Epilepsy Talk

Epilepsy Studies: True or False? | November 15, 2020

There’s a “Golden Rule” which says: “He who has the most gold makes the rules.”

And who might that be? And what are the methods used?

Some are simply amazing. (Or at least I thought so.)

But they all follow the “Golden Rule.”

Did you know about the “The Foreign Factor”?

These days, most pharmaceutical companies are doing 100 percent of their testing offshore.

In countries like Kazakhstan, Malawi, Uganda, Iaşi, Mégrine, Tartu, Estonia, Bangladesh.

Why these remote never-heard of outposts?

Because it’s very cost-effective.

Think of some guy who makes a paltry amount a month, suddenly offered a windfall of money just to take part in a simple test.

No mind that he may have malaria or tuberculosis, which can skew the outcome of clinical trials. As long as he’s breathing, he’s eligible!

Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.” 

Inside the United States, doctors who oversee trials are required to fill out nasty forms showing any income they’ve received from drug companies to guard against financial bias in the trials.

One big factor in the shift of clinical trials to foreign countries is a loophole in FDA regulations: If studies in the United States suggest that a drug has no benefit, trials from abroad can often be used instead to secure FDA approval.

And the FDA does so little monitoring that the companies can pretty much do and say what they want.

In fact, the inspector general found that 20 of the largest U.S. based pharmaceutical companies now conduct “one-third of their clinical trials exclusively at foreign sites.”

And if you’re vying to come to market, you’re competing with up to 2,900 different drugs for some 4,600 different conditions.

So you better get that clinical testing done fast. And favorably.

Meanwhile, Nero is fiddling while Rome is burning…

At the same time that controversy is swirling around new drugs, the FDA continues to slap medicines with new warning labels — especially those famous (and useless) black-box warnings that indicate the most serious potential reactions.

Yet do they really know, since most of the problematic drugs have all undergone testing outside the United States?

Well, things aren’t so rosy in America either…

Once upon a time, clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards.

But the money just isn’t there any more.

Today, it’s mainly “independent contractors” who recruit potential patients.

They make the rules, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns.

The people doing the work on the front lines are not independent scientists.

They are wage-earning technicians who are paid to gather a certain number of human beings. Sort of like a cattle round-up!

Data is made available to the public on a need-to-know basis. And guess what? The outcome is always favorable to the interested parties.

Outcomes are not only selectively reported, but negative results are reported in a positive manner and conclusions are often not supported by results data.

For instance, a comparison of study characteristics reported in FDA reviews of New Drug Applications found that 9 of 99 conclusions had been changed in the publications, all in favor of the new drug.

Published evidence tends to overestimate efficacy and underestimate safety risks.

This is particularly troublesome since these documents are being used to support decision-making in the health care system.

Reporting bias may result in inappropriate health care decisions by policy makers and clinicians, which harm patients, waste resources, and misguide future research.

But hey, you can always do post marketing studies. To prove the further efficacy of your drug or even to expand its use!

Biased studies — Misleading Statistics — Marginal Efficacy — Unacceptable Risk

If the effects are adverse, just play them down. (Can YOU read the warning paper that comes with your prescription written in mouse type?)

How can they downplay these side-effects? Here are a few possibilities:

Falsifying studies…

“Burying” studies that show negative results…

“Doctoring” statistics…

Hiding the side-effects…

Hand-picking study subjects…

Defining 5% occurrence as “rare”…

Removing study subjects early, who do very poorly…

Selling drugs with marginal efficacy…

And the guinea pig is YOU.

No one even wants to work in the NIH anymore, because it’s no longer fun. Or profitable.

No exotic conference locations, no multi-thousand dollar honorariums, no bonuses.

If you’re caught affiliating with a pharmaceutical company, you’re chopped meat.

And there’s a good chance you’ll be caught.

In a recent survey, 70 percent of the eligible U.S. and Western European clinical investigators interviewed said they were discouraged by the current regulatory environment, partly because they are compelled to disclose financial ties to the pharmaceutical industry.

Even newspapers are left blowing in the wind.

They don’t know whether the hand-fed studies are true or false.

They certainly don’t have the time or resources to find out.

So they take the PR release, and report according to the party line.

But in this game of truth or dare, they’re pawns. Just like so many other people.

The bottom line?

No one is innocent, everyone is culpable.

That’s why you must become your own #1 health care informant — do your own research.

The truth must be mined, from the flood of sometimes misleading published information.


But it’s there, if you look hard enough.

