I’ve previously posted about what I’ve seen as symptom/side-effect shaming or whatever you would call that, within the MS Facebook community. What I didn’t get into is the absurd amount of data I’ve found, that is generally unknown by both the public and healthcare providers, whether that be through simply being unaware of resources, or deliberately for the sake of not losing sight of more prominent concerns.
A lot of the data I’ve been looking at has been resources for adverse reactions, physician regard for patient concerns, and disclosure practices of pharmaceutical companies. Or rather, a lack of, and the reasons behind this. The research I’ve been going through is more patient-focused, I hope to use it to provide a solution that benefits those that can be helped by it. I don’t want to go into details for this project yet, for several reasons, but I don’t want to sit on the things I’m seeing in case their relevancy isn’t apparent or, people just don’t happen across them.
Following is a small list of medical studies and articles, including brief summaries.
This is painfully incomplete, I’m only going to post the most relevant or interesting of what I’ve been reviewing, and it will probably read more like a quick reference, but I think the information is incredibly compelling (perhaps a little dry, granted) and might be useful for some. I may post updates in the future, or add posts as a series, data provided. I’m recovering from my latest Ocrevus infusion and am a bit out of sorts, so I hope this makes sense.
I like and trust my physicians, and would always refer to them first if I have an issue with a prescription. The likelihood of reaching a solution by going through them first is much greater than just validating the problem by itself. My process would be to check prescribing data to see if it’s a well-documented issue, if not, I would research through databases such as the following to find correlation. Then I might go to forums or public groups. In the end, I would still always talk to my doctors before attempting to self-treat.
None of this is intended as medical advice, just meant to help inform so that anyone seeing it might better understand prescribing, resources, and even how at times doctors themselves are lead to believe inappropriate data/have insufficient access to data themselves.
The FAERS system is maintained by the U.S. Food and Drug Administration; patients and physicians can voluntarily report adverse effects, while pharmaceutical companies are required to report severe side effects. You can search by prescription to see what side effects or outcomes have been reported, and often these aren’t included in the prescribing data. This is a fantastic resource if you’re experiencing something that no one seems to have ever heard of, to see if you know, there’s precedent for this experience. I would tread with caution, as anything that MIGHT be attributed to medication is also here, whether or not a correlation is validated.
A safer/more responsible alternative to the FAERS database would be DailyMed, from the U.S. National Library of Medicine. Here you can look up specific medications with the “accepted” data with regards to your prescriptions. This is where I’d suggest going if you’re not having something “weird” going on since FAERS is such a hot mess.
This is a first-stop primer as to how to find out if a medication is having X effect on you, with resources to submit data to the FDA about side effects that may be related. It’s the “this is what’s real, don’t look behind the curtain” take, where they responsibly direct you to speak with your physician or look over your prescribing data.
If/when you do have weird happening and think it’s probably a drug, this is where you can go to report it to the FDA. This is where the physician and patient submissions to the FAERS database come from, and is generally intended for severe side effects (might explain why non-severe things like hair loss are generally glossed over, particularly with regards to medications that have dozens of other side effects).
“With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed,” said Thomas Moore, a senior scientist the Institute for Safe Medicine Practices, a nonprofit that tracks drug safety issues. “It is time for the FDA, the medical community, and industry to start work on a badly needed modernization” of this “critical tool” for monitoring safety.
This article outlines how in 2014, the FDA had over 500k reports of serious or fatal side effects, and of those only 4.7% of those were filed by patients and doctors. Of the remaining 95.3% of reported side effects, most were incomplete. Included in those incomplete reports, 40% were “expedited reports”, which must be filed within 15 days due to the serious nature of said side effects.
