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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serious side-effects from GlaxoSmithKline's withdrawn Lotronex,
for
bowel disorder. 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 Lotroxex was withdrawn in November 2001,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 clearly known in
advance. Murder is defined as "intentional or premeditated
killing." How exactly 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
disorder. 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 Irritable
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
Irritable Bowel Syndrome Association. Do they accept
pharma funding? You bet!
 An
advert on the association's website clicks through to the Novartis
IBSVillage
--which offers to handhold you while it
lines you up for bowel drugs.
Over fifty different prescription drugs are detailed on these
groups' websites, 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 the research. The IBS Support Group
bulletin board canvassed members to take part in the survey. Given
the group's support for Lotronex, that can hardly have resulted
in a balanced survey enrollment.
DrugVoice told the FDA they had 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 symptoms.
 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. Their
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 ischemic colitis side-effects from the existing bowel
disorder 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 some time, the
initial reduction in the dose of Lotronex is a hollow precaution.
Under the latest recommendations, new users of the drug may be
upped --after only one month-- to the full strength dose which
led to fatalities. And, we already know that prescribing practice
with Lotronex often means long term use of this supposedly short
term drug.
Tighter guidelines from the FDA would have protected the vulnerable,
but would also have financial implications for the manufacturer.
Instead, the demands of those who found Lotronex beneficial are
being used to protect profits. As a result, many will be placed
at risk. Predictably, some will end up disabled. Some will die.
Pharmaceutical companies continue unabashed to finance drug advocacy
groups that serve pharmaceutical industry objectives. Tonight,
they will wine and dine yet more doctors --illuminating their
often toxic drugs with a rosy after-dinner glow.
Tomorrow, the avoidable deaths of patients will continue. As
ever, steadily on the increase. How much more of this can the
American public continue to stomach?
 SickofDoctors.com
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