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The right answer is to understand the medium and use it to advance both the public health and specific marketing objectives. The two are not mutually exclusive.
Let's take blogs as our example.
Blogging is a potent weapon in both the war of ideas and the marketplace of communications. Blogs are wonderful tools when used appropriately. They are pithy, witty, and timely. A wonderful triple play – but counter-intuitive to many pharmaceutical marketing cultures. Brevity is the soul of wit – but not necessarily of medical marketing.
The tools of the blogosphere are immediacy, emotion, humor, asperity and acerbity. “Let me ponder the nuances of your argument” is just so 20th century. The best bloggers are both incisive and sassy. Blogs act as message accelerators. While a good Op-Ed is absorbed, a timely blog is injected, main-streamed into the collective consciousness of a variety of interconnected audiences. Good blogs resonate.
How can healthcare companies take advantage of this phenomenon? One word – engage. But engage carefully. Legal and regulatory issues abound, but a smart place to start is to spend quality time identifying which blogistas are the most relevant to a product or an issue or a company and then read them every day throughout the day. The best blogs are updated more than once a day. It's hard work, but it's worth it. And, relative to metrics, it isn't the top 10 – it's the right 10.
Blogs are the new frontier of pharmaceutical communications. The best bloggers are activist, educated, unpaid, unprompted and uncontrolled. Blogs are real-time focus groups without either the design or permission of the sponsor. Its voyeuristic marketing – wonderfully, terribly, brutally naked in both honesty and utility. The medium is the message.
And the message is being regularly trawled by the mainstream media for “what's next.” I blog every day and regularly get calls from “traditional” journalists to discuss what I'm saying and where I think its going. And if your cognitive mapping is having a hard time accepting this proposition – ask Maureen Dowd.
Some interesting tidbits from the FDA’s June 24th meeting on the issue of transparency.
“FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.” -- PhRMA Assistant General Counsel Jeffrey Francer. As an example, Francer pointed to FDA approval decisions that do not track with advisory committee recommendations. "That's often confusing, not only to those of us in industry, but people generally."
Absolutely. But, since transparency cuts both ways, wouldn’t it be equally beneficial for pharmaceutical companies to proactively release complete response letters received from the agency once a final action has been taken?
Transparency thrives in an atmosphere of clarity. And that was also a topic of conversation.
BIO’s Director for Science and Regulatory Affairs Andrew Emmett, commented that the FDA does not meet and communicate with firms on a consistent basis early in the development and review process. He urged, and appropriately so, that the agency work with industry to minimize barriers to such meetings.
Emmett also called for the agency to provide more information so industry can understand how FDA makes decisions. There needs to be "regulatory transparency and clear articulation of FDA's policies and expectations."
Since it can take several years for FDA to finalize guidance, "This leaves companies to ascertain FDA policy by interpreting the agency's regulatory decisions and enforcement actions, which is an inefficient way for industry to understand and meet the agency's regulatory expectations."
If we’re going to go “open kimono” on this, then the real 800 pound gorilla in the room is the fact that many inside the FDA prefer to leave guidances in draft form – because that ambiguity gives them almost unlimited and perpetual power. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
FDA transparency cannot be achieved without FDA predictability. Predictability is power in pursuit of the public health.
On a related note (and at a different venue – the annual DIA meeting in San Diego), Sandy Kweder (Deputy Director, FDA Office of New Drugs) and Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) discussed the need to begin REMS conversations as early as Phase II. Dal Pan commented that "REMS are as new for us] as they are for all of you. It's not that we hold some secret and we're just not telling anybody about it. We're all navigating through this and trying to figure it out.”
Looks like the FDA is getting down to some serious social science
According to the Pink Sheet, a study proposed by FDA to evaluate how benefit information is conveyed through direct to consumer advertisements could end up showing drug marketers how to describe "high" and "low" efficacy drugs.
The proposed study will evaluate how consumers' interpretations of a drug's efficacy after viewing DTC ads compare to the efficacy data in the product's label.
The study will be conducted in two concurrent parts - one looking at print ads and one at TV ads - and examine three factors: drug efficacy, visual format, and type of statistic.
The agency defines drug efficacy as a quantifiable, objective metric that can be conveyed in graphical representations of the drug versus placebo, with "high efficacy" meaning "noticeably better than placebo" and "low efficacy" meaning "minimally better than placebo."
The agency traditionally has discouraged companies from making such qualitative claims - or even making too much of quantitative numbers - in its advertising. But the proposed study endpoints suggest a growing FDA comfort with, and even an interest in, consumers receiving this kind of information.
Testing Pfizer-like pictographs
The study will examine graphs, pictographs and pie charts as ways to visually present that efficacy information, and whether statistical information is best conveyed as frequency, relative frequency, or percentage.
The test product will be for a cholesterol treatment and modeled on an actual drug, such as Pfizer's Lipitor (atorvastatin), with labeling used as the reference for defining efficacy levels and the objective metrics for clinical performances.
The study will include 4,500 participants, 2,250 in each group (television or print). The subjects will read or view one advertisement version, and then make a series of judgments about the drug in a 20-minute interview.
