It says multinational suppliers, not Chinese companies, will reap most of that bonanza.

In a news release promoting a new report about the Chinese market, InMedica says shipments of analog X-ray equipment to China will decline at a compound annual growth rate of 14.2 percent over the next five years while the overall Chinese X-ray market increases at a compound annual growth rate of 9.5 percent.

According to the release, the Chinese government, as part of a health-care reform announced in 2009, bought a lot of analog equipment for rural clinics. Many of those clinics are now trying to upgrade to digital.

China’s larger hospitals, in both rural and urban areas, are also going digital. The release says level 3 and large level 2 hospitals are looking to digital X-ray equipment to increase revenue. Once a hospital reaches its effective capacity of 100 daily patient scans per digital radiography (DR) system, it’s ready to buy an additional system.

The release quotes Owen Tang, a Shanghai-based analyst for InMedica, as saying that “almost all new systems purchased by these hospitals will be high-specification flat panel detector-based DR X-ray.” He added:

Unlike other kinds of X-ray equipment, such as mammography and fluoroscopy X-ray, DR equipment can help hospitals increase their revenue stream based on their more frequent use. In fact, return on investment is a critical factor for hospitals making a purchase decision, as current investment from the government is not enough.

Most of this new equipment will come from multinational companies, the release says: “Most level 3 hospitals and big level 2 hospitals [are] only willing to purchase the equipment from nondomestic suppliers.” Chinese manufacturers are concentrating their marketing on county-level hospitals.

No wonder GE Healthcare last year moved the global headquarters of its X-ray business to Beijing.

Related seminar: The Business of Radiology

In Keillor’s fictional Lake Wobegon, all the women are strong, all the men are good-looking, and all the children are above average. At the much less bucolic FDA, some scientists and doctors are fighting with administrators over approval of radiological devices, and the administrators are fighting back by monitoring the staffers’ personal e-mail.

Meanwhile, the FDA announced a tentative deal with medical device makers that would double its user fees in exchange for a faster and more transparent device-review process.

So, kind of a roller-coaster week.

Last week began with the news that six former and current FDA staffers, including two doctors and an MD/PhD, had filed a lawsuit alleging that the agency had spied on their nonwork e-mail, which the staffers had accessed through work computers. The suit also charges that the FDA fired or otherwise retaliated against them for leaking documents to Congress and the press.

Science magazine has a good summary of the situation, including a link to the lawsuit. What’s most significant for the medical community and the public is the viciousness of the infighting as FDA managers push for approval of radiological devices against the advice of their own medical and scientific experts.

The Washington Post points out:

Most of the devices the scientists and doctors questioned have received approvals only in the past two years, making it difficult to evaluate whether the fears that the FDA scientists and doctors expressed were valid.

Against that backdrop, the FDA announced on Wednesday the user-fee agreement, which is intended to speed up that very same approval process for medical devices. DOTmed News quoted Stephen Ubl, president of the Advanced Medical Technology Association trade group, as saying:

We believe this agreement is a potential game changer for the FDA, for industry, and, most importantly, for patients and the American economy.

The FDA said the agency would collect $595 million, plus adjustments for inflation, in user fees over five years, allowing it to hire more than 200 full-time-equivalent workers. “The FDA and the industry expect that the agreement in principle would result in a reduction in average total review times,” said the agency’s announcement.

Great. But the FDA has to do a better job in balancing the legitimate economic and political pressure to get useful devices approved with its duty to make sure that the devices are indeed useful as well as safe.

The Washington Post story quotes one of the lawsuit plaintiffs as saying a team of FDA experts three times recommended against approving a computer-aided imaging device for detecting breast cancer. Each time, the plaintiff said, middle managers agreed. Then, after the third rejection, a senior manager approved the device.

Something’s wrong, and adding more money and more staff won’t fix it.

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Meanwhile, the device industry still hates an upcoming excise tax; see our Facebook page.

