The suit charges that the company generated at least 90 percent of its business by paying kickbacks to doctors for referrals and that unnecessary imaging tests put some patients at heightened risk for cancer.

U.S. Attorney Barbara L. McQuade of Detroit announced the suit last week. It targets Universal Imaging, Inc.; Phillip J. Young and Mark Lauhoff, identified by the government as “its current and former owners”; and Gwendolyn Washington, MD, of Southfield, Michigan. (At least for the moment, the Universal Imaging Web site lists “Phil Young” as president and founder; it doesn’t mention Lauhoff.)

The U.S. attorney also announced settlements totaling $1.56 million with 14 physicians or physician groups who, according to the government, accepted payments in return for referring patients to Universal.

A news release from McQuade’s office said:

McQuade praised radiologist Dr. Richard Chesbrough and his wife, Kim Chesbrough, who formerly worked at Universal and who filed a qui tam whistleblower suit under the False Claims Act bringing many of the facts in the case to the government’s attention.

The government alleged that, though Michigan law required Universal to be a nonprofit corporation, it transferred its equipment to a for-profit company with the same owners and made fraudulent lease payments to that for-profit entity, illegitimately benefiting the owners.

The government charged Dr. Washington—who after some apparently high-flying years faces a bleak future—with endangering the health of her patients. In November, the 67-year-old primary-care physician was sentenced to 10 years in prison for, according to an FBI news release, “public corruption, health care fraud, and conspiring to illegally distribute prescription drugs.”

The FBI said that from 2004 through 2010, she performed or ordered numerous unnecessary tests, billing Medicare and Blue Cross Blue Shield of Michigan more than $5 million. The news release said:

Most significantly, Dr. Washington ordered unnecessary and actively harmful nuclear stress tests for her patients at a frequency beyond that of any other medical practice in the country. Because each of these tests is the radiation equivalent of at least 80 to 120 chest X-rays and because excess radiation creates a greater risk of cancer, Dr. Washington exposed her patients to a substantial risk of cancer.

Sad.

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Related seminar: Cardiovascular & Pulmonary Imaging

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)

CardioGen-82, the generator, produces rubidium-82 chloride injections, used for PET myocardial perfusion studies. The rubidium has a half-life of 76 seconds.

But in June, two patients set off sensitive radiation detectors at U.S. borders months after undergoing PET stress tests. A third patient was found to be carrying similarly elevated levels of radiation months after the same test.

The Sarasota Herald-Tribune reported on the situation in September. (You may also have seen our Facebook post about it.) Two of the three patients had received their PET tests at the same Sarasota, Florida, cardiology center.

The incidents triggered a voluntary CardioGen-82 recall. As DOTmed News reports, the recall may have significantly reduced the number of PET scans and even affected the purchases of scanners.

On Monday, Bracco Diagnostics, the maker of CardioGen-82, sent a letter to its customers saying, “Bracco anticipates a limited and progressive reintroduction of the product to commence in the 1st or 2nd quarter of next year.” (The Society of Nuclear Medicine has an excellent Web page devoted to the CardioGen-82 issue, including links to the letter and other pertinent documents.)

Bracco said it had been “in constant communication” with the Food and Drug Administration to determine the cause of the elevated radiation in the three patients. The letter continued:

Our investigation findings, to date, continue to support that the unexpected radiation levels may have been due to user error or strontium breakthrough higher than what is expected with normal generator use or a combination of both.

“Strontium breakthrough” refers to strontium-82, used by the generator to make rubidium-82. If some of the strontium “breaks through” into the patient along with the rubidium, it can cause elevated radiation levels. Strontium has a half-life of four weeks.

Everyone, including the FDA, seems to agree that the radiation levels found in the three patients pose minimal risk, if that. And, fortunately for those who could benefit from PET stress tests, the Bracco letter says:

Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end.

Related seminar: Cardiac Imaging

The FDA sent the letter on September 20 to G. Michael Purdy, PhD, Columbia’s executive vice president for research. It details problems involving the school’s Radioactive Drug Research Committee (RDRC), which oversees research involving radiopharmaceuticals.