FDA first will test whether, within each format, the participants were able to distinguish between low- and high-efficacy drugs. Then, it will look at whether the participants' efficacy estimates differ across formats and how accurate the estimates are.
Comments on the proposed study, called "Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisement for Prescription Drugs," are due by Aug. 21.
All to the good. And it sure beats the ignorant "drug facts box" – the a la nutrition facts panel idea,that’s being kept alive via legislation introduced by Senators Jack Reed (D, RI) and Barbara Mikulski, (D, MD) which, BTW, would also require comparative effectiveness information to be included in product labeling.
Vey
Roche.
Roche is leaving the Pharmaceutical Research & Manufacturers of America trade association effective June 30.
Roche describes the action as a "business decision" by "the newly combined Genentech-Roche US commercial organization."
According to the Pink Sheet, "As a practical matter, the departure will add to the strain on PhRMA for resources as it works on all fronts to build alliances and promote its reform agenda. The pending mergers of Pfizer/Wyeth and Merck/Schering-Plough will further reduce the group's core member base. The association traditionally adjusts dues following periods of consolidation."
"To be sure, if the same public program that competes with the private entities also gets to write and enforce the rules of the competition, that might create a problem. But almost all serious observers anticipate that the public program alternative currently being proposed will not also control the regulatory framework in which services are offered; it will simply be available as another option, and will survive only if it can succeed as a genuine alternative to those private companies. "
Read Op-Ed here.
Can we say delusional?
Let's take a look at how public plans work here and around the world. Do they compete like the postal service (oh sorry, no real competition) or do they set the prices and lowball providers and then just expand budgets in response to demand generated at taxpayer expense without regard to profitability, waste, corruption.
Does Medicaid compete? Medicare? How about the Indian Health Service?
Further, we already have public options such as Medicaid and SCHIP. What we don't have are more private choices that promote prevention and well-being and that should be the point of reform.
Making the government the lowball option is a bait and switch that will eliminate individual choices of health care plans. Why? Government's can tax and spend without the timely accountability that only a private choice based system protects.
Aetna's profits declined this year because it lowered prices to gain market share even as it spent more on medical services, disease management and prevention. Reform should encourage more of this and build on such efforts rather than kill them.
That's what is at stake. And more.
The panel was chaired by the always alert Julie Zawisza, CDER's Director of Communications and I was joined on the dais by Ray Kerins (Pfizer) and Steve Usdin (BioCentury).
We coverered a lot of ground, but what really was on the mind of the audience was the FDA's stance (or lack of one) on issues related to social media. We talked about DDMAC letters and the risk communications advisory committee, blogging, Facebook, Twitter -- and yes, even Cheerios. And the general consensus was that the agency was behind the curve.
I know, duh. But that's when Julie Z. stepped up to the plate with the following comment, "The FDA has no intention to stiffle the use of social media." It might have sounded like a throw-away line -- but if that sentiment is genuine (and Ms. Z, is as genuine as they come), then there's hope for FDA to be both regulator of and partner in using social media to communicate important public health information. In fact, Julie said (twice) that she was going to talk with Janet Woodcock about holding a series of external meetings on the subject of "Web 2.0."
She also, aptly, pointed out that when it comes to understanding, regulating, and using social media channels, it's important to understand that "it's not just information, but context and perspective."
You go girl.
According to President, Hugo Chavez, “we consider that patents cannot be a restriction or a trap ... An invention or a scientific discovery should be knowledge for the world, especially medicine,” said Chavez, adding: “that a laboratory does not allow us to make a medicine because they have the patent - no, no, no.”
The proposals were announced on national television by the Minister of Trade, Eduardo Saman, who told the nation that “patents have become a barrier to production, and we cannot allow barriers to the access of medicine or transnational medicine companies to impose their rights on the Venezuelan people."
“We are revising all the doctrines and laws related to patents, which should be compatible with the international treaties that we have signed and respect and honor,” he added.
But, there’s always enough money to invest in a vast military. So much for “respect and honor.
Last time the prescription drug plan for senior citizens was in the news it was being vilified by many members of the majority party. Some even saw it as an election wedge issue. And then there was the whole Non-Interference Clause thing.
And then the politios and pundits saw that Part D was a huge success with America's seniors and coming in well under budget projections. And that was the last we heard of it.
Until yesterday.
Yesterday's announcement of the $80 million deal not only put Part D back on Page One -- but also introduced a new fan -- President Barack Obama. Now, it seems, we have a President who embraces the program designed to maximize free-market public/private partnerships and provide maximum healthcare choices for program participants.
Who'd a thunk it?
This plan will also do away with the silly Catch 22 of not being able to include medicines provided via patient assistance programs (PAPs) towards spanning the infamous donut hole -- something that the Bush Administration was not able to do. It's kind of a Nixion-going-to-China thing, although I'm sure the President would wince at such a comparison.
Maybe it would be more palatable to say that, when it comes to healthcare reform ... it takes a village.
Sorry. And I know how excited everyone is and everything.
FDA regulation of tobacco? Bad idea. Really.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. With FDA as the nation's tobacco Tsarcoe Selo it will be difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs. After all, now it’s the FDA’s responsibility.
Can you say “FEMA?
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program will be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself -- is that really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
Sorry about that. Really sorry.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
