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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Related seminar: Radiology Review Course

She had a doctor’s order. She had insurance coverage. She’d had a breast ultrasound. She had a family history of breast cancer and a personal history of breast lumps. She’d had a benign breast lump removed the previous year, after an ultrasound and a mammogram.

But she was 26. Both facilities, she said, told her she was too young for a mammogram.

Katie Schaber responded by e-mailing WKMG-TV Local 6 news in Orlando. The station contacted Libby’s Legacy Breast Cancer Foundation of Orlando, which in turn contacted the Women’s Center for Radiology in Orlando.

In January, Schaber got her 3-D mammogram, which did find an anomaly in her left breast. A follow-up MRI at the Women’s Center found no problem. The center advised Schaber to have another follow-up in six months and a mammogram every year.

Julie Miller, MD, a diagnostic radiologist at the Women’s Center, told Local 6 she has seen girls as young as 17 with breast cancer. Dr. Miller added:

If the patient is young, you would start with an ultrasound to minimize radiation. But you certainly wouldn’t stop at that point just because of her age.

Schaber had gone to Sand Lake Imaging of Orlando in December, armed with her doctor’s prescription for an ultrasound and a mammogram. The clinic did the ultrasound but then declined to do the mammogram.

On her blog, Schaber wrote, “A doctor reviewed my ultrasound and said that, since I was so young and since he didn’t think the scan showed anything too serious, he wouldn’t do a mammogram.”

Sand Lake Imaging said federal law prohibited it from discussing the case.

Next, Schaber tried Florida Hospital Celebration Health of Celebration. Again, she said, she was told the hospital would do an ultrasound but not a mammogram.

Jennifer Roberts, media relations manager for the hospital, told Local 6:

We must abide by our accredited appropriateness criteria approved by the American College of Radiology for diagnostic mammography and breast ultrasound. These criteria recommend that women 29 and under receive an ultrasound and/or provide adequate health history, including previous exams, prior to performing a diagnostic mammogram.

Schaber, a reference librarian at Full Sail University in Winter Park, Florida, has detailed the story on a deeply personal (and award-winning) blog called from IF to when. It focuses on her diagnosis of infertility and its effects on her and her husband’s lives.

Regarding the mammogram issue, she told Local 6, “It seems a little odd to me that I have to keep fighting for something that so many women find uncomfortable. But I think that it is important.”

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Bad news for those who hoped soy isoflavone supplements might protect against breast cancer. See our Facebook page for details.

Related seminar: Breast Imaging and Intervention: A Comprehensive Review (discount and free shipping)

Mary Hamer, MD, of Lake City, Florida, has been financially supporting van der Sloot, who pleaded guilty on January 11 to killing Stephany Flores, a 21-year-old student he had met in a casino in Lima, Peru. A Peruvian court sentenced him to 28 years in prison.

van der Sloot, 24, has also been suspected in the 2005 death in Aruba of Natalee Holloway of Mountain Brook, Alabama, a Birmingham suburb. On January 12, an Alabama judge officially declared her dead. U.S. authorities are attempting to extradite van der Sloot so he can face fraud and extortion charges associated with the Holloway case.

Dr. Hamer said van der Sloot’s lawyer, Jose Jimenez, deceived her into sending the $75,000 as bail money. Peruvian law does not allow bail in murder cases. Jimenez said it was a miscommunication based on a mistranslation of “parole” as “bail.” He said he has returned the money, minus fees. Dr. Hamer said that she hadn’t received it and that she was near bankruptcy. She told RadarOnline:

I have sent Jimenez about $100,000 in legal fees, bail money, and other expenses. I’ve sent them because he has asked me to pay his legal fees.

van der Sloot is asking for more. The Daily Beast reported that on the day he was sentenced, he wrote Dr. Hamer a series of letters asking her to continue supporting him. He said he needed $69,000, plus $1,000 to buy a new phone.

“You will always be in my heart, but this, what you are doing to me now I do not comprehend,” he wrote. “Why do you want to hurt me?”

Before the sentencing, Dr. Hamer attempted to persuade Peruvian authorities to release van der Sloot to her custody, saying she would rehabilitate him. In an e-mail on January 11, she wrote what she called “My humble request for clemency and mercy for the honest and sincere confession of Joran van der Sloot. In 2022, Mr. van der Sloot will present his thesis of peace to the Peruvian people and the world.”

