FDA Corruption Charges Letter Verified

by RS Bailey

In 2009, just as President Obama was taking office, nine scientists and physicians working at the Food and Drug Administration (FDA) sent him a letter, openly stating and giving examples of FDA corruption that was being perpetrated at its highest levels. The nine signers had their names blacked out for fear of reprisals. The FDA recently authenticated the letter, which is about as close to an admission of corruption as the government is likely to get.

 

THE LETTER: Department of Health And Human Services Dated March 8,2010

 

The FDA “is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.” This statement was made by FDA associate director of the Office of Drug Safety, Dr. David Graham almost two years ago.

 

In 2009, I remember reading an article quoting An FDA official who was trying to make the sales of some nutritional supplemental illegal because a drug company was developing a product from it. The article quoted him as saying the sale of the supplement was unfair competition. Since that time numerous incidents have taken place blatantly showing that the FDA no longer is a watchdog for the people but rather an organization increasingly designed to facilitate getting products to market.

 

The letter reveals more, stating in no uncertain terms that “the Director of the Office of Device Evaluation (ODE) has: Ordered physicians and scientists to ignore FDA Guidance document, knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions, issued illegal documents that are not publicly available and would circumvent scientific and legal requirements, failed to properly document significant decisions, made and allowed false statements in FDA documents, allowed manufacturers to market unapproved devices, removed Black Box warnings FDA experts recommended, bypassed FDA experts and failed to properly label devices ,and excluded FDA experts from meetings when manufacturers didn’t want them there.” And this is only the tip of the iceberg.



FDA Administrators routinely become employed by companies representing Pharmaceutical or Agribusiness companies or come from those companies to “facilitate” their interests. FDA Commissioner, Lester Crawford, approved Merck Pharmaceuticals’ Vioxx. By this time most everyone has seen the TV commercials for law firms trolling for clients in class action lawsuits because Vioxx is linked to 140,000 heart attacks and 60,000 deaths. After resigning Crawford became senior council for Policy Directions Inc, Merck’s PR firm.

 

It should be noted the FDA doesn’t actually conduct any scientific clinical trials of any drug it approves; it relies entirely on a drug company’s self-funded tests to determine whether the drug is safe or not. “If the drug company doesn’t present evidence that there’s a safety problem, the FDA presumes that the drug is not unsafe.” And FDA scientists are kept out of the meetings if they disagree or their input ignored.

 

As the letter in question stated, “The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.” The Wall St. Journal reported “managers have ordered intimidated and coerced scientists to manipulate data in violation of the law.” The letter also names names and speaks of, “extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA.”

 

These days the FDA is also involved in much more that the drug market, they are approving the genetic modification of agricultural crops despite the clear scientific evidence showing the very real danger of continuing to do so.

 

In the beginning of the letter it clearly states, “…those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.”

 

It has not happened yet. It should be noted that the Pharmaceutical and Agricultural companies in question are among the largest contributors to political campaigns and involved in spending the most money lobbying members of both political parties.

 

Perhaps it’s time to drop a line to your Senators and Congressperson to ask what’s going on.

 

References:

 

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32 Responses to FDA Corruption Charges Letter Verified

  1. steven sanfilippo

    It seems odd to me that the FDA wants to get there hands in electronic cigarettes when it is the most effective way to quit smoking. They asked for 25,000 signatures for our voices to be heard, we got that and they raise that number to 100,000. Seems to me that it isn’t about protecting us. What it is really about is the mighty dollar and how this way of quitting smoking is effecting sales of their quit smoking drugs such as Chatex, etc.

    • Electronic cigarettes aren’t safe either. They have unregulated amounts of nicotine in them. Most of the “juice” is made in peoples garages, not laboratories. what’s going to stop someone from giving you a lethal dose of nicotine and you never even knowing. There is no research determining if propylene glycol being “vaped” over long periods of time has any health issues. That and the flavoring in your lungs. Some of those flavors are so acidic that they can dissolve plastic! Why would anyone want to put that in their lungs? Electronic cigarettes need some type of regulation, it’s the wild west right now.

