The FDA, Transparency, and Reality

As we have stated in this blog many times, transparency, as in nearly all matters, can be a good thing.

So by all means -- a 21-gun salute for the FDA’s 21 proposals that allow the public a better view at what transpires between the agency and industry, including summary safety and efficacy data from pre-approval and marketing applications.

Why the touch of tone? Because what the FDA wants to do will cost money and eat up valuable time. And skeptics might ask: Will these new rules really improve the public's health?

We actually think so! But, industry insiders may not be looking at it that way. In our view, transparency will uncover those issues in which the agency and industry have differences -- now, those problems will get thrashed out, but usually during the time compressed approval process, when conflict avoidance is the word of the day and if conflict occurs is usually not a positive outcome.

We all know consensus is not reached without significant debate -- and that typically does not happen quickly. Why does industry panic?  Is it because these business constraints seem to happen only at critical moments in their business cycle?  It seems like the age old going to the gym argument. Maybe if we went to the gym and worked out before we needed to desperately do it, maybe the change would not be so hard. 

Because we live in a sound-bite world, a full explanation of these problems will rarely be published, digested, and carefully considered, and most likely will be misconstrued. Does this help improve public health? Not likely, because again the presumption is that medicines are generally safe and people may not care until after the fact. 

No man-made system works perfectly – who isn’t shocked when something goes off without a hitch?

While it seems like each party should fight for its point of view, people just want their various afflictions solved.

We just think this transparency issue needs to be moved forward. These 21 proposals are not perfect, but they do begin that process. Please engage in discussing the solutions.  

Is Conflict of Interest Pushback Begining to Happen?

Is it possible that physicians and clinical researchers are beginning to push back against their Conflict of Interest (COI) critics? We'd like to think so.

The proof? The Association of American Medical Colleges (AAMC) and other university associations recently asked the National Institutes of Health to loosen up its proposed financial reporting requirements, which have few exceptions. The AAMC et al essentially said that the NIH’s proposed transparency rules are unnecessarily strict. This new opinion differs from the AAMC’s earlier support.

In its letter to the NIH, the AAMC said:

“There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.”

Let’s look at the numbers. In its letter, and we’re essentially quoting, the AAMC says it represents 150 U.S. and Canadian medical schools; about 400 teaching hospitals and health systems; and 89 academic and scientific societies. That’s 125,000 faculty members and 106,000 resident physicians. And that’s only the AAMC. The Association of American Universities represents 61 research universities.

You get the point. That’s a lot of physicians who have chosen a life of medical research or is the place where they develop their medical training. It’s possible that those physicians raised a concern about what the NIH was proposing – and the AAMC leadership listened. A good example of a group listening to what its constituents want for policy and not letting someone in government dictate their way of life.

And maybe that’s the way this COI crisis will resolve itself. Not in a public forum, for all to hear, but in back rooms, away from glaring eyes and media attention. It happened earlier this summer, if you remember, with the AHA and the ACCME drama.

It’s not how we would like it – the unintended consequence is that the public is not hearing the full-throated discussion, but we also think that not everyone cares about how this "sausage" policy is made, but that these COIs do not harm or cause inappropriate care to be delivered.

But at least, if we're right, physicians on both sides of this issue are talking to one another, thrashing this whole thing out.  The next question is how those talks will impact industry collaboration.

The Foreign Corrupt Practices Act and Industry

As promised last year -- the Department of Justice is following where industry members conduct their business. At last count, [that we know of] the DOJ had notified at least 12 industry and device manufacturers that they were under investigation for possible violations of the Foreign Corrupt Practices Act. The feds want to know if these 12 tried to influence how physicians would determine the results of industry members’ overseas trials on any drugs that came back to the U.S. market. (To get the Lexocology article about the investigation, you'll need to register.)


