Drugs in disguise

The study of medicine has been around in some form probably for as long as we have been recognizably human, however, ideas of how to ensure the quality and efficacy of medicines have only evolved very recently. In prescientific cultures, it was the norm to accept unconditionally what the ‘traditional authority’ had to say about healing. Whether medical knowledge came from a respected group of elders, a mysterious shaman, or the church, it was the final word and wasn’t open to inquiry. Often, medical systems were more an artifact of each group’s cultural history than they were a useful collection of knowledge about medicinally active plants to be found in the local environment.

The major shift in thinking came around 1400 to 1700, during what we now call the Medical Renaissance. Thanks to the reformation of the church and a decline in conservatism, the shackles were finally removed from medical science, and a much needed rebirth was allowed to happen. Physicians like Andreas Vesalius, Ambroise Paré, and William Harvey began to question ‘traditional authority’, disproving many of its theories, and discovering that many of its treatments were useless, even downright dangerous. For the first time, students of medicine were encouraged to check their findings so that they could better understand the human body, and ensure the safety and efficacy of treatments.

The initial spark for this huge shift in medical thinking didn’t come from a new freedom of inquiry, but from tragedy, one of the greatest to ever befall mankind: the Black Plague, when 45–50% of the European population was wiped out during a four-year period.(1) With the shortcomings of contemporary medical knowledge so glaringly evident, people became frustrated with the old, stagnant ways of thinking about health. If half of your friends and loved ones died from an unknown disease, you would probably question the state of medical knowledge too.

Unfortunately, it has always taken tragedy to catalyze medical reform, and historically, the development of drug regulation has been no different – its history is written on tombstones. In 1937, the improperly prepared sulfanilamide medicine, Elixir Sulfanilamide, caused the death of over 100 people. Harold Watkins, the chief pharmacist and chemist at the company that manufactured the drug, was unaware that the solvent they were using was poisonous to humans, and at the time there were no regulations requiring premarket safety testing of new drugs.(2) When pressed to admit wrongdoing, the owner of the company infamously stated, “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”(3) Evidently Watkins had enough guilt for the two of them, as he promptly committed suicide. Following the crisis, Congress enacted the 1938 Food, Drug, and Cosmetic Act, giving the FDA the authority to oversee the safety of drugs and to outlaw misbranded and adulterated drugs.(4) However, it took another, much worse tragedy to truly give the FDA the authority to decide which drugs made it to the market. This time, the drug responsible was thalidomide. Initially hailed as a “wonder drug”, it was primarily intended as a sedative and hypnotic, but was also used to alleviate morning sickness in pregnant women. Shortly after the drug went to market, 10,000 cases of phocomelia (malformed limbs) in infants were reported throughout Europe, Australia, Canada, and the United States. Approximately 50 percent of the woman who had given birth to deformed children had taken thalidomide during the first trimester of pregnancy. In response, US Congress passed the Kefauver-Harris Drug Amendments. For the first time, drug manufactures were required to prove the efficacy of their drugs before they could sell them.(5) These disasters, among many others, prompted the introduction of tougher regulations for the testing and licensing of drugs worldwide, and increased awareness of the risk of negative side effects.

What is a Drug?

No medicine is completely safe. If something has active ingredients of any kind, there is the potential for adverse side effects in a high enough dose. Even after safety and efficacy has been established, it takes special training, access to necessary information, and an understanding of that information to know how much of which drug is required for a specific indication, and then you have to understand how different drugs interact within the body – an almost impossibly complicated task when dealing with more than two drugs. Thus, there is an inherent risk to all drugs, and they must be treated with extreme care. This is why it is crucial to understand what qualifies as a drug, and what doesn’t.

