FDA

[Guest guest]

Satire: The top ten things we'd see if the FDA were put in charge of

the criminal justice system...

1. Telephone con artists who scam senior citizens out of their life

savings would be put in charge of direct-to-consumer drug

advertising.

(Explanation: Senior citizens are being financially exploited by drug

companies who use direct-to-consumer advertising to con people into

asking their doctors for drugs they don't even need.)

2. All murderers would be set free as long as they carried a large

warning label that said, " Warning: I may kill you. " (Explanation: The

FDA allows prescription drugs with fatal side effects to remain

perfectly legal as long as they carry warnings that most people

simply

ignore.)

3. Convicted drug dealers would be given medical degrees and allowed

to write prescriptions. (Explanation: The FDA and U.S. authorities

aren't against all drugs, they're only against the drugs they can't

control. Many prescription drugs are far more dangerous to the human

body than marijuana, for example.)

4. Car thieves would be given new jobs stealing phytochemical

discoveries from medicinal plants in the Amazon rainforest that could

be patented and sold as monopoly drugs. (Explanation: Drug companies

frequently exploit natural medicinal compounds in plants, then modify

and patent them for manufacturing prescription drugs, even while

discrediting the healing potential of the very same medicinal plants.

Lovastatin, for example, was stolen from red yeast rice, a natural

supplement that lowers LDL cholesterol. Ephedrine, the active

ingredient in Sudafed, was copied from ephedra, a medicinal herb that

has now been outlawed by the FDA even while Sudafed remains perfectly

legal.)

5. All rapists would be given four years to run free before being

taken off the streets, even though they were known to be dangerous.

(Explanation: The FDA allows dangerous drugs to remain on the market

for years, with hundreds of thousands of people being injured by

them,

before issuing a recall. Rezulin and Vioxx are just two of many such

examples. Antidepressant drugs and statin drugs are probably next in

line.)

6. Convicted white collar criminals and accounting fraud artists

would be given top jobs at pharmaceutical companies. Unless, of

course,

they already work there. (No explanation needed.)

7. Drug smugglers would be shot on sight, but only if they are

smuggling legal prescription drugs from Canada. (Explanation: The FDA

continues to try to ban prescription drugs from Canada in the hopes

of

protecting the profits of U.S. drug companies. In one case, a bus

load

of American senior citizens was detained and searched by FDA

employees

for drugs. Not illegal drugs, mind you, but prescription drugs.)

8. All felons serving time in prison would be set free. Why? The FDA

would claim that no particular felon could be considered dangerous,

since all felons are dangerous. (Explanation: The FDA defends the

safety of obviously dangerous drugs by explaining that all drugs are

dangerous. Therefore, the thinking goes, you can't single out any

particular drug as being especially dangerous, so they should all

remain on the market. Bizarre logic, huh?)

9. All crimes would be declared legal, but only if committing those

crimes generated revenues for powerful corporations. (Explanation:

Pharmaceutical companies are allowed to commit all sorts of crimes

against the public in terms of compromising public safety, lying to

consumers in drug ads, and distorting drug trials to achieve a

desired

outcome. It's all allowed by the FDA, with virtually no regulatory

response, as long as profits continue to flow.)

10. Free speech about health and medicine would be outlawed in a

Senate bill sponsored by Sen. Orrin Hatch. After all, the FDA doesn't

want people to be exposed to any " dangerous " ideas or information

that

might question the agency's authority. The list you're reading right

now would be the first item to be outlawed, followed by a China-style

internet filtering system that would suppress all non-FDA-approved

text across the entire world wide web.

This effort is dedicated to Dr. Graham, a genuine American

hero.As a chief drug safety researcher for the FDA, Dr. Graham has

shown enormous courage and dedication to his professional

responsibilities in standing up against the FDA and telling the

truth about dangerous prescription drugs. Dr. Graham, if you ever

get blackballed by the FDA and Big Pharma, just talk to

Newstarget.com. We have lots of options for you...

