Physicians

PHARMA/PYSICIANS: United is getting grumpy at the oncology-industrial complex

While I’ve been focusing on pricking egos in the HBS common room, Greg Pawelski has been keeping vigil on our friends over in the wonderful world of chemo. The main recent development is the FDA issuing a warning about overuse of the anti-anemia drugs Eopgen, Arenesp and Procrit. Amgen (which makes the first two and JVs the latter) is running into problems because of this. Greg believes that things may be worse than that. He wrote to me saying:

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.

Whether or not there’s any truth in that it’s clear that bigger guns than Greg’s are being aimed at the issue. And one such gun belongs to United Healthcare which has found some pretty disquieting things about the use of some big time biotech drugs including Epogen and Herceptin among its cancer patients. Lee Newcomer, United’s ex-Senior Medical Director (but still an employee) told a meeting last week:

In reviewing records of patients who were prescribed the drug erythropoietin — an expensive agent that boosts blood supply in patients with anemia — <snip> 44 percent of those patients had blood work-ups that would indicate they were not anemic. Last year at the NCCN meeting, Newcomer also cited 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 Newcomer said about 12 percent of drug orders — which costs thousands of dollars per treatment — were for women who tested negative for HER2 overexpression.

So right there, real questions abut the inappropriate overuse of the two most popular biotech drugs. But that’s not all. What about overuse of other drugs that may also be innapropriate, but that we’re not so sure about?

Newcomer also said that, when he scrutinized prescribing habits for treatment of patients with pancreatic cancer, "we had doctors writing prescriptions for 188 different combinations of treatments, yet we know that there are only two drugs that have any activity against that disease."

<snip>

Newcomer said that 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. "But that doesn’t explain its true cost," Newcomer said. "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 calculation, it costs $354,000 per year of life extended with Avastin.

And of course, there’s a message in all this for Pharma and the Oncology-Industrial Complex.

Newcomer and other panelists said that unless the prices of the drugs are controlled, a major backlash against the pharmaceutical industry is brewing.

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  2. 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

  3. “scientifically bankrupt paradigm”
    The internet blogger Pawelski loves to hate the scientific method.
    This is the same guy who loves to tell vulnerable cancer patients on blog after blog that they are, in fact, doomed, if they don’t make use of his totally unproven cell culture assays.
    He calls the heads of Hopkins, Farber, and Sloan, “evil academicians.”
    Please.

  4. Charlie Rose had his latest installment of his 12-part Science Series, focusing on the importance of scientific research in human health. Episode Four was an in-depth discussion of the latest research in cancer. Always glad to see an authoritative, informational program being sponsored by a huge drug company with billions riding on the behavior patterns of physicians and patients – it ensures that the reporting will be completely free from any sort of bias. Packing the panel with academicians whose entire careers are utterly dependent upon mega-trials funded 100% by the same drug company further reinforces patients’ confidence that the information conveyed will be balanced and fair.
    Perhaps they, oncology research fellows and others, see the hand writing is on the wall. In an effort to establish cancer treatment guidelines, even the Community Oncology Alliance’s (COA) QSP Committee recommends that CMS broaden acceptable guidelines, and not limit the guidelines for “individual” practice use. According to its’ chair, ASCO has technology assessments that are very limited and updates which are not timely (and as we now know, not ‘open’ and accurate). NCCN guidelines are fine but many practices use other guidelines or develop evidence based treatment guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence based standards for their practices. The self educated oncologist doesn’t “submit” to the status-quo. They can think for themselves.
    Conventionally, what clinical oncologists have been attempting to do is to define the “best” treatment to give to the “average” patient with a given disease, otherwise known as the lowest common denominator theory of cancer chemotherapy (roll-the-dice). For 30 years they have been attempting to define the best drugs to give to the average patient, with no real progress with regard to identifying better chemotherapy regimens for the average patient. It is a scientifically bankrupt paradigm which has not fostered either efficient or humane progress in cancer chemotherapy.

