"" Ralph Moss—Cancer Consultant: LETTER IN SCIENCE TRANSLATIONAL MEDICINE

Friday, January 19, 2018

LETTER IN SCIENCE TRANSLATIONAL MEDICINE



My colleague, Tibor Bakacs, MD, PhD, DSc, of the Hungarian Academy of Sciences, and I have just had an e-letter published in the journal Science Translational Medicine (STM). STM is an offshoot of Science, the weekly magazine of the American Association for the Advancement of Science (AAAS). STM has an impact factor of 16.789, making it the 11th most influential journal in the entire medical field. (The impact factor reflects the yearly average number of citations to recent articles published in a journal.)

STM is a kind of "Formula 1" testing ground for medical science. In other words, cutting-edge medical technology usually debuts here in an atmosphere of fierce competition for space and attention. As an example, the paper we were commenting on was written by 39 authors from top institutions. It pertains to one of the most promising breakthroughs in cancer therapy--the combination of immunotherapy with cancer-killing (oncolytic) viruses. This is the subject of intense research at Sloan-Kettering Institute, M.D. Anderson Cancer Center, and many other centers.

Our 900 word e-letter demonstrates several important point that could positively impact the worldwide discussion. We show that an un-engineered Newcastle Disease Virus (NDV) vaccine is still superior to anything coming from Big Pharma. We illustrate the "proof of principle" case of a wheelchair-bound Israeli patient, with a grade IV recurrent glioblastoma multiforme (GBM) and a Karnofsky performance score of 40, who experienced a complete and long-lasting remission through the use of an attenuated Newcastle vaccine called MTH-68. This patient is alive and well more than 20 years after his complete remission. According to the consensus of experts GBM is incurable. The median survival for grade IV GBM after tumor- directed surgery and chemoradiotherapy is 14.6 months. We found no other high grade, recurrent GBM case published in PubMed, which comprises more than 27 million citations for biomedical literature from MEDLINE, life science journals, and online books.

The fact that this remission came about through the repeated use of an attenuated non-engineered virus is a very important observation. It means that the virus can be administered safely and in a virtually non-toxic fashion almost anywhere in the world.

Dr. Bakacs and I met in the early 1990s through our mutual friendship with the brilliant late Hungarian-American general practitioner, Laszlo Csatary, MD of Alexandria, VA. Bakacs is a clinically trained scientist with over 30 years experience, author of 75 scientific papers in leading medical journals. We have remained close friends and collaborators for decades.

In 1999, Csatary and Bakacs, et al. published a letter on this exceptional case in the Journal of the American Medical Association. In the same year, I joined them, along with Josef Beuth, MD, of the University of Cologne, in a more comprehensive case series on the beneficial effects of NDV.

In 2013, the Israeli patient's physician, Arnold I. Freeman, MD, of Hadassah Hospital, Bakacs and I published a follow-up review of this exceptional GBM case in the Journal of Clinical Oncology.

In the past, Dr. Bakacs and I often found our articles and letters on this topic rejected by the major journals. (This is a saga in itself.) Nonetheless, we continued to publish in less impactful scientific journals. We are now guardedly optimistic that our perspective on NDV will be heard by those who are in a better position to change the course of treatment.

We are well aware of the formidable barriers to acceptance that remain for non-toxic, inexpensive and widely available treatments. In addition to confronting scientific dogma, one also has to confront the economic barriers to acceptance.

This takes some explaining.

It takes many millions of dollars to gain approval for new treatments. Some people have pegged the cost of developing a new drug at $2.6 billion! Although this is probably exaggerated, the process is still exceedingly expensive. This high cost actually serves the interests of Big Pharma, since it serves as a barrier to the entry of inexpensive drugs into the marketplace. 

The high cost of drug development then becomes the main justification for charging unconscionable amounts for new drugs. For example, in 2017 the Food and Drug Administration (FDA) approved a new form of cancer immunotherapy (called Kymria®) at $475,000 for a single infusion!

This has created a "gold rush" atmosphere around cancer drugs. No profit-driven company is likely to develop a simple natural treatment in such an atmosphere. Treatments made from attenuated non-engineered viruses are too readily available to be of much interest to Big Pharma. Most of the talk these days is of engineered forms of the virus. This means producing unique and patentable forms, which cannot be easily "knocked off," and whose sale can be legally monopolized for years. That's where the big money is. But if inexpensive vaccines are eliminated in favor of highly expensive engineered ones, this will also have disastrous consequences for billions of people worldwide. They will not be able to afford the treatment, or will be bankrupted in the process. So a great deal is at stake in how this debate over NDV is resolved.


References

2018 Science Translation Medicine e-letter:


http://stm.sciencemag.org/content/10/422/eaam7577/tab-e-letters

Research into bioengineered forms of Newcastle Disease Virus Vaccine:

Zamarin D, Holmgaard RB, Ricca J, et al. Intratumoral modulation of the inducible co-stimulator ICOS by recombinant oncolytic virus promotes systemic anti-tumour immunity. Nat Commun. 2017 Feb 13;8:14340. 


1999 Review of NDV in Anticancer Research:

Csatary LK, Moss RW, Beuth J, Töröcsik B, Szeberenyi J, Bakacs T. Beneficial treatment of patients with advanced cancer using a Newcastle disease virus vaccine (MTH-68/H). Anticancer Res. 1999 Jan-Feb;19(1B):635-8.

Freeman, Bakacs, Moss Abstract in the JCO:

http://ascopubs.org/doi/abs/10.1200/jco.2013.31.15_suppl.e13029

Cost of Kymria: 

http://www.onclive.com/web-exclusives/novartis-sets-a-price-of-475000-for-car-tcell-therapy


Cost of new drug development:

https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html