Avandia, diabetes drug causes heart attacks

[Guest guest]

Dear Health Freedom Advocate,

 

Below is an article from Byron Richards in the USA. Thanks to a New York

Times article on 6th June 2007, the Avandia diabetes drug scandal is now under

the

spot light, even though the dangers first came to light previous to March

2006.

 

This is just another carbon copy of the VIOXX cover up by the FDA, and of

course our TGA are by proxy!

VIOXX killed 55,000 people and the TGA didn't pull the drug from the market

place, instead they let Merck voluntarily withdraw it after some time and much

bad press.

 

On 23 Oct 2003 - Avandia Received Australian Pharmaceutical Benefits Scheme

(PBS) Listing.

 

Our tax dollars go towards propping up these drugs that that are killing

people. Our tax dollars are directed into the coffers of the drug companies via

the PBS, the governments take from the poor and give to the rich, this is really

nothing but an elaborate money laundering scheme. It should be called the MLS

and not the PBS!

 

So far the TGA hasn't given a class 1 recall for Avandia (or VIOXX) as it did

in the case of PAN and its health supplements, which did not kill anyone or

cause serious, irreversible health damage! The TGA has not even issued a class

2 recall (may cause death)...or even placed warnings on the box. The drug is

still available from Glaxo Smith Kline in Australia even though it turns out

that Avandia delivers a whopping 43% increased risk for heart attacks.

 

TGA Recall Criteria

 

TGA Class 1 recalls ( likely to cause serious, irreversible health damage or

death)

TGA Class 2 recall (adverse events that are reversible or mild)

TGA Class 3 recalls (no serious adverse events are expected to occur)

 

 

Since its release over 8 years ago it has been taken by 6 million people in

the US alone. If the figures (43%) are correct then this equates to Avandia

potentially injuring 2.58 million people in the US alone. But I guess the TGA

believes this is ok, as long as they can help their drug cartel buddies make a

few more million dollars before the evidence becomes absolutely overwhelming and

the public outcry deafening here in Australia....all the while banning and

regulating access to natural health supplements!

 

Please read on....

 

FDA COLLABORATION WITH BIG PHARMA RAISES EYEBROWS

By Byron J. Richards, CCN

June 7, 2007

NewsWithViews.com

 

The Andrew von Eschenbach FDA era is upon is. The Avandia scandal is the tip

of the iceberg. Is anyone ready? The words “illicit financial collusionâ€

have

been replaced by the politically correct term, “collaboration.†On May 30,

in defense of his cozy relationship with Big Pharma and Big Biotech von

Eschenbach told reporters, “This is a collaboration, but it's not just a

collaboration with drug companies, it's a collaboration with academia and with

other

agencies. " And he forgot to include that it is also a collaboration with various

Senators, such as Senator Bennett (R-UT) and Senator Hatch (R-UT), as can be

seen by the highly lucrative Critical Path Initiative program for cardiovascular

disease research at the University of Utah.

 

Plainly stated, the FDA is set on becoming a drug company involved in every

aspect of drug development for the next century. This pipe dream involves using

sophisticated FDA software and related technologies to set the standards for

the future of medicine, which will soon require your DNA in an FDA-owned

supercomputer if you would like medical care. The FDA will help design all drugs

from the ground up. The FDA, through the Reagan-Udall Foundation for the FDA,

will control all patents and licensing arrangements regarding the drugs that are

developed.

 

Under this plan the fox will not only be in charge of the henhouse, the fox

will eat hens at will. Privacy issues, genetic discrimination, and required

implantable RFID chips will be the order of the day. Billions of dollars are at

stake. Wall Street can’t wait. Drug safety and the health options of all

Americans hang somewhere in the balance, including access to safe and effective

dietary supplements (the only true competition).

 

What will the FDA do when safety problems surface in the drugs it develops?

Will the FDA put consumer safety ahead of its own financial interests? What

legal liability will the FDA face when their drugs injure or kill? The FDA has

already thought this through and is doing what it can to make sure citizens have

no rights to sue when injured by FDA-approved medications.

 

Senators have already approved this FDA plan as part of the recently passed

S.1082 – without asking a single question about it! The battle now moves to

the

House (HR.1561). A hurdle has been placed in front of the FDA, the

unfortunately timed Avandia scandal is prying open the door to FDA and industry

financial collusion, wherein tens of thousands of people die based on FDA

management

decisions while Big Pharma makes billions. It is time for Americans to wake up,

as your health options are about to seriously diminish.