Strictly speaking, there is no single accepted definition of the word “drug”, as the word has different meanings in different contexts. However, this isn’t a question of semantics. Legal and colloquial distinctions usages aside, the simplest, biochemical definition is: anything that has a physiological effect when ingested or otherwise introduced into the body.(6) Your body doesn’t distinguish between things that are intended to be used as drugs, and things that behave like drugs but aren’t putatively regarded as such. Drugs can come in many forms, such as ointments, injections, pills, or powders. Even the line between drugs and food can be blurry. Eating certain foods can trigger the release of the same chemicals in the brain involved in addiction and withdrawal, and can effect the absorption of prescription drugs, altering their effects.(7) It is irrelevant where something comes from, or what form it takes. As far as you body is concerned, a drug is a drug.

Drugs in Disguise

Drugs aren’t like ordinary consumer products, because people’s lives hang in the balance. The way that they used to be sold boggles the mind; anyone could set up shop, and they were under no obligation to prove that their products did what they were supposed to and weren’t going to cause harm. In this unregulated market, drugs had unknown safety and efficacy at best, and killed people at worst. Thankfully, we are now protected from ineffective, potentially dangerous drugs. Or are we?

Having managed to position themselves ambiguously between medical and food manufacturers, “nutritional supplement” manufacturers bypass the regulations that drugs are subjected to. However, drugs are what they are selling, in all but name.(8) By rallying their troops, they have forcefully acquired an exorbitant privilege: virtual immunity against regulation. Taking advantage of the widespread climate of distrust and disillusionment toward government caused by events like the Vietnam War and Watergate, they convinced their customers that the government was trying to take away their goodies, warned retailers that they would be put out of business, and portrayed health regulators as selfish conspirators who were in bed with the medical profession and big pharma. In this way, they have been able to overturn every attempt by regulatory bodies to regulate their products as drugs.

During the 1970s, when the FDA tried to limit false claims and require warning labels on potentially dangerous supplements, angry supplement consumers and sellers persuaded congress to pass the Proxmire Amendments, which prohibited the FDA from setting standards to limit the potency of supplements and regulate them as drugs based on their potency.(9) In the early 1990s, Congress was considering two bills that would have given federal agencies greater power to combat health frauds. One would have harshened the penalties for violating the Food, Drug, and Cosmetic Act. The other would have made it illegal to advertise nutritional or therapeutic claims that would not be permissible on supplement labels. During the same period, the FDA was also considering tightening regulations for these labels. Alarmed, the supplement industry and its supporters generated an avalanche of complaints to Congress. The end result was the Dietary Supplement Health and Education Act, appropriately nicknamed the “snake oil protection act” by the New Yorke Times.(10) The DSHEA made “dietary supplements” a separate regulatory category, and expanded the types of products that could be marketed under this category. It went far beyond the usual definition of “dietary supplements”, and included things like herbs, amino acids, hormones, as well as any preparation, combination, or constituent of those ingredients. The DSHEA made it nearly impossible for regulatory bodies like the FDA to regulate anything that fits into this overly inclusive category.(11)

Today, supplement manufacturers are supposed to indicate their new product is safe and effective prior to introduction. However, they can use anything that they want for evidence. To date, the FDA does not have any standards for what the evidence must contain, or how trustworthy it must be. It is left entirely up to the manufacturer submitting the premarket notification to choose what information provides the basis for their conclusion that their product is safe and effective.(12) It’s an empty gesture, superficially making it seem like some effort has been made to ensure safety and efficacy. The truth is, supplement manufacturers and distributors are still living in a time where anyone can sell anything they want. They just have to jump through a couple of hoops first. As a result of this leniency, useless and dangerous ingredients are being allowed on the market all the time. The FDA has to wait until after a product is released to find out whether it is truly safe, through reports of adverse events. Until enough people get hurt for a noticeable pattern to emerge, there is nothing to protect consumers from dangerous supplements. In other words, tragedies have to happen before these products can be taken off the market…shouldn’t we be beyond that by now?

The False Dichotomy

Why do people fall for the false dichotomy between prescription drugs and herbal remedies? They instinctively draw a line between “artificial” drugs created by pharmaceutical companies, and “natural”, herbal remedies. They reason that herbal remedies must be safe because they are “natural”; must be effective because they have been used for thousands of years; and must be something other than drugs because they aren’t produced artificially. Additionally, they often believe that herbal remedies are created by small, “mom and pop” businesses who actually want to heal you, whereas pharmaceutical companies only want to temporarily treat your symptoms so that you’ll come back for more. I think that is a fair, non-straw-man summary of a common set of beliefs.

