Chemotalk Newsletter

Chemotalk Newsletter, Vol. 21:  January 1, 2010

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Hello, 2010!  Over the past several months, there have been countless health-related stories in the media, covering every aspect of our health care concerns.  Here are three recent, and especially pertinent pieces from The New York Times:

               SEEKING A SHORTER PATH TO NEW DRUGS

                            By Natasha Singer

    What's smaller than a breadbox, can cost $800 million or more, and takes more than eight years to research and develop?

    A new medicine, according to data from the Tufts Center for the Study of rug Development in Boston.

    And that's just for traditional drugs made by using old-fashioned chemical molecules.  Developing new biopharmaceuticals - those high-tech wonder drugs fashioned from living cells - can cost $1.2 billion according to the center.

    Such amounts, of course, are staggering.  Mind you, those costs aren't only for the drug that has successfully made it through the testing gamut to your medicine cabinet, but also for all earlier iterations that failed.  In fact, most of the of the cost in drug development is the price of failure, said Mervyn Turner, the chief strategy officer at the drug giant Merck.

    This linear, trial-and-error method is no longer a sustainable model for big pharmaceutical companies.

    "We've invested far too long in bad ideas," Dr. Turner said in a phone interview.  "It is really important to stop that at an earlier stage in the cycle."

    Now big-picture thinkers, within the industry and outside it, are re-examining every stage of drug develop - from molecule to market - in an effort to foster faster innovation.  It's a holistic approach, called "systems thinking," that originated in methods that engineers used to streamline projects in the aeronautics and automotive industries.

    The Massachusetts Institute of Technology, for one, started a pharmaceutical innovation program this year to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

    "Aerospace had to change from 'higher, faster, further,' the mentality of performance at all costs, because they could not stay competitive," said Deborah Nightingale, a professor of the practice of aeronautics and astronautics, and systems engineering, at M.I.T.  Aeronautics had to re-examine cost in concert with quality, she said.  "They had to become better, faster, cheaper."

    Perhaps that's why initiatives at M.I.T. And other places are all the more important if the industry is to be nudged forward.

    The M.I.T. project, called New Drug Development Paradigms, has gathered a powerful consortium of interested parties - including major drug makers and federal health authorities.  One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system.  Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

    If that is to happen, some drug companies that have been fierce rivals will have to play nicer.  Think of it not so much as swords into plowshares but as silos into platform-sharing.

    One idea is for drug makers to share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

    Although many companies have committed to publishing the results of clinical trials, whether or not they succeed, drug makers don't typically publish information about projects that fail at an earlier stage.  A result is that companies waste many millions going down experimental paths that their competitors have already found to be dead ends.

    M.I.T. Is proposing dead-end drug disclosure, a concept that goes by a euphemistic mouthful: "precompetitive information sharing."

    Drug makers may realize that the financial and medical value of sharing such information outweighs the competitive risk, said Dr. Gigi Hirsch, the executive director of the M.I.T. Center for Biomedical Innovation, the locus of the drug project.  "There should be more information available about failed compounds in the interest of the greater good," Dr. Hirsch said.

    In the absence of a public database on failed drug compounds, a small group from the Sloan School of Management at M.I.T. And the Harvard Business School has created Pharmer's Market, an online prediction market that uses crowd-sourcing to forecast the likelihood of a drug's success.  Introduced last month, the market has invited biomedical researchers and other drug industry experts to place anonymous bets, using virtual money, on the likelihood that certain breast cancer drugs, currently in clinical trials, will succeed or fail.

    After the clinical trials conclude, researchers can assess whether this kind of collective intelligence may be a useful predictive tool for drug companies, said Ragu Bharadwaj, who helped devise the project as an M.I.T. Graduate student.

    Many drug companies, meanwhile, are already incorporating new paradigms for collaborating on drug innovation.  Two years ago, for example, Merck established a virtual lab, called External Basic Research, where company scientists can collaborate with outside researchers on identifying novel "targets" - the disease pathways to the body that medicines are intended to treat.

