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 RETURN
OF THE KILLER BOWEL DRUG
Thirteen people are dead, many are disabled and thousands suffered
serious side-effects from GlaxoSmithKline's withdrawn Lotronex drug
for bowel disease. But the FDA is about to reintroduce the drug.
by Fintan Dunne,
Editor
SickofDoctors.com
25th April 2002
 Almost
a year ago today, in April 2001, GlaxoSmithKline treated some 60
doctors and guests to a four-course dinner at an exclusive Boston
restaurant. Beginning with cocktails and hors d'oeuvres, moving on to
tenderloin and lobster. Later, a Glaxo researcher lectured on Glaxo's
Imitrex migraine drug. The speaker skipped lightly over data on side
effects, which warns of fatalities. Just another
typical evening of drug marketing.
As those well-fed doctors relaxed to digest their meal, all across the
USA on that April night, women were writhing in agony from the
intestinal side-effects of Lotronex --a Glaxo bowel drug. Many were
soon dead. Lotroxex was withdrawn in November 2001, with some saying
it should never have been approved in the first place.
Remember the last Terminator movie? In one unforgettable scene, Arnold
Schwarzenegger shattered his his robotic adversary into a thousand
frozen pieces. Incredibly, the android slowly reassembled itself. Heat
from a furnace melted the pieces. They coalesced to form a quicksilver
pool. Within minutes the malleable robot was back in business.
 Just as GlaxoSmithKline is
effectively back in business with the bowel drug that killed up to
thirteen women and disabled many more. Those deaths all but ended
Lotronex's potential, according to analysts quoted in the Financial
Times late last year. But, like in the movie -you just can't keep a
bad thing down. Following a recent FDA advisory panel meeting,
Lotronex is set to come back. Warn your daughters.
Yes, I really mean warn your daughters. Because Lotronex is not
advocated for males. Strangely, it seems only to be "effective" in
women with Irritable Bowel Syndrome(IBS). While you digest the subtle
implications of that, let's recall exactly what your daughters have to
fear.
Soon after the launch of Lotronex(alosetron hydrochloride), reports of
side effects such as severe constipation and ischaemic colitis, a
restriction of blood flow to the colon, began to surface. A May 2001
editorial in The Lancet slammed the FDA, maintaining these serious
side effects were evident during the pre-approval process.
The Lancet said scientists within the FDA who raised concerns about
the drug were sidelined and excluded from future discussions. An
independent review of research found serious flaws. Yet the FDA had
allowed the product on the market. "The decision was to prove fatal,''
said Lancet editor Richard Horton.
Fatal for probably thirteen unfortunate women. Death from intestinal
failure is not pleasant. Let me apologize to the bereaved families for
having to point that out. This is a deadly serious reality. The
potential for fatalities from Lotronex was already known. Murder is
defined as "intentional or premeditated killing." How does Glaxo
manage to literally get away with murder?
THE JEFFREY FACTOR
 GlaxoSmithKline
should honor Jeffrey D. Roberts with some kind of award. If it wasn't
for Jeffrey, Lotronex would now be consigned to history's dustbin of
failed drugs. He founded the
Lotronex Action Group which pleaded at the recent FDA review
meeting --successfully it now seems-- for the return of Lotronex.
Members of the group gave persuasive, emotional testimony about how
indispensable and beneficial Lotronex had been for their bowel
disease. The group received no funding from any pharmaceutical source.
Their campaign was organized around a free Geocities website with
pop-up advertising banners. All of which makes the group look like a
down-home grassroots movement.
But appearances can be deceptive. Turns out that the Lotronex Action
Group is an offshoot of the
Irritatible Bowel
Syndrome Support Group, which was founded back in 1987 by the same
Jeffrey D. Roberts. That organization does accept pharmaceutical
funding. They also charge pharmaceutical companies up to $1,500/month
for drug advertising spots on their well-trafficed
website.
Both these groups are closely linked to yet another Jeffrey D. Roberts
vehicle: The
Irritatible Bowel Syndrome Association. Do they accept pharma
funding? You bet!
