"Big Pharma" Owns Their Regulators - But Not For Long...


Opinion by Consumer Advocate Tim Bolen


Wednesday, March 15th, 2006


Health Canada, North America's "North of the border" version of the US FDA, has, so far, spent two million dollars ($2,000,000.00) prosecuting a Canadian based nutritional supplement company, Truehope International, to collect a five hundred dollar ($500.00) fine.


Yup,  you read that right.  Health Canada has spent, so far, two million bucks to get a five hundred dollar fine. 


More amazing is that they probably won't be able to collect the fine, because they are in Court over it right now - and they, and the Health Canada employees involved in this fiasco, will get personally sued, by Truehope, for their efforts.  And, they SHOULD be personally sued... 


So, what's this all about?  It's about "the role" of Health Canada, and the US FDA.  Most North Americans believe that those agencies are in existence to regulate the drug industry - because that's what "we the people" set them up to do.  But, that's not what's really happening. 


Right now, "Big Pharma" owns their regulators - and those agencies act, not to regulate drugs, but to damage, and destroy, competition to pharmaceutical interests - like True hope International - and their product EM Power Plus, an nutritional product designed to correct certain mental illnesses - which it does.  Their track record is phenomenal.


Health Care in North America is a disaster, and the fact that "Big Pharma" owns their regulators is one of the reasons why this is so.  The system itself, in the US, is rated seventy-second (72) in quality worldwide but is absolutely, without question, the most expensive.  It's number one (1) in the world in cost. 


North America's reliance on the "pharmaceutical model" for health care - simply spoken "drugs, drugs, and more drugs" is the ONLY approved paradigm - and the government regulators assigned to monitor the drug world, in the strangest of betrayals of their public obligation, have focused, not on the myriad problems of those mega-dangerous offerings, but on the elimination of competition to drugs - like vitamins, supplements, oxygen therapies, electro-medicine, etc.


But that "focus" is being challenged on several fronts.


In the US, there has never been any doubt the the Food & Drug Administration (FDA) is "Big Pharma's" lap dog.  The revolving door between "Big Pharma" and the FDA in terms of the constant changing of jobs, back and forth, is just an an accepted thing. 


Health Canada, the FDA's counterpart north of the US border, is just a smaller, colder, version of the FDA.  It's there, though, that the one of the major battles between the regulators and their "non-drug" victims is unfolding - and the Canadian media is having a field day humiliating Health Canada for their actions to try to stop the sale of a certain vitamin supplement designed to counteract the mental health disorders, etc.  The product, EM Power plus, designed by Truehope Nutritional Support of Alberta, Canada has become a focal point in the fight between the forces of "health" versus "medicine."


Health Canada, through the Truehope case, is under HEAVY fire - not only in a Canadian Court, but in the Canadian media, who has found the basic argument used by Health Canada that "if you claim that something is good for you, then it becomes a DRUG, and is regulated as such..." to be completely silly, and self-serving, for Health Canada and its master, "Big Pharma."  


This is the case to watch.  For, if Truehope loses, they'll pay a five hundred dollar fine.  But if they win, and they will, Health Canada will never be able to operate quite the same again.   According to the results of public information requests, Health Canada has spent two million dollars prosecuting this case. 


Health Canada, in its ruthless assault against Empowerplus, seems only to have relied, in its investigations, on information provided by the formally discredited "quackbuster" operation.  Their source seems to be one Terry Polevoy MD, formerly a Pediatrician, but now a "pimple doctor" who operates out of Kitchener, Ontario. Polevoy wrote, with the help of a security guard, a book called "Pig Pills," which, laughably, is only published on the internet.  The book is supposedly about EM Power Plus.  The official "quackbuster" operation, run,  I believe, out of a New York ad agency doesn't acknowledge Polevoy.  He's not on any of the typical "quackbuster" organization boards, or advisory committees. 


We're tuning in on the second-to-last chapter of this interesting story about two small town Canadians, who simply would NOT let Health Canada bully them.  They insisted on their rights, they pressed the issue continuously,


What's the last chapter going to be about?  Well, after Health Canada loses this Court battle, Truehope will pursue, through a "malicious prosecution" lawsuit, all those involved at Health Canada, and with Health Canada, that forced Truehope, and their customers, to go through this process.


