Friday, July 30, 2010

The Jupiter Study Dust-Up

When the Jupiter study researchers published their results about Crestor (rosuvastatin) in 2008, this is what they had to say about certain elements regarding the study and its effects on heart disease:

Results showed a true benefit in the rosuvastatin group; there was a 44% lower risk of a first cardiovascular event. Regarding the secondary endpoints -- each component of the combined primary endpoint -- and the subgroup analyses also indicated a substantial risk reduction in cardiovascular events for those patients who were treated with rosuvastatin. As for the absolute risk reduction: because most patients were relatively healthy, it was relatively small.

Why this detail? To talk about the current conflict of interest-related dust-up in the recent Archives of Internal Medicine article.

The Jupiter trial involved 17,800 people and pitted Crestor vs placebo to see if the statin reduced the risk of heart disease in those with high levels of CRP, despite their normal levels of dangerous cholesterol. The FDA, which expanded Crestor’s use this year to people with high levels of CRP and other factors, apparently had no problems with the Jupiter study.

In a FiercePharma story, the Archives authors question the validity of the results from the 2008 study, wondering aloud why the trial was stopped nearly two years into it. The study authors more than suggest there was conflict of interest here because 9 of the 14 Jupiter researchers were financially involved with AstraZeneca, which paid for the Jupiter study. “The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study,” the Archives authors write.

"The trial was financially supported by AstraZeneca," says spokesman Chris Sampson in the FiercePharma story, "but AstraZeneca played no role in conducting data analyses and had no access to un-blinded trial data."

It was an independent monitoring board that stopped Jupiter prematurely. The Archives researchers say it was never made clear what the predetermined benefit to one group over the other, was. They also argue that there were too few deaths to be able to say that it was the statin that should have all the scrutiny.

The lead Jupiter researcher told Time that the study population was healthier than other populations, and the study would have had to go on for a long time to “document a difference in heart-related death rates.” The Archives authors “suggest it would have been better to let the trial continue, and find out.”

It strikes us that these authors raise some old issues that were around in 2008. For one thing, the study’s principal author, Paul M. Ridker, is a co-inventor of the patents on the inflammatory markers, but his employer, Brigham and Women’s Hospital, holds the patent. 

It also strikes us that the FDA’s recent action to approve Crestor for otherwise healthy individuals with high CRP levels is not going to hurt other statin manufacturers.

It’s one thing to question the data soon after a study is out; it’s another thing to malign reputations two years after the fact. There’s no call for it. 

Tuesday, July 27, 2010

Patient Non-Adherence: This Packaging Idea’s a Wrap

Walter Berghahn is a very smart man.

Berghahn, who chairs the board of the Healthcare Compliance Packaging Council and is vice president of packaging technology, AmerisourceBergen Packaging Group, wrote recently in Pharmaceutical and Medical Packaging News that patient adherence could be improved with smarter drug packaging.

Today, “Prescription vials do less to communicate with the patient than does the average OTC package,” Berghahn writes.  Think about it. Before a patient pops his antidepressant, ACE inhibitor, whatever, if he has any questions, he has to find the answers on a 1-inch by 3-inch amber vial – phone numbers, amounts, restrictions, warnings, and so on. If he can’t see too well, that can be a problem. Sure, if it’s a new script, he can look at the literature; but will he? Will he even understand it?

Berghahn points out in his article that he’s not the first to have thoughts of this. The Institute of Medicine talked about it four years ago in its preventing medication errors report, blaming 33% of errors on labeling and packaging issues. But industry has never taken this subject seriously. Not sexy enough for the marketers to do something about it, and because of the siloed nature of companies, manufacturing is not the place to start. Throw in a healthy dose of medical affairs, and you are sure not to have something done.

Berghahn also singles out Pfizer and Wal-Mart for using some compliance-cognizant packaging. The notion of RFID technology in unit-of-use containers is good, but is it practical?

But Berghahn wants more: He wants all stakeholders to recognize that smarter packaging, maybe like this programmable cell phone idea we found in PubMed, could help alleviate the compliance problem. And then he wants the stakeholders to do something about it.

Like we said. Berghahn is a very smart man.  

Saturday, July 24, 2010

The Nemeroff Affair

The Charles Nemeroff/Tom Insel affair is noteworthy for a few reasons.

1. If there are clear rules, there are no excuses

2. People in high places do really stupid things, so companies need to be concerned about good Thought Leader management practices.

