Our lives begin to end the day we become silent about things that matter – Martin Luther King

Recently, the non-profit organization Benzodiazepine Information Coalition (BIC) and World Benzodiazepine Awareness Day (W-BAD) launched an initiative, asking the iatrogenically injured benzodiazepine community to report their adverse events and injury caused by benzodiazepines to the FDA’s MedWatch Program.

The initiative developed after speaking to the non-profit organization Public Citizen which has an especially successful track record of petitioning the FDA for labeling changes around dangerous drugs. A lot of their success comes from their passion, the high-caliber quality of their volunteers and employees, and their large access to funding to fight fights individuals themselves and small groups would never be able to afford to take on. From Public Citizen’s website:

Public Citizen has been assessing the quality and efficacy of drugs and devices since its founding in 1971. When we feel that the information provided to doctors or patients is misleading, insufficient, or just plain wrong, we do not hesitate to express an opinion. Worst Pills, Best Pills, our monthly print newsletter and our Web site WorstPills.org have been at the forefront of the provision of information to patients. We also use the law, petitions, and letters to monitor the FDA and coax the agency into action. Our actions have contributed to 23 drugs being pulled off the market. Public Citizen has also been instrumental in getting “black box” and other warnings on drugs.

Upon speaking to the kind, knowledgable and helpful Public Citizen folks in their DC office, they informed us that benzodiazepines are on their “Worst PIlls” list of drugs, flagged drugs to never take. We informed Public Citizen that there was a petition in 2010 submitted to the FDA by benzodiazepine activists which was denied (to see that petition, follow this link and scroll to the bottom of the page). Public Citizen encouraged us not to give up and that many times, as was the case with the fluoroquinolones and other drugs, it takes more than one petition attempt to elicit change. Public Citizen reminded us that there is a general consensus in the drug world that only about 1 percent of serious events ever get reported to the FDA and encouraged our community to report. They also suggested for us to re-petition the FDA, but only if we can present new evidence of harm since the last petition.

BIC and W-BAD believe there is new compelling evidence of risks, dangers, and harms since 2010 that can be presented with the help of the benzodiazepine community. We also believe that we can, hopefully with the help of Public Citizen and perhaps other similar non-profit organizations (like Quarter Watch), develop a compelling second petition to the FDA.

We cannot do it alone, however. We need the benzodiazepine-injured community in the United States (as the FDA is solely a US government organization) to organize and support this effort. We need you to help us help you.

If you are neutral in situations of injustice, you have chosen the side of the oppressor – Desmond Tutu

It is no coincidence that Cipro and Levaquin were in the 10 most reported drugs to the Medwatch system by healthcare practitioners and consumers in 2011. This is, no doubt, why the fluoroquinolone class of drug received a black box warning (the FDA’s strongest warning on products), with follow up instructions to doctors to change their prescribing of them after successive FDA petition attempts.

Essure, a permanent birth control system which harmed many thousands of women, had similar results in petitioning the FDA and receiving a black box warning:

From November 2002 to May 2015, the agency received 5,093 reports about Essure. Most of the reports were voluntary and came from women experiencing problems.

Prior to the FDA panel review of the device in September 2015, the agency said it found 20,000 complaints from women who shared stories on Facebooks and Twitter [similar to how our community shares our experiences online]. In addition, the FDA also saw a “dramatic increase” in reported adverse events.

Upon discovery of this increase in adverse event reports, the FDA called a panel hearing on Sep. 24, 2015. During the meeting, the FDA noted more studies and it ordered Bayer to conduct postmarket surveillance studies about Essure’s benefits and risks. Despite the fact that some women were advocating a ban of Essure, the FDA did not ban the device, but it did recommend a black box warning — its most serious warning — for adverse events and also issued recommendations. Some of the FDA recommendations for Essure focused around provider education and informed consent for patients (both of which benzodiazepine activist efforts have been calling for for decades). The agency advised that:

  • Patients should be carefully selected and should sign a patient checklist acknowledging they understand complications.

  • Doctors should counsel patients on risks.

  • More training is needed for physicians.

