Actions Speak Louder Than Words

For years now, women have suffered at the hands of drug companies and the Food and Drug Administration. Women have died because of the exclusion of women in drug research trials. The FDA has done the bare minimum to improve the drugs marketed towards women. Even though a large percentage of women are being harmed by drugs, the FDA is very lax about how drug companies conduct their research and who they market towards. I think that we cannot allow the FDA to continue ignoring the needs of women and the women dying because of the drugs that have been marketed towards them. 

Source: Michelle Llamas

Actions speak louder than words. We cannot have an organization - that is meant to prevent citizens from receiving harmful products - that is allowing companies to create drugs and then market them to a gender that they have not tested those drugs on. We cannot have an organization that is creating policies that state that these companies must perform studies with all genders if that organization is not putting in the effort to enforce those policies. What is holding drug companies accountable if there is no enforcement? Nothing. They will do what they view is best for them without care for who they are hurting in the process. 

In Doing Harm, Maya Dusenberry (2018) says the rationale that drug companies provide for not studying their drugs on women is because they are complicated and it is more difficult to study women's results. Because of this it does not make sense to me why researchers won't study their drugs on women but will still market their drugs to them. Obviously drug companies do not care too much if women react poorly to their drugs, so long as they can gain a profit from those women. Because drug companies are not studying their drugs on women, women are being harmed and even dying. One example of pharmaceutical companies harming women by not adequately studying their products is in the product of Essure. Essure is a birth control device that creates scar tissue in the fallopian tubes. In 2002, the FDA approved this device and since then they have received over 5,000 reports of harm being done on women who have this device. 

Source: Paul Venema 

Another example that fits with harm being done by both the FDA and the pharmaceutical companies is what happened to Julie Ann Bronson. In Michelle Llamas article (2018), she lays out how Bronson was convicted after hitting three people with her car and continuing to drive until she was stopped by police. In Bronson's testimony she explained that she had take two Ambien - which is a sleeping aid - after she had some wine and then went to bed. She said she had no memory of what happened. In KSAT's report of the incident and the hearing, a toxicologist Dr. Janci Lindsay testified that sleep driving is one of the side effects of Ambien. If sleep driving was a known side effect why were individuals still being prescribed Ambien? This side effect resulted in damage being done to the three individuals who Bronson hit and to Bronson herself. 

In 2014, 60 Minutes did a report on Ambien. In this report, it was found that doctors wrote about 40 million prescriptions on this drug every year. Eventually, it was revealed that women were being recommended a dosage that was more than they needed and this resulted in an increase of the risk for impaired driving (Llamas, 2018). Julie Bronson must have been one of those individuals who was still taking too much, because of these incorrect dosages, and this may have been the reason why she went driving but could not remember a thing. After this information came the FDA cut back on the dose for women, but it was revealed that the FDA knew about this issue in 1992 when they received data showing that the amount of Ambien in a woman's blood was 45% more than in a man's. The FDA chose not to act until the public became more aware of this issue (Llamas, 2018). 

The FDA has made surface-level steps to try to rectify the wrongs they have caused by allowing pharmaceutical companies to conduct their research however they want. They have created solutions to this issue which are not really solutions. In 1988, the FDA created guidelines which told drug companies to analyze their data by gender, but half of the studies reviewed failed to do so (Dusenberry, 2018). Here the FDA created rules for companies to follow for their studies, but the FDA did not have any enforcement power to ensure that these companies were following these guidelines. So, most of these drug companies continued ignoring the results that their studies conducted with women gave. 

Source: HerStories - Pratt Info School

In 1977, the drug thalidomide - used to prevent morning sickness - was revealed to have caused severe birth defects. After this became public, the FDA banned women who could become pregnant from participating in these studies (Llamas, 2018). This in turn ended up banning practically all women from participating since most women can get pregnant. This may have set a precedent for future studies and led researchers to not include women because they could complicate the results. What's interesting is that the FDA chose to ban women from participating rather than banning the drug. This specific drug is going to be marketed to pregnant women, so if in the studies pregnant women are being harmed this drug should be removed instead. 

For the FDA to just place policies with any real enforcement does nothing for women taking these drugs. Drug companies will continue to study mainly on men and disregard women for being too complicated. For most pharmaceutical companies, their objective is to get more money. So, if they can conduct their studies on the "easier" gender and be able to get their drug out on the market quicker, that is what they are going to do. The Food and Drug Administration needs to put more weight on their words. They need to have some mechanism for punishment for drug companies instead of urging or encouraging drug companies to include more women in their studies. Words are incapable of persuasion in these cases. Actions are much more powerful. 

Sources:
Dusenberry, M. (2018). Doing harm. New York: HarperOne.
Llamas, M. (2018). How the fda let women down. Retrieved from https://www.drugwatch.com/featured/fda-let-women-down/