Related seminar: Radiology Review Course

Michael Bailey, PhD, one of the project leaders, summed up the research this way:

We have a diagnostic ultrasound machine that has enhanced capability to image kidney stones in the body. We also have a capability that uses ultrasound waves coming right through the skin to push small stones or pieces of stones toward the exit of the kidney so they will naturally pass, avoiding surgery.

Dr. Bailey is a co-investigator with the Smart Medical Systems and Technology Team at the National Space Biomedical Research Institute (NSBRI) in Houston. He is also a researcher at the Applied Physics Laboratory at the University of Washington (APL-UW) in Seattle. He was quoted in an NSBRI news release.

Astronauts are particularly susceptible to kidney stones because it’s difficult to keep them hydrated. Also, bones demineralize in reduced gravity, leading to elevated levels of salt in urine, which is a kidney stone risk factor.

Dr. Bailey and Lawrence Crum, PhD, principal investigator for the Smart Medical Systems and Technology Team and also an APL-UW researcher, have tinkered with an ultrasound machine to create a combined B-mode and Doppler mode. In Doppler mode, for reasons that are not yet understood, a kidney stone can appear brightly colored and twinkling. So, said Dr. Bailey:

We present the stone in a way that looks like it is twinkling in an image in which the anatomy is black and white, with one brightly colored stone or multiple colored stones.

The stone can then be targeted with a focused ultrasound wave to push it toward the ureter. The stone moves about a centimeter per second.

This technology obviously can be used on the ground as well. Dr. Bailey said the focused wave could clean up stone fragments that typically remain after kidney stone surgery.

“Space has demanded medical care technology that is versatile, low-cost, and has restricted size,” said Dr. Crum. “All of these required specifications for use in a space environment are now almost demanded by the general public.”

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A radiologic technologist asks a friend to be a guinea pig for a test of new MRI software. The test saves the friend’s life. Read about it on our Facebook page.

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

We reported on the launching of this study in 2010. It built on research done in the 1970s and 1980s by Mostafa Fahim, PhD, of the University of Missouri in Columbia.

The North Carolina researchers found that ultrasound applied to the testes of rats did indeed reduce sperm counts below what’s considered the threshold of fertility for humans. The most effective regimen, they discovered, involved two 15-minute treatments two days apart, with the testes heated to 37°C (98.6°F).

The study was published online Monday in the open-access journal Reproductive Biology and Endocrinology. The research team also has a Web site about the project.

There are a few questions. As principal investigator James Tsuruta, PhD, said:

Further studies are required to determine how long the contraceptive effect lasts and if it is safe to use multiple times.

Dr. Tsuruta was quoted in a news release from BioMed Central, which publishes Reproductive Biology and Endocrinology.

A very comprehensive news release from the Male Contraceptive Information Project discusses the new research and the contradictory history of ultrasound contraception research (as well as the experiences of a couple of do-it-yourself researchers). It is well known that heat can reduce sperm production, but Dr. Tsuruta said heat apparently isn’t the only mechanism by which ultrasound works:

There is something special about heating with ultrasound. It caused 10 times lower sperm counts than just applying heat.

Many questions remain: How long does the contraceptive effect last? Is it reversible? Will it work the same way on humans? Would men really come back for two clinical visits in two days? Would men be enthusiastic about direct application of ultrasound to the testes in the first place? What are the long-term effects on sperm production?

“I am convinced that any procedure which leads to subfertility in males is likely to have effects on embryo development,” said Brian Setchell, PhD, of the University of Adelaide in Australia, an expert in animal reproduction. “The effects are not only after heat. Sperm from obese males produce embryos that develop more slowly, and there is evidence for diabetes, various toxins, and therapeutic agents having the same effects in males.”

Depending on the availability of research funding, which seems to be scarce in this field, we may learn the answers to these questions. Stay tuned.

