New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales

New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales

"Meet the new blockbuster," reports the Wall Street Journal; ie, drugs that treat intractable diseases afflicting "small numbers of patients shown by testing to likely benefit from the drug. Such targeted therapies can be brought to market faster and at less cost, and health plans will pay high prices even for long courses of treatment" (find the article here).

One such drug is Pfizer's Xalkori (crizotinib), a "newly approved for a rare form of lung cancer, for which Pfizer plans to charge $115,200 a year per patient."

At that rate, Pfizer needs only about 9,000 patients worldwide to generate $1 billion in annual sales of Xalkori. In comparison, 1,671,000 Lipitor patients are required to generate the same sales figure. I demonstrate this in the following chart, which requires a logarithmic scale to represent both these numbers visibly on the same chart (see chart below).

Meet the New Big Pharma Economies of Scale: A smaller market can provide blockbuster sales as long as health plans back expensive therapies.

The catch is having diagnostic tests that pinpoint patients most likely to benefit.

Pfizer seems confident it can do this. "There's been a change of paradigm," said a Pfizer researcher. "The new school of thought is, 'If you find the patients that the drug will work in, and if you see enough benefit, we will find a way to get this to market.'"

The new drug development "paradigm" requires a new marketing paradigm as well. That marketing paradigm will focus almost exclusively on medical specialists such as oncologists.

Under the new marketing paradigm it will be difficult to justify broadcast direct-to-consumer (DTC) advertising (eg, TV) because it will cost too much to reach the small group of potential patients with such a broad brush (my guess is that pharma marketers only spend a lot on broadcast DTC when the target audience is greater than 10% of the adult population).

The Internet and especially social media is ideally suited to marketing to a small community of patients such as Linnea Duff who took crizotinib in a clinical trial. Linnea was featured in the Wall Street Journal article. Not mentioned in the article, however, was the fact that Linnea writes the "life and breath: living with lung cancer" blog, which she started during her clinical trial experience. The blog prominently features a "Pfizer Video" (see here).

I don't know if Pfizer paid Linnea to include the video on her blog -- she doesn't say one way or the other, although she did NOT include this equally nice video from the Massachusetts General Hospital (MGH), which ran the clinical trial in which Linnea participated. That video is available on YouTube (here).

I wish Linnea the best of luck -- she is still terminally ill and is "happy each day that she is given" as a result of her treatment.

Her story, however, is a powerful marketing tool and I am sure the future of pharma marketing will include many such patient stories that can circulate online among close-knit patient communities that previously were "orphans"; ie, neglected by the pharmaceutical industry.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

"The drug industry is floundering in its ability to provide the public with many of the basic medicines that are absolutely required for the treatment of a host of diseases," said Paul Torrence, former Section Chief, MIH, in a recent OpEd piece (see here).

Torrence called for a National Institute of People's Medicine that "would ensure that drug inventories are always well stocked. It would additionally be the driver and funder of cutting-edge drug discovery and development for antibiotics. Working through out-sourcing and contract mechanisms, the NIPM could rejuvenate research funds-deprived academics and mobilize small pharma to manufacture requisite medicines.

According to the FDA, "In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration, 132 of which involved sterile injectable drugs. In 2011, FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding" (see Drug Shortage FAQs).

Various causes of the current crisis have been suggested: (1) manufacturing quality issues, (2) market manipulation (eg, price gouging), (3) mergers of pharma companies who cut out low profit margin drug lines, and (4) lack of profits to be made from certain generic drugs.

Whatever the cause, the American Society of Health-System Pharmacists (ASHP) calls the current drug shortage in the US a "crisis" (view this video -- interview at 36 mins, 30 seconds).

The last time we heard of a crisis affecting the entire nation was the 2008 "financial" crisis. That was met with swift action by the US government, which intervened in the market to help ward off the crisis in lending (ie, shortage of money).

If the government can address a national money shortage crisis, why can't it also address a national drug shortage crisis?

Can the United States Ensure an Adequate Supply of Critical Medications?

That's the question ASHP asked in an FDLI Food & Drug Policy Forum article (attached to above cited post), the introduction to which states:

"This dramatic rise in the extent, duration and severity of shortages is occurring in an environment that is characterized by a near absence of communication between drug manufacturers and the Food and Drug Administration (FDA). This lack of transparency is a significant barrier to efforts to address drug shortages, and it represents a real and growing danger to patient safety. FDA has worked diligently to address this issue, but this work is hampered by the agency’s inability to require reporting of information that could be instrumental in minimizing the impact of a shortage or averting it all together."

More resources:

• Cancer drug shortages getting worse, FDA says (USA Today)


• Cancer Drug Shortage: Why Is This Not Front-Page News? (Health Beat Blog)

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

There's Room for Only One Osteoporosis Celebrity Spokeswoman: Sally Field Is Out, Blythe Danner Is In

There's Room for Only One Osteoporosis Celebrity Spokeswoman: Sally Field Is Out, Blythe Danner Is In

Amgen -- the company that along with Pfizer signed on Phil Mickelson to shill for ENBREL -- has now signed on Blythe Danner to shill for PROLIA, a drug to treat postmenopausal osteoporosis (see the press release here).

Here's Blythe on the "Act 2 Reduce Fractures" fully-branded web site (click image for larger view):

You are probably not OLD enough to know who Blythe Danner is, but postmenopausal women probably remember her in such classics as To Kill a Clown (1972), or as Robert De Niro's wife in the acclaimed series Meet the Parents, Meet the Fockers, and Little Fockers. If you are not yet of menopausal age, you no doubt have heard of Blythe's equallly environmentally friendly daughter, Gwyneth Paltrow.

Depending on the patent expiry of PROLIA, Gwyneth might one day also be a PROLIA spokeswoman. Gwyneth is currently 39 years old, whereas Blythe is 68. Hmmm... 29 years difference. By the time Gwyenth is menopausal PROLIA is sure to be off patent -- unless, that is, AMGEN comes up with a new formulation for the drug.

