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● More on the HRT Debate . . . . .4● On the Scene at the

most recent meeting of the National Cancer Advisory Board . . . . . . . . .24

● Seeking New Pathways to Apoptosis, with Arsenic & CP461 . . . . . . . . .26

● Biomarkers Key Target in New Round of Anti-Angiogenesis Research . .31

● Ovarian Cancer Trials Focus on Increased Efficacy, Lower Toxicity in Refractory Disease . . . . . . .32

Whole-Body CT Screening: Scanning or Scamming?

The opinions of expert groups are nearly unanimous that people without symp-toms or a family history or other specific risk should not get whole-body CTscreening scans, because there is no evidence any benefits would outweigh therisks and costs. Yet newspapers, TV, and radio are filled with upbeat adsencouraging their use. When patients heed marketing over expert consensus,what can and should clinicians do? Page 5

Antifungal EchinocandinsImproving Care of

Immunocompromised Cancer Patients

This new class of cyclic lipopeptide drugs have a novelmechanism of action against pathogenic fungi, makingit easier to treat persistent fungal infections, which haveproliferated in recent years. Page 12

ECRI Study SaysNo Proof ofClinical Utility forDuctal Lavage

A new analysis from the interna-tional health technology assessmentsafety agency concludes there isinsufficient information to reachconclusions about the clinical utilityof ductal lavage, and that there isno apparent clinical benefit toscreening asymptomatic womenwith nipple aspiration. Page 38

VIEWPOINT: TheNew Limitationson Resident Work Hours

The Director of NYU’s HumanisticAspects of Medical Education Pro-gram on the implications of the newnational reduced work hours forresidents, a change mandated bythe ACGME that will go into effectin July, prohibiting residents fromworking more than 80 hours a weekand more than 24 hours at a stretch.

Page 16

From Fuzzy Logic to Artificial Neural Networks…

A host of sophisticated bioinformatics tools are acceler-ating the development of cancer drugs & detection. Anupdate from a recent NCI workshop. Page 23

No. 3 in Our ChemopreventionSeries: Skin & Colorectal

Cancers as Research ModelsChemoprevention aimed at intraepithelial neoplasia isan area of intense study, with much research in skin andcolorectal cancers. Both have precursor lesions easy tosurvey, and each—actinic keratoses and adenomatouspolyps—are separate from surrounding normal tissues,countable, and measurable. Page 40

ONCOLOGYTIMES

Celebrating

Years of Excellence

VOLUME XXV NO. 3 / FEBRUARY 10, 2003

*OT 021003 2/24/03 4:23 PM Page 1

PAGE 5 / FEBRUARY 10, 2003

By Andrew Holtz, MPH

T he opinions of expert bodies andmedical societies are nearlyunanimous: Individuals withoutsymptoms or a family history or

other specific risk factor should not getwhole-body computed tomographyscreening scans, because there is no evi-dence there are any benefits that wouldoutweigh the risks and costs. Yet news-papers, television and radio are filledwith upbeat ads for CT screening.

When patients heed marketingover expert opinions, what can andshould clinicians do?

One Scan Leads to Another

“We’ll get a request from a physiciansaying, ‘Patient had screening study.They recommended further scans.Please do what they said,’” says radiol-ogist Kendall Barker, MD, Section Headfor CT scanning for Kaiser Perma-nente’s Northwest Region.

He doesn’t see much leeway at thatpoint. “I feel like we are pretty muchforced to do that,” he explained. “Iguess there could be an occasional casewhere we could look at the scan andsay, ‘Well, we just don’t agree withtheir interpretation. We don’t think itwas anything to begin with.’

“But a lot of times the findings arein fact indeterminate. We don’t knowfor certain what they are, and so youmay have to do something more to dis-prove disease.”

In Dr. Barker’s experience, the sus-picious findings in CT screening scansusually turn out to be benign cysts orhemangiomas.

“We’ve seen only a modest numberof cases to date, but I have the impres-sion that it is gradually picking up,” hesaid. While he says the health conse-

quences of CT screening for an individ-ual are almost always of no conse-quence, the potential cost and burdenfor the system are daunting.

