DRUG REACTIONS AND UNDER-REPORTING
“Off-label prescribing is widespread in Canada and the United States. For 160 drugs commonly prescribed to U.S. adults and children, 21 percent were for off-label indications… In this case, 73 percent had little to no scientific backing and once again psychoactive drugs such as gabapentin had the highest level of off-label use. Moreover, doctors do not seem to know what are and are not approved FDA use for many of the drugs that they prescribe.” The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits (June 19th, 2014 issue of Health Affairs Blog) by Joel Lexichin. Not sure what the term “OFF LABEL” means; click on the link.
“Last year, nearly 4 billion prescriptions were filled in retail U.S. pharmacies. These are staggering numbers. Yet, despite the steady upward trend of prescriptions filled per year, (about 300 million more annually) are we any healthier? I would certainly argue this is not the case. In fact, the World Health Report of 2000 ranked the United States number 37 in overall healthcare. Despite numerous policy changes and enormous increases in healthcare spending, it isn’t looking more promising at the time being.” United States Tops 4 Billion Annual Prescriptions: Is Our Health Improving? by Chris Sovey from the October 5, 2012 Healthy Consumer. That number is now at least 4.45 billion prescriptions.
“In 1993, Dr. David Aaron Kessler, commissioner of the FDA from 1990 to 1997, told the Journal of the American Medical Association that only 1% of serious adverse events are reported. This means that the true number of deaths from FDA-approved drugs and devices is 100 times higher than reported. Other authorities, including Dr. David Bates, an associate professor of medicine at the Harvard Medical School, suggest the figure is closer to 5%.
Dr. Bates writes: Hospitals have had strong incentives not to identify too many of these adverse drug events. Reporting large numbers of adverse events and any serious preventable event brings intense scrutiny from regulators and the public. Thus, most hospitals have relied on spontaneous reporting, which only identifies about 1 in 20 adverse reactions and leads to the perception that injuries from ADRs are less common than they really are.” From ANH USA’s The Problem of Underreporting
After being in practice for over a quarter century, I can say with authority that whether pushed or prescribed, drugs mess people up. Let me repeat that in a different way. the more medicine you are taking — and I am not speaking of street drugs or OPIODS here — the greater the chances of winding up with a serious ADR (Adverse Drug Reaction), sometimes referred to as AE’s (Adverse Events).
This is because we Americans are taking a myriad of unnecessary drugs all day, every day, the the biggest chunk of our collective lives. In fact, the latest stats on the subject reveal that Americans fill about 4 and a half billion (that’s billion with a “B”) prescriptions per year, with numbers increasing annually.
Stop and do the math. That adds up to over 13 prescriptions per year for every man, woman, and child in the United States. That means that for every person who makes zero trips to the drug store, someone is making twenty-six. It’s not difficult to understand why there is a pharmacy franchise on every corner, or why ADR’s are a catastrophic problem for our nation.
But honestly, I don’t want to spend an inordinate time on ADR’s, AE’s, drug reactions, side effects, or whatever you want to call them. If you want to, you can go online and make your head swim with the absolutely freaky numbers (HERE are some statistics for you). What I am actually more interested in today’s post is the under-reporting of these ADR’s. What do I mean by “under-reporting”? Follow along as I show you another of the medical community’s dirty little secrets.
- The February 1997 issue of the British Journal of Pharmacology (Under-Reporting of Adverse Drug Reactions in General Practice) shed some light on this topic by revealing some shocking statistics, after following over 80 GP’s for only three days. Here are some ‘cherry picked’ sentences from this study’s abstract. “The average number of ADRs observed per day per GP was 1.99 which indicates that, as a whole, GPs might be expected to report only 1 out of every 24 ADRs to the pharmacovigilance centre. Under-reporting was lowest for serious and unlabelled effects and for drugs marketed recently. Adverse effects due to drugs are part of GPs routine activities.” Wow! GP’s deal, on average, with two ADR’s per day, which does make ADR’s a “routine” activity. Notice that only about 4% were reported.
