According to the FDA, it “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” Given this mission, it would seem to follow that the FDA should put the interest of public health ahead of other concerns, such as the profits of a pharmaceutical company. While many of those employed by the FDA are dedicated to this mission, federal agencies have an alarming tendency to be captured by industry. As such, it is hardly surprising that the FDA has acted in ways that benefit companies at the expense of public health. Charles Seife has provided a documented account of how this can occur in his article in the February 2018 issue of Scientific American. While the legality of this matter is up to the law makers and courts, the ethics of the matter are philosophically interesting.
On the face of it, the moral problem should be easy to solve. Since the FDA is tasked with protecting public health and is a federal agency, its moral duty is to do just that. To act in ways that put public health at risk to benefit a company would seem to be clearly wrong. Part of the problem, as noted by Seife, is that the FDA is very secretive, and this makes it difficult for the public to know the truth about the operations of the FDA and the products that it approves. Another part of the problem, also noted by Seife, is that the FDA seems willing to allow research misconduct to remain unreported.
While it is tempting to suspect foul play when approved drugs are later recalled or given new warnings, it must be noted that this is just what should be expected even when products are properly evaluated. This is because of how the inductive reasoning that governs trials works. While inductive logic is essential, it has a fundamental problem that is called, shockingly enough, the problem of induction. Since an inductive argument’s conclusion always “leaps” beyond its premises, the conclusion of such an argument can always be false—even when all the premises are true. Since the controlled experiments of the trials are inductive in nature, they can be properly run and still yield a false conclusion. These trials are then generalized to the entire population—which is yet another inductive argument and another chance for things to go wrong. For example, even a large sample used in the trials will not contain every genetic or physiological variation relevant to how a drug interacts with a person. As such, a drug that was tested as safe in the trials might yield unexpected results in some people. As such, one should not rush to judgment if an approved drug turns out to be dangerous to some or needs a warning label revision. That said, the concern about how the FDA operates remains—as Seife’s research indicates. As such, the FDA seems to have acted wrongly by putting corporate interests ahead of public health.
One seemingly obvious solution would be to make the FDA’s process and the data it uses completely transparent to the public. Under this solution, the public would have access to everything that occurs within the FDA as well as all the information provided to the FDA by the companies whose products are being evaluated. While this would solve the problems noted above, there is an obvious problem with such complete transparency.
Allowing full public access to the FDA’s information would also allow the same access to competing pharmaceutical companies (and others with a financial interest in the data). Such transparency would allow access to a company’s trade secrets, commercial and financial information; the problem is that this could cause “substantial competitive injury.” To use an analogy, it would be like playing poker and being forced to allow everyone to see your cards. Because of the potential harms to the companies, such full transparency would seem to be morally wrong.
It could be countered that all companies would be on equal footing and hence no one would have an advantage. Going back to the poker analogy, if everyone must show their cards, no one has an advantage. The easy reply to this is to point out that foreign companies that do not undergo FDA approval would have access to the data and this could give them a significant edge against companies that sought FDA approval.
Another counter is to argue on utilitarian grounds: even if the transparency harmed the competitive edge of companies, the advantage to public health would outweigh these harms. The response to this would be argue that the harms to the companies would exceed the gain or that the harms to the companies would also harm the public health. Since these concerns are reasonable, complete transparency seems morally problematic (at least under the current economic system). As such, what would seem to be needed is an approach that protects the public while also protecting the legitimate interests of the companies.
As Seife noted in his article, the information that the FDA has kept from the public includes data about harmful side-effects and concerns about the efficacy of products. This information has been redacted or withheld based on the harm that would be done to the company if the truth about the product’s side-effects and efficacy were known. While it is true that releasing such information would potentially harm a company’s profit, this does not seem to be a morally acceptable reason. After all, the mission of the FDA is to protect public health; protecting private profit at the expense of public health would be a clear violation of this mission.
While a company or individual does have a right to keep certain information private, this right does not extend to concealing danger to others. To use an analogy, while I do have the right to keep my medical records private, I do not have the right to keep an Ebola infection secret. To use another analogy, while a company would have a right to keep its manufacturing process for snacks secret, it has no right to keep secret the fact that the key ingredient is the rats that infest the factory that makes the snacks. The public does not have a right to know their trade secrets; but they do have a right to know if the snacks contain rats made into snacks using equipment covered in rat feces. Likewise, while the public does not have a right to know the legitimate trade secrets of a drug company, they do have the right to know the side-effects and efficacy of the drugs they take. As such, the FDA can fulfil its proper mission of protecting public health while also protecting legitimate trade secrets. Companies that want to profit on concealing data from the public with FDA collusion might be dismayed by this, but they have no moral right to expect the FDA to serve their private interest over the public health—especially when they can still make massive profits by making safe and efficacious drugs.
The simplest issue that invalidates the basis of the question is this: the interests of patients and drug companies are aligned. Both want new drugs that improve on existing therapies. All drugs have side-effects. These side-effects can manifest differently in different people. However, both parties want drugs to be as safe as possible. Drug companies of course want to sell, and not to have their drugs held up at approval stage, and the testing and approval stage is already so long that in the US, patients’ groups have already managed to get “Right-to-Try” laws, allowing some patients access to drugs not yet fully tested.
And yes, some companies sometimes hope that some negative effects are unrelated, and wrongly try to hide them, just as there are some whackos who want to edit their own DNA with a homebrew CRISPR kit so that their nosess can glow green.
How to get badly-needed drugs through testing, and get the best infomation about their side-effects, is a hard problem, but categorising it as some kind of zero-sum proposition will not provide either clarity or progress.
And, incidentally,
federal agencies have an alarming tendency to be captured by industry
is at best selective. All government departments have a tendency to be captured by the people they deal with most – especially large businesses and unions. The US Department of Education is effectively headquarters of the United Educators’ Unions of the US, for example.
Sir Humphrey Appleby summed it up well, speaking of the civil service as the interface between government policy and organisations, saying (from memory) “… and since the government changes its policy all the time, and the unions never change their policy at all, it’s simpler to implement the unioons’ policy.”
At a disadvantage here – access to the Scientific American article requires a one-time payment or a subscription; without it, I cannot (and have not) read the article.
I get that he is speaking about some serious gaps in FDA processes. I did read the JAMA article you posted, and I definitely get the point – but does Seifert’s (or anyone else’s) research draw a specific connection between the FDA’s malfeasance and corporate profit? Has it been shown that they are deliberately ignoring violations in order to benefit large pharmaceutical companies?
Within the context of CoffeeTime’s observation, I would have to say that pharmaceutical companies would want accurate, unimpeded scrutiny by the FDA. For the FDA to allow poorly researched drugs on the market would not increase corporate profit, rather, it would be more likely to damage a company severely, perhaps irreparably.
As CoffeeTime says, the interests of patients and drug companies are aligned; misconduct or malfeasance by the FDA damages both parties.
So again, I haven’t read the Scientific American article so I’m shooting from the hip here, but following the adage “Never attribute to malice what you can attribute to stupidity”, and realizing the FDA is a government agency, I suppose it’s quite possible that this entire issue is not the result of any kind of sinister plot to increase corporate profits and pocket some kickbacks, but rather plain and simple incompetence.
Drug companies are right to be secretive and paranoid. There are companies out there looking to break their patents. Even the smallest mistake could mean the loss of several hundred million dollars.
Or addiction and death for thousands…