Epilepsy Talk

Epilepsy Studies: True or False? | November 3, 2011

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. (Not on the top of my vacation list.)

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.medscape.com/viewarticle/703356_2

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://kansascity.injuryboard.com/fda-and-prescription-drugs/report-pfizer-mislead-regulators-public-on-neurontin.aspx?googleid=274348

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

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


23 Comments »

  1. When you work for NIH or FDA you cannot invest in companies affiliated w/ or close to a pharmaceutical company or medical supply firm. They are very strict.
    It is a courtesy to the US citizen.

    Like

    Comment by Toni Robison — November 3, 2011 @ 10:15 PM

    • Makes sense to me…

      Like

      Comment by Phylis Feiner Johnson — November 3, 2011 @ 10:51 PM

      • It’s unfortunate we sometimes have to find out a drug is dangerous through commercials by lawyer’s. isn’t it?
        Thanks for the info Phylis.

        Like

        Comment by Charlie — November 7, 2011 @ 3:49 AM

  2. Yeah. I hate lawyers, but they’re the least of our problems!

    Like

    Comment by Phylis Feiner Johnson — November 7, 2011 @ 1:05 PM

  3. I have never paid any attention to the clinical trials. I simply do not trust them. Some of them are done on rats, mice or rabbits. There is a huge difference between people and small tiny animals.

    I was asked to try the VNS when it first came out. I asked a lot of questions. The answers are the same today as they were back then, about 12 years ago.

    I said “NO” then and I still say no.

    Like

    Comment by Ruth Brown — November 7, 2011 @ 8:54 PM

  4. Charlie was strong-armed to try the VNS when it first came out and he said “no”.

    They were quite aggressive…and scary.

    Like

    Comment by Phylis Feiner Johnson — November 8, 2011 @ 12:22 AM

  5. I Agree w/ Phylis. I had to do my ‘homework’. And yes my drugs have serious side effects. And not just to me. I was told my drug was safe for PG. My son was born w/ quite a few pheno side effects. 😦 Drs blamed it on my Age & smoking. 😦 Researchers didn’t have All the Facts, even though my med was over 80 yrs old. 😦 By the time they figured it out, it was too late. 😦

    What scares me, now, is my Dr refuses to believe my meds are the source of my Bone Calcium Loss. Again, Age & smoking is the culprit. 😦 I am not a Rare Case??? 😦 My Gut Feeling was Rite about my Baby. And I know it’s Rite Now! 😦 I am on Advair & Pheno’s. Which to me, Increased my chances of Bone Calcium Loss. 😦

    This DR is Insane! First, he places me on an anti-biotic that can cause seizures. Then, he places me on a medication that can cause future breakage of the bones. I read the Info, on line. But, it didn’t dawn on me until I saw the Lawyer Cases/commercials. I Quit taking it!

    Makes No Sense to me. 😦 All I Do know, is pharmaceutical companies have been burying the truth about their pills/treatments & burying the truth about Alternatives as well. 😦 Pharmacy & DR Golden Rule: Hear No, See No, Speak No. Yet how is it, Friggin Lawyers know more about our drugs then a DR. 😦

    Like

    Comment by candi — November 8, 2011 @ 2:56 PM

  6. Candi, I know you do your research — in spades.

    But there’s gotta be a better source of information than a lawyer.

    Yet, with Big Pharma withholding info, I guess it’s a lose-lose. It’s only after the deed has been done (and sometimes not even then) that they disclose the facts and maybe even, the dangers. 😦

    Like

    Comment by Phylis Feiner Johnson — November 8, 2011 @ 3:45 PM

    • I guess the Only other Source of Info would be a one-on-one discussion w/ your Pharmacist about each med you take. At least they take/make time to do the ‘homework’. And are Supposed be up to date on All meds/side effects. Course If you have your own up-to-date PDR, you have the same Info they do. 🙂

      From what I have read, The Pharma Manufacturers/Reps only hide the facts from
      DRS. Or rather downplay or w/hold pertinent Info. 😦

      But, it still boils down to taking a med/treatment, that may or may not relieve/cure symptoms. That may or may not affect us adversely or create More problems down the Road. So, it’s Maybe GAIN – Maybe LOSE. Only as Individuals will we know. 😦

      Trial & Error. Not a Good Option, but, the only one we have. 😦 Unfortunately! 😦

      Like

      Comment by candi — November 8, 2011 @ 4:45 PM

  7. Yes, I’m well aware of all that was printed above…….Does any of this explain my distrust toward Medical Clinicals and Pharmacies.