At the most recent RadiologicalSociety of North America ScientificAssembly and Annual Meeting inDecember, Dr. Barker heard a presenta-tion by Giovanna Casola, MD, of theUniversity of California, San Diego, onthe results of 1,200 whole-body CTscreening scans at a for-profit facility inSouthern California.

Three out of four of the individualsscreens had referred themselves to thescanning center. There was at least one

finding in 87% of the scans. Recom-mendations for further testing or otherfollow-up work were entered in 32% ofthe records.

“You can imagine if your entireadult population in a health plan over acouple of years all went and got ascreening study, and a third of themneeded more work-up, then you’d beworking-up a third of your populationfor mostly benign disease. There’s a bigcost to that,” Dr. Barker notes.

Proactive Approach

At the Be Well Body Scan facility inChestnut Hill, MA, Medical DirectorMax Rosen, MD, urges physicians totake a proactive approach towardwhole-body CT screening of individu-als who do not have symptoms or otherindications that might suggest disease.

Ideally, he says, physicians shouldcommunicate with radiologists at localfacilities before patients undergo ascreening scan.

“We have some doctors in the Bos-ton area who are integrating this intotheir practice,” Dr. Rosen said. “We hada couple come in, and their doctor hap-pens to be across the street from me. Hecame over when I was ready to reviewthe scan with them, sat with them for10 or 15 minutes as we reviewed thescan, and was really part of the discus-sion and part of the process.

“Obviously that only works in cer-tain situations, but I think it’s very rea-sonable for patients to discuss withtheir doctors whether they should havethe scan done, and then, with thepatient’s permission, have the radiolo-gist call the primary care doctor.”

Of course, everyday practice doesnot always match that ideal collabora-tive scenario. Dr. Rosen admits some

(continued on page 6)

Increasingly the questionfor physicians is not

whether CT screening isgood or bad, but how tocounsel curious patients,

and then support and care for those patients

who get screened…only to be given results that

raise questions and fears.

Whole-Body CT Screening: Scanning or Scamming?

breast cancer, cardiac events, stroke,and clots among women who wereassigned to the treatment group weresmall. They do not state that the risk, atleast of breast cancer, was not statisti-cally significant and was based on sta-tistical assumptions that could renderthe conclusion invalid.

The piece in Oncology Times goeson to quote Dr. Robert Hoover, Directorof NCI’s Epidemiology and BiostatisticsProgram, who “noted that in 1989 aSwedish study suggested that combina-tion HRT might not only not decreasethe risk of breast cancer, but might infact increase it.”

That study, by Bergkvist et al, Therisk of breast cancer after estrogen and

estrogen-progestin replacement (N Engl JMed1989;321:293-297), reported a rela-tive risk of 4.4 among women who usedthe combination for more than sixyears.

Two months after this articleappeared in the New England Journal ofMedicine, it was reviewed in the Har-vard Medical School Health Letter (October1989;14[12]:1-3).

The reviewers commented: “Thereis a very important reason not to takethis figure [RR=4.4] literally. Therewere only 10 women in this group, toofew to provide a statistically stableresult. Indeed, on the basis of these 10cases, the true value had a 95% chanceof being 10% below the average, as highas 22.4 times average or somewhere inbetween.”

They go on to write: “Earlier re-search has given us no reason to expect

a strong association between estrogenreplacement and breast cancer.”

I fear the article in Oncology Timeswill validate the premature conclusionsof the Women’s Health Initiative, whichhas already generated headlinesaround the world warning womenaway from hormone-replacement ther-apy. This warning, which is generatinga great deal of anxiety (not good) anddiscussion (good), may be incorrect.

After the headline fever abates, abetter and continuing analysis of thisissue would be appropriate. For now,any specific change in practice on thepart of physicians or patients withregards to HRT should not be based onthe results of this study.

Avrum Bluming, MDClinical Professor of Medicine

University of Southern California OT

Letterscontinued from page 4

On the Cover:

A rtistic rendering of medical im-aging composite of body, with x-

rays, MRI, CT, and bone scan. © ScottCamazine/Photo Researchers, Inc.