After an inspection in May, the letter says, the FDA determined that: “The RDRC failed to assure the necessary conditions so that radioactive drugs used in research under their purview are considered safe and effective.”

The FDA detailed five specific failings, some of them pretty fundamental. For example, the FDA charged that the RDRC failed to ensure that any adverse effects from radioactive drugs in research studies be immediately reported. The letter references David J. Brenner, PhD, director of Columbia’s Center for Radiological Research and chairman of the RDRC:

Dr. Brenner acknowledged that no adverse events had been reported to the RDRC since he became Chairman in January 2007, and that there is no mechanism in place for the RDRC to receive such reports.

No mechanism in place? Seriously? Sure, FDA regulations can be a pain, but when your committee’s job is to make sure that those regulations are followed, shouldn’t you at least make an effort? Especially because, as the letter points out, the point is “to protect the safety and welfare of human subjects, including a potentially vulnerable population (i.e., subjects with psychiatric disorders)”?

The letter reminds Columbia that in April 2010, the FDA halted research at the medical center’s Kreitchman PET Center, a leading lab for the use of PET in psychiatric studies, because the agency found that the center had used impure radioactive drugs on study subjects. (For details, see our post.)

Regarding the latest incident, the FDA letter says the medical center promised changes in RDRC operations. However, the letter says, “this response is inadequate” because Columbia so far has not provided any details nor a completion date.

The letter also notes, “This letter is not intended to be an all-inclusive list of deficiencies related to the RDRC.”

Related seminar: Diagnostic Imaging Review: For Residents, Fellows and Radiologists

This comes after the Connecticut Medical Examining Board rejected a proposed settlement between the radiologist and the State Department of Public Health (DPH), saying a year’s supervised probation and possible loss of his medical license was too lenient.

It’s the latest twist in a tragic story that began on April 26, 2010, at New Milford Hospital in New Milford, Connecticut. Staff writer Susan Tuz of The Greater New Milford Spectrum has been chronicling the case.

On that date, Michael Waldman, MD, a radiologist who specializes in nuclear medicine, performed a thoracentesis on 74-year-old Thomas D’Amato of New Milford. As Dr. Waldman inserted the needle to remove fluid from the chest cavity, according to records of a DPH investigation reported by Tuz, he nicked the spleen.

Dr. Waldman immediately realized he had perforated the spleen but never told the patient, the investigation found. Instead, he left to perform another procedure, the investigation determined. After a follow-up chest X-ray and an hour of having vital signs monitored by the radiological staff, D’Amato was sent home without being seen again by Dr. Waldman, the investigation found.

Six hours later, D’Amato returned to the emergency room, complaining of shortness of breath and severe abdominal pain, according to the investigation. A CT scan found abdominal bleeding. D’Amato died on April 29.

DPH attorneys reached a settlement with Dr. Waldman. It called for him to be on supervised probation for a year and to be monitored by a consulting radiologist. Dr. Waldman did not admit to allegations of negligence but agreed not to contest the DPH findings, according to DPH documents. He also faced possible license revocation.

That wasn’t enough for the Medical Examining Board. At its August meeting, according to the Hartford Courant, it rejected the proposed settlement. The Courant quoted board member C. Steven Wolf, MD, as saying:

This case troubles me more than most. He knows immediately he punctured the spleen, yet he doesn’t tell the patient or the family. There is a wanton disregard for patient safety here.

In fact, according to Tuz’s reporting, D’Amato’s widow learned of the proceedings against Dr. Waldman from a newspaper account. She said, according to Tuz:

Our doctor had told me an internal investigation would be conducted. I assumed I would be advised of the findings. I wasn’t. When I saw the article in the paper, it knocked me out. … Friends told me at the time that I should sue. But I’m not that kind of person, and neither was my husband.

She apparently has changed her mind and now plans to sue Dr. Waldman for malpractice. During the DPH investigation, Dr. Waldman’s attorney, Jack D. Garamella, told the DPH that the doctor believed he had conducted the procedure and discharge correctly.

“The patient was completely asymptomatic when discharged,” Garamella wrote. “Dr. Waldman believed and continues to believe that there was no specific protocol with respect to the amount of time that an asymptomatic patient should be monitored.”