    This year, Dr. Stephen H. Friend left Merck, where he had worked as head of oncology, to start a nonprofit open-access information platform called Sage Bionetworks; the idea is to collect huge biomedical data sets to help researchers better understand the molecular basis of disease, ultimately leading to the creation of smarter drugs.

    The overarching goal of new approaches industrywide, said Thomas Unger, executive director of research and development at Pfizer, is to bring new medication to patients faster, using a system "that makes the drugs more efficacious, offers greater safety and ultimately reduces the cost of therapies."

                                * * *

            LAW SEEKS TO BAN MISUSE OF GENETIC TESTING

                     By Steven Greenhouse

    Family histories of fatal disease have been used against workers

    The most important new anti-discrimination law in two decades - the Genetic Information Nondiscrimination Act - will take place in the nation's workplaces next weekend (Nov. 21, 2009), prohibiting employers from requesting genetic testing or considering someone's genetic background in hiring, firing or promotions.

    The act also prohibits health insurers and group plans from requiring such testing or using genetic information - like a family history of heart disease - to deny coverage or set premiums or deductibles.

    "It doesn't matter who's asking for genetic information, if it's the employer or the insurer, the point is you can't ask for it," said John C. Stivarius Jr., a trial lawyer based in Atlanta who advises businesses about the new law.

    The biggest change resulting from the law is that it will - except in a few circumstances - prohibit employers and health insurers from asking employees to give their family medical histories.  The law also bans group health plans from the common practice of rewarding workers, often with lower premiums or one-time payments, if they give their family medical histories when completing health risk questionnaires.

    "Genetic information is very broad," said J. D. Piro, a principal in the Health Care Law Group at Hewitt Associates.  "It doesn't simply include my own genetic information, such as do I have a risk for cancer.  It also includes my family medical history - do I have any relatives who have had cancer or leukemia.

    Genetic tests help determine whether someone is at risk of developing an inherited disease or medical condition.  These tests identify variations in people's genes, like whether a woman has a predisposition for ovarian cancer.

    Such testing can help determine which course of treatment might work best for fighting a specific cancer or for helping a patient's body process a specific drug.

    The new law (called GINA) was passed by Congress last year because many Americans feared that if they had a genetic test, their employers or health insurers would discriminate against them, perhaps by firing them or denying coverage.  In a nationwide survey, 63% of respondents said they would not have genetic testing if employers could access the results.

    "The message to employees is they should now be able to get whatever genetic counseling or testing they need and be less fearful about doing so," said Peggy R. Mastroianni, associate legal counsel for the federal Equal Employment Opportunity Commission.

    The act takes effect on Nov. 21 for all employers with 15 or more employees.  It apples to group health insurers whose plan years begin on or after Dec. 7, and it took effect for individual health insurance plans last May.  The act does not apply to life insurers.

    The act would ban a company from not promoting a 49-year-old to chief executive because it knew that his father and grandfather died of a heart attack at age 50.

    "There's an absolute ban on the use of genetic information to make any kind of decision about employment," said Christopher Kuczynski, assistant legal counsel with the commission.  "There are no exceptions to that."

    Sharon F. Terry, chairwoman of the Coalition for Genetic Fairness, a group that backed the legislation, told of a woman who had informed her office that she was having a genetic test to determine whether she was predisposed to breast cancer.  She was soon fired, with her boss saying the company could not afford to keep her if the results were positive.

    One episode that created momentum for the legislation involved the Burlington Northern and Santa Fe Railway Company, which conducted genetic testing on several employees without their permission.

    David Escher, a track maintenance worker in Nebraska who developed carpal tunnel syndrome on both wrists, said he was mystified why Burlington Northern ordered him to see a doctor who drew seven vials of his blood.  Mr. Escher later learned that the railroad wanted to do genetic testing to determine whether he had a predisposition for carpal tunnel - in an effort to reduce its medical and workers' compensation costs.

