PHARMA/PHYSICIANS: Smoking Gun on the Chemotherapy Drug Concession? by Greg Pawelski

Neil Love, M.D. reports from a survey of breast cancer oncologists based in
academic medical centers and community based, private practice oncologists. The
academic center-based oncologists do not derive personal profit from the
administration of infusion chemotherapy, while the community-based oncologists do
derive personal profit from infusion chemotherapy, while deriving no profit from
prescribing oral-dosed chemotherapy.

The results of the survey show that 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% prescribed infusion 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 drugs, and 29%
prescribed the expensive, highly remunerative drug docetaxel. The existence of
this profit motive in drug selection has been one of the major factors working
against the individualization of cancer chemotherapy based on testing the cancer

This is not to imply that the academic center-based oncologists are without
their fair share of collective guilt. They were misguided in not recognizing
that they were trying to mate notoriously heterogeneous diseases into
one-size-fits-all treatments. They devoted 100% of their clinical trials
resources into trying to identify the best treatment for the average patient, in
the face of evidence that this approach was non-productive. However, such
unsuccessful experiments will never be viewed as such by the thousands of people
whose careers are supported by these experiments.

Henderson, et al, entered 3,100 breast cancer patients in a prospective,
randomized study to compare cyclophosphamide/doxorubicin alone versus
cyclophosphamide/doxorubicin plus Taxol (in the adjuvant, pre-metastatic
setting). The results were microscopically positive, at best, and cannot begin
to justify the enormous financial and human resources expended (while making no
effort at all to test and improve methods to individualize treatment).

But these results changed the face of the adjuvant chemotherapy of breast

Cyclophosphamide+Doxorubicin+Taxol became standard of care. Taxol recently
went off patent. Now the thrust is to identify on-patent therapy which is
microscopically better in clinical trials of one-size-fits-all treatment.
Already, the community-based oncologists are migrating to
Cyclophosphamide+Doxorubicin+Docetaxel (expensive/remunerative) so what was the
purpose of doing that 3,100 patient prospective, randomized Henderson study?


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7 replies »

  1. Pharmaceutical Industry Average Wholesale Price Litigation
    If anyone took any of these chemotherapy drugs between January 1, 1991 to December 31, 2004, you may receive reimbursement if you made a percentage co-payment or full payment for the following drugs:
    Over the course of the 1990’s, oncologists have been able to rely on the “sale” of chemotherapy drugs as an important source of revenue. Some oncologists acknowledge that the system created a perverse incentive. According to Dr. Edward L. Braud, from the Association of Community Cancer Centers, whose members treat more than half of the nation’s cancer patients, the potential for conflicts of interest was troubling.
    Several prominent cases, drug companies have been accused of using discounts to influence doctors. In a Minnesota lawsuit, Pharmacia was accused of having induced physicians to purchase its drugs, rather than competitiors’ drugs, by persuading them that the wider “spread” on the defendant’s drugs would allow the physicians to receive more money and make more of a profit, at the expense of the Medicaid program and Medicare beneficiaries.
    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, 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.
    Such inflated payments not only placed additional strain on the finances of the Medicare program, but also directly affected beneficiaries by inflating their required 20% copay. In addition, analysts have suggested that the varying spreads for different types of physician-administered medications create a conflict of interest which could affect the treatment decisions of some health care providers.

  2. The surgical procedure of removing tumors that are cancerous, the adjuvant treatment approach is essentially whichever kind of chemotherapy applied assuming there is no left-behind malignant cells. At this point preventive medicine is practiced by means of a sequence of treatments. The objective here is to help ensure no reappearance of the cancer growth. Using this method not only aids in preventing a recurrence during post-surgery, but definitely gives the patient a bit of a relief.

