OT: Who is Protecting the Public Health?

[Guest guest]

This article is off-topic but contains important information for anyone who

is concerned about the quality of medical care in the U.S. and some other

countries. These things are not just happening in the U.S. For example,

the playing fast and loose with scientific methodology in service of profits

also is happening in the UK countries, in particular in Great Britain.

 

Yes, the situation really is as dire as many people have suspected.

 

The article appears on Dr. Mercola's website. I believe the address is

http://mercola.com

 

(Specific links to articles on the Mercola site are long and frequently

don't work.)

 

Victoria

 

Who is Protecting the Public Health?

Can We Trust The Regulators?

By Meryl Nass, MD

 

Part 1 of 2

 

Twenty years ago, as a newly qualified doctor, I spent a lot of time in the

library reading review articles about my patients' diseases.

 

Twenty years later, my time in the library is too often spent reading about

problems and conflicts of interest within the medical establishment. Here

are a few examples:

 

Industry-funded research results in a much higher proportion of studies

showing positive results for new drugs, compared to publicly-funded

research.

 

Flawed regulatory oversight resulted in licensing, then withdrawal, of many

dangerous drugs in the past five years.

 

Established protections for human subjects in medical research, which did

not prevent the deaths of several subjects in high-profile cases recently,

are being undermined.

Can Medical Research Findings Be Trusted?

 

The education of my later years has produced a doctor who is forced to fall

back too often on anecdotal evidence and personal experience, rather than

trusting the " last word " of the experts and our top medical journals.

 

Despite all the information now at our fingertips, this loss of faith in the

quality of the available data pushes the practice of medicine backward, not

forward.

 

Report after report confirms that I would be foolish not to have serious

misgivings regarding the results of clinical trials, trepidation towards

newly licensed drugs, and a lack of trust in the so-called giants of my

profession.

 

Too many of these giants would enforce the practice of " evidence-based

medicine " and " clinical guidelines " on the rest of us: but the problem is,

who paid for the evidence and the guidelines?

 

JAMA recently reported that a full nine out of ten doctors on committees

that develop clinical guidelines had financial ties to the industry whose

products they recommend.

 

Six of ten doctors had financial ties to companies whose drugs were

considered in the guidelines they wrote. And pharmaceutical companies paid

for the development of 25 per cent of the guidelines.

 

If medical research is done properly, with good controls and enough subjects

for statistical validity, why do so many studies yield answers that are in

direct opposition to each other?

 

It was widely reported this week that mammograms do not save lives; the

studies that had claimed they did, were fatally flawed when they were

(finally) carefully examined.

 

There is no question that use of mammograms leads to earlier diagnosis of

breast cancer than not using mammograms. But this does not result in

improved life expectancy. Does it mean that we should stop seeking early

detection for breast cancer - that breast cancer is in some way different

from all other cancers?

 

Are We Even Asking the Right Question?

 

Is the problem the mammogram, or is the problem that aggressive treatment of

breast cancer could actually decrease life expectancy in many cases, so that

overall there is no treatment benefit in this disease? I don't know the

answer. Has anybody performed solid research to answer the question?

 

Because there exists a multi-billion dollar establishment that deals with

breast cancer in a fairly monolithic way, one is limited as to what

questions are allowed to be asked. (You can ask away, but who will fund your

research?) Research funded by the federal government is generally

constrained to stay within the existing boundaries of disease management,

despite its public funding. It will often mirror corporate-sponsored

research.

 

When you don't ask the right questions in clinical research, you can obtain

answers that result in worse patient care. Corporate sponsors of research

are not going to spend millions for a trial that could produce an answer in

conflict with their goals, if they can avoid it. (Unfortunately, their

" wrong " answer could have important clinical implications, but since the

industry has often tried to prevent publication of negative results, we may

never learn of these research findings.)

 

Since the drug manufacturer's primary responsibility, whether funding

research or in other matters, is to the bottom line, we should not expect

any other behavior.

 

However, the role of federal agencies is oversight and regulation. Their job

is to protect all those with a stake in clinical research: the researchers,

the subjects, and the public, who may someday need the treatment in

question. Federal agencies should simply acknowledge that pharmaceutical

companies have interests that will not align with those of patients and

physicians, and regulate them accordingly.

 

Loosening Institutional Protections

 

Over the last decade there has been a shift backward by regulatory agencies

charged with protecting the public health. Although the shift at FDA has

been blamed on the 1992 Prescription Drug User Fee charged to the

manufacturer to review new drugs and to expedite drug approval, the problems

seem to me to be much more profound.

