Big Pharma: Panacea, or Bad Medicine?

With the opening of the 2016 election campaign, incumbents, and attention-seeking challengers, are on the hunt for trophies to mount on the wall of political expediency. Combine that with the on-going battle over healthcare costs, and it’s pretty much guaranteed that some folks are going to be under intense scrutiny for at least the foreseeable future.

Pharmaceutical companies usually come in near the top of any list of villains during these periods. They’re big, they’re visible to anyone who watches television, reads magazines, or fills a prescription, and they make a lot of money. Big Pharma, as it is not-so-lovingly referred to, is regularly accused of charging too much for its products, promoting its drugs through underhanded manipulation of doctors and regulators, and actively opposing any effort to bring cheaper, generic versions of top sellers to the market.

Is it true? Well, yes and no. Yes, some medications are very expensive, drug makers do employ sales reps/marketing teams to promote usage, and many companies have been very aggressive in protecting patents on high-volume, high-profit drugs. In the recent past, several manufacturers have settled cases with state and federal regulators over allegations of promoting drugs for uses outside FDA approval, paying doctors for prescriptions written, and conspiring to delay introduction of lower-cost versions of brand-name medications. All make headline news, and provide ammunition for critics of the industry.

Before getting too far into the discussion, I need to inject some fair balance. I worked as a sales rep for pharma companies for 15 years, representing branded products to primary care physicians and specialists in eastern Missouri and southern Illinois. The companies I worked for ranged from small to mid-size to what most folks would describe as Big Pharma. I know I can’t be totally unbiased in my opinions, but I’m no shill for the pharmaceutical industry either. The public rarely gets the viewpoint of those out calling on doctors, nurse practitioners, physician assistants, and the other staff members who see patients every day, and I think most would be surprised at the level of commitment most reps have to their ultimate customers, the patients. That doesn’t make us saints, but it doesn’t make us evil, either, and our visibility means that, like it or not, we’re the face of the industry.

No one defends unethical or illegal behavior by pharmaceutical companies. As a sales rep, nothing will destroy your career faster than misrepresenting a product to the physicians that trust you to provide them accurate information about your products. Lie to a doctor one time, and your credibility is shot forever. No pharmaceutical rep worth their salt supports bad behavior by anyone in the business.

That being said, there’s another angle to the story that few people outside the industry, or the appropriate regulatory agencies, understand. When a pharmaceutical company is accused of promoting “off label” or other illegal activity, it faces two choices. It can admit wrongdoing, and negotiate a financial/regulatory settlement with authorities in order to put allegations and negative publicity behind it, or it can marshall its legal team, and go to court to prove its innocence.

Problem is, if the company loses its legal battle, in addition to any monetary penalty, it can be barred from participating in the Medicare & Medicaid programs for years. Without access to these programs, many small-to-medium companies would simply go under, and even a giant like Pfizer would be hurt. Mounting a successful defense still casts a company in a negative light, possibly for years, as the case winds through the legal system. So, the vast majority of cases are settled out of court, the company agrees to the penalty, and officials trumpet their success at bringing yet another greedy corporation to heel.

Is it justice? In many cases, yes, there was clear evidence of wrongdoing, and the company deserved sanction. In many others, we just don’t know, and that’s unfortunate, because like the guy on the evening news with a coat over his head, the public presumption is guilt. And ignorance of how the industry is regulated plays out in other areas as well.

Few people are educated about the patent life of pharmaceutical products. For most prescription drugs, a manufacturer is granted a 20-year period of exclusivity. The clock starts counting down when the molecule is registered, not when it’s later approved for sale in the US. Approval will only come, if ever, once the drug has cleared several years of clinical testing, and had its trial data reviewed. By the time the drug hits pharmacy shelves, 5-7 years of patent life will often have already passed. That shortens the time frame over which the costs of drug development can be recouped, increasing costs to customers, and even then, companies may need to expend additional funds to ward off patent challenges by generic manufacturers. Far from being a cartel of chummy co-conspirators, the pharmaceutical industry can often be a cutthroat marketplace. It is not an environment for the feint of heart.

