Who is Protecting the Public Health?

[Guest guest]

Who is Protecting the Public Health?

Can We Trust The Regulators?

By Meryl Nass, MD Redflagsweekly.com

http://www.redflagsweekly.com/nasspubhlth.html

Part 2 of 2 (Part 1)

Employing Bioterrorism Fears to Weaken Regulatory Oversight

You cannot compel people to become experimental subjects: that is the legacy

of Nuremberg. If a drug or vaccine is not fully-licensed, it cannot be

forced on anyone.

But it is desirable to have drugs ready to counteract a chemical or

biological attack If the illnesses anticipated from an attack do not occur

naturally in the population, one cannot test the new drugs for

effectiveness. It would be unethical to expose people to a chemical or

disease just to test whether the new drug is truly protective.

That results in a conundrum: if you have to prove effectiveness in human

trials to license a drug, but you can't do the trial, then you can't license

the drug. If the drug is not licensed, it can be used with informed consent,

but you cannot force people to take it.

The Defense Department was not satisfied with that. There is no provision

for informed consent on the battlefield, and a soldier who refuses an

experimental treatment could endanger the lives of his colleagues, so they

said.

Presidential Order 13139 was issued by President Clinton to deal with this

situation. It allowed the President, in consultation with the Secretary of

Defense and the FDA Commissioner, to require that troops take experimental

drugs or vaccines in special circumstances.

That should have been adequate to take care of the situation, but the

federal authorities were still not satisfied. The National Research Council

(of the National Academies of Science) was contracted to report on

protecting troops from bioterroism.

" How can we ensure safety of troops if we have to go through an onerous two

or five years of certification [for new drug approval]? " asked Love,

the study director.

His June 2001 report recommended that the Army seek exemptions from some

regulatory approval processes to speed up the development of new medical

treatments.

CDC did its part by contracting with ce Gostin, a law professor at

town University and professor of public health at s Hopkins

University, to create a " Model Law " that the states would be encouraged to

use.

It would give state officials the authority to involuntarily quarantine and

vaccinate citizens, among other things. Does it seem odd that HHS is giving

the states a blueprint to consolidate control over their citizens in the

event of bioattack?

FDA had already embraced the new regulatory culture. How better to both

speed up drug approvals, and save the President the political cost of

contravening the Nuremberg Convention than by weakening the current

requirements for drug licensing?

After acknowledging that the effectiveness of bioterrorism drugs could not

be tested in humans, and therefore animal efficacy tests should be used

instead, FDA prepared to throw out the baby with the bathwater. In 1999,

hints that human safety testing would be jettisoned as a requirement for

licensure began to appear.

The 1999 Annual Report for FDA's Center for Biologics said: " A research

program to produce vaccines, therapeutics and drugs to treat [bioterrorism]

outbreaks faces the challenge of not being able to proceed with Phase III

efficacy clinical trials.

Given ethical and safety concerns that would rule out infecting human

subjects with a deadly organism in order to test a vaccine or therapeutic

for efficacy, trials with humans cannot be undertaken. Therefore, the

regulatory process for approval of treatments must be modified to permit the

emergency use of antibiotics, therapeutics and vaccines that have been shown

to be safe and effective in animal models. "

Wait just one minute.

Nobody needs to be infected with anything to test drug or vaccine safety.

All you do is administer the drug or vaccine, and watch the recipient for

possible adverse effects. Could this leap of faith in animal models have

been a mistake?

After all, it is universally acknowledged that human adverse effects cannot

be extrapolated from animal tests. Each species responds uniquely to a drug

or vaccine. Vaccines that are safe in some species can be fatal in other

species, and this cannot be accurately predicted ahead of time.

Unfortunately, it looks like there is no mistake. The director of FDA's

Center for Biologics, Zoon, published a paper in " Emerging

Infectious Diseases " in which she reiterated the call to fully license drugs

for bioterrorism in the absence of any human testing.

She said that once licensed, the safety of the drugs can be assessed. It is

hard to reconcile this philosophy with Dr. Zoon's role as a federal

regulator charged with protecting the public health.

The latest episode in this saga concerns Congress' role in bioterrorism

prevention. A bill designed to fund federal bioterrorism efforts, called the

" Public Health Security and Bioterrorism Response Act of 2001 " was passed in

December by both the House (H.R. 3448) and the Senate (Senate Amendment

2692) on the same day it was introduced in both houses.

