Fwd: Who is Protecting the Public Health? Can We Trust The Regulators?

[Guest guest]

EXCERPT " 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? "

 

 

Who is Protecting the Public Health?

Can We Trust The Regulators?

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

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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manner that one rarely encounters in mainstream

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Corporate bottom lines and inadequate training

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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

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281:1728-34.

 

Wood AJJ. The Safety of New Medicines: The

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Lurie P et al. Safety of FDA-Approved Drugs

(Letter

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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

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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

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Emerging Infectious

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