Envisioning 2.0

. . . at Cato @ Liberty. Read it for the best of the healthcare wonk-o-sphere.

Much has been made of concerns about researchers’ financial conflicts of interest in clinical trials they are conducting. Many are concerned that when scientists have a financial interest in their research, they will be more likely to seek a favorable outcome.

While we know a lot about what medical professionals and ethicists think about this issue, less is known about what patients believe. Now, because of an interesting study published in this week’s New England Journal of Medicine, we have some clues.

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Each year, tens of thousands of physicians, marketers, pharmaceutical company executives and others descend on the annual meeting of the American Heart Association (AHA) to hear the latest and greatest in heart-related scientific research.

A major (unofficial) topic of this year’s meeting was the AHA-Pfizer flap. In late October, Pfizer released data from a clinical trial indicating that its experimental “good” cholesterol medication torcetrapib increases blood pressure. The news dealt a blow to Pfizer’s hopes that the medication will become the next Lipitor, as physicians may be hesitant to prescribe a heart medicine that raises blood pressure – unless the drug’s benefits outweigh the risks.

Pfizer’s decision to release the torcetrapib data infuriated the AHA. The medical society has a strict policy that prohibits those presenting data during its late breaking clinical trial sessions from releasing it prior to the meeting. On November 10, AHA announced that it was pulling Pfizer’s torcetrapib data because the company had violated its regulations. Pfizer later apologized to AHA for breaking its rules.
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The Wall Street Journal reported yesterday on how several key Democrats are looking to increase generic drug prescribing.  A key focus is on developing generic versions of biotech medications, which are typically very expensive.

However, biotech firms have a good argument on their side: it is very difficult to develop identical copies of many medications they develop.  This is because they are very difficult to manufacture and test, which is a major reason they cost so much.

A Prediction: If Congress pushes the legislation forward, look for biotechs to start a  communications campaign aimed at ensuring that the public understands what it takes (read: a lot of time and money) to develop biotechnology drugs.

One potential message that biotechs may communicate: “We have developed a number of drugs for very serious and rare conditions and we work hard to ensure that poor patients can afford our medications.”

For more on this issue, please see the following articles from other blogs:

- Drug Channels: The Attack On Generic Profits In Drug Channels

- The Health Affairs Blog: Evaluating Interventions With No Close Substitutes

An interesting article published in the New York Times last week notes that doctors are increasingly becoming concerned by the persistent health disparities seen in a large segment of the population. If you were to think that physicians are talking about women, minorities or any of the other usual suspects, you would be wrong. No, people are getting more worried about men and the fact that they get sicker and die sooner than women.

It has long been known that men tend to die of heart attacks, cancer and other illnesses more than women. However, as people have begun to focus more attention on women’s health, some have suggested that men are getting short shrift. According to the Times:

“The Men’s Health Network, a not-for-profit educational foundation based in Washington, has called for creating a federal office of men’s health to mirror the office on women’s health within the Health and Human Services Department, and it is backing a bill sponsored by Senator Mike Crapo, Republican of Idaho, and Representative Vito Fossella, Republican of New York, to do so. Several federal offices on women’s health were recently established to compensate for years in which women were often excluded from medical research, but there is no federal office of men’s health.”

The Communications Conundrum

I’ve worked on a couple of communications programs where we have focused on what prevents men from taking better care of themselves. Many do not want to go to the doctor or get needed checkups for a host of illnesses. Others ignore their high blood pressure and cholesterol. We were always looking for ways to get men to see their doctors, but it was a daunting task.

I think any effort to improve public health (whether for men, women, minorities or others) is always good. The tough part is designing communications programs that will entice men to make taking care of their health a lifelong habit. If anyone has examples of programs that have worked in the past, I’d love to learn about them.

at the Health Business Blog.  Get the best of the health policy wonk-o-sphere here.

Over recent months, the FDA has been focusing heavily on antibiotic safety, efficacy and clinical trials. Today, the New York Times reports that the FDA has asked an outside panel of experts to evaluate the safety of Ketek, a powerful antibiotic that has been linked to liver failure. The panel meeting will take place on December 14 and 15.

The FDA’s announcement comes after the Senate Finance Committee announced plans investigate how the agency handled the approval of the Sanofi-Aventis drug in 2004.

Regardless of the outcome of the panel’s investigation, it is clear that the FDA’s stance on antibiotics is changing. To learn more about this issue, please see the following posts on this blog:

- Antibiotics, Clinical Trials & More: An Interview With The FDA’s John Powers, MD

- Consumer Driven Healthcare: The Good, Bad and Money; FDA May Be Changing Tune On Antibiotic Trials

Dale Hunscher, who writes the blog FutureHIT, which focuses on healthcare information technology, has just published a very interesting and useful book, Business Blogging For Healthcare Professionals.

I took some time this morning to read through an excerpt of the book. From what I’ve read thus far, it is clear, concise and full of excellent advice for busy healthcare professionals thinking about why/how to start a blog.

Two people I respect, Dmitriy Kruglyak, publisher of The Medical Blog Network and Carol Kirschner, who writes Driving in Traffic have endorsed the book. Learn more about it here.

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, which focuses on social media, is below.

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The results are in. Voters pushed for change and handed the House of Representatives to the Democrats. As of this morning, the Senate is still up for grabs as votes are still being counted in Virginia and Montana.

Clearly, healthcare was not a major focus during this election. As Drew Altman and Robert Blendon noted on the Health Affairs blog, healthcare played “a relatively minor role in determining the outcome of the 2006 midterm election. . . . Elected officials will arrive back in Washington with little pressure from voters to change the current direction of the country’s healthcare system.”

Although healthcare was not a big topic, I predict that certain issues will garner Congress’s attention, drive headlines, power lobbying efforts and keep communicators awake at night. Some of the most important ones may include:

- Medicare Part D: In recent weeks, newspapers have been reporting that some seniors are facing significant financial burdens as they reach the so-called “doughnut hole” in Medicare Part D. This is a break in coverage for people who have annual drug costs that exceed $2,250. They will be responsible for paying for medications out of pocket until their expenses reach $5,100. Seniors at this level of spending will be responsible for paying $2,850 plus monthly fees out-of-pocket. In 2007, the doughnut hole is expected to increase to $3,051.

In addition, many people are displeased that the Medicare Part D legislation does not allow the federal government to negotiate drug prices with pharmaceutical companies. Nancy Pelosi, who is likely to become the new Speaker of the House, has said that she will write legislation that gives the federal government permission to haggle with drug companies over the price of medications.

- The FDA: The FDA has come under intense scrutiny by critics who say the agency is not efficient enough and is too close to the pharmaceutical industry. Look for oversight of the agency to increase.

- Reimportation: The Medicare Part D legislation features a provision that bars the reimportation of drugs from Canada. A recent Wall Street Journal/Harris Interactive poll indicates that Americans are not pleased with this part of the law. 82% of respondents strongly disapprove of this part of the bill. Look for the new Congress to take up this issue.

- Biologics (Generic Biotech Drugs): In the past year, lawmakers have focused attention on the high price of biotech drugs. Most recently, in September 2006, Representative Harry Waxman and Senator Hillary Clinton introduced the Access to Life-Saving Medicine Act. If passed, Waxman says this bill “will establish a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals.” Look for the new House to take up this issue during the next term.