SHOULD PHARMACEUTICAL COMPANIES MARKET THEIR PRESCRIPTION PRODUCTS DIRECTLY TO THE CONSUMER?

As I have explained before, for several reasons I believe this is a bad practice. Now the AMA is agreeing with me.

The AMA has called for a ban on direct-to-consumer marketing of prescription drugs and medical devices. The new policy calling for the ban was adopted at the Interim Meeting of the American Medical Association in November, 2015.

The physicians adopting the new policy pointed to excessive advertising budgets in the billions of dollars and the increasing unaffordability of prescription drugs as reasons why the ban is necessary. Moreover, excessive advertising is causing patients to demand new, expensive drugs when older drugs might be less costly, more effective, and more appropriate for the patient’s specific situation.

AMA members who voted for the policy also cited consolidation in the pharmaceutical industry and anti-competitive practices among drug companies as creating an untenable situation that leads to artificially inflated drug prices.

According to market research firm Kantar Media, advertising spending by drug manufacturers has skyrocketed by nearly a third since 2013, to a total of 4.5 billion dollars.

“Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA Board Chair-elect Patrice A. Harris in a press release. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

In addition to suggesting a marketing ban, the AMA announced it will step up efforts to monitor the pharmaceutical industry and advocate for federal regulators to take action when anti-competitive practices limit the viability of generic medications or manipulate the market to favor an expensive medication.

Notably, aside from the United States, New Zealand is the only country to allow direct-to-consumer marketing of prescription drugs and medical devices.

This is a welcome move that, in my opinion, is long overdue. For the benefit of all consumers, I hope it will eventually result in governmental legislative action!

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THOSE ANNOYING BAD SIDE EFFECTS LISTED IN DRUG ADS: GOOD OR BAD?

It seems like every few minutes on TV we must endure pharmaceutical ads that present a picture of someone dancing through flowers or occupying adjacent bathtubs (I could never understand the latter). Drug prices invariably match the obviously high cost of these commercials, following which we are given a broad array of nasty side effects (or worse), enough to scare the pants off any sane person!

So why do I question why this may not be such a bad thing? First, in order to qualify as an effective treatment, a drug must satisfy the Food and Drug Administration’s (FDA) rigorous requirements that involve testing of many volunteers—both for efficacy and safety. The resulting data are presented to the FDA and, after approval, are then generally published in high-quality peer-reviewed medical journals. After approval, the companies may then advertise a drug but must discuss its benefits and risks. However, these ads may not be false or misleading in any way. They must include certain key components within the main part of the ad: 1) The name of the drug (brand and generic), 2) At least one FDA-approved use for the drug and 3) The most significant risks of the drug.  Product claim ads must present the benefits and risks of a prescription drug in a balanced fashion. These ads also must include a “brief summary” about the drug that generally includes all the risks listed in its approved prescribing information.

Under the FDA Act of 2007, broadcast product claim ads (TV, radio, telephone) must include the drug’s most important risks (“major statement”) presented in the audio (that is, spoken) and either all the risks listed in the drug’s prescribing information or a variety of sources for viewers to find the prescribing information for the drug. This means that drug companies do not have to include all of a drug’s risk information in a broadcast ad. Instead, the ad may tell where viewers or listeners can find more information about the drug in the FDA-approved prescribing information. On the other hand, printed advertisements need to include the following statement: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.” This latter provision provides an avenue to detect delayed or additional dangers that may not have surfaced in the initial studies.

With such onerous requirements, I am surprised that companies bombard us with such a spate of ads, but, obviously, money talks!

But this liturgy of negative effects provides us with a potent—albeit hidden—advantage: They are only found in conjunction with FDA approved drugs, meaning that the drugs have been shown to be effective against some disease or symptom, and we are also aware of at least most of the potential dangers.

Now contrast these approved products with an enormous number of so-called “supplements,” a vague term that includes anything that supplements the diet, which may refer to an entire basket of products: vitamins, minerals, herbs, amino acids, enzymes, organ tissues, metabolites, extracts, or concentrates. Since they are not considered drugs, they need not comply with the FDA’s rigorous requirements to be marketed as drugs. They simply may not be promoted for treatment of any specific conditions or diseases. They may, however, make vague statements about presumably healthy effects such as “supporting the immune system, heart health, bone and joint health” and many other equally vague assertions. They regularly provide a disclaimer that their product “has not been evaluated by the Federal Drug Administration and is not intended to diagnose, treat, cure or prevent any disease.”  They universally lack credible scientific evidence that they are effective against any specific problem.  Most troubling, since they lack an effective means to track serious side effects, safety is often an issue. Many of us may not be aware that, recently, numerous serious deleterious health effects have been encountered in people taking various supplements that have evaded scrutiny prior to their infliction on the public.

I can simply conclude that, although I am not in favor of such widespread advertising of approved pharmaceutical products, they are legal under our first amendment rights, and we’ll have to live with them. Although there often are good, cheaper generic alternatives, the mere fact that dangers of a given drug are listed allows one to judge that they are not only effective but—paradoxically—reasonably safe. By contrast, when a given “health” product is advertised in the absence of these warnings, this is almost certain assurance that this product is not effective against anything, but worse—may not even be safe!