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The FDA: Patients or Companies First?

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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.

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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.

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Adult ADHD & Ethics

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In 2017, the World Health Organization released as six question “test” for adult attention deficit hyperactivity disorder (ADHD). While even proponents of the questions warn that people should not self-diagnose with the “test”, there is the obvious question about the effectiveness of such a diagnostic method. After all, as others have noted, almost every adult seems to exhibit the symptoms that the questions ask about. For example, difficulty in concentrating, unwinding and relaxing seem to be the plight of most people. I first learned of a similar sort of diagnostic tool at a mandatory training session on learning disabilities and another faculty member commented on this tool by saying “by those standards, I think we all have ADHD.” Everyone agreed. Because of these concerns, doctors tend to agree that the simple screening test is not sufficient to diagnose adult ADHD. While using an unreliably method of diagnosing adult ADHD would be problematic, there are also important moral concerns about this matter.

Coincidentally enough, many of the doctors who served on the advisory panel for developing the screening method have enjoyed the financial support of the pharmaceutical companies who produce the drugs used to “treat” adult ADHD. Such payments to doctors by pharmaceutical companies is standard practice and drives much of how treatment works in the United States.  Doctors who are not influenced by pharmaceutical companies as less inclined to prescribe the brand name products of companies, which is hardly surprising.

It is important to note that the fact that doctors are enriched financial by pharmaceutical companies that profit from ADHD drugs does not prove that the questions are not useful nor does it prove that they are wrong in expanding the number of people on ADHD drugs. After all, the possibility that a person making a claim is biased does not entail that the claim is false and to think otherwise would be an error of logic. That said, if a person is an interested party and stands to gain, then the relevant claims should be considered with due skepticism. As such, the doctors who are pushing the agenda of the pharmaceutical companies that enrich them should be regarded as lacking in credibility to the degree they are likely to be influenced by this enrichment. Which, one would infer, would be significant.  As is always the case in such situations, what is needed are more objective sources of information about ADHD. As should not be surprising, those who are not being enriched by the industry are not as enthusiastic about expanding the ADHD drug market. This raises reasonable ethical concerns about whether the industry is profiting at the expense of people who are being pushed to use drugs they do not actually need. Given the general track record of these companies, this sort of unethical behavior does seem to be the case.

Since I am not a medical doctor specializing in ADHD, I lack the expertise to properly assess the matter. However, I can offer some rational consideration of adult ADHD and its treatment with pharmaceuticals. The diagnostic questions focus on such factors as concentration, ability to remain seated, ability to relax, ability to let people finish sentences, ability to not procrastinate, and independence in regards to ordering one’s life. As noted above, these are all things that all humans have difficulty with at one time or another. Of course, even the proponents of medicating people do note that it takes more than the usual problems to make a person a candidate for medication. But, of course, these proponents do have a fairly generous view of who should be medicated.

One reasonable concern is that there are non-pharmaceutical methods of addressing problematic behaviors of this sort. While, as noted above, I am not an ADHD specialist, I do have extensive training in methods of concentration (thanks to running, martial arts and academics). As such, I know that people can be trained to have better focus without the use of profitable chemicals. Since these drugs have side effects and cost money, it would be morally and practically preferable to focus on non-chemical methods of developing positive traits. Aristotle developed just such a method long ago: training in virtue by habituation. But, it can be objected, there are people who cannot or will not use such non-pharmaceutical methods.

This is a reasonable reply. After all, while many medical conditions can be addressed without drugs, there are times when drugs are the only viable options—such as in cases of severe bacterial infections. However, there is still an important concern: are the drugs merely masking the symptoms of an underlying problem?

