What does it mean when we say a drug is being used “off label”? Technically, this means that an approved medication is being prescribed for an “unapproved” use or “indication.”
This may sound a little scary, but this practice is quite commonplace and should not be reason for alarm in most cases.
Medications, both prescribed and those sold over the counter (OTC) undergo extensive safety and efficacy trials within the manufactures and through their application process at the FDA (Food and Drug Administration). Often people do not realize that this process generally takes many years. Then, after extensive exposure in the marketplace, a medication that was studied and approved for one condition may exhibit a “side effect” that is discovered and eventually considered a viable treatment for a different condition altogether.
There are countless examples of these instances. There is a medication that was originally approved for itching, but it was found to increase the appetite, so it is now often prescribed to people who are not eating well. There is a medication for ulcers that was found to cause spontaneous miscarriages when taken orally which is very sad, but in trying to figure out how this happened, it was found that when used topically, it could induce labor in a woman who needs help with cervical dilation and thus helping the mother to have a safe delivery. One famous example was Rogaine. It was originally developed and used to treat high blood pressure, but the side effect “outgrew” (pardon the pun) the original purpose when it was discovered that previously bald men were growing beautiful heads of hair again. Some of these “unapproved” effects were happy accidents and others were/are actions or reactions that were totally expected. You may be asking the logical question: Well, if this is the case, why not just get the drug approved for the new or secondary use that was either previously known or later discovered?
It’s important to understand that Drug Manufactures often weigh their options based on the time investment, energy and expense of taking a drug through the arduous approval process for a secondary or new indication. Often, the process is deemed cost prohibitive or it is decided that an additional delay in releasing a pharmaceutical would cause undue hardship by postponing patients access to a viable treatment for the primary indication.
In addition, I would be remiss not to mention the financial factor. Pharmaceutical companies are eager to get their medications to market to start recouping the dollars they had to spend on research and development and the legal and administrative process to get the drug to the launch pad. There is also extreme competition between companies, the BILLIONS of dollars they spend in advertising each year and the dreaded patent expiration deadline. Often by the time a drug makes it to market, there may be only a few years left on the patent after which anyone can manufacture the chemical compound. For all these reasons, we must recognize that these companies are frantic to get the safest most effective drug out first to capture the lion’s share of the market and thus the dollars. Like it or not, that is the just reality.
So why are doctors and pharmacists in many states being censored, restricted, and even threatened when it comes to prescribing or filling prescriptions for medications using the “off label” treatment for COVID-19? This is a legitimate question because often these are medications that have been on the market for decades and have great safety profiles. This is the Million-dollar question… or maybe the billion-dollar question. You may have heard about some oral, outpatient medications being used by doctors in the treatment of COVID, including Hydroxychloroquine, Azithromycin, Clarithromycin, Ivermectin, Budesonide, Dexamethasone, Aspirin, Zinc, and others. There has been a lot of buzz in recent months in social media, newspaper articles, and your favorite mainstream media outlet and much of it has been negative and scary. I find it interesting that many of the drugs that have returned to the spotlight and have been under great scrutiny recently are very old, commonplace, affordable generic medications.
To be clear, I’m not suggesting any of these medications are a cure all or even that they are right for the reader necessarily but, that decision should be between the patient, the prescriber and the pharmacist. Information, data, study results or different voices in the medical community with different ideas based on different clinical experiences should not be censored by the media for political or monetary gain and this may be what is happening. Sure, both the state and federal governments have a role in public safety and have an obligation to impose certain safety regulations on the healthcare industry but since when does Twitter, Facebook, MSNBC, etc., have a right to push an agenda to withhold information through censorship and biased “factchecking” services? These practices silence the healthcare provider, devalues his/her education and experience by inserting often biased media influences between the healthcare professional and their patients. Physicians, Nurse practitioners, Physician Assistants, Pharmacists and nurses as well as other healthcare providers and researchers all have free speech as well. Of course, healthcare workers are held to a high standard because of our oaths and our commitment to “public safety” but as we have learned in recent months, “public safety” has become a subject of much debate.
Fortunately, in Texas, our Pharmacy Board and our Medical board has determined that the decision to prescribe off label for the treatment of COVID is within the normal standard of practice and pharmacists are allowed to fill prescriptions pursuant to a doctor’s order in these cases. The Medical Board does prohibit the claim that these treatments are “cures” but they are allowed to be prescribed without fear of sanctioning. Also, the Pharmacy Board has published warnings about filling excessive prescriptions for the purpose of stockpiling. They have cautioned pharmacy professionals about the dangers of shortages that could result by mass stockpiling. They do not want to create a situation in which infected individuals or individuals who are taking these medications for other conditions are unable to get the care they need.
As a professional, I wonder about the motivations for preventing or significantly impeding patients from accessing potentially lifesaving treatments while under the care of a physician. Most of these treatments are not medications that can be purchased over the counter in the United States (although in many countries they are available without a prescription). This means that a licensed prescriber and a pharmacist are involved in the decision and they are evaluating the appropriateness and monitoring the effectiveness which in turn provides an acceptable level of safety.
When there are known effective treatments available, to withhold those treatments and force thousands to shelter at home and wait for a vaccine that may take months or years to come to market and may or may not be any more effective than the current flu vaccine, is disconcerting if not outright unethical. I believe it is a good thing that there may be options available that could possibly prevent an infection or reduce the severity of an infection when used in the right way with the right patient. We should ask ourselves what the motivation would be for the alphabet agencies to withhold legitimate treatment options while pushing a narrative that the world should stand still while we wait for NEW vaccines, NEW antivirals and NEW plasma treatments. These new treatments may be great, but perhaps if we look at all the options, we may find safer more affordable options in our current quiver of solutions. Treatments that might prevent the advancement of the disease and reduce hospitalizations and deaths.
What about the patient’s rights? Congress and the President just passed the “Right to Try” Law a few months ago giving patients access to unapproved or experimental treatments for terminal illnesses and yet many people across the nation do not have the “Right to Try” medications that have been approved for decades and are safe options for COVID-19 (which has become a terminal disease for many). Many doctors are afraid to do what they know to be right for fear that they will be sanctioned by their State Medical Board or get sued for a normal practice of medication therapy. I think this Pandemic has highlighted the reasons many of us have feared unbridled managed care and socialized medicine because when we turn control of our healthcare, our very lives, over to the government, the bureaucrats and the media, we are doomed. The government, Big Pharma, the media and the health maintenance organizations can and now it seems, decide who lives and who dies. That seems a little like a “death panel” to me. We have had more than our share of deaths in the Rio Grande Valley so do not be afraid to ask the tough questions.
Wake up America.
Editor’s Note: The above guest column was penned by pharmacist Cherie Hodges. It appears in The Rio Grande Guardian with the permission of the author. Hodges can be reached at: [email protected].