      • First of all, it would be highly, HIGHLY, HIGHLY unlikely (impossible, really) to get a “lethal dose” of nicotine through inhaling it. If you’ve ever smoked, or vaped, you KNOW when you’re having too much nicotine. One puff of something that’s too strong, and you’ll get lightheaded and end up with a headache. You’ll toss the liquid, complain to the supplier, go to a message board and the word will get out, and they’ll be out of business. The way it should be.

        Secondly, we really, really – as a society – need to get over this irrational fear that someone “making something in their garage” is a horrible thing. Lab created products are constantly being contaminated – constantly – and aren’t any kind of insurance against potentially being harmed by something. If you know your supplier, and they are forthcoming with their business practices, it is NO ONE ELSE’S business whether or not you purchase something from them. If you don’t know your supplier, and they are not forthcoming with their business practices, don’t buy from them. Grow up. GROW UP and learn what you’re purchasing instead of relying on jackholes at the top telling you something is safe. Because, as clearly noted in this article, things that are regulated from the top are as shady as anything.

        Lastly, propylene glycol has been used for decades in asthma medications. Don’t you figure that if there was some hugely inherent danger in puffing on propylene glycol several times a day, we’d know it by now?

        Ultimately, the regulation should go like this: Here. There might be some dangers to doing this. We’re going to check into it, and until then you’re taking your own risks. Because you’re adults. And you’re allowed to take risks with your own body (because if you’re not allowed, then it’s not your own body).

        Keep the corrupt and broken, bought and corporate-infested FDA OUT of the one thing that’s helped me quit smoking. And if YOU are not vaping, it is not your business. Let the people who are actually partaking worry about it, yeah?

        • Asthma inhalers do not contain propylene gylcol. But, some anti-freeze does!

          • Wow. You’re either a shill or a troll to throw that out there. Antifreeze also contains water. Should we be concerned about water?

            Propylene glycol is used in antifreeze due to the fact that it lowers the melting point of water, which makes it less susceptible to freezing. It is also used as a preservative in foods, as well as medications and personal care products.

          • Oopsydoodles!

            http://www.ehow.com/about_5499611_danger-inhaling-propylene-glycol.html

            > PG has been used as the aqueous-based chemical additive in asthma inhalers and nebulizers since the 1950s, with no serious side effects known. PG, because of its water-retaining properties, is the compound of choice for delivering atomized medication. It is also a common diluent for injectable medications, constituting 40 percent of the intravenous form of Phenytoin, an anti-seizure drug.

          • You know what else can be found in antifreeze? Dihydrogen monoxide.

          • yea and all that booze people drink is also contained in petrol fuels…..whats your point?

          • You may be correct that asthma inhalers don’t normally contain PG, however there are various asthma and breathing medical treatments that do contain PG. The primary component of medicine when it is used in a nebulizer is propylene glycol. PG is a simple alcohol solution and has been GRAS (Generally Recognized As Safe) by the FDA since the 1950s. Some hospitals actually vaporize PG directly into their air supply which is then distributed throughout the entire building because PG is a natural anti-bacterial. PG is in so many products that every day consumers use today because it is a stable and safe substance

            You are also correct that some anti-freeze contains PG. Anti-freeze which has been directly formulated to be non toxic and environmentally safe. It’s not as if people are vaping diethylene glycol here, which is exactly what you want them to think with your completely unclarified statement.

            Stop your fear mongering.

          • It’s used as a base in an inhalant for lung transplants
            http://www.ncbi.nlm.nih.gov/pubmed/18158714

          • Propylene glycol is a non toxic ingredient in Anti-Freeze and is recognized as safe by the FDA. And yes, Propylene Glycol is used in Asthma inhalers and nebulizers.

          • Good to see you have absolutely no clue wtf you’re talking about. You’d make a great FDA employee.