And, that's what employees at the US FDA, and other regulatory agencies, need to worry about - personal liability for their unwarranted actions.


The Truehope "Empowerplus" Case



Negrete ONE - Aetna - ZERO


Aetna insurance came to this hearing with more Motions than Mrs. Smith has in her chocolate chip cookies.  I can't imagine what Aetna's legal bill is going to be from its battery of Attorneys.  For this hearing alone, according to the hearing transcript:


JOHN B. SHELY, Attorney at Law, Andrews & Kurth, 4200 6 Chase Tower, 600 Travis, Houston, Texas, 77002 , appearing for the Defendant/Counterplaintiff.  JAMES C. CRUMLISH III, Attorney at Law, Elliott Greenleaf & Sieszikowski PC, 1925 Harvest Drive, Suite 300, Blue Bell, Pennsylvania, 19422 , appearing for the Defendant/Counterplaintiff. JOHN M. PALMERI and FRANZ HARDY, Attorneys at Law, White & Steele, P.C., 950 17th Street, Suite 2100, Denver, Colorado, 80202-2804, appearing for the Defendant/Counterplaintiff. Wendy Laurento, in-house counsel for law and regulatory affairs with Aetna Inc.


Negrete came by himself - and it soon became clear that he had them outnumbered.  In essence, after the Judge whacked Aetna's butt, she made them take their pile of "Motions," and and dump them in the trash bin themselves.  Her words, eyeball-to-eyeball, so-to-speak, with Aetna's counsel, while they stood there, so-to-speak, with their pants down, were:


If anyone has an expectation that this case is going to be won or lost on motion practice or that the battles with regard to motion practice are going to be somehow determinative, I urge you to put aside that notion. The goal here is to have a full and fair opportunity for both parties to  present evidence as to disputed facts and apply the law.  I know that these two parties don't like each other.  It's apparent. I also know that there are several ways to handle a lawsuit. Some people play hardball, some people play softball; but I will tell you right now that the goal here is to have a fair process. And I have very little tolerance for hyperbole, attacks between counsel, or unnecessary motion practice. So I urge you to get focused on what it is you need to try and let's get on with it. Any need for clarification or further explanation?


Aetna, as you may have read in my earlier articles, made a counter-accusation earlier in the case, which, in essence, the Judge tossed out for lack of substance last month.  It appears, from this hearing, and Aetna's attorney's behavior, that Aetna can't seem to find a "defense" against Cavitat's onslaught. - and needs to rely on tricks...  Aetna's Motions for this hearing, were, basically, a rehash of the counter-accusation they already had tossed out.


The trial starts in June, and the Judge said about that:


We invite jurors to give comments after every single trial; and you might well find those comments interesting, particularly the comments that have arisen from civil litigation. They will be apparent to you. They are comments like: "No more exhibits. Do the attorneys think we are dumb? Why do the attorneys put on repetitive evidence?  Why couldn't the parties settle this case?" These are the kinds of comments that jurors make. And I urge you to consider that as you start fine-tuning your presentation for trial. We are asking jurors to resolve this civil dispute; and jurors do not like, in my experience, to have their time wasted or their intelligence insulted, and they particularly are resistant to situations where they are asked to make a determination between parties where they believe that the parties could have resolved the case themselves.


I can't wait to see how Aetna insurance is going to put "quackwatch.com's" Stephen Barrett on the stand, and explain how, and why, this old fart, who works out of his basement in Allentown, Pennsylvania, hasn't had a license to practice medicine since 1993, couldn't pass the exams to be certified as a Psychiatrist, has, at best, only had part time employment throughout his career, and was formally declared by the US Court system as "biased, and unworthy of credibility," has become Aetna's NUMBER ONE expert on health care practices.


Even more, I can't wait to hear how Aetna explains how, and why, they use formally discredited Robert S. Baratz, "Bobbie Bogus," as their expert on Dentistry, etc...


Stay tuned...

Tim Bolen - Consumer Advocate