Junkies, Part III

Junkies, Part III

   If you've been following this series of posts, you've read about the growing dependence on pharmaceutical drugs in the U.S., as well as the difficult job the FDA (Food & Drug Administration) has since it's hands are basically entirely controlled by Congress (indeed, throughout its history, FDA administrators have resigned in frustration due to being limited in what they can and cannot do).  And you've also read that in the U.S., supplement and vitamins are NOT inspected, tested or otherwise regulated so that market is an open one and quite probably a dangerous one (especially the combination of supplements such as St. John's wort with pharmaceuticals, an herb known to render most pharmaceutical drugs ineffective*, in some cases, leading to hospitalization).  So what this series has been attempting to show is little more than a buyer-beware message.  Our pharmaceuticals are getting out of hand, but at least they have a few hoops to go through (Congress is trying to loosen many of those tangles as well)...why?  Simply put, the money is huge.  In 2011, there were close to 220 million prescriptions written for opioid (pain killing) prescriptions alone...and, in an article in Time, "4 of 5 heroin addicts say they came to the drug from prescription painkillers."

   So again, let's step back.  There are a lot of people in genuine pain, an estimated 100 million in the U.S. alone.  Some are suffering from trauma or old age or just returning from war, but the pain is real.  And the FDA is genuinely concerned about the safety of the people taking such prescription medication, and genuinely recognizes the need to do so.  But with nearly 50 people dying daily from overdosing on prescription drugs, and with two pharmaceutical drug companies already pleading guilty to "criminal charges that they misleadingly marketed the drugs as safe," the FDA is a bit puzzled at why Congress is wanting to loosen their ability to regulate even further.  Says the article: Figuring out whether prescription drugs are safe and effective is the job of the FDA, but with the long term use of opioids, the agency faced a challenge.  There were no reliable studies proving opioids worked safely against chronic pain, because it would be unethical to require pain patients in a control group to go months on end without medication.  "It's not practical for us to require people to go for a year on a placebo," says Janey Woodcock, head of the FDA's Center for Drug Evaluation and Research...Instead, Woodcock says, the FDA followed its practice of extrapolating short-term studies to long-term use.  When Perdue Pharmaceuticals sought permission from the FDA in 1994 to market a powerful new opioid, OxyContin, to treat moderate to severe pain for extended periods of time, the FDA signed off and went so far as to tell doctors the drug "would result in less abuse potential" since it was absorbed more slowly than other opioid formulations.  Over the next 20 years, the FDA would approve more than two dozen new brand-name and generic extended release opioid products for treating long-term pain, including Endo Pharmaceuticals' Opana (a drug-deterrent that the company suggested be injected, which apparently has led to misuse and to a rise of HIV cases) in 2006.  "No one anticipated," says Woodcock, "the clinical community would take to this and start giving it out like water."

   It's a lucrative market, and tighter controls are showing a bit of progress, the number of overdoses moving up just slightly over previous years, indicating a slow down.  But in other countries, makers of counterfeit pharmaceutical drugs are finding the market too good to pass up, causing some companies to issue scratch-off verification codes to insure that the drugs are genuine (in one case, the deaths of over 100,000 children in Africa were blamed on counterfeit pharmaceuticals).  In the U.S. the illegal market has led to pharmaceutical manufacturing warehouses being broken into, a burglary that is proving more profitable than robbing a bank.  For the genuine pharmaceutical companies themselves, the pain-killing market is an $18 billion per year profit machine, and growing.  But the increased use of prescription drugs has led to finding traces of such drugs --from antibiotics to narcotics-- in city water supplies (a matter-of-fact report of one area in New York can be found on the government health site) as users flush prescription drugs into the toilet or innocently eliminate them from their bodies when going to the bathroom, according to a short piece in WebMD (the most practical and recommended way to dispose of drugs is to take them to your local pharmacy for disposal, or barring that, to place them in some wet coffee grounds or cat litter in a baggie and seal it before discarding).  A piece in Nova described how our drinking water is treated, but added, "One study found several pharmaceuticals in treated tap water, including atenolol (a beta-blocker), carbamazepine (an anticonvulsant), gemfibrozil (an antilipidemic), meprobamate (an antianxiety medication), and phenytoin (an anticonvulsant).  The concentrations of these compounds were very low, usually less than 10 nanograms per liter, which is parts per trillion"

   Okay, enough with the bad news.  We recognize that we have a problem, but more importantly, solutions are also appearing (would you believe 3-D printed pills?).  In the final part of this series, the bright spots will appear, what big data companies are doing, what's on the horizon, and most importantly, what might have led us into this state and how simple it might be to get out of it.  Bear with me...there's a light at the end of the tunnel.


*Again from author Catherine Price's book, Vitamania, comes this further explanation:  The primary compound in St. John's wort that's responsible for these interactions (as well as any antidepressant effects) is hyperforin.  Among other actions, hyperforin increases the production in the liver and small intestine of an enzyme called CYP34A, which is responsible for metabolizing (i.e. regulating the breakdown of) upward of 50 percent of conventional medications, says Bill Gurley, PhD, professor of pharmaceutical sciences at the University of Arkansas for Medical Sciences College of Pharmacy.   The more CYP34A your body produces, the more efficient your body will be at breaking down the drug, and the smaller the amount of the active form that will get into circulation.  "St. John's wort renders most drugs ineffective," warns Gurley--who also points out that, thanks to the herb's ability to render birth control ineffective, "there are a lot of miracle babies associated with the use of St. John's wort."  One additional thing the author points out later:  Grapefruit contains chemicals that affect the bioavailability of many drugs, including antianxiety medications, antihistimines, and statins, and these effects can linger for hours --if not days-- after you eat it.  Unlike St. John's wort, grapefruit inhibits the activity of CYP34A in the intestines, which means that the body breaks down and excretes less of the drug than it would otherwise, which is turn means that more of the active form of the drug ends up sticking around in your body.