht of the University of California San Francisco just published in PLoS Medicine zeroed in on the medication aripiprazole, which is prescribed treating bipolar disorder.

How was this powerful drug deemed safe and effective? Amazingly, the research team found the only evidence for the use of this medication came from a single trial. And, as they described in their paper, the scientists found key limitations of the drug study that clearly skewed the findings so they appear to support the use of aripiprazole for bipolar disorder.

Did this stop the FDA from approving the drug? No way. And neither did the fact that this single, poorly designed trial was sponsored by the drug manufacturer who produces aripiprazole.

Learn more: http://www.naturalnews.com/032279_Big_Pharma_fraud.html#ixzz1LSeNDosx

nstygma
05-08-2011, 11:19 PM
what can ordinary citizens do about these types of things?


A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.

ClevelandBronco
05-09-2011, 12:40 AM
what can ordinary citizens do about these types of things?

If at all possible, you should make arrangements to:

1. Die suddenly and unexpectedly.

If you cannot manage to die suddenly and unexpectedly, you should:

2. Never get sick.

3. If you do get sick, do not attempt to get well.

This message has been brought to you in the public interest.

durtyrute
05-09-2011, 07:57 AM
Imagine that

Pants
05-09-2011, 11:54 AM
Link the JAMA article instead, please. Natural News is not a real news organization.

nstygma
05-09-2011, 12:13 PM
If at all possible, you should make arrangements to:

1. Die suddenly and unexpectedly.

If you cannot manage to die suddenly and unexpectedly, you should:

2. Never get sick.

3. If you do get sick, do not attempt to get well.

This message has been brought to you in the public interest.
ahh, thank you. i choose #2, with a courtousy nod to #1.
however, the store around the corner sells wholesome grass and twigs for natural healing. perhaps that is acceptable as well?

Taco John
05-09-2011, 12:40 PM
In a free market system, the regulatory body responsible for adminitsering their seal of approval would lose an extraordinary amount of face in a scandal like this, and their up-and-coming competitor would be making noise about their success rate and strict processes and supplant the micreant. In a system where the government monopolizes this type of regulation, a story is whispered about in a blog, nobody notices or cares because the FDA is secure in its spot and the only thing you can do is shrug your shoulders and hope that you're not affected by it.