Jay S. Cohen M.D.       http://medicationsense.com      1337 Camino Del Mar   Suite C       Del Mar, CA 92014       Phone: 858.345.1760       Fax: 858.509.8944


Interview: Duane Graveline

Medical Doctor, Astronaut, and Critic of Lipitor and Other Cholesterol-Lowering Statin Drugs

Dr. Graveline began his medical odyssey at the famed Walter Reed Army Hospital during the time when America's space pioneers were just beginning to study the medical effects of space flight. After becoming a flight surgeon and participating in that space medical research, Dr. Graveline received international recognition for his research on zero gravity deconditioning, his work as a medical analyst of the Soviet bioastronautics program, and in 1965 for his selection as a scientist astronaut. In May 2001, Dr. Graveline was prescribed Lipitor and subsequently developed a severe case of amnesia. Subsequently, he established his website (www.spacedoc.net) as forum for information about the memory-related reactions linked to statin drugs. Based on his experience and those of others, Dr. Graveline has published a new book, “Lipitor, Thief of Memory, Statin Drugs and the Misguided War On Cholesterol.” This book has added relevance today as recent studies suggest that doctors should prescribe stronger and stronger doses of cholesterol-lowering statin drugs, especially Lipitor, the most prescribed drug in America.

Dr. Cohen: Dr. Graveline, you have written some strong opinions about the cholesterol lowering-drug Lipitor, the most prescribed drug in America. Why?

Dr. Graveline: I have discovered that the stronger statin drugs such as Lipitor can be associated with profound cognitive disturbances in some patients. There are now thousands of patient case reports of amnesia, forgetfulness, confusion and disorientation, at times severe and incapacitating. With some cases lasting months and years, another very important point is that cognitive side effects can appear after months and years of seemingly trouble-free use.

Dr. Cohen: Can you give some examples?

Dr. Graveline: A 70 year old lady who lives alone and chops her own wood feared she had intruders when she found wood for her buck stove all split and scattered about and discovered a plate of partially eaten food in her kitchen. She searched the house from top to bottom and was about to call the police when she noted that the tracks in the new snow outside her porch near the woodpile were hers. She was the unknown intruder. This unnerved her, but after she discontinued her statin drug, she reverted to her usual alert, independent self.
    A U.S. Air Force loadmaster wanted to know how long his Lipitor associated memory lapses might last. He stopped the drug on his own but knew his job was in jeopardy if he reported this event to his flight surgeon.
    A woman hiker "woke up" lost in the woods.
    A businessman awoke in his car miles away from anything familiar to him, and a passing highway patrol officer was convinced that his disorientation must be due to drinking or drugs. In a manner of speaking he may have been right, for this man was on Lipitor and since that episode has become an anti-statin activist.
    A CEO of a large company remains unable to formulate new memory and is no longer employable, an apparent victim of permanent memory impairment following amnesia episodes associated with Lipitor.
    The list goes on and on.

Dr. Cohen: You yourself developed amnesia after taking Lipitor. What happened?

Dr. Graveline: The first episode happened after I had been prescribed Lipitor for my modestly elevated cholesterol. I had returned from my usual morning walk in the woods when my wife noticed me walking aimlessly in our driveway as if I were lost. I did not recognize her and refused to enter our home. I reluctantly accepted cookies and milk and somehow she got me into the car to see my family doctor and neurologist. One year later, I was urged to resume taking Lipitor by my doctor, who refused to believe that a statin had caused the first amnesia episode. Hours after taking the first dose, my wife found me in the greenhouse with that "gone" look in my eyes again. This time, during the 12 hour episode, I regressed all the way back to my teen years with precise recall for all my high school friends and events. Gone were all memories of my college years, medical school, my marriage and four children. And my exciting 10 years in the USAF as flight surgeon and research scientist. I had no recall of being a family doctor for 23 years, a NASA astronaut, or the author of nine books. All of these memories were completely lost from my mind, just as if they never happened.

Dr. Cohen: The image we see of amnesia in the movies is humorous, not serious or dangerous. What is the reality?

Dr. Graveline: Experiencing total global amnesia is nothing like you see it presented in the movies. Imagine yourself with an abrupt and complete loss of ability to formulate new memory -- a conversation with a loved one, a beautiful scene, a major event in your life, all gone like a whisp of smoke. And in the retrograde form, add the loss of major memories of the life lived -- marriages, deaths, children, careers.

Dr. Cohen: You practiced medicine, right? Didn't you prescribe statin drugs like Lipitor and Zocor?

Dr. Graveline: I practiced medicine as a solo family doctor for 23 years until 1993. Since I am board certified in preventive medicine as well as family practice, I applied preventive medicine concepts liberally in my practice and, yes, these concepts included cholesterol control through the use of medicines. The statin drugs available during the last decade of my practice were not today's more powerful top-seller statins like Lipitor and Zocor. I used these earlier drugs liberally and encountered no major problems. However, cognitive and other statin side effects seem to come with today's more powerful drugs, and doctors and patients must be made aware of the negative aspects of their aggressive use.

Dr. Cohen: But just because a person gets a symptom while taking a medication, that doesn't mean the drug is the cause. What's the evidence on statins and cognitive problems?

