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January 29, 2004 LIFE AFTER LIPITOR: Is Pfizer product a
quick fix or dangerous drug? Residents experience
adverse reactions
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 expect to top $10 billion this year, Lipitor is
poised to become the largest-selling pharmaceutical in
history, surpassing
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."
For more information, contact Doug Peterson at
[email hidden] or visit Drug Information Technologies at
www.ditonline.com.