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Americans are now exposed to seven times more radiation each year from medical imaging exams than in 1980, according to a recent report from the National Council on Radiation Protection and Measurement (NCRP; Bethesda, Maryland). In 2006, medical exposure constituted nearly half of the total radiation exposure of the U.S. population from all sources, according to the report.

Kenneth Kase, MD, senior VP of NCRP and chairman of the scientific committee that produced the report, said last month that the increase was due mostly to the higher use of CT and nuclear medicine. "These two imaging modalities alone contributed 36% of the total radiation exposure and 75% of the medical radiation exposure of the U.S. population," Kase said. The number of CT scans performed in the U.S. during 2006 was estimated to be 67 million; 18 million for nuclear medicine procedures.

John Patti, MD, vice-chair of the board of chancellors of the American College of Radiology (ACR; Reston, Virginia), said one should be careful interpreting the study results. He told Biomedical Business & Technology that although the NCRP report estimates the total radiation dose to the total population, the individual dose to individual patients has actually gone down. He added: "The physicians who monitor these imaging machines have taken great care to control the individual patient's radiation dose."

The NCRP Report No. 160, "Ionizing Radiation Exposure of the Population of the United States," provides a complete review of all radiation exposures for 2006, according to the NCRP.

Background radiation, which in 2006 contributed fully half of the total exposure, comes from natural radiation in soil and rocks, radon gas which seeps into homes and other buildings, plus radiation from space and radiation sources that are found naturally within the human body. Other small contributors of exposure to the U.S. population included consumer products and activities, industrial and research uses and occupational tasks.

The NCRP said it is working with some of its partners such as the ACR, the World Health Organization (Geneva, Switzerland) and others to address radiation exposure resulting from the significant growth in medical imaging and to ensure that referrals for procedures like CT and nuclear medicine are based on objective, medically relevant criteria.

In a joint statement from the ACR, the Society for Pediatric Radiology (SPR), the Society of Breast Imaging (SBI), and the Society of Computed Body Tomography and Magnetic Resonance (SCBT-MR; all Reston, Virginia), urged Americans to understand why the increase occurred, consider the report in its "proper context," and "support appropriate actions to help lower the radiation dose experienced each year from these exams."

"It is essential that this report not be interpreted solely as an increase in risk to the U.S. population without also carefully considering the tremendous and undeniable benefits of medical imaging," said James Thrall, MD, chair of the ACR board of chancellors.

SCBT-MR President Sanjay Saini, MD, said, "Medical imaging has revolutionized medicine and is undoubtedly saving and extending lives everyday. It is vitally important that patients do not put off needed imaging care based on this report which neither quantifies the associated health risks nor specifies the radiation protection actions that should be taken."

But experts do have concerns about overutilization of these exams.

At a recent international conference David Schauer, executive director of the NCRP, cited self-referral, the process by which nonradiologist providers buy imaging equipment and refer patients to these in-office scanners as a primary, preventable driver of this dramatic increase in radiation exposure. Non-radiologist providers often lack even basic radiation safety training and may not be aware of potential repercussions to patients of ordering and often administering high volumes of scans, according to the ACR, SBI, and SCBT-MR statement.

Government Accountability Office reports as well as peer-reviewed studies published in the Journal of the American Medical Association and elsewhere have shown that when physicians refer patients to facilities in which they have a financial interest, imaging utilization is significantly increased, these organizations note.

From 1998-2005, in the Medicare system, the number of self-referred, in-office CT, MRI, and nuclear medicine scans performed grew at triple the rate of the same exams performed in all settings.

Private insurance studies indicate that as much as half of this self-referred imaging is unnecessary; in many instances needlessly exposing patients to radiation. Provider fear of litigation, advancing technology, and patient demand may have also contributed to this increase in exposure, the groups speculate.

"It's a large issue and it's an issue that's growing in magnitude," Patti told BB&T.

He added that, "We don't know to what extent it is [financially motivated]," but said it is safe to assume it is to some extent because "why else would the rate be so high" compared to the volume of scans in other settings. "There are some good, very valid reasons for this increase [in the use of medical imaging]."

And then there are some not-so-valid reasons, he acknowledged, such as those physicians who refer patients to receive imaging scans based more out of a financial interest than on medically relevant criteria.

Patti said the ACR is engaged in a process of widespread education about the issue, addressing the principals of radiation safety and appropriate use of imaging, which, when used properly can improve patient care and help cut medical costs.

Patti added: "When a report like this comes out, particularly one that's as complex as this in the way the statistics were generated, [it tends to generate fear] that there may be some danger here, well there really isn't."

Device pre-emption bill surfaces in House, Senate

The Supreme Court case of Riegel v. Medtronic – which appeared to tip the legal scales toward medical device firms and against patients – had many Democrats on Capitol Hill up in arms last year, and the response in the House of Representatives was the Medical Device Safety Act of 2008. The act would have rewritten the Medical Device Amendments of 1976 (MDA) to end federal pre-emption of state liability laws for non-defective PMA devices.

