Doctornauts or Physician Volunteers for Cures

The ideal purpose of our national health policy should be to accelerate the discovery of medical breakthroughs that will cure or much better treat diseases which would a) reduce patient suffering and premature death and b) dramatically and quickly reduce health care costs. One way to do this is to enact the Doctornaut Act which deals with medical discovery only. Cost reduction would then follow due to natural market forces.

To appreciate the rationale of this proposal one must understand the system which brings patients new medical therapies. We, unfortunately, are profoundly ignorant of it. Generally speaking, medical discovery involves two processes- the identification of potential therapies discovered in scientific laboratory studies or based on theory and the clinical testing of them in patients. If, for example, something like aspirin is shown to have pain killing-inflammation reduction potential in animals, it can only be proven to work in clinical studies in patients with headache and arthritis among others. The extremely good news is that, there are, and will be, enormous numbers of potential medical breakthroughs. The very bad news is that our system is almost perversely designed to block the clinical testing of the vast majority of them. The costs and risks are simply prohibitive particularly with natural substances and combination therapies.  And who pays the price?  Defenseless patients!

In addition to the tomes of data that characterize the barriers to clinical studies, I have personally experienced practically all of them. In 1965, as a young doctor at St. Vincent’s Medical Center in Greenwich Village, I conducted the first clinical study in the United States on carnitine. It took me almost 20 years utilizing all of my know-how, including experimenting on myself with a dubious intravenous solution of carnitine, before FDA approved it for Carnitine Deficiency, a rare and often fatal disease in children. And, unlike many therapies for rare diseases, it is inexpensive!

While FDA is thought by many to be the official culprit obsessed by anti-innovative safety issues that permeate our culture particularly regarding clinical research coupled with an unbudgeable cultural blindspot to its essential importance, there is another extremely influential player- the mass media. The death of one patient volunteer during a clinical study evaluating a new gene therapy was trumpeted by the media causing a national uproar causing the FDA to create additional barriers. Yet thousands of Americans are mutilated and murdered each year unnoticed.

The solution is not to reform FDA- have we not learned that it is not re-formable? We must maneuver around it. Given our cultural mindset, the most doable way, in my opinion, is for Congress to enact the Doctornaut Act. “Doctornauts” are physician patients who volunteer to participate in clinical studies conducted by physician researchers under the supervision of their colleagues with minimal FDA involvement as well as waving their right to sue. Let’s not forget that doctors are the most qualified to judge the benefits and risks of clinical studies, not laymen laden committees. If enacted, an array of highly promising candidates would be promptly clinically evaluated and, inevitably, breakthrough hits would soon follow. Who can, with studied reason and altruism, object to doctors taking such chances to help their patients in their battle against disease?  Patients would surely be happy, but would physicians accept the challenge?

FIM, the Foundation for Innovation in Medicine, has a particular interest in encouraging clinical research on natural substances because they offer the greatest promise to combat disease but lack financial backing because of the difficulty in obtaining strong patents. FIM sent a questionnaire to physicians asking “Would you as a physician-patient want the privilege to volunteer for clinical research of natural substances under the supervision of a physician-clinical researcher without FDA, institutional or other restraints?” Over 50 percent agreed. Today there are 800,000 physicians in the United States. If only 20 percent volunteered that would immediately make available 160,000 doctornauts!

You may be wondering how the Doctornaut Act would decrease health care costs. In fact, my colleagues on Capitol Hill believe it would do the opposite! They believe that it would accelerate the testing of new, expensive technologies, raising such costs. Not necessarily so- and here’s why. Low- cost therapy candidates will also be tested and will compete with high- costs ones in the medical marketplace. For example, the annual cost of the renal dialysis sector is well over $30 billion and growing with our aging population.  The largest percentage are diabetic patients. Diabetes is a metabolic disease where the natural biologic processes go haywire. It is not an unreasonable hypothesis to assume that the administration of an inexpensive nutraceutical mixture of logically designed dietary substances along with standard pharmaceutical therapy might normalize kidney function markedly diminishing the need for dialysis and saving billions of dollars. Another example involves cancer chemotherapy. For reasons not clear, anti- cancer pharmaceuticals often have a strong initial effect on killing tumor cells but the latter becomes resistant to them during therapy. Something happens inside those damnable cells. If we can prevent these changes from happening with a combination of an inexpensive non- patented natural substance along with chemotherapeutic therapy, and such a possibility already exists, then patients would benefit soon followed by substantial cost reduction – the best of possible worlds!