 

Years ago, a new treatment had to be proven safe before it could be used;

during the past 8-10 years, unless there was significant evidence of danger,

new drugs were assumed to be safe. In a 1998 survey, FDA's medical officers

themselves reported that standards for drug approval had declined.

 

Richard Horton, editor of The Lancet, last May described the FDA's process

for the re-licensing of a drug that had earlier been taken off the market.

He explained, step by step, how the FDA had a " two track process, one

official and transparent, one unofficial and covert. "

 

FDA controlled the composition of its advisory committee, and its agenda, so

the committee would not overturn the agreement already made between senior

FDA staff and industry executives.

 

Clearly, there is a big problem at FDA.

 

A move to weaken human subject protections in clinical research has occurred

parallel to this weakening of drug oversight.

 

CDC recently sponsored a trial of post-exposure anthrax vaccine use. FDA

approved the trial. The study's consent form acknowledged that preliminary

data showed anthrax vaccine could cause birth defects.

 

Since for the preceding two months antibiotic treatment had been 100 per

cent successful at preventing anthrax in those exposed, it was not at all

obvious that vaccination offered any additional benefit. Yet pregnant women

were invited to enroll as subjects.

 

Isn't it unethical to offer a vaccine to pregnant women that might cause

birth defects, and was unlikely to provide them with clinical benefit? But

that wasn't the end of it.

 

FDA just approved the license for anthrax vaccine, and approved a new

anthrax vaccine label, which became public five weeks after the CDC study

began. The new label clearly states that no animal experiments have ever

been performed to determine the vaccine's effect on pregnancy.

 

What logic led both CDC and FDA to experiment on human fetuses in the

complete absence of animal fertility data? How could pregnant humans be used

as guinea pigs, before any pregnant guinea pigs or mice were studied?

 

These Agencies Have Lost Sight Of Their Mandate To Protect The Public

Health.

 

Their lack of ethics might have been influenced by the Defense Department's

contribution to their budgets, which amounted to $2.5 billion last year for

CDC.

 

Additional moves are afoot to weaken the protections for children in

clinical research. Children cannot provide informed consent; therefore, how

can you ethically use them as experimental subjects? Until now, there had to

be a very good reason to use a child. For example, the child had to have a

disease that would benefit from a new treatment.

 

The Jesse Gelsinger case, in which a teenager died from participation in a

gene therapy experiment from which no personal benefit was expected,

demonstrated that fully informed consent is often missing in clinical

trials.

 

Informed consent is presented to potential participants by the researcher,

who has a vested interest in signing up subjects. Its oversight by

institutional review boards tends to be cursory. In the Gelsinger case, the

principal investigator, along with the University of Pennsylvania, had a

large financial stake in the outcome of the experiment.

 

Perhaps half the drugs used in children have never been licensed for

pediatric use. They are prescribed " off-label " by clinicians. Is this a

problem? Not for most drugs, such as antibiotics, which have demonstrated

safety and efficacy over many millions of doses. Both patients and doctors

are perfectly satisfied using such drugs in the pediatric population, on or

off label.

 

But in the case of other drugs, such as psychotropic medications, many

doctors are loathe to prescribe for children without adequate pediatric

testing. Drugs that are given indefinitely are better moneymakers than

antibiotics, which are only used for 10 days at a time. So expanding

approvals for chronic drug use into the pediatric age group could yield

handsome rewards.

 

Perhaps as a result, the rules for using children in clinical research are

being undermined. No longer would a child need to clearly demonstrate

potential benefit from a new treatment before being enrolled in a trial;

proposed rules would allow a child who is simply " at risk of " the condition

to be used as a subject. But most of us are " at risk of " most diseases.

 

Furthermore, new consent forms have been developed that allow adolescents to

provide a modicum of " informed consent. " (They were used in CDC's recent

anthrax vaccine trial.) Treating a child like a small adult for the purpose

of obtaining research subjects weakens the authority of the parent to

protect his child. When it is nearly impossible for an adult to understand

the legal implications of the consent form he signs, what must it be like

for a child?

 

When a family is paid for a child's participation in research, the parent

joins the researcher in assuming a conflict of interest.

 

Unless there is a clear potential benefit to the child, let's keep our

children out of the laboratory.

 

Continued in the next issue of the newsletter

 

 

--

 

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

encounters in mainstream news reports. Corporate bottom lines and inadequate

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Related Articles:

 

The Death of Medicine

 

 

 

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