Don’t bet on it, suggests a Kaiser Health News article. Writer Julie Appleby cites the example of vertebroplasty—the injection of medical cement into compression fractures of the spine in order to relieve pain (at a cost of $5,000 or more). In 2009, two studies said it didn’t work.

The studies, published in the August 6, 2009, issue of the New England Journal of Medicine (click here and here), said vertebroplasty, often done by interventional radiologists, produced no more pain relief than sham injections.

In November 2009, the Society of Interventional Radiologists issued a statement that picked apart the studies and concluded, “We believe it is premature—and possibly incorrect—to conclude that vertebroplasty is no better than a control sham procedure.”

Today, more than two years later, Medicare and most other insurers still cover vertebroplasty.

The Kaiser article also mentions the controversies that followed an October 2011 recommendation by the U.S. Preventive Services Task Force against routine screening for prostate cancer and the Food and Drug Administration’s reversal in November of its approval of Avastin for breast cancer treatment.

Some see such reactions as evidence that financial self-interest, consumer confusion, resistance to change, and other powerful forces will prevail against attempts to reduce health care costs. The article quotes Sean Tunis, MD, founder and director of the nonprofit Center for Medical Technology Policy in Baltimore, concerning the prostate screening and Avastin cases:

If we’re ever going to have a hope of spending less money on medicine, we’re going to have to stop paying for things that don’t work, or hurt people. You could not ask for two more clear examples.

On the other hand, the very fact that the FDA initially approved Avastin before changing its mind demonstrates that there are good reasons for questioning the conclusiveness of research about the effectiveness of a particular procedure. Said Jennifer Jaff, executive director of the Connecticut-based Advocacy for Patients with Chronic Illness:

If you find a medical journal article that says ‘no,’ I can find you one that says ‘yes.’

The PCORI (get used to those initials; you’ll be seeing them a lot) is an independent, nongovernmental board set up by the Patient Protection and Affordable Care Act and funded by a small annual fee on health insurance policies, including Medicare. Its 21-member board represents a broad range of health care stakeholders, including consumers, government agencies, insurers, and makers of drugs and medical devices.

But it’s purely an advisory body, with no power to enforce its recommendations. So it risks becoming an example of what it is trying to eliminate: an expensive procedure that provides no benefit to patients or the health care system.

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How has the American Board of Radiology reacted to last week’s CNN report accusing radiologists of cheating on the ABR qualifying exams? We take a look in today’s Facebook post.

Related seminar: Interventional Radiology Review

More than $8 million in grants from the National Cancer Institute (part of the National Institutes of Health) are fueling the initiative. It builds on advanced imaging tools that the center has developed over the past decade.

Zaver Bhujwalla, PhD, director of the center and principal investigator for the initiative, explained in a Johns Hopkins news release the scope of the effort:

By harnessing the very latest technology in noninvasive imaging—using any single or combination imaging modality of MRI, CT, SPECT, PET, laser optics, or ultrasound—we expect to develop tests that detect cancer faster and earlier, distinguish spreading or metastatic tumors from dormant ones, and develop better and more tolerable chemotherapy drugs that only attack cancerous cells, leaving healthy cells alone.

Wow.

Here are some specific lines of investigation:

• Using MRI to find proteins or other small molecules that could represent the earliest metabolic and biological changes in the formation of breast cancer.
• Using laser imaging to analyze collagen fibers in breast cancer tumors, which form distinctive patterns in metastatic cancer.
• Using SPECT, MR scanning, and optical- or laser-guided imaging to identify cancerous prostate cells by detecting a protein found only on such cells’ outside layer.
• Using PET scans to guide a viral-activated drug, bortezomib, to kill Kaposi’s sarcoma cells.

Other research teams will explore the speed of skin cancer progression, the amount of tumor shrinkage during pancreatic cancer treatment, the process by which cancer spreads to the lungs, and treatments to prevent the spread of kidney cancer to the bones.

This could be very exciting stuff. We’ll check back to see how things progress.

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Thanks to all of you for reading us this year. We’ll keep trying to be useful, interesting, and, yes, even fun in 2012. Please continue to check us out here at Radiology Daily, on our Facebook page, and on our Twitter feed. Happy new year!

