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PHARMA: What next for DTC regulation? by James Gardner

Those of you following along at home know that big Pharma is trying to get ahead of a suddenly hostile Congress (including Bill Frist turning on them) on the subject of DTC advertising. This week they’re holding hearings on direct-to-consumer promotion of regulated medical products. Joining us from Washington DC as a guest blogger, ********@*****************ve.com“>James Gardner of One to One Interactive shares his observations on today’s hearings. James is an authority on Internet marketing and how the channel should most effectively be used by pharmaceutical and device marketers. As well as sharing his observations, he’ll also be addressing the panel and advocating for the interactive channel to be regulated differently than traditional TV, radio, and print. His agency’s past and current clients include GlaxoSmithKline, Pfizer, Roche, Boston Scientific, Schering/Berlex, and Digene.

Hello, welcome, and a big “thank you” to Matthew for allowing me to share my observations from today’s FDA hearings on direct-to-consumer (DTC) promotion of regulated pharmaceuticals and medical devices. I’m in Washington for the day to address the hearings with a point-of-view on the internet’s role in DTC promotion, but I’m excited to also provide some color commentary.

As some of you surely know, the FDA announced its intention in mid-September to hold a series of public meetings on a range of issues related to DTC marketing. The FDA’s goal, quite clearly, is to develop a new regulatory paradigm for pharmaceutical and device marketers. While the FDA has been down this path before, the political and business environment today seems more conducive than ever to having real change actually happen. In that sense, these hearings could be an important regulatory milestone.

My personal expectation, shared by many (but not all), is that we’ll see several things emerge from this process:

  • Blanket restrictions on several currently popular promotional tactics
  • Significantly clearer guidelines articulated about still-permissible tactics, and
  • Much stiffer consequences for those failing to comply with the letter and spirit of the new rules.

I don’t see an outright ban on DTC promotions happening, although some will certainly advocate for that approach. Indeed, with the DTC promotion envelope continually and aggressively being pushed by adventurous marketers, one could plausibly argue that wholesale change is both inevitable and desirable.

That said, I think cooler heads will prevail and the FDA will choose a path of lesser resistance by instead adopting many of the voluntary guidelines articulated this summer by PhRMA, the industry’s trade group. Most of their proposals were quite sensible and all would serve as a good starting point for the FDA to regain control of the DTC promotion agenda, if nothing else. A pragmatist always, I see some positive change as being better than no change at all.

For those of you new to the world of FDA hearings, here’s what you’re missing:

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There’s a large podium across the front where the first group of FDA panel members are sitting. Below them, on the audience’s left, are additional panel members. Also below them, but to the audience’s right, sit the 3-4 speakers in each “wave” awaiting their turn to address the group. Speakers use a podium on the audience’s right, projecting slides on two very large television screens. If you look closely, you’ll also see that we’re using the National Transportation and Safety Board’s auditorium – hence, their “shield” on the wall behind the podium.

Speakers have 12 minutes to make their case. When their time ends, the moderator thanks them graciously for participating and helps field questions from his colleagues and, time permitting, the audience. Questions from the FDA panel to speakers are obviously allowed, but questions to the panel in return are generally frowned upon.

Kudos to the FDA — it’s all quite well organized. We’re keeping to the agenda and making good progress.

Tomorrow: Thoughts and reactions to Patrick Kelly from Pfizer and speakers from the ASHP, AARP, and other organizations. I’ll also post my presentation with the hope of stimulating some discussion!

