Thursday, March 01, 2007

FDA regarding the safety of drugs

"On February 13, 2007 the House Energy and Commerce Committee's
Subcommittee on Oversight and Investigations opened hearings
lambasting the FDA regarding the safety of drugs. The opening
statement by Chairman John Dingell (D-MI) set the tone, "It is clear …
that the FDA is badly broken. I expect that before we finish this
investigation, which is just getting underway, we will discover
whether the problems we have found are due to the work of scoundrels,
irrational penny-pinching, or because the doors to the FDA "hen house"
have been thrown open to foxes. It may be a combination of all three."

Testimony given on February 13th and 14th should have curdled the
blood of Americans from coast to coast. The mainstream media, which
receives several billion dollars a year in advertising income from Big
Pharma, failed to report on the bone-chilling testimony that plainly
depicts FDA fraud and collusion that is allowing thousands of our
citizens to die at the hands of Big Pharma profiteering. Testimony by
Charles Grassley (R-IA) paints a picture of a rogue agency with near
complete disregard for the law, an agency intentionally exposing
Americans to known peril while actively covering the trail and working
in partnership with Big Pharma.

Devastating evidence is presented by scientists and researchers
showing that the FDA approved a dangerous antibiotic (Ketek), while
knowing that the research supporting its safety was fraudulent and
that there was no evidence the antibiotic was even effective. In fact,
the FDA was well informed that the drug could cause serious liver
damage resulting in death, and that they would be exposing millions of
adults and children to the drug. The testimony exposes the inner
workings of the FDA; as a matter of routine its scientists are
threatened and their warnings are ignored. It is crystal clear from
the testimony that the Ketek example is one of many FDA flagrant
violations of the public trust, a common theme that reveals FDA
management and Big Pharma are in fact operating as one team. On
February 12, 2007 the FDA issued a press release stating that Ketek
was no longer approved for common bacterial sinus and bronchial
infections. The only reason the FDA issued this warning is because of
the Congressional inquiry into their cover-up of criminal behavior,
not because they had any interest at all in protecting the public.

Dr. David Graham, the FDA employee/whistleblower that is a constant
thorn in the side of Big Pharma, testified and stated that Eli Lilly's
antipsychotic drug Zyprexa needs a thorough Congressional
investigation. The drug is known to cause obesity and diabetes, is
approved only for adult schizophrenics with serious mental disease,
and is being paid for mostly by taxpayer-funded programs. The drug
accounts for 28% of Eli Lilly sales, leading numerous people to wonder
why the FDA sits by and allows billions of dollars of Zyprexa to be
prescribed for children with mild behavioral issues, when it was never
approved for use in children and safety for children is completely

The FDA Sits in Judgment on Life and Death

It comes as a surprise for many Americans that over 100,000 deaths per
year and over 3 million serious injuries are caused by drugs – more
often than not by the never disclosed or even expected side effects of
the drugs. These estimates are conservative, based on official
reporting. With reckless abandon, like a drunk driver swerving
out-of-control, the FDA has betrayed the public trust and made
repeated decisions that expose Americans to unnecessary risk of death
and injury.

Naively, most Americans think the FDA is protecting them from harm. A
wake-up call occurred last year when the Institute of Medicine
released their long awaited federally-funded report on the FDA and
drug safety. After extensively interviewing numerous FDA employees,
the report stated that the FDA has a dysfunctional organizational
culture wherein the FDA and Big Pharma hide relevant safety data from
the public. A report earlier in the year found the FDA could not even
keep track of which drugs were on the market, let alone make certain
any follow up was done to ensure safety of those drugs. To the
contrary, the FDA is doing everything in its power to make sure a
citizen cannot sue in state court when a drug injures or kills –
actively working against citizen's rights.

The FDA responds to its critics by saying it needs more money. Critics
respond by saying more money is not the answer; it is the executive
decision-making process within the FDA that is hopelessly broken. The
reality is that the FDA, if given more money, would do little more
than attack competition to drug companies (alternative health), forge
ahead with its illegal Trilateral Cooperation Charter with Mexico and
Canada, and forward its clearly stated agenda of bringing newer and
riskier drugs to the market faster with even less testing.

