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Chemotalk NewsletterChemotalk Newsletter, Vol. 31: November 1, 2010
I like to start out with a weather report, because I'm always getting bashed for living in Sunshine Land. Yesterday's news said we've set a new record for rain in October. True, this being California, it may be the only rain we get this season - predictions for another dry winter exist - but meanwhile, I get to wear rain gear and carry an umbrella. Good stuff. Here goes: Get ready, the "rationing of health care" issue is beginning to hit the front burner. From the New York Times: INSURERS TEST NEW CANCER PAY SYSTEMS By Reed Abelson Several large health insurers, including United Healthcare and Aetna, are focusing on one of the country's most costly diseases: CANCER. The insurers have begun tightening oversight of the care provided to patients with many different types of cancer, hoping to lower expenses by experimenting with new ways to pay specialists. UnitedHealthcare plans to announce on Wednesday (20th) a one-year project with five oncology practices, offering doctors an additional fee. The new fee is meant to encourage doctors to follow standard treatments rather than opting too often for individualized and unproven courses of therapy, which can include the most expensive drug combinations. By proposing a different type of payment structure, companies hope to lower doctors' dependence on a system that generates substantial sums for cancer specialists who routinely favor top-of-the-line treatments. Regional insurers in some states, including California, Washington and Pennsylvania, are negotiating similar limits with doctors and their clinics. WellPoint, another large insurer, is developing a way of paying oncologists to coordinate and manage patient care. By almost any measure, cancer treatments can be exorbitantly expensive. Cancer care in the United States costs almost $100 billion a year, and medical bills for the average patient on chemotherapy can top $100,000 a year. With the new health care law, everyone is under pressure to find ways to save money. Many specialists favor the most aggressive care even if there is little to no evidence the patient will benefit, because both doctors and patients have every incentive to spare no expense. Patients and their families often demand one last treatment. And oncologists can reap tremendous profits, sometimes earning more than half of their income on the difference between what they pay for chemotherapy drugs and what they charge the insurers for the patient's treatment plan. Dr. Lee Newcomer, the oncologist who is heading the UnitedHealthcare program, said that yearly double-digit increases in the cost of cancer care had forced insurers to confront the issue. "Oncology, or cancer care, has been a bit of a sacred cow," he said. With life and death questions at stake, insurers and supporters are quick to promote the new measures as a way to extract cost savings and also as a way to ensure that terminally ill patients are not subjected to unnecessary, often exhausting treatments that provide no hope. Still, detractors worry that these changes could represent a first step toward denying patients additional treatments or the latest CHEMOTHERAPY regimen cased solely on the cost. In other words, they argue that even if oncologists still decide what course of treatment a patient should receive, as those new plans allow, the new effort could be viewed as a move toward rationing care at the end of life. "We do not want to get into the realm where they are restricting treatments when they are clearly indicated," said Dr. David Eagle, an oncologist who is the president of the Community Oncology Alliance, a nonprofit lobbying group for community oncologists, who generally practice outside of an academic medical center. "In my view, the insurance companies have the ultimate conflict of interest,"" Dr. Eagle said. But many cancer specialists acknowledge that the current payment system is unsustainable. "It has all the potential to bankrupt the system," said Dr. Michael Neuss, an oncologist in private practice in Cincinnati. He described the existing payment plans as "our dirty little secret." "A lot of us want to get out of selling drugs," he said. Companies are also springing up to develop treatment guidelines and serve as intermediaries between oncologists and health plans. US Oncology, a network of affiliated cancer doctors, teamed up with Aetna in May to develop a program to persuade doctors to follow treatment guidelines. Another company, P4 Healthcare, is working with Highmark, a Pennsylvania insurer, and others. Cardinal Health, the large health care services company, bought P4 in July. "There's a lot of money to be made and saved," said Dr. Peter Bach, a health policy analyst and physician at Memorial Sloan-Kettering Cancer Center in New York, who also served as a consultant to the federal Medicare program. For example, doctors could choose less expensive therapies. When an oncologist considers different treatments, "it's hard not to look at price differentials," Dr. Bach said. In treating one type of lung cancer, for example, doctors can select from as many as eight treatments that are generally considered appropriate. Their costs under the Medicare program range from about $1,300 to $7,000 a month. Dr. Marcus Neubauer, a doctor near Kansas City, Kan., whose practice is affiliated with US Oncology and one of the five involved in the UnitedHealthcare experiment, pointed to the effect of rising costs when people are required to pay a large amount of their overall medical bills. "It's not just a payer problem; it's a patient problem, too," he said. Some insurers say there may be savings if doctors just follow standard treatments, rather than a variety of alternative regimens, or patients with the same type of cancer. "In medical oncology, there is tremendous variability in the way care is delivered," said Dr. Lonny Reisman, Aetna's chief medical officer. Aetna and US Oncology recently compared what happens when doctors treating certain lung cancer patients followed guidelines with what happens when the doctors did not. According to the analysis, treatment costs over a 12-month period were 35% lower when doctors adhered to standards, with no effect on patients. Aetna is now working with about 250 doctors in Texas and says it plans to expand the program next year to include even more cancer specialists in its network. In California, Blue Shield joined with Hill Physicians Medical Group to treat a group of state workers in Sacramento. Local oncologists are being rewarded for saving money, but Hill has made sure the doctors are still getting paid even if the patients' care becomes very expensive. Joseph P. Newhouse, a health policy professor at Harvard who has studied how the Medicare payment system affects doctors' choice of treatments, suggested that some payment options might give doctors an incentive to stop treatments if they lose money or make too much by not actively treating patients. "Wherever you set" the incentives, he said, "you're going to make errors." In the UnitedHealthcare program, for example, oncologists still get a fee even if the patient is not getting chemotherapy. To make sure no one is stinting on care, the oncologists involved review one another's treatment decisions and results. The doctors involved in the program say there is no danger that they will fail to treat patients who would benefit fro another round of chemotherapy. "These are patients we know by name," said Dr. Bruce Gould, an oncologist outside Atlanta who is one of the participants. "As medical oncologists, our goal is to take care of these patients and keep them living as long as possible." Specialists do worry that the complexity of caring for cancer patients may make any hard-and-fast rules about treatments difficult. Dr. Neuss offered an example involving two drugs, with the cheaper one requiring patients to undergo a much longer treatment than the more expensive choice. "What's the patient's time worth in that equation?" he asked. Dr. Newcomer of the UnitedHealthcare acknowledged that some trade-offs were not clear cut but could be judged on factors like the difference in cost between the drugs -- is it a few thousand dollars or a few thousand? "I think that's a perfectly legitimate debate," he said. * * * (Someone out there tell me, would you want the decisions on your health care made by the cost of the drugs involved? Because to a great extent, that's what this sounds like, to me...)
And more on medical economics, also from The New York Times ... PROVING INNOVATION IN MEDICARE By David Leonhardt The huge budget deficits that the country faces in coming decades are, above all, because of Medicare. The program will have to cover growing numbers of baby boomers while health costs are likely to keep going up. It won't be possible to pay the bill by cutting other programs. They're not big enough. Making big cuts to everything but Medicare and Social Security -- shrinking the military and other programs to their smallest share of the economy since World War II -- might save $200 billion a year by 2035. But by then, annual Medicare spending is projected to grow by more than $1 trillion. So any deficit strategy needs to focus on Medicare. In the new issue of the journal Health Affairs, two doctors, both former Medicare officials, have laid out a plan to do so. It would give expensive new treatments three years to prove that they worked better than cheaper treatments, or their reimbursement rates would be cut to that of the cheaper treatments. I understand that the idea will strike some people as -- gasp -- rationing. More modest ideas were shouted down during the debate over health reform. But I'd urge anyone who does not like the doctors' plan to think a bit about how Medicare should be changed. The status quo isn't really an option. We are now in a political campaign in which everyone seems to talk about cutting spending without offering many ideas for how to cut spending. When the campaign ends, all that talk won't balance the budget. Ne3ither will cutting waste, fraud, abuse and foreign aid. Nor will ending the war in Afghanistan and the Bush tax cuts for the rich. Policies like that can help shrink the deficit, yes. Raising taxes and tweaking Social Security can help even more. But you probably can't call yourself a fiscal conservative unless you are willing to support changes -- that is, cuts -- to Medicare. The treatment of prostate cancer offers a good example of the trouble with the current system. I devoted a column to prostate cancer last year, and the Health Affairs article -- by Steven Pearson of Massachusetts General Hospital and Peter B. Bach of Memorial Sloan-Kettering Cancer Center -- uses it as a case study, too. The brief version is that they options for treating prostate cancer include three forms of radiation. One of them, three-dimensional radiation, costs Medicare about $10,000. Another treatment, a targeted form of radiation known as I.M.R.T., came along a decade ago and initially cost about $42,000. Lately, Medicare has also started covering a third, proton radiation therapy, for which it pays $50,000. No solid research has shown I.M.R.T. To be more effective at keeping alive, with minimum side effects, than three-dimensional radiation. The backing for proton therapy is weaker yet. As Dr. Pearson says, "There is even less evidence on whether proton therapy is as good as other alternatives than there was for I.M.R.T. when it was the new kid on the block." But Medicare today doesn't pay for good outcomes. It pays for any treatment that it deems reasonable and effective. Obviously, the medical industry -- drug makers, device makers, hospitals and, depending how they're paid, doctors -- has an incentive to promote the most lucrative treatment. So too many people end up persuading themselves that the most lucrative one is the best one. As a result, I.M.R.T. Has supplanted three-dimensional radiation as the standard. Urologists have spent millions of dollars buying I.M.R.T. Machines, which then become profit centers for their practices, as Stephanie Saul of The New York Times reported. Most recently, proton therapy has been making inroads. Similar stories exist through medicine. Genentech has not shown that its expensive vision-loss drug is better than a cheaper alternative, but taxpayers still pay the bill. Implantable cardiac defibrillators have become increasingly intricate and expensive, without evidence that the more intricate versions are better at restarting a stopped heart. Then there are drug-coated cardiac stents. They cost much more than the uncoated kind and were gaining market share -- until evidence suggested that the coated stents sometimes harmed patients. In many of these cases, you can argue (and companies do) that the more expensive treatment will prove the better one once all the evidence is in. And sometimes it will. But sometimes it won't. In the meantime, life-and-death decisions are too often made based not on the best reading of the evidence, but on the best profit margin. The plan from Dr. Bach and Dr. Pearson would try to change this. It is from far the most radical out there. The full costs of treatments would be covered for three years, which would still give companies an incentive to innovate. After three years, absent evidence that a treatment was better, Medicare would pay no more than it paid or equally effective treatments. Only $10,000 of the bill for proton therapy, for instance, would be covered. The blank checks would not go on forever. New treatments would bring a windfall only if they improved health. "To me, this is the way you make the market work," says Karen Davis, president of the Commonwealth Fund, a health research group. Recently, private insurance companies, including Aetna and Cigna, have begun experimenting with similar policies, notes Mark McClellan, the former head of Medicare. Of course, any such Medicare system would have some downsides. Dana Goldman, a University of Southern California economist who lies the general idea, says he thinks five years may be a better window than three. That would allow more time for research into a treatment's effect on different subgroups. Even so, Mr. Goldman adds, no window could ever guarantee answers to every question. The point is that all systems have their downsides. If we spend large sums on treatments that don't make us healthier, as we are now, we waste resources that could have been used productively. Instead of going toward health insurance premiums, the money could have lifted our salaries. Or it could have paid or medical research and treatments that would have improved health. Unfortunately, today's political debate doesn't seem to have room for downsides. It conjures a world of free lunches -- unlimited Medicare, vague spending cuts, low taxes, and balanced budgets. It's a nice world, until it isn't. (This approach to cost cuts makes far more sense to me than the "new payment systems for cancer care" proposals, in which doctors and insurers appear headed for an unholy alliance. WHAT DO YOU THINK? SPEAK!) * * * Now for some much-needed good news: FORTEO MAY HELP REGROW BONE LOSS IN THE JAW By Jennifer Davis Two new studies suggest that the drug teriparatide, or Forteo, may help people who have lost bone in their jaw because of periodontal disease or osteonecrosis. Periodontal disease is severe, chronic inflammation of the gums that is a major cause of tooth loss. It affects 1 in 5 American adults, and it is seen more frequently in people with RHEUMATOID ARTHRITIS, than in the general population. Osteonecrosis is the death of bone tissue, and it can occur as a rare side effect related to the use of bisphosphonates, drugs used to treat cancer and osteoporosis.. Teriparatide is an injectable form of parathyroid hormone. It has been approved by the U.S. Food and Drug Administration for several years as a treatment for osteoporosis. Unlike medications that treat bone loss by stopping bone breakdown, however, teriparatide works by spurring the growth of new bone. In the October 16th online issue of the New England Journal of Medicine, researchers from Melbourne, Australia present a case study of an 88-year-old woman who developed osteonecrosis of the jaw after taking the corticosteroid medication prednisolone for 20 years and the bisphosphonate drug alendronate, or Fosamax, for 10 years. She developed jaw wounds and suffered from pain for a year before agreeing to try teripartide. After eight weeks, her symptoms disappeared, and her osteonecrosis resolved. Researchers say teriparatide appears to have healed the bone by stimulating new growth. But they stress this has been shown only in a few patients so they say a randomized, controlled trial is needed for further proof. "Osteonecrosis of the jaw has been difficult to treat, but we hypothesize that teriparatide may be a novel effective treatment, which requires further study," says Dr. Ada Cheung, an endocrinologist at The University of Melbourne in Australia. "If teriparatide was proven in a randomized controlled trial to heal osteonecrosis of the jaw, this would be a significant advance as there are currently no good treatments for osteonecrosis of the jaw. Patients can have painful symptoms for years and often require multiple surgical procedures to clean the infected bone as well as prolonged courses of antibiotics." A second study reported in the same journal tested teriparatide for the first time in the treatment of bone loss in the mouth caused by periodontal disease. Researchers at the University of Michigan studied 40 patients with periodontal disease. All were treated traditionally with periodontal surgery, but only half the group also received teriparatide injections for six weeks. After one year, the group given teriparatide had a 29 percent improvement in their bone levels, compared to a 3 percent improvement among those who didn¹t get the injections. The patients taking teriparatide also saw more improvement in depth of the pockets between their teeth and gums. "This is a small study but the very promising results suggest that this type of therapy could be very beneficial for patients with periodontal gum disease," explains the study¹s principal investigator, Laurie K. McCauley, PhD, professor and chair of Periodontics and Oral Medicine at the University of Michigan in Ann Arbor. McCauley stresses that her study did not evaluate the impact of teriparatide on osteonecrosis, but she says all of these reports taken together increase the likelihood there will be more research on this topic in the future. "There have been a few case reports of teriparatide use in osteoporosis patients with osteonecrosis with promising outcomes," McCauley says. "Our study suggests that it would be valuable to perform more studies of the action of teriparatide in oral bone that could support therapeutic approaches for osteoporosis patients in need of regenerating bone in the oral cavity." In an accompanying editorial, Andrew Grey, MD, of the University of Auckland in New Zealand agrees these initial reports and studies are promising, but he stresses many questions still remain everything from dosing to cost to long-term effects. Mark Varvares, MD, director of the Saint Louis University Cancer Center in Missouri has questions, too. He says while teriparatide might work for patients with early stage osteonecrosis, he has trouble believing it would make much of a difference for patients with a severe case of the disorder. "By the time we see patients, a good chunk of the bone is dead and the only way to treat it is remove it," Dr. Varvares says. "The bone can¹t be revived. It has to be removed once it gets to that stage. So I don¹t know how you would incorporate this new drug in treating patients with that disorder." * * * ADVANCES ON PANCREATIC CANCER REPORTED By Nicholas Wade Researchers have made significant progress in understanding the biology of PANCREATIC tumors, suggesting that there may be ways of identifying the usually fatal cancer at a much earlier and more treatable stage. A principal finding is that pancreatic tumors are not aggressive cancers. To the contrary, they grow slowly, taking an average of 21 years to become fatal. This creates an opportunity for detecting and removing the cancers at an early stage. At present they are diagnosed far too late, when the patient has on average only two more years to live and the cancer has already spread from the pancreas to other tissues. The new advances, reported in Nature, have been made by two cooperative groups, one led by Shinichi Yachida and Christine Iacobuzio-Donahue at the Johns Hopkins Medical Institutions in Baltimore, and the other by Peter Campbell and Andrew Futreal at the Sanger Institute near Cambridge, England. Both teams used a new method for decoding DNA very rapidly. This eans that instead of studying one gene at a time, researchers can now afford to look across the whole genome, tracking all the mutations that occur in cancer cells. The Johns Hopkins team was able to identify a long series of mutations that had accumulated in the original tumors of seven patients, as well as in the secondary cancers that had spread from the pancreas to the liver, lung and peritoneum, the membrane that lines the abdominal cavity. The mutations were then arranged in a family tree. Since the rate at which DNA-level mutations clock up is well known, the researchers could date the development of the patients' pancreatic tumors from the length of the branches in the tumor's family tree, said Bert Vogelstein, a leading cancer researcher and member of the Johns Hopkins team. It turns out that at least 10 years elapse between the first cancerous cell and the emergence within the tumor of the first cell with the ability to spread to other tissues, a process known as metastasis. At least five more years are required for this cell to develop metastatic ability. Both the Johns Hopkins team and the Sanger group are now looking for specific DNA changes that might help diagnose pancreatic tumors. A leading candidate is a gene called KRAS (pronounced kay-rass), which is involved in transmitting messages inside a cell. "Almost all of the pancreatic cancers have mutations in KRAS, so that's an ideal situation from a screening point of view," Dr. Vogelstein said. Scientists at the Sanger Institute have analyzed the same tumors as the Johns Hopkins group with a view to reconstructing the biological history of pancreatic tumors. They find that after the initial damage, possibly in the KRAS signaling gene, the natural controls on cell division are lost. "That unleashes a maelstrom of genetic instability," Dr. Campbell said. The cell divides so many times that it uses up its telomeres, the mechanism of the tip of every chromosome that forces a cell to self-destruct if it divides too many times. A few cells evidently dodge this mechanism and learn how to survive in the tumor environment. These survivors find that it is now in their interest to stabilize their genome and switch on the genes that rebuild the telomeres. The stabilized cancer cells now start to spread but must develop a further set of mutations that help them adapt to the specialized environment of the tumor's target tissues. "That is in some ways ominous for the treatment of caner, because all the metastasized tumors are slightly different and would need different treatments," Dr. Campbell said. There is some chance of picking up the KRAS mutation in stool, which is hard to do at present. "But the techniques are getting better all the time," Dr. Campbell said. * * * ENCOURAGING DATA ON MULTIPLE SCLEROSIS DRUG French pharmaceutical company Sanofi-Aventis, recently presented encouraging results on its MULTIPLE SCLEROSIS candidate, teriflunomide. Results from a phase III randomized, double-blind, placebo-controlled study showed that teriflunomide helped reduce annualized relapse rates by 31% compared to placebo. The study evaluated two doses of teriflunomide 7 mg and 14 mg. Sanofi said that treatment with teriflunomide helped reduce the risk of disability progression by 30% and 24% for the 14 mg and 7 mg doses, respectively. The candidate was found to be well-tolerated. Sanofi also presented long-term safety data on relapsing multiple sclerosis patients. Eight years follow-up data from a phase II study showed that the candidate was well-tolerated. The successful development of teriflunomide could provide multiple sclerosis patients with a new first-line treatment option. Teriflunomide is currently in two additional phase III studies. Another phase III study, is being conducted in patients with early multiple sclerosis or clinically isolated syndrome. * * * I've covered the Zamboni treatment for MS in a previous iteration of Chemotalk, but the increasing positive evidence seems to indicate that more coverage is warranted. So ... MULTIPLE SCLEROSIS: WILL VEIN SURGERY HELP PATIENTS? By Adrian Lee When Colm McLaughlin flew to Poland for an unproven medical treatment he felt he had nothing to lose. Diagnosed four years ago with MULTIPLE SCLEROSIS, he had been told by UK doctors there was no cure and little hope of improvement. Already struggling with fatigue, vision and balance problems the 47-year-old joined a growing number of Britons who are going abroad for the surgery. Colm, a father-of-two from Knutsford, Cheshire, used £6,000 of his savings to fund the treatment which involves opening blocked veins to improve the flow of blood from the brain. It¹s thought that scores of MS sufferers have travelled from the UK to Poland, Bulgaria, Germany, India and Egypt for the surgery. Although there are concerns about the treatment it will become available in the UK for the first time later this month. "Discovering that I had MS was earth-shattering," says Colm, a former café owner who has a progressive form of the disease and had blamed his initial symptoms on over-work. "Daily and weekly I didn¹t notice any difference but looking back I was getting gradually worse. My neurologist tried to be positive but there was nothing they could give me." For Colm the decision to seek the controversial treatment, which turns most of the thinking about MS on its head, was simple. "The more I read, the more it rang true. I was horrified it was not available in the UK but I was prepared to go anywhere. I felt I was in a no-lose situation." The procedure is similar to angioplasty treatment for heart problems. It involves inserting a device with a deflated balloon into a blood vessel in the groin and guiding it to affected areas, usually jugular veins on either side of the neck, where the balloon is inflated. That is the procedure in about 80 per cent of treatments although there are occasions when veins in the chest are widened. In some cases a stent is required to keep the vein open. The operation is known as CCSVI (chronic cerebrospinal venous insufficiency) treatment or the Zamboni treatment after the Italian doctor who pioneered this approach to MS. Colm, who was treated in June, says he has noticed a big improvement in his vision and intolerance to heat, another MS symptom. He adds: "My energy levels have also improved by about 70 per cent." Dr Paolo Zamboni claims that damage caused by blocked veins leads to destruction of myelin, which is a crucial sheathing coating human nerves. When myelin is damaged, this interferes with messages between the brain and other parts of the body. It is accepted that damage to myelin is present in MS cases but exactly how it happens is hotly debated. Dr Zamboni examined MS patients and found that in most the veins leading from the brain had signs of narrowing, twisting and blockage. It was something he didn¹t find in healthy patients. "I still have MS but the cause has been treated," says Colm, now a buyer for a civil engineering company. "It does annoy me that the treatment is not available on the NHS. MS robs many people of the ability to work so they will not be able to afford it." Blocked veins do appear to be common in many cases of MS, making CCSVI treatment an attractive theory but there have been no completed trials and there is little proper research. Work has begun in the US and Canada to monitor patients who have had private treatment but results may not be known for up to two years. However the treatment is to be offered for the first time in the UK by the Essential Health Clinic, run by Dr Tom Gilhooly, a Glasgow GP. Surgery on three patients will go ahead this month in Edinburgh, he says. "This is not a cure for MS but an interesting treatment," explains Dr Gilhooly. "Our belief is that there is a vascular element to MS. By removing the problem this could improve the symptoms of MS. There is a lot of anecdotal evidence to support this treatment. My feeling is that this will be found to be an extremely useful treatment and become available on the NHS but I accept that it is unproven. People have the right to choose and not have to go abroad." The treatment costs £5,950. Campaigners who support it are meeting in Glasgow for two days starting on October 29. They are considering legal action to force the NHS to offer the surgery. The MS Society warns patients to be cautious. It says it has not dismissed the treatment but wants to see strong evidence it is effective and safe. There are 100,000 MS sufferers in the UK and Scotland has the highest rate in the world. Most have a form which is characterized by sudden relapses but another type causes progressive deterioration. There are drug treatments to reduce relapses but there is no cure for MS, which eventually causes irreparable nerve cell damage. Conventionally MS is believed to be an autoimmune condition in which the body effectively turns on itself. "There are many unknowns about MS," says Doug Brown, head of biomedical research for the MS Society. "There are limited treatment options so it can be very frustrating. Unfortunately it takes time to develop new therapies." The MS Society spends £4million a year on research and welcomes applications to fund trials and investigations into CCSVI treatment. It is collaborating internationally with other MS organizations to study results of the controversial surgery. "We are receiving a lot of queries about this," adds Dr Brown. "We believe it is a very interesting avenue of research but it must go through the necessary trials. At present we do not have the evidence to draw any firm conclusions. Therefore we do not recommend that people seek this treatment." * * * NEW HOPES TO TACKLE BLADDER CANCER Combining chemotherapy drugs with radiotherapy could be an effective new treatment for bladder cancer sufferers, it has been revealed. Scientists at Birmingham (UK) University said the results of a major trial indicated that adding two commonly used chemotherapy drugs to traditional radiotherapy could reduce the chance of a patient's tumor returning by a third. The seven year trial, funded by Cancer Research UK, is the largest bladder cancer study of its kind in the world. Professor Nick James, from the University of Birmingham, led the trial alongside Dr Robert Huddart from the Institute of Cancer Research. A total of 360 patients were involved in the study. The results showed that patients receiving chemotherapy in addition to radiotherapy - known as chemoradiotherapy - had a tumor relapse rate of 33%, compared to a relapse rate of 46% in patients receiving radiotherapy alone. Professor James said: "These trial results are hugely promising, with a significant reduction in the risk of the cancer returning when compared to radiotherapy alone." He added: "Importantly, both chemotherapies used in this trial are cheap widely available drugs that are commonly used in cancer treatment already. This makes their use much more practical. Having surgery to remove the bladder is a major operation that can seriously impact a patient's quality of life. "We have shown that adding chemotherapy to radiotherapy reduces the risk of the most severe type of tumour recurring by nearly half. Hopefully these trial results will mean more bladder cancer patients are given the opportunity to avoid surgery and preserve their bladder function." This study was presented at a medical conference, and hasn't yet been vetted by peer groups. * * * NEW DRUG COMBINATION MAY IMPROVE MESOTHELIOMA TREATMENTS A MESOTHELIOMA drug approved for use in several European countries has received the backing of the international scientific community. The drug Tomudex (otherwise known as the generic raltotrexed), when combined with the chemotherapy drug cisplatin, appears to increase the survival rates of mesothelioma patients. This conclusion was backed by 2003 and 2005 studies by the Netherlands Cancer Institute, the European Organization for Research and Treatment of Cancer, the Lung Cancer Group and the National Cancer Institute of Canada. In a 2005 study published by the Journal of Clinical Oncology, researchers who tested the Tomudex/cisplating combination on 250 mesothelioma patients found that 23.6 percent of them had a positive response rate (compared to 13.6 percent for cisplain alone). * * * STATIN DRUGS MAY CUT RISK OF COLORECTAL CANCER An analysis of 22 studies involving about 2.5 million people shows a significant association between using cholesterol-lowering drugs called statins and a reduced risk for COLORECTAL CANCER. The analysis shows there was a 12% reduction of colorectal cancer risk among statin users. Also, the longer patients used statin drugs, the greater their reduction in risk for colorectal cancer. The findings are based on a review of 22 studies published through October 2009 and were presented at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio. Study researcher N. Jewel Samadder, MD, MSc, from the University of Michigan, Ann Arbor, says the relationship between statin use and a reduction in risk for colorectal cancer was consistent across various study designs. "This effect was largely consistent across study design with both case control and cohort studies showing a strong correlation," he says in a news release. "The length of statin use, both greater than six months and greater than five years of use was associated with reduction in colorectal cancer risk." The group of statins that showed the greatest effect in reducing risk are classified as lipophilic: atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altocor, Altoprev, Mevacor), pitavastatin (Livalo), and simvastatin (Zocor), Colorectal cancer is the third most common type of cancer in the U.S.; 102,900 new cases of colon cancer are diagnosed in men and women every year, and about 39,670 new cases of rectal cancer are diagnosed annually. The relationship between statins and cancer is unclear, but other research exploring the impact of statins at the molecular level suggests that these cholesterol-lowering drugs may help control the development of tumor, as well as tumor growth. "Observational studies have suggested that long-term use of statins is associated with reduced risk of several cancers, including breast, prostate, lung, pancreas and liver," says Samadder. "Our findings suggest that randomized controlled trials designed to test the hypothesis that statins reduce the risk of colorectal cancer are warranted." * * * RESEARCH UNEARTHS CLUES ON INFLAMMATION OF THE CENTRAL NERVOUS SYSTEM Scientists have found a type of cell that may limit inflammation in the central nervous system (CNS). They hope that this discovery could help in the treatment of brain disorders such as MULTIPLE SCLEROSIS. Barrow's Fu-Dong Shi of the Barrow Neurological noted natural killer (NK) cells, a type of immune cell that destroys tissue that has been infected by pathogens and malignant cells. While recent research has shed more light on the role of NK cells in other parts of the body, Shi's research is unveiling important discoveries about how NK cells work in the CNS. In multiple sclerosis, the body's immune system attacks myelin, a protective sheath surrounding nerve cells in the brain and spinal cord. By studying a pre-clinical model of multiple sclerosis, the Barrow research revealed that enriching an affected area with NK cells improved disease symptoms, while blocking NK cells to the CNS made symptoms worse. The research indicates that NK cells - especially those that originate in the CNS, as opposed to NK cells from peripheral organs - play a critical role in controlling the magnitude of CNS inflammation and immune response. "These studies provide novel insight into the biology of NK cells and might lead to the design of NK cell-based approaches for intervention in inflammatory and autoimmune disorders of the central nervous system," Nature quoted Shi as saying, adding "Our findings have important implications for understanding the efficacy of some drugs currently used in CNS diseases such as multiple sclerosis." * * *
For any of us looking for drug trials related to rheumatoid arthritis: INCYTE RECEIVES $19 MILLION MILESTONE PAYMENT FROM ELI LILLY Incyte Corporation, a drug discovery and development company, has earned a $19 million dollar milestone payment from Eli Lilly and Company based on the initiation of a Phase IIb clinical trial evaluating INCB28050 for the treatment of RHEUMATOID ARTHRITIS. This trial is being conducted by Eli Lilly as part of the exclusive worldwide license and collaboration agreement for Incyte's oral, JAK1 and JAK2 inhibitor. The compound will now be referred to as LY3009104. The Phase IIb clinical trial is a global, dose-ranging, study expected to involve 270 patients with active rheumatoid arthritis. * * * This story, from the small Rapid City (South Dakota) Journal, caught my attention because of a website it points to, available to all of us: RAPID CITY DOCTORS TAKE DRUG COMPANY MONEY Seven pharmaceutical companies have reported the amounts they paid to health care providers for such services as consulting, speaking and leading expert forums on behalf of the companies in 2009 and 2010. Those companies are Eli Lilly, Glaxo SmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson and Cephalon. There are more than 70 other companies that have yet to report. Under the new health care reform law, they will be required to do so by 2013. ProPublica, a nonprofit investigative organization, recently compiled the reports on its website at http://projects.propublica.org/docdollars. Is your doctor getting paid by drug companies to speak or serve as a consultant? If so, how much? The new online database is making those questions easier for patients to answer. ProPublica, an independent investigative organization out of New York, has published "Dollars for Docs: What Drug Companies are Paying Your Doctor." The database allows patients to look at individual doctor payments, state-by-state payments and even lists the top 384 doctors nationally who received more than $100,000 from pharmaceutical companies. The one caveat to the "Dollars for Docs" report: It includes payments from only seven pharmaceutical companies that currently report. More than 70 other companies have not disclosed payments. Under the health care reform law, all companies will be required to report by March 2013. "Dollars for Docs" lists payments made Eli Lilly, Glaxo SmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson and Cephalon. Payments are listed as compensation for such activities as speaking, consulting, "expert-led forums" and patient education programs. Some of the companies that have reported compensation are doing so as a result of major lawsuits, said Charles Ornstein, one of the authors of "Dollars for Docs." In the past three years alone, $7 billion in lawsuits have been paid by pharmaceutical companies. But the problem goes back further than that. In 2001, TAP Pharmaceuticals paid the government $875 million to settle claims that it paid kickbacks to doctors and cheated Medicare by filing false claims. In 2004, Pfizer was fined $430 million to resolve criminal and civil charges that it paid doctors to prescribe its epilepsy drug, Neurontin, for conditions not approved by the FDA. Those lawsuits shined a spotlight on the relationship between doctors and pharmaceutical companies and spurred pharmaceutical companies to become more conservative. Many passed internal restrictions on gifts and other freebies to doctors and, at least locally, some companies cut back on the number of pharmaceutical representatives they employed. Despite the changes, pharmaceutical companies are still allowed to pay doctors for speaking and consulting. Critics of such practices argue that by doing so, the companies are influencing the providers to prescribe certain medications. The lectures by doctors receiving payments from drug companies include endorsements of those companies' products. But Shawn DeGroot, vice president of corporate responsibility at Regional Health, said that isn't the case. Pharmaceutical companies pay experts in their fields as a way to provide continuing education to other physicians. Physicians who take advantage of such arrangements are rare, she said. "Ninety nine percent of the physicians are speaking to improve patient care," she said. "It fulfills a mission for everyone so as a professional group ... they can learn from each other." DeGroot said databases such as ProPublica are good thing for the industry as a whole. "It lends to the whole transparency concept. ... There won't be even any perceived conflict," she said. Dr. Thomas Repas, a Rapid City endrocrinologist, agrees. Repas received $7,088 from Glaxo SmithKline and Eli Lilly in 2009 and 2010 to give lectures about diabetes and diabetes medications. "I think it absolutely needs to be out in the open," he said of the payments he received for those lectures. Repas said he understands the concerns and has "thought long and hard" about the issue. He has certain guidelines for himself when it comes to lecturing for pharmaceutical companies. For instance, he only lectures about drugs he already uses and he focuses his lectures on the disease of diabetes, rather than merely the medication. He also stays away from companies that offer larger-than-normal sums of money. "I have known physicians who have gotten a lot of money, and I wonder about that," he said. Repas said the reality is he loves teaching and believes he can help improve patient care by sharing information with other doctors. "I have my own personal agenda: I want to get education out," he said. "I would love to be able to do that on my own, but I can't afford to do that. The drug companies allow me access to my peers." If patients have concerns after looking at the ProPublica database, he encourages them to talk to their doctor. That is, after all, the whole point. "I would hate for a patient to see that and have concerns and keep those concerns to themselves," he said. "If their doctor is ethical and doing this for the right reasons, they're going to have no problem answering that." * * * Finally, I'm starting a new "marker" on this newsletter. It's called "Coming Down The Road", and it will be the last entry item for the month, from now on. So ... Coming Down The Road RESEARCHERS DISCOVER 'CANCER MARKET' GENE U.S. and French researchers said they have discovered a genetic marker that is present in at least 11 types of CANCEROUS TUMORS and could lead to new tests and treatments for the disease. Researchers from the Mount Sinai School of Medicine and France's National Institute of Health and Medical Research said they found the follicle-stimulating hormone (FSH) receptor in over 1,300 cancer patients. "This new tumor marker may be used to improve cancer detection. Tumor imaging agents that bind to the new marker could be injected in the vasculature and would make visible early tumors located anywhere in the body," said Aurelian Radu of Mount Sinai, the study's lead author. The researchers stressed that further tests were required to confirm their findings, and to discover whether the marker is present in tumors linked to other types of cancer. But they said the discovery was "very promising" and could "ultimately provide a new diagnostic or therapeutic target to detect cancer early or stop growth." The research, published in the New England Journal of Medicine, evaluated tissue samples from the tumors of 1,336 people with 11 types of cancer: prostate, breast, colon, pancreas, bladder, kidneys, lungs, liver, stomach, testicles and ovaries. The study found that FSH, which is ordinarily found only in human reproductive organs, was present in the blood vessel cells of all the tumors evaluated in their study, regardless of the type or stage of the growth. "By contrast, this receptor was totally absent in the other normal tissues of the organism, including the normal tissue of the organ that was carrying the tumor," the study said. The researchers then examined the FSH receptors under an electron microscope, confirming that the receptors "accumulate on the blood vessels in the tumor but do not bind to blood vessels in the normal tissues." The presence of the marker in the vasculature of tumors provides a potentially promising way for researchers to choke the cancerous growths, the study's authors said. That means the research could help medical professionals develop both a new way to test for cancer, but also a new way to treat it. "New therapeutic agents can be developed that will block the tumor blood supply, either by inhibiting formation of new blood vessels, blocking the blood flow by coagulation, or by destroying the existing tumor vessels," Radu said. Nicolae Ghinea, a French researcher on the study, said an expansion of the research could take years, but "one can imagine a universal treatment for a universal marker." The study's authors said any future treatment could also prove easier for cancer patients to endure than chemotherapy and radiotherapy. The "future agents are expected to have reduced side effects, because the target (FSH) is absent from almost all normal tissues, and in the blood vessels of the reproductive organs it is present in much lower concentrations than in tumors," they said. * * * See y'all next month .... * * * 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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