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Lipitor - The Dangers of Statin Drugs

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Lipitor, a cholesterol lowering drug made by Pfizer and sold to millions of health conscious but ill informed patients, is one of the most profitable drugs the pharmaceutical industry has ever come up with. Sales account for a quarter of Pfizer's $ 32 billion annual sales. Expected to gross more than $ 10 billion this year, Lipitor is poised to become the largest-selling pharmaceutical in history, surpassing Pfizer's other wonder drug, Viagra.

But the price to society is much higher than a mere 8 to 10 billion dollars. Lipitor and other drugs in the statin class, such as Bayer's version Baycol - removed from the market by its maker - are not only lowering cholesterol. These drugs apparently ruin perfectly good lives with "side effects" that lead to slow degradation into physical disability. The story of Doug Peterson and other residents of Tahoe City may be coldly dismissed as "anecdotal evidence", but there is no excuse for scientific statistical sofistry. Every tragedy is real - when it happens to you, the risk is 100%.

Let's look at the pharmaceutical profit model for a moment. Drugs are developed and they have to be sold, otherwise - no profit. In the case of Lipitor and its similars, that means a market has to be created. Cholesterol, a beneficial substance in the human body, is targetted as a bad sign of impending heart disease. Drugs are promoted to "lower cholesterol". Mind you, not to prevent heart disease but to turn off the blinking warning lights. Billions are made, a huge empire of multinational corporations is built to "take care of our health" - by selling us drugs. National economies are all but bankrupted by the costs of health care, most of it to pay for drugs. What's more, national and personal economies are also bearing the cost - sometimes vastly greater than the mere cost of a prescription - of these drugs' side effects, the cost of drug induced illness and disability.

Who is responsible? The drug barons? The medical researchers? The media which never told us?Or none of them?

I like what Karla, Doug's wife, has to say: "We are hoping he is going to get better. That's our number one goal. Anger is a waste of energy at this point. We are trying to recover and get the word out."

Also Doug is taking the matter with a good deal of philosophy: "At this point, I consider myself lucky I'm not in a wheelchair," says Doug, who is currently in phsyical therapy. "There are no guarantees in life. Your birth certificate doesn't come with a warranty."

In other words: Do it yourself. The responsibility is ours. if you think you can help get the word out about what is really happening.

January 29, 2004

LIFE AFTER LIPITOR: Is Pfizer product a quick fix or dangerous drug? Residents experience adverse reactions

(Article originally found in Tahoe Tribune)


By Melissa Siig, Tahoe World Staff


At first glance, Tahoe City resident Doug Peterson looks like he is recovering from a stroke.

His speech is slurred, he has difficulty walking in a straight line, and he can't sign his own name. By afternoon, he is so fatigued he has to sit down for the rest of the day. When asked his age, Peterson says he is 52. His wife Karla, standing nearby, corrects him. He is 53.

Doug has never had a heart attack, and until the onset of the symptoms almost three years ago, was an active skier, biker and scuba diver. Now he is limited to walks on the treadmill. Doug traces his problems to a drug he started taking almost three years before his health began deteriorating - Lipitor. Two other Tahoe City locals have also experienced negative side effects from taking Lipitor or other statins, the name for a family of cholesterol-fighting pills.

While there is no concrete evidence linking Doug's health problems to Lipitor, after doing years of research, meeting with doctors and talking to other statin sufferers all over the world online, he and Karla are convinced of the connection. Pfizer, the maker of Lipitor, claims the drug is effective in lowering cholesterol and has minor side-effects. But as Doug and others would ask, is it worth it?


WONDER DRUG OR DANGEROUS PILL?

Doug, who has hereditary high cholesterol, was first prescribed Mevacor, a statin made by Merck, in 1998. Six months later, his doctor had him switch to Lipitor, which comes in higher doses, and upped his dosage from 10 to 20 mg. His cholesterol dropped from 285 to a low of 160.

