Wednesday, July 15, 2009

Do statins cause transient global amnesia?

Within a report titled Are Clinical Trial Results Compromised By Money? at the denvernewschannel, one finds the text:

After astronaut and flight surgeon Duane Graveline's cholesterol went up from 230 to 270, NASA doctors put him on Lipitor. But an under-reported side effect changed his life.

"I didn't know my wife and I didn't know my home," Graveline said.

Graveline was suffering from transient global amnesia. Graveline found studies not widely reported that show statins impact cholesterol in your brain that affects memory.

"Not one of these has been reported back to the medical community," Graveline said.


In the area of COX-2 inhibitors, one recalls the lack of discussion of negative effects in the context of VIOXX.

Graveline's story has been reported sporadically in the press.

**Milwaukee Journal Sentinel (Wisconsin), 28 March 2004 (page 1A):

In addition, there have been numerous accounts of statin users experiencing mental problems.

For Duane Graveline, a retired doctor and astronaut, the memory problem was so bad that he wrote a book about it: "Lipitor, Thief of Memory," which was published in February [2004].

Graveline began using Lipitor four years ago after his annual NASA physical showed an elevated cholesterol level. He was put on a low dose of the drug. About six weeks later his wife found him wandering in their front yard. He could not remember recent events, he said.

"I didn't know who she was," Graveline said.

Within about six hours, his memory returned. A neurologist determined that he had had a bout of transient global amnesia. Graveline said he suspected it might be related to Lipitor, so he stopped taking it.

A year later, NASA doctors again told him he needed to get his cholesterol down and persuaded him to go back on Lipitor.

Six weeks later, he said, he had another bout of amnesia, only this time he lost memory of everything after high school.

When he was told that he was a former astronaut and that he was married and had children, "I laughed," he said. "I thought that was absurd."

It took about 12 hours for his memory to return to normal, Graveline said.


The FDA knows -->

Parks, of the FDA, said the agency is aware of reports of cognitive problems among statin users and is monitoring the situation. She noted that many of the people who take the drugs are older and may have other conditions that cause memory problems.

Studies, however, have raised concern that statins may cause cognitive problems and irritability.

One study looked at 308 men who were given a placebo or the statin Zocor for six months. In memory tests and a test involving a complex maze, the statin users did not perform as well as those on the placebo. The difference was subtle but significant, said the study's lead author, Matthew Muldoon, an associate professor of medicine at the University of Pittsburgh School of Medicine.

"We don't know why it's happening," he said.

Muldoon said one theory is that along with cholesterol, statins may lower levels of omega-3 fat, which is vital to a healthy brain. Another possibility is that the drugs also lower levels of a substance known as Coenzyme Q10, an anti-oxidant and essential nutrient for cells.


**Buffalo News (New York), February 9, 2006 (page C3):

"I am a retired family doctor and former astronaut. Two years ago at my annual astronaut physical at Johnson Space Center (JSC) I was started on Lipitor. Six weeks later I experienced my first episode of total global amnesia lasting six hours. They couldn't find anything wrong with me, so I suspected Lipitor and discontinued it.

"Other doctors and pharmacists were unaware of similar problems. Believing it must have been a coincidence, I restarted Lipitor a year later. After six weeks I landed in the ER with a 12-hour episode of total global amnesia. I am more convinced than ever of a Lipitor relationship."

The astronaut-physician is Duane Graveline, M.D. In response to his experience, we heard from other readers who had suffered episodes of total global amnesia while taking Lipitor, Zocor or similar drugs.

Total global amnesia is a temporary but frightening loss of memory. Dr. Graveline forgot that he was a physician or an astronaut and didn't even recognize his wife. He has summarized his experiences in a new book called "Statin Drugs: Side Effects and the Misguided War on Cholesterol" (available on the Web at www.spacedoc.net).

Recently we heard of another disturbing experience. Michael Kirk-Duggan is a retired professor of business law and computer science. He was diagnosed with probable Alzheimer's disease that was progressing very rapidly. He went to his 50th college reunion with a sign around his neck that said: "I'm Mike. I have Alzheimer's disease." At his youngest daughter's wedding, he did not recognize people he had known more than 20 years.

His decline made it clear that he would need long-term nursing care. But then he read our column about statins and memory problems. With his doctor's awareness, he discontinued the Zocor he had been taking. Although it took many months, he gradually regained his memory and cognitive ability. He is back to reading three newspapers a day and is sharp as a tack. A complete neurological work-up showed no signs of Alzheimer's disease.


