Obstacles to Clinical Advances P@e •Major Challenges

NUCLEAR MEDICINE FACES BRIGHT FUTURE WHEN NEW DIAGNOSTIC AGENTS REACH MARKET

“Ifthere is any way to bring about some action in the efforts to improvethe regulatory process, I believethat we will see a huge resurgence in nuclear medicine.We all have products in R&D, and we all need assistanceto bring them out to the medical community.―

N uclear medicine faces a cine in providing physiologic data, “Thisyear we hope to introduce bright future, according to they said. new hepatobiliaryandliver imaging several industry represents ClayLarsen,productmanagerfor agents, as well as rubidium-82 for tives interviewed by Newsline in nuclear medicine systems at Picker PET scanning. At The Society of November 1985,although some ma International, an instrumentation Nuclear Medicine's (SNM) annual jor obstacles stand in the way.These manufacturer in Northford, CT, said meeting this year, we hope to unveil manuflicturers believe that a con thathe senses muchmoreinterestin a new class of technetium-99m- certed effort from the medical and in the marketplace today in nuclear labeled heart agents. These new pro dustrial communities is needed to medicinethanhe did two yearsago. ducts will help lift nuclear medicine clear these obstacles and move into Although other modalities such as X to that next plateau,―he added. a new era for nuclear medicine. raycomputedtomography(CT) and Judy Walker, business segment H. WilliamStrauss,MD, director nuclear magnetic resonance imaging managerat Du I@ntNEN Medical ofthe Division of NuclearMedicine (NMRI) generateda lot of excitement Products in North Billerica, MA, atMassachussettsGeneralHospital, within the medical community,and said, “Ifwe didn't feel very positive said last year that “nuclearmedicine steered certain procedures away from aboutthefutureofnuclear medicine, is poised to takeanothermajorstep nuclearmedicine, “there'sgoing to you wouldn't see the significant forward that would lift our specialty be a backlash against these other amount of research dollars being in to the ‘nextplateau'“(see Newsline, modalities once people realize that vestedin developingnew radiophar July 1985, p. 683). nuclear medicine—especially with maceuticals to move the whole in Members of the nuclear medicine new radionuclides—isgoing to give dustry up again.― industrialcommunityagreed with Dr. them unique information,―said Mr. Medi-Physics, Inc., a radiophar Strauss, and the nextplateau that they Larsen. maceutical manuthcturer in Arlington described includes an expanded use “We'revery ‘bullish'on nuclear Heights, IL, recently installed a of single-photonemission computed medicine,―said Peter Bergeron, 70-MeV cyclotron to produce tomography (SPECT) with new director of sales and marketing at iodine-123.The company has a new agents for brain and heart imaging as SquibbDiagnostics, a radiopharma drug application (NDA) on file with well as with monoclonal antibody ceutical company in New Brunswick, the US Food and Drug Administra products, the introduction of very NJ. Mr. Bergeron said that his tion (FDA) for iodine-123 iodoam short half-life radionuclide genera research group recruited academic phetamine (IMP), an agent used for tors, and more acceptance of positron scientistMichael D. Loberg, PhD, six brain perfusion imaging. emission computed tomography years ago to head its research and Charles Cruse, marketing manager (PET) for patientcare. In addition, development (R&D) program, and at Medi-Physics, said that the more referring physicians will “thefruits of this R&D effort are cyclotron is the largest in the world recognizethe valueof nuclearmcdi about to be realized. (continued on page 2)

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(continuedfrom page 1) agreement to develop imaging soft developments for examining physio totally owned and operated by private ware for Hybritech's monoclonal an logic processes.― industry, and represents a $10million tibody products, “whichindicates commitment to the future of nuclear where we believenuclear medicine is Transition State medicine. heading in the future.― In recent years, members of the “Monoclonalantibodies will rein WayneWebster,a marketingman nuclear medicine community have fuse the field with some of the ager for Scanditronix, Inc. in Essex, expressed concern over reduced momentum that has been lost,―said MA, a PETmanufacturerheadquar funds for patient care and research, Solange Israel-Mintz, director of tered in Uppsala, Sweden, said that the declining number of referrals, a marketingfor Centocor, a biotech the next plateau will probably be downturn in equipment sales, and the nology firm in Malvern, PA. reached within the next five to 10 stagnating process of providing new MarkLamp,nuclearmedicinepro years. “Ithink that the nuclear medi radiopharmaceuticals to physicians. duct manager at ADAClaboratories, cine department will become much In the United States,the Prospec an instrumentationfirm in SanJose, stronger within the hospital because tive PaymentSystem(PPS), introduc CA, said that his company has an of its outpatient status and the new ed in 1983 to trim Medicare reim bursements by using diagnosis related groups (DRGs), essentially made diagnostic imaging a cost center rather than a revenue generator for the hospital. The nationalized health care systems in several Euro pean countries have also faced con straints in tighter economies. Severalcompaniespointedoutthat nuclear medicine is not in any more trouble than the rest of medicine because of funding pressures, although some manufactorers recom mended waysfor nuclear medicine to better adapt to the cost containment environment. “Ithink nuclear medicine is in a state of transition now,and the prob lem seems to be that it has been diffi cult to keep pace with all the techno logic advances,―said Mr. Webster of Scanditronix. “Theresearch commu nity can continue move nuclear medi cine ahead by concentrating on the clinical applications of all of this technology' he said, adding that there seems to be a problem bridging research and clinical application. “Researchersneed to work with the end-user in mind, and could develop more software, for example, that Iodine-123iodoamphetamineSPEI'Timageofa normalcontrolpatient. “Cortical wouldmake diagnostics simpler' ex uptake appeai@relatedto gray-matterbloodflow, with gooddemaivation of interlobar plained Mr. Webster. fissure. In this tomographicslice at 2 cm aboveorbito-meatalline, basalganglia Everyone who does clinical re are clearly defined,―explainedB. LeonardHolman, MD, directorofthe Department search is product-oriented by defini of ainwal NuclearMedicineat Brighamand Women'sHospitalin Boston. (Re@ted fromHifiit, HolmanBL,LovettR, etal: InitialexperiencewithSPECF tion because they want something ofthe brain usingN-isopropyl1-123p-iodoamphetamine:Concisecommunication. they can ultimately use in patients, I NuciMed 23:191-195,1982) said Rudi D. Neirinckx, PhD, man

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ager ofpharmaceutical development at AmershamInternationalin Buck 6.@ rU MP@LE LJITH INFERIOP MI inghamshire, England. When a man ufacturer is funding clinical research, I @ however,the investigatorssometimes @-- -@ ‘ strayfrom the original intent, said Dr. Neirinckx, which does not lead to a viable product. If they are not re directed towardthe original goal, the r new radiopharmaceuticalwill take much longer to reach the market place, he explained. Manufacturers could also redirect theireffortsto helpthe field expand, said Dr. Neirinckx. “It'stime that we THALLIUM 201 INDIUM 111 puta lot ofeffort intodevelopingthe ANTIMYOSIN right kind of drugs and expand into fields which are not vulnerable to in LEFT LATERAL roads from other imaging modalities. Compwison of planar thallium-201 image with indium-ill-labeled antimyosin It'svery importantto developa drug (Myoscintl'A@,Centocor) image shown in the kft kitemiposition. A regjon of interest for a new application, rather than corresponding to the outer mwgin ofthe left ventricle on the thallium-201 study is drugs that are slight improvements supa,imposedowrboth images. “Thisstudy demonstratesthe abilityofthe monoclonal over existing agents,―he explained. antibody imaging agent to localize the area ofacute myocardial necrosis. A lwge area of abnormal uptake is noted in the inftrior @ilon the antimyosin study,― Overinterpretation of Data explained Harvey I. Berger, ME4 of the Department of Radiology at the Emory University School of Medicine. lain Stark, president of Scintromx (Courtesy of Emory University School of Medicine) USA Inc., an instrumentationcorn pany headquartered in Livingston, Scotland, said that he observes a theymayexpandthatconclusionand he explained, nuclearmedicinecan general tendency in nuclear rnedicine say that nuclear medicine doesn't not always provide accurate data. to overinterpretdata and not study work very well.―added Mr. Stark. “AlthoughSPECT devices have enoughpatients.“Oneareathatcon It was inevitable for CT to take improvedsignificantly,andthecorn cerns me as a manufacturer is that in brain scans away from nuclear puter technology has reached the vestigatorsacquiredynamic images medicine because very little activity point where it can acquire and of a 64 x 64 or a 32 x 32 matrix, crossed the blood-brain barrier, reconstruct the data in a reasonable andthen proceedto drawregionsof resulting in poor images, said Mr. amount oftime, we're still faced with interest as if it were a 128 x 128 or Stark. “Thallium-201is also a poor an integralproblem since we can't 256 x 256 matrix, and they haven't radionuclidebecause it's the wrong collect enough data because there realized that there is no accurate way energy and does not efficiently target really aren't the appropriate, photon of dividingup the pixels of informa themyocardium,―he said. “It'sless abundant, specially locating radio tion and knowing where the counts than-ideal procedures like these pharmaceuticals needed to make are coming from,―he explained. In which make people doubt nuclear SPECT really take off,―said Mr. addition,“asyoumoveawayfromthe medicine:' said Mr. Stark. Enos, addingthatmorecommunica collimator, the pixel diverges because tion is needed between the instrumen of the resolution of the camera Compromised Modality tation and radiopharmaceutical collimator system, and is not looking “Thegeneralmedical community manufacturers to work out these at the same location, resulting in sees nuclear medicine as a very corn problems. cross-talk between pixels,―he said. promised modality,―said Gary Enos, Mr. Starkof Scintronix also said This overinterpretationmakes it nuclear product line manager for thathe wouldliketo see morediscus difficult for other investigators to Raytheon, an instrumentation com sions between instrumentation and reproduce the results, said Mr. Stark. pany in Melrose Park, IL. With the radiopharmaceutical manufacturers. “Theythen may conclude that the less-than-ideal radiopharmaceuticals “It'squitepossible thatthesediscus techniquedoesn't workvery well, and available today for SPECT imaging, (continued on page 4)

Volume27 •Number1 •January1986 3 PJ@JM...;NewsIinesnm

while you're going through it,―she also statedthat she does not blame the “Ithink that FDA because biotechnology is so new and the agency is still develop radiopharmaceuticals are lost in the ing guidelines. FDA's Division of Oncology, and we probably Mr. Webster of Scanditronix, whichdealswiththeFDA'sCenterfor ought to push for a separate division.― Devices and Radiological Health, said that the FDA has helped his corn panybysettingupanoffice forsmall businesses which do not have a staff of regulatoryexperts. (continued from page 3) as formidable as the FDA's, and Theproblemareaseemstobe with sions don't take place because we clinical research is more readily ap the FDA's Division of Oncology, engineers and physicistsdon't unders proved.Therealso seems to be more under the Office of Drug Research tand chemistry well enough,―he said, cooperation in Europe between the and Review,which reviewsINDs and buthe wouldlike to see moresmall, regulatory agencies, industry,and the NDAS for drugs designed to treat informal scientific meetings where academic community. cancer, acquired immunodeficiency people from variousdisciplinescould The regulatoryprocess inJapanis syndrome (AIDS), and for diagnostic exchange information and educate more stringent than that in the United imaging agents. each other. States, and usually requires clinical “I'llbe quite candid about it. Mr. Cruse of Medi-Physics said studies on the Japanese population. There's one huge roadblock that is that one problem, however, is the Despite these factors,however,drug governing the growth of nuclear lengthy FDA approvalprocess. “The companies still reported that it is medicine, and that's the lack of instrumentation manufacturers are easier to get a new drug approved in resources within the FDA's Division beating down the doors to develop Japan than in the United States ofOncology to handle radiopharma newhardwareand softwareat the first because the Japanese regulations are ceuticals,―said Mallinckrodt's Mr. sign of a promising investigational clearer and “morelogical.― Kinder. newdrug(IND). It'sbeenestimated, Mr. Cruse of Medi-Physics said though, to take seven to 10years at Pinpointing the FDA Problem thatthisapparentlackof resourcesis a cost of approximately $90 million EvenintheUnitedStates,theFDA visible in the long waiting period bet fromproductresearchthroughFDA is not perceived as such an obstacle ween the application date for a new reviewand approval.Bythat time, the to the growth of nuclear medicine by drugandthe FDA'sresponse. “Con instrumentation companies are into all members of the community. sidering the limited resources, AIDS, their third and fourth generation of Karen A. Klause, vice president of and therapeutic drugs, it appears that equipment, and by that time there's the planning division at Hybritech, a radiopharmaceuticals are not the anothertechniquerightbehinditthat biotechnology firm in San Diego, highest priority in the Division of On will replace the procedure:' he CA, saidthathercompany“hashad cology,―he added. explained. no delaysand no complaintsabout the The manufacturers also said that “Thereare many opportunities out FDA'sresponsetime. Weworkvery they hoped the SNM and other there,―said RonaldKinder,director closely with them,― she said. medical associations would try to im of marketing for Mallinckrodt, a Hybritech has INDs for its mono provethis situation. “Thereappears radiopharmaceutical producer and clonal antibody products on file with to be a consensus that reducingthe nuclear pharmacy company in St. the FDA's Office of Biologic Re time and cost ofthe FDA reviewpro Louis, MO. “Butwhen you weigh the search and Review, but the company cess is possible without compromis time and expense involved in getting has not yet submitted an NDA. ing patient safety,and that this reduc a new drug approved, and you look Although Ms. Israel-Mintz of Cen tion would go a long way toward re at your returnon investment, it be tocor, which has an IND for indium vitalizing radiopharmaceutical devel comes a veryriskyventure:'he said. 111-labeledantimyosin(MyoscintTM) opment,―said StanleyJ. Goldsmith, Everyoneinvolvedinradiopharma on file with the FDA, said that“try MD, presidentof the SNM. ceutical development noted thatthese ingto get a product in monoclonalan C. Douglas Maynard,MD, chair products are used first in Europe tibodies approved is like finding your man ofthe Department of Radiology because the approvalprocess is not waythrougha mazethat'sbeingbuilt (continued on page 5)

