In June 2009 the FDA cut corners and fast-tracked the approval of a new medical device without ascertaining its safety because it resembled other similar devices that had been approved in the past. That's like saying ... well this nuclear reactor looks like another one we approved last year, so it must be safe. This metaphor is not far off the mark because we are talking about a device that directs radiation at the incision of a cancerous breast immediately after the tumor is surgically removed. It's supposed to be fast track radiation therapy. The woman can finish her radiation treatment before she wakes up from surgery. That was the big selling point. Instead of weeks or months of daily radiation treatments, wake up from surgery and its done. Slash and burn at its best.
In this case a silicon and tungsten shield is placed over the healthy tissue in the breast to protect the non cancerous areas of the breast from the damaging radiation exposure aimed at the fresh incision. The FDA forgot to test the safety of the silicon tungsten shields. Oops. Thirty women who received this treatment are left with metal deposits of tungsten in their breast tissue that show up on their mammograms. Not only does this make it more difficult to read the films and identify new breast cancers in women who have already had one bout of cancer, but tungsten is not without toxicity and now it is lodged in their tissue.
According to Dr. Diana Zuckerman,Ph.D., The Cancer Prevention and Treatment Fund, National Research Center for Women and Families
This is a great example of why potentially dangerous medical devices should be subject to clinical trials and inspections. Without those safeguards, it can take years to discover that a device is defective; meanwhile, thousands of patients can be harmed.
One woman is considering a disfiguring surgery to remove all the breast tissue contaminated with tungsten. After all, she is not eager to wait and see if she gets another cancer, bone marrow disease, immune disease or some other disease from toxic tungsten exposure over the course of her life. She has been a guinea pig once and she does not want to be guinea pig again.
This is reckless and irresponsible on the part of the FDA and on the part of the manufacturer, ICad. The FDA is a failed agency charged with protecting the public from dangerous drugs and devices. We expect the FDA to be thorough, not sloppy, responsible and in the the public interest, not negligent and granting favors to medical device manufacturers. Instead, the FDA seems lazy and unprofessional and unethical. Once again it looks like the FDA is in bed with industry. Is the FDA an agency with public safety as its priority? It seems like a lot of rhetoric.
This device was approved before a thorough safety assessment was made. I call that negligent. I call that irresponsible. I call that cutting corners. I call that unacceptable. I wonder who benefitted financially? I wonder whose signature of approval is on the documents at the FDA marked SAFE FOR HUMAN TRIALS? Who is accountable? This is human error and human negligence. This is our tax dollars at work. A group of breast cancer patients are paying the price.
The short term and long term risks of tungsten deposition into human breast tissue are not known. The cover being used by the FDA is that there are no known human studies on tungsten toxicity. Well, that is only partly true.
Looks like word spinning and avoidance of accountability and general lack of humanity and compassion. It took some digging to find information about the history of tungsten exposure in humans. It turns out that tungsten is widely used in the military. Tungsten is used to make bullets and other devices that violently kill. The military loves tungsten because it is such a hard and useful metal It does a good job making bullets and shrapnel. I found many references done by US Military, the British Military, the French Military and the Israeli military commissions concerned about tungsten exposure to its forces and concerned about tungsten buildup in the soil of the shooting ranges.
There are also a large number of animal studies which may or may not be able to be extrapolated to humans. The FDA is also splitting hairs, because tungsten metal itself is rare in nature and in industry. Tungsten binds to other molecules in biological systems. Tungsten also binds nicely to other metals for use in industry, for example nickel-tungsten alloys..a double dose of toxicity to humans. So, it is easy to say "Well we don't know enough about tungsten". In fact, enough is known about tungsten compunds to make me never want to have it lodged permanently in my breast and muscle tissue for several decades in any form.
In animals who have similar cellular physiology to ours, tunsgstate (a form of tungsten) is known to substitute for phosphorus and molybdenum in crucial cell functions. For example, the mitochondria, essential for life and cellular energy production are poisoned and rendered dysfunctional by tungsten because phosphorus is crucial to the production of cellular energy. (ATP a little energy packet essential to life...P stands for phosphorus). When tungsten substitutes for molybdenum in our cells, important enzymes crucial to normal cell functions are dismantled. Changes in molybdenum also effect copper metabolism. Copper is required for angiogenesis, the production of new blood vessels (as in after an injury or a surgery). These minerals are also crucial for normal blood cells, normal cells of immunity, normal bone marrow and the protection of our genetic material, our DNA. Having problems with mitochondrial function is at the root of many chronic illnesses. Some animal research indicates that tungsten is a potential carcinogen. Tungsten has also been shown to alter blood sugar metabolism. The symptoms of acute tungsten poisoning include diarrhea, vomiting, kidney damage. Not a pretty picture. There is very little information about chronic low level tungsten exposures.
The women who had tungsten delivered into their breast and deep into the muscle of the chest wall, where it now resides permanently and may enter the circulation and travel to other parts of the body, were participating in an FDA approved study. One woman stated that she felt comfortable participating in the study knowing the FDA had approved the device and had assessed its safety. Not so.
