What the role of the FDA really is

by Peter Johnson

In Gary Kohls latest article “A comprehensive list of Vaccine-associated Toxic Reactions,” he once again provides a plethora of unproven, and often erroneous “facts” which he thinks illustrate the dangers of vaccines. And while disputing those who vouch for their effectiveness, as always, he attempts to justify fear of vaccines based mostly on side effects that have long ago been openly acknowledge by vaccine manufacturers. He then  self-righteously denigrates family doctors and pharmaceutical researchers—who supposedly don’t give a damn if the products they sell will Kill large numbers of innocent children and adults?

 
Of course as part of his trope Gary refers to government agencies like the CDC and the FDA as, “Wholly owned subsidiaries of the pharmaceutical industry.” However, portions of this article from Forbes might provide some sorely needed perspective about those claiming that the CDC and FDA are controlled by big pharma;

https://www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/#454cbf628306
 

“Is the FDA Being Compromised by Pharma Payment”
As reported by John LaMattina
 
“A bit of history would be helpful to show the actual reasons why the pharma industry makes “contributions” to the FDA. Few remember that, back in the late 1980s there was a “drug lag” in the U.S. versus other parts of the world. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate in the U.S. than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. As a result, patients, physicians, advocacy groups, and pharmaceutical companies, were all concerned that access to important new medicines was being denied to Americans.”

 
“To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. PDUFA provided a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications…”
 
“Undoubtedly, this legislation helps to support the FDA and fuel needed growth. In 1995, the actual user fee  charged to each company filing an NDA in 1995 was $208,000. In 2014, the user fee will be $2,169,100. If you assume that as many as 50 NDAs are filed in a year, (in 2014) Congress is passing on $100 million of FDA funding costs to the industry.” 

 
In 2017, the cost of application fees was lowered its previous levels by more than 300,000 dollars, to $2,374,200, in order to speed the approval costs of new drugs, and the infamous Dr. David Gorski believes that too little oversight would make drugs and vaccines less safe.
 
“Despite Light’s assertion, I can attest that pharma companies don’t relish making these payments. The FDA is a government agency and should be funded entirely by the federal government. But pharma companies don’t have a choice. If  a company wants to market a new medicine for patients, it has to pay the user fee just to get the drug reviewed. Furthermore, anyone who pays attention to FDA’s behavior knows that the agency doesn’t automatically approve NDAs. Just in the last few months, the FDA has rejected, in the form of complete response letters, an insomnia drug from Merck, a migraine drug from Allergan, and a kidney cancer drug from Avios.” 

 
(My words)
 
“HMMMM? How come federal agencies like the FDA, which are supposedly controlled by big pharma, can require pharmaceutical  companies to pay large fees just to have their drugs and vaccines reviewed? And, why are they also free to reject any drugs made by well-known companies?”
 
 
About claims that the CDC and other government agencies are only in it for the money;
 
https://www.skepticalraptor.com/skepticalraptorblog.php/the-myth-of-big-pharma-vaccine-profits-updated/#Myths_about_vaccine_profits
“It’s estimated that in 2013 the revenue generate by pharmaceutical companies just for their drugs and vaccines exceeded 1.32 Trillion dollars, and  “According to the World Health Organization, estimated 2013 global revenues for vaccines was around US$24 billion. In other words, from the Big Pharma perspective, “vaccines make up around 1.82% of their total expected revenues in 2013.” 
 
“Every drug, whether a new vaccine or new drug for erectile dysfunction, costs aroundUS$2.8 from discovery to regulatory approval (although other analyses show a cost of US$3.8 to 11 billion) each to fully develop, depending on the drug and the market. But despite what some believe about Big Pharma, drug development is not a slam dunk. For example, for many drugs, only around 12% gain final approval from the FDA.”
 
“Since Big Pharma funds its own R&D, it has to pay for both its successes and its failures—using financial data from a typical broad-based pharmaceutical company like Johnson & Johnson, [it] spends about 11.4% of REVENUES (not profit) on R&D (pdf). So out of the US$24.0 billion in Big Pharma vaccine revenue, about US$2.7 billion is removed from the net profit for R&D expenses (which are not counted in the administrative expenses for this exercise), so we’re down to US$7.8 billion.”


“Big Pharma also has to pay taxes on net profit. And because Big Pharma has manufacturing, R&D, and administration facilities in modern nations, (they need access to intelligent, well trained employees), [and] they have a more difficult time in moving revenues outside of taxing authorities. They usually pay around 40% in taxes on the net profit. And they have to depreciate all of their capital…”

 
‘Companies need to acquire technology too, which costs money. Back to Johnson & Johnson (JNJ). They weren’t much of a player in vaccine manufacturing and sales until 2011, when they paid US$2.4 billion for Crucell, a manufacturer of vaccines. In other words, JNJ expended one year of profits for every vaccine sold in the world, just to purchase one vaccine manufacturer.”
 
“When all is said and done US$24 billion in Big Pharma vaccine revenue, means  around US$2.5 billion in net vaccine profits--(usually stated in accounting terms as EBIDTA).”
“It may actually be quite a bit less, because I’m ignoring things like cost of risk capital—even though Big Pharma is mostly self-funded, it’s not always so. And if that capital could make more money invested in gold or something, it’s a lost opportunity. Given this level of profit, and spread over 50 or so vaccines, it’s hard to imagine that Big Pharma executives are sitting in that Boardroom laughing about how they’re printing cash and storing the gold in gold bars because of vaccines.”