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(continued from page 4) at the Bowman Gray School of Med icine of Wake Forest University, pointed out that physicians in all diagnostic specialties, not only nu clear medicine, recognize the need for the developmentofmore pharma ceuticals for tracer methodology to targetcell activity. “Thisarea is a top priority in a recommendation from the Conjoint Committee on Diag nostic Radiology to the National In stitutes of Health (NIH) this year:' said Dr. Maynard, who is a member of the committee. “Peoplehave been talking about this problem for years. Ifthere is any wayto bring about some action in the efforts to improvethe regulatory pro cess, I believe that we will see a huge resurgence in nuclear medicine. We all have products in R&D, and we all a need assistance to bring them out to @ the medical community:' said Mr. .S. Kinder of Mallinckrodt. A tmnsaxial slice ofa rubidium-82PETimage ofthe myocardiumin a normal subject 80secondsafterinjection, MailinckrodiInstituteofRadiolo@ WzshingtonUniversity Thomas P. Haynie, MD, director of (Courtesy of Squibb Diagnostics) the Department ofNuclear Medicine at M.D. Anderson Hospital and Tumor Institute, said that there may cells to clinical investigators under an nology. In order for new procedures have been a logical reason historically IND. Ifsome investigators, however, to be clinically viable, they must be for radiopharmaceuticals to be under have not kept up with their clinical approved by the Health Care Financ thejurisdiction ofthe FDA's Division reports, warned Mr. Witkowski, the ing Administration (HCFA) for of Oncology. “Nuclearmedicine in FDA will react adversely. Medicare reimbursement, and also its early inception was targetedt@rd Keith R. Collins, nuclear medicine by Blue Cross/Blue Shield and other cancer, but today I think that radio product manager for Toshiba third-party payers. pharmaceuticals are lost in the Divi America, Inc. , a division of Toshiba sion of Oncology, and we probably Medical Systems headquartered in Reimbursement Approvals ought to push for the creation of a Nasu, Japan, said that he is also con Dual-photonabsorptiometry is one separate division under an individual cerned about the FDA's proposal to procedure which is not yet reim who spends his or her time working license medical software. “Ifthat bursed by Medicare. Richard B. on nuclear medicine applications:' happens, it could be a major disaster, Mazess, president of Lunar Radia said Dr. Haynie. especially since the US government tion, a bone densitometer manufac The FDA has shown some signs of decided that software cannot be turer in Madison, WI, said that “it understanding the problems of the patented. The drug manufacturers at is imperative that the existing struc nuclear medicine community, noted least are protected for a while with tore at HCFAbe changed. Technolog John Witkowski, director of their patents. Ifthe FDA gets involved ical assessment should have formal marketing for Syncor International, in licensing software, though, input from professional societies with a nuclear pharmacy company in everyone's software will be available less dependence on the governmen Sylmar, CA, that recently merged to everyone, and there will be no in tal assessment.― with Nuclear Pharmacy Incorporated centive at all to develop something Mr. Webster of Scanditronix said of Albuquerque, NM. The agency new,―he said. that he believes there will be reim allowed nuclear pharmacies to pro In the United States, FDA approval bursement for PET studies once the vide indium-ill-labeled white blood is only the first hurdle for a new tech (continued on page 6)

