Don’t Believe The Hype — Yet

February 7, 2006

Prologue: The Tale of the Over-Hyped Drug

Excitement is high around the latest potential blockbuster product from a major pharmaceutical company. Physicians and company spokespersons describe the new medication in breathless prose. “This drug has the potential to transform the way we treat this illness,” they proclaim. The firm fires up its PR engines and glowing stories about the medication begin to appear in medical and business press.

Despite the frenzy around the new product, a few suggest patience. They note that the company has only completed preliminary clinical studies and it will take a lot more testing before the full potential of the medication is realized. However, their warnings are ignored.

Then, disaster strikes. Phase III clinical trials reveal that certain patients taking the medication suffer from severe side effects. To make matters worse, the medication is not as efficacious as previously believed. The company’s stock price plummets and investors, patients and others demand answers from the suddenly beleaguered firm.

“The Tale of the Over-hyped Drug” is a familiar story to anyone following the pharmaceutical and biotech industries. The field is littered with the carcasses of once-promising medications that failed to meet expectations. Vanlev, Exanta and Iressa are just a few of the medications that have either under-performed or failed to win FDA approval.

Despite these object lessons pharma and biotech firms continue to hype unproven medications. One example is the much-heralded experimental hepatitis C drug, VX-950. In May, the Hepatitis C Association asserted that the medication “had the most powerful punch yet seen against this major cause of liver cancer.” (The New York Times published a report on the medication today.)

Some of the excitement around VX-950 is well-founded. Hepatitis C is a devastating disease. However, there are precious few effective treatment options for the illness. VX-950 appears to pack a powerful punch. When combined with interferon, a common therapy, VX-950 reduced blood levels of hepatitis C to undetectable levels, according to a press release issued today by Vertex Pharmaceuticals, makers of the drug.

However there is a catch to this exciting news. First, the Vertex study was a Phase II trial. Much larger Phase III studies will be required before the true effectiveness of the medication can be evaluated. In addition, the trial enrolled only 12 patients. While VX-950 demonstrated great efficacy in this group, it will be years before we know whether this treatment is what it seems.

According to the Times, the preliminary results of VX-950 clinical trials have not stopped Joshua Boger, the head of Vertex, from boasting about the drug. According to the Times: “Mr. Boger began his talk [at a J.P. Morgan health care conference last month] by showing a picture of the Apple iPod. ‘Every so often,’ he said, ‘there is a game-changing product — one that transforms a product category, one that transforms a company and one that transforms an industry.”

Strong words for a medication that one of Vertex’s own investigators is urging caution over. In a report by the Hepatitis C Association, Dr. Henk W. Reesink of Academic Medical Center in Amsterdam, Netherlands, warned that “nobody knows if [VX-950] will prove safe over time. Nobody knows whether its effects will continue long enough to cure hepatitis C virus infection.”

Given Vertex’s financial situation (it has lost nearly $1 billion over 16 years) it is not surprising that Boger is hyping the drug. VX-950 could reverse the firm’s fortunes. More importantly, VX-950 is a promising medication that has the potential to significantly improve the lives of those suffering from hepatitis C. Given this, I would hate to see this medication not live up to expectations.

I recommend caution. Under-promise and over-deliver. It’s not the most exciting of strategies, but in the volatile and unpredictable biotech industry, it’s a good one. I’ll be ready to believe the hype when the drug delivers. Until then, it’s wait and see for me.


Guest Article — Pharma: Have No Fear Of The Blogosphere

February 5, 2006

Update: Shel Israel, co-author of Naked Conversations, recently posted about a chat he had with an exec who says vendors are urging pharma to blog. He reports that Pfizer is too scared to blog because of fear of regulation. Shel: The next time you’re talking with a pharma exec, please direct them to the essay below. I think it may help to alleviate any fears pharma has of the blogosphere.

Original Post: Recently, I have been conducting research for a report I am developing on blogging in healthcare. Shahid Shah, a healthcare IT expert and a corporate blogging evangelist, graciously agreed to be interviewed for the report.