  5. Cancer Drugs’ Spectacular Costs Shifting Market Dynamics
    Tykerb (lapatinib) is one of the first oral agents with the potential to compete directly with the IV drugs which is both a high-volume and high-revenue part of office-based practices. Early use of Tykerb will likely be limited to patients whose breast cancer is refractory to Herceptin (trastuzumab). In the longer term, it could supplant or perhaps find a place in combination with Herceptin.
    Of course, will patients be able to afford the cost of these drugs? Herceptin’s wholesale price on an annualized basis is approximately $45,000 per year. Tarceva, $40,000 per year. Nexavar, $60,000 per year. Avastin, $47,000 per year. Will the price of Tykerb approximate these novel agents or exceed their costs? The problem is not unique to these drugs, but also to all of the new molecularly-targeted agents.
    Lee Newcomer, former chief medical officer and currently an executive with United Health Group, stated at the 12th annual conference of the National Comprehensive Cancer Network, that “Avastin improves outcomes in about 20% of patients, but we have no idea which cancer patients will benefit from a course of treatment. Because Avastin is included with numerous drug cocktails, it costs $354,000 per year of life extended with Avastin because of today’s ‘cookie-cutter’ approach to chemotherapy. You don’t know in advance who is going to respond.”
    Everyone is scared to death (and rightly so) at what is going to happen to the healthcare economic system with the introduction of increasingly expensive new drugs that benefit only a small percentage of patients who receive them, hence the headlong rush to develop tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.
    Profit is a powerful motivating force. Among medical benefit payors, the profit motive is entirely consistent with the goal of developing a molecular test, which is to identify efficacious therapies irrespective of drug mark-up rates.
    The FDA finds themselves under increasing pressure to allow new drugs into the marketplace, while at the same time protecting the safety of potential recipients of those drugs and also the financial interests of those who will have to pay for them. The pressure is so great that companion molecular diagnostics approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.
    It should be in the FDA’s interest in saving the healthcare system perhaps billions of dollars a year (and thereby the healthcare system itself) by ensuring that expensive treatments are used appropriately. It should serve their interest not only in discovering new cancer treatments, but also using currently-available cell culture technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.
    The methods of cancer medicine during the last thirty some years are coming to haunt the “one-size-fits-all” establishment. Technologies, developed over the last twenty years by private researchers, hold the key to solving some of the problems confronting a healthcare system that is seeking ways to best allocate available resources while accomplishing the critical task of matching individual patients with the treatments most likely to benefit them.

  6. I wonder if reporters arn’t put onto this story by insurance companies? Maybe this could be one of those situations where what makes the doctor money could also be helping some patients considerably?
    Medicare and insurance companies had pretty strict guidelines about how low the hematocrit must be in order for them to be eligible for reimbursement. But some patients feel draggy/listless/weak when their hematocrits are above the cut-off levels for reimbursement (meaning they have to wait until their levels drop low enough). The real loser in this are the patients who have to pay for the drugs, who would be happier were they just be moping around at home, as opposed to out living full lives.
    But on the other hand, new studies have raised questions whether these drugs might actually be harming them. Those study results suggest the drugs may make the cancer worse.
    Dr. Eric Winer, director of the breast oncology center at Dana-Farber Cancer Institute feels that these drugs are presumed to be entirely safe, given for supportive care and to improve quality of life, but not actually used to treat cancer. But the drugs may have been used in ways not approved on the labels.
    A study published in the New England Journal of Medicine last November found that patients treated aggressively with Procrit had a higher risk of heart problems or death than those treated less aggressively.
    Amgen, the maker of Aranesp, announced late January that in one of its clinical trials, patients were more likely to die than those getting a placebo. The trial was testing the drug in patients whose anemia was caused by the cancer itself, not by chemotherapy. While a Danish study in patients with head and neck cancer had to be stopped early because the cancer seemed to recur more in patients being treated with Aranesp.
    In February, the Journal of Clinical Oncology published a paper describing a small Canadian trial in lung cancer patients had also been stopped early because those getting Eprex were dying sooner. While Roche suspended patient enrollment in a lung cancer trial comparing its Cera against Amgen’s Aranesp because of greater than expected number of deaths in at least some of the arms of the trial.
    It is not known why the drugs may cause these problems. It is known that raising hemoglobin levels too high increases the risk of blood clots. While most of these trials did aim to increase hemoglobin above the levels recommended in the drugs’ labels, that was not the case with Amgen’s own trial.
    There is some evidence that clots were not the problem in the trials, but that Epo may spur tumor growth. Some studies suggest that certain tumor cells, such as those in head and neck cancer, have proteins on their surface that bind to Epo. When that happens, it sets off a cascade of reactions spurring growth.
    Studies done by Dr. Jennifer R. Grandis, professor at the University of Pittsburgh, found enough biologic possibility that they can serve as a growth factor for the cancer cell.
    Concerns about the safety of the drugs for cancer were first raised in 2003 by two studies that showed patients getting Epo had worse outcomes. Until then, these drugs had shown signs that they could improve the quality of life for cancer patients, even though their safety labeling has already been revised three times since 1997.
    Whiz bang therapies often get a pass on toxicities because they are just so darn cool. The problem is that few drugs work the way we think and few physicians/scientists take the time to think through what it is they are using them for.
    Source: TherapeuticsDaily

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