Better Care Through Clinical Trials



Amid hundreds of amendments offered in the health care reform debate, there is a non-partisan, non-controversial gem that will both help patients and speed the search for new cures to deadly diseases.

Senators Sherrod Brown [D-OH] and Kay Bailey Hutchison [R-TX] have proposed an amendment that would encourage patients with life-threatening diseases or conditions to participate in clinical trials by requiring private insurers to cover patients’ routine care. It is essential that the Senate pass this amendment as part of health care reform.

As a cancer physician, I can speak to the benefits of clinical trials in my field of oncology. Virtually every advance in cancer prevention, screening, and treatment over the last 40 years can be traced directly to clinical trials – colonoscopies; curative treatment for testicular cancer; improved survival for most pediatric cancers; chemotherapy after surgery to prevent recurrence; new personalized therapies that target specific characteristics of cancer cells; and symptom management. Thanks primarily to the knowledge gained through clinical trials, today two-thirds of cancer patients survive at least five years after diagnosis, compared with only half in the 1970s.

Yet, just 3 to 5 percent of adult cancer patients participate in clinical trials. While there are many reasons for this startlingly low percentage, one of the most significant is tackled by Senators Brown’s and Hutchison’s amendment: the lack of guaranteed insurance coverage. Some insurers refuse to cover any care costs once a patient enrolls on a trial – whether they arise from treating the cancer or from the cancer itself – as if these costs wouldn’t be incurred if the patient weren’t being treated for cancer.

The Senators’ amendment establishes a federal standard prohibiting private insurers from discriminating against individuals with life-threatening diseases who choose to participate in a clinical trial. It also prohibits insurers from denying coverage for routine care that would otherwise be provided if an individual was not enrolled in a clinical trial – such as x-rays, blood tests, and physician and hospital charges. Any state with laws that go above and beyond this proposed federal standard would be permitted to keep that stronger standard.

My organization, the American Society of Clinical Oncology (ASCO), which represents more than 27,000 physicians who care for people living with cancer, strongly supports this amendment. It will ensure that more patients will have access to potentially effective new treatments, while advancing the search for new cures to cancer and other life-threatening diseases. We hope that Senate leadership will bring it to the floor and vote yes.

In just a few years, cancer will be the leading cause of death in the United States, and will strike nearly half of us. We urgently need new cures. Supporting participation in clinical trials is an essential step that will benefit us all.

13 replies »

  1. Thanks for your posting.
    I always think it is sad when I read the stats that only 3 to 5 percent of adult cancer patients participate in clinical trials.
    In so many cases insurance refuses to cover their patient if they participate in a clinical research study.
    Hopefully with the new guidelines coming this will change and that 3-5 percent will increase.
    Of course finding a cure would be better!

  2. There is a tendency for major drug manufacturers hide data about the safety and efficacy of its drugs, and produce data of scant clinical value. Conflicts of interest have thoroughly corrupted American medical research. There are dangerous potential for conflicts of interest when pharmaceutical and other for-profit businesses control the dissemination of findings generated by medical research.
    The ability of drug companies to pick and choose the research they provide in support of their products is an outrageous conflict of interest and puts all patients in harm’s way. It can undermine public trust in and support for scientific research, endanger research subjects and patients, and boost medical costs by encouraging doctors and patients to use new treatments that are no better than cheaper alternatives.
    Studies with positive findings are more likely to be published than studies with negative results. Even negative results can provide useful information about the effectiveness of treatments. Any tendency to put negative results into a file drawer and forget them can bias reviews of treatments reported in medical literature, making them look more effective than they really are.
    Dangerous drugs have been allowed to reach the market because conflicts of interest have become so endemic in the system of drug evaluation, a trend that has been exacerbated by the rise of for-profit clinical trials, fast-tracking drug approvals, government-industry partnerships, direct consumer advertising and industry-funded salaries for FDA regulators.
    The collaborations between academia and industry has clearly brought discernible influence on clinicians, bringing with it erroneous results, suppressed data, or harmful side effects from these drugs.
    There is an inherent conflict of interest when organizations provide guidelines for treating disease who receive funding from corporations that benefit financially from those recommended treatments. There is no proof beyond reasonable doubt for any approach to treatment today. There is only the bias of clinical investigators as a group and as individuals.
    The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The choice of physicians to intergrate promising insights and methods remains an essential component of quality care.
    There should be more effective online patient networks to aggregate clinical data and effectively learn and research in real-time. Useful observational data can inform science and medicine and hopefully at a faster pace.
    Clinical efficacy trials don’t do “real world” studies under “real world” conditions. Patient outcomes need to be reported in real-time, so patients and physicians can learn immediately if and how patients are benefiting from new drug therapies.
    There is a need for quality peer-review, but there is also unlimited space on the Web to publish. It should be easier to publish well-designed studies that show if there is no effect to a treatment and therefore minimize publishing bias.

  3. Thank you for your posting.
    I hope this amendment goes through, and I do agree that insurance companies should pay for a certain standard of care.
    Clinical trials are need to find solutions or other treatments so that the people live longer and healthier lives.