Related seminar: Abdominal & Pelvic Imaging: CT/MR/US

Breast-cancer researcher Mina Bissell, PhD, explained:

Our data show that at lower doses of ionizing radiation, DNA repair mechanisms work better than at higher doses. This nonlinear DNA damage response casts doubt on the general assumption that any amount of ionizing radiation is harmful and additive.

Dr. Bissell, who holds the title of distinguished scientist at the Berkeley Lab’s Life Sciences Division, was quoted in a lab news release. The findings have particular significance for those who undergo such low-dose medical imaging procedures as mammograms.

The lab revealed the results of its research in a freely available study published online Monday in Proceedings of the National Academy of Sciences.

The decreased risk at low doses derives not from the amount of damage caused by the radiation but rather from how the body fixes the damage. The researchers found that after low doses of radiation, the body repairs double-strand DNA breaks (meaning the double helix is completely severed) on site. It’s a relatively simple procedure with relatively little chance of error.

But as doses increase, creating more double-strand breaks, the broken strands congregate at “radiation-induced foci” (RIF), which are aggregations of repair proteins. With lots of repairs going on at once, the opportunities for mistakes increase.

“We hypothesize that, contrary to what has long been thought, double-strand breaks are not static entities but will rapidly cluster into preferred regions of the nucleus we call DNA repair centers as radiation exposure increases,” said Sylvain Costes, PhD, a biophysicist who led the study.

“As a result of this clustering,” Dr. Costes said, “a single RIF may reflect a center where multiple double-strand breaks are rejoined. Such multiple repair activity increases the risks of broken DNA strands being incorrectly rejoined, and that can lead to cancer.”

The researchers are looking into whether their results, achieved with a single human breast cell line, will hold up with different lines and different breast cells. Stay tuned.

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MRI powers a tiny wireless camera that navigates the digestive system. Science fiction? Find out on our Facebook page.

Related seminar: ALARA — CT (As Low As Reasonably Achievable)

OK, we’re exaggerating. But apparently not by much. Cardiologists at Johns Hopkins say they’ve developed a protocol that has allowed safe MRI scans of patients with pacemakers and defibrillators—older devices, not the new MRI-safe models.

A study published in the October 4 issue of Annals of Internal Medicine details the results of 555 MRI scans performed on 438 patients who had pacemakers or defibrillators. Of the scans, 94 percent were conducted at The Johns Hopkins Hospital in Baltimore. The others took place at Rambam Medical Center in Haifa, Israel.

Henry Halperin, MD, senior author of the study and a professor of medicine, biomedical engineering, and radiology at Johns Hopkins, began testing implanted devices for MRI safety about 15 years ago. According to a Johns Hopkins news release, the safety protocol he developed is now being adopted worldwide.

“The newer pacemakers made after 1998 and defibrillators manufactured since 2000 come with electromagnetic interference protection,” Dr. Halperin said.

The protocol involves prescreening not only the type of device but also its configuration. If a lead is disconnected, for example, MRI is not recommended because the tip of the wire could become too hot.

During an MRI procedure, a nurse with experience in cardiac life support and device programming keeps a close watch on the patient, backed up by an electrophysiologist. Said Roxann Hansford, RN, a study author:

We reprogram the device to a safe mode while the patient is having the MRI scan. We carefully monitor the patient’s blood pressure, electrical activity of the heart, and oxygen saturation, and look for any unusual symptoms. After the test, we reprogram the device and carefully check its function.

Saman Nazarian, MD, the study’s lead author and a Johns Hopkins cardiac electrophysiologist, said, “The guidelines we have published can be used to make MRI more available to people who could benefit from early detection of cancer and other diseases and for guiding surgeons during procedures. MRI is considered superior to CT scans in many clinical scenarios, especially for brain and spinal cord imaging.”

In fact, he said, many patients with implanted devices had tumors or other serious problems diagnosed by MRI at Johns Hopkins—disorders that a previous CT, ultrasound, or other imaging test had missed.

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See our new Facebook post here. And find out what we’re tweeting here.

