The Selective Use of Science in Health Policy

11/18/2009 03:20 PM |

As I note in my article in the American Spectator today, (spectator.org/archives/2009/11/18/breast-cancer-follies) the US Preventive Services Task Force www.ahrq.gov/CLINIC/uspstfix.htm   (bet you didn't know it was effectively a mouthpiece for AHRQ comparative effectiveness research and  -- based on AHRQ research --  the final word on what and will be covered under all health care reform bills) has pulled the plug not only on the most reliable tool for breast cancer screening thus far, but also what is becoming an important test for determining whether women are at risk for heart disease. 

The rationale given in both cases:  What we know about the limits and net benefit of screening for everybody is precise - based on a review of studies that we decided are good enough to review -- and that we don't know enough about new tests and tools to use them. 

www.forbes.com/2009/11/16/mammograms-cancer-screening-business-healthcare-mammogram.html

The result?  Less screening now and delayed use of newer tools based on scientific advances for years to come. 

Follow the logic of the Task Force members:

"Dr. Kerlikowske counters that the new USPTF guidelines are based on a far more detailed and rigorous analysis of the mammography data than has ever been done before. (The USPSTF reviews its guidelines every five years.) "There is new evidence to precisely quantify benefits by age. It didn't exist before," says USPSTF's Diana Petitti. "Those lines of evidence came together to a conclusion that the net benefit of starting earlier rather than later was small."

Precisely quantify benefit?  Are we to presume that the benefit is exactly the same for all women without family history of breast cancer?  What about those who have not been screened for genetic inclination?  And what is net benefit?  Sort sounds like a collective benefit to me.  Meanwhile, what started all this is the untested assumption that too much screening leads to too much treatment.  Is that true?  Where is the precision for that number?

The decision to ditch the use of CRP to predict heart disease risk in women of the same ilk.   The concern is not public health, but what such tests do to generate "too much" treatment.  And again the evidentiary standard is one that ignores the very individual or subpopulation differences necessary to real precision in order to obtain a "net benefit" for a health system.    The willful disregard of the JUPITER data as it pertains to women is shocking.  Setting aside the real benefits of treating women with high CRP levels with statins in the trial,  the study demonstrates that testing for CRP is an important predictor of and precondition to reducing death from heart disease. 

online.wsj.com/article/BT-CO-20091117-715499.html

At the very least, the Task Force decisions should factor in the impact on compliance.  Ironically, the administration had no problem yanking adjuvant out of H1N1 vaccines to appease Mercury moms and others for whom believing vaccines poison children is a new religion.  Or as an administration official said in a recent hearing explaining the mounting delays in vaccine availability, which in turn has lead to doubts, cynicism and apathy about immunization: 

If adjuvants were added to the vaccine supply, many of the unadjuvanted doses would need to be taken out of the supply she said.

Also, public confidence in vaccines, in particular vaccines with adjuvant is low, she said. "And we didn't really want to rock the public confidence in a new vaccine with adjuvant."

http://www.medpagetoday.com/Geriatrics/Vaccines/17081

Caving in to unfounded fears is justified to promote public confidence.  But what about caving in to cost control concerns and claiming you relied on the best evidence available?  Both approaches are driven by politics, not by medical science.

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Who needs mammograms anyway?

11/18/2009 11:15 AM |

So why the fervent outcry from many Americans and health care organizations over the new federal guidelines pertaining to mammograms?

The Washington Post reports:

“The new recommendations took on added significance because under health-care reform legislation pending in Congress, the conclusions of the 16-member task force would set standards for what preventive services insurance plans would be required to cover at little or no cost.”

The American Cancer Society, which endorsed the recent health care bill that passed the House of Representatives, publicly condemned the new guidelines.

LIVESTRONG CEO Doug Ulman also joined in the criticism:

“Since the U.S. Preventive Services Task Force issued these reversals, LIVESTRONG and our partners at the American Cancer Society have heard from legions of women under 50 who are breast cancer survivors and many more whose lives were saved as a result of a routine self-exam. The work that has saved their lives must be sustained, not discarded.”

There is arguably a great deal of waste in our health care system. But to focus cost concerns on one of the most positive aspects of our system (cancer screening and cancer treatment) simply defies all common sense.

Indeed, First Lady Michelle Obama praised US superiority in this area of medicine just last month at a White House Breast Cancer Awareness event:

“And today, because of that work, the number of women getting regular mammograms has dramatically increased, and the five-year survival rate when breast cancer is diagnosed in time is 98 percent -- and that's compared to 74 percent in the early 80s.

“And today, we spend $900 million on breast cancer research, which is 30 times more than what we spent in 1982. So we have come a long way.”

And, just maybe, more government control of the health care sector is not the answer.

According to this June 2009 study by the Employment Policies Institute, both insured and uninsured American women fare substantially better than their Canadian counterparts (who we are told enjoy universal coverage) in the area of cancer screening:

“When it comes to cancer screening, 80 percent of insured women (in the USA) ages 40-64 had a mammogram within two years of the interview; and 87 percent when the period of receipt is extended to 5 years. That compares to 49 percent of uninsured women who had a mammogram within two years and 65 percent when the period is within 5 years. However, those screening rates are relatively high even for uninsured women when compared with screening rates in Canada, a country with universal health coverage. The Canadian health survey reports that 65 percent of Canadian women ages 40-69 had a mammogram within the past 5 years, the same percentage as uninsured women in the U.S. When it comes to Pap Smears, Canadian women also have about the same rate of screening over the past five years as uninsured women in the U.S. (80 percent), although those rates are below those of insured American women, among whom 92 percent were screened. Among U.S. men ages 40-64, 52 percent of those with insurance were screened for prostate cancer with a PSA test within the past 5 years, compared to 31 percent for men who are uninsured. (In Canada, the comparable percent is 16 percent.)”