[Guest guest]

good report! How about Lipitor, this past spring, it almost kolled my husband. he went into complete kidmey failure, was in icu one week and intensive care ywo more weeks, he still is not back to hos old self, lots of muscle pain, and he has now been found to have an irregulat heartbeat, which he didn;t have before. roxanne

[low dose naltrexone] fda

F.D.A. Failing in Drug Safety, Official AssertsBy GARDINER HARRIS New York TimesWASHINGTON, Nov. 18 - Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at." In testimony before the Senate Finance Committee, Dr. Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, used fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers. "We are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world," Dr. Graham concluded. Dr. Galson, the director of the F.D.A.'s Center for Drug Evaluation and Research and one of the agency's top civil servants, later said that Dr. Graham's new numbers "constitute junk science" and were "irresponsible." Dr. Graham, with more than 20 years of service at the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe. Dr. Kweder, deputy director of the F.D.A.'s office of new drugs, told the panel that Dr. Graham was not describing "the F.D.A. that I know" and that she did not see the five drugs he cited as "more concerning than any others." The clash was a rare public airing of tensions that have simmered in the agency for decades. It is a fight between those who focus on the potential of drugs to cure the sick and dying and those who see many medicines as high-priced commercial products with potentially risky side effects, between those who view pharmaceutical makers as beneficial partners and those who see the drug makers as antagonists needing to be curbed. "My personal view is that our system works very well," Dr. Kweder said. The exchange came during a hearing called by Senator E. Grassley, a Republican of Iowa and the chairman of the Finance Committee. Using his broad authority over much of the government's budget, Senator Grassley and his staff have been investigating the F.D.A. for months after several controversies swept the agency this year. The hearing focused on the last of these controversies: Merck's decision in September to withdraw Vioxx, a pain pill that became a $2.5 billion seller and one of the most widely advertised drugs in the world. Merck withdrew Vioxx when a study it sponsored found that after 18 months of use the drug doubled the risk of heart attack or stroke. Critics of the F.D.A. have said that studies from as early as 1999 and 2000 showed that Vioxx was a risk to the heart, and many asked why the F.D.A. had not forced the drug's withdrawal earlier. The critics' case has been bolstered by many e-mail messages from Merck and by company documents disclosed in lawsuits by users of Vioxx. In many of the documents, Merck executives and scientists discussed the possible link between Vioxx and heart damage years before the company publicly admitted that the drug could cause harm. Merck executives have said the documents are being taken out of context. V. Gilmartin, Merck's chief executive, testified Thursday that his company followed a "rigorous scientific process" as it examined the risks and benefits of Vioxx. But Dr. Graham and other witnesses severely criticized Merck, saying the company should have acted years earlier to confirm the risks of Vioxx. Dr. Graham raised his estimates of those in the United States who had suffered heart attacks or stroke as result of taking Vioxx to a range of 88,000 to 139,000, up from 28,000. As many as 40 percent of these people, or about 55,000, died as a result, he said. Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx. Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: "I was warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had extensive contacts within academia and could make life very difficult for me at Stanford and outside." Dr. Graham said that in his years at the F.D.A., he had recommended that 12 drugs be withdrawn. Only two are still being sold, he said. His list of the five most worrisome drugs angered pharmaceutical makers, although objections to most of these drugs have long been known. For instance, Accutane, a drug for severe acne, can cause birth defects. The drug's label has warnings about this risk, and the F.D.A. has long been trying to get physicians to confine prescriptions to those women who cannot become pregnant or who are taking birth control. Dr. Graham said that the F.D.A. needed to do a better job restricting the drug's sales. Carolyn Glynn, a spokeswoman for Roche, which makes Accutane, said that her company had worked with the F.D.A. for years to "address the risk of birth defects." Dr. Graham mentioned Crestor because, he said, it was the only cholesterol-lowering drug on the market that caused acute kidney failure. And the drug is more likely to cause a serious muscle-weakening disease than similar drugs, he said. AstraZeneca introduced Crestor last year, but sales have been disappointing largely because of worries about the drug's safety. Public Citizen, a Washington advocacy group, has called for it to be withdrawn. "We are confident in the safety profile of Crestor," said Bloom-Baglin, a spokeswoman for AstraZeneca. "To date, the F.D.A. has not given us any indication of a major concern regarding Crestor." But Dr. Kweder of the F.D.A. told the panel that Crestor's risks are "something that we are in the process of and have been evaluating very, very closely." Studies of the painkiller Bextra, also mentioned by Dr. Graham, have shown that it increases the risks of heart attack in patients undergoing cardiac surgery. In rare cases, the drug can also cause a fatal skin reaction. Despite these risks, Bextra, which is similar to Vioxx, has never been proved to be any more effective at reducing pain or protecting the stomach than older medicines like ibuprofen that are a fraction of the price and pose none of these suggested or proven risks. Bro, a spokeswoman for Pfizer, the maker of Bextra, said that the drug "has been found to be safe and effective when used as indicated to treat osteoarthritis, rheumatoid arthritis and menstrual pain." She said the F.D.A. planned to ask a panel of experts early next year to examine the safety of Bextra and Celebrex, a Pfizer pain drug. Meridia is a weight-loss pill, made by Abbott Laboratories, that can cause substantial increases in blood pressure in some patients. Public Citizen has called for Meridia's withdrawal because it has been associated with 124 reports of serious cardiovascular problems, including 49 deaths, said Dr. Sidney Wolfe, director of Public Citizen's health research group. Dr. Graham testified that few patients were able to withstand Meridia's side effects long enough to benefit from its use. "What's the utility of the drug?" he asked. Laureen Cassidy, a spokeswoman for Abbott, said, "Science continues to support the safe use of Meridia as a treatment for obesity." The fifth drug named by Dr. Graham was Serevent, an asthma medication made by GlaxoKline, which stopped a large trial last year after an interim analysis revealed an increased risk of asthma-related deaths and life-threatening episodes among those given the drug. "We have case reports of people dying clutching their Serevent inhaler," Dr. Graham said. After the study was released, the F.D.A. placed a "black box" warning, its most severe, on the drug's label. The agency concluded that the drug's benefits outweighed its risks. In a statement Thursday, GlaxoKline said that it "stands firmly behind Serevent, which is safe and effective when used appropriately and in accordance with labeling and treatment guidelines." Dr. Galson of the F.D.A. emphasized that the drugs mentioned by Dr. Graham "are all approved and are safe and effective like other drugs that are approved, recognizing that safe does not mean risk-free." Dr. Kweder of the F.D.A. defended the agency's handling of Vioxx and said that Merck had "acted responsibly" when it sold Vioxx. She said that Dr. Graham's estimates of Vioxx's toll were simply mathematical guesses and "not real deaths." And she said that it was not unusual when a drug went on the market "to have ongoing concerns about particular aspects of its safety." In his testimony, Mr. Gilmartin of Merck retraced many of the steps his company had undertaken and noted that while some early studies suggested that the drug might be a risk to the heart other studies found no problems. He said he believed so thoroughly in the drug that his wife took it until the day the company withdrew it.

