Friday, February 26, 2010

Pfizer's Bait and Switch Facebook Pfan Strategy

Yesterday afternoon at approximately 3 PM ET, @pfizer_news posted this tweet: "Become a Fan of Pfizers official page on Facebook: http://bit.ly/aGX49f" About an hour later I was sent this DM: 'Hi - Wanted to let you know that we just launched our official Pfizer Facebook page (http://bit.ly/aGX49f)... hope to see you there!"

I always make it my business to explore as many new pharma social media initiatives as possible. Therefore, I immediately logged on to Facebook and became a fan of Pfizer's official Facebook page. I was not the first fan. Despite having just been launched within the last 24 hours (I believe), Pfizer now has over 800 Facebook fans. The @Pfizer_news Twitter account now has over 5,000 followers!

When I became a Pfizer FB Pfan, Pfizer's Wall contained a bunch of short "medicine Safety" videos in which patients talked about their medical conditions and medications. I don't think any mentioned specific products by name.

One video was of a woman with osteoarthritis who expressed concerns about taking any medication at all. I thought this was an interesting video for Pfizer to post to its wall. So I decide to post a comment about it. However, "something went wrong" when I hit the submit button, as shown in this screen capture:
I didn't really think that Pfizer would allow comments, so this didn't surprise me. Maybe they are actually "fixing" this "problem." We'll see.

But I WAS able to SHARE this video by posting it to MY profile so that all MY FB friends could see it too! This is how it looked on my FB profile page (www.facebook.com/pharmaguy) a few minutes after I shared:
Today, however, those videos are gone and you cannot see the one I tagged on my FB profile page. They were replaced by product photos as shown in this screen capture:

Is this a classic "bait and switch" strategy? Pfizer enticed me to become a fan, which I did based on the interesting unbranded video clips. Then it switched to what it knows best: brand marketing.

Who wants to be a fan of a pharma Facebook account that only talks about its products? Not me. Hopefully, Pfizer is just experimenting and eventually it will come up with a more compelling reason for me and others to be a fan. Meanwhile, the fans keep coming. I guess you can fool most of the people some of the time!

P.S. If you are observant, you'll notice that I also became a fan of Victoria's Secret PINK Facebook page. I did this ONLY to see how a non-pharma company enticed people to become Facebook fans! BTW, Victoria's Secret PINK has 1,961,850 fans!

UPDATE (March 1, 2010): It appears that the videos are back up on Pfizer's Facebook page. You can share them (ie, post them to your Facebook profile), but you cannot submit comments on Pfizer's Facebook page. I guess that Pfizer saw that there was a comment button that lead to an error and they fixed it by eliminating the comment buttons. When I first wrote about this, a colleague thought that the videos were removed because you could share them on your profile and then all your friends could attach comments to them. It was thought that this "unauthorized" content attached to the videos would get Pfizer into trouble with the FDA. Probably not, IMHO.

Thursday, February 25, 2010

If Drugs Were Like Automobiles

According to an Institute for Safe Medication Practices report (see here) more than 1000 reports of patient deaths were received by FDA for rosiglitazone (AVANDIA) in the first three quarters of 2009, "more than any other drug we monitor."

In contrast, at least 34 deaths have been linked to Toyota vehicle problems going back as far as 2004, forcing Toyota to recall more than 8 million vehicles worldwide.

The top executives of Toyota had to appear before Congress and apologize profusely.

GSK (the maker of AVANDIA), on the other hand, is on an all out campaign to discredit the Senate investigation of AVANDIA.

If people are afraid to buy Toyotas, they should be about 400 times more afraid to take AVANDIA! I base this on an estimate of yearly death rates for AVANDIA (1333) vs Toyota (3.4).

Just as you can go out and buy a Honda instead of a Toyota, diabetes patients can go out and buy ACTOS instead of AVANDIA, according to Stephen Nissen, Chief Cardiologist at the Cleveland Clinic. If, that is, consumers evaluated drugs like they do automobiles.

Wednesday, February 24, 2010

Will FDA's SM Guidance Resemble Suggestions Made by Industry Group Back in October?

Pharma's Social Media Working GroupYesterday, during a Pharma Marketing Talk live podcast/interview, Cynthia Phillips, who is currently Senior Director of Regulatory Labeling and Promotional Compliance at Millennium Pharmaceuticals, Inc., and spokesperson for an adhoc Social Media Working Group (SMWG), told how her group met with the FDA in October, 2009, and presented the agency with a draft guidance on regulating social media. This draft guidance may be similar to the comments SMWG submitted subsequently to the public docket (see "A Pharma 'Social Media Working Group' Submits Comments to FDA").

Soon after its meeting with the SMWG, FDA held a public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

Back in October I said: "I think the preparations for this hearing have been pretty disorganized and hasty. It appears that not much planning has gone into it and I'm afraid that the whole experience will be anti-climatic" (see "Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing"). Now I understand why: Although FDA issued a notice for the public hearing on September 21, 2009, the agency may have been spurred to issue that notice AFTER the SMWG first contacted it to request a private meeting.

“We asked ourselves if we as a group could agree on some recommendations to try and help the FDA get comfortable with the idea of coming out with guidance,” said Phillips in the interview. “We started meeting over a year ago and came up with a draft guidance. We requested a meeting with DDMAC and saw them in October [2009]. Shortly thereafter they announced the public meeting at which we participated. We have since submitted our recommendations to the public docket.”

Which came first, the chicken (FDA) or the egg (SMWG), is not the most interesting part of the story. It is obvious that when the drug industry asks for guidance, FDA must listen. This is what makes this process different from that of 1996 when the FDA called the first public hearing on the use of the Internet by the drug industry. It did not issue guidance at that time, although that meeting was much better organized and representative of all stakeholders (see "FDA Public Hearing: Not Deja Vu All Over Again?"). This time, the meeting seemed like a mere formality that the FDA had to go through before issuing guidance.

In fact, as I said before (see here), I think the FDA already has draft guidance in hand -- the guidance submitted to it by the SMWG. If the comments submitted to the public docket by SMWG are similar to what it suggested to the FDA in October, then we have a pretty good idea what the FDA guidance will look like. BTW, FDA intends to release guidance on "Promotion of Prescription Drug Products Using Social Media Tools" before the end of this year according to its Guidance Agenda for 2010 (see here).

I also get the sense that the FDA will NOT address search engine ads, general websites, and display/banner ads. For one thing, as the SMWG said in its public comments, "There are interpretative issues that affect social media even more than the Internet. FDA has recognized the Internet only as a very similar form of media to both print and broadcast.” In other words, the industry is OK with interpreting print and broadcast guidance for the Internet (Web 1.0), but needs more guidance for specific social media uses that involve online discussions.

