What
Are the FDA and Big Pharma Up to Now?

by
Bill Sardi

Recently
by Bill Sardi: How
To Stay Out of Trouble When Taking Dietary Supplements

Is Avandia
(rosiglitazone) going to rise from the grave? Avandia is the one-time
$3 billion blockbuster anti-diabetic drug that plunged into disuse
in 2009 when a study published in 2007 showed, when used with other
anti-diabetic agents, it increased fractures in women as well as
the risk for heart failure.

Suddenly, the
FDA says it is going to revisit the data on this drug. It wants
to reassess safety risks. A Wall
Street Journal report says: “it is too early to know what
opinions the FDA will be seeking.” Is the FDA going to put
Avandia back on the market without restrictions it placed earlier?

In July of
2010 FDA investigators realized the major trial, published in 2009,
used to produce negative data regarding Avandia was flawed. That
data forced European healthy agencies to ban Avandia while the US
FDA decided to re-label it, restricting its use to patients for
whom other anti-diabetic drugs didn’t work with the caveat that
all prospective patients received information about its alleged
risks.

Sales of Avandia
declined in the aftermath of the new data to just $1.9 million in
2012. The maker of Avandia paid a $1 billion fine to the FDA regarding
criminal charges that it withheld safety data from 2001-2007 for
three drugs including Avandia.

Patients
not warned, despite mandate

Despite the
FDA mandate that patients who do receive prescription for Avandia
receive information about its risks, and despite a mandate that
sales representatives of drug companies inform doctors of both the
risks and benefits involving their drugs, rarely
do doctors ever hear about the potential harms caused by pharmaceuticals.
A report
in the Minnesota Post underscores the problem.

No truly
safe anti-diabetic drugs

There are no
truly safe and effective anti-diabetic drugs, save for metformin,
and metformin depletes
the body of vitamin B12 which can induce neuropathy, one of
the hallmark signs of diabetes. As an aside, it was recommended
that vitamin B12 levels be tested among metformin users way back
in the 1970s, but few doctors do that today.

The FDA first
approved Avandia in 1999. But expanded safety data on FDA-approved
drugs is not available till years after drugs are approved and come
into wider use. Initial safety trials involve very small groups.
So Avandia stayed on the market for over a decade before the FDA
took action to limit its use, largely because its maker wasn’t forthcoming
about adverse events associated with the drug.

Expanded
safety data on many drugs still not available

Avandia is
one of 90
medicines that underwent accelerated approval between 1992-2008.
Only two-thirds of drugs approved by the accelerated process have
followed through with expanded safety trials. So as many as 30
FDA-approved drugs are on the market with few statistically-proven
benefits and unknown side effects with prolonged use. The FDA
does nothing.

FDA knew
prior to 2009

European reviewers,
who are geographically distanced from the medical-political battles
in the US, reveal that the FDA
knew as early as 2001 that Avandia should not be used in combination
with insulin because its combination use was associated with
increased risk for heart failure. It wasn’t just the 2007 study
that doomed Avandia.

A revealing
report
published in the Texas Heart Institute journal points out that
Avandia works by increasing sensitization to insulin and therefore
combined use with insulin would produce excessive fuel in heart
muscle cells that can result in heart failure. The report points
to metformin as the preferred drug for diabetes. It should have
been a no-brainer for the FDA to limit combined use of Avandia with
insulin. But the agency took no action. Mindless doctors also proceeded
to over-treat.

Last year
investigators in Italy, reporting
in the journal Drug Safety, noted that the class of anti-diabetic
drugs that Avandia belongs almost doubles the risk for bone fractures
and quintuples the risk for heart attack.

But some reports
claim
the evidence against Avandia is equivocal. With mixed reports
over its safety, some researchers suggest the FDA’s restrictions
on Avandia may have been premature.

Expert reviewer
weighs in

Noted pharmaceutical
reviewer Bernard
Cheung writes in Expert Review of Clinical Pharmacology that
Avandia modestly reduces the long-term measure of blood sugar (hemoglobin
A1c) by just 1% (normal
HbA1c ranges from 4.0% to 5.6%) and mildly reduces blood pressure
and improves sensitivity of cells to insulin. (If cells are not
sensitive to insulin, glucose [sugar] cannot enter cells and blood-sugar
levels rise.)