3. Situations like these make it more difficult for companies to navigate the current conflict of interest issue, so understand what is happening in the marketplace around you and have plans to adapt to those conditions.

To recap: If you’ll recall, psychiatrist Charles Nemeroff, former chair of Emory University’s school of medicine’s psychiatry department, left Emory under less than auspicious circumstances. While there, he was receiving NIH funding – but was also getting lots of funding from pharmaceutical companies for speaker services – a major faux pas under NIH regulations. After a U.S. Senate Finance Committee embarrassed Emory with the information, Emory more than slapped Nemeroff’s hands. It told its star M.D. he could not apply for any grants for two years. For his part, Nemeroff claimed the conflict of interest rules were ambiguous.

Enter Insel, the National Institute of Mental Health director, and a former Nemeroff colleague at Emory. Insel received a call regarding Nemeroff from a potential employer, the University of Miami – which obviously wanted a reference. Insel did speak with Pascal Goldschmidt, dean and senior VP of the Leonard M. Miller School of Medicine at UM. But what was said?

Insel’s actions have a lot of people scratching their heads -- considering the current climate --  so much so that Insel wrote about it on his blog. Insel claims that all he did was answer a question about whether Nemeroff could apply for grants – but Goldschmidt easily could have gotten that information elsewhere, and Insel admits that he should have sent Goldschmidt elsewhere for the answer.

The U of M says it will keep an eye on Nemeroff. “There will be particular scrutiny of his activities to protect him and the institution and to [make] sure there is no bias in his work,” said Goldschmidt.

The take-home lessons here: Industry needs to manage its Though Leader relationships much closer and adapt to what will certainly be an ever-changing set of rules, regulations, and market conditions.

Monday, July 19, 2010

Another CME World

For argument’s sake, let’s say there is bias in CME and industry will no longer continue funding ongoing training for physicians – in real life, that’s what will be happening at the University of Michigan Medical School.

So let’s imagine a world without industry-sponsored CME.

Let’s say that money isn’t a problem. Let’s say that doctors will ante up and fund their ongoing education, either through their society dues or directly out of their own pockets.

Now let’s talk about the content of those courses. Where is the content going to come from? Certainly researchers and physicians from various schools will want to talk about what’s going on in their labs and clinics, but what about what the medications? In this country, industry develops drugs. In this country, smaller universities and the federal government do much of the basic research, and through licensing deals industry takes it from there.

Developing the information around new therapies, existing therapies and new product extensions are the roles of the drug manufacturer. They were at one time perceived to have most of the knowledge on drug therapy and devices that improved certain diseases.

One of the things that gnaws at us the most about this whole transparency dust-up: It doesn't seem that the purists have offered alternatives to filling the void of education on innovative drug therapies. What’s in place now, is known to have inherent bias, because health care professionals are naturally skeptical. Doctors need continuing education to stay clinically sharp– we as patients want them to have the most up-to-date information  because they will not stay on top of this information unless the continuing education comes to them. Have you looked at Pub Med lately? It’s impossible to keep up.

Industry and clinicians have been working together for years. Making the relationship transparent -- and yes, we agree it should be -- must be done with respect and dignity. Let's figure a way to find solutions to educate physicians about drug therapy.  Otherwise, we believe patient care could be impacted.  And that would not be good.

Friday, July 16, 2010

Is the Conflict of Interest Tide Turning?

Though we want to imagine physicians as mild-mannered healers, we can’t help but think that some medications would have helped at the recent meeting between folks at the ACCME and the AHA – the one where the ACCME kinda, sorta didn’t reverse its public stance about not letting industry scientists speak at CME-accredited AHA meetings.

Though they won’t admit it.

"We have definitely not reversed course," Murray Kopelow, chief executive of the ACCME, told the Milwaukee Journal Sentinel.

One week industry scientists can’t speak at an accredited event, two weeks later, they can? What happened in between? What should have been happening since the conflict of interest issue first reared its head – a conversation among doctors, on both sides of this debate. Up until now, it’s been the purists’ voices who have dominated the conversation. But after the ACCME announced its decision a few weeks ago, people like Francis Collins and Clyde Yancy objected.

“It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector,” said Collins, who runs the NIH.

