In the New York Times (Friday, September 18. 2015), a large-font headline proclaimed, “Jardiance, a Diabetes Drug, Cut Cardiovascular Deaths by 38%, Study Says.” The accompanying article goes on to state, “For the first time, a widely used modern diabetes drug has been shown to reduce deaths from cardiovascular disease, a long-sought goal of treatment, researchers announced on Thursday. In a clinical trial, the drug—Jardiance, sold jointly by Eli Lilly and Boehringer Ingelheim–reduced the overall risk of {dying from cardiovascular complications by 38 percent}.”
The article continued with the usual platitudes about how this was a “…landmark result”. Analysts estimated that, due in large part to this study, Jardiance sales will reach $2.7 billion in 2020.
For over 30 years, drug companies have been trying to show that treating diabetes with diabetic drugs will lower the risk for cardiovascular disease. Unfortunately, oral diabetic drugs have never been shown to have cardiovascular benefits. In fact there are many studies, some dating back decades ago, that the use of oral diabetic drugs increases the risk of cardiovascular complications and death. Therefore, if this study holds up, Big Pharma could have a pot of gold on their hands.
So, does this study really lower cardiovascular deaths by 38%? The study, paid for by Lilly and Boehringer, involved 7,000 people with Type 2 diabetes who already had cardiovascular disease. Therefore, the subjects were already at an increased risk for strokes and heart attacks. The subjects were randomly designed to receive either Jardiance or a placebo.
After a median follow-up of three years, 3.7 percent of those taking Jardiance died from cardiovascular complications compared with 5.9 percent of those taking a placebo. How the heck did they get a 38 percent reduction as stated in the headline?
The 38 percent reduction comes from using the less-than-accurate relative risk analysis (3.7 percent divided by 5.9 percent). I have written many times about why Big Pharma uses relative risk analyses in their studies. Why do they use the relative risk instead of the more accurate absolute risk? The answer is simple: Reporting the data as the relative risk makes a poorly-performing drug look much better than it actually is. Health care providers should never make a decision on whether a drug therapy is viable based on relative risk data. They should be using the more-accurate absolute risk analysis.
So, what is the absolute risk analysis from this study? Simply subtracting 3.7 percent from 5.9 percent provides the absolute risk difference which is 2.2 percent. So, the headline in the NYTs should have read, “Diabetes Drug Cuts Cardiovascular Deaths by 2.2%.” That would be an accurate description of the effectiveness of this drug, based on the data in this study, at lowering cardiovascular deaths.
How many people would need to take Jardiance to prevent one cardiovascular death? According to the data in this study, 45 people would need to take Jardiance for three years to prevent one cardiovascular death. That means the drug failed 98% (44 out of 45) who took it. And, keep in mind, that the drug (and others in its class) are associated with severe side effects such as bone fractures and a dangerous acid buildup in the blood. Furthermore, the drug costs $350 per month. Therefore, a drug that fails 98% who take it would cost $567,000 to save one life—assuming that 45 people took it for three years. And, that exorbitant price does not include other costs–such as doctor visits and costs due to adverse effects.
Who would take this drug (or any drug) if they were properly informed that the drug failed 98 percent of those who took it?
How does this misinformation about prescription drugs continue to happen? It happens because 99%–I am being conservative here–of health care providers are innumerate. In other words, they do not understand basic statistics. For many years now, Big Pharma has been pulling the wool over the eyes of doctors. Doctors are simply not knowledgeable enough to understand how Big Pharma has altered the statistics to make their mediocre drugs look much better than they really are. That is the reason we spend nearly 20% of our gross national product on health care—more than two-fold higher than the next Western country—and, compared to other Western countries, we finish dead last on every health indicator.
Folks, it is up to you to do your own research on whether a particular drug therapy is right for you. You simply cannot depend on the main stream media or your health care provider (in most cases) to properly counsel you.
More information about relative risk, absolute risk and the problems with the most commonly used drugs can be found in my book, “Drugs That Don’t Work and Natural Therapies That Do.”
One needs to also ask, just what the placebo was, as many are in and of themselves dangerous to the health of those in such “trials” to purposely sway the “good” effect of the drug!
Further, my having recently read both a fuller list of common side effects of empagliflozin (Jardiance) and a few blogs by users of the drug, I can only say that you would have to be out of your mind to even consider taking it.
