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?
1. van der Voet GB, Todorov TI, Centeno JA, et al; Metals and health: a clinical toxicological perspective on tungsten and review of the literature. Mil Med. 2007 Sep;172(9):1002-5. [abstract]
2. Marquet P, Francois B, Vignon P, et al; A soldier who had seizures after drinking quarter of a litre of wine. Lancet. 1996 Oct 19;348(9034):1070.
3. Marquet P, Francois B, Lotfi H, et al; Tungsten determination in biological fluids, hair and nails by plasma emission spectrometry in a case of severe acute intoxication in man. J Forensic Sci. 1997 May;42(3):527-30. [abstract]
4. Kraus T, Schramel P, Schaller KH, et al; Exposure assessment in the hard metal manufacturing industry with special regard to tungsten and its compounds. Occup Environ Med. 2001 Oct;58(10):631-4. [abstract]
5. Nemery B, Verbeken EK, Demedts M; Giant cell interstitial pneumonia (hard metal lung disease, cobalt lung). Semin Respir Crit Care Med. 2001 Aug;22(4):435-48. [abstract]
6. Barceloux DG; Cobalt. J Toxicol Clin Toxicol. 1999;37(2):201-6. [abstract]
7. Jordan CM, Whitman RD, Harbut M, et al; Neuropsychological sequelae of hard metal disease. Arch Clin Neuropsychol. 1993 Jul;8(4):309-26. [abstract]
8. Mitchell RR, Fitzgerald SD, Aulerich RJ, et al; Health effects following chronic dosing with tungsten-iron and tungsten-polymer shot in adult game-farm mallards. J Wildl Dis. 2001 Jul;37(3):451-8. [abstract]
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]
10. Moulin JJ, Wild P, Romazini S, et al; Lung cancer risk in hard-metal workers. Am J Epidemiol. 1998 Aug 1;148(3):241-8. [abstract]
11. Wild P, Perdrix A, Romazini S, et al; Lung cancer mortality in a site producing hard metals. Occup Environ Med. 2000 Aug;57(8):568-73. [abstract]
12. Peuster M, Fink C, von Schnakenburg C; Biocompatibility of corroding tungsten coils: in vitro assessment of degradation kinetics and cytotoxicity on human cells. Biomaterials. 2003 Oct;24(22):4057-61. [abstract]
13. Bachthaler M, Lenhart M, Paetzel C, et al; Corrosion of tungsten coils after peripheral vascular embolization therapy: influence on outcome and tungsten load. Catheter Cardiovasc Interv. 2004 Jul;62(3):380-4. [abstract]
14. Butler TJ, Jackson RW, Robson JY, et al; In vivo degradation of tungsten embolisation coils. Br J Radiol. 2000 Jun;73(870):601-3. [abstract]
15. Wester PO; Trace elements in serum and urine from hypertensive patients before and during treatment with chlorthalidone. Acta Med Scand. 1973 Dec;194(6):505-12.