Category Archives: Pharmaplasia

You can ignore but you can not hide from Change in Pharma

A few years ago, contrary to the recommendations in Pharmaplasia and in the face of an industry-wide “patent cliff” and a rapidly changing healthcare market, the Pharma industry went on a binge of mega-mergers and multi-billion dollar acquisitions.  The book Pharmaplasia had identified large organizational size as not only challenging but as a liability in the evolving new healthcare market.  But “Big Pharma” wanted to get “Bigger” and it took years for Pharma to appreciate the need for change that had been recommended in Pharmaplasia“eliminate facilities, people, and support systems that no longer have a role in the evolving new healthcare market.”   Now, more recently, we have seen unprecedented downsizings, including elimination of facilities and people in massive restructurings at some Big Pharma.

Sure,  change can take time, especially in large public corporations.  The status quo and doing “what we have always done” is easier but it merely delays the inevitable and can give current frontline employees a false sense of accomplishment and security.

There are over 20 specific recommendations for change in Pharmaplasia that could accelerate a positive evolution for Pharma.  If these recommendations are being ignored by your company for now, it may be just a matter of time before you are affected?

With the information and recommendations in Pharmaplasia you can determine how the changing Pharma business model will affect you in this evolving new healthcare market.  Better yet, Pharmaplasia can help you determine how to  align yourself with these changes so you can participate in these positive changes and not be caught off guard by the inevitable.  mike@pharmareform.com

How Pharmaceutical Companies can help Increase FDA Productivity

First, I am not going to defend the FDA or ignore its organizational dysfunction and seemingly antiquated review processes.  No doubt, the agency is underfunded and lacking in the necessary expertise to carry out its broad and geographically disperse responsibilities.   At the same time there are steps the pharmaceutical industry could take to help increase FDA productivity.

Historical precedent would suggest that pharmaceutical companies are more interested in getting products to the market than making sure their products are safe, effective, or even needed.  They tend to do the absolute minimum to get through the regulatory approval process (fastest, easiest indication first), hoping to argue there way through questionable safety data and relying on marketing to find expanded revenue opportunities in patients for whom they have little or no proof of efficacy or safety.   Some of the antics reported in the trade and lay press would suggest that pharmaceutical companies are continuously trying to find new ways to “game” the system.  If you need the details, there is a good review of the past forty years of industry missteps and flagrant disregard for regulatory expectations in the book Pharmaplasia™.   It is clear that the FDA has been put on high alert police mode by what historically has appeared to be an out-of-control, intentionally non-compliant, almost defiant pharmaceutical industry that can’t be trusted.

In this context, is it any wonder that the FDA is skeptically cautious, more demanding for proof of claims, and sometimes even slow and seemingly uncommitted when it comes to product approvals and issuance of guidance documents yet deliberate and critical, albeit intermittent and inconsistent in their enforcement?

Here are five steps the pharmaceutical industry could take to help improve the regulatory process and FDA efficiency.

  1. Focus on Innovation
  2. Makes safety issues easy for the FDA to understand
  3. Make manufacturing quality an organizational priority
  4. Commit to ethical and regulatory compliant marketing and sales
  5. Establish a base of credibility

Focus on Innovation

Despite the sunk costs of discovering and developing a product that companies hoped would turn out better than it did, don’t bog down the FDA review process with products that have little or no clinical benefits over what is already available on the market.  If you feel compelled to bring a comparable product to market, don’t try to make it sound better than it really is to substantiate a higher price.  Again, trying to angle for a labeling claim advantage that doesn’t really exist consumes FDA time and resources.

Make safety issues easy for the FDA to understand

It is mind-blowing to me that pharmaceutical companies can get to a final advisory board meeting prior to an expected approval and find out there is a concern and unanswered questions about an animal toxicology study or clinical finding?  Well, maybe the company was hoping it would just slip by and nobody would notice the data or they thought they could argue their way through the questionable or disturbing data.  Why not be proactive, anticipate the concern and just get the data to prove it’s not an issue?  Well, maybe companies still believe in the “don’t look for it unless it is a regulatory requirement” theory because they might find something they don’t like or can’t explain.  I appreciate the need for speed in development but you have at least 3 to 5 years after a product starts clinical studies to sort out any safety issues.  That is, if you really want to take the risk to understand the basic sciences of the concern or potential problem.