Because there are no long term human studies on tungsten metal (contrasted with studies on tungsten compounds), it is unknown and uncharted territory. Because we don't know does not mean it is safe. Most metals normally found in are in our bodies are in micro amounts. Exposures and abnormal levels of many metals such as lead, copper, cadmium, aluminum, mercury and iron all cause disease and functional abnormalities at abnormal levels. It is very likely that this may be true of tungsten as well.
The manufacturer of the device, ICad, was not paying for the study, but has since agreed to pay for toxicology studies for the women and for any surgical procedures they may need, such as disfiguring mastectomies that also remove the muscle of the chest wall.
Women who have these painful radical surgeries are not only disfigured but also suffer from many lifelong post surgical problems with scar tissue, nerve entrapment, chronic pain, loss of normal movement, not to mention the devastating emotional, sexual, maternal and social costs over the course of a lifetime.
What cost human suffering? What cost for changing a woman's life forever? Who pays for taking away peace of mind? Who pays for that?
We need to hold not only the manufacturer but also the FDA accountable for reckless and sloppy approval and ask that their fast track policies be reviewed. Let's find out who signed the approval and who is in bed with the manufacturer.
Is this yet another example of the FDA partnering with industry instead of overseeing industry and ensuring public safety? This reminds me of the BP oil spill and their government agency "safety" inspectors. And how about the failure to plan for a tsunami at a nuclear plant designed by General Electric where the backup pumps are installed in the basement which will definitely flood? What about the levies in New Orleans that local officials failed to maintain and thus failed to provide safety for its people in the event of a huge storm? Does anyone see a pattern here?
Dr. Nalini Chilkov is a well known expert on Integrative Cancer Care
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References
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9. Kalinich JF, Emond CA, Dalton TK, et al; Embedded weapons-grade tungsten alloy shrapnel rapidly induces metastatic high-grade rhabdomyosarcomas in F344 rats. Environ Health Perspect. 2005 Jun;113(6):729-34. [abstract]
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Seems like the 'new' silicone begins to go bad around 3 years later.
Now tungsten. What next? Too much treatment for too many women in the name of treating a disease that probably does not need so much treatment. Focus on the ones who are not benefiting from surgery or chemo! I favor integrative treatments absolutely with every single conventional method, no exception. Toxicity is insane in the cancer world. WHY? Aren't we people first, then 'cancer patients'? Doesn't seem like it. Knowing harm will be done should be reason to PLAN not to harm. Ann F. founder www.annieappleseedproject.org
The earlier a cancer is picked up, the easier it is to treat and the brighter the chances of success. Early breast cancer generally does not cause symptoms which make it difficult to detect. But a growing cancer may cause signs which include a lump, bump or thickening in breasts or in the armpit, or a dimple or puckering on the skin of the breasts and a change in the shape and appearance of the nipples. Most lumps in the breasts are not always a cancer. In fact, nine out of 10 lumps that women may feel in their breasts or around are benign and are not cancerous. They are due to fibrocystic changes in the breast tissue corresponding to hormonal changes over the menstrual cycle. Cancerous lumps can develop in ducts that carry the milk to the nipple or in the lobules that make it or in other parts of the breast tissue. Most of times, it starts in the milk channels and spreads into the breast tissue.
Investors complain to Congress that FDA review times are slow. Public hysteria like this points the finger at FDA complaining it is too fast. In the midst of this push and pull is our dimwitted Congress getting involved.
Has anyone seen how Congress changes direction more often than the wind? One day they are pulling up FDA for being too slow to approve devices and warning that they will cut funding. The next they are admonishing FDA for approving unsafe products. Is any of this posturing by Congress based on actual review of data? If you think yes, then I have a bridge to sell to you. Do you think any Agency or company or business can function properly in the midst of this hyperbolic environment?
And then there are the devices that just don't work. For example, lymphedema is common after breast cancer surgery, and can be very debilitating. A laser treatment is widely sold, but there is no evidence that the treatment is effective for most patients. FDA did not require clinical trials, and didn't consider that patients could harm themselves because the laser is self-administered by patients.
And then there is the Neurostar device that uses electro-magnetic pulses to the brain to treat depression. It requires one hour/day treatment 5 days/week by a physician for 6 weeks, so it’s very expensive. However, it works just as well if it is shut off instead of turned on. That's because the placebo effect is very strong. But the treatment itself is ineffective according to the data that they provided to the FDA and that is available on the FDA web site.
For more information: http://www.center4research.org/2011/03/3259/
Diana Zuckerman, Ph.D.
National Research Center for Women & Families
Cancer Prevention and Treatment Fund
www.center4research.org
www.stopcancerfund.org
they are probably responsible for more deaths then all the wars combined . They constanly attack the health food industry.with gestapo tactics. They approve drugs when the committee reccomends to not approve the drug. When Obama took office the scientists at the agence wrote him about the corruption within the agency
http://www.pogo.org/pogo-files/alerts/public-health/ph-fda-20100928.html
pubic - lol