OPINION PAGE

WHAT'S NEW
IN MEDICINE?

There is a revolution going on in
medicine.

There is an ocean of new ideas
and experiments is practically
every field of human health. But
as always, only a minuscule
percentage will ever turn out to
be workable. Which ones?
Nobody knows. The road to
success through clinical trials is
long, hard, treacherous and
expensive.

We can no longer depend solely
on our doctor to keep up with
the latest. If and when, God
forbid, we have to make a life
and death decision for ourselves
or for a relative, the time is too
short and the pressure is too
great to review the possibilities
in a hurry.

We better get ready in time by
constantly perusing medical
innovations of all kinds.

This site, along with many
others on the internet, is aimed
to help with this. It continuously
lists medical innovation news in
a brief, simple, concise manner
that does not require too much
time to keep up with and too
deep a background to
understand it. The items are
listed in alphabetical order by
medical problems for easier
access.

If you have any ideas or
suggestions for improvements,
please write to us:

medfrontiers@gmail.com

_____________________


THE RISING
COST OF
CANCER CARE
Until recently, almost all cancer
drugs were administered
intravenously. Today, about a
quarter of them can be given orally,
which means fewer visits to the
doctor.

But pills are often more expensive,
have higher co-payments, and are
reimbursed by insurers at lower
rates than IV drugs.

Patients with co-payments of more
than $500 were four times more
likely to abandon treatment than
those with co-payments of $100 or
less,  a study shows. Claims with the
highest co-payments had a 25
percent abandonment rate,
compared with 6 percent for co-
payments of less than $100.


If prices of drugs are set so
outrageously high there is going to
be a problem with cancer care.

For patients even with health
insurance in the US, out-of-pocket
expenses averaged $712 per month
for co-payments for doctor visits,
prescription drugs, lost wages,
travel to appointments and other
expenses.



The new chemotherapy drug
vemurafenib  shows promise in
treating malignant melanoma. But
the cost is expected to be quite high.


This  raises questions about the
drug's real-world impact.

The clinical trials  found that
vemurafenib reduced the risk of
death by 63% over six months
compared with a standard treatment.

That sounds impressive, but it's
impossible to predict how much time
patients really bought themselves. A
few patients may enjoy a few extra
years of life thanks to the drug, but
they will likely be the exception, not
the rule. "This is not the
breakthrough that we really need
for this population," a doctor says.
"There's been a lot of hype in the
news, but this is not a home run. It's
a really solid single."



An expensive single, at that.
Vemurafenib will likely cost tens of
thousands of dollars per year. It is
estimated at $50,000.

Earlier in 2011, the Food and Drug
Administration approved Yervoy
(ipilmumab), the first new melanoma
drug in 13 years.  A biologically
engineered drug designed to help
the immune system attack cancer
cells, Yervoy has been shown to add
a couple of months to the typical
patient's life. The price for that
extra time: About $120,000 for a
treatment.

As doctors understand more about
melanoma, they may find that
certain patients need both
vemurafenib and Yervoy or some
other pricey combo. It is expected
that vemurfamenib will be covered
by insurance, but of course not
everyone has such a luxury. For
many, a cancer diagnosis is a
gateway to bankruptcy or poverty.


Cancer is one of the costliest
diseases to treat, largely because
many patients are treated over a
long term, often with expensive new
drugs that are complicated to
produce and not available in
generic form. And as insurance
companies cut all benefits,
reimbursements on cancer
treatments have also declined.


When it's an expensive drug, we
have to have the hard discussion
about a very substantial out-of-
pocket payment. 'Do you want to
spend this money for an average
improvement of just a few months of
life?' Doctors are  very
uncomfortable having those
discussions because they want to
focus on the patient getting better.

_______________________


Doctors, when become
patients themselves,
don't always take their
own advice

When doctors step into their
patients' shoes, their treatment
decisions don't always line up
with the advice they give in their
clinics, a U.S. survey says.

Faced with hypothetical
treatment scenarios, when they
imagined themselves as the sick
person, doctors more often
chose therapies that carried a
higher risk of death but fewer
severe side effects, said the
survey, in the Archives of
Internal Medicine.

"I don't think any patient would
expect that. If they found out,
they would raise a lot of
questions," said Peter Ubel, at
Duke University, who led the
research.