Too many patients seem to forget that they are the customer and doctors are their servants and that they (the patients) need to arm themselves with information like Dr B has published here and say NO to their own Dr.
On a related blood sugar topic, I have read that 4 tablespoons of coconut oil / day will control high blood sugar. Is this true?
Elaine,
Eating a clean diet and drinking an adequate amount of water is a better place to start.
DrB
Dr. Brownstein,
Thanks for keeping everyone informed. I am a pharmacy doctor and currently work for big pharma, and you are absolutely correct. Your cost calculations to avoid an event are right on, however when you look at a drug study IMPROVE-IT evaluating outcomes of a cardiovascular drug Zetia, the NNT is even worse at 55. Therefore in calculating their cost to avoid one event, it’s upwards of $800,000. No wonder our sickcare system is broke. Obamacare cannot fix stats, and slick marketing.
Here’s a different take on this study, suggesting that like carb blockers (Acarbose) these new drugs that promote sugar dumping in urine are to some degree “low carb in a pill” and thus may have real benefits for some people:
http://www.dietdoctor.com/huge-diabetes-news-that-not-many-people-understand-the-significance-of
Dr. Fung also has a very interesting, deeply unconventional, view of type 2 diabetes that does not focus on blood sugar. He thinks this study lends support to that view.
I thought someone would bring up ” Wheat Belly”. Here is an article that talks about the book: http://www.youngagain.org/w25.html
I can say that I have loads of whole wheat pasta and weigh 125 pounds, my blood sugar is 100% normal, I have zero health problems, and I never get sick. Perhaps you can make a case for avoiding modern hybridized wheat, but that certainly doesn’t mean you have to be gluten free. Kamut, spelt, and einkorn are non hybridized forms of wheat that are even more nutrient dense than modern wheat but still have some gluten. And almost one even eats barley and rye, yet people think they can’t tolerate it. I personally am not convinced that modern wheat should have to be avoided if it’s whole grain without unhealthy ingredients. Even if you want to avoid all these grains, there is no reason at all to avoid such small amounts. According to gluten free ideology, one tiny bread crumb is equal to 100 loaves of bread. Does anyone really want to be that paranoid? Oats don’t even have gluten and yet people avoid it because it may have a few microscopic particles. That is absolutely ridiculous. Maybe 1 in 1000 at the very most will be affected by such small amounts. Even if you don’t want to eat grains containing gluten, at the very least you should not worry at all about trace amounts or avoid eating oatmeal unless you know for sure that you get sick from it, which is very unlikely, but may still be possible for a very small number, probably 1 in 1000 or less.
Ray Feldman says:
Daniel’s comment above about whole grains and wheat triggered this response in me.
I propose that if he read the book “Wheat Belly” by Dr. William Davis, M.D., he might feel differently. The book gives an excellent and thorough discussion on how our modern-day “wheat” is not the same wheat we knew in the 1950s, and earlier. He shows how it significantly differs genetically from earlier wheat, that it is addictive, and that just two slices of bread at breakfast will cause own’s blood sugar to spike more than a Snickers candy bar. He states how taking his patients OFF this modern-day “wheat”, has cured many of their illnesses which expensive prescribed drugs were unsuccessful in curing.
.
His book is now available in paper back for less than $9. I bought the hardbound version four years ago, and this summer bought a hardbound copy of it for each of my adult kids and their spouses. It has also started me on another health goal of maintaining my body pH to approximately 7.4 which is important. A whole chapter is dedicated to body pH.
There is much discussion today regarding how an acidic body pH (lower than 7.0) encourages cancer to flurish, and an alkaline pH (such as 7.4) can kill cancer. I think it’s interesting and has been helpful to me, and so has Dr. Simoncini’s book “Cancer is a Fungus,” as well as Dr. Brownstein’s book, “Iodine – Why You Need It” which I endorse on my pageBook page..
The full title of the wheat book is “Wheat Belly: Lose the Wheat, Lose the Weight, and Find Your Path Back to Health,” by William Davis, MD.
Anyway, based on some of the above comments, some may find this interesting.
.
Ray Feldman
Daniel’s comment above about whole grains and wheat triggered this response in me.