  3. The Oncologists’ Guaranteed Employment Act of 1998
    Hippocrates opined “first do no harm.” Osler preached above all else “examine the patient.” Salk asked us to “prevent the disease.” Which preeminent physician commanded that before anything else, “pre-radiate and administer chemotherapy for the tumor?” None, as far as this medical editor knows, but in 1998 this is the policy for all newly diagnosed patients with stage II-III gastrointestinal malignancies. No surgical excision of the tumor is to be performed before administration of weekly doses of 5-FU and daily irradiation of the tumor. The idea in colorectal carcinoma is that the tumor lesion is debilitated by chemotherapy and radiation. After a respite of 6 weeks, surgical excision of the mass is undertaken, removing the irradiated tumor. A similar strategy is mandated for cancer of the esophagus, stomach and intestine. At one time, when a tumor was diagnosed, surgery was undertaken immediately to explore the extent! of the tumor invasion and spread. No more. Now CT scan, endoscopy, intra-abdominal ultrasound stages the tumor, determines nodal involvement, and specifies metastatic spread. A tumor that has metastasized to a distant organ almost always disallows the normal surgical removal of the tumor. Medical strategy limits treatment for metastasized tumors to radiation and chemotherapy, leaving the malignant growth intact, without surgery. If the tumor has not spread beyond the local region, surgery is in order, but only with prior administration of chemotherapy and radiotherapy. Only if the tumor is discovered at a superficial stage is surgery alone the treatment of choice. Meaning that essentially all patients with cancer of the colon, intestine, stomach and esophagus will be obligated to undergo chemotherapy and radiation before having surgery. Sounds like a guaranteed employment act for oncologists and radiation therapists, doesn’t it?
    I wouldn’t have much of a “beef” about this except that this new medical strategy has had bad results for my family and friends. The older technique of only removing the tumor surgically worked out much better for my family. In the 1950’s my paternal grandfather had cancer of the colon, underwent a surgical resection of the colon tumor, survived for another 30 years. Of course, there was no chemotherapy back then and radiation therapy was limited to other types of tumors. In the 1960’s my maternal grandfather had cancer of the stomach with metastasis to the liver. He had a stomach resection and survived more than 20 years. He had no chemotherapy or radiation treatment. Both of these men celebrated their 90th birthdays! Living that long, my paternal grandfather fell victim to cancer again. He had a new primary tumor, cancer of the esophagus when he was in his late 80’s. He was treated with radiation treatment. He survived the radiation for a few years, apparently not dying from metastatic cancer.
    Contrast the survival my grandfathers enjoyed with two more recent examples of “cancer management” for my mother and also for my friend. In the early 1990’s my mother was diagnosed with cancer of the stomach. Her surgery was followed by chemotherapy. The chemotherapy agent, adriamycin, was administered intravenously in her forearm but leaked into the surrounding tissues causing ulceration. She required antibiotics and a skin graft before the ulcer would heal. When she sought a second opinion, chemotherapy was again advised, this time cis-platinum. She required hospitalization and suffered throughout the chemotherapy experience. She appeared to be without evidence of further tumor activity for 4 years. Then she began to feel ill and examination revealed metastasis to the liver. She never recovered, dying some months after being diagnosed with tumor spread to the liver.
    Last summer my friend Dave who had been suffering one or more years of heartburn, coughed up blood. His examination revealed adenocarcinoma of the esophagus. This diagnosis without apparent etiology is appearing more commonly in the US among relatively young men in their 40’s to 60’s. He was informed that he would need to have a surgical resection of the esophagus. However, before the surgery, he would undergo 6 weeks of radiation treatment, 5000 rads. Simultaneously he would undergo chemotherapy with 5-FU. As the treatment proceeded, Dave became progressively sicker, requiring endless anti-nausea medication. He was unable to eat, losing one pound of weight daily for weeks. The program was never completed because Dave became too sick. Returning home, he never stabilized. When a CT scan of his abdomen was redone, his liver demonstrated metastasis. With this diagnosis the surgeons declined to do the surgery of the esophagus. Dave died aft!er a progressive slow decline, watching TV at home, unable to carry out any of his normal parental or occupational activities. As a friend of his, I watched helplessly as the disease advanced relentlessly through its course.
    Dave never got to have his surgery. Was the tumor aggressively invasive or did the chemotherapy and radiation disrupt his immune system, irrevocably accelerating the tumor’s progression? We’ll never know. What if the surgery was done first? Might he not have had a longer survival? Adenocarcinoma of the esophagus is a very nasty tumor, but surgery is still the gold-standard of gastrointestinal cancer treatment. Dave never had a chance without the surgery. How about my mother’s cancer of the stomach? Her surgery was followed by chemotherapy. The chemotherapy was putatively to prevent the metastasis of the cancer. It didn’t work. The cancer eventually metastasized to the liver. Are we crediting radiation and chemotherapy with too much false hope for preventing tumor spread? One wonders how my mother would have fared if she never had the chemotherapy. My two grandfathers lived in an era before chemotherapy and when radiation was not p!art of the “protocol” for gastrointestinal malignancy. That was apparently fortunate for them; the absence of chemotherapy and radiotherapy contributed to their survival.
    Now chemotherapy and radiation is part and parcel of the protocol. Once the cancer diagnosis confirms a malignancy, unless it is superficial, chemotherapy and radiation is mandated before any surgery can be done. It’s not a choice. No chemotherapy, no radiation…no surgery! Of course, in the third world, only surgery is available, so this protocol is not a worry. Here in the US, however, expect to be radiated and poisoned. I don’t think that the cancer researchers have substantiated the case for radiation and chemotherapy in gastrointestinal cancer. I don’t think Salk would believe that we are preventing spread, that Osler would agree that we are understanding our patient’s disease, or that Hippocrates would concur that we are not doing harm.
    We should be able to choose surgery without chemotherapy or radiation and then seek alternatives of our choice to treat the “residual” cancer.
    Jonathan Collin, MD