"It has nothing to do with moral.
It has everything to do with
human nature. The doctors don't
even know they are behaving
this way."

In the survey, two sets of
questions were sent to primary
care physicians around the
United States. One set asked
about different types of
hypothetical colon cancer
surgery and another about a
treatment for bird flu.

The doctors received either a
survey that asked them to
assume they were the patient, or
one that asked them about their
advice for patients.

Of 242 physicians who
answered the colon cancer
questionnaire, 38 percent went
with the survey that carried a
higher risk of death but fewer
side effects for themselves. By
contrast, only a quarter said they
would recommend that
treatment to their patients.

READ MORE



___________________
How long must dying
patients wait for justice?


In a recent edition of the Wall Street
Journal, Gregory Conko, Director of
Food Safety Policy at the
Competitive Enterprise Institute, an
advocacy group based in
Washington DC, wrote an opinion
piece entitled, “Sick Patients Need
Cutting-Edge Drugs”.

The event that inspired this
passionate and demanding article
was the death of 13-year old Anna
Tomalis. Anna battled a rare form of
liver cancer called embryonal
sarcoma since September 2005. On
August 15, 2008, she lost that battle.

At first, surgery and chemotherapy
appeared to have worked for Anna.
But in March of this year, her
cancer recurred. With a little hard
work and research, Anna’s family
discovered an experimental drug
developed jointly by Ariad and
Merck called Deforolimus.

Anna was too sick and too young to
be admitted into the clinical trial,
but she fought to gain access to the
drug on a “compassionate-use”
basis. She and her family fought for
months.

READ MORE





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Common-Sense Medicine:
Will medical studies of
dubious validity decide
whether you get life-
saving treatment?

For lung experts everywhere, there
has never been much controversy
about smoking and lung cancer. If
patients stop smoking, their risk of
lung cancer drops dramatically. If
they don’t, our best chance to save
them is to detect the cancer early;
one study shows a 60 percent
chance of a surgical cure when
lung cancer is found at an early
stage.

The best test we have to screen
smokers is the spiral CT scan. This
uses computer-generated images to
examine the lungs from different
angles; studies have long shown
that a chest x-ray alone is
ineffective. But in the spirit of
regulatory medical practice, a
controversy has existed about
whether scanning the lung actually
prolongs life. Back in 2007, two
studies, one published in the New
England Journal of Medicine and
the other in the Journal of the
American Medical Association, came
to opposite conclusions on this
question.

Between 2007 and now,
pulmonologists have continued to
order the test, while insurance
companies have continued not to
pay for it, pointing to its expense
and the inconclusive evidence that
it actually saves lives.

The absurd controversy over this
test was a harbinger of what is to
come under Obamacare. Page 1,617
of the Obamacare bill puts aside
$500 million or more per year for
“comparative effectiveness”
research, i.e., questionable studies
intended to show that one test or
treatment is better than another.
Never mind that these studies can
easily be misinterpreted, leading to
claims that a life-saving test is not
useful; under Obamacare, they will
be used to decide what the
government will and will not pay for.

To end the controversy over spiral
CT scan, a study was conducted by
the National Cancer Institute (at a
cost of $250 million, funded by
taxpayers). More than 50,000
smokers and former smokers were
followed for eight years; one group
was screened with chest x-ray, the
other with spiral CT scan. The
preliminary results have now
become available, and they show
that the CT scan reduced lung-
cancer deaths by 20 percent and
deaths from other causes by 7
percent. In other words, the study
came to the same conclusions that
most doctors (and patients) had
already come to on their own.

In the brave new world of
Obamacare, I fear that there will be
too much focus on using
insufficient evidence to try to deny
essential tests. Medicine is an art
when it is practiced properly; I need
the best tools possible to treat and
cure difficult cases. Lung cancer is
certainly no exception. With more
than 200,000 new cases every year
and more than 150,000 deaths (less
than a 15 percent five-year survival
rate — it’s the number-one cause of
cancer death), it is crucial to
discover a tumor as soon as
possible, before it escapes the lung.

