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NIH researchers receive cut-price BRCA test
Author: Tom Hollon
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"610 NATURE MEDICINE ? VOLUME 6 ? NUMBER 6 ? JUNE 2000 NEWS Can Veronesi transform Italian research? Umberto Veronesi, the 74-year-old oncol- ogist who pioneered conservative surgi- cal treatment of breast cancer and founded the European Institute of Oncol- ogy (EIO), embodies the best hope yet of a catalyst for Italy?s biomedical research effort. Veronesi was appointed minister of health in a cabinet reshuffle at the end of April. He is the first ever physician?sci- entist to take up a top political post in an Italian government. In an interview with Nature Medicine, Veronesi said that his work will be directed towards a vigorous boost of translational research through the creation of a National Agency of Biomedical Research modeled on the German Max Planck Institutes. Achieving this requires the cooperation of universities and private and public research institutions. Moreover, he says ?The new agency should have a physical institute of its own, from which to coordinate the country?s research on the applications of nanotechnology, genetics and molecular biology,? which will be sponsored by the Ministry of Health and the Ministry of Research. However, the proposal evokes memories of another plan by Veronesi?s predecessor Rosy Bindi three years ago to create a biomedical research institute (Nature 388, 609; 1997). Arguments between the two ministries over respon- sibilities destroyed the effort. But Veronesi does have a successful track record?in Europe at least?in establishing new research initiatives and attracting par- ties from both the public and the private sector. Since the foundation of the EIO in Milan in 1991, he has been a leading advo- cate of the special European programs for cancer research, such as the Europe Against Cancer Programme. He says he will increase Italy?s investment in European col- laborative efforts, and says he favors ini- tiatives such as the creation of a pan-Euro- pean health database to shed light on the complex interplay between genetic and environmental factors. ?More than ever I will be active at the level of the European Commission to marry advances in basic research with programs of epidemiology and biostatistics,? he told Nature Medicine. If he is to achieve any of his goals, Veronesi must act quickly: He could be replaced in the next round of government elections in April 2001. Martina Ballmaier, Milan NIH researchers receive cut-price BRCA test Myriad Genetic Laboratories, the Utah- based company that owns the patents on the breast and ovarian cancer susceptibil- ity genes BRCA1 and BRCA2, has struck a deal with the US National Institutes of Health (NIH) for cut-rate prices on its gene tests in exchange for research data. Myriad might be hoping that its action goes some way toward defusing criticism of the company regarding its manage- ment of the BRCA-testing business. Myriad charges $2,580 for patient-re- quested BRCA DNA sequencing and mu- tation analysis (BRCA gene mutations are estimated to cause 7?10% of all breast and ovarian cancers). However, it is li- censing the sequencing service to NIH scientists country-wide for $1,200 per person on the condition that the tests are done for research purposes. The price cut is expected to spur studies of BRCA?envi- ronment interactions, the pathological effects of specific BRCA mutations and how BRCA mutations may correlate with cancer treatment outcomes. It should also improve understanding of the penetrance of BRCA mutations: women with a family history of breast cancer who also have BRCA mutations are at increased risk of the disease. But Jan Platner, director of Programs for the National Breast Cancer Coalition (NBCC), says it is not as clear what the risks are for women with the same mutations but who do not have familial predisposition to breast cancer. NBCC feels Myriad's mar- keting of BRCA testing has been too ag- gressive in light of the incomplete understanding of the prognostic meaning of BRCA mutations. Medical geneticists have seethed for years over the high costs of tests for some patented genes and the restrictions on who may perform them. Myriad?s en- forcement of its patent rights?in 1999, it forced University of Pennsylvania re- searcher Arupa Ganguly to stop offering BRCA tests?coupled with the compa- ny?s high prices, has made Myriad a par- ticular target of medical geneticists? ire. But Gregory Critchfield, Myriad?s presi- dent, argues that critics overlook the ex- pense of sequencing both strands of two exceptionally large genes (combined total- ing 17,500 base pairs) in which more than a thousand mutations have been found. He says that Myriad reserves sequencing for itself in part for quality-control rea- sons; only 13 laboratories are licensed for follow-up, and cheaper, analysis of muta- tions that Myriad identifies. Ganguly de- clined the offer of a follow-up license. Moreover, Critchfield insists that ge- neticists? fear that high prices prevent people from getting needed tests is groundless in the case of BRCA: Insurers recognize their life-saving value and do not balk at paying for them, he says. But Debra Leonard, president of the Association for Molecular Pathology, feels the time has come to put an end to restric- tions on their ability to do genetic testing. The group will ask Congress for a law free- ing them from liability for patent in- fringement if they offer diagnostic tests for patented genes. Within recent weeks, the company has been awarded two further BRCA-related patents: one for the CtIP gene, which suppresses breast and ovarian tumor growth through its interaction with the BRCA1 gene; and another patent extend- ing Myriad?s diagnosis and prognosis position on cancers caused by mutation of the BRCA2 gene. Tom Hollon, Bethesda anonymous letter on the deferiprone sub- ject to a prominent Canadian physician (Nature Med. 6, 485; 2000), is understood to have faired even better than Koren. HSC spokesperson Cyndi DeGuisti says the hospital has investigated Grinstein?s conduct and taken the appropriate action and that further details will not be re- leased because this is an internal matter. Meanwhile, the HSC is referring Olivieri to the College of Physicians and Surgeons of Ontario?a quasi-legal body with the power to supoena evidence and testimony and to have physicians struck from the medical register?and to the chair of the Department of Medicine at UoT, for refusing to answer five specific questions regarding her role in the de- feriprone clinical trial in 1997. DeGuisti points out that although Olivieri sub- mitted three volumes of written material to administrators, she refused to appear at five meetings on the subject and to answer the questions. At issue is the time delay between Olivieri?s discovery that deferiprone was causing signs of liver toxicity, her calling a halt to patient treatment and her reporting the findings to the hospital?s Research Ethics Board. Karen Birmingham, London � 2000 Nature America Inc. ? http://medicine.nature.com � 2000 Nature America Inc. ? http://medicine .nature .com "
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