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Few, if any, would argue with the statement that the Internet has revolutionized health-related communication.
What remains less certain, and unquestionably disturbing, is the degree to which this profoundly powerful tool—available to patients, physicians, researchers, and the general public—may actually be employed in ways that result in genuine harm.
A recent article featured in The New Yorker addressed this very topic, as it applies to traditional African medicine. Consider, for instance, the report from investigators at the University of Chicago, who queried a group of patients (n= 212) participating in phase I clinical trials on their use of unapproved biologically-based complementary and alternative medicine (CAM). Following their entry into the trials, these patients were scheduled to receive highly experimental anti-cancer agents. Thirty-four percent (n=72) of this population acknowledged that they were also using CAM while enrolled in the clinical trial. This figure is notable, and presumably a minimum percentage, as it is simply unknown how many more patients were not willing to openly admit they were regularly taking alternative medicines and supplements, possibly due to the disapproval such action would generate in their treating physicians.
The Proof is in the Prep
The University of Chicago research team correctly noted the potentially serious implications of their findings, both for the individual patients participating in the trials and for the impact on the research itself. Assuming the “herbal preparations” were actually biologically active, it is highly plausible that one (or more) of the following scenarios could occur, completely unrecognized by the researcher or patient. The herbal preparation could:
• Enhance the toxicity of the anti-cancer agent
• Independently produce a toxic eff ect that would be
incorrectly ascribed to the anti-cancer agent
• Interfere with a favorable biological eff ect of the
anti-cancer agent, possibly even leading to the inappropriate
abandonment of further study of the
drug in a particular setting
These outcomes may result in harm to the individual patients, as well as future patients participating in this particular trial, and may seriously interfere with an appropriate interpretation of the study. Where might patients (or their families) have learned about these “biological agents,” and where would they obtain their supply of these products? An even more provocative issue is the question of what information has been provided regarding these specific “biologicals” that would lead patients to make such a potentially risky decision to employ unapproved preparations when they are receiving highly experimental anti-cancer drugs, whose own side effects at this precise point in time are so poorly understood? A
number of sources for both information about and supplies of these supplements can be proposed, including health-food stores and the patient’s personal advisors (family, friends). However, it is also obvious that the Internet has increasingly become a major supplier of both the information and raw material that can lead to these potentially risky, if not outright dangerous, practices.
On the Internet, a health-related site describing what it claims is a truly eff ective, natural, and completely safe alternative (nonmainstream medicine-approved) cancer management strategy may appear to be as scientifi cally valid as a site explaining the results of a well-designed, peer-reviewed trial. Specifi cally, a randomized phase III trial conducted in the identical clinical condition noted the “modest impact on survival of a newly FDA-approved treatment that caused substantial, but generally manageable toxic eff ects,” according to JAMA.
Nature of the Beast
There is no clear reason to believe that the technical sophistication of—and bells and whistles contained within—a website will bear any relationship whatsoever on the medically relevant value of its content. However, human nature being what it is, when otherwise rational individuals (and their families) are forced to confront a truly life-threatening medical condition, is it any wonder that some patients may elect—with or without the strong encouragement of others—to take what is described as a “miracle herbal” preparation, along with the conventional (or experimental) treatment, regardless of what their oncologist may say? Also, when provided with two very diff erent messages—one off ering limited hope and concerns regarding toxicity, the other essentially guaranteeing a favorable outcome—which reality would patients, and their families, want
The New England Journal of Medicine states that although multiple examples of the health-related risks regarding “herbal medications” available on the Internet can be provided, none is more impactful than the 2003 report describing the number of sites still selling aristolochic acid. The FDA noted this herbal prep was the confi rmed cause of renal failure and urothelial carcinoma. The documented risks associated with completely unregulated information, and known websites selling a variety of “herbal products” revealed to be harmful, almost certainly represents the proverbial “tip-of-the-iceberg” when considering the inherent dangers of these unapproved agents purchased through the Internet.
A report published in The Lancet described telephone calls related to adverse effects from ingesting so-called “dietary supplements” that were made to poison control centers in the United States, including myocardial infarctions, liver failure, bleeding, seizures, and death. The report is just one more example of documented concerns with these completely unregulated ingested preps. An even greater concern, as noted in the University of Chicago report, is the potential for completely unsuspected or, as yet, poorly characterized interactions between herbal products and anti-neoplastic therapy being administered to cancer patients. It is difficult to even know where to begin an examination of these risks, since in contrast to traditional drug development—where a regulated pharmaceutical agent must be proven safe before being
accepted as a component of routine medical care—the alternative herbal medications are currently assumed by US law to be completely safe. They can also be marketed and sold without any oversight or formal safety/effi cacy evaluation until they are subsequently proven to be harmful.
Sadly, as the aristolochic acid example reveals, even when the profoundly dangerous nature of an herbal medication is firmly established, this does not stop those who choose to use the Internet to sell their products to an unsuspecting public and often desperate patients. Despite the difficulties associated with clearly defining the direct toxic eff ects of herbal preps that might be confused with that of chemotherapy—and the potential for negative interactions between “alternative medicines” and standard anti-cancer therapy—a number of highly, clinically relevant concerns have been documented. For example, St. John’s wort has been shown to increase the rate of metabolism of certain anti-neoplastic agents, potentially seriously interfering with the clinical effectiveness of docetaxel, irinotecan, and imatinib. It is incumbent on oncologists and their staff to appreciate both the availability and natural lure of these popular sites that make promises—even guarantees—for a favorable outcome. In a setting where traditional medicine must remain relatively or absolutely silent, the truly unfortunate objective remains to be the status of disease management in a particular clinical setting.
The presence of charlatans and snake-oil salesman who prey on understandably desperate individuals with cancer, and other lifethreatening illnesses, is by no means a new phenomenon. However, what is diff erent, and a matter of legitimate concern, is the vastly expanded access these individuals now have to cancer patients and their families. In fact, it would not be unreasonable to conclude that the Internet has permitted these salesmen entry into homes or workplaces of the patient to make their pitch.
In our open society where censoring of information is essentially never seen as an acceptable solution to concerns with problematic communication, the only rational response to unsubstantiated and potentially harmful, health-related claims is the delivery of data that includes truthful information regarding what is known about a particular alternative cancer therapy. Also important is that the data presents the most reasonable medical options in a particular clinical setting, including measures designed to optimize qualityof-life and ensure comfort (eg, pain control) in the presence of otherwise untreatable conditions.
Such communication with patients can take the form of a directed discussion regarding the dangers inherent with alternative medical approaches they may have discovered on the Web and may include specific recommendations that patients examine a diff erent type of site—those the patient’s physician, staff , and recognized sources (ASCO, ACS, NCI) have confi rmed provide objectively valid data of relevance to the individual patient. It hardly makes sense to propose that the rapidly increasing volume of unregulated health or cancer-related information available on the Internet is of no value. In fact, the Internet can serve as a profoundly important and truly unique mechanismfor communication—between patient and provider and between patient and patient. Enhancing an understanding of therapeutic options, hearing the perspectives of patients who have undergone such treatment, and learning how others have successfully coped with cancer, as well as transitioning to the status of a “cancer survivor,” may be of great benefi t to a particular patient.
Further, the Internet clearly permits cancer patients to become active participants in their own care, which can only be seen as a positive development. That being said, it is critical to note that the oncology team can play a unique role in guiding the patient’s journey into the profoundly complex maze of Internet-generated information, resulting in a genuinely positive outcome.