Drug safety bill passes in the Senate, key amendments defeated (Very Long)

[Guest guest]

Hi All,

 

We have not gained health freedom and still live with drug company tyranny

with the passage of S1082 in the Senate.

 

Below is Mike Adams report and analysis. Those of you wanting to sift

through the entire bill and amendments can find it at

http://thomas.loc.gov/cgi-bin/query/R?r110:FLD001:S05774

 

This bill now moves to the house . . . Keep in touch with Mike and others to

join any action you might think appropriate.

 

http://www.newstarget.com/021838.html

NewsTarget.com printable article

Originally published May 9 2007

FDA drug safety bill passes in the U.S. Senate; health freedom advocates

outraged at betrayal of American consumers

by Mike Adams

 

The U.S. Senate passed the FDA " drug safety " bill today (S.1082) with a 93-1

 

vote. A key amendment that would have called for genuine drug safety

protections for consumers -- the Grassley amendment 1039 -- was defeated by

a single vote (47 to 46). The new law deepens financial ties between Big

Pharma and the FDA, doubling the amount of money directly paid to the

regulator by drug companies, but it fails to explicitly protect foods and

nutritional supplements from overreaching FDA regulation efforts. The new

law also failed to end Big Pharma's monopoly stranglehold on American

consumers, further blocking the ability of citizens, businesses, cities and

states to import equivalent medications from countries like Canada (where

drugs are far safer than those sold in the United States, by any measure).

 

Health freedom advocates such as Byron Richards of Wellness Resources

(www.WellnessResources.com), John Hammel of the International Advocates for

Health Freedom (www.IAHF.com), and myself (www.NewsTarget.com) sought to

garner enough grassroots support for achieving the inclusion of key

amendments in the bill, such as the Dorgan amendment which, for four days,

appeared to end the medical monopoly that currently forces American

consumers to pay the highest prices in the world for prescription drugs.

Although hundreds of thousands of consumers contacted their lawmakers to

demand an end to the monopoly price fixing currently operating in the United

 

States, lawmakers seemed confused and could not bring themselves to support

any amendment that would have threatened the profits of Big Pharma.

Ultimately, the Dorgan amendment was quickly defeated by the Cochran

amendment, trapping Americans in a monopoly medical market that would be

considered illegal by nearly everyone if a corporation like Microsoft

attempted something similar.

 

S.1082 ultimately passed with amendments that primarily support the agendas

of Big Pharma and the FDA, expanding the powers of both. Very few provisions

 

were accepted that addressed the serious issues of corruption, conflicts of

interest, television drug advertising or genuine drug safety.

 

Health freedom advocates are now characterizing the final bill as the, " Big

Pharma Protection Act of 2007 " due to its emphasis on protecting the

monopoly drug market in the United States while doing very little to

accomplish its stated goals of increasing the " safety " of prescription

drugs.

 

 

Analysis by Mike Adams (opinion)

The passage of S.1082 is a terrible defeat for Americans, but a huge victory

 

for Big Pharma and the FDA. The bill expands the FDA's powers and keeps in

place a hugely profitable Big Pharma monopoly over U.S. consumers that is

right now bankrupting our nation.

 

At every step, Big Pharma-funded lawmakers voted to minimize any real safety

 

scrutiny and chose instead to dress up their drug-promoting agendas as

" public safety " measures. In the end, the only thing that's really safe is

the revenue stream of drug companies. An illegal monopoly on prescription

drugs has now been officially sanctioned by the U.S. Senate, and organized

medicine today is now unquestionably operating as a system of organized

crime. Lawmakers have been paid off, regulators have been influenced, and

the media is being bought with advertising dollars. Big Pharma now has a

near-total chokehold over everything to do with medicine in the United

States, from what is taught in medical schools to what's accepted as

" scientific " by the medical journals. The takeover of America by drug

companies is now nearly complete.

 

Of note, the most profitable corporations in the world -- the drug

companies -- have now demonstrated majority control over the United States

government. From this point forward, government and private industry will

now act as one incestuous, unstoppable entity to trap American consumers in

a system of fraudulent medicine designed to do nothing more than extract

dollars from their pockets. No meaningful reform will be tolerated. No

limits on FDA tyranny will even be openly discussed.