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

A new study, published online Tuesday in the European Heart Journal, suggests that the level of ionizing radiation to which they’re exposed does cause cell damage, but that the cardiologists’ bodies deploy protective countermeasures.

The study says interventional cardiologists are the health professionals who are most exposed to ionizing radiation, experiencing doses two to three times higher than those of radiologists—up to the equivalent of 250 chest X-rays each year. The Italian researchers compared 10 interventional cardiologists to 10 health workers who were not exposed to radiation.

The scientists found increases among the cardiologists in the levels of two chemicals: glutathione, an antioxidant that protects against cell damage from oxygen-carrying molecules called reactive oxygen species (ROS), and hydrogen peroxide, which indicates the amount of oxidative stress caused by the ROS. In the radiologists’ immune systems, lymphocyte cells showed increased susceptibility to apoptosis—programmed cell death.

Here’s what the researchers think was happening: the radiation was creating potentially harmful changes at the cellular level. The body reacted by nearly doubling the amount of protective glutathione and increasing the susceptibility of white blood cells to a natural dying-off process—possibly the body’s way of eliminating damaged and therefore potentially cancerous cells.

The study’s first author was Gian Luigi Russo, PhD, a senior research scientist at the Italian National Research Council’s Institute of Food Sciences in Avellino. “Our findings clearly emphasize for the first time,” he said, “that exposure to a level of radiation which is considered ‘safe’ by regulatory standards for interventional cardiologists can induce a profound biochemical and cellular adaptation whereby increases in the levels of reactive oxygen species in these workers are balanced by an improvement in antioxidant defenses.”

However, he added:

It remains unclear whether these changes are adaptive, beneficial modifications or the harbinger of clinically relevant adverse changes, since increased DNA damage, oxidative stress, and apoptotic activity have been involved in the development of a variety of diseases.

Dr. Russo was quoted in a European Society of Cardiology news release via EurekAlert!

An accompanying editorial in the Heart Journal says … well, frankly, not much. “A wider use of potentially dangerous technologies should, however, come with a more thorough awareness of their implications,” etc.

Here’s what it should have said: Everyone on the team, especially the interventional cardiologist her- or himself, needs to try to minimize incidental radiation exposure. And equipment manufacturers and operating-room designers need to do everything they can to corral stray X-rays. We keep discovering new ways that our remarkable bodies can ward off and repair damage, but we can’t count on those defenses to be perfect.

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Related seminar: Interventional Radiology Review

• The process is fundamentally flawed and should be scrapped;
• Even though it hasn’t actually approved any unsafe or ineffective devices;
• And the organization has no specific recommendations for a replacement process.

Can you blame the FDA for responding, in effect, “Um, thanks, guys; we’ll keep your suggestions in mind”?

In September 2009, the FDA asked the Institute of Medicine (IOM), a federally chartered but independent advisory group, for its thoughts about the FDA’s 510(k) clearance process for medical devices (including imaging machines). The 510(k) process allows certain products to be quickly cleared for sale and use if they are substantially equivalent to devices already on the market.

Last Friday, the IOM finally announced its report. It said the FDA had asked two questions: “Does the current 510(k) process protect patients optimally and promote innovation?” “If not, what legislative, regulatory, or administrative changes are recommended?”

To the first question, the IOM responded:

The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework.

In other words, the FDA should expend its “finite resources” on asking Congress, including a House of Representatives that is virulently suspicious of government regulation, for a new regulatory framework. Good luck with that.

And why should the FDA embark on this suicide mission? Are bad devices slipping through? Well, no. Using italics for emphasis, the IOM declared: “The committee is not suggesting that all, many, or even any medical devices cleared through the 510(k) process and currently on the market are unsafe or ineffective.”

As for the second question, the IOM listed a set of criteria for a new device-approval process: it should “be based on sound science,” “be clear, predictable, straightforward, and fair,” etc.

The IOM did not, however, propose an actual process. One IOM committee member, William W. Vodra, JD, former senior counsel at Arnold & Porter law firm, said proposing a new process was “well beyond our mandate,” according to HealthImaging.com.

