X-Rays, Cancer and the Godfather

xrays and cancer A nationwide Armenian-American organized crime group has been charged with trying to steal more than $160 million from Medicare.(1)

Among those in custody is Armen Kazarian. The FBI calls him the vor, or godfather, of the operation and investigators say he’s the first vor ever arrested for racketeering in the U.S.

He and fellow members of the group set up phony health clinics and billed Medicare for treatments that were never performed.

The groups supposedly took advantage of the user-friendly side of Medicare.  Medicare tries to pay health care providers promptly by not verifying whether treatments have actually been rendered before it sends money.

Any more groups taking advantage of Medicare?

How about unnecessary exposure to medical X-Rays?

X-rays have been classified as carcinogens by the World Health Organization, the Centers for Disease Control and Prevention and the National Institute of Environmental Health Sciences, because studies have shown that exposure causes leukemia and cancers of the thyroid, breast and lung.(2)

Mammograms

In 1995, the British medical journal, The Lancet, reported that since mammographic screening was introduced in 1970’s, the incidence of ductal carcinoma in situ (DCIS), which represents 12 percent of all breast cancer cases, had increased by 328 percent and that 200 percent of this increase was due to the use of mammography. Since the inception of widespread mammographic screening, the increase for DCIS in women under the age of 40 has risen over 3000 percent.(3)

Another study found that certain nuclear-based breast imaging exams that involve injecting radioactive material into patients expose women to far higher doses of radiation than regular mammography, increasing their risk of cancer in vulnerable organs beyond the breast, like the kidneys, bladder or ovaries.(4)

Many predictions are based on information from survivors of the atomic bombings in Hiroshima and Nagasaki, Japan, which found a statistically significant increase in cancer at high levels of exposure — 50 millisieverts, or mSv, about 16 times the current annual average for Americans from medical exams.(5)

However, it is not clear that lower level of radiation exposure are safe. Nor would it be unusual for a patient to exceed this level (50 millisieverts), according to a paper from the American College of Radiology.(6)

“It is worth noting that many CT scans and nuclear medicine studies have effective dose estimates in the range of 10 to 25 mSv for a single study, and some patients have multiple studies; thus it would not be uncommon for a patient’s estimated exposure to exceed 50 mSv,”  Dr. Fred A. Mettler Jr., principal investigator for the study, by the National Council on Radiation Protection, said, adding that:

“the International Commission on Radiological Protections has reported that CT doses can indeed approach or exceed levels that have been shown to result in an increase in cancer.”(7)

Richard Monson, epidemiology professor at Harvard School of Public Health, says;

“The health risks — particularly the development of solid cancers in organs — rise proportionally with exposure.  At low doses of radiation, the risk of inducing solid cancers is very small.  As the overall lifetime exposure increases, so does the risk.

xrays and cancerThe United States population’s annual radiation dose from medical procedures increased sevenfold between 1980 and 2006. There has been a particularly sharp rise in the number of CT scans — to 62 million in 2006, from 3 million in 1980.(8)

Alternatives

“I’m constantly monitoring radiation doses in my patients,” says Dr. Deborah Rhodes, an internist at the Mayo Clinic who is doing research to develop screening technologies that require less radiation exposure to the patient.

She considers the patient’s total past exposure, and then carefully weighs the risks and benefits of each test and any alternative approaches she can take.

Alternatives, for example, that may include the State-of-the-art breast thermography which uses ultra-sensitive infrared cameras and sophisticated computers to detect, analyze, and produce high-resolution diagnostic images of temperature and vascular changes.

By carefully examining changes in the temperature and blood vessels of the breasts, signs of possible cancer or pre-cancerous cell growth may be detected up to 10 years prior to being discovered using any other procedure. This provides for the earliest detection of cancer possible. The procedure uses no radiation.(9)

“Unfortunately”, she said, “this is something that isn’t well understood, not just by the public — but by physicians who order the tests.”

R. Edward Hendrick, a physicist who has studied breast imaging for almost 30 years, said he was motivated to quantify the radiation exposure from nuclear breast imaging technologies in a published paper because of similar concerns.