Now that the implicit pre-emption of drugs has been ended by the Supreme Court Case of Wyeth v. Levine, sponsors of the device bill can move forward without having to decide whether to deal with the drug side of the question.

Thus, the Medical Device Safety Act of 2009 (H.R. 1346) has been introduced into the House Energy and Commerce's health subcommittee by chairman Frank Pallone (D-New Jersey), who was the author of the first iteration of this bill. The new version is essentially a duplicate of last year's bill and would modify the MDA with the addition of a passage that states "nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

In a March 9 statement, Pallone said the bill "eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year," adding that he expects "to mov[e] it through my subcommittee quickly." However, device makers argue that defective devices have never enjoyed immunity from torts in state courts.

In a statement, Sen. Pat Leahy (D-Vermont), chairman of the Senate Judiciary Committee, said the Senate bill is "another important step to correct an erroneous reading by the Court of Congress' intent in enacting the Medical Device Amendments of 1976." Leahy made the case that MDA was "never was intended to, preempt the common law claims of consumers injured by a federally approved medical device." The Senate version (S. 1861) is sponsored by Leahy and Sen. Ted Kennedy (D-Massachusetts), who chairs the upper chamber's Health, Education Labor and Pensions Committee.

The original idea behind providing devices with pre-emptive power under FDA regulation was that innovative devices enjoy a short product life cycle compared to drugs, given the iterative nature of device design. However, recent case law has sparked a furor in the media on the issue. Democrats in Congress also resisted the Bush administration's position expressed via FDA, which was that non-defective drugs and devices be exempt from state liability laws.

Bill would put federal $$ into CRC screening

Rep. Kay Granger, (R-Texas) has introduced the Colorectal Cancer Prevention, Early Detection, and Treatment Act of 2009 (H.R. 1189) to the House Energy and Commerce Committee that would essentially parallel a bill that made the rounds in the 110th Congress by the same name with the exception of the date designation, which was 2007. In its current form, the bill would provide $50 million for programs that provide screening and treatment for the disease with a special emphasis on low-income Americans and those with no insurance or inadequate insurance. By 2013, the funding would rise to $250 million.

The bill has the support of the American Cancer Society Cancer Action Network (ACSCAN; Atlanta), which issued a statement from Robert Youle, chairman of the ACSCAN board. Youle said that given that "colon cancer screening could actually prevent cancer by detection and removal of premalignant polyps, the programs initiated by this legislation could potentially save thousands of lives, avoid suffering due to cancer treatments, reduce the burden of cancer costs and prevent many colon cancer cases and deaths altogether."

Youle said that with early diagnosis, the disease has a five-year survival rate of 90%, but survival at five years drops to 10% for late-stage detection. The association's numbers indicate that colon cancer is the third most commonly diagnosed type of cancer, with roughly 148,000 Americans diagnosed each year.

Granger's bill would help cover screening and treatment for those aged 50 and over at typical risk for the disease and anyone under the age of 50 who has a demonstrated risk. H.R. 1189 would also give states the option of using Medicaid monies for residents under the age of 65 who lack sufficient coverage to deal with the cost of treatment and follow-up.

AdvaMed issues guidelines for device DTC ads

The Advanced Medical Technology Association (AdvaMed; Washington) has issued guidelines for direct-to-consumer (DTC) advertising for member companies. The guidelines apply only to television ads, however, leaving out perhaps the primary vector for medical device marketing, the Internet. And unlike the code of ethics, adherence is not mandatory for member companies, leaving open the question of what the guidelines accomplish.

Steve Ubl, President/CEO of AdvaMed, noted "today's patients are voracious consumers of information," adding that "our DTC principals go beyond what is required by law." However, he also acknowledged that the document "speaks only to broadcast ads for non-OTC devices." As to why the guidelines omit other mediums for advertising, Ubl said "the principals take a dramatic step forward" and noted that "if there's an ad that's running on broadcast and on YouTube, it would be covered" by the guidelines.

The issue is not on the front burner on Capitol Hill at this point – given the greater prominence of patent reform and pre-emption of state liability laws by FDA regulations for PMA devices – but Sen. Herb Kohl (D-Wisconsin) has taken up the question of DTC ads for devices in his committee, the Senate Special Committee on Aging. In a statement dated Sept. 17, 2008, released for a hearing conducted that day, Kohl remarked that even though the sums spent on device advertising are dwarfed by the amount spent to advertise drugs, "a number of DTC ad campaigns have been launched [recently] in an effort to market specific and often complex medical device products."

Kohl also said FDA "has raised concerns about advertising [for] restricted medical devices," questioning whether those ads display risk and safety information with a sufficient prominence to catch the viewer's attention. Despite the congressional interest, Ubl maintained that "the goal [of the guidelines] is not to avoid legislation. The goal is to ensure that patients have accurate and fair information."

Among the features of the guidelines is a requirement that spokespersons who endorse a device in a television ad "should be actual users of the product, or their relationship to the product should be disclosed." Any statements by such individuals "must be able to be substantiated as if the representations were made by the manufacturer."

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