Google has also met with the FDA and proposed a new search ad format for the pharmaceutical industry. This format has already been used by Bayer (see "Is Google the New FDA?"). Perhaps the industry will just wait and see if the FDA issues any letters regarding that. So far, it has not. Therefore, no new guidance for search ads may be forthcoming.

Tuesday, February 23, 2010

Geez, GSK! Find Another Source of "Balanced" Commentary

GSK continues to use its "More Than Medicine" blog to focus on Avandia, one of its medicines receiving a lot of attention recently (see Steve Nissen to GSK (and FDA): "Put Patients First! It's Time to Pull Avandia from the Market.").

In an early-evening post yesterday, blogger "Michael F", complained of the "misleading headlines stating that 'FDA Report Advises Avandia be Pulled from the Market,'" which he noted "were re-Tweeted dozens of times." Then he pointed out that other commentary, which GSK found to be "more balanced" gained less attention.

Michael F cited "this piece in Forbes," as his example of a "more balanced" account (see here or screen shot below in case they delete or edit the post; click for enlarged view).


It's a faux pas to cite an opinion of a physician who was on your payroll as a consultant and speaker. As Ed Silverman over at Pharmalot pointed out, GSK paid Dr. Mintz $11,050 in the first quarter of 2009, something that Forbes originally neglected to point out (see "A Forbes Guest Blogger And His Pharma Ties").

Silverman noted that the Forbes oversight was corrected Monday when Forbes "placed an editor’s note on blog posts Mintz wrote over the past few days about Avandia and Advair, among other drugs, indicating his ties to various drugmakers."

Perhaps Michael F did not see that editor's note when he said that Dr. Mintz offered a "more balanced" point of view? Or maybe Michael F feels that Dr. Mintz could have a balanced point of view on this subject despite having been on GSK's payroll. That could be, but you should not use such a person as your spin poster boy!

Monday, February 22, 2010

Steve Nissen to GSK (and FDA): "Put Patients First! It's Time to Pull Avandia from the Market."

Internal FDA reports -- part of a fierce debate within the agency over what to do about GSK's Avandia -- obtained by the New York Times, say that "if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart" (see "FDA and GSK: Conflicting Opinions on Avandia Heart Dangers").

With such damning evidence in hand, why is there "fierce debate" within the FDA? Why doesn't the FDA take the drug off the market?

According to Cleveland Clinic's Dr. Stephen Nissen, in an interview with Mike Huckman (@mhuckman) on CNBC's Sqauwk Box, "the problem is we have a structural problem inside of the FDA. The very people that approved the drug in the first place are the ones being asked to pull it off the market. That means they [would be] admitting to themselves that they made a terrible mistake that cost a lot of lives. So they don't go there. We need to strengthen the Office of Surveillance and Epidemiology -- the safety side of the FDA -- and give them the authority to act decisively when these kinds of issues come up because we can't expect the people who approved the drug to be the ones to pull it off the market."

Previously, I pointed out the FDA could have limited Avandia's approved-for-marketing indication to a subset of patients or excluded a subset, such as patients with with Congestive Heart Failure (CHF). In fact, the Avandia label includes data showing that people with CHF can suffer adverse cardio events including heart attacks. To read the data in the label, see my post "Avandia: Enough Blame to Go Around."

Just as I predicted, GSK seems resolute in its fight to defend Avandia and keep it ON the market (see "GSK May "Step Into the [DTC] Void" to Defend Avandia"). In his interview today, Nissen remarked on one of the tactics GSK used to neutralize his review of Avandia's safety problems:
Huckman: One of the things the Senate report concludes is that Glaxo bullied or intimidated doctors like yourself who tried to sound the alarm on Avandia risks. Are you one of them? And if so, what did the company do to you?

Nissen: I'm not easily intimidated. They did come to the Cleveland Clinic without telling me they had stolen a copy of my manuscript and tried convince me I was wrong...

Huckman (interrupting): Now wait a second. I don't know if they "stole" a copy of your manuscript. According to the Senate investigation it was "leaked" to them by one of the peer reviewers for the New England Journal of Medicine who later claimed he "wasn't feeling well and didn't know what he was doing."

Me (to myself): Ha, ha! I wonder if the "leaker" was a physician on GSK's extensive payroll? (See "Pharma Begins to Reveal Payments to Physicians")

Nissen: Mike, by any stretch of the imagination, if you have stolen papers, it's theft. They could have easily not accepted that material. Not only did they accept the material, but they disseminated it throughout the company. Fifty executives saw it. They analyzed the manuscript, came to the conclusion that it was scientifically correct, and then planned a PR campaign to discredit it.
This hardly seems like the actions of a company that puts patients first, which is what Dr. Nissen urged the company to do at the start of his interview: "This is about asking Glax to put patients first."

Saturday, February 20, 2010

"An Eye on Big Pharma": I am Feautured in NYIT Magazine Article

 
I received an MA degree in Communication Arts from the New York Institute of Technology in 1988. The school's PR person somehow got wind of what I was doing and convinced me to be interviewed for an article in the school's alumni magazine. The article just appeared in the Winter 2010 issue (see image above). That's me on the lower left in my home office dressed in my signature blue shirt and yellow tie (I decided that a Hawaiian shirt would be too casual for the photo shoot).

The article is entitled "In Sickness and In Health: NYIT graduates speak out on the furure of medicine." I'm honored to be in such distinguished company of people who are making real contributions like Eric Fleischman (D.O. '86) working for the Clinton Foundation's HIV/AIDS Initiative in Thailand. My remarks about "rising drug prices" in the US pales by comparison, although I don't remember saying drug prices have "bollixed up" the health care debate. Oh, well, any PR is good PR.

Computer Graphics and Rings of Uranus
My focus at NYIT was computer graphics and my most memorable moment occurred during a classroom discussion of the utility of computer graphics. The professor asked a question like "What benefits have computer graphics brought us?" I almost immediately blurted out "If it weren't for computer graphics, we would not have seen the rings of your anus!" Of course, I was referring to the planet "Uranus," whose name pronunciation has changed since 1988 (probably because of remarks similar to mine from school kids everywhere). Needless to say, after a stunned silence, the class broke into loud laughter. Despite that remark, I went on to ace the class.

This taught me that, despite what my teachers always said, you won't be seen unless you make yourself heard!

Friday, February 19, 2010

Can Pharma Fill the HCP-to-Patient Social Media Vacuum?

In today's #hcsmeu (Healthcare Social Media in Europe) discussion via Twitter, I posed the question "Patient support via Twitter: is there a need for Pharma to do it? or should it be left to HCPs?" Actually, this was how Andrew Spong, a leader of the discussion, nicely rephrased it. 

