No. I Am NOT Paranoid about Drug Company Evildoing

The drug companies will do whatever it takes to keep their blockbuster drugs selling, and often what it takes is deliberate hiding of research results that point to the dangers of the drug.

I urge you to read this New York Times article published today in full:

NYTimes: Diabetes Drug Maker Hid Test Data on Risks Files Indicate

But keep in mind that the media know Avandia is a dangerous drug because the company ran one study too many--one that demonstrated that it was killing people. They do not have a clue about the dangers of other drugs, even those that are already well documented (like the way that Actos causes heart failure and serious osteoporosis with long term use). Nor do the people who write about health in the media do any research beyond printing up press releases and interviewing a few high profile doctors who are inevitabley highly paid as "consultants" by the big drug companies.

And, of course, the media know nothing at all about the many other drugs whose makers have been more successful than Glaxo at hiding the research that turned up serious problems connected with their drugs.

Which is why you really DO have to be paranoid--very paranoid indeed--about any new drug. And if you have diabetes the drugs you really need to be paranoid about are the "gliptin" drugs that lower blood sugar by impeding the action of the gene that makes an enzyme, DPP4, that degrades GLP-1. Januvia (sitagliptin) and Onglyza (saxagliptin) are the two "gliptins" that have been approved for use. There are others in the pipeline.

The problem with these drugs is this: while inhibiting DPP-4 does, in fact, boost GLP-1 levels and lower blood sugar, the body uses DPP-4 for many OTHER functions besides getting rid of GLP-1. The most important of these function is this: the immune system uses DDP-4 to kill cells that have become malignant--i.e. those first cells that left alive turn into dreaded cancers including melanoma, lung cancer, ovarian cancer and prostate cancer.

All of us develop cancerous cells as we go through life. But our immune system recognizes them and kills them. It is only the rogue cells that escape this process that go on to kill us. DPP-4 is one of the tools the body uses to kill these cells before they can grow into tumors.

And here is why you need to be paranoid about the gliptin drugs: Though the function of DPP-4 as a tumor suppressor is well known, the drug companies have never revealed that they have done a single research study to examine what happens to the body's ability to defend against these cancers when DPP-4 is inhibited.

The tests that are required as part of the FDA drug approval process will not answer this question. The cancer-related testing is made up of only two kinds of tests.

One is a test tube study, The Ames Test, that only can tell if the drug damages DNA. The DPP-4 inhibitors do not damage DNA. They don't cause cancer, either. They just turn off the enzyme that destroys cells that have become cancerous before they can do harm.

The other required test that is part of the approval process is the rodent test. These tests check whether large doses of the drug give cancer to short lived rodents. This is not a useful test for a drug that promotes human cancers that may take years to develop. How many rodents live long enough to get prostate cancer? Nor is it helpful for melanoma, which is not a problem for fur covered animals.

The acceptance trials for these drugs are very short--no longer than two years--and because they are so short they aren't likely to show the increased cancer risk in those taking them if the cancers take four or five years to become evident. Even so, the acceptance trials for Januvia did show a slight rise in cancers in the people taking Januvia--a fact that was obscured by the way that the company chose to report tumors--mixing together both benign and cancerous lesions.

I have documented this issue extensively here: Januvia. I urge you to read it carefully. Keep in mind the same issues cited for Januvia also apply to Onglyza.

It took a long term study (intended to find something else that would have sold much more of the drug) to reveal that Diovan raises the incidence of cancer. (Note that this story was carried almost entirely by the business press that worried that this finding would harm drug company profits!)

It was a long term study intended to find something else that would have sold more Avandia that showed the world that Avandia was killing people. You can be sure that the drug companies have learned their lesson--and it isn't to test their drugs more carefully. These experiences have taught the drug companies this: Don't run long term studies of drugs that are earning you millions.

The New York Times article points out that though the drug companies are now legally required to publish the results of all trials they run, they are doing so, in the words of the New York Times in postings that "are often little more than cryptic references."

But rather than just obscure the results of studies, smart drug company executives will merely avoid running studies in the future that could kill their golden geese.

