Treating the Diseases of Medical Research

Many promising treatments are going unresearched because they cannot be patented. An alteration of an existing piece of US legislation: "The Orphan Drug Act" may allow pharmeceutical companies to profit from this research and hence show interest.
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April 27, 2012 - PRLog -- Imagine research which suggested that ulcers were caused by a bacterium and could be treated by a very high dose of antibiotics in conjunction with a strong antacid. If this discovery were true it should ‘self-promote’. That is, it should, without any intervention other than publishing the finding, surface as the truth which is observable, repeatable and verifiable. If it does not emerge as the accepted truth, then by contraposition, it was not the truth to start with. That is the dogmatic view of accepted by mainstream medicine and the associated politics which surround it.

There is however another interpretation available to us. Perhaps we failed to observe the truth of the antecedent statement because we were wearing glasses forged by a system designed not to see it. You see antibiotics are not re-patentable, nor are antacids. Both of these medications have already been patented (most of the patents have indeed expired) and you can’t re-patent a medication for human use except perhaps a ‘use patent’ which is the weakest form of patent and almost impossible to enforce.

Use Patents

If it was discovered that taking a ‘Tylenol’ (generically known as Acetaminophen) a day for 4 weeks got rid of acne, then the researcher could apply for a ‘use patent’ for Acetaminophen in treating acne, but once the truth was out, everyone would simply buy a month’s worth of Acetaminophen and administer the treatment themselves. It would be impossible to have the cashier at the pharmacy ask: “Are you taking Acetaminophen for acne?” and upon a positive answer add a surcharge to fund the research that went into the discovery. Can you imagine? In anything short of a Utopian world, the researcher and the investor who provided funds to get the treatment protocol through all the levels of testing would make nothing.

“You can’t handle the truth.”

The truth about the medical research system is a bit more insidious in that if indeed Acetaminophen was effective at a four week regimen in treating acne, we’d likely never see nor hear of such research at all. Imagine the original researcher, perhaps a clinician who discovers that his/her patients on long term Acetaminophen are acne free. S/He then runs a little trial in their own clinic giving 4 weeks Acetaminophen to one group of patients and a placebo to another group. We’re already in huge trouble and that clinician risks losing his/her license for experimenting on a group of patients without following proper procedures. A clinician is NOT a researcher. Clinicians are free to apply the results of research but not to conduct it. The most a law abiding clinician can do is mention his/her hunch to a researcher and hope for the best.

Patent or Perish

Now the ball is in the court of the medical researcher. Suppose a medical researcher hears of this hunch from several clinicians and is convinced it warrants further investigation. The bar for acceptance of a new treatment is a Phase III clinical trial involving multiple universities and research establishments and requires a fully randomized trial involving thousands of patients. These trials and the approval process are hugely expensive running anywhere from 100’s of millions to near billions of dollars depending on who gives the accounting. In order to recoup this loss drug companies need watertight patents to protect their investments in the years after the discovery. So if you were a medical researcher with a 4 Week Acetaminophen protocol for acne and a plant derivative from an ultra-rare, previously unknown, rain forest mushroom which improves the survival for cancer by 15% on average: which would you present to your boss? If you answer that question honestly you’ll come to the realization that a 4 week protocol of Acetaminophen to cure acne will fail to surface as truth because not due to its inherent lack of truth, but because it is filtered out by a filter media which absorbs all things unprofitable.

Now the four week protocol of Acetaminophen to cure acne is fiction, as far as the author knows. However, the high dose antibiotic in conjunction with a strong antacid as a cure for many persistent gastritis problems and ulcers is not. The initial reports of a bacterium called Helicobacter Pylori (H. Pylori) living in the stomach and causing repeated stomach upset and ulcers was met with high levels of scepticism. The common thinking of the time (80’s and 90’s) was that bacteria couldn’t live in the acid environment of the stomach where the acid was similar in strength to a car battery. As you might now suspect, the treatment of the condition, a simple already patented antibiotic and antacid was more of the problem for the treatment of the disease than the pesky H. Pylori bugs that were actually causing the problem. Lacking a treatment derived from a rare rainforest mushroom, patent protection was unavailable and the researchers were unable to provide their colleagues with the results of a Phase III randomized trial to convince them.

Laughter is often the chorus of the minions about to accept the truth.

The researchers were ridiculed and dismissed until Dr. Barry Marshall in Western Australia drank a beaker of the bugs and rapidly developed nausea, vomiting and gastritis. He published the result of the endoscopy which confirmed gastritis and the presence of H. Pylori. Following a protocol of strong antacids and antibiotics, the infection was cleared. The paper was quickly accepted and the treatment of chronic ulcers and gastritis has undergone a paradigmatic shift. In 2005 Drs. Barry Marshall and Robin Warren (co-discoverers) were awarded the Nobel Prize in Medicine. This sounds like a medical success story, but is it?

In 1994 the National Institutes of Health in America issued a statement that ulcers and chronic gastritis were likely the cause of H. Pylori. This announcement came some 12 years after the 1982 original discovery. By the late 90’s early 2000’s there were breath tests for H. Pylori available to doctors instead of the more laborious blood tests. But what if legislative and systemic devices were in place that would have allowed Drs Marshall and Warren to bring their discovery to light earlier?

Orphan Drug Program a Model for Treatments Orphaned by Non-Patentability

In the early 80’s, legislators in the US were trying to solve a similar although, strictly speaking, unrelated problem. Orphan diseases which are classified as diseases affecting less than 200,000 people in the United States were bereft of treatments and cures largely for the related problem of discoveries have too few patients against which to recoup the investment of research dollars. Through a variety of systemic changes including reduced requirements for Phase III trials, tax benefits, subsidization and most notably enhanced patents protection (7 years without competition). In the years prior to this legislation only 38 drugs were approved in the US for orphan diseases. From the inception of the Orphan Drug Act in 1983 to 2004, 1129 drugs have received orphan drug designation and 249 have received full market authorization.

The Financially Orphaned Treatment Act

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Page Updated Last on: Apr 27, 2012 News
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