FDA Reform Advances - But is it Enough?

Thursday, May 10, 2007

FDA Reform Advances - But is it Enough?

by Mark S. Senak
Eye On FDA

Yesterday the Senate overwhelmingly voted on an FDA Reform package (93-1 vote) that is a legislative solution to many of the issues that have heavily tarnished the agency's once gold standard image. The bill is the much awaited "Kennedy-Enzi" bill, also known as The Enhancing Drug Safety and Innovation Act of 2007. Now, the House will take up matters and when passed, it will go to the White House later this summer.

But the reform packaged in the bill is only a solution to the extent that a lack of authority was the problem. After all, up until 6 years ago, the agency did fine without these added powers.

That is not to say that the legislation is not needed - it is. In fact, the agency probably needs more authority than given in the context of this bill.

But what looks to be the eventual passage of the bill should not signal that the problems are now addressed. How those reforms are employed matters every bit as much as having them to execute. This should be viewed as a process and not an event - and FDA reform legislation is only the beginning of that process.

Source: EyeOnFDA.com

RELATED READING:
- Loading Up the PDUFA Cart
- Food Safety: FDA Communications During Crisis

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1 Comments:

Anonymous said...: Resolving The Worsening
Crisis At The FDA
5-11-7

The FDA has been taken over by the very industries that it was meant to
regulate. This is outrageous; this is tragic; at times, this is even
criminal. The unholy alliance between corporation and state have bled out
even the pretense that the FDA is working for the benefit and safety of the
American people. The FDA is a failed bureaucracy under corporate control.
This sad litany affects every single American, and is compellingly detailed
in this article by Stephen Fox. His analyses are at times horrifying, yet
are always medically and legally accurate; his recommendations concerning
corrections, especially at the state (rather than Federal level) are
insightful.

KP Stoller, MD
President, International Hyperbaric Medical Assoc
Medical Director, Hyperbaric Medical Center of New Mexico
http://www.hbotnm.com/
______________________

By Stephen Fox

Never before in Human History has food chemistry been so precarious and so
critical to the health of billions. This results from multinational
corporate biochemical mayhem going unchecked by regulatory bodies in every
nation, the worst two being the United States Food and Drug Administration
and Chinas total lack of standards. This crisis is worsening, demonstrated
by the FDA failing to discern the imported melamine from China in the wheat
and rice gluten additive to pet food that has already killed at least 4000
pets, and the failure to prevent imports of diethylene glycol, the fake
glycerine from China added to medications as a sweetener, which has killed
hundreds, especially children, from Panama to India to Bangladesh.

These egregious vignettes, however, pale in epidemiological comparison with
harm done by the manufacturing of neurotoxic and carcinogenic food additives
in general, which is rapidly destroying health in hundreds of nations. My
own theory is that melamine, not normally very toxic, became poisonous when
mixed with cyanuric acid in the bottom of the vats in China, a theory also
advanced by Richard Goldstein at the Cornell College of Veterinary Medicine.

Food-flavoring workers in California were recently diagnosed with
bronchiolitis obliterans, a rare and life-threatening form of lung disease,
also known as popcorn workers lung, particularly in workers at microwave-
popcorn factories; the disease destroys the lungs. Since 2001, studies have
shown links between the disease and a chemical used in artificial butter
flavor called diacetyl. Flavoring manufacturers have paid out more than $100
million as a result of lawsuits by people sick with popcorn workers lung
over the past five years. One death from the disease has been confirmed
among workers; how many have gone undetected in the general population?

Lawsuits against Pfizer and Zoloft have resulted in the FDA recently
requiring antidepressant manufacturers to add suicide warnings to their
products, a belated public relations gesture. Even the normally unflappable
Dr. Andrew Von Eschenbach, Commissioner of the United States Food and Drug
Administration, was very recently appointed a new Assistant Commissioner for
Food Safety and Security, Dr. David Acheson, M.D. A 1980 graduate of
University of London Medical School, Acheson trained in internal medicine
and infectious diseases then taught at Tufts Medical Center and researched
food borne pathogens, focusing on Shiga toxin- producing E. coli. He also
participated in FDA discussions about the fact that heating french fries to
425 degrees transforms the starch into the carcinogenic acrylamide. (In 2003
and 2004, then Attorney General of California Lockyer tried to officially
label french fries as containing a chemical known to the State of California
to cause cancer, over the objections of the fast food lobby and the FDA
commission at that time. Perhaps the present AG of California, Jerry Brown
will continue this vital consumer protection battle).

Rep. Rosa DeLauro, Connecticut Democrat and senior member of the House
Appropriations Committee, blasted Achesons appointment as a
mere "reshuffling of management" doing little to prevent future
outbreaks. "The agency should have a sense of the barriers, gaps and most
critical needs in our food safety system," DeLauro said. "What is needed to
adequately protect our food supply is strong enforcement authority that
would require mandatory recalls of contaminated products and a commitment
from agency management to follow-through with safety investigations."

This pet food thing has shown people, including people at the very highest
levels of the administration, that something needs to be fixed. If this isnt
a wake-up call, the people are so asleep they are catatonic, stated William
Hubbard, Associate Director of FDA from 1991 to 2005. As long as the system
depends on government inspectors to detect problems and pull dangerous
foods, its a failed system, said Michael Taylor former Director of the
Agriculture Departments Food Safety Service. Former FDA Commissioner David
Kessler, who served under both Bush I and Clinton, maintained that major
improvements were needed from Congress, the industry and the FDA."The food
safety system in this country is broken," Kessler told the Oversight and
Government Reform Committee. Kessler said the FDA needed more money for food
safety efforts and should make it a higher priority. "Food safety can't be
delegated to second-tier management within the agency, and the fact is that
food is a second-tier priority within the FDA," Kessler said.

