Showing posts with label #FDA. Show all posts
Showing posts with label #FDA. Show all posts

Wednesday, July 09, 2025

Post 758 - The Story of Pharmacology in Under 1000 Words

The Story of Pharmacology in Under 1000 Words

 


In  the beginning, anything could be a drug.  Whether it was ground from a plant or found in an animal, it was ingested, applied, or injected by our ancestors.  Eventually, scribes wrote things down to help remember what was beneficial (for use in the community) or poisonous (for use against an enemy).  Priests became physicians, rituals became office calls, and hieroglyphics became prescriptions.  Physicians lost the time to make their own medicines, so they turned the work over to apprentices who became pharmacists.  Throughout the whole evolutionary process, everything worked just fine and everyone became healthier.  Well, not exactly.

In the United States before 1906, if you wanted a drug and you had the money, you could just go out and buy it.  Prescriptions were only a recommended option, and in some states, licensing any health professional was actively discouraged.  

Patent medicines were loaded with morphine, cocaine, cannabis, or mercury compounds (so much so that archaeologists tracing the path of Lewis and Clark could identify fort locations by the levels of mercury still remaining in the explorers’ abandoned latrines).   

Morphine was so widely used during the American Civil War that, after 1865, over 100,000 soldiers had some form of habituation or addiction to the narcotic.   

The demand for drugs, licit and illicit, was sufficient enough for Sears to issue a separate drug catalogue at the start of the 20th century, essentially creating the first mail-order pharmacy.

In response to scandals of patient deaths and addictions, President Theodore Roosevelt encouraged the passage of the landmark Pure Food and Drug Act in 1906.  Considered a radical measure in its time, the act initially could only assure that ingredients and their amounts were listed on a patent medicine label (you could still get “arsenic tabules” for your complexion, but at least you knew it contained arsenic; this was considered a major breakthrough for consumer safety).

Plants served as the primary source for drugs.  The term pharmacognosy, meaning “knowledge of drugs,” essentially meant the knowledge of plants.

Eventually, specific chemicals were discovered, isolated, or synthesized, and the sources for drugs began to shift from plants to the chemist’s bench.  The idea was to create an inexhaustible supply of drugs.  Being able to minimize unexpected responses came from carefully controlling the dose.   

Even with the progression of the Food, Drug, and Insecticide Agency into the present-day FDA (its focus becoming foods and drugs), it still had little power to protect consumers.  The fine against a Dr. James Peebles for selling “bitter almonds” (cyanide) as part of a treatment for epilepsy was a mere $5 in 1913.   

It took further health disasters to prompt the creation of safety regulations.  In 1937, deaths from a toxic solvent in the antibiotic sulfanilamide prompted a law requiring new drugs actually be shown safe before marketing (the Food, Drug, and Cosmetic Act of 1938).  Serious birth defects in 1962 linked to thalidomide inspired the Kefauver-Harris amendments to assure that drugs were tested for safety and effectiveness before marketing.

Package inserts for patient information eventually appeared in 1970.

In between these laws came the Durham-Humphrey act, dividing drugs into the categories of non-prescription, prescription, and controlled substances: 

    Controlled substances were those drugs with the potential for addiction or abuse.
    Non-prescription drugs became commonly known as over the counter drugs or OTCs.  
    

The Drug Enforcement Agency (DEA) appeared in the early 1970s;  and, with it, the establishment of controlled substance schedules or categories, ranked by the drug’s potential for abuse.  These categories became schedules I (one) through V (five), and are still in use today:


Pharmacology Today in Under 300 Words

Modern pharmacology is a combined study of anything that can interact with living systems.  It builds upon knowledge of physiology, chemistry, botany, biochemistry, and mathematical theorems.  Even the study of pharmacognosy, after decades of being brushed aside as irrelevant, has reappeared with the increased interest in “herbal” or “natural” therapy...in some ways, we have not journeyed far from the explorers who traveled with Lewis and Clark in 1803.

