FDA halts promotion of vioxx

House of Cards

Here’s an interesting quote from the HSI archives:

“The FDA has ordered Merck to halt all promotion of Vioxx
because the ads minimize the popular drug’s safety risks –
particularly a startling increased risk of heart attack.”

That quote comes from an e-Alert I sent you more than three
years ago. No, that’s not a typo: THREE years.

On the heels of a 2001 study that showed certain Vioxx users
might have a sharply increased risk of heart attack, the FDA
had just ordered Merck – the maker of Vioxx – to stop
advertising the drug without a proper warning. Almost
exactly three years later Merck pulled Vioxx from the
market, admitting that the risk of heart attacks was

Sound familiar? Last week, Pfizer representatives announced
that they would stop advertising Celebrex on the heels of a
study indicating that the drug may increase heart attack risk.

Somehow I have a feeling that Celebrex isn’t going to hang
in there for another three years.

Arranging deck chairs on the Titanic

If you’ve been following the news (and how could you avoid
it?) you know that the roof is caving in for this class of drugs
(COX-2 inhibitors) that millions of people have been using to
manage pain associated with arthritis.

But Merck and Pfizer aren’t the only giants taking a hit. Last
week, over-the-counter painkiller naproxen (the brand name
is Aleve) got caught in the crossfire when a study that
compared Aleve to Celebrex was halted, citing evidence that
Aleve may also trigger heart attacks and strokes.

Meanwhile, FDA officials are trying to carry on as if this
were all business as usual. But I can’t recall a time when
they’ve appeared quite so flat-footed in their feeble defense
of the agency’s review procedures.

On the Today show last week (it was a busy week!), Dr.
Lester Crawford – the FDA’s longtime acting commissioner
said, “We probably need a new generation of these kinds of

I guess he’s imagining some sort of “New and Improved!”
COX-2 inhibitors.

Well Let us know how that goes for you, Dr. C. In the
meantime, people who are in pain need safe alternatives now.

A little needling

You might wonder if I’m enjoying a “told you so” moment,
but that’s not the case at all. For HSI members, nothing has
changed really. We’ve known for years that COX-2
inhibitors and nonsteroidal anti-inflammatory drugs
(NSAIDs) like Aleve posed a variety of unhealthy side

So while TV network news anchors wring their hands over
consumer confusion and frustration, we continue to look for
effective arthritis and osteoarthritis treatments that aren’t

For instance, in an issue of the Annals of Internal Medicine
published just last week, researchers at University of
Maryland School of Medicine reported on a study of 570
subjects with knee osteoarthritis. All the subjects were over
the age of 50, and all reported “significant pain.”

Divided into three groups, subjects received acupuncture
treatment, “placebo” acupuncture (where fake points were
used), or general instructions on how to manage pain. At the
end of the 14-week trial period, subjects in the acupuncture
group reported a 40 percent reduction in pain compared to
the other two groups. The acupuncture subjects also had a
significant improvement in knee mobility and function.

Side effects? None.

Plenty of options

But maybe you aren’t a fan of needles. No problem. In the e-
Alert “Sir2, With Love” (4/8/03), I told you about an anti-
inflammatory nutrient called nicotinamide (a derivative of
niacin – also known as vitamin B3).

When researchers at the National Institutes of Health
compared the effects of nicotinamide to placebo, the arthritis
patients who received nicotinamide supplements improved
by almost 30 percent in a variety of areas, such as arthritis
impact and pain, as well as joint range of motion and
flexibility. In these same areas, the placebo group
deteriorated by 10 percent during the 12-week study.

And in the e-Alert “Tremors & Aftershocks” (10/18/04), I
told you about a study in which cod liver oil was shown to be
very effective in reducing the amount of enzymes that are
known to trigger the cartilage damage typical of

Over the years, HSI has written about many natural arthritis
therapies. In the June 2001 HSI Members Alert, we told you
about the topical deep-tissue oil “Pain Away,” a formula that
combines 10 proven painkillers. In July 2000, we covered
Ayurvedic herbal formulas like Boswellia, an anti-
inflammatory. And in a 2001 e-Alert, I told you about
Lyprinol, a natural remedy proven to inhibit one of the
biochemical pathways required for inflammatory response.

So there’s no need for consumers to be frustrated or
confused. If they’re willing to venture off the path of
mainstream medicine they’ll find natural treatments that can
be effective without endangering their lives.

and another thing

It seems there is no end to questions about vitamin C.

In an HSI Forum thread titled “Vitamin C for Constipation,”
a member named Dan notes that very large doses of vitamin
C can loosen the bowels. His question: “Why not use ‘large’
doses (let’s say 2-3 grams at a time) of Vitamin C to relieve
constipation? I have never heard anything bad about taking a
lot of vitamin C, and it must be better for you than Ex-Lax
and the other OTC stuff. Any thoughts?”

Yes there are. Here’s a thought from a member named
Marilyn: “It is a common practice in Europe to use vitamin C
to relieve constipation! And as you said much better than the
chemical way.”

In previous e-Alerts, HSI Panelist Allan Spreen, M.D., has
told us how vitamin C should only be taken to “bowel
tolerance.” But is it safe to purposely exceed bowel
tolerance? When I put this question to Dr. Spreen he
confirmed that vitamin C has been used as constipation relief
for years. In fact, it’s an excellent (and fast) bowel cleanse if
the dosage is high enough and is taken for several hours in
order to fully flush the bowel. And as a bonus, the vitamin C
also has a detoxifying effect.

If there’s a downside, it’s this: You need to take quite a large

Dr. Spreen: “Just 2-3 grams won’t do it, in my experience, for
a patient with bad constipation. It can, in fact, require 2-3
grams of C PER HOUR for several hours to get the job done.
If you’re ill with other maladies the dose can go up, while for
a healthy person (who maybe just overdid the low-
fiber refined pasta, bread, and cakes for too long) the dose
may be far lower before loosening the stools.

“Perhaps an easier solution (though not taking advantage of
the other benefits of vitamin C) would be the use of
magnesium supplements. This nutrient is the closest thing to
‘dial-a-stool’ I’ve ever seen, as some amount taken at bedtime
will cause a normal movement in the morning. I usually start
with 500 milligrams orally (any type), and keep increasing
the amount each night until the desired effect is reached.”

For those who try the vitamin C method, Dr. Spreen has one
more note: Things can get a little “breezy.” He writes, “The
gas it generates before loosening the stools can really get
your attention.”

A small price to pay to get things moving again.

To Your Good Health,

Jenny Thompson
Health Sciences Institute