POLICY: The uninsured, health care costs, and the insurance industry’s vacuous response

It won’t surprise regular readers at THCB but there are a lot of uninsured people in this country, and the problem is getting worse. Why?  Well some bright wonks (John Holahan and Allison Cook at the generally liberal Urban Institute) have some answers and a closer look at the uninsured in a special for Health Affairs. (And of course only liberals care about this stuff–I’m happy to say that unequivocally, and not even all of them do!). They’ve mined the CPS for the 2000-2004 period and have come up with these conclusions (which I quote from freely as many of you can’t get Health Affairs for free–something else that should be changed if any Foundations are listening). Here’s what they found:

(1) The number of uninsured Americans rose by 6.0 million between 2000 and 2004 (the U.S. population increased by 10.0 million). The increase in uninsurance occurred primarily because of the decline in employer coverage, which fell both because a large number of Americans were not working and because coverage declined among workers. The latter no doubt reflects increases in health insurance premiums, which rose much faster (12.2 percent per year) than wages (2.9 percent per year) during this period. The percentage of small and midsize businesses (3–199 workers) offering health benefits also declined, from 68 percent in 2000 to 63 percent in 2004). Employers seem to have tried to shift the cost of health insurance to workers, and it is likely that a growing share of workers chose not to accept employers’ offers.The change in coverage was affected also by the shift in employment from industries that historically have had high rates of coverage to industries that have not, as well as from large firms to small firms and self-employment. Employer coverage rates fell in all types of industries and firms, but the declines were particularly great in low-coverage industries and in small firms. The fact that employer coverage rates fell among workers, not just among those who lost their jobs, suggests that rates of coverage could continue to decline, even as the economy improves.(2) About two-thirds of the increase in uninsurance was among people below 200 percent of poverty. This is due to increases in both the size of the low-income population and the uninsurance rate of that group. Importantly, however, middle- and higher-income Americans were also clearly affected. The remaining one-third of the growth in uninsurance (2.0 million) occurred among those above 200 percent of poverty, even though this group only grew by 900,000. Thus, the lack of health insurance coverage is clearly beginning to affect middle- and higher-income Americans.(3) Much of the increase in the uninsurance occurred among young adults, whites, and the native-born. About 50 percent of the uninsurance growth was among those ages 19–34; about 55 percent among whites; and about 73 percent among native-born citizens. Thus, rising uninsurance is clearly not a problem affecting primarily racial and ethnic minorities and noncitizens. Further, more than half of the increase in the uninsured occurred in the South, where uninsurance rates were already the highest in the country.(4) Children actually gained health insurance coverage. The expansions of coverage in Medicaid and SCHIP that occurred in the late 1990s meant that children’s coverage was maintained, even with the loss of employer coverage. The expansion of public programs increased enrollment substantially. The result was actually a slight decline in uninsurance among children. Adults’ experiences were in sharp contrast, primarily because adults experienced the same declines in employer coverage but did not have the same access to public coverage. Also, people ages 55–64 actually saw improvements in both income and health insurance coverage. Without the gains seen for this group, the overall picture of rising uninsurance would have been much worse.The decline in employer coverage is likely to continue. Increases in health care costs, and thus health insurance premiums, are likely to continue to grow faster than workers’ earnings. The decline in employer coverage will be further exacerbated if the shift from working in large and midsize firms to small firms and self-employment and from high- to low-coverage industries continues

So to recap, the problem of uninsurance (which is a problem for everyone but mostly of course for those uninsured) is largely borne by a) the working poor (less than 200% of poverty)  — although its increasingly making its way up the income ladder, b) the young, and c) whites, d) southerners, and e) anyone likely to work for a small firm rather than a big one. What’s driving this is the higher cost of health care and the fact that employers are opting out of offering (affordable) benefits. Meanwhile public programs (i.e. Medicaid) are only picking up kids. Given the preponderance of lower income whites in the South who vote Republican, I’d be very interested in these numbers if I was a Democrat looking for new voters.

Of course as I’ve said many times on THCB, the presence of the uninsured is a safety valve allowing the participants in our health system to ratchet up costs as much as they can, because those who can’t pay can be jettisoned into the uninsured pool. No one is responsible for the global cost for the whole system, because if they were they’d bring it down for everyone, not just those uninsured, and the total dollars going into it would be less. (At least that’s how it’s done in every other country).

But the scale at which that jettisoning is going on (due to those cost increases) is even worrying those who make their living selling insurance. Here’s what the CEO of Independence Blue Cross (the Blues in Philly) had to say about the fact that premium for his PPO product is up 65% in the past 5 years and now costs $17,000 for a family:

One day soon, if the cost of health care continues to escalate, employers and families won’t be able to afford the solid coverage of Personal Choice,"

So what is he going to do about that? Well there is the odd nod to pay for performance and disease management, but no one will be surprised to hear that like his competitors, CHDPs and better technology are the cures for Independence.

