CHEMO PROFIT MOTIVE

Is your Oncologist looking out for your needs or their own?

The American Society of Clinical Oncologists (ASCO) says, “Oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient’s health status and treatment preferences.” This was printed in Journal of Clinical Oncology, August 20, 2011 vol. 29, no. 24; 3328-3330. By: Burstein et al, American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Chemotherapy Sensitivity and Resistance Assays.
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How about those published reports of clinical trials?

More chemotherapy is given for breast cancer than for any other cancer and there have been more published reports clinical trials for breast cancer than for any other form of cancer. Yet with all this data, the NCI’s (National Cancer Institute) official cancer information website on state of the art chemotherapy for recurrent or metastatic breast cancer makes it clear that no clear consensus on treatment has been reached.
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What treatment protocol should be used?

“Whether single-agent chemotherapy or combination chemotherapy is preferable for first-line treatment is unclear. ” -NCI

What is the best drug or regimen for me?

“At this time, no data support the superiority of any particular regimen.”-NCI

British Medical Journal, 2003; 326
Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. By: Melander, Ahlqvist-Rastad, Meijer and Beermann.
“…for anyone who relies on published data alone to choose a specific drug, our results should be a cause for concern…any attempt to recommend a specific drug is likely to be based on biased evidence.”
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So, it would appear that published reports of clinical trials provide little in the way of guidance. In the absence of real guidance from published reports of clinical trials, what is the basis for chemotherapy treatment selection?

Profit? Let’s look at what the studies show.

1. The Journal of the National Cancer Institute (JNCI) commented that “private-practice oncologists typically derive two-thirds of their income from selling chemotherapy” (JNCI 2001;93:491).
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2. The Quality of Cancer Care: Models of Excellence
A proposal submitted to the National Cancer Policy board August 31, 1998
By: Dr. Thomas J. Smith, MD, FACP
Dr. Christopher E. Desch, M.D, FACP
Dr. Bruce E. Hillner, MD, FACP

From the Massey Cancer Center and the Department of Internal Medicine at Virginia Commonwealth University
“…oncology incomes are dependent on interventions*. “Chemotherapy is the only commodity sold in large quantities in doctor’s offices in the United States.” Many guidelines would restrict the use of chemotherapy and supportive care upon which current physician incomes are based. For example, in our current practice, billing for chemotherapy could mean the difference between an annual salary of $220,000 and $40,000.” * An act that alters the course of a disease, injury, or condition by initiating a treatment or performing a procedure.
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3. Health Affairs, Volume 25, no.2 (2006):pages 437-443
Does Reimbursement Influence Chemotherapy Treatment For Cancer Patients?
By: Mireille Jacobson, A. James O’Malley, Craig C. Earle, Juliana Pakes, Peter Gaccione and Joseph P. Newhouse. In a joint Michigan/ Harvard study of 9,357 patients, the authors documented a clear association between reimbursement to the oncologists for the chemotherapy of breast, lung, and colorectal cancer and the regimens which the oncologists selected for the patients. In other words, this study confirms that oncologists tended to choose cancer chemotherapy regimens based on how much money the chemotherapy earns the oncologists.
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4. The Online Journal of Health Ethics, Volume 3, Issue 1, Article 1. Reimbursements sway Oncologists’ Drug Choices ‘Letter to Editor’, By: Gregory D. Pawelski.
Regarding the Michigan/ Harvard study entitled ‘Does reimbursement influence chemotherapy treatment for cancer patients.’ “It confirmed that medical oncologists chose cancer therapy based on how much money the chemotherapy earns the medical oncologist.”
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Below is the March 8, 2006 New York Times article describing the study:
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One of the more interesting aspects of this story is the following:
[Quoted from the above New York Times article]:
“An executive with the American Society of Clinical Oncology, Dr. Joseph S. Bailes, disputed the study’s findings, saying that cancer doctors select treatments only on the basis of clinical evidence. ‘All of us are looking at clinical trials,’ he said.”

