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Statins, PN, and physicians research report

From the website http://www.medicationsense.com/artic...cts012108.html
Please excuse the formating. Much didn't transfer from the website.

Alternatives to statins are a combination of very high fiber diet low red meat diet, controlled sugar/fat/starch diet, red rice yeast (I take 1200 mg/day), pure crystaline niacin (I take 2 gm/day), and plant sterols. All is as advised by my cardiologist. My cholesterol and HDL/LDL ratio are now at the target range.

Quote:

STATIN SIDE EFFECTS: DO DOCTORS TAKE PATIENTS' COMPLAINTS SERIOUSLY? A New Study Reveals What Happens When Patients Complain of Statin Side Effects to Their Doctors

Patients frequently complain that doctors ignore their complaints of side effects with statin, cholesterol-lowering drugs. Joe and Teresa Graedon, the authors of the People's Pharmacy newspaper column, have published myriad letters on this topic. Here are three examples.

I have taken Lipitor for several years. I now notice numbness in my feet and sporadic memory loss, difficulty balancing my checkbook and using the computer. I have a Ph.D., so this is alarming. My doctor says Lipitor is not to blame. My cholesterol is great and not to stop. Is there any evidence that Lipitor could be connected to these symptoms?1

I have been on cholesterol-lowering medication for some time. I had been telling my doctor that my medication was doing something to my muscles and he would not believe me. I changed doctors and the new one discovered that my muscles enzymes were 800 (normal is 200). He took me off the medication and my enzymes came down. When I went on a different statin, they climbed back up again.2

My doctor insists I must take statins to lower my cholesterol even though I experience pain with all of them. Sometimes the pain gets so bad that I struggle not to cry when I walk down the hall of my child's school. My doctor says I should accept "a little discomfort." He says this pain is rare but I know a lot of people who have had the same muscle pain.3

It has been proven that statins can cause numbness in the limbs, cognitive and memory problems, muscle pain and severe muscle injury. Nevertheless, many doctors still insist that statins do not cause side effects.

A research team at my university, the University of California, San Diego, undertook an investigation of doctors' behavior when dealing with patients who complaints of statin side effects. When patients provided good descriptions of their symptoms, did doctors acknowledge the possibility of statin side effects and assist the patients accordingly? Did doctors submit reports to the FDA? Led by Dr. Beatrice Golomb, the researchers published their results in August 2007.4

The researchers focused on three types of side effects commonly caused by statins. The first type involved muscle pain, tightness, cramping, or weakness. In private consultations, patients described their symptoms to 138 doctors. According to the patients, fifty-three doctors (38%) acknowledged the possibility of statin side effect. Eighty-five doctors (62%) dismissed the possibility.

Patients presented symptoms of cognitive disorders, including impaired memory or thinking, to 56 doctors. Sixteen doctors (29%) acknowledged the possibility of a statin side effect. Forty doctors (71%) dismissed the possibility.

Patients presented symptoms of nerve injuries (neuropathies) including pain, weakness, or loss of function to 49 doctors. Seventeen doctors (35%) acknowledged the possibility of a statin side effect. Thirty-two doctors (65%) dismissed the possibility.

One might ask whether the doctors received enough information to make a connection between the statins and the side effects. In preparation for their consultations with the doctors, patients received materials to help them provide ample descriptions to the doctors. Indeed, separate analysis of patients' symptoms determined that nearly 80% of the cases met the scientific criteria for a definite or probable drug reaction.5

After the interviews with the doctors, patients described their doctors' attitudes about their symptoms (Table 1 below). Many doctors attributed patients' symptoms to age or imagination. Some flatly denied that statins caused any side effects or that statins caused these specific side effects. Yet practicing cardiologists know that muscle symptoms occur in about 35% of statin users, even though the drug companies' claim an incidence is only 5%.

Some doctors in the study denied that statins caused nerve injuries, yet it has been shown unequivocally that patients taking statins are 16 times more likely to develop nerve injuries than similar persons receiving no medications.

Overall, these results demonstrate that according to patients' reports, nearly two-thirds of the doctors in this study failed to diagnose obvious statin-related adverse effects. These findings are disturbing because they indicate a very poor level of medical care among doctors prescribing statin medications. The implications for patients are alarming.

