Question 1: I have heard you have done your own analysis of the FDA adverse drug report information. What have you found?
Answer: Most people who have encountered side effects from a statin drug know that the adverse drug reporting system in the U.S. is called Medwatch. All patients and doctors are encouraged to report their statin associated problems using Medwatch's online reporting system.
When, in 1999 and 2000, I first experienced transient global amnesia (TGA) a few weeks after starting Lipitor, I reported both of these episodes to Medwatch. Doctors then told me that, "Statins do not cause amnesia." Since then I have advised hundreds of others to report their TGAs also.
In the past seven years I have found no evidence that doctors had acquired any understanding of the potential of statin drugs to cause cognitive problems. Curious, I decided to obtain copies of the Medwatch data and look for myself. After counting out many hundreds of statin/TGA case reports I knew that they were all there in Medwatch but nothing had been done with them. None of this critical information about the amnesia potential of Statins had been reported to doctors. Later I was to find that this was true for all the other really serious problems turning up in my repository, like permanent neuropathy, chronic myopathy, chronic neuromuscular degeneration and ALS-like reactions.
Although all had been dutifully reported to Medwatch, not one word had come back to the doctors. Their statin information base was still back where I was in 1999 - "A few muscle aches and pains and tendency for mild liver inflammation." Is it any wonder the doctors fail to believe their patients reports. Neither FDA nor the drug company has told them the truth. It was only four months ago that Ralph Edwards of the World Health Organization's Vigibase reporting system out of Sweden made the first official report about excess numbers of ALS reported in statin users world-wide.
Question 2: You have talked about reductase inhibitors as causing mevalonate blockade. How does this come about Answer: Twenty years ago on the eve of birth of the multi-billion dollar statin industry, the drug companies announced their new reductase inhibitors, known as Statins. All they did was block the reductase step of the cholesterol synthesis pathway and they worked marvelously well. Physicians were excited to finally get a drug that really lowered cholesterol. What they did not tell us was that these new wonder drugs also blocked completely the mevalonate pathway and, of course, none of us picked up our dusty biochemistry book to see for ourselves. If we had, the statin industry would never have survived birth.
The mevalonate pathway is shared by many extremely vital metabolic pathways for such things as Coenzyme Q10, dolichols, normal phosphorylation and selenoprotein synthesis and to inhibit cholesterol is to inhibit all of these. It is like girding a tree. You cannot limit your girding to get just one branch. Merck filed for and obtained two patents for CoQ10 supplementation back in May of 1990 because they knew what was coming but they never implemented the combination pill and decided to wait things out. CoQ10 inhibition now accounts for some 60% of statin associated side effects. The rest are just as disastrous in the consequences to our health and well-being.
Question 3: What is the mechanism of action of the association between statin use and cancers?
Answer: Provocation of certain cancers is now thoroughly documented. The reason has nothing to do with cholesterol reduction, the original purpose of the statin drugs. Only a few years ago did any of us learn about the true mechanism of action for the statin drugs. Cholesterol reduction has nothing to do with it. Statins work their benefits through an entirely unsuspected anti-inflammatory and immunomodulatory action. We now know that atherosclerosis is an inflammatory disease. Cholesterol is nothing but an innocent by-stander. Statins inhibit platelet activation, smooth muscle migration, lymphocyte adhesion and macrophage attraction, the principle components of the inflammatory reaction. But at the same time it alters your immune status creating its so-called immunomodulatory effect. That is what lays the groundwork for cancers - your altered immune reaction.
Question 4: What do you think of Merck's request for OTC of lovastatin 20mg?
Answer: This is being debated this week in Washington and we think it has a chance despite the ALS question raised by WHO, the tens of thousands of statin damaged victims in our repositories and even the cancers that are increasingly appearing in medical journals because generally speaking this movement has the support of the entire medical community. Because FDA and the drug companies are responsible for physician education, few physicians are informed about the real scope of side effects.
