Popular Culture 20110527: Prescription Drugs Adverts

This piece is a result of a couple of pieces that I have written before and some interaction in comments on pieces from others about prescription drugs advertisements.  They are rife in the popular culture these days, on TeeVee, on radio, and in print.  I really think that this is a horrible idea, and will explain as time progresses.

First, I must do a bit of historical treatment.  When I was in pharmacy school (I did not stay long, because I decided that I should be on the other side of the wall, developing new drugs, but that did not work out either) adverts for prescription drugs were only allowed in professional medical journals.  I mean it.

Those you 50 or older will probably, if you think hard enough about it, days when these drugs were not in the popular media.  Some of you might also recall that tobacco adverts were!  I still remember the jingles for cigars and cigarettes.

Upon doing some research for this piece, I found that there is a name for this:  Direct to Consumer advertising, or DTC.  I also found that only two First World nations allow it.  Those would be New Zealand, the home a dedicated reader and commentator, and the United States.  That is correct!  No other First World nations permit DTC adverts! This topic has bothered me for a long time, and for many reasons.

The first DTC advert was for a pneumonia vaccine, Pneumovax, from Merck, that appeared in Reader’s Digest in 1981.    At the time, this was uncharted territory because the pharmaceutical companies just had never done it before.  It looks like this drug is still on the market, with some improvements.

FDA regulations were sort of unclear at the time, and in the United States the regard that we have for The First Amendment to the Constitution sort of trumped good sense.  Before I continue, I will say that the companies have the right to advertise in the popular media, but just because there is a right does necessarily make their choice a good idea.  In my opinion, they are getting very close to the “shouting FIRE in a crowded theater” line.

The next one seems to be the Lilly drug, Oraflex.  It was supposed to treat arthritis pain and FDA dropped the hammer on not only the drug, but its adverts as well.  It turns out that this particular drug, and many other non-steroidal anti-inflammatory drugs (NSAIDS) have really serious health considerations, mostly cardiac ones.  This drug came and went in 1982, and I do not think that the advert ever made it to the popular media, but Lilly had the material prepared.

In 1983 Boots placed adverts for Rufen, its prescription answer to Motrin.  Both of those drugs are brand names for ibuprofen, now commonly available OTC.  That campaign only indicated that Rufen was cheaper and did not make any medical claims.

FDA banned DTC after this episode, and then allowed it again in 1985.  However, the requirements for safety information were so onerous towards the pharmaceutical industry that few were run, since they would require many print pages or many minutes of TeeVee time.

Schering tried to skirt the new regulations in 1995 when they launched a campaign for Claritin, and had some success in not being fined for it.  Then the scene shifted radically in 1997 when FDA allowed print and TeeVee adverts essentially like the ones we see now.  Almost all safety warnings were no longer required and advertising expanded extremely quickly.

In 1997 the entire US spending for DTC drugs was $220 million.  In 1998, after the new guidelines, the spending on Claritin ALONE came to $142 million.  Then it got even worse.

With the change in administration, under the Bush FDA a change of policy required the Office of Chief Council to review and approve of any cease and desist letters to pharmaceutical companies for improper adverts, thus greatly increasing the burden on FDA to rein in misleading or deceptive adverts.

Congress almost got involved in 2005, prompting PHARMA, the industry’s trade group to issue its own set of guidelines to keep control of the situation, and those guidelines are what are followed today, so the industry is really operating from the rulebook that it wrote.

Because of the huge amount of money that the pharmaceutical industry can throw at the Congress, it is unlikely that any restrictions will be placed on adverts at least for the near future.  Here is why the industry wants to keep it the way that it is:  prescription drugs not advertised is this manner have an average increase in prescription rates of 5.1%, whilst for DTC drugs it is 34.2%!  DTC adverts work.

Here is the text about the topic, lifted directly from the FDA webpage that addresses it.

Your healthcare provider is the best source of information about the right medicines for you.

Prescription drug advertisements can provide useful information for consumers to work with their health care providers to make wise decisions about treatment.

It does go on to explain “good” adverts and “bad” ones, and even urges consumers to report adverts that they think might be questionable.  How many people read FDA web pages?  And the adverts offer no reference to contacting FDA, of course.

There is a common thread in almost all of the adverts:  chronic, essentially for life, use.  Think about how many antibiotic adverts you see.  I can think of only one, for a tetracycline class drug marketed for roseaca, a chronic skin condition, so the use of it is intended to be for a quite extended period of time.  Practically all of the drugs in adverts are intended to manage chronic conditions, not cure them.  If the drug actually cured the condition, then they could only sell it to a given person for a little while, but if symptoms return after the drug is discontinued, then the pharmaceutical company has a customer for life, or until the patent expires and a generic form is available.

What kind of conditions are prone to be treated with highly advertised drugs?  Here is a brief list, by no means comprehensive and in no particular order:

Depression

High cholesterol

Erectile dysfunction

Diabetes (interesting the monitoring equipment and delivery systems are advertised, not the insulin)

Sleep disorders

Bladder control problems

Osteoporosis

Alzheimer’s

Allergies

Birth control

Dry eyes

Asthma

The common threads are that these conditions tend to be very long lasting are not cured but rather just controlled by drugs AND that there are drugs still on patent (thus, no generics) so the brand name is the only game in town.

Note that you never see adverts for Prozac any more.  That is because it went off patent in 2001, so cheap generics are common.  One that is heavily marketed at present is Abilify, originally developed for major psychoses.  Like many drugs for psychoses, this drug may also cause tardive dyskinesia, a serious neurological disorder where uncontrollable movements develop.  This side effect is not seen with agents like Prozac.