    Like

    Comment by mkfarnam — December 5, 2011 @ 7:09 PM

    • I think, in all cases, you have to find a human being in those areas that you can trust.

      Like

      Comment by Phylis Feiner Johnson — December 5, 2011 @ 7:18 PM

      • I agree Phylis,
        That’s why I use a small local Pharmacy that takes time explaining all aspects of my meds instead of a big name chain. My daughter uses a big chain and has no problems,though. I just like the personal service from the same guy I’ve known for years.

        Like

        Comment by Charlie — December 6, 2011 @ 2:03 PM

      • Ditto for me!

        Like

        Comment by Phylis Feiner Johnson — December 6, 2011 @ 2:22 PM

  8. When the “health industry” is controlled & manipulated by “profit” obsessed businessmen, instead of “health” professionals devoted to healing the unfortunate sick,

    When “profits” are the driving force of a “health” industry & far more significantly important than the well being of society & a common man,

    When “health” insurance is a privilege for those who can afford it ONLY,

    Therefore, what’s a few UNINFORMED EXPENDABLE lives maximizing the profits of the corporate “health” industry to stratospheric levels of the market value & the stock share, bonuses & retirement funds of the corporate executives?

    Too bad, the governments that claim to represent the well being of society are ALREADY are part owners or in the pockets of corporate industry that financed their political power.

    Like

    Comment by Gerrie — December 15, 2011 @ 2:11 AM

  9. Don’t forget to add in the insurance lobbyists. 😦

    Like

    Comment by Phylis Feiner Johnson — December 15, 2011 @ 2:14 PM

  10. Found the article in the Guardian (UK pub) today.

    Scary and eye-opening!

    Like

    Comment by Phylis Feiner Johnson — September 30, 2012 @ 6:33 PM

  11. SAD TO KNOW, the “civilized-governemnets” who shed crocodile tears for “HUMAN RIGHTS” are NOT as “civilized” as they claime to be.

    “Government Regulations, Standards & oversightes” seem NOT apply to global corporate industries, praying on expendaple people.
    Therefore, EXPENDABLE PEOPLE MAKE GOOD PRAY & for global corporate industries, praying on expendable people makes more QUARTERL EARNING & PROFIT.
    The cheaper the pray, the more the profit.
    Makes you wonder, what makes humans any different than vultures.

    Like

    Comment by Gerrie — October 2, 2012 @ 10:11 PM

    • As the say, “he who has the most gold wins.” 😦

      And if you’re rich, you get the “priviledge” of medical care the the “option” of living.

      Just think of all those Americans on Medicaid who hit the donut hole and are screwed. To get back on “coverage,” you need to spend 2,800!

      Well gee, if you had that, you wouldn’t be on Medicaid in the first place!

      And some of those drugs are incredibly expensive. And they CAN be, because of patents. No competition.

      They don’t call it the “donut HOLE” for nothing…

      Like

      Comment by Phylis Feiner Johnson — October 3, 2012 @ 11:42 AM

      • Phylis,
        Imagine working hard ALL YOUR LIFE TIME, paying ALL kinds of local, state, federal taxes & health insurance deductions (when you are HEALTHY ENOUGH & don’t even need medical attention), to ONLY end up short-changed when you became ILL, GOING BROKE & BROKEN, bunkrupted with ENDLESS Ambulance, Hospital, Doctor’s & Pescription BILLLS AFTER BILLS,

        Phylis,
        As has been said,,, “NO ONE CAN TAKE ADVANTAGE OF YOU, WITH YOUR CONSENT”.

        Therefore, it’s long over due that Society URGENTLY NEEDS to device a way to stop this ENDLESS abuse
        I’m NOT sure how but there had to be BETTER WAY than just scoping to the sytem, milking & bleeding people to death.

        THERE HAVE TO BE A BETTER WAY OUT OF THIS “LEGAL” LOOTING.

        Like

        Comment by Gerrie — October 3, 2012 @ 9:20 PM

  12. I think it’s called a democracy…

    Like

    Comment by Phylis Feiner Johnson — October 4, 2012 @ 7:43 AM

  13. The problem with everything today.. In my book is it is all the about the money thing…

    Like

    Comment by Ron — July 21, 2013 @ 10:49 AM

  14. You couldn’t be more on the money!!! 🙂 🙂 🙂

    Like

    Comment by Phylis Feiner Johnson — July 21, 2013 @ 7:00 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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