Monday, November 29, 2010

Pharma's Brave New World -- Patient Adherence

And so it continues. The pharma world persists in shedding jobs, despite signs – admittedly wobbly signs -- that the economy is recovering.

Bayer recently joined the job-shedding queue, announcing it planned to eliminate 4,500 positions – but would recreate more than 2,000 jobs when it expanded into emerging markets, primarily in Asia.

Bayer’s announced reasons for eliminating the positions were spiraling research and development costs, competition from generics, and costs from health care reform.  Not really a surprise ….

Interestingly enough, pharma members expanding into China and India will face similar business challenges in those countries eventually.

It’s time for the 30,000-foot view. From our vantage point: America is no longer the glory market. The industry is undergoing a paradigm shift; members are looking for other places to make their fortunes. The huge markets of China, India and other Asian markets are exactly where they should be going. Shareholders will only put up with so much for so long.

So where does that leave the industry staffs in United States? Where should pharma members focus? Our answer: Patient medication adherence! More to follow.

Monday, November 22, 2010

Pharma’s Wake-Up Call: More Individuals, More Often

Today’s topic of conversation: Why the DOJ has begun focusing on pharma execs -- and not just their companies.

Just recently, the feds announced they don’t want pharma executives doing business with the U.S. government if their company has been convicted of ripping off Medicare -- which is above and beyond existing legal restrictions.

According to the Washington Post, the new DHS guidelines say executives can be barred from doing business with the federal government from the time they knew about the fraud, or if the inspector general determines the executive should have known about the fraud.

And, in an unrelated, highly unusual move, the DOJ charged a former GSK attorney of various counts of fraud, alleging that she lied to federal authorities about what she knew regarding off-label promotion of Wellbutrin SR.

Let’s look at the numbers. According to these attorneys, who specialize in representing whistleblowers, “Over the past two years, the Department of Justice has collected over $2 billion from big pharmaceutical companies in fines, damages and civil penalties for defrauding Medicare and other health care programs funded with tax payer dollars.”
 That’s just the companies. Just think what the DOJ could collect if it also went after the execs. Think Jeff Skilling, Bernie Madoff, Michael Milken – who paid $600 million in fines for his financial sins.

According to the whistleblower attorneys, the DOJ doesn’t have to get personal. Under the False Claims Act, the offending pharma company could be forced to pay a $10,000 penalty for each script written under the offending scheme.

That’s certainly a lot of money – but it doesn’t have the same impact as being personally charged with a crime, or crimes.

"The current administration is feeling that they want to increase enforcement in this area, and they're of the belief that monetary settlements aren't sufficient, and they need to charge individuals to deter the conduct," Jeffrey Senger, former acting chief counsel with the FDA, told the Washington Post.

“The theme of [a] drug-law industry conference last month was ‘more individuals, more often,’” wrote the New York Times.

For those industry members who aren’t reading the writing on the wall, it’s either time to get new glasses or a very good translator.

Wednesday, November 17, 2010

Prescription Abandonment: Opportunities Lost

It’s a shame that industry’s rep is in tatters right now. Pharma should be delivering an important message to American businesspeople, but they likely won’t pay attention – one, because of the messenger, and two, because it would cost them money – initially -- to fix the problem.

We’re talking about prescription abandonment. A new Annals of Internal Medicine study confirms what common sense tells us: people with limited resources will not pay for prescriptions they cannot afford. The study – conducted in tandem with CVS Caremark over the summer – shows that if a co-pay hits the $40 and above range, people are more apt to forgo the drug, especially if it’s a new script.

An accompanying editorial  also notes the obvious: Someone who doesn’t fill a prescription undermines his treatment, faces increased healthcare costs down the road as well as potentially life-threatening results.

That someone also affects the workplace – in terms of days off, reduced productivity, and so on.

The Annals study isn’t the first. A WSJ blog, citing a Wolters Kluwer study, notes that nearly 10% of new scripts for brand-name drugs weren’t filled in the 2nd quarter of 2010 – an 88% hike over the same time period in 2006.  Comments to this WSJ blog were Scrooge-like. “The bottom line is that people are too unaware of what the actual costs are for health care,” wrote one. “If you don’t think your health is important enough to spend any of your own money [even when insurance is available to you], why should the taxpayers, your employer, or anyone else think it’s important?” wrote another.

Let’s look at a map. Folks at Kaiser Permanente figured out how many prescription drugs people take in the U.S. In two words, it’s stunning. In Tennessee, people between 19 and 64 take an average of 16 medications; in North Dakota, it’s 13, in California, less than 9. We argue that this map shows that people will fill their prescriptions – when they can.

But if big employers do what they’re threatening – shift more healthcare costs to workers – what will happen to those employees at the bottom of the payroll?

A little forethought is needed here. Think about those diseases that are relatively symptomless at first, like type 2 diabetes. Regular doctor’s visits and blood draws would show creeping A1C levels. Diabetes under control is cheaper than diabetes out of control.

Are employers and government agencies being penny wise, pound foolish? We’d say so! We’d also urge industry marketers -- despite pharma's current reputation -- to use these data to help solve the problems and focus on medication adherence solutions that work!

Monday, November 8, 2010

Reporters, Pharma-Sponsored Seminars: Keep the Brick in the Wall

From the should-we-create-another-shade-of-gray department: Are journalists who attend seminars underwritten by corporate sponsors still objective?