Getting specifics on what the DOJ has found hasn’t been easy: As this WSJ story on Merck points out, Merck wasn’t charged with anything. The Financial Times reported that the DOJ "was looking at whether pharma companies had ignored a 'systematic risk' inherent in the global drugs business and ignored obligations under local and US anti-bribery law."

What ostensibly rattled the DOJ’s proverbial cage was that report this summer from the Inspector General of the Department of Health and Human Services. You all saw it – the one that said 80% of all FDA approved drugs in 2008 were based on trials conducted in foreign countries. And of course, the FDA had conducted very few inspections of those sites.

We say ostensibly because of what the DOJ said last year. The feds said they were interested in looking at industry through the legal lens of the FCPA. In that speech [second paragraph], the assistant AG talked about how much money the department made in other cases it had tried -- $1.6 billion in one, $579 million in another. The assistant AG mentioned that the department has brought more prosecutions since 2005 (58), than between 1977, when the FCPA was passed, and 2005.


We think the DOJ will continue to examine industry practices in a manner that will make it more difficult to operate, cost more to complete innovative drug research, and challenge or change the way the industry conducts business. Maybe it’s time to say, enough.

The Variability of Patient Care

Back in May, Hospitals and Health Networks Magazine published an article by John Glaser, CIO of Partners Healthcare in Boston.  He is now CEO of Siemens Healthcare's Health Services unit, and a thought leader you might want to watch.  We thought this article was particularly relevant because it discussed the two types of care that EMRs need to account for, sequential care which follows certain processes and iterative care or the discovery/ diagnosis of disease.

Why is this relevant to pharma marketers?  Because industry marketers need to think differently!  They need to comprehend that electronic barriers are going to impede their product's prescribers and subsequently adoption of their product. And depending on the product, many marketers are only focusing their messaging on that iterative care piece.  But the real dollars are in the sequential care processes that follow the initial diagnosis. This we believe is where many companies and their agencies need to be focusing their message development.

We think this article begins to help marketers understand the issues going forward and offer some examples of other industries that adapt to situations.  Glaser says, "We may be able to learn from other settings in which iterative and sequential activities are occurring simultaneously —for example, soldiers in combat situations, pilots landing planes in the Hudson River and scientists conducting experiments. These settings must also balance the information technology needs and the implementation mindset."

Even Neil Versel at FierceEMR said, "Ever notice how so many examples of how EHRs can improve care focus on diabetes? That's because diabetes care has many clear protocols, copious amounts of scientific evidence that gets included in clinical decision support and clear quality measures."

Our summary point to all of this suggests, EMRs will have a tremendous impact on the future of product selection for prescription medicines and medical devices.  If you do not know a lot about this now, you may want to learn more quickly.

CRMs: Reaching Physicians in Cyber Space

In our conflict-of-interest focused world, industry critics are doing their best to keep industry members away from one of their prime customers: physicians. But e-marketing, specifically customer relationship management systems, may be one good way to reach physicians.

Hospitals, always in the market for paying customers, are starting to invest in these CRM systems, according to this American Medical Association story.  Hospitals are primarily looking for ongoing relationships with patients. After the CRM software gathers a patient’s information, it can create personalized Web content for patients, targeted mailing campaigns, and phone support services.  Something the industry has done for years and not ever gotten much credit for it!

But unlike industry, hospitals have never really done a good job of fostering or empowering the physician-patient relationship. The article speaks of one hospital in Illinois in which its marketing team speaks with doctors about the types of content and tools the physician wants to include on patients’ personalized Web sites.

But certainly these CRMs are also geared towards physicians.  Some CRMs specifically are used as recruitment tools. Has the industry missed another opportunity to get involved in this “evolving e-physician community?” Hospitals are wary of the future these days, perhaps partnering with them would make excellent sense, from many vantage points. Again, this whole thing is not called Customer Relationship Management for nothing!

Mobile Health Tech Study: Get Linked

A new PricewaterhouseCoopers' Health Research Institute survey says that physicians recognize that mobile health technologies can help with patience adherence issues, physician shortages and other long-standing healthcare problems.

