Antioxidants for radiation protection: Ehrlich versus Harrington

[Updated] In response to our previous post, James Ehrlich submitted a detailed response to Robert Harrington’s comments. Here are Ehrlich’s comments, followed by Harrington’s response. CardioBrief welcomes additional comments from knowledgeable professionals.

Comments from James Ehrlich:

As a medical advisor for Premier Micronutrient Corporation and a colleague of Dr. Matthew Budoff, I am fully prepared to provide to Dr. Harrington all of the animal data revealing significant radiation protection (and human data revealing significant reductions in biomarkers of oxidative stress). Of course, if he actually reviewed the website http://www.bioshieldpill.com before he made his comments, it is unlikely he would have made such gratuitous and fallacious comments.

I would also encourage Dr. Harrington to completely read a new textbook on the subject (called BioShield) written by Dr. Kedar Prasad, the nation’s first phD in radiation biology and a recognized authority in this field. I think Dr. Harrington will be overwhelmed by the data and why such a safe pill representing an additional layer of protection should logically be given to individuals subjected to elevated levels of ionizing radiation.

It has been proven for many years that a significant factor in radiation induced injury and carcinogenesis is from mutagenic free radical production (reactive oxygen and nitrogen species). PMC’s scientists have proven that BioShield safely and efficiently quenches these damaging free radicals in humans and animals….and have multiple studies showing better survival and less organ damage in animals receiving radiation after such protection.

I am curious whether Dr. Harrington believes that wearing lead aprons prior to exposure or adding SPF 30 has a benefit beyond physical protection given the fact that nobody has conducted long term studies of fertility or skin cancer in a randomized group of people.

Certain things in medicine are biologically plausible AND have extremely suggestive animal data associated with it—but long term (20 years) cancer outcomes cannot reasonable be studied.

Tests on DNA fragmentation will be forthcoming on human lymphocytes exposed to radiation. Meanwhile, offering a patient or a healthcare worker a completely innocuous pill that definitely lowers damaging free radicals prior to exposure seems very reasonable.

We are gratified that a world class cardiologist like Dr. Budoff has demonstrated a willingness to extend his efforts at lower patient exposure beyond physical means and subscribes to the concept of PAMARA—=Protect as Much as Reasonably Achievable which includes the scanner-centric concept of ALARA, that he already diligently follows.

Response to Ehrlich from Bob Harrington:


People passionately said same things about a variety of vitamins before they were actually tested in well done RCTS. I’m skeptical when people claim biological plausibilty and animal tests to support their claims about efficacy in human beings. This OTC product may actually work. I don’t know. That’s my only point.

Update: Victor Serebruany tells CardioBrief that he totally supports “Harrington’s skepticism.” He points out that animal studies of antioxidans, including selenium, vitamin E, and vitamin C, suggested there were cardiovascular benefits of antioxidants, yet “no randomized study yielded any CV benefit.”

Please see the Comments session below for further discussion, including a response to Harrington and Serebruany by Ehrlich.

===========================================================

Don’t lose touch with CardioBrief. Click here to sign up for a daily email newsletter.

===========================================================

Comments

  1. James Ehrlich, MD says

    Well, i don’t think this should be Ehrlich vs Harrington at all. I have sent Dr. Harrington the data and am confident he will quickly realize (as should Victor Serebruany) that whereas, it is always a good idea to maintain a healthy skepticism, it is also a very good idea to actually review the actual data before making negative comments.

    I think we clinicians and other non-radiation biologists should be very humble in recognizing that whereas we may have received a smattering of radiation physics in our training, we have not kept up with the literature on radiation biology and the related science in anti-oxidants.

    I recommend that all posters on this site should register their opinions after reviewing the extensive animal and clinical data on bioshieldpill.com and especially read the excellent British Journal of Radiology review article on the “Rationale for using a multiple anti-oxidant strategy for addressing low dose ionizing radiation”. The inescapable conclusion will be that the typical reader is completely “out of his league” in this field and that it the pill does exactly what is claimed..it “addresses ionizing radiation” . No claims for cancer protection or improvements in health were ever made.