“I would go to the international breast meeting and the big radiology meetings, and nobody had a clue what the doses and risks were.”

Dr. Lee Green, professor of Family Medicine at the University of Michigan says;

“It’s not enough just to know how many women were saved, we have to know how many were hurt to save them.”

How many are saved?

If 2000 women are screened regularly for 10 years, one will benefit from the screening, as she will avoid dying from breast cancer.(10)

At the same time, 10 healthy women will, as a consequence, become cancer patients and will be treated unnecessarily.

Why?

Pseudo-Cancers

Some of the cancerous tumors and so-called precursors of cancer that are found by screening grow very slowly, or not at all (“pseudo-cancers”). They would therefore never have developed into a real cancer. Since it is not possible to tell the difference between the dangerous and the harmless cell changes, all of them are treated. Screening therefore results in treatment of many women for a cancer disease they do not have, and that they will not get.(11)

These women will have either a part of their breast or the whole breast removed, and they will often receive radiotherapy, and sometimes chemotherapy. In the USA it has been calculated that after 10 rounds of screening, 49 percent of healthy women will have experienced a false alarm.

William R. Hendee, a distinguished professor of radiology, radiation oncology, biophysics and bioethics at the Medical College of Wisconsin in Milwaukee, called on radiologists to spearhead a campaign to reduce overuse of imaging technologies that expose patients to radiation unnecessarily and drive up health costs in the process.

Are the radiologists unnecessarily exposing patients to drive up costs?

Yes, if a study appearing in the October edition of Journal of the American Medical Association and funded by the National Cancer Institute is to be believed.

Lead author Dr. Camelia Sima of Memorial Sloan-Kettering Cancer Center in New York said the study of Medicare patients with cancers so advanced they had limited life expectancies and little hope of cure, revealed:

a culture of screening on autopilot.

The study concluded:

A sizable proportion of patients with advanced cancer continue to undergo cancer screening tests that do not have a meaningful likelihood of providing benefit.

Dr. Allen Lichter, CEO of the American Society of Clinical Oncology, who wasn’t involved in the research said;

“Doing screening tests on patients whose life expectancy is extremely limited because of cancer is just not a cost-effective thing to do.

The authors have done a wonderful service by pointing this out.”

The study is the first to look at the issue of over-testing in late-stage cancer. It raises new questions about over-diagnosis and over-treatment in the U.S. health care system.

Why does mainstream medicine keep recommending these medical tests?

Money

A $100 mammogram for all 62 million U.S. women over 40, and a $1,000+ biopsy (medical test involving the removal of cells or tissues for examination) for 1- to 2-million women, is an $8 billion per year industry.(12)

In 2008, a total of 5,827,326 screening mammograms were performed, and CAD, systems which use a digitized mammographic image that computer software then searches for abnormal areas of density, mass, or calcification that may indicate the presence of cancer, was used in 4,305,595 (74 percent) of them.(13)

What about the manufacture of the devices?

The success of the medical device industry is apparent when you examine the numbers being produced by manufacturers in this market. Most of the top 10 companies posted healthy double-digit gains over the fiscal year(2006).

TOP MEDICAL DEVICE MANUFACTURERS

1. Johnson and Johnson $17.7B
2. GE Healthcare $12.1B
3. Medtronic $10.1B
4. Baxter International $9.8B
4. Cardinal Health $9.8B
6. Tyco Healthcare $9.5B
7. Siemens Medical Solutions $9.2B
8. Philips Medical Systems $7.5B
9. Boston Scientific $6.3B
10. Stryker $4.9B

The Medical Product Outsourcing global magazine reports that in-depth company examinations show, new product innovation usually plays the most prominent role in determining success and sustainability.(14)

For a new product to be allowed onto the market the device has to pass the scrutiny of the FDA.

The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments responsible for protecting and promoting public health through the regulation and supervision of  pharmaceutical drugs (medications), medical devices, electromagnetic radiation emitting devices (ERED) etc.

