The internet and it’s applications like Twitter have created a seemingly endless source of timely information. Sorting through the noise however to get to tweets that can help and get you the information you really need can be a real challenge. This is especially true in the world of pharmaceuticals, biotechnology, and healthcare. In a previous post I listed my top 10 internet sources but only mentioned a couple of helpful Tweeters. While I follow only a small number and I’m sure there are plenty of other good tweeters, those who seem to have consistently delivered content or links that have been helpful in keeping me current include (no particular order):
Who do you follow that is really helpful in keeping you current? firstname.lastname@example.org
The residual effects of pharmaceutical industry indiscretions of the past will linger for some time but also make it all the more important for the industry to be more truthful and forthcoming in their marketing and corporate communications. The recent disclosures and concerns about GSK’s handling of the potential for cardiovascular events associated with the use of Avandia® just further highlights the challenges facing the industry in reestablishing trust.
So what to do from a marketing perspective? I fully appreciate the need to grow sales and deliver results but if the only way you feel you can do this is by not being truthful, not being fully truthful, or not being forthcoming about risks, you can not expect to reestablish trust in the market. Trust requires truth and integrity and consistent behavior over time.
One way to get after this is to assess what you are doing and begin to make any necessary adjustments in your marketing planning to reflect truthful disclosures and integrity in marketing. You can’t expect people to trust you or what you say about your product if you can’t be truthful and honest with yourself in doing your own product assessment.
1) Product Assessment (based on FDA approved label claims only)
- What indications are approved for your product?
- What limitations on use does your product have?
- What patient population is most likely to benefit from your product? Do you know which patients will not respond well or as you might expect?
- How would you describe this population within the confines of your approved label claims?
- Does your product have two well controlled peer-reviewed published clinical data to support the patient populations you plan to market to? (this means the trial data used for the approved claims are available to clinicians for their own evaluations and interpretations)
2) Market assessment (given your product profile and label claims as assessed above)
- What market is available to you? How large or small is it?
- What limitations are there on your market potential? (e.g., age constraints, drug interactions, etc.)
- How much of the market is not available to you due to potential for side effects or adverse reactions?
- How much of your current revenue is beyond the approved label claims? Are you actively or passively trying to increase sales beyond your approved label claims?
3) Competitive assessment
- What other products have similar label claims?
- Is your product the best product on the market to treat the approved indications? Why? Why not?
- Is your product risk profile (side effects and adverse reactions) better or worse than competitive products?
- Do you have label claims or two well controlled peer review published trials to favorably differentiate your product from competitive products?
- Do your competitors have label claims or two well controlled peer review published trials to favorably differentiate their product from your product?
- If your product is the market leader, how did it get there?
- First to market?
- Definitive favorable product differentiation based on label claims
- Marketing presence (e.g., share of voice, spend, or execution)?
- Market expansion beyond approved claims
- Implied favorable product differentiation from competitors
4) Marketing communications assessment
- Is your messaging consistent with the patients identified in the product assessment above?
- Are the claims you want to make, or are making, consistent with your label claims or two well controlled peer-reviewed published trial data?
- Does your advertising imply or suggest a broader market than label claims might include? Is this intentional?
- Are adverse reaction and side effects an important part of your communications plan or are they merely a regulatory necessity?
- Is your communications strategy inclusive of building trust in your advertising and promotion?
5) Tactical plan assessment
- Are programs consistent with label claims and the indicated patient populations
- Are your tactics designed to capture patients beyond the label claims of the product?
- Are your tactics designed to encourage market expansion through off-label use driven by “physician choice”
- Are there veiled inducements (e.g., speaker fees, sponsorships, consulting fees, or promises of clinical trial participation) to encourage healthcare providers to espouse implied product differentiations or implied uses beyond label claims?
- Are your medical education programs designed to capture patients identified in the product assessment above and to encourage appropriate product use or are they intended to expand use beyond that population.
- Do you find yourself rationalizing why something is ok and consistent with labeling? Are your activities defensible without rationalizing?
- Do you have organizational controls to make certain execution of the tactical plan is consistent with the intended plan and can not stray (e.g., no maverick sales promotions, no locally funded inducements)
As you go through assessing your own products you should have additional questions that make you stop and think about the intent of what you are doing verses what you say you are actually doing. To reestablish trust in marketing, communications and actions must be truthful, must not be misleading, must be compliant (regulatory and legal), and must consistently support the best interest of patients over time. No amount of revenue or profit opportunity can or should be able to change this. Remember, trust and integrity are not a matter of convenience or circumstance.
Next we will discuss pricing practices and their impact on reestablishing trust.
The answer to sustainable growth in the pharmaceutical industry is a continuous flow of innovative new products the market is willing to buy at the prices that make it worth doing. Back in the 1990’s and early 2000’s, when industry R & D seemed to be able to produce whatever products were needed, it was nearly impossible for struggling small biotech companies to even get an audience with Big Pharma R & D to discuss their innovative new technologies. The “not invented here” mentality that kept potential new treatments from Pharma R & D I believe has now come back to haunt the industry. Given the 10-15 year development time for new products, the math would suggest the 1990’s would have been a good time for risk taking exploration of innovative new technologies and aggressive licensing. While some might suggest biotechs wanted to much for their technologies, I would argue, most never got to that stage of discussion.
Unfortunately, we will never know how many truly innovative products met their premature death at biotech companies that could not find sufficient funding to continue development or who were unwilling to give away their companies to Venture Capitalists. Yes, the industry figured this out to some extent recently, but too late. And even now the rigors of a Big Pharma due diligence reviews are painful and beyond the resource capabilities of most small companies. How many technologies get written off because the company doesn’t know how to present the technology to Big Pharma or because they didn’t do the studies a Big Pharma would have?
Pharma business development and R & D need to look at technologies not with a “quick to market” mentality but how they might be able to exploit technologies, perhaps even beyond where the biotech has taken the research. Biotechs need to also be realistic about financial expectations and the value added by Pharma R & D and commercialization capabilities. Unfortunately, the 1990’s may have been a missed opportunity but I also fear a lot of valuable technologies and innovative product opportunities may have died during the financial crisis of 2008-2009, due to Big Pharma evaluation criteria and expectations.
It appears the pharmaceutical industry may have dodged a few healthcare reform bullets, at least temporarily, with the pending legislation. Again, maintaining the industry business model status quo while enhancing their potential customer base by tens of millions of newly insured patients.
So the industry “bought” some time.
It is not clear that companies have figured out that the need for change is still there. Even the hot legislative issues of government negotiated prices, additional rebates or other price control strategies, and importation are not going away. Market expectations also remain high for more effective and safer products at market sensitive, value-based prices. The market is also no less weary from the “hype”, questionable ethics, and financial “conflicts” of traditional sales and marketing tactics. Public trust and confidence has probably not improved as a result of the multimillion dollar lobbying campaign.
Healthcare reform should be acting as a catalyst for change. Now is the time for pharmaceutical companies to formulate new, more market receptive strategies, and retool their R & D to deliver truly innovative new products, dramatically reduce their operating expenses, and reestablish corporate cultures that embrace integrity. Unfortunately, the “dodged bullets” and “bought time” may have just mitigated the organizational “need for change” and sense of urgency.
Companies that remain committed to change, address their organizational challenges, and correct the market driven concerns will find they are creating a competitive advantage for when the market, and not legislators, decide how to employ pharmaceuticals in the delivery of healthcare. An increasingly cost conscious “managed” market with expectations to have better treatments for more patients at lower costs awaits the industry.
My name is Mike Wokasch. Wokasch resume
The premise of this site is to explore how pharmaceutical companies and the industry in general must change the way they do business in order to meet, or even exceed, the expectations of the evolving new healthcare market. The intent is not to disparage past industry practices, but to identify what has to change and why. And despite my 30-year career in the industry, I am neither here to defend nor speak for it.
I invite your contributions. It is my hope that our discussions will help to formulate specific recommendations that can help pharmaceutical companies adapt to the ever-changing needs and expectations of the healthcare market. As we get into the topics you may find my suggestions, ideas, and commentary to be a bit critical of past or current industry practices. I would also be surprised if you did not find some of the content to be controversial as we explore the need for change. The intent is to be constructive and develop high impact, results oriented solutions. Feel free to leave comments or to e-mail me directly (email@example.com).
It is my hope that you find this site informative and useful in your job. I look forward to your opinions, insights, and perspectives on a wide variety of topics as they relate to the pharmaceutical industry and healthcare reform.