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In 2013, the United States Food and Drug Administration (FDA) approved 27 new drugs.

Many of those with a vested interest in healthcare, especially investors and analysts, view that number as “a barometer of industry innovation and the federal government’s efficiency in reviewing new therapies” as Matthew Perrone wrote for the Associated Press.

And compared to 2012, when the FDA approved 39 new therapies, some investors, analysts, and journalists are sounding the alarm bell about this decline in new drugs approved and what it means for pharmaceutical research and development.

Case in point: John Carroll, writing for Fierce Biotech, argues that the 27 new drugs approved in 2013 represent an “ominous” trend that “that once again raises big questions about the productivity and sustainability of the world’s multibillion-dollar R&D business.

Yet in my view, using the number of new drug approvals to measure the success of pharmaceutical companies is short-sighted. Don’t get me wrong – Carroll argues later in his article that 2013 was actually a good year for drug companies overall. But as we head into 2014, it’s important to look back at the broader landscape and achievements of both FDA and biotechnology and biopharmaceutical companies. Here are three trends that I hope continue in 2014.

  1. Fewer approvals doesn’t mean less revenue: According to the industry publication EP Vantage, combined revenues from drugs approved in 2013 represent an estimated $18.7 billion, easily beating last year’s projection of $16.4 billion.  The Wall Street Journal also noted that sales of drugs in company pipelines “are expected to more than offset the drag from pills losing patent protection in coming years.”
  2. “Me-too” drugs are going by the wayside: Innovative, life-saving drugs are coming to the forefront, especially for hard-to-treat conditions and rare diseases. In fact, one-third of drug approvals last year were for rare diseases. Biogen Idec won approval for its multiple sclerosis drug Tecfidera, Gilead got the nod for Solvaldi for Hepatitis C, and Roche’s Gazyva received approval for chronic lymphocytic leukemia. This is truly great news for patients.
  3. Innovative therapies are also coming to market more quickly: The FDA’s breakthrough therapy designation (BTD), along with adequate funding for the agency, is working. Drug makers, FDA, investors, and, most importantly, patients, are all benefitting.  The BTD, awarded to drugs that may treat a serious or life threatening disease or condition or show strong clinical evidence of an improvement over existing therapies, went into effect in 2012. Last year, only three products were approved with this designation. However, the FDA has granted BTD status to 37 compounds, according to Leerink Swann, and represents a “big influence” on investors.

Of course, the macro R&D landscape isn’t without its challenges. One that I’ll be especially interested to see in 2014 is whether, as The Wall Street Journal suggests, there’s a slight shift this year away from oncology drugs to other areas of unmet need, which I’d argue suffered last year.

In 2013, oncologic drugs, by my count, represented almost 30% of total approvals. Yet according to Barclays, one-third of R&D spending is going towards oncology and inflammation even though they account for less than 17% of total projected revenues. Drugs for cardiovascular disease and neurological illnesses together comprised only 18% of all drugs approved. Deutsche Bank has said that drugs for schizophrenia and depression form a $33 billion market, with investors willing to tolerate the high-risk nature of R&D for these products.

So, what do you hope to see from industry and FDA in 2014? I’d love to hear your thoughts.

I wrote recently about the cancer conundrum patients and caregivers face as survival and cure rates increase.

This week, I’m taking a look at China to better understand global shifts in healthcare and how companies and organizations can address them.

The idea came from Alice G. Walton’s great Forbes post summarizing two studies (abstracts here and here) in The Lancet that document the increase in non-communicable diseases – including dementia, heart disease, and COPD – the country is seeing as its economy and wealth explode. This is even more amazing when you consider that China is pushing for 250 million of its citizens to live in an urban setting in just 12 years.

The fact that this data shows the leading causes of “loss of health” in China have changed so drastically in only 20 years is remarkable. Just look at these stats:

  • Neonatal and infant mortality decreased 59% and 80%, respectively
  • Communicable diseases such as lower respiratory infection and childhood mortality from diarrhea decreased by 90%
  • Life expectancy is up, from 69.3 to 75.7 years, rising 8%. This is even more incredible when you consider that:
    • U.S. life expectancy is 78.64 years and has only increased 10% over the last 50 years
    • Life expectancy for men and women in the U.S. is getting shorter, and recently was ranked lowest and second lowest of 17 developed countries, according to the National Research Council and Institute of Medicine
    • Chinese people lost the fewest years of life to disability of any of the G20 countries

As Ms. Walton wrote so well, this means that in China, people’s individual behaviors, not the spread of contagious diseases, are the biggest threats to their health over the long term.

It’s clear that better access to care in China has played a role in diminishing horrible diseases and conditions like pre-mature births and congenital anomalies. But similar to the challenges created by longer cancer survival rates, as China and other developing nations gain better incomes and urbanization, they face new health challenges. These will be made more difficult by the fact that many health issues, such as heart disease, take years to develop, often lack noticeable symptoms, and are based heavily on diet.

So, how can companies and organizations engage health stakeholders in China? I asked Chris Deri, WCG president, to weigh in. Chris spent nearly three years working with major companies in Beijing. Here are four ideas on changes that organizations can affect:

  • Remember your audience, and keep it custom: High cholesterol, stroke, and obesity may often be newer concepts for Chinese compared to the U.S., where they’ve been drilled into our consciousness for years. Therefore, unbranded disease education and awareness campaigns are very important. Organizations willing to engage on a local level and develop custom education and engagement strategies for this massive market will stand to benefit as access to care continues to improve. Organizations also need to help Chinese patients understand that modern medicine doesn’t mean miracle pills. Health literacy is urgently needed.
  • Show patients why physicians matter: Healthcare spending is increasing at an incredible rate. As of 2011, Beijing planned to up its per-capita funding for basic health services to 25 yuan, or $3.8, per capita, up 67% from a year earlier. Yet patients have never been angrier about healthcare and the difficulties of accessing it. It’s even resulting in patients committing terrible violence and crime, including murders, against physicians. Organizations that help provide continued training for physicians and make patients more literate about modern diseases, can make a big difference in better, safer care for all.
  • Get mobile: As of 2012, China had at least one billion mobile phone accounts. Providing health information on mobile platforms – both via text messaging and via richer content such as apps, will be a crucial way to reach patients and physicians.
  • Eliminate the stigma: Partner with organizations that can help decrease stigmas associated with these new diseases. This is particularly true for dementia and Alzheimer’s, which affect 9.19 and 5.69 million Chinese respectively. In 1990, the numbers were 3.68 million and 1.93 million, respectively. South Korea’s already done a good job with this, as demonstrated by this remarkable program. Some companies are already doing great work in this area, whether it’s partnering with national mental health organizations to improve patient care or contributing much-needed research dollars to further advance scientific innovation.

China’s prosperity will clearly affect its citizen’s long-term health. Organizations willing to engage on a local level and develop custom communications strategies for this massive market will stand to benefit as access to care continues to improve.

 

Beating cancer is awesome. What’s more awesome is that we’re seeing an increase in the amount of cancer patients winning their fight as we enter what I see as an incredibly promising period in cancer research and treatment.

Those who followed the American Society of Clinical Oncology meeting, and led conversations around it (see my colleagues Brian Reid and Greg Matthews work on how oncologists are getting social), are well aware of the inspiring work the oncology community is doing on behalf of cancer patients. From immunotherapy as a potential breakthrough in melanoma and other cancers to vinegar – yes, vinegar – for cervical cancer screening, cancer research will continue to decrease mortality rates for cancers.

All this progress, however, creates a new and welcome challenge. Long-term cancer survivors (70 percent of patients now live for at least five years after diagnosis) and their caregivers, are about 25 percent more likely to experience anxiety than those who don’t have cancer, and it can be a significant health concern ten years after diagnosis. Anxiety is also likely to last longer than depression.

These findings are the result of a meta-analysis (a combination and compilation of several previously reported studies (27) on 500,000 patients reporting on depression or anxiety in cancer patients) published last week in The Lancet Oncology.

Anxiety is a very understandable response to surviving cancer. It’s easy to see why someone who’s had cancer and is grateful to be alive still is anxious. Imagine waking up with a pain in your side, or a sore throat, or a stiff back, and wondering, hoping, praying, it’s not your cancer returning. In the case of caregivers, I imagine the fear they feel each time they take their husband, wife, father, mother, sister or brother to a routine physical and hope that it’s just that, routine.

This meta-analysis finds that that by 2020, the number of people diagnosed with cancer each year will exceed 21 million. If every person diagnosed with cancer has just one caregiver, we’re talking about 42 million people each year who will be dealing with cancer’s long-term effects. Yet this meta-analysis shows that once a patient is discharged from hospital care, they receive infrequent check-ups from the medical teams and minimal counseling.