In the United States, most adults do not get enough sleep and are under considerable stress. This is due, largely, to the economic system that we accept and tolerate. It is well known that lack of sleep and stress cause exactly the sort of woes that are seen as symptoms of adult ADHD. As such, it seems reasonable to think that problematic adult ADHD is largely the result of the American way of life. While the drugs mask the real problems, they do not solve them. In fact, these drugs can be seen as analogous to the soma of Aldous Huxley’s Brave New World. If this is true, then the treatment of ADHD with drugs is morally problematic in at least two ways. First, it does not really treat the problems—it merely masks them and leaves the real causes in place. Second, drugging people in this manner makes it easier for them to tolerate a political, social and economic system that is destroying them which is morally wrong. In light of the above discussion, the pushing of ADHD drugs on adults is morally wrong.

 

 

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Getting High for Higher Education

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English: A domestic US propaganda poster circa...
English: A domestic US propaganda poster circa 2000. (Photo credit: Wikipedia)

Two major problems faced by the United States are the war on drugs and the problems of higher education. I will make an immodest proposal intended to address both problems.

In the case of higher education, one major problem is that the cost of education is exceeding the resources of an ever-growing number of Americans. One reason for this is that the decisions of America’s political and economic elites damaged the economy and contributed to the unrelenting extermination of the middle class. Another reason is a changing view of higher education: it has been cast as a private (rather than public) good and is seen by many of the elites as a realm to exploited for profit. Because of this, funding to public schools has been reduced and funding has been diverted from public schools to costly and ineffective for-profit schools. Yet another reason is that public universities have an ever-expanding administrative burden. Even the darling of academics, STEM, has seen significant cuts in support and public funding.

The war on drugs has imposed a massive cost on the United States. First, there is the cost of the resources devoted to policing citizens, trying them and incarcerating them for drug crimes. Second, there is the cost of the social and personal damage done to individuals and communities. Despite these huge costs, the war on drugs is being lost—mainly because “we have met the enemy and he is us.”

Fortunately, I have a solution to both problems. After speaking with an engineering student about Florida State’s various programs aimed at creating businesses, I heard a piece on NPR about the financial woes of schools and how faculty and staff were being pushed to be fund-raisers for schools. This got be thinking about ways universities could generate funding and I remembered a running joke from years ago. Back when universities started to get into the “businessification” mode, I joked with a running friend (hence a running joke) that we faculty members should become drug lords to fund our research and classes. While I do not think that I should actually become a drug lord, I propose that public universities in Florida (and elsewhere) get into the drug business.

To be specific, Florida should begin by legalizing marijuana and pass a general law allowing recreational drugs that can be shown to be as safe as tobacco and alcohol (that sets the bar nicely low). The main restriction will be that the drugs can only be produced and sold by public universities. All the profits will go directly to the universities, to be used as decided by boards composed of students and faculty.

To implement this plan, faculty and students will be actively involved. Business faculty and students will develop the models, plans and proposals. Design and marketing students and faculty will handle those aspects. Faculty and students in chemistry, biology and medicine will develop the drugs and endeavor to make them safer. Faculty and students in agriculture will see to the growing of the organic crops, starting with marijuana. Engineering students and faculty will develop hydroponics and other technology.

Once the marijuana and other drugs are available, the universities will sell the products to the public with all profits being used to fund the educational and research aspects of the universities. Since the schools are public universities, the drugs will be tax-free—there is no sense in incurring the extra cost of collecting taxes when the money is going to the schools already. Since schools already have brand marketing, this can be easily tied in. For example, Florida State can sell Seminole Gold and Seminole Garnet marijuana, while my own Florida A&M University can have Rattler Green and Rattler Orange.

One practical objection is that the operation might not be profitable. While this is obviously a reasonable concern, the drug trade seems to be massively profitable. Also, by making such drugs legal, the cost of the war on drugs will drop dramatically, thus freeing up resources for education and reducing the harms done to individuals and the community. So, I am not too worried about this.