It seems there's not enough room in the postmenopausal osteoporosis celebrity spokeswomen market for two aging stars. Sally Field, who shilled for BONIVA for many years, is no where to be seen on the BONIVA web site. She has been replaced by generic postmenopausal women as in the screen shot below:

Cute, but no Sally Field!

Come to think of it, I haven't seen Sally on TV in a long while. I mean on a TV commercial for BONIVA. I look forward to seeing Blythe, however. Maybe Gwyneth will do a cameo appearance?

Unlike Sally, Blythe has never won an Oscar. Her spokesperson paycheck from AMGEN, therefore, must be much less than the one Sally received from MERCK. My guess is that AMGEN shot most of its celebrity spokesperson wad when it hired Mickelson (see "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign").

Google's Settlement with Justice Department Paves Way for FDA Social Media Guidelines

Google's Settlement with Justice Department Paves Way for FDA Social Media Guidelines

Google has agreed to pay $500 million to settle DOJ charges. In the settlement, Google acknowledged that it helped illegal online pharmacies target ads through its AdWords platform. It was one of the largest forfeitures ever paid in the U.S. (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales").

This will help the pharmaceutical industry and FDA in their long-standing battle against US citizens buying drugs online from Canadian pharmacies.

It will also pave the way for the FDA to release long-awaited guidelines for the use of Google Adwords and other "space-limited" online applications (eg, Twitter) by the pharmaceutical industry for branded drug promotions.

I pointed out previously (see here) that as part of the DOJ criminal investigation, undercover agents for the Food and Drug Administration contacted Google posing as representatives from rogue Internet pharmacies.

I suggested that because of FDA's involvement in this case, the agency delayed issuing guidance relating to the proper use of Google Adwords for branded Rx advertising. FDA did this -- IMHO -- to force Google to the bargaining table and to ultimate accept the draconian terms mentioned above. In other words, FDA was holding Google's pharma Adword business "hostage" until a settlement was reached.

Recall that the brouhaha with Adwords as far as pharma marketers were concerned all started with FDA issuing those 14 warning letters in April 2009. These letters were all about Google's Adwords. I had also pointed out long ago that Google was aiding and abetting illegal pharma Adwords by suggesting exactly the format that the FDA later found violative (see "That Girl from Google").

Now that Google settled, FDA should be willing to give back to the search engine giant its pharma Adword business, which was substantial prior to the 14 letters.

P.S. Back in April 2009, shortly after the FDA sent out the 14 letters, I asked this question: "WHY DID IT TAKE THE FDA THIS LONG TO GO AFTER VIOLATIVE ADWORDS WHEN I WARNED THEM ABOUT THIS AS FAR BACK AS 2006?" (see here).

At that time, I thought it had something to do with the new administration in Washington, DC. But I learn now from the DOJ press release (here) that "In 2009, after Google became aware of the investigation by the Rhode Island U.S. Attorney’s Office and the FDA/OCI Rhode Island Task Force of its advertising practices in the online pharmacy area, and as a result of that investigation, Google took a number of steps to prevent the unlawful sale of prescription drugs by online pharmacies to U.S. consumers."

Maybe the release of the 14 letters was the incentive Google needed to "take a number of steps."

Boehringer vs Facebook Social Media Socialism

Boehringer vs Facebook Social Media Socialism

Now that Facebook's new commenting policy is forcing every pharmaceutical to rethink it's Facebook strategy -- ie, take down all disease-specific pages but keep corporate pages -- many drug companies are revising their corporate FB pages.

Boehringer-Ingelheim (BI) stands out in its attempt to stand out from the crowd of pharma FB pages by designing a colorful Welcome page and icons (see image below; click on image for enlarged view).

Compare this with Pfizer's Info page:

Pfizer's page is an example of the sameness seen in almost every Facebook page created by dolts like you and me who cannot afford to allocate resources on customizing our pages. It's what I call "social media socialism" -- the least common denominator available to all users (regardless of their ability or resources) that satisfies a minimal need: ie, to have a presence on Facebook.

Boehringer's FB page, however, shows what you can do with dedicated resources and creativity.

Yet it's still a mystery to me how Pfizer is able to have 31,656 "likes" versus BI's paltry 13,008 "likes." Yes, Pfizer is probably much more widely known among the general population than is BI. But even the #2 pharma company (GSK) has only 14,074 "likes" (Astrazeneca has 10,035 "likes").

BI and AZ are doing almost everything right in social media in terms of allocating resources and engaging in conversations (see "OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!", for example), yet they are not getting the ROI -- in terms of numbers of followers and "likes" -- that Pfizer gets. Recall that Pfizer has NO dedicated social media resources and does NOT engage in meaningful SM conversation (see "Pharma Tweets: Followers Trump Content. Pfizer vs. Sanofi Case Study" and "Pfizer, Show Us Your Social Media 'Playbook'").

Something's not right.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

The NJ-PA Pharma "Brain Drain"

The NJ-PA Pharma "Brain Drain"

"In pharmaceuticals, they are not laying off 500 people here and there," said Alma Azua-Cassady, who worked in health-care marketing until she lost her job at AstraZeneca P.L.C. in December 2008. "They are laying off 12,000 people at a time," she said. Alma was quoted in today's Philadelphia Inquirer (see "As Big Pharma downsizes, a major loss of brain power").

The article included the chart on the left, which tracks pharma jobs in NJ and PA over the past 10 years.

Seems that PA pharma jobs losses started in 2003, whereas NJ losses started in 2006. It illustrates what the Inquirer calls a "huge brain drain in what has been one of this region's key industries."

The article blames generic drug competition as the drug industry loses patent protection on blockbuster drugs and consolidation (ie, mergers) in the industry as a result.