Another article of interest:

Conflicts of Interest Often Under-Reported in Clinical Trials


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  1. Reason why they should drop the prohibition of cannabis at the Federal level. Epidiolex is stupidly expensive

    Liked by 1 person

    Comment by pmracc33186 — November 15, 2020 @ 11:28 AM

  2. I know a person who wenrt to the NIH as it has been 30 years now that the person has been seizure free. This person would eat the dirt off of the NOH floors & believe anything they do there is 100% perfect for every persons health & condition/s that they find & will find answers for any person. So back in 2000 I went to the NIH and they claim WE WANT TO LEARN FROM YOU & LISTEN TO YOU as to WHAT WE WILL DO FOR YOU in hoping to cure, heal or treat your condition the best way we know about. Yeah right,, as I had every tests done there as I had done 40 years previously & had my brain surgery there. Oh yeah NEW DRUGS I was willing to take, and NO DRUG stopped the seizures so I had my brain surgery. That was NO answer or healing for me as it only changed the seizure condition I had. As for CARING WHAT WE SAY ABOUT OUR CONDITION, & WHAT WE BELIEVE AS TO WHAT MIGHT BE THE MAIN CONCERN AS TO WHY SEIZURES HAPPEN,, forget it, as their MUTE SWITCH IS SET ON HIGH and your voices gets silenced to where they believe that YOUR BRAIN BECOMES THEIR PROPERTY TO CURE OR TO DAMAGE MORE. You end up living with their results with no guilt from their heart or brain in the process. A cousin I have use to be a Full Time RN at a hospital for 30 years and was a HEAD NURSE in her department floor. When she finally retired she said that DRUGS USE TO TAKE 20 + years to get approval from the NIH. Now, as she said this 3 years ago NIH approves drugs quicker with LESS CLINICAL TRIALS so that a drug is 5 years or less getting approved. So tell me WHY more than fewer AED’s cause INSOMNIA, which would work together with FOODS, DRINKS & DRUGS that have MSG’s, ASPARTAME’s, NITRATES & NITRITES that all are EXCITOTOXINS, which help to produce INSOMNIA, that you do not have to have the food & drink toxins in them, not when AED’s alone gives you INSOMNIA, so you stay up more NOT SLEEPING but EATING & DRINKING things with MSG’s, ASPARTAME’s NITRATES & NITRITES, & ALL of those toxins WILL & DO cause Grand Mals & other seizures that ANYONE can have when you have INSOMNIA. If my brain cells can figure that out, What brain cells in another person CAN’T figure it out as to WHY seizures are more of a problem with the newer drugs approved by NIH in the last 30 years, than what drugs had been like & less seizures were happening from 1995 & years before that ? But wait,,, Do all AED’s after 40 years taking them DESTROY the immune system of the brain to where NO AED’s after you are 40 will stop seizures from happening, after you started taking these drugs before 6 months old ? NOBODY EVER CARES TO ANSWER THAT. And THEY know that answer.

    Liked by 1 person

    Comment by James D — November 15, 2020 @ 2:31 PM

  3. “Mute switch” is a good way to put it.

    And you can thank the FDA for the quick turn-around approval.


    Comment by Phylis Feiner Johnson — November 15, 2020 @ 3:02 PM

  4. This is all the more reason to look for and be open to non-pharmaceutical options for seizure control. Diet and lifestyle factors can, in many cases, be as effective if not more effective than any medication.

    Liked by 2 people

    Comment by paleobird — November 15, 2020 @ 5:39 PM

  5. Some tough truths here Phylis. Thanks.

    Liked by 1 person

    Comment by Flower Roberts — November 15, 2020 @ 6:02 PM

  6. at least for now they have to use their own people to find the vaccine for covid (do they?)


    Comment by Gail Barry — November 16, 2020 @ 5:13 AM

    • Gail,,, Their people are NOT as expendable neither as cheap as the poor third world uninformed people to be taken advantage off & used for guinea pigs used for lab test & first trials. Therefore the status quo will still remain the same for the volunteers to keep making more money at the expense of the helpless people.

      Liked by 1 person

      Comment by Gerrie — November 16, 2020 @ 7:03 AM

  7. To use third world people — who are completely innocent — as guinea pigs for our benefit is deplorable.


    Comment by Phylis Feiner Johnson — November 16, 2020 @ 9:53 AM

  8. 1. I do object to the term “side effects.” They are effects. You may not like them. You are not supposed to notice or complain.

    2. The energy behind your writing, Phylis, could light up a good-sized city. Thank you.

    Liked by 1 person

    Comment by HoDo — November 19, 2020 @ 4:14 PM

    • Not notice? Not complain? So, we’re supposed to be stoic, also?


      Comment by Phylis Feiner Johnson — November 19, 2020 @ 5:04 PM

      • Yes, good patients are always completely stoic, their upper lips are the stiffest, they never admit that pain bothers them; and they always do what they are told.

        Liked by 1 person

        Comment by gherbke@ yahoo.com — November 19, 2020 @ 6:12 PM

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    About the author

    Phylis Feiner Johnson

    Phylis Feiner Johnson

    I've been a professional copywriter for over 35 years. I also had epilepsy for decades. My mission is advocacy; to increase education, awareness and funding for epilepsy research. Together, we can make a huge difference. If not changing the world, at least helping each other, with wisdom, compassion and sharing.

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