How the Pharmaceutical Industry Profits from False Claims
and a Brand New Online Tool that Can Help You Get Better
Health Care
December 02, 2012
Story at-a-glance
Evidence shows drug companies frequently hide vital
information about their drugs in order to get it on the
market and keep it there
Nearly 40 years’ worth of research has yielded no evidence
whatsoever to support the hypothesis that depression is
caused by abnormalities in your serotonin system.
A common antidepressant, selective serotonin reuptake
inhibitors (SSRI’s) are a much less effective treatment for
clinical depression than is commonly thought. In fact, some
suggest it’s the drug’s action on the serotonin system that
might be responsible for the drugs’ ability to cause violent
and suicidal ideation
SSRI’s are strongly linked to suicidal behavior. Other side
effects less commonly known and/or discussed include
homicidal tendencies, birth defects, miscarriages, and
voluntary abortions due to the baby being diagnosed with a
birth defect
Although most drugs “work” in the sense that they have an
effect, many cause more harm than good.
Rxisk.org is a website designed to create a people’s
movement for safer drugs. One of the features on the site
will allow you to go through a series of questions that will
help you determine whether ailments you’re having are
associated with any of the drugs you’re taking. At the end,
you will get a report that you can then bring with you to
your prescribing doctor, to aid you in making a more
comprehensive risk versus benefit analysis
By Dr. Mercola
Pharmaceutical companies have kept the wool pulled over
Americans' eyes for many years, and had many convinced that they
were working fervently to develop safe medications that would
cure and prevent virtually every disease plaguing the world.
But these modern-day messiahs are not the saints they would
have you believe … not even close.
According to Dr. David Healy, who has had the opportunity to
investigate the circumstances behind the approval of certain
drugs at a level that very few others have been able to, drug
companies frequently hide vital information about their drugs in
order to get it on the market and keep it there.
The drug companies that manufacture some of the best-selling
drugs in the world have committed some of the greatest crimes
against human health, and all of them have at one point or
another been found guilty of criminal activity—some have been
nailed several times.
So much so that several pharmaceutical companies are on the
Top Corporate Criminals list. Yet we entrust our health, our
very lives, to these same corporate "personages" who cannot be
put in jail for cutting lives short, and who view billion dollar
fines as nothing more than the cost of doing business.
As recently as July 2,
GlaxoSmithKline plead guilty to three counts of criminal
misdemeanor and other civil liabilities relating to the
prescription drugs Paxil, Wellbutrin and Avandia, and agreed to
pay a total of $3 billion in fines.
In 2009
Pfizer was fined $2.3 billion to resolve criminal and civil
allegations that the company illegally promoted uses of four of
its drugs, including the painkiller Bextra and their
antipsychotic drug Geodon.
Dr. Healy, a professor of psychiatry in North Wales and Great
Britain is a former secretary of the British Association for
Psychopharmacology and author of over 175 peer-reviewed
articles, 200 other pieces, and 20 books, including Let Them
Eat Prozac (one of my favorites), and Pharmageddon,
another favorite.
His time is divided between an active psychiatry practice and
research.
For example, he has studied the serotonin-uptake theory in
depressed patients, and is adamant that there's no evidence
indicating that depressed patients have something wrong with
their serotonin system, which makes selective serotonin reuptake
inhibitors (SSRI's) a dubious treatment for depression. It may
even be part of the equation for why some people become suicidal
on SSRI's, even if they've never had such tendencies before.
"We've got 30 to 40 years' worth of work, and no
evidence has come to light that there's anything wrong with
the serotonin system in people who were depressed," he
says.
Profits Before Life—The Sad History of Antidepressant Drugs
Dr. Healy's conviction that SSRI's can make people actively
suicidal was originally borne directly out of his own clinical
experience. Since then, the research demonstrating this link has
become quite clear, and this class of drugs now carry a "black
box" warning. What's really infuriating though is the evidence
that has since emerged showing that pharmaceutical companies
knew about it, and hid it, and it wasn't until it became an
obvious issue in clinical practice that a warning was finally
issued. People literally lost their lives because these
companies didn't want to risk sluggish sales.
"I got involved as an expert witness in some legal
cases that involved these drugs," Dr. Healy explains.