 

The Avandia Scandal

 

On June 6, 2007 von Eschenbach and various FDA employees testified before

Henry Waxman’s (D-CA) Committee on Oversight and Reform. Waxman set the tone

by

reviewing the FDA history of Avandia approval and post marketing activities,

outlining what he called “a number of missed opportunities.†Von Eschenbach

skirted all issues by saying the FDA is still reviewing data and will hold an

advisory committee hearing on July 30, thus attempting to delay the spotlight on

this scandal so that HR.1561 can come to the floor of the House without the

Avandia scandal hanging over its head.

 

The Avandia scandal is becoming quite a dog and pony show. On June 6, 2007

the New York Timesrevealed a stunning event that occurred in March of 2006

wherein FDA safety supervisor Dr. Rosemary Johann-Liang approved a black box

warning on Avandia to warn about the risk for congestive heart failure. The von

Eschenbach team ordered her to retract her approval of the warning. She was then

stripped of her power to make such warnings and removed from supervision of the

safety of Avandia. In other words, FDA management actively blocked a needed

public warning regarding the dangers of this drug, consistent with eight years

of FDA failures to ensure proper post-marketing studies of Avandia regarding

heart attack risk.

 

Of particular interest is the FDA’s technical defense of its position

regarding the approval of the drug in the first place. The drug was approved

based on

a “biomarker†or surrogate endpoint – meaning that approval of the drug

was

based on its ability to change blood sugar levels, not whether it improved the

health of a diabetic. Avandia works by throwing a gene switch known as PPAR

that is involved with multiple chemistry reactions at the cellular level, a

fundamentally unpredictable and powerful drug target. By focusing on the

biomarker called blood sugar the FDA was able to ignore the key safety question

which

was, “At what expense to health is blood sugar being lowered?â€

 

It now turns out that Avandia has a whopping 43% increased risk for heart

attacks as well as an increased risk of death from using the drug. This

information is only coming to light after eight years of use. The FDA sat on the

heart

attack risk data and failed to warn the public, enabling the drug to become a

blockbuster and rake in 3.2 billion in annual sales. GlaxoSmithKline made no

proper effort to determine the heart attack risk of Avandia in proper

post-marketing studies, which the FDA condoned. And as stated in the testimony

of Bruce

Psaty, MD, “FDA failed to warn or inform in timely manner.â€

 

It is important to understand that the future of all drug development under

the Critical Path Initiative and the Reagan-Udall Foundation for the FDA will

rely on this type of biomarker evaluation (surrogate endpoints) to rush drugs

to the market faster with virtually no proof of desired clinical outcomes. The

American public will then be subject to a safety experiment. This approach to

new drug development will sentence unsuspecting citizens in our country to a

never-ending stream of Avandia-like scandals.

 

I’ll Stroke Your Back, You Stroke Mine

 

It is not an accident that Andrew von Eschenbach’s permanent appointment to

head the FDA was slipped through at the end of last year during the Lame Duck

session, with most Senators asleep at the wheel. About the only Senator not

sleeping was Charles Grassley (R-IA), who stated during von Eschenbach’s

confirmation hearing:

 

>>>>“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done

a superb job in the position he is currently occupying [acting head of the

FDA].…That is an insult….In my interactions with the Department of Health

and

Human Services and the FDA these last 8 months, I have seen a complete and utter

disrespect for congressional authority and hence the law.… This body [the

Senate] should not walk hand in hand with the executive branch and sit idly by

as

instances of abuse and fraud continue to endanger the health and safety of

American people.â€

 

As Grassley’s warning fell on deaf ears, Orrin Hatch (R-UT) rose in defense

of von Eschenbach:

 

>>>>“To me it is simply unconscionable that the Food and Drug Administration,

one of the best little agencies in Government, has gone leaderless for such a

period of time…I know Dr. von Eschenbach well. He is a man of integrity….I

urge my colleagues--no, I implore my colleagues--to do what is right and vote

[for] this nomination….it is what the American people deserve.â€

 

Apparently we got what we deserve. Why was Hatch so adamant about placing a

bio-tech sales rep at the top of the FDA? Hatch is a large recipient of Big

Pharma money. He holds a key position on the HELP committee that created Senate

bill S.1082. He is currently designing legislation to protect Big Pharma and

Big Biotech from generic competition in the next generation of biological drugs

–

a windfall worth billions for the industry. Hatch wants to place this

legislation into S.1082/HR.1561 as an amendment when the bill goes to conference

committee.