I find it very unlikely that the makers of Januvia, Onglyza, and the not-yet-approved other "gliptin" drugs are unaware of the fact that their drugs turn off a cancer fighting gene. And that is why it is certain they've learned from the Avandia fiasco that the easy way to avoid exposure is to avoid conducting long term studies of a profitable drug.

Meanwhile, tens of thousands of people with diabetes will die of unnecessary cancers. Their doctors will tell them, "People with diabetes are known to have a higher risk of cancer"--which is true. But they'll ignore the fact that they gave these people with diabetes a drug that turns off a cancer fighting gene.

Doctors are very ignorant about how the drugs they prescribe work. They know only what the drug companies tell them which is often highly oversimplified if not actually misleading.

if you doubt this, ask your doctor what else DPP-4 does besides lower blood sugar. It is very unlikely he will know. In fact, if you ask him how DPP-4 lowers blood sugar, it is possible he won't know that either--it does it by slicing up the GLP-1 molecule. I have heard from many dozens of cancer survivors who, like me, were prescribed Januvia by doctors who had no clue what DPP-4 was or what its relationship was to cancer. When their patients asked them about it, the doctors' response indicated that they they trusted that these drugs had been tested to eliminate the possiblity that they caused cancer during acceptance testing.

They weren't. And because of the Avandia lesson, they probably won't be the subject of the long term testing that could reveal this.

Stick with drugs that have been around for more than fifteen years and you are much more likely to avoid unpleasant surprises.

 

Dangerous Celebrity Doctors Who Prey on People with Diabetes

Not a week goes by than I don't get an email from someone directing me to the web site of yet another physician with poor or nonexistent credentials in endocrinology who's trying to duplicate the financial success of people like Neal "I'm a psychiatrist but that doesn't keep me from making millions giving bad advice about diabetes" Barnard or Joseph "even a stopped clock is right twice a day" Mercola.

What all these doctors have is common is this: little or no experience treating people with diabetes and grandiose claims that they have discovered secrets that will cure or reverse your diabetes. They publish bestselling books that propel them to TV stardom without anyone in the publishing or media community ever checking what happens to people with diabetes who follow their advice.

Barnard, in case you've been living under a rock, is a vegan activist who heads the PETA front group misnamed Physicians Committee for Responsible Medicine. His books claim that the cure for diabetes is a vegan, extremely low fat/high carbohydrate diet--a diet that leaves most people with diabetes fighting ravenous hunger, rollercoastering blood sugars, and advancing complications.

Barnard has no training in endocrinology. He's a psychiatrist who doesn't appear to have practiced much in his specialty. But he is a genius at self promotion and over the years he has promoted himself to where he is on peer review committees funding diabetes research and is a darling of the American Diabetes Association. This should be no surprise. The ADA is so invested in the low fat/high carbohydrate which it has promoted to people with diabetes for decades that they gravitate to anyone whose charisma might postpone the day when America discovers how poorly it has been served by the organization whose flawed advice, maintained in the face of decades of evidence against it, has been killing their loved ones with diabetes.

What you won't find on Barnard's TV show is any advice about testing after meals to see what foods raise your blood sugar, of course. But he's convincing (as so many psychopaths are). So Barnard will retire a multi-multi-millionaire and tens of thousands of people with diabetes who see him on legitimate looking TV shows will end up with unnecessary compliations as a result of eating the diet of grains, fruits, pasta, and soybeans he has convinced them are a healthy diet.

But there plenty of questionable self-promoting doctors who have jumped on the Low Carb bandwagon, too. Dr.(DO not MD) Joseph Mercola is the most notorious. Mercola won his first adherents in the alternative health community by turning against grains. Fine. There are problems with grains and I'd be the first to admit it. Since then he's jumped on whatever is the currently fashionable cure all, (right now it is Vitamin D).

But the problem with Dr. Mercola is that if you visit his site you'll see that he popularizes health ideas that are true (though discovered by others) so that he can sell you cures that are highly questionable verging on the fraudulent. His site funnels you into the "Products" and "Services" sections that sell branded worthless supplements like acai berry, and overpriced items like a $39 Vitamin D spray that will give you the same dose as a bottle of $6 capsules from Walgreens.

But Mercola doesn't stop there. Having lured you in with not entirely unreasonable content (available on hundreds of other sites) he does his best to sell you some some very bogus natural health cures. These include homeopathy, acupressure (though Mercola is NOT a trained acupuncturist, a discipline that takes several years of training), and chiropractic (though Mercola is also not a trained chiropractor). His articles on media outlets like the Huffington Post start out by citing some natural health idea beloved by the alternative health community--something along the lines of the ever popular "Aspartame is poison!" but then seguey into promoting his branded higly fringe cures.

In fact, a careful look at Mercola's credentials suggest he's a marginally trained D.O. with very little clinical experience treating metabolic disease. The hospital he cites on his web site as being the one he was once affiliated with, St. Alexius Medical Center, Hoffman Estates, IL, turns out to be a small Catholic mental health hospital. He is not board certified in any specialty that would suggest he has expertise in treating metabolic disease and his "professional affiliations" are not impressive. Most are fringe groups or things you can join if you have a medical degree and write a check. His publications appear to mostly be letters to various journals citing his personal theories not actual research.

This is not to say that all Mercola's health post are wrong. Only that he picks up ideas from elsewhere and uses them to lure people in so he can profit from selling his questionable products and services. And because he is plugging so much questionable content, his site is not helpful to people with diabetes.

These are just two of the celebrity doctors who want your money and who don't care that they are selling you crap that will not keep you from developing diabetic complications. There are plenty more. My site has become so visible I'm getting inundated with PR mailings from a host of celebrity doctor wannabes, all of whom have in common that they have something to sell and web presences that make it clear they have no clue what it takes to control diabetic blood sugars.

And that is the crux of why I'm posting this. It's one thing when money-hungry celebrity doctors market themselves to "the worried well," all those vaguely hypochondriac people who have nothing wrong with them except, perhaps, boredom or normal age related ailments. The worried well respond strongly to placebos and that is what most of these celebrity doctors' branded products really are.

But it's another issue entirely when they move from fleecing the worried well to pretending they have real solutions for people with diabetes. Diabetes does not respond to placebos.

Diabetes does not reverse in response to any supplement. Chiropractic can not lower your blood sugar. Acupuncture will not cure diabetic neuropathy. There is, in short, nothing any celebrity doctor is selling that will cure your diabetes and a lot that they promote that will make it worse because the false hope they give you keeps you from learning about the tried and true tools that could lower your blood sugar and keep you healthy.

What these effective tools have in common is that they don't require you to buy much beyond a blood sugar meter and possibly some safe prescription drugs any family doctor can prescribe--the most effective of which is $4/month generic metformin.

The only diet that will keep you healthy if you have diabetes is one that keeps your blood sugars below 140 mg/dl (7.7 mmol/L) at all times. What this diet will be varies from person to person. For many of us it will be a diet low in carbohydrate. For a very few who have a rare subset of diabetes where they are fat sensitive it may be one lower in fat. You won't know what diet will control your personal form of diabetes until you employ a blood sugar meter as described HERE. Follow the technique described on that web page and within 2 weeks you should have a very good idea what foods make up a safe diabetes diet for you.

But even that diet will not "reverse" your diabetes, because nothing has ever been shown to truly reverse established diabetes. Diet and medications can stop your diabetes from destroying your body and give you normal health, which is good enough for most of us. It isn't a miracle. It requires self-discipline and daily choices about what to eat and how to use our energy. But it works. Unlike the one-size-fits-all miracle cures of celebrity doctors.

There is no miracle cure for diabetes. It takes work, study, and an annoying amount of daily effort to preserve your health if you have abnormal blood sugar. Doctors who claim to have discovered health secrets usually have one real secret--they've gotten bored with treating patients and have decided to take the quick way to making a fortune and retiring from practice.

How To Evaluate The Credentials of Any Would-Be Celebrity Doctor

When someone with M.D. after his name sets himself up as a diabetes authority--or tells you that he has found "secrets" that will cure all that ails you--ask the following questions.

1. What is this doctor's board certification (if in fact he has one)? An endocrinologist or cardiologist should be board certified and actively practicing in that specialty for years before self-appointing himself an expert. A legitimate doctor should have completed a residency in the field he purports to be an expert in. Look at what medical school the doctor attended too. Brighter doctors get their degrees at schools associated with major teaching hospitals.