"The doctor was very pleased," said Doug, "but meanwhile the symptoms started."

In the fall of 2000, Doug began having restless sleep patterns. His twitching and flying arms got so bad that Karla had to sleep in another room. One time, Doug even fell out of bed. The couple didn't think anything was seriously wrong until a few months later when Doug started slurring his words. This was followed by a loss of balance and the beginning of what Doug calls the "statin shuffle" - a slow, wobbly walk across a room. Next to slide was Doug's fine motor skills. It took him five minutes to write four words, much of which was illegible. Finally, he tired easily and his cognitive memory processing diminished. He had trouble following books with complex plots.

Confounded by Doug's illness, over the next two years the Petersons traveled all over California meeting with neurologists, internists and acupuncturists. Doug had MRIs, brain scans and neurofeedback tests done. Last February, Doug's doctor suggested he go off Lipitor to see if the drug was causing his health problems. After three weeks, the symptoms persisted, so the doctor put Doug back on the pill. Since Doug wasn't exhibiting the most common side effect, muscle cramps, and his liver function tests came back normal, the physician was doublly sure that Lipitor was not to blame.

Finally, last spring, a doctor in Pasadena suggested Lipitor could be the culprit. Doug went off the drug in May, and since then his symptoms have stopped their downward spiral and his health has slowly started to improve. According to Karla, his mind is sharper, his balance is better and his speech is more clear in the mornings, before he gets tired. But he still has a long way to go.

"Before, I was a good father and family person," said Doug, who has two children with Karla. "At this point, I can't do that much."

A former Navy diver and owner of Sierra Tahoe Computers, a repair and service business, Doug has had to cut down his work schedule because of his fatigue and loss of hand coordination. He is considering going on disability, but Karla remains optimistic.

"We are hoping he is going to get better. That's our number one goal," she said. "Anger is a waste of energy at this point. We are trying to recover and get the word out."


DID PFIZER DO ENOUGH STUDIES?

Since Parke-Davis (later acquired by Pfizer) developed Lipitor in 1997, it has become the number one prescribed cholesterol-lowering drug in the United States, with more than 18 million Americans having been prescribed the drug. New York City-based Pfizer, the world's largest pharmaceutical company, derives a quarter of its $32 billion in annual sales from Lipitor, according to an article in SmartMoney. With sales expected to top $10 billion this year, Lipitor is poised to become the largest-selling pharmaceutical in history, surpassing Pfizer's other wonder drug, Viagra.

Lipitor is proven to lower total cholesterol by 29 to 45 percent. As with any prescription, it comes with a list of possible side effects, such as muscle pain or weakness and liver dysfunction. Pfizer's Web site states, "The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away." In a nine-month study of 2,502 patients, Pfizer found that more serious side effects, such as facial paralysis, colon inflammation and gallbladder pain, occurred in less than 2 percent of those treated.

Pfizer was unable to commment on reported adverse side effects in time for the Tahoe World's deadline.

The problem, say the Petersons, is that Pfizer has not conducted any long-term studies. Doug's health issues didn't start for two and a half years after he started taking Lipitor. Similarly, Tahoe City psychologist John Altrocchi, 75, was on Mevacor for around three years when he started to develop calf pain that became so severe he could hardly walk. He also experienced a case of temporary memory loss called transient global amnesia (TGA), which has been linked with statins. A day after watching the 1998 Super Bowl game, Altrocchi had no memory of the event.

"There's no way you could prove that Mevacor was responsible for the TGA, but it's very possible," said Altrocchi, who stopped taking the drug about three years ago and convinced his brother, a retired neurologist, to go off Lipitor. "Especially for older men, I think it's wise to get off statins right away. There is very little evidence they do much good."

While most symptoms seem to start after a few years, Ed Ontiveros of Homewood began having physical problems within 30 days of taking Lipitor. After experiencing muscle aches and weakness for a few days, the 75-year old fell in the bathroom and didn't have the strength to get up. Since going off the drug, he's had no problems.