I propose that if he read the book “Wheat Belly” by Dr. William Davis, M.D., he might feel differently. The book gives an excellent and thorough discussion on how our modern-day “wheat” is not the same wheat we knew in the 1950s, and earlier. He shows how it significantly different genetically from earlier wheat, that is it addictive, and that just two slices of bread at breakfast will cause own’s blood sugar to spike more than a Snickers candy bar. He states how taking his patients OFF this modern-day “wheat”, has cured many of their illnesses which expensive prescribed drugs were unsuccessful in curing.
.
It is now available in paper back for less than $9. I bought the hardbound version four years ago, and this summer bought a hardbound copy of it for each of my adult kids and their spouses. It has also started me on another health goal of maintaining my body pH to approximately 7.4 which is important. A whole chapter is dedicated to body pH.
There is much discussion today regarding how an acidic body pH (lower than 7.0) encourages cancer to flurish, and an alkaline pH (such as 7.4) can kill cancer. I think it’s interesting and has been helpful to me, and so has Dr. Simoncini’s book “Cancer is a Fungus.”
The full title is “Wheat Belly: Lose the Wheat, Lose the Weight, and Find Your Path Back to Health,” by William Davis, MD.
Anyway, based on some of the above comments, some may find it interesting.
.
Ray Feldman
Wendy, and others with the same opinion on gluten, celiac disease affects only 1 in 100 people at the very most and probably much less. There is a difference between avoiding refined grain products with added oils and sugars and other bad ingredients and being completely gluten free. For 99.9999% of the population, eating oats or barley or organic whole wheat pasta or other whole grains products without the added sugar and oils and other mysterious ingredients will improve your health, not harm it. Being worried about “hidden gluten” is even more foolish. There are only a very small minority of people, much less than one percent, who may get sick from such microscopic amounts of gluten. If you are afraid of a tiny crumb of bread, you have problems that are much more serious than celiac disease or gluten sensitivity.
Please read for more info: http://www.youngagain.org/c23.html
Dr. B
If I were running an engineering study with 3.7 % versus 5.9% failure I could not with any confidence say these numbers were different enough to act on. The variability of death amongst a group might totally account for the difference.
For example if we broke the 3,500 people in the placebo group randomly into 7 groups of 500 would they all have a 5.9% death rate or about 30 deaths per group? Answer is probably no since variability kicks in. This variability has to be factored in to get a confidence level as to what the tests mean. Same goes for the drugged group.
Don,
EXACTLY!!!! These differences are beyond ridiculous! Look at Dr. C’s comments on the great statin debate. A board certified, well-known cardiologist basically states that these ridiculous numbers are ok with him.
DrB
Hi Dr. B.,
You do a great service with your blog posts. Thank you very much.
Some are overwhelmed by the math.
– O.K., 3.7% of half of the 7000 persons in the test (assume two random samples of 3500 each) = 130 died “from any cause” within about 3 years when using the drug Jardiance.
– Compared to 5.9% of 3500 = 206 died “from any cause”, including diabetes, when not using the diabetes drug.
Which means 336 or 4.8% of the total died from something during the test.
5.9%-3.7%=2.2% Therefore, the percentage of deaths over three years for those receiving Jardiance was 2.2% lower than the percentage of deaths for those who were not taking the diabetic drug. Remember, all 7000 had diabetes.
Playing with numbers, someone could say 206-130=76; and 76 is about 38% of 206; so the number of deaths for the one set was reduced by 38%, which is misleading, especially since most persons would relate that 38% to the 7000, which is 2660 few deaths. It’s all semantics to make things look better than they are.
A September 17, 2015 article in “The Detroit News” stated, “…Dr. Silvio Inzucchi, director of the Yale Diabetes Center and a professor at Yale School of Medicine. He was part of the committee overseeing the study.”
“ ‘Patients who took this drug had basically a 1-in-3 chance of avoiding death,’ Inzucchi said, adding that due to the findings, ‘The highest-risk patients should speak to their doctors about their diabetes management.’”
Wouldn’t the statement saying “a 1-in-3 chance of avoiding death” (33%) then mean they had a 67% of not avoiding death in 3 years when taking Jardiance? Surely he didn’t mean to say this. But then, most doctors aren’t trained in statistics. [:>)
There is so much emphasis on drugging patients with expensive chemical compounds to treat symptoms, rather than treat the heart of the problems, such as eliminating modern-day wheat, corn syrup, processed sugar & refined salt from our diet; use unrefined salt; do proper exercise; and supplement with Iodine, vitamins C, D3, etc. If these were done, there would be little need for all the expensive drugs.
