Anti-radiation Pill:None Yet

Anti-radiation pill containing antioxidants is a new line of research.Work is in progress in a few centres.But no pill which was clinically found effective is available yet. There are a few instances of anti-radiation pills with unproven benefits getting marketed through advertising campaigns. I have been keeping track of one such formulation called BioshieldRadiation since July 2009.The promoters of the pill did not publish any result showing its effectiveness in any peer reviewed journal. They made presentations at conferences and started issuing press releases to promote the pill. They advertised the pill at an attractive website. Auntminnie.com a trade journal uncritically published an interview with the promoters of the pill.A few physicians endorsed the pill and started prescribing it.This may lead to unbridled use of CT scan for screening. Physicians may assure the patients not to worry about radiation dose if they consume the anti radiation pill
WEBSTORY
You can access the press releases
http://www.news-medical.net/news/20110328/New-pill-may-protect-DNA-from-radiation-damage.aspx
dated March 28,2011 Accessed on November 24,2011

http://www.businesswire.com/news/home/20090630005381/en/Nutritional-Supplement-BioShield-Radiation%C2%AE-Offer-Radiation-Protection-Pill
dated June 30,2009 (Accessed on November 24,2011

http://www.prweb.com/releases/BioShieldPill/2011/prweb5144934.htm
dated April 8, 2011 Accessed on November 24,2011

Finally USFDA issued a warning letter to the company
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm253423.htm April 28,2011
The original Bioshieldpill.com carries this message “This domain name expired on 11/16/2011 and is pending renewal or deletion”.

The British Medical Journal accepted my article on Anti-Radiation Pill to be published as a feature. They decided against publishing it after two years of protracted correspondence! Presently the company is marketing the pill as non-drug supplement.

Recently there was discussion in Radsafe news group on another Anti radiation pill produced by Dr Chris Busby for the children of Fukushima. Mr George Monbiot exposed Dr Busby in an article in the British Newspaper The Guardian.

http://www.guardian.co.uk/environment/georgemonbiot/2011/nov/22/christopher-busby-nuclear-green-party?newsfeed=true

I should have sent my article to The Guardian in July 2009. Error of judgement! I thought the best place to discuss the issue is a medical journal

On November 5,2011 I published an article on Anti Radiation pill as a PTI Feature

PTI FEATURE
VOL NO XXVII (45) November 5, 2011
SCIENCE
PF-178/2011

Anti-radiation pill: None Yet
Dr.K.S.Parthasarathy

Anti radiation pill containing antioxidants is a new line of research.
A company based in Nashville, USA, persuaded people who undergo regular or occasional exposure to ionizing radiation to consume BioShield-radiation, its anti-radiation pill, claiming that it reduces the harmful effects of radiation. Instead of publishing its finding in a peer reviewed journal; the company published press
releases and presented papers at conferences.
Since the pill is a cocktail of antioxidants, the company believed that it did not require any approval from the US Food and Drug Administration. FDA thought otherwise and slapped a warning letter against the pill. After listing a few uses of the pill published in the company’s website, FDA warned that the company’s products are not generally recognized as safe and effective for those uses. Since then the company advertised that it is coming up with a new website!

The company was eyeing a global market. It has been selling the pill on line. It made unproven claims and recommended debatable protocols. Eric Barnes of Auntminnie.com, a trade journal uncritically published the claims of the promoters of the pill.

The company claimed to have set aside 115,000 doses or a four-month supply for 1000 adults, to be shipped to workers and people living close to the crippled Fukushima Daiichi nuclear power plant.

———————————————————————————————————…..due to high demand, the product currently has limited availability and interested individuals are asked to restrict their on-line purchase to no more than three bottles in one order”, the press release implored. The company may have successfully created a consumer demand.

“The efficacy of antioxidant strategy for biological radiation protection in humans against low doses of radiation has not been tested”. Dr K N Prasad, an inventor of the pill admitted He clarified that direct experiments with radio-protective antioxidant formulations cannot be performed in humans for ethical reasons. How did they recommend when and how many pills a person should consume to ensure safety against radiation? The query went unanswered. The company is making unproven claims; the protocols it recommends are equally debatable.

Prasad suggested that the implementation of the proposed recommendation of boosting antioxidant levels may allow prospective studies among radiation workers to determine its efficiency in reducing health risks of low doses of radiation in present and future generations. Such a study will benefit the company; the pills’ sale will reach astronomical scales! For statistical reasons, to get reliable results, probably millions of workers may have to eat the pill.

