FDA failed to pass on the deadly warning to the one million Americans already taking Avandia.

When defending drugs they’ve let loose on the public “there’s never enough evidence to prove they’re dangerous” . . . regardless of how many tens of thousands of deaths they cause; attacking nutrient supplements, the FDA always claims “not enough evidence they’re safe” despite not a single shred of evidence to the contrary.

The FDA's actions in 2007 with Avandia are part and parcel of the agency's absolute unwillingness over the last decade to reverse even the most atrocious decisions so the front-line troops (in this case diabetic patients) are the ones who suffer in large numbers.  The case against Ritalin and Celebrex is every bit as strong but in all three of these incidents the FDA seemingly is willing to risk more live and more problems by just printing a stronger warning label.

The FDA which makes twenty-man raids of natural foods stores and offices of doctors who dare to prescribe nutrients (vitamins, minerals, etc.) for their patients has uniformly shown itself to be gutless and toothless when dealing with big food, and big drug companies and the USDA (Agriculture Department). 

The FDA has issued several statements at various times in their history that "no supplement has ever been proven to cure any disease or heal any medical condition."  Amazing that they've never heard of Vitamin C and scurvy; of Linus Pauling's Nobel Prize; or Louis Ignarro's Nobel Prize.

No Drug Too Deadly for Approval

and Continued FDA Backing

            Many Americans find it difficult to believe that the FDA is a corrupt agency. Well “blatantly corrupt” is the mildest term appropriate for the FDA. As Rajjpuut has been saying all along through the eleven earlier anti-FDA rants, we know that health care change is coming this summer . . . if they only make one change let it be wholesale radical elimination or total reform of the Food and Drug Administration. The outrages continue to mount: Ritalin, Celebrex, Avandia . . . Thalidomide is back again approved by the FDA (Rajjpuut does not make these things up) despite the horrendous birth defects it instigated in the 60’s. COX-2 inhibitors are allowed again despite 60,000 deaths according to the British Journal of Medicine evaluating the FDA advisory panels decision. The online website naturalnews.com put it this way:

“The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.

“With this decision, a ‘ full safety approval’ by the FDA has now become meaningless. If the agency can put its stamp of public safety approval on a drug that has killed tens of thousands of Americans and that was removed from the market by its own manufacturer following the revelation of studies showing alarming increases in heart attack risk, then what, pray tell, could possibly be the FDA's definition of a dangerous drug?

“For the FDA to consider a drug dangerous, it apparently has to kill more than 60,000 Americans. I'm curious what threshold must be reached before the FDA actually does its job and seeks to protect the U.S. public. Do 250,000 people have to die before the FDA calls a drug unsafe? 500,000 people? How about a million people?”

“There can no longer be any doubt whatsoever about the FDA's true purpose. Regardless of what the agency publicly states, when it comes time to make key decisions about the safety of U.S. consumers, the FDA will side with drug companies every time. We've seen it time and time again: with the FDA's reluctance to pull obviously dangerous drugs off the market in a timely fashion (Rezulin, for example), with the FDA's attempts to silence its own drug safety scientists (censorship of Dr. David Graham, for example), and with the FDA's collusion with drug companies in suppressing clinical trials and other forms of evidence that raise safety questions about prescription drugs. Corruption runs deep at the FDA, it seems.

“This decision with Vioxx and other COX-2 inhibitors was a defining moment for the U.S. Fraud and Drug Administration. It was a moment where the agency could have sided with public safety and held fast to a position of responsibility and ethics. Instead, it chose to favor drug company profits and put its stamp of approval on a class of drugs that is arguably the most deadly drugs ever to hit the open market.

“A sane, ethical FDA would have not only banned COX-2 inhibitors outright, it would have put an end to direct-to-consumer advertising that ultimately led to the over-hyping and over-prescribing of these painkillers in the first place.”

Well said. The FDA does not even appear to be even making a pretense of doing the job it was created for. This once proud federal agency created immediately after the outcry following Upton Sinclair’s novel expose` “The Jungle” outraged the public in 1906 to demand protection from business charlatans in the food and drug industries. Nsaids, as a class are among the most dangerous, least necessary, most expensive and most hyped of any class of drugs.   COX-2 inhibitors are easily the most dangerous of the Nsaids.  Attacking nutrient supplements, FDA always claims “not enough evidence they’re safe;” when defending drugs they’ve let wallow onto the shelves “there’s never enough evidence to prove they’re dangerous” . . . regardless of all the deaths they cause.  This is one dozen rants now . . . the story ought to be clear.  Defend yourself from the protection of the FDA.