One health objection is that drugs are unhealthy. The easy reply is that while this is true, we already tolerate very unhealthy products such as tobacco, alcohol, cars and firearms. If these are tolerable, then the drugs sold by the schools (which must be at least as safe as tobacco and alcohol) would also be tolerable. The war on drugs is also very unhealthy for individuals and society—so ending at least part of the war would be good for public health.

One moral objection is that drugs are immoral. There are three easy replies. The first is that the drugs in question are no more immoral than alcohol and tobacco. If these can be morally tolerated, then so can the university drugs. Second, there is the consequentialist argument: if drugs are going to be used anyway by Americans, it is better that the money go to education rather than ending up in the coffers of criminals, gangs, terrorists and the prison-industrial complex. Third, there is also the consequentialist argument that university produced drugs will be safer and of higher quality than drugs produced by drug lords, gangs, terrorists and criminal dealers. Given the good consequences of legalizing university-manufactured drugs, this plan is clearly morally commendable.

Given the above arguments, having universities as legal drug sellers would clearly help solve two of America’s most serious problems: the high cost of education and the higher cost of the ineffective and destructive war on drugs. As my contribution to the brand, I offer the slogan “get high for higher ed.”

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What Makes Drugs Bad?

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A box of Cannabis
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As the drug violence continues to escalate and the American economy continues to decline, the debate over legalizing drugs has heated up once again.

The basic economic argument for legalized drugs is that doing so will save law enforcement money and that taxing such drugs will bring in revenue. Critics point out that the taxes on alcohol and tobacco only pay a fraction of the cost of dealing the problems these legal drugs generate. In reply, the illegal drugs do not generate any income for dealing with the problems they generate. As such, taxing them would at least provide some income for dealing with the problems they generate.

The basic moral arguments for legalizing drugs are that doing do will reduced the harms generated in the current system (drug violence, imprisoning of non-violent people for drug crimes, and so on) and that people have a moral right to use such drugs (just as much as they have a right to the legal drugs).

While these are appealing arguments, it is important to consider what it is that makes drugs bad.

The first thing that is bad about drugs is the physical damage they do directly to the body. Grossly oversimplying things, drugs are known as intoxicants for a reason-many of them work by making the body toxic (that is, by poisoning the body). As such, it is hardly shocking that drugs can do short and long term damage to the body.  For example, alcohol is well known for causing liver damage and pot has a lasting impact on memory. The delivery system of drugs often do damage as well. For example, the smoke that delivers the nicotine or THC can cause serious problems with the respiratory system. As another example, needles can transmit various diseases, such as HIV.

As the above examples show, legal drugs do considerable physical damage to the user. Illegal drugs, such as heroin, Ecstasy, and crystal meth, can do considerably more damage than the legal drugs. However, the most contested illegal drug, marijuana seems no more harmful than alcohol and tobacco. If the direct harm of something serves as grounds for making it illegal, then tobacco, alcohol, cars, and junk food should all be outlawed. After all, these things kill many people each year. If we do set a threshold of harm as the basis for legality, then it seems likely that some illegal drugs (mainly pot) would fall under that threshold and thus should be legal. Really dangerous drugs would, of course, remain illegal. Naturally, setting the threshold for harm would be challenging-it would have to be set so that cars, alcohol, tobacco and junk food would all be legal, despite their massive death tolls. Or, we could set the threshold lower at the price of outlawing these killer things.

The second thing that is bad about drugs are their indirect harms. These include a multitude of things. One of these is that excessive drug use can come to dominate a person’s life, leading them to fail in their responsibilities and to live a life that is not worthy of a human being. Of course, this is not a problem unique to illegal drugs. Many people have been lead down the path of ruin by their overwhelming desire for money, sex, alcohol, power or fame. People always seem quite able to find something to ruin their lives and it seems unlikely that legalizing drugs will significantly increase this tendency.

There is also the concern that people will harm themselves or others while under the influence of drugs. Of course, this same concern applies to alcohol-something that is often involved in traffic fatalities.