    "I was really mad," Mr. Escher said.  "They were trying to do this through the back door.  With genetic testing, they can learn lots of things about you that you don't even know.  If they can do genetic testing and find some problems, you might end up getting fired."

    Burlington Northern reached a $2.2 million settlement in 2002 that was distributed to 36 workers who were either tested or asked to submit to blood tests.

    While the act makes it illegal for employers to intentionally acquire genetic information, it includes a "water cooler" exception, as in a case where a manager overhears one employee telling another that his father had a stroke.

    Under the act, it is legal for a manager to garner genetic information from an obituary, for instance, that an employee's mother died of breast cancer.  And if a manager asks why a worker took off a week to care for his father under the Family Medical Leave Act, it generally will not be considered illegal if the employer learns that the worker's father has pancreatic cancer.

    The act nonetheless prohibits use of such inadvertent knowledge to alter the terms, conditions or privileges of someone's employment.

    "The challenge becomes what if down the road, the employee has a lot of absences or his performance is off, and you discipline the employee," said Michael P. Aitken, director of governmental affairs for the Society of Human Resource Management.  "The employee could come back and say, 'That's because you knew I had a genetic marker.'"

    The act and its accompanying regulations allow group health plans to request family medical histories to help determine whether an employee should be placed in a disease management or wellness program to combat, for instance, high blood pressure.  The regulations stress that employees must give that information voluntarily and that the group plan cannot request such information before health plan enrollment or use it in any way for underwriting."

    Under the regulations, group health plans, in seeking information for wellness programs, cannot attach a request for family medical history to any penalty or, as is far more common, any benefit.  But wellness programs can request family medical history if there is no financial benefit attached.

    "This can be a big deal," said Mr. Stivarius, the Atlanta lawyer.  "A lot of people incentivize employees to provide this family medical information.  They give them some extra paid time off if they participate in surveys.  Now they can't do that."

    Mr. Piro of Hewitt said many employers were only now realizing that their health risk questionnaires might violate the law.

    "A lot of employers have to scramble to scrub this information out of their health risk questionnaires," he said.  "The alternative is to modify their reward structures so that they're not considered to be purchasing or requiring the genetic information."

    Susan Pisano, a spokeswoman for America's Health Insurance Plans, said the new rules were a challenge for insurers because they were taking effect during the open enrollment period.  She said her industry group disagreed with the federal agencies' interpretation that the law bans incentives to encourage employees to fill out family medical histories.

                                * * *

       A FORTUNE TO FIGHT CANCER

                        By Andrew Pollack

            Cost of Drugs is Soaring, Defying Reform

    A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs.

    The price of the new drug, called Folotyn, is at least triple that of other drugs that critics have said are too expensive for the benefits they offer to patients.  The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer.  The price of Folotyn " seems way higher than I heard of before," (says) Robert L. Erwin, president of the Marti Nelson Cancer Foundation, a patient advocacy group.  "I can't imagine there not being a backlash against the pricing."

    Drug makers in general have been raising prices sharply in advance of the possible passage of health care overhaul legislation, according to various studies.  But the price of cancer drugs has been an issue for several years.

    Critics, including many oncologists, say that patients and the health system cannot afford to pay huge prices for drugs that, on average, provide only a few extra months of life at best.

    And Folotyn has not even been shown to prolong lives - only to shrink tumors.  The drug was approved by the Food and Drug Administration in late September as a treatment for peripheral T-cell lymphoma, a rare and usually aggressive blood cancer that strikes an estimated 5,600 Americans each year.  It is available for sale, but its manufacturer, Allos Therapeutics, does not plan to start actively promoting it until January.

    Allos defends the price, saying it made a significant investment to develop the first approved drug for this type of cancer.

    "It's a very aggressive disease, and patients right now have no options," said James V. Caruso, the chief commercial officer for Allos, a 17-year-old publicly traded company based in Westminster, Colo., that has no other drugs on the market.

    Mr. Caruso also said the price of Folotyn was not out of line with that of other drugs for rare cancers.  Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said.  So the total cost of using Folotyn will be less than for many other drugs with lower monthly prices.

    "We believe we are fairly priced," he added, "and we're benchmarked" against other drugs.  In a conference call with analysts last month, Mr. Caruso said Allos had "not had pushback of any type at this point" from insurers.

    Some drugs for rare cancers are close to Folotyn's price.  Genzyme's Clolar for pediatric leukemia costs about $34,000 a week, though the company says that only two weeks of treatment are typically needed.  Genzyme's drug Campath, for chronic lymphocytic leukemia, costs about $5,000 a week for several weeks.

    GlaxoSmithKline is charging up to $98,000 for a six-month treatment course of Arzerra, a drug approved in late October for chronic lymphocytic leukemia, which strikes about 15,000 Americans a year.  About $60,000 of the cost would be incurred in the first eight weeks, when the drug is given more frequently.

    Gloucester Pharmaceuticals, which won approval in November for a drug to treat cutaneous T-cell lymphoma, another rare cancer, declined to discuss what it would charge when that treatment, called Istodax, goes on sale in January.

    Despite such comparisons, Dr. Lee N. Newcomer, senior vice president for oncology at the big insurer UnitedHealthcare, called the price of Folotyn "unconscionable."  He said that Folotyn alone would cost as much as UnitedHealthcare now typically spends in total to treat a lymphoma patient from diagnosis until death.  That median expenditure now, he said, is $87,000 for a little over a year of treatments.

    But Dr. Newcomer said insurers would be obligated to pay for Folotyn because there were no alternatives.

    Folotyn has not yet shown an effect on longevity.  In the clinical trial that led to approval of the drug, 27% of the 109 patients experienced a reduction in tumor size.  The reductions lasted a median of 9.4 months.

    But considering all the patients in the trial, only 12% had a reduction in tumor size that lasted for more than 14 weeks.  The trial did not compare Folotyn to another drug or placebo.

    "This drug is not a home run," Dr. Brad S. Kahl, a lymphoma specialist at the University of Wisconsin, said during a meeting of an advisory committee to the F.D.A. on September 2.  "It's not even a double.  It's a single."

    Saying that even a single was helpful, Dr. Kahl was part of a majority on the panel that recommended approval of the drug, 10 to 4.

    But after recently learning what Allos planned to charge for Folotyn, Dr. Kahl said he was "disappointed" by the "excessive" price.

    "It dampens my enthusiasm for using that drug," he said.  "It creates these huge ethical quandaries about trying a drug that has a modest benefit for the average patient at enormous expense."

    Folotyn is given by a rapid intravenous procedure once a week for six weeks out of every seven.  Even to try the drug for the first seven-week cycle to see if it works would cost over $50,000.  In the clinical trial, the median duration of use was 70 days, which would cost roughly $70,000 to $80,000.  But some patients used the drug for many months.

    In a note to clients in October, Joshua Schimmer, an analyst at Leerink Swann, estimated that a typical treatment would last 3.5 months and cost $126,000, or about $36,000 a month.

    For investors, a high price is usually a good thing.  Mr. Schimmer's note was entitled "Folotyn Prices High, Reiterate Outperform."  He estimated annual sales of the drug in the United States reaching about $300 million by 2014.

    Patient advocacy groups say that while they wish prices were lower, high prices might be needed to encourage companies to develop new drugs.

    "It's a two-edged sword that we have to live with and deal with," said Louis J. DeGennaro, chief scientific officer of the Leukemia and Lymphoma Society, which has received donations from Allos and other companies.  "A peripheral T-cell lymphoma patient," he said, "at first blush will see this therapy as a very good thing."

    Allos, which is still unprofitable, has lost $350 million since its founding in 1992 and failed to win approval of a previous drug.

    "Every dime that goes into the company supports Folotyn," Mr. Caruso said.

    At the time Folotyn was approved in September, stock in Allos briefly peaked above $8.50 but has slipped since then, closing up 16 cents at $6.62, or an increase of nearly 2.5%, Friday (December 4).

    After the approval, Allos raised $93,000 million in a secondary stock offering.  In the prospectus for that offering, the company said that one of the risks for investors was "the relative price of Folotyn as compared to alternative treatment options."  It said there was a risk it might have to lower the price or offer discounts to successfully market Folotyn.

    Like many other companies with high-priced drugs.  Allos has established a program to help patients arrange insurance reimbursement.  It says it will give with the drug free to uninsured patients who cannot pay for it any other way.

    And because a patient's out-of-pocket co-payments alone - Medicare's is 20% - could be thousands of dollars a month for Folotyn, Allos is financing a co-payment assistance program run by the National Organization for Rare Disorders, a patient advocacy group.

    While this helps patients, it also helps the company sell more of its drug.  If the 20% Medicare co-payment is made, then Medicare will pay the other 80% of the drug's price - or about $24,000 a month.

                    THE DEVELOPMENT OF A CANCER DRUG

    Folotyn, known generically as pralatrexate, is an improved form of methotrexate, a decades-old chemotherapy drug that by itself does not appear to be effective against peripheral T-cell lymphoma, a rare blood cancer.

    The invention and early human testing of pralatrexate was done by three not-for-profit institutions - the Memorial Sloan-Kettering Cancer Center, the Southern Research Center, the Southern Research Institute and SRI International.  The federal government paid for some of the research.

    Allos Therapeutics licensed the drug from the three research organizations in December 2002 for an initial payment of $2 million.  It has since paid an additional $9.8 million.

    Since licensing the drug, Allos has spet about $100 million in research and development, most of it, but not all, for Folotyn.

    The company is also testing the drug as a treatment for more common cancers, including lung cancer.

                                * * *

            NEW FIELD OF 'CARDIO-ONCOLOGY' SUGGESTED

    Certain types of chemotherapy can cause heart problems, and cardiologists and oncologists need to work together to protect patients, especially those at greatest risk, say Italian researchers who reviewed available scientific literature.

    Because many nations have aging populations, a growing number of people have both cancer and cardiovascular disease, the researchers said.  The review, published in the Journal of the National Cancer Institute, summarized the potential toxic effects of chemotherapeutic and chemopreventive drugs on the cardiovascular system. The researchers also stressed the importance of evaluating people's cardiovascular risk before they have chemotherapy, called for new chemotherapy guidelines that include collateral effects on the cardiovascular system and recommended creation of a new interdisciplinary field of "cardio-oncology."

    Led by Adriana Albini, chief of oncology research at the Clinical and Research Institute Multimedica in Milan, the researchers said that using imaging techniques and biomarkers to identify high-risk patients would play an important role in reducing cardiovascular harm and death.  They also called for assessment of cardiotoxicity in phase 1 trials of new chemotherapy drugs that pose less heart risk.

    "Today's oncologists must be fully aware of cardiovascular risks to avoid or prevent adverse cardiovascular effects, and cardiologists must now be ready to assist oncologists by performing evaluations relevant to the choice of therapy," the authors of the review wrote.

                                * * *

            HERB APPPEARS TO COUNTER LIVER DAMAGE FROM CHEMO

    A medicinal herb, milk thistle, appears to reduce liver damage resulting from chemotherapy, according to new study published in CANCER.

    Chemo drugs often cause liver inflammation, making it necessary to lower the dose or suspend treatment until the inflammation subsides. These interruptions in therapy can make treatment less effective.

    "We found that milk thistle, compared to placebo, was more effective in reducing inflammation," said lead researcher Dr. Kara Kelly, from New York-Presbyterian Hospital/Columbia University Medical Center's Herbert Irving Comprehensive Cancer Center in New York City.  "If these results are confirmed, milk thistle may allow us to treat liver inflammation or prevent it from occurring, which will allow better delivery of chemotherapy drugs," she added.

    Milk thistle, a longtime folk remedy, is often recommended to treat liver damage and mushroom poisoning. No other treatment for liver toxicity exists, Kelly said.