Make manufacturing quality an organizational priority

First, the answer to industry manufacturing issues is not lower quality standards, fewer FDA inspections, or less rigorous, less critical inspections.  In fact, I am a proponent of maintaining high quality standards,  more frequent and more rigorous inspections, including of foreign facilities.

As challenging as pharmaceutical manufacturing can be, I don’t see why pharmaceutical companies should expect anything other than a clean slate, no 483’s,  when the FDA inspects their facilities.  With appropriate management manufacturing expertise and robust quality systems in place, avoiding 483’s should not be a matter of chance or wishful thinking but rather a matter of fact.  Clean, high quality, cGMP – compliant manufacturing would make FDA inspections (and follow-up) easier, less laborious, and less time consuming.

Commit to ethical and regulatory compliant marketing and sales

“Pushing the regulatory envelop” and “off-label” promotion can drive revenues and increase your market opportunity but also puts tremendous additional workload on the FDA.   So much so that it is clear that pharmaceutical companies have taken advantage of this burden by trying to be clever in their advertising and promotions knowing full well the FDA can’t police everything and the chances of being caught are remote.  Even if caught, the consequences are minimal (a “slap on the hand” in the form of a letter) unless the Department of Justice pushes for some financial penalty.  And then,  it just becomes a cost of doing business.  Unfortunately, pharmaceutical companies may feel they will be at a significant commercial disadvantage if they don’t “push the regulatory envelop” because “everybody is doing it.”

An industry-wide commitment to ethical and regulatory compliant marketing and selling would make non-compliant outliers more obvious and allow FDA to focus resources  on the more egregious and potentially harmful marketing and sales activities.

Establish a base of credibility

If the pharmaceutical industry were trusted, credible, and committed to regulatory compliance the FDA would not have to spend as much time, effort, and resources trying to sort out the “gamers” from bona fide efforts to bring safe and effective innovative new products to market, to maintain high quality manufacturing standards, and to market products in compliance with the approved label claims.  Yes, I believe there are companies and their CEOs who profess this to be their intent, but the historical record suggests there are few who have been able to deliver or credibly live up to this commitment.

mike@pharmareform.com

Price war over Pharmaplasia™ at Amazon.com

As a first time author and publisher it’s been an interesting road from drafting, writing, and editing to finally publishing Pharmaplasia™.  Fortunately I had some fantastic professional help putting it all together.

My intent was to call out the historical missteps of the pharmaceutical industry, provide some deeper organizational and business insight (rather than superficial sensationalized hype) as to why they happened, and identify a better path forward for pharmaceutical companies, especially in light of the evolving new healthcare market.   After a year and a half of grueling long hours of writing and editing I was told the work really begins after you have your book written and published.   I was stunned but can now tell you they were absolutely correct.  Marketing and selling books  is challenging and time consuming.

Recently,  a customer who was interested in purchasing a bulk supply for their pharmaceutical company alerted me to the fact that my book cost $49.99 on Amazon.  At the time I only had the Kindle e-book version available on Amazon for $9.99,  so I was totally confused.

So I searched Amazon.com and to my surprise, in addition to my Kindle version,  Pharmaplasia™ was listed as a “Collectable” (presumably because it was a signed paperback copy) and it was (and as of today,  still is) priced at $49.99.  Anybody who wants a signed paperback copy can send me a check for $49.99 and I’ll be happy to send you a signed paperback copy.

So last week I put the paperback copy up for sale at Amazon for $19.95 (plus shipping and handling) and unintentionally started a price war with my own book.  Within days, somebody decided to offer “new”, “never opened” paperback copies for $19.90.  This is really interesting because I have the inventory in my house except for those that I have sold (mostly through my website) or provided for review purposes or to friends and family.

So you don’t have to spend $49.   Pharmaplasia™  only costs $19.95 (plus shipping and handling) for the paperback and $24.95 (plus shipping and handling) for the hardcover.  Both are available by clicking on the Buy Now button to the right on this website.  The paperback and Kindle version are also available at Amazon.com.  And for those interested in discount pricing for bulk purchases for your group or company, please shoot me a note mike@pharmareform.com and I’d be happy to work with you on pricing and delivery.

mike@pharmareform.com

Journal of Medical Marketing Publishes Review of Pharmaplasia™

 

The Journal of Medical Marketing (January 2011) has published an extensive (2+ pages), informative review of Pharmaplasia™, which is now available online.   The author concludes his review :

“As I closed the book for a second time, I felt like I’d had a friendly and useful conversation with an eloquent, intelligent and very experienced man who cared about pharma and had some useful things to say.  I’d have been mistaken to expect his book to give all the answers to the challenges faced by the industry, but if I’d hoped for a more modest but still worthwhile contribution to a complex debate, I’d have felt my time reading the book to be well spent.”

