Editorial note: This post is by Dr. Duane Graveline, Author of Lipitor Thief of Memory (referred to in an earlier post), and other books. The original of this post is on his website. Dr. Graveline has sent this account of what can be found in FDA’s Medwatch system for Lipitor. RxISK makes data like this available for free and in easy to use form. It lets you explore what might be there for your statin under the headings Dr Graveline has used here.
Reporting your problem to RxISK will allow you to report also to Medwatch but in addition will give people the opportunity to explore what age group and gender are primarily affected but above all will let you and Duane Graveline and others see where in the US or elsewhere these problems are happening. If you bring a RxISK report to your doctor we will be able to build up maps of where doctors agree these drugs do indeed cause these problems.
Again FDA has opened the shelves of Medwatch to those of us wishing to review for ourselves the status of statin ADRs. This has been all the more imperative since FDA has been extremely reluctant to report side effect data on the statin class of drugs. Some of you may recall that I was last able to access Medwatch data in 2006. Following that, in the beginning of 2007, access to Medwatch data was denied despite legal pressure on the part of my lawyers. Even in 2006 the process had not been easy for it meant I had to tackle the immense challenge of reviewing manually some 64,000 Lipitor ADRs using the “find” mechanism on my PC. This was necessary, I was told, since the appropriate software for reading Medwatch data was available only to FDA and drug company officials. The rest of us had to be content with the time-honored and accurate but painfully slow process of counting each case one by one using the search mechanism of our
What prompted me to do this personal search of what most would agree is FDA’s business is the almost total lack of awareness of our doctors of statin associated cognitive dysfunction, emotional and behavioral disorders and cases of disabling neuro-muscular degeneration now prevalent in the medical community. Clearly our doctors have not been informed. Yet, I know from the 18,000 emails on which my website was created of the many thousands of Medwatch reports that have been submitted. In many cases I have been instrumental in helping distraught victims make their FDA report. What is wrong with our ADR reporting system, I wondered?
Based upon my personal cognitive experience with this drug, amnesia was the first search term I entered. Not unexpectedly, out popped 1,302 case reports for amnesia in the Medwatch files. Adding the search term “memory impairment” yielded me another 663 cases. This total of 1,965 reports of serious cognitive dysfunction associated with the use of Lipitor seemed to fit quite well with the total numbers of such reports I now have recorded in my repository. I had recommended to most victims that they do online Medwatch reporting and had helped more than a few to do just that.
A word of caution concerning gross under-reporting deserves to be mentioned here. First of all, anyone experienced with the operation of such optional reporting systems as Medwatch fully realize that they are lucky if one percent of the actual events get reported. So for every 100 cases of memory loss only 1 or 2 will ever be reported. That is the nature of self-reporting systems. Additionally only the more severe forms of cognitive dysfunction get reported – the transient global amnesia and severe memory loss. Never included and therefore expected to be missed are the more minor forms of cognitive loss such as confusion and disorientation and unusual forgetfulness.
Then we have the category of short term cognitive loss with durations measured in seconds and minutes that by their very nature will rarely be recognized even by the victim and yet might be so critical to a pilot. The passage of time is too short for recognition yet special studies have revealed just how common these are.
Despite the fact that in Feb. 2012 FDA for the first time announced cognitive dysfunction as a major side effect of statin drugs, they immensely under-played its seriousness. At no time did they even mention transient global amnesia, a strange form of completely incapacitating amnesia in which the victim abruptly, without the slightest warning, loses the ability to formulate new memory and this is accompanied by retrograde loss of memory for decades into their past. Our past decade has seen an epidemic of this once rare condition. but FDA failed to even mention transient global amnesia. They instead mentioned the possibility that periods of confusion and disorientation might occur that usually were mild and passed with no complications. Never a word was said about the possibility of a military or civilian commercial pilot suddenly encountering this form of amnesia with possible retrograde loss of critical training. And one does not have to be a pilot to be concerned about this – anyone whose occupation requires 24/7 vigilance which could include a school bus driver, heavy equipment operator or even, hopefully, our Chief of State.
Applying additional cognitive search terms gave me 222 reports of “dementia”, 523 case reports of “disorientation” and 602 reports of “confusional state”.