    For the study, Kelly's team randomly assigned 50 children undergoing chemotherapy for acute lymphoblastic leukemia to receive milk thistle or a placebo for 28 days. All the children had liver inflammation at the start of the study.  Twenty-eight days later, the children who had received milk thistle had improved liver enzymes, compared with the children who received a placebo.

    The milk thistle group had significantly lower levels of one enzyme in particular, AST, and a trend towards lower levels of another enzyme called ALT.  In addition, milk thistle appeared to help patients tolerate higher doses of chemotherapy. Sixty-one percent of the children receiving milk thistle needed dose reductions, compared with 72 percent of the children receiving placebo.  Researchers noted that this difference is not significant.

    Related lab experiments showed the herb did not lessen the effectiveness of the chemotherapy drugs, and Kelly thinks milk thistle might reduce liver inflammation for patients with other cancers who are taking other types of chemotherapy as well. Further research is needed, she said, to determine the appropriate dose and duration of milk thistle therapy.  Her team also hopes to evaluate the herb's ability to prevent chemo-induced liver inflammation.

    Still, some experts remain unconvinced about the herb's value in cancer treatment. Dr. Julio C. Barredo, director of pediatric hematology-oncology at the University of Miami Miller School of Medicine, said that the study's small size, the low doses of milk thistle used and the short time frame of the study make the findings inconclusive.

Also, there was no difference in the delay of treatment in either group, he said.  "Improvement in one liver enzyme did not lead to patients who received the drug being delayed less than patients who received placebo in getting their chemotherapy," Barredo said.  "I don't think that you could recommend that people go and take this supplement when they are taking chemotherapy from the results of this study," Barredo said. "Maybe a larger study, using a higher dose is warranted."

    Liver inflammation from chemotherapy usually abates when treatment stops or doses get reduced, Barredo added.

                                * * *

        ADDING CHEMO TO TAMOXIFEN HELPS SOME BREAST CANCER PATIENTS

    Adding chemotherapy to standard cancer-suppressing tamoxifen can boost survival in  postmenopausal women with the most common type of breast cancer, known as estrogen receptor-positive, and it's best given before the tamoxifen regimen starts, according to a new study.

    "Chemotherapy with Adriamycin adds to your survival benefit over and above what tamoxifen would do if you are  postmenopausal and have positive lymph nodes and estrogen receptor-positive cancer [the most common type],"  explained Dr. Kathy Albain, the lead researcher and professor of medicine at  Loyola University Chicago Stritch School of Medicine.

    And in another study, Albain found that screening breast tumors with an available multi-gene test spots patients who may not need this form of chemotherapy, despite fitting the standard profile.  Both studies are published in the journal The Lancet, and in The Lancet Oncology.

    In estrogen receptor-positive cancer, tumor cells carry many receptors on their surfaces to which estrogen can attach, fueling tumor growth. Tamoxifen works by blocking the receptors.  Experts have long debated whether women with  estrogen receptor-positive cancers -- whose growth is fueled by circulating  estrogen -- would get more benefit from having a chemotherapy regimen on top of tamoxifen.

    Albain led a research team from multiple centers that followed nearly 1,500 breast cancer patients for up to 13 years, with a  median (half longer, half less) of nearly nine years. All were past menopause and had hormone receptor-positive cancer that had spread to at least one lymph node in the armpit area.  Albain's team assigned 381 women to tamoxifen alone, 587 to chemotherapy alone and 590 to both, with some receiving tamoxifen and chemo together and some in a sequential manner.  Tamoxifen was taken daily for five years. The  chemo regimen used is called CAF, for "cyclophosphamide, Adriamycin and  5-fluorouracil."  In all, after accounting for study dropouts, 1,460 women received treatment.  The combined treatments of chemo plus tamoxifen increased the women's disease-free survival by 24%, Albain found.