EDITORIAL BOARD

Chairman: Robert C. Young, MDPresident, Fox Chase Cancer Center, Philadelphia

James O. Armitage, MDDean, University of Nebraska Medical Center College of Medicine

Joseph S. Bailes, MDExecutive Vice President of Clinical Affairs US Oncology, Dallas

Paul A. Bunn, Jr., MDDirector, University of Colorado Cancer CenterGrohne/Stapp Chair in Cancer Research University of Colorado Health Sciences Center, Denver President, American Society of Clinical Oncology

Harold P. Freeman, MDPresident and CEO, North General Hospital, New York CityChairman, President’s Cancer PanelDirector, Center for Reducing Health Disparaties, NCIDirector, Ralph Lauren Center for Cancer Prevention and Care,New York City

Joan Hermann, LSWDirector, Social Work Services, Fox Chase Cancer Center

Linda White Hilton, MSN, RN, FAANDirector, Department of Patient AffairsMD Anderson Cancer Center

Richard T. Hoppe, MDProfessor and Chairman, Department of Radiation OncologyStanford University School of Medicine

Robert J. Mayer, MDProfessor of Medicine, Harvard Medical SchoolDirector, Center for Gastrointestinal OncologyDana-Farber Cancer Institute

Peggy A. Means, MHAExecutive Vice President and Chief Operating OfficerFred Hutchinson Cancer Research Center

Frank L. Meyskens, Jr., MDDirector, Chao Family Comprehensive Cancer CenterProfessor of Medicine and Biological Chemistry University of California, Irvine

Joseph V. Simone, MDPresident, Simone Consulting, Dunwoody, GAClinical Director Emeritus, Huntsman Cancer Institute

Ellen StovallPresident and CEO, National Coalition for Cancer Survivorship

Paul A. Volberding, MDProfessor of Medicine, University of California, San FranciscoChief, Medical Service, San Francisco Veterans Affairs Medical Center Vice Chair, Department of Medicine, UCSF

Jane C. Weeks, MD, MScDirector, Center for Outcomes & Policy ResearchDana-Farber Cancer Institute, Harvard Medical School

Norman Wolmark, MDChairman and Principal Investigator for OperationsNational Surgical Adjuvant Breast and Bowel ProjectAllegheny General Hospital Cancer Center, Pittsburgh

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Business, editorial, and production offices are at 345 Hudson St., 16thFloor, NY, NY 10014. 212-886-1244, fax 212-886-1209, OT@LWW.com.Printed in USA Copyright 2003 by Lippincott Williams & Wilkins.Indexed in the CINAHL® database of nursing and allied healthliterature. Periodical postage rates paid at Hagerstown, MD, and atadditional mailing offices. SUBSCRIPTION INFORMATION,ORDERS, OR CHANGES OF ADDRESS (exceptions listed below):16522 Hunters Green Parkway, Hagerstown MD, 21740, 800-638-3030; inMaryland, call collect 301-714-2300. ANNUAL SUBSCRIPTIONRATES: US $160 individual, $220 institution. All other countries exceptJapan, $220 individual, $276 institution. Airfreight charges added for alldestinations outside of the United States, Canada, and Mexico. Singlecopies $22. In Japan, contact Igaku-Shoin, Ltd., 3-24-14 Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan. POSTMASTER: Send address changes toOncology Times, 7400 Linder Ave., Skokie, IL 60077-9819. No part of thispublication may be reproduced without the prior written permission ofthe publisher.The appearance of advertising in Oncology Times does notconstitute on the part of Lippincott Williams & Wilkins a guarantee orendorsement of the quality or value of the advertised product or servicesor of the claims made for them by their advertisers.

INTERNATIONAL

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ONCOLOGYTIMES

*OT 021003 2/24/03 4:23 PM Page 5

physicians are less than pleased whenthey learn patients have been screenedat his center.

“Sometimes when I’ve called doc-tors because one of their patients washere, the initial response has a bit of anedge to it,” Dr. Rosen concedes.

“But I think because I am callingthem and communicating with themdirectly, that edge disappears in about10 seconds. And the conversationalways finishes up with, ‘Thank youvery much for taking care of mypatient, and thank you for calling me.’ Ican’t stress enough how important thatcommunication is.”