So how will the absurdly expensive
NCI study affect the comparative-
effectiveness tribunals of
Obamacare? Will the Independent
Medicare Advisory Board (when it
gets started in 2014) continue to
deny this screening test based on
the claim that in the wrong doctor’s
hands it leads to too many biopsies
and surgeries? Or will this latest
study (known as the National Lung
Screening Trial) lead Medicare and
other insurance providers to pay for
it?
At a time of economic struggle, did
we really need $250 million in
taxpayer money to pay for what we
already knew?

As the Obamacare insurance
blanket stretches to cover millions
more people, more and more
either/or choices will be made. If
this useful, expensive screening
test for smokers is now covered as a
result of this study, which useful
MRI or PET scan will be denied as a
result?

— Marc Siegel, M.D., is an associate
professor of medicine


________________


Why Personalized
Medicine Is Bunk
...An ugly secret that the genetic
testing industry doesn't want you to
know is that we have virtually no
information about the relevance of
most genetic mutations.
We can sequence your entire
genome with reasonable accuracy
but we really don't know what to do
with the information we get. Most of
the information that we do have is
derived from correlation studies. For
example, if we compare patients
with colon cancer to those without
across the entire genome we can
find some genotypes that occur
more frequently in the cancer group
than in the non-cancer group. But if
you're a healthy person and your
test shows up with the "cancer"
genotype, does that mean you will
likely develop colon cancer? It's
impossible to know without
conducting a long-term clinical
study: follow 10,000 people with the
mutation in question for 20 years
and see if they get colon cancer at a
higher rate than people without the
mutation. With 3+ billion places the
genome might differ and thousands
of diseases to worry about, that's
more than three trillion clinical
trials we'd need to run in order to be
able to make good use of
information from the entire genome.
Is there anything of value we can
look forward to from the application
of genetic information to diagnosis
and treatment? Yes, but the reality
is a lot less sexy than the "right
drug for you" story that is being
hyped.

___________________


The Medical Revolution
Where are the cures promised by
stem cells, gene therapy, and the
human genome?

The disappointments are so acute in
part because the promises have
been so big. Over the past two
decades, we've been told that a new
age of molecular medicine—using
gene therapy, stem cells, and the
knowledge gleaned from unlocking
the human genome—would bring us
medical miracles. Just as antibiotics
conquered infectious diseases and
vaccines eliminated the scourges of
polio and smallpox, the ability to
manipulate our cells and genes is
supposed to vanquish everything
from terrible inherited disorders,
such as Huntington's and cystic
fibrosis, to widespread conditions
like cancer, diabetes, and heart
disease.
MORE...

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NEVER TRUST THE
PROMISES OF A
SCIENTIST

Taralyn Tan
Scientists around the globe want to
believe that their work will comprise
the "next big thing." Perhaps they
have their sights set on publication.
Perhaps they look to get their work
featured on the cover of a
prestigious scientific journal. Heck,
why not aim a bit higher and set
one's sights on the Nobel Prize?

Whatever incentives or goals
researchers dangle before
themselves, the fact of the matter is
that biomedical research is a slow
endeavor. A single breakthrough
comes at the expense of months and
years of failure (or, more
euphemistically, "troubleshooting").
Thus for a biomedical researcher, a
strong dose of optimism and a belief
that, "Hey, we're really onto
something good here!" are not just
useful things to have. They are
essential to one's survival.

So, it comes as no surprise to hear
that another over-eager scientist
waved his arms before a rapt
audience and spouted grandiose
hyperboles regarding his field of
research: stem cells. Earlier this
month, Dr. David Warburton of the
Saban Research Institute of the
Children's Hospital, Los Angeles,
declared, "In about 20 years' time
we will have stem cell banks just
like we now have pharmacies with
medicines in them. You'll get a
diagnosis for a specific problem and
be given stem cells to treat that
problem."

MORE...

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Use of Expert Testimony
Questioned in Malpractice

A new study calls to the stand the
legitimacy of expert witnesses,
those doctors and other medical
specialists hired by lawyers in
medical malpractice suits to
convince the jury that someone
somewhere goofed.

The study, published in the August
issue of the American Journal of
Roentgenology, implies that you get
what you pay for — which is a good
thing for malpractice lawyers, who
can hire those experts who deliver
the "right" answer or who benefit
from hindsight in their medical
interpretations.