Brian D. Smith   Journal of Medical Marketing (2011) 11, 90 – 92. doi: 10.1057/jmm.2010.33

The Journal of Medical Marketing currently has a free trial so you can freely view the pdf file.

mike@pharmareform.com

The Reality of Pharmaceutical Industry Predictions is Coming True

The commentary and highlights of pharmaceutical industry challenges noted in Duff Wilson’s article “Patent Woes Threaten Drug Firms” in The New York Times (3/6/2011) and the Morgan Stanley report “An Avalanche of Risk? Downgrading to Cautious” come as no surprise if you have read the book Pharmaplasia.  This disconcerting pharmaceutical industry situation has been decades in the making and unfortunately, will take decades to turn around.

Those looking for or postulating near-term quick fixes from strategic restructurings, mega-mergers, technology acquisitions, or breakthrough serendipitous discoveries to resolve the industry dysfunction will be sadly disappointed.  As described in Pharmaplasia™, the problems in the pharmaceutical industry are deep rooted and involve more than just a lack of  R & D productivity.

Sure there are going to be the occasional successful new product introductions that give us hope that the industry is recovering but even those introductions will have been the result of decades of development work and there will be too few to really make a significant impact on restoring healthy consistent revenue growth for the industry.  For the pharmaceutical industry there are no quick fixes and it could take decades for the impact of the multitude of strategic efforts today to really begin delivering the types of financial results expected from the magnitude of investment being made by the industry.

In addition to fixing R & D, the pharmaceutical industry business model must become more efficient (increase operational productivity and reduce waste), must be more responsive to healthcare market needs, and must replace traditional sales and marketing tactics with healthcare market embraced programs.  Success will depend on competent leadership that is more interested in satisfying evolving new healthcare provider needs and patient well-being than “driving revenues”, satisfying Wall Street, and building personal financial wealth.

In the end, a more prosperous future for the pharmaceutical industry will come from discovering and developing truly innovative new treatments that provide clinically meaningful benefits over currently available therapeutic alternatives.  This will take a major change in R&D philosophy with a much more comprehensive basic sciences approach to finding preventions, treatments, and cures for diseases rather than relying on historical “tweaking of chemistry” and “trial and error” approaches of matching compounds with postulated disease targets.   mike@pharmareform.com

Pharmaceutical Representative Magazine Publishes Review of Pharmaplasia™

Pam Marinko, cofounder of the Atlanta Medical and Pharmaceutical Representative Association and a member of Pharmaceutical Representative ‘s advisory board gives Pharmaplasia™ 4 of 5 stars in her review in the December 2010 issue of Pharmaceutical Representative Magazine.

“Having been in Pharma most of my professional career, I appreciate the author’s perspective and fact-referenced historical account of pivotal events.  Even though I don’t agree with some of the conclusions, they could stimulate some great conversations.”

Pam Marinko, Pharmaceutical Representative Magazine, December 2010

mike@pharmareform.com

How to Affect Change with the help of Pharmaplasia™

I really appreciate all of you PharmaReform readers who have purchased Pharmaplasia™.  Thank you.

I’m sure many of you realize how hard and seemingly impossible it is at times to affect the magnitude of change we have been talking about for over a year now at Pharma Reform and as described in Pharmaplasia™.  This is especially true in large organizations where the changes have dramatic financial implications for the company, puts careers and the livelihood of so many people at risk, and that are clouded by uncertainty at every step of the transformation.  Yet a more prosperous pharmaceutical industry for the future will require dramatic change.   Some people won’t want to change while others will just complain that things must change but they’ll feel helpless in being able to affect the change.

As a reader of Pharma Reform you have probably even thought, “this is all well and good Mike but… how do I get my management and corporate executives to start thinking differently about these issues and the need to formulate plans that make sense for the evolving new healthcare market?”