Another indirect harm is crime. People who use drugs sometimes turn to crime to get the money they need to buy drugs. Of course, people turn to crime to get things that are legal-so this is not a unique problem for illegal drugs. In fact, making them legal would lower the prices and thus probably reduce such crime.

Another significant part of drug crime involves those who deal drugs. These people use violence against their competition and the police. While legal business do engage in violence (see, for example how some companies operate overseas), that is fairly rare. For example, you do not see folks from Bush shooting it out with the folks from microbreweries. So, legalizing drugs and making them a legitimate business would reduce such violence. Of course, there would still be plenty of corruption and other misdeeds-but that is preferable to people being gunned down in the streets.

Much of drug crime arises simply because drugs are illegal. People do point to use and small time selling as harms because these are illegal. However, the main harm seems to be that resources are being expended to deal with small time dealers and users that could be better used against serious crimes. We are also overloading our prisons with such criminals. This wastes resources and also does serious social harm by removing people from the community, by helping to transform such people into real criminals, and by making it difficult for such people to get jobs after they are arrested (because of the criminal record). This is, of course, a straightforward matter: does locking people up for small time dealing and drug use do more harm than good? The evidence seems to be that it creates far more harm.

Another indirect harm that people consider is the moral harm. Some folks see drug use as inherently immoral and regard tolerating it as damaging to society. Of course, many of these folk are fine with alcohol and tobacco.

The moral concern is a legitimate one. However, to use this to justify keeping drugs illegal requires either arguing why alcohol and tobacco should be legal or arguing that they should also be illegal. This could be done by arguing that illegal drugs are relevantly different from the legal drugs.

In many cases, people do make such arguments. In the case of hard drugs like heroin and crystal meth, the arguments seem quite reasonable. In the case of marijuana, the argument seems rather weak. People often make such an argument by comparing excessive marijuana use to moderate alcohol or tobacco use. However, the proper comparison would involve comparing the same level of usage-how, for example, one joint stacks up against a bottle of whiskey.

One of the main concerns of legalization is that it will increase the availability and use of drugs, thus increasing the harms generated by the drugs. Of course, this leads to two obvious questions. First, would legalization increase use? Second, would the harms of legalization outweigh the benefits?

In regards to the first question, intuitively one would expect an increase in use. After all, if a person can pick up a joint where she can buy a six pack, people will probably consume more drugs.

Of course, getting drugs is really, really easy. When I was in high school, college, and grad school, pot and other drugs were easily available. In fact, when I was in college I would have had to go to all the way to Big Bear to buy a beer, but pot was always available next door or down the hall. Even today I could make a call and have a bag of pot in fifteen minutes-and I don’t even do drugs or have any special involvement with drugs. It is just that everyone knows someone who sells or knows someone who knows someone who sells (or who shares). Even if you think that you don’t know anyone like that, ask around a bit and prepare to be surprised.

There is also the concern that legalizing drugs will make it easy for kids to get drugs. The obvious reply to that claim is that it is already easy for kids to get pot. I’m from tiny Maine town and went to tiny schools, but pot was readily available to the kids. I’m confident that hasn’t changed at all. At worst, legalization would leave availability the same. Kids would still smoke pot, but now they’d get it the same way they get alcohol.

While I am for legalizing certain drugs, I am, oddly enough, an anti-drug person. Drugs damage the body and mind. They often rob people of what is best in life. They do a great deal of harm to society. They are, in short, a scourge. However, our war on drugs has not helped and has, in fact, made things worse. As such, I am in favor of the lesser evil-while still recognizing that it is a evil.

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Mexico & the War on Drugs

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As Mexico continues to be plagued by drug violence, that same violence threatens to flood across the border into the United States.

Since this is a complex problem, there is no simple solution. Well, actually there are two simple solutions. One is wildly improbable, the other just a bit less so.

