Envisioning 2.0

Over the past year, we have witnessed significant changes in the healthcare social media landscape – especially in the blogosphere. Healthcare providers are beginning to embrace blogs as a means of sharing information and their experiences with colleagues, patients and the general public. Major healthcare organizations, including the Centers for Disease Control and the publishers of the journal Health Affairs have launched Weblogs to facilitate dialogue about important subjects. These developments are cause for celebration.

However, fully embracing social media means much more than simply starting a blog or launching a podcast. It requires making a commitment to engaging in open and honest dialogue with stakeholders. Transparency and honesty are highly valued in the social media arena. However, this requirement has led many players in the healthcare system to fear it. Another reason is that many do not understand why social media is important or think those developing user generated content will have much impact on the healthcare system.
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In recent years, we have seen a lot of publicity on class action lawsuits filed by people claiming that they have been harmed by drugs manufactured by pharmaceutical companies. What has received less attention is the fact that we are beginning to see an increase in litigation by people asserting that they have been harmed in clinical trials.

According to an article, “Emerging Litigation Involving Human Research Subjects: A Future For Class Actions?,” published in the summer edition of the American Bar Association publication, The Brief:

“Human subjects of clinical research are increasingly suing the pharmaceutical and medical device companies, research institutions, and individuals who conducted the research. Recent litigation has even named review board members and patient advocates as defendants. The claims range from negligence, lack of informed consent, and fraud to more novel theories such as violation of a constitutional right to be treated with dignity.”
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Consumer-Driven Healthcare

New research published today on Health Affairs’ Website indicates that employers are increasingly embracing new “consumer driven” health plans. These forms of insurance place more financial burdens on patients by asking them to pay more for their care. Health Savings Accounts (HSA) are currently one of the most talked-about form of consumer driven insurance.

The study also indicates that one key criticism of consumer driven plans may hold water. Opponents of HSAs have suggested that wealthier and healthier people will populate these plans, while traditional insurance plans are left with sicker patients. Interestingly, (according to the Washington Post) the study shows that early enrollees in HSAs “tend to have higher incomes and be in somewhat better health than their counterparts in traditional plans.”

With consumer driven plans becoming more popular, people will be motivated to try and find information on the cost of medical care. Today, the Washington Post reports that a number of online services are attempting to fulfill this need. However, these Internet resources are currently less than stellar.
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ABC News has been focusing on the healthcare system lately.  In fact, they have even gotten some healthcare bloggers to write about it.  Matthew Holt and David Williams have both chimed in on this difficult subject.

Also, get the best of the health wonk-o-sphere in the latest (two-part) edition of the Health Wonk Review here and here.

I’d like to apologize to my readers for the recent problems you may have been having accessing this blog. Over the past week or so, prblogs.org has been having some server issues, which has resulted in the blog being unaccessible from time to time. Thank you for your patience and for reading this blog.

This article is part two of an ongoing series inspired by the Seattle Times special, “Suddenly Sick.” The Times’ series examines how the pharmaceutical industry promotes medications for a range of conditions, including hypertension and obesity. Click here to read other installments of “Disease Mongering Or Saving Lives?”

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A few weeks ago Bayer admitted that it had failed to tell the Food and Drug Administration about data from an analysis of 67,000 hospital records indicating that its heart surgery drug Trasylol may be linked to the increased risk of death, kidney damage, congestive heart failure and other dangerous side effects.

Last week, Forbes.com reported that Bayer has hired a lawyer to investigate how the company could have made such an egregious mistake. (Sidney Wolfe of Public Citizen said that Bayer’s failure to disclose the data was illegal.)

Bayer’s move is reminiscent of the one Merck made after Vioxx was withdrawn from the market. It hired Judge John S. Martin Jr. to investigate the circumstances leading up to the Vioxx withdrawal. Critics have called Martin’s report, which exonerates Merck’s senior management of wrongdoing, a “white wash.”

While scanning the headlines for interesting healthcare-related stories, I often find little tidbits of information and save them to blog about in the future. In this series, From the Back Pages I post links and commentary on a few of them. This month’s edition is below.

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In recent years, the headlines have been filled with news of efforts to ban bad health behaviors like smoking by passing legislation or imposing regulations.  A few years ago, New York City famously banned smoking from bars and restaurants leading to much hand wringing and praise. (There are signs however that smoking bans help restaurant and bar workers.  A study released in this week’s JAMA, suggests that a smoking ban in Ireland improved the health of these individuals.)

A couple of weeks ago, public health officials in New York City and Chicago accelerated the trend by calling for a ban on trans fats contained in partially hydrogenated oils used for frying and baking foods.  This move has attracted criticism as well, partly because the public health benefits of the ban are not well established. It is unclear how many lives will be saved if trans fats are banned.

However, the question remains, is legislating public health a good thing in the long term?  How should (and do) these efforts fit in with health promotion and communications activities?  Will we see the emphasis and funding for health education and promotion decrease as more bad behaviors are regulated out of existence?  Will people react to legislation by engaging in more bad behaviors as a means of bucking the system?

I’m not sure.  What do you think?

Earlier this year, I took a close look at Vertex Pharmaceuticals’ communications strategy for its new Hepatitis C treatment, VX-950. At the time, I cautioned against believing the hype about the drug until the company produced data supporting its safety and efficacy profile.

Right now it looks like VX-950 is on the right track. Standard & Poor’s recently conducted an analysis of the company suggesting that more positive data is forthcoming about the product. It says:

“In the second quarter of 2006, Vertex initiated the PROVE 1 (260 treatment-naive patients dosed with VX-950 compared with standard care in the U.S.) and PROVE 2 (320 patients in the EU) trials. The PROVE 1 trial is fully enrolled, and the company expects to release 12-week safety data for 80 patients by the mid- to late fourth quarter 2006. We believe that, based on prior safety data already presented, the odds favor a positive result from this trial. We think further positive results will have a favorable impact on the shares.

In the first quarter of 2007, the company expects to release three-month sustained viral response (SVR) data, which will measure the viral load 12 weeks after 12 weeks of treatment is stopped. In our view, this will be the key data for VX-950, as preliminary SVR is considered indicative of longer-term sustained response.

By mid-2007, Vertex expects to have 12-week treatment data for 180 patients and some follow-up data that it will use to design the Phase III trials. In all, the company believes that more than 1,000 patients will be enrolled in clinical trials by mid-2007.”

Clearly, Vertex has a long way to go before this drug is ready for review and potential approval by the Food and Drug Administration. However, these preliminary data indicate that the drug looks promising and will hopefully become a much-needed treatment option for those with Hepatitis C. (The FDA designated VX-950 for fast-track status in 2005.)

For more information on VX-950, please click here.