You’ve Got To Be Kidding!

dreamstime_xl_12613362dreamstime_xl_30599614 (1)Being a woman of a certain age I’ve become all too familiar with the pharmacy counter. The usual afflictions of age have not escaped me although, most of the time, I feel invincible.

The human body is a finely tuned synchronous marvel of wonder. A beating heart, arguably the most important organ in the body, beats approximately 100,000 times in a day, 35 million times in a year, and approximately 2.5 billion times in a lifetime. I’m exhausted just thinking about it! The pumping action of this organ, roughly the size of two fists in an adult, is responsible for circulating 6 quarts of blood throughout the body three times every minute. In one day, the blood travels a total of 12, 000 miles to every cell in the body.  Any interference in the blood’s pathways, for example, too much cholesterol in your bloodstream, can form a substance called plaque. Plaque builds up in the layers of your arterial walls, making it increasingly difficult for the heart to circulate your blood.

Hold on! I can just hear the brain, liver, and kidneys taking umbrage to my view that the heart is the most important organ in the body, as they all play a vital role in our well-being , but without this amazing organ our bodies would cease to exist.     

I would surmise that most baby boomers, regardless of how vigorously we exercise, eat right and keep our doctor’s appointments, fall prey to either one or all of the diseases attributed to aging: hypertension, arrhythmias, high cholesterol, type 2 diabetes and the like. In order to treat these maladies, medication is often prescribed that should keep symptoms at bay, prevent complications, and return our biometrics to within normal range. That’s the goal.

It is estimated that pharmaceutical manufacturers collectively invest billions of dollars in the research, development and marketing of life promoting medications. In order to bring medications to market, rigorous testing is done, the results of which are submitted to the Federal Food and Drug Administration (FDA) for approval. The benefits of the drug have to outweigh the risks in order for the FDA to approve the drugs for market. It’s those risks that I am concerned about.

The pharmaceutical business is a well-oiled machine.  Pharmaceutical manufacturers’ are an integral part of the health care team as the brilliant minds and monies devoted to the research and development of life saving drugs are vital to our very existence. Once approved for market, according to stats reported on Mercola.com “80,000 drug reps” call on doctors to educate them on their new drug and/or convince them to use the drugs their companies represent.  According to Mercola.com the pharmaceutical industry combined spends approximately “19 billion dollars on their promotional budget”.  In spite of this hard selling promotional activity, I hope that the vast majority of doctors are prescribing the best medication for their patients, but here’s the rub.

A 2006 observational study published in 2006 JAMA Internal Medicine and reported in an article written by Dr. Brian J. Secemsky, a blogger for the Huffington Post, stated that “only 35% of 235 observed physician-patient encounters included any discussion regarding the side effects of newly prescribed medications”.

In an August 28, 2007 Washington Post article written by Ishani Ganguli, a second year medical student, based on a survey published in Drug Safety, a peer reviewed journal, of 650 patients taking statins, the patients had to initiate a discussion with their doctors regarding side effects.

47% of the respondents said their doctor dismissed their muscle or cognitive problems and said they were not statin related.

51% of the respondents with nerve pain, called peripheral neuropathy, said their doctors denied a connection to the drugs.

32% said their doctors denied a connection between their symptoms and statins.

29% said their doctors neither endorsed nor dismissed the possibility of a symptom link and statins.

More frustrating to me was the fact that “many doctors blamed the “normal aging process “or “denied symptoms entirely”.

As the article pointed out, failure to recognize a cause and effect relationship between the statins’ side effects and patients’ symptoms means that significant adverse drug reactions are not being captured and reported to the FDA through its Adverse Event Reporting.  The FDA reviews data from these reports in order to determine risks to patient safety.  Anyone who watches television is acutely aware of the number of side effects that accompanies commercial advertising in the promotion of drugs. As doctors are often juggling many patients and appointments, the time consuming side effect discussion may seem prohibitive, but time cannot be an excuse for a patient to remain uninformed regarding potential side effects that may impact the quality of their life.  

When I woke up last Wednesday, unable to lift my arms overhead, my first thought was that I must have slept wrong. As I began to process the absurdity of that thought, after all both of my shoulders and arms were in pain and I was unable to move either extremity more than 30 degrees in any direction.  I started a process of elimination as I racked my brain for a reason that made sense.  My mind was a blank.  It was only after ibuprofen, a trip to the massage therapist, alternating heat and cold wraps, and searching on line for an acupuncturist or chiropractor, that I suddenly had an A-Ha moment. I began to google the medications I was currently taking and lo and behold as I read the side effects attributed to statins I finally understood the causative culprit. Prominently listed among the numerous side effects were joint pain and muscle pain. Those words leapt off of the page.  I immediately stopped taking that day’s dose.

The next morning I called the prescribing doctor’s office and explained the sequence of events leading up to my call.  “Oh yes”, was the response. That medication can cause joint and muscle pain.  “Stop taking the medication for 7 days and then let us know how you feel” Since I already stopped taking the medication, those instructions were easy to follow.

Whose job is it to make sure patients are given “informed consent” when a new prescription is ordered?  From my experience, even today’s pharmacists do not do an adequate enough job with patient education.  Should there be a specially trained pharmaceutical health practitioner whose primary responsibility is drug safety? I believe the cost of this service would be more than offset by the reduction and awareness of potential adverse medication reactions and as such will have a positive impact on patients’ lives.

The current state of affairs as it relates to drug safety and unreported, unrecognized side effects is sorely lacking. The time has come for this extremely important patient safety issue to be addressed!   

If you or someone you know is experiencing or has experienced side effects as a result of medications you can report side effects to the FDA directly by logging onto the

FDA’s MedWatch website:

http://www.fda.gov/medwatch

 

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