The first solution is for  drug users to stop buying  illegal drugs. Without a profitable market for drugs, there will be little incentive for those involved in the Mexican drug trade to continue in the business. Of course, the chances of drug users giving up their drugs is close to zero-even if doing so meant a reduction in murder. I suppose that it is easy to ignore all that blood on one’s hands when one is high.

The second solution is to legalize certain drugs and get the tobacco and alcohol corporations involved in their production and distribution (after all, they have experience in selling harmful drugs). This would eventually erode the market for illegal drugs and reduce the violence significantly. That this will work is supported by what happened after the repeal of prohibition-organized crime largely got out of the alcohol business.

What will most likely happen is that the US and Mexico will continue to bicker about the problem, then the police actions will step up as more people die. Eventually, the violence will spread into America and then the US will take action on this side of the border. Then the problem will be reduced down to a level that most people are willing to tolerate and the US-Mexican drug situation will simmer away until the next time it makes the news. And thus the eternal war on drugs will go on and on and on.

Mexico & Drug Violence

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While America’s economic woes have been dominating the news, Mexico has been wracked with terrible drug violence.

One thing that really struck me about the coverage of the violence in the US media is the emphasis on how the drug violence might affect Americans. For example, one commentator remarked, at length, about how US college students should be careful about going to Mexico. Naturally, a clip prominently featuring hot American college girls dancing around in their bathing suits was played. While I took this as an ironic contrast to the seriousness of the violence, no doubt its intended purpose was quite different.

While warning college students is certainly a good thing, the emphasis on how the drug violence might impact Americans does seem to show us as being rather selfish and self-focused. After all, while other people are being murdered, it hardly seems decent to be worried primarily about whether college kids will be able to party wildly in Mexico in safety. In another bit of irony, some college students no doubt help fund drug operations in Mexico by purchasing drugs.

While exact figures regarding criminal activity can be hard to determine, it seems likely that a major consumer of Mexican drugs are Americans. Americans have (or perhaps had) the money to buy drugs in abundance and also the appetite for them. Of course, we also like to preach against drugs and take self-righteous stands as well.

As a nation that consumes a significant amount of these illegal drugs, we would certainly seem to bear some moral responsibility for the drug violence in Mexico and elsewhere. As long as the drugs are in demand and are illegal, then we can certainly expect drug violence to be a relatively common occurrence-not only in Mexico, but elsewhere (including the United States).

People have long called for the legalization of drugs and have contended that doing so would significantly reduce drug violence. After all, the argument usually goes, we do not see beer dealers shooting it out in the streets (unlike during prohibition) nor do we see tobacco companies engaged in violence. The standard counters against this argument tend to be moral in nature.

One moral argument is that drugs are simply immoral and hence must not be tolerated. Of course, the strength of this argument depends on whether drugs are immoral or not (or rather, whether the currently illegal drugs are more immoral than the currently legal drugs).

Another moral argument is based on an appeal to the moral harms of drugs. The contention is that legalizing drugs would create significant harms and harms that presumably exceed the harms caused by keeping drugs illegal.

For example, it might be argued that the damage done by drug using people to themselves and others would exceed the damage done by the problems stemming from drugs being illegal. After all, it could be argued, alcohol is legal and is still involved in many deaths (often automobile related) and health problems. Just imagine the damage that would arise if marijuana, heroin, and such were made legal.

Of course, it would have to argued that drug use would spike dramatically if such drugs were legalized. After all, people already use drugs and those harms are already occurring while drugs are illegal. Perhaps use would spike-if so, this argument might be reasonable.

Another way to cut down on the drug violence would be to significantly reduce demand. If little money could be made from illegal drugs, then there would be far less incentive to engage in such violence. Of course, this would require that drug users give up drugs-or at least cut way back on their consumption. This, however, seems rather unlikely. While most people do not like the violence, it is difficult to imagine people giving up their drug use.

The most likely thing is that people will keep using drugs, they will remain illegal and drug violence will continue in up and down cycles.

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