The researchers did not publish any study on the beneficial effects of BioShield Radiation. Till it is done, the company’s claim will remain just that; a claim!

Wearing lead aprons, using short exposure times and keeping sufficient distance are methods to control radiation exposure from any source of ionizing radiation. The biological advantage, if any, arising out of consuming the anti radiation pill is yet to be proved .The unproven “biological” benefit is not as robust as time, distance and shielding which offer safety from a source of radiation.

In an interview to AuntMinnie.com Dr.James Ehrlich MD, an advisor of PMC claimed that Dr Michael Kufner and colleagues from the University of Erlangen tested the radiation protection powers of BioShield, both in vivo and in vitro. According to him, ingesting BioShield before scanning led to reductions of 20% to 30% Double Strand Breaks (DSB) compared to identical scans acquired without the product. Again, there are no publications in journals…
Fred Mettler Jr, Department of Radiology and Nuclear Medicine Service, New Mexico VA Health Care Services, and colleagues examined chemical radio-protectants, including antioxidants and conceded that there is, promising research, and that they are, still not the standard of care in medicine. But years of research would be needed to prove their efficacy and to assess their long-term toxicity on humans.
The company referred to three “professional publications” on its web site; the authors of these articles set up the company and are promoting the pill.

“Based on published data on antioxidants and radiation protection, it is possible to develop a non toxic, cost effective mixture of antioxidants (dietary and glutathione-elevating agents) that can provide biological protection against radiation damage in humans. Indeed, such formulations referred to as Bio-Shield are available commercially’’, Dr. Prasad, a co-founder of the company wrote in one of the articles.

The British Journal of Radiology appears to have lowered its bar while allowing the author to describe how BioShield may be used as an anti-radiation pill by patients receiving diagnostic radiation doses, radiation workers, frequent fliers and by populations living in regions with high background radiation. It is surprising how a paper which promoted the product escaped the attention of the reviewers.

The camaraderie between the company and some cardiologists may lead to unbridled use of CT scan units. Three physicians, Matthew Budoff, Associate Professor of Medicine, David Geffen School of Medicine at UCLA, .James Adams, Medical Director, CT Scanning Centre, Cardiovascular Associates of Marin and San Francisco Larkspur, CA, and Stephen Raskin, Director, Cardiac Graphics, Highland Hospital, Alameda County Medical Centre, Oakland, CA endorse the pill. The endorsement now vanished with the website.
High radiation dose is a disincentive in cardiac CT screening. CT protagonists may assure the patients that radiation damage is no reason to worry if they consume BioShield-Radiation! This assurance is not scientifically substantiated. Physicians endorsing the product are already prescribing it.

One of them, Dr. Budoff is a member of a task force of the Society for Heart Attack Prevention and Eradication (SHAPE), which promotes cardiac CT screening of all males between age 45 and 75, and females between 55 and 75. (Please see
(http://www.theheart.org/collection/The-SHAPE-guidelines.do). SHAPE’s guidelines are not supported by mainstream specialists.

Yet another company is trying to sell calcium containing vitamin pill to the “children of Fukushima”. Obviously its aim is to scare innocent public and persuade them to buy their pill. Popping such pills before and after radiation exposure surely will benefit the company and not the consumers of the pill.

PTI Feature

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About ksparthasarathy

I am a former Secretary of the Atomic Energy Regulatory Board. I am a former Raja Ramanna Fellow in the Department of Atomic Energy. Free lance journalism is my hobby
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10 Responses to Anti-radiation Pill:None Yet

  1. Sankaranarayanan says:

    You may remember that K N Prasad was considered an international authority in radiobiology & radiation protection . His book on radiobiology published by CRC Press ( a prestigious ,very selective publisher) was a standard reference book . When scientists sell themselves to commercial interests, people become the victims.That is also what ‘commercial medicine’ is about ! Buyer beware !!

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  2. I will be interested to learn what Mr. ksparthasarathy has to say about the fact that there will be a presentation at the largest and most prestigious radiology conference in the world (RSNA) this week of the data PROVING in HUMANS that BioShield is the world’s first commercially available pill that can SIGNIFICANTLY protect DNA from the radiation from CT scans–work done by highly regarded independent radiologists and radiation biologists. This represents the second major conference that has ACCEPTED the science for their annual scientific meetings (it was presented at the Society of Cardiovascular CT in July 2011).

