by Josh Hodnik
Pharmaceutical companies in the United States have paid out billions in settlements due to class action lawsuits, close to 20 billion to be exact. From 2001-2010 pharmaceutical companies accounted for 25 percent of all federal class action settlements, and over half of these settlements were due to drug safety issues. Class action lawsuits against pharmaceutical companies are on the rise. Over the past 20 years, pharmaceutical companies have settled more than 165 cases. Of those, 75 percent were settled between 2006 and 2010.
Attorney and author John Grisham wrote a popular book on this subject called the ‘King of Torts’. This book may be based on fiction, but many facts about the crookedness behind many class action lawsuits are pretty accurate. Class action attorney’s that deal with pharmaceutical drugs are on the prowl for any study that may benefit them in their pursuit to profit from big pharmaceutical companies.
The latest study to fuel one possible class-action lawsuit against prescription drug makers was published in the November 2013 issue of JAMA (Journal of the American Medical Association). This study claimed that testosterone replacement in men, that are deficient in testosterone, showed a 5.8 percent increase in mortality, myocardial infarction, or stroke. The study involved 8709 men with a total testosterone level lower than 300 ng/dL. Besides having low testosterone, all of these men underwent coronary angiography in the Veterans Affairs system between 2005 and 2011. Of the 8709 men involved in the study, 1223 received testosterone replacement therapy about 18 months following coronary angiography. 3 years after the coronary angiography it was estimated that there was a 19.9 percent risk of mortality, myocardial infarction or stroke with the no testosterone group. On the other side, the risk with the group given testosterone was estimated at 25.7 percent.
If you were just to look at the comparison in the estimated risk factors between the two groups, it would seem obvious to most that testosterone does in fact increase mortality and heart disease. But there are multiple flaws in this study. For one, testosterone levels were not monitored before and during therapy. Also, estrogen and red blood cell count levels weren’t checked with the men given testosterone. It is not uncommon to have issues with estrogen and red blood cell count with testosterone therapy, but these levels are usually checked and monitored to make sure that the patient is responding well to the treatment.
There is one big concern that questions the validity of this study that many seem to ignore. The group that did not receive testosterone in this study was given a PDE5 inhibitor. These drugs have been used to treat erectile dysfunction. Viagra is a drug that falls into this class. These drugs were given to the non-testosterone group because they wanted an increase in sex drive by both groups. What didn’t the authors of this study discuss is that PDE5 inhibitors have been shown to have positive effects on the cardiovascular system. In fact, two PDE5 inhibitors have been approved for the treatment in some cases of hypertension because of their ability to relax blood vessels. The Journal of Cardiovascular Pharmacology and Therapeutics states that PDE5 inhibitors have potential as a drug to treat coronary artery disease and a drug that could help improve health in patients suffering from heart failure. The authors of the JAMA study failed to factor in the PDE5 into their findings, but with what we know about these drugs, the findings of the study published by JAMA could actually be showing a decrease of heart disease due to PDE5 instead of an increase because of testosterone.
PDE5 inhibitors are designed to treat erectile dysfunction in men by relaxing the blood vessels and increasing blood flow. PDE5 inhibitors, such as Cialis and Viagra, have been shown to increase testosterone and lower estrogen in men. This makes the administration of the PDE5 inhibitors to the patients not taking testosterone more of a factor in this study. Again, testosterone and estrogen levels were not monitored throughout this study, so the group that didn’t take testosterone may have had elevated testosterone and lower estrogen levels due to the PDE5 inhibitor. This in itself could have cardiovascular benefits.
The Journal of the American Heart Association recently published a review after examining over 100 studies that were based on the association of testosterone and cardiovascular disease. The authors concluded that low levels of testosterone are associated with higher rates of mortality, obesity, and diabetes.
Testosterone therapy has been shown to reduce blood sugar levels, improve cholesterol levels, decrease body fat, and increase lean muscle mass. These are all factors that promote cardiovascular health, and this would go against everything that was concluded in the study published by JAMA. There are decades of literature that show the negative impact low testosterone can have on cardiovascular health while testosterone therapy has been shown to have a positive effect.
This recent study published by JAMA has gained a lot of attention. It has many men that are on testosterone replacement therapy questioning their safety. It has also started the process of a class action lawsuit against makers of testosterone gels, creams, and injections. This study is flawed in many ways, and it baffles me that it has gotten so much attention when many studies show a completely different conclusion. There was no monitoring of testosterone levels on anyone during the study. Estrogen levels and red blood cell count were not checked either. Estrogen levels often rise in men when taking testosterone, and estrogen is known to put men at a higher risk for heart attack or stroke. Red blood cells can also increase while taking testosterone. The risk of a heart attack or blood clot is increased when red blood cells are elevated.
It is hard to say how different the outcome of the study would have been if the group not taking testosterone wasn’t given the PDE5 inhibitor. It has been shown that estrogen in men causes a greater risk for heart disease, and PDE5 inhibitors have been shown to decrease estrogen. It has also been shown that low levels of testosterone creates a greater risk for heart disease, and PDE5 inhibitors have been shown to elevate testosterone levels.
The group given testosterone showed a higher rate of mortality and cardiovascular disease, but this may be due to higher estrogen levels and not testosterone. All the data from previous studies over the years would point to this conclusion. This study has too many flaws to be considered legit, but when it comes to class action lawsuits, it’s all about how the jury and judge interpret it. It will be interesting to see what this bogus study will lead to.