 

During this rare window of opportunity for real, positive change that could

have protected Americans from the predatory marketing practices of

criminally-operated drug companies, our lawmakers utterly failed us. Our

Senators have sold out to Big Pharma influence, and through their votes,

they have doomed the United States to inevitable medical bankruptcy that

threatens the future of the nation itself.

 

As corporations continue to flee the U.S. due to overwhelming health care

costs, our own Senators believe a monopoly drug racket should continue to be

 

protected! They believe that the FDA should have even more power over

consumers, and that the American people should be treated as medical guinea

pigs, involuntarily taking part in a massive drug experiment called, " Test

the drugs on the population. " Any real safety issues will only be dealt with

 

after the fact -- after they've killed hundreds of thousands more Americans.

 

 

Chemical warfare against the American people

With the passage of S.1082 and the emboldening of the FDA and Big Pharma, a

war has been declared on the American people, and it is far more dangerous

than any terrorist action. It is a war against Americans' health, and the

U.S. Senate has now condemned itself as a band of sellouts for giving

official legislative approval for the waging of that war against Americans.

It is a war that will produce millions of casualties over the next decade.

Dropping a nuclear bomb over a major American city would kill fewer people

than the FDA / Big Pharma / Big Government agenda will now kill, thanks to

the actions of our lawmakers. (And that's using statistics from the Journal

of the American Medical Association, by the way.) As shameless as ever, this

 

dangerous law has been sold to consumers as a " drug safety " bill.

 

But prescription drugs are not safe, even if they are purchased at the

highest retail prices in the world. (Paying more for a drug does not make it

 

safer.) FDA-approved prescription drugs have killed far more Americans than

all the terrorists events recorded in American history, combined! The FDA is

 

the single greatest threat to the health and safety of the American people,

and today, with the passage of S.1082, the U.S. Senate has clearly said that

 

it believes the FDA should have even more power over the people. Apparently,

 

enough Americans have not died yet. The body count has not yet reached a

number sufficient to override campaign funding bribes paid to senators by

drug companies. The pharmaceutical holocaust is not yet large enough to

demand real reform.

 

It is my belief that with this vote, U.S. Senators have betrayed their

nation. They have sold out the health and safety of the American people to

the wealthiest and most profitable corporations in the world: Drug

companies. Our senators have stolen from the poor and given to the rich.

They've allowed a criminal price-fixing enterprise to continue dominating

medicine in America today, and they've failed to take any meaningful action

to deliver what Americans demand the most: Free market access to medications

 

that are provably safe and effective.

 

Our Senate has failed us, just as conventional medicine and the FDA have

failed us. Today is a sad day in the history of these United States, for it

is a signpost that announces the fact that from now on, our government shall

 

operate solely in the interest of corporations.

 

Lincoln's Gettysburg Address once described a government " of the people, by

the people and for the people. " Today, that dream is unquestionably lost. As

 

my CounterThink cartoon depicts below, we are now a nation of the

corporations, by the corporations and for the corporations.

 

The U.S. Senate has now positioned itself as the adversary of the American

people when it comes to any decisions involving health or medicine, and most

 

people in this nation have no idea what just happened. Our Prozac-popping

populace is too mind-numbed by prescription drugs to save themselves from a

medicated future of personal and national bankruptcy. I advise all remaining

 

sane citizens to start making plans now to protect themselves from the new

merger of Big Pharma and Big Government. S.1082 has all come down to one

thing: a Big Medical Scam.