  4. All over-the-counter drugs you purchase at the pharmacy, have dosage, usage and side-effect declarations on the label. Even prescription drugs that are purchased from a pharmacy have print-out and/or labels. It has been brought to my attention, under the concept of the Chemotherapy Drug Concession, the oncologist’s office (except for some urologists) is the only place you can buy drugs that are not labeled.
    This means that “informed consent” is the only thing close to “labeling” of these chemo agents. Numerous oncologists have been playing fast and loose with “informed consent,” many times ignoring it in spite of the fact that doing so is against the law. Without the proper administration of “informed consent” or consultation, the patient receiving chemotherapy is less informed than a person purchasing and using a package of Tylenol or Benadryl.
    Another way of looking at it is that not only does the oncologist have complete logistical, administrative, marketing and financial control of the process, he/she also controls the “knowledge” of the process. This amounts to total control. In economic terms, it would be in violation of the antitrust laws. The result is that the oncologist selects the product, selects the vendor, decides the markup, conceals details of the transaction to the degree he/she wishes, and delivers the product on his own terms including time, place and modality.

  5. Compared to infusional therapy, oral-dose anti-cancer drugs can make receiving cancer treatment more convenient for patients by allowing flexibility in taking medication without disrupting work or other activities. They can often result in less time (or no time) spent in office-based oncology practices because of the absence of intravenous administration and its related side-effects.
    How many oncologists have been thinking of giving a patient oral chemotherapy, instead of infusional therapy? I wonder how much of that extra $130 paid per infusional-chemotherapy recipient per treatment day, helped to make their decision? Ammendities at hospitals are just as accommodating as office-based infusion rooms.
    These targeted cancer therapies will give doctors a better way to tailor cancer treatment. Treatments may be individualized based on the unique set of molecular targets produced by the patient’s tumor, and these important treatment advances will require individualizing treatment based on testing the individual properties of each patient’s cancer.
    What the new MMA started was the removal of profit incentive from the choice of cancer treatments, which were financial incentives for infusion-therapy over oral-therapy or non-chemotherapy, and financial incentives for choosing some drugs over others. Patients should receive what is best for them and not what is best for their oncologists.

  6. If it makes you feel any better the Medicare Modernization Act puts into effect (starting in 2006) mechanisms that limit doctor’s reimbursement for drugs. Although this imbalance may still occur, it will be great deal less.
    On the minus side, lots of oncologists and other doctors will now be sending patients to hospitals to receive their infusions.

  7. While such studies seem to demonstrate that physician compensation drives treatment decisions, I’m sure that there are other, logical explanations for these differences in behavior. I just don’t know what they are…