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

So why, ask two experts at The Johns Hopkins Hospital in Baltimore, should we think that the imaging-based virtual autopsy, or “virtopsy,” is ready to replace the traditional direct physical inspection of the body’s internal organs?

Pathologist Elizabeth Burton, MD, deputy director of the autopsy service at Johns Hopkins, said that despite the dazzling postmortem scans depicted on such TV series as Bones and the various CSI shows:

The traditional autopsy, though less and less frequently performed, is still the gold standard for determining why and how people really died.

Dr. Burton was quoted in a Johns Hopkins news release. She and Johns Hopkins clinical fellow Mahmud Mossa-Basha, MD, state their case in an editorial in today’s edition of Annals of Internal Medicine.

A German study in the same issue shows some of virtopsy’s strengths and limitations. Among 47 people who underwent both virtual and conventional autopsies, 102 new diagnoses were found. Virtual autopsy by CT scan missed 20.8 percent of the new diagnoses, particularly air pockets in collapsed lungs (which can impede breathing) and bone fractures. Conventional autopsy missed 13.4 percent, most commonly heart attack, pulmonary emboli, and cancer.

That suggests that the best approach would be a combination of traditional autopsy with scanning. Dr. Burton agreed. “It’s not a question of either traditional autopsy or virtopsy,” she said. “It’s a question of what methods work best in determining cause of death.”

For example, she said, imaging can pick up a spot on a lung. But it can’t tell whether that spot is cancer, a fungal infection, tuberculosis-related granuloma, or a benign mass. For that, you need a physical examination.

On the other hand, a conventional autopsy without scanning might have missed that spot altogether. “Steady progress in imaging technology is refining conventional autopsy,” said Dr. Mossa-Basha, “making it better and more accurate.”

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

Or maybe both. Or neither.

The “what’s wrong” assessment comes from Ezekiel J. Emanuel, MD, PhD, and Steven D. Pearson, MD, in an op-ed piece last week in the New York Times. Dr. Emanuel, a bioethicist and former White House adviser (Rahm Emanuel, mayor of Chicago and former chief of staff for President Obama, is his brother), is a vice provost and professor at the University of Pennsylvania. Dr. Pearson is president of the Institute for Clinical and Economic Review at the Massachusetts General Hospital’s Institute for Technology Assessment.

Proton beam radiation therapy for cancer can be focused more precisely than other types of radiotherapy, minimizing damage to healthy tissue. However, proton beam machines are tremendously expensive, making the therapy rare and costly.

And, according to Drs. Emanuel and Pearson, unnecessary. They wrote:

The higher price would be worth it if proton beam therapy cured more people or significantly reduced side effects. But there is no evidence showing that this is true, except for a handful of rare pediatric cancers, like brain and spinal cord cancer.

John Noseworthy, M.D., Mayo’s president and CEO, took “serious issue” with Dr. Emanuel and Pearson a couple of days later in a notably calm op-ed piece of his own, this one in the Star Tribune of Minneapolis-St. Paul.

Mayo decided to build the proton beam facilities, he said, only after six years of researching the therapy:

The evidence shows proton beam therapy improves the effectiveness of cancer treatment while sparing surrounding key organs and tissue. The medical effectiveness of proton therapy and its benefit to our patients was the critical factor in our decision to establish these programs.

Dr. Noseworthy summed up the case for such admittedly expensive experiments in a single succinct paragraph: “Mayo Clinic always does what’s best for patients. We will use the proton beam only if it is the best treatment for the right patients. Our program will help to establish this therapy’s appropriate role in medical practice. If there is no benefit to a particular proton therapy for a particular illness, we will discontinue its use, just as Mayo Clinic has for the past 150 years with other technologies and programs too numerous to list.”

That process is one of the ways medical science advances. It also can be really expensive. Drs. Emanuel and Pearson, among others, may contend that we can’t afford it.

But can we afford not to explore what may be significant advances in treatment just because of initially high financial cost?

