Novartis: “Zero Tolerance” Bribery Policy

In the wake of a spate of fines and sanctions against drug-makers and the embarrassing headlines that follow, Novartis has issued a stern and highly public message to its employees. The message, although carefully worded, is clear: “Bribery will not be tolerated here”

The move comes just three weeks after Pfizer was charged with violating the Foreign Corrupt Practices Act. Apparently Pfizer employees and agents in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia made improper payments to foreign officials to obtain regulatory and formulary approvals, sales and increased prescriptions for its medicines. Worse still, they tried to conceal the bribes by improperly recording payments in accounting records as legitimate expenses for promotional activities, marketing, training, travel and entertainment, clinical trials, freight, conferences, and advertising.

Pfizer is by no means alone. Earlier this year, Teva Pharmaceuticals and Bristol-Myers Squibb received subpoenas in relation to overseas bribery. And last year, Johnson & Johnson was fined $70 million for bribing European doctors and paying kickbacks to Iraq to illegally obtain business.

Clearly David Epstein, who heads Novartis Pharmaceuticals has been taking note. In a recent blog post he states that the company has “zero tolerance for bribery – it’s illegal, unethical and goes against the integrity and transparency we stand for.”

To ensure every Novartis employee fully understands what bribery is and how to avoid it, they’ve developed an updated version of their Global Anti-Bribery Policy.

This does not introduce new standards, but is meant to clarify, with simple language, the principles already set forth in our Code of Conduct, focusing on day-to-day situations where bribery issues may arise. This includes guidance on ensuring third parties we engage for certain common business activities operate under similar standards and principles as we do,” continues Epstein.

And just so everyone is completely clear, the policy spells it out: “Employees must not bribe and they must not use intermediaries, such as agents, consultants, advisers, distributors or any other business partners to commit acts of bribery. Novartis does not distinguish between public officials and private persons so far as bribery is concerned: bribery is not tolerated, regardless of the status of the recipient

While we applaud Novartis’s integrity, other commentators have been quick to point out that the Novartis missive amounts to little more than a smoke and mirrors.

Pharmalot’s Ed Silverman called it a smart legal move. He observes that should any trouble arise later, Novartis can point to its efforts to spell out specifics to employees.

What do you think?

The biggest-selling drug in 2018 will be…

EvaluatePharma, a UK based company specializing in pharma and biotech analysis has been gazing long and hard into its crystal ball.

Having scrutinized the world’s leading 3,500 pharmaceutical and biotech companies they have come up with a list of what, they believe, will be the top 10 selling drugs in 2018.

  1. Januvia       (diabetes) – $9.7 billion
  2. Humira        (arthritis) – $8.2 billion
  3. Avastin        (cancer) – $7.5 billion
  4. Enbrel          (arthritis)  – $7.2 billon
  5. Revlimid     (myelodysplastic syndrome) – $6.75 billion
  6. Prevnar 13  (pneumococcal vaccine) – $6.72 billion
  7. Rituxan         (cancer) – $6.3 billion
  8. Lantus           (diabetes) – $5.9 billion
  9. Remicade     (arthritis) – $5.8 billion
  10. Advair            (COPD)  – $5.7 billion

Surprised?  No conventional molecules, no cholesterol lowering agents, no blood pressure meds and not a single new drug among the top ten.  However, they predict the #11 best seller will be GS-7977 – the much anticipated oral hepatitis C drug from Gilead Sciences .

Not so surprising, given the obesity epidemic sweeping the western world that 2 of the front runners are diabetes drugs. Likewise, given the globally aging population – 3 are for arthritis.

#5 may be a surprise to many. Few people had ever heard of myelodysplastic syndrome before ABC news anchor Robin Roberts announced last week that she has the disease.  Still, it’s predicted number 5 status doesn’t mean that an epidemic is expected – it’s still relatively rare with only 10,000 or so new cases detected each year. Its lofty status on the list is more to do with the price. It costs a staggering $10,000 or so for a 28 day supply of the pills.

Other predictions from the EvaluatePharma World Preview 2018 report:

  • Worldwide prescription drug sales are forecast to total $885bn in 2018 an increase of 3.1% from 2011
  • Over $290bn of pharmaceutical sales are at risk from patent expirations between now and 2018
  • Pfizer was the top company for prescription drug sales in 2011, but  Novartis will top the list by 2018
  • Global pharmaceutical R&D spend forecast will grow by 1.5% per year to $149bn in 2018
  • Anti-coagulants (blood thinners) are set to record highest growth of major therapy categories to 2018

Interesting stuff. But the problem with such long term predictive models is that they are but a snapshot  trying to project out six years.