Food for thought.

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Health Insurers and CER

11/18/2009 09:33 AM |

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Why Not Punish Rising Auto Prices Too

11/17/2009 01:58 PM |

The NY Times saw fit to print that Rx sticker prices are rising on the front page of it's shrinking and increasingly expensive paper (didn't the times just raise it's price?)

http://www.nytimes.com/2009/11/16/business/16drugprices.html

http://www.nytimes.com/2009/11/17/business/economy/17econ.html

But when it ran an article on auto sales rebounding (see above) it failed to mention this which was on the AP.....

As auto sales rebound, price increases are likely

Written by Associated Press | | news@toledofreepress.com

When Rebbie Lewis McGowen decided to replace her 2000 Dodge Stratus sedan with a new loaded-out Jeep Grand Cherokee, she was amazed that her favorite dealer agreed to a price that was about the same as she paid for a similar Jeep nine years earlier.

“That’s why I jumped on it the first day I saw it,” said McGowen, 61, who got the silver sport utility vehicle from River Oaks Chrysler Jeep in Houston for about $34,000, $7,000 less than the sticker price.

Like many U.S. buyers, she took advantage of a depressed auto industry, one that in recent years has had too many factories churning out too many cars and trucks for too few buyers, forcing big discounts. Although sticker prices have risen, actual sales prices aren’t a whole lot different than they were nine years ago.

So far this year, average sale prices actually have dropped by about $800 to $25,586, according to J.D. Power and Associates.

But industry analysts don’t expect that trend to continue much longer. General Motors Co. and Chrysler Group LLC came out of bankruptcy protection with far fewer factories, and Ford Motor Co. for the past few years has been closing plants to align its output with demand.

Analysts say that with the industry’s massive restructuring, the big discounts that American consumers have gotten used to could go away as auto sales recover from the worst slump in more than a quarter-century.

“I just think it happened to be this point in time that I was able to make such a deal,” McGowen said. “Next year, when the 2010s come out, it’s not going to be the same situation.”

Growth in rebates, low-interest loans and other incentives may be starting to slow, reports the Edmunds.com automotive Web site. Across the industry, the average incentive per vehicle dropped from $2,869 in June to $2,735 in July.

But that could be an anomaly driven by increased demand from the government’s Cash for Clunkers program, which likely will expire in September. July’s figure is still $90 higher than the same month last year, according to Edmunds.

In addition to the restructuring, all of the Detroit Three are trying to develop better cars, ones that are so stylish, efficient, safe and reliable that people will pay more for them, similar to what Toyota Motor Co. and Honda have already accomplished in the U.S. market.

At Ford, the only one of the Detroit Three to evade bankruptcy court, getting more money per car is part of a strategy to return to profitability, Chief Financial Officer Lewis Booth said recently.

“We’ve all got to learn to flex the revenue muscle,” said Booth, who adds that Ford’s actual sale prices are up this year, even in a down market. “It’s driven by our new products, and that’s why were getting improved transaction prices. We’re getting a mixture of reduced incentives and higher value from the customer. We’re selling more higher-service cars, more options, and all of those are good for profits and revenue.”

Now that people are demanding we reimport drugs to reduce prices, why don't they be consistent and demand importation of cheap cars from China and India...?

 

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Health Care Hoops– A Flagrant Foul

11/17/2009 12:14 PM |

Government-Run Health Care means making referees into players. The Public Option: A Flagrant Foul
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Ad Hoc

11/17/2009 08:24 AM |

According to Evan Tracey (Campaign Media Analysis Group, a group that tracks political advertising), those opposed to the healthcare bill passed by the House (led by the U.S. Chamber of Commerce)have spent $24 million on TV commercials over the past month to $12 million spent by those who support the legislation (led by Healthcare for America Now and Moveon.org) This is a reversal from the previous spending advantage by bill supporters enjoyed through most of this year.

Why? Consider that Senate Majority Leader Harry Reid (D, NV) is drafting the Senate’s version of the bill behind closed doors.

"There's no input from any of us, no input from Republicans" said R. Bruce Josten of the U.S. Chamber of Commerce. "So what option do we have than to take our message and story to the American people?"

And the American people need to hear all sides of the argument. According to a new Associated Press poll, 43 percent of Americans oppose the health care plans being discussed in Congress, while 41 percent are in support. An additional 15 percent remain neutral or undecided.

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Schock Value

11/16/2009 11:27 AM |

Linda Gorman writes: “A little noticed feature of the health reform legislation is the common tendency to regulate insurance premiums in a way that will force young people to pay more so that older people can pay less. The legislation would gouge people at the time of life when their wages tend to be low in order to subsidize people at a time in their life when wages tend to be high.”

She’s absolutely right. No matter which proposal you look at in either the House or Senate, young Americans will get a raw deal.

CMPI recently interviewed Congressman Aaron Schock – the youngest member of Congress at age 28. We asked him about this issue and more.

Schock is optimistic that young Americans will come to recognize that the current proposals under consideration in Congress will lead to less choices and control for them in health care, not more.

Perhaps more importantly, Congressman Schock correctly notes the deleterious effect this legislation would have on an already precarious job market.

It amounts to a double whammy for America’s youth.

For Congressman Schock’s perspective on this issue, watch our interview with him here:

Congressman Aaron Schock (R,IL) on Health Care reform from CMPI on Vimeo.

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Quote of the week

11/16/2009 11:22 AM |

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Friday the 13th -- Day Two

11/14/2009 01:57 PM |

You know in all those slasher movies how the audience always yells, “don’t go in there!” when the heroine starts to peer into a dark closet?  Well Day 2 of the FDA’s Part 15 hearing on social media was kind of like that – especially when it came to the featured topic of the day -- social media and adverse event generation.

