Envisioning 2.0

Wayne Pines, who served as associate commissioner for public affairs at the Food and Drug Administration, has weathered his share of crises. Recently, he spoke with my firm Envision Solutions about effective crisis communications and the negative public opinion of the pharmaceutical industry and the Food and Drug Administration. He had this to say about the value of working with experienced crisis managers:

“Many communications professionals claim to be crisis managers. Everyone alive in 1982 takes credit for helping Johnson and Johnson manage the Tylenol crisis. In fact, few communications professionals really have managed crises, and still fewer have been effective spokespeople during one. So, my advice is: Be modest about your skills and experience. Don’t delude your company or client, and especially yourself, into thinking you know what you’re doing. Learn from others by reading or communicating with experienced people. (I often see inexperienced people learning at their company’s or client’s expense.) Admit when you need help, and seek it.”

Read more from Pines in the latest edition of my firm’s quarterly newsletter, Envisioning by clicking here.

at the Health Care Blog.

An article published in the Memphis Business Journal recently highlights the tough road ahead for those seeking to get more people enrolled in consumer driven health plans (CDHP). Younger, healthier and wealthier people have signed up for Health Savings Accounts (HSAs) but the majority of the insured are loath to try them out. Michael Dreve of UCL Financial Group explains why most of the low hanging fruit has already been plucked:

“When someone is told that under an HSA their doctor’s visit will cost them $180 for primary care and $230 for a specialist, they’ll typically retreat for the PPO and the $20 co-pay. What they don’t see, Dreve says, is the $1,300 the employer is paying each month. Brokers call it the ‘hidden paycheck.’”

Experts say that the key to winning over skeptical employees to HSAs and other forms of CDHP is education and flexibility. Specifically:

-Plant the seeds early with middle managers and explain the benefits and drawbacks of CDHPs

-Explain the positive financial implications of HSAs

-Where possible, have employers match employee funds placed into HSAs to increase acceptance

-Don’t force people into an HSA; show them the benefits of switching from a traditional managed care plan and let them decide what they want to do

It’s been a wild, wild few weeks at the Food and Drug Administration. Since Andrew von Eschenbach took the helm, the agency has engaged in a number of defensive moves designed to assuage critics and pre-empt Congressional action. However, the agency can’t seem to catch a break as observers on all sides pan the FDA’s actions. In addition, von Eschenbach had to backpedal after he made remarks that seemed to indicate he would punish FDA officials who went around the system. Take a short ride on the FDA rollercoaster with me as I highlight some recent agency-related events.

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“Technological breakthrough.” This is the headline of an article focusing on Pfizer’s new inhaled insulin product Exubera that was published in the March 2007 edition of Med Ad News. According to the article:

“Pfizer executives tout Exubera as a major, first-of-its-kind, medical breakthrough . . . The Wall Street Journal recognized Exubera first in the biotechnological and medical category as a technological breakthrough with the bronze award overall for its ‘Technology Innovation Award’ in 2006.

While Pfizer is being praised by industry insiders for succeeding in bringing inhaled insulin to market, consumers and physicians are not so pleased with Exubera’s product design. Jim Edwards of BrandWeek and Amy Tenderich, who writes the blog DiabetesMine, have been two journalists highlighting Pfizer’s issues with Exubera. Edwards observed:

“Last year, Pfizer paid Sanofi-Aventis $1.4 billion for Exubera, a new inhaled insulin product for diabetics that Pfizer forecast would produce $2 billion in sales every year. What Pfizer got for its cash was a device that looks a lot like a marijuana bong—and a brand that analysts, doctors, drug sales reps and some patients believe is a struggle to sell because it is so inconvenient to use.”

Tenderich said:

“Why is it that Apple can spend millions designing the perfect — and perfectly aesthetic — little machine just to play music, while we wait decades for inhalable insulin and end up with a big plastic bongish-thing in bad colors? It has to be a Consumerism issue. Because for the most part, we don’t shop for our D-devices at Wal-Mart. We don’t buy them as Christmas gifts. We don’t replace them every time a cool new feature is added.”

Pfizer is launching a direct-to-consumer advertising campaign, which according to Bloomberg, is designed “to overcome the product’s higher cost and the inconvenience of the device used to administer the drug.”

Clearly, there is a disconnect between the folks at Med Ad News/The Wall Street Journal and everybody else when it comes to Exubera. Pfizer will be working hard to bridge the gap between its belief that the product is groundbreaking with physician and consumer perceptions of it. I think the company will have a hard time without designing a more functional and aesthetically pleasing product.