Some journalists say yes, some say no. What do we think? We think a good friend, a first-rate journalist, hit it on the head: If it’s a trade association, then that would be okay. Why? It’s an amorphous group, she says. You know what you’re getting, you know what the agenda is. If it’s a sole company, “you don’t know what they have in mind.”

The sole company that’s raised the stink in the blogosphere is Pfizer.

Here’s the background. The National Press Foundation offered a four-day seminar to a small group of journalists to learn about covering cancer. It’s the second year that the seminar’s been offered. Pfizer, one of NPF’s sponsors, underwrote the seminar both years. According to the NPF’s Web site, the foundation’s mission is to educate journalists about complex issues. It has numerous corporate sponsors, including Toyota, Gannett, Allstate, Merck and Pfizer – the latter donating $100,000 plus. (Prudential Financial, another sponsor, underwrote a seminar on retirement, but we were hard-pressed to find any media stink about that seminar.)

Politics Daily argued the ethical dilemma that such a connection creates; the NPF, on the other hand, argued that newsrooms are stretched for cash so that training journalists in these difficult topics isn’t taking place. NPF controls the agenda, it said, so it is confident that church and state, so to speak, are kept in their respective corners.

We can appreciate what the NPF is doing. A conscientious journalist who doesn’t have a solid background in writing about cancer will be frustrated in dealing with this topic. And attending pharma-underwritten seminars is one way to become educated.We just think it is importance that independence of educational content be refereed by NPF. 

This operating principal helps NPF and journalists feel confident the "firewall" is trustworthy. Maybe we’re na├»ve, but it seems we are very concerned these days with assuming people/situations are guilty until proven innocent.

Friday, November 5, 2010

Pharma, COI, and Principled Interactions

One thing’s for sure: Pharma members are going to need scorecards to keep track of what kind of industry-thought leader interaction each academic institution allows. For example, the University of Iowa does not permit the distribution of drug samples, nor can its faculty use ghostwriters. They can’t appear on speaker bureaus, either.

In Boston, physicians who work for Partners Healthcare – Brigham and Women’s Boston, Massachusetts General -- face similarly strict rules. If you recall, one Brigham faculty member resigned in protest over the fact that he could no longer earn money, speaking on behalf of pharma. But its rules on CME aren’t as stringent as those at Stanford University, or at Memorial Sloan Kettering, according to this same Globe article.

But at Yale, leadership there has adopted a more nuanced approach to dealing with perceived conflict of interest issues and interaction with industry.

“We rejected the idea that all interactions [with industry] are wrong and the notion that any relationship is a conflict of interest,” Ronald Vender, MD, chief medical officer for the Yale Medical Group and associate dean for clinical affairs for the Yale School of Medicine told Medical Marketing and Media. “[I]t's not that we are promoting interactions. But if one is going to have [them], we are promoting the concept of ‘principled interactions.'”
Well, what do you know -- a realistic approach. At Yale, these principled interactions require that faculty pay attention to the rules. Yale has established an “enforcement mechanism,” MM and M says.

Yale faculty must follow the rules regarding speakers’ bureaus, gifts, meals, interactions with sales reps, and so on. The one COI area that Yale put its foot down about is ghostwriting – it’s not allowed. Good for the Bulldogs. As we’ve said in this blog before, ghostwriting in this business is wrong. If a researcher needs an editor – and all writers need editors -- give that person credit at the end of the article.

About those scorecards. With academic institutions everywhere adopting new COI rules, the wise pharma member will want to know which institution requires what before making any contact with any institution. But who has time to get all that information? Maybe BioPharma Advisors can help you.

Wednesday, November 3, 2010

CBI KOL Management Conference-Princeton, NJ

We are attending the CBI KOL Management Conference in Princeton, NJ.  Click link for the agenda, follow our tweets by hashtag #kolmtg. 

We are part of Workshop presentation on Centralized KOL Management.  Send us an email if you would like a copy of that presentation

Monday, November 1, 2010

European Commission and Its Good Practice Recommendations

Et tu, EU? The European Commission has announced that it wants to see just how good a corporate neighbor pharma really is. The EC wants, says InPharm, “to examine corporate responsibility in the pharmaceutical industry with the aim of developing a series of good practice recommendations.”

What good corporate responsibility would entail seems to boil down to three areas, according to The Pharma Letter: ethics and transparency; access to drugs in Africa; and access to medicines in Europe. Further details, at least from scanning articles about this on the Web, are sketchy at best.

Are our European cousins piling on?

First, let’s define corporate responsibility. One definition says it’s “a voluntary approach that a business enterprise takes to meet or exceed stakeholder expectations by integrating social, ethical, and environmental concerns together with the usual measures of revenue, profit, and legal obligation. In another, it’s a “firm's sense of responsibility towards the community and environment ...

One says voluntary, the other says sense. Neither says obligatory. Are we suggesting that pharma should not be conscious of its moral and ethical obligations? Of course not. What we are suggesting -- and will continue to do so in this blog -- is that industry critics should be mindful of the unintended consequences of this constant drum-beat of criticism. (In the InPharm piece, the EC official does make note of pharma’s enormous economic contribution to the EU.)  As we have said again and again, let's focus on solving the problem!

Disruption of Research and Development of innovative medicines is serving no one!