As a reminder, the four criteria for an actionable adverse event are: (1) identifiable patient, (2) identifiable reporter, (3) specific use of a drug or biologic, and (4) adverse event.

During the course of the day, there were many graphics showing an ostrich with his head in the sand and another part of the anatomy sticking up, fully exposed, in the air.

Here’s what I had to say on the matter during my remarks on Day 1:

Adverse event generation is the real bête noire of social media. Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience?  Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity?  Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.

I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events.  Is this responsible?  Is it even supportable?  If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee.  “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.

Day 2 began with Boston Scientific’s Tony Blank (again representing AdvaMed) saying that industry expects to be held responsible for the responsible reporting of adverse events and for user-generated content (UGC) when it is sought for/requested by a regulated healthcare company – an important finesse.  He raised the dicey issue of anonymous AE reports, ending his comments with the question, “How can we separate the wheat from the chaff?”  How indeed?

Next was private citizen Kim Witczak, who called for the FDA to make the MedWatch program more accessible and user-friendly (a theme repeated during the course of the proceedings) and that proactive monitoring of social media by industry should be viewed as a “responsible act” – another oft-repeated theme.

Steve Findlay (Consumer’s Union) said that the current AERS is “a glass half full” and suggested that there’s a real need for better early safety signal communications mechanisms.  He proposed that a prominent and consumer-friendly AE reporting tool be a part of all industry marketing and communications efforts (both online and otherwise). He went even further, suggesting that similar efforts be required of third parties who receive industry funding.  He referred to a “voluntary burden,” but went on to use words like “mandatory.” Later on in the day, he also called for the FDA to “investigate” industry’s use of web optimization – and that FDA’s oversight of social media should be funded by user-fees.

This last point brings up an important issue – what parts of social media can/should FDA regulate?  The FD&C Act is pretty specific (and the First Amendment is pretty important) and (at least in my opinion) this will lead to relatively narrow agency guidance (when it comes).  This will surely be a crucial point of discussion in the weeks and months ahead.

Is social media really the place patients are taking their adverse event discussions?

Chris Schroeder (HealthCentral) shared new research showing that patients experiencing an adverse event would chose to (1) call their doctor (89%), (2) share their issue on a social media site (2%), (3) contact the FDA (1%). Chris also made the point that, in future guidance, FDA should define what “sponsor” means in the context of an industry “sponsored” Internet or social media site. He also observed that online ads adjacent to user-generated content shouldn’t lead to an advertiser being responsible for that UGC – just as ads on television programs (particularly live ones) aren’t responsible for the content of the programming.

Shaleen Gupta (Semantelli Corporation) introduced a new disease state – FOFDA (“Fear of FDA”).  He opined that, per AE reporting and social media, that we need to use technology to help “go beyond the noise.” This issue came up more than a few times – how to address the signal-to-noise ration. (Other speakers referred to this problem as “data smog.”

Jeff Francer (PhRMA) commented that AE reports uncovered via social media need to be addressed not via public response but through private communications --generating some interesting questions from the FDA panel as to how this could be done.

Rohit Bhargava (Ogilvy 360 Digital Influence) made the point that most AEs (broadly defined) on social media are anonymous.  Therefore they are not (technically) adverse events. A statement of the obvious and a narrow view of a significant public health problem/opportunity.

Rick Wion (GolinHarris) shared that one such client page (with the interactivity switched “on”) generated only one comment out of 400 addressed could be considered a negative product experience (and not even, technically, an adverse event).

Speaking of FaceBook, I believe the FDA should create a social media adverse event FaceBook page that people can “friend” in order to learn more about how to report “official” adverse events and through which the agency can push out important safety alerts and other important risk information. After all, as Arnie Friede pointed out in his remarks, MedWatch only captures about 10% of all adverse events. 

Side note:  Many (if not most) of the 69 people who testified over the two-day hearing were not FDA experts, leading to some pretty wild suggestions (such as the call for an “intergalactic social media taskforce”) but also some new and exciting ones.  It was clear (from both questions and body language) that the FDA panel was both unaccustomed and uncomfortable being regularly and aggressively challenged – like Anna challenging the King of Siam. “Is a puzzlement” was often written across the faces of the distinguished panel.

This “puzzlement” was particularly evident in the questions posed to multiple presenters by Gerald Del Pan (FDA’s Director of the Office of Surveillance and Epidemiology, CDER). Dr. Del Pan seemed perplexed that presenters wanted to talk more about communicating to patients than about outreach to physicians. And while that may sound narrow-minded, it needs to be understood in the appropriate regulatory context. Del Pan’s questions represent an appropriate understanding as to the regulatory limitations of what the FDA can do.  This is very important, because it will significantly impact the range and depth of future FDA social media guidance.  And that’s a good thing.

Per the low incidence of adverse event reporting, James Allen Heywood (PatientsLikeMe) asked, “What’s the value to a patient for reporting an adverse event?” Good question. Later on he made another important (and frightening) observation, “There is no longer an authoritative voice of authoritative information.” This statement caused the FDA panel to shift uncomfortably in their seats – but elicited no questions.

Diana Zuckerman (National Research Center for Women & Families) made that point that while AE reports are “anecdotal” and clinical trials are  “scientific -- both are important. And she’s right – particularly since AEs are a valuable source of post-market early safety signals. Finally she said that links to MedWatch should be “hard to miss rather than hard to find.”  Certainly.

John Mack (Pharma Marketing News) shared research showing that only 1 out of 500 AEs on social media meet all four adverse event criteria. 

Paul Roellig (Bulletin News) suggested that any forthcoming FDA regulations should be “technology neutral” so as not to give any one platform an unfair advantage.  Specifically, he was referring to e-mail based versus online platforms.

