CAM >  Big Pharma Conspiracy Theory?

Last update: 01/19/2019

New section added:  Are natural compounds at a disadvantage
because they cannot be patented?

Yes, Pharma are gov-granted monopolies overcharging public who cannot not buy life-sustaining drugs.

No, they're not suppressing cancer "cures."
It's not possible to know a drug cures without testing it! All trials on human subjects must be published by law.
 

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. 

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.  

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 not others?  

Furthermore:

	To know a drug cures a disease you have to test it in clinical trials. All research involving human subjects must be vetted by ethics committees and the independent FDA.  By law, all of these studies are posted on ClinicalTrials.gov with the results.
	Pharma, the entity that allegedly suppressing cures, is a collective of independent  companies, which cannot make binding decisions on behalf of all.
	Are we to believe that "the industry" tests and then submits 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?
	Are we to believe that FDA approves only drugs with limited benefit and that the agency  will reject drugs that are more effective?
	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 (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 efficacy?
	By Congressional statute the FDA is an independent reviewer of clinical trials submitted for marketing approval. Standards for approval include well-controlled studies of adequate size. If an FDA reviewer fails to disclose a financial conflict it is a felony.

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 patent protection:  

“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 composition patent.

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 eligible?

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 Natural Products http://bit.ly/1ly0UQS

* USPTO Guidelines Blur “Natural” And “Novel” Products | National Law Review http://bit.ly/1feK6KE

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.  

Yes, big companies deserve our scrutiny but they are also subject to regulatory oversight.  

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.  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.

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 journals.

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 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).

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 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.

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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