Related seminar: Cardiovascular & Pulmonary Imaging

Dr. Carter, director of imaging at Baptist Breast Health Center in Jackson, Mississippi, sandwiches two grueling workouts around his workday: an hour and a half in the morning and another 40 minutes in the evening. On weekends, he logs about 100 miles on his bicycle, runs two and a half miles, and adds some swimming.

As you’ve probably guessed, Dr. Carter competes in Ironman Triathlons, which involve swims, bicycle rides, and runs, all long-distance and all in the same day. On Sunday, he will race in the Ironman World Championship 70.3 at Lake Las Vegas in Henderson, Nevada. He’ll swim 1.2 miles, bike 56 miles, and run 13.1 miles.

That’s a piece of cake compared with the October 8 Ford Ironman World Championship on the Big Island of Hawaii, for which Dr. Carter has also qualified. There, in the original Ironman Triathlon (first run in 1979), competitors go double the distances: 2.4 miles swimming, 112 miles riding, and 26.2 miles running.

In an interview this week in the Jackson Free Press alternative newspaper, Dr. Carter said:

It is exciting to be the first athlete from Mississippi to qualify for both the Las Vegas and Kona event. Only a few [Mississippi] athletes have qualified for Kona, and none have qualified for Vegas.

Baptist Breast Health Center sponsors him, which is why he competes with bright pink bicycle wheels. According to a Mississippi Medical News interview, he works his triathlon experiences into pep talks for the center and for breast cancer patients. For example: “Consistency is the most important piece of the puzzle, whether winning an Ironman competition or beating breast cancer.”

The Breast Health Center, incidentally, is designed specifically for the comfort of women. “We recognize that women would much rather come to a place with soft surfaces, appealing decor, and especially designed just for them without going down halls in a gown and running into your husband’s business associate,” Dr. Carter said. “At the Center for Breast Health, it’s a very private and peaceful environment with women-only gowned areas.”

On Sunday, Dr. Carter’s environment will be neither private nor peaceful, but he’s looking forward to the experience. “My most important goal,” he said, “is my hope to make Mississippi proud.”

Related seminar: Radiology Review

Two biophysicists at the University of Oslo in Norway say they’ve discovered how to turn the body’s resistance to both radiotherapy and chemotherapy on and off.

“This is new knowledge that opens possibilities for better treatment,” said Physics Professor Erik Olai Pettersen, PhD. “But there is a lot of research work ahead, so we don’t dare say which cancers the discovery might help fight.”

Dr. Pettersen was quoted in a news release from the university. He is also coordinator of the international cancer research project Metoxia. He and University of Oslo Postdoctoral Fellow Nina Jeppesen Edin, PhD, have been studying radiation resistance as an outgrowth of research on natural background radiation.

One of their findings: a CT scan that detects a cancer may also make that cancer harder to treat. Said Dr. Pettersen:

Some lengthy CT examinations lead to so much radiation that resistance can be turned on. However, the radiation level in a standard X-ray examination is so low that resistance is not turned on.

Cancer cells pass on radiation resistance to their descendant cells for at least five years after being exposed to radiation, the researchers found.

They even pass it along to unrelated cells with which they come in contact. Dr. Jeppesen Edin discovered how they do it: cancer cells, when irradiated, send a signal molecule telling other cells to turn on resistance to both radiation and other toxins, such as the chemicals used in chemotherapy.

“This means that when we are exposed to a little radiation,” she said, “signal molecules are sent to our entire body via the circulatory system. The cells that are not irradiated also become resistant then.”

Sometimes, we might want to do that on purpose—for astronauts exposed to cosmic radiation, for example, or rescuers in a radiation emergency such as occurred earlier this year at the damaged Fukushima Daiichi reactor in Japan.

But for radiation therapy or chemotherapy, we obviously want to turn off the resistance. Drs. Pettersen and Jeppesen Edin think they’ve found a drug that will do so, but they haven’t yet tested it in animals or humans. They’re also not saying what it is, apparently because they’ve applied for a patent concerning its use.