Be Well Body Scan is a not-for-profit operation affiliated with BethIsrael Deaconess Medical Center inBoston. “We feel that this is an exten-sion of our academic department; so wewould not do anything here that wewould not feel comfortable doing at thehospital,” Dr. Rosen said.

Unlike the marketing materialsproduced by some commercial, for-profit scanning centers, Be Well’s Web

site emphasizes that CT screening is notfor everyone.

Also, Dr. Rosen says there needs tobe more awareness of the fact that“abnormalities” on a sophisticated scanimage are indeed normal in healthyindividuals.

‘Something’ is Almost Always Nothing

At Johns Hopkins Medical Institutions’Advanced Medical Imaging Labor-atory, Elliot Fishman, MD, goes furtherto downplay the significance of “find-ings” on CT screening scans.

“Most of the time, and I mean 90%of the time, if there is ‘something’ seenon one of these studies, it is somethingthat is of no significance or somethingthat is not important,” Dr. Fishman said.

Nevertheless, he strongly advocatesCT as a useful tool in the context of acomprehensive medical care program.“If I do a study, and we do a greatstudy, and we don’t see anything, that’sgood. But realistically, if you are a maleof a certain age, you need a PSA. If youare a woman, you need a mammogram.There are so many things you need thatare part of the whole process.”

However, self-referred whole-bodyCT screening scans lack the proper con-text, Dr. Fishman warns, urging physi-cians to be wary.

“My first word of advice is to pro-ceed slowly, without going into themega-work-up,” he says. “Say a reportcomes back: ‘possible metastasis in theliver or solitary mass right lobe.’ Well,seven to 10 percent of women havelesions in the right lobe that are heman-giomas.

So before you start working up the

patient and runningtheir bowel and doingx, y, and z to look forthe primary tumor, say,‘Wait a second, there’s agood chance this couldbe a hemangioma.’ Donot put the pedal to themetal. You are not deal-ing with a biopsy. I’mvery, very cautious.”

Dr. Fishman saysthe first step by a physi-cian should be to consult a radiologisthe or she regularly works with, in orderto get an independent review of imagestaken at a scanning center.

If it were up to the leading profes-sional organizations of radiologists,whole-body CT screening of asympto-matic individuals would not be doneoutside of clinical trials.

As a policy statement of the Amer-ican College of Radiology (ACR) putsit, “To date, there is no evidence thattotal body CT screening is cost efficientor effective in prolonging life.”

James Borgstede, MD, Vice Chairof the ACR Board of Chancellors andthe Chair of ACR’s Patient Safety TaskForce, says the college issued its cau-tionary statement in response to a ris-ing number of questions from mem-bers.

Despite the skeptical approach toCT screening, he recognizes that once ascreening study has been done, the situ-ation is changed. “Now we are dealingwith the reality of a finding on an

examination, andwhile we may nothave recommend-ed that evaluationto begin with, weare confrontedwith the findingand we have totake the nextstep,” Dr. Borg-stede says.

The ScanChangesEverything

“Once you embarkupon this course,

then you’ve got a commitment that youreally have to evaluate, from an ethicalpoint of view, from a medical-legalpoint of view, and from a purely healthcare point of view; you have to goahead and find out what this abnormal-ity is,” Dr. Borgstede notes.

“First, physicians need to reassuretheir patient that they are going to take

Whole-Body CTcontinued from page 5

PAGE 6 / FEBRUARY 10, 2003

James Borgstede, MD:“Physicians need toreassure their patients thatthey are going to take careof the person, whetherthey agreed or disagreedwith the decision to get theinitial scan. I think there issome value in reassuranceof the patient that a lot ofthese findings are falsepositives, in some situationsup to 90% of the lung scanfindings, for example, arefalse positives.”

One resource oncologistscannot easily turn to arepractice guidelines for

investigating findings onCT screening scans.

When individuals decide to get aCT screening scan, they usually

pay out of pocket. A scan of the chest,abdomen, and pelvis in a mobile CTscanner can be had for $398. At theother end of the scale, a Hawaiianresort spa and scanning center offersairport pick-up, lei greeting, spa treat-ments, meals, and two nights lodging,in addition to five imaging tests andother exams, all for $4,000.

