Comment Submissions - Announcement of Additional Public Comment Period on Acetaminophen

As a full-time Medical Oncologist practicing in Chico, California, I feel extremely educated on the use of acetaminophen whether alone or combined with the many pain meds used by my cancer patients, as well as the current state of medical care for Californians. The agent in question, phenacetin, which is in acetaminophen has been questionably linked to tumors of the kidney when used in supra-therapeutic doses for extended periods of time. (It has been discounted as a risk for other cancers. However, most studies did not support this cancer risk in kidney cancer than did support it, and I would strongly encourage you to pool the total numbers of patients in all the kidney cancer trials looking at this question when considering this data. It should also be noted that kidney cancer occurs in higher rates in smokers who also use more acetaminophen than nonsmokers and have poorer absorption and elimination of medicines such as acetaminophen due to the tobacco effects. It is not clear that the couple of trials showing increased kidney cancer incidence with acetaminophen usage took in to account smoking. There are also racial and gender disparities with the rates of kidney cancer; I would recommend you to look closely at those studies to make sure this was accounted for in these trials. In addition, acetaminophen can cause hypertension which can lead to kidney cancer which may be why the patients in these couple of trials had higher rates with supra-therapeutic doses or long term use: not because of the acetaminophen but because of the hypertension from long term, higher usage of acetaminophen. Where do we stop with 'potential causes' of cancer and alarming the public? Should we also list that public drinking water has been linked to kidney cancer? It has by the way. It is appropriate to be vigilant with protecting the safety of our communities but putting alarming messages out that show up in local newspapers and dramatic news reporting, as it has in Chico, CA, is not a thoughtful way to lead. Our messages need to be clear, thoughtfully explained, and true. The trickle down effects of mandates and warnings will often lead to unintended consequences. For instance, look at the opioid crises and policies which were quickly enacted but not adequately thought through. We physicians in California (and the US in general) are being pitted between the legislative bodies within the CMA, California licensing boards, and other regulatory boards AND our patients because of the challenges patients have to obtain pain relief. I have many cancer patients who are forced to maximize their acetaminophen intake (4 grams per day) along with high doses of ibuprofen because of the inability to get prescription pain medicines for their real cancer pain from providers, especially PCPs, often nowadays advanced practitioners who do not feel comfortable prescribing prescription pain pills even if it is for real cancer pain. Not only PCPs, but also surgeons, ER docs, and hospitalists are limiting prescribing, and even the pharmacies are refusing to fill opioid medicines because of the regulations. Patients tell me 'it is no use to go to the ER cause they won't help me'. So my patient suffer and use high doses of over-the-counter meds such as acetaminophen, ibuprofen or aspirin. I have been told by physician leaders overseeing this movement limiting prescribing opioids that our cancer patients were an 'unfortunate unforeseen side effect' of the limitations put in place to protect people. Tell this to people panicking because of the lack of control for their painful bone cancer. If we make what few over-the-counter medicines either unavailable, or severely limited, this will drive patients to use more mind-altering substances (alcohol and CBD/THC) or illegally obtaining medicines which we know is responsible for more of the opioid deaths than the legally obtained controlled substances. I ask you to look very closely over the data you obtain linking acetaminophen to cancer and make sure it is a clear risk, even when controlling for other risk factors such as other meds, other health problems (hypertension), gender, age, race, tobacco use, alcohol use to name a few. Don't just accept it as true without clear evidence. Thank you for you time considering this. The thoughts I have written are my own and not those of the facility I work for. Mandy Robertson, MD Medical Director of Medical Oncology and Hematology Enloe Regional Cancer Center Chico, CA