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Today’s Facebook post? Click here.

Related seminar: Radiology Review

University of Pennsylvania engineers coated iron oxide nanoparticles with glycol chitosan, a sugar-based polymer that reacts to acids. The sugar keeps the particles from binding or being absorbed by the body, but this particular formulation allows them to become ionized in acidic environments and thus attracted to such areas.

Enter the Warburg effect: Most healthy cells are aerobic, getting energy primarily from oxygen, but cancer cells are anaerobic, getting energy from glucose and turning it into lactic acid. Cancer cells also disrupt the blood flow around them, making it harder for the body to clear away the acid.

So acid-attracted iron oxide nanoparticles will cluster around tumors and make them stand out on MRI images. Said Andrew Tsourkas, PhD, who did the research along with graduate student Samuel H. Crayton:

One of the reasons we like our approach is that it hits a lot of tumors; almost all tumors exhibit a change in the acidity of their microenvironment.

Dr. Tsourkas, an associate professor of bioengineering at Penn’s School of Engineering and Applied Science, was quoted in a Penn news release. The research was published in the December 27 issue of ACS Nano.

The new coating could work well for other uses too, Dr. Tsourkas said:

You can take any nanoparticle and put this coating on it, so it’s not limited to imaging by any means. You could also use it to deliver drugs to tumor sites.

It gets better: The more malignant a tumor, the more it disrupts blood vessels, and therefore the more aciditic its environment. So the new nanoparticles do a good job differentiating malignant from nonmalignant tumors.

That could particularly benefit patients getting an MRI scan as a secondary breast cancer screen. MRI’s high sensitivity but low specificity can work against it, as Dr. Tsourkas explained: “The screening detects a lot of tumors, but many of them are benign. Having a tool like ours would allow clinicians to better differentiate the benign and malignant tumors.”

That explains why the research was funded partly by the Department of Defense Breast Cancer Research Program (yes, such a thing exists).

Related seminar: CT/MRI of the Abdomen and Pelvis

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

The study, released this week, covered providers who travel to nursing facilities, private homes, and other nonclinical locations to provide X-rays of the extremities, pelvis, spine, skull, chest, and abdomen.

The inspector general found that 20 suppliers “exhibited questionable billing patterns.” Specifically, those suppliers billed Medicare for a total of $12.8 million for return trips to nursing facilities on the same day. Those payments may or may not have been legitimate. As the study said, “Claims data do not provide sufficient information to determine whether the supplier billed correctly for two separate trips to the facility or whether the supplier administered tests to the two beneficiaries during a single trip and incorrectly claimed full reimbursement of the transportation component for each beneficiary.”

The study found another $6.6 million in clearly incorrect payments. Medicare covers portable X-ray services only if they were ordered by a physician. The study found $4.3 million in payments for X-rays ordered by nurse practitioners, $1 million ordered by physician assistants, $900,000 ordered by podiatrists, and $400,000 ordered by registered nurses, chiropractors, and other nonphysicians.

The inspector general suggested that Medicare tighten its procedures, follow up on the questionable payments, and collect the $6.6 million in overpayments. The Centers for Medicare and Medicaid Services agreed.

So our government is trying to be more efficient and root out fraud. We applaud that. But couldn’t the inspector general more effectively use its resources by going after bigger fish?

Don’t get us wrong; we’re not in any way endorsing fraud or errors in Medicare payments. But Medicare paid about $225 million for portable X-ray services in 2009—out of total Medicare payments of $454 billion. That’s about five hundredths of 1 percent. Of the 352 suppliers of portable X-ray services that the inspector general studied, it found possible billing problems with only 20.

Frankly, this report seems to be, if anything, a vindication of the portable X-ray industry. When it comes to billing practices, the vast majority of suppliers seem to be following the rules.

Related seminar: Imaging Advances: Abdominal, Thoracic, Skeletal

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)