FDA to Increase Oversight of Medical Radiation Scanners
February 11, 2010
The New York Times
By Walt Bogdanich and Rebecca R. Ruiz
The federal Food and Drug Administration said Tuesday that it would take steps to more stringently regulate three of the most potent forms of medical radiation, including increasingly popular CT scans, some of which deliver the radiation equivalent of 400 chest X-rays.With the announcement, the F.D.A. puts its regulatory muscle behind a growing movement to make life-saving medical radiation — both diagnostic and therapeutic — safer.
Last week, the leading radiation oncology association called for enhanced safety measures. And a Congressional committee was set to hear testimony Wednesday on the weak oversight of medical radiation, but the hearing was canceled because of bad weather.
The F.D.A. has for weeks been investigating why more than 300 patients in four hospitals were overradiated by powerful CT scans used to detect strokes. The overdoses were first discovered last year at Cedars-Sinai Medical Center in Los Angeles, where patients received up to eight times as much radiation as intended.
The errors occurred over 18 months and were detected only after patients lost their hair.
In making the announcement, the F.D.A. said it hoped to reduce unnecessary radiation exposure from three medical imaging procedures: CT scans, which provide three-dimensional images; nuclear medicine studies, in which patients are given a radioactive substance and doctors watch it move through the body; and fluoroscopies, in which a radiation-emitting device provides a continuous internal image on a monitor.
“These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk,” the F.D.A. said. “Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts.”
Patients today receive far more radiation than ever before. The average lifetime dose of diagnostic radiation — excluding therapeutic radiation — has increased sevenfold since 1980, prompting widespread concerns that certain procedures are overused and that they needlessly expose patients to an increased risk of cancer. Children and women are particularly vulnerable.
Last month, The New York Times documented the harm that can result when complex machines that generate radiation are programmed incorrectly and when basic safety procedures are not followed. The Times also found that a patchwork of laws and regulations to protect patients are weak or unevenly applied.
The F.D.A. has long had jurisdiction over medical devices, but it has made limited use of its power. Consumer groups, for example, have repeatedly contended that the agency allows manufacturers to sell new devices without first having to prove their safety and efficacy.
In its announcement, the agency said it might require manufacturers of CT scanners and fluoroscopic devices to incorporate new safeguards into the design of their machines and to provide better training to medical personnel. The agency said it plans to hold a public meeting on March 30 and 31, “to solicit input on what requirements to establish.”
Among the proposals under consideration: that devices display, record and report equipment settings and radiation dose; that an alert be issued when the radiation dose exceeds an optimal dose for most patients; and that devices be required to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.
The F.D.A. said it would also work with the Centers for Medicare and Medicaid Services to incorporate new safety practices into the accreditation process of imaging facilities and hospitals.
“I think it is very timely in light of concerns about radiation exposure and the possibility of overexposure,” said Dr. James Thrall, professor of radiology at Harvard Medical School and chairman of the American College of Radiology. “I think it will nudge the industry.”
A major issue, Dr. Thrall said, is that “there is nothing on the machine that tells the technologist that they’ve dialed in a badly incorrect radiation exposure.”
Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health, said manufacturers were generally supportive of the agency’s proposal. “We are using a variety of tools available to us — both regulatory in nature and collaborative in nature — to maximize benefits,” Dr. Shuren said.
The Medical Imaging and Technology Alliance, an association of manufacturers of radiological equipment, issued a statement supporting the F.D.A. initiative, while calling for mandatory accreditation of advanced imaging facilities and for establishing minimum standards for personnel who perform medical imaging exams and deliver radiation therapy treatments.
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G.E. Attempting to Silence Medical Imaging Critics
January 22, 2010
Natural News
By E. Huff
GE Healthcare, a British subsidiary of multinational giant General Electric, is suing Henrik Thomsen, a senior radiologist and professor of radiology, for sounding the alarm about the dangers of the company’s medical imaging drug, Omniscan. After witnessing kidney patients who had received the drug develop potentially fatal conditions, Thomsen publicly exposed the drug’s dangers which caused a firestorm of controversy.
In an effort to muzzle Thomsen, GE Healthcare has already spent more than 380,000 British pounds, or about $610,000, in legal fees pursuing litigation against him. Utilizing loopholes in Britain’s libel laws, the company is alleging that Thomsen falsely accused GE of suppressing sensitive information about the drug’s risks at an Oxford scientific congress presentation in 2007.
Investigation into these claims has shown that Thomsen accurately described his clinical experience and that no such misrepresentation took place. When questioned about this fact, GE spokesmen had no response other than to suggest that Thomsen indirectly slandered the company through insinuation.
Many in the scientific community have expressed outrage over the blatant misuse of British libel laws to silence honest and open debate and dissemination of unbiased information about medical procedures and drugs. Scientists and clinicians who act on behalf of patient safety by highlighting the facts rather than corporate talking points should not be gagged by powerful corporations who leverage their influence and money to manipulate the legal system for their own gain, say those who support libel reform.
