Death of the Pharma Sales Rep?

We’re not feeling a whole load of Christmas cheer among the pharmaceutical industry this festive season.

First came the news that GSK is phasing out all payments to doctors and will no longer be bonusing their reps based on sales.  Now, a new study suggests the end of the road may be nigh for pharma sales reps.

According to a survey of nearly 3,000 physicians undertaken by CapGemini and QuantiaMD, when it comes to receiving clinical and medical info, reps rank last as a resource behind print, digital media and phone links.

• 67% of physicians say digital media is their preferred source of information from drug-makers
• 40%  believe digital media has the most relevant and personalized content
• 52% believe sales reps will eventually become information coordinators
• Only a paltry 20% say reps are their favorite source of information

In parallel, more health care providers are shifting toward larger, organized health systems, which make it more difficult for reps to reach physicians for visits. Sixty four  percent of those surveyed say they restrict rep visits and 31 % of physicians in organized health systems do not allow reps any access, due to corporate policies.

Newer and younger physicians are more likely to rebuff reps – as many as 80%  impose restrictions. 90% of new physicians are joining organized health systems right out of medical school.

“Physicians today are in a time crunch, juggling more commitments than ever before and no longer have the time to dedicate to in-person meetings with pharmaceutical representatives. So the reliance on more digital channels comes as no surprise,” said Dan Malloy, Senior Vice President at Quantia. “This study supports what we’re already seeing from our 200,000 members–that a physician-centric, digital communication model is the most effective way for reaching and engaging doctors.”

On a more positive note, reps slightly edge out other resources when it comes to finding product info and patient education.

Hala Qanadilo, a principal in life sciences at CapGemini says, “While the more traditional face-to-face, in-office visits might decrease, the role of these representatives is projected to be as important as ever. Moving forward, they will need them to be the directors of multiple information sources, customizing their outreach so it is more personalized and physician-centric.”

How are you tackling the changing healthcare environment in these increasingly restrictive times?  We’d love to hear from anyone out there in Pharmaland.

A Record Year for the FDA

Regulators have taken much of the blame for the drug industry’s monumental problems, especially their inability to bring new products to market, leaving the US lagging behind many other countries. Now the FDA is fighting back.  The Agency just announced that it green-lighted 30 new drugs in 2011 – a 7-year high.  Among these, Johnson & Johnson  and GlaxoSmithKline received approval for three new drugs each.  FDA Commissioner Margaret Hamburg also noted that it had been the first regulatory authority worldwide to give the nod to a number of novel treatments including  as Seattle Genetics lymphoma drug Adcetris. One possible reason for the increase in new drug approvals was the Agency’s willingness to meet with pharmaceutical companies before data were submitted.  Another may be the industry’s focus on submitting better data, particularly in regard to drug safety.  “I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” says Citigroup analyst Yaron Werber. Even so, the pharma industry is expecting some tough years ahead with increased generic competition for many of the top-selling drugs. And it remains to be seen whether the industry and the FDA can stay with the 2011 pace for approvals or whether they will sink back to the low numbers experienced in years past.