Claim 1: “Herbs are natural, therefor safe.”

This leap of logic stems from the notoriously naive naturalistic fallacy. It’s absurdity would be amusing if it wasn’t taken so seriously by so many. The fact that people fall for it just goes to show how separated they really are from nature: in reality, nature is a dangerous place where one must fight constantly to survive, and if something isn’t trying to kill you, there’s a good chance you’re trying to kill it. For now, let’s just ignore that fallacious premise, and go straight to the conclusion that herbs are safe. It is demonstrably false. Adverse side effects from so called “natural” remedies are well documented. Between 1983 and 2004, 1.3 million reports of adverse reactions to supplements, vitamins, and minerals were reported to poison control centers in the United States, and 175,268 required hospitalization. In 2012, it was estimated by the FDA that 50,000 adverse reactions occurred every year.(13) As herbs have become all the rage, and are more readily available thanks to globalization, more toxic effects are being observed. Compounding the problem is the fact that, once exotic herbs reach the west, they aren’t necessarily being prepared or used in the same way as their traditional counterparts. The traditional way isn’t always best, but there is an undeniable risk in randomly altering dosage and preparation without any kind of safety testing. For example, Mahuang, an herb found in relatively small doses in Chinese medicines, is used in far higher concentrations in the West. This has resulted in a number of cases of sudden cardiac death, many of which occurred in young adults who used ephedra, a concoction that contains Mahuang, and didn’t even stray from the recommended dosage.(14)

Here is a list of common, natural herbs which have a potential for unwanted side effects:

Blue cohosh: neonatal heart failure.(15)
Valerian: hepatitis, insomnia (ironic, considering one of the things it is meant to treat is insomnia).(16)
Kava: liver damage.(17)
Nutmeg: hallucinations (one side effect which may actually be desired).(18)
Wormwood: seizures.(19)
Stevia leaves: in high doses, possible decreased fertility.(20)
Concentrated green tea extracts: liver damage.(21)
Thujone (found in absinthe): neurological damage.(22)
Concentrated garlic: increased risk of bleeding.(23)

It’s not just the supplements themselves that can be harmful, but what’s contaminating them. Herbal remedies exported from overseas are sometimes contaminated with lead and other heavy metals. In 2004, researchers at Harvard Medical School found that 20 percent of Ayurvedic remedies obtained from shops near Boston’s City Hall contained potentially harmful levels of lead, mercury, and arsenic.(24)

Claim 2: “Herbs have been used for thousands of years, therefor they must work.”

Many age old herbal remedies have proven to be useful, and have therefor been assimilated into modern medicine. Indeed, there may be a correlation between a herbs traditional use and its actual usefulness. However, it does not logically follow that something “must” be useful because it has been used for a long time. Nonetheless, people use this fallacious appeal to antiquity to continue to cling to an herb even after double blinded, placebo-controlled trials have shown it to be no more useful than placebo.

The appeal to antiquity is especially disingenuous when applied to medicinal claims, because nearly all pre-scientific systems used for deciding whether something had medicinal properties were based on “vitalism”, an illogical superstition which fails to grasp mechanistic concepts that are absolutely integral to the study of medicine. Vitalism claims that living things are infused with an essence. Essentially, it is a form of begging the question, because it attempts to explain something by invoking a circular concept that says nothing new about the thing it is attempting to explain. Historically, this has attracted the ire of many famous intellectuals. Molière parodied it in Le Malade imaginaire, where a vitalist “answers” the question, “Why does opium cause sleep?”, with “because of its soporific power”, Thomas Huxley compared vitalism to stating that water behaves the way it does because of its “aquosity”, and his grandson Julian Huxley compared vitalism to explaining how a railroad locomotive works by saying that it has “locomotive force”.(25) An example of a vitalistic system used in pre-scientific medicine is the “Doctrine of Signatures”, which states that herbs that resemble parts of the human body can cure ailments that affect that part of the body, because they seem to share similar qualities. This lead William Coles, a 17th-century botanist and herbalist, to believe that walnut could cure headaches because, in his opinion, they resembled heads.(26)

