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March 30, 2007
What Patients and Consumers Want
by Michael Martell
MS&L Germany: 1. Health Survey 2007
The right for public information does not apply to all pharmaceuticals
Two out of three Germans want more information about Rx drugs
When it comes to Rx products, information is not easily accessible for patients in Europe. Unlike in the United States, where advertising of Rx products is possible even in lay media to a certain extent, Europeans face many restrictions concerning information to the public – a somewhat awkward notion if you consider that self-responsibility for one’s own healthcare (especially in terms of financing) is increasing at an ever-accelerating pace.A couple of years ago, the EU Commission failed in its attempt to ease restrictions on the information ban.
In Germany, for example, 60% of the public agrees to a liberalization of the information ban on Rx medications. Approximately one fourth of all interviewees would welcome a complete liberalization of all information available on these products. These are the major findings of a recent survey by MS&L Germany, which was conducted by TNS Healthcare in Q1 2007, including 1.003 interviewees of 14 years of age and over.
Further interesting aspects of the survey are the finding that females more strongly prefer the liberalization of information than males, as well as the fact that the level of agreement to a liberalization of the ban is rising with the increase in monthly net income. “Regardless of the differences between men and women or factors like the monthly net income of interviewees, the trend is obvious: Germans want to more freely access relevant informa-tion about Rx medications, and they want to inform themselves from a variety of sources”, says Michael Martell, Managing Director of MS&L International Public Relations in Germany.
The results of the survey show today’s lack of information in the larger part of the population. As people wish to be more informed about medicines, this also implies a big challenge and responsibility for the implementation of communication about Rx products. Thinking of physicians and pharmacists only – that is by far not enough in healthcare communication. With the growing burden for patients to cover healthcare costs themselves, they should at least be given the possibility to access the information about their condition and medications. “Experience from other countries clearly demonstrates that responsible information transfer from the pharmaceutical industry to the patient is not only possible, but that it is also appreciated by the public”, Michael Martell concludes.
Posted by michael_martell at 03:37 AM
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March 27, 2007
Death is Cheap
by Peter Pitts
Dead people are very cost efficient. They have no need for costly hospital procedures, pharmaceuticals, or home care. On the other side of the pharmacoeconomic spectrum are people who suffer non-fatal medical events like a heart attack or stroke — and survive due to every kind of help our health care system can provide. Such interventions are often both extensive and extended. But we are compassionate and civilized and value life. Individually and collectively we choose and support expensive care over expedient demise. That’s why it’s so urgent that we recognize the exigent issues surrounding our nation’s ill-placed focus on acute care while chronic care issues remain precariously in the background — in terms of both policy and press coverage.
Consider the IDEAL study. After a slamma JAMA editorial extolling the findings that Lipitor (80mg) provides incremental reductions in multiple endpoints including non-fatal heart attacks (a whopping 17% decrease in fatalities) and cardiovascular events in high-risk patients compared to simvastatin (20/40 mg) — the mainstream press played down the whole study as only marginally significant. Well, life is lived between such margins — and when it comes to CVD, those margins are pretty wide. In 2005, $393.5 billion was spent on CVD — nearly twice the amount spent on cancer care. Between 1970 and 1990 life expectancy in the US rose an astounding 6.2 years — due largely to new therapies for dealing with CVD.
Today we have the opportunity to further extend our ability not only to live but also to thrive at a high level of performance. And the impact on our health care system — not to mention our society will change the world … but only if we pay attention.
Posted by peterpitts at 12:09 PM
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March 26, 2007
LA Supplemental
by Peter Pitts
The New York Times editorial page thinks that the FDA should be 100% funded by legislative appropriations. Here we go again.
First, a correction that you will not see in the Gray Lady:
The Times writes that PDUFA fees “help finance the approval process …”
True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.
So what’s the big deal where the money comes from? Two big reasons:
(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.
(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the “drug-lag?” Yes, folks – it was real.
And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agency’s critics that, if only the FDA worked harder, they could replace “conflicted” advisory committee members with ones equally talented and more pure.
Malarkey.
Ladies and Gentlemen – mediocrity is not an option.
When legislators try to rewrite history we suffer the inevitable consequences.
Posted by peterpitts at 08:35 AM
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March 20, 2007
Buddying Up with the Amigo Society
by Peter Pitts
May I recommend Unlocking Ideas: Essays from the Amigo Society.
Edited by Francesca Ficai; Introduction by Jacob Arfwedson; Arne Björnberg; Manuel Campolini; Pat Cox; Brian Crowley; Duncan Curley; Johan Hjertqvist; Pavel Hrobon; Johnny Munkhammar, Peter Pitts, Jan Remans, Anders Sandberg.
The Amigo Society conferences, held in Brussels, were set up in 2004 to bring together public policy experts, media representatives and members of civil society to debate these and other issues of importance to an enlarged Europe.
Taking concrete examples from all over Europe and North America, this collection examines the broad motivations behind, influences on, and opportunities for future health and welfare policy reform. It also looks to the future – drawing in new fields of policymaking such as biotechnology, tailormade medicines and other technologies expected to drastically alter Europe’s healthcare landscape.
And driving it all, the final set of essays examines consumer empowerment as the major factor which will push forward reform of Europe’s health and welfare systems.
The book can be found at:
http://www.stockholm-network.org/publications/list.php#75
Unlocking Ideas: Essays from the Amigo Society assembles the highlights of these debates over the past two years and provides exciting new insights for the reformers of the future.
