Natural News sent me this and I have to agree with this writer 100%. The FDA is all over the place regulating everything they can, but this time they may have taken on more than they bargained for. Read what is written here and see if you agree. I particularly enjoyed paragraph number two. Give me a break. Any adult can buy a pack of cigarettes and most kids can get their hands on them too and yet our own stem cells that can heal us are considered a prescription drug and are not available to us? I think the FDA needs to be advised of what is good for us and what is not by someone other than their cronies. Their advisory panels obviously have fallen down on the job.
(NaturalNews) There's no other word to describe it: The U.S. Senate's tobacco control bill is pathetic. It bans candy cigarettes and fruit-flavored cigarettes, but doesn't even require cigarette companies to disclose the ingredients they use until nearly a year-and-a-half later. The bill bans the use of the word "light" from cigarette packages, but even the tobacco companies admit this will make virtually no difference, as smokers have grown accustomed to buying cigarettes labeled with color codes that indicate a "light" designation.
And perhaps most importantly, this bill now puts the FDA in the position of approving the marketing and consumption of a product that directly promotes heart disease, strokes and cancer. The FDA, in other words, will now lend its stamp of approval to a product that openly kills people.
Tobacco as an FDA-approved drug?
If the FDA has any ethics whatsoever, it must ban tobacco products outright. For how can the Food and Drug Administration approve the marketing and selling of a deadly carcinogenic product when, at the same time, it bans cherry growers from describing the everyday health benefits of cherries?
The U.S. Food and Drug Administration is responsible for approving the marketing and distribution of both foods and drugs. Cigarettes are obviously not foods or dietary supplements, and since tobacco is inhaled for its pharmacological effects, that clearly puts cigarettes in the drugs category. So if this bill becomes law, it will force the FDA to declare tobacco to be a drug.
So if tobacco is a drug, then where are the safety tests required for drug approval? The FDA assaults fruit and herb companies on a daily basis, threatening them with being shut down for selling "unapproved drugs," and yet now the FDA is about to be put in the position of approving an admittedly deadly product that has no health benefits whatsoever while contributing to serious degenerative disease!
Interestingly, this position is not at all unusual for the FDA. The agency has already granted approval to thousands of toxic chemicals that openly harm human health -- pharmaceuticals. FDA-approved drugs, after all, kill over 100,000 Americans each year. If the FDA's portfolio of drugs includes tobacco, that number will rise to well over half a million Americans killed each year by FDA-approved drugs!
Furthermore, it would make laughable any claim by the FDA that it is working to "protect the public." As the agency approving the marketing, sale and consumption of a product that inarguably kills over 400,000 people a year, the FDA would cement its position as a peddler of poison.
The War on (some) Drugs
Placing tobacco under "approved" status at the FDA also raises a glaring contradiction in the U.S. government's so-called "War on Drugs." Tobacco is, without question, a psychoactive, highly-addictive drug that is consumed by people in an addictive and destructive way. Marijuana, by comparison, is less addictive, making it far less destructive to health overall. So why is tobacco about to become an FDA-approved drug while marijuana remains an herb whose very possession results in a consumer being branded a criminal and thrown in prison?
Putting tobacco in the FDA's portfolio only serves to highlight the hilarious contradictions in U.S. drug policy, showing it to be solely about protecting corporate drug profits, not protecting people from dangerous drugs.
Wanna sell more drugs? Push more tobacco...
Has anyone realized the huge conflict of interest in turning over tobacco regulation to the FDA? The FDA's biggest customers (corporations that pay the FDA money) earn their profits precisely from treating the very diseases caused by tobacco consumption. This creates an incentive for the FDA to promote more tobacco, thereby boosting the long-term revenue potential of its Big Pharma clients.
This obvious conflict of interest is one reason why the FDA cannot be trusted to regulate tobacco in a way that serves the public interest. Rather, tobacco regulation is likely to be used as a way to promote more tobacco use by declaring it to be "approved" by the FDA.
It's astounding that it took the U.S. Senate over fifteen years to pass a tobacco bill that turns out to be a pathetic attempt to reduce smoking and, in fact, might actually increase the perception of cigarettes being "safe" and "approved" by the U.S. Food and Drug Administration.
Light up, kids! It's FDA approved!
Thursday, June 11, 2009
Wednesday, June 10, 2009
Contacting the FDA
Here is some useful information you can use when contacting your legislators or the media concerning the FDA's mandate to regulate our own stem cells as prescription drugs.
The FDA has taken the position that our own adult stem cells are biological drugs. You can view the FDA’s code of regulations at http://edocket.access.gpo.gov/cfr_20...1cfr1271.3.htm The FDA defines stem cells as a type of “human cell, tissue, or cellular or tissue-based products” (HCT/P’s). You will want to focus on 21 CFR 1271.3(d). It defines HCT/P’s as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
Over the past 5 years that definition has undergone a very significant change. Originally, human cell tissue/products were defined as “any human tissue derived from a human body and intended for transplantation into another human”.