Daniel Palestrant (Sermo) observed that on the physician-only site, participant ability to discern hyperbole is “uncanny.”  An example of social media’s ability to self-correct?  Maybe.

Donna Wray (TGaS Advisors) cautioned industry on commenting on every social media site, citing “the danger of giving crazy talk validity.”  Sound advice. But “crazy” is certainly in the eye of the beholder.

Jonathan Richman (Dose of Digital) commented that “Community Norms” are not the same as “Regulated Norms” – another nod to the reality (both legal and otherwise) that FDA can only hope to impact a small part of a much larger issue.

Fabio Gratton (Ignite Health) shared data showing that only 27% of consumer who visit a brand.com site access safety information.  Of that 27%, 32% find the site via a paid search, 19% access the site directly, and 10% find the brand site via a search engine. The important take-away is that paid search options lead to more use of safety data. The more direct public health point is that the FDA’s bevy of sponsored Google link NOVs (and the resulting decline in consumer clicks on them) has actually led to less consumer use of on-line risk information.  A dangerous unintended consequence.

Relative to industry oversight of the Internet, Robert Grammatica (Rapp) asked, “To whom should manufacturers be responsible?  His answer, “to the patient.” Amen. He also mentioned that social media sites that succeed are those that are designed to do more than just sell product.  Common sense but not common enough practice.

Jim Walker (Cadient Group) talked about the importance of social media as a tool to enhance health literacy and suggested that the FDA offer a kind of “X Prize” to those who can develop ways to achieve this laudable goal.  Well – maybe not FDA.  Secretary Sebelius – are you listening?

Wendy Blackburn (Intouch Solutions) shared research demonstrating that the more prominent safety information is on a brand.com site, the greater the “bounce” rate. (“Bounce rate” is the rate at which a visitor to a site leaves that site.) Frightening.

The final presentation of the day was by the Pfizer duo of Freda Lewis-Hall and Cliff Thumma.  They presented research on using social media to communicate with physicians (example: 64% of physicians have smart phone and 81% will have them by 2012). They ended their remarks with an appropriate end-of-hearing comment to “sustain the momentum.”

And so, at 5pm – right on time – DDMAC Director Tom Abrams returned to the podium, released a big sigh and said, “Wow.  We made it.”

Well, not quite yet.  Not by a mile.  Having held the Super Bowl of Part 15 hearings, while a memorable accomplishment, isn’t the end. Nor is it the beginning of the end. And, no, it’s not even the end of the beginning.  It was just the end of the day.

CONCLUSIONS

Where will this all lead?  Abrams said, “We have much work to do … and it’s too important not to do it right.” Certainly.  But it’s not an excuse to do nothing – the fear of many in the room and in the healthcare industry.

The FDA docket closes in February.  After that, DDMAC will review all the materials – and there will be a lot of material to be reviewed by a pretty spare DDMAC staff. That will take time.  Then the FDA will have to decide what – if anything – it want to do.  And that also will take time. 

So what will we see and when will we see it?

Don’t hold your breath.  FDA operates in FDA time (“the time it takes to get it right”) -- almost the opposite of social media time (immediate gratification).

My prediction – a guidance sometime in late 2010 or early 2011 that focuses on three issues: (1) the range of adverse event reporting responsibility (not a redefinition of what an adverse event is), (2) ways to make MedWatch more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and, obviously, online) and, (3) the creation of “safe harbor” parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.

Aaron Burr said, “Never do today what you can put off till tomorrow. Delay may give clearer light as to what is best to be done.”

But things didn’t turn out so good for Mr. Burr.

Better for the FDA to heed the words of Benjamin Franklin, “You may delay, but time will not.”

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Pixels and Pills

11/14/2009 09:12 AM |

The folks from "Pixels & Pills" caught up with me at the Part 15 hearing.  Here's the video clip.
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The Super Bowl of Part 15 Hearings

11/12/2009 10:41 PM |

It may have been cold and blustery outside in L’Enfant Plaza, but inside the air was heavy in anticipation and the NTSB Conference Center was packed for Day One of the FDA’s Part 15 Hearing on Social Media.  The atmosphere was electric (or as electric as it can be for a room full of FDA policy wonks and IT geeks).  

Yes – it’s the Super Bowl of FDA Part 15 hearings.

For those of you who keep track of such things, the docket for today’s hearing was ranked #1 (as in the most heavily visited) by regulations.gov.

Woot!  Woot!

DDMAC panjandrum Tom Abrams did his best not to look like a deer in the headlights. But the crowd was restless. Would he really be able to squeeze 31 presentations into a single day?

Well, when the going gets tough, the tough get going.  And so, at the strike of 8AM, Tom Terrific brought the crowd to order and called the first presenter.

First up was Alan Coukell of the Pew Prescription Project.  Not an auspicious beginning.  He hit a sour note at the top by opining that, “Social media is the same as mass media.”  Hmm.  He also offered that some space-limited social media apps might not be viable for healthcare social media usage. Alan – don’t give up so easily – and work on those presentation skills.

Next up was the always effervescent John Kamp (representing the 4As and the Coalition for Healthcare Communication.) He picked up the tempo quite considerably by pointing out that the Internet is the “go-to” medium and that the FDA should step forward and set the global “gold standard” for social media regulations.  He also wisely pointed out that the FDA should develop its guidelines in collaboration with the FTC.

Then came the Eli Lilly’s lovely and talented Michele Sharp who wisely pointed out that social media must be used to advance the public health.  Bravo.  She called for guidance both of the written and “executive” varieties, pointing out the dangerous unintended consequences of either too much or too little regulatory direction. She called for a series of FDA public meetings with stakeholder groups. Showing her Hoosier roots, she pointed out that, when it comes to both the Internet and social media, “the barn door is open and it’s never going to be closed.”