Posted by peterpitts at 09:45 AM
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March 19, 2007
The Side Effects of Side Effects
by Peter Pitts
Here's an interesting article from Medical Marketing & Media, with many good interviews (Dan Troy, Scott Gottlieb, Steve Galson, Andy von Eschenbach, Dan Carpenter, Sheila Burke, etc.), on the timely question, Wither PDUFA?
Voila la link ...
Worth a look.
Posted by peterpitts at 08:37 AM
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March 13, 2007
Thank you for not regulating
by Peter Pitts
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
Pending legislation (Kennedy-Cornyn and Waxman-Davis) aims to give the FDA broad authority over tobacco products, providing the agency with oversight over virtually every aspect of tobacco company operations. The knee-jerk reaction is "great!" But, when you ask ""Would such legislation result in fewer smokers and reduced death and debilitation from tobacco? the answer is very unclear -- with the weight of logic and evidence saying otherwise.
For example, proposed legislation would set 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. Who did these things? Largely the states. If FDA became the nation's tobacco czar, it would become difficult if not impossible to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
And 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? Let me put it this way -- none. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current PDUFA-IV negotiations, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues (and there are many others) the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So, for now, thank you for not regulating.
Posted by peterpitts at 06:45 AM
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March 12, 2007
Kids R'nt Us ... Yet
by Peter Pitts
Here's the lead from a story that ran in the Philadelphia Inquirer on a new study showing that nearly 80 percent of the children cared for at academic children's hospitals got at least one medicine outside the age parameters approved by the FDA:
"Most children treated at major pediatric hospitals are given medicines not approved by the Food and Drug Administration for use in patients so young. The study, in today's Archives of Pediatrics & Adolescent Medicine, found that the sickest children and those undergoing surgery were most likely to get a so-called off-label drug. But altogether, nearly 80 percent of the children cared for at academic children's hospitals got at least one medicine outside the age parameters approved by the FDA."
Why is this so? Well it's because of the big, bad, evil pharmaceutical industry don't ya know:
"The risk and benefits of many drugs in children are poorly studied, often because the drugmakers had little financial incentive to do so."
Well, not precisely. It's not the financial incentives so much as the difficulty relative to the return. I know, that sounds like verbal gymnastics. Try this -- the real issue is that FDA permitted pediatric clinical trial design makes it difficult if not impossible to precisely determine which medicines in what dosages work in specific circumstances in specific pediatric patient populations. In other words, if personalized medicine in adults is difficult, in children it is nearly impossible.
Yet another important reason for the FDA to embrace adaptive clinical trial design and to become a research hub for 21st century clinical trial design. And that, of course, is part of what makes the Critical Path program so, well, critical to the future of America's health.
Here's a link to the Inquirer article:
http://www.philly.com/mld/inquirer/16841956.htm
According to Samir S. Shah, the study's lead author and infectious-disease doctor at Children's Hospital of Philadelphia, "We don't know whether in the absence of off-label use there would have been fewer deaths or more deaths. I suspect that in many instances the drugs were beneficial and in a smaller number of cases the drugs were harmful."
That's good news. What would be even better news would be getting the right drug in the right dose to the right child at the right time based on sound science and under the FDA's imprimatur.
Tempus fugit.
Posted by peterpitts at 12:11 PM
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March 10, 2007
Global Women’s Equality? Not Really, Especially When it Comes to Health Matters
by Stephanie Koze
March 8, 2007 marked International Women’s Day. While gender and health equality are the expected norm – and almost taken for granted – in the U.S., advances in gender equality and women’s health globally need some work.
Consider the recent women’s health stories in the U.S. compared to the global news. Last week, U.S. media focused upon the benefits of fad diets in women, Botox, and other non-threatening health issues. Global media, however, asked why the Millennium Development Goals – established by the United Nations five years ago – promote gender equality and empower women, but they do not prioritize health issues, such as sexual health and violence against women.
According to a recent editorial in The Lancet, (vol 369; March 3-9, 2007), women count for three-quarters of the 960 million people worldwide who cannot read. What about their health? If they can’t read, how can they take, or administer medicine properly, let alone fight for access to healthcare?
Posted by stephanie_koze at 03:07 PM
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March 01, 2007
Even Empowered Consumers Require Activation
by Holly Heline Jarrell
We consumers have never been more empowered to maintain personal health. Our ability to find, filter and digest massive amounts of information, our access to the latest scientific and medical developments, and the national spirit of self-reliance that has permeated American society since the mid-1990s should all add up to a nation equipped to achieve better health. Yet, a very recent Harris Poll suggests that empowerment doesn’t always lead to positive action (see link: http://www.harrisinteractive.com/harris_poll/index.asp?PID=734 ).
The February 27 longitudinal poll among more than 2000 Americans puts added weight behind the obesity crisis: Since 1983, the proportion of people aged 25-plus who are obese has risen from 15% to 37% - an increase of 147%. Likewise, the percentage who are merely overweight rose from 59% in 1983 to 81% today.
By contrast, smoking is down to 23% of the public – but that’s only a 6-point decline over 24 years. And as Harris Interactive rightly points out, the big story here is not the change, but the slowness of change. Slowness despite abundant knowledge and educational resources – the real tools of empowerment.
The Harris Poll aptly demonstrates that when it comes to real change in personal health, consumers don’t just need to be empowered, they need to be activated.
Posted by holly_heline_jarrell at 05:17 PM
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