Aside from the above, the Essure patient activism efforts also garnered news attention and legislation. Because of patients’ groups formed by women injured by Essure — including the Facebook support group Essure Problems — a number of lawmakers took notice and sponsored bills intended to make medical devices safer. Even Erin Brockovich joined the campaign alongside the women harmed by Essure and Googling ‘Essure class action lawsuit’ and ‘Fluoroquinolone class action lawsuit’ now returns pages and pages of meaningful results that are currently in the litigation or settlement phase.

Notice the similarities in these two cases? Both the fluoroquinolone and Essure injured communities organized and managed to compel its injured members to report their injuries to the FDA. They also sought assistance from health and patient safety advocacy groups like Public Citizen. Now ask yourself if benzodiazepine victims deserve the same outcome and if you want this to stop happening to future generations? Is the inconvenience of filling out one fairly simple form worth changing the direction of benzodiazepines? Every single participation matters.  Many of us spend months to years disabled by these drugs. That warrants filling out a short form.

For those who are still unconvinced or skeptical, perhaps making the argument that the benzodiazepine class of drugs have been causing prescribed harms for almost sixty years with one failed FDA petition under their belt, consider Darvon and Darvocet. Both drugs were on the market from 1955 to 2010 (55 years) and were recalled because of serious toxicity to the heart with 2,110 deaths reported between 1981 and 1999. The UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen. (Please note that BIC and W-BAD are not calling for and have never called for a total ban or recall on benzodiazepines, as we are aware that benzodiazepines have some relevant very short-term uses and that already-dependent patients need continuing prescriptions to taper.) The reason for the ban on these was because the two drugs named had compelling evidence that they injured patient’s hearts and there were other drugs that were similar enough these two brands were not needed.

When it comes to drug harms, it is similar to a court of law: if there is no evidence, it essentially didn’t happen. Everyone is familiar with hearing stories of abuse where no police report is ever filed by the victim, usually out of fear (this is not a judgement on abuse victims who do not report their abuse, but rather just an example for comparison sake). As a result, the victim may not  receive the protection and safety they are entitled to, or they may be downright disbelieved, because they did not create a paper trail of the abuse. If, as an injured community, we fail to report the adverse benzodiazepine and/or Z-drug drug events, the FDA can simply say “it was not reported, therefore it did not happen”.

The world will not be destroyed by those who do evil, but by those who watch them without doing anything – Albert Einstein

Similarly to victims of abuse, people who have been iatrogenically injured by benzodiazepines are scared, paranoid and distrusting of “the system”—and understandably so, as this is the same system that initially failed to protect them, harmed them, and sometimes then harmed them twice by flat out denying the existence of their harm. Many in the benzodiazepine-injured communities have expressed trepidation about reporting their harm, concerned over privacy or that the prescription they are using to taper off of the benzodiazepines safely will be refused or revoked. The fear and hesitation is understandable, but is not really warranted.

The FDA offers the following statement in regards to the privacy of the MedWatch reporting system:

FDA recognizes that confidentiality is an important concern in the context of adverse event reporting. The patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to allow for timely follow-up in serious cases, the reporter’s identity may be shared with the manufacturer unless specifically requested otherwise. The FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

It is also important to note that, pursuant to HIPAA laws, your medical providers and pharmacists are allowed to report adverse events in their patients (perhaps even in your case) to the FDA without first obtaining your consent:

HIPAA specifically permits covered entities (such as pharmacists, physicians or hospitals) to voluntarily report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.

Similar concerns have been voiced that the MedWatch form is “too hard” or “too confusing” to complete. We understand that with the cognitive impairment that often results from benzodiazepine prescription, use and/or withdrawal that it is often difficult to complete tasks such as reading, writing, typing, etc. For this reason, Dr. Christy Huff of BIC, with several other volunteers who understand the form, have graciously volunteered their time and energy to help anyone who needs assistance completing the form. You may also ask a family member or friend to help you complete the form, as you do not have to be the one to complete it in order to submit. Please also keep in mind that the form is essentially composed of an empty box where you type out the harms that the drug caused you. Many people do that on facebook support groups and in forums all day.