Under a bizarre law enacted in 1992 known as PDUFA (Prescription Drug
User Fee Act) the FDA receives over half the money it needs for new
drug approvals from Big Pharma itself – a system more akin to Big
Pharma paying the mob for protection than the FDA ensuring drug safety
for the public. This law must be renewed later this year and already
the FDA is asking for even larger sums of money from Big Pharma. The
fox is indeed buying the keys to the henhouse. Life and death hang in
the balance.

The FDA is Now Headed by a Biotech Sales Rep

Dr. Andrew von Eschenbach is now the permanent head of the FDA, voted
in by the Senate during the lame duck session. His extensive financial
connections to biotech companies and the cancer industry were never
investigated. Senators, mostly under the spell of Big Pharma's wallet,
simply rubber stamped his approval. One Senator, Charles Grassley
(R-IA), had the courage to speak up. His Senate confirmation testimony
regarding Andrew von Eschenbach on December 7, 2006 was accurate,
frank, and to the point:

"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…Under Dr. Von Eschenbach, the FDA has not only avoided
transparency, it also has threatened those who are trying to
desperately expose the truth…."

Andrew von Eschenbach wants to make sure that no American can ever sue
a drug company in state court. He wants these laws in place because he
plans to turn a whole new array of dangerous biotech drugs loose on
the American public, while at the same time turning the FDA into a
drug development company – providing software that guides the
development of all new biotech drugs. If Americans could sue when they
are injured, they'd be suing the FDA. It is time for Americans to wake up.

Politics – Not as Usual

A major battle is brewing in the House and Senate over the future of
the FDA. The battle lines do not split down traditional Republican and
Democratic lines. The Congressional leaders on the good side are those
who realize the insanity of Americans being needlessly killed by drugs
and have the guts to stand up to the Big Pharma money lobby and take
action in the face of extreme vested interests and the personal threat
to re-election security.

Leaders on the other side are beholden to the Big Pharma golden idol
and have track records so entrenched with Big Pharma profiteering that
they should be considered enablers and in some cases co-conspirators
in the FDA/Big Pharma crimes. Topping this list are Edward Kennedy
(D-MA) and Orrin Hatch (R-UT), followed by numerous Congressional
sheeple who will do anything to maintain their positions of power –
based in no small part on the flow of money coming to their campaign
coffers from Big Pharma.

It is true that the Republican leadership of the last six years has
stalled all meaningful attempts at FDA reform. However, it should be
pointed out that a Republican (Charles Grassley of Iowa), standing on
true conservative values, is spearheading the campaign for meaningful
FDA reform.

What Can Americans Do

Americans must demand an independent office within the FDA to monitor
drug safety. Such a bill has been introduced by Senator Grassley and
deserves the support of all Americans. S.468 (also HR 788), the Food
and Drug Administration Safety Act of 2007, would create an
independent office within the FDA to monitor the ongoing safety of
drugs. No other solution will work. This is the type of legislation
that Big Pharma and the current FDA management deplore.

Without major public support it is highly unlikely that the Grassley
bill will even get a hearing. This is because the Senate committee in
charge of health legislation, known as the HELP committee (Health,
Education, Labor, and Pensions) is controlled by Edward Kennedy (D-MA)
and Mike Enzi (R-WY). Kennedy and Enzi have been negotiating with Big
Pharma and the FDA for over a year. Last year they used the issue of
drug safety as a political ploy to present a Trojan Horse bill (S
3807: Enhancing Drug Safety and Innovation Act of 2006.) Never has a
name been more misleading. It should have been called "Exposure of
Americans to Risky Medications and Creation of a New FDA Drug Company
Act of 2006." This bill would not have stopped any of the drug
scandals of the past five years and would actually act to create a
drug company within the FDA! Kennedy and Enzi are planning to
reintroduce an updated version of their fake drug safety bill, which
they can readily bring to the floor of the Senate for a vote.

Only an independent office within the FDA can effectively monitor drug
safety. Hundreds of thousands of American lives are at stake and the
health of millions hangs in the balance. Rome is burning. Can the
voice of the people be heard over the wallet of Big Pharma – a bank
roll that is ironically funded by U.S. taxpayer and U.S. corporate
dollars? Shall we fund our own demise or shall we stand and be heard?"


No comments: