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1. In randomized clinical trials of breast and colorectal cancer, new effective adjuvant treatments show decreasing absolute benefit, while new treatments of metastatic disease show unchanging levels of benefit at rapidly escalating costs.
   The current research and treatment model makes no difference in outcomes, but adds a lot of profit to researchers, oncologists and pharmaceuticals. How about targeting “individuals” with “individualized” therapy?
   From Annals of Oncology
   http://www.medscape.com/viewarticle/726663?src=emailthis

2. MAXIDEX WARNING
   I had eye surgery and in the p[ost-op pack was MAXIDEX(dexamethasone) drops by Alcon Labs.
   Two days later I was BLIND
   USE EPOCRATES.COM TO VERIFY

3. To address one of the comments above, a recent NYT expose found that Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price. And then get paid to administer them!
   http://www.nytimes.com/2007/05/09/business/09anemia.html?ex=1183608000&en=38ab5c9f9e5e39eb&ei=5070

4. F.D.A. Warning Is Issued On Anemia Drugs’ Overuse
   Superficially, it sounds like a great expose, greedy clinics/doctors trying to make money by pushing drugs. The New York Times article states that the drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug. That’s not really a new revelation. We’ve been down that road before without much done to change it.
   According to Dr. John Glaspy, director of UCLA’s Outpatient Oncology Clinic, one complicating factor, experts say, is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors’ decisions. However, patients with anemia, which can cause sluggishness in its early stages and can be fatal in advanced phases, can get blood transfusions, typically every few weeks, instead of using EPO.
   Could it be that increased numbers of red cells deliver more oxygen to the tumor cells and thereby increase their activity across the board, including with respect to invasion, proliferation, and metastasis? On one hand they’re developing drugs to halt and reverse angiogenesis while on the other hand they’re helping the tumor to obtain more oxygen with existing vasculature. And nobody in charge foresaw that? Amazing how they can apply differing standards for proof or benefit when profit is involved.
   http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06EEDB1331F933A25750C0A9619C8B63
   In panel discussion that highlighted the 12th annual conference of the National Comprehensive Cancer Network, Lee Newcomer, former chief medical officer and currently an executive with Minneapolis-based United Health Group, pointed out that in reviewing records of patients who were prescribed the drug erythropoietin — an expensive agent that boosts blood supply in patients with anemia — said that 44 percent of those patients had blood work-ups that would indicate they were not anemic.
   Erythropoietin is a hormone that stimulates red blood cell precursors in the bone marrow. As a therapeutic agent, it is produced by recombinant DNA technology. It is used in treating anemia rsulting from chronic renal failure or from cancer chemotherapy. A six-month course of treatment can cost more than $10,000 per patient.
   Len Lichtenfeld, deputy chief medical officer for the Atlanta-based American Cancer Society, told United Press International, “Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs.”
   Newcomer said he objected to prescriptions for erythropoietin written for patients with hematocrit higher than 36. Low hematocrit, the ratio of the volume of red cells to the volume of whole blood, is an indication of anemia, Lichtenfeld said.
   Normal range for hematocrit is different between the sexes and is approximately 45 percent to 52 percent for men and 37 percent to 48 percent for women. Lichtenfeld said clinicians generally would not treat a hematocrit that was about 36 percent.
   Newcomer also stated at the meeting that when he scrutinized prescribing habits for treatment of patients with pancreatic cancer, their were doctors writing prescriptions for 188 different combinations of treatments, yet there are only two drugs that have any activity against that disease.
   Newcomer also cited in the meeting last year that the use of the new breast cancer drug tratuzumab, sold as Herceptin, which has been found to be helpful in a group of women with breast cancer that overexpresses a certain gene known as HER2. The drug is ineffective in women with normal levels of HER2, yet about 12 percent of drugs orders — which costs thousands of dollars per treatment — were for women who tested negative for HER2 overexpression.
   One of the newest biological targeted agents, bevacizumab, sold under the trade name Avastin, which is rapidly being included in numerous drug cocktails because it has been shown to extend survival in diseases such as colon cancer, can cost as much as $47,000 a year for one person.
   Newcomer stated, “We know that Avastin improves outcomes in about 20 percent of patients, but we have no idea which cancer patients will benefit from a course of treatment.” According to his calculations, it costs $354,000 per year of life extended with Avastin.
   http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070316-20215500-bc-us-cancercosts-analysis.xml

5. A National Coalition for Cancer Survivorship (NCCS) poll found that 89% of Americans said that the distinction between oral and intravenous applications should be abolished so that Medicare beneficiaries can have access to the best drugs to treat their form of cancer.
   Apparently, Medicare has gone far in accomplishing that task. Nearly all generic cancer drugs and 70% of brand-name cancer drugs are covered by the Part D plans. Most of the brand-name drugs not covered had generic equivalents that are covered. And a number of trusted, old (generic) agents have been found to be just as effacious as the more expensive brand name ones.
   Many infusional therapies are typically biotechnology drugs made of complicated proteins that are injected. This makes them several times more expensive than traditional pill-form pharmaceuticals.
   More chemotherapy is given for breast cancer than for any other form of cancer and there have been more published reports of clinical trials for breast cancer than for any other form of cancer. So, according to NCI’s March 31, 2006 official cancer information website on “state of the art” chemotherapy for recurrent or metastatic breast cancer, it is unclear whether single-agent chemotherapy or combination chemotherapy is preferable for first-line treatment.
   At this time, no data support the superiority of any particular regimen. So, it would appear that published reports of clinical trials provide precious little in the way of guidance. There are many cancer drug regimens, all of which have approximately the same probability of working. The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient’s cancer.
   Cancers that can be treated with oral chemotherapy include, breast cancer, colon and colorectal cancer, Leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, acute promyelocytic leukemia, acute non-lymphocytic leukemia, Lymphoma, cutaneous T-cell lymphoma, small cell lung cancer, non-small cell lung cancer, Kaposi’s sarcoma, prostate cancer, multiple myeloma, ovarian cancer, brain tumours.
   Oral chemotherapeutic agents are easy to use and offer the promise of less frequent visits to oncology-based offices and their infusion rooms. This promise is not trivial, especially as we have come to realize that many forms of cancer may be managed with these drugs, especially when they offer the equivalent outcome as intravenous drugs.
   Medicare Part D Greatly Expands Access to Cancer Treatments, Says Health Affairs Study
   http://www.engelpub.com/News/Index.cfm?articleid=370782

6. Many physician offices are refusing to give chemo treatments in their offices now, but are fast to pass them on to the hospital. They are losing $ by administering it in the office, but by sending them to the hospital’s IV clinic the patient will pay more out of their pocket. Good for the hospital and doctor’s office, but not the patient. I have seen patient’s turn down treatment because they do not want to pay the higher cost share at the hospital clinic. That is not good for anyone.

7. I think that it’s at least cruel to make those statements.

8. M.D. Anderson Cancer Center is taking a new look at how to evaluate new medicines and treatments for cancer. “We need to rethink how we design and conduct clinical trials in the U.S.” says Dr. Donald Berry, one of its scientists. He feels that we should turn the ‘statistical method’ used to evaluate new drugs on its head, stating that it limits innovation and learning.
   What he’s talking about is the adoption of the Bayesian method of science because it is more in line with how science works. They are putting this approach to the test with more than 100 cancer-related phase I and II clinical trials being planned or carried out using the Bayesian approach. Of course, the Bayesian method is no stranger to the technology of Cell Culture Assay Testing (Chemosensitivity Testing). In fact, it is what gives credit to the accuracy of assay testing.
   Clinical trials test the efficacy (not the accuracy) of a drug. The efficacy of a drug is to produce a desired effect, which is tumor response (shrinkage). Single arm clinical trials provide the tumor response evidence that is the basis for approving new cancer drugs. The Bayesian methology can bring some much-needed “accuracy” to the forefront of clinical trials.
   Clearly, more effective cancer therapies are desperately needed, and after 30 years of investigation aimed at intensified multi-agent chemotherapy, we should look for other avenues of study. In an era of ever-increasing numbers of partially effective cancer therapeutics, there is an obvious need for more accurate methologies. We cannot afford any more ‘trial-and-error’ treatments.

9. The last time Congress helped “cancer” doctors, Committee Chairman Senator Chuck Grassley (R-IA) found out that the value of the approximately $300 million-a-year demonstration project for oncology to report on a cancer patient’s level of nausea, vomiting, pain and fatigue was for nothing. Providers were being paid an additional $130 per infusional-chemotherapy recipient per treatment day to simply forward data that had already been collected. This year, Congress is being hoodwinked into some other financial incentive to reimburse oncologists that report whether their treatment adheres to practice guidelines published by either NCCN or ASCO.
   As the “Patterns of Care” study shows, the Medicare reforms haven’t solved the problem. Medical lobby opponents of the reimbursement change are working to interest Congress in reversing the change of direction, back to the existing economic and clinical problems that Congress attempted to correct with the new law, by increasing the temptations for oncologists to overuse injectable drugs, over oral drugs, or even non-chemotherapy.
   I guess the answer to your question is, primary care doctors don’t, cancer doctors do. I believe cancer patients should receive what is best for them and not what is best for their oncologist.

10. I wasnt aware that reimbursement changes depending on route of administration.
    Do primary care doctors get paid more for adminstering sumatriptan for migraines in injectable, rather than pill form? Thats news to me.

11. At a symposium, the speaker, one of the most renowned neuro-oncologists in the world, was asked what the difference was between two drugs (ccnu vs bcnu). His response was “one is oral, one is IV. The only reason to use the IV version is the doctor can charge to administer it.”
    CMS appeased ASCO-influenced physicians last year by giving them an additional $130 per infusional-chemotherapy recipient per treatment day in return for submitting information about the patient’s level of nausea, pain and fatigue. Senate Committee Chairman, Chuck Grassley (R-IA) had found out that the value of that approximately $300 million-a-year demonstration project was for nothing. Providers were being paid $130 to simply forward the data that had already been collected.
    The academic center-based oncologists are not without collective guilt. They are misguided in not recognizing that they continue to try and mate a notoriously heterogeneous disease into “one-size-fits-all” treatments. They predominately devote their clinical trial resources into trying to identify the best treatment for the “average” patient, in the face of evidence that this approach is non-productive. However, such unsuccessful experiments will never be viewed as such by the people whose careers are supported by these kinds of experiments.
    What was interesting about the “Patterns of Care” study was that it is contemporary, after the Medicare reform. It shows that the Medicare reforms haven’t solved the problem. It’s not that all oncologists are bad people. It’s just an impossible conflict of interest, it’s the system which is rotten. The solution is to change the system. So far, Medicare reform hasn’t achieved that.

12. What does the literature say about the relative outcomes of the various treatments in question?
    Are the choices of either group putting patients at risk?
    Harvey

13. The ASCO President says that we go by the literature, which has defined which are the best regimens. Well, how does he explain why the academics prescribe oral dose Xeloda to their metastatic breast cancer patients who aren’t on their protocols, which keeps them from clogging up their chemo rooms and resources, which they want to use for the patients on their clinical trials, while the community oncologists almost universally prescribe infusion therapy, with the most popular drug being the still on patent Taxotere (docetaxel), which I do surmise has one of the best “spreads” between acquisition costs and average reimbursement.
    Two scientific “evidence-based” studies with a dose of reality (pun intended).

14. For another take on this, see our post:
    http://hcrenewal.blogspot.com/2006/03/complexity-conflicts-of-interest-and.html
    on Health Care Renewal:
    http://hcrenewal.blogspot.com/