Shahid is well-known in healthcare blogging circles and beyond. He was recently interviewed by Backbone Media about healthcare blogging. Shahid runs the HITSphere blog aggregator as well as his own Healthcare IT Guy blog. He was also featured in DataMations magazine’s recent Blogging Your Way Up the Career Ladder article.

Given Shahid’s expertise on this subject, I decided to invite him to talk with a little more specificity about pharmaceutical and regulated products blogging. His article appears below.

Corporate blogging is certainly not new but it hasn’t really taken off because executives are always nervous about public statements they make, especially if they run a public company. Until now only small firms, who have much to gain with direct 2-way contact with their customers, have really engaged their clients through blogs. Now, however, even the big companies as different as McDonalds and Microsoft have become corporate bloggers with different degrees of success.

The pharmaceutical industry is certainly one group of companies that could use increased goodwill that comes from direct contact with their customers. If anyone should be blogging from a corporate perspective it should be big pharma because what it does directly touches the lives of its customers in a way very few other industries do. The level of importance people give to their health and the way that they bond with their healthcare providers (and by extension the drugs they take) is very important. Most pharma companies are worried about the FDA and cite that as a big concern about why they don’t blog. But, I think that’s a mistake.

Pharma shouldn’t worry too much about what the FDA has to say specifically for blogs. Blogging does not impact anything that wouldn’t already be public anyway. For example, if a pharmaceutical firm has a call center where they answer questions about their drugs’ on-label use, a blog would be no different. In fact, drug firms can improve customer service by providing tips, tools, and guidance on how best to use their drugs. I would recommend that firms start to create blogs that start to tell stories of why scientists (in their own words) are focusing on certain diseases, how far technology has come along, how exactly drugs go from an idea to discovery to production. All these would bring customers closer to them, not alienate them. And, the FDA won’t complain about anything that doesn’t cause off-label use. Fard and I spoke with an FDA counsel this week and they basically said the same thing (without providing specific or official legal guidance). Anything that’s covered by existing guidance would apply to blogs, too.

If a drug vendor starts a blog or discussion forum about its products and doesn’t mis-communicate about efficacy of its products or fitness for a particular purpose it shouldn’t get into trouble. Companies won’t have problems with regulators if they stick to the truth about their products and improve the way customers interact with them. That doesn’t mean they shouldn’t be careful about what they say — but that goes for anything a company says. It’s not something special to blogging but blogging does make it easy for people to say whatever they want (like folks do in an email).

So, if you’re not blogging today don’t blame the feds. If you’re not creating corporate blogs, it’s due to a lack of vision and innovation and perhaps a lack of respect of your customers, not the FDA. Guys like me and Fard can help you devise an appropriate strategy to allow direct communication, improved customer service, and who knows in a few years people may stop thinking of big pharma in a poor light like they do now.

Oh, and by the way, don’t think that just because you’re not blogging about your own products that nobody else is. Nature abhors a vacuum but so does the blogging community. Third parties are already talking about your drugs and company in their own blogs and forums. Why not take the initiative and help navigate people to the “official” word about your drugs?


Issues Management Moment: Michael Moore Issues Casting Call

February 3, 2006

Michael Moore has issued an appeal to HMO workers, pharmaceutical company executives and others involved or impacted by the healthcare industry to relate their experiences to him. This appeal, which was posted yesterday on his Web site, is titled, “Send Me Your Health Care Horror Stories.”

Rumors have been swirling for months that Moore was going to focus his documentary on the pharmaceutical industry. In fact, some suggested that he would show up at medical meetings — with camera crew in tow — ready to film interactions between physicians and pharmaceutical representatives.

It is possible that he may still decide to do this, his Web site indicates that he is going to focus his ire on the HMO industry. However, knowing Moore, no area of the healthcare industry is safe.

Healthcare crisis communicators and issues managers start your engines. It’s going to be a long and bumpy ride.