Last modified: November 19. 2004 12:00AM

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[Guest guest]

Wow!, Great article, and all of it true Roxanne

[low dose naltrexone] FDA

>

>

> Satire: The top ten things we'd see if the FDA were put in charge of

> the criminal justice system...

>

> 1. Telephone con artists who scam senior citizens out of their life

> savings would be put in charge of direct-to-consumer drug

> advertising.

> (Explanation: Senior citizens are being financially exploited by drug

> companies who use direct-to-consumer advertising to con people into

> asking their doctors for drugs they don't even need.)

>

> 2. All murderers would be set free as long as they carried a large

> warning label that said, " Warning: I may kill you. " (Explanation: The

> FDA allows prescription drugs with fatal side effects to remain

> perfectly legal as long as they carry warnings that most people

> simply

> ignore.)

>

> 3. Convicted drug dealers would be given medical degrees and allowed

> to write prescriptions. (Explanation: The FDA and U.S. authorities

> aren't against all drugs, they're only against the drugs they can't

> control. Many prescription drugs are far more dangerous to the human

> body than marijuana, for example.)

>

> 4. Car thieves would be given new jobs stealing phytochemical

> discoveries from medicinal plants in the Amazon rainforest that could

> be patented and sold as monopoly drugs. (Explanation: Drug companies

> frequently exploit natural medicinal compounds in plants, then modify

> and patent them for manufacturing prescription drugs, even while

> discrediting the healing potential of the very same medicinal plants.

> Lovastatin, for example, was stolen from red yeast rice, a natural

> supplement that lowers LDL cholesterol. Ephedrine, the active

> ingredient in Sudafed, was copied from ephedra, a medicinal herb that

> has now been outlawed by the FDA even while Sudafed remains perfectly

> legal.)

>

> 5. All rapists would be given four years to run free before being

> taken off the streets, even though they were known to be dangerous.

> (Explanation: The FDA allows dangerous drugs to remain on the market

> for years, with hundreds of thousands of people being injured by

> them,

> before issuing a recall. Rezulin and Vioxx are just two of many such

> examples. Antidepressant drugs and statin drugs are probably next in

> line.)

>

> 6. Convicted white collar criminals and accounting fraud artists

> would be given top jobs at pharmaceutical companies. Unless, of

> course,

> they already work there. (No explanation needed.)

>

> 7. Drug smugglers would be shot on sight, but only if they are

> smuggling legal prescription drugs from Canada. (Explanation: The FDA

> continues to try to ban prescription drugs from Canada in the hopes

> of

> protecting the profits of U.S. drug companies. In one case, a bus

> load

> of American senior citizens was detained and searched by FDA

> employees

> for drugs. Not illegal drugs, mind you, but prescription drugs.)

>

> 8. All felons serving time in prison would be set free. Why? The FDA

> would claim that no particular felon could be considered dangerous,

> since all felons are dangerous. (Explanation: The FDA defends the

> safety of obviously dangerous drugs by explaining that all drugs are

> dangerous. Therefore, the thinking goes, you can't single out any

> particular drug as being especially dangerous, so they should all

> remain on the market. Bizarre logic, huh?)

>

> 9. All crimes would be declared legal, but only if committing those

> crimes generated revenues for powerful corporations. (Explanation:

> Pharmaceutical companies are allowed to commit all sorts of crimes

> against the public in terms of compromising public safety, lying to

> consumers in drug ads, and distorting drug trials to achieve a

> desired

> outcome. It's all allowed by the FDA, with virtually no regulatory

> response, as long as profits continue to flow.)

>

> 10. Free speech about health and medicine would be outlawed in a

> Senate bill sponsored by Sen. Orrin Hatch. After all, the FDA doesn't

> want people to be exposed to any " dangerous " ideas or information

> that

> might question the agency's authority. The list you're reading right

> now would be the first item to be outlawed, followed by a China-style

> internet filtering system that would suppress all non-FDA-approved

> text across the entire world wide web.

>

> This effort is dedicated to Dr. Graham, a genuine American

> hero.As a chief drug safety researcher for the FDA, Dr. Graham has

> shown enormous courage and dedication to his professional

> responsibilities in standing up against the FDA and telling the

> truth about dangerous prescription drugs. Dr. Graham, if you ever

> get blackballed by the FDA and Big Pharma, just talk to

> Newstarget.com. We have lots of options for you...

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

Wow that is strange, instead of a newsletter I get the FDA warning. to.