Because all reports come in via Medwatch, they can be studied for years by FDA and never get reported to doctors. And the media is just a laugh. All major media is under the direct control of the drug companies because of the immense volume of media advertising. When you tell media about the problems you can thoroughly document, they immediately phone their doctors who are even less informed and so goes the battle. Extremely vital health information dying a slow death because of the necessity for a "balanced program", the usual term the publisher uses rather than "we just had a call from a drug company." These always manage to crop up in the last few days before the event is to be presented. Most media are effectively owned by the drug companies and if you do not know this, you lead a very sheltered life.
Answer: You bet they did. During the clinical evaluation phase of Lipitor, Pfizer had 11 cases of amnesia and severe cognitive disturbance reported by their 2502 volunteers for a severe cognition impairment rate of 5/1000. Five out of every one thousand people who received Lipitor would experience a severe and unheralded amnesia-like response. You can imagine what one word of this truth would have had on marketing. Imagine the response of politicians, movie stars, business leaders, airline pilots, heavy equipment operators, school bus drivers and even doctors, if they learned of these figures - five out of every thousand, and millions of people were on them. Of course, I have seen this documentation. All the drug companies knew that impaired cognition was coming. When you know basic neurophysiology, you know it is inevitable with cholesterol lowering.
Question 6: Dr Golomb has published several articles on statin and emotions and personality disorder. Why do you think that occurs?
Answer: Even a simple internet search will tell you of the inhibitory effect of Statins on dolichols. This is all part of the mevalonate pathway I just mentioned. Because few doctors know anything about dolichols, none of them picked up on this, but dolichols orchestrate our entire neuropeptide synthesis system. Insufficient dolichol gives impaired neuropeptide synthesis. Everything we are - every thought, every sensation and every emotion, the product of a peptide strand, the makeup of which is under the control of dolichol.
This is not just a chance occurrence, this has to happen. And if the drug industry says they did not see this coming they need new biochemists because this is basic biochemistry. They have known this was coming for years. You should see them squirm now as they try to dodge statin associated suicides. Lawyers are helpless with this. All they do is call their doctors for an opinion and of course the doctors are worthless with this, even the shrinks, for they have never been told and are too focused on easy things to bother to look it up. The drug companies are no doubt smiling as they read this but I am going to continue to tell the truth.
Question 7: Do you know of Ralph Edwards of WHO and his ALS report?
Answer: The WHO report could not have been better timed. Over the past 18 months I had begun to see a big increase in ALS reports in statin users. Soon I had collected some 35 reports. FDA knew nothing or denied everything about this; I am not certain which terminology is more appropriate. I decided to share it with Joe Graedon of the People's Pharmacy column. He did an incredible job for me back in 2000 when I was looking for a statin/cognition relationship. Just his mentioning my cases of Lipitor associated amnesia in his column gave us hundreds of reports of cognitive effects and many other amnesia reports from people that had no awareness of a possible relationship.
When he did the same thing with 35 ALS reports we picked up over 100 additional ALS/statin reports from people who had no idea there was a possible relationship. And they are still coming in! All of these reports have been turned over to FDA. Right in the middle of all this came this incredible WHO report that Ralph said he agonized over for months knowing the uproar that would ensue. "WHO reports excess numbers of ALS and peripheral neuropathy among statin users worldwide. And we had to hear this from WHO, not the FDA who we pay to monitor this.
The benefit of this form of doctor education is that we have noticed in cases where the doctor stopped the statin immediately, the ALS-like response tended to slowly regress whereas in those where the doctors continued on the same statin or perhaps changed Statins, the ALS progressed to its more serious and aggressive form. So we had clues that early cessation of the statin was very helpful and probably have prevented a few cases. Still, I have not seen a formal doctor notification of this and must assume FDA still is "studying" this, incredible though it may seem to this thoroughly experienced retired family doctor.
Jay S. Cohen, M.D. is a nationally recognized expert on medications and side effects.
He is the author of "Over Dose: The Case Against The Drug Companies" and
"What You Must Know About Statin Drugs and Their Natural Alternatives."
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor