Pharma Reform

Corporate integrity should start at the top of the organization and every employee must do their share to make it a reality but pharmaceutical company physicians and scientists are the best hopes for reestablishing pharmaceutical industry trust… if they can survive in their organizations.

Integrity and objective science were once the hallmark of pharmaceutical research.   Valid testing methodologies, rigorous analysis and interpretation of data, and accurate complete disclosure of findings and understandings provide the medical community with a sound basis for making informed clinical decisions.  Too many case studies over the past several decades, however, have raised serious questions about the integrity and objectivity of pharmaceutical research.

Not to make excuses but, physicians and scientists at pharmaceutical companies are subjected to intense organizational pressures that can cajole them into compromising their objectivity and scientific integrity.  These pressures come in subtle and sometimes not so subtle forms.  Emotional attachment, satisfaction of personal ambitions, peer pressure, and management can all influence decision making and can provide a rationale for questionable actions taken.

Emotional attachment results from years and sometimes careers worth of product development, creating an instinctive need to nurture and protect “their babies”.   Wanting to maintain a positive outlook, securing incentive compensation, enhancing professional stature, and wanting to be a part of the team can all drive the behavior of individuals and groups to do things they might not otherwise consider.

Perhaps the single biggest challenge for industry physicians and scientists trying to maintain scientific integrity is dealing with the implicit and explicit demands and expectations of management.

Some of the types of scientific integrity issues we are talking about include:

• Designing studies around problems without disclosing the problem
• Data manipulation
• Covering up, hiding, or minimizing relevant negative data
• Disproportionately highlighting efficacy benefits to mitigate safety issues
• Not challenging or correcting company statements (or marketing) when they know they are scientifically not valid, incomplete, or misleading

None of these happens in a vacuum as it would be rare that they could be accomplished by a single individual without the knowledge of others.  At the same time, an individual physician or scientist puts their career at risk when they challenge organizational thinking and management prompted or endorsed indiscretions.

That being said, pharmaceutical industry physicians and scientists are often the only ones who have the corporate platform and organizational position power to guide management regarding what can be supported scientifically or what can or can not be claimed clinically.   They are in the best position to insist on integrity in drug development as well as in how the company promotes its products. They are in the best position to clarify and correct misleading corporate commentary, statements, or implications.

When integrity and objectivity of the science around a product are ensured, when scientists hold their management accountable for accurate and complete disclosures, and when they don’t let marketing and sales make misleading or false claims, then pharmaceutical industry physicians and scientists will provide the basis for restoring confidence and credibility in the work they are doing.  An organization that embraces integrity will value these physicians and scientists and reward them for keeping the company honest.  Unfortunately, companies that do not embrace integrity will probably find a reason fire these these physicians and scientists, if they don’t decide to quit first.

mike@pharmareform.com

Those who have read this blog know that I am not into making excuses for pharmaceutical industry misbehavior.  At the same time, it is important to understand the impact of how outsiders (those not involved in the pharmaceutical industry) are going to interpret actions and behaviors.   What might appear to be clearly unethical or illegal to an outsider may require an informed interpretation of circumstances or intent.

Think about it.  At what point are consulting assignments and advisory payments to physicians a bribe or kickback?  Could providing lunch for the office staff really be a bribe or kickback?  Is any comment about product efficacy or safety that is not verbatim out of the package insert possibly “off-label” promotion?  When are graphic interpretations or implications from an advertisement “off-label” promotion?  At what point do random side effects and adverse reactions become “hidden” if not publicly broadcast to the media?  Are systematic miscalculations of pricing always an indication of fraud?  When is competitive pricing considered price fixing?  At what point does editorial assistance become “ghostwriting?”

I am not an attorney and this is not a legal discussion.  Rather, this is about past history of proven and alleged pharmaceutical industry misbehavior including illegal activities.  Perhaps most disappointing has been the fact that as prosecutors pieced together their better informed perspective of alleged illegal activities they often found both willful intent and additional even more egregious activities to support the initial allegations.   The seemingly endless offenses have tainted the perception of prosecutors, legislators, healthcare professionals, regulators, industry critics, and of course, patients.  Virtually everything the industry does is now suspect and often transformed into allegations of unethical if not illegal activities.  Even normal course of doing business activities (e.g., presenting a favorable product profile, trying to influence prescribing, and providing samples) are now being viewed as inappropriate and possibly illegal.

It all boils down to a lack of trust and credibility.  The industry can’t even credibly defend itself to maintain normal business practices because there are just too many cases that demonstrate companies are willing to betray this trust and take advantage of the market for financial gain.  Unfortunately, the pharmaceutical industry doesn’t seem to be too concerned or you would have seen a dramatic change in behavior.

Before trust and credibility can be reestablished the industry and company executives must be on their best behavior.  Once again, actions and consistent behavior will speak louder than words or intermittent gratuitous gestures.  Trust and credibility are much harder to reestablish than to maintain.

mike@pharmareform.com

• High drug prices that seem unsubstantiated in the context of value
• Promoting new products as innovative when they are merely chemical modifications with modest improvements at best over products already available
• Questionable and sometimes illegal marketing and sales activities that unnecessarily put patient health at risk
• Annoying television advertising with warnings that make you wonder why you would want to take the drug in the first place
• Seeking help from a patient advocacy group only to find out it is more likely a Big Pharma front to access and influence patients
• Waiting in the doctors office while the drug sales reps see the doctor
• Hiding or downplaying safety issues, adverse effects, and potentially fatal drug related-events to increase or preserve sales
• Inappropriate payments and other perks going to physicians that suggest companies are buying prescribing influence
• Promotional infiltration of continuing medical education
• Abusive and deceptive use of medical journals for scientific promotion
• Waiting for years to receive nominal compensation for harm done as companies deny responsibility and drag out legal proceedings.
• Arrogant executives dismissing or denying any wrongdoing despite evidence, legal or congressional testimony, and even their own internal communications that suggest otherwise
• C-level executives being rewarded with generous compensation packages in the face of multi-million dollar and even billion dollar fines and settlements for regulatory non-compliance and alleged illegal activities

Did I miss a thing or two? Looks like a check list for Pharma to start reassessing what they can do to improve their image with the public and the healthcare system.  I think it is important to note that these are not fixable with multimillion dollar public relations campaigns or policy statements from PhRMA and no amount of life-saving products will make these go away.  Why?  Because these are the public’s reality based on actions and behaviors of the industry, not misperceptions.

Establishing, or in this case, reestablishing trust and credibility with your customers is critical for long-term success for any business.  Without trust and credibility, many yet to be discovered best treatment options may be slower to be accepted and unfortunately, may not get to the patients who need them, when they need them.

mike@pharmareform.com

I have long been a proponent of the need for change and cleaning up the bad behaviors of the pharmaceutical industry to reestablish trust and credibility. At the same time, with the challenges and constraints the industry now face one has to wonder if Big Pharma will be as attractive a place to invest or as attractive a place to work as it has been in the past.  Investors willing to make huge investments that carry high risk and talented research scientists with expertise are two essential ingredients to Big Pharma success.  If these go away,  it is scary to think of a world without Big Pharma (imagine no Big Pharma in the past or future):

• Fewer treatments that have contributed to the health and well-being of society and in many cases, saved lives (contributing significantly to increasing life expectancy)
• Many physicians would be less well educated about drug treatment options, especially any new products, without the advertising and promotion efforts of Big Pharma
• Fewer patients would be aware of or have access to information about their diseases and treatment options
• Medical schools, professional medical societies, scientific meetings and conferences would be financially challenged with severely constrained medical education programming without Big Pharma support
• Medical journals would have far fewer well controlled clinical trials of sufficient size to reach clinical significance to publish
• Many medical journals would not exist without Pharma advertising support
• Millions more patients would not be able to afford their medicines without assistance from pharmaceutical companies
• Start-up biotech companies would find it nearly impossible to find investors who are looking at Pharma as development partners (to help fund expensive development trials) and possible acquisitions as an exit strategy for their biotech investments
• Hundreds of thousands of well paying jobs would not exist and along with those jobs would go the money that those people put back into their local communities (not to mention the corporate taxes and philanthropy).
• There would be a smaller generic drug market (no generics without proprietary products to copy)
• There would be little hope for developing and commercializing (making products readily available to patients in need) the yet to be discovered new treatments

While some may take exception to these points and might suggest there are better alternatives to Big Pharma, and others may also feel I have missed a few points,  it is still hard to imagine a world without Big Pharma and I don’t believe it would be good for the healthcare market or for patients.

Unfortunately, the good the pharmaceutical industry does is often overshadowed by sensational misbehavior, the seemingly endless number of product liability cases, and the nagging reinforcement of perceived high prices every time patients get their prescriptions filled.  It is time for the industry to change.

“Get the dirt and fog off the windows so the sun can shine in.”

With all the good the pharmaceutical industry has to offer, it should be an industry the market and patients embrace and appreciate, not despise.

Thanks to Dick Bergman comment for getting me thinking about this.

mike@pharmareform.com

With the continuing investigations and charges of pharmaceutical companies for off-label and other illegal promotional activities with the subsequent meaningless fines and settlements being levied, (relative to the revenues generated by the alleged illegal activities) one has to wonder whether investors are being duped or rewarded.

If investors were aware of the fact that the blockbuster drugs that pharmaceutical companies are touting could not generate the same billions of dollars of revenue if the company had to stick to labeled claims for promotion and depend primarily on indicated uses, would they invest to the same extent?  In the spirit of full disclosure (think SEC), should companies be required to disclose that off-label promotion and use is part of their strategy (not just a possibility) and a major source of revenue that carries the risk of regulatory and legal action if the company is caught or charged and forced to go through expensive legal proceedings that could result in costly settlements?

Or, with the nominal settlements and fines being levied, are investors being rewarded for recognizing the clever business savvy of the pharmaceutical companies that know how to play the game with full understanding that they have little downside and huge financial upsides for ignoring the regulatory and legal constraints on pharmaceutical advertising and promotion?   We’re not talking about the activities of the one-off maverick sales or marketing person. We’re talking about the orchestrated initiatives where pharmaceutical companies know about  and develop plans to take advantage of the bigger market and revenue opportunity if they encourage and illegally promote their product for off-label uses.

Here is another way to look at this.  What if fines and settlements resulting from illegal promotional activities also required pharmaceutical companies to disgorge (forfeit) all product related revenues (attributed to illegal activities or not) during the period in which the alleged illegal activities occurred?

Would investors be as interested in investing or as forgiving of the companies that had to forfeit their revenues for illegal activities?  How many investors would expect disclosure up front if forfeiture of revenues was a real possibility from the planned off-label promotion?

Without getting into whether companies would legally fight rather than ever “settle” if disgorgement of revenues was a possibility, until the fines and penalties approach the revenues generated from the illegal activities, there is no disincentive ( these companies have already decided to ignore any concerns for patient safety), and every incentive, to continue to take advantage of the nominal financial downsides.

At the very least, however, there ought to be a disclosure requirement so that investors can make informed decisions, which for some investors might include investment choices based on supporting ethical and legal business practices.

mike@pharmareform.com

You are the product manager, marketing manager, or even VP of Marketing.  You understand the regulatory and legal constraints on your marketing but are there ethical considerations depending upon how your product compares to other therapeutic options?  Let’s start with the easy one ….

You have the treatment of choice with few, if any, other therapeutic options that can help patients for a particular indication.  Any ethical issues in promoting your product?  Probably not, unless you really go out of your way to exaggerate the efficacy or safety of the product beyond what you can prove.  How about when your product benefit and indication is for a small patient population for which you already have a majority of the market and the company expects you to grow revenues next year? Any ethical issues now? Probably not if you continue to promote within your market but what about bigger “off-label” indications?.

How about a product that is as good as everything else to treat a particular disease?  Your product is no better or no worse than the other products.  You might have a few features that are better but the other products have a few that are better than yours.  Neither your product nor competitors has a clear efficacy, safety, or feature advantage that clinically matters.   What are the ethical issues for promotion in this situation?  How about comparative advertising when you know there is no difference?  Can you make your product look better than the other products? This is probably the most likely scenario for most products today.  Probably not too many ethical issues yet unless you exaggerate your benefits beyond your clinical proof or downplay your safety issues to create a competitive advantage.

Now, same scenario as above (no difference) but you are the branded product and there are several generic versions of therapeutic alternatives (in the same class of drug) for the indication?   Are you tempted to make a difference out of no difference to maintain your branded product sales? Is it ethical to expect patients (or insurers) to pay more for the same therapeutic outcome? I can hear it already…branded products are de facto better than generics.

How about when you have a product that is not as effective or as safe as competitive products or therapeutic alternatives?  Getting more interesting isn’t it?  The company still has revenue growth expectations so what are you going to do?  Should you be trying to get more patients on your product if it isn’t as safe or effective as other products?  You are probably thinking it is the physician’s choice, not you making that decision….right?  If you can convince the physician to use your product, it’s their decision…right? How do you feel about that?  How does your manager feel about this?  How does your company feel about this?  What would they say if you raised the issue with them?

While I’m not certain product managers or companies for that matter are thinking this way,  they are faced with these issues everyday in the pharmaceutical industry.  Think about the products your company promotes.  Which scenario do each of the company’s products fit into?  How are they being promoted?  How do you feel about that? Anybody in the company asking these questions?

What’s the answer to this dilemma?

How about company executives (VP Marketing or higher) recognizing the issues and making the call so as not to put front line marketing managers in a difficult, potentially career jeopardizing position?  In the future,  have more products in the first scenario ….innovative clearly differentiated products that you are proud of and that you can promote without having to compromise your ethics.

mike@pharmareform.com

Every aspect of pharmaceutical marketing will be impacted by healthcare reform.  While the marketing of prescription drugs has become increasingly difficult as we have discussed before pharmaceutical companies should be anticipating even more challenges as healthcare reform evolves.  These challenges will be driven primarily by the need to control costs, a market interest in minimizing the influence of pharmaceutical marketing and sales, and a diminished trust of the pharmaceutical industry.

Over the next few posts we will evaluate the impact of the changing market on marketing from the customer perspective.  The intent is not to be all inclusive but to get you thinking about how it might affect your tactical programs.  Customers go through an adoption sequence which most marketers are familiar with (awareness, interest, evaluation, trial, use, and endorsement).

Awareness (customer becomes aware of the product and familiar with the brand name)

Previous tactics included:

Press releases, journal advertising, sales rep calls, exhibits and scientific presentations at medical meetings and conferences, direct mail, physician to physician word of mouth, and office tchotchkes                                               (reminder items to maintain awareness and visibility of the brand name)

New tactics include:

Internet distribution of press releases, Internet marketing, DTC (direct to consumer) advertising, sports sponsorships (i.e., NASCAR), social media (Facebook, Twitter, etc.) and word of mouth

The evolving market and healthcare reform challenges for raising awareness (electronic communications including the internet makes this one of the least impacted marketing issue)

• Elimination of office tchotchkes (already in place) makes keeping brand name “top of mind” at the point of prescribing more difficult
• Decreasing sales rep access to physicians
• Increasing regulatory constraints on internet and social media
• Limited access to managed market decision makers (PBMs, insurers, government)
• Increasing concerns for pharmaceutical company participation in scientific meetings and conferences

Solutions to challenges:

Perhaps the best solution to this issue is to have a truly innovative product. News media will jump on these products, especially if they are independently endorsed. Managed market decision makers who identify innovative products they want their plan participants to have access to will find ways (including working with pharmaceutical company marketing) to make sure prescribers in their plans are aware of the product.  Similarly, medically recognized innovative treatments of choice will find much less resistance to being presented and discussed at scientific meetings and conferences.

Again, raising awareness is probably the least affected by the evolving new healthcare market and healthcare reform.  Next we will discuss the impact of stimulating interest in a particular product which is certain to be impacted to a much greater extent.

mike@pharmareform.com

The ability to mass market through social media could provide pharmaceutical companies efficient reach and frequency capabilities (more people, more often) never before possible.  From internet websites and webinars to Twitter, Facebook, and the ever-increasing number of new web-based tools and channels all provide unprecedented access to healthcare providers and patients alike.

Unfortunately, the industry is constrained by traditional regulatory requirements and worse, a lack of clarity regarding the regulatory interpretation for applying those requirements to the use of this evolving new media.  The FDA is struggling with how to manage, regulate, and control this new media opportunity which has the potential for rapid “viral” distribution of pharmaceutical company provided product and disease-related information.  PhRMA has drafted suggestions for how the industry could employ social media while maintaining regulatory compliance. (PhRMA letter to FDA February 26, 2010)

So, what’s the fuss?

The issue is simple.  Based on past performance and behavior, the pharmaceutical industry can’t be trusted.  Even with guidance, standards, regulations, and laws the industry has demonstrated that they will do whatever it takes to sell their drugs.  Pharmaceutical companies even ignore their own PhRMA codes and guiding principles that are supposed to “assure that promotion of medicine is truthful, scientifically accurate, and non-misleading.”

If pharmaceutical companies had an established base of credibility and had historically demonstrated they could be trusted to provide truthful, scientifically accurate and non-misleading information in their promotions their use of social media would be much less an issue.  With a trusted pharmaceutical industry, regulators could have responded more proactively and would be less concerned about trying to anticipate every potential abuse to make sure they leave no loopholes in their compliance standards which would provide the industry a legal way to abuse or take inappropriate advantage of social media promotion.

Nobody argues the value of informed healthcare providers and patients accomplished through dissemination of truthful, scientifically accurate and non-misleading product or disease-related information.  If the industry could be trusted to do this, regulation would be simple and everybody would benefit.  Time for the industry to work on reestablishing trust and credibility.

mike@pharmareform.com

Prescription drug prices are a major source of distrust, frustration, and irritation for everybody in the healthcare market except pharmaceutical industry executives.  Payers and insurers find it difficult to justify paying for expensive branded products when they know less expensive generic drugs would probably work just fine for many patients.  Physicians struggle to explain to their patients that despite the high price, the brand they have selected is the best product for their particular situation.  Patients struggle to pay for the biggest out-of-pocket healthcare expense they have, often deciding whether to buy food, split their pills, or go without their medication to make it through the month.  With unemployment hovering around 10%,  more people are without insurance, making prescription drugs even more unaffordable for many.

