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.

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.