"When you get involved as an expert witness in legal cases,
you get to go behind the scenes. You get to go into the
company archives, and you get to see what the clinical
trials really showed, and what the company personnel really
thought about the issues.
Then it was clear that the trials also really showed
those problems. It was clear that the companies knew there
was a problem, and they were in the business of trying to
hush the whole thing up.
... The regulators also clearly knew there was a
problem, I would say from very early on. They may well have
known there was a problem even before the drugs came to the
market. They certainly knew there was a problem shortly
after Prozac was launched and a great number of people
complained about the fact that they had a problem on this
drug.
When they looked at the data – the kinds of data that
the FDA, for instance, would have been able to see when they
held the first public meeting about whether SSRI drugs,
Prozac in particular, could cause people to become suicidal
– they had a lot of data that the rest of us didn't have.
They had data on the other SSRIs that haven't yet been
marketed.... I'm sure it was very clear to them then that
the SSRIs can cause people to become suicidal."
Publicly, the FDA argued that putting a warning on the
drug might deter people from treatment, so by doing the right
thing, we might end up with a detrimental outcome. However, no
one addressed the fact that not putting a warning on the drug
might make more people use them, hence killing more people, more
indiscriminately. This is exactly the situation we're dealing
with now. Even with the warning, antidepressants are prescribed
more or less willy-nilly, for everything from anxiety to pain,
high blood pressure, and insomnia—minor ailments that in NO WAY
warrant such a huge risk.
"[The information] the FDA had points very clearly
not just to the fact that [SSRI] drugs can cause a problem,
but that on balance, they harm more people than they help,"
Dr. Healy says. "How the FDA squared this, I'm not
sure."
SSRI's Likely Harm More People than They Help
In addition to suicidal thoughts and behavior, there also
seems to be an association between antidepressants and other
violent behaviors, such as homicides and school shootings.
Unfortunately, while suicide has become a well-established (yet
oft-ignored) side effect, the data on other types of violence
is, again, being hidden.
"We haven't had hearings about this issue," Dr.
Healy says. "People haven't had access to the data.
There's been no publications around it. This is one of the
biggest problems on which there's a huge amount of data, but
to which we've got little or no access."
Dr. Healy estimates that possibly 1,000 to 2,000 people
taking an SSRI drug commits suicide each year in the US who
would not have done so were they not on the drug. He also
believes there's a comparable number of people who will commit a
violent act against others as a result of the drug, who would
not have done so otherwise. Then there's the issue of
generational harm. Birth defects, miscarriages (as many as
20,000 per year), and voluntary abortions due to the baby being
diagnosed with a birth defect are other devastating side effects
that get little if any attention.
Why is that?
Why is so little attention given to the very serious nature
of the side effects associated with these drugs? Why are
antidepressants seemingly handed out like candy to cheer people
up, as opposed to treat serious mental conditions?
A major part of the problem is the too-cozy-for-comfort
relationship between drug companies and psychiatrists and other
prescribers. Adding to that problem is the fact that drug
companies are actively hiding and suppressing negative data on
their drugs, so psychiatrists prescribe drugs without having the
real facts.
Psychiatry is Committing "Professional Suicide"
Dr. Healy was recently featured in Time Magazine1,
after giving a speech at the American Psychiatric Association's
(APA) second largest annual meeting. The topic of the session
was conflicts of interest in psychiatry. Maia Szalavitz writes:
"Arguing that his profession is "committing
professional suicide" by failing to address its dangerously
close relationship with the pharmaceutical industry, he
likened psychiatry's attitude toward its faltering
legitimacy to the Vatican's widely derided response to its
child-sex-abuse scandal by priests — essentially that
psychiatry is brushing off justifiable concerns as hype
instead of dealing with the source of the problem.
Few experts believe that psychiatry's relationship
with the drug industry is healthy. While several speakers at
the session pointed out that other specialties are similarly
entangled with industry, "everyone does it" is generally not
a valid defense where conflicts of interest are concerned.
... "I'm going to argue that we need you to be
biased. We want you to be biased by treatments that work,"
Healy told his colleagues. "I don't mind if you're my doctor
and you've given talks for industry. My concern is not that
you've been paid by industry, but that you've been fooled by
industry. The key conflict is whether people are hiding data
from you."
