From TUMS® to Tragedy
In 2000, through a series of mergers, GlaxoSmithKline acquired TUMS. I can almost
hear the boardroom discussion.
CEO: Well, gentlemen, TUMS is a good brand. Makes us a couple hundred million a
year, but, I’m sure we can do better
. Any ideas?
Joe: Problem is that “heartburn” is not something that people take very seriously.
They only use TUMS when they need it.
Harry: Not true. Our promotion to medical organizations has paid off big time. All
over the world, doctors are recomm
ending TUMS as an effective calcium
supplement to be taken every day.
Chief Scientific Officer: What? Are you kidding me? You marketing fellows have gone
too far. Do you know that we have absolutely no evidence that TUMS can support
, or provi
de any benefit at all outside the stomach?
Harry: What are you talking about? The product is made of sugar and calcium!
CSO: And it’s an antacid, for crying out loud! I
n order for calcium to be absorbed, it
has to be ionized by stomach acid.
icky picky. You scientists just don’t get it. We’re selling close to 40 billion
bottles of this product a year. I don’t hear any complaints from the sales group.
VP Sales: No, we’re actually delighted. But we have an even better idea. Let’s create a
ier name for heartburn, and make a prescription drug to treat it. When fluid
comes up from the stomach into the esophagus, it’s called reflux. What about Gastric
VP Marketing. Not scary enough.
CSO. Well, technically speaking, it is gastro
VP Marketing: Add the word DISEASE and you’ve got it. Gastro
CSO. Well, it’s not really a disease; more of a condition or process.
VP Marketing: Nope, we’re going with Gastro
-esophageal Reflux Diseas
e. GERD for
short. Why didn’t we think of this before? Doctors love an easy fix for a disease, and
there are millions of people with heartburn I mean GERD.
And thus Tagamet® was born, followed by Zantac® and Pepcid®. These H2
receptor blocker went beyond the acid
-neutralizing effect of TUMS to actually
suppress acid production by the stomach. And they worked quite well.
Until other drug companies, who missed the blockbuster market for H2 blockers,
upped the ante. If H2 r
stomach acid production, by golly,
there must be a way to stop it altogether.
Thus Prilosec, Prevacid
, Protonix and Nexium were born. These are proton pump
inhibitors (PPIs) that directly affect the ability of the stomach to prod
hydrochloric acid. Since they were more powerful than the H2 blockers, and
promoted with the most extravagant advertising campaign in pharma history,
doctors wrote millions of prescriptions in the first year. By 2005, sales topped $13.9
billion in the US alone.
Worldwide, these drugs now account for more than $25
billion in annual sales.
No one is going to deny the value of these drugs in acute care – for the treatment of
ulcer or serious reflux disease, but the vast majority of sales fall into the
inappropriate use category. This includes people who were prescribed a PPI for
-term use, but were never taken off the drug, as well as millions of people who
-medicate with over
-counter PPI’s. Prilosec (Omeprazole) and Nexium (are
vailable without a prescription.
Costco now has their own brand of Omeprazole. Disount coupons are available on
line. Prilosec was buy one get one free at a local drug store last month.
THIS is a
, and except for a few editorials in GI jour
nals, no one is talking
So lets talk about it.
Antacids like TUMS and Rolaids™ act by neutralizing stomach acid to a small but
significant degree. H2 receptor blockers like cimetidine (Tagamet™) raise the pH of
the stomach from 1
to maybe 2. PPIs can increase the pH of the stomach from 1 to 5.
And your science teacher will explain why that is more dramatic than it appears.
You see, pH is a logarithmic scale, where each unit represents an order of magnitude.
This means that PPI’s basically (excuse the pun) stop acid production altogether.
The Side Effects
Your stomach secretes hydrochloric acid for a very good reason. Actu
ally, a number
of very good reasons. Stomach acid activates pepsin, an important digestive enzyme.
Without pepsin, protein digestion is serious
ly impaired. Calcium and other minerals
must be ionized by stomach acid in order to be absorbed. Thus PPI use is associated
with increased risk for osteoporosis and fractures. The absorption of vitamin B12 is
in the absence of HCL.
PPI’s can affect the absorption and metabolism of a raft of prescription drugs.
Manufactuers simply say: “May interfere with drugs for which gastric pH affects
bioavailability;” which is good information for your doctor, but how is the average
Walgreens shopper going to figure that out?
Remember, the average 65 year old in
America uses six Rx drugs in a year, many concurrently. PPI’s can d
absorption of some meds and
increase blood levels
digoxin, a drug
commonly prescribed for heart disease, this increases risk for a serious adverse
PPI’s decrease the activity
of Clopidogrel (Plavix™), a common blood thinner. So
think about this: Millions of people take Plavix or the generic version
every day to
prevent a heart attack or stroke. But even a slightly increased dose of their PPI (like
some people would take on Thanksgiving) can completely inactivate this drug.
Then there’s the infec
. One of the principle functions of stomach acid is
to destroy microbes that accompany our much of our food. So it was only a short
time before it was apparent that people using PPI’s were more prone to gastric
infections, including clostridium C
lostridium difficile (C. diff) a bacterium capable of
causing serious illness or death
There’s more. Even perfectly healthy people can aspirate small amounts of fluid
from the stomach into their airways. This commonly happens at night when we are
down. Recent research suggests that, in addition to C.diff, the bacteria that
cause pneumonia also find a happy home in stomachs of people using PPIs, which
this accounts for the increased risk for pneumonia in this population.