I was actually looking for some more specific insights about how Twitter could be used for patient support such as those in my "What's Your Opinion About Branded Patient Support via Twitter?" survey. But I was glad the topic got shifted somewhat into a debate of the role of pharma versus healthcare provider in patient support.  

Marc Monseau, the Twitter and social media face of Johnson and Johnson, suggested the following uses of Twitter by pharmaceutical companies (see me in my Hawaiian shirt and Marc Monseau in this video from Digital Pharma 2009: http://bit.ly/aEIvT4):

1. Customer Service
2. Provide Expert Advice and Information
3. Traditional News and Information Provider
4. Suggestion Box
5. “Engage with you in some other fashion”


What did he mean by "Customer Service?" I could ask him, but it's better we deconstruct that concept here and decide what WE mean by it.

First, who is pharma's "customer?" That's a bit like the blind men describing an elephant. To a PR, corporate communications person like Monseau, the customer might be the media - reporters and such. To the medical affairs people it would be key opinion leaders and other healthcare professionals. To the managed markets people it would be P&T committees and other managed care professionals.

But what about the consumer and specifically the patient? Who inside pharmaceutical companies think of the patient as their customer? Officially, no one. The product manager and other marketing people certainly want to reach out to consumers and spend a lot of money doing that. To them, however, the consumer is a TARGET, not a customer to be supported. Once a consumer becomes a patient, the brand team virtually ignores him or her.

Yes, everyone within a pharmaceutical company has the patient "top of mind" in every thing they do. Maybe. But I question if TOP executives put patients first. I've documented many times here on this blog where it appears that top pharma executives think Wall Street analysts and investors are their customers that they have to support. When was the last time you, as a patient, was invited to listen in to a CEO presentation?

OK, so pharma companies have a problem viewing patients as customers because they have no one inside their organizations whose job it is to specificly think of patients as their customers.

A platitude that's often repeated at industry conferences focusing on the Internet is that you need the "buy in of top management" to be able to implement a successful social media program. Bull! As I just said, top management's main concern is Wall Street. They want ROI because that drives profits, which drive stock prices. They are not interested in tactics; ie, how you get ROI, they just want ROI.

Another obstacle in SM evangelists' quest to get pharma more "engaged" with consumers/patients via social media is the sacrosanct physician-patient "relationship." Pharma is loathe to "interfere" with that relationship. But is there really a relationship? I don't see myself having a relationship with any of my physicians. They do not contact me by email or via Twitter or even by phone! I have a better relationship with CVS, which calls me every so often to remind me to refill my prescriptions. But my physician does not call me to remind me to come in for a test to make sure those prescriptions are not destroying my liver!

What the drug industry really should stay out of is the conversation between me and my physician once I am in the office. But if CVS can call me to remind me to refill my Lipitor prescription, why can't Pfizer DM me via Twitter and remind me as well? In fact, there are many other "support" activities pharmaceutical companies can offer patients via Twitter, including:
  • Drug/device safety alerts (eg, drug recalls, medical device malfunctions, emerging safety issues)
  • Prescription management, including pharmacy refill reminders
  • Daily health tips from authoritative sources
  • Publishing disease-specific tips
  • Clinical trial awareness & recruitment
  • Enhancing health-related support groups (e.g. buddy-systems for depression)
  • Providing around-the-clock disease management
  • Patient-sharing of health-related experiences
  • Issuing dietary/lifestyle tips
(Thanks to Phil Baumann who compiled a list of "140 Health Care Uses for Twitter", which included many of these activities.)
Some people will say that there are not enough patients using Twitter to justify this. However, everyone who uses Twitter is or will be a patient. What the naysayers mean is that there is no mass audience, no ROI! Parden me, but ROI should not be the goal of customer support!

In order for any customer support channel -- whether it be Twitter, email, or phone -- to work, it must be promoted and require opt-in. Pharmaceutical companies already solicit visitors to drug.com Web sites to sign up for email messages, which are most often merely marketing messages. They could also solicit patients to sign up for Twitter support if they had a mind to do it.

So, when you ask how pharma can engage consumers via social media, first define what you mean by "engage" and who you mean by "pharma." Does engage mean "market to" or "have a conversation with" (if so, a conversation about what?). It's not likely you'd get many consumers to opt-in to engage in marketing conversations with pharma. But if you offered something of more value to patients, then you might succeed in gaining a lot of followers via Twitter.

Also, don't forget the "who." Among all the pharma Twitter accounts, I only can recognize a human being behind 2 or 3 of them. All of these people are dedicated and competent, but all are part of corporate communications, which is the least trusted source of information as far as consumers and patients are concerned. Where's the consumer ombudsmen within pharma that can build the necessary trust before engaging consumers? That's the question you need to ask and answer to determine if social media can be successfully used by pharma.

Thursday, February 18, 2010

A Snarky Look at Sneaky Marketing Tactics Pharma Hasn't Avoided

My friend Jonathan Richman (@jonmrich) often sees the pharma marketing glass half full, whereas I often see it half empty. It's just the way we are wired. The goal, however, is the same -- improve pharma marketing.

Jonathan likes lists. In a recent article entitled "10 sneaky marketing tactics you need to avoid" published on iMedia Connection, Jonathan lists some dubious marketing tactics that companies should avoid. After just a cursory reading of his list, it is obvious to me that pharmaceutical marketers have not been very good at avoiding most of these and other sneaky tactics.

#1 Sneaky Tactic Pharma Has Not Avoided: "AstroTurfing"

"Simply put," says Richman, "AstroTurfing is when a company or group creates a campaign designed to look like a grassroots consumer movement when, in fact, it's completely artificial."

Some time ago, I pointed out one instance of "astroturfing" in the pharma realm: the RLS Foundation. The Restless Leg Syndrome (RLS) Foundation -- a US patient organization -- has very close ties to GSK -- a UK-based company that markets ReQuip for treatment of (RLS). In fact, I believe that the RLS Foundation was established by GSK. Here are some interesting factoids that support my thesis (see "Restless Pharma Marketing", for more details):
  • GSK is a Gold Corporate Sponsor of the RLS Foundation, which means GSK has given the foundation a good chunk of change;
  • at least one member of the Foundation's Medical Advisory Board has financial ties to a pharmaceutical company (GSK) with a treatment for RLS;
  • the PR activity of the organization seems to have picked up right when that company's drug (ReQuip) hit the market;
  • the first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK;
  • Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, had the "pleasure" of "collaborating" with GSK to do studies supporting the data on the prevalence of RLS in the US and in Europe;
  • the color scheme of the RLS Foundation's Web site matches that of the Requip product site.
#2 Sneaky Tactic Pharma Has Not Avoided: Spam and violation of privacy rights

Jonathan calls this "Lucky guess (aka, we were 'smart' enough to acquire your email address, so we're sending you stuff)." This falls under the heading of contacting someone without their permission. This actually happened to me when I participated in a focus group for erectile dysfunction. I received a phone call from the agency doing the research because I requested information from the Levitra Web site -- I did not give my phone number, but gave my address so they could send me the information. The researchers were "smart enough" to obtain my phone number from my address and bingo! "Lucky guess!" Read all about my experience in the Pharma Marketing Blog post "Market Research: Privacy Matters."

#3 Sneaky Tactic Pharma Has Not Avoided: Anonymous tidying (aka, we fix what we don't like and hope you don't find out)"

"If you try to cover up your identity online, people will find out. Always," says Richman.

Oh boy! Where to start here? You can find some good examples of this sneaky tactic in my "Web 2.0 Pharma Marketing Tricks for Dummies" (click here and use code 'free68' to get it FREE). In there you'll find out how pharma marketers or their agents pose as consumers on social networks, alter Wikipedia entries about drug information, and lots more sneaky stuff.

#4 Sneaky Tactic Pharma Has Not Avoided: A little off the top (aka, we reject reality and substitute our own stylized version)

Pharma marketers routinely do this by overestimating the number of people who MAY have the medical condition that the drug is approved to treat. Sometimes, it is claimed, pharma marketers create diseases where none really exists. This is called "disease mongering." You can read about that in this Pharma Marketing News article: "Disease Mongering: When Is the Line Crossed?" I also have documented this "sneaky tactic" a number of times here on Pharma Marketing Blog. See, for example, "40over40: Lilly's DTC ED Awareness Campaign in the UK" and, more recently, "Danica Patrick: NASCAR Driver, Super Model, Superbowl Lingerie Ad Model, & COPD Spokesperson All Rolled Into one!"

I am not going to address the remaining 6 "sneaky tactics" on Richman's list; I need to take my morning shower, especially after revisiting all these sneaky tactics. Some of the tactics probably don't apply to pharma because they are used to promote consumer products in ways that pharma has not yet mastered. Or it is impossible to know if these tactics have actually been employed. Also, there are many other "sneaky tactics" that Richman doesn't mention, but which are employed by pharma marketers (see "Dummies").

Wednesday, February 17, 2010

FDA Fan Club Launched on Facebook

"Should FDA have a Facebook page?," asks Mark Senak on his EyeOnFDA blog. "It is only a matter of time before Facebook, or some message platform equivalent, is realized as necessary."

I decided that if FDA won't come to FaceBook, then FaceBook should come to FDA! To do that, I launched the official FDA Fan Club on FaceBook. Everyone who is a "fan" of the Food & Drug Administration is welcome to join and post their feelings about the FDA. Hopefully, this will help the FDA become a better organization by seeing what its "fans" have to say! Access the FDA Fan Club here.

Monday, February 15, 2010

Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

"A preliminary study suggests the same type of botulinum injection used for cosmetic purposes -- Botox -- may be associated with reduced frequency of migraine headaches that are described as crushing, vicelike or eye-popping (ocular), but not pain that is experienced as a buildup of pressure inside the head, according to a report in the February issue of Archives of Dermatology, one of the JAMA/Archives journals" (see press release here).

This caught my attention because (1) this study was supported in part by a grant from Allergan Inc., the company that markets Botox, (2) co-author Dr. Burstein serves as a consultant to Allergan Inc. and receives honoraria for lectures and grants for clinical and animal research, and (3) the authors admit how difficult it is to demonstrate that Botox is more effective than placebo for treatment of migraine headaches.

Regarding the latter point, the authors write: “The initial promise of a new prophylactic [preventive] therapy for migraines was met by the challenge of replication of these results,” as subsequent studies have failed to demonstrate botulinum was more effective than placebo.

Sounds like the end of the road for Botox as a treatment for migraine. But wait! The authors acknowledge that “researchers have searched for patient characteristics that may predict a favorable treatment response.” In other words, let's find some migraine patients for whom Botox works.

According to this study, Botox may be effective in the treatment of "imploding" or "eye-popping" headaches but NOT "exploding" headaches. Among all participants who responded to treatment, patients with exploding headaches experienced an average reduction in migraine frequency of 11.4 to 9.4 days per month (ie, not much improvement), whereas frequency in participants with imploding or ocular headaches reduced from an average of 7.1 days per month to 0.6 days per month.

“These preliminary data are intriguing, and our results provide support for the hypothesis that patients with migraine that is characterized by imploding and ocular headaches are more responsive to botulinum toxin type A than those with migraine characterized by exploding headaches,” the authors write. “Our findings invite consideration of using botulinum toxin type A injections to prevent migraine headaches and may promote the role of the dermatologist in the treatment of patients with migraine. However, well-controlled trials need to be conducted to confirm these findings.”

The article estimates that 28 million Americans suffer from migraine headaches. It does not specify how many suffer "imploding" vs "exploding" headaches. It does say that 10 of the 18 patients studied experienced the former type. From that, one might assume that 15-16 million Americans suffering from migraines could be helped by Botox -- AND smooth out those wrinkles at the same time!

I am sure that Allergan will be packaging reprints of this study to hand out to physicians even though Botox is not approved for the treatment of migraines. The Allergan reps may even use my faulty analysis to claim that there are 15-16 million potential migraine patients out there that dermatologists can tap into.

New FDA guidelines permit this kind of off-label promotion -- I mean "freedom of speech," also known as "freedom of expression" in Botox ads like the one on the left, which I modified to show how it might look after FDA approves Botox for "eye-popping" migraine relief.

Allergan is the the drug industry poster boy for off-label promotion; it is currently suing the FDA "seeking a ruling that would allow [it] to proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of BOTOX" (see press release).

Friday, February 12, 2010

PhRMA (Intern) Finds Replacement for Billy Tauzin!

"Billy Tauzin," reports the New York Times, "one of the highest paid lobbyists in Washington, is resigning as president of the pharmaceutical industry’s trade group amid internal disputes over its pact with the White House to trade political support for favorable terms in the proposed health care overhaul."

"Christopher A. Viehbacher, a board member of PhRMA and chief executive of Sanofi-Aventis, said in an interview on Wednesday that he still held hope the health care package could pass Congress. 'The most important thing to me in this whole process is that PhRMA was not the bad guy,' he said, adding, 'It has not been without its political cost because it is actually difficult to be bipartisan in all of this.'"

PhRMA Intern, however, was quoted as saying "The bipartisan train has left the station! It's time that PhRMA has leadership that can stand up to the liberal bullies!"

Here's the latest episode of PhRMA Intern, where she successfully has recruited Tauzin's replacement:

PhRMA (Intern) Finds Replacement for Billy Tauzin!