Sunday, April 20, 2025

Post 739 - The Laissez-Faire Pharmacy - An Article from 1997

With RFK Jr's brainworm/roadkill approach to healthcare these days, this article seemed rather relevant once more:
 
      Ninety-two years ago (note: this would have been 1905), the general public had direct access to nearly any drug available on the market. Morphine, cocaine, opium, and strychnine were available by mail from Sears' catalogue; a prescription was often but a formality and "patent medicines" containing unknown and often addictive agents made millionaires of unscrupulous entrepreneurs.  Consumers believed the ads, took the "cures," and often died; their memories endured as "unsolicited testimonials" to the treatments that shortened their lives.

     When Theodore Roosevelt pushed for the creation of the FDA in 1906, lobbyist pressures saw to it that the agency would begin its life as a toothless child.  It took medical disasters and consumer deaths to give it the power to determine which drugs should be available only with a prescription. That scrap of paper became the control valve on potentially harmful medications; products that didn't make the cut were considered generally safe if properly used.

     The 1980s, a noteworthy decade for its hands-off approach to governmental regulation, produced an ever increasing collection of drugs entering the marketplace, many representing only variations on existing treatments.  The FDA seemed willing to approve anything that might further stimulate the piranha -churned economy; if one of the new entries later proved to be harmful, or perhaps deadly, it could always be removed.

     The past few years have seen a less passive FDA, yet, with all the criticism levied upon outgoing chairman David Kessler in his efforts to strengthen the agency, it was under his administration that several drugs were deregulated to nonprescription status.   There have been further deregulations on the part of other therapies, most notably of the naturopathic, or herbal variety.  With each deregulation came the presumption of safety on the part of the consumer, and with each deregulation the main source of public information came primarily from advertising and mass marketing.  Once again, consumers believed the ads and took the "cure."  In a sad regression to the turn of the century, some have fallen ill; others have died.
 
     Consumers saw a commercial announcing that Anacin or Excedrin are now "aspirin free" and some presumed all Anacin and all Excedrin were aspirin free, with disastrous results.  The natural products ephedra and golden seal have caused deaths from severe elevations in blood pressure.  Both plants were, and are, promoted as "natural" treatments for infections or fatigue.   Even the ubiquitous acetaminophen, more commonly known as the heavily advertised Tylenol, can cause severe liver damage in high doses.

     Of recent concern has been the deregulation of prescription antacids into "nonprescription strengths," heavily promoted as a casual alternative to previous antacids (one of the disturbing messages of these ad campaigns is that the consumer shouldn’t change his eating habits, he should just take another pill). One of these newer antacids is cimetidine, currently marketed as Tagamet HB.  Cimetidine has been shown to interact with other drugs used as  blood thinners to treatments for asthma and epilepsy; to reduce the effectiveness of some antibiotics; to increase the toxic effects of strong pain killers.   It's now available at your grocery store, next to "aspirin free" Anacin and capsules of golden seal.
 
     Then follow the drugs-du-jour: the melatonins, the DHEAs, the chromium picinolates.  At best, they can be harmless (some could say worthless); at worst, can cause side effects that are difficult to predict and won't be listed on the bottle.

     Education becomes an issue here, since a nonprescription drug can be safe and useful when properly used.  Unfortunately, the primary source of public information is from the companies who are selling the goods.  They're businesses, after all, out to make money, and side effects won't sell a product--especially to a consumer looking for a quick fix.  If a company is going to point out a flaw, it certainly won't be theirs.  We have seen this in campaigns pitting one newly deregulated pain killer against another for its interaction with alcohol; again, it was a case of the pot calling the kettle black.

     With more deregulation on the horizon, consumers need to be increasingly wary of overblown claims, especially those made by marketing teams who treat their health as just another commodity
to be packaged and sold.  They need to rely more on information from a properly trained, well-informed health care provider instead of hype from a glossy magazine spread.