HUGE BREAKTHROUGH in Breast Cancer Diagnosis; When Will We See It in the U.S.?? (If Ever…)

By InsightAnalytical-GRL

According to the medical industry, mammograms are a must for early detection of breast cancer.  The benefits of early detection is well worth the risks of being irradiated on a regular basis.

What if there was a much simpler and safer way to test for this disease?

Well, a few days ago on Radio Australia I heard a segment on Australia’s “Smart 100 Awards.” In fact, the number one “smart idea” was a simple procedure to help in the discovery of breast cancer.

This isn’t a new story. In fact, 10 YEARS AGO, a retired professor of physics named Dr. Veronica James published an article on the subject in Nature magazine.  As reported on March 4, 1999 by ABC (Australia):

Pubic hair may reveal early breast cancer › News in Science (ABC Science).

C. Johnson, The Lab


A single pubic hair may provide all the information needed for early detection of breast cancer, preliminary studies by an Australian scientist suggest.Hair from breast cancer patients has a different molecular structure to hair from healthy subjects, Dr Veronica James and colleagues report in the current issue of the journal Nature.Moreover, all hair samples from women who were healthy but carried the BRCA1 gene – which is associated with a high risk of breast cancer – showed the same structural anomaly, raising the possibility of an early diagnostic test.

SNIP

The changes in molecular structure showed up when hairs were bombarded with a beam of highly focused x-ray beams, generated in synchrotron facilities in Japan and the USA. A synchrotron is a device that accelerates protons or electrons in a magnetic field. When the accelerated protons or electrons are suddenly stopped, the energy is released as intense x-ray beams.

SNIP

Initially Dr James studied scalp hair only. When the data looked interesting she set about looking at a larger sample of hairs, but on that occasion the results were inconsistent.

“We saw all sorts of odd-bod changes. But it looked like some of the hair had had treatment. One sample was black, white and yellow.”

When she eliminated hair samples that had been permed less than three months before collection, the pattern was clear.

To avoid problems caused by hair treatment, she approached Professor John Kearsley, an oncologist at St George Hospital in Sydney, and asked if patients could supply pubic hair samples.

SNIP

If a reliable test proved possible, the cost could be as low as $20 a sample.

“You would just put a few hairs in an envelope. You wouldn’t need access to a mammography machine.”

MORE

Imagine that. No mammography machine. No pain, no radiation.  And the original testing was done on machines in Japan and here in the good old U.S. of A.

10 years later…

I wake up to hear the interview with Dr. Peter French, the Chief Scientist at Fermiscan, Ltd., who describes the whole process again. This is the NUMBER ONE innovation honored in  Australia this year.  And, there is actually a TEST now According to the Fermiscan website, the company has already completed a  “2,000 patient trial and has commenced a clinical study using the Fermiscan Test in conjunction with current screening to assess the use of the test by physicians in a clinical setting.”

Here’s the transcript of the interview:

8 June  2009

Hair Test to Detect Breast Cancer

How a strand of hair can test for breast tumours

Hair Test to Detect Breast Cancer
Contact: Dr. Peter French, Chief Scientist
Fermiscan Holdings Ltd
Level 5, 48 Hunter Street, Sydney, NSW 2000
International Telephone: +61 2 9245 4460

TRANSCRIPT:

DESLEY BLANCH : A revolutionary test that detects the first signs of breast cancer from a few strands of a woman’s hair was named as the most innovative product in Australia in the inaugural Smart 100 Awards. Here’s how it works. The Australian researchers report that hair from women with breast cancer can be distinguished from hair obtained from women without the disease — by exposing hair samples to high-powered X-rays from a synchrotron particle accelerator.

When hair is exposed to x-rays, the radiation is defracted in a distinctive pattern by the alpha-keratin that forms hair.

Fermiscan’s test is based on technology developed by Veronica James, a retired physics professor from the University of New South Wales in Sydney and from whom the company has acquired the patent rights.

Dr Peter French is chief scientist at Fermiscan Holdings. Here is part of an interview he gave me last year, where he explains X-ray defraction and how its pattern differs between normal hair and hair from women with breast cancer.

DR PETER FRENCH : X-ray diffraction is really sending X-ray particles through substances, often biological substances such as hair or crystals of proteins or DNA and, as they go through, some of those particles are deflected by the underlying structures of the substance that they hit. So in the case of hair, they’re deflected by as you said the alpha-keratin that makes up the hair fibre.