The article goes on to detail some the more unsavory aspects
of conflicts of interest—the kind of suppression activities that
lead to demolished careers, and worse. Dr. Healy has been
personally targeted by drug companies for speaking out against
various drugs and exposing wrongdoing. His presentation at the
APA included a document obtained via a Freedom of Information
Act request, which reveals Eli Lilly's plan for countering his
public discourses on how drug companies hide drug data. One of
these strategies includes planting people in the audience of his
presentations to argue the industry's view.
What Clinical Trials Do and Do Not Show
According to Dr. Healy, in the clinical trials done to bring
antidepressants to market it is virtually impossible to show
that they have an overall positive effect. Part of the problem
that few consider is the fact that clinical trials are not
designed to answer some of the most important questions we have
about any given drug, such as: Does this drug save lives?
"From what we know of the data that's there, the
answer is no, they [antidepressants] don't save lives,"
Dr. Healy says. "Clinical trials also aren't designed to
answer the question, "Will these drugs get people back to
work?" From the data we have, we have no reason to think
that these drugs will be more likely to get people back to
work than placebo would, for instance.
In terms of what most people understand the word
"work" to really mean, which is [in the vein of the
questions] "Will my life be saved?" or "Will I be able to
get back to being employed?" we have no evidence that these
drugs "work." What we've got is clinical trials based on
rating scales, where you can show that the drug does
marginally better than placebo on these rating scales. But
that's all we have."
Fortunately, there are other alternatives, which have been
shown to have a more life-enhancing effect than antidepressants,
such as niacin (vitamin B3). The renowned and recently deceased
Canadian psychiatrist Dr. Abram Hoffer was a strong advocate of
the use of niacin in psychiatric illness, specifically for
schizophrenia, for which there don't seem to be many really good
treatments.
What he discovered was that niacin deficiency is a major
contributor to pellagra, the symptoms of which mimic depression.
He believed there's a subgroup of people who have an
increased nutritional requirement for niacin, making them not
merely deficient per se, but niacin dependent. When
they don't get it on a regular basis, and typically in far
higher doses than normal, they're predisposed to psychiatric
illnesses. Dr. Healy believes there may be significant value in
niacin supplementation, adding that one of the mechanisms of
niacin is detoxification, especially lead. This makes sense,
since it it's a potent vasodilator, which would increase supply
to the filtering organs, thereby aiding in the excretion
process.
What's the Mechanism of SSRI's that Make Them so Pernicious?
According to Dr. Healy, the mechanism of harm has not been
clearly established. The most likely mechanism of harm is the
fact that they act on your serotonin system.
"Serotonin is the most primitive neurotransmitter
there is. Even in a single-celled creature, it's there. When
you're acting on it, you're acting on a mechanism that is
very primitive and very, very profound," Dr. Healy says.
"So, it may be just purely the action on your serotonin
system that is the problem.
Now, people who say, "I know SSRIs work" are doing
the same kind of thing as saying "I know red wine works." If
you have a nice glass of red wine in the evening, you feel
mellowed out and chilled out... The SSRIs can work in the
same kind of way, and can do a useful thing, which is: chill
people out. You can get people who were stressed from work
who are now a little less stressed at work because of the
SSRI they're on. In that sense, they can clearly work—not
for all people, but for a portion of people.
But when you test them out in groups of people who
are clinically depressed (just as we would find if we were
to test alcohol out in groups of people who are clinically
depressed in six- to eight-week trials) it's actually rather
hard to show that they do any better than placebo. They
have, in fact, much the same rates of improvement compared
to placebo, as we would expect to find if the drug we were
actually testing was alcohol rather than Prozac, for
instance."
... What you've got in the case of the SSRIs
is much more like a psychic aspirin.
They numb you slightly. They take the
emotional pain away. But they do this only when your
serotonin system's working normally. And they make your
serotonin system more abnormal after you've been on a course
of treatment than it was to begin with."
Do Prescription Drugs Save Lives?