It was Yancy, president of the AHA, who met with Kopelow after the ACCME’s sweeping announcement in mid-June. According to Medical Marketing and Media, Yancy told the ACCME that his group had its own “independent peer-review process and procedure for accepting abstracts.” Apparently, that was good enough for the ACCME. The ACCME now will allow industry scientists to speak at accredited events, as long as the accreditor – the AHA, whoever – has control of the information being discussed.  Yancy brought up another interesting point in the MM and M article – he said industry abstracts presented at meetings are far and few between. “Over the last three years, only about one-half of one percent of abstracts at AHA's annual confabs have been presented by industry scientists. … which is pretty interesting when you consider all the hand-wringing that's taken place as of late.”

Did the ACCME cave to big-name pressure? Maybe, maybe not. What this scene reveals is that those physicians who are not happy about being labeled guilty until proven innocent should say so. It also reveals that when some physicians say, “hey wait a minute, let’s use some common sense,” others might actually agree with them.

Wednesday, July 14, 2010

We’d Rather Be Writing About Something Else

We wouldn’t be writing about the showdown going on between Zimmer Holdings and its former star orthopedic surgeon if good Thought Leader development principles had been in place.

To recap: Dr. Richard A. Berger, who was a long-time consultant for Zimmer, is publicly biting the hand that formerly fed him, angry that the medical device company did not pay attention to data he had collected, showing a knee replacement device failed prematurely. In a statement that it gave to the New York Times, Zimmer said it had investigated Zimmer’s complaints, and said “he had disagreed with its findings.” According to the Times, Berger, of Rush University Medical Center in Chicago, presented his findings at two meetings of the American Association of Orthopedic Surgeons. Patient complaints started coming in four years ago, a year after he implanted this particular model, according to Berger.

There is the usual back and forth: Zimmer blames Berger’s technique, Berger counters with – I was a star, now I’m the problem? Zimmer says this particular model was a success – but doesn’t have “separate test data … because the F.D.A. had not required the company to study it in patients before selling it,” to quote the Times

Should the situation have come to this? We suggest that had an active Thought Leader management process been in place, this issue could have been resolved and managed in a manner that could have had the same outcome, but without all the acrimony.And, for those of us who think having objective data showing a medical device works before it’s inserted into our bodies is a good idea, there is hope: the FDA is entertaining the notion of tightening the medical devices' approval standards. That will benefit patients.

Yes, these approval standards will mean more time spent on design and implementation -- which will increase the cost of bringing the product to market, which, overall, may not be a bad thing. At a recent town meeting between FDA officials and medical device professionals, the latter said current regulations lack clarity and are threatening the “survival of some venture-backed companies."

Wow. A win-win situation! Doesn’t happen too often, but it could with the right kind of management approach.

Monday, July 12, 2010

It’s Time to Give Up This Ghost

We’re very puzzled by this ghostwriting business.

If industry has anything to do with a journal article, from conceiving it, creating content matter, finding the author, writing the article, editing the article, producing the article – anything at all – it should say so, in black and white, for all to read.

Ghost of a chance, you say? We are not that naive to know that is not how it works.

So we'll ask: Has industry been dishonest in the drug creation? In conducting the clinical trial? In gathering the data? In presenting its findings to the FDA? We do not believe so.   Thought Leaders validate their work, test their processes, and publish their articles with points of view to create debate. That is the value of the current system. We often talk about the unintended consequences of increased scrutiny on this subject.  Our concern is that innovation and science will suffer.

No doubt, the temptation to massage the data can be overwhelming, so keep this in mind: Some journals are now demanding that industry-sponsored trials must be independently tested. After JAMA imposed its regulation in 2005, some folks did a study, comparing industry-submitted articles from 2002 and 2008 – and found there was a 21 percent fall in submissions. Innovation occurring at the expense of gains in medical breakthroughs is one thing, but are companies really so profit-focused they forget why they are in the business?

Are we seeing the impact of this transparency and will there be a positive outcome?  More to follow on the subject I am sure.

Friday, July 9, 2010

A Reason for Collaboration

Here's a scary stat that industry and providers should be paying attention to:

A recent McKinsey Quarterly article says consumers are paying for more of their own healthcare costs than their employers do! It caught our attention because the example the authors used was a multi-facility hospital system and its inability to collect the debt owed.  The so-called balance after insurance was growing at 30% a year and it was growing less for those without insurance - 19%. The balance after insurance is the fastest growing portion of healthcare-related bad debt, and will probably continue to grow as "more insured patients enter the market following passage of the new health care law."  This is scary to our industry because the burden is falling on the patients. If they are not going to pay their own healthcare bills, who will?   