The results of the Healthcare unwired survey, which involved 1,000 physicians and 2,000 consumers, suggest that physicians and the public alike are ready for mobile health technologies. But PWC says various stakeholders, including some in industry, are essentially ignoring this news. The primary reason: The way the U.S. health care system makes its money. Because only in-person consults are reimbursed, the system is dependent on volume to make its money, so it is not likely to embrace the idea of reducing that volume or transferring that model to lower-cost care -- Americans feel they are entitled to the best healthcare.

According to the survey results, most physicians said they would like to receive healthcare data from their patients’ smart phones or cell phones. (Three out of 10 consumers surveyed were good with tracking it that way.) While these might not seem like big numbers, this is the start of the innovators' curve and this country will reach the tipping point. Our goal is to make our readers aware this "IS" coming and like many other changes, try not to let these opportunities slip by.

We believe that receiving such data could help with patient adherence, 88% of the physicians polled said they would want their patients to monitor certain numbers at home, especially blood sugar levels, blood pressure, and weight. Moreover, 57% of the physicians said they’d like to receive similar data from discharged patients under their care -- this lack of data is one of the biggest issues in medicine today and causes millions of dollars in inefficient care.

A few years ago, physicians, as a group, were not technologically in tune. But that has changed. In this survey, 63% said they are using personal devices to help their patients – and these devices aren’t connected to hospitals or their practices. Of those using smart phones and cell phones, 56% said the technology quickens the decision-making process, and 40% said these tools shave time spent on administration.

And time is what it’s all about: 45% of the doctors said Internet visits would allow more patient access, and 43% said mobile health technologies like e-mail and texting could reduce actual office visits. The gains, PWC says, would be huge. They could:

• help with physician shortages;

• reduce costs of hospital readmissions; and

• increase access for those patients who put off care because they won’t wait for an appointment.

The actual study (you'll need to register to get it) points out two (pharma and retail pharma) members that are tapping into this market: Bayer and CVS Caremark. Bayer has integrated its digital glucose monitor, DIDGET, into the Nintendo game console. And CVS has an iPhone app that allows members to get information on refills and other pertinent information.

Our point is that the industry needs to embrace change, especially technological change like the ubiquitous use of mobile phone technology.  

Are Pharma Reps Robots or Salespeople?

We're wondering about the wisdom of it all. Back on July 7th the WSJ Blog asked the question of whether pharma reps are robots or sales people.

At issue: Does Novartis owe some reps OT under federal law for working more than 40 hours per week?  According to the law, it depends on the work. If the salespeople are closing deals away from the office, then it doesn’t owe them the OT; if the salespeople aren’t closing deals, then money is owed. Novartis obviously argued the former. But the blog post and one of the reps bringing forth the lawsuit actually contend they are more like “robots,” because they lack the “discretion and independent judgment” needed under the definition of outside sales representative to fit that description.

We understand why the company would not want to provide back pay, and why sales reps feel like they’re entitled to their back pay. But let’s face reality, this case highlights something we must all come to terms with and the customers the industry speaks with may be telling us as well.  Reps are like robots, they no longer possess or are given the "discretion and independent judgment" once seen in this profession 15 to 20 years ago.

When we speak with family and friends who are in the industry today, it is clear they do not like their jobs because it is so programmed, so heavily regulated, and to be honest, risky. The majority of good sales people just want the ability to converse with their clients and customers.  So much of this has been clouded for so long, we really question the value a rep brings to an interaction with a physician today.  And to be honest, maybe market forces are solving that problem for us.

Our whole point in bringing this up is to appeal to the legions of sales executives in the industry. Do some self-examination, make some reasonable fact-based decisions on reducing the troops.  Realize that the U.S. market is not the favorite marketplace any longer, and that customers demand more from your organization.  Help to make that a reality.