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April 30, 2007

Drug Ads and Great Expectations

by Peter Pitts

"The doctor of the future will give no medicine, but will interest her or his patients in the care of the human frame, in a proper diet, and in the cause and prevention of disease"

-- Thomas A. Edison

Welcome to PiP.

For those of you out there who aren't fans of Charles Dickens, here's the Cliffsnotes background on the literary character of the same name ...

Great Expectations is the story of Pip and his initial dreams and resulting disappointments that eventually lead to him becoming a genuinely good man. The significant changes that Pip's character goes through are very important to one of the novel's many themes. Dickens uses Pip's deterioration from an innocent boy into an arrogant gentleman and his redemption as a good-natured person to illustrate the idea that unrealistic hopes and expectations can lead to undesirable traits.

Yes, Pip as an allegory for Pharma.

Now welcome to PiP -- Personalized Information to Patients

As Congress debates the (clearly unconstitutional) idea of granting the FDA authority to ban DTC for any new drug's first two years of availability, the science of personalized medicine will ultimately make this debate meaningless.

As we attain the knowledge to prescribe the right medicine in the right dose for the right patient at the right time, patients and physicians will rely more on gene testing than product advertising. Indeed information will no longer only mean information about a medicine or a disease -- it'll mean information about your personal biochemistry -- hence Personalized Information to Patients.

In the not so distant future, ads for gene tests may very well replace and surpass those for medicines. Talk about disease awareness! Talk about early and accurate diagnosis! Talk about moving from an acute to a chronic care model!

But it needs to be more than just science talk and silly pieces of ersatz legislation. And that's where the FDA's Critical Path program comes into play.

If we want health care advertising to move beyond the current Cliffsnotes of health information -- DTC -- to the real deal -- Personalized Information to Paitents -- PiP -- we must create the regulatory tools that allow it to happen.

Otherwise it's just talk.

Posted by peterpitts at 10:03 AM
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April 19, 2007

The Sorrow and the Pity

by Peter Pitts

Virginia Tech sorrow and media SSRI hysteria notwithstanding, some important new science ...

Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients' chances of having suicidal thoughts and behaviors.

The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs' risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.

Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.

Here's a link to the AP story:

http://www.chron.com/disp/story.mpl/health/4729234.html

Posted by peterpitts at 09:38 AM
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April 17, 2007

FDA, Defend Thyself

by Peter Pitts

The other day a senior FDA official asked me what the agency should do to combat all the negative media coverage. My response, “Do something because nothing isn’t working.” In retrospect that was a bit harsh. FDA has been doing things, mostly from rule-making to infrastructure, that are making a difference — albeit not any that the MSM or many elected officials seem to notice.

Can more be done to aggressively battle a blood-thirsty media and bandwagon pols? Don’t get me started.
Actually — do get me started.

Here are a few things that FDA can start doing right now to reclaim communications momentum:

1. Respond Aggressively

Rather than waiting for attacks and then playing government-speak non-responsive rope-a-dope, it’s time for the agency to call it like they see it. That means when so-called “advocates” and “concerned” politicians attack the agency for doing its job, the agency should point out the inconsistencies in their arguments and then use that opportunity to segue into a more productive conversation about how to make things better.

2. Drive the Agenda

Don’t wait to respond. Drive the agenda – and publicly. FDA is, as already mentioned, doing a lot of good, progressive, innovative, and urgent things (can you say “Critical Path”), but who knows about it? It’s FDA’s responsibility to use the bully pulpit. He who tooteth not his own horn, that horn shall go untooted.

3. Feed the Beast

On a related note, FDA must keep the media busy, because idle hands do the devil’s work. Case in point, during my tenure at the FDA reporters were (believe it or not) complaining that the agency was so active that they weren’t able to take any time off. Today the media and media-hungry pols are driving the FDA agenda. To say that’s unfortunate is an understatement in the extreme and to say that it is deleterious to the public health is true beyond dispute.

It’s time for the agency stop playing defense – and especially do in advance of the forthcoming hardscrabble PDUFA reauthorization.

Posted by peterpitts at 12:28 PM
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April 13, 2007

Knock Knock. Who's There? Liberal Bloggers on Health Care.

by Peter Pitts

Liberal bloggers on health care who?

The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?

Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).

Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:

* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."

* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.

* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.

Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."

Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal voice.

Here's a link to the complete report:

http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf

And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.

As far as I'm concerned -- the more the better.

Posted by peterpitts at 08:13 AM
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April 12, 2007

PBM(J)

by Peter Pitts

Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.

PBMJ = Prescription Benefit Misjudgment.

At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.

At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.

Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.

This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.

Net/Net: a back-door route toward a VA-type pricing system.

Posted by peterpitts at 06:11 PM
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April 11, 2007

Using Email to Capture Media Interest

by MaryEllen O'Donohue

Seasoned public relations professionals have fond memories of the fax machine as the only and often preferred means of communication with reporters. Often times, a reporter would respond “Fax me” to a phone pitch, especially when on deadline.

Nowadays, fax machines are things of the past and with the ubiquity of the internet, email has become a powerful tool for securing placements and running a successful media relations campaign. Just by sending a handful of emails to the right contacts, you can maximize media interest from top-tier outlets on behalf of your company, product or cause.

Of course, sending a handful of emails is easier said than done. In fact, some women’s magazine and daily newspaper health editors have told us that public relations professionals underestimate the role that an email subject line and the first paragraph of an email can play in capturing their attention. For instance, the words “press release” should never be included in the subject line. Rather, to spur media interest, keep your subject line compelling, yet short and simple, and be sure that it includes your story idea. (Media overlook lengthy headlines and instead, prefer intelligent, considerate contact.) Furthermore, your subject line should be relevant to the information you are sending them; one paragraph in the body of the email addressing the 5 W’s…the Who, What, When, Why & Where….will do. Because many reporters only read whatever falls in the “preview” page of their emails, summarizing your pitch in one paragraph will help.

Ultimately, pitching via email can be done effectively if you think like an editor and convey your pitch as concisely and painlessly as possible. Don’t try to write their whole story but give them news they can use. Be sure to stand above the crowd of publicity spammers who send headlines such as “Company x is proud to announce” or “we are pleased to announce…”

Posted by maryellen_o'donohue at 03:50 PM
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April 06, 2007

French Twist

by Peter Pitts

I've just returned from a breakfast (kindly sponsored by the Government of France) with seven leading French journalists. The topic: health care. Needless to say, it was a wide-ranging conversation. A few items of note:

(1) My French is really rusty.

(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.

(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.

(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.

(5) And we talked about patient information. Empowering the consumer? Mon Dieu!

(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.

(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)

But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.

And, no matter what language you're speaking, it sure sounds familiar.

Posted by peterpitts at 08:04 AM
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April 04, 2007

Sometimes Safety

by Peter Pitts

Can drug safety be a sometimes thing?

I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see Sunday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.

(Remember, don't call them generic biologics. Words count.)

These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.

Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?

Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.

Sorry fellas -- ain't that easy.

I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.

Yup -- zero.

The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.

Posted by peterpitts at 04:02 PM
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