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

After its launch in the late 1950s, Upjohn’s Orinase (tolbutamide) became the first blockbuster hypoglycemic (blood sugar lowering) drug. Its success was born of failure. It wasn’t a replacement for insulin. Even if used early, it didn’t stop people from becoming insulin dependent. But attempts to create an early use market led to a focus on raised blood sugar levels and the creation of Type 2 Diabetes.

Diabetes is a rapidly fatal disease first recognized in antiquity. Insulin was one of the miracles of twentieth century medicine. With its discovery, people otherwise doomed to die were given a second chance. It didn’t just save lives it led to the very best medical teamwork between those with diabetes and those looking after them, as outlined in Annemarie Mol’s The Logic of Care.

Meds: Pills that Kill Created by Billiam James

The New Normal

The rebranding of raised blood sugar levels as a disease called diabetes was not a comparable blessing. This is not a disease. It is not diabetes. It won’t kill like diabetes. Severely raised blood sugars over a prolonged period can raise the risk of cardiovascular problems just as markedly raised blood pressure or cholesterol levels can, but clinical trials have shown again and again that except for Metformin the treatment is worse than the problem.

Sales of Orinase took off on the back of a marketing of raised blood sugar levels renamed Type 2 Diabetes. It is this that has given rise to the supposed epidemic of Diabetes we now have. An epidemic that is a major cash cow for the pharmaceutical industry.

The trick has been repeated across the board from anxiety states to bone thinning. The formula  – rebrand some variation as a disease, have committees of experts regularly lower the acceptable blood sugar levels or bone densities so that an ever growing number of people can be diagnosed, condition people to think we have a problem through a dripfeed of press releases, hire some celebrity patrons; voila – a sales epidemic.

How do you stop a bandwagon?

In 2002 the Women’s Health Initiative Study of Hormone Replacement Therapy (HRT) managed to stop the bandwagon when it linked HRT to early deaths. But this hasn’t worked in the case of diabetes. In 1969, a major NIH study of treatments for Type 2 Diabetes caused consternation when it found that Orinase killed. Doctors protested – how could doing something as obviously sensible as lowering blood sugars be a bad thing? Later studies showed that it was indeed a Bad Thing. That lowering the sugars of those with higher than normal to ‘normal’ caused more harm than good.

Orinase had blazed the blockbuster trail and it was too valuable to Upjohn to give up lightly. They fought back, recruiting academics to contest the findings. Six years later when Jaws the first movie blockbuster was released, Orinase was still claiming its victims proving that Hollywood romance doesn’t apply to Great White Drugs feeding in healthcare waters.

The sequels to Jaws had almost no box office impact. But in the wake of Orinase, we have had even greater horrors from the even bigger Rezulin and Avandia blockbusters. Parke-Davis’ Rezulin (troglitazone) caused liver problems and death. It continued to be marketed direct to consumers in the US for years after its UK withdrawal. GlaxoSmithKline’s Avandia (rosiglitazone) caused heart problems and death, estimated in the tens of thousands.

The Cautionary Tale That Wasn’t

Now a new set of menaces stalks the waters – the Gliptins and the Incretins. The Gliptins are Sitagliptin, aka Merck’s Januvia, Janumet, and Juvisync, and Saxagliptin, aka Bristol Myers Squibb’s Onglyza and Kombiglyze. The Incretins are Exenatide, aka Amylin’s Bydureon and Lilly’s Byetta, and Novo-Nordisk’s Liraglutide, aka Victoza.

The script is more like The Cautionary Tale That Wasn’t as repetition increases rather than dulls these horrors. An innocent Chrissie Williams goes swimming and is savaged by something from below. Martin Brody (Roy Schneider), a sheriff in the Regulators Office, investigates. Amity Island’s successor to Mayor Vaughan leans on Brody. Brody then goes out of his way to obstruct Matt Hooper (the scientist – Richard Dreyfus) and Quint (the journalist – Robert Shaw) when they turn up.

From thalidomide through to Rezulin and the Gliptins, Quints have blazed the way. These are the hard bitten journalists like Morton Mintz for thalidomide, David Willman on Rezulin – out big story hunting. In the case of Avandia, the shark hunters were Panorama’s Shelley Jofre and Andy Bell. Jofre and Bell put the evidence of Study 329 in the public domain that led to fraud charges against GSK and the company agreeing to post its study results on the company website enabling Steve Nissen to discover the excess of cardiac problems on Avandia. Jofre is the nightmare that wakes Brody from sleep – a horror movie called Lips.