The article cites the "multiplier effect" -- a term economists use to measure the ripple effect of each dollar as it moves through the economy. Rutgers' economists, for example, estimate that each dollar that a pharmaceutical company spends on salary dollar adds roughly $1.50 to the economy.

The unemployed pharma people the article talks about used to work for BIG pharma companies like Merck and Astrazeneca. These people are finding it hard to find similar jobs at other big pharma companies.

A recruiter was quoted as saying "The companies who are hiring are smaller, midsize companies. These are great companies - but they don't have the sheer volume of jobs that the Mercks of the world did." The small firms worry that former employees of big companies are too specialized, unable to handle a range of tasks.

Coincidentally, I just received a resume in the mail from someone who was recently laid off from a SMALL specialized pharmaceutical company located in Yardley, PA, which is a town just down the road from where I live and work. The company recently merged with another small pharma company to form a new "specialty pharmaceutical company."

It seems that consolidation is not just limited to the big guys. Perhaps we will see a new wave of layoffs of people working in small specialty pharma companies as well!

Unfortunately, all this employment "drain" has nothing to do with "brains," just the relentless pursuit of profits at all costs whether it be a big or a small pharma company!

Social Media "Flash Mobs": Pharma's Worst Facebook Nightmare!

Social Media "Flash Mobs": Pharma's Worst Facebook Nightmare!

Last week I  presented two case studies of how pharmaceutical companies are dealing with Facebook's new commenting policy that requires most pharma pages to allow commenting (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?"). These cases illustrated two different approaches to shutting down pharma FB pages in anticipation of the commenting policy change.

The trend seems to be to shut down pharma product or disease awareness FB pages while maintaining the corporate pages. Two examples of this trend are the Pfizer (here) and GSK (UK; here) FB pages, which are open and allow comments (with post-moderation; ie, deleting offending comments AFTER posting).

So, how's that working for Pfizer and GSK?

GSK is experiencing the kind of attack that beset one of Sanofi's Facebook pages awhile ago (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page"). That is, an organized attack by disgruntled patients. In fact, a blog post (here) gives specific instructions for how to participate in this Facebook "flash mob" action:

1. Sign up to the GlaxoSmithKline Facebook page.
   [Do this by clicking the 'Like' button.]


2. Open comments under the "Glaxo "Builds Bonnie Babies" advertising hoarding opposite Kings Cross Station, London in 1921, UK" thread.


3. Ask them a question about one of their products.


4. Sit back and watch consumer queries get deleted.

GSK is now busy dealing with all the comments coming in.

Here's a typical exchange:

"Joanne" posts this: "Hi , A friend of mine is taking paroxetine and she is thinking of having a baby. Is paroxetine a teratogen?" 

To which GSK responds: "Hi Joanne – We are not allowed to discuss product information or offer advice to individuals about medicines. Please ask your friend to speak to her healthcare provider if she has any concerns about her medication." 

To which Joanne responded: "i too would like to know why the only answers here appear to be consult your healthcare provider, surely we should be asking GSK the makers of these drugs as surely GSK would know more than any GP? after all surely it is GSK who do all the trials ect and not the gps?" 

To which GSK responded: "Unfortunately, we have had to remove from this thread a series of comments that mentioned prescription medicines or contained defamatory messages. Due to the regulations that govern our industry, we are not able to discuss our medicines or offer advice to individuals about medicines on this Facebook page."

Whew!

Pfizer took a pro-active approach and opened a thread on its new policy with this post:

"Now that you can respond to our posts, please know that we may sometimes need to remove a comment. Click on the 'Not Seeing Your Comment?' link on the left to learn why. Thank you for visiting us!'

Pfizer was immediately embroiled in a comment war with "Dana" and removed one of her posts and added this comment: "Hi Dana – It looks like your earlier post was blocked, as it led to a discussion about products. As a regulated industry, there are a number of rules that concern how we talk about our medicines. In light of that, we have elected not to have any conversations regarding prescription products on our Facebook page. That being said, why don’t you reach out to us at www.pfizer.com/contact, and we can address your question."

Of course, Dana expected this, having previously posted "Take your time. I bet you're just thinking of a really good answer to my question." After Pfizer explained why they deleted her question, Dana said "'Reach out to us'. What a cute marketing phrase. What genius thought of that. So you won't tell us, the American people, why our hospitals don't have the supplies they need. Also cute."

And so it goes.

All this raises a number of questions:

• Will these types of comments and exchanges continue to plaque pharma FB pages?


• Will pharma need to employ additional internal or external resources to manage FB comments? Is it boom time for vendors offering this service?


• Considering that corporate pages are targets for "muppets" -- a term @Alex__Butler uses to describe people who attack pharma pages -- will pharma EVER re-open product and disease specific pages that are even more juicy targets for social media "flash mobs?"

Only time will tell.

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements (83 full unique advertisements) in biomedical journals found that only 18 percent (15) were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death. The study was published online on August 17, 2011 in the journal Public Library of Science (PLoS) One (here; also see press release here).

I've had some communication about this study with Dr. Deborah Korenstein, MD, Associate Professor of Medicine at Mount Sinai School of Medicine, lead author of the study, and Joseph S. Ross, MD, Section of General Internal Medicine, Yale University School of Medicine, a co-author of the study.

The major question I had was what "FDA guidelines" did they use to measure compliance against? The article was very non-specific in that regard, but I was sent the "Master Guide for Ad review," which was used to assess compliance with 20 FDA "Guidelines" (find the Guide attached to this post).

Actually, "guidelines" is the wrong term to use because what the authors used to create their assessment "Master Guide" was the original FDA "Regulations" (ie, Code of Federal Regulations Title 21, Sec. 202.1 Prescription-drug advertisements; find it here).

For example, one of the assessment items asks reviewers: "Are there unsupportable efficacy claims related to comparisons with other drugs?" In support of that, the authors cite this language in the Code: "Contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience." This is just one of the reasons that would make an ad "false, lacking in fair balance, or otherwise misleading" according to the regulations.

