Invest in Healthcare, But What Exactly?

A recent Wall Street Journal piece regarding why pharma is having problems producing effective product caught our eye. The Feb. 9 op-ed article, called “Health-Care Investment: The Hidden Crisis” [subscription-only access] lays out ways that Washington “can remove some of the barriers to growth in medical research.” Its author: Michael Milken.

He argues that “improved public health translates directly into greater national productivity, which underpins all economic growth.” He cites figures showing how life-expectancy gains have added to America’s prosperity, and expresses concern that cuts in NIH funding “will cause some younger medical scientists to either change careers or take their work to places like Singapore” which welcome researchers.

The barriers he talks about are the usual suspects: anticipated patent expirations, regulatory issues, qualms about litigation exposure, and high U.S. taxes on repatriated overseas earnings.

Mr. Milken is on point linking ROI and extended lifespan. The study he cites –- that gains in life-expectancy since 1970 have added $3.2 trillion per year to "America's national wealth" – is impressive. We further argue that if more attention were paid to medication adherence, then that figure would be even more impressive.

Mr. Milken also argues that the FDA needs more resources to “keep up with the pace of innovation in such areas as medical-device development and regenerative medicine.” Agreed – let alone with inspecting clinical trials on foreign soil.

But let’s also consider this: The FDA needs resources to find different ways to solve their medical information problems. While the FDA guards public health, the FDA doesn’t produce good guidance on medical information and as a result industry may not provide good medical information to the patients using its products. A few years ago, the public didn’t have access to this information, but now it does. And the public will be talking about this information on social media sites. We believe the FDA isn’t moving quickly enough on its social site regulations or being adaptive enough about the content it regulates. It needs the time and resources to define flexible policies, not to apply additional funds to enforcement.


To our way of thinking, the FDA should become less regulator, and more healthcare-outcome policy initiator and promoter.

Patient Bloggers and the "T" Word

What an opportunity for industry to regain the public’s trust – or at least some of it.

We’re talking about industry’s use of social media to promote and market product, an excellent way to bypass mainstream media and hone the message. Even though the FDA is expected this month to present guidelines on how pharma can market medicines on Twitter, Facebook, and the like, the agency really has no say on what individual patient bloggers may say about their relationships with industry members.

To quote Pharma Marketing Blog's John Mack: “FDA cannot enforce transparency -- it has no authority over patients who are free to do and say what they like without mentioning any relationship they may have with pharma companies.”

According to Pew Research, about 61% of adults turn to the web for health information, and no doubt some of those people read those blogs. But do those bloggers disclose their relationship with pharma members, if one exists? We think they should.That is why like Sally Church (@maverickNY) we are going to create a disclosure section of this blog and our web site. Trust can be re-built one brick at a time.

And that goes for industry as well: The pharma member who ensures that the blogger discloses the connection is that much closer to establishing company loyalty among the readership.

It’s the T word, folks.  But stay tuned, because the storm around content creation in the industry is the next chapter in this story.  

FDA Warning Letters: The 30,000 Foot View

In 2008, the FDA issued 21 warning letters for what it considered misleading marketing tactics. So far this year, the agency has issued 68 – Baxter International Inc. received one in early September. A week after the FDA said that the drug maker made misleading claims about the efficacy of its lung drug, Aralast, Baxter withdrew the offending material.

We think it’s time to take the 30,000 foot view on the FDA’s aggressive game plan.

Are industry members behaving so badly that the agency has had no choice but to triple the number of warnings? We think that’s unlikely. What is more likely is that the FDA is reacting to political pressure to rein in industry members. While in some cases there is arguably a need for such pressure, we have to ask: Are patients getting good information from all this regulation, and is it even valuable?

From our vantage point, the FDA's promotional review processes are over-regulating marketing materials, and all these warning letters show that. One unintended consequence of the agency’s overzealousness -- as well as some industry attorneys' -- is that the public thinks that industry products are unsafe. Now our interpretation of the FDA's guidance is to warn and make people aware of the risks, but should the risks outweigh the benefits a new therapy can have?


Could all this "regulated information" being put out by companies be creating more harm than benefit?  More patients are looking for product information on the Internet. What happens when they end up on sites where the information is less than accurate?

While we suggest that industry members follow FDA regs to the letter so they can avoid embarrassing mentions in the media, we also would love to see the agency explain how its mandates are contributing to the public’s health. Is the end product of a FDA promotional review really well received by the public?

Prescription Drug Web Sites: A Few Wrong Rubs

A study that looked at the Web sites of the top 100 pharmaceutical brands and concluded that the FDA needs to exercise more control over how these sites look rubbed us the wrong way. The paper, called “Manufacturers' prescription drug web sites: A gray area of discourse and ethics,” was presented at a conference in June. If the study’s on the Web, we couldn’t find it.

A few words on the wrong rubs.

First, women do most of the health-related shopping in the U.S., and few of them – or so says the Pink Study – get their information about a drug from the brand’s Web site, so is there a excessive reason to be alarmed? The Pink Study, primarily of college-educated ladies, showed that these women rely on their own research to get the answers they need about prescriptions they’re received. While the web may be one source of information, it is not the sole source of the information.

As for others who visit the Web site: Presuming that consumers will be misled by information they read on the site presumes that all consumers are stupid. This we believe is an assumption our FDA believes is true.  Even the study authors – from Dartmouth and the University of Minnesota -- want the drug information pages to be tagged with a genre name such as “infomercial.” But do people realize that most if not all the content on a drug web site is regulated?  The content needs to be "fair and balanced" according to the FDA; the industry spends a lot of money to hire attorneys to make sure this happens.

But in all fairness, maybe we're shooting the messenger here. While we understand the FDA's need to protect the American consumer from inaccurate, false and misleading information, might the study's findings also be a reflection of the agency's regulations? If the study authors understand that the FDA controls the content, the study doesn't reflect that. The FDA sets policy, and it's FDA policy or lack of leadership that skews content in this way.

Yes, some of the fonts on the Web sites are small, there’s no question about that. It would not be a big deal for the FDA to say: Make it 18-point, or something like that. But what is needed here is leadership, something the FDA doesn't seem to want to provide companies with that it regulates, or what the American consumer may want.

Something else bothered us about this whole thing, but it had nothing to do with the study. It had to do with the way the press covered this story. There was a time when the press made an effort to get both sides of the story. Not here. After putting the title of the paper in Google, we searched all the entries. Not one media outlet that covered the release of the study called any industry member for comment.

Not sure if that’s a sign of the quality of journalism today, or an indication of industry’s reputation. Either way, it’s not good. Food for thought as marketers try to get a handle on their marketing channels.