- Three years later in Y2K, a position-paper released by the World Health Organization (Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre) revealed that less than 10% of the doctors are reporting ADR’s. “Under-reporting is a common phenomenon in all countries. Correcting for under-reporting is difficult, however, because its extent is unknown and very variable. Even at established centres the reported proportion of serious reactions may not be more than 10%. Several of the countries participating for many years in the WHO Drug Monitoring Program receive 200 or more adverse reactions per million inhabitants annually from about 10% of physicians. In many other countries, however, the reporting rates are much lower.” In other words, all of the data on ADR’s — even in the “developed” countries — seems to be coming from the few physicians who actually report. And for the record, this study does not say that 10% of reactions are being reported, it says that only 10% of physicians report at all.
- We see the same principle in play with CHILDHOOD VACCINATIONS. Barbara Loe Fisher of the National Vaccine Information Center (NVIC) stated that, “Former FDA Commissioner David Kessler estimated in a 1993 article published in the Journal of the American Medical Association (JAMA) that less than one percent of doctors report injuries and deaths following the administration of prescription drugs“. Fisher went on to say that this estimate, “may be even lower for vaccines. In one study that our organization conducted in New York in 1994, only 1 doctor in 40 ever reported to VAERS [the Vaccine Adverse Event Reporting System].” This is particularly true with FLU VACCINES.
- Is this only an “American” problem? Nope. The September 2006 issue of the Canadian medical journal BCMJ (the British Colombian Medical Journal) carried the study, Drug Safety: Side Effects and Mistakes or Adverse Reactions and Deadly Errors? In it, authors Carleton and Smith concluded that, “Adverse drug events are a leading cause of preventable patient harm. Patients can suffer from an adverse reaction to a drug, an improper dose, or a lack of drug treatment. Adverse drug reactions rank as one of the top causes of death and illness in the developed world and have huge socioeconomic significance. It is estimated that as few as 5% of all adverse drug reactions are reported to appropriate agencies. Children are particularly vulnerable. Medication errors are estimated to account for more than 5% of hospital admissions.” Many experts would argue that the stat given in the last sentence above is far too low.
- In a 2006 meta-analysis of peer-review on the topic from the medical journal Drug Safety (Under-Reporting of Adverse Drug Reactions: A Systematic Review), the authors concluded that, “The median under-reporting rate across the 37 studies was 94%. There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs“.
- Three years later the same journal published a review of 45 papers on the same topic (Determinants of Under-Reporting of Adverse Drug Reactions: A Systematic Review) but asked the question “why?”. In other words, why are the rates of ADR’s so high? After saying that, “A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation,” they revealed why reporting wasn’t happening (these are in the order listed). “medical specialty [doctors under-report more than those who work with them, such as nurses, techs, etc.], ignorance, diffidence, indifference, insecurity, complacency, lethargy, lack of time, lack of interest.“
- A 2010 issue of the peer-reviewed scientific journal Postgraduate Medicine (Improving the Reporting of Adverse Drug Reactions in the Hospital Setting) started their paper (written by two medical doctors, a pharmacist, and an MBA), with some interesting facts on who is and who isn’t reporting. “The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest.” “Voluntary” is nice. I certainly wish the IRS would allow me to “voluntarily” pay my taxes. What voluntary reporting of ADR’s does in healthcare, however, is completely skew what we oxymoronically refer to today as “EVIDENCE-BASED MEDICINE,” making almost every drug you can name appear to be much safer than it really is.
AND JUST THIS YEAR — 2014 — WE LEARNED THESE TIDBITS
- In a story that was published just one short month ago by Rachel Lutz in the Pharmacy Times (Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training), we see that these educational efforts still aren’t paying off as she revealed that, “A lack of training on pharmacovigilance likely leads pharmacists to underreport adverse drug reactions (ADRs), according to a recent analysis.”
- But do educational efforts work in reducing ADR’s? Maybe they do in some countries, but listen to these conclusions of a study published in one of this year’s issues of ISRN Pharmacology (Effect of Educational Intervention on Adverse Drug Reporting by Physicians: A Cross-Sectional Study). After looking at CME (Continuing Medical Education) efforts to educate practicing Indian physicians about the need to report any ADR’s, and then comparing the educated physicians to docs that did not undergo CME, they concluded that, “The most important revelation of this study was that although adequate knowledge and the right attitude about adverse drug reaction reporting were instigated in the doctors after the educational intervention, the practice was still neglectful in both groups.” In plain English, this means that the educational efforts of the past two decades don’t seem to be making a lot of difference.