It is a reflection of our cultural blindspot that Congress has never had a Hearing on what patients want – to create a system that will generally accelerate medical discovery for all diseases and other conditions that ail us. Paradoxically, there have been numerous Hearings on health care costs and ways to cut them.

Congress has gotten it backwards!

We are currently addressing major health issues.  Doctornauts should be somewhere on the top of the list.

 

7 Responses to “Doctornauts or Physician Volunteers for Cures”

  1. Epidemiologically, how do the 160,000 doctornauts stack up against the general population?

  2. I think what’s unfortunate about the Doctornaut Act is that it’s a result of the failed policies of the FDA that prevents the general population from participating in clinical trials. Ideally, clinical trials should be easier to conduct, and we should have more doctors and scientists conducting innovative research to find cures. But due to the regulatory hurdles, fear of lawsuits, and exorbitant cost of developing a new drug, most of this important research has come to a grinding hault. The general concept behind the Doctornaut act makes sense to me — doctors know better than the general population about what is safe, they can make informed consent decisions and won’t be duped by some other doctor, so why not unbind their hands so they can participate in clinical trials — which can sometimes be a risky proposition.

    There is no way that Congress is going to act to force FDA to open up clinical trials to anyone and everyone due to the myriad of problems that could occur from this — but if they were to take some simple action to unbind the hands of medical professionals, it would be a dramatic step forward and help to push clinical research. Every step forward matters, and this is a realistic step forward.

  3. If doctors can try the drugs before they treat patient for clinical trials, the doctor could be better know how drug can be benefit to curing patient’s diseases. I tried many medications while I treat to patients, especially on while I treat patients who were presenting infectious diseases. When Patient recovered from their diseases caused by immune system inefficient prevent the contagion pathogenic microbes, my immune system become healthy to protect myself than before by generated the antibodies to protect myself . It is how could I treat about 20-to 40 patients who have the contagion infectious diseases per day, but I would remain healthy. And I got better known about those medications and I tried on intend protect myself able to resist the contagion infections while I treat patients.
    Not only Doctors should try the drugs but also the drug designer should try the drug before they give anyone to trial it. If the drug producers afraid about drug toxic might be harmful themselves health, why they do not worry about that drug will be toxic to patients. Also the FDA should involve the trial on drug before they proved the drug for general clinic uses for patients and put on over counter for public commercials. I worked in antecedent of FDA in china, we trial the most of consumer food, nutrition and drug products that manufactures apply for our authorization prove their products safety.
    In human medicine development history, Chinese medicine was discovered and developed by the first Chinese Doctor who trialed all of these drugs by him.

  4. Current both basic, pharmaceutics and clinical research in the direction of developing drugs are conducted by the ideals of killing cancer cells. The chemotherapy drugs used in clinical trials demonstrated that these drugs are no benefit on cure patient’s diseases, but exhibited significant adverse effects on harming patient’s healthy. It implies about all of other new drugs designed based on the theroy on killing the cultured cancer cells in vitro, are not suitable for clinic trials on patients.
    FDA have proved these drugs without care about the facts of the unflavored outcomes from clinic trials; which demonstrated that these chemotherapy drugs kill patients while kill cancer cells. These facts of patient’s death caused more and more law sues for complaining about the malpractice in clinical trials.
    FDA’s rules should be built on proposes of preventing the malpractice on harm patients in clinic trials. Research and Pharmaceutics should able develop medications based on proposes to cure diseases but not worse patients’ health.
    Current drugs can only kill cancer cells in cultured condition are definitely unsuitable for clinic trial in patient first. If pharmaceutics urgently pursue the profit from these drugs without able proving whether drug is safety for patient’s health, they should verified the drug safety in the phase I trials of administrating those drugs to the researchers and pharmaceutical drug designers. Culture tumor cells undergo cell death caused by drug can not present the drug’s effects from affect the nature cells growth in vivo. In addition, inappropriate culture cell condition also can caused cultured cell death if the technician does not know how could culture the cell keeping alive. Thus drug able induce cell death in cultured unable fully present whether the drug able specific kill this type of cells in cultured. it only imply that drug might able kill all kinds of cells including whole human body, it is poison.
    FDA should require the research proves from the outcome of comparing regarding to whether drugs killing the cultured cancer cells (which is called as tumor cell line) faster? or kill the cultured primary cells which isolated from adult cells healthy human donations faster?
    Only if the drug can kill the specific tumor cells but have no any adverse effects from the normal adult human primary cells; this kind of drugs might be qualified considerable about for clinical trials. If the drugs demonstrate that they can kill normal cells faster than kill the tumor cell line. It indicates the drug is harmful to patients than cancer cells.
    To test and prove about whether the drug would be benefit for cure diseases, should not be difficult from the experiments in comparing about how drugs can affect tumor cells with normal primary adult human cells. However, I cannot find research reports about how these research professors can success culture the primary adult cells on exhibiting the normal cytophysiological functions. How could we trust about their biology results? Whether the only fraud about the research advertisemnts for huge profit sales on the poison to patients?
    When those drug producers unable prove whether drug are poison to human life or benefit to human health, the most of sample way is let these pharmaceutical developer professors and clinical trial doctors to prove the drug safety from trial the drug in themselves body first, to convince people that drugs might capable used as the medications for cure patients or poison for kill patients. Otherwise, if doctors are afraid from the drugs toxic poison, but pursuing on deceiving patient volunteers in clinical trials with the high risk on harm patients. I believe this behavior is intended on plan of murder for money. So the law sues on clinical malpractices should be encouraged.

