Who is Protecting the Public Health?

[Guest guest]

Can Medical Research Findings Be Trusted?

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.

Is that what you call (medical) science?

When medical professionals do not trust to (medical) science, can you call it

" science " ?

Some members of this group would rather trust science, then their own

experience.

Well ... ... think again!

Your toilet bowl may no more about your health, and how you should maintain

it, then your doctor.

Smart is believing only half of what you hear,

brilliant is knowing which half to believe.

Regards

Agnes

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Who is Protecting the Public Health?

Can We Trust The Regulators?

By Meryl Nass, MD

http://www.mercola.com/2002/mar/2/public_health.htm

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.

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 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

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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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Related Articles:

The Death of Medicine

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