That hit to the wallet does damp-en public enthusiasm for CT screen-ing. According to a market surveyperformed by Be Well Body Scan inthe Boston area, cost was the mostcommon reason people cited for notwanting a CT scan.

Recognizing that an initial testoften raises new questions, Be Wellincludes a limited amount of follow-up testing in the basic package.

“If somebody has something,particularly in the liver or the kidney,sometimes in the CT scan it looks likea cyst, but you just can’t be 100%sure; we will do an ultrasound to clar-ify that finding or the abnormality in

the liver or the kidney, as part of theexam without charging extra for it.We are doing it so people leave withas few loose ends as possible,” BeWell’s Medical Director, Max Rosen,MD, says. But he concedes that scan-ning centers cannot offer a full work-up after every scan that shows somesort of abnormality.

Radiologist Jim Borgstede, MD,Vice Chair of the ACR Board ofChancellors, says the initial scans arenot the problem—“The real problemis the false positives that come out ofthat screening scan. Who pays forthose?” he asks.

“You know, the patients willcome in and pay the money for thescan, but then as soon as something isfound in the scan, which is typically afalse-positive finding, then theirinsurance kicks in. And if you have ahealth care plan, now suddenly some-body in your plan gets one of thesescans, that changes the profile of yourhealth care plan, and that, in effect,changes your premiums. So I thinkwe have to think about this from an

epidemiologic and a populationbasis.”

Some experts go even farther,arguing that until CT screeningproves its worth, individuals who optfor CT scans in the absence of symp-toms or clear risk factors should bearthe full cost of the consequences.

Elliot Fishman, MD, Head of theAdvanced Medical Imaging Labor-atory at Johns Hopkins MedicalInstitutions, notes that a positive scanoften leads to a steady stream of regu-lar follow-up scans, a cash cow forscanners, but a drain on health plans.

“As far as I’m concerned, theyought to do this: If you self-refer, youare responsible for everything,” heargues. While he supports coverageof screening ordered by a physicianas part of comprehensive care, Dr.Fishman warns about the cost to soci-ety of uncontrolled CT screening.

“Truthfully, it could break thesystem. You start running up thesecosts chasing nonsensical things,” hepredicts. “I’m not here to have myinsurance rates go up because people

decide on their own they are going togo for studies at second-rate placesand then get more studies to followsomething that’s of no importance.”

The potential price tag for self-referred CT screening is as uncertainas potential health benefits. In a ple-nary session debate on CT screeningat December’s Radiological Society ofNorth America Scientific Assemblyand Annual Meeting, Bruce Hillman,MD, Chair of Radiology at the Uni-versity of Virginia, said yet-to-be-published results of a study of CTscanning indicated that screeninghealthy 50-year-old individuals forkey cancers, aneurysms, and heartdisease could cost $150,000 per yearof life saved.

On the other hand, MichaelBrant-Zawadzki, MD, Medical Dir-ector of Radiology at Hoag MemorialHospital in Newport Beach, CA,pointed to other analyses of more lim-ited screening for lung cancers thatpredict CT scanning might cost lessthan $50,000 per year of life saved.

—AH

Who Pays?

*OT 021003 2/24/03 4:23 PM Page 6

care of the patient, whether they agreedor disagreed with the decision to getthe initial scan. I think there is somevalue in reassurance of the patient thata lot of these findings are false posi-tives, in some situations up to 90% ofthe lung scan findings, for example, arefalse positives.”

He also suggests that physiciansconsult with radiologists within theirmedical group or hospital to decidewhat, if any, steps should be taken toanswer questions raised by the CTscreening scan.

Guidelines Lacking

One resource oncologists cannot easilyturn to are practice guidelines for inves-tigating findings on CT screening scans.

At the American Society of ClinicalOncology, a spokesperson said thatASCO does not have a policy positionor guidelines regarding body scans ofasymptomatic individuals who do nothave identifiable risk factors.

Meanwhile, some other specialtygroups have taken steps to help theirmembers navigate the aftermath of CTscreening. In recently revised guide-lines on the management of chronic sta-ble angina, the American College ofCardiology and the American HeartAssociation included guidelines forworkup of asymptomatic patients fol-lowing CT screening, not as an en-dorsement of the screening, but merelyacknowledgment of “the clinical realitythat such patients often present forevaluation after such tests have beenperformed.”

The guidelines go on to suggestwhich, if any, follow-up tests or proce-dures should be considered, based onthe patient and the finding on thescreening scan.

For example, the updated guide-lines point out in which circumstancesa stress echocardiogram is preferable toan exercise electrocardiogram. That sortof specific consensus advice is not yetreadily available to oncologists or otherphysicians faced with a mass on anabdominal CT image.

Is Resistance Futile?

In the absence of practice guidelines,oncologists are left to pick and choosefrom the advice offered by individualsin the field. Dr. Rosen at Be Well Body

Scan suggests physicians become famil-iar with the scanning centers in theirarea.

“Find out who is doing screeningin their area, call up the medical direc-tor or one of the radiologists at the site,and say, ‘I’d like to come see what youare doing, I’d like to talk with you, andI’d like to maybe start thinking abouthow, for my patients who want the ser-vice, how I can integrate this into mypractice.’

“It doesn’t have to be for all theirpatients. They don’t have to be recom-mending it to everybody. But for the

patients who are interested in it, I thinkit can actually be a very useful tool for

the clinician,” he says.Dr. Borgstede of the American

College of Radiology agrees that localresearch, including tours of local scan-ning centers, can be useful; in part tohelp build a persuasive argumentagainst screening CT.

“It’s always better to have knowl-edge. If that gives the primary carephysician some knowledge so they cancomment to their patient, that’s proba-bly better, I think it will give them morecredibility. I think it will also give themcredibility with their patients if they

(continued on page 8)

PAGE 7 / FEBRUARY 10, 2003

If it were up to the leading professional

organizations ofradiologists, whole-body

CT screening ofasymptomatic individuals

would not be done outside of clinical trials.

The impact of screening CT on patient-physicianrelationship bears some

similarity to issues relating to alternative orcomplementary medicine.

*OT 021003 2/24/03 4:23 PM Page 7

By Andrew Holtz

O ne morning last spring, ThomasA. Conley, RRPT, CHP, got an

early-morning surprise when readingthe newspaper: “There was a hugecolor four-page ad for screening allover Kansas. That was the first I’dheard of it.” As the Director of the Ra-diation and Asbestos Control Section of

the Kansas Department of Health andEnvironment, he is supposed to knowabout all the CT scanning operations inhis state.

What made the ad especially sur-prising, he said, is that it promoted amobile CT screening operation thatdoes not employ on-site physicians.

“In Kansas, screening is illegal,”Mr. Conley explained. “The regulations

basically say that any human exposurehas to be specifically and individuallyordered by a physician after an exami-nation.” As elsewhere, mammographyis exempted from the Kansas screeningban.

Mr. Conley ordered an inspectionof the mobile screening operation.“People would call in and schedule itand then they’d have a doctor in Flor-

ida electronically sign an order thatthey faxed to the truck that the scannerwas on.”

The scanning operation was run bytechnicians. “They electronically sentthe images back to Florida to be read bytheir radiologist and then they wouldmail a report,” he said.

What’s more, the mobile scannerwould not accept customers withsymptoms or other indications suggest-ing disease, a position diametricallyopposite to that of the Kansas rules thatsay individuals should be exposed toCT radiation only when there is reasonto suspect something is awry.

Last August, Kansas regulators andCATScan 2000, the company runningthe mobile screening centers, signed aconsent agreement. CATScan 2000 paida $5,000 fine and rolled out of Kansas.The company still operates six mobileCT scanners in 14 states. Radiation con-trol officials also sent notice to CT scan-ner operators around the state that

(continued on page 11)

PAGE 8 / FEBRUARY 10, 2003

Regulatory Ins & Outs of Self-Referral for CT Scans

“A lot of those laws are really paper tigers,

because there are a lot of ways to circumvent

the intent of that law; so I’m not really sure

that it really protects thepatient,” he said.

have toured the site and they say, ‘I’velooked at this and I don’t think this is ofvalue.’