Thursday, February 11, 2010

Few Comments Submitted to FDA Regarding Regulation of Internet

Although the FDA opened a docket on September 21, 2009, for public comment on regulating pharmaceutical company drug promotion on the Internet and social media (see "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!"), only TEN (10!) comments have been collected as of January 28, 2010 (maybe one or two more after that). This was revealed by DDMAC's Jean-Ah Kang in an interview with IgniteHealth's Fabio Gratton (see "A Conversation with DDMAC’s Dr. Jean-Ah Kang").
"Right now," said Kang, "we already have the 77 presentations from the hearing and the ten or so comments that have been submitted to the docket as of today [1/28/2010]."
At least 3 of those comments are mine! You can find all the comments on www.regulations.gov here.

Meanwhile, over 400 people have responded to my online survey/questionnaire, which asks the same questions as does the FDA. My questionnaire, however, makes it EASY for anyone to submit comments to the FDA. Many questions are pre-programmed with answers that you can select.

Results of this survey will be formally submitted to the FDA before the 28 February 2010 deadline. The submitted data will include all comments BUT will not include names or any other information that identifies who made the comments. The data will allow FDA to see if the comments come from consumers, healthcare professionals, pharmaceutical company employees, or pharmaceutical vendor employees.

PLEASE TAKE SURVEY/QUESTIONNAIRE HERE: http://bit.ly/cyUoV5

After you complete the survey, you will be able to see a summary of responses, not including comments or other identifiable information about respondents.

Your comments are confidential (anonymous) and any contact information or identifying information you opt-in to supply at the end of the survey will NOT be submitted to the FDA.

Wednesday, February 10, 2010

I'm Not the Only One to Suggest Corporate Donation to Haiti Relief is Lagging!


I have lamented the fact that, so far, pharmaceutical companies have donated to Haiti only about 14% what they gave to tsunami relief in 2005 (see "So Far, I Have Donated More to Haiti Relief Than Pharma (as % of Daily Income)").

I just found the chart on the left in this week's Newsweek magazine. It appears that pharma is not alone in terms of how little aid it is actually giving to Haiti compared to other recent disaster relief efforts. Not that money matters, of course.

Meanwhile, here's my pharma Haiti relief tally to date (as of Feb 12, 2010):

pharma Haiti relief tally chart

Waiting for Goduidance

In ACT I of Samuel Beckett's play Waiting for Godot (rhymes with go) the character Estragon looks about and says to Vladimir, the other main character in the play:
"Charming spot." (He turns, advances to front, halts facing auditorium.) "Inspiring prospects." (He turns to Vladimir.) "Let's go."
Vladimir says: "We can't."
Estragon: "Why not?"
Vladimir: "We're waiting for Godot."
I was reminded of this play while listening to a panel discussion yesterday at the 9th Annual ePharma Summit in Philadelphia. At least one panel member -- Dennis Urbaniak, VP, Customer Channels and Innovation, sanofi-aventis -- advised attendees not to wait for the FDA to publish its much anticipated guidelines regarding regulation of pharmaceutical marketing on the Internet and social media sites.

"If you are expecting clarity in any kind of guidance," said Urbaniak, "I would encourage you to go back and read current guidance about any other advertising channel that exists today. My fear is that there is a bunch of people out there hoping to get the answer and once it comes it's still going to be vague because it has to be -- you have to take your own risk position. And it's going to take another year for you to figure out what to do. So I'd like to shift the dialogue away from 'Is it coming?' and 'When is it coming?' because it implies that the answer IS coming."

But like Godot, the "answer" will never come.

Urbaniak suggested that the dialogue be shifted to "How can we take what we know today and responsibly put forward guideposts now?"

Personally, I do not think that FDA guidance is particularly vague. Guidelines for broadcast DTC, for example, clearly state what has to be included in TV drug ads; namely, information where consumers can get more complete information. The guidance specified using a 1-800 number or referring to a publication where the complete prescribing information can be found. That's pretty clear to me.

But I think the main point Urbaniak was trying to make was that no matter what the FDA guidance may specify, each company will have to interpret it according to its own tolerance for risk. Some pharmaceutical marketers like to take risks and push the envelope. They are willing to get FDA warning letters and push back when necessary. Others are more risk-adverse and do not want to receive any letters from the FDA.

At the end of Beckett's play, Vladimir says: 
"We'll hang ourselves tomorrow. Unless Godot comes."
Estragon says: "And if he comes?"
Vladimir: "We'll be saved."

Save yourself! Understand your risk tolerance and put up your social media marketing guideposts. If you need help, take my Social Media Pharma Marketing Readiness Self-Assessment. Good luck!

Monday, February 08, 2010

FDA Blasts Lilly's PAH eCommunity Videos!

In a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly's drug approved for the treatment of Pulmonary Arterial Hypertension (PAH).

The patient videos present statements made by Adcirca users, “Traci” and “Carolyn" who make the following claims among others:
  • “I can walk, and stairs don’t bother me [after Adcirca treatment] . . . . Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”
  • “Exercising and stairs and heat used to bother me and it didn’t bother me anymore [after Adcirca treatment].”
  • "Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience," said the FDA letter.
  • “I could walk a block without stopping and having to take a deep breath [after taking Adcirca]. I don’t have to drag my oxygen tank with me as many places as I used to.”
  • “I am exercising again . . . and I couldn’t exercise [before Adcirca], now I am walking on the treadmill. You know and I am walking along the beach, slowly I am beginning to do a lot more of the exercising that I used to be able to do”
FDA said:
First, “Traci’s” and “Carolyn’s” statements misleadingly imply that patients treated with Adcirca will greatly increase their walking time and distance (e.g., “from . . . five minutes . . . to one hour,” “spending all night at the mall”, “now I am walking on the treadmill,” and “walking along the beach”). These statements significantly exaggerate what was demonstrated in the clinical trials for Adcirca. As stated above, the placebo-adjusted mean change increase in 6-MWD was 33 meters. Thus, there is only data to support that study subjects can increase their walking distance by 33 meters in six minutes.
Does the FDA really believe that Traci and Carolyn are real patients? I don't think so -- FDA is careful to put their names in parantheses, ie, "Traci" and "Carolyn." Maybe if Lilly and other drug companies used actual patient video testimonials, there would not be so many misleading statements.

When you try to access the videos of the Adcirca Web site, this is what you get:

Hallelujah! The Recession is Over! Sales of "Lifestyle" Drugs Like Botox & Cialis On the Rebound.

As reported over at minyanville.com ("Sign of the Times? Cosmetic Surgery Is Back"):
According to a survey done by MEDACorp, plastic surgery and cosmetic procedures were up during the fourth quarter [of 2009] for the first time since the downturn began in 2007.