  2. James Ehrlich, MD says

    i forgot to leave the reader a convenient place to find relevant literature on the rationale for using a multiple anti-oxidant strategy. Please read the first 3 published articles at http://www.bioshieldpill.com/publications.htm and a summary of the animal studies at
    http://www.bioshieldpill.com/efficacy.htm

    Dr Harrington has already admitted to me that he hasn’t read the data before registering his opinion and i am sure the same holds true for V. Serebruany

    I find it interesting that people feel the company is making “wild claims of efficacy” when the package only makes one claim—“addresses ionizing radiation” which we all know produces high levels of free radicals. Is it really astounding that anti-oxidants address oxidative stress???

    So, instead of Harrington vs Ehrlich, i hope cardiobrief will re-state the “controversy” as between those of us who have actually reviewed the science and published literature vs. those who are just “shooting from the hip” because of the fact that micronutrients have not always shown value in every situation

  3. Dr. Ehrlich, I don’t believe you’ve fully addressed the issues here. No one is attacking the science behind the pill. But there is no clinical evidence or data to demonstrate clinical benefit, and the company claims on its website that clinical trials would be unethical. The laboratory benefits of antioxidants in cardiovascular disease were overwhelming, and yet every clinical trial has failed to show even a hint of benefit.
    You write that “No claims for cancer protection or improvements in health were ever made” yet its hard to understand why else would anyone would take this pill.
    One other point: the website claims that the pill is intended for multiple uses, including dental x-rays and single commercial flights.
    It strains credulity to believe that clinical benefit for these purposes could ever be demonstrated. Claims such as these call into question the credibility of the company and the product.

    • James Ehrlich, MD says

      The clinical benefit that is claimed and is completely addressed and has been proven in both human and animal studies is that the pill effectively quenches the high levels of free radicals produced by ionizing radiation. It has been unquestionably proven by others that it is the oxidative stress state that is the primary mutagenic factor in the fragmentation of DNA and the ultimate development of cancer in humans…a phenomenon that takes 15-20 years to express itself in those who get cancer. What has also been shown (and indicated on the website) is the dramatic difference in the histology of the lungs of irradiated rabbits and the survival of sheep after receiving an LD50 of radiation with half of the animals receiving BioShield. There are also clear proof of genetic differences in drosophila, a species that can be examined in a short time.

      You are welcome to believe that converting a high oxidative stress state to a low level of damaging radicals is not of benefit. It is not a matter of ethics that a demonstration of a cancer benefit will never be shown….one can never conduct such a study (20 year study) carefully matching people who were similarly irradiated 20 years earlier taking bioshield vs those who were not.

      The reason we only list “addresses ionizing radiation” and put the obligatory ” product is not meant to treat, diagnose, prevent or cure disease” is for legal protection…otherwise we would have to get FDA approval.

      You might want to re-read Dr. Harrington’s comments if we really believe “no one is attacking the science here”. He admitted to me by email he didnt even read the science.

      I am curious whether you avoid using a lead apron during xray procedures (dental, etc) or avoid using SPF 30…just because nobody has demonstrated a benefit…certain things are safe and extremely biologically plausible and yet not proven. Certainly, i would consider wearing a parachute if i jumped out of a plane and yet i am not aware of any randomized clinical trial proving its benefit.

      A dual isotope nuclear stress test exposes patients to up to 1500 chest xrays in radiation. I believe a completely safe pill absolutely proven to dramatically attenuate proven mutagenic free radicals is a reasonable additional measure to take….and fortunately surrogate markers for the success of the pill and animal experiments have been completed by a highly respected team of antioxidant scientists and radiation biologists.

  4. Dear Dr. Ehrlich, Let me make clear: I’m a journalist and not a scientist, and I have no intention of engaging you on the scientific aspects of this discussion. I hope others will do so if they see fit.
    But there are still a number of questions about this product and the company that are appropriate for a journalist to raise.
    I am concerned that the company literature appears to come from only a few limited sources. For a new therapy to enter clinical practice there should be multiple sources for research. Can you cite any other established and independent medical group or organization who has endorsed this therapeutic approach?
    Regarding lead aprons, I would note that these are not biologically active substances, and that their use has been endorsed and even mandated by multiple established and independent medical groups. When the RSNA and the ACS and CMS establish this product as a standard, or even a reasonable approach, I will drop my inquiries.
    But for now all my journalistic instincts sense that something is not right here.

