The Food and Drug Administration (FDA) is often a poorly understood component of the healthcare industry, sometimes viewed as unnecessary, the bad guy, or a champion of the people. We’ve mentioned the FDA’s role a few times in our articles, and this time rather than it being a one or two paragraph mention in the middle of other topics, we’re going to dig in specifically on the FDA.
Before the FDA
To understand the importance of the FDA, we have to look back in time a bit, to get an idea what was going on that lead to it’s rise.
You’ve probably heard the term “snake oil” before, and haven’t thought much about it. The name originates from 1800’s, when Chinese immigrants brought with them an Eastern medicine remedy for pain and inflammation: oils from a chinese water snake. It gained popularity with railroad workers here in the United States to lessen the pain of a hard day’s labor. And, of course when it became popular, suddenly there were a ton of different people selling snake oil to help with those aches and pains.
There’s three problems with this:
- There’s not a whole lot of evidence that the snake oil worked, or how it worked if it did. It contained Omega 3 fatty acids that may have affected inflammation in joints and muscles. Without some real research, though, it’s hard to say if it really worked.
- Almost all of the products being sold after the initial wave of popularity contained zero snake oil, despite making claims otherwise. One of the most famous, Stanley’s Snake Oil, contained mineral oil, beef fat, and turpentine.
- There’s nothing that tells a potential user that the ingredients in the Stanley’s “snake oil” isn’t actually harmful. Turpentine, for instance, can cause difficulty breathing when inhaled, or cause burns or blueish skin coloration in some people.
Snake oil (and snake oil salesmen) became synonymous with the idea of fake medicine that preyed on a populace that had little or no access to information about the active ingredients, and no regulatory bodies that could verify claims or ingredients. In the best case scenario, snake oils failed to be beneficial. In the worst case scenario, they could extremely harmful.
States began creating a patchwork of regulations, but it varied from state to state. Testing to verify ingredients, claims, and purity had no universal process or even recommendation.
And medication wasn’t the only problem. Our food supply even suffered from a similar lack of consistency. Ground beef or sausage could contain, well, anything. There were few standards for handling how long meats could remain on the shelf before sale. There was little or no testing for dangerous pathogens or spoiled products. (Since this article is on the FDA’s role in medication, we won’t be digging further into the food supply issues, or even it’s role in counter-terroism.)
In 1906, President Theodore Roosevelt signed the Food and Drug Act into law, giving the first real framework to an overall solution. This first act set up for a variety of agencies who over saw:
- Quality & Strength
The 1906 law didn’t cover everything – it just acted as a starting point. More laws were passed as time moved forward, such as the 1938 Food, Drug, and Cosmetic Act. There, the FDA was branched into dealing with cosmetics, but it also changed how medications were dealt with. Now, instead if just testing quality, for instance, the idea that a medication had to be beneficial began to arise.
Pre-market approval has been one of the areas that has changed considerably over the years. It wasn’t enough so say that a medication was useful for diabetes – it had to be proved before it could ever be sold. This sounds like a very obvious concept, but when you look back at the above section concerning snake oils, why it’s required becomes evident.
Effect On Modern Healthcare
One of the first things it did was establish some consistency. It might sound obvious that if a medical professional prescribes 200 mg of ibuprofen, the patient expects that they will receive 200 mg of ibuprofen. The medical professional expects a certain level of results from that 200 mg – if the medication is inconsistent, there’s a chance for over or under prescribing. With ibuprofen, that might not be a big deal. With a heart medication, inconsistency could be lethal.
It also established a standard for the concept of evidence based medicine. Just saying a medication does something wasn’t enough, nor saying it wouldn’t harm a patient further; it now had to be rigorously proved.
Accountability also became a huge thing. Prior to a federal level system, it wasn’t particularly easy to handle a situation where a product may have further complicated someone’s health issues. Or, the product flat out didn’t work.
Honesty in marketing and branding are one of the other things that ends up being a big deal, though it’s often difficult to monitor and enforce, particularly in the Internet era. The idea is simple: you can’t stay a product cures diabetes unless it cures diabetes. You also can’t market it as having ibuprofen in it if it doesn’t actually have ibuprofen in it. Like a lot of the things mentioned in this article: it seems like common sense, but without laws and someone to enforce it, it happened a lot.
Why The Bad Guy?
At the beginning of the article, it was mentioned that sometimes the FDA is viewed as the bad guy by some, and viewed as the champion of health by others. We’ll avoid conspiracy theory material here, and instead focus on what could be perceived as a serious shortcoming of the FDA approval process that gets it painted in a bad light.
For a medicine or medical device to be approved, there’s quite a long research process involved. It may take 2 to 5 years for a new medication to finish all it’s clinical trials, and reach the FDA approval level, which then may take another 6 to 9 months to complete based on the trial results. If there are questions as to it’s effectiveness, or if it may represent a potential harm to the public, the medication may have to go back through the process all over again.
In the Internet connected era of communications and news, everyone is clamoring for a great story. So, it’s not too uncommon to read headlines such as “New discovery cures cancer!” But, that new discovery has to go through the while FDA process: testing has to be done, clinical trials have to be done, the medication must prove it’s self, and it has to go through FDA approval. If someone has a friend or family member suffering from a disease that the new medication could potentially help, it’s hard to see a new medication take so long. (And, it should be pointed out: sometimes those headlines are completely wrong. A “cure for cancer”, for instance, is a really complicated issue, since not all cancer is the same.) Since the responsibility to make sure medication is safe for everyone who uses it stops with the FDA, they are painted as the bad guy.
But, the FDA has evolved over the years, and a great example of this the Expanded Access setup (otherwise known as “Compassionate Use”), which allows for special access to medications that have reached the point of entering trials (investigational medications). This means there exists the potential for life-saving medications to reach patients quicker in certain situations – though, there’s a risk involved with it, since the medication hasn’t gone through all it’s trials yet.
While that might seem like a win for everyone involved, it isn’t. Take the case of an AIDS medication in the 90’s:
In the second week of March 1990, headlines across the country described an unusual scientific controversy over the distribution of an investigational drug called dideoxyinosine (ddI) to thousands of patients with acquired immune deficiency syndrome (AIDS). Newspapers reported that patients receiving the drug through a new expanded access program had a much higher death rate than patients enrolled in conventional clinical trials of the drug. In one case, a Harvard faculty member was quoted as saying that death rates in the expanded access program were ”a disgrace, an absolute disgrace.'”
The paper linked above, and the quote, shows why the FDA is careful about allowing medications out into the marketplace too quickly, and why even that draws criticism at times.
Simply put the FDA:
- Moves Too Fast
- Moves Too Slow
- Allows Too Much Access To Things Being Researched
- Allows Too Little Access To Things Being Researched
- Is Too Restrictive
- Lets Too Much Past
It’s a system that isn’t ideal for every situation, but it’s provided a vast improvement on where food and healthcare was at one time, and continues to be refined with time. It will never be a perfect system – that’s not possible for every scenario.
As the science of medicine continues to progress, the FDA will continue to move with it. New ideas, such as certification for biological medical entities (for example, maggots used for medical procedures) are always being added to the FDA’s list of concerns. It might be easy to think the FDA has covered most of the bases for medicine, and there’s little likelihood of it having to brach out farther. If you look at how far medicine has come since the first Food and Drug Act was passed in 1906 – they were most concerned about medication. Concepts like MRI machines weren’t a consideration back then, and it’s impossible to say what new concepts will be under the FDA’s pervue in another 110 years.