Analysis: Senate committee approves drug safety bill, but FDA still runs on Big Pharma money

"Jan Drew" wrote in message
t...
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Is it a step in the right direction? Sure it is.

Absolutely. This is definitely good news. I will be letting my senators know
that I want them to vote for the bill.

Thanks for letting us know.

Is it a real solution to FDA corruption and Big Pharma influence over
conventional medicine? Not even close.

Again, correct.

Jeff

http://www.newstarget.com/z021800.html

NewsTarget.com printable article
Originally published April 19 2007
Analysis: Senate committee approves drug safety bill, but FDA still runs on
Big Pharma money
by Mike Adams

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5
to approve a bill that aims to strengthen FDA oversight of drug company
advertising and post-approval follow-up studies. The bill was sponsored by
Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward
Kennedy. The primary motive for the bill is to give the FDA more power to
stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to
the bill's provisions, saying it would slow down drug approvals. Republicans
also argued that the banning of drug advertisements on television was
"unconstitutional."

The bill aims to accomplish several things:

1) Allow the FDA to fine drug companies that fail to conduct post-approval
safety studies.

2) Allow the FDA to ban advertising of new drugs for two years after their
initial approval.

3) Allow the FDA to review the safety of newly approved drugs 18 months
after approval, and then again at 36 months (three years).

4) Raise the amount of money paid to the FDA by drug companies for the
review and approval of their drugs.


Analysis, commentary and satire by Mike Adams
Okay, let's get to the real story here. The bill has good intentions, but
even if it passes, it still leaves the FDA fully in charge of a medical
monopoly, paid and influenced by drug companies, and does nothing to outlaw
direct-to-consumer drug advertising.

Relevant facts about the FDA and Big Pharma:
a.. The FDA is funded in part by the drug companies themselves. Employees
who work at the FDA know that drug companies ultimately help fund their
paychecks. This creates a dangerous level of collusion between a regulator
and the industry it claims to regulate, turning it into a business /
customer relationship. This is one reason why the FDA is so eager to please
Big Pharma: That's who's paying (part of) the FDA salaries!

b.. The United States is the only advanced nation in the world that allows
drug companies to advertise directly to the public. It is a dubious practice
that has no scientific or medical justification whatsoever. It was legalized
in 1998 by the FDA and contributed directly to the Vioxx fiasco as well as
the mass medication of American children with mind-altering drugs. Drug
advertising should be banned outright. A two-year ban is better than
nothing, but an outright ban is the only reasonable resolution of this
issue.

c.. Just because this new Senate bill would "allow" the FDA to fine drug
companies for failing to conduct follow-up safety studies doesn't mean the
FDA will actually do so. Much of the language in this bill assumes the FDA
actually desires to regulate drug companies and protect the American public.
Yet past behavior by the agency has proven the FDA has very little interest
in protecting the public. Thus, any "optional" language in the bill may
ultimately be useless. A good bill would require the FDA to take specific
actions, levy certain fines, and oversee the necessary safety studies.

d.. The fact that the Bush Administration is speaking out strongly against
this bill is an indication that it's a step in the right direction. Big
Pharma has strong financial ties to the Bush Administration and its top
officials. Any proposed law that would tighten safety requirements and
dampen the advertising and promotion of medications would suppress the
profits of drug companies. Hence, Republicans are arguing against the bill
in order to protect their campaign supporters -- the drug companies.

e.. The Republican argument that banning drug advertising on television
would be "unconstitutional" tells us all just how quickly and easily some
Republicans have forgotten what the Constitution really says. Freedom of
Speech does not protect the right to harm (and ultimately kill) American
citizens through a mass campaign of false advertising that promotes deadly
products to people who are being tricked into thinking they really need
them.

f.. Humorous observation: Some lawmakers no doubt think that the Fourth
Amendment, which protects us from "unreasonable searches and seizures," must
be referring to anti-seizure medications.
Doing a poor job? Just ask for a raise...
Whose idea was it anyway that the FDA is doing such a fine job with
regulating the drug companies that it deserves to be paid even MORE money by
Big Pharma? It's certainly nothing new in Washington: The worse you do the
job, the more money you get.

But the idea is ludicrous. Why should the FDA be even more financially
beholden to drug companies than it is already? Shouldn't we be trying to
extricate the FDA from drug company influence and let the agency stand on
its own, funded with public money, and operating on some sort of sworn oath
to protect the consumer?