Do you see the significance of the change? The new regulation currently in effect purports to give the FDA the authority to regulate even those tissue products being used for autologous purposes such as tissue products being used in a bypass surgery or our own stem cells being used in our own treatments. The change in wording in this regulation gives the FDA more authority than Congress has ever authorized.
The really shocking part of all of this is that the FDA made these changes to the law without public comment. Federal law states that the FDA cannot make new regulations without giving notice to the public and offering the public the opportunity to comment.
Undoubtedly if the FDA had followed the proper procedure, the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA the authority to regulate the practice of medicine, something Congress has NEVER granted to the FDA.
By changing just this one little simple phrase in the regulations, the agency has given itself vast new powers to regulate stem cells as biological drugs. The cell based therapy group at the FDA (CBER) depends on this little phrase for its existence. Without the phrase, the FDA has no authority to regulate our own stem cells as a drug. With the phrase, the FDA gives itself unheard of authority and a whole new section of the federal government (CBER) a reason to exist.
This is why ASCTA (American Stem Cell Therapy Association) is so important. Working together we can rectify this situation and return the practice of medicine to physicians working with patients concerning their personal healthcare. To begin this process, please join ASCTA at www.safestemcells.org If you are a physician go to www.stemcelldocs.org Once there, you will find a link to contact the FDA. The following is a suggested message you can send:
Gentlemen:
I oppose the change made in 21 CFR 1271.3(d) from “any human tissue derived from a human body and intended for transplantation into another human…” (2004 and prior) to “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” (recent regulation). This change allows the FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.
The FDA has taken the position that our own adult stem cells are biological drugs. You can view the FDA’s code of regulations at http://edocket.access.gpo.gov/cfr_20...1cfr1271.3.htm The FDA defines stem cells as a type of “human cell, tissue, or cellular or tissue-based products” (HCT/P’s). You will want to focus on 21 CFR 1271.3(d). It defines HCT/P’s as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
Over the past 5 years that definition has undergone a very significant change. Originally, human cell tissue/products were defined as “any human tissue derived from a human body and intended for transplantation into another human”.
Do you see the significance of the change? The new regulation currently in effect purports to give the FDA the authority to regulate even those tissue products being used for autologous purposes such as tissue products being used in a bypass surgery or our own stem cells being used in our own treatments. The change in wording in this regulation gives the FDA more authority than Congress has ever authorized.
The really shocking part of all of this is that the FDA made these changes to the law without public comment. Federal law states that the FDA cannot make new regulations without giving notice to the public and offering the public the opportunity to comment.
Undoubtedly if the FDA had followed the proper procedure, the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA the authority to regulate the practice of medicine, something Congress has NEVER granted to the FDA.
By changing just this one little simple phrase in the regulations, the agency has given itself vast new powers to regulate stem cells as biological drugs. The cell based therapy group at the FDA (CBER) depends on this little phrase for its existence. Without the phrase, the FDA has no authority to regulate our own stem cells as a drug. With the phrase, the FDA gives itself unheard of authority and a whole new section of the federal government (CBER) a reason to exist.
This is why ASCTA (American Stem Cell Therapy Association) is so important. Working together we can rectify this situation and return the practice of medicine to physicians working with patients concerning their personal healthcare. To begin this process, please join ASCTA at www.safestemcells.org If you are a physician go to www.stemcelldocs.org Once there, you will find a link to contact the FDA. The following is a suggested message you can send:
Gentlemen:
I oppose the change made in 21 CFR 1271.3(d) from “any human tissue derived from a human body and intended for transplantation into another human…” (2004 and prior) to “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” (recent regulation). This change allows the FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.
Friday, June 5, 2009
The recent furor concerning CNN's despicable coverage of stem cell treatments overseas has kept me pretty riled up over the lack of caring of the FDA and in general, the politicians in Washington D.C. What CNN did was simply, in their own bumbling way, magnify the situation that now exists for those of us that are terminally and chronically ill in this country. Our own government is holding us hostage. In an effort to please Big Pharma and not see their budget cut, the FDA must continue to create new avenues for their own agency. Declaring our own stem cells to be drugs is an avenue they could not resist even though they have no legal jurisdiction in the practice of medicine and they did NOT go through the required period of public commentary before making this declaration. This is a real no-no and something that ASCTA intends to challenge via the courts.
If you are not familiar with ASCTA (American Stem Cell Therapy Association), then get familiar by visiting their site at www.safestemcells.org. If you are a physician www.stemcelldocs.org You do not have to be a doctor that is giving stem cell treatment or even one that embraces it, however, if your patients choose to have treatment done, you must care enough to back this effort that promises safe treatments in the U.S. for them. You should also consider that the FDA's actions could threaten the way you treat your patients as well.
If we let the FDA take a pass on this gross overstepping of its regulatory boundaries, we will rue the day. Our own stem cells will become the domain of large pharmaceutical companies, setting progress back years in this country. We are already falling shamefully behind. Many countries allow treatments and many also offer clinicals for thousands and thousands of patients. The U.S. has a few clinicals and allows only a very limited number of treatments.