It is time for people to show up in droves to report this drug that has abused and taken uncountable lives. We constantly see posts made and shared and online with an undertone of desperation (and sometimes warranted anger) asking for help, recognition and change. W-BAD and BIC want to help, but you must make the report first!  Without these reports, we have no evidence to go further and our hands are tied. Without these reports, the victims of benzodiazepine abuse will be forced to remain in the echo chamber that are the largely “underground” support groups until they are ready to organize themselves and take the formal steps. The sooner we organize, the more help we can get, the faster we can move to the restorative phase of addressing our injuries legally, and the more maiming, suffering and loss of life we can prevent. It’s a no brainer. Every report counts. Unfortunately, the burden has been passed to us, the victims, to take action.  We need to answer the call, or concede that we lost. Which one should we choose?

Success is not final, failure is not fatal: it is the courage to continue that counts. ― Winston S. Churchill

Please also note that the benzodiazepine victim support forum BenzoBuddies has recently gotten behind this initiative with support and posted information asking its members to participate.

In summary,

Who should complete the MedWatch voluntary reporting?

  • Injured patients (this includes people at all stages: those in tolerance, those tapering, those in CT, those who are healing or already fully recovered)

  • Families of injured patients, if their loved ones died or are incapacitated as a direct result of benzodiazepine prescription

  • Medical professionals (which can include your doctor or pharmacist). Please note this is an optional additional step, and not required for you to complete your form.  If convenient and safe, you can ask them to fill one out in your next visit.

Your report should remain factual and be as comprehensive as possible. The FDA does not want to hear about how you’ve learned that this is a 60-year scandal nor are they likely to watch a YouTube video you send them made by your friend Jane about her benzodiazepine withdrawal. Please just stick to the facts of your own case when reporting.

So, what have we learned from looking at the examples of other drug-injured communities?

  • Reports to the FDA MedWatch program are used as compelling evidence to make changes in drug labelling/warnings and/or to remove dangerous products from the market

  • For-the-people non-profit organizations like Public Citizen can and have had success petitioning the FDA about dangerous and harmful drugs

  • It sometimes takes more than one FDA petition to be successful

  • Telling your story on social media (Facebook, Twitter, YouTube, etc) is not always for naught (see the Essure case where the FDA found 20,000 complaints from women injured by the product on social media). Remember this for World Benzodiazepine Awareness Day on July 11th.

  • If you don’t report it, it didn’t happen

  • Warnings on drugs and/or labelling changes and drug market status can happen even after many decades of prescribing

  • When these injuries are noted, oftentimes legislation and/or class action lawsuits can follow as a result

  • The FDA can and has advised, in the cases of certain drugs/products/devices, for physician training and/or informed consent (exactly what benzodiazepine victims have been calling for)

  • Lastly, and perhaps most importantly, the organizing of drug-damaged communities works, so long as community members participate. BIC and W-BAD are run by and composed of mostly benzodiazepine-sick members who cannot fight or do this alone. Without a supportive and active community that is willing to get behind us in initiatives, we will accomplish nothing and may as well close our doors.

There is, and always has been, power in numbers. We know there are many thousands of us injured. In any grassroots activism movement, the change results from the collective efforts of community members who show up in unity to support initiatives aimed at change. Aside from the FDA MedWatch report, this goes for all other initiatives too, such as campaigning in your respective locations, participating in World Benzodiazepine Awareness Day and the like.

Please do not question that benzodiazepine policy will change in the coming years.  With the focus on opiates, and bills such as the one in Hawaii that never consulted a single benzo victim, it is clear they’re hitting the national radar. It comes down to whose story will be told?  The physicians and lawmakers who ignored us, or the victims themselves. If we are tired of people dismissing us, we must act on opportunities to set the story straight.

Never doubt that a small group of thoughtful, committed citizens can change the world; indeed it is the only thing that ever has – Margaret Mead

Thank you for completing the FDA MedWatch report, for organizing in unity as a community, for your participation in World Benzodiazepine Awareness Day on July 11th, for continuing to share your stories far and wide, and for your future support of BIC and/or W-BAD in important upcoming initiatives. Thank you for helping us to help you.

To participate in the FDA MedWatch Report initiative go here.

To participate in the FDA MedWatch Report initiative, instructions on how to complete the report can be found here.

How else can you help us help you? Please share this initiative and encourage your peers to participate.