The pharmaceutical industry has been totally insensitive to these market /patient issues as they continue to raise prices on many of their most popular, highest volume drugs.  The Congress’ Government Accountability Office calling the increases “extraordinary” with prices for many brands doubling from 2000-2008 while some increased substantially higher yet.  A recent study also revealed that branded prescription drugs increased 9.3% when the CPI was running -0.3% during the same period (2008-2009).

The industry response to the market concerns about high drug prices hasn’t changed for as long as I can remember (at least 30 years I’ve been in the industry).  They continue to highlight the dismal research success rate (1 in 10,000 discovery compounds makes it to the market), blame the high cost of R & D, and the need to recover their high costs in a short period of time as the reasons for their high prices.  Nobody in the healthcare market has ever bought that rationale for high prices and I don’t think that is going to change.  More recently the the industry has tried to also deflect high price accusations with stories about lower overall drug prices (which includes over 70% of prescriptions being filled with less expensive generics), drug costs as a diminishing share of healthcare cost (also because of generic drugs use and the out of control other healthcare costs), and claiming their free samples and the industry’s token prescription assistance programs make the high prices more affordable for everybody.

“What the market will bear” pricing strategies have led to unsubstantiated initial high product launch prices (relative to other therapeutic options, adding little or no real clinical benefits) and subsequent price increases which often outpace inflation.

Pricing is a marketing responsibility with huge corporate financial implications.  The internal pressures to set the absolute highest possible price to achieve revenue and profit targets can be intense.  In many cases it becomes a very impersonal, quantitative spreadsheet modeling exercise providing executives with the comfort that forecast numbers (think quarterly revenues and profits) will be delivered.  More often than not, the price leader is the baseline metric against which new product pricing is evaluated, whether or not the new product has real clinical benefits over the price leader.

Price increases are taken as needed to make the financial numbers or to make the numbers look better?  You may even be able to do two small increases in the same year to get a bigger annual increase rather than taking it all at once.  With all the patients currently on a chronic product it is unlikely they will switch just because of the price increase and formularies are not likely to throw the product off just because of an increase,  so the thinking is ….go for it.

So what to do as a marketer?

The industry must start being more market sensitive and value based in its pricing practices.  Eventually, the market will force this issue as cost management becomes an increasing priority for the evolving new healthcare market.  But it shouldn’t take the market imposed price intoilerance to make this change.  Remember the idea is to reestablish market trust.

So, what is the real value and can you substantiate the value of your product against other therapeutic options?  This is not rationalizing small clinically meaningless differences.  It is time to “show me the data” and be more realistic about the value of your products relative to other therapeutic options.  If a generic drug can do the same as your product for most patients, how is it that you can charge 5 or 10 times the generic drug price and say you have “fairly priced” your product?  Can you really expect insurers or patients to pay the equivalent of the price of a new home in exchange for a drug that gives them merely a chance (not a guarantee) of maybe living a few more weeks or months?  Have you really priced your product “fairly” and consistent with its value…as perceived by the market?

For marketers with products that have clinically meaningful benefits that clearly exceed those of other therapeutic options, reestablishing trust comes by setting prices that are considered by the market to be consistent with the product value.  Product value should be proven if the benefits are real and meaningful.  So again, “show me the data” that patients will be able to relate to and appreciate.  Patients and insurers do not mind paying for what they value.  They mind feeling like they are being ripped off and don’t have a choice.

The biggest challenge marketers will face trying to execute this market sensitive, value based pricing strategy is the organizational pressure from executives and senior managers who have expectations for continuing the financial windfalls of “what the market will bear “ pricing strategies.  Unfortunately, I don’t expect many pharmaceutical industry executives to embrace this concept until the market forces them to consider making the change.  It will take strong marketing managers to help organizations realize how important this painful but simple change can make a huge difference in how companies are perceived.    Regardess of whatever else companies do to improve market trust,  without a change in pricing practices, reestablishing market trust is not possible.

mike@pharmareform.com

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?
  1. First to market?
  2. Definitive favorable product differentiation based on label claims
  3. Marketing presence (e.g., share of voice, spend, or execution)?
  4. Market expansion beyond approved claims
  5. 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.

mike@pharmareform.com