I next searched among words that might reflect the curious effects of statin drugs on emotion and behavior now being reported. I found 347 reports using the search terms “aggressiveness”, “paranoia” and “irritability” commonly reported in statin users. Use of the search term “depression” yielded 1,142 reports of which 118 expressed “suicidal ideation”.
Since it also was in Feb. 2012 that FDA first mentioned the persistent seriousness of rhabdomyolysis, the next search term I entered was rhabdomyolysis, an especially serious form of muscle damage with a fatality rate of 10%. You may recall that it was rhabdomyolysis that brought down Baycol with some 60 deaths in the year 2004 causing Bayer to remove it from the market. Deaths in these cases is due to the blockage of renal tubules by the muscle cell fragments that have ruptured muscle cell membranes and been carried to the kidney by the circulation.
I counted 2,731 Medwatch reports of rhabdomyolysis. With the case fatality rate being 10%, the use of Lipitor has resulted in 273 deaths up to now. Removing Baycol from the market in 2004 did not even slow down the loss of lives from rhabdomyolysis. Lipitor quickly took up the slack and similar rhabdomyolysis death rates are occurring from Zocor, Crestor and the others. They all do this with comparable effectiveness. Each year Lipitor accounts for slightly more than 20 deaths from this cause. Applying additional search terms bearing on the muscular system I found 1325 reports of “myalgia” and 494 reports of “musculoskeletal stiffness”.
Applying the search term “renal failure” gave me 2,240 responses, comparing favorably with the 2731 Medwatch reports of rhabdomyolysis cases, knowing that many, if not most, of these would be accompanied by varying degrees of renal involvement.
Being well aware of the great numbers of reports of peripheral neuropathy in my repository, most of them associated with the use of Lipitor, the next term I chose was neuropathy. The prevalence of Lipitor-association for neuropathy was so great that attorney Mark Krum originally selected his 50 lawsuit candidates primarily from the several hundred that already were in my repository at the time. Attorney Krum should be given credit for the effort he made to bring the consequences of statin use into greater public awareness but his efforts were doomed for failure from the very beginning. No single lawyer or law firm can compete against the immense resources of the drug companies with billions of dollars in ready reserve for contingency purposes and legions of dedicated lawyers.
Of even greater importance is the fact that the drug companies also had the minds of the medical community. Doctors were unaware of the immense numbers of serious side effects that were piling up in Medwatch repositories and FDA seemed dedicated to keeping that information securely locked away in Medwatch files, presumably being reviewed but never being reported upon. For the past decade I have been waiting for official FDA reporting of adverse events ADRs only to be disappointed when none have appeared or what has been released have been watered down snippets of warning such as that announced in Feb. 2012 for diabetes, cognition and rhabdomyolysis. Was this the best FDA could do after a decade?
My response to use of the search term “neuropathy” was 1,294 reports to Medwatch. It should be mentioned that almost all of these peripheral neuropathy reports have proven to be very resistant to traditional treatment and now deserve to be called permanent. Using the term “Guillain-Barre syndrome” gave 98 reports, and, prompted by hundreds of case reports I have received complaining of leg and arm pain, the search term “pain in extremity” gave 3,498 reports. This figure better reflects the statin neuropathy load.
Next I put in the search term, “hepatitis”. Before I tell you the number, I first must qualify it by warning you that there are many different kinds of hepatitis. There is hepatitis A, B, C, cholestatic, autoimmune, fulminating, acute, chronic and viral, including cytomegalovirus. All of these terms are used in this compilation of Lipitor damage reports. However, the overwhelming majority of these reports said simply, “hepatitis” with no qualifier. Since hepatitis always has been a warned concern from statin use you must make up your own mind in interpreting the 2,102 total cases that resulted. When I realized that “liver function abnormalities” also was being used in the Medwatch diagnoses list, I used it as a search term, reporting 842 liver function abnormalities in addition to my 2,102 hepatitis cases for a grand total of 2,944.
I should add here my thoughts on the way liver function test guidelines have been grossly manipulated during the statin era. Perhaps 20 years ago we doctors still were guided to use the guidelines that I had been accustomed to since my medical school training. Now, starting close to 1990, the time when statin use began to get seriously under way, we were asked to replace our usual routine of using the mean plus 2 standard deviations (SDs) with the mean plus 10 SDs to determine when an elevation of liver enzyme due to statins was significant or not. This incredible distortion of reality was done in order that we not get too excited about a 2 Sds elevation when working with statins. Our previous guidelines no longer applied. I am still trying to figure out how the clinical pathologists got away with that. It made no sense then and much less sense now. Inflammation is inflammation. When dealing with statins we had been asked to accept smaller amounts of inflammation as the normal. The new reality!