The FDA does not even appear to be making a pretense of doing the job it was created for. This once proud federal agency created immediately after the outcry after Upton Sinclair’s novel expose` “The Jungle” outraged the public in 1906 to demand protection from business charlatans in the food and drug industries. Nsaids, as a class are among the most dangerous, least necessary, most expensive and most hyped of any class of drugs.   COX-2 inhibitors are the most dangerous of the Nsaids.

If the citizens of America with all the wealth of information about this most corrupt of agencies continue to stand for it, then they deserve the fruits of FDA decadence heaped upon them. Rajjpuut hopes we are a better more alert and informed people and will rise up and contact our elected officials about this most corrupt evil empire in our midst: The FDA.

Ya’all live long, strong and ornery,

Rajjpuut

FDA failed to pass deadly warning to the one million Americans already taking Avandia.

Stronger Warning Labels?

Yeah, that Ought to Do It!

            There are some environmental extremists who believe devoutly in NPG, Negative Population Growth (npg.org/whatis.html) as the only hope for Planet Earth. Some of the more enthusiastic of them in England have even suggested a “perfect Terrestrial population of four hundred seventy-eight thousand humans. Since the present population of our world is estimated at six and a half billion . . . their best of all possible worlds would require the death of 93.5% of all those presently living. It’s comforting to find out that the NPG group has found a productive outlet for their energies working for the Food and Drug Administration (FDA) in Washington, D.C. The sheer gall of the FDA is only surpassed by its sheer incompetence and they are definitely NPG’s favorite friend . . . .

In early August, 2007, in a classic example of stupidity and by a 22-1 vote the FDA refused to ban the dangerous diabetes drug Avandia, despite 80,000 known deaths, a suspected 205,000 heart attacks and strokes, and knowing it would continue to kill thousands more in the future. Today almost two years later, congratulations NPG advocates, you hitched your wagon to the right horse. Avandia, Actos and the now defunct Rezulin are a class of drugs called TZD’s, oral anti-diabetes drugs developed in the 1990’s.  Rezulin was dropped early on for causing liver damage in a small but significant percentage of the user population. Avandia and Actos were said to be free of liver damage . . . however, recent data shows that both significantly increase the risk for liver problems and Avandia is a cardio-vascular system nightmare: dramatically increasing risk for both heart attacks and stroke.

Ya’all live long, strong and ornery,

Rajjpuut

                In this series of rants against the ultra-corrupt FDA (Food and Drug Administration), Rajjpuut’s premise is that since health care change is coming almost certainly this summer . . . if there were only one improvement that could be made in the American health care mess, that would be to eliminate or totally revamp the FDA. Here we see the FDA at their very hypocritical worst . . . .

                The FDA, approver of the poisonous substances Ritalin and Celebrex which has refused to remove either one of those killer drugs from the market after FDA exaggerations of the two drugs' safety proved to be absolutely erroneous, has attacked cereal maker General Mills for revealing their scientific study showing Cheerios reduces cholesterol 4%.   “Only FDA approved drugs are allowed to make such claims,” is the official FDA lie, ‘er line, on the issue. General Mills, You believed our lies? Shame on you! We’ll bust you to private! 

                Staying true to form, the FDA which is single-handedly most responsible for boosting iatrogenic deaths in America into 4^th place among all deaths (iatrogenic deaths are those caused by medicines and medical treatment) in the nation, fails to mention that the simple fact is this: less than 47% of those who die from heart attacks have elevated cholesterol. The 33 year old lie that high cholesterol brings heart attacks makes statins (cholesterol  lowering drugs) the most profitable of all the billion dollar drug bonanzas in American history for the huge pharmaceutical companies and has probably killed, maimed and injured more Americans than all of our war dead from all the wars in our history, while costing individuals and the government hundreds of billions of dollars for these expensive, dangerous drugs that cure nothing and arguably make strokes much more probable.

