By: Philip | 12-03-2017 | News
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FDA Withholds Potentially Damning Evidence On Controversial Drugs

If the FDA lying about kratom (as recently released FOIA documents suggest) is the bullet then the news released today at Scientific American may just be the smoking gun as far as FDA corruption. The FDA recently issued an advisory regarding kratom, alleging it was a dangerous and addictive drug with the potential to worsen the opiate epidemic. This is utter hogwash and based on "junk science" as per Dr. Jack Henningfield, an authority on addiction and abuse and a former chief of the National Institute for Drug Abuse (NIDA) and Johns Hopkins professor. When a Reuters reporter asked the FDA for more information about their allegations in the kratom advisory warning, the FDA referred them to the Freedom of Information Act (FOIA). This was apparently a bluff, which was called in mid-November. According to FOIA documents published at MuckRock, the FDA appears to have lied about having "clear data" and "evidence" supporting their "junk science" claims about kratom's potential dangers, as well as the make-up of consumers and how it is marketed.

It goes further than this, Reuters had previously written regarding <a href="">Big Pharma breathing a sigh of relief</a> with Scott Gottlieb helming the FDA. Time magazine and many others had called Gottlieb as far back as 2005 on the <a href=",8599,1109304,00.html">many potential conflicts of interest due to his multiple pharma ties.

<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr"><a href=";ref_src=twsrc%5Etfw">#FDA</a> isn&#39;t really fooling anyone with their <a href=";ref_src=twsrc%5Etfw">#kratom</a> press release. It&#39;s time for the people to have a say in decisions made by the government, end the corruption. <a href=";ref_src=twsrc%5Etfw">#KeepKratomLegal</a> <a href=""></a></p>&mdash; Nina (@Neenahh1) <a href="">November 18, 2017</a></blockquote>

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<blockquote>“They delivered hundreds of pages simply marked, for example, ‘57 pages removed,’ or ‘43 pages removed… Other documents have whole pages, paragraphs or sentences redacted with no explanation for what has been withheld or redacted and why. In fact, the FDA redacted some of the same documents differently and even redacted one of my own letters to them on a different matter….”

Reporters like me have encountered similar roadblocks when covering the FDA. (For example, when I was trying to investigate how the agency was handling a massive case of fraud that undermined the data behind a number of approvals, the agency refused to release the names of the drugs that were affected.) On occasion, the agency is not just slow to release information about problems it's finding with drugs, but it has even been willing to reassure the public about products that later turn out to be dangerous. So the public can't rely upon the agency to release everything that's important to know, and objective data that the agency uses to make its decisions have become quite valuable for understanding, not just the FDA's decision process but also whether it's been making good calls or bad ones</blockquote>

Scientific American author Charles Saife knows the FDA corruption beat well and describes the peculiar difficulties with covering the FDA is their reticence to release information to reporters or even other facets of the Federal government. Saife writes of Sen. Chuck Grassley, exasperated at the FDA for "using every trick under the sun" to weasel out of sharing information related to their approval of yet another entry into the canon of "killer drugs that should never have been approved."

<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr">&#39;The FDA has had a &quot;revolving door&quot; problem for years. Some, like Daniel Fabricant — the former head of FDA’s division of dietary supplements — even return to the FDA, then bounce back to work in industry again.&#39; <a href="">@DrFabricant</a> <a href="">@SGottliebFDA</a> <a href=";ref_src=twsrc%5Etfw">#corruption</a><a href=""></a></p>&mdash; Kendra Parris (@parrislaw) <a href="">November 25, 2017</a></blockquote>

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In the case of Sarepta the FDA seems to not only have approved a dangerous drug knowingly, but intentionally obscured the known adverse effects of the said drug, eteplirsen in this case, but there are many just like it. There are, of course, those who give the FDA the benefit of the doubt. <a href="">Ellis Unger, MD wrote a letter to a Dr. Saper</a> who accused them of "scientific misconduct." Dr. Unger adjudicated for the FDA as best he could, at least.

