Are Pharma Sales Reps Service Employees?

Are Pharma Sales Reps Service Employees?

The Supreme Court agreed to decide whether drug companies have to pay their sales representatives for working overtime hours, "a question that could have considerable financial impact on the industry," according to the Wall Street Journal (see "Supreme Court to Decide if Pharma Reps Are Exempt from Receiving Overtime Pay"). The question (see here) before the court in case "CHRISTOPHER V. SMITHKLINE BEECHAM CORP" is:

The outside sales exemption of the Fair Labor Standards Act exempts from the overtime requirements of the Act "any employee employed ... in the capacity of outside salesman (as such terms are defined and delimited from time to time by regulations of the Secretary ...)." 29 U.S.C. § 213(a)(1). The Secretary of Labor has implemented various regulations that "define and delimit" the outside sales exemption and, filing as amici in this and other related matters, has interpreted these regulations to find the exemption inapplicable to pharmaceutical sales representatives. A split exists between the Second and Ninth Circuits concerning whether this interpretation is owed deference and whether the outside sales exemption of the Fair Labor Standards Act applies to pharmaceutical sales representatives.
The questions presented are: 

1. Whether deference is owed to the Secretary's interpretation of the Fair Labor Standards Act's outside sales exemption and related regulations; and  
 
2. Whether the Fair Labor Standards Act's outside sales exemption applies to pharmaceutical sales representatives.

If the Supreme Court rules that pharma sales reps are NOT exempt as per Q#2, some sales reps worry that they will become "service" employees. "This will be a similar model to UPS / Fed Ex etc. Log in.............track activity..........gps............clock out at 5:00 pm." (see this CafePharma thread in the GSK discussion board).

This is interesting considering that the pharmaceutical industry is now moving away from the sales force being the primary channel of promotion focused on a narrow stakeholder audience to that of "a multi-faceted influence model where it has to really maximize its return on investment,” according to Mark Sales, Head of Global Brand and Stakeholder Management at Kantar Health (see "The Changing Pharma Commercial Model in 2010 and Beyond"; a PMN article sponsored by Kantar Health). The new sales model drivers are all about becoming more customer-centric and service model-focused. So, a NO ruling by the Supreme Court in this case would be a good thing for the pharmaceutical industry, aside from the billions in additional expenses?

Reps also worry that their companies would cut back on the number of sales reps and overtime hours to forestall the added expenses going forward. "The problem is that if overtime has to be paid out it will lead to more cuts," said an anonymous CafePharma poster. "Lets face it, the impact of reps has been going down for quite a while."

What do pharma sales reps do in "overtime" (after 5 PM) anyway? It may be "role-playing": "Would the role playing to India at 9:00pm count as overtime?," asks another anonymous CafePharma poster. "Get ready for bye bye role plays after 5pm," said another.

Some reps do not think this is an issue at all: "Since most reps really only work a couple hours a day, this really looks like a non-issue." To which this response was made:

"Actually it's a huge issue! Other big pharma companies have had to pay and pay big! This could cost GSK hundreds of millions. As to your comment about a couple of hours, please stop with that nonsense. I avg about 9 hrs per day. It's not back breaking work (that's why I went to college) but it is work. Inventory at the storage facility, lifting boxes, conference calls, emails, coordinating lunches/dinners, knowing and understanding the complex molecules and how they interact invivo/invitro, analytics, ability to utilize Microfoft word/excel, intrapersonal skillls, the list goes on an on...oh but you say reps only work 2 hours. When are reps supposed to answer email, voicemail, build a business plan? On their office day? Ohhhh that's right, there is no office day. So when does all this work get done? According to you we only work 2 hrs a day. C'mon dude! Look, I'm not saying the law suit is a good thing, but the pharma companies had their cake and got fat eating it."

Deconstructing Pitts' Guiding Principles for Pharma Social Media

Deconstructing Pitts' Guiding Principles for Pharma Social Media

Peter Pitts over at DrugWonks Blog has put together 11 "principles that must serve as the basic substrate of regulated social media participation" (see here). Pitts offered these principles because he is urging the pharma industry to participate in social media and not wait for FDA guidelines "not because of its potency as a marketing vehicle – but because it’s the right thing to do." Let's take a closer look at "Pitts' Principles."

Principle  1. "We engage in social media to help improve the lives of patients and advance the public health of our nation."

"improve" is the key word here. We all have different definitions of what it means to "improve  the lives of patients and advance the public health of our nation." I, for example, think it is very important to make sure all Americans have affordable healthcare insurance and support efforts to close the gap in Medicare Part D coverage (ie, the "doughnut hole"). The drug industry may not agree with me 100% on this. Lilly, for example, hosted a Twitter "chat" that tried to convince people that Medicase isn't broken, so don't fix it, but I asked "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?" (read this post). Also see "More Pharma Twitter Chats: Medicare is Topic."

Even if we agree on how to improve patient lives, it has not been proven that social media actually can help in this effort. There are plenty of other ways that the drug industry can -- and does -- do things to help improve patient lives. Perhaps social media can help in those efforts (see, for example, "Boehringer Ingelheim and Ashoka Make More Health via Social Media."

Principle 2. "We will thoughtfully engage in social media while remaining in compliance with both the letter and the spirit of FDA regulations."

The word "thoughtfully" requires definition, IMHO. There have been many occasions when pharma companies have seemed to put little thought into their social media activities (see, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons"). 

Seriously, however, "thoughtful" implies best intentions as in showing consideration for the needs and sensibilities of other people (eg, "how thoughtful of you!"). Perhaps Pfizer lacked "thoughfulness" when it promoted on FaceBook a Chapstick ad that angered quite a few women (see "Pfizer's Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop").

Principle 3. "Our social media engagements will have both strong public health themes and appropriate marketing communications."

IMHO, "appropriate marketing communications" is the big elephant in the room that cannot be dealt with UNTIL the FDA says what is and what is not "appropriate." This requires more than being compliant with the "spirit of FDA regulations" as noted in Principle 2. It requires being compliant with the "letter" of FDA regulations. Of course, without the "letter" being written by the FDA, there can be no compliance with it.

Principle 4. "All social media messages and partnerships must be accurate, appropriate and transparent."

Pitts said "One principle that runs as a red thread throughout all of these 11 principles is transparency. Real, honest transparency – not the usual translucency that 'in compliance' often brings." I can't agree more. But this is where the drug industry will have problems. I can cite many instances of lack of "transparency" in pharma's social media activities that I have blogged about. For example, during a Lilly-hosted Twitter chat about Medicare, I suspect an employee or agent hired by Lilly posed as an ordinary citizen (@ellsbelles3) who posted "I keep hearing that Medicare Part D is working and not to change it. what does that mean?" This sounded suspiciously like a setup from a phony ordinary citizen similar to "Joe the Plumber" (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Although I suspect that Lilly was not being transparent about this, I cannot prove it. That's the problem with transparency in social media -- nobody can prove you are not a "real patient" and it's very easy for unscrupulous players to manipulate the game (ie, conversation).

Principle 5. "We believe that social media presents multiple opportunities to learn more about how our products impact the lives of patients."

Sounds good to me. I hope that pharma is actually listening and learning. It would be interesting to know exactly what the industry is learning about its products from monitoring social media. However, very few companies will even admit they are monitoring social media for fear that FDA will learn that they are not reporting adverse events they hear about (see Principle 7).

Principle  6. "We believe that social media engagement allows us to correct errors and misperceptions about both our company and our products."

"correct errors and misperceptions" is really a slippery slope. Who defines what is "correct" and "not correct"? There are many scientific studies and clinical trials whose results are challenged by the drug industry but that are accepted as correct by other experts. All sides of a debate involving scientific evidence should be discussed with the (transparent) participation of the industry. But if the goal of the drug industry is to "correct" other points of view, then the industry will not be engaging in discussion but trying to manipulate it. Also, keep in mind that the industry itself has often been caught make false statements about its own products -- hence all the warning letters from FDA!

A little pedantic aside: "misperceptions" is a curious word choice. Since Pitts is known to choose his words carefully, the distinction deserves some analysis in the present context of "misperceptions" of drug products by the general public.

According to Grammarist: "To perceive is to become aware of something directly through the senses. To conceive is to form something in the mind or to develop an understanding. So to perceive is merely to see something, and to conceive is deeper. But perception often involves passive evaluation, and this is where the line between the verbs perceive and conceive becomes blurred. Think of perceptions as relatively shallow interpretations, and conceptions as more creative interpretations involving substantial thought or imagination. Think of a misperception as a mistaken impression... and a misconception is a mistake of imagination or interpretation." A simpler distinction: Misperception, means to not understand, misunderstand; Misconception means a mistaken thought.

It's possible that patients, for example, might believe that a muscle ache after being prescribed a statin for high cholesterol is a side effect of the drug. This could be a "misperception" (not a a true pain) or a "misconception" (a real pain but not caused by the drug). Another example: some patients may believe the risks of a drug outweigh the benefits and then decide not to adhere to the treatment regimen prescribed by their doctors. Is this a "misconception" or a "misperception?" Of course, it may be neither: the risks may actually outweigh the benefits!

Anyway, perhaps a better word to use in this context would be "misunderstandings."

Principle 7. "We believe in using social media to discover adverse drug experiences, which will then be addressed off-line."

I like this, but would like to see more real-world examples. I recall only one example of a pharma company that has publicly embraced discovering AEs via social medias: ie, UCB, which partnered with PatientsLikeMe  to create an online, open epilepsy community that includes a pharmacovigilance program to monitor the site for adverse events and report directly to the FDA adverse events associated with UCB products (see "Finally, a Drug Company Embraces Social Media, AEs Included!"). I haven't heard much about this lately -- did UCB find many adverse events and what else did they learn (ie, re Principle 5)? I've seen several studies by agencies that work for the pharmaceutical industry that suggest very few reportable AEs are found on social media sites. PatientsLikeMe, however, reported that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (see "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members"). Also see: "The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting."

Principle 8. "We will strive to interact in a timely manner, appropriate to the general expectations of social media."

I expect there's a difference in opinion of what is meant by "timely." As has been demonstrated many times, pharma can get into trouble when it does not respond in a timely fashion to social media crises as was the case with Sanofi's response to a disgruntled patient (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). The ultimate decision of whether a response is "timely" or not is up to the customer (ie, patient, physician, or payor). Whether "striving" is adequate or if "succeeding" is better, remains to be seen.

Principle  9. "We believe that social media must be regularly monitored and our programs measured in real time to gauge effectiveness."

See my comments under Principle 5. The industry also is struggling with how to "measure" social media campaigns. There is also a question whether or not social media should even be campaign-oriented, which implies a beginning and an end.  We've already seen pharma companies shut down Facebook pages and abandoning their social media audiences (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?"). Companies are blaming new Facebook rules for the shut-downs, but I think "campaignitis" has hit -- new marketers come on board and want to run their own "campaigns" or the "campaigns" were not as successful as expected. Which leads me to ask, How do you measure social media success?

Principle 10. "We respect but are not responsible for user-generated content that resides on sites we do not control."

This should not be a principle. It's just common sense. Duh! But wait! The word "control" needs to be defined. Comments to FDA by several drug companies addressed this.

Principle 11. "We believe the path to engagement is through useful and thoughtful content and commentary."

I've already commented on "thoughtful" (see Principle 2). "engagement" is a key word here. What do pharma marketers really think of when they think of "engagement?" Is it the same as what you or I think of? If pharna social media programs are controlled by marketers or corporate communications people, it's difficult for me to think the goal is not just "engage" but also to "convince." That was my criticism of the Lilly chat regarding Medicare (see "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). Also see "Will Patients Find Value in Discussions with Pharma Marketers on Social Media Sites?" 

A book can be written about this stuff and I suspect someone out there is already finished with the first draft. I thank Peter Pitts for drawing up these 11 principles around which we can organize an ongoing discussion. I invite your comments.

What's On Pharma's 2011 List for Santa?

What's On Pharma's 2011 List for Santa?

At this time every year, the good "boys and girls" of U.S. pharmaceutical industry send a letter to Santa that includes a list "presents" they would like to receive. Help me create this list.

I've put together a list as a starting point. Please select the items you think are appropriate to include in Pharma's letter to Santa. Feel free to add an item if it's not on the following list. Also: @PharmaSanta is putting together his "naughty" & "nice" list of pharma companies. Help him! See Q2.

Results of this poll will be summarized in a future  post to Pharma Marketing Blog.

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer, World's Most Innovative Drug Company - Not!

Pfizer is the world's most "innovative" drug company, not in terms of developing new drugs to treat, for example, high cholesterol -- which it failed at spectacularly (see "Why Pfizer Flopped"), but at keeping old drugs on the market beyond their patent expiration date and competing with generic drug companies. I am referring, of course, to its efforts to keep Lipitor on the market competing with generic versions after Lipitor's Nov 30, 2011, expiry date. Lipitor Won't Go Gentle Into that Good Generic Night! as I commented on in a previous Pharma Marketing Blog post (see poem here).

The first phase of Pfizer's innovative "Save Lipitor" plan was an unprecedented level of direct-to-consumer (DTC) marketing of Lipitor. In 2010, Pfizer was the biggest DTC spender -- it's $967.5 million DTC budget for that year was more than double the DTC spend of its closest rival, Eli Lilly (see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"). Of that amount, approximately $251 million was spent to advertise Lipitor to consumers. An additional $410 million was spend promoting Lipitor to physicians ($1500 of which went to "wining and dining" my physician; see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") and supplying free samples (see chart below).

Just a week or so ago, I learned that Pfizer reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- that would compel many drugstores to block prescriptions for a generic version of Lipitor (see "Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE").

Now, according to this WSJ article, Pfizer is planning to sell Lipitor at generic prices directly to patients. "If successful," says the WSJ, "the risky move could rewrite the industry's playbook for selling medicines." So, THAT's the "Playbook" Pfizer is writing (see back story on that here).

All this sounds like good news for patients like me who have been advised by their physicians to switch to Lipitor because "it's a second generation statin that will be available in generic form." But wait! First of all, my drug plan has to be in cahoots with Pfizer to offer it to me at the generic price (actually, to request pharmacies and PBMs it works with to NOT substitute a true generic version of Lipitor when my doc writes "Lipitor" on the script).

But the savings will not be passed on to employers who will pay higher rates to keep Lipitor on their plans' formularies. What are employers likely to do in that case? They'll pass the added expense on to their employees by requiring them to contribute more to their health coverage!

Calling Merck: Help Save the Honey Bee!

Calling Merck: Help Save the Honey Bee!

The European Parliament has called on the pharmaceutical industry to play a role in finding a solution to halt the rapid decline of the honey bee (see "Can Big Pharma Halt Honey Bee Decline?"). There may even be(e) monetary incentives in the works for any drug company that agrees to develop new medicinal products designed to combat bee diseases.

Merck, which famously uses a honey bee as its Nasonex drug icon (see left) and which is famous for developing vaccines, should be(e) the first to step forward, support this resolution, and announce it is willing to take on the challenge, IMHO. Provided, of course, it gets a major share of those monetary incentives!

Think of the possibilities!

First, Merck would earn the undying love of Europeans facing economic disaster should its honey bee population disappear; did you know that "Albert Einstein once said that without bees, man would live no more than four years"? Thus spoke Hungarian Socialist Csaba Tabajdi, who drafted the resolution.

Whaaa?? A socialist wants to give the capitalist drug industry monetary incentives? This bee problem must really be(e) serious! However, given Europe's current man-made financial crisis, many Europeans may have fewer than 4 years left regardless of the fate of honey bees.

Second, Merck is committed to animal health: "Our Animal Health business is an industry leader and delivered strong revenue growth in 2010 in both companion and production animals, as well as all geographic regions. Merck remains committed to the animal health business and the diversification it brings. We intend to continue to capitalize on growth opportunities in our broad and innovative portfolio" (2010 Annual Report).

Third, imagine the direct-to-consumer (DTC) marketing opportunities should Merck launch a full-bore attack on honey-bee-disease-causing agents that threaten every honey bee, INCLUDING Merck's famous Nasonex icon. I'm thinking that Merck can use that icon to promote its efforts to save the honey bee. It can use Twitter to reach out to Europeans (but, of course, NOT the branded fake @Nasonex_Bee account). I'm also thinking that this non-branded DTC effort would not violate EU restrictions on promoting brand drugs to consumers.

Merck would have an easy time convincing EU parliamentarians to approve laws REQUIRING all flowering-plant farmers to use the Merck anti-honey-bee-disease-causing agent vaccine or whatever. Heck, it could extend the law to require ALL farmers -- even those who grow crops that do NOT require honey bees for pollination -- and even home owners with lawns or other plants, to apply its product. Better yet, the state can take over completely and send out helicopters to spray whole swaths of the countryside!

Of course, you wouldn't want to eliminate COMPLETELY the honey bee scourge! That would not help Merck "continue to capitalize" on its investment, assuming those government subsidies do not cover 100% of the research and development. You must continue to have high sales to recoup those costs!

One fly (or is it a bee?) in the ointment: part of Merck's plan to "diversify" may include developing other agricultural products such as pesticides (see, for example, this Merck EPA Application to Register Pesticide Products).

"Research has shown that pesticides made by the pharmaceutical industry are a cause for the weakening of bees. But instead of asking them to stop producing those pesticides, the European Parliament now asks that same industry to develop medicines against the effects of their pesticides," says Bas Eickhout, Dutch green member of parliament, who presented the house with an alternative resolution asking for a moratorium on the use of harmful pesticides.

Given that 25% of members of the EU Parliament support Eickhout's resolution, I'd say it's time for Merck to send to Brussels its lobbyists left over from its push to get U.S. state legislatures to pass bills requiring ALL children to be vaccinated with Gardasil (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question")!

Cancer Drugs: Greener Pastures for Pharma R&D and Wall Street

Cancer Drugs: Greener Pastures for Pharma R&D and Wall Street

Two news items regarding medical/pharmaceutical research caught my attention today. Both involve stem cells.

The first item was about research results revealed at the American Heart Association's annual conference. US researchers found stem cell therapy in humans has been "surprisingly successful in replacing damaged muscle and getting the heart to pump better" (see "Stem cells give new hope to heart attack survivors").

This is indeed "promising news for people at risk of heart failure" and is squarely focused on unmet patient need.

The other news item was about Geron, the "pioneering" stem cell therapy biotech company, that decided to withdraw entirely from the field and to dismiss nearly two-fifths of its employees (see "Geron withdraws from stem cell research"). The reason? According to the company's CEO, "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital" (my emphasis).

near-term value inflection points for shareholders

I guess Geron's CEO could be using shareholder value as an excuse instead of revealing a basic research failure despite good intentions to meet patient needs. Stem cell research must be difficult and payoff too long term. It's probably much better to focus on cancer-drug research. That's a proven cash cow that every pharma company seems to be chasing these days. Yet I don't expect many cures, just treatments that keep the cow on greener pastures.

Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

Occupy Pfizer! Protest It's Deal to Block Sales of Generic Lipitor! #OccupyPFE

"I'm mad as hell and I'm not going to take this any more!"

I love that line from the 1976 movie Network. The whole scene in which fictional news anchor Howard Beale goes on a "rant" is even more appropriate today. You can watch the YouTube version at the end of this post.

Today, however, I'm mad as hell at Pfizer in particular and plan to boycott its products or even "occupy" its corporate headquarters in NYC -- or maybe symbolically "occupy" it here on the Social Media Network and urge my readers -- much as Beale urged his fictional UBS Evening News viewers -- to at least stand up and say to Pfizer "I'm mad as hell and I'm not going to take this any more!"

Why am I mad as hell at Pfizer? I just read a story in the New York Times that explains how Pfizer has reached a deal with several PBMs -- middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers) -- the results of which is that "many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins" (see "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor").

That's why I just issued my Howard Beale "call to action" via a Twitter post: "Pfizer-PBM Deal Means Many Drugstores Will Delay Sales of Generic for Lipitor: ow.ly/7sEkz @pfizer_news: I'm mad as hell!"

Recall that I wrote a recent spoof about Pfizer's plans to keep Lipitor alive in the market (see "Lipitor Won't Go Gentle Into that Good Generic Night"). Little did I realize, however, that the PBM-Pfizer deal would result in drug stores refusing to substitute the generic version when filling prescriptions for Lipitor or to give patients Lipitor even when the prescription is for a generic version. The reason is that because of the rebates Pfizer offers to the PBMs, the co-pay for Lipitor scripts will be lower than the amount the patient would have to pay for the generic! The PBMs pocket the profits, wheres the payers (taxpayers like me and employers like me) get stiffed with the higher bill for Lipitor scripts.

"Raymond F. Kerins, a Pfizer vice president and spokesman, issued a statement saying Pfizer was committed to supporting patients’ continued access to Lipitor. He declined to answer further questions Friday afternoon," reported the NY Times. Typical of Kerins, who does not like to reveal much (see "Pfizer, Show Us Your Social Media 'Playbook'").

Most patients taking Lipitor won't even know what's going on except that their out-of-pocket co-pay will be decreased. But as more patients pay a portion of their employer-sponsored healthcare coverage, they should be concerned that employers may pass along the added expense (to them) to their employees. And even though the Pfizer-PBM deal will end in six months and Lipitor co-pays will rise back up, it would still hurt employers who will remember the shakedown when they adjust their employee benefit plans!

I also have a personal stake in this because my Doctor -- who has received payments from Pfizer in 2010 (see "Physician Bailout: On Average, Pharma Pays Every US Physician Over $750 Per Year") -- wants me to switch from a generic of Pravachol to brandname Lipitor to control my high cholesterol level. Just on the basis of the above story and the fact that my doctor was wined and dined by Pfizer, I feel that I should boycott Lipitor until I can truly get a generic version.

Am I putting my health at risk by refusing Lipitor? I don't think so. When I think how mad and helpless I would feel while taking Lipitor because of this PBM-Pfizer deal, my blood pressure would rise and I would be at greater rise of having a heart attack. I wouldn't, however, be at a greater risk of committing suicide as Howard Beale did in the movie Network, unless, of course, I was also taking Chantix!

I urge you to post a note to Pfizer on Twitter (@pfizer_news) and say that you oppose its PBM kickback plan and that you are now "occupying" Pfizer by sending out daily tweets with a similar message until Pfizer backs down. Use the hash tag #OccupyPFE (PFE is Pfizer's stock symbol -- a fitting acronym considering Pfizer's deal will mainly benefit its investors).

Here's the "mad as hell" scene from Network:

Your Wife, Your Choice - Diapers or Detrol (now Toviaz)?

Your Wife, Your Choice - Diapers or Detrol (now Toviaz)?

Pfizer's @pfizer_news Twitter account just posted this tweet:

"Toviaz top-line primary endpoint results positive in overactive bladder study of nocturnal urinary urgency http://t.co/OU60l6oZ" (see here). 

The link is to a press release that reports the results of a study that purports to show that Toviaz (a reformulation of off-patent Detrol) is "statistically significantly superior to placebo" in treating OAB (Over Active Bladder). The "statistically significantly superior" results were "based on patient self-reporting," which is a very subjective measure of efficacy to say the least.

OAB is one of those "medical conditions" that has been refurbished by the drug industry so that more people -- especially women -- can believe they have a problem requiring treatment by a pill rather than by some other, less invasive, means. I wrote about this before -- see "Overactive Bladder: 'Pharmacia instrumental in creating new disease' says Former VP." Pharmacia was purchased by Pfizer after that post was made.

An anonymous commenter to that post said:

"In the case of OAB, Pharmacia (and later Pfizer and others) provided an acceptable name for the condition, increased awareness, and provided access to effective treatment for a large group of patients (women especially) suffering a hugely difficult condition. Your wife, your choice - diapers or Detrol?"

I thought the last sentence was worth immortalizing in the title of this post because it is said that OAB is one of those conditions that "women especially" suffer from.

The Pfizer press release claims that "approximately 33 million Americans are estimated to suffer from overactive bladder symptoms." It doesn't say how many of these Americans are women, but the Toviaz Web site features a woman posing as a patient ("Not an actual patient") as in this banner:

Yesterday, I asked "Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?" (see here). Toviaz ads (eg, the Toviaz.com Web site) demonstrate how women are targeted by direct-to-consumer (DTC) advertisers. As I mentioned in yesterday's post, I plan to discuss this in an upcoming Pharma Marketing Talk LIVE podcast discussion tomorrow (see "How to Score With Women (as a Marketer) via Social Media").

One other thing I have to say about the @pfizer_news tweet is that it is an example of a branded tweet that may not comply with FDA regulations because it mentions a brand name drug plus its indication but does not include any "fair balance" (ie, major side effect information) as required by law.

Most pharma social media initiatives such as company blogs and twitter accounts (including @pfizer_news) are managed by corporate communications people who are increasingly taking on the role of brand marketers. These people tend to think of themselves as outside of FDA's purview. Consequently, Pfizer may claim that the Toviaz-branded tweet is notice of a press release, not advertising, and that the press release contains the necessary fair balance (albeit one click away).

In the post about OAB mentioned above, I included slides from a Pharmacia VP that demonstrate the importance of PR and the media in "creating a new disease." One slide said "Drive potential patients to physician offices by using DTC and PR with symptom recognition." Another slide (see below) shows that the Media are an important component in creating consumer demand:

Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing

Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing

"FDA’s regulations censor manufacturers," says the Medical Information Working Group (MIWG), an "informal" group of pharmaceutical companies that includes Allergan, Amgen, Boehringer Ingelheim USA, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, Purdue Pharma, and sanofi-aventis U.S.

In a "friends of the court" brief to the court hearing the appeal  of the Caronia off-label promotion case (see here), the MIWG contends that a manufacturer that "speaks about the lawful off-label uses of its products subjects itself to potential enforcement action unless FDA and DOJ determine, in their sole discretion, that they will not treat the speech as evidence of an 'intended use' for the product. This creates a chill on manufacturers’ speech, which has serious potential consequences for physicians, patients, and the public health."

Because of FDA's regulations that "lack coherence and clarity," MIWG claims physicians will have difficulty obtaining "objective, balanced, and accurate information on important unapproved uses of approved products." Furthermore, MIWG contends that pharma companies are "uniquely positioned to provide physicians with such information."

That's rich, considering that the drug industry often has difficulty providing "objective, balanced, and accurate information" on APPROVED uses of drugs as evident from all the FDA warning letters, which address this difficulty (for a list of the most recent letters, see here).

Should the heat the drug industry is bringing against FDA's off-label authority succeed, I envision off-label "woolly mammoths" (aka, sales reps) breaking free of the chilly ice and running amok among physicians offering "objective, balanced, and accurate information" - all without any oversight!

Much has been written about this legal issue, which you can find here, here, and here. Aside from the "objective, balanced, and accurate" claim, what caught my attention in the language of the brief was the overlap in the arguments presented with arguments pharma (eg, Pfizer) has made about how FDA should (or should not) regulate the promotion of Rx drugs via the Internet and social media.

On page 10 of the brief, for example, the argument is made that so-called "safe harbors" (eg, FDA guidelines for distribution of off-label reprints; see "FDA's Good Reprint Practices Guidance") are "not the product of formal rulemaking" and are "in most instances explicitly 'non-binding'." This was the argument Pfizer made against FDA issuing social media guidelines (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). As part of that argument, Pfizer said that "for FDA to regulate in this sensitive area [social media] through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result." (NOTE: Both documents are written by some of the same lawyers.)

Another parallel appears on page 11 of the brief, which delves into "unsolicited requests." The brief noted that FDA allows pharma company representatives (eg, paid physician speakers) to provide off-label information in response to an "unsolicited request" (eg, a question from the audience; perhaps from a physician "planted" in the audience for that specific purpose?).

Recall that the FDA's 2011 guidance "agenda" called for the agency to issue guidance regarding "unsolicited requests" from any source, including the Internet. That particular guidance, says FDA, was part of its promised social media guidance (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Before FDA can do THAT, it has to contend with the legal issues raised by MIWG in its brief.

This push for an end to FDA's off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question -- the Caronia off-label promotion case -- will end up in the Supreme Court. In the meantime, FDA is probably thinking "let's wait and see what happens before we issue any new guidance that 'lacks coherence and clarity'."

Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?

Do Women Take More Drugs Than Men Because They Need To or Because They Are Targeted by DTC Advertising?

Aside from Viagra, there's hardly a prescription drug I've heard of that women are NOT the major users of. Take, for example, this bit of information regarding Ambien as reported recently in the New York Times:

"According to IMS Health, a health care consulting firm in Danbury, Conn., the use of prescription sleep aids among women peaks from 40 to 59. Last year, the firm said, 15,473,000 American women between those ages got a prescription (overwhelmingly for Zolpidem, the generic form of Ambien) to help them sleep, nearly twice the number of men in that age group."

The article, titled "Sleep medication: Mother's new little helper" (find it here), goes into detail why mothers -- as opposed to fathers -- are so dependent on sleep aids. One woman is quoted as saying "The minute I had children I was like the mother listening in the woods for the bear. I don’t know if men are less vigilant, but my husband doesn’t wake up in the middle of the night. He could sleep in a dunking booth.” Yes, mom, men can be as vigilant! As a father of grown children living at home, I am often up at 3 AM wondering where the heck they are!

Here are other examples of this women/drug user phenom:

• "Women are twice as likely to take anti-depressants than men (Overall, 40% of females and 20% of males with severe depressive symptoms take antidepressant medication says CDC). Actually, for all degrees of symptoms, women are 2.5 times more likely to take antidepressants than men" (see here).
• There seems to be a proliferation of "real" diseases that "primarily affect middle-aged women." That, for example, is how fibromyalgia is described (see here).

Forgive me, but I have problem with these articles trying to explain why women -- more than  men -- need drugs. Specifically, I don't buy the argument that women need more drug X to treat Y than do men because more women suffer from Y than do men.

Could it be that women feel they need more drugs than men because they are more targeted by direct-to-consumer (DTC) ads? That's a question I'd like to discuss during my next Pharma Marketing Talk LIVE podcast this Wednesday (see "How to Score With Women (as a Marketer) via Social Media").

Other questions to be discussed include:

• Who said "social media is all about women" and what does this mean for the pharmaceutical industry?
• What does it take to be an effective social media partner when comunicating with women?
• Let's talk about "moms" and not "Sex in the City" conspicious consummer of high-end goods type of women. What is pharma doing to woo moms via social media?
• While it is possible to imagine women having relationships with certain consumer brands via social media, is it possible for them to have similar relationships with health and/or drug brands?
• Is it even possible for pharma brands to establish relationships with women via social because of regulatory restrictions on pharma branded marketing?
• What are the best digital marketing strategies to create trust in mhealth?
• Do you think there will be a day where everybody will use mhealth devices in their daily basis?
• What sector of the population do you think is more reluctant to use mhealth devices?

You can join the discussion by calling in by phone (the callin number is 347-996-5894) or via chat on the BlogTalkRadio site (here; you must be a BlogTalkRadio member to join the chat).

