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

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|

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Resources:

https://www.dailymail.co.uk/health/article-5609901/Top-medical-journals-accused-skewing-research-receiving-MILLIONS-bribes.html

https://www.livescience.com/8365-dark-side-medical-research-widespread-bias-omissions.html

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.raysahelian.com/drugcompany.html

https://www.medpagetoday.com/blogs/campbells-scoop/82068

 

 

 

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