Epilepsy Talk

Epilepsy Studies: True or False? | August 3, 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.

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:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4340084/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6293126/

https://onlinelibrary.wiley.com/doi/full/10.1002/epi4.3

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.raysahelian.com/drugcompany.html

 


21 Comments »

  1. An interesting read…..sad…

    Liked by 2 people

    Comment by Cynthia Waller — August 3, 2020 @ 10:45 AM

  2. So it basically means we the public are the guinea pigs. Pretty soon they won’t be able to do testing on animals, thanks to stupid emotional people who care more for the life of a mouse than to find a cure for mankind. But for these clinical tests don’t they have to show the same results in more than one testing facility and come up with independent conclusions? I believe the good doc or techs outnumber the bad, but of course big money and profits and coercions can change that. UGH.

    Liked by 2 people

    Comment by Zolt — August 3, 2020 @ 11:34 AM

  3. Yes, we are the mice and the suspiciously “approved” drugs are the trap.

    And in response to your question, as soon as they get the desired result, they stop testing.

    Until then, they persevere, until they hit gold. And those are the results that they report.

    Like

    Comment by Phylis Feiner Johnson — August 3, 2020 @ 11:40 AM

    • Makes me wonder if they ever test the different people of different cultures? And if that makes or can make a difference? Just curious

      Liked by 1 person

      Comment by Kathy S.B — August 14, 2020 @ 11:59 PM

      • Definitely. The third world country participants are from all sorts of different counties, backgrounds (poor) and ethnic groups.

        Liked by 1 person

        Comment by Phylis Feiner Johnson — August 15, 2020 @ 9:20 AM

  4. […] Epilepsy Studies: True or False? — Epilepsy Talk […]

    Like

    Pingback by Epilepsy Studies: True or False? — Epilepsy Talk – Epilepsy & Cerebral Palsy — August 3, 2020 @ 12:02 PM

  5. Ugh this was sickening to read. And we have little choice in the matter.

    Liked by 2 people

    Comment by Hetty Eliot — August 3, 2020 @ 5:52 PM

    • We’re in a maze. It’s not a pretty sight. But think of those poor (literally) people who are going through the tests and trials. They’re really the ones to feel sorry for.

      Liked by 1 person

      Comment by Phylis Feiner Johnson — August 3, 2020 @ 6:47 PM

  6. Gosh, that was uplifting, Phylis. Honestly, I always wondered what would lead to my eventual demise, side-effects from a seizure ( fall, concussion, fractured bones, etc), or the hideous long term side-effects of understudied anti-convulsants!!

    Liked by 2 people

    Comment by skolly9 — August 3, 2020 @ 6:23 PM

    • Well so far I have had all of the above and now stomach or gastrointestinal problems too!! And I’ve been on the same medications since I was 8 years old. I am now 50 years old.

      Like

      Comment by Kathy S.B — August 15, 2020 @ 12:01 AM

  7. Tough choice. Even tougher odds. 😦

    Like

    Comment by Phylis Feiner Johnson — August 3, 2020 @ 6:49 PM

  8. For corporate empires crusading to make limitless profits in the name of “free market economy”, human lives are expendable bargain to carry out the mission regardless of any location on earth.
    Obviously, poor nation around the world with limited information, resources & protection would make it easier, faster & cheaper to carry out the corporate empires mercenary mission for capital windfall.
    And as long as public healthcare & medical treatment is made to be profit making crusade under “free market economy”, the corporate empires who have a lot to gain from the adversity of human race will continue to pursue for higher profits by any means necessary as the US opioid crisis has proved to be deadly outcome of forged “medical studies”, before the politicians elected to “serve the public” ended up forced to intervene & make long sought prosecutorial decisions to stop the tragic drama.
    Sadly, it’s going to take a whole more than corporate financed & funded politicians/authorities/legislators to stop the corporate fraud, deceit & deception profiting from helpless population.
    Gerrie

    Liked by 2 people

    Comment by BahreNegash Eritrea — August 4, 2020 @ 4:32 PM

    • The people I feel sorriest for are the starving people in these poor countries, who sign up for an unknown, random test, just to feed their family.

      Liked by 1 person

      Comment by Phylis Feiner Johnson — August 4, 2020 @ 6:51 PM

      • While you’re definitely right to feel sorry for the helpless people trapped in poverty made ginue pigs in exchange for pocket money to feed their starving families, it ain’t any consoling to know the designated beneficiaries from the unsupervised & unregulated forged “researches & tests” made to buy the overpriced products of the outright fraud, either, as the article clearly indicates.
        Sadly, the whole trial & tribulation for profit vs. medicine makes for a circle of double edged sword.
        Gerrie

        Liked by 2 people

        Comment by BahreNegash Eritrea — August 5, 2020 @ 12:25 AM

      • Yes!! Makes me wonder if they do it simply so they could feed themselves or their families?!

        Liked by 1 person

        Comment by Kathy S.B — August 15, 2020 @ 12:04 AM

      • Yes. They are desperately poor and have limited means of life sustaining necessities.

        Liked by 1 person

        Comment by Phylis Feiner Johnson — August 15, 2020 @ 9:23 AM

      • They should not be made to be lab rats!! That is SO INHUMANE

        Liked by 1 person

        Comment by Kathy S.B — August 16, 2020 @ 11:15 PM

  9. I agree, Phylis. That somehow, for many, the lives of rats are more important than those of people struggling to survive in impoverished countries. wow.

    Liked by 2 people

    Comment by skolly9 — August 4, 2020 @ 7:05 PM

  10. Yes, Gerrie, it is a double edged sword. The only winners are the greedy Big Pharma.

    Liked by 2 people

    Comment by skolly9 — August 5, 2020 @ 8:34 PM

    • Yes Skolly, In the age of civilization where nations are spending a whole lot of money in a race for space exploration, nuclear bombs & endless wars, it’s sad to note the poor & sick in human race are neglected & exploited for big pharma vultures to take advantage of their unfortunate predicaments to the point of bankruptcy, losing their homes & looting their lifetime earned resources in the gamble for “medical treatment”, while the oligarchy who promised & swore to “serve & protect the public” are standing by inaction, watching the whole tragic drama unfolding.
      And now, Covid19 wrecking the whole world, it may have come for the time of devine intervention & desperate need to rescue human race from the predators in the Big Pharma & warmongering oligarchy breaking up the tormenting cycle.
      Gerrie

      Liked by 2 people

      Comment by BahreNegash Eritrea — August 6, 2020 @ 6:05 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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