While the world was still celebrating the New Year, the United States Food and Drug Administration (FDA) released a statement regarding an international outbreak of measles. Most of the cases were linked to vaccines, and one brand in particular — Viagra.
Concerned that this could be the start of a larger outbreak, the FDA required drug manufacturers to issue a warning about the possible side effects of their products. Specifically, they stated Viagra and Cialis could raise the risk of stroke and bleeding, particularly in men with existing cardiovascular conditions.
It was a dramatic move, but what was the reason behind it?
Let’s take a trip back in time to December, 2018.
Measles
On Dec. 6, 2018, the World Health Organization (WHO) declared the start of a new era in the fight against communicable diseases. It was reported that more than 1.7 million cases of measles had occurred worldwide in 2018, more than double the number of cases seen in 2017. And the trend wasn’t showing any signs of slowing down. In fact, since the start of this year there have been more than 100,000 new cases reported each week.
With the number of cases skyrocketing around the globe, it’s no wonder health experts have been left perplexed. While the vaccination rates have increased, resulting in fewer cases of measles, other infections have seen a surge in preventable illnesses. Most cases of measles are preventable through vaccination. But as people become less likely to be immunized, the risk of outbreaks such as this one increases.
Viagra
Measles isn’t the only disease that has seen a resurgence in 2018. The same can be said of the sexually transmitted disease (STD) known as human immunodeficiency virus (HIV). While the number of new cases decreased in 2017, the rate of infection remained steady. In fact, there were more cases of HIV in the U.S. in 2018 than in any previous year. The Centers for Disease Control and Prevention (CDC) attributes the increase in HIV cases to the fact that more people are becoming aware of their status and seeking treatment. However, not everyone agrees. Conservative politician Pat Mullins from Virginia sees the increase as a direct result of the LGBT community’s push for equal rights. He asserts that many gay men are choosing to take advantage of the fact that HIV has a much more hopeful outlook these days and are focusing on their health. He says the disease is now considered “manageable”, which has a whole different meaning when applied to HIV.
Cialis
Another drug that saw a surge in use in 2018 was Cialis. The erectile dysfunction (ED) drug topped the list of pharma revenue’s “Top 10 Products” for 2018, bringing in $9.9 billion in global sales.
This is almost certainly a result of more people discovering the benefits of the daily pill. Cialis has been around for 20 years, and like many other pharmaceuticals, has undergone various trials and been tested on a large scale to establish its efficacy and safety. One of the studies that helped to create awareness about the drug was the TreatMENT trial, which evaluated Cialis in combination with either vardenafil or tadalafil against a placebo. Study participants were required to take daily supplements for 12 weeks, and then were allowed to self-administer the medication for an additional four weeks. Based on the results of this trial, Cialis has been approved in the U.S. for the treatment of ED in adults, and has seen sales increase by 132% since 2012.
The Debate
While the FDA has cracked down on some pharmaceutical companies in the past over fraud-related practices, the agency has generally remained neutral when it comes to prohibiting or allowing drugs to be sold over the counter (OTC). This is largely because the agency recognizes that when it comes to medicines, the risks usually outweigh the benefits. That being said, the agency does have the authority to approve or disapprove new drug applications, which they did for Viagra and Cialis.
For decades, the debate over whether or not to allow pharmaceuticals such as Viagra and Cialis to be sold OTC has been contentious. And although the FDA has not yet approved the drugs for OTC sale, the debate continues. For instance, in 2018 the FDA approved a new drug application for Reveal, a once-a-day medication that treats erectile dysfunction. However, it is a prescription drug, and as a result, must still be approved by the FDA before it can be sold across state lines.
The Future
Even if the FDA were to lift its ban on the OTC sales of Viagra and Cialis, it wouldn’t necessarily mean that every state would follow suit. Some — particularly in the south — still cling to the tradition of “medicine man”, referring to the old days before mass vaccinations when people would seek out practitioners who practiced alternative medicine. In these states, pharmaceutical companies face a legal battle, as they cannot simply distribute their products across state lines. That being said, the trend towards legalization and medicinal marijuana is leading to a more conducive environment for pharmaceutical companies to do business.