Since the unexpected association of ALS with statin use was reported by Ralph Edwards of World Health Organization using their Vigibase data, my next investigation of Lipitor Medwatch data was for search terms that might give a measure of ALS occurrence. “Unusual weakness” turned up 2,516 case reports, “balance disorders” gave 596 responses and “coordination abnormalities” gave 195 responses. Since I have this condition I can speak with authority on the subject of balance disorders. A kindly neighbor lady was so concerned on seeing me walk by her home she offered to drive me the rest of the way. Until that moment I was unaware of the effect of my walking on the public eye. Clearly this good Samaritan sensed me as disabled. My transition to walker took place the following day.
The Peoples Pharmacy website carries an unexpected goldmine of ALS incidence data in the following link: https://www.peoplespharmacy.com/2009/07/31/statins-and-als/ Please check out this resource.
Joe Graedon started this link in 2007. In it he has invited anyone struck down by statins with symptoms suggestive of ALS (Lou Gehrig’s Disease) to comment on their status for the benefit of others. The last time I dug for gold here I was quite certain I had found at least 300 solid cases of ALS with hundreds of others who still might go in that direction since, as many of you understand, it sometimes takes years for ALS to unmask itself. There is no solid test.
Relevant to diabetes, it is now generally accepted that the incidence rate of new diabetes in statin users is 13%. – an amazing “user” penalty for a medicine that is supposed to diminish the risk of cardiovascular disease. I used the search term ‘pancreatitis’ to see how much of this diabetes might reflect organ damage. I found 604 reports of pancreatitis.
I see this as part of a whole body process of mitochondrial DNA damage aggravated by the use of statins. Even on our good days, mitochondrial mutations occur by the tens of thousands leading to progressive mitochondrial loss followed in time by cell loss and finally, with sufficient time, organ damage in the well known process of aging. All of this is the inevitable consequence of normal metabolic activity. It is theft of electrons from adjacent tissues, including DNA strands, that causes the damage. CoQ10 plays a major role not only in energy formation via electron transfer but also anti-oxidation, minimizing buildup of oxidizing byproducts of metabolism and slowing down DNA damage. Via inhibition of CoQ10, statins play a major role in what amounts to enhancement of the aging process.
Applying the search term cancer (of all kinds) gave me 1642 official reports to Medwatch of which 422 were reported as breast cancer.
I next tried the search term “cardiac failure” and turned up 720 reports. CoQ10 inhibition is felt to be the major contributor to this condition. My next search was “myocardial infarction” out of curiosity as to how many might there be in a group already on Lipitor. The figure was 2,520 – another attention getter – especially when I got 610 additional reports using the search term “coronary artery occlusion”. When you get a total of 3,030 cardiac events in a group already on statins you are justified in wondering just how much protection is being offered?
Use of the search term “cerebrovascular accident” yielded 1562 reports with another 159 inferred by the use of the search term “aphasia”.
My last search term use is based upon the report from the French data-base concerning their experience with statins and tendon complications (see link), finding 96 reports in the period 1990 to 2005. I reported 191 from Lipitor for a comparable time period and 436 from Lipitor over the time period of this report. This relatively obscure finding is based upon the role of cholesterol in tendon and ligament function. Most orthopedic surgeons are well aware of this relationship. (http://www.interscience.wiley.com/journal/arthritiscare)
FDA has a first rate monitoring system but a grossly deficient one for reporting findings back to the medical community. The average primary care physician in our country today, knowing that only a few of patient problems get reported to FDA, would be startled to see these figures, especially the ones for cognitive dysfunction, neuropathy, rhabdomyolysis, depression, neuropathy and hepatitis. These are the people who write the prescriptions for statin use.
“any doctor attempting to practice medicine without such information is liable for malpractice”
From my 23 years of experience as a primary care doctor I would say that any doctor attempting to practice medicine without such information is liable for malpractice. Only with this information can proper, informed judgments for treatment plans be made. It pains me to see my colleagues being maneuvered into this position.