Through all these scenes, the drumbeat is the same – savaged bodies washed up on shore are discounted by Brody with lines akin to ‘there may be a signal but we don’t have conclusive evidence of a problem’.  The half torso might have been because the poor girl swam into a boat’s propeller. More bodies washed up makes no difference. Observations like this don’t prove causality – you’re only noticing these things because of media reporting – young girls bodies wash up on the beaches round here the whole time. Going swimming puts them at increased risk of getting chopped in two – everyone knows that.

That Hooper guy he’s a scientologist or an expert witness hired by some lawyers – mark my words someone like that has just got to have something wrong with them, why else go round the place scaring people?

Look Quint, if you really want to test it out, we’d have to do a controlled trial like dump half the crew of the Indianapolis in shark infested waters to test out what’s going on.

But Mr Brody if the ships propeller is on, how would you be able to tell if this is down to sharks or not?  Indianapolis,  isn’t that where Byetta comes from?

The Byetta and Januvia stories are unfolding in the classic way. Quint in this case is Deborah Cohen in the BMJ. Hooper is Peter Butler and colleagues from UCLA who found evidence that these drugs cause cell proliferation triggering pancreatitis and cancers in both pancreas and thyroid glands. The science is pretty convincing – give the drug to animals and problems appeared, stop them and the problems clear up. Butler and his group have been ostracized.

The illusion of zero risk

Companies are so adept at handling these issues that they probably welcome the appearance of controversy – it increases sales. If you’re a doctor, come to Amity Island where there is more action on the beaches than anywhere else. Doctors, have we got the deal for you, your very own heated infinity pool – to give you the illusion you are in the water without any of the risks.

Over the top? Not a bit of it. In the case of Victoza, Liraglutide, there was very strong evidence that it could cause thyroid cancers. The regulators said they were prepared to allow the drug on the market with clear warnings which would of course make it a second line treatment. But warnings are gold-dust to companies and sales of Victoza hit blockbuster status soon after it came on the market. Just like Rezulin.

RxISK and You

But Quint and Hooper have a new weapon these days – the combination of RxISK and you.

1. Put Januvia or Sitagliptin, Onglyza or Saxagliptin, Byetta or Exenatide, Victoza or Liraglutide into the Search box on RxISK.org.

2. Go to the Established Side Effects tab and look at what the European Medicines Agency has to say about the side effect profile of each of these drugs. You’ll find pancreatitis is established as caused by each of them and that thyroid cancer is established for Victoza. This is data not available to Quint from any other source.

3. Go to the Reported Side Effects tab and click on All Side Effects (A-Z). Head for pancreatitis and pancreatic cancers as well as thyroid cancers and let your jaw drop  – over 150 pancreatic cancers for Januvia and over a thousand cases of pancreatitis, with over 300 cases of pancreatic cancer for Byetta and over 4,000 cases of pancreatitis. And what’s this – 99 cases of thyroid cancer on Byetta?

4. Have a look at the Outcomes tab – how many deaths and hospitalizations?

5. Anticipating the brush off from Chief Brody certain to come your way – it is well known that diabetes causes pancreatitis and cancer so these reports prove nothing – check out the figures for pancreatitis and for cancer on Metformin, the most commonly used pill for lowering blood sugars, or for the previous blockbusters Avandia, now withdrawn, or Actos known to cause bladder cancer. You’ll see vastly less cases of pancreatitis or cancer and no thyroid cancers. Decide for yourself what chopped Chrissie Williams in half. Make up your own mind whether it’s safe to get back in the water – or whether the swim is worth it.

6. Help us track down the Shark. Get yourself a free RxISK report. Become one of the first to leave a RxISK story for these drugs. Between us we can build a HeatMap of where these problems are happening. If they’re happening in Martha’s Vineyard but not in North Carolina or Santa Monica this will give the Quints and Hoopers among us vital clues they’ve never had before when chasing sharks.

7. Take your RxISK report to your doctor. This will be like dropping a replica shark in the infinity pool – s/he will either react magnificently and become a key player in saving your life and that of others or you’ll see him in his true colors.

“Chemicals”

There are just two bits to the script we need to change to get things right for the new Spielberg thriller “Chemicals”. Martin Brody is never there when you need him. But Martine Brody is – someone’s wife, mother or daughter is invariably the one who refuses to act like nothing is wrong.

Someone who knows the Great White Lies are what you need to watch out for.

Spielberg’s skill in Jaws makes you look one way while the shark comes from behind. You are now looking closely at pancreatic and thyroid cancer, heart and liver failure. These are a high price to pay for people who didn’t have a disease to begin with.

But just as your pulse settles down…..

To be continued

Illustration: Meds: Pills that Kill, © 2013 created by Billiam James


RxISK: Research and report prescription drug side effects on RxISK.org.

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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

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. William Cory says:

    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 –

    • David_Healy says:

      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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