Apparently, “what legislative, regulatory, or administrative changes are recommended?” does not constitute a mandate to recommend legislative, regulatory, or administrative changes.

In essence, the IOM suggested not-really-a-solution for not-quite-a-problem.

The FDA said it would take public comments about the IOM report. In the news release, you can almost hear Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, speaking through clenched teeth:

We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today. … FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.

We suspect that the next time the FDA asks the IOM for advice will be never.

Related seminar: Radiology Review

“In our initial small study, we found that preadministering to patients a proprietary antioxidant formulation resulted in a notable dose-dependent reduction in DNA injury,” said Kieran J. Murphy, MD. He added:

This could play an important role in protecting adults and children who require imaging or a screening study.

Dr. Murphy is a professor at the University of Toronto as well as vice chair and deputy chief of medical imaging and director of medical imaging research at the university. He presented his findings at the 36th Annual Scientific Meeting of the Society of Interventional Radiology, which began Saturday and concludes Thursday in Chicago.

He wasn’t kidding about it being a small study. According to Time magazine, it involved blood samples from two of Dr. Murphy’s colleagues, drawn both before and after they had taken the antioxidants. The blood samples were irradiated. The post–antioxidant treatment samples showed 30 percent to 50 percent less DNA damage, as measured by the presence of a protein that repairs DNA damage.

When ionizing radiation strikes water molecules in the body, it creates free radicals, which can cause cell damage. Antioxidants neutralize free radicals. Dr. Murphy said he got the idea to try antioxidants from the list of antioxidant vitamins that his mother-in-law was not allowed to take when she was undergoing radiation treatment for breast cancer. She was told that the antioxidants would interfere with the radiation’s ability to damage cancer cells.

Many antioxidants are not absorbed well by the body. So Dr. Murphy and his colleagues had to create just the right mixture.

“Our intent was to develop an effective proprietary formula of antioxidants to be taken orally prior to exposure that can protect a patient’s DNA against a free radical–mediated radiation injury,” said Dr. Murphy, “and we have applied to patent this formulation and a specific dose strategy.” He was quoted in a Society of Interventional Radiology news release through EurekAlert.

Next, say the researchers, will be a full clinical trial in Toronto.

Related seminar: Interventional Radiology Review

Boris A. Karaman, MD, filed suit in September 2009 against East Liverpool City Hospital in East Liverpool, Ohio (about an hour northwest of Pittsburgh). The suit claimed that the hospital induced Dr. Karaman to become chair of its radiology department with promises of providing appropriate clinical facilities.

Dr. Karaman’s lawyer, Charles L. Richards, said the hospital did not fulfill those commitments. Richards said the doctor, a neuroradiologist, had to perform neurointerventional procedures in the hospital’s cath lab under conditions that did not meet American College of Radiology or American College of Cardiology standards.

According to The Review newspaper in East Liverpool, the Columbiana County Common Pleas Court last week dismissed with prejudice (meaning they can’t be resurrected) both the doctor’s complaint and the hospital’s counterclaim. The court ordered each party to bear its own costs.

The court divulged no other details about the settlement. Dr. Karaman had sought monetary damages and a ruling regarding a $150,000 loan the hospital gave him when it hired him in January 2008. Dr. Karaman had claimed that because the hospital breached its agreement, he wasn’t obligated to repay the loan.

The hospital’s new (as of November 2010) chief executive officer, Kenneth J. Cochran, issued a statement saying: “We’re excited to have resolved our legal issues with Dr. Karaman and look forward to a future of providing quality radiology services. This settlement is a result of our renewed focus on physician alignment and improving both access to and quality of care.”

The hospital has contracted with Foundation Radiology Group of Pittsburgh to provide radiology services. Dr. Karaman now works for, yes, Foundation Radiology Group.

According to HealthImaging.com, Richards (Dr. Karaman’s lawyer) raised the possibility of further court action.

“In my 41 years of litigation, I’ve never seen anything like this,” Richards said. “For whatever reason, the hospital has not carried out its duties under the settlement agreement.”

Richards didn’t elaborate on the hospital’s alleged failings, but he did say, “They’re going to have to answer to the court now because I’m tired of it.”