Speaker #3 was Boston Scientific’s Tony Blank (speaking on behalf of AdvaMed).  He pointed to that organization’s guiding principles for communications and also thanked his young kids for keeping him current on social media. (Word.)  He spoke to the issue of “net” impressions (not going there) and how future FDA guidance will have to deal with the ambiguities inherent in dealing with a medium that changes both form and function on a regular basis.  His analogy was that the Internet is a “white wall.” Regulated industry writes on that wall – while others come in afterwards and spray graffiti on it.  Industry, Tony pointed out, cannot be responsible either for the street art – or for cleaning it up.

Next on the docket was yours truly.  It was an awesome experience.  My closing comment was, “Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance. My complete testimony can be found at www.drugwonks.com. 

Rohit Bhargava (Ogilvy 360 Digital Influence) offered a way to determine manufacturer accountability.  He called it the “3Cs” – Creation.  Compensation.  Collaboration.  If there’s a “yes” to any of these three, says Rohit, then a company is responsible for content.

There was, during the course of the day, much conversation about “responsibility.” So before I continue the Day One recap – here’s what the current FDA guidance says on the matter as a point of reference:

“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”

("Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines:” http://www.fda.gov/cder/guidance/4177dft.pdf.)

Next up was Jeff Francer of PhRMA.  He called for guidance to facilitate the use of social media, “the same tools being used today by both the FDA and the White House.”  Well Jeff – yes we can!  Maybe. He (a la Kamp) also called for risk information to be presented (a la FTC) via “prominently displayed” hyperlinks. And, of course, he discussed PhRMA’s idea for some kind of FDA “Good Housekeeping Seal of Approval.” This set the FDA panelists on edge.

Jeff was followed by John Mack (Pharma Marketing News).  John shared an online survey of his readers (354 respondents). One finding was that Pharma companies should all have public social media policies that embrace transparency.  Can’t argue with that.  He also suggested a special hash tag for any industry-sponsored tweets. And he added another voice to the anti-sidewiki sentiment by declaring, “Google -- tear down this sidewiki!”

End of Panel 1.

Ensuite, ex-FDA attorney and all-around nice guy Arnie Freide. Always keen to point out regulatory precedent, Arnie argued that, since the FDA already created “fair balance and adequate provision” to address risk communications, the agency has the authority to invent a similar procedure for social media – and that no new legal authority was required for the agency to do so.  There goes that excuse. He also pointed out, vis-à-vis the issue of sponsor “interest,” that the agency already addresses a very similar concern in its regulation of CME.

Then came James Sandino (the Sandino Group). He told us about social media “back in the day.” That means he worked on Upjohn’s Rogaine – when “social media” meant a 1-800 number.  Thanks for the memories.  He also said that social media is a healthcare communications “canary in a coal mine.” In other words, it’s a way to determine – swiftly – if a marketing campaign is going to die.

Next was David Adams (Internet Advertising Bureau) who looked like he was waiting on the reception line at the wrong wedding.  His big point was that “uncertainty is bad.”  Nuff said.

But it was only a momentary lull, because next on the hit parade was everyone’s favorite finger-pointing know-it-all Diana Zuckerman (National Research Center for Women & Families). And she didn’t disappoint. Her first point was to explain why there weren’t more consumer groups on the docket. “They’re too busy on the Hill working for health reform.” Then she commented (relative to the one-click rule) that “one click away is one click too many.” She then talked about how pharmaceutical companies “game” Wikipedia (although she had no evidence to cite).  As she commented, “You just don’t know who to trust.” (Translation –- but you can trust me.) And, since using social media is “cheaper” than either broadcast or print, that the FDA should insist that more risk information be provided by marketers. But her best suggestion was that Congress should impose social media user fees. You just can’t make this stuff up.

Then Robert Winder (VuMedia) made the point that “Anonymity is a bad thing on social media.” A point taken up later per the issue of sponsored Google links. But more on that shortly.

Then Wayne Gattinella (WebMD) discussed how social media enhances the doctor/patient relationship and how such engagement leads to better patient outcomes.  Now you’re talking. 

Final speaker of Panel 2 were the three little maids from WEGO Health (Jack Barrette, Bob Brooks and Marie Connelly). They shared some interesting social media consumer comments.  My favorite, “It makes us feel like we’re not yelling into the air.” Been there.  Done that.

And at long last lunch.

Panel 3.

First afternoon presenter was Tiffany Mura (Consensus Interactive) who called for the FDA to create a Social Media Advisory Committee.  (Isn’t this something that should logically fall to the Risk Communications Adcomm?)  She called for social media regulation based on the four principles of speed, responsibility, reasonable effort, and transparency.

Next was Alex Vandevere (Global Prairie Integrated Marketing) who wondered whether we need social media guidelines or guide rails?  Not sure what that means – but I like the phrase. 

Then Craig Audet (sanofi-aventis) shared that his employer considers itself a healthcare company – not a pharmaceutical company. Très bien!  He then wisely suggested that the static elements of social media programs developed by a pharmaceutical company (oops, excuse me, by a healthcare company) be submitted to the agency via Form 2253 (at time of first use) – but that the ensuing user-generated content be allowed to take place in real time. Hard to argue with the realities of the web.

Next was Mark Gaydos, also of s-a, but representing the Social Media Working Group (AZ, s-a, BMS, Millennium, and Amgen).  He made a few excellent points. First was that company sites should comply with transparent “terms of use.” That companies should acknowledge and appropriately respond to off-label questions. And that social media sites (such as FaceBook and YouTube) with the interactivity features turned off are not social media.” Nice to have that moose finally on the table.