Most go straight through, but a few are deflected and after they’re deflected or they bounce off the underlying structures, they end up interfering with each other and causing a distinctive pattern of, mainly, arcs. So you see a picture of a circle in the middle with a whole lot of arcs around it and the arcs reflect the spacings of the underlying structures of the hair.

Now this has been a technique that has been used to look at hair structure for probably 50 years, so there’s nothing new in that. What was new was that the advent of the Synchrotron technology, which was really available from the late 90s enabled Dr James to show that in some cases, that women had an extra additional feature in the pattern, which wasn’t an arc it was actually a circle and this circle appeared in the hair from women who had breast cancer and she published this originally in “Nature” in 1999 and that was really how the work started.

DESLEY BLANCH : And, how early do you believe your test could detect this disease?

DR PETER FRENCH : We’re still working on that. So far though, we know that we can detect cancers that are at least 9 millimetres in size and probably smaller, and that’s certainly, usually below the level that a woman can feel the cancer with breast self-examination, for example.

DESLEY BLANCH : And where’s the hair cut from and how much hair is required for the test?

DR PETER FRENCH : We need about 20 strands or fibres of hair and it’s cut from the back of the head, usually behind the ear, which is the area of the hair which is usually less environmentally damaged. Some environmental damages which can cause us problems in the tests include dyeing and perming of the hair, and therefore we need about four weeks of regrowth post any dyes or perms so that we can get an accurate result with the test. So hair is simply cut from behind the head and we examine the part of the hair very close to the scalp.

DESLEY BLANCH : And what does breast cancer do to the hair structure?

DR PETER FRENCH : Well, this is still an area that we’re trying to understand. The mechanism would be something along the lines we propose that the breast cancer itself secretes a range of cytokines, growth factors and other proteins that can cause a change in the way that the hair follicle works and it does this by secreting these proteins and other molecules into the blood stream. The blood stream contacts the hair follicle and we believe that some of these molecules can cause a change in the way the follicle works and the way that it puts out the highly ordered normal strands of hair.

DESLEY BLANCH : And do we understand the reason for the ring pattern?

DR PETER FRENCH : Again, this is an area that we’re investigating. The ring usually means that there’s a disordering of an ordered crystalline-like pattern and so what we believe is that it’s likely that the normal highly ordered arrays of alpha-keratin filaments that are present in the hair are disrupted in some way by the presence of the cancer secreting these molecules into the blood stream.

DESLEY BLANCH : Fermiscan Holdings’ Chief Scientist Dr. Peter French describing their breast cancer test which was voted in at Number One in Australia’s Smart 100 Awards.

So the question becomes: when does this great idea make it’s way over here? And, if there ARE trials one of these days, how long with the FDA drag its feet in approving such a test? Or will this major breakthrough die overseas at the behest of our wonderful, profit-oriented “health care system”?  It will be ironic if women here are deprived of this test, considering that the initial research by Dr. James was run on machines in Japan and HERE, in the U.S.

Go visit the Fermiscan website and read the details of the trial and look at the simple charts. It seems that for women under 70, the sensitivity of the test is about 74%.  This is only 4% lower than mammography and ultrasound combined.  (Ultrasound and mammograms alone are only about 50%.  Sensitivity refers to the ability to actually CORRECTLY detect cancer.

Sounds pretty darned good to me for a test which involves snipping a few hairs…

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14 Responses

  1. […] This post was Twitted by FamHealthGuide – Real-url.org […]

  2. […] from breast cancer patients has a different molecular structure to hair from … Read more: HUGE BREAKTHROUGH in Breast Cancer Diagnosis; When Will We See It … This entry is filed under Cancer. You can follow any responses to this entry through the RSS 2.0 […]

  3. GRL,

    It will never fly here. It’s too inexpensive. If big medi can’t bill for it, it has no future.

    • GG ~
      my thoughts exactly!
      in fact my words almost to the letter.

      If the insurance and pharma industries can’t profit from our ill health, then it is not gonna happen.

      • It is something to help women — women in this country are third class citizens. Must use the “medical” profession to keep women in their place and treat being female as a medical “problem”.

  4. Will Obamacare pay for it?

  5. I have been following a promising treatment for chronic kidney disease. My husband may one day face real dialysis.

    This treatment showed great promise but the rights for the drug keep going back and forth between 2 different companies.

    If you look up BMP-7 for treatment of chronic kidney disease you will find a wealth of information. The hope for this treatment is that people could get off of dialysis or never have to go on. I have written , called all the usually first steps and you can not get any response.