On a broader scale, doctors' refusal to make an obvious diagnosis of statin side effects suggests that these same doctors would not submit a report to the FDA. The FDA Medwatch system is our primary means of identifying dangerous drugs and taking proper remedial steps. Medwatch relies mainly on reports submitted by doctors to indicate whether a drug is safe or harmful. This study provides strong evidence that with statin side effects, the number of reports received by Medwatch represents a gross underestimate of the scope of the problem.

Now that the FDA has this knowledge, what should be done? The FDA needs to initiate independent studies that actively define the true incidence of statin adverse effects in everyday medicine. The FDA must determine the percentage of doctors who fail to make obvious diagnoses of statin side effects and who fail to submit Medwatch reports. The FDA must pressure statin manufacturers to underwrite intensive training for doctors in diagnosing and reporting statin side effects. The FDA must also launch an initiative to encourage patients to submit their own reports to Medwatch.
Will the FDA act? Unlikely. The FDA has come under intense criticism in recent years for failing to ensure the safety of our medications. FDA officials have announced new initiatives to improve safety monitoring.

Experts, however, are not impressed. The FDA continues to underfund Medwatch, and it does not provide adequate personal for Medwatch to function effectively.

We have to remember that the FDA is a highly politicized agency. The drug industry has demonstrated considerable sway over the FDA. Not surprisingly, the FDA demonstrates far more concern about the needs of the drug industry than about our needs for safe medications.

If you are taking a statin drug and you encounter symptoms that might be a side effect, research it yourself before you go to your doctor. If the doctor is more concerned about defending the drug than helping you, find another doctor.

TABLE 1. DOCTORS' COMMENTS
Below are some of the comments by doctors, as reported by patients in this study.4
Adverse effect attributed to age (11 doctors).

Just normal aging process.
Can expect some problems at your age.
Well, you're no youngster.
No way, you're just getting old.

Dismissed importance of symptoms (69 doctors).

Doctor said would have to live with side effects and did not seem to care.
Ignored complaints about side effects.
Doctor shrugged and said some people just live with it, then laughed.
Did not seem to be concerned with side effects.
Didn't take seriously.
Made me feel I was alone in my inability to take statins because of `minor discomfort.'
Said I must continue [statins], protecting the heart was most important.

Dismissed existence of symptom (16 doctors).

Acted as if it was imagination.
Doctor suggested it was imagination.
Don't think doctor believed me.
Told me I just didn't like taking pills.
Nothing wrong with me, it's all in my head.
She `pooh-poohed' me and said keep taking Lipitor.

Dismissed relation to statins (55 doctors).

Almost impossible.
Cannot be statins.
Not possible.
Denied possibility.
Can't be.
Statins are not cause of problems.
Said problems couldn't be due to Lipitor.
Said: "This has nothing to do with the Pravachol."
Said: "That's not a side effect of this drug."
They [doctors] were very skeptical even though I presented Pfizer's own report on side effects.
Statins could not be cause of symptoms.
Neither doctor [internist, neurologist] believed me -- my pharmacist suggested Lipitor as a cause.
My chiropractor suggested it may be the Lipitor, my M.D. didn't think so.

Dismissed relation of muscle symptoms with statins (43 doctors).

Didn't think Lipitor caused muscle weakness because their was no pain.
CPK didn't indicate statin-related adverse effect.
\Wouldn't consider Lipitor the cause of body aches.
Specific muscle pain would not indicate medication, only general muscle pain.
Doctor didn't think cramps were caused by statins.
Dr. Philip that there was no connection between pain and the statin drugs.

Dismissed relation of cognitive symptoms with statins (18 doctors).

Statins do not cause memory loss and may, in fact, help it.
No research linking statins to memory problems.
Doctor said statins would improve (not worsen) memory.
Memory and peripheral neuropathy are not acknowledged side effects of statins.
Hopefully discussion of Lipitor, focused elsewhere.
I was the first to tell him [doctor] about this side effect (memory problems, fragmented thinking] and since then he has had other patients with similar problems.

Disbelief that statins could cause adverse effects in general (12 doctors).

Doctor said there were no side effects.
Doctor had heard of no difficulties.
Said Lipitor has minimum to no ADRs.
Literature did not support ADRs.
Can't be the statins, thinks it is a miracle drug.
Said that only 1% of patients have side effects.