Mark was followed by David Zinman (Yahoo!) who also made the point that the FDA’s NOVs on sponsored links has resulted in making these ads less transparent to the user. He also discussed an idea to add drop-down ISI (Important Safety Information) boxes to promotional videos – since online viewers aren’t as likely as TV viewers to watch 30 seconds or more of fair balance/adequate provision.

Next up was David Wolin (Waterfront Media) who repeated what others had already said. Not his fault – but it was already getting pretty deep into the docket.

Next was the J&J duo from J&J, Philomena McArthur and Liz Forminard. They discussed the power of social media to enhance health literacy and, as a result, safe use. Clearly music to the FDA panel’s ears.  They also made the important point that “clicking through” to information (in this case, risk information) is accepted practice both on Internet and social media sites – and is a whole lot better than the infamous “see our ad in the Saturday Evening Post.” I’m sure Norman Rockwell is turning in his grave.  Finally, that new rules to govern social media must be as flexible as the medium itself. (I envisage Tom Abrams as Gumby. Pokey we already have.)

And then came Big Mark Bard (Manhattan Research). People had been quoting his research all day, so it was nice to actually hear from the man himself.  A few interesting data points – physicians want pharmaceutical companies to participate online 70% to 30%. Asked the same question, consumers aren’t quite so convinced (35% approve, 25% do not and 40% are unsure).  Another interesting factoid is that while physicians and consumers are both online in great numbers –physicians are on with greater frequency (it’s their job) while consumers pop in and out (based on anecdotal need).

End of Panel 3 and most of the seats are still taken.

First speaker of the fourth and final panel was Stan Valencis (Acsys Interactive) who pointed out that 13% of Americans hospitals have social media sites.

Then John Mangano (comScore) shared that there are 1,700 dedicated healthcare websites in the U.S. and that 78% of condition sufferers and 56% of caregivers visit those sites.

That was followed by Fard Johnmar (Envision Solutions) who said, “Internet searchers are like animals on the hunt.  They go where the information scent is the strongest.” Pretty feral stuff for an FDA hearing. I wonder what the regulatory analogy is for marking your territory?

Rounding the clubhouse turn was Lawrence Mickelberg (Euro RSCG 4D) whose contribution to the day was this memorable soundbite, “Healthcare begins at search.” Pithy and important.

Coming down the stretch, was W. John Reeves (McCann Healthcare Worldwide) who pointed out that (are you ready for this) digital content on the web has increased 876,000% from 1999 to 2009.
 
The final presenters of the day were Mary Anne Belliveau and Amy Cowan (Google). They presented a proposal for newly formatted sponsored links that includes a “more information” link and an even more robust version for products with a black box.  We’ll see.

And so to bed.

To sleep, perchance to dream … of social media guidance.

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The Caves of Caution, Complacency and Compliance

11/12/2009 07:44 PM |

Many thanks to all who sent such kind comments on my FDA Part 15 testimony today.  My complete remarks can be found here.

A few tidbits:

As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”

The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.

Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point.  Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.

As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”

One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?

Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled.  Information “out” is not.  Errors and hyperbole are, for better or worse, freedoms of the press.

According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find

Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever.  Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors.  And yet that is precisely the advice being regularly given by regulatory consultants.  It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.

Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience?  Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity?  Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.

I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events.  Is this responsible?  Is it even supportable?  If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee.  “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.

As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”

Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
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Patients are a virtue

11/11/2009 08:14 AM |

According to CDER Office of New Drugs Director John Jenkins, a crucial piece it creating a risk/benefit assessment model is the patient perspective.

"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk," Jenkins said.

Jenkins continues, "A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."

And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”

Providing people with different therapeutic options is another important aspect of risk-benefit assessment, Jenkins said. "We at FDA consider having a range of choices available to be a very important aspect in the practice of medicine." Even though a drug may not be a best in class, he noted, it may still be the best choice for an individual patient.

There also are various societal expectations about "how we should interpret and apply the standard," he said. He gave the example of when FDA was first criticized for being too slow in approving drugs, and later criticized for being too fast in drug approval, and now it is once again criticized for being too slow.

"So as regulators we have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”

John Jenkins taking about “societal expectations” within the context of new drug review?

Bravo.

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If You're Old, Black or Brown... You're Going Down

11/10/2009 05:35 PM |

The media's refusal to focus on the direct damage health care reform will inflict on the nation's poor and elderly is a disgrace, part of a willing effort to ignore the true human and economic cost of the proposals before Congress:

Here is an anecdote about how Medicaid performs today:

Holes in the safety net: Medicaid falls short just as some need it most
As need rises, patients struggle to find doctors who take the insurance plan

By Tom Curry and JoNel Aleccia
msnbc.com
updated 11:13 a.m. ET Aug. 11, 2009

GOSHEN, Ind. - For weeks now, 2-year-old Ashley Soto's hair has been falling out in clumps and bunches.
Doctors at the Maple City Health Care Center, a neighborhood clinic where the toddler's family receives most care, couldn’t diagnose the problem. The child needed to see a specialist, but no local dermatologist would agree to accept Medicaid, the government’s safety net plan. Instead, Antonia Mejorado, 33, has to drive nearly two hours to see a dermatologist willing to treat her daughter's potentially serious illness.

“There is not a doctor around here that takes Medicaid,” said Mejorado, whose husband, Osvaldo Soto, 33, has recently seen his hours cut to almost nothing at a local mechanic shop....

About one in five physicians say they are not accepting any new Medicaid patients, largely because of low payments or delays in reimbursements, according to the Center for Studying Health System Change in Washington, D.C.

‘A lot of things are scary’
Ashley Soto, the 2-year-old with unexplained hair loss, is eligible for Medicaid because she was born in this country. The child’s parents, who are from Mexico, are not. Her mother worries that a serious diagnosis could mean more long days traveling the 75 miles between Goshen and Michigan City, Ind.