For those still contemplating the purchase of Pharmaplasia™, I am certain that as readers of Pharma Reform you would relate to the suggestions and recommendations proposed in Pharmaplasia™ but more importantly, you’ll be well informed and inspired with confidence to begin making your case for change where you feel you can have an impact.  But, how do you do that without sounding like a “whiner” or feeling like the “lone soldier?”

OK.  Here is a self serving but low risk strategy to help you at least get your management to start thinking about what this evolving new healthcare market really means to your company and what they can be doing about it.  If you have already bought a copy of Pharmaplasia™ and read it, this is going to be easy.  If you haven’t bought and read Pharmaplasia™, that’s the first step. Buy a copy and read it.  Wait…I’m not done yet.  Hang on.  This is not just about selling more books, although that would be nice.

If you agree that your company could benefit by at least exploring some of the suggestions and  recommendations in Pharmaplasia™ or  from just talking about the issues, pass the book on to your manager (or somebody else who you feel could help make a difference) with the simple recommendation that Pharmaplasia™ presents some interesting perspectives that are worth reading about.  That’s a pretty benign, low risk commentary and referral.  Then follow up to see what they thought about it and see if they think it’s worth discussing further or doing something about.

If nothing else, Pharmaplasia™ gives you a great opportunity to instigate thinking about the future (rather than day to day activities) and have a non-judgmental discussion around specific issues that might pertain to your company, to better understand your management’s thinking and to explore their strategic rationale.  If you can get the book back from them, you can then pass it along to another person who could help make a difference.

OK.  If you keep passing it around like this I might not sell as many books but that’s not the point.  Neither is agreeing with everything in the book.  The point is to stimulate thinking about your company in the context of the evolving new healthcare market and encourage discussion (not complaining).  Perhaps you will identify some areas where you can take easy first steps to make a change for the better or perhaps even get to the point where it makes sense to “Invite Mike to Speak.”

So. You can remain frustrated, complain all you want, and see what happens or you can make this small effort to contribute to change and maybe you’ll be surprised by the initial impact you can have, even in a large organization.

mike@pharmareform.com

Pharmaplasia™ reviewed in the context of Pharma Issues and Challenges

A review of Pharmaplasia™ was recently published as commentary to a discussion about well publicized issues and challenges facing the pharmaceutical industry noting:

“How did we come to this, and is there hope that these companies will behave differently moving forward.  That is the subject and basis for the book Pharmaplasia written by Michael Wokasch.  The book does a very good job of describing the history of the pharma industry, with emphasis on the past 20 years and the conditions under which the companies chose to pursue marketing tactics with such questionable ethics.”

“All these topics are well covered and discussed in ‘Pharmaplasia’.  For those interested or involved in the industry, it is an important book to read, and I’m very glad I did.”

Ralph Casale

The Motley Fool CAPS blog

http://tinyurl.com/3xfq4b2

mike@pharmareform.com

pharmaplasia

PharmaReform is no substitute for Reading Pharmaplasia™

As a reader of PharmaReform.com are you wondering why you should read Pharmaplasia™?

If you have found PharmaReform  helpful and informative you may want to consider reading Pharmaplasia™.    It  is a perfect compliment to the discussions we have at PharmReform.

Unlike most books about the pharmaceutical industry that take a sensationalized, exposé approach,  in Pharmaplasia™ I try to arm you with the background and information necessary to help you facilitate a change for a better future.  You will not find this insider’s perspective, analysis,  or assimilation of  recommendations anywhere else on the web or in any other books written about the industry.   Pharmaplasia™ provides  specific practical solutions to  many of the the major issues the industry is now facing,  from the implications of healthcare reform to marketing and sales challenges, diminished R & D productivity, and the loss of public trust.

The philosophical perspectives behind Pharmaplasia™ and PharmaReform.com are consistent but the book provides much more depth and important details about the root causes of the industry’s dysfunction (like me,  you may think you know what these are, but I didn’t), explains why it happened, and answers tough questions many people (especially executives) in the industry are afraid to address openly.  Without the background and context provided by the book,  even the recommendations for changes discussed at PharmaReform can seem random and perhaps even idealistic.

For those who still have questions, I invite you to check out the revised Pharmaplasia™ page or shoot me an e-mail. I’d love to hear from you.

Enjoy the read.

mike@pharmareform.com