But the authors also talk about how an automated payment network would reduce bad debt, cut administrative costs and save money.The authors state that less than 20% of clinical data today is available in electronic forms.
"Digitizing, standardizing, and normalizing this data so that they can be used for operational and clinical decision making will require large capital investments and create ongoing operating costs. Few health care industry players have the scale or sophistication to manage these issues on their own," the article says. Might it make sense for industry to help lead that charge?  Finding innovative solutions with medicine is not just based on taking a pill or using a device, it is finding out what works and what does not.   

As the pharma, biotech, and medical device companies move toward outcome-based risk sharing payment arrangements, willingly or unwillingly, we all must have access to this information so we can analyze normalized clinical, claims, and payments data. I encourage the industry to not miss a seat at the HIE discussion table as it has done with the EHR debate.  

Thursday, July 8, 2010

Pharma’s Achilles’ Heel

So, how are you doing on determining your company’s fair market value calculations?

Say it ain’t so – you’re still not putting it off, are you?

Okay, as a public service, we’ll rant again. A couple of quotes to set the appropriate tone:

“The trend is clear: Enforcement activity will increasingly focus on holding individuals responsible for the legitimacy of relationships between pharma companies and the physician-consultants they engage.”

“The states are using new codified rules ‘to close their budget gaps…there is a continuing trend of enforcement actions.’”

Friends, do not ignore what is happening here: Federal and state legislators want industry to “legitimize” its relationships with Thought Leaders. Industry will literally pay the price if it does not. The old ways are out: Lawmakers want, in writing, the reasons you paid Dr. Smith, Dr. Jones, Dr. Miller, and so on, those particular fees for the particular service they provided. And they better be justified. The new motto may as well be “consistency in fee determinations.”

So, as much as you’d rather do another project, you need to set aside copious amounts of time to get a fair market system plan in place. You need to talk to departments you normally don’t deal with – you’ll be amazed at how many departments use physician consultants in myriad ways -- and gather data from far and wide, inside and outside your company.

Hiring a consultant, someone well schooled in FMV determinations, is probably a good idea. Relying on the Office of the Inspector General is no help – “they advise only that the method must be ‘reasonable.’ And remember – you are now required to post all those fees on the Web in several of the states.

Let us know how we can help you!

Wednesday, July 7, 2010

The Case for REMS

FiercePharma Manufacturing's special report on planning for REMS was spot-on in our opinion.  But we'd like to stretch the concept just a bit: What if the industry acted as if every product needed a REMS program?  

Yes, we understand what a drag industry considers REMS to be on sales potential--there is no question about that. Also, having a REMS plan means the product's life cycle would be under more heavy scrutiny, which means there will be less room for error. (Actually, we think that's okay.) But if industry could get beyond that - get beyond that REMS is a regulatory tool - and consider what a boost REMS could be to sales potential, then we'd be getting some place.  

What about considering the incorporation of a REMS program into early Phase 1?  What if it was focused on patient monitoring and measuring adherence?  Could this approach force departments within a company that did not normally work together, to begin closer collaboration from the start of the product's life cycle?  We think so!  Think of the potential, think of the problems that could be avoided.  What about the public trust factor, is it possible to imagine the industry's image could be improved?  Let us know your thoughts.

Monday, July 5, 2010

An Invitation to Get Connected

In marketing guru's Seth Godin's recent blog post, he talked about creating value by organizing people online with like skills who can "generate information useful to others" and otherwise solve problems.

"Build a network of experts and make it available for hire."  That thought is how we developed BioPharma Advisors 7 years ago. People are often amazed at our network of experts that we can put together for projects.  Really bright, intelligent people who are known problem solvers, who have multiple industry experiences, who want to solve really complex business problems.  And we do it at rates much less than the large consultant firms.  Harnessing the power of our "Free Agent Nation" is compelling for many life sciences companies that need talent but may not be able to afford them full time.

So for those of you who do not know about BioPharma Advisors, have a look at the rest of our blog, follow us on Twitter (BioPharmaRob) or connect with Rob Nauman through Linked in. Anyway you can, just get connected. You never really know when you might need that instant network of friends outside your own company.

Saturday, July 3, 2010

Selling the Brand: A Rethink May Be in Order

If industry wants to sell to women and to survive, then industry may want to rethink how it tries to attract them.