This is a document, 77 pages in length, outlining industry guidance for “Content and Format of Labeling for Human Prescription Drug and Biological Products”. My favorite excerpt from the document:
“State law requirements can undermine safe and effective use in other ways. In the preamble accompanying the proposal, FDA noted that liability concerns were creating pressure on manufacturers to expand labeling warnings to include speculative risks and, thus, to limit physician appreciation of potentially far more significant contraindications and side effects (65 FR 81082 at 81083). FDA has previously found that labeling that includes theoretical hazards not well grounded in scientific evidence can cause meaningful risk information to ‘‘lose its significance’’ (44 FR 37434 at 37447, June 26, 1979). Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health.”
As a patient experiencing “less significant” side effects and feeling dismissed by a physician who didn’t understand the side effects I was experiencing even existed, I feel like the emphasis should be on facilitating these discussions with our health care providers. I can understand not wanting to include side effects that don’t have a confirmed association, though given side effect reporting is inadequate, limiting “physician appreciation of potentially far more significant contraindications” sounds deeply concerning.
21st Century Cures Act has sped up approval for drugs and removed red tape. As a result, per this article, 19 out of 20 drugs submitted were approved, at a rate of 96%.
[ 21st Century] “The Act now includes a provision that allows for the consideration of “real-world evidence,” which includes “sources other than randomized clinical trials.” Some of these alternative methods are associated with established biases.
Many health care researchers, including me, believe that relaxing methodological standards will put the public at risk. Risks take several forms. All drugs have potential benefits and side effects. Several systematic reviews suggest that as standards for conducting and reporting clinical trials tightened, the studies became less likely to show that treatments offer benefits to patients. Overestimating treatment benefits may harm patients by subjecting them to side effects for treatments that may not help them.
“When side effects are underestimated, patients may not be aware of the potential harms their medicines may cause.”
Measurements for efficacy of the drug now include “surrogate markers”, such as tumor shrinkage, which was assumed would lead to a longer/higher quality of life, but in half of the 36 new cancer drugs (at the time of this writing), only half showed evidence of improved life expectancy. Of the 18 drugs that did not improve quality of life, two made life “worse”. This Act also allows for drugs to essentially be tested on patients, unaware that they have not been previously tested.
Golden’s experience is a classic example of how medications can cause other conditions unrelated to the health problems they’re prescribed to treat. Unaware of this, patients very often consult their doctors about this “new” condition — only to be prescribed yet another drug that could produce still more side effects.
This syndrome is known as a drug “cascade.” It’s not as well studied as more dramatic problems with prescription drugs — such as when apparently safe drugs turn out to be deadly — but it is of growing concern. Experts estimate that tens of millions of people are suffering every day — often without knowing why.
More than 75% of Americans ages 60 and up take two or more prescriptions, and 37% use at least five.
Slightly more than 60% of patients who complained about muscle-related reactions — which are so common they are listed on package inserts — said they felt their doctors did not appreciate the impact the symptoms had on their quality of life, said the report in the August Drug Safety, the peer-reviewed journal of the International Society of Pharmacovigilance.
These data are with regard to patients taking statins, though it seems relevant in terms of how this occurs. When patients report side effects to their doctors, many denied association to their prescriptions. With reported muscle pain/weakness, 47% denied a connection. 47% similarly denied connection to difficulties with cognitive function, and 51% denied association with peripheral neuropathy.
(The average age with which a patient starts on statins is 62, so I could see why side effects of this nature may likely be inappropriately associated with age.)
This is an article from the Harvard Health Blog, generally imploring patients to communicate with their doctor about why a medication would be appropriate for them, as well as indicating that the doctor should themselves review the medication side effects. When it comes to the patient experiencing side effects, “Whatever you experience is real, so make sure you keep a list and let your doctor know.”
Patients may refrain from discussing side effects with their doctors out of concern for their doctor’s reaction. They tend to report side effects more often when these side effects are severe, and doctors may respond inappropriately, such as ignoring their concerns. Some have suggested providing patients with side effect checklists to encourage patients to report. Doctors may inappropriately focus on medication adherence over patient safety in the event of a medication error.
NICE guidelines (National Institute for Health and Care Excellence) recommend that physicians ask their patients about any concerns they have regarding their medication, and it’s likely when implemented that this tactic will yield results.
