It�s hard to tell the difference between the new radio ads
for the McDonald�s breakfast menu and the �wakefulness� drug Nuvigil in Chicago
because they both begin with the sound of someone snoring and alarm clocks.
But whereas McDonald�s helps the morning lethargy with
economically-priced breakfast items, Nuvigil helps it with a drug that can cause �a serious
rash or a serious allergic reaction that may result in hospitalization or be
life-threatening,� also known as Stevens Johnson syndrome. SJS patients are
treated in burn units if they are lucky enough to survive.
You can thank pharma lobbying for the approval of a drug (armodafinil) in
the US that causes SJS as an �important treatment option� for conditions that
may not even exist like �excessive sleepiness� (ES) and �shift work sleep
disorder� (SWSD). You can also thank pharma lobbying for the watered down
warning which says, �may result in hospitalization or be life-threatening,�
instead of, �may result in hospitalization or death,� the way it was probably
In fact, the FDA rejected Nuvigil�s chemical cousin Provigil (modafinil)
in 2006 after testimony in advisory committee hearings revealed that up to 400
children were projected to die if it were approved for ADHD. Not get sick; die.
Cephalon�s Nuvigil has other perks besides the �rash, hives,
sores, swelling, or trouble swallowing or breathing� for which you need to �call
your doctor right away or get emergency treatment.� It also can cause �mania, delusions,
hallucinations, suicidal ideation and aggression, some resulting in
hospitalization� say company warnings and should be used with caution �in patients
with a history of psychosis, depression, or mania.�
And for those who think being hospitalized for SJS or a psychiatric
meltdown is still preferable to being drowsy at work, there is more bad news.
Nuvigil may not even work. It �may not stop your ES [excessive sleepiness]
completely,� says the prescribing information. Oops.
While pharma lobbying explains the parade of dangerous approved drugs,
sometimes withdrawn after being �tested� on the public (Vioxx still turned a
profit after the death settlements were paid) it doesn�t explain why people
want to dose themselves with iffy drugs and �ask their doctor� when told to. Is
it the Madeline syndrome in which a health problem means identity and
attention? A hobby; something to do? Is it the same dare devil impulse that
makes people send love letters to mass murderers like New York�s Son of Sam
David Berkowitz in prison?
Still for fans of high-priced, risky brand drugs their insurance
companies will pay for, raising everyone�s rates, there is also once-monthly
Boniva touted by actress Sally Field.
Boniva is a bisphosphonate bone drug, which pharma thought would replace
its other wonder drugs for women, hormone therapy until, like HT, they were
found to cause the very conditions they were supposed to ameliorate.
Since 2004, the New England Journal of Medicine, Annals of Internal
Medicine, the Journal of Clinical Endocrinology & Metabolism, the Journal
of Orthopedic Trauma and the journal Injury have all reported paradoxical
fractures and/or delayed healing linked to bisphosphonates. But who are you
going to listen to -- medical journals or Gidget? (Field is famous for her US
television roles of Gidget and The Flying Nun.)
And there are other perks to bisphosphonates besides broken bones.
According to last week�s British Medical Journal, �The risk for
esophageal cancer nearly doubled in patients given 10 or more prescriptions for
oral bisphosphonates, and the risk associated with the drugs increased over
time.� The FDA found similar �safety signals.�
No wonder the radio ads say not to take Boniva if you have difficult or
painful swallowing, chest pain or continuing or severe heartburn or you can�t
sit or stand for an hour. If you can�t, you risk erosive esophagitis,
inflammation, bleeding and perforation as the bisphosphonate pill tries to goes
down. (See: need for convenient once-a-month version.)
You also don�t want to take Boniva, say the ads, if you have low blood
calcium or severe kidney disease or if severe bone, joint and/or muscle pain
develops as other medical journals report is likely. In fact, the risks with
Boniva are so profound and varied, when Field says �You have only one body and
one life� at the end of the commercial, you expect her to say, �so don�t take
Martha Rosenberg is a Chicago
columnist/cartoonist who writes about public health. She may be reached at firstname.lastname@example.org.