  4. At present, medical oncologists prescribe chemotherapy according to “fixed” schedules. These schedules are standardized drug regimens that correspond to specific cancers by type or diagnosis. These regimens, developed over many years of clinical trials, assign patients to the drugs which previously worked for some percentage of patients.
    Specialty medical societies protect the status of treatments which are only marginally and minimally and inconsistently effective. This prevents serendipitous and fortuitous discovery. I feel that truly effective treatments do not need prospective randomized trials.
    Large academic cancer institutions that are soulfully involved in clinical trials feel a subtle pull towards getting patients involved in those trials. Some researchers discourage patient empowerment so they can call the shots through these trials. They’ve even broaden their appeal by encompassing community hospital oncology practices.
    These researchers seem to have a readiness to believe that the clinical trial is more reasonable for the patient and that other options do not offer an advantage. Many of these academic researchers, supported by those specialty medical societies and other fraternal organizations, are often paid phenomenal amounts of money for enrolling patients in clinical trials, making financial gain the key motivation.
    Cancer chemotherapy could save more lives if pre-testing were incorporated into clinical medicine. The respected cancer journals are publishing articles that identify safer and more effective treatment regimens, yet few community oncologists are incorporating these synergistic methods into their clinical practice. Cancer patients suffer through chemotherapy sessions that do not integrate all possibilities.
    The ultimate tragedy is that the course of oncology therapy has been driven not by compassion or true concern for the patient, rather, the perpetuation of a research culture that cannot conquer a disease.
    A dysfunctional culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication even though their proven activity has little to do with curing cancer.
    I keep holding out hope that clinical level oncology will eventually
    shift from gatekeeper to integrative medicine, and with that shift will come a more imaginative approach to therapy models and treatment plans.

  5. Although my wife unfortunately contracted NSCLC as a non-smoker, she was fortunate that her targeted (smart drug) therapy for NSCLC is being covered 100% by our insurance company, even though the hospital is considered ‘out-of-network’. The hospital and my wife requested an exemption and it was granted. Some of her costs are covered by the pharmaceutical company for diagnostics not required as ‘standard of care’. The remainder would otherwise have been borne by us – a substantial sum.
    In her case, the drug is working most effectively, so far. Pharmaceutical companies are most stringent in their measurement of drug effectiveness during clinical trials. If there is evidence that the drug is not working, the patient is quickly dropped form the trial. Therefore, no matter how the expense of care is covered, the cost for those whose disease do not respond to the drug is not significant relative to the cost for those who remain in trial a long time – my wife is into her 14th month.
    Bottom-line, the drug is treating a deadly disease and patients with medical insurance who are being kept alive by the drug should certainly be eligible for coverage.
    Patients with or without medical insurance should have equal opportunity to participate in trials that could save/extend their lives. If the patient has insurance and the drug is working, his/her insurance company should cover ‘standard costs’ for these treatments with the pharmaceutical companies paying the rest.
    If trial-eligible patients do not have medical insurance, the pharmaceutical companies should pay for their care.
    Just my opinion.

  6. Insurance carriers are required to cover “standard of care.” Clinical trials are “investigational” in nature. Investigational protocols are not supposed to be covered by Medicare or private insurance. Until the trial is completed, it is not known whether the investigational treatment is as effective as the standard treatment. Let the pharmaceutical companies continue to pay for their chemotherapy concession.

  7. The Association of Clinical Research Organizations represents private research companies that last year conducted more than 9,000 clinical trials involving nearly two million participants. Approximately 20% of this research is in the area of oncology where our members are working on 67 new cancer treatments.
    Each day we experience first hand the many barriers to clinical trial participation, including concerns over insurance coverage. As such, we strongly support the Brown-Hutchison amendment to require all health insurance products to cover the routine costs associated with participation in certain clinical trials (#2871).
    This issue is especially important for cancer patients who may require ongoing routine care even as participation in a clinical trial may provide their best or last treatment option. Less than 5 percent of cancer patients currently participate in clinical trials. If this percentage increased to 10 percent, important research could be completed in one year compared to the current three to five years presently needed, according to the National Cancer Institute. This is one example of why removing impediments to participation is so critical.
    In general, all costs associated with the actual clinical trial are absorbed by the research sponsor, most often a pharmaceutical or biotech company. Nevertheless, study participants may continue to need routine care associated with their condition that is outside the scope of the trial. They should not be denied insurance coverage for this routine care nor should their coverage be compromised in any way because of their participation in a qualified trial.

  8. I thought that insurance carriers are required to cover “standard of care”, even if the patient is involved in clinical trails. (# routine/specialty care visits, standard of care meds, etc).
    The clinical trial should be budgeted to cover trial related costs – but clinical trials (and their sites) should be able to bill insurance if the patient recieves standard of care for their condition (normal tests, labs, x-rays).

  9. Birel86x–
    Thanks for bringing this up.
    Anyone who uses the phrase “5 year survival rates” when talking about the strides we have made in addressing cancer ignores the epidemmic of early diagnsosis in the U.S.–an epidemic that carries its own risks, including diagnosis of pseudo-disease.

  10. The 5 year survival rate is a misleading measure. More people survive past 5 years since we are finding smaller and smaller lesions earlier in their life cycle.

  11. Conventionally, oncologists rely on clinical trials in choosing chemotherapy regimens. But the statistical results of these population-based studies might not apply to an individiual. For many cancers, more than one standard treatment exists. What are the data which prove that an empiric, “one-size-fits-all” treatment identified by the clinical trials paradigm of randomized trials to identify the single best treatment to give to the “average” patient is clearly the most promising treatment to receive? One wonders why just 3 to 5 percent of adult cancer patients participate in clinical trials. Insurance coverage isn’t one of the reasons.

  12. Having insurance coverage for those in clinical trials would be very valuable to many people who have no further options for known treatment and would, at the same time, enable researchers to access more volunteers. That said, the insurance industry will probably fight for some ability to control the costs of such efforts so we would not likely see all research efforts receiving this funding. It would only be those for which the costs were not very high in comparison to the costs of what would be considered comparable treatment. Still, it would open the doors to some level of increased patient involvement in order to advance the research.

  13. Clinical trials already gets tax rebates and is one reason why we pay high price because we are told that innovation carries a price.
    Probably clinical trial is not packaged and sold well enough to insurance. Why not just relate payment to outcome? After all some clinical trials have adverse effects too.