 

 

 

 

Analysis by Byron Richards (opinion)

The Senate has sold out the American people. Anyone voting for change in the

 

last election can now plainly see the shenanigans of a Democratic-controlled

 

Senate. Under Republicans no FDA reform ever took place. Big Pharma owns so

many Republicans that all meaningful legislation to curtail the deaths and

injuries of American citizens at the hands of Big Pharma and the FDA had

been completely thwarted for the past six years. Under Democratic control

sweeping FDA reform favorable to Big Pharma was proposed and the majority of

 

meaningful reform was blocked or seriously watered down. Which is worse? As

Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA

bill) was an " elaborate scheme. "

 

The final passage of S1082 was never in doubt (final vote was 93-1). In

fact, Kennedy and Enzi gave Big Pharma a 40 yard head start in a 100 yard

dash; it wasn't much of a contest. Their legislation perpetuated the user

fees allowing Big Pharma to buy mob-like protection from the FDA. The bill

created the Reagan-Udall Foundation for the FDA to hold FDA-related patents

and allowed the FDA to license technology to drug companies -- thus turning

the FDA into a drug company with vested interests in specific medicines.

None of these blatant conflicts of interest, which are also primary safety

issues, seemed to bother any senators at all.

 

 

Hypocrisy Gone Wild

The bill claimed to be a safety bill and all arguments from either side on

any issue were always presented as safety related. Thus, every Senator was

using the same set of words to describe both sides of the issue. Each side

claimed the other was using the safety term hypocritically, resulting in a

bewildering debate. All of this was staged to confuse the public and

perpetuate a myth that safety legislation was being meaningfully debated.

 

What was really being debated was the extent to which the Big Pharma

monopoly would be allowed to continue, an issue that was too politically

incorrect to describe publicly. The debate was actually about how sharply

Big Pharma's exorbitant profits and reckless behavior would be curtailed

compared to how many Americans would be exposed to injury and death at the

hands of Big Pharma.

 

Earlier in the week a fight broke out between a contingent of Democrats lead

 

by Senator Kennedy (D-MA) and a larger contingent lead by Byron Dorgan

(D-ND). However, when the Kennedy clan joined the Republicans their odd Big

Pharma-sponsored coalition held an advantage. This group of Senators

undermined the free market and perpetuated the high cost of drugs in this

country compared to all others countries -- a 50 billion dollar gift to Big

Pharma.

 

Double talk became the order of the day. On the one hand it was funny to

watch, as Democrats attacked each other. On the other hand it was sad to

watch, as this pathetic debate will result in window-dressing reform, with

enough Big Pharma loopholes to drive a Mack Truck through. Attempts by well

meaning senators to correct flagrant flaws in the legislation were either

watered down to the point of nonsense or blocked entirely.

 

Many key issues were not addressed, such as the FDA's legal position to

prevent citizens from suing drug companies, the massive (and oftentimes

illegal) off label promotion of drugs by the legion of Big Pharma sales

reps, medical journals that are full of fraudulent Big Pharma promo pieces

that misrepresent the safety and efficacy of drugs currently on the market,

and a large percentage of doctors on the take from Big Pharma.

 

 

Big Pharma Wins Key Amendment Votes

On the final day it all boiled down to two keys votes. One vote was on the

Grassley amendment #1039 which would have given true power to scientists in

the FDA responsible for regulating the safety of drugs already on the

market. The FDA and Big Pharma were adamantly opposed to this amendment. The

 

vote was Big Pharma 47 -- Americans 46, defeating the amendment. This vote

was not only a sell out of Dr. David Graham and other FDA scientists who

have gone to Congress as whistleblowers to save American lives, it was an

" acid-test " vote on who is truly on Big Pharma's payroll. Click here to see

how your senators voted.

 

The other key vote came on the Durbin amendment #1034. This amendment sought

 

to prevent Big Pharma from placing " experts " on FDA Advisory Committees --

which make the final decisions on the safety of drugs. Durbin argued the

obvious point that hundreds of millions of dollars are at stake as well as

the lives of Americans and that such flagrant conflicts of interest must be

stopped. He pointed out that the FDA Advisory Committee that ruled on the

safety of Vioxx had 10 " experts " on the Big Pharma bankroll, resulting in

over 50,000 deaths. Kennedy and Enzi argued that these conflicts of interest

 

were necessary and a fact of life and needed for science to progress. The

vote was Big Pharma 47 -- Americans 47, and in this case the tie went to Big

 

Pharma and the amendment was defeated. Click here to see how your senators

voted.