The survey encompassed facial injectibles, breast implants, laser procedures, and Latisse for eyelash growth. The results of the survey indicated that procedures for botulinum toxins like Allergan’s (AGN) Botox and facial fillers like Medicis Pharmaceutical’s (MRX) Restylane increased the most year-over-year in the fourth quarter of 2009, each up 8.1%. Procedures for breast implants increased 3.5% and laser work was up 1.6%.
Cialis is also having a good year, reported the IndyStar (see "Lilly's Cialis meets with success, challenges"):
"Lilly has been able to double the price of the drug since its launch in 2003, to about $16 a pill. Last year alone, during a recession, Lilly increased the price of Cialis twice. Competitors, including Pfizer (maker of Viagra) and GlaxoSmithKline (maker of Levitra), also raised prices."
It seems that you can never have too few wrinkles or be too erect even if it means sacrificing the necessities of life like a new Lexus (Toyota) or season football tickets.

Friday, February 05, 2010

Danica Patrick: NASCAR Driver, Super Model, Superbowl Lingerie Ad Model, & COPD Spokesperson All Rolled Into one!


Lately, I and about 1000 other people who "follow" @boehringerus (Boehringer Ingelheim) on Twitter have been getting several messages like this one:

#4COPD robs people of their ability to breathe. Get screened 2 see if UR at risk & talk to your Dr about your results http://ow.ly/13Vkn

It's part of a huge effort to roll out the new "DRIVE4COPD" campaign that BI is sponsoring. BI is jamming its Twitter account with similar messages (see image on left, click to enlarge).

This is a huge social media campaign that involves not only Twitter but also Facebook, Flickr, and YouTube. It features the NASCAR racecar driver Danica Patrick.

I just saw Danica a couple of nights ago on a TV show promoting the upcoming SuperBowl ads. She will appear in a lingerie ad, I believe. But she has all her clothes on in the DRIVE4COPD campaign, which is included in the photo montage below:


The campaign points out that "COPD is the 4th leading cause of death in the US" and "an estimated 24 million Americans are affected" and "over half of them don't even know it."

In fact, I didn't know that I MAY have COPD! But thanks to the COPD POPULATION Screener™, which the DRIVE4COPD campaign urges every one to take (see the DRIVE4COPD Web site), I now know it and will talk to my doctor about it, which is the goal of DRIVE4COPD.

You too can find out if you MAY have COPD by taking a simple 5 question test! I had no doubt that I would score high enough to be at risk because:
  1. During the past 4 weeks, I DID feel short of breath "a little of the time," like when I had to shovel some snow, and
  2. I DID cough up some "stuff," such as mucus or phlegm, but "only with occasional colds or chest infections," and
  3. I HAVE smoked at least 100 cigarettes in my ENTIRE LIFE, though I quit smoking about 30 years ago, and
  4. I agree (but not STRONGLY agree) that I do less than I used to because of my breathing problems, and
  5. I am a man of a certain age (but I won't say how old).
This is not the first time that I have taken such a screening test without any idea who came up with the questions or how the answers determine whether or not you have a medical condition. In small print, however, I see that the COPD Population Screener is a trademark of QualityMetric Incorporated, which, as far as I can tell, gets its data from surveys of patients.

After taking the SCREENER, you can vote for which DRIVE4COPD Race Team Member (Danica, Bruce Jenner, Jim Belushi, Patty Loveless, or Michael Strahan) you want to win the "Race for the Missing Millons." I don't know exactly what that means, but guess who I voted for?

Regardless of the scientific validity of the COPD Screener, or the other tricks employed to get people involved, I think DRIVE4COPD is a worthy campaign even though BI may profit from it (BI markets Spiriva for the treatment of COPD).

AFTERWORD: NASCAR is a sponsor of DRIVE4COPD along with BI and has renamed an upcoming Daytona race the "DRIVE4COPD 300." Now that I think about it, I find NASCAR and COPD to be an odd coupling. Here's a smog-producing organization/event sponsoring a cause to help people breathe better! In fact, the whole idea of "driving" for COPD is odd! I guess BI doesn't mean that we should all go out and drive our cars for COPD awareness. At least not our Toyota cars!

Thursday, February 04, 2010

Did Cephalon Pay James Mcmillen $101,650 to Help Promote Actiq for Off-Label Use?

In a recent post, I wondered why a doctor from Dillsberg, PA, a town with a total area of 0.8 square miles and only 2,063 people, would be the 5th highest paid physician on Cephalon's list of payments to physicians. That doctor -- James Mcmillen -- received $101,650 in 2009 (see "Transparency Vs. Translucency in Reporting Physician Payments").

Since I first posted this bit of information, I learned that:
(1) Cephalon agreed to plead guilty to promoting painkiller Actiq, narcolepsy pill Provigil and the epilepsy treatment Gabitril for uses that weren’t approved by FDA. As a result of the plea agreement, Cephalon was REQUIRED to post all payments it made to physicians in 2009 and quarterly thereafter.

(2) Dr. James Mcmillen is a member of the National Fibromylgia Association (he's listed on the Association's Web site here).
Could it be that Doctor Mcmillen was paid to promote Actiq for the treatment of fibromyalgia, which is a use not approved by the FDA?

BTW, Actiq gets high ratings from patients for the treatment of "Fibromyalgia syndrome (FMS)" on RevolutionHealth (see here) -- the Wisdom of the Crowd health web site founded by Steve Case (listen to this podcast interview of Jay Silverstein, COO of Revolution Health).

FURTHER THOUGHTS: I have learned a few more interesting tidbits about Dr. Mcmillen's relationships with the drug industry. In 1999, for example, Merck tried to "neutralize" Dr. Mcmillen because his message about the drug Vioxx was "consistently negative" (see this series of Merck emails). "We need to neutralize this physician as soon as possible," said Merck's Arthritis & Analgesia Specialist, Thomas McCready.

It appears that Dr. Mcmillen was, at the time, working for Searle, a company that co-marketed (with Pfizer) Celebrex, a product that competed with Vioxx before the latter drug was pulled from the market for safety reasons.

In his email, Merck's McCready listed all the work that Mcmillen was doing on behalf of Searle:
  • Speaking engagements 200 days per year (approx. 400-500 programs)
  • Conducts Speaker Training teleconferences
  • Conducts Sales Rep Training teleconferences
  • Primary Care Investigator
First, I am amazed at Merck's intelligence regarding Mcmillen's activities with Searle. They must have good informants! Second, Mcmillen appears to have been working FULL TIME for Searle! How else can you do 200 speaking engagements per year!

Now I know why a physician from "podunk" (ie, Dillsberg, PA) can earn over $100K from Cephalon -- Mcmillen, according to the Merck memos, is affiliated with the prestigious Hershey Medical Center, which is located nearby.