    By the way, there is now NO FDA concerns about BioShield—their only concern was the fact that potassium iodide was mentioned on the website which they believe is a “no-no”. If one mentions a drug in the same sentence as a supplement, they believe the company is acting like a drug. Very soon, you will see HUGE international orders of BioShield…a SAFE and PROVEN supplement.

    Hopefully, this will quiet Mr.ksparthasarathy who has been unreasonably critical of the approach of the company.

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  3. Dr. James Ehrlich,
    I am happy that we are able to continue our discourse though you feel I have been “unreasonably” critical. My only desire is to see a scientific article on BioshieldRadiation pill published in a peer reviewed journal. I was waiting for it since July 2009 when news release about the product started appearing.
    Conferences are good venues for discussion; often conference submissions are seldom reviewed critically.
    In April 2011 you told me that a full manuscript on your studies is being developed and will be submitted to Radiology and other good journals. I hope that your efforts will be successful

    The abstract you sent me in April 2011 did not contain the experimental details such as how many patients participated in the study etc You wrote that the stage is being set for very large studies supported by Siemens or American College of Radiology or German radiology society. .
    I have access to RSNA material, I did not see your paper. I shall appreciate getting a copy or telling me in which session you are presenting it,

    As updated on November 16 FDA’s website
    http://www.fda.gov/newsevents/publichealthfocus/ucm247403.htm#sofar answered the following question
    “Has FDA taken any action on these types of products thus far?”
    Thus:
    FDA has issued Warning Letters to firms promoting a variety of fraudulent products that claim to prevent or treat the harmful effects of radiation exposure from the nuclear power plant incident in Japan as a consequence of the earthquake and tsunami. Among the firms that received the letters, along with the radiation protection products they market is Premier Micronutrient Corporation – “Bioshield Radiation® R1”, “Bioshield Radiation® R2” –

    Parthasarathy

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    • thanks for your reply. Dr. Richard Semelka (professor of radiology at University of North Carolina) will be presenting our Erlangen data at RSNA in Chicago this week. I will look for the oral presentation listing and update you. In addition, we (Dr. Semelka, Kuefner and Erlangen colleagues, me) have submitted a lengthy manuscript to the journal RADIOLOGY and hope it will be accepted there…if not, we will re-submit it to other journals.

      On your own blog, you are obviously welcome to provide opinions….but i hope you do not pretend it is unbiased “journalism”. You are obviously critical of individuals and entities we respect– the British Journal of Radiology (for accepting Prasad’s papers), AuntMinnie.com, highly regarded U.S. cardiologists who endorse the concept of biologic radiation protection, SHAPE society, the practice of cardiac CT screening and the concept that a corporation in healthcare wants to be financially successful beyond making a difference. I guess all pharmaceutical companies should give away their medications and not even try to recoup their investments in research. Although we have resolved our differences with the FDA (whose main concerns were fallacious) by promising to revise our website (not to mention potassium iodide), you persist in believing that the warning letter should be of concern. As a government agency, it is their job to send out such notices without examining the science….and now they have retreated after considerable and friendly discussions.

      Dr. Prasad has just published an additional textbook on the subject of biologic radiation protection….it is now his 6th published book in radiation biology. You are welcome to criticize his hope that his formulation is also commercially successful. There is indeed a reason that the U.S. government after doing research with PMC has multiple contracts with PMC and is the still the largest source of revenue for the company. I guess the U.S. departments of defense, naval research, NASA, U.S. marines and others also “lowered the bar” when they decided to work with our radiation biologists !!

      We are proud to promote our completely SAFE and now PROVEN formulation of anti-oxidants which represent the world’s FIRST commercially available pill PROVEN to significantly protect human cells (53% decrease in DSBs–Erlangen study) from ionizing radiation. We are not surprised that we are now dealing with multiple countries seeking help.

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  4. Update….I just found out that you are correct that the abstract was not presented at RSNA as our lead author could not make the event….however, he gave me much better news with the American College of Radiology that i will reveal at some point.

    Sankaranarayanan is correct that Dr. Prasad is an international authority in this field…sadly, he is a bit offended by what has been written here.

