Epilepsy Talk

Epilepsy Studies: True or False? | July 20, 2019

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 wind fall 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.

Other articles of interest:  NEWS! AED Safety Risks Withheld
https://epilepsytalk.com/2013/08/18/news-aed-safety-risks-withheld/

Conflicts of Interest Often Under-Reported in Clinical Trials
http://www.medpagetoday.com/MeetingCoverage/PRC/41482?xid=nl_mpt_guptaguide_2013-09-10&utm_source=guptaguide&utm_medium=email&utm_content=mpt&utm_campaign=09|10|2013&userid=678261&eun=g5845718d10r&email=pfj@pfjohnson.com&mu_id=5845718

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Resources:

http://en.wikipedia.org/wiki/Placebo

http://www.citizen.org/Page.aspx?pid=2887

http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

http://www.aboutlawsuits.com/drug-testing-lab-falsified-results-19940/

http://www.vaughns-1-pagers.com/medicine/prescription-drug-side-effects.htm

http://www.raysahelian.com/drugcompany.html


13 Comments »

  1. Amazing how crooked the BIG PHARMA people are. I thought back in 2000, at 40 years old, that I was going to the best place on the planet, thinking that the NIH was going to have my best treatment for me, so a brain surgery was no option in my life. So they tell you that YOU are the boss, & WE will learn everything from you in order to help OTHERS in the future so you are VERY IMPORTANT for being at the NIH. Well it was not anything as they said it was going to be, even as I had the last word what any future tests & experiments I had done to me. they all were tone deaf to say they cared what I thought or what I KNEW as to how & what triggered my seizures, so they had NO DESIRE to take me seriously as i had ALL THE SAME TESTS DONE TO ME, as I had done by other neurologists I saw in the previous 30 years before going to the NIH. All they are is a medical lab for pushing FREE DRUGS TO PATIENTS so as I had that done for me & drugs given to me and they say I need to take MORE of a drug, than what the drug manufacture says you should not go above a certain MG dose a day. So we are ALL RATS or MICE everywhere there is a doctor, no matter if it is NIH, Johns Hopkins University , MAYO CLINIC or whoever that doctor is where he or she is at. That’s why I just recently today said to my mom, I need to have a GRAND MAL seizure that will end this once & for all. You get tired of hearing AL THE LIES after 59 years then a neurologist will say, ”’NO MATTER WHAT YOU DO OR WE WILL DO, I WILL ONLY HAVE A 3% chance of having & living a seizure free life before I die. What I did not tell him is that AFTER I DIE,, I will finally have a life that I can not imagine ever having, and I will then be healed FOREVER & never live with seizures ever again. << THAT is why I never fear death, because it's a promise that was given to me when Jesus was hanging from that cross on Calvary. Let BIG PHARMA & DOCTORS LIE,, they have had their fill & will pay & live the fury of God in time. VENGANCE is mine says the Lord,, I will repay. ROMANS 12:19

    Liked by 1 person

    Comment by C D — July 20, 2019 @ 11:32 AM

  2. C D, You say you “only have a 3% chance of having & living a seizure free life before you die…”

    Have you considered an RNS?

    Responsive Neurostimulation (RNS) Shown to Reduce “Untreatable” Seizures

    https://epilepsytalk.com/2017/01/12/responsive-neurostimulation-rns-shown-to-reduce-untreatable-seizures/

    Like

    Comment by Phylis Feiner Johnson — July 20, 2019 @ 12:59 PM

  3. Thought-provoking. I’ve traveled a long road trying to understand why I suffered the opposite side effect from one of the biggest go-to AEDs on the market (Lamictal). For 3 years I’ve dealt with insomnia instead of fatigue/drowsiness, and it grew only worse as doctors increased the dosage for intractable seizures. It’s been a nightmare. I finally proved my case after mining through research data to discover that for a precious few individuals, the reverse side effect is reported. It has taken a very long time to get here, but I’m finally back on a dosage that allows me to sleep. Patients must be educated and proactive, ready to be equipped to function as their own best advocate. This also helps the neurologist who with dozens/hundreds of patients simply does not have the time to pore over every individual case. Mine was very appreciative of my personal research. He seemed very confident in accommodating my request to change my medication regimen.