As cancer care and survivorship improves, the medical system will need to adapt and think beyond a cancer cure to continued cancer care. Hospitals, insurance companies and pharmaceutical companies that can partner together to provide this continued care will gain long-lasting trust from both survivors and their families. And that’s something to be thankful for.

P.S. Sunday is Father’s Day. I know that men (myself included) would prefer to have a tooth pulled than talk about our health. But sons (and daughters) owe it to dad to talk about health and whether they’ve taken steps lately to understand their risks for cancer and take action. Oh, and don’t forget to thank dad for all the great advice and “Dad jokes” he’s probably given you over the years. I’ll certainly be thanking mine.

Quick. Word association. What are two words from the FDA that healthcare marketers and communicators almost universally fear and dread?

The answer: Warning Letter (but I’ll admit “not approved” is also at the top of the list!)

For those unfamiliar, the FDA, and in this case the Office of Prescription Drug Promotion (OPDP) issues warning letters when a company or organization insufficiently or inaccurately communicates a medical product or device’s benefits and risks. This includes not fully describing the side effects associated with a product or using language or visuals that imply a product treats a certain condition which the FDA has not approved. A warning letter is what it sounds like; a cautionary notice – “Strike 1” to use a baseball analogy – from the FDA that a company should consider revising its communications to avoid enforcement action.

Of course, Warning Letters can be viewed through different lenses, with the chance for confusion. It’s like the batter who thinks he’s received ball four when the umpire calls strike 3. Different interpretations and views of the information, and the warning letters themselves, in healthcare communications can seriously impact future marketing efforts much like disagreements over the strike zone can affect a game’s outcome.

Luckily, the FDA does not issue warning letters without explanation or allowing for questions. Today at 11:30 a.m. ET, the OPDP will host an Enforcement Webinar that lets viewers directly communicate questions on Warning Letters and Untitled Letters November 2012 through March 2013.

During this time, the FDA issued six Untitled Letters for misleading claims about the efficacy or risks associated with products treating a variety of diseases and conditions.

Here are the three questions that I’d like the OPDP to answer today:

  • Looking forward, do you have a sense of particular areas of concern when it comes to trends you’ve seen with drug promotion? For example, are you seeing more violations in terms of overstating efficacy claims or understanding potential risks?
  • There was only one online letter dealing with a company’s web site and podcast. What are your primary concerns regarding potential violations on digital platforms? Where do you see the biggest risk for sponsors?
  • How do you plan to include the information you’ve used for these Untitled Letters in whatever policy FDA eventually issues regarding social media promotion?

I’ll be live-tweeting tomorrow’s meeting using the hashtag #FDAletters. Please follow along and look for another update on this blog later this week. And if you have additional questions for the FDA, please leave them in the comments section. I’d love to see them.

The Securities and Exchange Commission is finally catching up to the times. On Tuesday, the SEC issued a report giving publicly traded companies the leeway to announce market-moving news via social media channels, as long as a company clearly states the channel it will use.

The news is welcome, especially for an agency that expects transparency, but I wonder if these social media channels are still underused when it comes to communicating with shareholders and, more importantly, how investors will welcome the SEC decision.

The Wall Street Journal, reporting on the SEC’s decision, cited a 2012 survey from Stanford University that said only 14.4% of companies communicate with shareholders via social media. This comes despite the fact that over 75% of the survey respondents said they use social media to interact with customers. In this case, it seems companies, while rightfully focusing on social media to improve corporate reputation and customer loyalty and satisfaction, aren’t using it to mitigate risk and communicate fully with investors.

The reluctance to frequently use social media to share market-moving information is understandable for several reasons.

  • First and foremost, the lack of guidance from the SEC likely kept companies from communicating more easily with investors and other interested parties
  • Second, despite the ease of using channels like Twitter and Facebook, social media does have its limits. Facebook, in my mind, still exists primarily for consumer announcements and brand engagement, and Twitter’s 140 character limit doesn’t always support the easiest disclosure
  • Third, a press release is a deeply rooted part of any company’s communication repertoire, and this is unlikely to change

Still, despite the challenges of social media, in my view, the pros greatly outweigh the cons. Companies do not and should not dispense with a press release or 8-K announcement in favor of using social media exclusively. Instead, the communication should be multi-channel. Social media should provide ease and speed of access, which any stakeholder values, while a press release should provide fuller, deeper context around a significant, market-moving event. It will be interesting to see how companies take to the new SEC guidance and harness social media to more fully engage investors and all interested stakeholders.

Here’s the secret to succeeding in business. Ready? First, make a good product that works well and is delivered efficiently. Second, never forget how important your customers are, or you’ll lose them. Repeat.

It works for almost every industry. A lot of people think Coke tastes great. Why else drink it? Exxon refines crude oil into gasoline. It makes your car run. Sell. Repeat.

But when it comes to healthcare and its delivery, the system isn’t working nearly as well as it could, the products offered don’t provide the results you deserve, and customers – patients – don’t always receive the benefits they should. This was a theme that really stuck for me as I listened to some extremely smart and accomplished people speak this week at TEDMED.

Despite this inconsistent, often frustrating system, there’s a lot of hope and progress being made to fix it, with evidence-based medicine, the effective use of data and mutual accountability leading the way at putting patients first.

Here’s a look at what leaders of the CDC and FDA, the executive health editor at Reuters, President Obama’s chief technology officer and a cancer theoretician and mathematician had to say about improving patient health. See what I mean about extremely smart and accomplished people?

Dr. Thomas Frieden (Director, Centers for Disease Control and Prevention)
In the early 90s, tuberculosis ran rampant in New York City, spreading through hospitals, homeless shelters and resisting multi-drug treatment. It was so bad, Dr. Frieden said, that physicians didn’t want to complete their residencies in New York for fear of contracting tuberculosis themselves.

Dr. Frieden had initial success in bringing tuberculosis under control. But at a chance meeting with a physician who had contracted tuberculosis in a concentration camp during World War II, Dr. Frieden was asked an amazingly simple question that proved transformative: “How many patients did you cure?” Dr. Frieden, “terribly ashamed”, didn’t know the answer.

He began a process called cohort reviews. Traveling to every part of the city, his team reviewed patients one by one until they knew exactly how many had been cured. “Data and information isn’t just statistics, it’s what is locally relevant,” Dr. Frieden said. And if the data isn’t being used with the intention of making patients the VIPs, it’s not being used well. “If you’re not measuring with brutal honesty, you won’t succeed.”

There was one other point from Dr. Frieden’s presentation that’s worth noting. Advertising and media outreach works: Last month, the CDC launched a hard-hitting campaign, Tips from Former Smokers, on what tobacco really does to people. The reason? Media campaigns are “an evidence-based strategy to educate the public regarding the harms of tobacco use.” Did the evidence hold up? You bet. Dr. Frieden says calls to quit lines doubled in the first month.

Dr. Ivan Oransky, Executive Editor of Reuters Health
Dr. Oransky used a simple, and timely, story to demonstrate the situation Americans face with their healthcare. Billy Beane, of Moneyball fame, was himself, albeit shortly, a major league baseball player. Scouts all thought he’d succeed but their predictions were wrong. The healthcare system, Dr. Oransky argues, is as bad at predicting what will happen to people as scouts were at predicting that Billy Beane wouldn’t make it as a ball player. For the healthcare system to work, and work well, its delivery and service must improve. A system where patients feel they’ve received bad care unless they’ve been diagnosed or prescribed medicine doesn’t create good service. Dr. Oransky said:
“We have a system where if you build it, they will come. Billy Beane learned that it wasn’t swinging for the fences, it was watching for the guys who like to walk. We need to figure out, is that a good pitch or should we let it go by and not swing at everything?”

Todd Park, U.S. Chief Technology Officer
Dr. Park didn’t have any gizmos or gadgets. He was just a self-described “fanboy” who said something pretty remarkable is happening in Cincinnati, Ohio. It’s not the chili.

By most measures, Cincinnati was average when it came to healthcare delivery. The city decided it wasn’t content with average. So a few years ago, stakeholders representing many constituencies got together regularly to understand health status in their community and the performance of the healthcare delivery system. They started small, with flu coverage, at which they were, again, “resoundingly average.”

To fix it, first these stakeholders developed a set of common performance metrics and an ongoing measurement system to help achieve goals. Second, they realigned how healthcare is paid for. Insurers and providers wanted to pay for value. Doctors were offered extra incentives and other resources to help them coordinate care more proactively and accelerated deployment of electronic health records and educated clinicians on how to use these new tools. Finally, they put patients at the center. They published a website that gave them much better information on flu. Treatment improved. It’s also working for diabetes, where between 2010-2011, the cohort of patients receiving perfect diabetes care improved greatly.

Dr. Jacob Scott, radiation oncologist and cancer theoretician, Moffit Cancer Center
Dr. Scott thinks of himself as a long-range scout searching the world of biology he’s seen and what is limiting our success in healthcare. If that sounds different than many doctors you know, it’s because Dr. Scott has had a unique experience. He studied physics, served in the U.S. Navy on a nuclear submarine and while studying medicine, decided he should also study mathematics at Oxford University.

Much of what limits success in healthcare, Dr. Scott argues, is medical school. When he arrived, medical school was “like a backstage pass to everything cool about being a human being.” However, medical school, which Dr. Scott says rewards medical students based only on GPA and MCAT scores, is not doing enough to encourage creative thinking and unique partnerships that can look at healthcare’s biggest problems, especially in oncology. Instead, medical school needs to remind students that it’s not the information they leave medical school with, but the ability to face problems critically and step out of their comfort zone, that will make the biggest difference in medicine.

Dr. Peggy Hamburg, Commissioner, U.S. FDA, and Larry Brilliant, president and CEO, Skoll Global Threats Fund
Mr. Brilliant interviewed Dr. Hamburg on a range of issues that are front and center in healthcare right now. Here are some excerpts from the conversation:

Balancing the need for innovation with regulation and safety: Dr. Hamburg said that smart regulation matters if you want to translate science and technology into the products people need. Smart regulation improves the quality and utility of a product while ensuring there’s trust and confidence in it from patients and physicians. She added that a lot of people at the FDA don’t understand the process of innovation and running a business. By reaching out and talking to CEOs and entrepreneurs, the FDA has learned a lot.

On speeding the approval of drugs and devices: Drugs and devices are very different, Dr. Hamburg said. On the drug side, the FDA leads the world in terms of first to market on a majority of drugs and in the time of that review process. Devices are more complicated. FDA is faster the majority of the time compared to European colleagues but slower for pre-market approvals.

The impact of globalization on drug safety: As drug development has moved offshore, so have safety trials, and the challenges of globalization are immense, Dr. Hamburg said. Of the drugs taken in the U.S.,
40 percent are manufactured in another country and 80 percent of the ingredients are manufactured elsewhere. That’s just on drug side.

On drug shortages: Dr. Hamburg said this is a problem that’s increased in recent years in a way that worries all of us. The biggest shortage has been with sterile injectable drugs, many of which are generics or older drugs. They are hard to make and the manufacturing equipment is old. Economic forces are also at play. The FDA is working to learn about shortages much, much earlier, she said, and collaborates with manufacturers to make sure the drug remains available. It also means identifying other manufacturers who can scale up to meet a shortage and those who could make the drug but aren’t, or go overseas and work for an equivalent drug that isn’t approved but could.

Listening to music on my iPhone on the way to dinner Saturday night (Corner Bistro, hamburgers, yummy, sorry to digress), I realized the way I experience music has evolved drastically since I was a teenager. Then, I held new CDs in my hand, anxiously ripping apart the packaging and listening to the album in my room from start to finish as I looked at nothing more than the artwork. Now, I’m skipping songs after 30 seconds while checking e-mail and playing Angry Birds.

I realized all this while reading a great article by John Pareles, music critic for The New York Times, about how the music industry and consumers have changed in this ever-digital age, as music moved from records to mp3 players and now away from Earth and to the “cloud.” Much of Pareles’s article focused on these cloud services and companies that offer online storage for your music collection, making entire song catalogs available from any device with an internet connection.

Pareles writes that when the musician Bjorck releases her next album, every track (every track!) will have a smartphone app. Bjork herself says that she aims for the songs “to be a spatial experience, where you can play with lightning or crystal or the full moon and the song changes.” It certainly seems the days of sitting in your room, listening to music, are gone, and musicians have to do more and more to break through the infinite quantities of music available on the web.

So what does this have to do with health? In my view, as communicators, we need to help our clients change the way they create content. Just as consumers aren’t playing records end to end, patients and other audiences seeking healthcare information aren’t satisfied to get that information from one source or channel. And I’d bet that while they’re seeking information on health, they have a multitude of other things competing for their attention. Case in point: a fascinating visual from Go-Globe.com shows that worldwide, every minute on the web:

  • Over 168 million e-mails are sent
  • Google serves nearly 700,000 search queries
  • Twitter blasts 98,000 Tweets

Our goal should be to consistently partner with clients to create content that works within regulatory frameworks but makes them experience health and knowledge in a meaningful way and across channels where important dialogue is created. It’s certainly a challenge but one I’m excited to tackle, perhaps as I skip through Bjorck songs on my iPod and send out a few e-mails.