Posted on Thu, Feb 04, 2010 @ 03:34 PM
Nearly three months have now passed since the FDA's Division for Drug Marketing 
Advertising and Communications (DDMAC) held its hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” So far the response from DDMAC and direction provided to industry can be measured by the almost deafening sound of crickets coming from the direction of Washington DC.
Hopefully, before we're too far along into 2010, DDMAC will provide constructive guidance to industry on the use of social media to communicate with patients. They certainly had plenty of feedback from interested parties during those hearings.
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.
Posted on Mon, Nov 09, 2009 @ 09:40 AM
For better or worse, on November 12 & 13, 2009, the U.S. Food and Drug
Administration and its Division for Drug Marketing Advertising and Communications (DDMAC) will convene a hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”
Sorry, if you didn’t register by October 9, you will not be able to attend in person; however, all are welcome to participate. Healthcare communicators, especially healthcare PR folks, should submit questions and comments to: “Electronic Comments,” identified with docket number FDA-2009-N-0441, at http://www.regulations.gov. Everyone can watch and listen to this hearing for free by registering here.
The hearing will be just that. Be prepared to listen to more than 80 (that’s right, eighty) 15-minute presentations by healthcare communication leaders from industry, academia, government, media and non-profits. And, for one who has endured my fair share of FDA hearings, don’t expect any action, other than the obligatory, “We thank all of you for coming, for your time and thoughtful insights.” “We will take all of your comments under advisement and will continue to compile outside comments and reconvene in 2010.”
We can expect that FDA and DDMAC will float a straw man document for comment in 2010. And, perhaps after another hearing, they might finalize new regulations in 2010. For those of us involved in healthcare communications, healthcare PR and medical communications, these new regs will help us reduce our risk of DDMAC violations. However, it remains to be seen if these new regs will help or hinder industry communication to physicians, patients and caregivers.
Posted on Fri, Oct 23, 2009 @ 11:18 AM
Do you want to lead? Remain teachable. This is especially true for healthcare communications and marketing professionals who want to engage the digital health consumer (in other words, all of us).
Next week, we'll be participating in the e-Patient Connections Conference in Philadelphia, organized by my friend Kevin Kruse. If you want to see a Who's Who of leadership in digital healthcare communications and social media, check out the speaker line-up and the program for this event.
So here's a Healthcare PR Blog shout-out to Kevin Kruse and his team a Kru Research for putting this meeting together.
I'm sure we'll have a few things to blog about following this conference. We look forward to seeing our friends and colleagues at this event.
Stay tuned.
Posted on Thu, Oct 01, 2009 @ 10:50 AM
With all the noise in the news lately about the healthcare reform battles being fought, there was some very positive news for the pharmaceutical, biotechnology and medical technology industries yesterday that I think may have gone unnoticed by many.
On Wednesday September 30th, President Obama announced a plan to spend $5 billion on medical and scientific research, medical supplies and upgrading laboratory capacity.
This is great news for the pharmaceutical, biotechnology and medical technology industries. Promising new treatments and technologies discovered as the result of NIH-funded research are usually developed and commercialized by private sector companies. More investment in NIH research means more opportunities for technology transfer to pharma, biotech and other companies through Cooperative Research and Development Agreements (CRADA). The list of successful pharmaceutical and biotechnology products developed as the result of CRADAs is extensive, and includes breakthrough cancer treatments such as Taxol and Velcade.
Government investment in medical research has contributed to enormous growth for the pharmaceutical, biotechnology and medical technology industries through technology transfer. Most importantly, these investments have improved the lives of millions of patients.
Posted on Fri, Sep 18, 2009 @ 05:58 PM
As a healthcare communications pro with experience in many therapeutic areas, I 
am always interested in how we can use our skills to improve patient's lives. In this information age, communication is power. I am excited about how, as strategic counselors, our ability to improve dissemination of information can influence companies and institutions to bring about improvements in patient care.
HIV/AIDS is a perfect example of how communications can change behavior and facilitate change. In just 25 years, what was once a diagnosis that meant almost certain death has now become for many a chronic condition that can be managed through a combination of medicines. In the history of medicine, this level of progress is unprecedented.
I don’t want to minimize the continued global threat of HIV/AIDS in many parts of the world, including inner cities and the developing world. This is an ongoing issue that demands sustained effort if progress is to be made in these areas.
But amazing progress has been made in understanding the disease and treating it, to the point where today many HIV positive people will never develop AIDS and will not end up dying of the disease.
How did this amazing progress happen in HIV/AIDS in less than 25 years, while in other areas like cancer, for example, certain diagnoses continue to mean that the patient will almost certainly die of the disease?
I’ve often thought about this, and there a number of possible answers depending upon who you ask. But I strongly believe that three key factors certainly helped speed progress in treating HIV/AIDS far faster than anything seen before.
1) A new age of patient advocacy
AIDS activists rewrote the rules on how to get everybody’s attention and how to motivate governments, regulatory bodies, NGOs and the pharmaceutical industry. Early AIDS activists were often militant, sometimes did outrageous things, and caused great upheaval in government and corporate circles. But by forging grass-roots advocacy organizations, and using information technology, especially the Internet, they got results.
2) Changes in the regulatory environment
Perhaps one of the most historic achievements of the AIDS activists was the major change in the worldwide regulatory environment. In 1992, the FDA introduced an accelerated approval process for HIV medicines in response to pressure from AIDS activists. HIV/AIDS activists also ushered in expanded access and compassionate use programs in the late 1980s. These programs offer patients with life threatening diseases access to experimental drugs before they receive regulatory approval.
3) The global communications revolution
We owe a great debt of gratitude to the early HIV/AIDS advocacy pioneers. They created a template for disease activism that represents best practice today in diseases such as cancer, diabetes and Alzheimer’s. The Internet has given birth to countless new media channels and a media environment that is nearly infinite in depth.
As healthcare communicators, we have the privilege of helping companies and organizations determine the best combination of media tools. The application of these new media tools, if orchestrated appropriately, can help improve the lives of millions of patients, families and caregivers.
Posted on Wed, Sep 02, 2009 @ 04:25 PM
The New York Times had a great story today by Andrew Pollack about the 
continuous push by Big Pharma and smaller specialty companies to become major players in oncology.
The article focuses mainly on Pfizer and the significant investments that the company is making in oncology--a major shift in strategy for the company, which historically has mainly focused its R&D efforts in other therapeutic areas.
The Healthcare PR Blog wrote about the explosive growth of the oncology market, and the fact that this trend looks set to continue in the years ahead, back in June of this year.
Check out the New York Times story and The Healthcare PR Blog entry from June. There are some very interesting forecasts and figures in both pieces.
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.