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Influence Only Can Buy

by

It’s not news that the Federal regulatory agency we the people depend on to provide us with SAFE food and drugs is in shambles. A group of dedicated middle and lower echelon government employees will most likely take the blame for policies that have resulted from the revolving door used by upper level management sell-out/collusion with the pharmaceutical industry.

I can only relate a personal experience to substantiate the above accusation. In 1982, the , with influence from George H.W. Bush (Reagan’s vice president) and Dan Quayle (later to be Bush I’s VP)—both with ties to Indianapolis-based Eli Lilly and Company—was encouraged/instructed to fast-track synthetic ‘human’ . [This was before the term ‘fast track’ entered the lexicon.]

human was the FIRST biotech ever approved. As such—with no guidelines to navigate an emerging industry—one would have expected that the Agency would have sought to err on the side of safety and demand MORE rather than LESS rigorous standards for approval. With Dr. Henry I. Miller, M.S., M.D. (now of the Hoover Institution) serving as the biotechnology industry’s “inside man”, the product—again, THE FIRST OF ITS KIND—garnered approval in a period of less than six months, far short of the usual 18-month process which was typical at that time. A good deal of shenanigans and string-pulling which occurred has remained well hidden. Miller, the most vociferous proponent for approval, initially met with a number of well-founded objections and roadblocks from other concerned scientists, including his own boss. As a second-banana in the hierarchy, his advocacy alone could not guarantee approval. However, by merely biding his time and waiting for his boss to go on vacation, he successfully circumvented the roadblocks, ignoring the objections, re-defined himself as the resident biotech expert (paving the way for his future career outside of public service), and achieved the industry’s goal.

Miller actually achieved more than the industry could have hoped. He used existing rules to gain approval for the product under the ‘small molecule’ guidelines; and when beneficial, used the absence of rules, to insulate the product from yet-to-be-codified but more stringent regulations to follow. A genius? Perhaps, but in my opinion, a very evil genius. (Remember, also, that all this occurred during the Reagan era where industry innovation and economic expansion were given dominance over bureaucratic safeguards that had long served public interests.)

As a diabetic of 26 years (at that time), the new —Humulin®—was of little interest to me because the natural analog insulins were already providing me very good control and what I considered an acceptable quality-of-life. In fact, only about 5% of diabetics experienced problems (ranging from mild itching of injection sites not unlike those some users of Lantus® experience today to more severe) with the 27 varieties that populated the . All these insulins were derived from pork or beef abattoir pancreatic tissue.

For that 5% who experienced problems, provided an opportunity to try a synthetic product, heralded as HUMAN . The talking point/selling point used to encourage its use was: “Why would anyone want to take anything BUT human ?”

Eli Lilly embarked on an aggressive campaign to change the dynamics of the market. Doctors were encouraged (bribed or coerced) to switch patients to the new HUMAN product. Charitable advocates (ADA and JDRF) experienced increased advertising revenues which, in turn, helped influence their position regarding the product. Still, by the end of the decade, the desired goal of switching all patients to human was not attained. But, when one essentially OWNS the market, there were a number of other tactics available.

In 1993, Eli Lilly began removing the standard animal (natural) insulins from the . Influence (political or financial or both) was used to encourage the government and the to imply that a threat of BSE and other animal-borne diseases existed in natural insulins. Omitted from any discussion of BSE/animal-borne diseases was the fact that Human production began with a media culture with even more suspect animal tissue components. In other words, beef and pork pancreases—properly prepared—have little to no chance of contamination. After several crystallizations, the in a natural analog batch is more pure than in products.

The ultimate insult to diabetics came from Dr. Loren Grossman, VP of Lilly-Canada, speaking before a HealthCanada committee. His admission that “not all diabetics can take human ” was followed by a corporate decision to remove ALL natural insulins from the U.S. . This statement and subsequent corporate actions reveals disdain, disregard or utter contempt for diabetics whose very lives depended on continued availability of natural insulins.

Did I mention that (and analogs) provide the perfect opportunity for the cartel to provide an unending, and ever-changing supply of new, patented synthetic products for a vulnerable population? Did I mention that each newly-patented foreign hormone approved by the will quickly—and more expensively—replace its predecessor as products go ‘off-patent.’ The -stream is unending, as is the supply of human guinea pigs (diabetics). Astoundingly, the first-approved human had no long-term follow-up reporting requirements. With such a precedent oversight by the , we can expect that each new product will meet with the same lax, long-term safety oversight.

Having been receptive to new technology, I tried most of the new products and emerging protocols, up to and including pump therapy. In my opinion, sudden death, dead-in-bed syndrome, hypoglycemia unawareness, complications, and driver accidents are increasing BECAUSE and influence-peddling by the pharmaceutical industry have been wildly successful.

The 5% of diabetics who NEEDED non-animal source insulins has been replaced by a similar group who NEED natural insulins. Additionally, 30-40% of the diabetic population might lead more “normal” lives, with better A1c’s as proof, had they been offered the option of using natural insulins. The cartel, with both and influence, do not want this information known. After more than two decades, we have yet to see the , or other health-centered agencies (NIH, NIDDK, CDC) undertake comparative studies, so the truth remains hidden.

: A Voice for Choice by Dr. Arthur Teuscher (a world renowned endocrinologist) provides an eye-opening analysis of this saga, and is a cautionary tale of how an over-mighty pharmaceutical industry has, under the guise of progress, adversely influenced the best interests of those with diabetes. It should be required reading for all diabetics and their healthcare partners.

After hearing the mantra for years, I am growing tired of doctors, pharmacists, government representatives and the cartel telling me to “get over it—that the new age protocols are here to stay.” Much like Dr. Grossman, they are essentially telling me it’s okay for me to NOT have an that was on the market, that I prefer, that I need—just go ahead and die, just don’t tell anyone! Could it be that the cartel (and diabusiness) is operating on the belief that UN-natural selection, for profit, is parallel to natural selection, where the weakest die anyway? To say this another way: genetic cleansing is okay as long as there is profit involved for the cartel.

ABOUT THE AUTHOR

brent.jpgBrent is scientist, advocate and author of a wonderful book called “Too Profitable to Cure” (available at www.tooprofitabletocure.com).

grew up in Vermont. After graduating from the University of Vermont, he obtained a Ph.D. in plant science from Kansas State University. At the age of 14, he was diagnosed with Type 1 diabetes. The impact of the disease, coupled with his scientific background, influenced both his career and avocation choices.

Living with diabetes for over 50 years, he has witnessed many changes in the treatment of the disease…but is distressed that the cure is no closer now than when he was diagnosed. From a not-unbiased viewpoint, he addresses the current state of healthcare for those who suffer from chronic diseases, and contends that profit, not humanitarianism, is driving American healthcare. As an entrepreneur/inventor, he is aware, and appreciates the profit motive that drives capitalism. However, he feels the bottom line should not be tainted with the smell of dead bodies. With Yankee pragmatism, he identifies culprits and urges activism as a countermeasure.

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