 An advert on the association's
website clicks through to the Novartis 'IBSVillage.com" irritable
bowel site --which offers to handhold you while it lines you up for
bowel drugs.
Over fifty different prescription drugs are detailed on this website,
many of which have serious side-effects. Yet alternative and
complimentary medicine approaches get little mention. Try acupuncture
or peppermint tablets, is the sparse advice.
At the April 23rd, 2002 FDA advisory panel meeting, Lotronex Action
Group and the IBS Support Group were joined in their entreaties by
DrugVoice.
This for-profit consumer research and strategic advisory company, in
their own words: "obtains revenue from health care companies
interested in the consumer insights we provide." Quite so.
DrugVoice conducted research with over 2,000 IBS patients, many of who
were former Lotronex users. DrugVoice offered prizes to the patients
who took part in it's research. The IBS Support Group canvassed it's
members to take part in the survey. Given their support for Lotronex,
that can hardly have resulted in a balanced survey enrollment.
DrugVoice told the FDA they concluded that an important need for
Lotronex exists, albeit with careful monitoring.
Lotronex Action Group and the IBS Association told the FDA that
Lotronex is safe if dispensed properly, with benefits far outweighing
the potential risk for adverse side affects. Funnily enough,
GlaxoSmithKline also told the FDA that Lotronex is safe if dispensed
properly, with benefits far outweighing the potential risk for adverse
side affects. Given the FDA's previous approval of Lotronex, you can
see what a cozy little party this meeting would have been without the
dissenting voices that spoke of the other side of Lotronex.
HOLLOW PRECAUTIONS
Ann DuPre Royall was in the clinical trial of Lotronex. "I
developed severe pain from constipation [and] nausea and I was doubled
over in pain on the bathroom floor," Royall wrote. "I was taken to
[the hospital] where I spent two days. It left me so weak that it has
taken me two years to feel better. ... Please do not give in to
GlaxoSmithKline's request to reintroduce this horrible drug."
Public Citizen --the consumer advocacy organization whose complaints
led to the withdrawal of Lotronex-- were also scathing in their
testimony to the panel.
Their analysis of the drug trials showed that at the reduced
dosage, Lotronex was no more effective than placebo. They called for
restricted prescribing, patient registration, and exclusion of anyone
without debilitating disease.
 Sidney M. Wolfe M.D.
Director, Public Citizen's Health Research Group told the panel that:
"the risk of ischemic colitis coupled with the marginal benefit beyond
that seen with a placebo alone --results in a risk benefit ratio
clearly unfavorable to patients...[and] likely, if not certain, to
result in the need to ban the drug again."
The FDA panel recommended that Lotronex be approved. The
caveats include that only severely affected patients with confirmed
diagnosis, and no effective alternative, should be medicated. They
also determined that the dosage of the drug should be halved for at
least the first month of use. The recommendation is not binding, but
the FDA invariably follows such advice.
"At this point, I can't say for sure whether this drug will come back
or not," Victor Raczkowski, MD, the FDA's deputy chief of
gastrointestinal drugs,
told WebMD. He admitted that identifying patients in danger of
suffering serious adverse events was going to be impossible.
"...There are no risk factors to identify what patients may be at risk
for these events," Raczkowski said. A telling admission.
 That is precisely the
problem with Lotronex. It is very difficult to tell apart ulcerative
collitis side-effects from the existing bowel disease the patient has
already. And ischemic colitis often has no warning symptoms before
causing damage that can require surgical intervention or cause
permanent disability.
Furthermore, as side-effects may not appear for up to 24 weeks, the
initial reduction of the dosage of Lotronex is a hollow precaution.
Under the recommendations, new users of the drug may be upgraded after
only one month to the full strength dose which caused the original
fatalities.
Pharmaceutical companies continue unabashed to finance drug advocacy
groups that serve pharmaceutical objectives. Tonight, they will wine
and dine more doctors --illuminating their often toxic drugs with a
rosy after-dinner glow.
Tomorrow, the avoidable deaths of patients will continue to
steadily increase. How much more of this can the American public
continue to stomach?
SickofDoctors.com
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