    Stryker had the rights and developed a treatment for severe bone fractures, they still hold the rights for that treatment, they sold any future development to a small company Curis, which is turned sold the rights for development of this as a treatment for chronic kidney disease to a branch of Johnson and Johnson. They held the rights and did nothing for 5 years, the rights then went back to Curis, who has once again turned it back to Stryker, with the hopes of further development,that was 18 months ago, still nothing.

    J & J hold the rights to Procrit which a lot of CKD patients need to treat the anemia that they suffer. Of course this is a conflict of interest would you say. As long as they held the rights they controlled the research and in turn protected their interest.

    One other fact, sorry this is so long but reading the post just reminded me of all the potential in health care that is just sat on, Medicare covers everyone who needs dialysis and the last number I saw it is about 50,000 a year to treat one patient, if they want to say money you would think the Gov for look into the potential in BMP-7. Another conflict with this possible treatment is all the money that is made by dialysis centers. They would stand to lose a ton of money, unless the Govt bailed them out.

    Now comes this health care plan and the costs of the last 6 months of life. Scares me crazy as I have heard in Europe people are denied dialysis if the Govt deems you are not worth the cost. People can live on dialysis for years but not live long without it.

    So as the future of this need way of detecting breast cancer, I wish is was so and maybe it will be but trust me just because something makes health care less expensive and more comfortable for the patient does not mean it will happen, I am sure you all know that.

    Sorry thank for letting me vent and I know this was a little off topic, but this brought up a lot of issues for me.

    • Kathy, I have CKD and am following a protocol offered by the late Dr. MacKenzie Walser of Johns Hopkins…a low protein diet with amino acid supplementation (no urea formed). His book, “Coping with Kidney Disease” is at Amazon and a MUST!

      Look up Calwood Nutritionals for info on the amino acids and papers on that, and info on the diet…

      In the early 90’s Al Gore set up a study but Ross Labs barged in and used their supplements instead of the one used by Walser. Of course, this mess didn’t confirm Walser’s results! BUT, the protocol is being used in China and Italy also on board.

      I am also doing intravenous Alpha Lipoic Acid, already in use in Europe for liver and neuropathy problems. ALA has been researched for years by Dr. Burt Berkson and I am so lucky, he is here in NM!! He’s got a PhD in biology which helps. He just got back from Scotland where he spoke at a meeting…he worked with the FDA on this but nothing will happen because of Big Pharma. And Bush blocked the importation of the ALA pharmaceutical product from Germany, so the ALA comes from Italy and is processed in California. Let’s see if Obama and company lift that ban from Germany! HA HA!

      There is now a study going on at Vanderbilt Univ. on Alpha Lipoic Acid and the kidney specifically, although you can find papers on the subject already out, esp. dealing with diabetic kidney problems.

      Look up Berkson/ALA on the internet…you’ll find him…

      His book on ALA is also at Amazon…

  6. I was discussing all this today with someone who had the idea of possibly being able to send samples for testing overseas.
    I’m thinking of emailing Fermiscan about this….

  7. insightanalytical, thank you for your input, I really did not know why I posted on your site, first time for me, although I do come here and have seen you on other sites, I guess I was just lead here.

    We do have the book you mentioned, I will check out ALA, unfortunately we do not live near NM.

    Just wondering had you heard of BMP-7?

    • No, but I found a few things of interest when I searched~
      I have a sister-in-law who works for Janssen (part of JNJ) doing support for doctors. I’m going to pick her brain. My brother is coming in on 6/20 and I will send him back with some questions…

      People come here from all over the country and also from foreign countries. The last couple of weeks I’ve enjoyed meeting a woman with pancreatic cancer from Scotland. She left on Wednesday and will be continuing in Scotland. She met Berkson at the conference last month and he helped arrange treatment with a willing doctor there!~

  8. very good information,thank in advance

  9. Breast cancer can be detected early and with proper examinations. As long as the patient is aware of the symptoms, detection shouldn’t be as hard.

  10. Hi, this article is about my extraordinary mother and she can be contacted directly at the following email:

    veronica.james@anu.edu.au

    It would be best to talk with her direct, as opposed to analyzing what Fermiscan has done with her research for patients, which is nothing

    Fermiscan are NOT the people to look after her research. They stole her idea from her, she has worked for over 20 years in this research and Peter French and hi cronies stole her idea and then tried to commercialise it without success. (They were trying to replicate her results and couldn’t). so they failed. then Mum was working on another patent to do with cancer detection through fingernails. Again, Fermiscan rn over and tried to steal this new patent from Veronica. this time it failed majorly in the Supreme Court.

