Pharmaceutical Advertising

As reported by DrugStoreNews.com, there has been a lot of discussion in the biotechnology world over the appropriate names of follow-on biologics.  “Follow-on biologics,” also known as “biosimilars,” are “biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods” (Wikipedia).

Because generic pharmaceutical drugs are by law chemically identical to branded drugs, brand name drugs and generic drugs carry the same name.  As such, companies that manufacture biosimilars demand this standard and practice to be used for their products.  For example, Enbrel is an autoimmune drug made by the company Pfizer and Enbrel’s generic name is etanercept.  Generic drug companies in Europe have openly said that the use of the same generic name has not been a problem over the past six years of their availability.

However, some biotech companies assert that biosimilars are actually made from different cell lines, and are therefore chemically unique, thus requiring separate nomenclature and review.

Over the past week, half a dozen US senators have taken concern over the recent development regarding biosimilar naming, as Biotechnology Industry Organization is a trade group that is at risk for losing billions in sales if biosimilars are allowed to use the same names as the drugs to which they are similar.  The Organization is worried about the competition these biosimilars will bring and possible confusion for American citizens.

In the end, what is most relevant here is the risk for confusion among consumers and the medical community.  If doctors believe in a certain case that a biosimilar ought to be avoided in clinical use, but the desired generic or branded drug carries the same name as the biosimilar, it isn’t unreasonable to believe that there may be problems.  Any drug that is chemically unique ought to have a unique name, regardless of how similar it is to another chemical.

I’ve had the opportunity to email Dr. Elliott several times since interviewing him and he’s just an all-around good guy.  That sentiment was amplified today when I saw this column on CNN:

(CNN) — If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, "Propaganda," by Edward Bernays, the father of public relations in America.

For Bernays, the public relations business was less about selling things than about creating the conditions for things to sell themselves. When Bernays was working as a salesman for Mozart pianos, for example, he did not simply place advertisements for pianos in newspapers. That would have been too obvious.

Source: How to brand a disease — and sell a cure – CNN.com

Just as some believe the worst thing that happened to the legal profession was lawyer advertising, I believe the worst thing that happened to the medical profession is pharmaceutical advertising.  While I don’t know if Dr. Elliott feels that way, you can tell by reading his post that he is not a fan of the way in which pharmaceutical companies hype diseases.

A little skepticism is a healthy thing:

Many patients taking prescription drugs believe that pharmaceutical companies have too much influence over their physicians’ prescribing practices, according to a new survey.

* * * *

About half of the medication users believed that their doctors were too eager to write a prescription when other non-pharmacological options are available.

Source: Consumer Reports Survey: Patients Think Doctors Too Cozy With Pharma – ABC News

I’ll be honest with you. I don’t trust pharmaceutical sales reps.  Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients.  Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe.  This leads to a gigantic incentive to engage in off-label marketing and other unethical practices.

Perhaps this is going to stop at GSK.

Starting next year, bonuses will be determined “in part, by customer feedback, and by a sales professional’s adherence to the company values of transparency, integrity, respect and patient-focus,” the company said earlier this week. (Here’s the Dow Jones Newswires story.)

Source: Bonuses For GSK Pharma Sales Reps Won’t Be Tied to Sales – Health Blog – WSJ

Time will tell.

I think one of the most dangerous practices out there is that of pharmaceutical companies wooing doctors with free gifts and meals.  In states where it is legal, you have a group of sales reps (most of whom aren’t doctors) coming into doctors offices, giving them gifts of tangible value, and telling them how safe and effective drug X is.  Doctors get lulled into a trusting relationship with these sales reps, and they prescribe medications without properly investigating the safety of the drugs. 

Well, two years ago Massachusetts put a stop to that practice.  Sadly, now they want to bring it back:

A two-year-old state ban on gifts in the medical and pharmaceutical industries would be repealed under an economic development bill that the House budget committee began polling its members on yesterday.

Source: Ban on drug industry gifts could be lifted – The Boston Globe

Why do they want to bring it back?  Because some businesses are complaining that they lost profits.  So what?  If doctors won’t prescribe drugs based upon the safety and efficacy of the drug, then they shouldn’t prescribe it because the nice sales rep brought lunch for the whole office from Cheesecake Factory.  (And sorry, Cheesecake Factory, if you can’t attract customers who aren’t basically using you as a bribe, you should be out of luck, too.)

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use.

Washington Bureau – When your doctors writes you a prescription, that’s just between you, your doctor, and maybe your health insurance company–right?
Wrong. As things stand now, the pharmaceutical companies that make those prescription drugs are also looking over the doctor’s shoulder, keeping track of how many prescriptions for whose drugs the individual physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, healthcare advocates and legal authorities.

Source: States, Consumer Advocates Challenge Rx Data Mining — baltimoresun.com

I agree wholeheartedly.

The nation's leading group of general internal medicine physicians has taken the U.S. Food and Drug Administration to task over drug safety and urged the agency to adopt a raft of new consumer safeguards for prescription drugs.

The American College of Physicians recommended that the FDA place limits on the advertising of newly approved drugs to the public, and require that prescription drugs that are new to the market bear a symbol alerting consumers to that fact. The internists also urged the agency to improve its system of detecting drug-safety problems once a newly approved drug is in broad circulation, and said the agency must do a better job of monitoring the safety of drugs manufactured abroad.

The first years of a prescription drug's availability can be boom times for manufacturing giants, who generally "roll out" a new FDA-approved drug with a flashy and expensive marketing campaign aimed at doctors they hope will prescribe the drug and patients they hope will ask for it by name. Those efforts often make new drugs "blockbusters" soon after they reach the general patient population.

The problem: The general patient population is generally less healthy, more diverse, less careful about following use instructions and on more other medicines than were the subjects the drug companies used in their preapproval clinical trials. As a result, safety and effectiveness problems are sometimes detected only when a drug goes into wide circulation. The result is that, when drugs are withdrawn from the market over safety concerns, it is typically in the first couple of years they're on the market.

Source: Doctor group calls for warnings on new prescription drugs | Booster Shots | Los Angeles Times