Envisioning 2.0

I will be taking a break from blogging for the rest of the year.  I will return during the first week of January.

I’d like to thank:

- Everyone who has subscribed to and read this blog over the past year

- All those who have agreed to be interviewed for articles

- All those who have left comments and helped to spark additional conversation and posts.

Thank you and Happy Holidays!

This article is part three of of a three part 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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While scanning the headlines for interesting stories, I often find little tidbits of healthcare-related 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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An article published in today’s New York Times reveals how Eli Lilly and Company worked with its sales force to market its anti-psychotic Zyprexa.  The Times suggests that the documents show how Lilly convinced doctors to prescribe Zyprexa for an off-label indication (dementia).  The medication is approved for the treatment of schizophrenia and bipolar.

Lilly denies that it asked its sales force to market Zyprexa for unapproved uses.  According to the Times, a Lilly spokesperson said the company: “never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration as required by law.”

Click here to read the Times’ article.

Yesterday, the Wall Street Journal reported on a debate that is raging within the OB-GYN community about the utility of testing pregnant women for herpes and treating them if they have it.  The title of the article, “Drug Firm’s Cash Sways Debate
 Over Test for Pregnant Women,” clearly suggests that herpes drug maker GlaxoSmithKline is benefiting from this debate.  The article highlights the efforts of Dr. Zane Brown a herpes expert who has conducted lectures on behalf of the drug maker.  Brown is an advocate for herpes screening.  However, the medical evidence indicates that screening is not medically necessary or cost effective.

Dr. Roy Poses, who contributes to the blog Health Care Renewal, views the Brown case as another example of the pervasiveness of conflicts of interest in medical care today.  Poses has written a number of articles focusing on this issue this week on his blog.  A few days ago he discussed the recent indictment of  Dr. Pearson Sunderland III, of the National Institutes of Health who conducted consulting work for Pfizer while serving the agency.   Suderland has plead guilty to the charges.
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at MSSP Nexus Blog.

Earlier this year, my firm Envision Solutions and The Medical Blog Network launched the first global survey of healthcare bloggers. Today, we released the results of this poll, which will be discussed during the Healthcare Blogging Summit this afternoon in Washington DC.

Following are some key results of this survey:

- Many bloggers are writing for altruistic or personal reasons, i.e., to share their experiences or educate others

- A number of bloggers hide their identity to protect themselves, friends, family, patients and careers

- Many respondents view their fellow bloggers’ statements with a critical eye. However, they are confident most bloggers will make it easy for them to access a range of perspectives via their blogs

- About half of those contacted by PR professionals write posts based on information they receive from them

- Respondents are split on whether running advertising compromises the integrity of healthcare bloggers. However, many are willing to invite advertisers to appear to their blogs

Click here to download the full results of this survey.

After months of political wrangling the Senate confirmed Andrew von Eschenbach, MD as the head of the Food and Drug Administration last night. His ascension to the top spot at the agency comes at an opportune time as it faces a number of very difficult challenges.  Some of the most important include:

-    Expanding the FDA’s budget given the raft of additional regulatory duties it is being asked to take on

-    Streamlining and improving the review of direct to consumer advertising/marketing

-    Managing conflicts of interest on FDA advisory panels

-    Monitoring the safety of medications after they have been approved by the agency

-    Determining whether and how to develop a generic market for biotech drugs

Look for von Eschenbach to appear at a number of Congressional hearings on these issues next  year.

Pfizer has already lost $20 billion in shareholder value because its stock plummeted after it announced its decision to halt testing on its experimental cholesterol medication torcetrapib. However, does Pfizer stand to lose more money due to litigation? Heather Won Tesoriero who contributes to the WSJ Law Blog had this to say:

“The company is unlikely to get hit with personal injury lawsuits because the patients took torcetrapib in clinical trials. According to Roger Morris, health group chair at Quarles & Brady, there’s some fairly standard language used in informed consent that typically absolves companies of liability in clinical trials at the negligence level or below. But lawyers say Pfizer will likely see securities-fraud litigation. The company’s stock closed down 10.6%. How far and long the stock sags will help plaintiffs’ lawyers weigh the merits of a shareholder suit, says Scheff, whose big pharma clients include Schering-Plough and Johnson & Johnson.”

Although experts are not certain that Pfizer will be sued by clinical trial participants (or their families), I would not be surprised if it happened. As I noted in this post, patients are filing suits where they claim that companies, scientists and review board members were negligent and did not properly inform them of safety issues relating to the drug they agreed to help test.

In addition, there is precedent for a shareholder suit. Earlier this year Bristol Myers-Squibb (BMS) paid $185 million to investors who charged that the company mislead them about Vanlev, an experimental high blood pressure medication. They said that BMS’ rosy statements about Vanlev’s safety and efficacy profile artificially inflated the price of the company’s stock.

Only time will tell if Pfizer will have to dedicate some of the money it is saving by slashing staff to defending against lawsuits. However, because Pfizer’s CEO is a lawyer, I’m sure that already has his legal team to preparing for potential litigation.

In a stunning development, Pfizer announced last night that it would cease development of its “good” cholesterol raising medication torcetrapib. The company spent $800 million to study the drug. One can only assume that the company decided that it would be very difficult to sell a heart medicine that paradoxically increases blood pressure.

Learn more by clicking here.

Update: The Wall Street Journal reports that Pfizer decided to stop the torcetrapib trials because patients taking the drug (or a combination of lipitor and trocetrapib) suffered more deaths.  After reviewing the data, Pfizer decided to pull the plug.