    That day, in a judgment that took two-and-a half hours to read to the court, Justice Robert McDougall dismissed Fermiscan’s case against Prof James and ordered that the company pay her legal costs.

    The case took up five days and was the second time Fermiscan had used legal action against the scientist, whose original technology interprets patterns in sophisticated Xray images of hair samples to show molecular changes in patients with breast cancer.

    Thrown out of court were Fermiscans claims that Prof James’ later inventions involving skin and nail tests were owned by them as “improvements” on her original hair diagnostic test.

    The first time the company took legal action against the inventor was in 2006, when it obtained a search order authorising a no-warning raid of Prof James home to seize all her documents over an alleged patent infringement dispute.

    However, when Prof James sought to publish her new study, the company claimed she had breached the settlement terms and that it owned the new inventions.

    “Every time I hear a car pull up outside, I worry it’s going to be another subpoena. I just couldn’t go on if I had to go to court one more time. Please don’t ask me any questions,” the shaken professor whispered.

    So, this is what they have done to Professor James – they have gagged her. The tactics Fermiscan has used against a distinguished scientist are a disgrace.

    The rest of the biotech sector should condemn the way this talented researcher, who gave away her life’s work in the hope of saving others lives, has been treated.

    Every self-respecting person working in the life sciences sector who values peer review of scientific discoveries has a responsibility to make sure the case concluded by Justice McDougall is the final chapter in this saga.

    Earlier this year, she signalled her intention to patent her new discovery, only to be slapped with a writ.

    Each time BNW has called Fermiscan, chief executive David Young has been too busy to talk. A call to Fermiscan’s founder and current corporate strategist, Leon Carr, also was not returned.

    You remember Leon? The investment banker linked with the now defunct Medicine Quantale.

    Well, now Leon has another company called Rellcain and it recently agreed to sell a 19.9 per cent stake in Fermiscan to Polartechnics.

    Also a women’s health diagnostic biotech, Polartechnics has launched a takeover of Fermiscan.

    Polartechnics chief executive Ben Dillon, who surprisingly was willing to talk to BNW, said the adverse finding against Fermiscan did not automatically rule out the merger, but he would wait to read the full judgment before making a call.

    Yep, look forward to reading the detailed judgment, which should be available from the court transcribers here:

    http://www.lawlink.nsw.gov.au/scjudgments/2009nswsc.nsf/6ccf7431c546464bca2570e6001a45d2/399a75edcecdcf26ca2575d6007a8f5d?OpenDocument

    Fermiscan is suing the inventor of its x-ray diffraction hair test Prof Veronica James claiming a new test using finger nails and skin is an improvement on their patent.
    Prof James sold the 1998 hair x-ray diffraction patent to Fermiscan in 2004 and has been the subject of legal action brought against her by Fermiscan – including an Anton Piller order allowing the company to search and seize her private property.
    Following the initial court action, the company and Prof James reached a settlement which included an agreement that Prof James would not disparage the company, which has been interpreted as a silencing order against the scientist.
    Middleton’s intellectual property partner Jane Owen is not bound by the settlement and told Biotech Daily there would be a hearing at the New South Wales Supreme Court on May 25, 2009.
    Ms Owen said Fermiscan alleges that Prof James has breached the settlement clause preventing her from disparaging the company and that Fermiscan alleged that work Prof James had undertaken on x-ray diffraction of finger nails and skin was “an improvement” to the original patent they acquired from Prof James in 2004.

    On January 3, 2008 Prof James filed international patent application PCT/AU2008/000005 entitled ‘Biometrics Diagnosis’ with the Australian Patent Office.
    On July 17, 2008 the World Intellectual Property Organisation published the application on its website with the description: “The invention provides a method of detecting neoplastic or neurological disorders comprising exposing skin or nails to X-ray diffraction and detecting changes in the ultrastructure of the skin or nails, and also provides an
    instrument when used in the method of detection.”
    An adjunct professor at the Australian National University’s Research School of Chemistry, Prof James article entitled ‘Fiber diffraction of skin and nails provides an accurate diagnosis of malignancies’ was published online in the International Journal of Cancer on February 3, 2009 byWiley Interscience (www.interscience.wiley.com).