While most molecules never make it to market, the costs of research and development still accrue. Pfizer invested a cool billion dollars in a novel cholesterol medication that held much promise, but failed in late clinical trials, and was withdrawn. There have even been rare instances where FDA-approved drugs have been recalled after release, due to undiscovered problems that never materialized in pre-approval testing. It’s the cost of doing business in a heavily regulated industry where public safety is a priority.

Simvastatin, the generic version of Merck’s blockbuster cholesterol drug, Zocor, is still listed as one of the most prescribed meds in the United States, with millions of patient-years of use, and a library of clinical data supporting its value in reducing the risk of cardiovascular events. Still, years after going generic, the FDA announced changes to the simvastatin prescribing information that restrict its use in certain patients, or when used in conjunction with certain other medications. Fortunately, the market had other drugs in the same class available as substitutes if doctors felt it prudent, or patients were unnerved by the FDA’s actions. Those alternative medications might not have been available had some critics had their way and refused FDA approval to any “me too” drugs once a first version had been cleared for sale.

What about all that marketing activity? The sales reps, the TV commercials, the billboards, and the print ads? Yes, it can, at times, be off-putting to hear about bladder leakage, or four-hour erections during every commercial break of a sporting event. And it can be aggravating to sit in a doctor’s waiting room with a small army of drug reps, some of whom gain access by bringing lunch to the office, while their ultimate customers don’t get so much as a bag of chips. Hey, is that pasta con broccoli I smell?

The sheer volume of lunches, treats, and giveaways supplied by sales reps definitely became a distraction. This most visible aspect of drug marketing, which began as a way to gain time with physicians to promote new medications, or new indications for established meds, morphed over the years into a quasi drug rep catering business. It became less about education, and more about food. There were actually medical practices that listed pharma-supplied lunches as perks in their help wanted ads! Even drug reps had grown to hate the superficiality of it all, as their knowledge and training re the risks and benefits of their products took a back seat to dishing out salad, bussing tables, and chasing signatures. Fortunately, those days are pretty much gone, but lost along with it is the opportunity to help doctors and staff stay abreast of new products and new information.

With the additional administrative/record-keeping duties heaped on doctors with the advent of electronic health records and healthcare reform, how can physicians possibly stay current re medications without support? When new information, good or bad, comes out, it’s often reps who bring that news to doctors. When you consider that there are literally hundreds of medications for everything from high blood pressure to alzheimer’s to diabetes, it’s impossible for prescribers to keep current on all the data. Since the typical rep only needs to be an expert on a handful of meds, they can serve as a tremendous resource, and bring real value to the office. For the future, successful reps will need to focus on bringing that value on every call, and not wasting their customers’ time with marketing slogans or flashy digital presentations. Some companies are ahead of the curve, directing their sales teams to assist patients in understanding the proper use of their medications, and providing information on discounts/rebates/programs available to lower the out-of-pocket costs of their prescriptions.

In some ways, the industry has been hurt by its own success. The development of effective treatments for many conditions once thought impossible to relieve short of surgery or other radical treatment, means that today, millions of people enjoy a better quality of life by simply taking a pill. That success has a price tag, though, and for every new/improved treatment, patients will demand access to it.  So, before condemning pharmaceutical companies for over-production, and over-promotion, let’s consider the other side of the ledger.

How often do critics stop and consider the people whose lives have been saved by the availability of effective medications? Do they recognize that tamoxifen, a pill indicated to treat/prevent breast cancer, was credited by the World Health Organization as the first treatment to actually reduce the mortality rate from cancer? Or that the pharmaceutical company that developed it gave away hundreds of millions of dollars of tamoxifen free to patients who otherwise couldn’t afford it? How many grandparents are active enough to keep up with their grand-children due to effective treatments for arthritis, COPD, or heart failure? As one doctor informed me, “You know, I’ve never had a patient thank me for the heart attack they never had. And, that’s OK, because I know it.”

So, by all means, keep close watch on marketing efforts by drug companies. Insist they play by the rules, and be transparent re product costs and pricing. Support a new role for sales reps as advocates for doctors and patients, helping them access the information, discounts and rebates so often available from manufacturers, but so rarely utilized. Finally, keep in mind that there are two sides to every pricing issue. One is the true cost of bringing the medication to the pharmacy, and the other is the cost of not treating the condition or illness. There is no prescription that is more expensive than the one that is needed, but never filled.

——Raymond T Kyle  2015  Kyle Policy Partners