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$600,000,000 and $800,000,000. This is
clearly beyond the financial capabilities of most people and
institutions. As mentioned above, no company would spend such a
vast sum without the assurance of obtaining a patent to protect
their investment. I would, however, like to also address the
broader issue of the manner in which drug trials are currently
being conducted.
How
often have you seen a headline touting the latest clinical trial
results for a new cancer drug, claiming a “cure” is just around
the corner? How many of these miracle “cures” are still being
touted a year or two later? Indeed, if so many “cures” are being
found, why are age adjusted cancer rates continuing to rise? The
answer is simple: there is little substance behind the hype.
Despite
organized medicine’s insistence on placebo-controlled, double
blind studies as the “Gold Standard” for medical research, such
studies are NEVER
conducted for cancer drugs. The reason for this is obvious – it
would be unethical to deny treatment to a patient suffering from
a lethal disease. As a result, clinical trials for cancer drugs
are always comparative – measuring the effect of the new drug
against an existing alternative.
On the
surface, this seems a reasonable approach. After all, it would
be unconscionable to allow a patient to die just to test a new
drug. But what goes unsaid, however, is that even a marginal
improvement in results (as little as 5%), without consideration
of other aspects such as more serious side effects, is enough to
get a cancer drug approved.
A
specific example will illustrate this point.
In
1997, two new drugs, Anastrozole and Letrozole were hailed as a
major breakthrough in treating breast cancer. Both were members
of a family of drugs that inhibited the production of estrogen.
Estrogen has been shown to accelerate the growth of some types
of breast cancer. Ads for Anastrozole bragged that it had a
56.1% survival rate – an impressive result for late-stage breast
cancer. But claims about cancer drugs are often not what they
seem.
The
claim of a 56.1% survival rate, of course, implied that more
than half of the patients taking the drug benefited
significantly from taking it. But, the actual source of the
claim was a study comparing the two-year survival rates of
patients taking Anastrozole with those taking Megestrol Acetate,
an older drug that also inhibited estrogen production. What the
study actually showed was that women treated with Anastrozole
had a median time of 26.5 months to death, while those treated
with Megestrol Acetate had a median time of 22.5 months.
Although this difference was not statistically significant, it
was heralded as a “breakthrough.”
But
there was something else the ads did not reveal.
Anastrozole could cause more than fifty
different side effects including such potentially fatal
complications as blood clots. It also could cause congestive
heart failure. In contrast, Megestrol Acetate had far fewer side
effects.
In the
case of Letrozole, it too, had over fifty serious potential side
effects, and only one
in five patients even responded to the drug!
Despite
these dismal results, both Anastrozole and Letrozole are now
among the accepted chemotherapy drugs used to treat advanced
breast cancer!
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