Treading Lightly – A New Approach for Pharma

Last week, the Wall Street Journal reported on a dramatic change occurring in the pharmaceutical industry. The on-line article explored how many of the big pharma companies are changing their commercial model in response to the current economic and regulatory conditions. Most notably, drug reps are being encouraged to soften their sales pitches and re-position themselves as a trusted resource for the doctors they call upon. British drug giant GlaxoSmithKline (GSK) for example, has stopped evaluating salespeople based on the number of prescriptions written  Instead, they look at how well physicians rate their representatives. GSK, Merck and Lilly are also asking their representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment. Companies hope to get a foot in the door by providing practical help, such as assistance educating patients about their diseases or navigating reimbursement. Why now?  Clearly, prescribers, who are under increasing pressure from health plans to curb costs, have less time for, and patience with, persistent sales representatives. Plus, the government has been cracking down on aggressive, and off-label marketing. For some, myself included, this is nothing new. Almost 20 years ago when I worked in pharma, I rarely “detailed” my products. Instead, I helped “my doctors” build websites for their own practices, helped to organize, and on occasions even moderate, their clinical meetings and assisted them with….well just about anything they wanted assistance with, be it product related or not. The strategy worked, sales grew and my competitors, even those with better products or prices were neutralized. “Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits are,” says David Ricks, president of Lilly’s global business unit. Unfortunately, salespeople still can’t provide the one thing many doctors want above all – time!  Even though pharmaceutical companies are attempting to engage prescribers in a more pleasant way, they still don’t always get a positive reception because nothing is being done to solve the doctors’ time problem. The bottom line is that physicians need to fit more patients – not sales reps – into their workday. Although it’s estimated that pharma sales reps  pay 115 million visits to 340,000 doctors each year, 23% of doctors surveyed by market research firm SK&A in 2010 said they don’t see drug reps at all. Eli Lilly decided to adopt its new approach after watching launches of new drugs fail. One problem the company identified was a mismatch between what doctors expected based on sales pitches, and what the products delivered. Before the change in tactics, psychiatrist Carey Cottle, MD says he was more likely to write prescriptions for a competing antidepressant like Pfizer’s  Effexor over Cymbalta, because Lilly representatives had a “high-pressure, car sales-type approach, and it was just not appropriate.” Now, surveys of doctors show that 85% are satisfied with Lilly, up from the 60% before the company changed ways. And business is up too. Sales of Cymbalta were >$450 million higher during the first nine months of 2011, than during the same period in 2010. We’d love to hear what doctors and sales reps think about this.

Drug Reps Set to Become Slaves to Their iPads

In recent weeks SRxA’s Word on Health has run a number of stories about iPads.  For the record, we don’t have shares in Apple, nor do we even have iPads, though we’re keeping our fingers crossed that Father Christmas might bring us one this year.   This latest iPad related post is particularly interesting as it could potentially change the pharmaceutical industry forever.

Last week, GlaxoSmithKline (GSK) sales reps were handed a lesson in “be careful what you wish for.”  If they win their ongoing U.S. Supreme Court appeal over overtime pay, their employers may well make them slaves to their iPads by introducing factory worker style rules for clocking in and out.

For our readers unfamiliar with the case, hundreds of GSK ’s pharmaceutical sales reps signed on to a class action lawsuit demanding overtime pay. The suit  was filed in 2006 by lead plaintiff Anthony Coultrip, who worked for GSK between 2003 and 2005 and hinges on a counter-intuitive definition of what a sales rep actually is. Under federal labor law, salespersons who earn commissions are exempt from protections requiring overtime pay for extra hours worked. Drug reps, however, don’t actually “sell” drugs – they merely promote them and the sale occurs later at the pharmacy. The GSK reps argue that makes them “promotion workers” whose work is so routine that they ought to get overtime.

Anyway…back to the story. If the Supreme Court rules in favor of Mr Coultrip and his colleagues, and institutes overtime pay, life for the nation’s 90,000 drug reps could change dramatically.  Instead of the relative independence and limited accountability that they enjoy today, the life of a pharma sales rep could become a nightmare  of check-ins, surveillance, time-sheets and electronic monitoring.

Hardly surprising given that a huge sum of money is at stake here.  Since the litigation began, at least 19 pharmaceutical companies have been sued by sales reps demanding overtime pay.

To try to minimize overtime payment liability, industry analysts predict that clocking in and out of work via an iPad will soon become the most important act of a rep’s day. Failure to clock in and out may result in loss of pay for that period of time.  Repeatedly “forgetting to clock in or out” may result in disciplinary action including the possibility of termination.

Taking this to extremes, industry insiders predict a scenario in which:

• Reps will be GPS tracked to verify time and location for all work related time during the work day.
• The same tracking will also be used to verify mileage for business versus personal use of the company car.
• Any rep planning to take more than two hours of personal time during a workday may have to get prior approval for a vacation day.
• Drug reps work will not be allowed to work more than 8 hours per day or more than 40 hours per week without prior written approval from their manager.
• If reps receive emergency customer calls, outside of their work day hours, they will have to adjust subsequent work time so as not to exceed the 40 hours per week maximum.
• They will be required to clock out and back in for their mandatory 15 minute breaks, in the morning and afternoon.  They will not be allowed to skip breaks or to do work related activities during breaks.
• Because all work related travel time will count against the 8 hour work day, most company meetings will be by tele- or video-conference to avoid travel.