He says this
drug is supposed to be used as an adjunct to diet and exercise,
not as front-line treatment for diabetes. But that is what it became.

Dr. Cheung
says Avandia is “thought to be a poor value for the money in
institutions where treatment is paid for by public money.”

Dr. Cheung
notes that Avandia induces weight gain that in turn increases the
risk for diabetes itself. Every anti-diabetic drug save for metformin
induces weight gain.

Dr. Cheung
says an updated meta-analysis (grouped studies) still shows an increased
risk for heart attack with Avandia, though there was no increased
risk for cardiac death. But FDA reviewer David Graham (infamous
as a whistleblower in the Vioxx drug scandal where the FDA covered
for this anti-inflammatory drug when it was killing thousands),
using a review of Medicare records, has found that Avandia does
not produce a significant increased risk for heart attack, though
it does for stroke and heart failure.

As an aside,
the most promising agent that addresses the problems posed by Avandia
is resveratrol, known as a red wine molecule. Researchers in The
Netherlands note that Avandia
induces calcification of arteries whereas resveratrol abolishes
this effect in a lab dish. For diabetic patients who remain
on Avandia, resveratrol may be a good companion.

Modern medicine
is out-pricing itself

It’s bad enough
that thousands of Americans are dying prematurely due to the side
effects posed by FDA-approved drugs, but to add insult to injury,
why do they have to be so expensive?

Raiding pools
of insurance money is the current game for hospitals and pharmaceutical
companies.

Let’s first
take a look at hospitals. A cherished friend recently died suddenly
after a brain hemorrhage and a 12-day ordeal in the hospital intensive
care ward. The cost – over $1 million (over $80,0000 a day)! Unfortunately
he had cancelled his health insurance policy the year prior and
was a year away from going on Medicare. His wife is left to pay
the bill.

John Lawrence,
writing
in the San Diego Free Press, says hospitals are playing
a game of “your money or your life.” He opens his invective
against US hospitals this way:

“Hospital
care in the US has morphed into a multi-headed monster in which
every advance in medical technology ups the cost of medical care.”
Like a recent article characterized a lecherous Wall Street investment
firm, Lawrence says US hospitals are “a great vampire squid
wrapped around the face of humanity, relentless jamming their
blood funnels into anything that smells like money.”

The hospital
Chargemaster

Mr. Lawrence
refers to “the Chargemaster,” a master file of billable
items hospitals can add to a patient’s bill from a lowly aspirin
tablet to 5-way heart bypass surgery.

The Chargemaster
for a hospital in San Diego lists over 54,000 billable items. All
price for all items are far removed from their actual cost to hospitals,
says Lawrence. Both hospitals and physicians participate in schemes
to run up the bill and profiteer on the side with consulting agreements,
stock options, royalty agreements, research grants, and an endless
list of other side amenities such as pens and scratch pads for the
office and airline tickets to medical conferences.

America certainly
has the most inventive doctors. Physician consultants are paid millions
for their medical device inventions.

Meanwhile,
the public suffers. Mr. Lawrence points to the fact 69%
of those who have experience medically-related bankruptcy were insured
at the time of their filing. The irony is that Obamacare is
headed towards feeding this over-priced system and does nothing
to reduce healthcare costs in its first decade. Lawrence points
fingers at politicians who want to reduce Medicare entitlements
but maintain outrageous reimbursement policies for over-priced drugs.

Blame the
man at the top

Tom Freeman
of Pinon Hills, California, posts a blog that blames
the executive branch of government for th perilous situation in
American healthcare today. Mr. Freeman says physicians are not
solely to blame, though they may be cited for piling on. The blame
goes much higher says Freeman. Here is how he explains it:

“When
George W. Bush took office in 2001 one of the first things he
did was politicize the agencies that came under his cabinet. The
Food and Drug Administration was one of the first to be converted
from a regulatory function to an agency assuring profits for an
industry it was supposed to be regulating. This is when dangerous,
even deadly drugs began appearing on the market.