"First," he said, "we must better respond to the emerging trends in health-care consumerism." IBC efforts in this area already include rolling out a variety of consumer-directed health plan options and launching its Connections Health Management program, which helps subscribers better manage chronic illnesses. <snip> Frick also wants to see the company expanding its use of technology to drive down administrative costs and improve customer service.

Now, as an actual health plan customer I’m in now way objecting to health insurers bring their customer service into the 1990s, but suggesting that this is going to cure the underlying cost of health care is rubbish. Meanwhile over at The New Republic, non-Volvo driving liberal Jonathan Cohn has a great article explaining why (again not news for THCB readers) that consumer driven plans are in general worse for poor and sick people. But don’t bother telling that to the insurance industry. it’s decided that CDHP is all it can sell, and it’s the only idea it’s got.

So I was interested in the response when in the middle of a mostly vacuous interview (PDF transcript here) Jack Rowe at Aetna last month was asked by a single payer advocate whether we should have an insurance industry at all.

BERNIE FEDDERLY [misspelled?]: And the one thing you would do to bring down a healthcare cost would simply be to go to a national healthcare plan – a single payor plan, which would eliminate those costs. The best thing we could do is probably get Aetna out of the healthcare field. How do you take on that?

JACK ROWE MD I think we disagree. I think Aetna’s part of the solution. It’s not part of the problem and I think there are lots of ways that private health insurers can improve the quality and access of care and help control the costs. I don’t think it’s proven that having a national system would help correct the healthcare cost problems. The costs, most economists agree, are driven up–not by health insurers, whose operating margins are, as you probably know, are well less than 10 percent on average but by demographic changes and technological advances. Neither of which are under our control. Those are a couple of other ways we disagree but I’m sure there are others.

Frankly if I was getting $18 million a year I’d have a better defense of my position than that, given that I’ve admitted that you could get 10% savings right off the top by nationalizing me, and given no reasons for not doing it. Especially when my business strategy (for all the BS in his talk about Aetna promoting racially sensitive health care) was to boot about half the people on my insurance rolls off them (no prizes for guessing whether they were the healthier half or not) and thereby add to the uninsurance and cost problems of the nation and its taxpayers because of it. Rowe’s lesser paid colleague Frick over at Independence at least has a bit more humility.

"I’ll be the first person to tell you we don’t have all the answers," Frick told DVHC members. "And I’ll be the first to tell you we don’t always get it right the first time, but we stick with it until we do."

Of course doing something that you know is not going to work expecting that it will is pretty close to the text book version of insanity. And his conclusion sounds frighteningly like that.

If health insurers gave a rat’s arse about the problems of the uninsured or health care costs, they would have a come-to-Jesus moment, get together and plot out a way that the uninsurance problem and the cost problem could be solved with them still remaining in the mix. That’s kinda of where they were forced to in the Clinton plan, and it still seems a better long-term option to me. As it is, they seem to be determined to take the short-term cash, and help the system break down to a point where a future government will be forced to take them out and replace them with a government-run plan. But there’ll be a whole lot more pain, suffering, and anguish before then.

QUALITY/POLICY: Vince Kuraitis on Medicare DM

On Friday, November 4th, 10:00 AM – 10:45 AM Pacific (1:00 PM – 1:45 PM Eastern), Vince Kuraitis, Principal. Better Health Technologies and a leading Disease Management guru will be doing an audioconference of this presentation as part of Managed Care OnLine’s (MCOLs) Managing Health Care Costs Web Summit. I’ve seen an advance copy of his presentation and if you are interested in figuring out what  the heck is going on within the Medicare DM experiment that was called CCIP and is now called something else, I suggest that you sign up.

(If you don’t work for a corporation that can pay the freight but are still desperate to see it, Vince might be able to help, so email  me).

BLOGS: Typepad apparently sucks

Typepad apparently has decided to start being unable to handle its traffic, or something. Anyway it just started eating posts, including a long one I just wrote. I hit save. It gave me an error message and a blank slate, I may have time to rewrite it, but with these web-base tools, if it’s gone, it’s probably gone (unlike say Word which tries to recover stuff).

So I may have to follow my post, but moving blog hosts is a total pain.  Anyone got any ideas? (I bet Typepad wishes it had eaten this one!)

TECH: Just a little more about the PHR

You can skip this one if you’re bored but the Personal Health Record and associated stuff just won’t quite go away. I’ve not only got a tawdry past associated with the PHR/CHR, and have spent far too long thinking about it, but I’ve also fooled myself into creating a paper for a forthcoming academic presentation on the subject–which will be an archeology of the attempt by commercial vendors to get the PHR up and running.

Now USA Today has a piece on PHRs which goes onto talk about yet another new one (Mymedicalrecords.com) which is basically a "fax paper in vault" which looks exactly like half of the ones that came out in 1999, such as PersonalMD.com.  And BTW their technology was backwards even for then! So it look as to me as though USA Today has been a little bit snowed.

So let me give you my four categories of PHR

1) The PHR that is looking into a real EMR.  See the version that PAMF or Group Health of Puget Sound uses based on their Epic system.

2) The PHR that looks into the claims database of an insurer and changes the view of the CRM system the patient sees.  This is the one that I was selling back in the day, and that WebMD via its Wellmed purchase is now just offering to plans, and has had Empire launch (and Wellpoint announce it will be launching). The recent IBM announcement is in this vein, although I doubt any American trust their employer enough for that to be a success. (see yesterday’s 60 Minutes as to why)

3) A PHR that allows a patient to look into their doctor’s system if they have one, or not. RelayHealth has a version of this, and Medem’s iHealthrecord is able to look into Allscripts EMR (and theoretically a bunch of others too). This is the ultimate answer for most of America (or some version of it) but it’s dependent on using physicians as a distribution channel to patients and that’s a bit of nightmare.

4) A standalone device like Quicken, that may in some way be able to take in some portion or version of the EMR from providers. This is the route Capmed is going, and where RedMedic, MymedicalRecords, et al are heading.  I remain very, very skeptical about this — particularly their attempts to make consumers pay for it — but to be fair that’s what MedicAlert does and plenty of people are buying that bracelet.

Of course if you want to get everyone using one of these PHRs you’d be better off putting your whole state or national insurance system into it, as the Germans are doing.

Meanwhile, back in the UK, they are trying to get their related Choose and Book system up and running. This is a referral and appointment system between GPs and hospital specialists. (Note that in the UK there is very little patient self-referral). The answer seems to be that it is slowly beginning to work (in some places) and that it is increasing the role of the patient in choosing who they are referred to. (A choice which didn’t really exist before). Meanwhile, this article focuses on the early adopter the Whittington hospital, in North London, using Choose and Book. Of course The Whittington has always been ahead of the game introducing new and amazing things to the world. Yup, I was born there!

CODA: The USA Today piece horribly misquotes Mark Bard as saying that DrKoop.com had this PHR idea back in 2001 but never really got it going. DrKoop.com had this PHR idea before it was up and running in 1998, but couldn’t get it right and took the easier route of instead being a web health content portal. It never got the PHR thing into any level of production and having been an Internet star in 1999, it was on the famous March 2000 Barron’s list of companies that were losing too much money to survive (the article that helped start the dotcom crash). By 2001 it was basically going under. At least I hope Mark is being mis-quoted!

HOSPITALS: Friday Night Update by John Pluenneke

When the going gets tough, the tough form a 501(c)(3) tax-exempt non-profit organization.

HealthSouth Corp. founder Richard Scrushy has formed a nonprofit group focusing on churches and religious charities. Richard and Leslie Scrushy Ministries was incorporated in Jefferson County last month.Records list the charity as being based at 2310 Marin Drive, the private company housed on the Scrushy estate in Vestavia Hills.

SAT MORN. CODA: In New Jersey, a poll this week shows Republican Doug Forrester trailing Democrat Jon Corzine by about 10 points in the race for the Governor’s job. That’s a bit of surprise for some people, as analysts had thought the Republicans had a real chance in the state thanks to local disgust over a series of scandals involving corrupt Democrats. Forrester is a PBM man and a part owner of a privately-held benefits company called BeneCard, which is apparently currently having some problems of its own.  Interestingly, in a state where the pharma industry plays a major economic and political role, Corzine has played the pharma card hard – running attack ads which criticize his opponent’s link to the drug industry. This is not a good sign for the GOP …

POLICY/POLITICS/TECH/HEALTH PLANS: Trown out in the trash

Politically this has been quite a week. Don’t you think that John Kerry just wishes that we had five year Presidential terms and that he was going into the election this November, rather than a year ago? This week even the great flip-flopper himself came out with a plan as to how to get our troops out of Iraq. Pity he laid off all the attacks till the election was over (and same with Al Gore too!). Bush keeps ranting on about final victory in Iraq as if he had any idea what the hell he was talking about, and that he hadn’t declared Mission Accomplished two years ago. Now he finds that most of the cabal running the country’s foreign policy for the past 4 years are on their way to disgrace and/or jail, and that his incompetence in choosing a secret wingnut instead of a well-known one for the O’Connor seat on SCOTUS has lost him (at least temporarily) the support of the loony right.

What has any of this got to do with health care?

Well as they say on The West Wing, there are a couple of stories sitting in my backlog that I want to throw out in the trash. First BusinessWeek had a profile of David Brailer, stressing that he honestly believes that there’s a free-market solution to interoperability in our current health care system. Well he’s even lost Neal Patterson on that one (and yup last year Patterson spent a fortune failing to get his wife elected to the House as a Republican). Meanwhile, another leading health care IT exec who wants to get himself elected to Senate as a Republican (Rich Tarrant of IDX) is sounding somewhat like a commie in his support for Medicare and Medicaid. (Hat-tip Don McCane) Finally there was an extraordinary long interview in the New York Times with the founders of AFLAC (itself a pretty useless insurance product) in which they showed that you can make a duck famous while having absolutely no idea about how to fix the US health care system, even if you vaguely understand the problem.

All of this leads me to believe that the business class that runs the country is somehow getting around to this problem, and that they might not object to it being solved. If the Administration’s problems continue to pile on for all the crimes and cock-ups they’ve caused us in the last five years, then next October we might, just might, get a change in the Congress and put us on the road to a Democrat in the White House in 2009. If that happens (and I know this is all speculation) then health care will have to be the first issue on the domestic burner — which is a little sooner than I’d predicted. All pure speculation just now, but this week might be the turning point.

PHARMA/POLICY: The status quo versus the NHIN

Here’s my FierceHealthcare editorial this morning:

In a little over a week from now, there’s a special election in California with several propositions on the ballot–mostly to do with the political future of Arnold Schwarzenegger. But the two initiatives to do with drug pricing (Props 78 and 79) have seen an out pouring of money, almost all of it from drug companies. Their "Yes on 78, No on 79" commercials have plastered the airwaves, and the non-partisan Healthvote.org shows that by September 29 (i.e. not counting the last 10 days of campaigning) Big Pharma had donated nearly $80m for the joint campaigns, versus less than $2m spent by their opponents in favor of Prop 79.

The pluses or minuses of two propositions in one state are not the point of this editorial. The point is that a powerful piece of the status quo (Big Pharma) is prepared to spend so much to defend itself against what some might argue is a relatively minor attack on their pricing policy in only one state. The logical conclusion is that real reform of our health system, which will by definition require changes to the economics of physicians, hospitals and insurance companies, will meet even more vigorous resistance in defense of the status quo. Optimists who believe that the development of a National Health Information Network will cure healthcare’s problems might do well to note that the amount provided by Congress for that initiative to change the entire health IT system is only a fraction more than the amount Big Pharma’s rustled up for its single issue campaign in California.

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