Posted on Tue, Aug 31, 2010 @ 04:20 PM
Are you or your healthcare PR firm prepared to handle clinical trial-related crises? Please review my 10-point primer published in the latest issue of Communique magazine to learn more.
For a PDF of the article, click here.
Posted on Fri, Dec 04, 2009 @ 11:14 AM
The In Vivo Blog has a very interesting discussion about a recent Pink Sheet/CMS 
Summit Panel discussion that suggested that the FDA may be practicing "stealth" comparative effectiveness through an increasingly greater focus on superiority data (rather than, I presume, non-inferiority data). Read it here at In Vivo.
The blog raises a number of interesting points, not the least of which is the question that is on many people's minds, including physicians, patients and industry: "is the FDA becoming too conservative?"
I believe that this question needs to be considered as part of the overall discussion, debate and analysis of issues such as the decline in new molecular entities, fewer first action FDA approvals, and fewer treatment options available for patients who need them.
A decline in R&D productivity has contributed to these issues to be sure, but I don't believe that industry is to blame for all of it. Open and honest discussion and debate is in the best interests of everybody, especially patients.
--David Avitabile
Posted on Wed, Aug 26, 2009 @ 03:47 PM
Ok, I am backlogged on my reading, so what else is new? If you are 
a healthcare public relations professional you are, by definition, behind on your reading! If I can scan my newspapers, multiple news aggregators, and Twitter messages each day I’m ahead of the game.
However, I did take the opportunity to review PharmaceuticalExecutive’s Fifth Annual Press Audit. While this appeared earlier this year, its findings are very relevant today, and will be valid until they field and report the 2010 press audit results. For those involved in healthcare communications and pharmaceutical and biotechnology public relations, these data are profound.
The PharmExec audit reveals that while articles covering pharma’s marketing, sales and other promotional practices have fallen, they have been replaced with articles about drug safety issues. During 2008, Approximately 83% of articles focusing on pharmaceuticals and biotech were about drug safety concerns. Negative articles about drug safety issues are at a five year high. And, while overall media coverage of pharma is down, the majority of this coverage is negative, with only a small percentage considered positive (12%).
Considering these data, along with the ever increasing regulatory and political headwinds facing the pharma industry, we believe strongly that we need to restore confidence in the industry. As leaders in healthcare PR and pharma marketing, we are proud of the work we do each day to raise awareness of new ground-breaking medicines and medical technologies. We are passionate that pharma technology and R&D will contribute to cost savings in this era of healthcare reform and increased rationing.
Many of our clients serve cancer patients and their families. And, as we have witnessed today with the loss of Senator Ted Kennedy to cancer, the victory over this global scourge is still somewhere in the future. Senator Kennedy’s death is a terrible loss. However, we know that his life was extended months longer than it would have been just ten years ago because of the great strides we have made in the fight against brain cancer.
As healthcare communications professionals, I believe it is our responsibility to support a balanced portrayal of the pharmaceutical industry, and communicate with patients, legislators, the business community and the general public about its valuable contributions to extending and enhancing human life.
Posted on Wed, Aug 12, 2009 @ 02:07 PM
As a healthcare communications professional, it has been
very interesting to witness 
the continuous clashes over healthcare reform between
concerned citizens and our nation’s political leaders taking place at Town
Hall meetings throughout the country.
First of all, I think a bit of perspective is in order. The
United States has a long and colorful history of vigorous debate, ideological
clashes and differences of opinion. Just read about the presidential election
of 1800 between John Adams and Thomas Jefferson. Or read about the Whiskey Rebellion of
1794, where President George Washington decided to declare martial law and send
troops to Pennsylvania to put down a rebellion of farmers opposed to federal
taxes on whiskey. The new taxes were introduced as a way to pay down the
national deficit, which was a real concern following years of war with Britain
and massive borrowing from France, Spain and Holland to finance the American
Revolution.
The current debate over healthcare reform, and the scenes
taking place at Town Hall meetings throughout the US, is tame by comparison to
these early struggles. Viewed in historical context, one could even argue that
the current national scene is an example of democracy at work.
However, as the debate continues, neither side is communicating
effectively. Supporters of reform seem unable to define clear, effective key
messages. Political leaders are falling into classic traps by allowing
themselves to be provoked and driven off message, and few if any seem to be
prepared to handle the hostility that they are facing. On the other side,
hyperbole, misinformation and shrillness don’t seem to be working either. The
work goes on in Washington, and displays of hysteria at Town Halls could have
the undesirable effect of marginalizing opponents of healthcare reform at a
time when different views should be heard and considered.
Most rational people agree that the current US healthcare
system is badly in need of reform. There are legitimate concerns over what
shape healthcare reform should take, how much it will cost, and how it will
impact the lives of ordinary citizens. Whether we succeed or fail hinges upon
how well we as a nation can define the critical issues, engage all the
stakeholders in this debate, listen to differences of opinion and create a
shared understanding of the way forward.
In other words, we need to communicate.
Posted on Tue, Aug 04, 2009 @ 12:43 PM
Unless you missed it, on Friday, July 31, 2009, the
Energy and Commerce Committee 
of the House of Representatives approved H.R.
3200 “America’s Affordable Health Choices Act.” This bill, which will require
much more work, has successfully found more consensus than opposition. It rests on a variety of reforms, most
evident are underwriting practices of
health insurers.
The devil is always in the details, so we can expect
major debate over healthcare reform when legislators return from their August
recess. Based on current healthcare
spending growth rates, most reasonable Americans understand that some form of
healthcare reform will be required to stem the tide of rising healthcare
costs.
Healthcare communications professionals, the media and
others who are following this debate are asking a number of critical questions.
Will a new healthcare law reduce costs or raise costs? How will such an extensive overhaul be
funded? How will the insurance industry compete against a public healthcare
insurance option? Will healthcare
reform harm the biomedical industry by hampering investment and
innovation? How will cost
containment translate into rationing, and how will Americans react to
government-mandated rationing?
Will the quality of physicians and care improve or deteriorate if there
is a government-run system?
I have seen all of these questions raised by both sides,
however, the major question I have not heard much about from either side (and
perhaps I’m not listening hard enough) has to do with tort reform. There just doesn’t seem to be much
rhetoric or debate around allowing doctors to practice more preventive medicine
and less defensive medicine.
The point of healthcare reform is to reduce cost and
improve access to quality healthcare for all Americans. An abundance of
lawsuits against doctors, hospitals and insurance companies has had a massive
impact on the rising cost of healthcare in this country. Yet the amount of
media coverage on the issue of tort reform specifically as it relates to
healthcare reform has been minimal at best.
A number of op eds have been published on the issue of
healthcare reform, both for and against, and many of these have been pretty
inflammatory depending upon the political stance of the writer. One of the very
few op ed writers who has made a strong case for tort reform as part of
healthcare reform is Charles
Krauthammer in the Washington Post.
Now let me be clear: I don’t necessarily agree with all of Krauthammer’s opinions
on the issue of healthcare reform. However, he does raise the issue of tort
reform, and the need for it, in order to reduce healthcare costs. On that
issue, I believe he has a point.
There does need
to be legal recourse for patients in legitimate
cases of medical malpractice. However, for our leaders to focus on cutting out the
waste and fraud in our current healthcare system while ignoring the very real
need for tort reform as part of the overall healthcare reform package is disappointing.
Why haven’t we heard more about malpractice tort reform
and capping malpractice awards?
Any healthcare reform will be a hollow victory without
malpractice tort reform.