Re: Vexing Vioxx

[Guest guest]

Dear Washington Post Editors:

In your January 2, 2006 editorial titled

" Vexing Vioxx, " you close with:

>It does not, however, alter our view that

>the courts are the wrong place to resolve

>disputes about drug safety.

As a scientist and long-time student of the

process, I must disagree because there is

no effective ethical scientific " panel " in

America today that can be trusted to

impartially decide issues of science, as

clearly demonstrated by: a) the apparent

knowing manipulation of the Vioxx studies by

" scientists " to hide/minimize the many risks

(heart attack, stroke, and severe silent

ulceration of the stomach) associated with

this drug so that they and/or their employer

might have the benefit while the public assumed

the risk and the numerous other product

cases, which have been cited in the past two

years.

Having seen the Institute of Medicine (IOM)

apparently prostitute itself to the instructions

of its employer (the Center for Disease Control

and Prevention [CDC]), I can attest that,

learning from " Big Tobacco, " Pharma and the

Healthcare Establishment have succeeded in not

only subverting their regulatory agencies, the

administrative and legislative branches of

government, and, with their advertising dollars,

much of the media, but have also subverted,

through their grants and licensing agreements,

many of the academics who would be selected to

judge these issues to the point that it is

obvious that many " scientific " decisions are

being made on the basis of what benefits the

Establishment with little or no regard for the

adverse health and other effects on the public.

Moreover, as the " Public Readiness and Emergency

Preparedness Act " provisions hidden in the 2006

defense appropriations bill (HR 2863) clearly

indicate, the Congress and the President seem to

have conspired to abridge the 7th amendment and

unconstitutionally restrict a plaintiff's access

to compensation for the harm that they and Pharma

know that their " life saving " products are

inflicting or will inflict on the American public.

Yet I see no " outrage " or even much in the way

of accurate reporting in the media about any

of the aspects of this " odious " legislation.

Finally, while the courts may be " the wrong

place to resolve disputes about drug safety, "

the courts in the Vioxx cases are only being

asked to resolve the issue as to whether the

a person (or his family when he dies) is entitled

to be compensated for the outcome observed

(a heart attack) associated with a drug, Vioxx,

which has a real BUT concealed risk (that should

not NOW [after the NEJM article] be in dispute)

to cause a heart attack and, therefore, by the

firm's knowingly concealing the risk, effectively

condemned the person who was severely injured or

killed by the subsequent drug-related heart

attack to harm or death; is, at a minimum,

civilly liable therefore for its negligence; and

should be required to appropriately compensate

those harmed by the drug firm's culpable actions.

With respect to your:

>The New England Journal of Medicine's retraction

>is expected to have an enormous impact on

>the thousands of lawsuits against Merck.

>But it is still not clear that doctors

>prescribing Vioxx several years ago would have

>behaved any differently had the journal article

>showed that the risk of heart problems was very

>slightly higher. Scientific judgments about the

>risks and advantages of drugs are not black and

>white -- which is why they are best made by

>scientists and by the regulatory agency that

>employs them, not by jurors through the lens

>of hindsight

>

I offer the following rebuttal.

Since you are even less qualified than the

jurors of which you speak to judge the import

of concealing drug-related heart attacks and

strokes, and you have deliberately misstated

and/or improperly minimized the risk projection

( " very slightly higher " ) for the drug Vioxx,

it is clear that the media is even less qualified

to make judgments about the " scientific " and

legal issues that this " opinion " piece raises

here than a jury after hearing the evidence.

Yet, paid (through their advertising dollars),

you seem to jump in and apparently blindly tout

the Establishment's view as if it were a reality

rather than your parroting of their views on

this issue.

Factually, contrary to your views (that scientific

" judgments about the risks and advantages of drugs

are not black and white " ), as long as an adequate

unbiased population is assessed by scientifically

sound, appropriate, and unbiased study plans and all

the risks, costs of those risks, and the true

benefits of a prospective drug are assessed against

the best current drugs (and not a placebo), scientific

judgments about the true risk (all costs to the public)

and benefits (true benefits to the society) are

independently assessed without regard to the " profit "

to the drug company proposing a new drug, then such

judgments can be almost black and white.

Unfortunately, the Healthcare Establishment and the

regulatory agencies have been subverted to the point

that the submitter is allowed to present the data (and

conceal the bad news) as it sees fit and is only

required, in most cases, to prove that the new drug

MAY (statistically at the 95% confidence level) be

somewhat better than a placebo (often using " surrogate "

endpoints chosen by the submitter).

Moreover, as Dr. Graham has testified, possible

problems seen by the government reviewing

scientists are suppressed by their superiors

who are more interested in helping Pharma get

their " new " drugs approved than they are in

protecting the health of those who will be

prescribed these new drugs.

In addition, if the government and their

scientists were the solution, then drugs for

non-life-threatening conditions with

significant health risks, like Vioxx and

Bextra, would not have been approved nor

would the less-than-effective but dangerous

Pertussis and Hepatitis B vaccine components

have been continued to be licensed and

recommended for general use in children and

babies.

Furthermore, many of the members, often the

majority, of the " scientific " advisory panels

that the government currently uses to recommend

drug-product actions have obvious conflicts of

interest that, at a minimum, cloud their ability

to impartially judge the " risks " and " benefits "

of a proposed " new " drug and do not seem to

properly consider the costs to those harmed in

their review deliberations.

Additionally, by infiltrating the panels that set

the thresholds for " normal " levels (thresholds

that are used to indicate when drugs are needed),

Pharma has been able to influence the lowering

of the " treatment " intervention levels for

cholesterol and other physiological parameters

even though the principal benefits, if not the

only true ones, seems to be to provide Pharma

with more customers for its products so that

it can sell more and make a larger profit.

Since this editorial suggests that your paper

has bought the Establishment's argument that

the Seventh Amendment to the Constitution

should be ignored, it would seem that your

paper is in favor of abolishing the Bill of

Rights whenever they conflict with the

interests of the Healthcare Establishment

whose advertising dollars help support your

paper.

Hopefully, those who read this response will

recognize the threat to their liberty that

your position represents, rise up and take

back America from the corporate and power

elites who seek to steal the American dream

and replace it with a greed-driven corporate

" bottom line " plutocracy that does not value

the freedom or rights of the individual,

including the right to a civil trial by jury

for injuries inflicted by drugs that

were once " guaranteed " by the Constitution

of the United States of America but, through

judicial rules and legislation, have been,

and are being, subverted by the interests of

the rich and powerful in America.

Respectfully,

Dr. King

http://www.dr-king.com

PS: Pharma is currently engaged in gutting its

middle- and working- class employment in

the United States by simply transferring

its product development and, where it can,

its dosage-form manufacturing operations

to third-world countries in Asia (e.g.,

Singapore, India, China) with significantly

LOWER:

a) labor,

raw material (that often are of lower

quality [Asian-produced components

typically have higher heavy-metal and

impurity levels]),

c) manufacturing facility, and

d) local direct (e.g., safety and health)

and indirect (e.g., environmental

discharges) regulatory

COSTS as well as with:

e) a significantly lower risk of an

in-depth FDA inspection.

In general, to mask their 3rd-world

production of the dosage-form units,

the final packaging operations are

still being conducted in the U.S. so

that the finished packaged product

has a U.S. label and the U.S. consumer

mistakenly thinks the drug product

was made in America from American-

quality components by Americans.

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