 
At the end of his recent article Gary includes a long, long, list of (adverse reactions ), which (may) result from using vaccines?. And, although Kohls says pharmaceutical companies are making profits while claiming that their vaccines are 100% safe—that’s just not true! In fact, in one of my recent rebuttals of Gary I provided a similar list of vaccine side effects that the pharmaceutical industry acknowledges! However, perhaps I, should also heed the list of  negative side effects found on the labels of my own drug bottles? 

 
Wow! Isn’t it strange how such, “corrupt” organizations agree to provide large amounts of info about  the negative side effects of their own drugs? What happened to those secretive, greedy pharmaceutical companies and corrupt doctors, who we are told, don’t give a rip  if children live or die?
 
And about Kohl’s strange idea that Amish communities which are not vaccinated enjoy natural immunity:
 
https://www.vaccinestoday.eu/stories/top-5-videos-herd-immunity/
 
Specifically at the video link below, you will learn how, close-knit communities. (like the Amish) do not remain immune to large outbreaks of infectious diseases unless those living near them are also  vaccinated sufficiently to establish herd immunity:
 
https://youtu.be/eSp-y2k_5tM
 
https://www.vaccineconfidence.org/usa-officials-hope-to-change-minds-amid-exquisitely-contagious-measles-outbreak/
 
Does Gary really think that lists of potential side effects are NOT completely accessible to all patients before they use big pharma’s vaccines or drugs? You’d think that, if big pharma were truly evil, it would also use lobbyists to eliminate the requirements to list the bad side-effects of any vaccine or drugs (in plain view of consumers)? Also, why should greedy Pharma executives even think of establishing the VAERS (Vaccine Adverse Event Reporting System)? If they are supposedly so ruthless, and willing to sell unsafe medications which they know (WILL KILL) many unsuspecting consumers? That fact is that, under law, each time we pick up prescriptions from our drugs stores, they have a list of side effects on the bottle or bag which contains those prescriptions. So, why are some drug companies considered evil because they sell properly tested vaccines and/or drugs, and openly list the bad reactions that are (possible) with their use?

 
As I said, big pharma and our government agencies have never tried to hide the negative side-effects of their products…a fact which also currently applies to many other drugs—not just vaccines. 
 
Personally, I have serious arrythmia, for which I take several medications that help. Here are some of the known side effects of just one of them:
 
SEVERE ALLERGIC REACTIONS WHICH MAY CAUSE, HIVES, FACIAL SWELLING, ASTHMA, SHOCK, SKIN REDDENING, RASH, BLISTERS, STOMACH BLEEDING, HEART ATTACKS, HEART FAILURE, STROKE, FEELING FAINT, VOMITING BLOOD, BLOODY OR BLACK STOOLS, PERSISTENT STOMACH PAIN, CHEST PAIN, TROUBLE BREATHING, WEAKNESS IN PARTS OF ONE’S BODY, SLURRED SPEECH, LEG SWELLING, PAIN LASTING MORE THAN 10 DAYS, FEVERS THAT GET WORSE OR LAST FOR 3 DAYS, REDNESS OR PAIN, AND WARNINGS THAT WOMEN SHOULD NOT USE IT DURING THE LAST THREE MONTHS OF PREGNANCY—UNLESS DIRECTED TO BY A DOCTOR—BECAUSE IT MAY CAUSE COMPLICATIONS IN PREGNANCY AND HARM UNBORN CHILDREN, OR MAY CAUSE ACCIDENTAL OVERDOSES THAT NEED MEDICAL ATTENTION AT POISON CENTERS!

 
After you acknowledge that all of these side effects above, are openly acknowledged by the company that makes them, you may want to ask, “why then, do people keep using this dangerous medication when its manufacturer has openly listed a host of dangers that (could) potentially result from its use”? Well, first guess what this medication is—That’s right! Common, ordinary, over the counter ibuprofen!

 
Then  there is a common fluid which most of us drink many times a day—which is also known to contain very small amounts of contaminates like Iron, Copper, nitrates, nitrites, hydrogen sulfide, lead, pesticides, fecal matter, chlorine, and may also become hard due to calcium, magnesium and other mineral deposits. But, anti-vaccine advocate are not trying to ban the use of our drinking water--even though tap water (could) potentially cause harm those who drink it?—as it has in some areas.

 
Do you see the point?—It’s easy to spread scary but innocuous information about vaccines which actually represent no serious threats. And, whether Gary or any other anti-vaccine advocate believes it or not, concentrations of Aluminum, mercury,  and formaldehyde in vaccines are so miniscule, that they really don’t pose a significant risks to the health of vaccinated patients—Big pharma also does not facilitate some immoral and/or twisted endeavor to kill innocent children just to make more money! 

 
Can you understand why prominent Drs. and researchers sometime become upset when some innocuous aspect of vaccines is exploited to frighten parents and patients in general?
 
One more thing—in regard to personal testimonies, I recommend the  articles on this website. 
 
http://www.vaccineinformation.org/infants-children/testimtomonies

Also, here is a link to an article written by a woman health professional who explains the very real danger of failing to vaccinate children:
 
https://bluntmoms.com/hey-non-vaccinators-youre-welcome/