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Don't throw out the baby with the bathwater!
| Content Provider | Semantic Scholar |
|---|---|
| Author | Kamen, Barton A. Kieran, Mark W. |
| Copyright Year | 2005 |
| Abstract | The recent disclosures by the two largest manufacturers of selective COX-2 inhibitors have led to the removal of one product (Vioxx) and a suspension of clinical trials with the other (Celebrex). This is the direct result of information demonstrating a possible threefold increase in the incidence of cardiovascular disease in adults using these drugs over extended periods of time for inflammatory conditions or to decrease the incidence of colorectal polyps. It would be at best redundant, and it is not the purpose of this column, to simply jump on the bandwagon and render opinions about Big Pharma, drug development and regulatory agencies in light of these events, or other high-profile issues such as the shortage of influenza vaccine or the safety of antidepressants. One only has to read recent books, book reviews, journal articles, or an interview with a Nobel Laureate and scan the lay press, especially since September 30, 2004, to appreciate the magnitude of the perceived problem. However, here it does seem appropriate to examine the impact of the recent data regarding nonsteroidal anti-inflammatories (NSAIDs) as it affects the development of treatment for children (and adults) with life-threatening diseases and/or diseases with severe chronic morbidity. ‘‘Collateral damage’’ is the military expression for destruction of non-military targets. The war on cancer has at its disposal a particularly potent armamentarium (radiation, conventional chemotherapy, and surgery) that has a large potential for causing significant morbidity (ie, shortand long-term side effects) and mortality. Attempts to increase the therapeutic efficacy for even a small increase in the percentage tumor cell kill or a decrease in normal tissue damage may improve the risk/benefit ratio for a patient. This is why the latest problems of drug safety, regulations, marketing, and advertising that are in our journals and the lay press need to be revisited from the view of a pediatric hematologistoncologist. The risks physicians present and parents and patients are willing to assume in order to attempt potentially curative therapy for children with cancer is (and should) be different than those accepted by patients with nonmalignant conditions or those enrolled in a chemoprevention trial. Comparing the malady and the general health of the young patient with cancer to an adult on a prevention trial is like the proverbial comparison of an apple and an orange. In treating our patients, the occurrence of treatment-related avascular necrosis of bone, cognitive impairment, cardiac, renal and reproductive failure, auditory compromise, secondary malignancies, and death are but a few of the risks we ask them to take. For many of our treatments, these risks are much greater in severity and incidence than those being reported for COX-2 inhibitors. Even nonmalignant conditions having high morbidity, such as sickle cell anemia and autoimmune diseases, are treated with bone marrow transplants and conventional chemotherapeutic agents because the risk/benefit ratio seems favorable. We (parents, patients, and caregivers), while working to minimize toxicity (collateral damage), accept these risks. At diagnosis, the stakes are high and the potential for cure very realistic for many children and young adults. At disease recurrence we attempt to ‘‘salvage’’ patients in the context of clinical trials and application of new drugs or paradigms for treatment where the risks are equal or greater, and the benefits less or unknown. In spite of this, we allow those involved (family, patients, and caregivers) to weigh the relative risks and benefits in the context of progressing disease and make a decision right for them. When the risk of a cardiovascular event increased from about 0.75% to approximately 2% to 3% in chemoprevention trials, the withdrawal of Vioxx was deemed a proper action |
| Starting Page | 59 |
| Ending Page | 60 |
| Page Count | 2 |
| File Format | PDF HTM / HTML |
| DOI | 10.1097/01.mph.0000155872.67424.2e |
| Alternate Webpage(s) | http://hero-health.org/wp-content/uploads/2017/10/Dont-throw-out-the-baby-with-the-bath-water.pdf |
| Alternate Webpage(s) | http://librarysparks.com/pdf/librarysparks/2012/lsp_aug12_ker_litrecipe.pdf |
| PubMed reference number | 15701976 |
| Alternate Webpage(s) | https://doi.org/10.1097/01.mph.0000155872.67424.2e |
| Journal | Medline |
| Volume Number | 27 |
| Issue Number | 2 |
| Journal | Journal of pediatric hematology/oncology |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