In his book Pharmageddon, Dr. Healy expands on the
skewed data and other manipulation techniques employed in drug
trials. While we spend a great deal of time discussing
antidepressants in this interview (which you can listen to in
its entirety by following the hyperlink provided above), the
situation in terms of proving benefit is the same for other
drugs.
Statins, for example, can indeed lower your cholesterol
levels, and many do so quite well. So in that sense, they
"work." But as with antidepressants, if you ask the question "Do
these drugs save lives?" the answer becomes rather murky.
"If you ask the question "Are people going to be
better able to work on these drugs?" then the answer is
clear: They're actually going to be LESS able to go to
work," Dr. Healy says. "They're going to have a
range of problems and other symptoms that they didn't have
off the pills.
Now, if you got marginally raised lipid levels, that
is not something that interferes with your capacity to work.
But if you're on a drug like one of the statins for
instance, you are on a drug that may cause muscle aches,
pains, cognitive failures, and may seriously interfere with
your capacity to work."
Osteoporosis drugs are another good example of drugs that,
overall, do more harm than good.
"They say up to a third of women over the age of 50
have osteoporosis," Dr. Healy says. "But they
don't. This is an osteoporosis that's created by the DEXA
scanners that the pharmaceutical companies gave away for
free when they were marketing drugs for osteoporosis. If you
scan bones, you'll almost always find little bits of
thinning here and thinning there.
So you can create the diagnosis of osteoporosis, and
you put these women on pills. Because they're on pills, they
think their bones are brittle, so they'll probably do the
wrong thing, which is they'll think they shouldn't go out
and mow the lawn. They shouldn't jog... because their bones
are brittle and they might have a fracture. But in fact,
getting out to mow the lawn, jog, and get physically fit is
a much better thing for them to be doing than to be taking
osteoporosis pills, unless they've got very severe
osteoporosis."
Personally, I don't see a reason for ever using an
osteoporosis drug. They're extremely poisonous, and they
kill your osteoclasts, the cells responsible for destroying old
damaged and unnecessary bone cells that set your osteoblasts up
to replace it with new bone tissue. This creates a dynamic
balance of bone resorption and bone building. They make your
bone denser, but at the same time they make them weaker.
Why You Don't Want a Doctor Who Follows All the Latest
Guidelines
The sad truth is, there's no easy way to determine what you
can trust when it comes to medical research and official
treatment guidelines. So much of it has been tainted by economic
conflicts of interests. An important point made by Dr. Healy is
that a doctor who strictly keeps to the guidelines is going to
be far more controlled by the pharmaceutical industry than might
be good for your health...
"We're in a world where you want a doctor who, for
the sake of giving you good care, is prepared to take the
risk of losing their job, because this is the world that
good doctors increasingly are being forced into. They're
being forced into being the kind of physician that says, "I
know the guidelines are wrong. Yes, they based it on the
latest evidence. But the industry actually controls the
evidence, and as far as they do, they control the guidelines
process also. I'm going to go by what seems to be the best
thing for me to do for my patients."
Unfortunately, there's no simple way to pick out
articles in the literature and say, "We can believe this and
not that." In fact, you could almost say that the articles
in what we used to think of as the best journals in the
field – like the New England Journal of Medicine, JAMA, and
other journals like this – are more likely to be compromised
than articles in perhaps journals that are less well-known."
A perfect example of this is the article I recently did on a
study that was widely promoted in the media, which declared that
eggs were associated with as much risk for strokes as smoking.
It was a critically flawed study. And when we looked at the
funding of the study, we discovered strong ties to the
pharmaceutical industry. Two of the three researchers in
question, have declared interests in statins. Now do you think
the companies that make statins might have a vested interest in
getting you to be afraid of eggs and cholesterol? Of course they
do. The third researcher helped create the vegan "Portfolio
Diet," which only allows egg substitutes and then only
sparingly, so he too has a financial stake in scaring people
away from eggs.
How Outsourcing Clinical Trials Can Skew or Hide Unsavory
Findings
Another significant problem that most people don't have a
clue about is how outsourcing clinical trials to other countries
can affect their believability. Even trials done in the US have
been plagued with fraud, such as enlisting patients that don't
actually exist. The matter of potential fraud increases with
overseas trials, because the FDA does not have the ability to
double-check the veracity of the data even if they wanted to
(and even in US trials they rarely do).
