Almost thirty years ago I launched one of the first cholesterol lowering statin drugs while working for a large pharmaceutical company. Literally it was one of the first statin prescription products made available to physicians to prescribe for patients. First it is important to talk about what is a statin? The class of this prescription medication is an ‘HMG-CoA reductase Inhibitor’. HMG-CoA reductase is an enzyme in our body (in particular our liver) that is responsible for producing approximately 70 % of the total cholesterol in our bodies. Therefore a statin prescription inhibits this enzyme from actively producing cholesterol. And hence, patients see a reduction in cholesterol.
It is important to tell you that if you are currently taking a statin prescription do not discontinue this medication without consulting you health care provider. There is a very good reason for this and this is the fact that doing so could actually cause you to have a cardiovascular event. A cardiovascular event can be defined as an event that may cause damage to the heart muscle. One example would be a heart attack.
Where did the first statin come from? This is a very important question. Pharmaceutical companies all look for market potential when they pursue making a new product. They look at how many people have the problem. Obviously if a large number of people have the problem they can make billions of dollars if they can come up with a solution that they can patent. The key word here is patent or own exclusive rights. Without a patent they would not bother because they could not get an insurance plan or you to pay hundreds of dollars per person every single month indefinitely until the patent expires (generally 7 years). Only then if a generic is made available does the price come down. Now for the answer. For thousands of years RED YEAST RICE was and is used as an herbal medicine to lower cholesterol in Asian countries. Specifically it was discovered that a substance in RED YEAST RICE called monacolins was responsible for the reduction in cholesterol. Since these monacolins were all natural a pharmaceutical company could not market them profitably unless they could obtain a patent. Hence the creation of a semi-synthetic ‘monacolin K’ known as lovastatin was created and submitted to the FDA. In 1987 the FDA approved lovastatin due to the fact that it was shown to lower cholesterol, just like red yeast rice. The synthetic monacolin K was patented due to the fact that it was synthetically created.
In 2011 the FDA added a warning to the labels (package inserts) of the statin drugs. This warning included an increased risk of myopathy, rhabdomyolysis, muscle injury, skeletal muscle tissue breakdown, tenderness, weakness, and unexplained fatigue. It is alleged that these occur rarely. The truth is that physicians do not report these problems each and every time when they are encountered.
The following patient is a female, 70 plus years of age, and diabetic alerts her family that she has muscle pain and swelling in her arms and legs. She reports that she has difficulty walking and it is getting worse. As the days go by patient reports that she has increased swelling in her legs, arms, and hands. In addition she complains about fatigue and that she can hardly get out of bed or a chair due to the pain. The family realizes that the problem is serious her hands are so swollen that she cannot even grasp a fork or spoon. She is immediately admitted into the local hospital. Physicians seem perplexed they run blood work and obvious CPK (muscle enzyme) levels are elevated. Yet they do not attribute it to the statin prescription. She remains on the statin and the family is told that she will probably not make it. Relatives are notified and they descend from all over the US. Weeks of hospitalization and no improvement just tons of monitoring. Finally it is decided that she should be transferred to physicians and a larger hospital in the Capital city. The hospital she was in was smaller and served a community of 15,000 residents. Upon transfer the first thing the physicians do is discontinue the statin medication. By this time her three sisters have travelled from all over the United States to pay their respects. Amazingly with prayer day by day she starts to improve. We first noted that the swelling has started to go down in her arms and hands. The above picture was taken after she started to recover. At this point the patient has spent up to 6 weeks hospitalized. Slowly but surely she was able to start grasping a utensil and then feed herself. The hospital initiated physical therapy to get her to walk again. Finally after 2 to 3 months the patient was released and she was able to return home with her daughters to take care of her while she recovered. Day by day she continued to improve. It is now over a year and the patient continues with physical therapy and needs assistance with her home. She is able to feed herself and walk and she is finally able to drive again. She continues to have difficulty with everyday chores and requires assistance. Her life has been drastically impacted by her exposure to statins. One of her physicians was overheard speaking to a fellow doctor that this was not the first patient to experience this on a statin. In addition the physician told the other one that she personally would never take a statin. This was reported first hand by the youngest daughter. This story is a true story and obviously it is still on my mind because this was and fortunately is my mother.
I look back and almost feel responsible because I recall my employer (pharmaceutical company) telling me that there were no safety concerns and that it was my job to tell doctors that this drug was safe and effective.
When I reviewed the legal proceedings surrounding red yeast rice you can see the obvious egg on the face of those protecting the pharmaceutical company interests. I put together the website http://www.bestredyeastrice.com/ back in 2009 when many consumers when first alerted to it’s cholesterol lowering properties by ABC news. On that site there are links to the news media stories and published clinical data surrounding red yeast rice. In addition you will find information regarding why you should not stop taking your statin medication without consulting your doctor.
Several years ago I had the pleasure of meeting the cardiologist Mimi Guarneri, MD. I heard her speak at a national meeting for the Natural Products Association. I learned that she had performed over 10,000 angioplasties and heart stents over the years. In 1997 she was one of the founders of the Scripps Center for Integrative Medicine in La Jolla, CA. I asked her about the statins and asked her about red yeast rice. I also talked with her about my background coming from the pharmaceutical industry and the statins. The thing Dr. Guarneri stressed about red yeast rice is getting a quality product manufactured by a reputable manufacturer.
This is the Red Yeast Rice product that Dr. Guarneri recommends. It is manufactured by Designs for Health.
The following is the Red Yeast Rice product that I take personally. HPF Cholestene which is manufactured by High Performance Formulas, LLC.
My story is quite different from my mother’s. When my physician wanted to start me on a statin he said that he knew that I would tell him why I would not be taking a statin. And he was correct. I quickly referenced the clinical data as published in the Annals of Internal Medicine, June 16, 2009, and the information from McGill University. “Patients Who Stop Statin Risk Death, Say Researchers.” I told him that basically I did not want to be a poster child for one of those lawsuit commercials we see every evening on the television. Of course he wasn’t real thrilled but said that I could return in 45 days for additional blood work to recheck my cholesterol. Well I immediately started taking red yeast rice and watched my diet trying to avoid foods high in cholesterol. Interesting enough after my blood results were returned there was no additional push to start a statin.
To learn more about Dr. Guarneri she has a book which is excellent. It can be found here: