Big
Pharma Conspiracy: Are they withholding cures for cancer?
Here we address the theory that alternative medicine is a legitimate option, equal in
plausibility to standard medicine, based on the conspiracy theory:
See
Among the Top 10 [Dubious] Conspiracy Theories is .... Big Pharma
http://www.livescience.com/strangene...heories-1.html
While discovery and marketing of
medical products is driven by profit, companies must first prove the agent effective for a specific medical
condition, which is a challenging regulatory process, involving investigators, data monitoring
boards, and FDA review. The process requires controlled studies describing the methods up
front, such as the
number of patients, the defined medical condition, and how outcomes are
measured, both positive and adverse.
In contrast:
Alternative Medicine has no such requirements. For example, we have no idea about rates of response or how a response is even
defined for a given alternative practice. One in a thousand? None?
We
must take the practitioners word for it, or take on faith the accuracy
and truth of a testimonial.
The conspiracy theory is just not plausible:
Three in five Americans will get a serious cancer - including scientists, medical doctors, regulators, owners of drug companies - including, sadly, their loved ones and children.
-- Thus, a conspiracy to hide cures for cancer would
require the complicity of medical doctors and experts when their children get cancer.
Would not the parents with knowledge of the conspiracy relent when
their child was diagnosed? Silence under such circumstances
would be unthinkable, and also criminal.
The conspiracy theory also does not explain the high
cure rate for some cancers (eg. > 80% for Hodgkins disease), and
that the majority of childhood cancers are cured. Is the conspiracy for some types of cancers and
not others?
Furthermore:
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Pharma, the entity that allegedly suppressing
cures, is a collective of independent
companies, which cannot make binding decisions on behalf of all.
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And if a conspiracy existed, why would any company
invest so much time and money
developing and testing new cancer drugs?
Are we to believe that "the industry" submit drugs for FDA approval with limited
potential to cure in order to keep the conspiracy alive? ... or that they are
intentionally
passing on an opportunity
to become wealthy and save lives for the good
of its competitors!
Would we not see the companies that have developed cures
protesting such a system,
vigorously by taking strong legal action?
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Are we to believe that FDA
approves only drugs with
limited benefit and that the agency
will reject drugs that are more
effective?
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Are we to believe that Congress has enacted laws to ensure
independent review
of new drugs
by the FDA as part of this conspiracy? Or that the American
public,
through its representatives, are complicit in the "conspiracy?"
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Is our imperfect medical system partly to blame for
fostering said conspiracy theory?
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Admittedly, financial conflict of interest can lead to the misuse of clinical science, such as the overuse of certain
approved tests and drugs - or the use of one drug over another.
However,
this influence can only occur when there is no standard of care
for a condition, when multiple (proven) protocols or procedures exist for a
medical condition.
Lack of evidence from comparative studies provides a fertile landscape for "creative"
marketing, bias, and defaulting to what is more profitable, even
if unconsciously. We
support the Comparative
Effectiveness Research initiative for this reason.
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Admittedly, inappropriate marketing after the approval
of medicines does sometimes occur.
However, FDA regulates drug commercials for that reason - the ads must include
the indication and the known risks.
While physicians can prescribe off-label use of approved drugs
(for indications it was not approved for), the sponsors cannot
promote such use in advertisements, and this use must be based on
plausible science regarding the mechanism of the drug for the
unapproved indication, and also clinical reports
supporting efficacy published to respected medical
journals.
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Inappropriate influences on approved
medical practice requires our vigilance, and perhaps new legislation -
but these influences are generally subtle and offset by clinical
practice guidelines, set by professional associations based on
clinical evidence from studies.
Progress is uneven at times and varies for different
medical conditions. But knowledge and practice is based on a
body of scientific and clinical knowledge. That is, clinical
practice is a group endeavor, evidence-based as opposed to based on
the theories of individual practitioners acting independently
without standards of evidence.
You might look up "Standard of Care" or "Clinical
Practice Guidelines" to read more about such standards.
Brief background on drug development and approvals:
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Before drugs can be marketed in our country they must
be proven effective for a specific medical condition or
indication, such as first line therapy for follicular
lymphoma.
The evidence for approvals must be based on clear and convincing
evidence of meaningful clinical benefit -- proving that the
intervention provides benefit relative to the disease untreated,
or treated differently ... or that it addresses an unmet clinical
need.
The evidence of clinical benefit - that the positive effects outweigh the risks - is derived from independent review of studies involving human subjects -- typically randomized controlled studies carried out by investigators at multiple centers.
Responses are measured independently based on standards for
response that predict clinical benefit. Follow up of the
participants is required, as is the detailed accounting of adverse
events.
- And such studies are subject to vigorous independent FDA
review, and study methods must also be approved by Institutional
Review Boards (IRBs).
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If benefit is proven, marketing exclusivity
(a temporary monopoly) is granted to the sponsor. This
reward provides an incentive to persuade companies (and investors)
to do the expensive and high-risk research and testing, a test
that is often failed - and these are very expensive failures.
So the long-shot chance to make a substantial profit is what drives
the expensive and high-risk research to develop and test drugs for
the diseases that afflicts us. Removing profit incentives would have a chilling effect on
clinical research.
However, profit incentives also makes it necessary to have a rigorous and
independent review of the clinical data submitted to win
marketing approval.
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In conclusion:
The conspiracy theory to withhold cures
from the public is just not credible or plausible, and is not
supported by any evidence.
That drug research is done for profit
does not support or give credence to the conspiracy theory or
alternative medicine.
Profit incentives are
provided by our society to encourage needed but difficult clinical research.
However, this agreement
does not dictate what is approved by FDA, which, by law, is based on
the rigorous review of evidence from clinical trials, and that
evidence must be substantial.
Ironically, sadly, the peddling
of false hope for profit is what drives alternative practices,
which runs unabated with no regulatory oversight or standards for
evidence.
More work is needed to remove
inappropriate market influences on clinical practice of approved
interventions, but clinical practice is mainly guided by
evidence from clinical research, subject to peer review, and vigorous
regulatory review for the initial indication.
KarlS
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