REFERENCES
1. Graedon J, Graedon T. Does Lipitor affect memory and nerves? People's Pharmacy newspaper column, June 20, 2007:www.PeoplesPharmacy.com. Accessed Jan. 4, 2008.
2. Graedon J, Graedon T. Patients find statins can have side effects. People's Pharmacy newspaper column, Apr. 18, 2005:www.PeoplesPharmacy.com. Accessed Jan. 4, 2008.
3. Graedon J, Graedon T. Can statins cause debilitating muscle pain? People's Pharmacy newspaper column, Sept. 12, 2007:www.PeoplesPharmacy.com. Accessed Jan. 4, 2008.
4. Golomb BA, McGraw JJ, Evans MA, Dimsdale JE. Physician response to patient reports of adverse drug effects. Drug Safety 2007;30(8):669-675.
5. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics 1981;30:239?]45.

__________

In terms of reporting:

NOTHING gets reported post-release to the FDA. I've found it impossible to get my doctors to submit reports; they make all sorts of excuse. The most common is this: To prove this is a side effect, we'd have to re-start the drug; if you are willing to re-start the drug, and you develop the problem again, I'll report it. FDA does not require this.

But..patients can report to FDA, and I've been doing that. I have no idea what they do with this data.

I've looked for it online, and it's not available to the public. I've called the drug manufacturer's when I've had side effects, and asking if they've seen this before, and they say that's proprietary information. Even talking to the doctors who man the lines at drug companies for drug problems (anyone can call and geta doctor), the doctors appear to be reading prepared statements.

Post-release surveillance does not exist.

That's so scary.

Quote:

Originally Posted by LizaJane (Post 206941)

NOTHING gets reported post-release to the FDA. ..
Post-release surveillance does not exist.

Clinical trials are for a brief time only (a few weeks or months), with selected test subjects. Then, the drug is prescribed for long time periods (years or decades) with the only selection being the presence of a condition or symptom.

Sarcastically, the important thing is that drug company profits are at record levels, and that those same companies contribute a lot of money for political campaigns and physician workshops in beautiful resorts. If this weren't the best of all possible worlds, one could be driven to bitter cynicism.

This is more evidence that total trust may not be justified. We need to be critical and control our lives and our medical care. If you have PN, fibromyalgia, chronic fatigue syndrome, or other neurological type symptoms that started after you started taking statin drugs, know that there are less convenient but safer alternatives to lower blood cholesterol, LDL/HDL ratio, reduce c-reactive proteins and other inflamatory signs, and generally protect the heart, nervous system, muscles, and general health. Some physicians are informed and supportive about these alternatives.

I hope that other people in this forum have had experiences with "complementary" treatment for high cholesterol and blood lipids, and report those experiences back to the group.

And the worst part of this--

--is that there are studies--admittedly, many are from countries with socialized medicine, where the profit motive is not as active in suppressing those with deleterious outcomes--that can easily be consulted (as we all do), but most American doctors are highly resistant to both Googling info on what patients tell them AND continuing medical education from sources that are not also pharmaceutical.

I've heard the argument that today's doctors simply do not have the time to research patients complaints, and so rely on the phrama companies for thier drug information. I can empathize with the time crunch, but it's only one more argument for changing our profit driven system--people get hurt, AND it winds up costing everyone more in malpractice and lawyer fees, as a lot of adverse effects COULD be prevented.

But, of course, we've never been big on prevention, either--we prefer to blast through, make a mess, and then clean up the mess when it gets too big to ignore.

for the respondent who is taking red yeast rice--you ARE TAKING A STATIN. RYR is mevacolin K, the SAME ingredient in Mevacor. Although the amount of statin in Red Yeast rice is much less, It IS A STATIN...
the FDA compiled listing of all reported adverse effects from statins is availaable under the freedom of information act--you need to write to the FDA petitioning for the information. good lluck.

Quote:

Originally Posted by olsen (Post 207365)

Yes this is very true....

Also Red Yeast Rice from China has come up contaminated with a real statins, Lovastatin (Mevacor). If readers here want to use Red Yeast Rice, I suggest you verify that yours does not come from China.

Dr. Jarvik...controversy:

Should Dr. Jarvik be pushing Lipitor?

Here is an explanation of how this is affecting us all:

http://www.nytimes.com/2008/02/07/bu...d09&ei=5087%0A

Quote:

A Congressional committee, concerned that the Lipitor ads could be misleading, has said it wants to interview Dr. Jarvik about his role as the drug’s pitchman.

Some of the questions may involve his credentials. Even though Dr. Jarvik holds a medical degree, for example, he is not a cardiologist and is not licensed to practice medicine. So what, critics ask, qualifies him to recommend Lipitor on television — even if, as he says in some of the ads, he takes the drug himself?