John Mack, publisher of the popular blog Pharma Marketing Blog, has launched a Rozerem boycott. He is doing this because Takeda, the company that manufactures the sleep aid, violated “its pledge to abide by PhRMA’s Guiding Principles for DTC Advertising.” These voluntary regulations prohibit drug companies from running “reminder ads,” which mention a drug name but not what it is designed to treat or its side effects.

The FDA recently sent Takeda a warning letter because it ran a reminder advertisement, that suggested “pediatric patients” might benefit from Rozerem. In a surprise announcement, Takeda said that it had nothing to do with the commercial. Matt Kuhn, Takeda’s director of public relations, told Medical Marketing and Media: “To date, our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question.”

The company’s critics responded to Takeda’s statement with skepticism. Given the usual scrutiny pharmaceutical companies place on their public statements and marketing campaigns, they could not believe that Takeda was unaware of the reminder advertisement.

Mack has been engaged in a months long campaign against Takeda’s advertisements because they feature imagery that does not highlight the drug’s efficacy profile. He is also skeptical about whether the campaign has increased Rozerem’s sales. Brand Week reported that Takeda’s Rozerem-related marketing costs have outstripped the drug’s revenues.

Despite Mack’s problems with Takeda’s advertising strategy, it appears that some consumers like the commercials. According to a USA Today Ad Track poll, 12% of consumers surveyed said they like the ads “a lot.” However, 19% dislike the commercials. In addition, 11% feel they are “very effective.”

Although these positive numbers are very modest, Takeda’s ad agency is pleased with the results of the poll, partly because the Rozerem ads are scoring higher than other drug commercials, which Americans don’t like very much.

One thing is certain, the Rozerem wars will continue.

at Managed Care Matters.

If you live in New York, it is likely that you have seen the numerous television commercials attacking Governor Eliot Spitzer’s proposal to cut $1.2 billion from hospitals and nursing homes. Opponents of the plan say that if Spitzer succeeds the state healthcare system will less rather than more healthy.

Complicating the battle is the state’s effort to close or merge “dozens of hospitals and nursing homes.” According to the Opportunity Agenda, a communications and research organization, historically hospital closures have disproportionately impacted people living in minority neighborhoods.

To help the public better understand the impact of hospital closures on minorities, the non-profit has developed a series of interactive maps “designed to visually illustrate the economic and racial disparities that exist in New York City’s health care system.” According to the Opportunity Agenda:
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With all of the news about Walter Reed, you may have missed some other health-related Congressional action that has been brewing over the past few weeks.

First, Congress has responded to news reports about drug eluting stents and Eli Lilly’s Zyprexa by launching probes into how these and other medications are marketed and researched. Rep. Henry Waxman sent letters to several companies requesting information about these issues earlier this week.

Second, the drive for generic biologics is proceeding apace and the former head of the Centers for Medicare & Medicaid, Mark McClellan, is bullish on this new trend. In an article I wrote on HealthCareVox, I said that the growing furor over expensive biologics may damage the otherwise stellar reputation of the biotech industry. BIO, the industry trade group, is lobbying Congress hard to shape legislation favorable to its members, but if McClellan is correct, we should see a bill (written by Waxman) debated sometime this year. However, McClellan warns that before passing a bill, Congress must address concerns about potential adverse events and other safety problems caused by biogenerics that are not manufactured properly.

Clearly, recent events indicate that Congress is taking aim at two issues critics of the biotech and pharma industries have longed complained about. The off-label marketing investigation may cause pharma’s communications departments to become even more risk adverse and conservative than they already are. Depending on how biotech companies respond to the push for generic biologics, we could see a spate of negative media coverage or none at all.

It will be interesting to see how the Democratic Congress continues to flex its (healthcare related) muscles in the future.

An interesting article published in today’s New York Times reveals the perils of the individual insurance market – especially for people with pre-existing conditions. The Times focuses on the plight of the uninsured middle class, including freelancers and independent contractors. According to the article, realtor Vicki Readling:

“[D]oes not receive health benefits from an employer. She tried to buy a policy in the individual insurance market, but — having had cancer — could not obtain coverage, except at a price exceeding $27,000 a year, which was more than she could pay.”

Yes, many uninsured are not poor, unemployed or illegal immigrants. Instead, one-third have incomes of more than $40,000 a year.

For consumer-driven healthcare boosters, this group represents an ideal market, but many high deductible plans are too expensive for them to purchase. Can sites insurance shopping services like the one being planned by Revolution Health help?

Only time will tell.