The FDA and Obama

Mysty119

New member
At the Injury Board.com website, under the topic Major Medical and FDA & Prescription drugs, you will find this article.
Why do the allegations in this piece not surprise me? And further; why does it not surprise me that the FDA attorneys handled it the way they did?

OBAMA ASKED TO ENSURE A CLEAN SLATE AT THE FDA
Bold assertions were made against the Food and Drug Admistration to President Obama in a letter written April 2, and most of the assertions do an excellent job at capturing the frustration of scientists, physicians, and the American people have with the decisions by FDA officials.

Over the last decade, the FDA has come under serious criticism for politically motivated policies and regulation. In 2006, the FDA regulated the ?Plan B? drug for women to be only accessible by those 18 and over. With little scientific finding to support this decision, the FDA acted arbitrarily in order to promote the political purpose of deterring sex at an early age. Whether a person agrees or disagrees with the reasoning, this arbitrary and politically-motivated decision goes against the FDA?s mission statement, which is the promotion and advancement of human health. A federal judge in New York agreed with this finding, and ruled that the FDA overstepped its authority and sought to impose a capricious agenda on the American people.

The letter goes on to call out managers and attorneys within the FDA who, as the letter alleges, fostered this political ideology and censoring which has undermined the FDA?s purpose. In one case, Dr. Donna-Bea Tillman approved a medical device used for the detection of breast cancer despite every FDA expert involved recommending against the approval (three times). This decision was made after a phone call between Dr. Tillman and congressman Christopher Shays. After this and another instance of wrongdoing was published, acting Commissioner Dr. Frank Torti and FDA attorneys sent out a company-wide e-mail instructing all employees to ?comply with? obligations to keep certain information ? confidential ? [including] e-mail to and from employees within [the] FDA [that document the] deliberative process.?

It remains to be seen what major policy changes will be made within the FDA, but if the allegations in this letter are true, things can?t get much worse.
 

barbara

Pioneer Founding member
Bea - Thanks for this very informative post. It is time for a change in the way the FDA is allowed to do business. Obviously, the original purpose of the FDA has been lost amid conflicts of interest, corruption and political favors. This type of post inspires me to continue my campaign to help ASCTA. I know you are doing your part as well. Thank you.
 

Mysty119

New member
Feel free to...

I went to this site and posted my two cents worth. Feel free to do the same.
It's the Injury Board.com website, under the topic Major Medical and FDA & Prescription drugs
 

barbara

Pioneer Founding member
Bea's Injury Board. com comments

Great response Bea. Great comments. I added mine as well. Please everyone, add your two cents on these blogs and boards to help support ASCTA.


Posted by Bea
April 21, 2009 2:28 PM

I am certainly not surprised that the FDA or it's attorneys would want to hide the FDA's wrongdoings. This is just one of their "wrongdoings"-----
The FDA wants to declare our own stem cells as drugs!!! This means that any clinic or doctor that uses our own stem cells will be held to GMP (Good Marketing Practice) guidelines as the FDA will consider that they are "producing a drug" if there is the slightest manipulation of any kind performed.
The problem with not culturing or expanding our cells for treatment is that without it, there usually is not a relevant amount of stem cells extracted to do us any good. Simple cell culture will bring the numbers up to where they can be beneficial.
The irony of it all is that fertility clinics are not held to these same standards and yet they are "manipulating cells" on a daily basis. They are allowed to do this using guidelines that physicians have written. And, they are allowed to use GTP (Good Traceability Practice) and GLP (Good Laboratory Practice). ASCTA (American Stem Cell Therapy Association) wants the same for stem cell clinics and doctors using our own stem cells. It makes sense. The GMP guidelines do not even pertain or make sense for the most part for stem cell therapy.
Big pharmaceutical companies have billions of dollars involved. If we cannot move forward on this very quickly, then we will lose and we will wait years (5-10) for legalized treatment to be available in the U.S. with our own stem cells if any manipulation is involved.
ASCTA is a group of doctors and patients coming together to fight this. Safe stem cell guidelines have already been written for labs and doctors. There will be a transplant registry that member physicians will use for each therapy they are involved in. Each physician will be able to practice safe stem cell therapy in his or her own field of expertise. Patients will benefit because they will not have to travel out of the country. Many patients are simply too sick to do this anyway. The FDA simply does not care if we die.
Every single day, fertility clinics are able to continue their work, unregulated by the FDA. There are over 8500 published articles Dr. Centeno of the ASCTA says on mesenchymal stem cells alone, with another 2500 being published this year. Treatments have been given for a wide variety of diseases with no complications.
Our Congress states that "the FDA is not allowed to regulate the practice of medicine". That is up to the doctor.
What can possibly be motivating the FDA to do this? In one word, MONEY. After all, if we can be helped or healed by our "own" stem cells, we won't be needing to take all those drugs that they sell! Big pharma has billions of dollars invested. They aren't real excited about a healthy population that doesn't need a lot of drugs. The FDA seems to be intertwined with big pharma in a way that no regulatory agency should be.
The FDA has failed us in many ways. Just google this phrase: ?FDA admits?, and see what you come up with. The FDA must return to a culture that places public health concerns ahead of industry profits.
I ask you to please not allow the FDA to declare that our own stem cells are drugs. After all, is our own blood taken from us prior to a scheduled surgery for re-injection into our bodies at the time of surgery, classified as a drug? Will they next be regulating our choice of who gets our other body parts when we die?
 
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