|Year : 2015 | Volume
| Issue : 2 | Page : 9-13
Hufnagel Bioethics Institute
|Date of Web Publication||5-Jul-2017|
V G Hufnagel
Hufnagel Bioethics Institute
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Hufnagel V G. Morcellation Controversies. Acta Med Int 2015;2:9-13
The motto and conduct of the founding of the Royal Society. The purpose is to strive to expose the domination and power of authority that controls society and thought. Nullius in verba means ‘take no ones word for it’. It focuses on the honor of science and to look at the facts and findings to determine through experimentation. Debate is the fire of truth being forged in the heat of challenge.
| Genetics|| |
I have had some study in formal genetics. I was a medical student at UCSF and took course in genetics. I got to see the creation of growth hormone. Then, I was a NIH fellow at UCSF in reproductive genetics. I was there for the in utero surgery development.
The department of pediatrics UCSF was the go to place for short stature. There was a business deal with Geneteck.
People who could afford growth hormone got treatment for short Stature. UCSF had a patent of HGH. Two of the fellows Peter Seeburg from Germany and David from San Deigo were recruited to leave UCSF and join Genetech.
Peter admitted to bring the samples from UCSF lab and taking them to Genetech. He also admitted to fraud in a peer review article. He was later the head of the Max Plank Institute. David Goeddell denied everything Peter admitted to. Peter was no longer head of MPI and became a staff professor as his censorship took place for his admissions. No one went after David he was head of his own company. No admission, no censorship.
UCSF had its patent ripped off and had to wait decades for restitutions which was 200 million settlement with Genetech. Prior to recombinant DNA there were many scandals in the world of short stature. Kabi a Swedish pharm-corporation purchased pituitaries and was known for a lack of policy in where these came from.
Today this history has faded. Years pasted and battles took place in the courts that ending in the provision of some 200 million dollars to UCSF and the five researchers. When Seeburg took the stand for UC during the trial and he offered explosive testimony. He said that when he was working as a scientist at Genentech in 1979, he had used growth hormone made at the UC lab and brought it to Genetech.This material was used to make the DNA vectors from which Genentech produces Protropin. What's more, he testified that he and former Genentech scientist David Goeddel, now chief executive officer of the South San Francisco biotech company Tularik Inc., had agreed to misrepresent the source of the DNA in a 1979 paper in Nature. Goeddel has vigorously denied that they used the UC material or struck any such agreement. Legal experts have questioned whether Seeburg's testimony was relevant to the underlying patent case, and some have argued that it shouldn't even have been admitted in the trial (Science, 11 June, p. 1752).
| Today in the News|| |
Genetics has given us ways to determine to study genes and learn about their patterns.
Researchers have found that 11 genes increase 2-5 days before sepsis takes hold in patients. In time we may use this change to screen patients and prevent sepsis. In the America we have some 750,000 deaths from sepsis each year.
Cambridge researchers found that genes turn on more in the summer and this was associated with Vitamin D levels and warm sun exposure.
Researchers in Kansas have a rapid 50 hour genetic sequence test for newborns. This allows faster identification and treatment for genetic diseases in newborns.
WHERE TO GO: You can go on the web site COUNCILFORRESPONSIBLEGENETICS.ORG for more information.
| Genetic Wars|| |
I had colon cancer and wanted to have genetic studies to see my risk factors. The cost in 2008 in America was $3,000. My paternal grandmother died of colon cancer in her life time there was no routine colonoscopy. Today she would of survived w ith the removal of a polyp. My mother had breast cancer and Father had brain cancer. Getting genetictesting was a reasonable concept with my family history.
However this was not covered in my health insurance. I was able to do work in exchange for getting my studies done. This was a privilege of my medical education.
The cost however for patients without health insurance prevented most Americans from getting genetic testing. In America the financial crimes had changed everything in daily life. People lost their homes and more.
One company basically controlled genetic testing: Myriad Genetics. They offered no payment plan when I asked. And had no free testing back in 2008.
Myriad had the patents on several genetic tests. The held the reins to the future of genetic testing. These tests help to in determination of disease occurring, and probability of response to treatment. This can help predict the future health of a patient.
Again in 2008 many American s could afford a $3,000 US lab test. Americans were losing their homes and being laid off work. This is the have and have not's medical care that took place in the US until Obama Care came into being.
I offered to create an audio/video education program for patients for Myriad. The counseling staff wanted the program to help educate the public on genetics. However Myriad's president told me NO. He stated Myriad had several focuses.
- to create and patent new genetic tests expand on tumor markers
- Provide genetic tests in US and collect up front for studies
- Myriad was not an educational center.