Hundreds of people in both the U.K. and the U.S. have died from the side effects of Omniscan and two other similar medical imaging drugs. Filled with toxic contrasting agents like gadolinium, a toxic heavy metal, Omniscan is implicated in causing nephrogenic systemic fibrosis, a skin condition that can cripple a person and possibly cause death.
Legal action is being taken against the companies that produce these drugs by patients in both the U.S. and the U.K. ProPublica, an independent, nonprofit news organization in the U.S. whose purpose is to serve the public interest, has been closely watching the effects of medical imaging drugs, divulging the truth about the dangers they pose.
Nevertheless, GE Healthcare is holding its ground in the fight against Thomsen. As it stands, the company has achieved success in silencing Thomsen as he now refuses to discuss the risks associated with Omniscan in public forums. Until libel reform is enacted, officials believe that companies will continue to misuse the courts to silence the truth and achieve their own ends.
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New Mammogram Recommendations
January 11, 2010
Natural News
By E. Huff
Several years ago, the U.S. Preventive Services Task Force (PSTF) issued an updated set of recommendations about mammogram screenings, suggesting which and how often women should get them. Since the last time the group issued its recommendations in 2002, new study data emerged that has led to a few changes. Its new guidelines, suggesting that women over 40 only need a mammogram every two years, has led to a firestorm of criticism from professional and advocacy groups as well as politicians.
The American College of Radiology and the American Cancer Society were quick to condemn the new findings, ones that PSTF has explained made the best sense based on current published data. The group consulted the Evidence-Based Practice Center at the Oregon Health and Science University for all current, relevant information about breast cancer screenings and arrived at what it says is a well-informed conclusion concerning routine screenings for older women.
Dr. Heidi Nelson, the lead researcher at the university who compiled the information for the PSTF panel, and her team scoured all available data on the subject and constructed it for review. Fifteen outside scientists were tasked with reviewing the information prior to being presented to panel members.
One of the primary studies was a recent British study that compared 54,000 women who received routine mammograms beginning at age 40 with 107,000 women of the same age who did not receive them. The results of this comprehensive study revealed that there was virtually no difference in breast cancer death rates between the two groups.
A comprehensive analysis of all available studies, including a few that showed some benefit from routine mammograms and others that did not, led to the conclusion that there is only a minimal benefit to receiving routine mammograms.
What researchers have found is that for every 1,900 women between the ages of 40 and 50 that are screened yearly for breast cancer using mammography, one death is prevented in the following two decades. Five women would have died regardless of screenings, so out of six potential deaths, one would have been prevented.
On the other hand, the potential harm induced by mammography screenings includes excessive testing and over-diagnosis, including many false positives. Analysis revealed that women have a 10 percent change of being falsely diagnosed. A significant number of cancers detected are not even malignant, yet mammograms are unable to differentiate between harmful and benign cancers.
Over-diagnosis, which is a growing concern among medical professionals, was not properly assessed or understood in 2002 when the last recommendations from PSTF were published. Many women are needlessly undergoing invasive and harmful surgery, radiation treatment, and chemotherapy for cancers that are not even harmful.
Dr. Russell Harris from the University of North Carolina, one of the panel members, explained that mammography is only effective at diagnosing one type of cancer, the malignant, slow-growing kind that can be effectively treated when diagnosed early. This kind represents only 15 percent of deadly cancers.
Precise numbers of over-diagnosis were not easy to pinpoint since estimates ranged from six percent to upwards of 50 percent. Dr. Timothy Wilt from the University of Minnesota, however, estimated that about 30 percent of cancers detected by mammography are over-diagnosed, meaning that they were either benign or untreatable.
Statisticians from the Anderson Cancer Center in Maryland were tasked with assessing screening intervals. Based on an analysis of a large cross-section of women, the group determined that there is virtually no benefit from mammography screenings for women in their 40s. Thus they determined that these women could reduce their risk of harm from mammography by getting screened every other year rather than annually.
What do these findings ultimately reveal? First, mammography screenings come with a myriad of potentially negative side effects while offering scant benefits. Over-diagnosis being the primary concern among researchers, countless women have undergone and continue to undergo dangerous procedures needlessly. More often than not, benign tumors are improperly diagnosed at the expense of the woman’s health.
The radiation involved in the screening process also contributes to increasing a woman’s risk of developing breast cancer. By subjecting the body continually to low-dose radiation, otherwise harmless cancer cells are encouraged to multiply and spread.
The fact that even mainstream research is now proving that mammograms provide virtually no benefit should be a wake up call to physicians everywhere who embrace the practice. Safer screening methods like thermography confer the same benefits while eliminating radiation exposure.
Since screenings of any kind can still lead to a false diagnosis, a woman’s best bet is to prevent breast cancer nutritionally. Anti-cancer foods and nutrients will prevent malignant cancer cells from ever developing in the first place. When combined with exercise and a healthy lifestyle, there is no reason why any woman should ever develop a deadly form of breast cancer.