However, not all  reps believe they deserve overtime. On cafepharma , the anonymous bulletin board for drug industry gossip, some have suggested that reps don’t work the hours they are meant to work, let alone qualify for overtime.

What’s better?  Is overtime pay worth the loss of freedom and Draconian restrictions?  As always, we’d love to hear from you.

To Give or Not to Give? – That is the question!

Few people in the respiratory community will have missed the study published last week in the New England Journal of Medicine (NEJM) that demonstrated Spiriva is comparable to Serevent in adults with uncontrolled asthma.

For those of you who did, SRxA’s Word on Health is pleased to provide you with a quick recap:

210 people with uncontrolled asthma were enrolled in a three-way, double-blind, triple dummy study.

All patients were treated with a beclamethasone inhaler (Qvar) to which was added Spiriva (tiotropium bromide), Serevent (salmeterol xinafoate) or a double dose of Qvar.

Results showed that Boehringer Ingelheim’s Spiriva, which is not currently FDA approved for asthma,  worked better than doubling the dosage of Teva’s Qvar and was just as effective as GlaxoSmithKline’s Serevent.

Interesting stuff, but in our opinion that was not the real news!

In an accompanying editorial, editors of the NEJM, chastised GSK for failing to provide free study drug to investigators from the National Heart, Lung, and Blood Institute. Apparently manufacturers were approached to supply both active drug and placebo inhalers, and while Boehringer Ingelheim (the manufacturer of tiotropium) and Teva (the manufacturer of Qvar) agreed to provide the materials, GlaxoSmithKline (the manufacturer of Salmeterol) refused.

The net result of this, say the editors was that investigators had to spend $900,000 from the National Institutes of Health (NIH) – and therefore they say, from taxpayers – to repackage the active drug and to create a visually identical placebo for use in the trial.

In a passionate conclusion to the editorial, Curfman, Morrissey and Drazen say:

“The most precious commodity that drug manufacturers possess is the trust of their research subjects, and to maintain this trust they need to be willing to put their products at risk. When they refuse to provide their drugs to legitimate investigators, the researchers will get their studies done without company help. It will take more time and cost more money, but in the end, the research will be done and the company will be perceived as having acted in its own self-interest rather than having worked to enhance the health of the community.”

This story was picked up by various news media who continued the vilification of GSK.

Here at Word on Health we’re not so sure that this criticism is justified.

First, pharmaceutical companies are not required to donate products for third party studies.

Second, Serevent is already licensed for the treatment of asthma. The company has previously performed numerous trials to demonstrate its efficacy and safety, including four studies on its effects in patients with asthma on concomitant inhaled corticosteroids.  In other words GSK did not need this study.

Boehringer, on the other hand did.

Two years ago, safety concerns were raised with Spiriva inhalers. Although the FDA has since said that recent data do not show a connection between the inhaler and previously reported risks of stroke, heart attack and death, doubts continued to linger in the market.  Additionally, as Spririva is not yet approved for use in asthma, any data that could show efficacy in this indication would potentially be an important step in gaining an additional licensed indication.

It is also worth noting that the total cost of the study was > $5.3 million. Tax payers money was being spent regardless.

And finally, it’s not as if Glaxo don’t pay their dues.  They are a member of the Partnership for Quality Medical Donations (PQMD), an alliance of pharmaceutical companies and humanitarian agencies that works to encourage the donation and timely delivery of appropriate medicines to people in need. They were one of the biggest donors of drugs and emergency medical relief following the monsoon floods that hit Pakistan in August; they have provided in excess of $1 million dollars of drugs to Haiti since the earthquake, more than $2 million to South East Asia. They also helped out following floods in El Salvador, wild fires in California, cyclones in Myanmar and the 2009 earthquake in China.

Should companies be forced to donate product to studies that are of no interest to themselves, or should they be free to spend the money and donate their product where they wish?

Should highly respected medical journals be allowed to single out companies for exercising their right to chose how they allocate their product?

Word on Health would love to know what you think.

In the interests of full disclosure we’d like to point out that none of the companies mentioned in this story are current clients of SRxA.