FDA Medwatch Reports For Lipitor (1998 To 2007)
"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 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. 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 he make proper, informed judgments for treatment plans. It pains me to see my colleagues being maneuvered into this position."
This "first rate monitoring system" is typical of governmental regulatory bodies such as the EPA, USDA, etc. and is essentially public relations diversionary tactic to placate the masses. Most regulatory bodies are really created by the industry and have little or nothing to do with consumer protection. Akin to health care which is really sickness care these bodies pretend to protect the consumer. In fact these agencies like most "activist/health/environmental/industry associations and groups, in whole or part, are funded by corporations with vested interests. This is the most effective and the best public relations tactic money can buy." The agencies are in fact designed to shield, deflect and or pass the buck of corporate indiscretions though self serving regulations essentially created by vested interests to exploit the consumer. When sued they force secrecy as part of the settlement....
Statins are probably the greatest fraud in medicine and billions are spent to perpetuate a lie: That is, toxins and toxiods cure disease, is clearly is the reason that "Drug makers spend more on marketing than research" like $57 billion+. Yes that is a b and not m! With figures like that imagine how much they rack up in profits?
Adaped from: Quackbusting The Quackbusters - Free e-book
Now that the patents are expiring some of the their shenanigans are coming to light...
Chris Gupta
See also:
WHO-US Adverse Reaction Reports For Statins - When Where What?Statins Inhibit Important Biochemical Pathway - Cause Predictable 'Side Effects'
MEDWATCH REPORTS FOR LIPITOR (1998 to 2007)A few months ago by a stroke of good fortune a friend of mine obtained for me a copy of the Medwatch ADR (Adverse Drug Reactions) results for the drug Lipitor. It encompassed the time period 11 November 1997 to January 2007 and a pathway for me to count for myself Lipitor's contribution to statin side effects.
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. Yet, I know that thousands of reports have gone into Medwatch (see spacedoc.net). What is wrong with our ADR reporting system, I wondered?
For more see: Management Of Statin Damage
Based upon my personal experience with this drug (see Lipitor, Thief of Memory), amnesia was the first search term I entered. Not unexpectedly, out popped 399 case reports. Adding the search term memory impairment added me another 263 cases. This total of 662 reports of serious cognitive damage associated with the use of Lipitor seemed to fit quite well with the total numbers of such reports entered in my repository. Indeed, I had recommended to most that they do online Medwatch reporting and had helped more than a few. A paper has just been submitted by Graveline and Cohen to the medical journal Pharmacotherapy titled "Atorvastatin Associated Memory Loss: Analysis of 662 Cases of Cognitive Damage Reported to Medwatch."
Although focused on cognitive side effects, it seemed natural to add a few more relevant search terms and see what resulted. The first term I chose was neuropathy, knowing of the hundreds of neuropathy cases in my repository and many of them associated with Lipitor. Indeed, attorney Mark Krum, selecting only from those cases associated with Lipitor use, has recently announced near 50 neuropathy filings. Out popped 547 reported to Medwatch during this time interval. I would not call this minor especially since almost all of them have proven to very resistant to traditional treatment and now deserve to be called permanent.
Next I tried the king of them all, rhabdomyolysis. This as you may recall was the nemesis of Baycol, amassing nearly one hundred deaths before being removed from the market. Naturally, deaths from rhabdomyolysis are only a small part of the total number of hospitalizations. Still the number of 1,592 jolted me. I knew we were still having deaths from this cause but somehow never expected that this number of hospitalizations would be caused from just this one statin drug. I referred to Sidney Wolfe's Table 1, done at the time he was trying to gain support for Baycol's removal from the market.
Even though cerivastatin (Baycol) was the big player in the rhabdomyolysis field back then, it is obvious that the contribution of cases from other statins was considerable, especially from Zocor, Lipitor and Pravachol. We find that about half of all rhabdomyolysis cases were due to statins other than Baycol, so all doctors expected to see more of this dread complication despite Baycol's withdrawal from the market. But still the number 1592 reported for Lipitor seemed excessive, particularly when a glance at Wolfe's figure 2 shows us that approximately 10% of rhabdomyolysis cases result in death. Need I say that my 1592 reports translates out to be about 159 deaths after applying Wolfe's 10% figure!
I then referred to another of Dr. Wolfe's graphs of statin rhabdomyolysis events by drug for the time period 10/1/03-9/30/04, Table 3, and find that although Lipitor remains a major player, Crestor now shares center stage along with Zocor. Totaling the rhabdomyolysis reports for the year (253 plus Crestor's 68 gives 321. Applying Wolfe's 10% figure to the 321 total cases for the year gives us 32 deaths from statin rhabdomyolysis in the year 03-04). The estimate for the average number of Lipitor rhabdomyolysis deaths/year during this time period is 20. Clearly Lipitor is a major player in muscle damage problems.
I next searched among words that might reflect the curious effects of statin drugs on emotion and behavior now being reported. I found 166 reports from search terms focusing on the aggressiveness (24), hostility (11), anger (30), paranoia (16) and irritability (85) commonly reported in statin users and 602 reports of depression (517) and suicidal ideation (85).
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 interpretating the 951 total cases that resulted. When I realized that livr function abnormalities also was being used in the Medwatch diagnoses list, I used it as a search term, reporting 375 liver function abnormalities in addition to my 951 hepatitis cases.
The remainder of my informal survey included 318 reports of pancreatitis, 574 reports of myalgia, 178 reports of asthenia, reflecting the inevitable effect of all statins on energy levels and probably subject to gross under-reporting, since very few individuals might relate their overwhelming weakness to statin therapy.The myalgia did not surprise me for muscle aches are what statins do. The known weakness and debilitation of CoQ10 lack made asthenia predictable but the numbers of pancreatitis reports associated with Lipitor use caught my attention. I expect the mechanism here has to do with lack of cholesterol bio-availability in cell wall structure, an observation shared by liver cells as well. My repository holds many reports of pancreatitis and some of pancreatic cancer associated with Lipitor use.
I next tried the search term cardiac failure and turned up 338 reports. Many of these are associated with statin induced CoQ10 inhibition and as such are similar in etiology to the asthenia, just described. 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 1258 – another attention getter – especially when I got 505 additional reports using the search term coronary artery occlusion. I terminated my Medwatch review efforts with the search term cerebrovascular accident with 720 reports to which another 5 were added by the search term cerebral artery occlusion.
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 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. 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 he make proper, informed judgments for treatment plans. It pains me to see my colleagues being maneuvered into this position.
Duane Graveline MD MPHAuthor: "Lipitor, Thief of Memory"
and "Statin Drugs Side Effects"
posted by Chris Gupta on Monday March 3 2008
updated on Tuesday March 18 2008URL of this article:
http://www.newmediaexplorer.org/chris/2008/03/03/fda_medwatch_reports_for_lipitor_1998_to_2007.htm
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