This gives you the background of the position Myriad. One of the staff worked with the President and I was able to provide a one hour audio to the media department at Myriad.
The Myriad case was high profile and high cost going on for years before getting the US Supreme Court. A great deal of money is needed to take on a wealthy corporation. Myriad was challenged by the Association for Molecular Pathology. Here is where the assests of an organization and its membership can be pulled together to take on a Goliath. You send out asking for donations to take on such an effort.
The AMP case was lead by the ACLU (American Civil Liberties Union). The ACLU takes on these large issue cases in America. The can fight with a team of attorneys against Myriad who hired a full army of legal counsel with its enormous income as the exclusive test center for the BRACA gene. The basic claim is that a Myriad cannot patent isolation of a gene because this already is existing in nature.
Myriad had been in business and was the only lab a woman could go to for breast and ovarian cancer gene testing for years. Of extreme importance was Myriad had all the cases and all the knowledge of the genes and the findings. No one else was in the business so that Myriad had monopolized the science. They had years of knowledge with their proprietary data base of BRCA mutation information. When a lab does a test over and over again special knowledge is obtained over time. There could be no second opinion. No lab existed other than Myriad. Having the only tests available the income each year to Myriad was over 400 million each year. This was enough money to sue those wanting to get into gene testing and use the patent claim to keep others out.
When you have cancer it is valuable to know if there is a mutation in your genes putting you at risk. If a member of your family gets cancer you want to know if there is a genetic link. Did I get a gene from my grandmother? You also need to know for your children. Are my two daughters at risk?
I was able to speak directly with Peter. He was to the point.” Myriad is here to do tests and charge for them. We are a clinical Laboratory we increase income by patents of new genetic tests that only we can perform. We are not an educational institution. We grow by doing more tests. We are the genetic lab for now and in the future.We have no interest in any educational program. “ I felt I was on the street looking up at the Tyrell Corporation (Blade Runner). This man was making 20 million a year and his superiority oozed. I was very thankful he let me do one audio for Myriad. I could not afford the test at that time.
Myriad was able to benefit from its patents allowing it to monopolize the BRCA tests for breast and ovarian cancer. Myriad had its focus on the exclusion. One in every ten women is at risk for breast cancer. Exclusion of a market to test for the BRCA gene is also an issue of human rights.
| Bioethics|| |
What also occurred during the last decade was the fascination with genes, the wealth of owning patents, and the wealth of replicate DNA to make products like HGH that basics we needed in sorting out ofcancer risk factors was not taking place.
In the 1980's when I worked to explain that hormone testing was essential in evaluation of women for cancer risk, I was not challenged or debated, I was burned at the stake for having such an idea. I did a study of 300 women and found that all of the hyperplasia patients had severe hormone imbalance that could be easily treated and prevent cancer of the uterus. Drawing female hormones and related studies was not exotic. I approached several national labs and I could not even get the labs to help me create a protocol program. Little has changed in this area because it is not seen a big money maker. You cannot charge $4,000 and ever lab can do these tests.
Every lab was spending all of its money on genetics and anything else was not glamorous enough to consider for development. I was told to bring them a genetics test.
We are lacking a protocol for decades as to the relationship to hormones and female cancer. Basic blood tests are tied directly to breast cancer have not advanced over two decades. The hormone blood test for a full panel is some $200.00 USA. The lack of balance of estrogen to progesterone is an add risk factor to breast, colon and uterine cancer. As women age their hormone status can change each decade. Simple blood level studies can assist in the risk assessment of women and provides vital predictive data for the woman and her physician. This is a standard of care we do not have in America because of politics and economics.
This week a patient called me she is being thrown into the fire pan to have immediate chemotherapy for her breast cancer. No one has ordered her estrogen levels, progesterone, Vit D, thyroid studies, or sex binding hormone levels. I suspect she will have low to zero progesterone, and a high estrone level. None of the routine studies where performed to help her program but the chemo will start. Concepts like topical treatment are not even in the discussion because of the past focus has been exclusive also. We need the genetic information and we can use that for treatment analysis. So what happens after the chemo when her body fat keeps on making high rates of estrone and no progesterone?
In American practice these simple important studies are not the standard of care. This $200 of testing which is covered by insurance when the physician properly orders the test can benefit any woman and actually prevent these cancers by early detection and prevention of years of over stimulation of the estrogens. So much needs to be done on this front. Education of risk assessment is more than a gene test.
Myriad had litigated against all others who sought to get into the genetic market. It was able to make it too costly for others to enter this market with its patents in place, an army of attorneys and money to fund the litigation.