    The article says that an early diagnosis of malignancies correlates directly with a better prognosis, but for many malignancies there are no readily available, noninvasive, costeffective diagnostic tests with patients often presenting too late for effective treatment.
    “This article describes for the first time the use of fiber diffraction patterns of skin or fingernails, using X-ray sources, as a biometric diagnostic method for detecting neoplastic disorders including but not limited to melanoma, breast, colon and prostate cancers.
    “With suitable further development, an early low-cost, totally non-invasive yet reliable diagnostic test could be conducted on a regular basis in local radiology facilities, as a confirmatory test for other diagnostic procedures or as a mass screening test using suitable small angle X-ray beam-lines at synchrotrons.”

    The abstract is at http://www3.interscience.wiley.com/journal/121664971/abstract.

    Fermiscan alleges that x-ray diffraction of skin and nails is merely “an improvement” on Prof James’s original patent for x-ray diffraction of hair to detect breast cancer.
    Fermiscan managing director David Young told Biotech Daily that he was “prohibited from talking about it”.
    “We are not talking about it until it’s resolved,” Mr Young said.
    “We hope one day she will win a Nobel Prize for the technology and [it will] make her very rich,” Mr Young said. “She has a royalty stream for the product,” he said.

    Asked whether the matter could not be resolved without legal action, Mr Young said he wished it could be.
    Prof James’ solicitor Jane Owen said the skin and nail test was “absolutely a new invention”.
    “The diffraction process has been used since the 1930s to examine biological materials,” Ms Owen said. “The difference is the use of different biological materials to test for cancers and different cancers to those in the 1998 Fermiscan patent.”

    “It’s a complete over-simplification to think you can substitute a nail for a hair and then expect to automatically predict the results will be the same. The new patent application is for different biological materials for the detection of different and further types of cancer.”
    “If Fermiscan’s claim was valid, it would be tantamount to saying that they own all x-ray diffraction processes for all biological material. Their patent simply doesn’t go that far,” Ms Owen said.

    Prof James has an Order of Australia Medal for her services to the deaf and there is an annual two day camp called the Veronica James Science Challenge for Hearing Impaired Children supported by the University of Sydney’s Faculty of Medicine through its department of pathology. Prof James has worked on breast cancer since the 1980s.
    Fermiscan was down 1.5 cents or 7.89 percent to 17.5 cents.

    BIOTECH DAILY EDITORIAL
    Whatever the merits of the case Fermiscan is mounting against Prof Veronica James, it is simply bad for the biotechnology sector when a scientist is hounded by a company.

    Fermiscan is spending its investors’ money to take the most drastic action possible against the inventor of its technology and soon it will be requiring Polartechnics shareholders to follow suit.

    It is not credible that the company cannot find a creative role for Prof James assisting in this most interesting method of non-invasively detecting very early cancer.

    Together they could be saving women’s lives.
    It is most poignant when the circumstances of the plaintiff Fermiscan are compared with those of the defendant Prof Veronica James

    Prof James is receiving legal assistance on a no-win, no-pay basis and is supported by women concerned with the high incidence of breast cancer. She should be allowed to retire in dignity and comfort, instead of facing endless court cases because she continues to research her life’s passion.When she could not find suitable equipment, she designed and engineered it herself. She should be celebrated as a great pioneering scientist.
    Fermiscan is spending investors’ money, for what purpose? If Prof James disparages their test, originally based on her work, so what?

    This is science. Evidence rules. The company has not explained why legal action is necessary. And to the best of Biotech Daily’s knowledge neither Prof James nor Fermiscan have been able to clearly demonstrate superior results with the x-ray diffraction of hair process above the standard of care of mammography and biopsy.
    If Prof James’s skin and nail test does prove superior, Fermiscan could apologize, waive all previous agreements, pay a suitable fee and hire Prof James as a consultant.
    Regardless of any facts and argument to be played out in court, one thing is clear, this case should never have begun and Biotech Daily strongly opposes the silencing of scientists with anything other than scientific evidence.
    Biotech Daily believes that regardless of subsequent events, originating scientists should be celebrated by those who seek to capitalize on their creativity.
    The Fermiscan Polartechnics merger will give the new company, Novus Diagnostics, an opportunity to reappraise the relationship with Prof James.

    Mum wants to have patients send their samples direct from home without seeing their doctor. Then the samples will be taken to research synchrotrons to anaylze.

    Fermicscan would have done wonders for the world with my mums patent if they didn’t try to steal it from her and from the patients who she was trying to save.

    I would recommend talking with Veronica direct via her email, NOT through Fermiscan….Only $75,000 is required to help millions of not only women, but also men.

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