      • Electronic cigarettes are a lot more safe than you imply, and the research that has been done on them clearly shows that. Propylene glycol has been researched for decades. Your comment seems to be made in haste and based on assumptions and personal opinion. Please try to educate yourself and spend a little time reading all the research linked to on casaa.org before coming anymore conclusions.

        • casaa.org only has five studies cited. Only one study deals with consumer safety. In which, they took 32 smokers who consumed 20 cigarettes or more a day and had them “vape” for four weeks. Then they measured their vitals. FOUR WEEKS! That’s not a long term study. And, they used people who were already smokers, peoples who already had health problems. How is that a valid study? The other studies are irrelevant, dealing with depression and withdrawal symptoms.

          No, my comment was not made in haste and I’m well educated on the matter.

          • Actually, you have *proven* yourself to be uneducated on the matter with your comment on Propylene glycol above.

            Since you’ve been proven to spread misinformation, would you mind telling us how much are you paid to spread these lies? Only a paid shill would deliberately spread such easily refutable lies.

          • You should probably exert more haste in researching a topic then.

            Have you ever taken a pack a day smoker off cigarettes for 4 weeks? It’s a significant study if you know anything about it. Trust me, you’re the definition of “Armchair Professor”. Stick to the forums, troll.

          • Actually, no you aren’t. You’re spreading misinformation and ignoring when people call you out on it, then you continue spreading your BS. It’s cute that you think you’re educated on the subject but it’s very apparent you haven’t a clue. Self assurances that you know what you speak of are irrelevant and already proven false.

            It’s also cute to “cherry pick” and imply that the CASAA studies are the only studies either performed or currently being conducted. Nearly any serious and non-biased study has found risks comparable to caffeine consumption.The very fact that CASAA is ALL you came up with in your initial post shows you obviously didn’t look very hard.

            I suppose next you’ll tell us about the PHD/Bachelor’s in Biochemistry AND Physics you possess. On the internet I’m a finnish supermodel. What’s your story?

            P.S. Before one proclaims their intelligence, perhaps one should address their ignorance.

      • Coke can dissolve nails, better take that off the market too! The things that can crack a plastic tank used in egigs are usually citrus. I buy e-liquid that is all US made and the nictine is sourced by the same place that Johnson and Johnson get their nicotine. Please do some research and don’t fall for the scare tactics.

        • Your gastric acid has a pH of about 2-3.5. Coke has a pH of about 3. Pouring coke in your stomach is a whole lot different than inhaling acid into your lungs.

          • Why the fear mongering? ACID… so scary wooooooo. And made in dirty BATHTUBS, oh my. Some e-liquid might have components that are acidic, that will crack a plastic tank that’s not made for that application. And gastric acid has a PH of has a pH of 1.5 to 3.5 so you missed by .5 You can twist your “facts” to fit your statements as much as you please, that doesn’t make them relevant. Lighten up Francis.

      • What is made in the overly taxed “garages” (LIE), has been grossly exaggerated to undermine the small businesses that together while providing safe alternative non-tobacco nicotine flavored e Liquid for Electronic Cigarettes, have nearly encroached on… what funds politicians, FDA, Big Pharmaceutical Companies, that have dubbed themselves THE NEW WORLD ORDER! Out of control mega profiteers whose support is funded by Blood Money, the ill health of SMOKERS, since the middle of the last century. I WILL NOT LET YOU BLAME, SHAME, and TAX ME TO DEATH. Electronic cigarettes are an adult product, no matter the flavor, intended for recreation and are not medical, drug or tobacco products! See you in court (UNITED STATES SUPREME COURT!)

  2. Thank you for this. So well written…do you think that you could update their Wikipedia bios?

  3. Pingback: New Tobacco Sheriff in FDA Town

  4. Watergate Seagate

    Walter Seagate, since you seem so enthusiastic to disparage e-cigarettes, can you please link the clinical trials that prove the claims that you’re making?