2. What hospital does he practice out of? Legitimate doctors have hospital privileges at good hospitals. A doctor who only practices out of his own clinic may be a doctor who was kicked out of his last hospital for harming too many patients or one whose credentials are very marginal.

3. How much time has this doctor spent treating people with diabetes and what evidence is there that his patients do better than the average besides his say so?

4. If his ideas are not mainstream, how much evidence does he give to support them and what is the quality of that research? Typically celebrity doctors will cite only three or four studies--sometimes without giving you any citations to the actual studies. The studies they cite may be small poorly conducted studies that were cherry picked to support the simplistic theory the doctor already came up with before doing any research.

5. What is this doctor selling? The more branded products and non-physician services you see for sale, the more dangerous the doctor is likely to be to your health. Doctors who no longer practice medicine except on TV shows are often the most dangerous to your health because it is years since they've actually treated a patient with a serious medical problem.

6. Does the doctor promise a miraculous cure available only with his products or services or only to those who follow his advice? If so remind yourself there is NO one cure for any form of diabetes. There is no one diet or drug that works reliably for every person with diabetes, either.

7. Check out what real people with diabetes have to say about any celebrity doctor's approach on online discussion groups. You'll see several linked on the right column of this blog. Be aware that there are shills promoting supplements on all online groups, so if you see someone enthusing about something expensive, click on their profile and see if they post about anything besides that supplement or treatment. But besides the shills most online discussion groups have a core of regulars who have been posting for years and whose comments may be useful. Read their opinions before you become just another victim of a doctors whose concern for his own fame and fortune is greater than his knowledge of what it really takes to survive diabetes.

 

Friends of the Blog: Feedback Wanted!

My web stats tell me there are two different types of people who read this blog. One is people who find old posts thanks to Google Search. Google loves both this site and my main Blood Sugar 101 site, so even posts a few years old get a steady stream of visitors.

The other is blog subscribers--people who come in every time I post something new. A few of these regulars post comments. The rest just read and leave. But thanks to the magic of page stats I can see how many silent regulars we have here, too, and there are a lot of you.

As most of my regular readers know, this past year I haven't had the time I usually have to research and post about the latest diabetes news because, much to my amazement, last June I sold a novel and two sequels to a major publisher. The novel was finished, but the sequels weren't even begun,and because big publishers demand that their authors deliver new books very quickly, I have had to dig in this past year and work my butt off to meet my deadlines.

Since I have one more year to go on this current contract I'm not going to be able to post here three times a week for at least another year. That means that when I do post I want to give my devoted readers what they want the most. The question is, what? I hope you, who are reading this current post, can give me some feedback to help me do this.

Typically I do a couple different kinds of post. I comment on really important news about advances or new discoveries in the diabetes field. I warn you about the many highly publicized, poorly designed studies that come up with misleading and sometimes downright dangerous conclusions that result from poor study design or cynical manipulations on the part of the companies who fund them.

I also post about the tips and tricks that can help readers lower their blood sugar. Some of these posts may state things that are not news to those of you who have had diabetes but the mail this blog generates suggests that those simple posts are the ones that have the most impact on the many newly diagnosed people who find this site every week.

So tell me. Over the next year, what kinds of posts would you like to see when you find a new post on this blog? What do you find here that you find the most helpful in your ongoing struggle with diabetes?

I realize that readers will have different needs and that some of you might not agree with other's ideas of what is most important. That's good. I want to hear from as many of you as possible to get a feeling for what keeps you coming back and what helps you preserve your health.

Post your ideas in the comments section. What kinds of posts would you like to see here over the months ahead?

 

Timing Your Metformin Dose

The biggest problem many people have with Metformin is that it causes such misery when it hits their stomachs that they can't keep taking it even though they know it is the safest and most effective of all the oral diabetes drugs.

In many cases all that is needed is some patience. After a rocky first few days many people's bodies calm down and metformin becomes quite tolerable.

If you are taking the regular form of Metformin with meals and still having serious stomach issues after a week of taking metformin, ask your doctor to prescribe the extended release form--metformin ER or Glucophage XR. The extended release form is much gentler in its action.