Mcmillen was also working for Merck at the time as an investigator. He was set to participate in Merck's clinical trials for its second generation COX-2, but was informed that his participation in that study was no longer needed.

Merck met with Dr. Mcmillen and reviewed his slides relating to COX-2's and Vioxx. McCready said he was "open to coaching" and to making the "necessary changes" Merck recommended. McCready, however, questioned whether Mcmillen would make the changes. McCready said the ball was in Mcmillen's court.

That's where the story from these memos/emails ends. I do not know if Mcmillen "won" the Mexican standoff with Merck and got back on its payroll or not. According to the person who alerted me to the Merck memos, "McMillen ran drug trials at his site including for merck. His experience led him to believe that Vioxx was bad -- lots of hypertension & CHF & renal problems. He spoke out about this while on the merck study. They came after him hard. He did not back off. He was a hero in this area."

I'll leave it at that.

FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!


DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration Silver Spring, MD 20993

TRANSMITTED BY FACSIMILE

Richard Fosko, RPh, MPH, Director Regulatory Affairs
Meda Pharmaceuticals, Inc.
265 Davidson Avenue, Suite 300
Somerset, NJ 08873-4120

RE: NDA #20-114

ASTELIN®(azelastine hydrochloride) Nasal Spray
MACMIS #18201

Dear Mr. Fosko:
As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a waiting room sign (sign), entitled “Astelin ‘House Cleaning’ Waiting Room Sign” (ID AST8079), for ASTELIN® (azelastine hydrochloride) Nasal Spray (Astelin) submitted by Meda Pharmaceuticals Inc. (Meda) under cover of Form FDA 2253 (2253). The sign is misleading because it omits and minimizes important risk information associated with the use of Astelin, broadens the indication, and overstates the efficacy of the drug. Thus, the sign misbrands Astelin in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(a) & 321(n). Cf. 21 CFR 202.1(e)(5), (6)(i) & (7)(viii).

Broadening of Indication
The sign is misleading because it implies that Astelin is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, it prominently presents the headline, “Allergic to house cleaning?” and suggests Astelin will treat this condition. House cleaning is typically associated with exposure to perennial allergens such as dust mites, molds, and pet dander. Astelin is not approved to treat perennial allergens associated with perennial allergic rhinitis, therefore please stop implying it will cure house cleaning allergy.

DDMAC requests that Meda immediately cease the dissemination of violative promotional materials for Astelin such as those described above. Please submit a written response to this letter on or before February 9, 2009, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) in use for Astelin that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS #18201 in addition to the NDA number. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Astelin comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,
{See appended electronic signature page}
Robyn Tyler, Pharm.D., J.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
-------------------- -------------------- -------------------- ------------------------------------------
---------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------
----------------------------------------------------
Application Submission
Submitter Name Product Name
Type/Number Type/Number
NDA-20114 ORIG-1 MEDA ASTELIN NASAL SPRAY
PHARMACEUTICA
LS INC
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
ROBYN C TYLER 01/26/2010

Is M&A Frenzy Short-Circuiting Pharma R&D?

Pfizer, "the world's premier biopharmaceutical R&D organization," plans to cut research spending by up to $3B reports this Wall Street Journal story. This, says WSJ, is "an attempt to wring efficiencies following its take-over of Wyeth without sacrificing future product development."

But Kenneth "Eric" Milgram, Ph.D., former Director, Systems Biology Technologies at Wyeth, has a different point of view. Dr. Milgram believes that the current merger & acquisition frenzy in the pharmaceutical industry will short-circuit R&D. Of course, Dr. Milgram is not a disinterested party, having been laid off due to the acquisition of Wyeth by Pfizer.

"Why is it that a high-end grocery store like Wegman's can go 94 years without having any layoffs and almost every month you hear about layoffs in the pharmaceutical industry?" asks Milgram.

Wednesday, February 03, 2010

Transparency Vs. Translucency in Reporting Physician Payments

"Transparency" is a word you often hear today. It's being used a lot in relation to Wall Street bonuses. It's also used by pharmaceutical companies who are reporting payments made to physicians.

The latest pharma company to report its physician payments is Cephalon. "Cephalon supports transparency in its financial relationships with healthcare professionals," says the intro to the page where financial data are presented (see "Fee for Services Paid to Healthcare Professionals"). "We believe it is important for the public to understand that our partnerships with healthcare professionals allow us to develop and bring new medicines to market, address the needs of patients, and assure the safe and appropriate use of our medications."

Now I could be "snarky" and debate whether or not all these "fees" are for "services" actually performed. No amount of transparency can counteract this kind of suspicion. So I won't do that.
[UPDATE: I will note that Cephalon did NOT voluntarily publish its list of physician payments. This was pointed out by Eric Milgram in his post "Pharma Gets Failing Grades for Initial Transparency Efforts" to Pharma Conduct Blog: "Cephalon [is] the first drugmaker to be required under a corporate integrity agreement [CIA] with the Department of Health and Human Services to publicly disclose its payments to physicians." This CIA, which you can find here, states "By January 31, 2010, Cephalon shall post in a prominent position on its website an easily accessible and readily searchable listing of all physicians who received any Phase I Payments (as defined below in Section III.M.3) directly or indirectly from Cephalon during Calendar Year 2009 and the aggregate value of such payments in the calendar year." Payments to be reported include: "all payments or transfers of value (whether in cash or in kind) made to physicians and/or to Related Entities. The term Payments includes, for example, payments or compensation for services rendered, grants, fees, honoraria, and payments relating to research or education. The term Payments also includes food, entertainment, gifts, trips or travel, produot(s)/item(s) provided for less than fair market value; or other economic benefit. The term Payments does not include: i) samples of drug products that meet the definition set forth in 21 C.F.R. § 203.3(i), or ii) discounts, rebates, or other pricing terms."]
I do want, however, to point out that the presentation of these data is "translucent" rather than "transparent." I used PhotoShop to create a view of the Cephalon data as if seen through translucent glass to illustrate my point (see image on left).

Cephalon uses the latest technology -- ie, Adobe Flash -- to display the data on its web site. It's cool. You can scroll down the list and you can search the list, but only for first name and last name. You can even find all the physicians on the list whose last or first name begins with "M" or any other letter!