 

It is obvious that Hatch has his hand in the Big Pharma cookie jar. Von

Eschenbach is certainly playing his role in rewarding Hatch for his support,

helping us to gain a clear picture of what von Eschenbach means by

“collaboration.â€

On June 1, 2007, von Eschenbach was in Utah promoting a new Critical Path

Initiative project with the University of Utah. It is called the Cardiovascular

Drug Safety and Biomarker Research Program. This project could be worth

hundreds of millions, even billions of dollars to the state of Utah. I wonder

why the

FDA chose Utah for this no-bid contract known as a collaboration?

 

Hatch Walks an Interesting Fence

 

A key problem with S.1082 is that it contains a sneak attack on dietary

supplements that will enable the FDA to remove helpful dietary supplements from

the

market at its whim in order to protect drugs from competition. This is being

done through trick language the FDA has installed in bill S.1082, specifically

relating to the Critical Path Initiative and the Reagan-Udall Foundation for

the FDA.

 

Because there are many dietary supplement companies in Utah, Hatch has also

been a major supporter of the dietary supplement industry and is responsible,

along with Tom Harkin (D-IA) for the law known as DSHEA which provides access

to dietary supplements in this country.

 

In the past month Hatch and Harkin were flooded with objections and concerns

regarding this sneak attack on dietary supplements. This led to a conversation

between Hatch, Harkin, Kennedy, and Enzi wherein they state that S.1082 will

not affect dietary supplements. HOWEVER, UNTIL THE LANGUAGE IS CHANGED IN THE

BILL ITSELF THE THREAT TO DIETARY SUPPLEMENTS IS VERY REAL AND IS A HUGE

PROBLEM.

 

This is fully explained by Jonathan Emord, our nation’s leading health

freedom attorney, in an interview he recently had with me that can be heard by

clicking here.  http://www.wellnessresources.com/health_freedom.php

 

The Senator’s conversation, called a colloquy, has been used by the Natural

Products Association (NPA) to neutralize concerns of its health food stores

regarding this issue. It is obvious that NPA takes its marching orders from

Hatch. Why are Hatch and the NPA trying to convince consumers that they are

protected when nothing could be further from the truth? I’ve asked this

question to

David Seckman, head of NPA, and received no answer. It is quite a disservice to

the dietary supplement industry when leaders pretend real problems do not

exist. 

 

Hatch takes in more money from Big Pharma than he does from dietary

supplement companies – and as a veteran politician he walks both sides of the

fence

with considerable skill. It is vital that Hatch and Harkin help change the

language within Senate bill S.1082 to actually protect dietary supplements.

 

This will require a major public demand, in both the House and to these

Senators, to make this happen. You can take action now by clicking here.

http://www.wellnessresources.com/health_freedom.php

 

 

Take Action Today! We currently need to flood Sen. Hatch and Harkin's offices

with letters. Please send a letter to Hatch and Harkin, plus your own

representatives telling them to amend HR.1561 (S.1082) to protect dietary

supplements.

 

1. - Send a letter to your own representatives.  

To email Sen. Hatch and Harkin make sure to use the links below.

 

2. Email Sen. Orrin Hatch (R-UT) > CLICK HERE

http://capwiz.com/wellnessresources/mail/?id=586 & type=CO & state=UT

 

3. Email Sen. Tom Harkin (D-IA) > CLICK HERE

http://capwiz.com/wellnessresources/mail/?id=249 & type=CO & state=IA

 

 

Byron's Related News Articles:

 

Understanding the Threat to Dietary Supplements – Part 2 - Wednesday, May 16,

2007

 

http://www.wellnessresources.com/newsroom/index.php/content/articles/understandi\

ng_the_threat_to_dietary_supplements_part_2/

 

Understanding the Threat to Dietary Supplements - Part 1 - Tuesday, May 15,

2007

 

http://www.wellnessresources.com/newsroom/index.php/content/articles/understandi\

ng_the_threat_to_dietary_supplements_part_1/

 

 

 

 

© 2007 Truth in Wellness, LLC -  

Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health expert,

radio

personality, and educator. He is the author of Mastering Leptin, The Leptin

Diet, and

Fight for Your Health: Exposing the FDA's Betrayal of America.

Richards encourages individuals to take charge of their health, stand up for

their health rights, and not blindly succumb to propaganda from the

vested-interests who profit from keeping Americans sick. As founder of Wellness

Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary

supplement company since 1985, he has personally developed 75 unique

nutraceutical-grade nutritional formulas. www.wellnessresources.com FREE

Subscription to

Byron's Health Newsletter,

E-mail: byron

 

 

Michael Bending

Alliance for Health Freedom Australia

http://www.ahf-au.org

 

'All that is required for evil to prevail is for good men to do nothing'

- Edmund Burke (1729-1797), Irish born writer and politician -