Envisioning 2.0

We all know that when it comes to communications, actions speak louder than words. For those who have accused the FDA for caving in to the pharmaceutical industry and approving unsafe medications, new data compiled and published today by the New York Times belies critics’ assertions.

According to the Times:

- Only 1 out of 14 drugs submitted for approval during fiscal year 2005 were cleared by the agency during initial review
- It is getting tougher to get medications similar to those already on the market through the FDA – especially if they have side effects
- Drugs for diseases like cancer are receiving fast-track review and approval by the agency.
Read the rest of this entry »

Today the Wall Street Journal reported on a study that revealed that one out of eight heart attack patients stopped taking medication one month after they left the hospital.  That’s an incredible statistic, especially for people with such a serious condition.  This study also indicates that people who are older, single and less educated tend to be more non-compliant than other patient populations.

Clearly, this study and others indicate that compliance marketing is needed more than ever.  Pharmaceutical companies spend lots of time and money developing programs to encourage people to comply with their medication.  They have tried everything from hiring celebrities to talk compliance to implementing special reminder programs with varying degrees of success.

Managed care organizations interested in preventing hospitalizations have also produced initiatives focused on noncompliance. Again, they have been less than successful.

This new study indicates that people interested in preventing noncompliance might want to focus more efforts on older and less educated people.  However, before this happens, we will need to increase their health literacy, which is also at a generally low level.

Hopefully this study will result in renewed public and private sector efforts to improve compliance, which may help reduce the overall healthcare cost burden.

The Institute of Medicine issued a largely negative report on the FDA’s efforts to ensure that prescription drugs are safe and effective today.  According to the IOM:

“Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits have hampered the U.S. Food and Drug Administration’s ability to evaluate and address the safety of prescription drugs after they have reached the market, says a new report from the Institute of Medicine.  Noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.  Recommendations include:

- Labeling requirements and advertising limits for new medications
- Clarified authority and additional enforcement tools for the agency
- Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
- Mandatory registration of clinical trial results to facilitate public access to drug safety information
- An increased role for FDA’s drug safety staff
- A large boost in funding and staffing for the agency”

The FDA’s acting commissioner, Dr. Andrew von Eschenbach responded to the IOM’s report, saying:

“As the IOM report recognizes, much progress and reform of FDA’s safety oversight enterprise is already underway.  Specifically, the FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues.  All drugs have risks. Our challenge is to uncover these risks as soon as possible.  Through initiatives like Critical Path and Personalized Medicine, we are also working to improve the tools we use, to more effectively evaluate new products and processes.

I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission.  Over the next months you will be hearing extensively from us about these new endeavors, including a number of initiatives aimed at improving the opportunities for employees of FDA to shape a more effective work environment.”

Earlier this week, Wal-Mart announced that it would sharply reduce the price of generic medications it offers to as little as $4 for a 30 day supply. Wal-Mart’s move has already had a profound influence on the stocks of pharmacy retailers and generic drug companies. However, despite Wal-Mart’s size, some are saying that the program will have a limited impact on the overall marketplace.

There are also policy and communications implications of this move. Most importantly:

It Will Bolster Wal-Mart’s Image: The move may gain Wal-Mart some supporters in the influential elderly population who will benefit from having access to inexpensive medications — especially those on fixed incomes. BusinessWeek reports that the generics program is part of a “carefully orchestrated” campaign to improve its image and brand. Action always counts much more than a soundbite and this program will earn the company some much-needed goodpress.

Will This Impact The Healthcare System? Right now the Wal-Mart program is focused on generic drugs. What would happen if Wal-Mart decided to reduce prices for routine healthcare? PBMs are not very happy about the deal because it may reduce their market share and negotiating power. Overall, Wal-Mart’s move illustrates the power of a global business to change the rules of the game in healthcare.

For more coverage of this issue, please see:

-The Health Business Blog: Can Wal-Mart Save The American Healthcare System?

- 24/7 Wall Street: Implications Of Wal-Mart As A Drug Dealer

In an extensive interview published in the September edition of Pharmaceutical Executive, Senator Charles Grassley, a long-time critic of the Food and Drug Administration (FDA), blasts the agency for putting patients last and pharmaceutical companies first. Following are some of his more biting comments.