FDA Moves the Cheese on Drug Approval Numbers

FDA Moves the Cheese on Drug Approval Numbers

The FDA and the pharmaceutical industry are bragging about the number of "new" drugs approved in "fiscal year" 2011 (October 1, 2010 through September 30, 2011). In a report (find it on the FDA site here), FDA said it approved 35 "innovative drugs" during that period. PhRMA -- the drug industry's trade association -- said that 35 "new molecular entities" received FDA approval in fiscal year 2011.

One has to be careful about how you define a "new" drug in order to compare one year's performance to another. Also, there's the fiscal year numbers vs. the calendar year numbers.

For example, "new molecular entity" is a well-defined FDA term that even has an acronym: NME. FDA defines a New Molecular Entity as "an active ingredient that has never before been marketed in the United States in any form." NMEs go through a New Drug Approval (NDA) process.

In its report, FDA does NOT say there were 35 NDAs approved in FY 2011 as would be inferred from PhRMA's statement. Instead, FDA uses the term "innovative drug," which it does NOT define. It does, however, also refer to 35 "new drugs." Typically, FDA would use these terms to mean NMEs.

It's all a bit confusing to us mice trying to find the "cheese."

Let's look at the data on a calendar year basis.

FDA has new drug approval data available on its web site here. These data -- reported on a calendar year basis -- include NMEs (usually small, non-biological molecules) and BLAs (biologics license applications). The latest available data covers calendar year 2010 during which FDA approved 15 NMEs and 6 BLAs for a total of 21 total "new drugs."

Unfortunately, we cannot compare the number 35 for FY 2011 recently mentioned by FDA and PhRMA with the number 21 for calendar year 2010 to determine how much better the FDA/drug industry is doing. Obviously FDA wants to paint the rosiest of pictures in order to justify approval by Congress of new user fees being paid to the FDA by the drug industry to "expedite" the approval process.

So, how many NMEs and BLAs has the FDA approved so far this CALENDAR year? Well, on July 7, 2011, it was reported that FDA approved 20 "new drugs" as of that date, "just one short of the total for all of 2010, according to a top agency official" (see "2011 New Drug Approvals May Exceed 2010 Total, But...").

On FDA's Drugs@FDA, you can search for "Original New Drug Approvals (NDAs and BLAs) by Month," which includes all applications approved for the first time during the selected month including New Molecular Entities (NMEs) and new biologics (note: "Not all biologics are in Drugs@FDA"). Anyway, accessing these data, I come up with 23 "new drugs" (NMEs). Or maybe it's 25, which includes two "drugs already marketed, but without an approved NDA." In any case, calendar year 2011 is shaping up better than calendar year 2010.

FYI, I've plotted the yearly data from 1994 through 2010, which clearly distinguishes between NMEs and BLAs (see chart below).

Chantix May Be More Dangerous Than Smoking!

Chantix May Be More Dangerous Than Smoking!

Reuters reports (here) that Chantix is "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch," as reported by authors of a recent study (see "New study says Chantix raises suicide risks"). Here are more details as reported by Reuters:

The new study relies on adverse events from the FDA's Adverse Event Reporting (AER) System from 1998 through September 2010. They analyzed 3,249 reports of serious self-injury or depression linked to Chantix (varenicline), GlaxoSmithKline's Zyban (bupropion) antidepressant that was approved for smoking cessation and nicotine replacement products. They found that 2,925 cases, or 90 percent, of suicidal behavior or depression reported to the FDA were related to Chantix, even though the drug was only approved for four of the nearly 13 years of data included in the study. By comparison, there were 229 cases of suicidal behavior or depression related to bupropion and 95 cases related to nicotine replacement products.

The authors also looked at an antibiotic comparison group and found that adverse event reports of suicidal/self-injurious behavior or depression were otherwise "rare in a healthy population receiving short-term drug treatment."

I looked at the data in the study and carved out the data relating only to "completed suicides" and "suicide attempts" reported in the AEs studied. I figured these were the most serious adverse events. Here's a pie chart showing how Chantix compares with the competition:

In words: 88% of reported completed and attempted suicides among this group of products were found in Chantix AERs (595 Chantix cases vs. 75 Zyban cases and 6 nicotine cases). NOTE: 77% of the AERs were submitted to FDA directly by pharma companies; 40% originated with healthcare professionals and 60% originated with consumers.

This seems to be quite an increased level of risk to accept compared to the slightly better benefits of Chantix vs. the competition.

In its promotion of Chantix (among the TOP 10 DTC advertised drugs in 2010; see "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"), Pfizer cites studies that show 44% of Chantix users were "quit during weeks 9 to 12 of treatment (compared to 18% on sugar pill)." As the authors of the PLoS study point out, however, the picture is not so rosy after 52 weeks: "by 52 weeks a large majority in all groups had resumed smoking -- only approximately 25 - 27%of varenicline [Chantix] patients had remained largely abstinent compared to 17 - 19% of bupropion [Zyban] patients and 9 - 12% of the placebo group." No wonder the authors conclude "The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation."

Pfizer is using patient testimonials in its DTC advertising and positioning Chantix against nicotine treatment products as shown in this Chantix Web site creen shot:

If I were "Herb," I'd wouldn't be so "intrigued" by "non-nicotine" Chantix if I realized that I was 88 times more likely to attempt suicide or actually kill myself while on Chantix than if I used a nicotine patch/gum/whatever. Besides, at Herb's apparent age, stopping smoking is not likely to improve his health outcomes -- his years of smoking probably have already limited his life expectancy. Why add possible suicide to the mix?