"It [reduced cholesterol] is not worth it with the side effects," said Ontiveros. "You may not live as long, but you sure don't want to die earlier."

Doctors are quick to prescribe Lipitor, says Karla, because they perceive it as a magic bullet in the battle against cardiovascular disease, the leading cause of death for Americans, and it's easier than prescribing a long-term regime of healthy diet and exercise. But the evidence that high cholesterol leads to heart disease is not conclusive, said Altrocchi, and there is even speculation that cholesterol provides protection for the brain and spine.


THE ROAD TO RECOVERY

The Petersons say Pfizer is too powerful to take on alone, but would consider joining a class-action lawsuit against the company. However, lawyers have told them a lawsuit is only possible if Lipitor gets recalled by the Food and Drug Administration. (Another statin, Baycol, was recalled by Bayor in 2001 after 31 people died of kidney failure while on the drug.) The Petersons filled out a complaint on the FDA Web page and encourage other Lipitor sufferers to do the same.

Frustrated by doctors who doubt the connection between Lipitor and health problems, the Petersons are awaiting the results of a study being conducted by Dr. Beatrice Golomb, a neurologist at the University of California-San Diego, on the effects of statin drugs. As reported by the Wall Street Journal this week, Golomb found that 15 percent of statin patients developed some cognitive side effects. In the meantime, the couple is focusing on Doug's recovery and staying positive.

"At this point, I consider myself lucky I'm not in a wheelchair," said Doug, who is currently in phsyical therapy. "There are no guarantees in life. Your birth certificate doesn't come with a warranty."

visit Drug Information Technologies at www.ditonline.com.


Here is an update from 12 February:

February 12, 2004

Letters to the Editor

Lipitor article draws debate

I've had some interesting conversations with community members after the "Life After Lipitor" article was printed on Jan. 29. I am not a doctor and do not want to give medical advice, but I believe that cholesterol-lowering statin drugs can harm some of the people taking them.

Statins are extremely popular drugs and we know that they are being prescribed to millions of people. Last year, more than $13 billion was spent on the two top selling statin drugs. U.S. citizens pay three times as much for medications than people in other first world countries, yet overall we have a shorter life expectancy (see Time magazine, Feb. 4, 2004.) So it is interesting to note that spending more on medications does not necessarily prolong life.

We are ultimately responsible for our own health. Heart attacks occur because of many different risk factors. Cholesterol is just one of many. Other factors include weight, age, stress, diet, smoking, exercise and family history. We still have a lot to learn about how to prevent and treat heart disease.

In the past, my doctors told me that statins did not have serious side effects. But when I read the very fine print about possible adverse reactions, I found over 130 side effects reported by the manufacturer. I realize that statins and most other drugs have side effects and there is a risk in taking any medication.

I believe the manufacturers report that 2 percent or less of statin patients develop most of the known side effects, while other researchers are reporting problems in up to 15 percent of patients. We do not know what the total figure will eventually prove to be, and it may be far greater than what we initially suspected. If you are one of the people who are harmed, then the percentage probably doesn't matter to you!

The side effects of statins seem to be related to several factors, including the age of the patient, dosage, type of statin, and duration of treatment. Some statins are far more powerful and therefore, I suspect, more likely to cause side effects than others.

To me, there seems to be three groups of statin patients. The first group includes the people who take the drug without any apparent side effects. The second group includes people who use statins but are developing side effects. Then there is the third group that took statins, had problems and stopped taking the medication.

If you are in the first group of patients and are tolerating your statin medication, please be aware of the possible side effects of the drug. They are listed in very fine print on the manufacturer's information sheet. If you are taking the drug and are developing unusual symptoms, consider the possibility that the problems may be related to your medication and know that the symptoms are likely to continue as long as you take the drug. For those of you who already experienced problems with the medication and stopped taking it, try to be patient. The more severe your symptoms, the longer it seems to take to recover.

Doug Peterson

Tahoe City



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