Pharma Conspiracy: Are they withholding cures for cancer?
address the theory that alternative medicine is a legitimate option,
equal in plausibility to standard medicine, based on the conspiracy
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.
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?
must take the practitioners word for it, or take on faith the accuracy
and truth of a testimonial.
Is the conspiracy theory 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
Pharma, the entity that allegedly suppressing
cures, is a collective of independent
companies, which cannot make binding decisions on behalf of all.
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" submits drugs for FDA approval with limited
potential to cure in order to keep the conspiracy alive? ... or that they are
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?
Are we to believe that FDA
approves only drugs with
limited benefit and that the agency
will reject drugs that are more
Are we to believe that Congress has enacted laws to ensure
of new drugs
by the FDA as part of this conspiracy? Or that the American
through its representatives (who also get cancers), are complicit in the "conspiracy?"
And if a conspiracy existed, why would any company
invest so much time and money developing and testing new cancer drugs
... when most investigational new drugs fail to demonstrate
Are natural compounds at a disadvantage
because they cannot be patented?
A natural product might be defined as a compound taken directly
from its source in nature - such as from an animal or plant (a
leaf from a tree). Noting here that there is no structural
difference between man-made versus natural compound (made by a plant or animal).
Nor is there any inherent (magical) safety or toxicity advantage for
natural compounds. We may
associate "natural" with safety. But many plants
and animals produce poisonous compounds in order to avoid being eaten by
animals and insects, or to kill off competing plants.
Consider how many common house plants are toxic to our pets.
There are many proven cancer drugs that have been purified or
synthesized from natural sources, such as Taxol (yew tree),
vincristine (periwinkle), and etoposide (may apple).
Noting that it's unwise for any patient to self
treat by eating these plants.
Even natural compounds considered safe at dietary levels can be toxic at the doses
needed to have therapeutic effects against cancer.
Identifying the dose that can be safely given to have a
treatment effect require clinical
trials that gradually increase the dose and monitor for toxicity
and concentrations of the compound (or the metabolites*) in the
blood (PK studies).
* Some drug compounds are changed (metabolized) by the
body prior to circulating in the blood
Natural compounds can be useless in their native forms due
to impurities or because the native source provides an
insufficient amount of the active ingredient. You might have to
consume bushels of leaves to
see a therapeutic effect - and your body would have to process
all the impurities of those leaves as well.
* Furthermore, compounds that are
taken orally may be merely excreted - never reaching the blood
system and hence never affecting the tumors unless, perhaps, if they are
located in the colon.
Most often the active compound derived from natural products
needs to be altered to optimize the binding to the treatment
target or to reduce its toxicity. So the issue of patent
law for natural products is rarely a true issue - one that inhibits the study.
We can be assured if such compounds
existed in the native form, the NCI or privately funded research
would take action ... again because everyone is affected by
cancer, every family, no matter how privileged.
And if such a compound was identified .... the clinical study
would be the same: you have to first identify the safe dose and
determine if there is activity at that dose,
then run prospectively defined clinical studies to demonstrate
it is safe and effective for a specific type of cancer.
We are not qualified to make assertions about patent law as it
pertains to natural compounds. However, it appears from the
following that patent law is not an insurmountable challenge for
the study of natural compounds to treat disease. Here the questions and answers in a Supreme Court proceeding
indicate that a new method of extraction, or function, or to
achieve a higher
concentration of a natural product can make it eligible for
“JUSTICE GINSBURG: Mr. Hansen, Respondents say that
isolating or extracting natural products, that has long
been considered patentable. Examples were aspirin and
whooping cough vaccine. How is this different from
natural products? …….
JUSTICE ALITO: Can I take you back to Justice Ginsburg’s
question, because I’m not sure you got at what troubles
me about that. Suppose there is a substance, a chemical,
a molecule in the leaf – the leaves of a plant that
grows in the Amazon, and it’s discovered that this has
tremendous medicinal purposes. Let’s say it treats
breast cancer. A new discovery, a new way is found,
previously unknown, to extract that. You make a drug out
of that. Your answer is that cannot be patented; it’s
not eligible for patenting, because the chemical
composition of the drug is the same as the chemical that
exists in the leaves of the plant.
MR. HANSEN: If there is no alteration, if we simply pick
the leaf off of the tree and swallow it and it has some
additional value, then I think it is not patentable. You
might be able to get a method patent on it, you might be
able to get a use patent on it, but you can’t get a
JUSTICE ALITO: But you keep making the hypotheticals
easier than they’re intended to be. It’s not just the
case of taking the leaf off the tree and chewing it.
Let’s say if you do that, you’d have to eat a whole
forest to get the value of this. But it’s extracted and
reduced to a concentrated form. That’s not patent
MR. HANSEN: No, that may well be eligible, because you
have now taken what was in nature and you’ve transformed
it in two ways. First of all, you’ve made it
substantially more concentrated than it was in nature;
and second, you’ve given it a function. If it doesn’t
work in the diluted form but does work in a concentrated
form, you’ve given it a new function. And by both
changing its nature and by giving it a new function, you
may well have patent …”
* In the News:
USPTO Patent Eligibility Guidelines: A Topsy Turvy Approach for
* USPTO Guidelines Blur “Natural” And “Novel” Products |
National Law Review
Identifying an active
compound in nature is only a small part of what it takes for
patients to derive benefit from it. Just as we would not fly
across the Atlantic in a plane built in our neighbor's garage, it is
unwise to self-treat based on untested theories from friends and
strangers who present them on the Internet.
companies deserve our scrutiny but they are also subject to
The expertise and
financial resources of large
companies are needed to reliably develop treatments for disease for
many reasons, such as:
The source in nature
must be abundant and the process of extraction must be reliable.
Many hundreds of trees may be needed to obtain a sufficient
quantity of taxol for just one patient.
The dose and schedule
of the compound must be determined through clinical testing,
which is a very expensive process requiring oversight and
scientific methods. Patients must enroll in the trials in
order to evaluate the safety and activity of the compound - as
for any compound.
The development of any
treatment product (synthetic or natural) requires good
manufacturing standards to ensure proper and consistent dosing
and that the compound is free of contamination and that the
product can be distributed to medical doctors at a scale that is
needed to treat all patients with the disease.
Is our imperfect medical system partly to blame for
fostering said conspiracy theory?
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.
this influence can only occur when there is no standard of care
for a condition, when multiple (proven) protocols or procedures exist for a
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.
Inappropriate marketing after the approval
of medicines does sometimes occur.
However, FDA regulates drug commercials for that reason - the ads MUST include
the indication it is used for
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 of drugs 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 credentialed medical
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 published in respected peer-reviewed journals.
Progress is uneven at times and varies for different
medical conditions, particularly for indications where there is no
consensus on best practice. But, unlike alternative medicine, knowledge and practice is based on a
body of scientific and clinical knowledge that requires
testing the interventions in people with the disease. 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:
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
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
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
- And such studies are subject to vigorous independent FDA
review, and study methods must also be approved by Institutional
Review Boards (IRBs).
If clinical benefit is proven
for a drug product, 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
However, profit incentives also makes it necessary to have a rigorous and
independent review of the clinical data submitted to win
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
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
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.