So, ASCO’s Dr. Bailes maintains that drugs are chosen only on the basis of “clinical evidence.” Well, here’s what’s odd about that statement:

5. In Patterns of Care in Medical Oncology, volume 2, issue 1, 2005, Dr. Neil Love, M.D., wrote “Management of Breast Cancer in the adjuvant and Metastatic Settings.” Dr. Love reported a survey of (1) breast cancer oncologists based in academic medical centers who do not derive personal profit from the administration of infusion (i.v.) chemotherapy and (2) community based, private practice medical oncologists who do derive personal profit from infusion (i.v.) chemotherapy, while deriving no profit from prescribing oral-dosed chemotherapy. The results of the survey could not have been more clear-cut. For first line chemotherapy of metastatic breast cancer, 84-88% of the academic center-based oncologists prescribed an oral dose drug (capecitabine), while only 13% perscribed infusion (i.v.) drugs, and none of them prescribed the expensive, highly remunerative drug docetaxel. In contrast, among the community-based oncologists, only 18% prescribed the oral dose drug (capecitabine), while 75% prescribed infusion (i.v.) drugs, and 29% prescribed the expensive, highly remunerative drug docetaxel. The existence of this profit motive in drug selections is clearly not based on the interests of the patient, but on the income of the oncologist.
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6. New York Times– 2007, Cancer Drug Representatives Spelled Out the Way to Profit
Dr. Robert Geller, an oncologist who worked in private practice from 1996 to 2005 before leaving to join a biotechnology company, said that cancer doctors knew the profits they could make and in some cases would change treatment regimens or offer unnecessary care to make extra money.
“It’s clear that physicians stopped making decisions based on what made scientific or clinical sense in lieu of what made better business sense,” Dr. Geller said.
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7. Journal of Oncology Practice, 2011 Mar; 7(2 Suppl): 2s–15s.
National Oncology Practice Benchmark: An Annual Assessment of Financial and Operational Parameters—2010 Report on 2009 Data By: Thomas R. Barr, MBA and Elaine L. Towle, CMPE, “On average, 65% of oncology revenue comes from the administering of drugs.”
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8. Journal of Clinical Oncology, Vol 31, No 5 (February 10), 2013: pp 530-535
Medical oncologists’ perceptions of financial incentives in cancer care. By: Malin et al.
“A substantial proportion of oncologists who are not paid a fixed salary report that their incomes increase when they administer chemotherapy and growth factors…The chemotherapy concession is the source of approximately 65% of the revenue in a typical oncology practice dwarfing the income from evaluation and management.”
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9. Journal of Clinical Oncology, Vol 31, No 5 (February 10), 2013: pp 517-519
Are Oncologists’ Financial Incentives Aligned With Quality Care? By: Yu-Ning Wong
“The work by Malin et al complements other empirical data that suggest that oncologists respond to financial incentives…an oncologist is much more generously reimbursed for administering an expensive intravenous drug than having a complicated end-of-life conversation with a patient and family.”
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10. Journal of Clinical Oncology, Vol 31, No 23 (August 10), 2013: pp 2973-2974
Financial Incentives in Cancer Care and Impact on Prescribing Practice
Hui-li Wong, Kathryn M. Field, Jeremy D. Shapiro, Joseph J. McKendrick, and Peter Gibbs
“It would be naive to think that medical oncologists are immune to the attraction of financial incentives that affect their practice.”
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11. Journal of Clinical Oncology, 2014, Vol 32, No 36 (December 20), pp 4027-4028
Payment for Cancer Care: Time for a New Prescription
By: Lowell E. Schnipper, Harvard Medical School, Boston, MA, &
Neal J. Meropol, Case Western Reserve University, Cleveland, OH.
“The hypothesis that physician behavior is impacted by reimbursement in an FFS (fee-for-service) environment is supported by many studies. For example, Hadley et al1 found that use of breast-conserving surgery rather than mastectomy was more frequent in geographic regions in which reimbursement was higher. Others have found that following the MMA (Medicare Prescription Drug, Improvement, and Modernization Act), chemotherapy use was increased for drugs that maintained more generous reimbursement.”2,3
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1. Hadley J, Mitchell JM, Mandelblatt J: Medicare fees and small area variations in breast-conserving surgery among elderly women. Med Care Res Rev 58:334-360, 2001 LINK
2. Jacobson M, Earle CC, Price M, et al: How Medicare’s payment cuts for cancer chemotherapy drugs changed patterns of treatment. Health Aff (Millwood) 29:1391-1399, 2010 LINK
3. Jacobson M, O’Malley AJ, Earle CC, et al: Does reimbursement influence chemotherapy treatment for cancer patients? Health Aff (Millwood) 25:437-443, 2006 LINK

12. Dr. Ezekiel J. Emanuel, Ph.D., chairman of the department of clinical bioethics at the National Institutes of Health, ruffled more than a few feathers at the annual meeting of the American Society of Clinical Oncology in May of 2001. His presentation was later published in the Annals of Internal Medicine, 2003 Apr 15;138(8):639-43. The title is Chemotherapy use among Medicare beneficiaries at the end of life.
Dr. Emanuels’s presentation was a news sensation since it pointed directly to greed as a motivating factor in elderly patient care. His study clearly demonstrated that many cancer patients receive chemotherapy at the end of life, even if their kind of cancer is known to be unresponsive to the drugs. His findings ”strongly suggests overuse of chemotherapy at the end of life.”

CONCLUSION:
“Among patients who died of cancer, chemotherapy was used frequently in the last 3 months of life. The cancer’s responsiveness to chemotherapy does not seem to influence whether dying patients receive chemotherapy at the end of life.”
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The Philippine Daily Inquirer Reported the story, “Chemotherapy unjustified at times, says study.”
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The British Medical Journal reported, “Chemotherapy may be overused at the end of life.”
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The New York Times reported, “Study suggests overuse of chemotherapy near life’s end.”
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The New York Post printed, “STUDY: CHEMO WASTED ON TERMINAL PATIENTS.”
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13. The Journal of the National Cancer Institute, 1992, 84 (10): 810.
An Ethical Approach to Chemotherapy in Private Practice, by Dr. David Young, M.D.
Regarding patient treatment ethics,“there are physicians who disregard these principles in order to maintain a very lucrative chemotherapy practice. Patients are routinely continued on ineffective chemotherapy despite obvious progression of disease. Others are given adjuvant chemotherapy for long periods, even extending to 5 years for high-risk resected tumors, despite a lack of supportive studies…Physicians who knowingly prescribe ineffective chemotherapy to patients with refractory cancers are unlikely to be challenged, given that community non-oncologists and insurance representatives have no mechanism to identify ineffective treatment.”
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14. The New England Journal of Medicine, 2011; 364:2060-2065
Bending the Cost Curve in Cancer Care. By: Dr. Thomas J. Smith, M.D., and Dr. Bruce E. Hillner, M.D. “Medicare data have clearly shown that some oncologists choose chemotherapy in order to maximize income for their practice. A system in which over half the profits in oncology are from drug sales is unsustainable.”
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15. New York Times– 2007, Incentives Limit Any Savings in Treating Cancer
“There’s pretty good evidence at this point,” said Dr. Richard Deyo, M.D., professor of medicine at the University of Washington, “that there are plenty of patients for whom there’s little hope, who are terminally ill, whom chemotherapy is not going to help, who get chemotherapy.” Dr. Robert Geller, M.D., says, “When you start thinking of oncology as a business, then all these decisions make sense.”
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16. BMC Health Services Research, 2012, 12:481
Unsupported off-label chemotherapy in metastatic colon cancer, by; de Souza et al.
“We found considerable utilization of expensive anticancer regimens in metastatic colon cancer without supporting evidence… more than one in eight patients received at least one regimen that is not considered standard of care.”
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Health- “Chemo for Late-Stage Cancer Patients May Be Unjustified”
University of Chicago- ”Many patients with advanced cancers get treatments that won’t help“

17. PLoS Medicine, 2011, 8(4): e1000431.
Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints
By: Kesselheim et al.
This study stated that Pharmaceutical manufacturers encouraged: off-label use through direct financial incentives to physicians… Lavish gifts or honoraria were mentioned in most complaints (35/41, 85%), with many whistleblowers reporting strategies to target these gifts to physicians who were high off-label prescribers (18/41, 44%). In some cases, physicians might be invited to serve in focus groups or as consultants to the manufacturer…not to obtain expert advice, but to provide money to prescribers to positively reinforce off-label use.”
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18. The New York Times Dr. Drug Rep, November 25, 2007, By. Dr. Daniel Carlat, M.D.
“…one recent study indicates that at least 25 percent of all doctors in the United States receive drug money for lecturing to physicians or for helping to market drugs in other ways.”
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19. Journal of Oncology Practice, November 2011, vol. 7 no. 6S, pages 67s-82s.
National Oncology Practice Benchmark, 2011 Report on 2010 Data, By: Thomas R. Barr, MBA and Elaine L. Towle, CMPE. Drugs and infusion revenue accounted for 73% of total revenue in 37 oncology practices, while evaluation and management activities were responsible for only 8% of this revenue.
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“My doctor gave me six months to live, but when I couldn’t pay the bill he gave me six months more.” -Walter Matthau

According to Medscape, Oncologists were the 10th highest ranked specialty, with an average income of $278,000. About 10% of oncologists earn $500,000 or more; about 14% earn $100,000 or less. The commission profit from chemotherapy drugs administered in their offices is very lucrative and unique to Oncologists.

