Why you can’t always believe drug company studies: Farxiga

Why you can't always believe drug company studies: Farxiga


As you know, your faithful editor Matt Cook, also known as the Cookster, scours medical literature.

I spend hours every day to bring you the most important health discoveries.

I bring you studies that have been concealed, ignored, or possibly even censored.

Today I want to show you what studies I do not ever use and why.

I probably don’t use 98/100 studies that I read.

I can only use one or two studies that I read out of 100 because so many of them are bogus.

Some are so just outright poorly done, or sometimes cleverly biased.

The studies conducted in recent years funded by drug companies invariably use statistical wizardry.

And they just cannot be counted on for the truth.

In fact, they produce results that are often shockingly wrong.

You, the person taking the drug, are the real guinea pigs testing the drug.

And then ten years or 15 years later, after the drug has brought billions of dollars in profit to the Big Drug companies, the truth trickles out.

Often, we find out then that the drug causes some problems. Oops.

Now the drug is taken off the market.

Or, more likely, they’ll give it what is called a “black box warning” which does not affect the drug’s profitability.

Doctors can still prescribe it — at the patient’s peril.

If you think the FDA is looking out for you, you are sadly mistaken.

This study is typical of the studies that your doctor is using to assure himself that the drug is indeed safe.

Of course, this assumes he’s using any studies at all to make decisions.

But most doctors are busy and want to feel that the studies the drug salesperson shows them are correct.

Unfortunately for them, and their patients, that’s not always the case.

This is a drug called Farxiga, and it is a diabetes drug.

The drug developer Astra Zenaca funded this study.

Now there may be nothing wrong with a study funded by a drug company.

It could be a good study.

But it generally is NOT a good study.

More often, researchers statistically manipulate the study results to show the outcomes you see.

And this study is a good example of why I’m showing you the problem.

Most physicians are only going to read the very beginning of the study and not ever really look at the study deeply.

It’s very difficult and tedious to read full studies, let me assure you.

There are a million things I would rather do such as slit my wrists or get a root canal without anesthetic, LOL.

But I read the full study to make sure that I give you an accurate view of my thoughts.

So, the study starts out with the background.

And doesn’t this sound like a great thing?

That’s pretty much what the doctors will think.

Dapagliflozin, a selective inhibitor of sodium–glucose cotransporter 2, may improve glycemic control with a lower dose of insulin and attenuate the associated weight gain in patients with inadequate control despite high doses of insulin.

Now, let me introduce you to the game of “proxy endpoints.”

Proxy endpoints are some phony measurement that shows the drug works.

It has nothing to do with whether the drug actually fixes diabetes or saves lives.

It’s just about some intermediate measure that probably is meaningless anyway.

In this case, they use hemoglobin A1C, which I know your doctor probably pays a lot of attention to.

But it’s only over a very short period, 24 weeks.

This is a drug that they’re expecting a patient to take for decades, and yet they only tested for 24 weeks!

Hmmm, I wonder why that is.

800 patients were analyzed. After 24 weeks, mean hemoglobin A1c decreased by 0.79% to 0.96% with dapagliflozin compared with 0.39% with placebo

That is a very small decrease in A1C see if you think about it.

It’s too small to manipulate in any way, but it’s still really a very small decrease.

It’s less than a 1% decrease.

That’s like nothing.

Daily insulin dose decreased by 0.63 to 1.95 U with dapagliflozin and increased by 5.65 U with placebo.

For some reason, patients in the study had to raise their insulin dramatically.

Well, except for the patients taking the drug who had to lower it a little bit.

This is a huge red flag.

Why do all these patients in the study somehow have to raise their insulin levels by over five units?

Is that normal consequence of having diabetes?

Many diabetics are stable on their insulin for a long time.

This to me indicates a statistical problem with the study and how it was manipulated to show this result most probably.

I’m confident that if you look very closely at the study — more closely than we can, you will find that they discovered this placebo effect of patients increasing their insulin by ignoring some results and amplifying others.

Body weight decreased by 0.92 to 1.61 kg with dapagliflozin and increased by 0.43 kg with placebo.

That is a very low body weight loss, roughly 1 or 2 pounds over six months.

It’s statistically insignificant.

Why is it even here?

It’s here because it addresses that the results that they hope doctors look at.

Compared with the placebo group, patients in the pooled dapagliflozin groups had a higher rate of hypoglycemic episodes (56.6% vs. 51.8%),

events suggesting genital infection (9.0% vs. 2.5%),

and events suggesting urinary tract infection (9.7% vs. 5.1%).

There is no interpretation of this in the study.

But in fact, this drug doubles the number of urinary tract infections and almost quadruples the rate of genital infections.

It probably is because of the drug and how it works.

According to the drug company application:

Dapagliflozin is an inhibitor of sodium glucose co-transporter 2 (SGLT2), the transporter responsible for the majority of renal glucose reabsorption.

Primary mechanism of action (MOA) of dapagliflozin is to increase the elimination
of glucose in urine.

So, what this drug does is it interferes with your body’s use of glucose — especially in the kidney.

It basically prevents the kidney from putting glucose back into the bloodstream.

So, now the glucose is just peed away.

That means that you’re going to have sugar in your urine — a lot of sugar.

That probably creates a tremendous environment for bacteria and fungus, don’t you think?

And, what is the effect of inhibiting the proper metabolism in your kidneys?

It is quite possible and even probable that this drug causes long-term damage to the kidneys — and possibly all the organs.

This effect of increasing genital infections and urinary tract infections is a very serious drug side effect.

It’s much more serious than just a few extra infections.

And here we get to the heart of the problem.

Our study was sponsored by AstraZeneca and Bristol-Myers Squibb. The sponsors were involved in the study design and the data collection, review, and analysis. The report was prepared by the authors, with editorial assistance funded by the sponsors.

This is the nail on the head.

If you think that scientists can resist the statistical manipulations and influence of their funding source you are sadly mistaken.

This entire study is a typical drug company study.

I routinely ignore this type of study — except perhaps for looking at the side effects of genital infections and urinary tract infections.

That is a clue to what the drug is doing to the body and probably why it’s a terrible drug.

There’s nothing in this to show any real effect on diabetes or anything significant that I would want even to consider taking this drug.

I would run so fast the other way if it were me.

Your doctor may not feel the same way.

Feel free to show him this newsletter.

And be very questioning of any drugs that your doctor prescribes you, especially newer drugs.

 

 


Matt Cook is editor-in-chief of Daily Medical Discoveries. Matt has been a full time health researcher for 26 years. ABC News interviewed Matt on sexual health issues not long ago. Matt is widely quoted on over 1,000,000 websites. He has over 300,000 daily newsletter readers. Daily Medical Discoveries finds hidden, buried or ignored medical studies through the lens of 100 years of proven science. Matt heads up the editorial team of scientists and health researchers. Each discovery is based upon primary studies from peer reviewed science sources following the Daily Medical Discoveries 7 Step Process to ensure accuracy.
Long-Term Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Receiving High Doses of Insulin: A Randomized Trial 
http://annals.org/aim/article/1090721/long-term-efficacy-dapagliflozin-patients-type-2-diabetes-mellitus-receiving 

CENTER FOR DRUG EVALUATION AND RESEARCH 
APPLICATION NUMBER: 202293Orig1s000 
CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) 
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293orig1s000clinpharmr.pdf 

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