The Unpatentable Drug Issue

There is a gap in the FDA drug approval process that costs lives around the world

The Federal Drug Administration drug approval process is patent-based. FDA drug approval usually takes 10 to 12 years and 100 to 500 million dollars ref. Without a full patent and full ownership of the drug candidate, no pharmaceutical company will invest in drug development as they do not own the rights to the drug. The FDA expects drug companies to have patent protection to allow them the ability to recover the high drug research and testing costs. Even orphan drugs need patent protection and the FDA often goes one step further by granting marketing exclusivity to compensate for the smaller markets those drugs serve.

DCA is unpatentable. It is so unpatentable that Dr. Michelakis could not even get a trivial 'method of use' patent for it. ref. And DCA is just one of a growing number of materials known to have great anti-cancer effects, but do not fit into the system ref.

There is no system in place for the development of unpatentable drugs, materials in the public domain that have never been patentable. These potential therapies do not qualify as generic drugs either, as generics are formerly patented drugs for which the research data has been submitted, the drug approved, but the patents have expired. No data is in place for drugs that are not patentable.

Even Orphan Drugs require patents. And to help, the FDA may grant marketing exclusivity to the company to help them recover development costs. It took an act of Congress to make the Orphan Drug Act a reality. And digressing a bit, it appears the Orphan Drug Act is something of a failure, with only 16% approved and only 2 drugs being approved per year for 5600 ultra-rare diseases. ref.

Drugs in the pharmaceutical pipeline are supported by large budgets and eager champions pushing hard to get an FDA approval. This becomes a financial homerun for the company. No such arrangement exists for unpatentables. There are no champions, no funding, no lobbyists.

DCA is being used by large numbers of people around the world, with great effect and safety, and at very low cost. There are many other great unpatentable therapies available. However, without a system in place to allow research on public domain drug candidates, these therapies have no future. We cannot expect or demand private money be used to finance the research. And using public money to finance drugs that compete with those from private companies is a difficult road to take as well. But it is the only way to do it.

The money involved in medicine is enormous, the political pressures extreme. The drug companies, medical associations and insurance companies all profit greatly from the current system and have no incentive to change it. Just think of what might happen if a drug to treat cancer that costs $20 a month was brought up before an FDA review panel for approval. Can you imagine the behind-the-scenes battle that would occur? The money will win. And we will lose.

Are these unpatentable items safe? Almost all of the medical establishment would say no, as there are, indeed, no large-scale scientific studies. Who will do them? And can we trust the people that would do the research? What pharmaceutical company wants to see DCA approved for use against cancer? That approval would slash the sales and profits of its drugs. With billions of dollars at stake, we can expect drug companies to interfere with the research.

Current FDA-approved cancer therapies can ruin people in many ways. They often have devastating health effects, and can increase the chance of getting cancer in the future ref1. ref2 Then you can go broke. Medical bills are the number one cause of bankruptcies in the US. ref. And after all the fear, the sleepless nights of worry, the damage to your body caused by chemotherapy, radiation or surgery, even the loss of your home, you just might die. The 5-year survival rate for many cancers is still less than 5% and that is with FDA-approved therapies. Money, fame or brains won't save you: Sam Walton, Peter Jennings, Richard Feynman, it does not matter

DCA works. It is dirt cheap. It is safer than nearly any chemotherapy on the market. And the side effects are trivial compared to what standard therapies often do to people.

But you cannot have it. Is it fair and just that we are denied access to DCA and other drugs because there is no process in place for their approval? Should we be denied access, even allowed to die, without the chance to use them? We must solve this injustice. If the FDA requires extensive studies to be done, then public money must be used as these drug candidates are in the public domain and are therefore owned by the people. And these studies must be done by people not connected with any pharmaceutical companies.

The medical establishment will say "they may make it worse". The alternative is a 100 percent chance of death, which I think is much worse. We face a choice: the risk of additional harm from using one of these unapproved drugs or dying without trying.

The decision to use these drugs should be up to the patient or the caregiver. The right to live is the most fundamental human right. If a person has a terminal illness, I personally think they have the right to try to save their life. The government should not block access, especially when they have no system in place for the approval of these drugs. A failure on the part of the government to deal with the issue is not sufficient reason to deny our right to try and save our own lives. Should we tolerate laws that trample our most basic rights?

We need to solve this problem. If a person is terminally ill, that person should be allowed, by law, to try whatever they want to save their life.

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