According to congressional investigators, the Food and Drug Administration has allowed drugs for cancer and other
diseases to stay on the market even when follow-up studies prove their ineffectiveness.
The FDA’s “wonder” drug marketing Fast Track System – whereby drug companies only have to promise to do the
research and clinical studies later – AFTER their “wonder” drug is brought to market – is now finally being exposed
for the failure such drug company collusion could only, eventually lead to. Ideally, before too many more people
become ill or die from unknown and untested for side effects.
A report due out this week from the Government Accountability Office (GAO) will also reveal that the FDA has never
pulled a drug off the market due to a lack of required follow-up research regarding actual benefits — let alone fatal
or erroneous side effects – even when such information is more than a decade overdue. And when pressed about
that policy by Associated Press writers, FDA officials said they have no plans to get more aggressive.
The GAO report says that the FDA should do more to track whether drugs approved based on preliminary results
actually live up to their reported promises.
The FDA already responded that the report paints an overly negative picture of its so-called "accelerated approval"
program, which is only used to approve drugs for the most serious diseases.
As a note, the currently available H1N1 “Swine Flu” vaccines have YET to go through clinical trials and – despite
reports that continue to flood in on significant and sometimes fatal side effects from the EU and US, these untested
vaccines continue to be promoted and, in some states, made mandatory for whole population segments.
THE FDA’S DRUG FAST TRACK SYSTEM
In 1992, the FDA began speeding up the approval of novel drugs based on a drug’s theoretical results, or laboratory measures that suggest
the drug may make improvements in patient health. HIV drugs, for example, are cleared based on their potential virus-lowering power. H1N1
“swine flu” vaccines have as well.
WHO DO YOU TRUST?
Obviously drugmakers favor the FDA “fast track” program because it helps them get products to market sooner without conducting long-term
patient studies that can take years and cost hundreds of millions of dollars. However, a stated condition of obtaining quicker approvals is
that the drugmakers must conduct thorough follow-up studies to show the drug's benefits actually panned out. Too few are in compliance and
none are pulled off the market should their reports reveal inept effectiveness or dangerous drug side effects.
The GAO report, according to a copy obtained by the Associated Press, identified several drugs still on the market that never lived up to
their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to
missing or unimpressive follow-up data.
"FDA has fallen far short of where it should be for patient safety," said Sen. Charles Grassley, R-Iowa, who requested the investigation.
Of the 144 follow up studies that the FDA has already required under the program since 1992, only 64 percent have been reported as
completed and more than one-third are still pending, according to the GAO. Investigators said the FDA does not rigorously track whether
companies are making progress on their required studies.
FDA officials say they have overhauled their tracking system, but citing one example as in the case of Shire Laboratories' low blood
pressure treatment ProAmatine. The required study for the “winder” drug has gone incomplete for more than 13 years. The GAO found that
ProAmatine has generated more than $257 million in sales, even though the clinical benefit of the drug has never – ever – been established.
Not surprising, Shire spokespeople would not respond to a request for comment.
In numerous other cases, the FDA continues to fail to act even when company studies show drugs did not improve patient outcomes.
The FDA approved AstraZeneca's lung cancer drug Iressa in 2003 based on early claims that it reduced the size of tumors. But later studies
showed the drug did not. Still, the FDA has left the drug on the market, despite hundreds of reports of it causing a sometimes fatal
While the FDA officials explain that access to Iressa has been restricted to a small number of patients who have shown benefit, the agency
now recommends all other patients try two alternative drugs and Iressa "is not being made available to new patients according to
spokespeople at AstraZeneca.
The GAO report concluded that the FDA has no policy for pulling ineffective or wholly dangerous drugs off the market when they were
approved through this “fast track” system. When GAO investigators confronted FDA officials about this lack of enforcement, they reportedly
said it would be difficult, if not impossible to draft a standard policy for withdrawals, given the unique circumstances of individual drugs.
And THIS is the government agency responsible to protect US citizens from dangerous drugs while enforcing adequate testing of drugs
being proposed for consumer use.
"FDA should explain the principles it uses to make decisions such as drug withdrawals," said Principal Deputy Commissioner Dr. Joshua
Sharfstein, in an interview with the AP. "But we don't want to lock ourselves into a specific set of criteria that takes away the flexibility to do
what's right for the public health."
Sharfstein added that the agency has a task force assigned to look at policies like drug withdrawals.
Some consumers advocates say that's not good enough.
"The FDA has talked a lot about doing more enforcement, but this is an area where they're basically defending not enforcing the law," said
Dr. Sidney Wolf, of the consumer advocacy group Public Citizen.
Wolfe said the lax policy sends a message to companies that there is no penalty for failing to complete studies.
The GAO recommends the FDA clarify when it will pull drugs off the market.
"As the scientific experts charged with overseeing the use of drugs it approves, FDA should be in a position to implement this
recommendation," the report states.
Clearly the FDA is not in the business of protecting US citizens from poisons or snake oil pushers. Rather they are in the business of fast
tracking pharmaceutical “wonder” drugs and keeping them available on the market long enough for huge drug company profits - with or
without sufficient efficacy, safety testing, and side effect elimination.
Why should it take a congressional investigation to bring to light their inadequacies, confront them with their findings only to be replied to with
further FDA justification and reasons why nothing will change???
WHAT CAN YOU DO?
Take a stand!
Contact your government representatives – (get their email and mailing addresses here: http://www.winhs.org/contactgov.htm).
Let them know that something had better change and that they need to help ensure that the government addresses FDA inaction, corruption
and drug company collusion.
Drugs are being allowed onto the market without the required clinical testing needed to prove their efficacy and prevent serious and
sometimes fatal side effects. Clinical studies continue to be wholly fabricated or significantly and often dangerously edited.
No one is really held accountable.
At a time when Health Care Reform is of interest to both sides of the political debate, the FDA needs to be forced to do its stated job and
the corruption and apparent collusion with the pharmaceutical industry need to be fully investigated and dealt with.
Write your government representative today!
All the best,
Rudi C. Loehwing
World Institute of Natural Health Sciences
The "Business" of Drug: Congressional Investigation Confirms FDA Leaves
Bogus and Even Dangerous "Wonder" Drugs on the Market...
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