<blockquote>I think this represents sloppy science, not scientific misconduct.</blockquote>

But what if this "sloppy science" results in thousands of deaths while accruing billions from drugs that never should have been made public? One of the leading preventable causes of death in the United States is not prescription overdose from opiates. Though some 90 on average die per day from an overdose of opiates, this number is dwarfed by the 128,000 people who will die in the U.S. from taking their prescribed medications as advised. That's over 350 people each day, even in leap years. 6 drug channel companies made the top 25 of the Forbes 500 last year, pharma manufacturers made less owing to factors such as the cost of new drug development. Even accounting for such major costs the top 10 pharma companies managed comfy sums between $11.2 billion and $71.9 billion. In case you were wondering, $71.9 billion dollars divided by 128,000 deaths equals 561,718.75… what unit would it be? Death/Dollars? Dollar/Deaths? Ah well, let's think silver linings here… wasn't the planet overpopulated anyway?

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Charles Saife fears that what these repeated incidents show is that the FDA, not unlike Robocop, has a covert mission beyond that of merely protecting the public. "The public's interest in knowing the truth about a drug is secondary to the interest in protecting a company from harm." Ultimately, this is proving "toxic for our confidence in the FDA."

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10 Comment/s
Melissa marshall No. 13268 2017-12-04 : 08:37

Kratom is helping people live a healthy productive life!! It is a natural tea! It scares the FDA that people will nolonger need their over priced poision! Its about time we call the real health crisis out! #iamkratom

Anonymous No. 13284 2017-12-04 : 09:49

The FDA needs to return to its Pre-AIDS policy days of requiring extensive testing before fielding medications.

Remember back in the early 90's the FDA loosened its long standing policy requiring of years of testing and sampling to accommodate the increasingly violent ACT-UP protester demands for releasing AIDS med's.

Anonymous No. 13287 2017-12-04 : 10:03

Regarding KRATOM, lets discuss ALL the FACTS:

* 660 Poison Control calls covering interaction, seizures, deaths .

* State and Federal and CDC documented deaths, reactions, and etc.

ALL Sides need to be truthful.

Just do a "

Google Kratom deaths by state" .

Anyone doing so will quickly see it is NOT 100% harmless. Sure there are people stating they have been using it for years without problems.

NEW USERS - should carefully review the FACTS from both sides and avoid decisions based solely on opinion and personal use statements from either side of the issue.

Interesting to note: One of the uses for Kratom in the past.

Employers and task masters in Asian History have used it to pacify workers and speed up their productivity.

Anonymous No. 13300 2017-12-04 : 13:35

Anonymous 12387 sounds like they are talking about fda approved pharmaceuticals. I have NEVER had a seizure from kratom. I HAVE however started having seizures while taking opiods and trying to get OFF of the opiods after NEVER having a seizure IN MY ENTIRE 41 YEARS OF LIVING. I literally beat cancer, I'ver overcame a stroke, learned to walk again, and healed multiple organ failure only to have ALL of that stripped away in 4 years due to fda approved "drugs". KRATOM IS A TEA LEAF, NOT A DRUG. IF YOU CLAIM TO WANT TO SOLVE TO OPIOD EPUDEMIC, YOU CANNOT BE AGAINST KRATOM.

Anonymous No. 13305 2017-12-04 : 14:57

Anonymous 13287, considering that ALL the kratom "associated" deaths involved poly-substance, and quite a few of them included loperamide, which can cause sudden cardiac arrest, I have to ask how many of those 660 calls also included other substances? Have you looked over the dictated notes or listened to the call recordings? And, what were the outcomes of those calls? Let's look at ALL the FACTS.

Anonymous No. 13315 2017-12-04 : 17:24


Even if those 660 calls were all valid, none ended in death. Forensic toxicology expert Dr. Karl Ebner and molecular biologist Dr. Jane Babin and former head of the National Institute of Drug Abuse have throoughly debunked the supposed "kratom deaths" multiple times.

Dr. Henningfield notes that even in cases where scientists TRIED to induce lethal toxicity or respiratory depression in rodents weighing a few ounces they could not. This doesn't happen with alcohol, sedatives or opiates. A certain amount of those drugs WILL kill a rodent. Kratom constituents have NOT ever in laboratory (or other) conditions.

As far as "660 calls" over a period of several year.s Did you know HUNDREDS die from laundry pods each year? 100,000 calls or so each year for antihistamines. Around 100,000 calls for acetaminophen. Should we ban them? Coffee kills EVERY YEAR. A recent study explored 50 caffeine overdose deaths in the last few years.

Compared to laundry pods, nicotine, processed sugar, alcohol, acetaminophen, caffeie and LOADS of other products it's not only less dangerous, but MUCH more healthy. Kratom has several health benefits that are supported by rigorous scientific research.

350 to 360 people die EVERY DAY from taking their prescription drugs AS ADVISED. That's 4 times as many as die from opiate overdose. 350 people PER DAY, but kratom is a danger? Get your priorities straight.

Elle No. 13316 2017-12-04 : 17:44

First replying to Anonymous No. 13287 - People should understand that if you land in the ER, the healthcare staff will call Poison Control to check on ALL substances that have been mentioned to be in your system to check for contraindications with other things you took & what they might give you for treatment. If you mention you’ve taken kratom, since this is not a widely known supplement, almost all responsible Drs will call poison control and get the information on kratom (along with anything else you take that they want more information on) so they can get a better understanding of the situation. A call to poison control does NOT insinuate that kratom is the CAUSE of what issue you are having. The truth is that kratom helps pain so it only makes sense that people who are also taking prescription drugs and street drugs might also have this SAFE supplement in their system along with other things that are really the cause of people’s health issues. The list of complaints has been released and out of 42 not a SINGLE one had just kratom in the system. It was all a combination of opiates, benzodiazepines, steroids, antidepressants and other prescription drugs known to interact. There are also a few than include loperamide which is known to be severely abused by people trying to beat withdrawal and causes fatal cardiac events. Mitragyna Speciosa (kratom) has been legal in most of America always because people do take this responsibly and it has an incredible track record of safety. In studies done with lab mice they could not cause an overdose with kratom, it wasn’t possible. The only was to kill the mouse was to give it so much plant matter that it got constipated and suffered a bowel obstruction which could happen by force feeding any plant. Kratom does not cause respiratory depression.

The people who take kratom are veterans, parents, caregivers, and hard working citizens. Kratom doesn’t impair you, it allows you to lead your normal day with a reprieve from some of the worst chronic pain and mental health issues. If you take away kratom, which should be available in the toolkit for all sorts of patients since it is so effective and safe, you are taking away American rights. This is an effective plant that doesn’t have the dangerous side effects of pharmaceuticals. It should be lauded but because there’s no money it for the pharmaceutical companies they want to remove it from competing with their market.

Remember, we have filed an FOIA and so far we have received NO evidence to back the wild claims from the FDA. Their own internal FAERS system does not even have record of these claims.

Still believe that FDA could only have your health and safety at heart? Look up #Essure and read about the 20,000+ serious complaints and legal filings about this dangerous FDA approved implant that they are STILL promoting and implanting into American women everyday (even though it’s been pulled from the market in all other countries!) this implant migrates and causes intractable pain, bleeding, inflammation, systemic allergic reactions, a whole cluster of horrific symptoms that lead to women losing body parts every single day as doctors have to cut their uteruses out to stop the damage.

If you are interested in learning more about kratom, I implore you to gonto and read a wonderful compiling of actual science, the 8 factor analysis, and experiences from the awesome people it helps. While you are there if you could sign the petition and the open letter it would help us greatly. Thank you for reading. #kratomsaveslives #keepkratomlegal


Joy No. 13321 2017-12-04 : 20:12

This article perfectly sums up the current situation with the FDA (& DEA). The scheduling of #kratom is NOT for our benefit! The banning of a safe, natural plant ONLY benefits the rich pharmaceutical companies. Whether the American people suffer and/or die is not the FDA’s or our government’s priority. #keekkratomlegal #iamkratom #kratomchangeslives

John Deininger No. 13324 2017-12-04 : 21:07

Anonymous No. 13287. Would you mind sharing a source for that little 'history lesson' about "employers and taskmasters in Asian history"? As you seem fond of presenting facts without context (sort of like the FDA) you'll forgive me for not taking your word for it.

Glen No. 13325 2017-12-04 : 21:26

This is nothing new. The FDA, CDC, and DEA are So crooked only to benefit their agendas! They did this with the False "opiod epidemic" to! Thats mainly just the street drugs, but big pharma is making a Lot more profit off this "epidemic"! Just like that, the FDA has Already given big pharma the exclusive rights to mass produce medicinal mj and Krantom. They havent even finished making both Federally illegal, but they have been working on it obviously.

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