How to (Try) to Protect Yourself From ADR’s: The Six Big Clues I Wish I Had Seen

This is Part 2 of 2 articles.  The following excerpt is taken from Part 1 entitled:    Adverse Drug Reactions (ADRs):  We’re ALL at Risk, or what I like to call  “We’re All Sitting Ducks, Sacrificial Lambs, and Playing Russian Roulette With ADR’s”

 

I’m lying in my bed, with my arms and legs straight out.  I figured out pretty fast that any stress whatsoever on the tendons, makes things worse for days, weeks even.  “Stress” includes not only trying to walk or use my arms or legs for any reason at all, but also simply bending my arms, or my knees, or my fingers, in one position for too long.  What’s “too long”?  Maybe 3-5 minutes or so.  I can’t use crutches or a wheelchair, because both of those involve use of my arms and shoulders and hands, which are also out of commission.  I can’t type or use the computer, because every tendon in my fingers, hands, wrists, and arms are affected and severely painful.  I can’t hold up a book to read, because the weight of the book is too much and I can’t bend my arms, without increasing the tendon pain.  The weight of the sheets on my toes causes severe pain in the tendons there.  There must be tendons around the eye muscles too, because it hurts simply to move my eyes.  So I lay there in my bed, with my arms and legs flat out, with my head still and my eyes closed, waiting.   Waiting for what, I’m not sure.  It’s hard to believe that I went jogging and bike riding and swimming only a few days ago.  I’m also in shock.  How in the world could a simple antibiotic that I took for a simple UTI do this to me?  

And so began my own journey into the world of “ADR’s” – Adverse Drug Reactions.    Within a few days and a few pills, I became one of the millions of people in this country who experience an Adverse Drug Reaction (ADR) every year to a pharmaceutical drug that is deemed “safe” for use (see refs).    It turns out my particular ADR was not only severe in onset, but permanent, leaving me disabled for life.   For those interested, you can read about my story here, in the rest of this website.

My story is not unique.   Tens of thousands of people have been afflicted with my particular ADR alone, and of course millions of other people get hit with all sorts of ADR’s from any number of pharmaceutical drugs, vaccines, or medical devices every year.   Despite the supposed checks and balances in “the system” to help ensure a drug is safe for use, Pharma, the FDA, and medical and pharmacy professions are failing miserably in this endeavor.   I discuss this more here, in “Adverse Drug Reactions (ADRs): We’re All at Risk” and here, in “ADR’s Are Here To Stay, and Getting Worse“.    So the big question remains:  Is there anything we can do to protect ourselves?

 

What Can We Do to Protect Ourselves?  The Six Big Clues I Wish I Had Seen

Despite the fact that Pharma, the FDA, and the medical and pharmacy professions are supposed to be looking out for your interests, the sad truth is, we’re still on our own.    As with so many other things in our society, it’s “buyer beware” with pharmaceuticals, vaccines and medical devices as well.    Only in this case, your very life may literally be at stake.    I, and millions of others like me, found this out the hard way.    Knowing what I know now, and looking back, here is what I would do if I had it to do over again.

Using myself as an example, with my particular ADR to a common antibiotic, here’s what I wish I had done before taking those few pills.   The links I’m providing are for my particular ADR, but the same can be done with any pharmaceutical, vaccine, or medical device you might be prescribed.    I suspect you’ll be able to think of a few more “Big Clues” of your own.

  1. First of all, I wish I had gotten on the internet and checked out patient drug review websites such as Askapatient, Consumer Affairs, and WebMD to see the reviews from patients themselves.   A quick look there would have given me Big Clue #1 that something is very wrong here.   The stories here are much different than the label warnings of “a little bit of GI distress ” or “see your doctor if you have tendon pain”.   I would have seen the long term or permanent disability stories of pain and suffering, with the same characteristic groups of symptoms over and over again, thousands of times over, and how meaningless the phrase “see your doctor” was in these particular cases.
  1. After that, I wish I would have followed up the links to the numerous websites, blogs, Facebook pages, and forums dedicated to attempting to help victims of this toxicity and warn others to prevent it from happening in the first place.   And the key word here is “numerous”, because there is no shortage of them when it comes to these particular drugs.   Supporting this are all the TV News stories aired across the nation.   This would have been Big Clue #2 that something was very wrong here.
  1. After that, I wish I would have gone to PubMed and done a search on “Fluoroquinolone”, “Ciprofloxacin”, or “Levaquin” and seen the hundreds, possibly thousands, of traditional peer reviewed published research studies that come up on adverse effects of these drugs.   Now that I know that these hundreds of papers are just the tip of the iceberg, and represent the most positive spin Pharma can present, this would have been Big Clue #3 that there’s a lot more going on here than meets the eye.   I have no doubt that there is plenty of alternative data sitting in the deep underground vaults of Pharma which will never see the light of day if they can help it.
  1. After that, I wish I would have done a search on “fluoroquinolone lawsuits”, and seen the pages and pages that come up, only one of which is here.   Having a bunch of late night personal injury commercials and numerous ongoing litigation is never a good sign for the drug you’re about to take, so this would have been Big Clue #4.
  1. After that, I wish that ProPublica’s “Dollars for Docs” and “Prescriber Checkup” lists would have existed back then, so that I could check to see if my prescribing physician was receiving drug company money, and if so, why that is.   If she had, and the money was for the particular drug she was going to prescribe me, this would have been Big Clue #5 to use extra caution and question my doc carefully about the risks and benefits of this particular drug.
  1. After that, I wish I would have done a search on “Adverse Drug Reaction Epidemic” and seen all the articles that pop up, some of which I supply in the references below.   They are a sobering read.    Statistics vary, but ADR’s are considered to be anywhere from the 6th to the 4th leading cause of death.   And these numbers don’t even include the disability, the diabetes (1, 2), and the undetected and unacknowledged other disorders they might be causing or contributing to, and which just happen to be skyrocketing in epidemic proportions.
  1. And after seeing these Six Big Clues, I sure as hell hope I would have never even considered, much less taken that class of antibiotic for a simple, uncomplicated UTI.    I hope I would have gotten together a “Physician’s Packet” , including the examples of physicians themselves who have experienced these ADR’s, and provided that to my physicians to help educate and warn them as well.   I hope I would have discussed with my physician whether my particular case really warranted that antibiotic by reviewing the responsible and appropriate use of that entire class of antibiotics with her.   In my case, the drug I was offered was not addictive in nature, but many of them are.   Had my searches revealed that quality, I would have definitely questioned and discussed that with my doctor as well – what was the chance I would become another one of Pharma’s addicts and “customer for life”?