Back in the day, many considered this way of thinking quite profound. Today, it is interesting, but clearly wrong. Yet herbs that have been traditionally used for a long time usually have their roots in bizarre, unscientific methodologies like this. Is that really something to brag about? Modern pharmacology has its roots in herbalism, and many drugs are still derived from herbs (ephedrine, warfarin, digitalin, aspirin etc.). However, herbs didn’t evolve specifically to heal us. When they have useful properties, that is just a happy accident. Modern biotechnology allows us to isolate their useful ingredients, and improve upon them so that they can be targeted towards specific processes and have fewer negative side-effects. This should be celebrated, not feared.

Claim 3: “Herbs aren’t drugs.”

This one is rather easy, because in showing that herbs have the potential for unwanted side effects, I have already proved it wrong. Like I said, a drug is anything that causes a physiological effect when introduced into the body, and herbs contain pharmacological active ingredients that have physiological effects on the human body. These ingredients exist in unpredictable doses, are often not well understood, and sometimes haven’t even been identified. Just like conventional drugs, herbal remedies can interfere with other drugs. For example, St. John’s Wort can increase the rate at which the liver metabolizes other drugs. The only thing that separates herbs from prescription drugs is that they are sold deceptively as “dietary supplements.”

Claim 4: “Manufacturers of herbal remedies want to cure you, Big Pharma wants to keep you sick.”

This is an incredibly popular conspiracy theory, and it will probably be around for as long as peddlers of alternative medicine find it useful to depict themselves as the only alternative to a corrupt tyrant. It relies solely upon the “cui bono” fallacy: whichever party gains the most from an event must be the cause of that event (ironically, I came dangerously close to committing this fallacy in the last sentence). The same logic is used by those who reason that 9/11 was an inside job, because the Bush administration gained from going to war in the Middle East. Just like 9/11 “truthers”, Big Pharma conspiracists offer this line of reasoning as if it constitutes real evidence. One common charge is that the cure for cancer is being withheld so that Big Pharma can continue to profit from treating it’s symptoms. Ridiculous. Big Pharma isn’t a single monolithic entity, it consists of doctors, universities, health organizations, research laboratories, private companies, and government agencies, competing with each other to make scientific discoveries. There is no organized plot to keep people sick. If one of them discovers the cure for some debilitating disease, they jump on it. Yes, Big Pharma is driven by money. But why would Big Pharma want to make us all sick? Just like the alternative-medicine industry, it is easier for them to profit from making us think we’re sick, by pathologizing normal biological and social variation. That is why, if you watched too many TV ads, you could be led to believe that high cholesterol is a disease, when it is really just a risk factor. However, alt-med practitioners are arguably even more guilty than Big Pharma when it comes to disease mongering: chiropractic subluxations, chronic lyme disease, full body PH imbalances resulting from modern diets, morgellons disease, and heavy metal poisoning resulting from vaccines are all imaginary ailments that alt-med companies capitalize on.

Conclusion

I will leave you with an excellent quote from Paul Offit, one of my skeptical heroes. In a single paragraph, he sums it up perfectly.

Although conventional therapies can be disappointing, alternative therapies shouldn’t be given a free pass…. All therapies should be held to the same high standard of proof; otherwise we’ll continue to be hoodwinked by healers who ask us to believe in them rather than in the science that fails to support their claims. And it’ll happen when we’re most vulnerable, most willing to spend whatever it takes for the promise of a cure.