In reality, life is a movie, with a frequently changing plot. For example if J&J’s canagliflozin can reduce obesity and improve blood sugar levels better than Januvia then the projected No. 1 ranking is suspect, at best.

Pharma Reps being replaced by iPads and Portals

As previously reported here, industry downsizing has resulted in the loss of over 30,000 sales positions over the past 5 years.   Now, according to a recent article in the Wall Street Journal, big pharma companies have found a way to replace many of the sales reps they’ve been laying off in recent years.  Apparently the void is being filled by digital sales tools such as websites and iPad apps. Doctors can use the tools to ask questions about drugs, order free samples and find out which insurers cover certain treatments. The changes are designed to cut costs and to reach doctors in ways other than the traditional office visit, which many busy physicians say they find intrusive and annoying. In 2009, one of every five doctors in the U.S. was what the industry calls a “no see,” meaning the doctor wouldn’t meet with reps. Just a year later that jumped to one in four.  Currently about three-quarters of industry visits to U.S. doctors’ offices fail to result in a face-to-face meeting. Throughout the 1990s and early 2000s, drug companies dramatically increased their U.S. sales forces, an escalation most companies came to regret as the economy took a downturn.  Many of those same companies are now involved in this digital shift including Sanofi-Aventis, Merck, Pfizer, GlaxoSmithKline, Novartis and Boehringer Ingelheim . Citing data from market-research firms, Eddie Williams, head of Novo Nordisk‘s biopharmaceutical business in the U.S., said 72% of U.S. doctors own a smartphone, and 95% of them use it to download medical applications. Novo Nordisk has several applications available on iTunes, including one that helps doctors calculate blood-sugar levels and another iPad/iPhone application which offers tools to help doctors diagnose bleeding disorders. Other companies such as Eli Lilly  are now considering “on-demand portals” that will allow doctors to access information instantly as they are treating patients. Although some companies have yet to be convinced of the benefits of e-marketing, most agree it is the way forward. Following the launch of Pradaxa in the U.S., Boehringer Ingelheim put together a digital-marketing package to target doctors, but found that sales calls to doctors’ offices were still the most powerful tool for driving new prescriptions, says. “No doubt digital marketing does have an impact…but I don’t believe, however, the shift happens overnight,” said Wa’el Hashad, the company’s VP of marketing. SRxA can help pharmaceutical clients with all of their digital marketing needs. Whether it’s interactive e-learning platforms, webinars, podcasts, e-newsletters, e-surveys or website design and development our fully customized, physician approved offerings will exceed your expectations. Contact us today to learn more.

Pharma Philanthropy

All too often the pharmaceutical industry is portrayed as evil and greedy. In an attempt to correct this misconception or at least redress the balance a little, SRxA’s Word on Health is pleased to bring you news of its more compassionate side.

According to figures just released by the Committee Encouraging Corporate Philanthropy poll, drug companies gave away more than $13 billion in cash and products last year.

More than half of the $2 billion increase in corporate philanthropy last year came from pharmaceutical companies donating medicine through their Patient Assistance Programs and investing in other initiatives.

While 40% of the 110 companies – polled annually for the past four years – boosted their giving last year by more than 10%, another 17% decreased their giving compared to 2009.

One of the reasons we have seen for increased giving across the board has been increased funding to serve basic needs in communities where companies are working, and pharmaceutical companies, in particular, are in a really important position to do so,” said Alison Rose, the committee’s manager of standards and measurement.

Companies in the consumer staples, financial, industrials and information technology sectors also contributed to the increase in 2010 corporate philanthropy.

