Drug costs threaten patent protection
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NATURE MEDICINE • VOLUME 9 • NUMBER 1 • JANUARY 2003 9 NEWS The Netherlands Cancer Institute in Amsterdam is to become the first insti- tution in the world to use microarray techniques for the routine prognostic screening of cancer pa- tients. Aiming for a June 2003 start date, the center will use a panoply of 70 genes to assess the tumor profile of breast cancer pa- tients and to determine which women will re- ceive adjuvant treat- ment after surgery. Adjuvant therapies include chemo-therapy, hormonal ther- apy (typically tamoxifen) and some- times radiation therapy. Over 80% of breast cancer patients in the US and Europe currently receive adjuvant ther- apy, and a fraction of the women who do not receive adjuvant therapy suffer tumor recurrences. However, these costly treatments are ridden with side ef- fects such as premature menopause, weight gain, mild memory loss and fa- tigue. Presently, standardized prognostic cri- teria are used to determine who will benefit from adjuvant therapy. These criteria rely on indicators such as histol- ogy, biochemical markers of invasive growth, and the presence or absence of hormone receptors and cancerous lymph nodes. But these conventional indicators can give the misleading im- pression of a non-aggressive tumor—or, alternatively, lead to overtreatment. The Dutch institute, which is affiliated with the 200-bed Antoni van Leeuwenhoek hospital, will use microarray profile analysis in conjunction with conven- tional prognostic tests. The institute treats around 1,000 breast cancer pa- tients each year, 400 of whom undergo surgery and would have tissue samples available for microarray analysis. Laura Van’t Veer, a researcher at the institute, helped develop the microarray test for the hospital. She notes that the approach could reduce the number of women receiving adjuvant therapy by as much as 35% while allowing fewer women with high-risk tumors to slip through. These estimates are based on retrospective studies testing the ap- proach in banks of tumors, the most re- cent of which was published last month in the New England Journal of Medicine (see News & Views page 16). “There are at present many women that are overtreated by chemotherapy that based on [microarray] criteria actually have a good profile...” says Van’t Veer. David Botstein, a Stanford researcher who is also develop- ing microarray sig- natures for breast cancer, foresees that the burgeoning data from the various mi- croarray studies will eventually become standardized. But for now, he greets the Amsterdam announcement with enthusi- asm, “It makes perfectly good sense.” Wider use of the Dutch microarray test in other institutions may have to await confirmation of the microarray signatures by an independent analysis, says Sjoerd Rondenhuis, an author on the NEJM study. The Dutch microarray tests are also planned for use in numerous clinical trials. For example, the European Organization for Research and Treatment of Cancer is finalizing plans for a large-scale trial to test the prognos- tic value of microarrays on lymph- node–negative patients. Patients will receive adjuvant treatment based on their microarray signature. Their out- comes will be compared with patients evaluated solely according to conven- tional European criteria, called St. Gallen criteria. In other trials of novel treatments, researchers will give pa- tients a microarray test and then later determine how patients with certain profiles responded, says Van’t Veer. Charlotte M. Schubert, New York Microarray to be used as routine clinical screen A good prognostic signature Drug costs threaten patent protection News that prescription medicines have become the fastest-growing sector of healthcare outlay in the US will add strength to proposals by the Bush Administration to ease regulations on generic production of brand-name drugs. According to a survey released in December by Mercer Human Resource Consulting, the cost of American healthcare rose by 15% last year, the largest in- crease since 1990. Individuals paid an average of $10 for generic drugs and $35 for brand-name drugs. The previous month, US Secretary of Health and Human Services Tommy Thompson announced plans to eliminate legislation that allows pharmaceutical companies to invoke a 30-month delay on generic copies being produced. This rule gave innovator drug companies the chance to protect their patent rights in court. However, companies have frequently invoked multiple 30-month delays, indefi- nitely delaying approval of generic drugs. Thompson’s new rule would end that possibility. Around 40% of drugs currently sold are generic copies. Between now and 2006, patents are set to expire on four times as many drugs as normal during that time period, making them susceptible to copying without even a 30-month delay pe- riod. As Nature Medicine went to press, the Pharmaceutical Research and Manufacturers Association (PhRMA), which represents much of the pharmaceutical industry in the US, was expected to lodge its opposition to removal of the 30- month rule. PhRMA’s view is that allowing faster access to cheaper generics dis- courages drug makers from investing huge sums into the research and development of new and potentially breakthrough compounds. PhRMA claims its members spent more than $30 billion in 2001 discovering and developing new medicines, and should be allowed to reap the profits from those in- vestments. For example, the patent on Merck & Co.’s successful osteoporosis drug Fosomax was recently challenged by two generic drug makers, Teva and Ivax Pharmaceuticals. The court ruled that Merck’s patent on the drug, which generated $455 million in sales last quarter, was valid until August 2007. But Thompson insists that the change “would bring relief from the high prices that American consumers frequently pay for prescription drugs.’’ Citing his own dollar figures, he predicts that the rule “could save consumers approximately $3.5 billion every year.’’ MARLENE CIMONS, WASHINGTON, D.C. © 2003 Nature Publishing Group http://www.nature.com/naturemedicine
Transcript of Drug costs threaten patent protection
NATURE MEDICINE • VOLUME 9 • NUMBER 1 • JANUARY 2003 9
NEWS
The Netherlands Cancer Institute inAmsterdam is to become the first insti-tution in the world to use microarraytechniques for the routine prognosticscreening of cancer pa-tients. Aiming for aJune 2003 start date,the center will use apanoply of 70 genes toassess the tumor profileof breast cancer pa-tients and to determinewhich women will re-ceive adjuvant treat-ment after surgery.
Adjuvant therapiesinclude chemo-therapy, hormonal ther-apy (typically tamoxifen) and some-times radiation therapy. Over 80% ofbreast cancer patients in the US andEurope currently receive adjuvant ther-apy, and a fraction of the women whodo not receive adjuvant therapy suffertumor recurrences. However, thesecostly treatments are ridden with side ef-fects such as premature menopause,weight gain, mild memory loss and fa-tigue.
Presently, standardized prognostic cri-teria are used to determine who willbenefit from adjuvant therapy. Thesecriteria rely on indicators such as histol-ogy, biochemical markers of invasivegrowth, and the presence or absence ofhormone receptors and cancerouslymph nodes. But these conventionalindicators can give the misleading im-pression of a non-aggressive tumor—or,alternatively, lead to overtreatment. TheDutch institute, which is affiliated withthe 200-bed Antoni van Leeuwenhoekhospital, will use microarray profileanalysis in conjunction with conven-tional prognostic tests. The institutetreats around 1,000 breast cancer pa-tients each year, 400 of whom undergosurgery and would have tissue samplesavailable for microarray analysis.
Laura Van’t Veer, a researcher at theinstitute, helped develop the microarraytest for the hospital. She notes that theapproach could reduce the number ofwomen receiving adjuvant therapy by asmuch as 35% while allowing fewerwomen with high-risk tumors to slipthrough. These estimates are based onretrospective studies testing the ap-proach in banks of tumors, the most re-cent of which was published last monthin the New England Journal of Medicine
(see News & Views page 16). “There areat present many women that areovertreated by chemotherapy that basedon [microarray] criteria actually have
a good profile...”says Van’t Veer.
David Botstein, aStanford researcherwho is also develop-ing microarray sig-natures for breastcancer, foresees thatthe burgeoning datafrom the various mi-croarray studies willeventually become
standardized. But for now, he greets theAmsterdam announcement with enthusi-asm, “It makes perfectly good sense.”
Wider use of the Dutch microarraytest in other institutions may have to
await confirmation of the microarraysignatures by an independent analysis,says Sjoerd Rondenhuis, an author onthe NEJM study.
The Dutch microarray tests are alsoplanned for use in numerous clinical trials. For example, the EuropeanOrganization for Research andTreatment of Cancer is finalizing plansfor a large-scale trial to test the prognos-tic value of microarrays on lymph-node–negative patients. Patients willreceive adjuvant treatment based ontheir microarray signature. Their out-comes will be compared with patientsevaluated solely according to conven-tional European criteria, called St.Gallen criteria. In other trials of noveltreatments, researchers will give pa-tients a microarray test and then laterdetermine how patients with certainprofiles responded, says Van’t Veer.
Charlotte M. Schubert, New York
Microarray to be used as routine clinical screen
A good prognostic signature
Drug costs threaten patent protectionNews that prescription medicines have become the fastest-growing sector of
healthcare outlay in the US will add strength to proposals by the BushAdministration to ease regulations on generic production of brand-name drugs.According to a survey released in December by Mercer Human ResourceConsulting, the cost of American healthcare rose by 15% last year, the largest in-crease since 1990. Individuals paid an average of $10 for generic drugs and $35 forbrand-name drugs.
The previous month, US Secretary of Health and Human Services TommyThompson announced plans to eliminate legislation that allows pharmaceuticalcompanies to invoke a 30-month delay on generic copies being produced. This rulegave innovator drug companies the chance to protect their patent rights in court.However, companies have frequently invoked multiple 30-month delays, indefi-nitely delaying approval of generic drugs. Thompson’s new rule would end thatpossibility.
Around 40% of drugs currently sold are generic copies. Between now and 2006,patents are set to expire on four times as many drugs as normal during that timeperiod, making them susceptible to copying without even a 30-month delay pe-riod.
As Nature Medicine went to press, the Pharmaceutical Research andManufacturers Association (PhRMA), which represents much of the pharmaceuticalindustry in the US, was expected to lodge its opposition to removal of the 30-month rule. PhRMA’s view is that allowing faster access to cheaper generics dis-courages drug makers from investing huge sums into the research anddevelopment of new and potentially breakthrough compounds.
PhRMA claims its members spent more than $30 billion in 2001 discovering anddeveloping new medicines, and should be allowed to reap the profits from those in-vestments. For example, the patent on Merck & Co.’s successful osteoporosis drugFosomax was recently challenged by two generic drug makers, Teva and IvaxPharmaceuticals. The court ruled that Merck’s patent on the drug, which generated$455 million in sales last quarter, was valid until August 2007.
But Thompson insists that the change “would bring relief from the high pricesthat American consumers frequently pay for prescription drugs.’’ Citing his owndollar figures, he predicts that the rule “could save consumers approximately $3.5billion every year.’’
MARLENE CIMONS, WASHINGTON, D.C.
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