Related seminar: ALARA-CT (As Low As Reasonably Achievable) (brand new)

• 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

Yes, says Rakesh A. Shah, MD, in an opinion piece in the current issue of the Journal of the American College of Radiology. Dr. Shah, a radiologist at Winthrop-University Hospital in Mineola, New York, worries that the United States will run out of helium in a relatively few years.

That would be a problem for radiology. About one fourth of the U.S. helium supply goes toward health-care uses, particularly cooling MRI magnets and generating radioactive isotopes for nuclear medicine.

But if it’s so abundant, what’s the big deal? Well, as common as it may be across the galaxies, its supply on earth is limited. More than one third of the world’s stock, and nearly half the U.S. supply, comes from the Federal Helium Reserve, a series of underground wells in Texas where helium has accumulated as a result of millions of years of radioactive decay.

And we’re deliberately emptying that reserve. A budget-conscious 1996 federal law mandated that the most of the reserve’s helium be sold by 2015. A fascinating article by Anna M. Tinsley earlier this month in the Fort Worth Star-Telegram says that the sales are a little behind schedule but probably will be completed by 2020.

And then what? Most helium is found in natural-gas wells. Only a few contain significant amounts of helium. So far, we can’t manufacture it.

What’s more, we don’t recycle most helium. Whether it escapes from children’s party balloons or old MRI machines, most of the helium that gets into the atmosphere dissipates into space.

So will we soon lose the ability to supercool MRI magnets? Robert Richardson, a Nobel Prize-winning physicist who studies helium, has told the Star-Telegram:

The Earth is 4.7 billion years old, and it has taken that long to accumulate our helium reserves, which we will dissipate in about 100 years.

It would seem smart for us at least to pay more attention to recycling and conserving. As a bonus, it might spare little kids the trauma of watching their party balloons float away up into the sky.

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Related seminar: Abdominal & Pelvic Imaging: CT/MR/US (all-new release)

Bogdanich was the interview subject on the NPR show Fresh Air. He talked with host Terry Gross about his investigative series “The Radiation Boom,” which was a Pulitzer Prize finalist this year. (It didn’t win, but Bogdanich already has two other Pulitzer Prizes and a share of a third, so perhaps he wasn’t too disappointed.)

In Times stories (not all of them part of the “Radiation Boom” series) that go back to June 2009, Bogdanich has reported on a variety of issues dealing with medical radiation. The first story focused on a doctor at a veterans’ hospital in Philadelphia who, while implanting radioactive seeds intended to treat prostate cancer, routinely missed the prostate. Overall, Bogdanich reported, the hospital’s cancer unit botched 92 of 116 cancer treatments over a two-year period.

He has also reported on major radiation overdoses for suspected stroke patients during CT scans, high radiation doses from cone-beam CT scans performed on children in dental offices, serious injuries caused by poor calibration or radiation leakage during stereotactic radiosurgery, unnecessary and unshielded full-body X-rays of premature babies—and, over and over, poor training and lax to nonexistent regulatory supervision and reporting requirements.

During the Fresh Air interview, he said:

Hospitals want more patients, and as soon as a new gee-whiz medical device comes out that is some lifesaving device, every hospital wants to get them as quickly as possible, and sometimes they move too quickly. They buy them, they install them, they don’t spend the kind of money necessary to train the staff and to develop the kind of protocols necessary to ensure that mistakes … are minimized.

Regulations, licensing requirements, dosage-reporting guidelines, training procedures, and rules for reporting medical errors vary from state to state, he said. Some states don’t require any licensing or training at all for technicians operating complex and potentially dangerous machines.

Speaking of the “Radiation Boom” series, Bogdanich said:

I think we made it clear that these are wonderful devices that save countless lives, and people need to get it when they need them, but they need to ask questions. People were not asking questions, and, frankly, doctors who were treating the patients were not giving the patients the information they needed.

Bogdanich argued on behalf of the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy (CARE) bill, which the American Society of Radiologic Technologists has been pushing in Congress since 1999. The bill would establish minimum federal standards for technicians who perform medical imaging and deliver radiation therapy.

The reporter said he knew of no organized opposition to the bill or other major reason why it hasn’t passed. Congress, he said, just seems to have other priorities.

Related seminar: Radiology Review Course