    Similarly, you seem to ignore that there is a preponderance of evidence that regular cigarettes cause massive societal harm. Most people are using e-cigarettes as a form of harm reduction, why not allow the evidence to speak. Many of the claims you’re making are blatantly false or merely speculation. For one, asthma nebulizers have contained propylene glycol since around the 1940′s.

    You seem like a shill for e-cigarettes or pharma, who responds so consistently and promptly along the party line to every post, just my two cents.

  5. Pingback: E-Cig News and Legislation • FDA corruption | thecapecoralvapestore.com

  6. ok so everyone is in a pissing match about is PG bad for you. well i dont think anyone can argue that cigarettes ARE BAD FOR YOU. there is no room for any arguing there. CIGARETTES WILL KILL YOU. PG most likely wont. enough said.

    and saying the ingredient x is found in product y so ingredient x is unequivocally bad is just stupid and shouldnt even be acknowledged.

  7. Congratulations Walter Seagate. Many people will read your alarming posts and decide not to try ecigarettes. Those people will wind up continuing to smoke tobacco, because we all know the published data from clinical trials of current smoking cessation products show failure rates of up to 95%. These people will continue to smoke and get sick or sicker and eventually die from smoking related illness. Give yourself a pat on the back because hey, your doing your bit to make this happen!

    I myself have been ‘vaping’ since 10/16/2009 which was when I quit a 37 year pack and a half day cigarette habit that I am 100% SURE was slowly killing me by switching to ecigarettes entirely. My doctor used to check my lungs by stethoscope at every visit because I was always congested and hacked all the time with a wet flemmy smokers cough. After a couple of years checking my lungs after I switched to vaping and finding that, in his words, ‘they sound perfect’ He doesn’t always check my breathing. The reason for this was I quit breathing in smoke on a regular basis and I now breathe in vapor – usually propylene glycol, which is in many food, drug and cosmetic products because as stated by government health agencies that….well here is what they state…

    “Propylene glycol is considered Generally Recognized As Safe by the U.S. Food and Drug Administration, and it is used as an humectant (E1520), solvent, and preservative in food and for tobacco products, as well as being the major ingredient in the liquid used in electronic cigarettes (along with vegetable glycerine and, more rarely, PEG 400). It is also used in pharmaceutical and personal care products.[4] Propylene glycol is a solvent in many pharmaceuticals, including oral, injectable and topical formulations, such as for diazepam and lorazepam that are insoluble in water, use propylene glycol as a solvent in their clinical, injectable forms[7].”

    In conclusion, I’m quite certain that switching to ecigarettes has improved my health and quality of life at the very least and literally saved my life at the most.

    Everything I’m saying I know first hand to be true and I can sleep well at night knowing that. How have you been sleeping Walter? Is money really that important to you that you perpetuate the death of over 5 million people a year? Hey, I’ll bet your a lawyer…amirite?

    Ralph

  8. Pingback: CSP Daily News | February 25, 2013 Analysis: FDA’s Tobacco Transition Zeller inherits a lot of uncertainty; will he bring quick answers? | Vape Mongers

  9. PHARMACEUTICAL COMPANIES CONTROL POLITICIANS, DOCTORS, FDA, AND ALL THE SO CALLED HEALTH(sic)CARE ORGANIZATIONS, RIGHT ON UP TO THE PRESIDENT OF THE UNITED STATES OF AMERICA. THEY ARE THE NEW WORLD ORDER. THIS IS UNCONSTITUTIONAL and the PEOPLE HAVE SPOKEN remember the people, we the people? hm?

  10. Pingback: The FDA : sigh :

  11. Wish some of these comments had “like” buttons!

    “Likes” go out to Steven Sanfilippo, Elle, James Callahan, Mike, Brandon, Todd, Jenny Tailia, rwoodin, and Lisa Belle.

    Can’t add anything more since these people already said it! :)

    As for Walter Seagate, he needs a “you’re either an idiot or a troll” button!

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