So where is all this pharma money going?  According to the websites of the Top 5 global pharmaceutical companies examples of corporate giving included:

  • Johnson & Johnson contributed $588.1 million in cash and products towards 650 philanthropic programs in more than 50 countries
  • Pfizer contributed to numerous charitable projects worldwide including > $47 million for cancer and tobacco control and $7.5 million to HIV / AIDS prevention
  • Roche notes that as a result of some of their 2010 initiatives 47,000 patients received free medicines, 1,100,000 infants were tested for HIV, 11,000,000 doses of flu vaccine were donated and 2,000 orphaned children  were given primary healthcare and other services and assistance through support to the UNICEF & ECPP
  • GSK among their many programs around the world, donated more than 1.6 billion tablets of a drug used to combat intestinal worms.  In the US, GSK supported numerous cancer charities and  provided health education in non-traditional venues for African Americans, Latinos and other ethnic minority communities and set up programs across six states to help high-risk and homeless children receive the specialist medical care they need.
  • Novartis supports many programs both in the US and internationally. In the US alone, their patient assistance programs provided products worth $232 million to more than 100,000 patients in need. Additionally, they have provided free treatment for leprosy patients worldwide, leading to the cure of about 5 million patients since 2000 and has delivered more than 320 million treatments of its antimalarial drug without profit to several malaria-endemic countries

These are but a few examples of the type of corporate responsibility being shown by the pharmaceutical companies day-after-day.  Ladies and gentleman of the Industry we applaud you.

FDA Gets Tough on Asthma Drugs

The U.S. Food and Drug Administration (FDA)  has ordered four drug manufacturers to conduct additional post-marketing clinical trials of their long-acting beta-agonists (LABAs).  LABAs to be studied are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck and Co.’s Dulera, and Novartis AG’s Foradil.

The clinical trials will examine the use of LABAs when used in combination with inhaled steroids. Each of the LABAs plus a corticosteroid will be compared with the steroid alone in patients 12 years of age and older. A total of 46,800 patients will be studied.  Another trial will include 6,200 younger patients, aged 4 to 11, using Advair Diskus.

Last June, the FDA issued warnings on LABAs, saying they should never be used on their own to treat asthma. Although LABAs relax the muscles of the airway to help patients breathe easier, they can cause an increased risk of asthma symptoms that can lead to hospitalizations and death.

The studies will begin later this year, but results are not expected until 2017.

The huge size of the studies signals that FDA wants to be completely sure about the safety profile of these drugs as they are used so widely.

Clearly however, such large study populations might pose financial challenges for the manufacturers.

As of now, Word on Health has heard that Glaxo plans to fully comply with the requirement and Astra Zeneca is finalizing their study protocol with the agency.

Novartis said it was still reviewing the post-marketing requirements issued by the FDA, while Merck said it would have a comment shortly.

We’ll of course bring you updates as they occur.

Big Brother may not be watching, but the FDA, it seems is!

Here at SRxA, we all know how much physicians like to put on their marketing hats. In future, it seems, they might have to reach for their safety helmets instead!

According to our fellow bloggers at Good Promotional Practices doctors are starting to be held accountable to the same promotional compliance standards as pharmaceutical companies.

As most of our readers know, when FDA approves a drug it does so for a given use or indication. However, physicians are still free to make their own decisions based on how a device is used based on their best judgment. When a drug, biologic, or medical device is used for some indication other than the one approved by the FDA it is said to be “off-label.”

In this almost perfect dichotomy, it is perfectly legal, in the United States, for a physician to use a drug or device for “off-label” but it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Furthermore, based on the flurry of DOJ, OIG and FDA activity, such as the massive fines leveled out to Allergan ($600M), GlaxoSmithKline ($750 M), Novartis ($422 M) and Pfizer (2.3 billion) companies must keep the practices of their marketing and sales department in check to ensure compliance.

Until now the “it is unlawful to market, advertise or otherwise promote off label use of a drug” has been aimed at Pharmaceutical companies and third parties acting on their behalf.  Now people are asking “What if the hospital or physician group is doing the marketing themselves, not the company?

We’ve all seen the billboards and free in-flight magazine ads promoting the latest medical treatments from liposuction to joint and hormone replacement.  With physicians are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Blogger Sean McCarthy uses the example of the irregular heart rhythm Atrial Fibrillation (AF, AFib).  While there are very few approved drugs or devices to treat atrial fibrillation, upwards of 2.5 million Americans suffer from this debilitating condition.  Not so surprising then, that physicians use an array of off-label drugs and devices to treat this disease. So, now the hospital or physician communicates their ability to help AFib patients by promoting their latest treatment for the disease on a billboard or newspaper article. Isn’t this the same thing as a company promoting off-label use?

State Attorney Generals, the DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.  McCarthy says he’s heard rumors of a state Attorney General investigating a doctor about his referral patterns and advertising activities.

Who better than the pharmaceutical industry to take the lead in providing education to physicians  to help them prevent compliance snafus.  After all we’ve been there, done this!

Contact SRxA today to see how we can get you started.