In 2007 a group of experts from industry, academia, and the government released the report FDA Science and Mission at Risk, which states:

A strong Food and Drug Administration (FDA) is crucial for the health of our country. The benefits of a robust, progressive Agency are enormous; the risks of a debilitated, under‑performing organization are incalculable.

Is the FDA under‑performing?

Some critics of the FDA say that manufacturers’ requests for evaluation of drugs and devices are processed by the FDA too hastily and with a bias toward approval. They see the FDA as frequently bowing to the wishes of the industry it regulates and as susceptible to pressure by politicians who in turn had been influenced by industry lobbyists.(15)

The FDA has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

Critics contend that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had brief reviews.(16)

In 2008, a large group of FDA scientists and physicians wrote then-House Energy and Commerce Chairman John Dingell about the issue of improper and possibly illegal pressure exerted on FDA scientists ­during the FDA’s process of approving the efficacy and safety of medical devices.

They wrote that senior managers had;

“ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.”

In response to the allegations, the Inspector General’s Office of Investigations (OI) conducted a 2009 investigation.

The Project On Government Oversight (POGO)  an independent nonprofit that investigates and exposes corruption and other misconduct said that this investigation – whose conclusions are entirely favorable to management – was fundamentally flawed and that it did not deal with the alleged regulatory violations, including the retaliation against whistleblowers.

They also noted that top FDA leadership is using the investigation’s favorable – but seriously flawed – conclusions to mislead Congress and the public about the practices condemned by the whistleblowers.

These practices include the authorization of  the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, used with screening equipment made by Fujifilm Medical Systems.

Officials at the FDA overruled front-line agency scientists and approved the sale of the imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.(17)

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all FDA submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

The person who finally approved the device for marketing was a senior manager, Dr. Donna Bea Tillman, head of the Office of Device Evaluation.

In September 2007 Dr. Tillman had agreed with the expert reviewers that the device should not be approved for marketing. Later, however, beginning in December 2007 and culminating in a final approval decision in April 2008, she changed her position and approved the device, over the objections of the medical and scientific experts, while giving little or no explanation in the Administrative File for the change in her position.(18)

Between the disapproval and the approval, several events occurred:

  • She had private communications with the vice-president of iCAD without including any members of the review team and without informing them at the time that these private communications had occurred.
  • She failed to file a record of these communications in the Administrative File shortly after they occurred, as is required of such communications. When she received new information from the manufacturer, she failed to show this information to the reviewers, as is required. The new information is also supposed to be incorporated promptly into the Administrative File, but it wasn’t. Instead, it was put into the Administrative File after the decision was made to approve the device for marketing. This violation is both serious and easily verified.
  • She failed to use the device’s final labeling that was prepared by FDA’s own experts.  The accuracy of such final labeling is crucial.
  • In internal documents obtained by the Times, Congressman Christopher Shays is described as having called an FDA supervisor about iCAD’s device. A company, Fujifilm, whose own device was to work in conjunction with iCAD’s device, is in his congressional district.

The 2009 investigation found that many issues were “management decisions, administrative in nature, and outside the scope of the criminal investigation” and that the investigation “failed to find any evidence of criminal activity on the part of FDA employees.”

The restriction of the investigation to criminal activity – for which the investigators say they found no evidence – apparently occurred about halfway through the period of the investigation.

Is that the end of the matter?

Not necessarily.  In September 2010, the Department of Health and Human Services (DHHS)  re-opened an investigation into allegations of flagrant wrongdoing at the FDA’s Center for Devices and Radiological Health (CDRH). (19)

POGO remain

gravely concerned that current FDA leadership is hiding behind the seemingly favorable outcome of the 2009 investigation and is using this outcome as an excuse for not taking the necessary corrective actions.

The result:

tragic injuries and deaths caused by defective medical devices. The approval by FDA of these defective devices was, and continues to be, enabled by the wrongdoing never addressed by the 2009 investigation.(20)

If the Godfather and his Armenian-American organized crime group had been legitimate doctors or politicians, or had worked for the FDA, I bet they would have got away with it.

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