Swimming with Great Whites? If you’ve got “Diabetes” look away now.

June, 20, 2013 | 5 Comments

Comments

  1. Wonderful timing! The American Diabetes Assn opens its annual scientific meeting tomorrow in Chicago, with this controversy a-boiling. The ADA has made an unprecedented call for drug companies to share their raw patient data on these drugs with independent reviewers:

    http://www.diabetes.org/for-media/2013/american-diabetes-association-incretin-therapy.html

    Now the ADA is historically pretty industry-friendly I think, so who knows how “independent” a review it will take to satisfy them. Yet another brand-new drug called alogliptin (NESINA) from Takeda, already on the market in Japan, will get its U.S. kickoff at this meeting.

    After the Avandia scandal broke, the FDA announced that any new diabetes drugs would need to come with cardiac safety studies – and several big ones have been launched. I worry the drug companies may use these to deflect questions about the pancreatic risks, especially since those might not show up till someone’s been on the drug a couple of years (?) For instance, there’s a study called CAROLINA being launched by BI and Lilly comparing their gliptin drug Tradjenta to an older drug called glimepride for cardiac safety. (Maybe glimepride is a real dog of a drug? I haven’t heard of anyone taking it, and most of the FDA reports come from Japan not the US.)

    Patients in Chicago can sign up for the CAROLINA study right now. Guess where? Suburban Clinical Research (SCR), the one with ties to Sacred Heart Hospital – the place that was raided by the FBI for defrauding Medicare and subjecting patients to unneeded surgery. SCR’s director, Dr. Percy May, is out on bail you’ll be glad to know.

  2. I read your article “Swimming with Great Whites” with interest. Type 2 diabetes (in my opinion) is indeed a ‘created’ disease. What is NOT a created disease is Type 1—and what has happened in this field is (again, in my opinion) criminal—but no one will look back far enough to discover the roadmap laid down by Eli Lilly in bringing to market synthetic insulins.

    The litigious/criminal behavior that spawned rDNA insulin provides a story in itself. The manner in which the first synthetic insulin garnered FDA approval is yet another story that is jaw-dropping. The FDA approved rDNA synthetic insulin (Humulin) with the caveat this was a niche-market drug for those who were allergic to natural (animal-derived) insulins. The FDA required post-marketing studies, no studies have been provided. Humulin and Ultralente Humulin (slow-release formulation) have both been determined to be quite problematic for many Type 1 diabetics. (In fact, slow-release human Ultralente was quickly removed from the marketplace.) Ignoring bad results (hypoglycemia unawareness, allergic reactions, dead-in-bed syndrome, sudden death, coma, emergency room visits, etc.), has become commonplace. Looking at HRT studies (which you brought to light of day), would support that synthetic insulins have become as dangerous to Type 1 diabetics as did synthetic hormones used by women.

    I spoke personally with a Harvard professor of biochemistry who was closely associated with Harvard’s original work to create a synthetic hormone (aka synthetic insulin). He stated flatly that there was no guarantee that today’s products are exactly identical to the biochemical structure they were trying to copy and batch-to-batch production runs are difficult to control.

    Today’s doctors are ruled by mentors (many with vested interests) who insist that testing often is a requirement of treatment. (Yet, 20-year-old technology still rules the meter-market, allowing for +/- 20% error rates). Tight control (which is impossible to maintain over any sustained period) places the onus for compliance on the patient. Most young diabetics have no autonomous symptoms that warn them of impending dangers—instead they rely only on inadequate monitors that give them a moment-in-time snapshot of their bG.

    In my day (I’ve been diabetic for 56 years), the shakes, sweats, nausea, muddled-thinking were all warning symptoms that I’d better be on high alert—and do something to save my own life. Today’s patients—because of the treatment (synthetic insulin that does NOT produce warning signals and bG meters that only give an often-inaccurate indication of current bG)—are in constant peril and yet do not know what they do not know.

    Lilly, in bringing their products to market, CONTROLLED the competition. They withdrew one after another of time-proven, necessary natural insulins, substituting the latest-greatest, highly profitable patented, synthetic “insulin.” Our political system cannot force a company to provide a needed life-sustaining insulin because Lilly convinced the FDA there was an “equal” product on the market.

    Currently, we are embroiled in non-transparency for more-recent drugs. What will it take to get a researcher/investigator to look far enough back to see the original roadmap?

  3. Dr. Healy: You wrote above,

    “But warnings are gold-dust to companies and sales of Victoza hit blockbuster status soon after it came on the market. Just like Rezulin.”

    How/why are warnings gold-dust to companies?

    Thank you —

    • For companies anything that leads to conversation about the drug increases sales. When FDA slapped a category D – causes birth defects – warning on Paxil, the company’s view appears to have been this was the time to get a lecture tour going to increases sales because FDA would be increasing the frequency with which doctors heard the word Paxil. Or as the PR woman for Prozac in the UK told me many years ago I was doing more for the sales of Prozac than anyone else by going round talking about the risks of suicide.

      This is the reason for Rxisk – company marketing feeds on awkward critics and warnings – but if given thousands of voices reporting issues it may be more difficult. We all need to AbbVie – see a more recent post

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