- The FDA Is More Worried About PR Than Patients: “There is a culture within the FDA that’s more worried about its public relations than it is about patients. Now I can say the same thing about the FBI, and I have. It may not just be an FDA problem, but a culture problem in all government. You see it, for instance, when the Office of New Drugs approves something, and the Office of Drug Safety raises questions about it. The Office of New Drugs doesn’t want egg on its face, so it tries to squash the controversy.”

- The FDA Is Too Cozy With Pharma: [I]t seems to me, the relationship between FDA and pharmaceutical companies is too cozy. We see evidence of this in some of the telephone notes and e-mails we’ve had access to. It’s just not right. The only person that should be across this table from the FDA is John Q. Public. It seems like FDA officials see themselves too much as facilitators working with the drug companies—instead of regulators.

- Drug Ads Don’t Effectively Communicate Drug Side Effects: “I’ve watched so many of these commercials and feel that the dangers [of drugs] are not as obvious as they ought to be. When the person presenting the commercial gets to the lines about safety, they go very very fast. It just seems to me that that compromises the safety issues of some drugs. And so I’m not looking at it from the standpoint of whether there ought to be drug advertising or not. I’m looking at it from the standpoint of it being effective advertising regarding drug safety. We have asked the Government Accountability Office to examine DTC advertising on safety issues. A report should be out early next year.”

(The current edition of Pharma Marketing News features a very interesting analysis of risk vs. benefit information in print DTC ads. It’s worth a read. Click here to access the article.)

Click here to read Grassley’s remarks. I’ll be focusing on the topic of the current communications enviornment faced by the FDA in the next edition of my firm’s newsletter, Envisioning.

This is the last major article in an ongoing series on this blog titled: “The FDA and the Pharmaceutical Industry.” Posts filed under this category focus on the intersection and relationship between the agency and drug companies.

A few months ago, I conducted an interview with Dr. John Powers, Lead Medical Officer for Antimicrobial Drug Development & Resistance at the FDA. During this wide-ranging discussion, we talked about a number of important topics, including efforts to curb the spread of antimicrobial resistance, the drawbacks of non-inferiority trials and FDA advisory boards. Powers’ extensive commentary appears below. Read the rest of this entry »

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. Read the rest of this entry »

Not Even A Pen: Stanford University is instituting a new policy aimed at curbing the influence and access of drug reps on physician-decision-making. The new policy, set to go into effect on October 1 will:

- Ban doctors from accepting samples and publishing articles “ghost-written” by industry contractors

- Prohibit doctors from accepting pens, mugs and other small gifts

- Sales reps will be banned from areas where patient education and treatment occur

Commentary: Does the Stanford move signal a trend? With many common marketing practices being proscribed what methods will pharma turn to drive sales? A few options include:

- More public relations (See this article from HealthCareVox for more.)

- More eMarketing (See this article from HealthCareVox for more.)
Read the rest of this entry »

According to the Wall Street Journal, Bristol-Myers Squibb decided to fire CEO Peter Dolan last night. The board took action after a federal monitor recommended that Dolan and the company’s general counsel Richard Willard be sacked because of their actions relating to the botched deal with Apotex to protect Plavix’s patent.

The monitor, Frederick B. Lacey said that Dolan’s Plavix-related actions violated the terms of an agreement the company made with the federal government after a three-year investigation into its efforts to provide wholesalers with more product in an attempt to meet sales targets.

Dolan is the third CEO of a pharmaceutical company to be dismissed in the past 16 months. Pfizer’s Henry McKinnell was fired in July and Merck’s Raymond Gillmartin was forced into retirement in 2004.

See below for previous coverage of Merck on this blog.

- The Failed Plavix Deal and the Coming Wave Of Generics

- Vanlev Postmortem: BMS Pays The Piper

Over at HealthCareVox, I’ve been blogging quite a bit about the impact of social media on healthcare communications. Writing these posts got me thinking a lot about how to encourage people in the healthcare industry to engage social media more deeply. To assist, I decided to develop a new free e-book, “From Command & Control To Engage & Encourage.” This publication is designed to help people in the healthcare industry communicate successfully in a world where social media is becoming increasingly influential.

For more on this e-book and the ideas that inspired it, please see this post on HealthCareVox. To download the e-book, please click here. Feel free to pass it on to anyone you feel will find it useful.  (Please help the ideas in this e-book spread.  Click here to learn how.)