The author describes an experience when they developed a stomach ache after taking a prescription antacid and their doctor said it shouldn’t have done that, even though the side effect was listed. They went to internet message boards for answers and support. J. Douglas Bremner, a professor of psychiatry and radiology at Emory University School of Medicine in Atlanta, says (regarding doctors):
“They’re not really trained to be scientists, they’re trained to be apprentices. That’s what the drug companies know… If they can get the person who trains them to change what they’re prescribing, they can get them to.”
When pharmaceutical companies provided Mr. Bremner slides for continuing-education, they favored those companies’ drugs. Adriane Fugh-Berman, a professor in the Department of Pharmacology and Physiology at Georgetown University Medical Center claims doctors “prescribe irrationally”, “pushing” new drugs over old, branded drugs over generics, and suggesting medications “for diseases invented or exaggerated by drug companies.”
Director of PharmedOut at Georgetown, Fugh-Berman, says “We’re in sort of a bad situation now where the people in control of prescribing drugs know the least about the drugs”, and that patients need to do independent research on independent sites, like the government database MedlinePlus, that are free of the pharmaceutical industry influence.
One last review of studies…
This is huge. While the length of the review is only 21 pages, the studies they review to come to their conclusions would be overwhelming. This research evaluates both patient and physician experiences and perspectives when it comes to patients seeking information on their own, and encompasses both positive and negative experiences. Ultimately resulting in the Conclusions:
Results of this review contribute to the understanding of the patient-physician relationship of Internet-informed patients. Our main findings show that Internet health information seeking can improve the patient-physician relationship depending on whether the patient discusses the information with the physician and on their prior relationship. As patients have better access to health information through the Internet and expect to be more engaged in health decision making, traditional models of the patient-provider relationship and communication strategies must be revisited to adapt to this changing demographic.
This review did outline that most doctors seem receptive to hearing patient-discovered information about medications/conditions, and open to that communication, but that patients themselves were fearful of bringing up the subject for a variety of reasons. A positive reaction from a physician can have an overall net positive effect on the doctor-patient relationship, but at the same time, if the doctor has a negative reaction, that would also be reflected similarly on the relationship.
The actionable advice that could be derived from this review, would be to have a family member come with you to an appointment to help you remember to have the discussion at all (a prohibiting factor), as well as help, navigate the conversation.
I think the medical community is improving. With the internet, access to data/research, and an increasingly knowledgeable average patient-consumer, there is a positive shift in having these conversations. At the same time, a lot of “old-school” physicians and policies are in place that can still provide a considerable hurdle for many patients without other options. Many consumers don’t want to know all of the possible side effects they might experience and don’t want to look at a bunch of data without context, don’t have the time, or just expect their doctor to be knowledgeable enough that they’d inform them if their experience were related.
A lot of things need to occur in this space to increase awareness of these issues across the board while being mindful of the patient, putting them and their concerns and unique circumstances first. Maybe there’s just too much here for it to be functionally adaptable for the masses, but there has to be a better way. Maybe it’s the wrong agencies are the ones handling it, maybe with advances in machine learning, we can better consolidate what’s necessary and provide physicians with more accessible resources.
None of this is intended to disparage doctors, their education, or interactions, I love my team and I’m grateful to have the relationship with them that I do. I know I can go to my GP or neurologist and we can have an open conversation about my treatment, they never leave me feeling invalidated or without resources. I just know this hasn’t always been my experience, and too often isn’t the experience of others.
Doctors aren’t omnipotent, they can’t know everything. Even the best doctor doing all they can, can and will miss things. To some extent even “the system” is working against them. You have other options and resources. If your provider won’t listen to you, please ask for a referral for a second opinion. You literally can’t be first priority to your doctor, and if they’re not giving you the help you need, you have to put yourself first over their feelings. They will probably understand, and if they don’t, they’re not the doctor you need anyhow.