Volume27 •Number1 •January1986 5 @ snm Newslin—

volume environment:' he added. Several manufacturers indicated that nuclear medicinephysiciansneed to bridge the gap between themselves and other medical doctors. “Nuclearmedicinephysiciansneed A B to become more familiar with their results so that they can converse with referring physicians and make a bet ter case for their services instead of just puffing out numbers and images:' said Dr. Mazess of Lunar Radiation. Cl.. In addition to educating referring physicians about nuclear medicine, nuclear physicians need to educate Anterior scan ofa normal hepatobiliamysystem using technetium-99m mebrosenin themselves in the specialties that pro at S mm (A), 10 mm (B), iS mm (C), and 30 min (D). vide referrals. Dr. Neirinckx of (Courtesy of Squibb Diagnostics) Amersham said that he is learning more about neurology so he can bet (continuedfrom page 5) newsletters, and technical reports to ter market his company's new agent modality is available in more clinical physicians. for cerebral blood flow SPECT irn situations, “andthat'll be happening Mr. Webster of Scanditronix stated aging, technetium-99m hexamethyl within the next two to five years.― that it is important for industry to have propyleneamineoxirne (HMPAO). Don P@rrine,vice president of sales a cooperative effort with the SNM in “Youmust understand their special for Computer Technology& Imaging providingthese educational materials ty better if you're going to convince (CT!), a PET manufacturer in Knox because “it'ssometimes difficult for them that your technology has an ap yule, TN, said that one problem with a company to put together an un plication they need:' he added. HCFA is that it places the burden for biased presentation.― According to Mr. Perrine at CT!, the costs of proving efficacy prin Mr. Larsen of Picker said depart “primarycare groups are heavily in cipally on teaching institutions and ments that market their services can volved in PET decision-making. We industry. “Ifthe government could realize dramatic results. “Youcan work closely with nuclear medicine, sponsor programs that demonstrate find a 150-bed hospital with three of course, but other groups such as both narrow-based efficacy and gamma cameras, two computers, and oncology, neurology, neurosurgery, broader-based cost-effectiveness, it a full schedule in a department that psychiatry, and cardiology are deep could help improve their medical markets, whereas you can find a ly involved in planning programs and technology assessment process:' he 500-bed hospital with two cameras, determining how the equipment will said. “Thistype ofprogram would fit an antiquated computer, and declin be used.― in with the government's DRG con ing statistics in a department that does Rather than taking a defensive cept, and the net effect would be a not promote its services,―he noted. stance, Mr. Perrine said that nuclear significant savings in health care Michael Bono, president of Amici, medicine could take an offensive delivery,―he added. Inc. , a nuclear respiratory products stance and recognize new oppor manufacturer in Royersford, PA, tunities that require this type of team Marketing Nuclear Medicine agreed. “Nuclear medicine is a work. “Toset up a protocol, primary Despite these issues, everyone business within a hospital, and for it physicians need to be involved. It's agreed that the specialty has valuable to succeed, their customers have to very difficult, however, for them to services to offer referring physicians, be aware of what they offer—allthe interpret PET information, which is and several manufacturers said that time. The size of the lab or institu where nuclear medicine fits into the they are receiving requests from their tion doesn't matter. It's the dynamics team,―he explained. customers for advice in marketing the of the individual running the depart In some institutions, noted Mr. nuclear medicine department within ment that increases the business. If Perrine, this type of cooperation be the hospital. Companies are pro they don't market their capabilities, tween clincial departments may not viding educational materials on they'll sit there waiting for the refer be possible. “Itbecomes very clear marketing and business management, rals to come and continue in the low early on that the chances ofPET gain