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  5. ittanmomen says:

    Hallo Mr. Parthasarathy,

    was the study released and peer reviewed in the meantime? It seems the company wants to start creating websites in Japan, presumably to “help” Japanese people threatened by radiation from the Fukushima fallout…

    Please see this link

    http://www.linkedin.com/groups/Advice-requested-on-introducing-radiation-54168.S.103969317?qid=687333ce-34c6-48ee-a795-d1cea83259b5

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  6. The definitive study proving the radiation protection capabilities of this formulation will be published in the most prestigious radiology journal in the world in the July 2012 issue (Radiology–the journal of the RSNA). The data has already been presented at the 2011 Annual meeting of the Soc of Cardiovascular CT.

    This should END comments alluding to speculations on your website that it is unproven–accepted by PEER reviewed publication and meeting.

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    • I am happy to hear that a paper on BioshieldRadiation will be published in “Radiology” of July 2012. That no paper on the formulation was published so far is not a speculation but a fact.

      But that is not important. Auntminnie(Sept 2009) referred to the possibility of Dr Richard Semelka collaborating with the Italian group led by Dr. Picano. Since I was expecting to read the paper by Semelka at RSNA (he did not present it there), I hope that the Radiology paper may be based on that collaboration which was expected to include many institutions.On my query in April 2011, Dr Picano with whom I had correspondence on many topics informed me that there was no progress on the proposed collaboration.

      I prefer papers published in peer reviewed journals to presentations at confernences and press releases. I hope that the paper will be a based on statistically sound analysis

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  7. I respect the fact that Dr. Parthasarathy has reserved judgment on BioShield until we have publications. Now there are 2 textbooks written by Prasad about BioShield and its value and he did publish a nice article in British Journal of Radiology many years ago on the rationale of his approach. Go to http://bjr.birjournals.org/content/78/930/485.full

    Dr. Semelka is very close friends with Dr. Picano. However, we decided to choose Erlangen Germany based radiation biologist Dr. Michael Kuefner who has developed a DNA breakage assay so sensitive, that he can quantify breaks per cell differences between various CT scanners–he is the lead author on the upcoming paper that shows a 58% decrease in-vitro and in-vivo in double strand breakages using BioShield. We hope to work with Dr. Picano in the future. Your readers might want to google Kuefner at the University of Erlangen.

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    • I am glad that you gave the reference to the BJR article of Dr Prasad. After reviewing related literature he prescribes the protocol of the anti-oxidant cocktail developed by him and his collaborators . He and his coworkers published another paper in BJR. Conflict of interest is obvious. Did the Journal lower the bar?

      I queried the BJR on this issue The publisher replied thus

      “The British Journal of Radiology is a peer-reviewed journal, and therefore all articles are peer reviewed by at least two experts in the field. We are confident that the peer review of this article, and its subsequent publication, conforms with standard practice.

      As with any BJR article, members of the public are invited to comment. Letters from the public are sent to the authors for their comments; and normally the letter and author response are published together.

      However, these articles have been in the public domain for several years and one would have expected these concerns to be raised sooner. As a result, I’m afraid that we are unable to take this matter further”.

      Obviously, if an alert reader took up the matter as soon as the article was published, the conclusions would have been probably different.

      I was was aware of the study design for the project suggested by Dr Semelka in his interview with Eric Barnes of Auntminnie.com. This article can be accessed at
      http://www.auntminnie.com/index.aspx?sec=sup_n&sub=cto&pag=dis&ItemID=87211

      Dr Semelka said that depending on the eventual level of involvement of Dr Picano, the project could begin in Europe and then expand to include several of the Italian team’s collaborating institutions, in addition to U.S. sites, for a large-scale evaluation of the product’s effects in the radiology suite. It would have been an ideal study

      Human body is constituted of cells, tissues and organs. The sensitivity of these to radiation varies significantly. In my correspondence with Dr Picano, I sought his view on the following statement

      “I believe that if the cocktail of antioxidants has to be effective in neutralizing the free
      radicals formed, the exposed individual has to consume amounts of antioxidants to fill and saturate every cell; they may need more to compensate for losses due to other mechanisms. Penetrating ionizing radiation being truly secular may create free radicals throughout the body including the endogenous tissues. If that is true, is popping a pill or two before 30-60 minutes of a medical diagnostic procedure going to be beneficial?”

      “a nicely worded study HYPOTHESIS” Dr Picano wrote back

      I believe a satisfactory explanation to the hypothesis will be required in deciding the effectiveness of any anti-oxidant cocktail in reducing the harmful effects of ionizing radiation.

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