    When her  team looked at which delivery protocol worked best -- simultaneous tamoxifen and chemotherapy or chemo followed by tamoxifen -- the sequential approach was found to be better, giving slightly better disease-free survival.  Ten-year disease-free survival estimates were 57%  for the combination group and 48% for the tamoxifen-only group, the  researchers found.  However, women receiving chemo were more likely to have drops in white blood cells, important for fighting infections, the  team noted. And they were also more prone to blood clots, congestive heart failure and other complications.

    In a second study, Albain's team analyzed whether a gene test, called Oncotype DX, could predict which women would benefit from chemotherapy. Genomic Health, which makes the test, helped fund the study,  along with the U.S. National Cancer Institute.  The test, which Albain said is already widely  used, is done on the tumor itself. "This puts 21 genes together and  comes up with a score," she said. The score -- low, intermediate, high  -- predicts the risk of recurrence over 10 years if a woman used tamoxifen  alone.  When the researchers performed the test on 367 specimens, they found a low score identified those women who may not need the chemo, despite the fact that they have cancer that spread to lymph nodes.

    "This is a positive study, there's no question," said Dr. Joanne Mortimer, vice chair of medical oncology for the City of Hope Cancer Center in Duarte, Calif., of the first study.  "This study tells us [that] if you have positive lymph nodes [and are  postmenopausal with estrogen receptor-positive cancer], you should have both chemo and tamoxifen, because the survival was better."  But, she added, "when you give everyone [who has the estrogen receptor-positive, node-positive breast cancer] chemotherapy, probably there are some who don't need it."  According to Mortimer, that's why the gene test looks promising -- it may spare some women from having to have chemo while ensuring that those who will benefit from the treatment get it.

                                * * *

    Finally, we frequently hear that alcohol consumption increases risk of breast cancer, but how that happens is rarely explained.  This story fills that gap:

        ALCOHOL RAISES RISK OF BREAST CANCER RECURRENCE

Study Shows Drinking More Than 3 Drinks a Week Is Linked to Return of Cancer

    If you've been diagnosed with breast cancer, you may want to cut down on alcoholic beverages.  That's the suggestion of researchers who found that cancer is 34% more likely to come back in breast cancer survivors who drink more than three drinks a week, compared with those who abstain or drink less.

    Drinking more than three drinks a week also raised the risk of dying from breast cancer by 51%, says Marilyn L. Kwan, PhD, a staff scientist at Kaiser Permanente in Oakland, Calif.  "Women with breast cancer who are postmenopausal or overweight seem to be most susceptible to the effects of alcohol."

    The findings were presented at the San Antonio Breast Cancer Symposium.

    Previous research has linked alcohol to an increased risk of developing breast cancer, but little is known about alcohol's effect on women who have already been diagnosed with the disease.  So Kwan and colleagues followed 1,897 women who had been successfully treated for early-stage breast cancer between 1997 and 2000. About a year after diagnosis, they were asked whether they drank alcohol, how much they drank, and their drink of choice.

    Over the next eight years, 349 of the women suffered a recurrence of their breast cancer, and 332 died of the disease.  "We don't think the type of alcohol mattered, but it was difficult to examine since 90% of the women in our study drank wine," Kwan says.

    But how much they drank did matter; women who indulged in two or more glasses of wine per day were most likely to suffer a recurrence, she says.

It makes sense that alcohol would raise both the risk of developing breast cancer and the chance that it will come back, Kwan says. "Alcohol increases levels of estrogen in the body, and breast cancer is fueled by estrogen."*

    Jeffrey Peppercorn, MD, a breast cancer specialist at Duke University, says that women who are diagnosed with breast cancer often want to know what they can do to lower their risk of recurrence.  "Limiting alcohol consumption is one step they can take," he says. "I tell women we're not sure that any amount of alcohol is safe ... but that it would be prudent to limit consumption except on rare, special occasions."

* Clearly, the breast cancer referred to in Kwan's study is estrogen-positive breast cancer, not other types such as triple-negative.

And if you have any thoughts of how this newsletter could be improved, please email me directly, at jesmer_e@pacbell.net

Elaine Jesmer

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