Once a common solution for the Miseries of Menopause, hormone replacement therapy (HRT) with estrogen was abandoned almost overnight in 2002 with the publication of the Women’s Health Initiative (WHI) results. The WHI did not dispute the fact that HRT is the best method of reversing post-menopausal symptoms such as hot flashes and insomnia but it did overturn some cherished beliefs as far as women’s heart health is concerned.
Women have a much lower risk of heart attack then men until they reach menopause. At menopause when the ovaries stop making estrogen the risk of heart attack climbs rapidly until it equals that of men. Common sense suggests that if losing estrogen causes increased heart attack risk then replacing the estrogen should prevent this. What the WHI appears to show is that HRT does not protect women from heart disease, but may actually increase the risk above the normal post-menopausal risk. Worse yet is the WHI conclusion that HRT increases the risk of breast cancer and of blood clot complications (thromboembolic disease). It is no wonder that in 2002 HRT took its place with smoking as the scourge of womens’ health.
Since that time scientists have reevaluated the WHI data and more work on HRT risk versus benefit has been done. What is evolving from this reassessment is that the use of progesterone in the WHI participants and the time from onset of menopause until the time HRT was started, both play important roles in how often women developed heart disease or cancer. Additionally, a new class of drugs when use together with HRT may block the cancer risks associated with HRT. In Part 2 of this article I will be covering these aspects. Stay tuned!
Gary Pepper, M.D.
Editor-in- Chief, metabolism.com
The lawsuits against Avandia are being prepared and opportunists are lining up for a payday. Unfortunately, everyone else will wind up a loser, and here’s why.
Avandia, one of only two available medicines with unique properties to treat diabetes, was approved in 1999. From the very first day Avandia was approved a heated debate arose whether Avandia or its sister drug, Actos, was the better drug for diabetes treatment. Both had similar abilities to lower blood sugar and both had the same downside of causing significant weight gain and fluid retention. Avandia showed a slightly worse effect on cholesterol profiles which convinced many diabetes specialists to choose Actos over Avandia. The choice between drugs has also been heavily influenced by cost considerations such as whether the drug was covered by the patient’s insurance carrier. I personally treated numerous patients with both drugs and found them about equal in all respects.
The lawsuits against Avandia will contend that the medication caused heart attack or stroke. The truth of this contention is very much in question, but the murkiness of the water doesn’t stop the lawyers from trying to take a bite out of the flesh of GSK (GlaxoSmithKline), the maker of Avandia.
Several years ago research studies seemed to indicate a small increased risk of heart attacks in users of Avandia. Ever since there has been a heated debate about whether this was a true risk or just the result of overly aggressive interpretation of the available data. There are two major analyzes on the subject of heart attack risk with Avandia. One, written by a doctor on the payroll of a competing drug company, looked at results from 14 thousand patients on Avandia and found a small increased risk of heart attack or stroke and the other study analyzed another 14 thousand Avandia users and found no such association. Under pressure from the public, in 2007 the FDA placed a strong warning on the label of Avandia regarding the possibility of the drug causing heart disease, but Avandia was permitted to remain on the market. The FDA warning was updated and upgraded in 2010. The publicity surrounding Avandia’s potential risks basically halted the use of the drug in the U.S.
Now enter the opportunists. Advertisements fill my email in-box from lawyers looking for customers who want to sue the drug manufacturer in class action law suits. Try goggling “Avandia side-effects” and you will find the first several pages of results are ads looking for lawsuit clients. In the last month I received two requests for patient records from these lawyers. Both patients had heart disease at the time they started the medication. One patient who recently died was over 80 years old, and the other who had significant heart disease and other diabetes complication to begin with, is still alive more than 7 years after treatment with Avandia. I wonder how much benefit these patients received from the medication which allowed them to survive as long as they did despite all the other problems they had related to their diabetes.
Why should you care about whether a small army of opportunists each get a few thousand dollars from the drug manufacturer and a few lawyers become millionaires? Because it is just this sort of legal action which is convincing drug makers to back away from developing other potential diabetes treatments. It takes a decade and a billion dollars to bring a new drug in front of the FDA. This doesn’t include the cost of developing drugs which fail to even make it to FDA review. Then the FDA approval process is tortuous and uncertain. Passing this hurdle, any new drug can come under attack (like Avandia) for “possible” side effects making the company vulnerable to devastating legal costs and bad publicity. It isn’t economically feasible to develop new diabetes drugs in the United States. As a result, new drug development is grinding to a halt. We will all suffer due to lack of innovation, not only for diabetes treatment but for treatment of many other dangerous diseases.
Gary Pepper, M.D.
Editor in Chief, Metabolism.com