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Angella
11th August 2012, 10:07 PM
With only a few weeks to go before the annual October rush promoting mammograms begins, a new study published in the Journal of the National Cancer Institute is raising some doubts on mammography's purported merits.

The findings showed mammograms have little or no influence on reducing the number of women who die from breast cancer … and considering there are serious health risks involved, too, what, then, is the point?

Mammograms Again Shown to Have Little to No Value

Breast cancer mortality rates in Sweden have been declining since 1972. Even though this was before mammography was introduced, the reductions have continued and many have attributed it to mammography screening.

The researchers that authored the current study also expected to see a reduction in breast cancer deaths associated with mammograms, but the results showed otherwise:1

"County-specific mortality statistics in Sweden are consistent with studies that have reported limited or no impact of screening on mortality from breast cancer among women aged 40-69."

In light of these findings, the study's lead researcher Dr. Philippe Autier, at the International Prevention Research Institute in Lyon, France, noted:2

"Information to women on mammography screening should better reflect uncertainty on the effectiveness of that test, and underline the risk of overdiagnosis and overtreatment."

And this is not the first time the effectiveness of mammograms has been called into question. In 2010, another study concluded that the reduction in mortality as a result of mammographic screening was so small as to be nonexistent—a mere 2.4 deaths per 100,000 person-years were spared as a result of the screening.3

Mammograms May Cause More Harm Than Good

Many women are under the impression that a mammogram is simply an innocuous test that might or might not help you detect breast cancer sooner. But research shows this screening may end up harming more women than it helps.

Earlier this year, the Nordic Cochrane Center issued a leaflet explaining the potential benefits and potential harms of mammography, stating that, based on the available research, it no longer seems reasonable for women to attend breast cancer screening. After systematically reviewing the randomized trials of mammography, they concluded that:4

"If 2,000 women are screened regularly for 10 years, one will benefit from screening, as she will avoid dying from breast cancer because the screening detected the cancer earlier.

Since these trials were undertaken, treatment of breast cancer has improved considerably. Women today also seek medical advice much earlier than previously, if they have noted anything unusual in their breasts...

Because of these improvements, screening is less effective today and newer studies suggest that mammography screening is no longer effective in reducing the risk of dying from breast cancer.

... Since it is not possible to tell the difference between the dangerous and the harmless cell changes and cancers, all of them are treated.

Therefore, screening results in treatment of many women for a cancer disease they do not have, and that they will not get. Based on the randomized trials, it appears that:

If 2,000 women are screened regularly for 10 years, 10 healthy women will be turned into cancer patients and will be treated unnecessarily. These women will have either a part of their breast or the whole breast removed, and they will often receive radiotherapy, and sometimes chemotherapy.

Treatment of these healthy women increases their risk of dying, e.g. from heart disease and cancer."

"Because the cumulative incidence among controls did not reach that of the screened group, we believe that many invasive breast cancers detected by repeated mammography screening do not persist to be detected by screening at the end of 6 years, suggesting that the natural course of many of the screen-detected invasive breast cancers is to spontaneously regress."

FDA Secretly Monitored Mammogram Whistleblowers' Emails

The U.S. Food and Drug Administration (FDA) secretly monitored the personal e-mail of nine whistleblowers—its own scientists and doctors—over the course of two years. The monitored employees had warned Congress that the agency was approving medical devices that posed unacceptable risks to patients.

Six of the monitored scientists and doctors recently filed a lawsuit against the FDA, charging that the agency violated their constitutional rights to privacy by monitoring lawful activity in personal email accounts, and using that information to harass and ultimately relieve some of them of their positions.

According to the Washington Post6:

"All had worked in an office responsible for reviewing devices for cancer screening and other purposes. Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers."

The FDA has declined to comment on the allegations, stating it does not comment on cases involved with litigation. However, according to internal FDA documents obtained by the plaintiffs under the Freedom of Information Act, the agency had asked the Department of Health and Human Services' (DHHS) inspector general to conduct an investigation back in May 2010, stating suspicions that the plaintiffs had improperly disclosed confidential business information about the devices.

The HHS inspector general's office found no evidence of criminal conduct, stating the doctors and scientists had legal right to share their concerns with Congress and journalists. Hence no investigation was launched. But the FDA was not satisfied.

On June 28 that same year, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health wrote that, "We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," and again requested action be taken against the employees in question. After consulting with general prosecutors, the inspector general declined the second request for an investigation as well. Now the question is whether the agency monitored their employees within legal limits, and whether the purpose of the extensive monitoring was reasonable. Senator Charles Grassley doesn't seem to think so, stating that:

"The FDA has a huge responsibility to protect public health and safety. It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress."

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

A recent article by Martha Rosenberg gives even more details about what’s really going on at the FDA7. She writes:

“For reporting the safety risks, the scientists became targets of the now-disclosed spy program and some lost their jobs. "It has been brought to our attention that FDA management may have just recently ordered the FDA Office of Criminal Investigations (OCI) to investigate us, rather than the managers who have engaged in wrongdoing!" wrote the FDA scientists in a follow-up letter a few weeks later to President Obama. "It is an outrage that our own Agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

Dr. Kavanagh worked as an FDA drug reviewer from 1998 to 2008, and reportedly encountered the same kind of hostile and coercive working environment as the device reviewers. Rosenberg interviewed Dr. Kavanagh for her article, in which he makes the following shocking statements:

“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs.

While I was at the FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”

Truly, this is an interview you’ll want to read in its entirety. It’s absolutely shocking. Dr. Kavanagh points out several of the ways drugs slip through the system. For example, drug safety studies usually include too few individuals and are too short to adequately evaluate health risks. Just one single adverse event during such a study can therefore be extremely important and must be taken seriously. Alas, according to this insider, in-depth evaluations and follow-up studies rarely take place. He also claims reviewers were specifically instructed to only read the summary and accept drugmakers’ claims without examining any of the submitted data!

“Other times I was ordered not to review certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed,” he says.

Dr. Kavanagh’s testimony sends chills up my spine, as it so clearly describes the inner workings of an agency that is putting your health at grave risk instead of protecting you and your family from dangerous drugs and medical devices...


source - Dr Mercola