For this study, a team of researchers
led by Richard Semelka, a professor
of radiology in the School of
Medicine at the University of North
Carolina at Chapel Hill, sent six CT
scans (of various parts of the body)
to 31 radiologists. Five of the CT
scans captured a range of injuries
seen in an emergency room, and
one CT scan of the spine was from a
lawsuit. The radiologists were
blinded to which scan was which,
and they were asked to interpret
them as they would in an emergency
room under normal working
circumstances.
Interpreting a CT scan can be a
subjective art; yet between 30 and
31 of the total 31 radiologists
subjectively came to the same,
independent conclusion that was
different from the paid expert
witnesses in that legal case — an
interpretation of the scan that was
indeed similar to what the sued
radiologist had concluded.

MORE...

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Hazardous WHO
Pandemic Hopes and
Dreams
Recombinomics
Commentary

The WHO has also been looking for
evidence that -- as is normal with
seasonal flu -- a variety of viruses
are circulating. For months after
H1N1's emergence, there was
virtually no sign of other influenza A
or influenza B viruses. Lately it's
been much more of a mixed picture.

"In a nutshell I'm looking for several
things," explains Chan, who
concedes most of these criteria
appear to have been satisfied.

"Lack of out-of-season outbreaks.
Reduced intensity of outbreaks. And
reduced dominance of the H1N1
pandemic virus and evidence of
some population immunity (to the
virus)."

Chan admits she's eager to move to
the post-pandemic phase so the
agency can focus on analyzing what
happened and incorporating the
knowledge gained into plans for
future pandemics.

The above suggest that WHO will
declare the end of the H1N1
pandemic today.  However, H1N1
does not read WHO press releases
or the hopes and dreams of
consultants.  The pandemic H1N1 is
a swine virus that has jumped to
humans, which has not happened in
a sustained manner since 1918.  
The similarities between the current
strain, and 1918 pandemic H1N1 or
seasonal H1N1 in circulation
decades ago has led to a reduced
infection rate among the elderly.  

However, the H1N1 virus can
aggressively target those under 65,
the demographic for over 90% of the
fatalities.  These fatal cases are
linked to the ability of the virus to
target the lower respiratory tract,
which has been linked to receptor
binding domain changes such as
D225G as well as low reactor
alterations at positions 157-159.  
Recently released 2010 sequence
has demonstrated that these genetic
changes are on the rise, raising
concerns for the emergence of a
more virulent H1N1 in the upcoming
months or years.

The acquisition of these new
markers via recombination has
similarities with the fixing of H274Y
in seasonal H1N1 in the 2008/2009
season.  H274Y confers Tamilfu
resistance and began to appear in
large numbers in seasonal H1N1 in
selective countries in the 2007/2008
season.  Although levels
approached or exceeded 50% of
H1N1 isolates in northern Europe,
the level was only 10% in countries
like the US and UK, while countries
in Asia, like South Korea had no
reported cases and the level was
only 3% in Japan, where use of
Tamiflu in seasonal flu patients was
widespread.  This distribution
surprised and baffled WHO
consultants, who maintained that
small changes in influenza genes
were due to random copy errors
which were amplified by selection.  
However, Tamiflu resistance in
Japan was low in H1N1 and there
was no reported resistance in H3N2
worldwide.  Moreover, all H1N1
resistance targeted the identical
genetic change, which was present
on multiple H1N1 genetic
backgrounds.

In the summer of 2008, H274Y levels
rose to 100% in H1N1 sequences in
South Africa and Australia.  
Although the overall levels of H1N1
were low, the fixing of H274Y in the
southern hemisphere in the summer
of 2008 spread to the northern
hemisphere in the 2008/2009 and
levels of 100% Tamiflu resistance
were reported worldwide, including
South Korea where the level was a
0% the previous year.

The potential for dramatic increases
in D225G and low reactor changes
at positions 157-159 remain and the
current pandemic H1N1 continues to
fatally infect those under 65,  WHO
hopes and dreams and associated
proclamations notwithstanding.


_____________________


Control Group: Patients
Take Biomedical
Research into Their Own
Hands

In Cade's time and the 50 years that
followed patients would get their
information about drugs from their
doctors. But nowadays they can
read the same reports their doctors
do, contemporaneously. They find
them online and use social networks
to discuss them with other patients.
This phenomenon has been called
the "patient 2.0 movement," and it is
changing the way doctors and
scientists do their jobs.

