War on Drugs: Pharmaceutical reps say times have changed
Intense scrutiny and mounting regulations have put a choke hold on the pharmaceutical industry from its boondoggle days.
Nowhere is this more noticeable than on the front lines, where pharmaceutical sales reps – or drug reps to most – have witnessed the highs and lows of an industry marked by decades-long double-digit profits.
Chris Bies of Kingsley has worked as a pharmaceutical representative for more than 20 years and remembers the fishing trips, golf outings and fancy dinners. “There was some abuse by some back in the day, there is no question,” said Bies, a district manager for Otsuka America Pharmaceutical, headquartered in Japan. Otsuka sells tablets, injections and medical devices.
Bies says that times have changed, but for the better. “I’m glad (the unregulated entertainment) went away,” he said. “From the outside looking in, the old ways would be perceived as entertaining our physicians. Medicine and entertainment do not go together.”
The tighter restrictions have had an impact on the face time drug reps get with their clients. There are tight limits on spending. Gifts – even pens and paper – are strictly prohibited. Lunches must include an educational element; some offices don’t even allow lunches or drug rep visits anymore.
One of the more popular ways to get in front of physicians – fancy dinners – have changed too. Dinners must include an educational, pre-screened speaker and may not include physicians’ spouses, a deal-killer for many overworked doctors.
“When they didn’t allow spouses anymore, it really cut our attendance,” said Bies. “You can imagine a doctor saying, ‘Hey honey, I’m going to get a wonderful meal and some wine, but you can’t come.’”
One of the reasons for the changes over the past decade was tied to the dinner programs’ physician speakers, who would be paid to discuss a certain drug, but would extol its off-label efficacy, said Bies.
“The biggest problem would stem from dinner programs because, for example, a doctor would speak on (seizure disorder and shingles nerve damage drug) neurotin, which is used all over the place for everything (from hot flashes to hiccups),” said Bies. “The physician would talk off-label, which means that it was off the FDA’s indications. You have to talk very specifically.”
The off-label talks were such a problem that the FDA began fining both the pharmaceutical companies and the physicians that spoke to off-label efficacy. To date, billions have been levied against a wide-range of companies and providers.
“The FDA is constantly looking to see if there are off-label promotions,” said Bies.
With his job, Bies oversees operations and manages four representatives in western Michigan and four in northern Indiana. He said a typical day for him now finds him alongside one of the reps on the road, calling on doctors and medical offices. That way he can make sure the account representatives obey the myriad rules and regulations of the industry.
“We do a lot of in-services, (explaining) what the product does,” he said, as well as noting any contraindications. He said just as in television commercials or other advertisements, drug reps have to be upfront with any possible side effects. “It’s not as much selling as customer service.”
Bies said the Federal Drug Administration tightened up regulations after seeing the deleterious impact of some drugs. He cited the relatively rapid approvals of drugs such as Viox, which was later taken off the market, and Celebrex, which is still available, as both increase risk of heart attack or stroke.
Another change Bies has seen is the ways in which representatives have become more specialized as their companies have had them represent a single drug rather than several. That also directs their efforts toward the appropriate practices. He now represents a neuraleptic, an anti-psychotic pharmaceutical for treatment of psychiatric disorders. So he mostly calls on psychiatrists and general practitioners. As the medication is approved only for adults, he does not call on any pediatricians.
While the industry moved in the direction of specialization, Bies said the pendulum may be swinging back in the other direction as the number of sales reps shrinks. He said that from a high of 120,000 nationally in the early 2000s, the figure has now dropped to approximately 40,000. He attributed the growth to the fact companies saw the success they were having with sales and figured more sales representatives would increase their return. But eventually there was a push back from physicians who found the number of sales reps taking time away from their patients.
Fellow sales representative Tracy T – who is not allowed to use her last name or say which company she represents – concurred. She said the cutback in the number of reps was overdue.
“There were 11 different reps from my company, now there are only three,” she said.
With that many reps dropping in on medical offices, she said, “(w)e weren’t bringing value as much as we were being disruptive.”
While the opioid crisis helped to spark an outcry for tighter oversight of the industry, Tracy said it was already trending in that direction. “There are a lot of rules and regulations in the industry,” she said. “The way we promote, everything I show a doctor has to go through regulatory (channels). It is very tightly regulated. For example, I could give out pens and paper (previously). Now there are no gifts of any sort.”
Despite the blowback the industry has received, she’s not ashamed of her work. Quite the contrary.
“I feel like I’m helping patients,” said the 14-year veteran of the industry. “I’m providing information to physicians to better help their patients.”
She said different physicians office have different rules. “Every office has different policies,” she said. “Some let us drop off coupons (for patients). Some we can walk right in. Some let us leave starters (samples), some say no.”
And some offices simply don’t allow representatives in the door. Bies said he estimates that about half the medical offices in the Traverse City area are open to visits from pharmaceutical representatives, while the other half do not allow them.
“The Traverse City area has always been a very closed town for pharmaceutical representatives,” he said.
That often stems from the hospitals with which an area is affiliated, he added. “I feel like that’s a disservice to patients,” Tracy said of those practices which do not allow pharmaceutical representatives at all. “Doctors may not have the most current information.”
A local general practitioner, who like Tracy preferred not to use his name, agreed with that sentiment.
“There’s new classes of drugs we didn’t learn about in med school,” that reps provide valuable information about, he said.
Both Bies and Tracy believe the information they provide is beneficial to the doctors and hence, to their patients. “I love the education part of it. I’m a teacher at heart. I provide information to physicians on the benefits to patients,” Tracy said.
She defends the industry, saying that the cost of drugs reflects the costs to develop and bring beneficial medicines to the market. “If (the industry) doesn’t make life-saving drugs, who will? I think that gets missed in the conversation,” she said.
She said the high cost of research and development is worth it. “We are doing so much good in the industry,” she said.
According to the investment and finance website Investopedia, the average cost for a new medicine from research and development to marketplace is nearly $4 billion, and can sometimes exceed $10 billion. Other sources, such as HealthAffairs.org, suggest that R&D costs for pharmaceutical companies do not explain elevated U.S. drug prices. Fortune noted that drug companies do indeed have large R&D expenses and still make large profits.
Even after the seismic shifts in the industry, both say they still enjoy their jobs and would encourage others to pursue it.
“I still recommend it to people looking at the industry,” said Bies. “You have to have passion. It’s not a 9-to-5, 40-hour a week job. You also have to be independent.”
While the job pays well, he said the best rewards come from people he’s helped. When he gets that feedback it makes the long hours worthwhile. “Doctors share success stories,” he said. “It’s rewarding. You know you’re helping patients.”