There should be no hold up on giving us what we need and want in this country. I am sick and tired of begging for my life and the life of others. I am tired of politicians who do not care enough to respond to letters, e-mails or phone calls and yet are always ready to take campaign contributions. Unless these politicians live in a fog, they have to know that we are a nation that is over medicated and on many fronts losing the battle to be number one in stem cell research and biotechnology. I am especially tired of lousy reporting filled with editorializing and outright lies as was the case with CNN.
We must fight back. We can't let the few brave doctors that are fighting for the right to give patients safe stem cell treatments be harassed and humiliated by the FDA and the press. We need to continue to expose the false premise the FDA is working under when they attempt to classify our own stem cells as drugs. This could open the door for the FDA to start regulating all surgeries, cosmetic procedures, stem cell products, etc. Do we really want that? I know I don't. I want my life back, not more regulation that threatens to take it away unless I make my way to Mexico or China or some other more visionary country.
If you are not familiar with ASCTA (American Stem Cell Therapy Association), then get familiar by visiting their site at www.safestemcells.org. If you are a physician www.stemcelldocs.org You do not have to be a doctor that is giving stem cell treatment or even one that embraces it, however, if your patients choose to have treatment done, you must care enough to back this effort that promises safe treatments in the U.S. for them. You should also consider that the FDA's actions could threaten the way you treat your patients as well.
If we let the FDA take a pass on this gross overstepping of its regulatory boundaries, we will rue the day. Our own stem cells will become the domain of large pharmaceutical companies, setting progress back years in this country. We are already falling shamefully behind. Many countries allow treatments and many also offer clinicals for thousands and thousands of patients. The U.S. has a few clinicals and allows only a very limited number of treatments.
There should be no hold up on giving us what we need and want in this country. I am sick and tired of begging for my life and the life of others. I am tired of politicians who do not care enough to respond to letters, e-mails or phone calls and yet are always ready to take campaign contributions. Unless these politicians live in a fog, they have to know that we are a nation that is over medicated and on many fronts losing the battle to be number one in stem cell research and biotechnology. I am especially tired of lousy reporting filled with editorializing and outright lies as was the case with CNN.
We must fight back. We can't let the few brave doctors that are fighting for the right to give patients safe stem cell treatments be harassed and humiliated by the FDA and the press. We need to continue to expose the false premise the FDA is working under when they attempt to classify our own stem cells as drugs. This could open the door for the FDA to start regulating all surgeries, cosmetic procedures, stem cell products, etc. Do we really want that? I know I don't. I want my life back, not more regulation that threatens to take it away unless I make my way to Mexico or China or some other more visionary country.
Wednesday, June 3, 2009
CNN show on people desperate for stem cell treatment was a sleeper
Did anyone happen to catch the CNN site today? Having declined to go on camera with them myself after getting a whiff of what they planned to dis on the Lou Dobbs show, I didn't really feel like watching it, but someone had to send me the article which recaps the show on desperate people leaving the country for stem cell treatment. Here's an excerpt:
"The International Society of Stem Cell Researchers and the FDA discourage Americans from traveling overseas for stem cell therapy. But clinics are operating worldwide -- many in China, and several in Russia, Latin America and Mexico."
"We do not encourage patients to seek therapies overseas that are not FDA-approved in the U.S.," an agency spokesman said in an e-mail to CNN, "as the products or therapies have not undergone the agency's rigorous review."
I could hardly control myself. It was the best laugh I had all day. All of a sudden CNN, the ISSCR and the FDA don't want me or my fellow patients with diseases that have no known cures leaving the country to try stem cell treatment. I think I will call the FDA tomorrow and find out just where I can get one of their approved treatments for COPD here in the U.S. I must have been in a fog for the last few years and didn't realize that these treatments were available here in the states. Silly me and thousands of others who thought we had to leave the U.S. when all along the FDA has these darn therapies available to everyone who desperately needs them right here.
"The International Society of Stem Cell Researchers and the FDA discourage Americans from traveling overseas for stem cell therapy. But clinics are operating worldwide -- many in China, and several in Russia, Latin America and Mexico."
"We do not encourage patients to seek therapies overseas that are not FDA-approved in the U.S.," an agency spokesman said in an e-mail to CNN, "as the products or therapies have not undergone the agency's rigorous review."
I could hardly control myself. It was the best laugh I had all day. All of a sudden CNN, the ISSCR and the FDA don't want me or my fellow patients with diseases that have no known cures leaving the country to try stem cell treatment. I think I will call the FDA tomorrow and find out just where I can get one of their approved treatments for COPD here in the U.S. I must have been in a fog for the last few years and didn't realize that these treatments were available here in the states. Silly me and thousands of others who thought we had to leave the U.S. when all along the FDA has these darn therapies available to everyone who desperately needs them right here.
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