One point came out early on was a woman could not have a second opinion before making a choice on a serious operation. There was no other testing lab available.
Angelina Jolie had no second opinion. You only had the Myriad test. Myriad was not into full patient education nor does it have to be. Another issue brought by AMP was that these patents restricted scientific research and the patients access to medical care. The celebrity of Angelina brought more women into BRAC testing. This was an economic boost to Myriad. It was not an fully educational advance for patients. Angelina caused women to learn about the test. Again, I tried in 2008 to get an national educational program on risk assessment and told no by Peter Meldrum. Angelina is viewed as a saint for going public and deserves this credit for making the test known. She also reached out to explain her personal issues which I hope people will realize this is part of taking responsibility for your health.
I contacted the surgical center Angelina had her breasts removed. The surgeon knew nothing about hormone testing as a risk assessment and never heard of breast fluid analysis. I took the time to speak with her office manager (husband) and he said his center was focused on breast operations not lab testing.
There was no mention in the news or by Angelina if a morcellator was used to remove her tubes or ovaries. The public and more over physicians, and even breast specialists today 2015 in America not aware that breast fluid can be used for evaluation for cancerous cellular changes. Few are aware of the horrific events associated with morcellation. And few look at hormones which are a key factor in the development of cancer. How many women have died from morcellation?
The Myriad $4,000 test has in some ways with the press and media kept other technology and means of evaluation from part of standard of care. Today what are the hormone levels in your body? Today what are the cells in your breast like? These both these tests are under $400. I 'd rather know by cells are changing before so many have changed I have a breast mass. Or add progesterone to decease my estrogen. I will have to BEG my physicians to order a breast fluid test this year. I will make a journal of this event.
The focus and interest still is on the gene. Myriad stood by the US governments policy of that patent protection was directly linked to the explosion in gene research. Patents bring in money to develop tests,devices, and formula. The advances for in cancer is that we have today tumor markers and we can tract drug response. Companies were willing to spend money on research if they could get a patent and have a position like Myriad had.
But the reality of exclusion of others companies by Myriad prevents a woman to have a second opinion. To have no choice is what monopolization provides. It also prevents other research and advances in medical science. When one owns everything and is all powerful and the doors of the mind close.
The Supreme court had already made the path it was taking in Mayo v. Prometheus case decision the year before. The Supreme Court found that merely isolating genes that are found in nature does not make them patentable. Myriad argued a business position having a patent encourage investment in biotechnology and promote innovation in the area. The ACLU argued that the patent held by Myriad had stifled research and the isolation of the gene was not inventive because it exists in nature.
Many learned how to identify the brac1 and wanted to enter the arena of genetic testing. Myriad had the patent on the gene. Myriad sued those who tried to compete. Ironically the patent for Myriad is up now in 2015 but it had a good ride for many years. When the decision came down that the ability to isolate the gene and its mutations this fell under the concept that one cannot hold a patent on what exists in nature. The Myriad stock fell. Myriad then announced it was expanding its services to Europe. A common event for medical devices not approved by the FDA in the US, next thing the corporation moves on to Europe.
In Australia 1/2014 the courts upheld that Myriad had a right to patent genes. However Myriad had already give its patent rights to the people of Australia making this a non issue.
“ Myriad wishes to gift Australian Patent No 686004 (the Patent) to the people of Australia.” On September 2, 2010, the Commissioner of Patents published notice of Myriad's offer to surrender the Patent in the Australian Official Journal of Patents, and interested parties that want to be heard before the offer of surrender is accepted”.
Views expressed here are totally of Dr. Vikki Hufnagel Medical Director of the International Women's FRS Center located in Baja, California Editorial board of Acta Medica International does not cut/edit/configure the invited editorials. VIKKI HUFNAGEL, pioneer in advancing women's medicine and crusader for Reproductive Health Rights, graduated from Medical School at the University of California in San Francisco. She then became Chief Resident, Obstetrics and Gynecology at Albert Einstein Hospital in New York.
With training, experience, and employing the state of the art and latest advances in surgical techniques, she created and developed “Female Reconstructive Surgery” (FRS). FRS is an alternative to hysterectomy for non-cancerous conditions such as fibroids and uterine prolapse. Women previously had no other options.
Dr. Hufnagel is the first to come forth and fully expose and document the massive female surgical abuses in the United States. (Hysterectomies in the United States, 1965-1984, Vital& Health Statistics; U.S. Department of Health and Human Services, December 1987). She provided testimony before the U.S. Congress and the National Institute of Health on gender issues in medicine.
Her book, No More Hysterectomies, revolutionized the women's health care field and the concepts concerning the role and function of the female reproductive system.
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