“A lot of things are scary — not having a doctor nearby in case something happens to her,” said Mejorado, who is also the mother of three other children ages 17, 14 and 14 months.
http://www.msnbc.msn.com/id/32127373/ns/us_news-the_elkhart_project/
Things are going to get a lot scarier....

From an AEI Report

Medicaid: The Forgotten Issue in Health Reform
By Robert B. Helms
AEI Health Policy Outlook, November 2009

"...the distribution of federal Medicaid expenditures per poor person ranges from a low of $2,014 in Nevada to a high of $7,753 in Maine, an almost fourfold difference. One of the objectives of the original Medicaid legislation was to allow states the flexibility to design a Medicaid program that reflected the preferences of their voters and their willingness to be taxed to support the program. Some states obviously prefer more extensive programs than others, but this choice has been influenced by the availability of federal, open-ended matching. This has had the effect of expanding the program in all states, while expanding it relatively more in higher-income states. The availability of federal funds has also reduced the incentive for the states to design cost-effective programs or to reduce the level of fraud and abuse.

The politics of fixing this conundrum are indeed daunting since it pits one region of the country against another, but to ignore this effect means Medicaid will continue to do a poor job of helping the vast majority of the poor and disabled. Expanding Medicaid eligibility to more adults and to higher-income families with 100 percent federal financing may have a marginal effect to narrow this distribution, but it will not change the basic incentives now built into the system of federal financing."

And efforts to equalize Medicaid spending by "redistributing" resources to the lower cost regions will only hurt the concentration of urban poor in rich states... The same goes for efforts to punish doctors who spend more per patient than 10 percent of the lowest spending docs... (Features in health reform proposals in both houses)

And we are going to increase health care coverage for 50 percent of the uninsured in this fashion?

From the MSNBC report:

"Medicaid reimbursement rates can be as much as 40 percent lower than those for private insurance, according to John Holohan, the director of the Health Policy Research Center at The Urban Institute, a Washington think tank.

Michigan, for example, recently announced a 4 percent cut in payments to doctors, dentists and hospitals who treat Medicaid patients. The move prompted a new exodus of doctors who’ve decided to limit care.

"I love what I do, but I can't keep getting cuts from Medicaid," Dr. John Pfenninger, a family physician in Midland, Mich., told the Associated Press. "It's time to say no. "

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Georgia on my mind

11/10/2009 07:39 AM |

From today's edition of the Atlanta Journal-Constitution:

Are higher co-pays the answer to controlling medical costs?

NO: Discouraging treatment is shortsighted and leads to more costs.

In the current national health care debate, let’s hope we never hear the words, “As Georgia goes, so goes the nation.”

Since 2005, Georgia politicians have been conducting a dangerous penny-wise, pound-foolish experiment with its state health program by hiking co-pays for brand-name prescription medications.

The results of that policy have been sicker, less productive state employees. These Georgians end up consuming more and costlier health care during the course of their lives, as their neglected conditions worsen.

The lesson here is that higher co-pays discourage patients from getting the treatment they need — especially when they reach upwards of $100.

Just consider what Daniel M. Hartung of Oregon Health & Science University calls the “co-pay effect.”

Professor Hartung and his colleagues analyzed the effect of even a small co-payment — $2 for generic drugs and $3 for brand-name drugs — for those pharmaceuticals that were available to Oregon Medicaid enrollees in 2003.

The co-pay fees were not required for patients who were unable to pay. The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with conditions like depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes.

They found that the patients’ overall use of prescription drugs decreased by about 17 percent after the introduction of the co-pay policy.

It should come as no surprise that any policy that encourages patients to stop taking their prescription drugs is a recipe for disaster.

There is already a growing national trend of Americans not adhering to their prescribed drug regimens.

A study by Wolter Kluwer Health found that fewer and fewer Americans are even bothering to fill their prescriptions.

In fact, during the fourth quarter of 2008, American patients neglected to fill 6.8 percent of their brand-name prescriptions — a 22 percent increase when compared to the previous quarter.

This practice — often known as prescription drug “nonadherence” — can have serious repercussions on a patient’s health.

For example, hypertensive patients who do not take their prescribed medicines as directed suffer 5.4 times as many poor clinical outcomes as those who do.

And poor outcomes are 1.5 times more common for heart disease patients who do not take their meds regularly.

This adds an additional $100 billion to $300 billion in health care costs each year.

The trend has been perpetuated by the fact the Americans with private health insurance have found themselves paying more for prescription drugs in recent years.

Why? Because insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of their prescription drugs costs out of their own pockets.

Many Americans mistakenly believe that this increase in out-of-pocket expenses is the result of higher drug costs. The data reveal otherwise.

In fact, the growth in prescription drug co-payments outpaced the growth rate of prescription drug prices four to one.

It’s easy to see why plans to increase the co-pays for Medicare beneficiaries will also have serious adverse effects on the health of our seniors, as well as on our health care system as a whole.

Unable to afford their prescriptions, many Medicare enrollees will begin treating strict obedience to their drug regimen as a luxury, not a necessity.

As more and more seniors choose to abandon their treatment, health care outcomes will suffer, as prices soar even higher.

Making health care decisions based solely on cost is a losing strategy over the long term for both the state and for the health of its residents.

But maybe those are the kind of shortsighted, budget-driven results you get when cost-over-care bureaucrats run your health plan.

Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

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Social Media Listeners

11/09/2009 06:19 PM |

We've discussed the speakers at Thursday/Friday's Part 15 hearing on social media -- and now we know who will be doing the listening (and questioning) from the FDA side:

• Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
• Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
• Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
• Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
• Kristin Davis - Deputy Director, DDMAC - CDER
• David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
• Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
• Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
• Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
• Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
• Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
• Robert Temple - Director, OMP - CDER
• Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH

It's almost showtime.
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Forced Redistribution of Healthcare Services

11/09/2009 11:43 AM |

The goal of the HR 3200 is to collectivize health care delivery by increasing taxes on businesses and individuals, the destruction of the private health insurance, including Medicare advantage and the redistribution of medical services along geographically regions.

Yes, the government will be empowered to redistribute health care spending along geographically areas. Doctors in the 20 percent of counties that have the lowest medicare expenditures will get a 5 percent bonus in the House bill. The House bill also propose to revamp hospital and physician fees to equalize geographical payment levels with the goal of forcing down higher spending areas to the lower spending regions. The impact on innovation, access to care and health will be devastating. Such efforts ultimately fail. Both Canada and the UK have substantially increased health care spending (at a faster rate than we have) and still have wide regional disparties in expenditures and outcomes. In the meantime, health outcomes in the US are better than they are in Canada or the UK for cancer and heart disease, the leading causes of death.
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Off-Label Fable

11/09/2009 08:19 AM |

Two new articles on the issue of off-label promotion.

The first, courtesy of Bloomberg.com, is far from courteous or unbiased.  Consider this quote from Jerry Avorn, a professor at Harvard Medical School and regular critic of the industry:

“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”

Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.

The Bloomberg article continues, “The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.”

That’s outside of any citation – that’s just the reporter talking.  Bad journalism.

And then back to Jerry Avorn:

“It’s an unbearable cost to a system that’s going broke. We can’t even afford to pay for effective, safe therapies.”

Now the article is confusing the issue of off-label promotion with off-label use.  And that’s a much clearer articulation of the article’s broader agenda.

The complete Bloomberg article can be found here.

A much better omnibus discussion of off-label promotion can be found in the November issue of Nature Biotechnology. An excerpt:

“… on October 2, Allergan, in Irvine, California, filed a lawsuit against the FDA seeking to challenge off-label regulations. Allergan contends that agency rules stop them from sharing safety information about off-label use of approved drug Botox (Clostridium botulinum toxin). The company contends that Botox is effective for as-yet unapproved uses in spasticity, and given that physicians are already using it for that purpose, it is important to communicate information to reduce the risk of adverse events. Indeed, Allergan claims the regulations violate the right to free speech under the First Amendment of the US Constitution. But it also stands to reason that if the information it seeks to communicate was in the literature, Allergan would not have needed to file the suit.”

The complete Nature Biotechnology article can be found here.

Also quoted in the Bloomberg article newbie FDA employee Peter Lurie, who makes an important point, “Most physicians don’t keep track of FDA-approved uses of drugs.”

All the more reason for a robust and expanded “safe use” program by the FDA. 

Label detailing aids anyone?

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Viral Media

11/06/2009 08:32 AM |

And about those “Canadian” websites …

From today's New York Times:

F.D.A. Fighting False Online Claims About Swine Flu Treatments

You can buy healing gels that “create a barrier between you and the potentially deadly virus now spreading across the globe.” Or “ionic silver” that kills every known pathogen, germ, bacteria, virus or fungus within six minutes. “Spray Swine Flu . . . Gone . . . with ionic silver on your hands,” one ad claims.

Now that the White House has declared swine flu a national emergency, and with the H1N1 vaccine in short supply, many Web sites have been peddling swine flu nostrums.

The Food and Drug Administration has identified 140 different dubious products sold online and has sent letters to 75 manufacturers. It is violation of federal law to market products that claim to prevent or treat H1N1 and that have not been approved by the F.D.A.

The agency has gone after sellers of gloves, inhalers, masks, shampoos, herbal extracts, air fresheners and an array of vitamins that make claims about fighting swine flu. Some of the Web sites were fly-by-night operations that have since closed down.

The complete New York Times story can be found here.

Food for thought for those who continue to foolishy call for risky drug importation schemes.

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From Gidget to Widget

11/05/2009 08:23 AM |

Some interesting findings from market research firm Verilogue.

The first is that, of 12,500 measured patient-doctor conversations in 2008, the research firm found only 23 requests for specific drugs.

That’s somewhat counterintuitive considering all the punditry and political bloviation about DTC advertising driving “unnecessary” prescribing. But it’s not at odds with studies (including those done by the FDA) that show that about 6% of all doctor visits in the United States are a direct result of a patient (also known as a consumer) having seen a DTC ad. Taken together, these results demonstrate that DTC ads drive patients to visit their doctors (a good thing) and that those visits do not result in inappropriate pressure to prescribe.

The other Verilogue item of interest is that the most frequently cited drug by patients was Boniva. The Boniva DTC campaign, features actress – and honest-to-goodness osteoporosis sufferer -- Sally Field.

Supportive data, via IMS Health, shows that prescriptions for Boniva were up 11% last year, and sales of the drug grew 25%, to $675.6 million. The message, according to Richard "Erik" M. Gordon, assistant professor at the University of Michigan's Ross School of Business, is “authenticity.” Gordon says that, "People want to believe a celebrity isn't just doing this because they were paid a pile of money."

Maybe so.  But, in the 21st century, solid healthcare communications is a lot more complicated than finding a celebrity sufferer --  it’s about moving from “Gidget” (the role that initially made Ms. Fields a household name) to “Widget” (social media tools that communicate healthcare messages – pharmaceutical and otherwise – in more immediate, trusted, peer-to-peer ways). Friends and neighbors.  Now that’s star power.

Bouquets to Boniva for doing it right.  And brickbats to Senators, such as Minnesota's Al Franken, who believe that DTC is deliterious to the public health despite mountains of evidence to the contrary.
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