If things were set right, the FDA should be Big Pharma's worst enemy. The
FDA should be hammering drug companies with stringent safety requirements,
skeptical thinking about drug benefits claims and huge fines for those
companies that get caught conducting fraudulent science or burying the
results of drug studies they don't want the public to see. To be really
effective, the FDA needs:

1) Complete independence from Big Pharma. This means the agency must run on
public funds only and receive no money from the industry it claims to
regulate.

2) A new set of scary teeth. The FDA needs to be able to take strong action
against drug companies by levying fines, banning dangerous drug products and
even confiscating pharmaceutical inventory. Don't you find it curious that
the FDA has raided lots of vitamin companies and confiscated countless
truckloads of nutritional products, but has never (to my knowledge)
conducted an armed raid on a major pharmaceutical company and confiscated
the brand-name prescription drugs that are actually killing people?

The truth is, the FDA treats Big Pharma with kid gloves. It even
"negotiates" with drug companies to decide on how, and when, and at what
size safety warning labels should be printed. This is absurd, and it shows
who's really in charge when it comes to drug safety (the drug companies
themselves!).

Then again, all this assumes the FDA actually wants to protect the public,
and I don't believe the agency wants to. I think the FDA just pretends to
protect the public in order to meet the minimum regulatory requirements that
prevent a real Congressional inquiry. The FDA seems to be merely going
through the motions of regulating drug companies, without actually pursuing
the task with any genuine sense of purpose.

It's like an empty shell of a government regulator. It might as well be
renamed to, "The Big Pharma Administration." Because that's where much of
the money comes from, and that's where the interests of the top decision
makers seem to be focused.

Kudos to Wyoming Sen. Mike Enzi for having the courage to co-sponsor this
bill. I've personally met Sen. Enzi, and he's among the most progressive,
energetic Republicans you'll find in the Senate. It must have taken really
political courage for him to put his name on such a bill, knowing that the
leaders of his own party would line up so strongly against him on this
issue.

For Senator Kennedy, the decision was probably a little easier. Democrats
are increasingly aligned against Big Pharma, and there's broad support in
the Democratic party for some sort of major health care reform that would
likely involve major FDA reforms at the same time.

But they both deserve credit for trying to move this bill forward. It's not
the bill that I want, but it's a bill that's better than what we have right
now. It's a step in the right direction, and sometimes that's all you can
realistically hope for in Washington.

In case anybody out there is interested in REAL reform that would rein in
the drug companies and protect consumers, here are the top five things that
need to be done:
The top five reforms we really need
1) Ban all direct-to-consumer drug advertising. It never should have been
legalized in the first place. There is no logical medical argument that
justifies the practice of promoting prescription drugs directly to
consumers.

2) Fund the FDA entirely with public money. It's crucial to disconnect the
FDA from the purse strings of Big Pharma. FDA funding should come from those
it answers to: the taxpayers.

3) Make the reporting of drug side effects mandatory. When doctors or drug
companies learn about a patient experiencing a side effect, it should be
mandatory to report that side effect to the FDA.


4) Require the open publication of all drug studies. Currently, drug
companies hide the studies they don't want you to see, and they only
publicize the (fraudulent) studies that produce the results they like. We
need to change this and shine some light on the results of ALL clinical
trials to let doctors, patients and everyone else examine the science for
themselves. (The pharmaceutical industry argues venomously against this.
They think drug studies should be kept secret.)

5) End conflicts of interest at the FDA. Require, by law, that anyone who
works for the FDA, advises the FDA or participates in FDA decision processes
has no financial ties whatsoever to drug companies or medical device makers.
No consulting fees, bribes, stock options or incentives. The people who make
decisions about the safety of the drugs approved in this country should have
no financial ties to the companies impacted by their decisions. It's common
sense.

Pretty simple, huh? Five reforms that would restore some honesty and
integrity to the FDA.

Protecting consumers from dangerous drugs is really not that difficult. The
necessary reforms are easy to see. It's just that drug companies have their
financial tentacles wrapped around so many legislators that real reforms are
politically strangled to death before they have a chance to get voted on
("killed in committee"). With some notable exceptions, Congress has been
bought out by Big Pharma. Wholesale, meaningful reform is currently not even
being debated. The only things being talked about are changes so tiny that
it's like pointing a rowboat two degrees to the left as it floats aimlessly
in a sea of corruption.

Is it a step in the right direction? Sure it is.

Is it a real solution to FDA corruption and Big Pharma influence over
conventional medicine? Not even close.