The main point
The likelihood of serious adverse effects increases the longer you take a PPI. Thus
-mandated prescribing information states clearly that the drugs are only to
be used for 14 days. This is insane for three reasons.
A. GERD is r
arely a self
-limiting disorder, without significant diet and lifestyle
B. When patients stop their PPI, they experience a wicked side effect known as acid
rebound that often sends them to the ER, where the standard of care is….
Thus everyone (the drug companies, conventional doctors, pharmacies and
) are participating in an irrational vicious cycle with no apparent solution.
To the average Joe, all the ads lead to one conclusion: “H
ey, if these drugs work so
well that I can wash my pizza down with a six pack of beer and not even burp, why
not get 24 hour “protection” with timed release Nexium
also available without
If you think I’m being too cynical, the Nexium OTC website site actually states:
m® 24HR works by blocking acid directly at the source,
complete protection from frequent heartburn – no matter what triggers it.
Of course at the bottom of the page, it states:
Use as directed for 14 days to treat frequent heartburn. Do not take for more
than 14 days or more often than every 4 months unless directed by a doctor.
Not for immediate relief.
” by whom?
door neighbor? An ad on TV or the discount
coupon you got in the mail?
This “advice” is coming from everywhere.
Harvard Health Newsletter
“If your symptoms are typical for gastroesophageal reflux (GERD, or simply,
reflux), the first step is usually to try a medication such as omeprazole
(Prilosec) or lansoprazole (Prevacid).”
I would argue th
at powerful drugs with common side effects are NOT the first step,
and I wonder when this formerly useful publication became the Harvard Drug Letter.
The first step, backed by published biomedical literature, is:
A. Diet and lifestyle changes:
Avoid overeating. Eat slowly. Chew well. No eating
on the run; especially not while driving. No food after 7:00 PM.
B. Aloe Vera, probiotics
and possibly digestive enzyme supplements.
Understanding the U.S.
commercial pharmaceutical supply chain. http://www.kff.org/
report.pdf. Published March 2005.
Joel J. Heidelbaugh, Andrea H. Kim, Robert Chang, and
Paul C. Walker.
Overutilization of proton-
pump inhibitors: what the clinician needs to know. Therap
Adv Gastroenterol. Jul 2012; 5(4): 219–
232. doi: 10.1177/1756283X12437358
In vitro activity of Aloe vera inner gel against Helicobacter pylori strains.
Cellini L, Di Bartolomeo S, Di Campli E, Genovese S, Locatelli M, Di Giulio M.
Lett Appl Microbiol. 2014 Jul;59(1):43-
8. doi: 10.1111/lam.12241.
The effect of Aloe vera A. Berger (Liliaceae) on gastric acid secretion and acute
gastric mucosal injury in rats. Yusuf S, Agunu A, Diana M.
J Ethnopharmacol. 2004 Jul;93(1):33
Hamman JH. Composition and applications of Aloe vera leaf gel. Molecules. 2008
From Tums to Tragedy Part 2
Now comes confirming evidence that PPI’s increase risk for heart attack
even in people with no other cardiac risk factors. The study
should sound a
serious alarm throughout the public health arena. But it probably won’t.
Worldwide sales of the
top PPI’s this year will top $4
2 billion dollars.
Here’s the problem:
PPI’s inhibit the production of hydrochloric acid by the stomach. Stomach
acid activates pepsin, an important digestive enzyme. Without pepsin,
is seriously impaired.
Calcium and other minerals must be
ionized by stomach acid in order to be absorbed. Thus PPI use is associated
with increased risk for osteoporosis and fractures. The absorption of vitamin
B12 is also reduced in the absence of HCL.
PPI’s can affect the absorption and metabolism of a raft of prescription
drugs. Manufacturers simply say: “May interfere with drugs for which
gastric pH affects bioavailability;” which is good information for your
doctor, but how is the average Walgreens
shopper going to figure that out?
Remember, the average 65 year old in America uses six Rx drugs in a year,
many concurrently. PPI’s can decrease the absorption of some meds and
increase blood levels of others. With digoxin, a drug commonly prescribed
heart disease, this increases risk for a serious adverse effect including
PPI’s decrease the activity of Clopidogrel (Plavix™), a common blood
thinner. So think about this: Millions of people take Plavix or the generic
on every day to prevent a heart attack or stroke. But even a slightly
increased dose of their PPI (like some people would take on Thanksgiving)
can completely inactivate this drug.
And, as I mentioned, this new study found increased incidence of heart
att ack even in people with no other risk factors.
Here’sthe citation and link:
Proton Pump Inhibitor Usage and the Risk of MyocardialInfarction in
the General Population
Nigam H. Shah et al. June 10,2015DOI: 10.1371/journal.pone.0124653
For Health Care Professionals: An excellent overview entitled
Overutilization of Proton
-pumpInhibitors: What the Clinician Needs to
Know, can be found her
Citation: Therap Adv Gastroenterol.2012 Jul; 5(4): 219–