You can’t really think the “profit motive” is anything new in medicine, can you?

Here are two significant examples of excess profiteering in medicine from a U.S. Congressional Report.

United States Congress, Health care reform : hearings before the Subcommittee on Health of the Committee on Ways and Means, House of Representatives, One Hundred Third Congress, first session November 10, 1993.

Pages 381-382
“A 1991 study by the state of Florida found that physicians in that state own the vast majority of certain health care facilities, and that these ownership arrangements have led doctors to order unnecessary tests and questionable treatments in order to increase their profits.The report, commissioned by the Florida Health Care Cost Containment Board, found that at least 40 percent of the practicing doctors in the state have invested in facilities to which they can refer patients. In the case of diagnostic-imaging centers, the study found that doctors own 93 percent of such facilities. In addition, the study reported that the number of tests per patient is almost twice as great in doctor-owned labs than in those not owned by doctors. Likewise, the average per patient charge in a joint venture facility was more than twice the charge in a non-joint venture lab.”
Suplee, Curt, “Florida Reviews Ownership of Clinics,” The Washington Post . August 9, 1991.
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Page 382
“The Consumer Federation of America reported similar findings in their study of doctor ownership of diagnostic testing facilities. The report concluded, “The rapid spread of physician ownership of diagnostic testing facilities is a much more likely cause of rising diagnostic costs than defensive medicine.”” The report found that physicians own or have compensation arrangements with one-third to one-half of all clinical laboratories. In the field of Magnetic Imaging Centers, physician ownership was found to exceed 50 percent The study also reported:
* Compared to tests ordered at independent labs, self-dealing physicians ordered 34 to 96\percent more tests;
* Prices are 2 to 38 percent higher at physician-owned labs than at independent labs;
* The total bill was 25 to 125 percent higher for physician-owned labs.”
Cooper, Mark N., “Physician Self-Dealing for Diagnostic Tests in the 1980s: Defensive Medicine vs. Offensive Profits,” Consumer Federation of America, October, 1991.
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Congressional Budget Office: Increasing the value of federal spending on health care.
Testimony before the Committee on the Budget, U.S. House of Representatives July 16, 2008
The Congressional Budget Office estimates that up to 30% of care delivered in the United
States goes toward unnecessary tests, procedures, physician visits, hospital stays, and other services, which include ineffective cancer treatments.
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Drug companies pay oncologists to promote (expensive) ineffective and toxic cancer drugs

2012- Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain drugs.

As part of the criminal agreement with the U.S. Department of Justice, GSK agreed to resolve its civil liability for the promotion of drugs for off-label, noncovered uses, paying kickbacks to physicians to prescribe those drugs, making false and misleading statements concerning drug safety, and reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.

“Patients rely on their physicians to prescribe the drugs they need. The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs. This case will help to ensure that your physician will make prescribing decisions based on good science and not on misinformation, money or favors provided by the pharmaceutical industry.” -John Walsh, U.S. Attorney for Colorado.
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Department of Justice case link

This isn’t the first time a big Pharma company has been “pinched” for illegal activities.

In 2007, Merck agreed to pay nearly $5 billion to settle lawsuits from consumers contending the painkiller Vioxx caused heart attacks and strokes. On NPR we got a very insightful quote from Dr. Catherine DeAngelis, M.D. editor of the Journal of the American Medical Association (JAMA). “What people should learn from this is you don’t believe anything, not one thing, put out by a pharmaceutical company. Just don’t believe it. You start from there. When you want to make money by selling products to people who don’t need it rather than putting your money into developing new drugs, then you’re going to get into this kind of trouble.” LISTEN HERE DeAngelis.mp3 “DeAngelis says she used to be skeptical of drug companies; now she’s cynical.”
Department of Justice case link   NPR link

vioxx-and-merck

“If all pharmaceutical manufacturers complied with the law, there would be no need for law enforcement actions,” says Susan Waddell, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services“But until they stop abusing the health care system and putting profits ahead of patient safety, OIG will continue to vigorously pursue corporations that flout the law.”

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