More money for more experts? Was Kessler joking? We wantonly add chemicals
to almost everything we consume as food, almost none of which existed 101
years ago when the Pure Food and Drugs Act was passed, the precursor of the
1937 FDCA that created the FDA (except for Saccharin from Monsanto, invented
in 1904). Ralph Nader published THE CHEMICAL FEAST in 1970. Everything is
done for superficial appearance or taste. Sodium hexametaphosphate added to
potatoes. Sodium Erythorbate, Sodium Nitrates and Nitrites TBHQ, BHA, and
BHT, some of which chemical relatives of embalming fluid routinely added to
meats and manufactured food products, result in cancers from heated
carcinogenic nitrosamines. Artificial sweeteners, made by adding chlorine to
sugar (Sucralose/Splenda) or Aspartame, metabolized as methanol and
formaldehyde. Take coffee beans; add mercurial fungicides during the
transport, then mix the coffee with chemicals like artificial sweeteners and
non-dairy creamers, or even just the regular old recombinant bovine grown
hormones, found in 99% of the USAs milk, all at higher temperatures which
release the proven brain tumor causing diketopiperazine from the Aspartame
molecule. Ship cases and cases of Diet Sodas to the Middle East, store them
out in the sun at 120 degrees, and then are you surprised when the troops
drinking 12-15 daily of these come home with neurological impairments
conveniently dubbed Gulf War Syndrome, as if someone else were responsible
for these Weapons of Mass Destruction?

Are you surprised when children drinking sodas for breakfast and having
manufactured junk food at lunch doled out in the federally funded school
lunch programs develop behavioral problems like the Attention Deficit
Hyperactivity Syndrome, or worse genetic afflictions like Autism? Or when
they fail academically or develop criminal pathologies at an early age, and
they develop Adult Onset Diabetes at the age of 10 or 11? Add in pesticides,
herbicides, fluorine and chlorine in the water, and unburnt hydrocarbons and
carbon monoxide in the air, and you have a witches brew of toxic chemicals
that is destroying health in the USA and other nations. When activists,
lawyers, and legislators try to take some tiny incremental step to begin to
correct even one of these problems, they are met with a solid wall of
bureaucratic intransigence, corporate lobbyists, stonewalling, and idiotic
denial of even the basic premises of their arguments, as if that to reveal
that critics are paranoiac will somehow defuse their arguments.

At the level of the New Mexico Legislature 2005-2007, it became absurd to
talk to State Senators about the obvious need to prevent Aspartame from
harming our children, while six out of nine of them were obliviously
guzzling their own can of Diet Coke! Only when bodies pile up killed by
chemicals, as they did from DDT, Agent Orange, Asbestos, Vioxx, and others,
will the corporate clamor and smoke and mirrors evaporate. Only when the
massive lawsuits and judgments begin to roll up will regulatory authorities
like the FDA be FORCED to rescind the approval for more of these harmful
chemicals, and will see state-level FDAs created by legislatures.

Once, I had hope about FDA Commissioner Von Eschenbach, a cancer survivor
who proclaimed that he sought to end cancer by 2015.However, in every single
case wherein he was contacted by Aspartame victims, physicians treating
Aspartame poisoning, citizen activists, and even state and national
Senators, he has either ignored them or else diligently toed the line of
cranking out corporate-pleasing lies. In his letter responding to 21 New
Mexico legislators asking for Aspartames approval to be rescinded, Von
Eschenbach said FDA has yet to be presented with credible scientific
evidence! Fact: FDA has always completely ignored or discredited evidence
laid before them (just google Ramazzini Oncology Foundation, Dr. Russell
Blaylock, Dr. H.J. Roberts, Dr. Betty Martini, and others, to read some of
the evidence).

I am suspicious of Dr. Acheson, the recently appointed Food Safety and
Security Deputy Commissioner. At best, he is a band-aid pasted on to thus
far unsolved afflictions, another gutless apparatchik appointed to appease
our increasingly angry public, yet not rock the boat of the grander
Administration schemes of corporate-driven Haliburton-corrupted
plutocracies, health be damned. Acheson has thus far obtained the ringing
endorsement of the Grocery Manufacturers of America, who lick his boots and
count on him to do absolutely nothing to correct the medical, neurological,
epidemiological, and educational harm done by the biochemical mayhem and
chemical feast called mainstream American cuisine.

Hillary Clinton very recently called on FDA and the Agriculture Department
to strengthen regulations for imported and domestic foods. In a letter to
Secretary Mike Johanns of the USDA and to Commissioner Andrew Eschenbach,
Clinton wrote that "On top of the direct threat to human health, this
contamination also threatens our agricultural industries. It is
unconscionable that America does not have proper mechanisms in place to
adequately test and track food and feed materials from overseas." She
asked: "What procedures you plan to put in place to test food and feed
products coming in from overseas, especially countries with lax food safety
standards? How you can improve the monitoring and tracking of products once
they enter into the United States? How you will alert the public to these
problems in the future?"

However, as long as we have current and prior Presidents and the rest of the
current Presidential candidates addicted to junk food, unable to recognize
the neurological harm done by their own guzzling of aspartame in diet sodas,
is there any political resolution possible to curtail general
fast food corporate abuses of human health? Please let me know what you
think!

Stephen Fox
Founder, New Millennium Fine Art
Stephen@santafefineart.com; 9:04 PM