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ing acceptance in those institutions physicians are presenting more Mr. Stark of Scintronix said that, are very small, simply because papers at scientific meetings of in general, the European market is in they're not drawing in all the groups primary care medical associations. dined to spend more on the camera that must participate in the program and less on accessories. “Wenow in order for it to succeed:' he added. No Turf Battles in Europe have an integrated multiformatter, for Mr. Webster of Scanditronix Most people in industry said that example, because the American agreed withthe team approach. “We they observed turf battles between market demanded it, whereas it is not look at the entire institution and at primary care and diagnostic special considered as important in Britain:' tempt to bring appropriate groups ists in the United States but not in he said. together to establish a PET program. Europe. Even within the diagnostic All ofthe equipment manufacturers There does seem to be some confu imaging community, Mr. Stark of interviewed stated that the industry is sion on the part ofend-users as to how Scintronix said that he found more under more pressure in the United to work together within their own in communication in Europe between States than in Europe and Japan to stitutions, which makes it seem as if nuclear medicine physicians, radiol give substantial discounts to its industry sometimes takes a ‘divide ogists, and physicists. Discussions customers. and conquer' attitude:' he said. between these groups are important, he said, because “youlearn the value Relief Sought from Discounting Forefront of Technology of their techniques and of your tests, David Archibald, director of Several other manufacturers said and you perhaps learn ways to im marketing for Siemens Gammasonics that they do notlimit their marketing prove your own techniques.― in Des Plaines, IL (of Siemens AG efforts to nuclear medicine depart Industry also described other dif in Germany), said that when nuclear ments; they also seek business with, ferences among the various global medicine started growing, manufac for example, cardiology, oncology, markets. Of the world market for all turers were eager to make special and neurology groups. Dr. Mazess at nuclear medicine products, the deals to get their equipment into the Lunar Radiation added that nuclear United States represents 60% , Japan most prestigious institutions. “It's medicine will also work more close 20% , Europe 15%, and Australia time to say that we can't afford it any ly with endocrinology, orthopedics, 5%‘accordingto Mr. Collinsof more. If we're going to continue to rheumatology, and gynecology with Toshiba. improve your product, we need relief bone densitometry. “Europeis extremely aggressive in from that pressure to discount.― Jessica I. Bede, vice president at monoclonal antibodies, more so than Lewis H. Rosenblum, general Capintec, Inc. , emphasized that this the United States:' said Ms. Klause (continued on page 8) dispersal of nuclear medicine tech of Hybritech. nology enhances the field and allows it to grow. “Ifwe redefine nuclear medicine as the ‘extendedarms' of nuclear medicine, such as nuclear cardiology, we can't help but feel op timistic about this field,―she explain ed. Capintec, based in Ramsey, NJ, produces accessories, including an ambulatory ventricular evaluation A B system. Nuclear medicine can provide the rest of the medical world with far reaching advances, said Ms. Bede. “Pioneerthem, and be the forefront of technology—butthen disperse it. I don't think it's really a turf issue at that point. It's educating the rest of the medical community,―she added. C 0 Mr. Lamp of ADAC said that one Fourviewsofa liver/spleen scan in a normal volunteer using technetium-99m micro factor which has helped the field aggregatedalbumin, anterior(A), posterior(B), rightlateral(C), and left lateral (D). significantly is that nuclear medicine (Courtesy of Squibb Diagnostics)