Chantix on Facebook?
P.S. I once thought Pfizer woud be smart to use social media to help people quit smoking while on Chantix (see "Chantix: Opportunity for Social Marketing Lost?"). Seeing this data, however, I don't believe Pfizer could do it because it would be swamped by adverse event comments, especially now that Facebook requires comments to be turned on for all FB pages, including pharma-sponsored pages.

Speaking of that, I found THIS Chantix FB page (content copied from wikipedia) that does NOT have comments turned on! What's up with that?

Google to Shutter Sidewiki on December 5, A Day That Will Live Famously!

Google to Shutter Sidewiki on December 5, A Day That Will Live Famously!

Yesterday, Google sent out an email (see here) informing users of its sidewiki service that it will close the service on December 5. Sidewiki allows users to post and read comments linked to specific web pages. It was launched in September, 2009, and I was one of the first people to use sidewiki to attach comments to a drug.com website (see "Google's Wacky Wiki is Whack! Pharma Should Demand Ability to Block It!").

In my presentation at the November, 2009, public hearing at FDA regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools, I famously called on Google to "tear down this Sidewiki" (it was the anniversary of the fall of the Berlin Wall; see transcript).

Google spent a lot of effort defending sidewiki in comments it submitted to the FDA after the November hearings, saysing "The service uses an algorithm to identify the best comments, based in part on user ratings, and seeks to display only comments that are judged to be of high quality."

I said it before (see here) and I'll say it again: Google... what a maroon!

Are Pharma Reps Important to Docs or Not?

Are Pharma Reps Important to Docs or Not?

Back in March, 2011, I reviewed a PhRMA sponsored survey of physicians the results of which PhRMA claimed shows that "nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines" (see "New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?"). If you look at a chart of the relevant data (see below), however, you see that the 80% mentioned by PhRMA includes 53% of physicians who find sales reps only "somewhat useful." Only 26% of physicians surveyed found reps "very useful."

Yesterday, I came across the Wolters Kluwer Health Point-of-Care survey of physicians, part of which looked at where physicians receive information to make decisions about diagnoses, treatment and ongoing patient care (see press release and executive summary here). This study asked physicians: "How often do you use the following sources to gain information used to diagnose, treat and care for patients?" The results are shown in the following chart:

The trends are comparable (eg, prof'l journals are rank near the top and sales reps rank near the bottom in both surveys), but you can't group the Wolters Kluwer categories "frequently" and "occasionally" together as well as you can group together PhRMA's "very useful" and "somewhat useful" categories. Because of the way PhRMA designed it's study -- using categories that can easily be combined -- they were able to spin the results favorably, whereas no such spin of the data is possible in the Wolters Kluwer survey.

So, looking at ALL the data, IMHO, the best that can be said in answer to my question is that most physicians find pharma sales reps among the least important sources of information they use to help them diagnose, treat and care for their patients.

P.S. (27-MAR-2012) I just came across another study attempting to answer the question "Do physicians find sales reps useful?" The study comes from Cegedim Strategic Data (CSD), a provider of integrated healthcare market research. CSD analyzed physician-reported diary entries of recent sales calls. Results from over 30 countries showed that overall 93.8% of physicians worldwide, both GPs and specialists, "find sales representative calls useful and of value to their practice, based on over 5.6 million product detailing mentions" (find more details here).

I believe CSD's methodology asks physicians to evaluate recent sales calls. This technique eliminates physicians who did not receive any sales calls, which skews the data to favor physicians who like sales reps to begin with. The CSD study does not compare usefulness of reps compared to other sources of information.

In any case, it's amazing how many studies are out there and how difficult it is to get a straight answer to a simple question.

Lipitor Won't Go Gentle Into that Good Generic Night

Lipitor Won't Go Gentle Into that Good Generic Night

Today's Wall Street Journal reports that "Pfizer Inc. isn't rolling over and conceding the market for its cholesterol-lowering drug Lipitor after the blockbuster brand loses its U.S. monopoly at the end of the month" (read the article here). Pfizer has an aggressive co-pay card/PBM discount plan that it hopes will allow Lipitor to maintain a 40% share of the combined market for Lipitor and its generic equivalents for at least 6 months after generic brands are launched.

This has prompted me to man-handle Dylan Thomas's famous poem as an ode to Lipitor and its fight against patent expiry:

Do not go gentle into that good generic night,
Patent expiry should burn and rave at close of day;
Rage, rage against the dying of the innovator's right.

Though wise marketers at patent end know generic is right,
Because their words had forked no lightning their Rx brands
Do not go gentle into that good generic night.

Good Rx brands, the last wave by, crying how bright
Their frail market share might have danced in a greener pasture,
Rage, rage against the dying of the innovator's right.

Wild marketers who caught and sang cholesterol numbers in flight,
Learned, too late, Lipitor's fate, they grieve it on its way,
Do not go gentle into that good generic night.

Grave Rx brands, near death, that see with blinding sight
Off-patent drugs could blaze like meteors and be gay,
Rage, rage against the dying of the innovator's right.

And you, my Lipitor, there on the sad market height,
Curse, bless, your loyal patients now with your fierce tears, I pray.
Do not go gentle into that good generic night.
Rage, rage against the dying of the innovator's right.