The conservatives
in the Bush administration said it was not fair to require a ‘box
car full of paper,’ and take years to prove the safety and efficacy
of newly made drugs. They went to a system using laws of probability
and random evaluation.”

The results
were horrible. Deadly drugs such as Vioxx killed 80,000 people worldwide,
yet were approved by the FDA. Resulin, a pill to control diabetes,
killed the first patient who used it, says Freeman.

25-cent
drug costs $55,000 a year

As if all this
weren’t enough insult to the average American, we now read of a
breakthrough drug called Tecfidera, newly
approved by the FDA for multiple sclerosis. It’s cost: $55,000
a year ($150 a day) for 480 milligrams of this wonder drug.

Of course,
it must have taken years to develop and test this novel molecule.
And exactly what is Tecfidera? Why it is dimethyl fumarate, a
molecule that was first introduced in the 1950s in Germany as a
remedy for psoriasis.

A 480 milligram
dose of pharmaceutical-grade dimethyl fumarate, the recommended
amount for daily treatment, can be purchased
from a chemical company for 24.4-cents.

Tecfidera
slightly
decreases the relapse rate of MS over other drugs (by 49%, less
than the 55% and 61% by competing drugs).

What Tecfidera’s
maker obtained was a patent claim on a 50-year old molecule by claiming
its dosing regimen was novel and worthy of patent protection. The
drug company’s chief executive officer said in
a press release that: “The patent for this dosing regimen
is recognition of the remarkable innovation Tecfidera represents
for the MS community.”

What is Tecfidera’s
unique biological action? Why it activates something called the
Nrf2
transcription factor that triggers the activity of internal
antioxidants in the body.

Uninsured
multiple sclerosis patients, recognizing Tecfidera is obviously
over-priced, have started to search for a more economical alternative.
One- patient says he has located a source of fumarate that costs
$5 for two hundred 480-milligram doses. One MS patient says he refuses
to accept the idea Tecfidera’s maker can charge over $50,000 for
a year’s supply of the drug when
it is a common food additive!

If searching
for an economical alternative, MS patients might venture to a health
food store. In the animal laboratory the red wine molecule resveratrol
prevented nerve loss in an animal model of MS and resveratrol
works without suppressing the immune system as other MS drugs do.
A year’s worth of low-dose near research-grade resveratrol can be
purchased for less than $400. Resveratrol
activates the same Nrf2 pathway as Tecfidera.

A physician
speaks out

A prominent
doctor, Peter Lind, DC, who practices in Salem, Oregon, has recently
spoken out against modern medicine’s current practice of regarding
every malady as a drug deficiency.

Dr. Lind notes
drugs cause disease, such as drug-induced Parkinson’s disease, liver
poisoning by the pain reliever acetaminophen (Tylenol) which is
the leading cause of liver transplants, and non-steroidal anti-inflammatory
drugs that induce gastric ulcers that result in over 100,000 hospitalizations
and 17,000 deaths annually.

The outspoken
Dr. Lind, writing
in The Washington Times, says adverse drugs events “result
in an estimated 2.5 million hospitalizations and 1 million urgent
care visits resulting in an additional indirect cost of $65 billion
each year to the health care system and result in about 100,000
deaths. However, there are current estimates that these adverse
drug events are being underreported by a factor of 10 times.”

Dr. Lind gristles
at the fact drugs companies settle lawsuits for millions of dollars
stemming from release of unfavorable study results while they make
billions in profits. The fines and lawsuits don’t amount to much
more than a slap on the wrist.

Dr. Lind boldly
says: “It is time to require non-drug practices as first-line
approach to health care.”

April
15, 2013

Bill
Sardi [send
him mail] is a frequent writer on health and political
topics. His health writings can be found at www.naturalhealthlibrarian.com.
His
latest book is Downsizing
Your Body.

Copyright
© 2013 Bill Sardi Word of Knowledge Agency, San Dimas, California.
This article has been written exclusively for www.LewRockwell.com
and other parties who wish to refer to it should link rather than
post at other URLs. 

The
Best of Bill Sardi