Related seminar: Neuro & Musculoskeletal Imaging

HCC—liver cancer—is the third-leading cause of cancer death worldwide, though it is much more common in areas where hepatitis B or C is prevalent, such as sub-Saharan Africa and Southeast Asia, than in the Western world. Many patients with HCC also have cirrhosis, which complicates cancer management and can itself cause death. Current guidelines recommend surgical resection of early-stage HCC for patients who have adequate liver function and chemical or thermal tumor ablation for patients where poor liver function or other factors rule out surgery.

RFA is highly repeatable, which can be a big advantage in controlling recurrences of cancerous tumors.

A research team from the Policlinico San Matteo Foundation in Pavia, Italy, led by Sandro Rossi, MD, conducted a retrospective study of 706 patients who presented with HCC from January 1998 through January 2008. Either percutaneous or laparoscopic RFA was performed.

The researchers obtained a “complete response” (no enhancing tissue at the tumor site and normalization of alpha-fetoprotein, or AFP, levels) in 696 patients (98.5 percent). Of those, 465 (66.8 percent) experienced a first recurrence during follow-up. RFA was repeated in 323 of the patients with first recurrences, restoring disease-free status in 318 cases (98.4 percent). For 223 patients, there was a second recurrence. RFA was repeated for 147 of those, again restoring disease-free status in 145 cases (98.6 percent).

No procedure-related deaths were reported, and fewer than 1 percent of sessions resulted in major complications.

Said Dr. Rossi, as quoted in a Wiley-Blackwell news release:

Our experience indicates that RFA should be the treatment of choice for patients with one or two small HCCs.

The researchers did note that the unpredictability of tumor progression, the possibility of tumor understaging, and the substantial risk of death unrelated to HCC complicate treatment planning for cirrhotic patients with HCC.

“Further research focusing on identifying tumor cell markers and genetic profiles associated with HCC growth patterns will ultimately help develop individualized treatment strategies for managing liver cancer,” Dr. Rossi said.

The research was published in October in the online edition of the journal Hepatology and appears in the January 2011 issue.

Related seminar: Abdominal & Thoracic CT/MR/US: Optimizing Practice

Deborah Huber filed the suit last week, seeking compensation for lost wages and other, unspecified damages. A spokesman for the company that runs the hospitals responded that it was “completely without credibility.”

The lawsuit says that Huber accepted the job with Norton Audubon and Norton Suburban hospitals in April 2009 at an annual salary of $110,000. She was fired, it says, on July 7, 2010.

The lawsuit alleges that Huber repeatedly told Norton officials that it was improper and compromised patient care when unlicensed employees operated radiation equipment. About June 1 of this year, the suit says, Huber contacted the Kentucky Cabinet for Health and Family Services to clarify whether unlicensed staff were permitted to operate such equipment during radiology procedures. She was told, the suit says, that they were not.

When Norton Healthcare learned that she had contacted the cabinet, the suit says, a Norton executive criticized Huber for not fitting in. The suit quoted the executive as saying, “This is very difficult, but it just isn’t a good fit.”

Huber’s lawyer, Christopher Haden, said in a statement:

This is a classic whistle-blower case.

He continued: “As a health-care provider, Ms. Huber had an obligation under Kentucky law to report what she believed to be health-care violations that resulted in compromised patient care. When Norton found out that Ms. Huber had contacted the state, her boss literally accused her of ‘blowing the whistle’ and fired her.”

Huber, in an interview with the Louisville Courier-Journal, said she had been given a 3.3 percent raise in June, shortly before the firing. She said she has not found another job and is is struggling to get by on unemployment benefits.

Norton Healthcare spokesman Steve Menaugh issued a statement saying, “Norton Healthcare, both before Deborah Huber’s short period of employment with our organization and since her departure, has maintained a fully accredited, high-quality radiology program at its hospitals. In this instance, the Commonwealth of Kentucky did not substantiate or validate a single instance of Ms. Huber’s allegations.”

The statement concluded:

This lawsuit is completely without credibility, so we will proceed through the judicial process.

Related seminar: Interventional Radiology Review