Big pharma loves COPD.
It stands for Chronic Obstructive Pulmonary Disease. And in the old days, we used to call this hard-to-treat disease emphysema.
Big pharma pines over the 15 million Americans who have COPD because they make excellent, lifelong customers. But here’s the problem…
None of the drugs to treat COPD work all that well. So patients go from drug to drug, struggling to find one that will help them breathe a little easier. That’s partly why the ad campaigns for COPD drugs are so relentless. It’s a hugely competitive and profitable market.
Recently, big pharma tried a new tactic to treat the 15 million Americans suffering with COPD–cholesterol-lowering statin drugs.
I don’t really know where big pharma first got the idea to use these dangerous drugs to treat COPD. Ultimately, it probably just ties back to good old corporate greed–pure and simple. Big pharma wants a bigger piece of the COPD pie. So they’re using old, failed cholesterol drugs in this new way to see if they can turn an easy buck.
It saves them time and money to use an old drug, instead of developing a new drug and getting it approved by FDA. (Once the FDA approves a drug for a specific purpose, doctors can prescribe that drug for any other purpose as well. We call this practice “off-label” prescribing. It’s a huge problem in the U.S.–and it’s only getting worse.)
The truth is, the jig is up for big pharma’s “miracle” cholesterol drugs. In fact, long-term studies show statin drugs do not reduce cardiovascular disease risk. And they do not reduce death rates. Plus, up to 20 percent of statin users suffer serious side effects. Eventually, half of this group has to stop taking the drugs because the side effects are so bad. (Even by the most conservative estimates.)
So big pharma needs a new plan of attack. And a new set of innocent victims. This time, it’s men and women with lung disease. And somehow, the pharmaceutical industry actually wrangled two clinical trials out of this cockamamie scheme.
The first clinical trial tested the effect of simvastatin (Zocor) on 885 patients with COPD.
All the participants had a smoking history of 10 or more “pack-years.” (This term means the number of packs smoked per day multiplied by the number of years smoked. For example, they could have smoked one pack per day for 10 years or two packs per day for 5 years.) They had also received oxygen, steroids, antibiotics, or hospitalization for COPD during the prior year.
Here’s a group already taking a number of potent and potentially dangerous drugs. So did piling on even more drugs help?
The researchers randomly divided COPD patients into two groups. One group took simvastatin. The other group took a placebo. The patients followed their designated protocol for up to 36 months at 45 different centers around the country.
During the course of the study, the researchers measured the patients’ COPD “exacerbations.”
An exacerbation is the medical term for “flare-up.” So the researchers wanted to measure how many times a patient’s COPD symptoms flared during the course of a year.
They found that patients in the placebo and the statin group experienced the exact same number of COPD flares during the year—1.4.
Researchers also measured how much time passed before the patients experienced their first exacerbation.
Now here’s where it gets interesting…
It took the drug group 223 days to experience an exacerbation. But the placebo group went exacerbation-free for 231 days.
In other words, patients taking the statin drug actually fared worse than the placebo group. Without taking the drug, patients had an extra week and a day free of flare-ups. This may not seem like much. But consider this…
Fifty-eight men and women (7 percent) of the patients died during the study. That extra week and a day could seem like a gift.
The results were so bad in this study, the data safety and monitoring committee shut it down before completion.
But as you know, big pharma never goes down without a fight.
Researchers in second clinical trial gave rosuvastatin (Crestor) to patients who suffered from Acute Respiratory Distress Syndrome (ARDS) associated with sepsis.
Sepsis is serious, life-threatening blood infection. And just about the last thing I’d give a sepsis patient would be a statin drug. In fact, in an upcoming Daily Dispatch I’ll tell you about other findings where doctors have concluded that no patient suffering from any disease should be given statins during the last six months of life.
But these researchers wanted to see if patients with sepsis who took rosuvastatin lived any longer. They also wanted to see if the drug helped patients breathe freely without a ventilator.
So, they randomly divided 745 sepsis patients into two groups. One group received the drug. And the other group received a placebo.
The researchers claim the two groups had the same outcomes. However, I looked closely at the actual results.
The drug group had a 29 percent mortality rate. But the placebo group only had a 25 percent mortality rate.
That means 109 men and women died in the drug group. But only 93 people died in the placebo group. That’s 16 extra deaths in the drug group. Given the metabolic damage caused by statin drugs, especially in critically ill patients, those numbers don’t surprise me.
I am surprised, however, the researchers concluded this difference was not “significant.” It certainly was significant to those 16 people who died for doing this poor research.
Like the first clinical trial I mentioned, this study was also stopped early by the data safety and monitoring committee because of the dangers and lack of effectiveness.
The National Institutes of Health’s National Heart Lung and Blood Institute (NHLBI) funded the COPD study. And both the NHLBI and AstraZeneca funded the ARDS study. (So the drug companies didn’t just waste their own money on these ill-begotten studies. The taxpayers bore some of the cost. In fact, most of the cost!)
Sadly, this is the kind of research the NIH funds nowadays. They give failed drugs to sick patients already taking other drugs. The results are terrible. Or downright deadly. But then, they go on to fund another one just like the last!
It makes me think of the old line, “What’s the definition of insanity?”
Answer: When you keep doing the same thing over and over again, but expect a different outcome.
The good news is, there are safe, effective, non-drug options for COPD.
In fact, last summer at about this time, I wrote a Daily Dispatch called, Little-known, safer options for COPD. This is a must-read for anyone with COPD. Especially at this time of year, when poor air quality and high humidity can increase your flare-ups.
1.”Simvastatin for the Prevention of Exacerbations in Moderate-to-Severe COPD,” New England Journal of Medicine 2014; 370:2201-2210
2. “Rosuvastatin for Sepsis-Associated Acute Respiratory Distress Syndrome,” N Engl J Med 2014; 370:2191-2200