Dr. Graveline: Initially, when I seemed to be the only case, my evidence was purely intuitive. Lipitor was the only medication I was taking when, six weeks later, I had my first attack of amnesia. A year later, at the time of my next astronaut physical, I was rechallenged with Lipitor and after six weeks an even worse bout involving both anterograde and retrograde amnesia occurred. Even though I was now convinced that both of my experiences stemmed from the Lipitor, no one else was. Only when I discovered the statin study at the University of California, San Diego, did the truth finally begin to emerge. I learned that there were several other cases just like mine. A few months later, when the People's Pharmacy column published my case report, a flood of cognitive case reports from patients all over the country on statins poured in. Until that time, these patients had assumed their lapses, forgetfulness, confusion and disorientation were from old age, senility or early Alzheimer’s. We now have thousands of case reports including many who are rechallenge cases like mine. And just recently, the journal Pharmacotherapy published a review article of 60 patients having statin-associated memory problems (Wagstaff, LR, et al., July 2003). In my judgment, the evidence for statins causal role is overwhelming.

Dr. Cohen: And that’s why you are now publishing “Lipitor, Thief of memory”?

Dr. Graveline: Yes. Generally speaking I have not been excessively critical of statins, and I repeatedly cite their value for high-risk patients for our options are few at this time. My only concern is with the lack of awareness of both patient and prescribing doctor of the potential of the statin class of drugs to seriously interfere with the memory process. Rare, yes, but with so many millions now on these drugs, we are talking about tens of thousands of people in whom memory impairment of varying degrees can be expected.

Dr. Cohen: How has the medical establishment dealt with all of this?

Dr. Graveline: Doctors, like their patients, have been completely uninformed about the cognitive side effect issue with statin drugs. Time and again they assure and reassure their distraught patients that their memory lapses are "to be expected at their age", or are possibly a "touch of senility" or perhaps even "early Alzheimer’s". So complete has been the 'brainwashing" of doctors by pharmaceutical reps and statin drug literature that a possible side effect to the statin drug is the last thing most of them consider. Now, after more than ten years of prescribing statins and reassuring patients of their safety, the last thing a doctor wants to hear is that he has been wrong all this time.

Dr. Cohen: What about the FDA?

Dr. Graveline: I am awaiting our watchdog FDA's explanation of the report in Pharmacotherapy involving 60 memory cases gleaned from the FDA's own Medwatch reports over the past four years. Unfortunately, during this time, the FDA has not seen fit to issue a special warning to physicians. Is that not the FDA's role?

Dr. Cohen: You've established a website (www.spacedoc.net) for people with Lipitor reactions. What's been the response?

Dr. Graveline: Over the past year my website has received just under 50,000 hits from patients all over the world interested in the side effects of statin drugs, especially the cognitive side effects of forgetfulness, confusion, disorientation, or amnesia. Currently between 100 and 200 hits daily are being received as a result of three articles I've posted: “Lipitor, Thief of Memory;” "Statins and the Flyer;" "Cholesterol, Friend or Foe?"

Dr. Cohen: You've warned that Lipitor and other statins may create a serious hazard in pilots taking these drugs. Why?

Dr. Graveline: As a former USAF and Army flight surgeon, one of the first thoughts that entered my mind after my experience with Lipitor was what might happen if my amnesia occurred while I was piloting my ultra-light aircraft? So you can imagine my concern when I learned that these drugs are commonly used not only by military pilots, but also are allowed by the FAA for flight crew members operating today's jumbo jets and other commercial aircraft. The e-mails I have received from flight crewmembers telling of their "memory lapses" or of an "inability to multitask" will make you shudder.

Dr. Cohen: You are familiar with my research and book Over Dose showing that patients are often prescribed excessive doses of Lipitor, Zocor, and other statins. What is your perspective on this?

Dr. Graveline: I believe that excessively high starting doses -- which incidentally are the initial doses recommended by the drug companies in package inserts and the Physicians' Desk Reference (PDR) -- are a huge problem with many medications, but it is especially true with statins. Another clear indication of this is that many cognitive side effects occur when statin doses are increased. I firmly believe a doctor prescribing drugs should follow your mandate to "start low and go slow." This simple rule, if followed, would greatly diminish our side effect problems. Another important factor is our growing awareness that cholesterol and LDL levels may not be reliable indicators of statin drug effectiveness. Statins appear to work by suppression of the inflammatory process underlying arteriosclerosis and its offspring atherosclerosis. A growing body of research data does now tell us that statins appear to have a direct effect on inflammation within artery walls and on platelet inhibition. Cholesterol reduction seems to be largely irrelevant to this process and to the resulting improvement in CV risk. There is reason to believe that the dosage of statins required for this anti-inflammatory action may be much less than presently prescribed starting doses with very favorable impact on the side effect profile. Much additional research is necessary to define the specific mechanisms involved.

Dr. Cohen's comments: Adding scientific weight to Dr. Graveline's concerns is the article in the July 2003 issue of Pharmacotherapy: "Statin-associated memory loss: analysis of 60 case reports and review of the literature." This article examines 60 cases of statin-associated cognitive impairments from the FDA's Medwatch system. 36 cases occurred with Zocor, 23 with Lipitor -- the most powerful statins -- and 1 case with Pravachol, with is also being prescribed at stronger initial doses today. Most interesting are the 4 rechallenge cases: people who again developed cognitive problems with a second course of statins, just as Dr. Graveline did. According to accepted guidelines for assessing adverse drug reactions (Naranjo et al., 1981), the development of symptoms on rechallenge is considered definite evidence of an adverse drug effect. Cognitive impairments, like most statin side effects, are believed to be dose-related: the stronger the drug and dose, the greater the risk. Some people do need strong doses of statins, but throwing millions on stronger doses than they need or tolerate is not the answer. More on this in my upcoming book that will be published this summer on statin drugs and natural alternatives for lowering levels of cholesterol, C-reactive protein, and other cardiac risk factors safely.

Dr. Graveline’s book, “Lipitor, Thief of Memory,’ can be purchased online at Buy Books on the Web:
www.buybooksontheweb.com.





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