Had I only known then what I know now and if I had done all of the above, I think there’s a good chance I’d be fine today, living my life as the healthy and athletic person I was, still blithely unaware of the horrific phenomenon of my particular ADR.  The worst mistake I ever made in my life was taking that antibiotic, because it effectively ended any quality of life for me.

 

Demand Change:  Our Lives Are at Stake

If it feels overwhelming, maddening, or just plain ridiculous that this is what we have to go through every time we consider taking a drug the doctor is offering us, I agree.     I’m all for “Buyer Beware”, and more warnings, because ultimately, that’s what it’s always going to come down to.    But unfortunately, with the current system, it’s also true that no matter how much you’re aware of the warnings, it’s still going to be a matter of Russian Roulette, Sacrificial Lambs, and Sitting Ducks.    Because ADR’s are here to stay, and can happen anytime, anywhere, to anyone, no matter how informed or warned they are.    In my particular case, I could have easily avoided the antibiotic, but that is not true in all situations.

And given that this is the case, we should all have an interest in changing the status quo and demanding change.   Your life – and the life of your children, your family, friends, loved ones – are literally at stake.   You can be one pill, vaccine, or medical device away from disaster (as I was).    Ask any victim of Lariam, Gardasil, DESLupron, Yaz, Statins, Fluoroquinolones, Vaccine-related ADR’s, Diabetes Drugs, Psychotropic Drugs, Addictive Painkillers, and hundreds or thousands of other ADR’s, or the millions of people per year who end up in the ER or the loved ones of those who died due to “fatal events”.

If you agree that more needs to be done other than simply relying on “Buyer Beware”, here are two options to consider for you to make your voice heard in this matter.

 

Send an email to Senator Elizabeth Warren

Senator Elizabeth Warren is well known as a consumer advocate who has made it her life’s work to fight for “the common man, the people, the middle and working class”.    She is also one of the few people willing to take on Pharma directly.    As she says here:

 “Over the last 10 years, some of our wealthiest drug companies—those that capitalize on government research to generate billions of dollars in revenues through the sale of blockbuster drugs—have found another way to boost profits.  They’ve been caught defrauding Medicare and Medicaid, withholding critical safety information about their drugs, marketing their drugs for uses that aren’t approved, and giving doctors kickbacks for writing prescriptions for their drugs. . . . The government has kicked thousands of small and medium-sized physician practices out of the Medicare program for fraud, but not one of these major drug companies has ever been kicked out.  The government convicts hundreds of people of health care fraud every year, but not one of these major drug company cases has even gone to trial” . . . Under Warren’s proposal, “the biggest and most successful drug companies” would have to contribute to the NIH’s budget whenever they settle criminal accusations with the federal government.  In addition to the fines that companies already pay, they would have to contribute 1 percent of their annual profits to the NIH for five years.

Regardless of how you feel about Sen. Warren, she’s probably the best we’ve got right now in terms of being an advocate.    She needs to know she’s not alone in her fight.    If you agree the current system needs changing, email her.    If you’ve been harmed by a drug, vaccine, or medical device, send her your story.   Tell her your dissatisfaction with the status quo.    Make suggestions for change that you would like to see happen.    Or simply tell her “Thanks” for being willing to tackle this issue and to fight for us.

I sent her my suggestion for change:   A Public Policy Plan to Utilize the Pharmaceutical Industry and Pharmacogenomics to Reduce Serious Adverse Drug Reactions, Develop Personalized and Individualized Therapy, and Provide a Functional Map of the Human Genome .    If you can’t think of anything to say to her, and you agree with enough of what I wrote here, feel free to simply send Sen. Warren a copy of this PDF.    The more emails she gets, the more she’ll be apt to continue fighting this battle.    Why should she fight for us if we’re unwilling to fight for ourselves?    So take a whole five minutes out of your life to shoot her an email.