If that still doesn't solve your problem, there is one last strategy that quite a few of us have found helpful. It is to take your metformin later in the day, after you have eaten a meal or two. My experience with metformin--and this has been confirmed by other people--is that it can irritate an empty stomach, but if you take it when the stomach contains food it will behave.

There are some drugs where it matters greatly what time of day you take the drug. Metformin in its extended release form is not one of them. As the name suggests, the ER version of the pill slowly releases the drug into your body over a period that, from my observations, appears to last 8 to 12 hours. Though it is supposed to release over a full 24 hours, this does not appear to be the case, at least not with the generic forms my insurer will pay for.

Because there seems to be a span of hours when these extended release forms of metformin release the most drug into your blood stream, when you take your dose may affect how much impact the drug has on your blood sugars after meals or when you wake up.

For example, the version I take, made by Teva, releases most strongly in a period that starts 2 hours after I take it and continues strong over the next 8 hours. If I take my full 1500 mg dose first thing in the morning, my blood sugars at lunch will show the impact of the drug most strongly. Dinner will be slightly less affected--i.e. if I ate the same lunch and dinner I'd see slightly better numbers at lunch and I see the least impact on my next mornings fasting blood sugars.

If I take the same full dose at 2 PM I will see the strongest effect on my blood sugar after dinner, but I will see a lower fasting blood sugar the next morning than I would if I took the drug first thing in the morning. The trade off is that my breakfast blood sugar will be higher on that schedule if I eat any carbs.

Metformin also builds up a cumulative effect on your fasting blood sugar after you take it for a week. This effect is not dependent on when you take it. If you miss a dose you will probably see a small but immediate difference in your post meal blood sugars. But if your stop taking it for a week you will not only see that effect the day after you you stop it, you will also see a second notable increase in your fasting blood sugar and pre-meal blood sugar about a week later.

If you are taking metformin primarily to lower high morning fasting blood sugars, it may make sense to take your full dose right before bed--but the trade off will be that this timing of your dose may give you the weakest coverage before lunch and dinner, which may leave you with higher sugars for many hours of the day which counteract any advantage you might get from having lowered your morning reading.

Some people take half their metformin in the morning and half at night. That might give a more even effect throughout the day but because you smoothe out any peak in the drug's effect, you might see slightly higher meal time sugars than you would if you took it all at once.

Personally, I have learned after a lot of experimentation that taking all my metformin ER in a single dose at 2 PM gives me the most benefits. First of all it keeps me from having stomach discomfort, secondly it gives me a little boost with my dinner numbers, and finally it knocks a little bit off my morning reading.

Your results might be different, but you won't know what works for you unless you test different schedules.

If you want to change the time when you take your metformin there is one rule you must follow: Don't ever take MORE than your full prescribed dose during a 24 hour period.

If you take all of your metformin at 6 AM don't take any more until 6 AM the next day. If you have been splitting your dose and taking half at 6AM and half at 6 PM don't take a full dose of metformin until 6 PM the day after your last 6 PM dose.

You do not want to overlap your doses because you do not want to give yourself an overdose. Overdoses of metformin are very rarely life threatening--there is a case on record of someone surviving an overdose of 63,000 mg--but from personal experience I can tell you they are unpleasant and can make you feel very sick indeed. My old family doctor prescribed me an overdose years ago after he confused the top dose for the regular with the ER form--the regular can be taken in larger doses. It made me very ill though I was fine the next day.

Also, if you are testing a new dosing schedule, give it at least a week before you decide if it is working for you. That will let the long term blood levels stabilize.

Another helpful thing to know about metformin is that unlike many medications, it is not one that will cause rebound problems if you stop it abruptly. If you stop metformin all that will happen is that your blood sugar response will gradually go back to whatever it was before you started taking it. And you can start it back up at any time after that without any problems save the usual side effects people experience the first few days on the drug.

If you are not seeing the expected results from metformin, you may be taking one of the weaker generic forms. My experience and that reported by Dr. Richard K. Bernstein is that various generic brands of metformin vary greatly in their impact.