-Paul Offit, Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine

Sources:

1. Wear, Andrew, Roger Kenneth French, and Iain M. Lonie. The Medical Renaissance of the Sixteenth Century. Cambridge University press, 1985. eBook. <http://books.google.co.uk/books?id=tlM9AAAAIAAJ&lpg=PR8&ots=PMBXh-lp6K&dq=medical renaissance&lr&pg=PR8

2. Akst, Jef. “The Elixir Tragedy, 1937.” Scientist. 06 2013: Web. 26 Nov. 2013. .

3. Ballentine, Carol. “Sulfanilamide Disaster.” FDA Consumer magazine. 06 1981: Web. 26 Nov. 2013. .

4. United States. Food and Drug Administration. FDA History – Part II. 2012. Web. .

5. Fintel, Bara, Athena T. Samaras, and Edson Carias. ” The Thalidomide Tragedy: Lessons for Drug Safety and Regulation.” Science in Society. 28 06 2009: Web. 26 Nov. 2013. .

6. Ophardt, Charles. “Drug Activity.” Chemwiki. .

7. Edlund, Mattthew J. “Is that a food or drug?.” Psychology Today. 05 05 2011: Web. 26 Nov. 2013. .

8. Novella, Steven. “Herbs Are Drugs.” Skeptical Inquirer. 37.2. (2013): Web. 26 Nov. 2013. .

9. United States. Food and Drug Administration. This Week In FDA History – April 22, 1976. Web. .

10. “The 1993 Snake Oil Protection Act.” New York Times 05 10 1993, Web. 26 Nov. 2013. .

11. Barrett, Stephen. “How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA .” Quackwatch. N.p., 02 02 2007. Web. 26 Nov 2013. .

12. United States. Food and Drug Administration. New Dietary Ingredients in Dietary Supplements – Background for Industry. Web. .

13. Offit, Paul. Do You Believe In Magic?: The Sense and Nonsense of Alternative Medicine. Harper, 2013. Print; excerpt from: Groopman, Jerome. “The Quackish Cult of Alternative Medicine – Dr. Paul Offit’s battle against charlatanism .” New Republic. 19 10 2013: Web. 26 Nov. 2013. .

14. Wikipedia contributors. “Ephedra.” Wikipedia, The Free Encyclopedia. 12th November 2013. .

15. Jones TK, , and Lawsom MB. “Profound neonatal congestive heart failure caused by maternal consumption of blue cohosh herbal medication..” PubMed. (1998): Web. 26 Nov. 2013. .

16. Hepatoxicity: MacGregor FB, Abernethy VE, Dahabra S, Cobden I, Hayes PC (1989). “Hepatotoxicity of herbal remedies”. British Medical Journal; Insomnia: United States. National Institutes of Health. MedlinePlus. Web. .

17. Clough AR, , Bailie RS, and Bailie RS. n. page. Web. 26 Nov. 2013. .

18. Brenner, N, O S Frank, and E Knight. “Chronic Nutmeg Psychosis.” Journal of the Royal Society of Medicine. 86.3 (1993): 179-180. Web. 26 Nov. 2013. .

19. “Wormwood Side Effects and Safety.” WebMD. Web. .

20. Melis, MS. “Effects of chronic administration of Stevia rebaudiana on fertility in rats..” Journal of Ethnopharmacology. 67.2 (1999): 157-61.. Web. 26 Nov. 2013. .

21. “Green Tea Polyphenols May Cause Liver Damage In High Doses.” Medical News Today. 26 02 2006: Web. 26 Nov. 2013. .

22. “Public statement on the use of herbal medicinal products containing thujone.” European Medicines Agency. Committee on Herbal Medicinal Products , 22 05 2012. Web. 26 Nov 2013. .

23. “GARLIC Side Effects & Safety.” WebMD. N.p.. Web. 26 Nov 2013. .

24. Saper, RB, SN Kales, J Paquin , MJ Burns, DM Eisenberg, RB Davis , and RS Phillips. “Heavy metal content of ayurvedic herbal medicine products..” Journal of the American Medical Association. (2004): Web. 26 Nov. 2013. .

25. Wikipedia contributors. “Vitalism.” Wikipedia, The Free Encyclopedia. 21 November 2013. .

26. Wikipedia contributors. “Doctrine of signatures.” Wikipedia, The Free Encyclopedia. 18 November 2013. .

Advertisements