A recent Pink Tank survey of 1,300-plus mostly college educated, middle class Boomers showed that these women are a) not enamored with industry advertising practices; b) do not fill out script without consulting friends and/or doing research; and c) more apt to try non-pharmaceutical solutions to health care issues. Oops. Not exactly opinions that expand the bottom line.

Some data from the survey:
18% skipped a recommended treatment or test in the past year
33% used home remedies or OTC medicines instead of visiting a physician in the past year
16% did not fill a script in the past year
75% forward health articles gathered from blogs, medical web sites, and so on, to friends and family, a third on a regular basis
60% are influenced by online product reviews
59% discuss specific brands with their doctors
26% go to a pharmaceutical company web sites for information about a brand
44% investigate a drug before filling a script

And more women are paying attention to the fine print: they want to know all the side effects. 80% of women pay attention to the side effects in TV ads, and 64% read the small print in magazine/newspaper ads if they are interested in the brand, the study said. The women in this survey feel that industry shortchanges them much of the time. 

We need to stop listening to all the advertising agency creative people and respond to the consumer. While the industry may be afraid of some of the unintended consequences from the FDA and others, they are now no longer in control of the “content” they produce. What once may have been considered credible is now not meeting the needs of health care professionals or the consumers. What do you think the long term of this might be?

Industry has a few options here. It can try and get involved in that post-doctor-visit conversation, supplying Web sites and phone numbers to answer questions, especially about side effects. It can do a better job of talking about those side effects in TV ads and elsewhere. The survey dropped names (Boniva, Ambien CR) of those brands that did a decent job of delivering a straightforward message. 

Marketers should consider assuming control of content development and stop letting the legal and regulatory folks in the company decide what is right and wrong. Think of all the problems, stress, and conflict within companies that has caused.

Industry may want to pay attention to this survey. We think this is another example of how the industry is not focusing enough on its customers. Thanks again to Matthew Arnold at Medical Marketing and Media for generating the story that got us thinking.

Thursday, July 1, 2010

Job Loss: Will Lessons Be Learned?

What a gutting! – according to an article in Firece Pharma reporting on a Gray and Christmas report - since 2009, more than 80,000 people have lost their jobs in the pharma industry. We can only hope they find jobs real soon.

But what does this mean for the industry itself? Will a new business model evolve?  Surely new efficiencies, or one can hope. Surely new ideas, as people who once worked for Wyeth, for example, tell their new Pfizer employers how they did things there.

But maybe it also means, for those employees who remain, that complacency is no longer a given. That turf can no longer be protected; that cooperation among departments has to occur; that years of mediocre service cannot be rewarded with more paychecks. Some articles suggest it is those on the outside not the ones who remain who benefit more.   

A recent BNET article points out that the recent mergers haven’t really produced these efficiencies, not in a big way, anyway. Pfizer, for example, went from being “below average” in terms of operating efficiently, to “average.” Merck, after its merger with Schering-Plough, did the same. The author concludes that it likely has to do with size of the company As Mike Wokash at Pharma Reform points out in BNET Talkback below the article points out these nine factors as reasons for the inefficiences:
  1. Dispersed accountability (nobody is really responsible)
  2. Dilution of expertise (overburden their limited best talent with increased workload expectations and give them less experienced and less expensive help to make it even more challenging)
  3. Focus on revenue generation at the expense of quality, training, safety, and customer service
  4. Historical spending becomes the basis for increasing expenses (empire building disguised as a growth rationale) which leads to a cumulative bloating of budgets over time
  5. Disconnect of leadership (especially C-level and corporate officers) from the realities of their workforce and their customers
  6. Poor and often conflicting organizational communications
  7. Inconsistent application of and execution against corporate mission and vision expectations
  8. Less than diligent management oversight which leads to a lack of intervention in time to prevent misbehavior, mistakes and poor decisions from occurring or having a negative impact
  9. Diminished employee morale in response to management indifference to their performance (employees get noticed most when they do something wrong)
We could not agree more with this assessment. Maybe the moves companies are making to "Business Units" will help overcome these challenges.  But as we see this evolve, it seems to look like more of the same, cost cutting and financial engineering to survive a storm, let more people go because we can always hire them back or find replacements. That is when businesses start to experience a swirling cyclical motion, when things that seem like new ideas are really not, but there is no one around to remember that we have "been there, done that."