Many pharmacies will let you try a different generic brand if you want to try it. Dr. Bernstein recommends Glucophage, which was the original patented form of metformin prescribed before the generics came on the market. I haven't tried it so I can't say how useful it is. But if you have a choice, you might ask for it.

One last issue I haven never seen reported before is this. If you have trouble sleeping at night because you frequently have to get up to pee, it might be better to take your metformin before 3 PM because metformin may increase your need to pee at night. This is probably because the kidneys help remove it from the body and work harder in the 8 hours after you take the dose.

 

Heat Harms Insulin, Meters, and Even Some Oral Drugs!

A recent article in Science Daily reports on a presentation given at this week's meeting of the Endocrine Society.

It's worth a look: Science Daily: Many People with Diabetes Do Not Know or Heed Dangers of Hot Weather

Unfortunately, while the points it makes are true, a much better title would have been Many doctors and pharmacies don't know or heed the dangers of hot weather.

Just this week I heard from someone whose insurance forces him to get his medications from a mail order service that refuses to ship insulin overnight or with any protection against temperature. This, even though the insulin manufacturer documented for this person that when insulin sits in a hot truck it dies.

Meters and test strips can also become unusable if left in a hot car. I've cooked a whole vial of strips by leaving them on a car seat when it was in the 90s outside.

The Science Daily article points out that even pills can be ruined by heat. That was new to me but I am no stranger to the phenomenon where one month's Metformin works a whole lot better than another's. Sadly, I am also no stranger to the phenomenon where when you complain to a pharmacy that your insulin is weak or there seems to be something wrong with your pills, they assure you it couldn't possibly be true and that no one else has complained about them.

No one else probably has complained, because they probably assumed it was something in their own physiology that made their blood sugars suddenly shoot up. Given the vague way that most people with Type 2 are prescribed insulin and their lack of understanding of how insulin doses should correlate tightly with blood sugars, it is no surprise that customers pay for their insulin and accept whatever they're given, even if it barely works.

Sadly, the problems caused by temperature are not limited to heat. I took an insulin pen with me, in my purse, when I dined at a restaurant last December when outside temperatures dropped to a low in the very low 20s. Even though I was only outside for maybe ten minutes, that was enough to freeze the pen. A faulty fridge can do the same thing. If you see ice crystals in your milk or vegetables, chances are any insulin you had in the fridge is toast, too.

But just try getting a replacement from your health insurance when your insulin pen dies. Good luck!

Because pharmacies get their insulin from wholesalers who won't ship it overnight or with temperature buffering anymore, there is no easy solution to this problem. The insulin you buy from the pharmacies is just as likely to have sat in a hot truck for three days as the mail order stuff.

Doctors aren't aware of this problem, and neither, based on my experience, are pharmacists. That means if you suddenly see unexplained high blood sugars after using a vial of bad insulin, the doctor may just raise your dose rather than insist that your pharmacy replace the vial.

What makes it more of a problem is that this issue is fairly. Five years ago mail order pharmacies always shipped insulin overnight with cold packs. The switch to sending it in hot slow trucks is a recent, cost cutting move--one that is going to result in more blindness, amputation and death for those who use dead insulin and more hypos for those who get used to weakened insulin and then get a vial of full strength.

I wish I had some sage words of advice to offer about how to deal with this. About all I can do is assure you that if you are experiencing major fluctuations in blood sugar response from vial to vial or pen to pen it might not be your physiology at fault.

If you use small doses, it is also a good idea to remember that some insulins weaken over time no matter what you do. I found Levemir very prone to weaken. On the other hand when I used Apidra it stayed potent for many months even though it was not refrigerated. The Apidra I used was a sample my doctor gave me since my insurance wouldn't pay for it. When the doctor got another batch, mailed to her in the summer, it arrived dead. No insulin can survive temperatures in the very high 90s for very long.

If you have a good vial or pen, protect it from heat and cold. A Frio pack works well for this. Don't leave your meter in a hot or cold car, either. And remember that even ten minutes of exposure, as you walk to a restaurant on a very hot or very cold day may be enough to weaken your insulin or render it useless.

Post your experiences with this issue in the comments, along with any solutions you might have found!