High cholesterol drugs, known as statins, and heavily marketed.  You can not look at the TeeVee without seeing adverts for them.  Although diet and exercise are the first line treatments for high cholesterol, the adverts do not emphasize that and just mention them in passing to keep FDA off the companies’ backs.  Most of the adverts that you see are for ones still under patent.  You will see few adverts for Lipitor in the coming months, since it goes off patent in June of this year.  Zocor went off patent in 2006, and do not remember any recent adverts for it.

Some of the heavily advertised drugs can be life saving, there is no doubt.  Depression can kill, as can high cholesterol, diabetes, and asthma.  This is sort of a slippery slope, however (and there is another slippery slope coming later).  I personally do not think that TeeVee or popular magazines are really the best places to get information about life saving drugs.  Official websites for name brand drugs, unless you go the the highly technical prescribing information that most people simply do not understand, are not either.

The best source for good information about drugs is from a pharmacist, and a physician comes in second.  I use this ordering because pharmacists receive far more training and education about drugs than physicians do.  However, pharmacists can not prescribe, so most people rely on their physicians as their primary sources of information.  Ideally, one’s physician and pharmacist should work together to provide information.  This is particular important for primary care physicians, who have many more kinds of drugs with which to be familiar in comparison with specialists who deal with a more limited set of medication.  Once again, your health care professionals are the primary sources for this information.

With that said, there is a wealth of information on the internet about drugs.  Some of it is excellent.  Unfortunately, much of it is bunk.  Whilst doing research for this piece I came upon a site, to which I will not link, that describes an important and useful drug used for treating benign prostatic hyperplasia (BPH, or “enlarged prostate”) as “this poison”.  Whilst it is true that women who are or could become pregnant should not touch the medication because of a risk of birth defects, calling it “this poison” is hardly correct.  Use internet information extremely carefully.  I can get away with it because I am a trained scientist and can separate bogus information from legitimate information.

The second slippery slope connected with drug adverts is the heavy advertisement of drugs for relatively trivial (i.e., non life threatening) conditions.  Now, I am sure that those who suffer from erectile dysfunction, sleep disorders, bladder control difficulties, or dry eyes do not consider those conditions as trivial, but to market drugs with significant potential for very serious side effects for such conditions is just not right.

Let us just hit the highlights of some of the side effects for the drugs prescribed for those conditions.  All of the erectile dysfunction drugs have the potential for causing serious sensory disturbances, such as sudden hearing loss (which may or may not be reversible), sudden visual impairment (again, possibly irreversible), priapism (an erection that will not go away, allowing the blood to stagnate in the penis, possibly causing permanent inability to achieve an erection due to damage of the corpus cavernosum), and serious interactions with other drugs.  Whilst these issues are glossed over in the adverts, the outcome for some of them are horrible.

Sleep disorder medications all have the potential to be addictive, to some degree or another.  The older drugs for sleep, chloral hydrate and short acting barbiturates, have pretty much fallen out of use, and were highly addictive physically.  They have been replaced by newer drugs that are less apt to cause addiction, but they still can.  Addiction can be treated, and with judicious use should not occur.  Of greater concern is the blackout phenomenon, where people do normal tasks in abnormal ways and then having no recollection of it.  These activities might be as innocuous and eating whilst unaware (there are reports of peanut butter coated cellular telephones, and a person who I know well went of a binge of eating chocolate covered orange sticks, in bed, and awakening the next morning with melted chocolate all over the sheets.  She did not think that it was chocolate at first, because she did not remember eating the orange sticks.).  These are pretty harmless, although the cellular telephones are ruined in many cases.  More serious are the documented cases where people “sleepwalk” or, even worst, “sleepdrive”.  The potential consequences of those actions can be deadly.

Bladder control drugs also can have serious side effects.  The ones in the adverts are anticholinergic drugs, meaning that they block the action of the important neurotransmitter, acetylcholine.  They are chosen to have the greatest affinity in the receptors in the bladder, but have wide systemic actions nonetheless.  Some minor side effects are dry mouth and sensitivity to light (because, like their big brother atropine, they affect the ability of the pupil to contract with high light levels), and sensitivity to heat (because these drugs also inhibit sweating).  The last one could be life threatening, because of the possibility of hyperthermia in hot weather.  There is another serious one as well:  permanent eye damage if the user has undiagnosed glaucoma.  These drugs increase intraocular pressure, already dangerously high in people with glaucoma.  Use of them can cause the pressure to increase to a level where irreversible damage to the optic root occurs.

Finally, the dry eye case.  The drug advertised for this condition is Restasis, which is a dilute, topical form of the potent immunosuppressent drug cyclosporine (the spelling varies depending on what source one reads), given to organ transplant recipients to prevent host/graft rejection.  This drug is a powerful one, and reduces the immune response tremendously.  The logic for using it in dry eye is that one’s immune response recognizes tear producing cells as foreign and by reducing that response locally, more tear cells survive.  The problem is that one can argue this also reduces the ability of the immune cells around the eye to fight off real infection, a serious threat to eyesight.  The advert, featuring a physician who also claims to use the product, cautions that it has not been studied in patients with a history of herpes infections of the eye.  No wonder why!  To do clinical studies in this group of people with such a drug would be highly unethical.

Well, that is it for tonight.  Remember, adverts are designed to sell products, not to treat patients.  I believe that caveat emptor is very apt here.

Next week we shall return to the my series about albums released by The Who, this time with the first part of Tommy.  For those of you who have not seen this series before, I have been writing extensive pieces, complete with audio and video clips starting with their first album, and now it is Tommy’s turn.  Sunday evening at this time my regular science series, Pique the Geek, will have a very technical and, hopefully, tasty treatment of curing meat, with history, methods, and the science behind this often overlooked topic.

Warmest regards,

Doc