If you don’t like Elizabeth Warren, and/or you don’t like my suggestion, write up your own ideas and email them to the politician or ‘person of influence’ of your choice or post them on a blog, forum, or your website.  Demand change.

 

Send an email to the 21st Century Cures Initiative

The 21st century Cures Initiative is a big push to find cures for cancer and rare diseases which may have answers in our genome, and to speed up the regulatory process for drugs and treatments to find these cures.    There are a lot of things in this Initiative, but as you can imagine, ADR’s certainly aren’t a major focus.    It’s a lot funner and exciting to create new drugs for “cures”, than it is to deal with the ADR’s those drugs will create.    And yet, you can be sure of one thing:  ADR’s will increase in tandem with the increase of drugs and devices on the market, especially the “speedier” they get there.    The Initiative says in its mission statement:

 “If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there’s not a major gap between the science of cures and the way we regulate these therapies . . . That is why, for the first time ever, we in Congress are going to take a comprehensive look at what steps we can take to accelerate the pace of cures in America.  . . . We know we don’t have all the answers.  That’s why we’re asking questions first.  We are listening.   We want to know how to close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives.    21st Century Cures is a truly collaborative effort. Please be advised that submissions sent to cures@mail.house.gov will be made publicly available on energycommerce.house.gov/cures as part of the effort to encourage continued discussion about opportunities and ideas to accelerate the pace of cures.   We thank you for participating.”

From the standpoint of a permanently disabled ADR victim, there are some concerning aspects to this initiative, which is heavily supported by the pharmaceutical, biotechnology, and device industries.      I sent a somewhat sanitized version (not as many snide remarks about Pharma) of my “Plan” above, which I re-titled “21st Century Cures Initiative ADR Proposal”.     I would encourage any victim of any type of ADR, or anyone else interested in this topic, to also write to these folks with your own ideas and stories.    Admittedly, we’re late to the game, as the House Committee on Energy and Commerce approved the 21st Century Cures Act on May 21, 2015.    So they are no longer making changes on the committee level.    However, I contacted them and received an email saying they will receive comments and proposed changes.    So hearing from lots of people about this issue is probably the only way they’ll get a clue.    They hope to have the bill on the floor sometime this month (June 2015), so if you’re going to act on this, it should be soon.    If you can’t think of anything to say to them, feel free to send in my 21st Century Cures Initiative ADR Proposal.

July 2015 Update on the 21st Century Cures Act:   Understanding the Controversies Over a Groundbreaking New Health Care Law

 

Please Forward and Share This Link With Everyone You Know

Every single person reading this is at risk for ADR’s in their lifetime.  No one is exempt.   So please share this link with everyone you know through personal emails, Facebook and other social media links.

When I look back at what I just wrote, it’s hard to believe I was so in the dark about my own risk for this prior to my own ADR.    ADR’s are only “rare” until they happen to you.   It only takes once, as I and so many others have found out.   So do your best to use the “Big 6 Clues” and whatever other personal strategies you use to stay safe, as that appears to be our best option so far.

Writing to politicians can feel like a true exercise in futility.    But it IS one avenue open to us, and only takes a few minutes of your time to shoot off an email these days.

Yes, chances are pretty slim of any real change occurring, but as Warren says here in this impassioned video clip, it’s a numbers game, and “The only way we get change is when enough people in this country say “I’m mad as hell and I’m fed up and I’m not going to do this anymore”.    So put aside your jadedness for a few minutes (as I had to) and take a few minutes to email Sen. Warren and the 21st Century Cures Initiative Committee to demand changes you’d like to see in the system overall and make your voices heard on these issues.   Because until and unless these changes occur, we’re all Sitting Ducks, Sacrificial Lambs, and Playing Russian Roulette with Pharma.    And you will be at risk of ending up like me.

 

 

Additional Resources:

FDA FAERS Reporting by Patient Outcomes by Year
When Medicine Hurts: The Silent Epidemic
Death from Prescription Drugs: The New Epidemic Sweeping Across America
The Pharmaceutical Drug Epidemic
New Prescription Drugs: A Major Health Risk With Few Offsetting Advantages
Adverse drug reactions kill 197,000 Europeans annually
The Epidemic of Silence with Adverse Drug Reactions
How Independent is the FDA?
Frontline: Dangerous Prescription
Bad Medicine: The Awful Drug Reactions Americans Report
Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?
Watchdog Group: Avoid 181 Prescription Drugs. Public Citizen Cites Poor Safety, Safer Alternatives for Most
6 Drugs Whose Dangerous Risks Were Buried So Big Pharma Could Make Money
Drugs most frequently reported for adverse reactions
Medical Mistakes Make it Dangerous to Go to a Hospital  
Medical Errors Should Not Be Our Third Leading Cause of Death    An excellent read.  “Here are six obvious, practical, common sense effective ways to prevent medical mistakes, reduce deaths, and lengthen lives.”

 

 

Table Of Contents