                The FDA, which has not shown the courage to attack big food or big drug companies for their improprieties; or to stand up to its sister in corruption the USDA, has however a proven track record for attacking health food stores and individual doctors who have the temerity to prescribe vitamins, minerals or other nutrients for some of their patients’ problems and the FDA now is attacking the most popular semi-healthy cereal in the nation. CLAP! CLAP! CLAP! It makes me so proud to be an American.

                In hypocrisy of the highest audacity, the FDA goes on to say, “. . . Companies that make claims about their whole grain foods are supposed to mention that fruits and vegetables are also part of a fiber-rich diet” which Cheerios does not.    Why are they doing this? Imagine if Cheerios improves its product some day and can say confidently after confirmation from say fifteen studies, “Cheerios reduces elevated cholesterol an average of 32% with a nine week period.” If that were to happen and the statement were true, than there would be clinical study information backing the idea that food can make you healthy: a claim that the FDA adamantly (but wrongly) refutes, “There has never been a supplement or a food that has been proven to cure any disease.”  

Now you and I know that if the doctors find after a few days in the hospital that all your horrendous symptoms show that you have scurvy, they’re NOT going to start feeding you 16 oranges and citrus fruits every day. No, they will probably give you about twelve to fifteen times the RDA of Vitamin C tablets . . . but the FDA statement denies that, denies the experiences of Captain Cook and the epithet “limies” given to British sailors;  denies the Nobel Prize of Linus Pauling; and denies the recent Nobel Prize of Louis Ignarro. The FDA protects the food industry and its lies; the FDA protects the drug industry and its lies; the FDA protects itself and its own lies . . . the FDA attacks those whose products have never been proven to do anybody any harm when used in proper dosage. The FDA is a major cause of America’s health problems and needs to step out of the way, change or blow themselves up.  The FDA, once a great agency created in response to Upton Sinclair's monumental novel expose` "The Jungle" in 1906 certainly will not protect the American people.

Ya’ll live long, strong and ornery,

Rajjpuut

The Hippocratic Oath says, “First Do No Harm” . . . indicating that 90% of the time, doctors could be sued for malpractice for prescribing drugs they know can do enormous harm according to the official list of side effects.

Drug Culture Created by the FDA

and Big Pharmaceutical Companies

Endangers Citizen’s Health

            We all know that Obama plans to put a new health care system in place. Most of us know that it’s doomed to failure at huge expense, (personally and economically) to the country . . . here are the reasons why: 

A.    Government spending programs seldom work. 

B.     The two earlier programs, Medicare and Medicaid, did not help and only made health and cost trends already in place much worse.

C.    And mostly because, the President is NOT expected to address FDA re-organization or FDA clean up in his new program: huge mistake, HUGE!

D.    Additionally, as far as is known, the President is not expected to address a single one of the points brought up by health educator Rajjpuut in his blog series “A Far Better Health Care Alternative.”

The Hippocratic Oath, which doctors swear to, says “First Do No Harm” . . . since study after study indicates that 70% of the expensive drugs Americans take actually have “no effect,” and all drugs created, that means 100% of them, have proven and listed side effects: arguably from 90%-100% of instances when a doctor prescribes a drug for a patient, he is at least technically, if not in fact, breaking the Hippocratic Oath. America is a drug culture. People believe health and happiness comes in bottles. The information found in this paragraph is highlighted because of whistle-blowers who in study after study say that internal memos and other documents generated by the drug companies themselves reveal pretty much those same two sad statistics.

            When it’s also considered that a huge percentage of drugs are only designed to mask or alleviate symptoms but NOT to cure any underlying conditions and all these drugs too have annoying, dangerous and/or deadly side effects . . . the magnitude of the problem becomes clear. The FDA, by approving these palliatives and their side effects is making America’s health problems worse. The fact that drug companies now have the option to legally bribe** the FDA to expedite putting the drugs on the market has exacerbated an already horrendous problem. 

Need Rajjpuut mention that statins are the single most profitable drugs of all time and PPIs are very nearly as profitable?????? Of course a more horrendous example of FDA corruption is the conflict of interest that lead to the Celebrex (used for osteoarthritis; rheumatoid arthritis and painful menstruation) disaster in the first place and that same conflict of interest has kept that deadly drug on the market right up to the present moment with extra warnings added to its packaging. “First Do No Harm,” indeed!

Live long, strong and ornery,
Rajjpuut   

**   the correct term is "bribe" but the FDA calls them "expedited evaluations" or "expedited reviews"

Regular readers of Rajjpuut’s little rants will recognize a strong personal antipathy toward the FDA (Food and Drug Administration). That once great organization created in 1906, the very year that Upton Sinclair’s monumental novel/expose` “The Jungle” hit the bookstore shelves, has degenerated into the most corrupt federal organization in America. Rajjpuut, health educator he, believes that only a complete top-to-bottom remake of the FDA will allow any health care plan, now or in the future, any hope of success. 

At the FDA it’s not considered “conflict of interest” if the public doesn’t know

At more than 90% of evaluation and recommendation meetings at least one member has a conflict of interest

is NO Concern of the FDA

            Before a drug is approved for the public the FDA will listen to a presentation by the drug manufacturer and then listen to expert witnesses.  Federal law prohibits the FDA use experts with financial stakes riding on the FDA decisions. According to NY Times Best-selling author Kevin Trudeau, however, this is a rule that is quite commonly waived.  Trudeau says that the FDA keeps these meetings secret as well as which companies are involved, what the nature of the conflict is, and how much money may be involved. Your tax dollars at work protecting you!  Rajjpuut has heard that waiving the conflict of interest rule might happen nine or ten times a month. Reuters and USA Today has run articles that imply a far greater degree of financial involvement than that, however -- that well over half the experts the FDA calls upon for testimony have a direct financial interest in the drugs or subject matter being evaluated. With stock ownerships, grant money, consulting charges or other incentives involved, Rajjpuut believes that if three times in every hundred instances the “expert” testified against his own best financial interests that would be very surprising. 

At the FDA what the public doesn’t know, can’t hurt them (“them” being the FDA). According to Trudeau, once the experts have been heard from (and there’s only one side represented in 85% of instances) it’s very rare that the FDA rules against their advice in broad general matters. If a specific drug is the subject of evaluation, the FDA appears far less biased: at these meetings only 30% of the experts on average have financial conflicts.

            Does this “unbiased” FDA evaluation process work? Listen to the extensive list of side effects that get mentioned every time some drug is advertised on the air. And what happens when the side-effects are truly dangerous or even deadly? The FDA very seldom “pulls” a drug from the market. Instead they typically recommend including another warning on the packaging. Before 1990 less than 60% of drugs were approved today it’s over 80%. Before 1990 about 5% of the drugs approved by the FDA were brand new to the world. Since 1998 the FDA has made enormous amounts of fees approving drugs, 2/3 of them first-time drugs on the market. It is now also considered part of doing business normally for the drug company to legally bribe** the FDA to conclude it’s business much faster than unbribed examinations take. 

            The Celebrex story is one of the most infamous of FDA approved drug debacles, Celebrex is still on the market despite a horrendous record with deaths and injuries. Despite this when it was reviewed the FDA recommended it stay on the market.  According to Kevin Trudeau virtually every advisory panel member profited from the decision to keep it on the market. Statins (cholesterol lowering drugs) are dangerous, expensive and amount to a virtual life-subscription. Guess what? Only 47% of the people who die from heart attacks have elevated cholesterol readings.  The FDA was aware of studies showing that cholesterol had no cause-effect relationship with heart attacks back in 1976. For several years the FDA allowed eggs to be attacked as dangerous causes of high cholesterol and to this day allows drug companies to sell dangerous, expensive statins with utter impunity.

Acid Reflux medicines (proton pump inhibitors) are potions without a real disease. 90% of the time when heartburn strikes, the cause is too little acid, not too much. Acid reflux medicine actually makes heartburn worse.

Rajjpuut wants to puke when he thinks about the FDA and its horrendous corruption, but he’s afraid someone might give him some FDA recommended medicine – oh no!

Regular readers of Rajjpuut’s little rants will recognize a strong personal antipathy toward the FDA (Food and Drug Administration). That once great organization created in 1906, the very year that Upton Sinclair’s monumental novel/expose` “The Jungle” hit the bookstore shelves, has degenerated into the most corrupt federal organization in America. Rajjpuut, health educator he, believes that only a complete top-to-bottom remake of the FDA will allow any health care plan, now or in the future, any hope of success.