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(continued from page 7) DRGs have not yet taken effect for “Weactually put it there to enhance manager at Picker International , said capital equipment, but when they do, the high-count-rate acquisition, but that European investigatorswantto be the major impact willjust be a delay since we designed it to be program at the leading edge of research, and in purchases because the need for mable, it is now also used for SPECT are more willingto pay for equipment equipment will not change. reconstructions and other processing than investigators in the United functions that require a ‘number States. “Inthis day and age, cost con Longer Life for Camera Systems crunching' type ofanalysis,―he said. tainment is as strong within the in Mr. Archibald of Siemens said that Most ofthe PET people believe that dustry as it is withinthe medicalcorn instrumentation manufacturers have DRGs will eventually work toward rnunity, and we can't afford to con reached the limit on price reductions. their benefit when the medical corn tinue to give equipment away:' he His company is now concentrating on munity realizes the financial savings added. making products that will havea use from the predictive value of PET in ful life of five to 10years, as opposed formation, particularly in determin “PriceWar―in Instrumentation to the industry average of five years, ing the prognosis of bypass surgery “Ifind that the medical communi so that the medical community will versus nonsurgical intervention in pa ty expects that their instrumentation still realize savings per year although tients with coronary artery disease. will be discounted to an absolutely the initial cost will be the same. low level, or that there will be no At Lunar Radiation, the marketing DRGs Forcing Shake-Out cost,―said Mr. Enos of Raytheon. strategyadaptedto DRGs by develop Diagnostic medicine was already “Andif we don't do it, someone else ing programs for physician partner heading toward a shake-out between will,―he added. ships in placement of outpatient in nuclear medicine, CT, NMRI, and Some people said that there is struments, said Dr. Mazess. ultrasound, said Dr. Neirinckx of almost a price war going on among Robert Ranieri, director ofsales for Amersharn, and the DRGs are just the major companies, and if the Atomic Products, an accessory forcing that shake-out to occur medical community did not apply so manufacturer in Center Moriches, sooner. “Overall,it will be healthy much pressure, everyone could hold NY, said he is seeing an increased and eliminate some unnecessary the line. movement toward private laboratories testing and poor technology, and we “Physiciansask @vhywe aren't de and outpatient clinics. He also said hope that nuclear medicine can ride veloping anything new, but the way that his company keeps track of feed out the storm,―he added. manufacturers are discounting, there back from the medical community, In addition to the cost containment is nothing to invest in future develop which helps significantly in tailoring factors,Dr. Hayniepointedout anoth ment,―said Mr. Collins of Toshiba. products to meet its needs. The latest er reason for declining statistics in nu version of Atomic's thyroid uptake clear medicine. “Whatwe do for pa Adapting to DRGs system, for example, includes more tients has become more lengthy and With the exception of the PET memory, automatic decay correction complex. We're getting more exact in manufacturers, most of the instru of the sample, increased count rates, the information we're supplying, but mentation companies said that they and a built-in monitor—all sugges it doesn't show up on the books as pa have responded to DRG pressures by tions from customers, said Mr. tient through-put:' he added. “valueengineering:' or producing Ranieri. better products at a lower cost to the Tsur Bernstein, PhD, product man “OurFates Are Linked― consumer, and by decreasing R&D ager for nuclear medicine at Elscint, Nuclear medicine will grow again, efforts. Inc. , an instrumentation company according to most manufacturers, if The radiopharmaceutical compa based in Israel, said that his products the challenges ofdeveloping new pro nies, on the other hand, said that they were prepared for DRGs because of cedures, streamlining the regulatory have shifted money away from their the cost-effectiveness of their inte process, and adapting to cost contain marketingeffortsand channeledmore grated systems. “Weset the trend for ment can be met by both the clinical into R&D. integrated systems, using the same and industrial communities. “Every Companies also said that they have computer capability for data acquisi one must recognize that our fates are tried to reduce the cost of a procedure tion and processing:' said Dr. Bern very much linked together:' said Dr. by, for example, making it more stein. He noted that this integration Neirinckx, “otherwisenuclear med labor-saving. Some manufacturers results in unexpected benefits, as with icine could become a pure research noted that there is a certain amount the array processor, for example, science.― of buying activity now because the which is an option in many systems. Linda E. Ketchum

8 The Journal of Nuclear Medicine