Both the House and Senate versions of the bill contain a provision mandating

that FDA finalize and implement a 1999 Notice of Proposed Rulemaking. This

action would allow animal efficacy tests to be sufficient to fully license

drugs and vaccines intended for bioterrorism. Although safety testing is not

explicitly addressed in the bill, given the statements made by FDA above, it

appears that safety testing in humans may be waived as well, as a

requirement for licensure.

Another way to look at this bill's provision is as a way of getting around

the absolute requirement for informed consent. As was pointed out earlier,

people are allowed to use experimental drugs and vaccines, as long as FDA

has approved the experimental use and the patient or subject has provided

informed consent.

By licensing what would previously have remained an experimental drug, one

opens up the possibility of forced use, with no need for informed consent.

The Nuremberg Convention, first nibbled at by mandating use of experimental

drugs in the Gulf War theater, looks like it is about to be completely

overturned.

This bill is now in conference committee. Congress should be informed that

despite having undergone human safety and efficacy tests to be licensed,

many drugs and vaccines have still had to be withdrawn from use due to

severe side effects, including death. These side effects were usually not

discovered until the drugs were given to large numbers of people.

In the case of drugs and vaccines for bioterrorism, it is likely that,

following an attack, the entire country will receive a drug or vaccine in a

crash program, over days or at most weeks. This leaves no time to assess the

adverse event profile of the drug in smaller numbers of people, before it is

given to the entire population.

If the " Model Law " is used, forced acceptance of drugs or vaccines that have

never been tested in a single human could be demanded of the entire U.S.

population. One poor choice of a drug or vaccine that is later found to be

dangerous could have a dire effect on a very large number of people.

Human Safety Testing Is Not Something We Should Allow To Go By The Board.

This article covers a lot of ground; I think it is the most important piece

I've ever written. Please at least read the final few paragraphs. The issues

covered (I've connected these dots to show a disaster looming) include

untrustworthy research, inadequate evaluations before new drug approvals, a

blueprint just provided by HHS to the states to legally compel citizens to

take drugs and vaccines, erosions of the Nuremberg protection mandating

informed consent for human experiments, and jettisoning the need for human

trials of drugs and vaccines before (possibly forced) use.

Meryl Nass, MD

Redflagsweekly.com

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DR. MERCOLA'S COMMENT:

Dr. Meryl Nass's article provides more referenced documentation as to how

the enormous conflict of interest is rapidly deteriorating traditional

western medicine.

It is my hope to facilitate medicine's transition to the terminal phase.

The US will spend 1.5 trillion dollars for health care this year.

The vast majority of these funds are just wasted.

You might have thought that most of this money went for hospital care.

Wrong.

Americans have spent more on prescription drugs than hospital care for the

last several years. Hundreds of billions are going to drug companies for

drugs that only treat symptoms and allow the person to continue to

deteriorate without addressing the underlying cause of disease.

Is This Situation Getting Worse Or Better?

Well, overall healthcare costs are rising by 7%, but we are averaging a

close to 20% increase in drug spending every year. The US Congress is on the

verge of approving a $100 billion bonus to drug companies. Before you know

it we will be paying one trillion dollars to the drug companies

One Trillion Dollars.

That is one thousand billion dollars. The late Senator Everett Dirksen from

Illinois was fond of talking about Defense Department spending by saying " a

billion dollars here and a billion dollars there, and before you know it you

are talking about real money. "

If you ask me spending one trillion dollars on therapies that rarely solve

the problem seems more than a bit extreme. It sure seems like there is more

than enough surplus in this amount to more than solve most all of our health

care problems.

Additionally, most of the surgeries that are done in the US are also

expensive and unnecessary thus increasing the cost of health care in the US.

Folks, there is a solution and it is my goal to facilitate that solution.

All we need to do is wake up the population to the inexpensive alternative

to drugs.

You can do your part by letting all your friends and relatives who are using

expensive drug based solutions for their health problems that there are

other options that will turn their health around.

The first step would be to encourage them to subscribe to this newsletter

which will keep them posted to many of these options and, more importantly,

in the near future will be able to help identify qualified health care

professionals in your local area who can help them implement these

strategies.

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The mission of redflagsweekly.com is to probe medical, scientific,

environmental, artistic and political issues in a manner that one rarely

encounters in mainstream news reports. Corporate bottom lines and inadequate

training in specialty journalism often provide the reading, viewing and

listening public with narrow and simplistic information.

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Related Articles:

The Death of Medicine

http://www.mercola.com/2002/feb/27/death_of_medicine.htm

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References

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Chalmers I. Underreporting Research is Scientific Misconduct. JAMA 1990;

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Rochon PA et al. A Study of Manufacter-Supported Trials of Nonsteroidal

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