And, for that matter, what qualifies him to pose as a rowing enthusiast? As it turns out, Dr. Jarvik, 61, does not actually practice the sport. The ad agency hired a stunt double for the sculling scenes.

“He’s about as much an outdoorsman as Woody Allen,” said a longtime collaborator, Dr. O. H. Frazier of the Texas Heart Institute. “He can’t row.”

The House Committee on Energy and Commerce is looking into when and why Dr. Jarvik began taking Lipitor and whether the advertisements give the public a false impression, according to John D. Dingell, the Michigan Democrat who is the committee’s chairman.

“It seems that Pfizer’s No. 1 priority is to sell lots of Lipitor, by whatever means necessary, including misleading the American people,” Mr. Dingell said.

Lipitor, the world’s single best-selling drug, is Pfizer’s biggest product, generating sales of $12.7 billion last year. But as it has come under competition from cheaper generic alternatives, Pfizer has used the Jarvik campaign, introduced in early 2006, to help protect its Lipitor franchise.

Pfizer spent $258 million from January 2006 to September 2007 advertising Lipitor, according to TNS Media Intelligence. Much of that went for the Jarvik campaign.

Qualifications:

Quote:

Jarvik is a medical doctor, but not with the strongest credentials. When he finished Syracuse University his grades did not permit entry into a U.S. medical school. So, he enrolled at the University of Bologna, Italy, but left after two years. Eventually Jarvik decided the mechanical aspects of the body fascinated him and he earned a master’s degree in medical engineering from New York University.

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After that he went to work for Dr. Willem Kolff, a Dutch born physician-inventor at the University of Utah who produced the first dialysis machine and was working on other artificial organs, including a heart. Kolff quickly assumed the role of Jarvik’s mentor and helped him earn an M.D. from the University of Utah in 1976, although Jarvik neither took an internship nor practiced medicine.

from http://www.msnbc.msn.com/id/16039753/

Don't miss the video example in the ad... it is on the left part of the screen.

This link is also interesting:
http://prescriptionaccess.org/blog/?cat=163

Reporting side affects

I've reported side affects directly to the drug companies who manufactured the meds - I was usually given to their clinical dept who asked many questions - from other meds I'm taking, medical conditions, and even sent release for me to sign that they send to my doctor to monitor (or I'm assuming also asertain their liability).... so my instinct is, they are protecting themselves...

I belive Dahlek did work with the FDA in one situation - and did receive a positive response.... hopefully she will be able to let us know more.... I always have heard one shouldnt take a med until its been on the market at least five years, and have in fact been prescribed meds that I didnt take for this reason - only to see them pulled from the market a year or so later after they hit they general population and were causing serious consequences or patient deaths.... I still try to stick to this philosophy....

Quote:

Originally Posted by olsen (Post 207365)

I tend to see these issues similar to Dr. Andrew Weil. Drugs generally are composed of one or two purified active ingredients. In contrast, herbs tend to have complexes of active alkaloids with similar but not exactly the same effects, and usually contain buffering agents. This has the effect of increasing safety, reducing side effects, and making the effects gentler and more extended in time than with drugs. In the case of (uncontaminated) red rice yeast, I'm not aware of any reported negative side effects.

A caution is in order. Just because it's an herb and "natural", doesn't mean that it's safe. Examples of toxic or deadly herbs are belledona, foxglove, oleander, amanita mushroom (also called death-cap or destroying-angel), and tobacco.

Our entire part of the state was shut down this last week, and this included 1000 stranded motorists on the I-90 system north of Rockford and south of Madison, some stranded for 11 hours until rescued by the national guard. We didn't make it onto the news as the weather down south was deadly...we were just cold and buried.....I did make it to the clinic for my daughter's appointment, which was just a few miles away, and it was empty in the clinic, except for...........TWO drug reps.

I had to laugh...what else can one do?

I suppose one could organically grow one's own treatments...eh, I better not get into that here.:eek:

Wings---very good point. I tend to confine my grazing to what I plant....and none of it is considered medicinal...no wait...I take that back....hot peppers---those are medicinal and packed quite a kick.

Once my daughter ate a toadstool (likely nontoxic-but the poison control center didn't know)....she was three, and she had to have syrup of Ipecac.....it took her 20 more years to ever eat another mushroom. I felt so awful giving her that stuff....IT works.