Using forums like PatientsLikeMe
(an online patient community),
Facebook and Twitter, patients with
ALS, cancer and a range of other
conditions are turning biomedical
research—a process once mystified
by jargon, privacy, peer review and
expensive journal subscription
fees—into an open-source and
collaborative effort. Although the
movement is empowering patients, it
worries some doctors. "The Internet
is really good for sharing
information, but not so good for
verifying it," says Richard Bedlack,
director of Duke University Medical
Center's ALS clinic. The movement,
he says, promotes uncorroborated
results and opens the window for
fraud, giving medical con artists the
perfect platform to tout or sell bogus
treatments detailed in counterfeit
reports, uncritiqued by experts in
the field.

More...

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China Never Investigated
Tainted Heparin, Says
Probe

WASHINGTON—The Chinese
government didn't pursue an
investigation into contaminated
heparin sent to the U.S. in 2007 and
2008, despite repeated requests
from the U.S. for help, according to
a congressional probe.

More...

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The Sad Truth About
$100,000 Cancer Drugs

The media is full of tales about
miracle survivors of advanced
cancer or other terminal illness who
have failed every standard
treatment and are rescued by an
experimental biotech drug, heroic
surgeon, or exotic new medical
device. I've written plenty of these
stories.  Generally, they start with
an anecdote that plucks out the
best patient in a clinical trial and
describes their near miraculous
recovery. Then they go on to
describe hard-working researchers
at companies like Amgen or Pfizer or
Novartis who are racing to cure a
dire disease.

More...

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Scientists want to
diagnose Alzheimer’s
sooner. So what?

Alzheimer’s is what I like to call a
black hole disease.

We don’t know what cures it. We
don’t know what causes it. We don’t
even know for sure when we have
it. The only thing we do know for
certain is that you don’t want to get
it.

The pharmaceutical industry has
spent billions of dollars in creating a
cure only to come up empty handed.
As a result, there’s a growing
realization that the Alzheimer’s
pathology is much more complex
than we initially assumed: there may
be not just one single factor that
causes it nor a single point in time
when we contract it.

So researchers are trying to expand
the field.

MORE...

_______________

Big gun clinical trials
versus the intuitive leap
in new medical therapy
discovery…
This is a piece I wrote awhile back
on the differences between the two
new therapy discovery pathways in
medicine, thought it would make an
interesting post…
"In theory, there is no difference
between theory and practice. But in
practice, there is."
Sun Tzu
Medicine has two arms for new
therapy discovery, the pragmatic
medical practice arm and the
research based, theoretical arm.
These two pathways have both
yielded ground breaking
discoveries. For example, great
medical advances such as coronary
bypass surgery, in-vitro fertilization,
and modern joint surgery have all
been birthed by responsible
physician experimentation. The
research arm has provided such
breakthroughs as modern
antibiotics, anti-hypertensive drugs,
and joint replacements.


_______________

Doctors Skirt FDA To
Provide Human Stem Cell
Therapy
The FDA has yet to approve stem
cell therapies for general use in
medicine, but that hasn't stopped
doctors in Colorado from providing
them anyway. Chris Centeno and
John Schultz have boldly formed
Regenerative Sciences Inc. in
Broomfield, Colorado. RSI provides
its patients with the Regenexx
procedure, an adult stem cell
transplant that uses your own cells
(autologous) to treat joint injuries
and bone damage. There's no
surgery needed. A needle extracts
bone marrow, RSI isolates the stem
cells and cultures them in your own
blood, and then these cells are
injected into the area where they
are needed. They've treated 348+
patients with 800+ injections and
show no signs of slowing down.


________________

Unforseen side effects

Doctors have forgotten the dictum,
“First, do no harm.” All these
medications lead to unforeseen side
effects. Once again, the perceived
benefit may not be worth the real
risk.

“Drugs to Treat Adult Onset, Type 2
Diabetes

Avandia is one of a newer class of
drugs designed to lower the blood
sugar of adults whose blood sugar is
higher than is said to be good for
them.

As we age, our own insulin is less
effective in helping our blood sugar
enter our cells to provide an energy
source. Some of us have this
tendency earlier than others,
particularly if we have a big gut-to-
butt ratio and/or we’re poor.

