Who is Protecting the Public Health? Part 2

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http://www.mercola.com/2002/mar/6/public_health2.htm

 

Who is Protecting the Public Health?

 

Can We Trust The Regulators?

By Meryl Nass, MD Redflagsweekly.com

 

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 Robert 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 Laurence Gostin, a law professor at

Georgetown University and professor of public health at Johns 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, Kathryn 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

 

 

 

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 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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Related Articles:

 

The Death of Medicine

 

 

 

References

 

Horton R. Commentary. Lotronex and the FDA: A fatal erosion of integrity. The

Lancet 2001; 357: 1544-5.

 

Drug After Drug, Warnings Ignored. With Study Results Ignored, Nation Got

Another Blood Pressure Drug. LA Times 2000.

 

Landow L. FDA Approves Drugs Even Wh

en Experts on its Advisory Panels Raise Safety Questions. BMJ 1999; 318: 944.

 

Friedman MA et al. The Safety of Newly Approved Medicines: Do recent market

removals mean there is a problem? JAMA 1999; 281:1728-34.

 

Wood AJJ. The Safety of New Medicines: The importance of asking the right

questions. JAMA 1999: 281: 1753-4.

 

Lurie P et al. Safety of FDA-Approved Drugs (Letter and reply). JAMA 1999: 282

 

Angell M and Relman AS. Prescription for Profit. Washington Post, 6/20/2001, A27

 

Wood AJJ and Woosley R. Making Medicines SaferóThe Need for an Independent Drug

Safety Board. NEJM 1998; 339: 1851-4.

 

Bodenheimer T. Uneasy Alliance: Clinical Investigators and the Pharmaceutical

Industry. NEJM 2000: 342: 1539-44.

 

Brennan TA. Buying Editorials. NEJM 1994: 331: 673-5.

 

Mucklow JC. Reporting Drug Safety in Clinical Trials: Getting the Emphasis

Right. The Lancet 2001; 357: 1384.

 

Chalmers I. Underreporting Research is Scientific Misconduct. JAMA 1990; 263:

1405-8.

 

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

Anti-Inflammatory Drugs in the Treatment of Arthritis. Achives of Internal

Medicine 1994; 154: 157-63. [Conclusion: The manufacturer-associated NSAID is

almost always reported as being equal or superior in efficacy and toxicity to

the comparison drug. These claims of superiority, especially in regard to side

effect profiles, are often not supported by trial data. These data raise

concerns about selective publication or biased interpretation of results in

manufacturer-associated trials.]

 

Ionnidis JPA and Lau J. Completeness of Safety Reporting in Randomized Trials.

JAMA 2001; 285: 437-43.

 

Woodward B. Challenges to Human Subject Protections in US Medical Reseaerch.

JAMA 1999: 282: 1947-52. [Conclusion: Nationally and internationally, there are

new pressures to subordinate the interests of the subjects to those of science

and society. The National Bioethics Advisory Commission, which is about to

undertake a comprehensive review of the US system of human subject protections,

faces a daunting task.]

 

Zoon KC. Vaccines, pharmaceutical products, and bioterrorism:

Challenges for the US Food and Drug Administration. Emerging Infectious

Diseases 1999;5:534-536.

 

 

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