Envisioning 2.0

Merck and now Pfizer are the latest pharmaceutical companies to announce that they have decided to offer “authorized generics” of two blockbuster cholesterol and depression medications that are going off patent.

The companies maintain that they are providing a service to patients and attempting to retain a sliver of earnings from soon-to-be generic medications. Critics say that Pfizer and Merck are engaged in a campaign to put generic manufacturers out of business.

For more on this subject, please see this excellent post by Adam J. Fein, Ph.D. of Drug Channels. The Wall Street Journal also has a report on this subject.

According to the New York Times, regulators are focusing increased attention on the links between medical device and pharmaceutical companies and doctor-run charities.

For more on public-private partnerships, see this post.

Over the past several months, I have had the privilege of speaking with a number of well-regarded scientists, physicians, epidemiologists and social scientists about a very contentious issue: race and medicine. I have been pleased that so many distinguished individuals have been willing to speak publicly and candidly about this difficult subject.

Although those I have interviewed have many different perspectives on this subject, a few common themes shone through. Most importantly:

-Race is social construct with biologic and economic consequences: I was speaking about race and medicine with the head of a major medical association the other day. During that conversation he said: “What is the difference between a white horse and a black horse? None. Yet, we make a big deal of differences between whites and blacks. Why do we do this?”

As many of the people I interviewed observed: At its simplest, race is a social construct, a means of grouping people. Yet, race has many consequences: social, economic and medical. While there are no significant differences between groups of people, race has consequences. Especially on health outcomes and how people metabolize different medications.

-The pharmaceutical industry and government need to do more to address racial disparities: Many of the people I interviewed said that drug companies need to do more to educate ethnic minority patients on risk factors and behaviors that can result in improved health. Some companies, like NitroMed (see the interview below) are making an effort, but more needs to be done. Especially in areas where there is little or no financial incentive to do so. Government can and should play a role in promoting social and health equity.

-Health disparities are real and persistent: A major theme of my interviews was disparities in healthcare. Everyone agreed that disparities are real, persistent and deserve increased attention.

I hope you have enjoyed this interview series and found it informative. While this is my final interview, I will certainly touch on this issue in the future. Click here to read the other interviews I have published on race and medicine over the last few months.

Read on for my interview with Dr. Michael Sabolinski of NitroMed.

About Dr. Sabolinski: Dr. Sabolinski is Chief Medical Officer of NitroMed. He has more than 20 years of experience in clinical research and medical products development. He joined NitroMed in 2002 after completing a distinguished decade long career with Organogenesis, Inc. where he held several positions including President and Chief Executive Officer, Head of Clinical Research, Regulatory Affairs and Corporate Development. During his tenure, he successfully managed the team that secured two FDA approvals of a living skin substitute, pioneering the path for stem cell products and other cell therapies.

Read the rest of this entry »

The Wall Street Journal (WSJ) reports this morning (subscription required) that the New England Journal of Medicine has corrected a study Merck published in the journal on Vioxx titled Approve.  In Merck’s original interpretation of the study, patients taking Vioxx only developed cardiovascular complications after taking the drug for 18 months.  Now a biostatistician hired by NEJM has concluded that patients’ cardiovascular risk could have increased before the 18-month period was up.  (Click here to view the correction.)

According to the WSJ:

“[K]ey results in the New England Journal of Medicine’s original publication of the study . . . were reached by a different statistical method than was described in the article, and that when the data were subjected to the stated method, the contention that risk increased only after 18 months didn’t hold up.”

Earlier this year, Merck admitted to the Food and Drug Administration (FDA) that it incorrectly described the statistical method it used to analyze Approve.

The Implications

Clearly, this correction will be a boon to plaintiffs seeking damages from cardiovascular events potentially caused by Vioxx.  What’s worse is that Merck will likely be accused of “gaming” the data to ensure a more favorable outcome for its embattled drug.  This may lead to calls for pharmaceutical companies to analyze and publish data using a variety of statistical methods to ensure that the results are consistent.

COX-2s Vs. High-Dose Advil

In separate news, the British Medical Journal published a meta-analysis of clinical trials indicating that high-dose Advil increases cardiovascular risk almost as much as COX-2 inhibitors like Vioxx.  Based on the results of this trial, the WSJ’s editorial board has asked the FDA to return Vioxx to the market.

A couple of quick hits today:

New Blog Carnival

[Name redacted] has launched a new blog carnival, The Patient-Consumer Parade. He started the blog partly because he was diagnosed with a rare bone disease. The first Patient-Consumer Parade will be up at www.patient-consumer.com on July 3. To submit a post, please use this blog carnival submission form or e-mail him at patient-consumer@marketmdmag.com.

Abortion Backgrounder

Norma Todd of Stateline.org sent me an e-mail about a new abortion backgrounder. It includes information about the states that will have a significant influence on the future of abortion. Click here to learn more about it.

The New York Times reports today that senators Michael B. Enzi and Edward M. Kennedy of Massachusetts are developing legislation that would impact how drug companies report clinical trial data and monitor drug safety.  The senators are being very coy about the details of the new legislation, which may be presented to Congress after the election season.  Click here to read more (registration required).

Observers have often noted that media tend to travel in packs. This means that a story has the tendency to get picked up by various media outlets over time. Of late, it looks like the media have been focusing increased attention on a very important subject: antibiotic resistance. Note the following:

-USA Today published a major story on the causes and consequences of antibiotic resistant bacteria

-Forbes.com highlighted (subscription required to access article) the dearth of new antibiotics on the market and effort to encourage pharmaceutical companies to develop new medications

-A slew of media report on the stoppage of a clinical trial testing the efficacy of a new antibiotic, Ketek, in children due to concerns about a potentially deadly side effect. This leads to renewed questions about whether about whether companies should test antibiotics in placebo-controlled trials.

-Today the New York Times (registration required to access article) reports on an intriguing study indicating that conventional wisdom about how long patients should be treated with an antibiotic should be reexamined.

All of these articles are very interesting and provide excellent information about current thinking on the management of bacterial infections.

I wrote about this issue in a recent post. I plan to publish an interview I conducted with Dr. John Powers about antibiotic clinical trials and bacterial resistance in a few weeks. Stay tuned for that interview.

The latest version of the Health Wonk Review is up at Workers’ Comp Insider.

I’ve just finished conducting an interview series focusing on the impact of healthcare blogs over at HealthCareVox. Check out the final installment by clicking here.

at the Harversian Canal.