--- In , Stauffer <gsgkill@...>

wrote:

>

>

> That FDA link i found on http://www.jimhumble.com/ linked down below under

(The MMS Newsletter signup is here) click on that it takes you to the FDA, seems

kind of funny finding it there. Maybe the whole site is the FDA?

>

[Guest guest]

Sodium Chlorite may become as controversial as marijuana for alternative

medicine. To think the state police could knock on my door for MMS? Wish the FDA

was as concerned about the gulf of mexico, and so many other serious health

issues.

--- In , Stauffer <gsgkill@...>

wrote:

>

>

> That FDA link i found on http://www.jimhumble.com/ linked down below under

(The MMS Newsletter signup is here) click on that it takes you to the FDA, seems

kind of funny finding it there. Maybe the whole site is the FDA?

>

[Guest guest]

Me too. What a cheek! dee

On 8 Aug 2010, at 14:50, healinghope wrote:

> Wow that is strange, instead of a newsletter I get the FDA warning. to.

>

> --- In , Stauffer <gsgkill@...>

wrote:

>>

>>

>> That FDA link i found on http://www.jimhumble.com/ linked down below under

(The MMS Newsletter signup is here) click on that it takes you to the FDA, seems

kind of funny finding it there. Maybe the whole site is the FDA?

>>

>

>

>

>

[Guest guest]

mercury in high fructose corn syrup

well

ha, I knew there was a reason I don’t follow the news J don’t

do HFCS anyway

the

thing is with the fda…few years ago they did try and outlaw it. mms

was not ‘under the radar’ but right in the mainstream news. Prior

to it being the buzz word suppliers sold it with ease for over 20 years, any

form you wanted including what is now called mms. It was with the big

hoopla of mms that the fda even took notice. Some of the suppliers got

together, I know one personally, hired a high power lawyer that has gone up

against the fda before (and won), found the loophole, that it had been used for

human consumption before some magic date, in the 80’s I believe, and the

attempt to outlaw it became a non issue. These suppliers spent weeks till

late in the night looking for the one instance that would grandfather it in.

Can

they pull it off and take it off the market…seems doubtful but I don’t

keep up on legalize. When I talk to my chemist friend, a supplier of many

products, not just SC, I’ll ask.

The

problem with mms and the reason it keeps getting attention is that suppliers,

promoters dig their own hole my making claims like cures 97% of all disease in

a few hours or days. Statements like this are not only erroneous but

bring the whole issue so in your face to the faceless fda it is asking for

trouble. Were this situation handled differently it would go away.

As

far as setting up a church for ‘protection…it works in certain

situations. Indians have secured the right to use certain illegal

substances in their ‘worship’.

>>>>>Article 32, paragraph 4 allows for States,

at the time of signature, ratification or accession, to make a reservation

noting an exemption for

plants

growing wild which contain psychotropic substances from among those in Schedule

I and which are traditionally used by certain small, clearly determined groups

in magical or religious rites.

>>>>>>>>>>>>>

A

group that uses ayahuasca in their religious rituals won in court.

Would

that transfer to a church that uses SC or ASC in their ‘religious’

rituals, doubtful. Especially when the ‘ministers’ are saying

they can heal the sick of 97% of all disease in a matter of hours or days.

That might just not float even if they did make SC illegal.

Members

of certain ‘religious’ groups can use controlled substances in

their ‘worship’ services. They are not pounding the street

for ppl to cure and give the substance too. Why, in order for a ‘minister’

to even administer the substance the receiver would have to also be a member of

the church and guidelines of using controlled substances in religious ceremonies

are not just join today and use tomorrow. Were that to be the case these

marijuana churches that tried to give this route a go would have

flourished. They didn’t…there was one in our area and the

members were raided, plants taken, jailed.

Take

in the fact that proponents of mms also say safe for babies, children and

pregnant…nah, that is just not going to float legally and I don’t

care what you call the ‘church’ or how you define it’s

purpose legally.

Anyone

who thinks so is just living in the clouds imho

Xxx

rose