 

Two-faced senators threw a dog bone to those promoting safety, as a second

Grassley amendment that called for stiffer civil penalties against Big

Pharma wrongdoing was approved.

 

The Senate has punted when given a major opportunity to protect the health

and well being of Americans. S1082 is the best " safety " legislation that Big

 

Pharma money could buy.

 

 

The Voice of Health Freedom was Heard

Many thousands of Americans flooded the Senate with objections to a clause

relating to the Reagan-Udall Foundation for the FDA, which could be used to

target dietary supplements by evaluating them as drugs for safety purposes.

While Enzi refused to change the language, we created such an uproar that

assurances are officially in the Congressional Record that this legislation

is not to be used to harass dietary supplements.

 

And we headed off a potential attack by Durbin -- who for some reason is

always trying to get vitamins classified as drugs (more safety hypocrisy).

Key to this effort was myself writing for NewsWithViews.com, Mike Adams

writing for NewsTarget.com, and John Hammell of the International Advocates

for Health Freedom. Support also came from many other groups who forwarded

the message. All of our efforts resulted in the following testimony on the

floor of the Senate as reported in the Congressional Record.

 

May 2, 2007:

 

Mr. HATCH. My office has been inundated by calls from people throughout the

country who believe that this legislation, specifically the provision

establishing a Reagan-Udall Institute, will overturn the Dietary Supplement

Health and Education Act of 1994. That has not been my reading of the bill,

but I wonder if other Senators have heard similar concerns?

 

Mr. HARKIN. Yes, I have received a good many calls as well. And, I have to

say that I would be very concerned, as I know the Senator from Utah is, if

anything in the bill we are considering, S.1082, would overturn DSHEA, a law

 

we fought side-by-side to see enacted.

 

Mr. ENZI. It might be helpful if I explained the provision you are

discussing, as my office has received many calls as well and I believe the

callers are not informed about this matter. Subtitle B of title II of S.

1028 establishes the Reagan-Udall Foundation for the Food and Drug

Administration. That simple purpose of that nonprofit Foundation is to lead

collaborations among the FDA, academic research institutions and industry

designed to bolster research and development productivity, provide new tools

 

for improving safety in regulated product evaluation, and in the long term

make the development of those products more predictable and manageable.

 

Mr. KENNEDY. That is exactly the purpose of the Foundation, which was

included in the drug safety legislation Senator Enzi and I introduced last

year. The Foundation will be financially supported by industry and

philanthropic donated funds. A chief scientist at FDA will promote

intramural research and coordinate it with efforts at the Foundation.

 

Mr. HATCH. That explanation is very helpful. What, specifically, would the

role of the Foundation be with respect to dietary supplements?

 

Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall Foundation

will in no way override, overturn or conflict with the Dietary Supplement

Health and Education Act. Nothing in this bill would have that effect.

 

Mr. ENZI. Yes, we took great pains to make certain there would be no

conflict with DSHEA. Regarding foods, and dietary supplements are generally

regulated as foods, the general directive of the Foundation is to identify

holes in the evaluation of food safety and identify ways to address those

deficiencies through collaborative research with industry.

 

Mr. HARKIN. So to make this absolutely clear, what you are saying is that

the bill we are debating would in no way interfere with consumers' access to

 

dietary supplements?

 

Mr. HATCH. To add to that point, it seems that the language could, in fact,

help dietary supplement consumers, because it would allow collaboration

between government and industry to conduct research on issues that might be

helpful to supplement consumers?

 

Mr. KENNEDY. Yes, that is the case.

 

Mr. ENZI. I agree with Chairman Kennedy's assessment.

 

Mr. HATCH. I thank you for those assurances and that clarification.

 

Mr. HARKIN. This has been a very helpful discussion, because Senator Hatch

and I could never support legislation that would interfere with DSHEA and we

 

are glad to receive the assurances of the chairman and the ranking

Republican on the committee.