  5. Current both basic, pharmaceutics and clinical research in the direction of developing drugs are conducted by the ideals of killing cancer cells. The chemotherapy drugs used in clinical trials demonstrated that these drugs are no benefit on cure patient’s diseases, but exhibited significant adverse effects on harming patient’s healthy. It implies about all of other new drugs designed based on the theroy on killing the cultured cancer cells in vitro, are not suitable for clinic trials on patients.
    FDA have proved these drugs without care about the facts of the unflavored outcomes from clinic trials; which demonstrated that these chemotherapy drugs kill patients while kill cancer cells. These facts of patient’s death caused more and more law sues for complaining about the malpractice in clinical trials.
    FDA’s rules should be built on proposes of preventing the malpractice on harm patients in clinic trials. Research and Pharmaceutics should able develop medications based on proposes to cure diseases but not worse patients’ health.
    Current drugs can only kill cancer cells in cultured condition are definitely unsuitable for clinic trial in patient first. If pharmaceutics urgently pursue the profit from these drugs without able proving whether drug is safety for patient’s health, they should verified the drug safety in the phase I trials of administrating those drugs to the researchers and pharmaceutical drug designers. Culture tumor cells undergo cell death caused by drug can not present the drug’s effects from affect the nature cells growth in vivo. In addition, inappropriate culture cell condition also can caused cultured cell death if the technician does not know how could culture the cell keeping alive. Thus drug able induce cell death in cultured unable fully present whether the drug able specific kill this type of cells in cultured. it only imply that drug might able kill all kinds of cells including whole human body, it is poison.
    FDA should require the research proves from the outcome of comparing regarding to whether drugs killing the cultured cancer cells (which is called as tumor cell line) faster? or kill the cultured primary cells which isolated from adult cells healthy human donations faster?
    Only if the drug can kill the specific tumor cells but have no any adverse effects from the normal adult human primary cells; this kind of drugs might be qualified considerable about for clinical trials. If the drugs demonstrate that they can kill normal cells faster than kill the tumor cell line. It indicates the drug is harmful to patients than cancer cells.
    To test and prove about whether the drug would be benefit for cure diseases, should not be difficult from the experiments in comparing about how drugs can affect tumor cells with normal primary adult human cells. However, I cannot find research reports about how these research professors can success culture the primary adult cells on exhibiting the normal cytophysiological functions. How could we trust about their biology results? Whether the only fraud about the research advertisemnts for huge profit sales on the poison to patients?
    When those drug producers unable prove whether drug are poison to human life or benefit to human health, the most of sample way is let these pharmaceutical developer professors and clinical trial doctors to prove the drug safety from trial the drug in themselves body first, to convince people that drugs might capable used as the medications for cure patients or poison for kill patients. Otherwise, if doctors are afraid from the drugs toxic poison, but pursuing on deceiving patient volunteers in clinical trials with the high risk on harm patients. I believe this behavior is intended on plan of murder for money. So the law sues on clinical malpractices should be encouraged.

  6. I feel so much happier now I unndastred all this. Thanks!

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