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How We Came About Current Cancer Guidelines
November 23, 2009
New York Times
By Gina Kolata
A few years ago, an independent group that issues guidelines on cancer screening decided to review its recommendations for breast cancer. It had last issued guidelines in 2002, but things had changed — there was new science and researchers had become more sophisticated in analyzing existing data.
So the group, the U.S. Preventive Services Task Force, started what it thought would be a straightforward job: gathering the newest science and asking about the benefits and risks of breast cancer screening, the best time to start and how often women should be screened.
The group ended up recommending that most women forgo routine mammograms in their 40s and test every other year instead of every year.
The response was swift and angry. Professional groups, like the American College of Radiology, advocacy groups, like the American Cancer Society, and politicians said the guidelines would deprive women of a life-saving test. And some said the guidelines were politically motivated to save money.
Panel members have been taken aback by the response. Their work seemed almost mundane, they say, just an effort to gather and evaluate the best possible evidence.
The task force, a 16-member panel of experts appointed by the Department of Health and Human Services, began its work as usual. It went to an academic center, in this case the Evidence-Based Practice Center at the Oregon Health and Science University, and asked for an extensive review of all the relevant papers published on breast cancer screening, including ones used in the last review. At that time, the task force recommended routine screening starting at 40, saying that there were benefits although they became greater as age increased. The Oregon group had done similar reviews for the panel, including a review for the 2002 guidelines.
This time, the panel hoped that it could get missing pieces of the puzzle. New studies allowed scientists to zero in on benefits and harms for women in their 40s and to evaluate with far more certainty not just whether women should be screened but also how often.
The Oregon scientists began by combing the literature. By November 2007, the researchers, led by Dr. Heidi D. Nelson, a professor of medicine, medical informatics and clinical epidemiology at the university, had finished its review and sent its work to 15 outside scientists for review, then sent it to the panel. Finally, the researchers were ready to make their first full presentation to the panel members.
Part of that evidence, which Dr. Nelson’s group included, was new results from a huge study in England of mammograms for women in their 40s. This study, published in 2006, compared 54,000 women offered mammograms starting at age 40 with 107,00 women the same age who were not offered them. Previous studies of women in their 40s had them starting at various times in that decade of their lives and so were less useful.
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In Spite of Science, Cancer Industry Still Pushing Mammograms
November 23, 2009
Natural News
By Mike Adams
The cancer industry has blatantly abandoned science these past two weeks by insisting women under 50 should receive annual mammograms even though the industry’s own scientific task force concluded that such screenings result in too many false positives. Essentially, the U.S. Preventive Services Task Force took a good, hard look at the science and concluded that mammograms harm far more women than they help (for women under 50, anyway). But when they announced the new recommendations that women under 50 should avoid mammograms — and women over 50 should only get them every other year — the cancer industry cried foul.
Radiologists, oncologists, Big Pharma pill-pushers and cancer industry non-profits all banded together to declare, “We are abandoning the science! We want more mammograms for more women, science be damned!”
Of course, they all still claim to be “scientific,” but what they really do is selectively cherry-pick which bits and pieces of the scientific evidence they choose to adhere to. And when it comes to these new mammogram recommendations, they’ve decided to simply abandon the science and keep pushing more radiation imaging tests for women (mammography).
The cancer industry is a complete failure
What you are witnessing here, folks, is the desperate last gasps of a failed industry. Their technologies do not save lives, their drugs do not cure cancer, and their “science” doesn’t add up. The cancer industry is a fraud, and now its fraudulent nature is finally becoming apparent to everyone. It even has the mainstream media (USA Today) describing the failures of mammography in articles like the one you’ll see here.
Here’s something else you need to know: The cancer industry hasn’t merely abandoned science in terms of mammography; it has also abandoned all science with the pushing of chemotherapy. Did you know there has never been a randomized, placebo-controlled study proving that chemotherapy saves the lives of breast cancer patients?
That evidence doesn’t exist. The whole “treatment” scam is based entirely on fiction. Chemotherapy only works at all against three rare types of cancer, and breast cancer isn’t one of them.
In defending the new mammography guidelines, Dr. Timothy Wilt, a member of the U.S. Preventive Services Task Force, said that the task force recommendations “were based on the most rigorous peer review of up-to-date, accurate information about the evidence about the harms and benefits of treatment.”
He repeated that women under 50 should never receive mammograms, and women 50 or over should only receive a mammogram every two years.
The American Cancer Society, quite predictably, has a real problem with that recommendation. Its entire success (and power) depends on more people getting cancer, and one of the best ways to make sure that happens is to keep pushing for more mammograms. In opposing the new mammography recommendations, the ACS has now abandoned science, too.
Chemotherapy: The chemical holocaust
When cancer doctors tell you that “chemotherapy will save your life,” they are lying to you. And they lie thousands of times a day, deceptively recruiting women into modern medicine’s version of a chemical holocaust.
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