Ray,
The “1 in 3 chance of avoiding death” that you quote is utilized by using the relative risk numbers. Relative risk calculations are used because they make a mediocre drug or treatment look much better than it actually is.
I know the stats are confusing. That is why I lecture to docs and try to teach them to understand how these studies are reported. It is impossible to properly evaluate a study if you don’t know statistics.
DrB
They do this for MS drugs also…get them on the drug as soon as possible/diagnosed to prevent MS from getting worse. The drug may not work and may cost $5000 a month. The people think the drug is working and fear stopping it and never got a chance to see if diet changes would help. The drug may hurt/kill people, but they take the risk due to fear and they trust their doctor who is like a parent/expert to them. They assume the doctor is ethical. Many people want an “easy fix” and may not understand science so leave it to the doctor to decide for them. They come up with new drugs or rename an older drug (minor changes) when the patent is done. Alternative doctors would try to help life style changes/diet changes/only help with things that would not hurt and usually are very cheap.
I love Alternative medicine because a person can try many things, but trying many drugs that may hurt and not help makes Conventional medicine a lot of money. Diabetes maybe due to Celiac which can affect the glands like the pancreas/thyroid etc and lower nutrients absorbed like Mg/Cr which may help with blood sugar/insulin. Oregon grape root may help lower blood sugar. Sugar may turn into fat and clog blood vessels. Eating only lower sugar fruit like lemon/lime/cranberry/rhubarb/granny apple/berries and more may help. I eat no gluten/dairy/soy/sugar/GMO…take vitamins/good oils/minerals…probiotic…LDN to help block hidden gluten and detox. Any food with a label and certified gluten free food/some spices/meat basting/nuts not sold in the shell and more may have hidden gluten on them. Many people don’t to change what they eat since gluten can be like Heroin to the brain and sugar like cocaine to the brain. EDTA IV chelations or Serrapeptase may help unclog blood vessels, but changing their diet/sunlight/exercise/good water/eating organic and 100% no glutendairy/soy/sugar/GMO may help.
Here’s how I would like my doctor to explain this to me:
“Your chance of getting diabetes over the next 3 years is 5.9 percent. If you take this drug, the chance goes down to 3.7 percent. And here are the additional financial costs and side effects you would have to bear …”
This gives a sense of the distinction in meaning between percentage point difference and percentage difference without using terms like “absolute risk” and “relative risk”
Just my two cents.
But what about this area of explanation: you often use a phrase like “a drug that fails 98% who take it.”
To me, “fail” means: “a collection of people who really needed this drug took the drug, but got the disease anyway.”
But that’s not what happened. These people were not destined to get diabetes in the first place. They never got it, drug or no drug.
So, I guess, in your usage, “fail” means “a collection of people who didn’t really need the drug in the first place had to suffer its side effects and costs anyways” ?
HI Dr B,
I think you need to look at your arithmetic. 3.7 divided by 5.9 is .62 or 62% not 38%
Here is actually how it works.
3.7% died on the drug
5.9% died on the placebo
Therefore 2.2% were “saved” by the drug.
You need to divide 2.2 by 5.9 and that is how you get 38% who were saved by the drug.
Please correct this. I love your columns and your point is well taken but not getting your arithmetic correct does not give you credence with those who would criticize you.
I am confused about the % in your article. You said “The 38 percent reduction comes from using the less-than-accurate relative risk analysis (3.7 percent divided by 5.9 percent).”
BUT 3.7% divided by 5.9% = 62.71 NOT 38%.
Am I missing something?
Dr B, Thanks for another informative article on the useless and danger of drugs that Big Pharma so glibly lies about,
I wish you would write an article about the hazards of taking Cipro, Avelox and Levaquin. After my husband had a serious anxiety reaction, which made it almost impossible for him to drive (while we were 2,000 miles from home), I learned how these drugs have mental side effects in over 90% of those who take them. They also cause tendons to snap, even years later. Some people are devastated by these drugs after only one to three doses.
Doctors, especially urologists, seem to prescribe these dangerous drugs without taking the black box warning, which isn’t nearly complete, seriously at all. My husband’s urologist did a urine culture and, though he found NO BACTERIA, he put him on Cipro for several months!
Thanks again for spreading the truth about dangerous and ineffective drugs.
Rebecca,
You are right about this class of meds. Cipro, et al, should only be prescribed as a last resort.
DrB