“It’ll be better than if they just say‘No,’ but they have very little knowl-edge. I think we still need to rememberthat at least from the point of view ofthe American College of Radiology, wedon’t recommend these examinations.”

The impact of screening CT onpatient-physician relationship bearssome similarity to issues relating toalternative or complementary medi-cine. Whether or not whole-body CTscreening is recommended or acceptedby physicians, patients are aware of thetest and some are undergoing it.

Increasingly the question for physi-cians is not whether CT screening isgood or bad, but how to counsel curi-ous patients, and then support and carefor those patients who get screened…only to be given results that raise ques-tions and fears. O

T

Whole-Body CTcontinued from page 7

*OT 021003 2/24/03 4:23 PM Page 8

screening is not an approved use inKansas.

“It was a complete administrativemisunderstanding,” says CATScan2000 CEO Gina Johnson. “Kansas has arequirement of a physical examinationby a doctor before a preventive CT scancan be performed; and our protocolwas not set up in such a way that wecould make that happen in a cost-effec-tive manner.”

Despite the Kansas incident, andthe skeptical view of leading medicalgroups, Ms. Johnson’s faith is unshaken

that her mobile CT screening improvesthe health and increases the longevityof customers.

“Absolutely and without ques-tion,” she said in an interview. But sheadded that the CATScan 2000 screeningtrucks and promotional materialsclaiming “New Technology Could SaveYour Life!” won’t roll into states thatrequire on-site physicians or otherwiserestrict self-referrals.

Each State Has OwnRegulations

National statistics regarding self-referred CT screening are difficult tocome by. Each state has its own regula-tions, ranging from those like Kansasthat act to restrict CT scanning to diag-nosis and treatment to a handful ofstates that have no rules prohibitingself-referred screening. (In general, theFood and Drug Administration regu-lates only the manufacturers of CTscanners.)

A draft statement from the Con-ference of Radiation Control ProgramDirectors (CRCPD) urges, “Until large-scale clinical trials have been performedand analyzed thoroughly and effective-ly, insufficient scientific evidence existsfor the efficacy and safety of the self-referral whole-body CT process. Un-necessary radiation exposure duringmedical procedures should be avoidedat all costs.”

Ron Fraass, Executive Director ofCRCPD, which is an association of the50 state directors of radiation use, saysa resolution calling on members to

actively discourage self-referral CTscreening was one of the few such mea-sures to pass unanimously.

Scanning center operators in Ore-gon say that state’s self-referral bandoes reduce the number of people whorequest a whole-body CT screen. How-ever, radiologist James Borgstede, MD,Chair of the Patient Safety Task Forceof the American College of Radiology,has doubts about the effectiveness ofself-referral bans.

“A lot of those laws are reallypaper tigers, because there are a lot ofways to circumvent the intent of thatlaw; so I’m not really sure that it reallyprotects the patient,” he said.

For instance, a radiologist at a scan-ning center can write a prescription for

a scan, as long as it doesn’t run afoul ofthe Medicare and Medicaid bansagainst physicians referring patients toscanning centers they have an interestin.

Dr. Borgstede predicts conclusiveresearch into the pros and cons of CTscreening will ultimately have moreinfluence than regulations.

For now, he urges people to beskeptical about marketing claims for CTscreening. “Have a ‘buyer beware,’‘caveat emptor’ type of approach andlet people know what they are gettinginto here. It’s a free country and peoplecan do what they want, but I think theyshould understand what the potentialconsequences are of getting one of thesescans,” he says. O

T

Self-Referralcontinued from page 8

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ACR Statement on CT ScreeningExams: www.aacr.org“The American College of Radiologyrecognizes that an increasing numberof computed tomography screeningexaminations are being performed inthe United States. Much CT screeningis targeted at specific diseases, such aslung scanning for cancer in currentand former smokers, coronary arterycalcium scoring as a predictor of car-diac events, and CT colonography(virtual colonoscopy) for colon cancer.