  5. James Ehrlich, MD says

    I join you in the hope that others contributing to Cardiobrief will engage the scientists at PMC on the scientific aspects of this discussion. Heretofore, the negative comments have come from individuals who are extending their concerns about micronutrients to an arena about which they are admittedly not well versed (radiation biology) and have attacked the lack of data without reviewing the data already presented on the website of the company….that should be an embarrassing untenable position to hold.

    There have been multiple groups of investigators since the 1950s who have verified the radiation protection capabilities of anti-oxidants and there have been expert consensus documents on radiation and its damaging consequences that have called for an additional radiobiologic approach. Given the lack of an outcry by clinicians about the dangers of medical radiation (it has mostly come from the public), it does not surprise me that there are not many groups pursuing this overall approach.

    In general, when it comes to a drug (with safety concerns) and various claims of specific efficacy, i agree there should be multiple sources of confirmation before clinical introduction. If a company wants to introduce a safe product that protects against wrinkles or dry scalp or chapped lips or oxidative stress (by supplying anti-oxidants with proven radiation protection capabilities), i see a much lower requirement for the need for multiple established medical groups. Again, biologic plausibility supplemented by confirmatory studies and a careful attempt to limit claims (addresses ionizing radiation) should rule the day here.

    One is certainly entitled to tell a patient getting a substantial dose of radiation (like a thallium) that “although there is a formulation proven to lower the damaging free radicals that have been proven deleterious to your health, i don’t think you should take this safe pill until there is evidence that reduction of noxious substances (free radicals) is actually beneficial”….or perhaps let the patient decide whether a $ 3 pill that might lower risks of cancer or other things is worth taking.

  6. James Ehrlich, MD says

    In answer to one of your questions, the studies I cite were not performed by PMC alone. They were performed in collaboration with NASA, the Russian Academy of Sciences, and the Armed Forces of Radiobiology Research Institute. PMC has collaborated with multiple federal and university laboratories in basic anti-oxidant and radiation research and human studies over the years including the naval health research center, naval medical research center, US army medical research institute of chemical defense, NASA, Meharry Medical College, Henry Ford Medical Center, University of Colorado Health Sciences Center, etc. To learn more about the science, go to http://www.mypmcinside.com/?id=science.html

    There are multiple human studies performed by these scientists that are not on the website of bioshield. To learn more about the scientists, go to http://www.mypmcinside.com/?id=about.html

    I am looking forward to healthy debate from your readers after they have read a few of the published articles and visited the website of premier micronutrient corporation. I think most will be very impressed with the credentials of the scientists involved in this important work

  7. I hope the readers of CardioBrief read the excellent and scholarly review of BioShield by editor Eric Barnes in today’s edition of AuntMinnie.com, the largest online radiology site.

    After reading the lengthy review including comments by thought leader Richard Semelka of UNC, it would be very unlikely that anyone would ask “where is the data?” and make the statement about “wild claims” that sadly was the beginning of an unnecessary strident exchange in cardiobrief.

    Please go to http://www.auntminnie.com/index.asp?Sec=sup&Sub=cto&Pag=dis&ItemId=87211&wf=3305

  8. Dear Dr Larry Husten, I had protracted correspondence with The British Medical Journal and Dr Ehrlich on the Bioshield Pill. After accepting to publish my article which was critical of BioshieldPill, The BMJ changed its view. The Editor of The BMJ profusely apologized for delaying taking a decision on my article after promising to publish it as a feature. Finally I published it as an article in PTI FEATURE, published by the Press Trust of India, India’s premier news agency. I had prolonged discussion with Dr Ehrlich who was an adviser to PMC the manufacturer of trhe pill. USFDA issued an advisory against the company. I understand that the promoters of the pill settled the issue with USFDA and continues to sell the product as a dietary supplement. Thanks largely to the efforts of Dr Ehrlich, The Radiology journal published a paper on Bioshield pill The journal also carried another describing its limitations.I request you to peruse my article and the train of letters I had with Dr Ehlrich at:https://ksparthasarathy.wordpress.com/2011/11/24/anti-radiation-pillnone-yet/

Trackbacks

  1. […] Update: Please see a subsequent post for a detailed response from James Ehrlich, along with a response to Ehrlich from Bob […]

Speak Your Mind

*