Friday, May 8, 2009

FDA fast tracks poison once again


FDA FAST TRACKS POISON ONCE AGAIN

Reported by Forbes - http://www.forbes.com/2009/05/07/fda-vanda-trials-business-health-care-antipsychotics.html



Is The FDA Easing Up?

by Matthew Herper,

How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.

After the Food and Drug Administration told Vanda Pharmaceuticals that the company's schizophrenia drug was "not approvable" last July, Wall Street marked the tiny biotech for dead.

The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.


Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.

But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.

Together with the July rejection of Fanapt, it seemed the FDA was setting a higher bar for new antipsychotics, demanding they must not only beat placebo results but also be at least as effective as existing drugs like Seroquel, from AstraZeneca ( AZN - news - people ), and Zyprexa, from Eli Lilly ( LLY - news - people ).

"The inference was that the FDA may be changing its policy and requiring superiority or distinctiveness for new drugs coming to a market that is already crowded," says Jeffrey Lieberman, chairman of psychiatry at Columbia University Medical Center. But the Fanapt approval "would suggest the agency is still doing business as usual."

Lieberman says he is "amazed" the FDA approved the drug. He says the approval is "probably a testament to persistence" on Vanda's part. "There's no harm in having it," he says. "It gives clinicians another option to choose from, but it doesn't really add anything in terms of any substantial advance in efficacy or safety."

Lieberman was the primary investigator for a government-funded clinical trial that showed there was little difference in how long patients stuck with the new class of antipsychotics, like Zyprexa and Risperdal, vs. the older, cheaper variety, such as Haldol. That study, called CATIE, led to soul searching by psychiatrists over how big the advantages of the new drugs were. These antipsychotics are now the best-selling drugs in the U.S., according to IMS Health ( RX - news - people ), a consulting firm.

-----------------------------------------------------------------------

So much for that new and improved FDA Obama promised in his "CHANGE" message.

The bought and paid for FDA is now even more corrupt and controlled by Big Pharma and the medical industry than ever before in our history. Before you take that next PILL, you better STOP and wonder what it really is in truth and how much harm it really does; because you can be damned sure our government or its representative the FDA will not be looking out for your interest or health. "Money speaks and the rest weep" is the new FDA motto and creed.

How about this for a scary "brave new world" scenario and thought; If the government can get the general population to buy into taking poisons on a grand scale; we can now save the over burdened social security system due to so few people living long enough to ever collect its benefits.

Jeez, how much blind faith people must have in a puppet government ran by greedy special mega international corporate interest? I guess the next step is having the UN save us all from ourselves; since we all know how above board and uncorrupted they are?


2 comments:

Mike Golch said...

sounds like business as usual.

Mark Krusen said...

Yep. Money talks.

FAIR USE NOTICE: This may contain copyrighted (C) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Terms and conditions on the use of the contents of the “Is Something Not Quite Right with Stan - A Mental Health Blog” site are for informational and entertainment purposes only. Stan does not represent or guarantee the accuracy, completeness, timeliness or reliability of the information or content (collectively, the "Materials") contained on, distributed through, or linked, downloaded or accessed from this website.

Stan encourages you to make your own health care and legal decisions based upon your research and in partnership with a qualified health care and/ or legal professional. The information posted here should not be considered medical advice and is not intended to replace consultation with a qualified medical professional if they exist. I do not answer specific medical questions.

Third party information is gathered from sources that Stan believes to be reliable. However, in no event shall Stan, or any third parties mentioned on this site be liable for any damages resulting directly or indirectly from the use of the content whether or not Stan is advised of the possibility of such damages.

Stan reserves the right, in its sole discretion and without any obligation, to make improvements to, or correct any error or omissions in any portion of the displayed materials.

You hereby acknowledge that any reliance upon any Materials shall be at your sole risk.

Disclaimer of Liability

The user assumes all responsibility and risk for the use of this web site and the Internet generally. Under no circumstances, including negligence, shall anyone involved in creating or maintaining this web site, or shall the website writer or any commenter’s be liable for any direct, indirect, incidental, special or consequential damages, or lost profits that result from the use or inability to use the web site and/or any other web sites which are linked to this site.

Nor shall they be liable for any such damages including, but not limited to, reliance by a visitor on any information obtained via the web site; or that result from mistakes, omissions, interruptions, deletion of files, viruses, errors, defects, or any failure of performance, communications failure, theft, destruction or unauthorized access.

ALL CONTENT ON THIS WEB SITE IS PROVIDED TO YOU ON AN "AS IS," "AS AVAILABLE" BASIS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. Stan MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEB SITE.

In states which do not allow some or all of the above limitations of liability, liability shall be limited to the greatest extent allowed by law.

Disclaimer of Endorsement - Reference to any products, services, hypertext link to the third parties or other information by trade name, trademark, supplier or otherwise does not constitute or imply its endorsement, sponsorship or recommendation by me. Nor is an endorsement by me is implied by such links. They are for convenience only, as an index in a public library.

Information Subject to Change - Any information on this web site may be removed without notice. Information may include technical inaccuracies or typographical errors. Furthermore, the information may change from time to time without any notice.

GENERAL INFORMATION - The information contained in this online site is presented and intended to provide a broad understanding and knowledge critical to psychiatric practices and humorous social interaction. The information should not be considered complete and should not be used in place of communication and consultation.

NO WARRANTIES “Is Something Not Quite Right With Stan - A Mental Health Blog” MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEB SITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL PRECAUTIONS NECESSARY TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THE WEB SITE IS FREE OF VIRUSES.

This site is not a monologue of truth. It is a catalyst for public debate about medical conduct and for entertainment purposes. The reader is urged to confront officials to clarify issues mentioned herein. This site is designed strictly to provide information for critical, literary, academic, entertainment, and public usage. A qualified and trustworthy medical professional must be consulted regarding medical issues, treatments, diagnoses, etc.; if they exist in all actuality or truth.