So, in short, the authors played the role of DDMAC reviewers and, based on THEIR interpretation of the regulations, determined if the ad under review was non-compliant with FDA "guidelines."

I took the liberty of plotting some of their results. Looking at the glass half-full, the following chart shows Percentage of Ads that are completely ADHERENT with FDA "guidelines" according to this study:

When assessing content, the reviewers looked at issues relating to "Safety," "Efficacy," and "References," as well as other content issues.

As can be seen in this chart only 47% of the ads (N=83) were deemed adherent to FDA "guidelines" regarding efficacy. The questions authors asked themselves when reviewing the efficacy claims in ads were:

1. Does the ad quantify benefits?


2. Were appropriate efficacy data or numbers presented?


3. Are there unsupportable efficacy claims related to comparisons with other drugs?


4. Are efficacy claims based on non-clinical data?


5. Are there unapproved efficacy claims?


6. Does the ad make unfounded claims regarding competitor drugs or does it claim inaccurately that advertised drug differs from other drugs?

For each question, the reviewer could check off "Yes," "No," "Not Sure," or "NA." Reviewers used language from the FDA regulations cited above to subjectively decide the answer. For example, in support question 4, the assessment guide quotes this language from the FDA regulations: "Contains ...data or conclusions from non-clinical studies ... which suggests they have clinical significance when in fact no such ...significance has been demonstrated." Ads that fit that description -- as subjectively determined by the reviewer -- were judged "Non-Adherent."

According to the researchers:

"Advertisements were considered adherent if they contained none of the 21 [actually 20 according to their "Master Guide"] features used by FDA to classify advertisements as misleading, non-adherent if they contained one or more of the features used by FDA to classify advertisements as misleading, and possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete."

Sometimes, the reviewer was "not sure" if the ad was adherent or not. In the case of efficacy claims, 31.3% of the ads fell into this category, while 21.7% were judged "non-adherent." The remainder -- 47% -- were "adherent" as shown in the chart above.

Well, if the MD reviewer is "Not Sure," maybe an actual FDA reviewer might also not be sure. But in that case, the ad would be put into the "adherent" bin. In other words, an FDA reviewer might consider that 78.3% (47% + 31.3%) of the ads were actually adherent with regard to efficacy claims.

The problem, note the authors, is that the FDA is NOT catching the ads that according to them are obviously non-adherent. Why not? "The limited resources of the FDA's Division of Drug Marketing and Advertising [DDMAC] are a major barrier to successful regulation of the pharmaceutical industry's multi-billion dollar marketing budget," said Dr. Korenstein who notes in the research paper that "DDMAC’s fiscal year 2008 budget of $9 million is dwarfed by the pharmaceutical industry’s $58 billion marketing budget."

"We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements," said Dr. Korenstein.

NIH Genie Grants Pharma's Wish: Turning Old Drugs Into Cash Machines

NIH Genie Grants Pharma's Wish: Turning Old Drugs Into Cash Machines

For the first time ever, scientists are using computers and genomic information to predict new uses for existing medicines. A National Institutes of Health (NIH)-funded computational study analyzed genomic and drug data to predict new uses for medicines that are already on the market (see "NIH Program Predicts New Uses for Old Drugs").

It is predicted that this discovery will put greater emphasis "on so-called drug repositioning as a way of lowering the costs of drug development and getting therapies to patients more quickly," according to a Wall Street Journal article (here).

There's only one catch: "an advantage of finding repurposed drugs is that, since they are already approved, doctors can prescribe them off-label for patients," says WSJ. "This opens the door to very low-cost, individualized personal therapies," said Yves A. Lussier, a professor of medicine and engineering at the University of Illinois at Chicago who wasn't associated with the study.

Yeah, but if the drug is too old -- ie, off-patent -- no branded drug company will be interested in getting the drug approved for a new indication UNLESS a new USE patent can be obtained. THAT's exactly what Pfizer did to extend the patent life of VIAGRA (see "Double-Dip Viagra Patent Means No Recession for Pfizer").

QED

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

If FDA Published Social Media Guidelines as a Facebook Page, PhRMA Would "Like" It!

If FDA Published Social Media Guidelines as a Facebook Page, PhRMA Would "Like" It!

PhRMA -- the US pharmaceutical trade association -- just now published an oblique critique of the FDA for fiddling with issuing its promised social media guidelines while pharma Facebook pages burn in response to new commenting policies (see "What We'd "Like": FDA's Social Media Guidance").

"After all," said PhRMA's Kate Connors, "the FDA is quite active online, with Facebook and several Twitter accounts. Our companies aim to be able to be just as engaged in discussions about health and science as the agency that regulates them, because we thoroughly believe that better information can ultimately lead to better health. To that end, we continue to wait for FDA’s guidance, and to hope that it comes soon."

Whoa! FDA you've just been "bitch-slapped" by PhRMA!

Double-Dip Viagra Patent Means No Recession for Pfizer

Double-Dip Viagra Patent Means No Recession for Pfizer

Pfizer proves once again that it's not all about the science when it comes to "innovation." It's also nice to hedge your bets by winning patent infringement cases to keep marketing exclusivity for as long as possible.

Yesterday, for example, Pfizer prevailed in its Viagra patent infringement action against Teva Pharmaceuticals USA, Inc. in the United States District Court for the Eastern District of Virginia.

It wasn't, however, your typical patent infringement case. Pfizer actually has TWO patents for Viagra. One patent, which expires in March 2012, covers sildenafil (Viagra's active ingredient) for use in treating heart-related conditions such as high blood pressure. During the clinical trials, however, Pfizer discovered that the drug can improve erectile dysfunction (ED), the condition for which it eventually received marketing approval from the FDA.

In 2002, however, Pfizer double-dipped into the US patent office and received a NEW patent for Viagra to treat erectile dysfunction. It was THIS patent, which expires in October 2019, that was upheld in court yesterday.

According to a Wall Street Journal article (here), "In siding with Pfizer, Judge Smith wrote that in the early to mid-'90s, a person trained in the art of drug development 'would have no expectation that oral administration of such compounds would be successful in treating ED, and thus such method was not obvious to try.'"

Hmmmm... But Pfizer filed for the ED patent in 2002, when it obviously KNEW full well that oral administration of Viagra would be successful in treating ED. Pfizer obviously also knew that it would be successful in the 90s because it stopped the cardiovascular trials and pursued the NDA for ED.

In court, Pfizer essentially argued that it was not technologically savvy enough to know that sildenafil could treat ED while at the same time it pursued FDA approval PRECISELY for that condition. Talk about having your cake and eating it too!

If the court decision is not challenged on appeal, Pfizer will enjoy "continued market exclusivity" that will boost earnings by "roughly 3% annually between 2013 and 2018, a period in which profit otherwise would be under pressure due to the expected loss of exclusivity later this year for Pfizer's top-selling Lipitor cholesterol pill."

It's good to be the Pfizer! Pfizer shares were up 2.2% to $18.25 in early afternoon trading Monday on the New York Stock Exchange.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Pharma's Facebook Free Ride is NOT Over! Take Advantage of This Loophole Dudes

Pharma's Facebook Free Ride is NOT Over! Take Advantage of This Loophole Dudes

Today is the day that Facebook will no longer allow pharmaceutical companies to disable comments made to their Facebook pages.

"Today is the day that many pharma and healthcare companies that like their Facebook Pages hoped would never come. Remain calm," said Jonathan Richman on his Dose of Digital Blog.

As Jonathan noticed, so far it doesn’t appear that Facebook has actually turned on comments on any pharma pages.

Facebook may be tardy in carrying out its threat, but that's NOT the "free ride" I am talking about.

No matter when the new policy is implemented, pharma Facebook pages such as this one for Lunesta (see screen shot below) can STILL have comments disabled (listen to this podcast interview of Jonathan Richman for the details).

The difference between the Lunesta Facebook page and the standard www.lunesta.com Web page is:

The Facebook page is FREE! The pharmaceutical company that markets Lunesta (Sunovion; formerly Sepracor) pays Facebook NOTHING to create and maintain this page, whereas it pays to create and maintain the drug.com site.

This is the best deal in town! Call it CUGC: "Corporate User Generated Content."

I hope the pharmaceutical industry doesn't cry too hard if and when Facebook implements its comment policy change. After all, there's a loophole you can drive a truck through.

Sarah McLellan Gives "Whole Lotta Love"

Sarah McLellan Gives "Whole Lotta Love"

You may know Sarah McLellan as the person who works for Pixels & Pills to interview attendees at pharmaceutical conferences. She interviewed me not too long ago at the BDI's Social Communications & Healthcare 2011 Case Studies & Roundtables conference (see "Pfizer, Show Us Your Social Media 'Playbook'").

There were always two things that impressed me about Sarah: (1) her beauty and personality, and (2) her knowledge of pharma marketing issues. OK, three things.

But wait, there's more to Sarah! She also likes to cook and writes a fantastic blog called The Aussie That Ate the Big Apple. Great recipes.

Sarah's also an actress and was a lead singer for the rock band Lez Zeppelin, an all-female tribute act, performing the work of Led Zeppelin. Here's Sarah performing "Whole Lotta Love":



That's it. I just wanted to give a shout out to Sarah. You can learn more about her here.

Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?

Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?

August is the cruelest month, especially for pharmaceutical company Facebook pages.

No doubt you've heard that as of August 15, 2011, Facebook will be opening up comments on ALL pharma pages with some exceptions (listen to these podcasts: "Implications of Facebook's Page Commenting Changes: Turning Off Comments May Be a Problem" and "Pharma Facebook Commenting Changes: The 'Final' Story"). That means that the pharmaceutical industry will no longer be able to shut off comments on their Facebook pages. This has lead to speculation that many pharma FB pages will be shut down come August 15.

A couple of pharmaceutical companies have already taken down their Facebook pages or announced they will do so. These include Janssen's ADHD Moms page, which was the first pharma Facebook page, launched in June, 2008, by McNeil Pediatrics (see The Pharmaguy Social Media Timeline™).

"A new Facebook policy, scheduled for Aug. 15, will specifically impact communities that are formed to help people learn more about disease conditions, such as ADHD Moms™, which we sponsor," says a note on the ADHD Moms page. 

"This new policy will alter our ability to consider the appropriateness of comments before they are posted which is important to us as a company in a highly regulated industry." 

"As a result, our ADHD Moms%reg; community will not be available after Aug. 14. Additionally, as of Aug. 9, our Moments™ tab will no longer be available. We want you to know that we value the community formed on this page and this was a difficult decision, but necessary given the Facebook policy change. We apologize to anyone in our community who may be disappointed by this decision."

Sanofi-Aventis said it would discontinue its VOICES page, which became infamous when it was attacked by a "disgruntled" patient (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").

"Please note that we will be discontinuing the sanofi-aventis VOICES page, effective August 9. We would like to continue this conversation with you, so we ask that you go to the Sanofi US Facebook page to do so."

This marks a turning point in pharma social media. Janssen effectively abandoned 23,725 (more or less) people (including 28 0f my Facebook friends) who "liked" ADHD Moms. It offered no alternative to these people other than third-party resources. Sanofi-Aventis, on the other hand, directed its 859 friends (including 22 of my friends) to its Sanofi US Facebook page, which currently is liked by 360 people (including 11 of my friends).

On the Sanofi US Facebook page, the company states that "To comply with applicable Laws and regulations, we do not use the standard Facebook wall for discussion." It does, however, allow comments on a special "Discussions" page where it previewsthem before being posted. "Just a friendly reminder that all posts are being moderated to ensure they comply with our Terms of Use," said Sanofi.

I had problems finding the Terms of USe, so I posted a question asking where I could find them. I received a reply within 2.5 hours (see screen shot below). The time stamp is odd - I actually posted my question around 3 or 4 PM Eastern US, but the time stamp says 2:20 AM; perhaps my Twitter pal @jonmrich can explain this discrepancy. Another thing Jon might be able to explain is how come Sanofi can still have comments shut off on its wall?

Did the new Facebook policy actually cause these companies to shut down their pages? Janssen seems to put all the blame on Facebook whereas Sanofi seems to blame "Laws and regulations," implying government interference. Of course, there are NO federal Laws or regulations specifically prohibiting Sanofi or any other pharma company from using the "standard" Facebook wall for discussions.

Blaming Facebook or "Laws and regulations" for this reminds me of the final scene of King Kong where the beast is lying dead at the foot of the Empire State Building:

Police Lieutenant: Well, Denham, the airplanes got him.
Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.

I think there are other reasons why these pages are being shut down -- (1) one (ie, ADHD Moms) may have outlived its usefulness, and (2) one (VOICES) may have been ill-conceived in the first place, giving no benefit to the company and having a tainted history. In these cases, it's just best to shut them down and move on.

Unfortunately, Janssen doesn't seem to have an alternative FB page. It just "abandoned" its 23,725 FB friends. In the scheme of things, this is not a big number considering that Janssen claims ADHD "impacts five million children in the United States, while nearly eight million adults have been diagnosed with the condition" (see here). 23,725 represents only 0.47% of the children's ADHD market. In other words, ADHD Moms was a dismal failure in terms of reaching this market - maybe.

Over the next few days I will maintain a vigil over the pharma Facebook death march. Help me by letting me know of other pharma Facebook pages that announce their demise.

Pharma Planet of the Apes!

Pharma Planet of the Apes!

Grady Forrer over at the Pharmaceutical Research and Manufacturers Association (PhRMA) blog laments that the new version of Planet of the Apes -- a movie I don't think he has actually seen -- does not jibe with reality (see Movie Dark Fantasy vs. Biopharmaceutical Reality).

"I do want to rail for a moment against the trite movie convention of the evil pharmaceutical company purposefully or negligently perusing research which results in harm to patients or, as in this case, humanity as a whole," said Forrer, who urges viewers to resume their disbelief after seeing the movie. I assume he means disbelief that science and the pharmaceutical industry can do harm. I'm all for that, up to a point.

Anyway, I thought Forrer's comments deserved a graphic that perhaps illustrates PhRMA's fear of how surviving humans might view the pharmaceutical industry's role in creating the NEW Pharma Planet of the Apes:

Two Doctor-Created Provenge YouTube Videos: Which One Would Dendreon Reps Prefer to Show Their Docs?

Two Doctor-Created Provenge YouTube Videos: Which One Would Dendreon Reps Prefer to Show Their Docs?

I read with interest today a Pharmalot post about Provenge after seeing this tweet from @jackbilson3: "Outstanding article & comments about Provenge from @pharmalot http://ow.ly/5XGzH".

Provenge is a "controversial and innovative Provenge prostate cancer vaccine" that Pharmalot says is experiencing problems because "many doctors, particularly those in smaller settings, were slow to adopt the $93,000 vaccine since they had to wait for reimbursement." Pharmalot interviewed one such doctor -- Leonard Liang, a Los Angeles urologist -- who gave his personal experience regarding reimbursement issues.

Of interest to me were the comments to the post in which "zuppy" accused Dr. Liang of bias because he owns stock in Dendreon, the company that manufactures and markets provenge. "zuppy" stated:

"I think it should be noted that Dr. Liang has a record of contributions to the Investor Village DNDN Message Board, that clearly demonstrates his shareholding interests in Dendreon. As for the YouTube video released 1 August, 2011, I found it inappropriate that a practicising Urologist with a public display of shareholder interest in Dendreon, would create and put on YouTube a video featuring one of his patients being treated with Dendreon’s Provenge."

Dr. Liang admits he owns stock and said "I have never not disclosed this." However, Dr. Liang does NOT disclose this in his video, which you can see below (while it's still available):



It's a rather long video, but informative. In it, Dr. Liang makes a very good case for Provenge. I especially like how he describes what is meant by mean survival rates of Provenge (25.8 months) vs. placebo (21.7 months). "Another way to look at the data," says Dr. Liang, " is that your 3-year survival rate is going to be a lot better."

 Basically, Dr. Liang paints a rosy picture in his video, emphasizing the positive and adequately explaining the risks, which are mainly "flu-like symptoms that go away." Is Dr. Liang biased because he owns stock in Dendreon? Who knows. But he certainly is promoting his infusion business -- his YouTube channel (here) links to his web site, which promotes his practice.

Dr. Liang, however, is not the only doctor who has produced a Provenge YouTube video. Another doctor -- Gerald Chodak -- has a prostate cancer YouTube channel (here) that includes the following video about Provenge:



I don't know if Dr. Chodak owns stock in Dendreon, but he points out one very important problem with Provenge that sheds further light on the reimbursement problem:

"One of the things that is unusual about this treatment," says Dr. Chodak, "is that it has no effect on the PSA results and it has no effect on whether the cancer may progress to other parts of the body...And that can make it a little difficult to determine if a man is getting a good response or not."

The point is that if it can be figured out who is NOT responding during treatment, the expensive Provenge infusions ($31,000 per pop) can be halted and other treatments tried. Obviously, payers are reluctant to pay for something that may not be working.

Anyway, I find it interesting that doctors like Dr. Liang and Dr. Chodak are producing videos that promote specific brand name products. My questions are:

• Can/should Provenge sales reps of Dendreon marketers provide urologists with links to these videos? Would FDA have a problem with that? 


• And which video do you think Dendreon sales reps would choose to share with their potential clients? Dr. Liang's of Dr. Chodak's?