"There's a trial recently that brought Abilify® to
the market with an indication for maintenance treatment for
bipolar disorder. This trial was run in approximately 30
U.S. clinical trial centers and two further clinical trial
centers in Mexico. In the trial centers based in the United
States, when you added all the patients together, you found
that Abilify® didn't do any good.
It couldn't beat placebo as a maintenance treatment
for patients who had bipolar disorder.
In the Mexican centers, however, it really did beat
placebo. It wonderfully beat it. All of the patients down
there who got Abilify® did well, and the patients who got
placebo did poorly. When you added the two Mexican centers
into the U.S. centers, overall you've got a marginal result,
which showed that Abilify® was slightly better than placebo.
But this was caused by the Mexican patients. Now,
clearly, the Mexican data looks very dodgy, very shaky. The
FDA knew this was happening, but didn't in any way
investigate the issues. They noted that it was odd, but they
didn't investigate the issues, and they didn't stop the
company, later, from publishing the trial without drawing
any attention to the fact that, "Well, you know, our results
don't look all that good when you leave the Mexican trial
centers out of the picture."
Dr. Healy's Take on the Future of Medicine
Dr. Healy doesn't cast too much blame on the FDA though,
stating that the agency always has been and probably always will
be an agency that contributes to public health, "but does so by
regulating the wording of adverts that the pharmaceutical
companies put out." He points out that it's not really the FDA's
job to evaluate the product or the practice of medicine,
stressing that this responsibility really falls on doctors.
"Back 30 to 40 years ago, we were a lot safer not
because the FDA were doing their job better, but because
doctors were doing their job better," he says.
I think it's medicine that has lost its way. I think
the FDA is still doing what it has always been doing, which
is a very minimal job. I mean, most people out on the street
want someone there to protect them from the risk that drugs
or industry may pose. They're hoping that that's the FDA,
when, in fact, that has never been FDA's brief. It's been
the brief of doctors to do that, and we've been failing at
that job more and more in recent years."
When asked what he thinks the solution is, Dr. Healy
responds:
"I think my solution is this: the job of the doctors
have been like the job of the pilot of a plane. Their job is
to get you from Chicago to Houston alive—not to get you
there 15 minutes earlier; it's to get you there alive...
Doctors seem to have forgotten this. If they can't
get you there alive; if they can't be the people whose
professional identity is linked to keeping you safe when you
go on treatment, they're going to be replaced by cheaper
prescribers – by pharmacists or nurses. Anyone can get you
on the pill these days. It takes an expert to keep you safe.
I think if doctors don't realize this, they're committing
professional suicide."
How You Can Get More Informed, and Be Part of the Solution
Dr. Healy is a strong advocate for doing things to make a
difference. And this was the impetus behind a brand new website
called
www.rxisk.org. His goal for this website is to create a
people's movement for safer drugs.
"We want people to go in there and report any of the
problems they may be having on the medicines that they're
on. They can report this to FDA as well. But if they report
to us, we're going to feed their reports through to FDA,"
Dr. Healy explains.
Potentially one of the most valuable features on the site
will allow you to go through a series of questions that will
help you determine whether ailments you're having are associated
with any of the drugs you're taking. At the end, you will get a
report that you can then bring with you to your prescribing
doctor, to aid you in making a more comprehensive risk versus
benefit analysis. The idea is to try and create better teamwork
between you and your doctor. Furthermore, you will get feedback
on potential problems with individual drugs long before you'd
get it from the FDA.
I feel this could be an excellent tool for anyone currently
taking any drug, as well as for anyone considering taking one.
Forewarned is forearmed, as they say, and when it comes to
drugs, you really need to do your due diligence, as the risks
are all on you—not on your doctor, the FDA, or the
pharmaceutical company.
Weighing the risks versus the benefits is crucial, but in
order to do this, you need reliable, truthful information, and I
believe
www.rxisk.org can be a valuable resource that will only
become more valuable with time, as people begin to use it and
file their own reports on side effects. So please, bookmark it
on your computer and refer to it whenever needed, and share it
on your social networks. Together, as a community, we can help
the movement for safer drugs.