This higher blood sugar and its
fellow-travelers (higher blood
pressure, higher cholesterol, and
lesser wealth) are associated with
earlier death, but only if any or all
are particularly severe.

For over 50 years medicine has
recruited the pharmaceutical
industry to smite each of these “risk
factors” a mighty blow in order to
spare us grief. Avandia is another
attempt to tackle persistently
elevated blood sugar.

It works. It lowers the blood sugar.
Furthermore, the earlier
generations of drugs designed to do
this also lower the blood sugar.
They work too.

However, no one feels better for a
lower blood sugar. Some feel worse
or get fatter depending on the drug.
And no one feels worse for a high
blood sugar, except for the rare
patient with adult onset type 2
diabetes who can mobilize an
extremely high blood sugar.

It’s like “high” blood pressure.

So Avandia does nothing for the
quality of your life. Does it do
something else — save your life, or
postpone the horrid complications
some patients can get with adult
onset type 2 diabetes and its fellow
travelers?

We don’t know for Avandia.
However the precedents are
daunting. Long-term experiments,
randomized controlled trials, with
earlier generations of drugs that
lower blood sugar are not
encouraging. One famous trial
lasted over a decade.

There is no precedent for any of
these drugs saving a life, a limb, an
eye, kidney or anything else
important. There is no demonstrable
benefit except the lowering of blood
sugar. Who cares?

I have practiced medicine for 40
years. I have never prescribed a pill
to lower blood sugar. I still see no
reason to do so. If I am
disadvantaging my patients, it’s to a
trivial degree at most. However, I
know I am sparing them known and
unknown hazards.

And I won’t let you measure my
blood sugar or the measure of its
persistent elevation, the hemoglobin
A1c. I don’t care, and I won’t care till
there is compelling science that
something meaningful can be done
if it is elevated.”
- Dr. Nortin Hadler, MD



________________________

Do Cholesterol Drugs Do
Any Good?
Research suggests that, except
among high-risk heart patients, the
benefits of statins such as Lipitor
are overstated
Martin Winn's cholesterol level was
inching up. Cycling up hills, he felt
chest pain that might have been
angina. So he and his doctor
decided he should be on a
cholesterol-lowering medication
called a statin. He was in good
company. Such drugs are the best-
selling medicines in history, used by
more than 13 million Americans and
an additional 12 million patients
around the world, producing $27.8
billion in sales in 2006. Half of that
went to Pfizer (PFE) for its leading
statin, Lipitor. Statins certainly
performed as they should for Winn,
dropping his cholesterol level by
20%. "I assumed I'd get a longer
life," says the retired machinist in
Vancouver, B.C., now 71. But here
the story takes a twist.


__________________


Never trust an expert!  
Ever wondered why so
much health advice is
contradictory? It's
because two-thirds of
medical research is
wrong or fraudulent

Have you been left confused by
expert health advice? Even people
like me, with years of experience in
science and medical journalism, are
left scratching our heads when
research is contradicted by other
studies or turns out to be wrong.

In early 2008, new guidelines for life-
saving emergency heart attack
treatment said you should no longer
bother with the 'mouth-to-mouth'
part of CPR (­cardiopulmonary
resuscitation). Instead, you should
pump the chest non-stop.

Having got my Red Cross certificate
some years ago, I wanted to know
more - but discovered that while
this change was endorsed by the
European Resuscitation Council,
the Red Cross still trains people to
give mouth-to-mouth.



________________

Code check with mobile
phone to check if a drug
is genuine or counterfeit

Sproxil, Inc.’s Mobile Product
AuthenticationTM (MPA) enables
consumers to text-message an item-
unique code for a rapid response
that confirms a brand’s
genuineness. In Nigeria, for
example, consumers purchase
medications with a scratch card
attached to the package. They then
scratch off the covering on the card
and text the unique numbers
underneath to a shortcode to
instantly receive a reply confirming
the genuineness or fakeness of the
product. A shortcode serves as a
“phone” number for receiving text
messages, or Short Message Service
(SMS), as they’re called. A shortcode
has five digits in Nigeria, compared
to 13 for a phone number (and 10
for a U.S. phone number). To date,
the company has coded more than
800,000 packages of Glucophage, a
product used to treat diabetes.



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