Pharma Tweets: Followers Trump Content. Pfizer vs. Sanofi Case Study

Pharma Tweets: Followers Trump Content. Pfizer vs. Sanofi Case Study

Everyone is tracking how the pharmaceutical industry uses Twitter and other social media. Jonathan Richman maintains the Pharma and Healthcare Social Media Wiki, which lists dozens of Twitter accounts (no rankings, although Jonathan does give out awards). EyeOnFDA Blog maintains its TWANK! Pharma Twitter Rankings, which is ALL about numbers, especially followers. And I maintain the Pharmaguy Twitter Pioneer list (see here).

None of these compilations says much about the quality of the content (ie, Tweets) pushed out by these sites. Some include 3rd-party measures such as Klout scores. But Klout is a poor barometer of how well pharma tweeters ENGAGE in conversation via social media. To demonstrate this, I compare recent tweets from @Pfizer_news ("The official site for Pfizer Inc., where we apply science and our global resources to improve health and well-being at every stage of life. I'm Jen Kokell, GMR") and @SanofiUS ("The official Twitter feed for Sanofi US. Tweets on news, updates, and other info come from Jack Cox and Stacy Burch. Intended for U.S. audiences only").

I picked these two because my friend @AndrewSpong posted this in today's #hcsmeu Twitter chat:

"despite only having been active since Jan '11, @SanofiUS has published nearly twice as many tweets as @pfizer_news"

To which @rohal responded:

"number of tweets is not a measure for effectivity of comm, quality of perception and understanding is!"

Sometimes marketers say "communication" when they really mean "messaging" or "marketing," which is one-way communication. By now social media should have changed what we all mean by communication; ie, two-way conversations. It would be interesting to measure this aspect of Pfizer's and Sanofi's Twitter accounts.

Before I do that, let's look at the numbers:

@Pfizer_news

• Followers: 17,705


• Follows: 2,078


• Tweets: 487


• Klout score: 51

@SanofiUS

• Followers: 1,728


• Follows: 1,676


• Tweets: 891


• Klout score: 46

Except for tweets sent, Pfizer beats Sanofi hands down in this numbers game -- although I am amazed that the Klout scores are relatively close considering that Pfizer has TEN TIMES the number of followers than does Sanofi. I am on record questioning how Pfizer obtained all these followers. It boosted its number of followers by about 3-4,000 in just a few days around Christmas 2009 How Did Pfizer Get So Many Twitter Followers?.

Since then, I've heard that Newt Gingrich has been paying to get fake Twitter followers (Gawker received a tip from a former staffer, saying that Gingrich had paid firms to create fake Twitter followers; search company PeekYou analysed his follower list, and found that 92% of them were dummy accounts. Adding insult to injury, PeekYou added that Gingrich's percentage of real followers was "the lowest we had ever seen"; see story here).

I'm not saying that Pfizer did this, but it would interesting if someone analyzed its Twitter follower list and other pharmaco Twitter follower lists.

For my case study, I merely compared 20 of the latest tweets from @Pfizer_news and @SanofiUS to see what was different about them (find my list here).

Here's what I learned:

Self-serving Tweets: 60% of Pfizer's Tweets (12 out 20) were self-serving in that they referred back to Pfizer press releases, blog posts, etc. The tone is overtly NON-CONVERSATIONAL; eg, "Pfizer did this...", "Pfizer did that.." as in "Positive top-line results for Pfizer’s Lyrica in Phase 3 study of patients with fibromyalgia in Japan on.pfizer.com/ntYymj" (there's a tweet FDA should take a look at!). In contrast, I found only 1 self-serving Tweet among Sanofi's last 20 Tweets (5%). If I met Pfizer_news at a cocktail party, I would find any excuse to run away! (Note: Whenever I meet Jen Kokell at conference receptions, however, I look for excuses to stay put!)

Retweets: Retweeting is usually a good measure of "conversation" vs. "communication" in Twitterdom. @Pfizer_news's Tweet stream did not include a SINGLE RT, whereas Sanofi's included 13 (65%). I did not include one RT that retweeted from another Sanofi account. An example of a Sanofi RT: "RT @andrewspong How do we achieve equality for patients with rare diseases? http://bit.ly/pA4bdb | pharmaphorum #rarecare #hcsmeu #hcsm" Not only does Sanofi RT, but it adds hash tags, another indication that it engages in conversation rather than one-way communications.

Hash Tags: Use of hash tags is another good indicator of how well a company engages in conversations via Twitter. Eight out of 20 (40%) of Sanofi's tweets included one or more hash tags, whereas only 2 (10%) of Pfizer's tweets included a hash tag.

Klout may or may not look at these things when computing a score for Twitter accounts. If it does, then IMHO Sanofi's score should be MUCH higher than Pfizer's. But I think the numbers still outweigh the relevance for Klout and even for industry pundits; ie, Followers trump Content!

In the old days of Web 1.0 the the adage was "content, content, content". Today, in the social media Web era, it appears the NEW adage is "numbers, numbers, numbers." It's a shame.

Is Over-the-Counter Lipitor in the Cards? One year's sales could cover original R&D costs!

Is Over-the-Counter Lipitor in the Cards? One year's sales could cover original R&D costs!

The Wall Street Journal (see here) reports that Pfizer is considering seeking approval from the FDA to sell Lipitor over-the-counter (OTC). Although OTC sales of Lipitor are likely to be only a fraction of the the annual $10 billion in global Lipitor sales currently enjoyed by Pfizer, OTC Lipitor may generate up to $1 billion in annual sales. That's almost enough to cover the original costs of bringing Lipitor to market in the first place; that is, if you accept the industry's estimate of $800 million to $1.2 billion as the cost of development for an Rx drug.