While she was complaining about Jimenez, he was also complaining about her:

She proclaims his innocence through incoherent arguments and has discredited me in the process.

That seems to sum things up nicely.

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Can the cognitive impairments of brain radiation be reversed by oxygen starvation? See our Facebook page.

Related seminar: Neuroradiology Review

The Columbia Daily Tribune newspaper of Columbia, Missouri (home of the university), reported Sunday that:

Multiple sources have told the Tribune that radiology employees, including low-level staff members, recently were instructed by the UM System General Counsel’s office not to delete e-mails or destroy documents, indicating an investigation.

The newspaper also reported that an internal audit published in late 2010 found that University of Missouri Health Care had been providing radiology services to Medicare patients at Women’s and Children’s Hospital in Columbia without proper physician orders. The audit found that 62.5 percent of the cases it reviewed lacked proper authorization.

University of Missouri System attorney Paul McGuffey told the paper, “The fact that physician signatures didn’t accompany orders didn’t necessarily mean services were unnecessary.”

The newspaper reported that a new computerized order entry system seems to have cleared up the problem.

It’s unclear whether the radiology department investigation is related. In fact, it’s not certain that there is an investigation. Neither the university nor officials at the U.S. Department of Justice and the Missouri Department of Health and Human Services would confirm or deny the existence of one—although, as the newspaper suggested, the document-preservation instruction is a pretty strong clue.

Here’s another: the quiet departure late last year of Kenneth Rall, MD, as radiology department chairman. “The announcement of his retirement,” the newspaper reported, “came in a three-sentence blurb tucked between news of a Xerox partnership and a weekly quiz in the Dec. 21 issue of MU Health Care’s ‘InSight’ newsletter.”

Dr. Rall remains a faculty member. Amolak Singh, MD, is interim chairman.

Dr. Rall’s past includes accusations of embezzling money from his radiology partners in the 1980s, the Tribune reported. He faced felony charges of writing checks for bogus Medicaid refunds and then signing the checks over to himself. A few days before the trial, the prosecutor overseeing the case said he had lost the evidence. Dr. Rall wound up with a misdemeanor stealing conviction.

He also testified that he had paid back $928,000 that he had gained from a check-kiting scheme in which he used the “float”—the time lag in communication between banks in those pre–electronic banking days—to inflate one account balance with nonexistent funds from another account.

We’ll keep an eye out for developments.

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On this Martin Luther King Jr. Day holiday in the United States, many health care workers are nevertheless on the job, serving patients, so we’re not taking the day off either. See our latest Facebook post here, and follow us on Twitter here.

Related seminar: National Diagnostic Imaging Symposium

A CNN story about the report, posted online earlier today, begins: “For years, doctors around the country taking an exam to become board certified in radiology have cheated by memorizing test questions, creating sophisticated banks of what are known as ‘recalls,’ a CNN investigation has found.”

Radiology residents memorize test questions, write them down immediately after the test, and compile them into recalls for future use by other radiology residents, even though they must sign a document agreeing not to share test material, CNN said.

Gary Becker, MD, executive director of the American Board of Radiology (ABR), told CNN:

We would call it cheating, and our exam security policy would call it cheating.

The ABR Web site includes links to the ABR exam security policy and a statement by Dr. Becker about exam security, plus a video that warns test takers not to use recalls.

About half of the written questions are new every year. The rest are recycled from previous years.

CNN interviewed radiologists and radiology residents last November at the Radiological Society of North America’s annual conference in Chicago. It concluded that “recalls have been widely used in most, if not all, radiology programs for more than a decade.”

Radiologist John Yoo, MD, told CNN that radiologists use the recalls as study guides. “It is sort of out of necessity to pass these examinations that you have to rely on the recall,” he said.

Another radiologist, Joseph Dieber, MD, told CNN the recalls were necessary because of the nature of the test:

Some of the questions are so obscure that unless you know that they like to ask questions about that topic, you’re not going to study it because some of them are completely irrelevant to the modern practice of radiology.

CNN said the report, “Prescription for Cheating,” would air at 8 p.m. Eastern Time tonight on Anderson Cooper’s AC360º show.

Related seminar: Radiology Review Course

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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Related seminar: Radiology Review

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