“Early data suggest that these tar-geted examinations may be clinicallyvalid. Large, prospective, multicentertrials are currently under way or inthe planning phase to evaluate whe-ther these screening exams reduce therate of mortality.

“The ACR, at this time, does notbelieve there is sufficient evidence tojustify recommending total-body CTscreening for patients with no symp-toms or a family history suggestingdisease. To date, there is no evidencethat total body CT screening is costefficient or effective in prolonging life.

“In addition, the ACR is con-cerned that this procedure will lead tothe discovery of numerous findings

that will not ultimately affect pa-tients’ health but will result in unnec-essary follow-up examinations andtreatments and significant wastedexpense.

“The ACR will continue to moni-tor scientific studies concerning theseprocedures.”

American Association of Physicists inMedicine: www.aapm.org “The use of computed tomographyfor total body screening of asympto-matic patients has not currently beenfound to be scientifically justifiable orclinically efficacious.

“The greatest concerns surround-ing this procedure are: (1) that theprocedure will lead to the discoveryof minor anomalies that have noinfluence on patient health, but theiridentification will lead to added med-ical examinations with associatedrisks and unnecessary medicalexpenses, and (2) the wide-scale useof significant radiation exposuresfrom total body screening CT for a yetunproven screening procedure.

“Total body CT screening shouldnot be confused with the scientific CTstudies of screening for lung cancer in

high-risk patients or cardiac scoringto identify calcification in coronaryvessels. Scientists in the AAPM willcontinuously assess the scientific liter-ature as to the efficacy of total bodyCT screening and make revisions tothis policy statement when appropri-ate.”

Food and Drug Administration:www.fda.gov/cdrh/ct“At this time the FDA knows of nodata demonstrating that whole-bodyCT screening is effective in detectingany particular disease early enoughfor the disease to be managed, treated,or cured and advantageously spare aperson at least some of the detrimentassociated with serious illness or pre-mature death. Any such presumedbenefit of whole-body CT screening iscurrently uncertain, and such benefitmay not be great enough to offset thepotential harms such screening couldcause.

“Statements by CT imaging facili-ties that imply FDA ‘approval,’ ‘clear-ance,’ or ‘certification’ of CT forscreening procedures misrepresentthe actual situation. FDA has neverapproved or cleared or certified any

CT system specifically for use inscreening (i.e., of individuals withoutsymptoms), because no manufacturerhas ever demonstrated to the FDAthat their CT scanner is effective forscreening for any disease or condi-tion.”

Conference of Radiation ControlProgram Directors: www.crcpd.org“No scientific studies have demon-strated that CT screening of individu-als without symptoms provides agreater probability of benefit thanharm.

“The main risks of CT screeningscans for an individual are: (1) abnor-mal test results for a benign or inci-dental finding, leading to unneededand possibly invasive follow-up teststhat may present additional risks; (2)normal findings that carry the possi-bility of inaccuracy and false reassur-ance which may lead the patient toconclude that further routine screen-ing tests such as for breast cancer, cer-vical cancer, colon cancer, hyperten-sion, diabetes, etc. are unnecessary;and (3) the increased possibility ofcancer induction from x-ray radiationexposure.”

CT Screening Exams: Official Statements

Thomas A. Conley, RRPT, CHP

CT scans do not appear to be use-ful for mass screening for lung

cancer, according to a study byJohns Hopkins researchers pub-lished in the Jan. 5 issue of the Jour-nal of the American Medical Asso-ciation.

"Direct-to-consumer marketingand media coverage has encourageddemand for lung cancer screeningdespite a lack of evidence for its effi-cacy," lead author Parthiv J. Maha-devia, MD, MPH, said in a newsrelease.

"These scans are not risk-free.

There is a downside, including highcosts and possible harm to individu-als who may unnecessarily get inva-sive procedures if the scan detects abenign lung nodule."

The NCI has begun an eight-year trial comparing CT scans withchest x-rays in the diagnosis of lungcancer.

"We're not down on the technol-ogy--just its injudicious use," saidcoauthor Neil R. Powe, MD, MPH."CT can be a very useful tool, butonly when recommended by a phy-sician for a specific clinical purpose."

JAMA Study: Little Value for Lung Cancer CT Screens

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