Unfortunately, you cannot do much else with the data. You can't search for doctors in your state or in your home town, for example. You cannot even see or calculate the TOTAL amount paid in the report period!
You can, however, see who got the most money because the list is broken down into several sub lists of physicians paid within a certain range. The highest-paid physician is Joseph Valenza of Sparta, NJ, who received $149,900 from Cephalon in 2009. Sparta is in a pretty fancy area of NJ where a lot of pharmaceutical executives live. Dr. Valenza may have many of them as patients.
But what about doctor James Mcmillen from Dillsberg, PA? He received a nice total of $101,650, which made him the 5th highest-paid physician on the list. I never heard of Dillsberg, PA and don't understand why it rates as the location of one of the highest paid physicians on Cephalon's list. According to the United States Census Bureau, the borough has a total area of 0.8 square miles. Some of my neighbors own almost that amount of land! Wikipedia says Dillsberg known for its farm tractor parade in October. As of the census of 2000, there were 2,063 people, 902 households, and 579 families residing in the borough -- probably none of them being pharmaceutical company executives.
But, I digress!

Cephalon's data do not reveal the hospital or medical practice affiliation of each physician. That makes the list a little less transparent than it could be.

IMHO, a more important weakness of the Cephalon physician payment "transparency" effort is that you cannot COPY the list and analyze it in Excel as I did with the lists for Merck and GSK (see "Pharma Begins to Reveal Payments to Physicians"; Pharma Marketing News Reprint #91-03. Use discount code PAY996 to get it FREE!).

Using Excel I was able to learn some interesting things about the Merck and GSK data such as the median and average payments and compare one company's payment pattern to the other's. I could easily see what the distribution of payments looked like by state. From my analysis of GSK's data I learned that New York physicians were favored by that company (see "Why Does GSK Prefer New York Physicians & Will Governor Patterson Ruin It for Them?").

Cephalon isn't the only company that reports its physician payment data in a translucent fashion. Lilly also uses Flash to create a very nice interactive table (see here).

BTW, if you would like the Excel spreadsheets containing GSK's and Merck's physician payment data -- so you can do your own analysis -- find them here. The GSK and Merck data were originally in PDF files that were easy to download and copy (not that easy, but possible). I suspect that in the future, these data will become a little more translucent (ie, compiled in password-protected pdf files that do not allow copying).

Tuesday, February 02, 2010

Crowdsourcing Vs. Science

I think the elevation of "crowdsourcing" as a legitimate indication for determining drug benefits or risks in the real world is a luddite-like anti-science trend that must be counteracted.

The latest example of this was just published on the Dose of Digital blog in the post "The Best Pharma Products According to Patients". In that post, Jonathan Richman reports drug ratings from iGuard.org and says:
"...which are the top-rated products? Forget about all those head-to-head trials that payors want, but most companies are hesitant to conduct (for many reasons). If you want to know which treatment is best, why not check out its ratings? How far away is a future where patients select which products they want to take by using reviews such as those found on iGuard? I’m sure some of you are scoffing at this idea because you think physicians should be recommending treatments, not iGuard. Two questions for those of you thinking this: aren’t objective ratings guiding treatment requests better than DTC TV ads that also aim to get people to ask for a specific treatment? And if these ratings are available, why would physicians ignore them? How long before they too use these types of reviews to decide which treatments to prescribe?"
Heaven forbid that physicians use these ratings to decide on treatment options for their patients!!! If Jonathan really believes this, then he is promoting the most irresponsible and anti-scientific methodology I have ever come across!

According to the person who coined the term crowdsourcing, “A central principle animating crowdsourcing is that the group contains more knowledge than individuals.”

Therefore, a group of patients who take a specific drug has more knowledge than a single individual. OK, maybe a group of patients has more knowledge than a single patient, but do they have more knowledge than a single physician who has treated a large number of patients?

But more than that, what is this "group" that rated drugs like Viagra on iGuard.org?

More precisely, how MANY people are in this group and who are they?

Richman presents a table of drug ratings and for each drug there is a column that is labeled "Number of Patients." The number of patients in the Viagra row is 21,500, which implies that the "Patient Effectiveness Score" of 6.7 for Viagra (vs. 7.4 for Cialis) is based on 21,500 ratings.

This is NOT the case. iGuard says it "tracks" 21,500 (now 22,000) Viagra patients but it does not say how many patients RESPONDED by submitting ratings. That is, we do not know what N is in this dataset. If it's the same order of magnitude as number of comments received (ie, 36), then this is NOT good science nor is it even good "crowdsourcing."

I am currently reading a small book that I recommend. It is entitled "The Numbers Game: The Commonsense Guide to Understanding Numbers in the News, in Politics, and in Life" by Michael Blasland and Andrew Dilnot. The title should have included blogs as well as "News" because more and more people are reading blogs that have even less fact-checking than your average newspaper!

Groundhog Vs. Child Celebrities

People for the Ethical Treatment of Animals (PETA) thinks it's time to replace Punxsutawney Phil, the groundhog, with a robot because "Phil is forced to be on display year round..." and is subject to "the displeasure of large, screaming crowds, flashing lights of cameras, and human handling."

In response, William Deeley, president of the Inner Circle of the Punxsutawney Groundhog Club, said Phil is "being treated better than the average child in Pennsylvania."

I did not think that said much about how children are treated in Pennsylvania or elsewhere, especially if they are celebrity children. So I prepared this PhotoShop montage:

Monday, February 01, 2010

Osso Bucco, My Russian Brother-in-Law, and Quentin Tarantino

This is just a shameless self-promotion of my skills as a cook. Be sure to catch the Tarantino reference:


New Regulatory Wrinkle: Cosmetic Doctor Gets FDA Warning Letter! Who Snitched?

In what has been called a "first," the FDA "has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine," according to the New York Times (see here).

"The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved," said the New York Times.

FDA, in its letter, cited statements made by Dr. Baumann in newspapers and television that "clearly suggested that Dysport was safe and effective before it was approved, and that it was in fact superior to the approved product Botox because it lasts longer and starts working faster than Botox."

Baumann was hired as a Phase III clinical investigator by Medicis Pharmaceutical, which hopes to market Dysport in the United States. FDA says that Baumann "became involved as an investigator in the research trials for Dysport in July 2006" and she made the statements while she was involved as an investigator for Dysport.

According to FDA’s regulations at 21 CFR 312.7(a), “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug” (emphasis added).

The FDA begins its letter: "As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has become aware..." of the promotional comments made by Baumann.

Now, how do you suppose the FDA "became aware" of these comments? Could it have been a "personal communication" from Allergan, the marketer of Botox, which was dissed by Baumann? "Reloxin, the new Botox, will likely come out later this year," said Baumann. "Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market—the Botox people (Allergan) raised their price another 8 percent this year!"

The FDA said "we are not aware of any adequate and well-controlled head-to-head trials that compare Dysport to Botox to determine whether Dysport lasts longer or starts working faster than Botox."

I don't suppose Allergan liked that Baumann dissed their product and I'm willing to bet they snitched on Baumann to the FDA.

Let the era of pharma-on-pharma snitching commence! Maybe there will be a "STOP Snitching" movement in the pharmahood!