- Just a few months ago, the Saudi Pharmaceutical Journal (Knowledge and Awareness of Adverse Drug Reactions and Pharmacovigilance Practices Among Healthcare Professionals..) wrote that, “Adverse Drug Reactions (ADRs) are scantly reported with poor contribution by healthcare professionals worldwide and in particular in developing countries.” So; how did their country (a country that is by any measure “developed”) stack up? “Most hospitals had follow-up documentation systems, but did not include ADRs reporting. There was no distinct pharmacovigilance system in place. Our study has demonstrated a lack of knowledge and awareness of pharmacovigilance and ADRs reporting among healthcare professionals in hospitals. The poor knowledge of ADRs reporting emphasized the urgent need to implement the appropriate strategies to improve the awareness of pharmacovigilance practices and ADRs reporting.“
UPDATED INFORMATION ON UNDER-REPORTING ADVERSE DRUG REACTIONS
- In 2015, Luke Timmerman, writing for Forbes (Failing To Report Severe Drug Side Effects: A National Embarrassment) stated that “The FDA doesn’t have the resources to do truly rigorous post-market safety surveillance, so it concentrates most of its energy on reviewing data from controlled clinical trials before it allows a drug on the market. Well-controlled, randomized clinical trials are the best thing we have for assessing drug safety and effectiveness before a product hits the market. But they are too small and too selective to provide a representative view of a drug’s safety profile once it starts being prescribed to many patients on the market.” This is why so many drugs get approved by the FDA even though they are later proved crappy and pulled off the market (or like TAMIFLU and others, should be pulled off the market). Later that same year the Canadian government came out with Canada’s Adverse Drug Reaction Reporting System: A Failing Grade, in which they concluded “Less than 10% of ADRs and perhaps as few as 1-2%, are thought to be reported in SRS [the Canadian reporting system]. A review of 37 studies from 12 countries, including one from Canada, provided an estimated median rate of under-reporting of 94%.“
- When you start looking at the drugs with the most side effects, at the top of the heap you’ll find STATINS — the drugs used to lower cholesterol. In May of 2017, two researchers from Auburn University published a study in Expert Opinion on Drug Safety called Empirical Estimation of Under-Reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), in which they concluded concerning statins, “The majority of drug-ADE pairs showed significant under-reporting. For example, roughly 0.01% to 44% of statin events were reported.” How in the name of corn on the cob can one study show a level of reporting side effects of statins of almost 1 in 2, while another shows a level of 1 in 1,000? Another study from 2017 — this one from April’s issue of European Psychiatry (Underreporting of Adverse Drug Reactions: Results From a Survey Among Physicians) concluded that “Drug safety surveillance strongly depends on the spontaneous and voluntary reporting of adverse drug reactions (ADR). From 176 completed questionnaires, most of the physicians stated that they report ADR they have observed to the competent authority rarely (33.5%), very rarely (33.5%) or never (10.8%). The majority (69.9%) had not reported any ADR in 2014.“
Bottom line; I could have gone on and on and on and on. In fact, I could have written a book. The cold, hard truth is that drugs are never as safe as you’ve been led to believe by YOUR DOCTOR, a TV COMMERCIAL, or Aunt Ethel, who claims that the reason she’s lived to be 103 years old is because of those wonderful YELLOW PILLS she’s been washing down with scotch for the last 45 years.
Unfortunately, I see lots (when I say “lots” here, I mean lots) of people who have been seriously messed up by our nation’s CULTURE OF DRUGS. Many are messed up by antibiotics (HERE), although it’s frequently statins, the drugs people take for DEPRESSION, or PPI’S that do a number on people as well.
And I dare not leave without at least mentioning the insane numbers of shots we give our children that contain ADJVANTS which are being increasingly shown to cause all sorts of neurological problems, including vast amounts of AUTISM. The truth is, it could be anything. If you think I am over-exaggerating, re-read the bullet points above — or better yet, take a moment to read the “trust us” slip of paper that comes with every prescription you purchase.
What’s my advice to you? Get serious about your health and your weight. If you are trusting your doctor to keep you healthy, one one of these days you’re in for a rude awakening. Start today doing whatever it takes to get off as many drugs as you possibly can (as always, seek your doctor’s permission before doing so). Isn’t it time to make the decision to get healthy? After all, you owe it to yourself (HERE). For more information on underreporting, HERE or HERE are recent posts.