**Lewiston Morning Tribune (Idaho), September 23, 2008:

(question) I have normal LDL cholesterol but low HDL, as low as 26. With diet and exercise, I can get my HDL to the mid-30s, which is not great. Lipitor lowered my LDL below 80, but sadly my HDL didn't budge.

After being on Lipitor for a couple of months, I woke up one morning and had no idea what day of the week it was or that the company picnic was the day before. At work, I could not make simple postings of dollar amounts from hard copy to electronic spreadsheet (I would forget the amounts).

At a meeting, I could not remember names, and later at home, I kept asking my wife the same question, as I could not remember her answer. She took me to a doctor, who thought I had a mini-stroke. Ultrasound, brain scans and all other tests were normal, so no stroke.

I mentioned Lipitor, but the doctor dismissed it ("no way"). At the end of the evaluation, I was diagnosed with transient global amnesia.

Not wanting to be a vegetable for the rest of my life, I stopped taking Lipitor. I now take Niaspan (prescription niacin), and my HDL has improved to 43. My LDL is 80, and my memory is better than ever. I hope this story helps others.

{We received a startlingly similar story from Duane Graveline, M.D., a retired astronaut and family physician, in 2001. He, too, was taking Lipitor when he had a scary experience with transient global amnesia (TGA).

Subsequently, we heard from others who also experienced TGA or other kinds of memory problems while taking statin-type cholesterol-lowering drugs. Anyone who would like to hear Dr. Graveline's story and learn more about this complication and other ways to control cholesterol may be interested in a CD of a radio interview we conducted with him and several other experts. To order a CD of this one-hour conversation on "The Dark Side of Statins," please send $16 to: People's Pharmacy (CD-523), P.O. Box 52027, Durham, NC 27717-2027.}



Elsewhere in the denvernewschannel report:

The push is on for more disclosure. This year the New England Journal of Medicine now requires authors to disclose any patents or royalties related to their research and it publishes the information with the studies.

There is reference to a study by Dr. Daniele Fanelli of the University of Edinburgh:

On average, about 2 percent of scientists admitted they had made up, falsified or altered data to "improve the outcome" at least once. Up to 34 percent admitted to other questionable practices including "failing to present data that contradict one's own previous research" and "dropping observations or data points from analyses based on a gut feeling that they were inaccurate."
In surveys that asked about the behavior of colleagues, 14 percent of scientists knew someone who had made up or changed data and up to 72 percent knew someone who had committed other questionable research practices.


Of questionable articles in medical journals, see


Papers in medical journals as infomercials?
, including mention of L.B. Ebert, Commercialization of Information: Science Journals as Infomercials, Intellectual Property Today, p. 5 (Dec. 1999)

Of Lipitor, see also


What happened to the guy who developed Lipitor?


http://ipbiz.blogspot.com/2006/06/lipitor-caught-in-squeeze.html

**In passing, on the subject of "hiding" negative information, note that drug companies are not the only ones who conceal unflattering things:

LeBron gets dunked on by Xavier player, confiscates all video which includes

The Crawford dunk would have been a temporary embarrassment for LeBron. Let's say the video was put on YouTube. It blows up for a bit, dominates blogs for 36 hours, everyone has a good chuckle and then it's forgotten about.

But by censoring the tape, LeBron turns the dunk into a legend. On video, it's just a dunk. Without video, the jam can reach mythic proportions. Because nobody can see it, the story of the dunk will grow in stature with each telling. Today, it was a simple two-handed slam. In a few days, it will be a 360-degree windmill. By the time Crawford makes his Xavier debut in October, he will have jumped off LeBron's shoulders, flipped in the air, slammed the ball home with his left pinkie and then handed LeBron $3.99 for his dry cleaning.


Cross-reference: Jordan Crawford, a sophomore at Xavier; Sikahema Effect (after Vai Sikahema, whose startlingly impolitic "Rutgers is Wrong" vanished from the net); Bell Labs/Alcatel, who removed their copy of the Beasley report on Jan-Hendrik Schon from the internet.

**Also, related to the paper on infomercials-->

Interestingly, in rejecting Plant Patent 5,751 on Nov. 4, the PTO may have gone to a low-tech, but unconventional, source: the 1971 book "The Yage Letters" by beat-generation writers Allen Ginsberg and William Burroughs which described their experiences under the influence of the plant (the ayahuasca). FROM: LBE, Commercialization of Information: Science Journals as Infomercials? IPT (Dec 99)



There was a later matter involving the University of Hawaii and the taro plant.

http://ipbiz.blogspot.com/2006/06/uhawaii-drops-patent-covering-taro-poi.html

http://ipbiz.blogspot.com/2006/01/patenting-of-taro-plant-creates.html

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