Those of you who are regular readers of this website know that I have been a very vocal advocate for change within pharma marketing.  I am frankly astounded that pharma marketing has changed so little in the past 5 years and at the exodus of talented people from healthcare marketing.

As I read through this competitors magazine, which was the May issue, I wanted to make sure it was May 2012 because it could have been May 2000.  I am not trashing the articles here but what I am trashing is the fact that so little has changed over the last 12 years in pharma marketing.  Sure there are some companies dabbling in new media and engaging patients but for the most part big pharma has completely ignored empowered patients to the point that most DTC marketing is becoming irrelevant.

Are there some Rx drug commercials that are going to drive new Rx’s ? Sure but that number has been getting smaller and smaller because less people are going to the doctor, less people are staying compliant and more people are skeptical of new drugs that have side effects.  While the Pradaxa DTC commercial is running on the Nightly News there are commercials saying Pradaxa has caused over 200 deaths for a litigation law firm.

There are a lot of very good and talented agency people out there but there are also a lot of agency people who will do whatever the client tells them to do even though they know it’s the wrong thing to do.  There are also a lot of people who make the trade show rounds as speakers who have never launched a drug or worked on an approved drug and yet there they are getting their ego’s  stroked with nice Power Points.

I know the drug industry has received a lot of black eyes over the last few years which is all the more reason why they need people like you and me.  They need people who are willing to put patients first and ask the hard questions rather than people who bend with the prevailing winds.  What we do is too damn important for it just to be “a job”.   The time for change is NOW or else DTC marketing risks being irrelevant forever.

Related articles

• DTC Marketers: TV ad effectiveness (trust) is declining (worldofdtcmarketing.com)
• The Pharma Corporation The Pathological Pursuit of Profit and Power (worldofdtcmarketing.com)
• DTC Advertising: Is it worth the money ? (worldofdtcmarketing.com)

Last year I led some market research into mobile apps across all demographic segments and several disease conditions.  While we did uncover some opportunities for mobile health we also learned that patients are very finicky about what they want in health apps and even more finicky about being reminded of their health conditions.

We found, for example, that type 1 diabetics are open to mobile apps that help them better manager their diabetes.  This was especially true for caregivers of type 1 diabetics but when it came to apps to help type 2 diabetics manage their health there was a lot of pushback such as “I don’t want to be reminded that I  have diabetes” and “I don’t want to have to consult my phone to choose what to eat from the menu”.

In younger demographics we found that people were more likely to download health apps that helped them make healthier choices in their lifestyles.  However the key for these people, since they are tech savvy, is to ensure that the health apps are up to date and provide real value as they define value.

Now what about apps that remind patients to stay compliant with medications ?  Buzzz, sorry, wrong answer.   The last thing patients wanted was their smartphones buzzing with a reminder to take their medication because they found it intrusive and they also had privacy issues with it.

In my opinion the future of mobile health is not via smartphone but in devices that patients can use at home to monitor everything from blood pressure to their heart.  Patients would use these devices at home and then the devices would wirelessly send the data to either their PC for collection or to their doctor.  Physicians would then be able to communicate with patients about the results via eMail or in person.

Does this mean that there isn’t a market for mobile health apps ?  No, not at all. What it means is that if pharma wants to get serious about mobile health they are going to have to integrate the level of expertise needed to ensure these apps are user friendly and have utility for their target audience not to mention the back end analytics to measure the impact and keep the apps up to date.

Related articles

• Revenues from Mobile Health Monitoring to Reach $1.9 Billion Globally by 2014 Says Juniper Research (prweb.com)
• Mobile strategy is about more than just apps and phones (worldofdtcmarketing.com)
• Mobile health app aims to help doctors with patient re-education (medcitynews.com)
• Good Mobile Health Quote From Intel (georgevanantwerp.com)
• Developing a cure for diabetes data fatigue (medcitynews.com)
• Mobile Learning in Consumer Health (slideshare.net)

This dishonor roll includes pharma giants Pfizer, which paid $2.3 billion to the government in 2009, and Eli Lilly, which settled civil and criminal chargesearlier in 2009 for $1.4 billion.

Soon there will be more additions to pharma’s billion-dollar-plus club:GlaxoSmithKline announced last November that it had reached an agreement in principle to pay $3 billion this year to resolve multiple government investigations into its sales and marketing practices. And Johnson & Johnson(J&J ) reportedly is in negotiations with the government to pay more than $1 billion to settle civil charges for the off-label marketing of Risperdal and Invega.

In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations.

The F.D.A. review, published in The New England Journal of Medicine online on Wednesday, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.

Requests for prescriptions to purchase over-the-counter medicines using flexible spending accounts or health savings accounts have become an unnecessary burden for doctors and patients, according to congressional testimony from physician organizations, patient advocates and representatives of OTC drug companies.

Rebates cut about $40 billion out of the drug industry’s sales ever year, says Pratap Khedkar, a principal at pharma marketing consultancy ZS Associates. We know that because the drug industry reports both its gross sales (before the rebates) and net sales (after the rebates are taken out). The size of the rebate average about 30% of a medicines sales, Khedkar says, and can be as low as single digits or as higher than 50% of gross sales.

Pfizer Inc. conducted an intriguing experiment in brand marketing this year, aggressively pushing the cholesterol-fighting drug Lipitor in the U.S. even after its patent expired on Nov. 30.

Pfizer officials told The Wall Street Journal that the company is no longer negotiating new contracts to sell Lipitor to health plans, which are signing up to sell generic versions at far lower prices. The company recently stopped sending sales representatives to promote Lipitor to doctors and halted advertising in print, on television and online, which once commanded a $271.9 million yearly budget.

“The environment, in general, is going to be much more hostile” to selling Lipitor at the levels Pfizer has, said Albert Bourla, who runs the business that sells Lipitor and other Pfizer medicines that have lost U.S. patent protection.

Fines for drug companies..   Erika Kelton, Contributor to forbes

Despite the prosecutions, huge fines and bad publicity, too many pharma companies have failed to change their ways. Billion-dollar settlements are to some just the cost of doing business. At my firm, we continue to see a steady stream of whistleblowers with powerful evidence of pharma wrongdoing – be it illegal promotion of prescription drugs; financial inducements to doctors and pharmacists to prescribe or sell certain prescription drugs; manufacturing practices that contaminate drugs;  and the use of phony science to support FDA approval or shady  marketing, to name just a few.

Yet the Pharmaceutical Research and Manufacturers of America (PhRMA), the major pharma lobbying group, claims its members are “committed to following the highest ethical standards and al legal requirements,” according to PhRMA’s website. To demonstrate this, PhRMA members developed the“Code on Interactions with Healthcare Professionals,” which states that:

Ethical relationships with healthcare professionals are critical to our mission of helping Patients . . . An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines.”

It is no small irony that nearly 60 pharma companies — including Abbott,Pfizer, Eli Lilly, Glaxo, J&J and Amgen – are signatories to the code. For at least three of them — Abbott, Pfizer and Eli Lilly – the PhRMA code was in place while they committed these billion-dollar-plus violations. (The details of the Glaxo, J&J and Amgen cases haven’t been announced yet since the whistleblower cases that started the government investigations are not public.)

The disconnect between the self-serving proclamations of “high ethical standards” and the reality of pharma’s conduct is vast.  In Abbott’s case, the Justice Department press release states that “Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies.”

Abbott’s disgraceful strategy, sadly, is not unique.  In the case of Pfizer, my whistleblower client was a Pfizer sales representative who provided compelling evidence to the government that Pfizer marketed the prescription painkiller Bextra for uses that had been explicitly rejected by the FDA and that put patients at serious cardiovascular risk. For its off-label marketing of Bextra,Pfizer paid $1.8 billion out of the $2.3 billion settlement in 2009. In the case of Lilly, qui tam whistleblowers provided evidence that the company was targeting nursing home and assisted living patients to sell Zyprexa for a host of unapproved uses.

It’s time for actions; not more words. The PhRMA code is little more than a public relations stunt that pharma companies themselves clearly view as a joke. But clinging to a business model that puts profits over patients’ health is no laughing matter.

Drug giant Pfizer offers an example of a corporation using social responsibility as little more than window dressing. While Pfizer promotes its free-drug programs, its CEO freely admits that the marginal cost of producing the drugs is so small that the free medicines cost almost nothing. Pfizer and other pharmaceutical manufacturers could ease human suffering by developing drugs to fight malaria and tuberculosis. But those diseases affect mostly poor people who couldn’t pay high prices for medications – hence pharmaceutical companies instead sell lucrative drugs to treat impotence. Even when an ostensibly responsible company such as Pfizer could place saving lives ahead of maximizing profits, it doesn’t seem to do so.

That apparent hypocrisy has led the nonprofit group Doctors Without Borders to refuse Pfizer’s offer of free drugs to treat illness in the Third World. The group reasoned that if it accepted Pfizer’s gift of no-cost Zithromax to treat Africans in Mali, it would be subject to Pfizer’s whims, including disrupted supplies of medications. Instead of taking Pfizer’s name-brand pills, Doctors Without Borders imported generic Zithromax to Mali.

While this book is extreme in its views of corporations one cannot help but wonder just how much truth the author is bringing to light.   Are the record fines that drug companies are paying for illegal marketing adequate punishment or are they just part of the expense of doing business ?

In the end “the corporation” is made up of people but can those people serve two masters (shareholders and patients) ?   Maybe I am an  idealist but I still believe what Mr Merck said a long long time ago “good medicine leads to good profits”.

Does anyone really believe that consumers trust pharma marketers messages anymore when they don’t listen and refuse to engage consumers ?  As one person who recently commented on my BLOG said “how can I trust new drugs when their always seems to be problems with them?”   Yet companies like BI keep running push DTC ads as if everything was great in the Rx drug market.

Late last year in some market research with HCP’s one of the key findings we presented was that HCP’s felt that DTC marketing & advertising was not driving patients into their practice to ask for advertised drugs.  ”Before if a drug solved a patients problem patients would come in and ask for them.  Now I don’t see patients asking for as many drugs by brand name anymore.”   Considering that less people are going to see their doctors that is disturbing.

In my opinion there are two primary challenges facing prescription drug marketing to consumers;

1ne: Budgets are being cut and tightened at a time when more money is needed to ramp up marketing with engagement.  This means more people who can listen and respond despite the FDA lack of guidance on social media marketing.

2wo: A lot of talented marketing people are leaving drug marketing.  It seems that every week I hear of a colleague who has moved from the drug industry to the consumer products  industry where marketers are more in tune with consumers needs and wants.

The lingering effects of this recession are that consumers are less willing to trust any big company or advertiser.  However until pharma marketers wake up and transform their marketing they are going to be as useful as snake mittens.

Related articles

• The truth about prescription drugs (worldofdtcmarketing.com)
• Time for the drug industry to get serious about digital marketing (worldofdtcmarketing.com)
• Findings from online health seekers (worldofdtcmarketing.com)
• How to save $550 billion in healthcare costs (worldofdtcmarketing.com)

America’s obesity epidemic is so deeply rooted that it will take dramatic and systemic measures – from overhauling farm policies and zoning laws to, possibly, introducing a soda tax – to fix it, the influential Institute of Medicine said on Tuesday.  Given the paralysis in Congress and personal interests that is not likely to happen.

In a 478-page report an agency refutes the idea that obesity is largely the result of a lack of willpower on the part of individuals. Instead, it embraces policy proposals that have met with stiff resistance from the food industry and lawmakers, arguing that multiple strategies will be needed to make the U.S. environment less “obesogenic.”  I’m sorry but I do not agree at all.

If we can graphically show American’s the cost to their lives of living unhealthy I believe it could and will have an effect.  American’s see themselves as thinner than they actually are and they need to be reminded that a size 52 pants is an indication that their lives are in danger.  In addition everyone in our healthcare system needs to band together to address unhealthy lifestyle issues with patients. This means that they pay additional dollars for being obese, that they get penalized for not going to their doctor for annual physicals and that they get free access to people who can help them plan out better menu’s and tell them the foods that are dangerous to their health.

Related articles

• U.S. obesity rate estimated to reach 42 percent by 2030 (rawstory.com)
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• Weight of a nation: 42 per cent of US may be obese by 2030, says study (refreshingnews99.blogspot.com)
• 42 percent of nation to be obese by 2030, study predicts (fox13now.com)
• Study: 42% of nation to be obese by 2030 (kshb.com)
• Obesity to affect 42% of Americans by 2030 with $550 billion in costs, say … – CBS News (cbsnews.com)
• Obesity Statistics: 42% Of America Obese By 2030 (inquisitr.com)

With all this, however, I also know that there are many good people who put patients first and make every decision like patients are working with us.  Because of the drug industry, a diagnosis of HIV is no longer a death sentence,  people can beat back cancer if caught early enough, and diabetics can lead somewhat normal lives.  Prescription drugs save millions of people every year but you will never read that on some sites like BNET which only point out the bad,  never the good.

Now an inconvenient truth that many people won’t acknowledge; all prescription drugs carry risks.

Why?  Well, first it can cost close to a billion dollars to develop and get approval for new drugs.  During the process of drug development, only 2-3 for every 10 drugs in the second stage of development will get approved and make it to market.  That’s a lot of money which is essentially lost in R&D.

When drugs are in development, the clock is ticking to get it to market so that the company can start to recoup costs (yes, drug companies are capitalist institutions).   Often, this ticking clock is running long before FDA approval, thus the pressure is on to get it approved and to market.  If the FDA granted patent protection when a drug was approved rather than while it was in development, drug companies could spend years conducting clinical trials with larger patient populations ensuring drugs are indeed safe.

Now the other ethical dilemma:  What if a drug can benefit 80-90% of the people using it but the other 10% either get no benefit or the drug causes their health to worsen ?   The FDA addresses this issue with “black box” warnings and “REMS” which require drug companies to work to either work with HCPs to communicate the risks or prohibit drug companies from promoting the products.  A lot of patients and eHealth consumers are aware of this and I believe that this is one reason we have seen such explosive growth of online health seekers.

As someone who likes to put patients first, I like to ask “what else can we do” to earn the trust of consumers and patients:

• Allow people who take their products to enroll in a database so that they can get updates on new reported side effects or other issues about their products.

• Work with pharmacies to make sure that people who take their products are getting the latest updates on label changes that affect them.

• Provide patients with answers when the media runs a story about an Rx drug from an “unpublished study”.

• The FDA could make their site more consumer friendly so people can actually navigate the site to get the information they need and understand the risks in language they understand.

Yes, all prescription drugs carry risks but today many people would not need prescription drugs if they ate right, exercised, and lost weight.  It’s way too easy to ask for a pill to lower your cholesterol than it is to actually control your cholesterol by what you eat.  Americans have become the fattest people on the planet and it’s costing us all billions of dollars in healthcare costs and lost productivity.

I also believe that if there is conclusive proof that people hid information from the FDA and patients because it may hurt sales, then these people should be held criminally liable and not be allowed to work in the healthcare industry again.  The problem with this, however, is that scientific data analysis is not always black and white.  It is not always conclusive and sometimes more information is needed.

CEO’s of drug companies have to communicate to everyone within their organizations that patients are more important than profits.   They need to make sure that people in the company get a chance to meet with patients and consumers on a regular basis so we can put a face on often faceless market segments.  Finally, we all have to have the courage to stand up and say “this is wrong” when we see things that could possible endanger patients, even at the risk of losing our jobs.  Linchpins need to make a difference but more importantly they need to be heard.

Related articles

• Bad journalism paints unfair picture of pharma industry (worldofdtcmarketing.com)
• The argument that drug companies “push drugs” (worldofdtcmarketing.com)
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• We Can’t Wait Update: Fighting Prescription Drug Shortages (whitehouse.gov)
• Prescription Drug Overdose (allaboutcounseling.com)

Health care in America costs more than in other industrialized nation and we aren’t even getting the world’s best care for our dollars

Quickly, let’s just note that Gardasil, though heavily marketed and lobbied, is probably not the most heavily marketed and lobbied drug ever or even close, and that sales have started to grow again. And then let’s take a look at those 20,000 adverse events and 100 deaths and figure out what they mean. It’s absolutely clear that these are for the most part not side effects from Gardasil. Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths.

The U.S. government will help drug companies find treatments for a host of diseases through a new collaboration in which researchers will test experimental drugs provided by manufacturers.

The National Institutes of Health said on Thursday that Pfizer Inc, AstraZeneca Plc and Eli Lilly and Co have agreed to make 24 compounds available for a pilot phase of the project, the biggest of its kind ever launched in the United States.

While the gold standard of medical research is the randomly controlled experimental study, scientists have recently rushed to pursue observational studies, which are much easier, cheaper and quicker to do. Costs for a typical controlled trial can stretch high into the millions; observational studies can be performed for tens of thousands of dollars.  But observational studies, researchers say, are especially prone to methodological and statistical biases that can render the results unreliable. Their findings are much less replicable than those drawn from controlled research. Worse, few of the flawed findings are spotted—or corrected—in the published literature.

Obesity and the form of diabetes linked to it are taking an even worse toll on America’s youths than medical experts had realized. As obesity rates in children have climbed, so has the incidence of Type 2 diabetes, and a new study adds another worry: the disease progresses more rapidly in children than in adults and is harder to treat.  “It’s frightening how severe this metabolic disease is in children,” said Dr. David M. Nathan, an author of the study and director of the diabetes center at Massachusetts General Hospital. “It’s really got a hold on them, and it’s hard to turn around.

The end of the week Opt Ed…

Last week a friend of ours called my wife to ask her some questions about cancer treatments as my wife is a Pharm D with expertise in cancer treatments and drugs.  My wife told her to go to the Internet to learn a more about some of the drugs she had recommended but much to our surprise her friend said “there’s just too many different websites and a lot of the information is too hard to read”. Welcome to the age of information at your fingertips..

Some drug companies have done a great job of reaching out to patients through alternate channels but the majority have not.  They have their reasons, or excuses I should say, but the fact of the matter is that patients, who are going online in increasing numbers for health information, are becoming confused and frustrated by what they find.

Of course this isn’t true for every health condition.  The resources, for example, around diabetes are great lead by innovative companies like Sanofi.  However when it comes to more complicated health conditions the amount of patient friendly resources lags.  I’m not talking about support groups, I’m talking about basic, easy to understand information on treatment options and how to work with your HCP to get the right treatment.

There is an amazing opportunity for the drug industry to blaze new trails in reaching out to patients but it’s not without risk.   What’s needed are some senior drug executives who understand that reaching out to patients is worth the risk of a letter from the FDA.

Americans pay the highest prices for physician visits, hospital treatments and prescription drugs and get expensive diagnostic tests like MRIs at a higher-than-average rate. More Americans are obese, too, though the nation’s population is younger than all the other countries.

Escalating prices for health care and high use of potentially wasteful, inefficient and unnecessary medical services are the main reasons for the rapidly escalating cost of health insurance, the growing ranks of the uninsured and the fiscal burdens of Medicare and Medicaid. Big price tags also lead Americans, even those with health insurance, to go without care they need.

This high spending cannot be attributed to higher income, an older population or greater supply or utilization of hospitals and doctors. Instead, the findings suggest the higher spending is more likely due to higher prices and perhaps more readily accessible technology and greater obesity.