How did I estimate the annual sales of OTC Lipitor? I used the Claritin Rx-to-OTC switch as a model. According the the WSJ article:

"Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago"

$3 billion in 2000 dollars is worth about $3.9 in 2010 dollars. Therefore, $401 million represents about 10% of pre-OTC income. If the same OTC/Rx sales ratio holds true for Lipitor, Pfizer can potentially sell $1 billion worth of OTC Lipitor in the first year (keep in mind that Claritin treats seasonal allergies and sales probably spike in the spring, whereas Lipitor sales would be sustained all year long).

But it is unlikely that Pfizer will depend entirely on OTC Lipitor sales to maintain this all important anti-cholesterol brand. It may do what Merck did after Claritin went OTC, which was to develop a new Rx formulation of the drug; ie, Clarinex.

Is Pfizer currently working on a new formulation for Rx Lipitor? I have no idea. It did, however, fail spectacularly to bring a new anti-cholesterol drug (torcetrapib) to market in 2006 (see "torcetrapib: '$800 Million' Failure but Kindler Safe"). Perhaps, after recent cutbacks, Pfizer no longer has the R&D resources to be as innovative as it once was.

One other thing to consider is this: the WSJ articles points out that Merck has been unsuccessful in its attempt to switch its anti-cholesterol statin drug Mevacor from Rx to OTC. FDA shot them down 3 times. The argument against OTC statins such as Mevacor (and presumably Lipitor as well) is that these drugs can be highly toxic to the liver if not used properly and require periodic blood tests to monitor such problems.

Adding to the debate is a benefit/risk analysis of statins based on a little-known but useful statistic, the number needed to treat. You can read more about that here: "The Statin Lottery: Number Needed to Treat Statistic". According to Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, people could do as well dieting and exercising to lower cholesterol while avoiding the cost and potential side effects of taking a statin every day. BTW, people pay out of pocket for OTC drugs that were covered by insurance when the drugs were Rx. Those costs could exceed copays.

I note with interest that Pfizer is currently in the middle of a direct-to-consumer (DTC) advertising campaign that disses diet and exercise as a way to lower cholesterol; see "New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?". I wonder if the target of this ad campaign is the FDA rather than the general public? Hmmmm....

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

FDA Intern & the Quest for Social Media Guidelines

FDA Intern & the Quest for Social Media Guidelines

There have been many theories attempting to explain why the FDA is dragging its feet in developing social media guidelines for the drug industry (see, for example, "FDA, DOJ, & Google: Conspiracy Theory, Part 2"). Whatever the reason, financially strapped and under staffed, FDA clearly needs help. To get this help, does the FDA plan to pull in any outside consultants, hire additional experts internally, or approach the drug industry itself to help craft the guidelines?

I learned that FDA Intern, strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of FDA Commissioner Margaret A. Hamburg or even former FDA commish Andy von Eschenbach, has actually been on the case, attempting to get FDA moving on developing social media guidelines!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

Let's join FDA Intern in her latest adventure:  

FDA Intern & the Quest for Social Media Guidelines

Alas, boys and girls, the FDA is not going to get any help from Pfizer's "Playbook." For more background & fun summertime reading, enjoy these previous Pharma Marketing Blog posts:

• F**k the FDA! Drug Industry Should Issue Self-Regulatory Social Media Guidelines!
• Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance
• Is This Pfizer's Social Media "Playbook?"
• Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media

[This post originally appeared in Pharma Marketing Blog. 
Make sure you are reading the source to get the latest comments.]

Point-of-Care Pharma Marketing: When Is It Appropriate?

Point-of-Care Pharma Marketing: When Is It Appropriate?

In the world of smartphone apps for physicians, Epocrates plays a leading role. The Epocrates iPhone app is free (with a $99 PREMIUM upgrade option) to physicians -- and anyone else -- who can use the app to find information on drug dosing, interactions and insurance coverage while seeing a patient. According to a New York Times article (see here), 70% of Epocrates' revenue comes from pharma point-of-care advertising; ie, messages from pharma advertisers that pop up as "DocAlerts" when the app is used to look up drugs, etc.

Some docs complain about the messaging, claiming they don't have time for that "nonsense." A few reviews on the iPhone app store suggest this is a common complaint:

"why must I be badgered with your alerts?"

"Paid for 'premium' subscription, getting nagging pharma clinical alerts that are rarely useful. Alerts don't go away unless you tap through them. If this is the case, should be free app."

According to the NYT article, "Epocrates is betting that the 320,000 physicians who use its apps, much like those who use Google and other advertising-supported data services, will tolerate some marketing to get the information they want at no charge." However, unlike Google, ads delivered directly to doctors while delivering care can have a much greater influence over their prescribing. If you are of the opinion that advertised drugs are usually more expensive and sometimes less safe than generics, then pharma paid DocAlerts (ads) are not in the best interests of patients and payors.

For pharmaceutical manufacturers, Drug information apps such as offered by ePocrates and ePrescribing may offer a new channel to influence physician prescribing at the point of care. “The beauty of the work we do with Epocrates is that we literally put ourselves in the palm of their hand,” said Dr. Freda Lewis Hall, chief medical officer at Pfizer.

Being in the doc's palm is one thing, but interrupting his/her workflow is another. When is it appropriate to "interrupt" physicians with commercial messages at the point of care? There are several more or less disruptive ways to provide messages in apps at the point of care, including:

• Ads appear via a splash screen when doc turns on PDA, smartphone, or iPad. The message not related to any prescribing transaction.
• Specific targeted messages are "triggered" by doc's drug lookup choice, demographic, and/or prescribing history and designed to influence doc's prescribing decision.
• Non-targeted messages delivered before, during, or after the prescribing process.

Which do you think is most appropriate and why? Please take a few minutes to respond to my "Point-of-Care Pharma Marketing" survey (click here). After finishing the survey, you will be able to see a summary review of the results to date. No open-ended results that may contain personal information of respondents will be shown. Also, at the end of the survey, you will find links to these FREE Pharma Marketing News articles:

1. ePrescribing: What Role Should Pharma Play?
2. Ready or Not: Gearing Up for the Expansion of ePrescribing

Thanks!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]