    Like

    Comment by Lissa Roberson — July 20, 2019 @ 3:12 PM

    • Ironically, I had the same reaction with Lamictal.

      At first, it made me crazy/hyper. But when I settled down and changed my bedtime dose to 6:00 PM, all was well.

      No side effects and virtually seizure-free for 10+ years.

      I only wish you had experienced such a successful outcome.

      But kudos to you, for being so proactive and persistent. And for doing your own research.

      WE know our bodies best. No doctor can climb into our heads and feel what we experience.

      So, as you said, you must be your own advocate.

      Like

      Comment by Phylis Feiner Johnson — July 20, 2019 @ 3:23 PM

    • Oh my gosh I had bad insomnia on Lamictal when I got off it I slept like a baby.

      Liked by 1 person

      Comment by Bonnie Sutherland — July 21, 2019 @ 12:23 PM

  4. When I was first prescribed Tegretol 35 years ago, it didn’t have the black box warnings about depression and suicidal ideation which it does now. I thought I wanted to kill myself because I was having frequent seizures (for which it did bupkis for me). And I almost did one night.
    One might say, “Oh but they would never let a product on the market that hadn’t been rigorously tested, would they?” Yes, they would. We are the guinea pigs.

    This is another problem with foreign based testing. Not all side effects are physical, many are mental. With language barriers involved, how many of these types of adverse effects even get communicated?

    Liked by 1 person

    Comment by paleobird — July 20, 2019 @ 4:04 PM

  5. A very good question.

    And the people participating in the tests don’t necessarily have the same body types (weight), chemistry, mental problems and other things that we experience in our culture.

    THEY may start out as the original guinea pigs. BUT we have to deal with the consequences.

    Like

    Comment by Phylis Feiner Johnson — July 20, 2019 @ 4:17 PM

  6. Phylis this is a wonderful article ! You’re right we all have to be our own health care informant!!

    Liked by 1 person

    Comment by maryleeparker — July 20, 2019 @ 5:08 PM

  7. If not us, then who?

    Like

    Comment by Phylis Feiner Johnson — July 20, 2019 @ 5:21 PM

  8. This interesting article reminds me of a Merry Lynch stock exchange business analyst once asking that ,,,, “Is currying patients wise business decision”?
    Obviously, the “medical industry” are business enterprises competing to make more money, therefore needs to have expendable ginue pigs to resolve the means, mechanism & equation of staying in business, “practicing medicine”.
    Unfortunately, the FDA regulatory, licensing & supervising laws making it easier & convenient to carry out fraudulent business practices, “practicing medicine” ends up costing too many unsuspecting, innocent voiceless lives, desperately seeking mercey to their medical hardships.
    As for the foregein victims of medical research, obviously there’s less risk/potential for liability claims against the Big Pharma, therefore the more tests are conducted outside the mainland, there’s greater & more expendable choice to carry out fraudulent medical practices, under the disguise of “currying patients”.
    In the end, it’s long overdue for the general public to demand better standard of health care.

    Liked by 1 person

    Comment by BahreNegash Eritrea — July 21, 2019 @ 3:50 PM

    • I couldn’t have said it better, Gerrie.

      The practice of medicine is just that.

      BIG Pharma practices and we live with the results.

      Like

      Comment by Phylis Feiner Johnson — July 21, 2019 @ 4:03 PM

  9. Have recently heard about the brain damage Dilantin causes. I have brain damage and am suing along with others. No one knew this side effect years ago. Thanks.

    Like

    Comment by Charleene Gorski — August 4, 2019 @ 4:18 AM

    • Gee, I was on Dilantin years ago and certainly didn’t know of this brain damage claim.

      And hopefully, I don’t have it! 🙂

      Like

      Comment by Phylis Feiner Johnson — August 4, 2019 @ 9:37 AM


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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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