 

 

On May 1 we sent out another urgent call to action because Durbin was

planning an end run around DSHEA that would further attack dietary

supplements. Once again the people flooded the Senate and on May, 3, 2007,

Senator Hatch responded to the concerns we raised. The Congressional Record

states:

 

Mr. HATCH. Mr. President, a number of questions have been raised about how

the Durbin amendment on food safety, adopted yesterday by a unanimous vote,

would affect regulation of dietary supplements..

 

For the edification of my colleagues, section 201ff of the Federal Food,

Drug and Cosmetic Act, FFDCA, contains the definition of dietary

supplements. That definition includes a proviso that supplements are to be

considered foods, except in the instance when a product makes a drug claim.

In other words, by Federal law, dietary supplements are generally considered

 

to be foods.

 

It is for this reason that the language of the original Durbin amendment

establishing a new adulterated food registry could have been read to apply

to dietary supplements.

 

This raised problems for me, and indeed for our colleague Senator Harkin,

since we had spent more than 2 years working with Senators Durbin, Kennedy,

and Enzi to draft, pass and enact the Dietary Supplement and Nonprescription

 

Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new

program so that reports of serious adverse events related to the use of a

dietary supplement or over-the-counter drug would be reported to the Food

and Drug Administration, FDA, on a priority basis.

 

As I said, the Durbin amendment contemplates a new adulterated food

registry. Under the provisions establishing that registry, reports of

adulterated foods would be made by many, if not all, of the same parties who

 

are required to file reports of serious adverse events associated with the

use of dietary supplements under Public Law 109-462. And so passage of the

Durbin amendment could be seen to supersede the law we enacted last year for

 

supplements, which I am relieved to hear was not the intent of our

colleague, Senator Durbin.

 

Consequently, the amendment we adopted yesterday contains language that

Senator Harkin and I suggested to make certain that dietary supplements

would not be covered by the new food safety language and thus last year's

law would not be superseded. To reassure those who are interested in the

Dietary Supplement Health and Education Act, DSHEA, I wanted to take a

moment to outline those changes.

 

First, there is new language in the section establishing the adulterated

food registry to express the sense of the Senate that: (1) DSHEA has

established the legal framework to ensure that dietary supplements are safe

and properly labeled foods; (2) the Dietary Supplement and Nonprescription

Drug Consumer Protection Act has established a mandatory reporting system of

 

serious adverse events for nonprescription drugs and dietary supplements

sold and consumed in the United States; and (3) the adverse events reporting

 

system under that act will serve as the early warning system for any

potential public health issues associated with the use of these food

products.

 

In addition, language contained in the Durbin amendment modifies the

definition of supplement contained in 201ff of the FFDCA so that supplements

 

will not be considered foods for the purpose of the new adulterated foods

registry. This in no way would alter the time-honored conclusion of the

Congress that supplements are to be considered foods. On the contrary, all

it would do is exempt supplements from the registry.

 

These changes, all contained in the amendment which was approved yesterday,

make clear that there are no new dietary supplement requirements in the Food

 

and Drug Administration Revitalization Act. It is my hope this will reassure

 

the many who have expressed concern that Congress was inadvertently

repealing Public Law 109-462.

 

The voice of the people has been heard. Let us not forget these promises nor

 

let the FDA forget them -- as the questionable language regarding the

Reagan-Udall Foundation for the FDA still remains.

 

Waking up the American public to the larger issue of drug safety is a much

more challenging task. Kennedy and Enzi are claiming that the Reagan-Udall

Foundation for the FDA is nothing but a friendly non-governmental research

foundation. I will fully document in a subsequent article that this is not

the case. It is actually the tool by which Big Pharma and Big Biotech will

lock in their profits for the next 50 years, as FDA joins them in the drug

development and marketing business. This is one of the greatest safety

threats in the history of America.

 

The battle now moves to the House and then to a conference committee. The

legislation is being ramrodded through before the general public knows what

is happening. Mainstream media, a primary client of Big Pharma, is

intentionally failing to explain the true meaning of S1082. There is still

time for Americans to determine their fate.

 

 

Be Well,

Marcia Elston http://www.wingedseed.com

http://www.aromaconnection.org

" Give thanks for a little and you will find a lot. " Hausa Saying from

Nigeria