Monday, May 16, 2011

Why price increases will no longer work-a thought for the CEO's of life science companies.

So this article in FiercePharma on Friday (5/13) caught our eye.  What is the moment when reality and perception converge for the Pharma industry?  What will happen when the CEOs of all the top life science companies need to tell their boards there is no more room for growth.  We hope someone in these organizations is spending some time on this subject, because the time is now.

We have always suggested there is a new way to engage with customers.  Regardless of the marketplace conditions, we believe that treating a customer as you would like to be treated as a person is the best approach. But why has the industry through the years continued to see things differently, then when faced with the patent cliff the drug industry faces, we seem to be out of answers.

Our advice, start to manage the expectations of your boards that lower earnings and revenues are going to be a way of life.  Look to BRIC nations for your future growth and develop harvest strategies for Europe and the US.   Several are still looking to research and development for the answer, but we believe the best thing you can do is to ensure you keep the business you earn.

Ask your senior leadership team what they are doing to make sure refills, re-orders and customer complaints are managed more effectively than the constant focus on creating demand for your products/services.  We realize you have a big number to fill every year!  It seems we spend a lot of time (and money) doing some of the same things.  Medication adherence programs work!  Why not mandate that all your products and brands make them an integral part of their marketing plan. 

Monday, May 2, 2011

The ACC and Philips: Common-Sense Collaboration

Anyone paying objective attention to what the new healthcare legislation has spawned has noticed creative juices beginning to ooze out here and there. To wit: Royal Philips Electronics and its from-hospital-to-home heart patient monitoring technology collection. Two desired endpoints here: Saving lives and saving money.

Next year – if the healthcare legislation stays intact – hospitals that have an inordinate amount of readmissions for heart failure, MI or pneumonia will start losing Medicare reimbursement. Year one: 1%, year two, 2%, year 3, 3%. After that, the list of readmitted conditions grows that can produce a penalty. Medicare has been paying big-time for unplanned hospital readmissions, according to a study in the New England Journal of Medicine: $17.4 billion in 2004.

Philips unveiled its tech collection at the recent American College of Cardiology conference; the ACC is one of its partners in this endeavor. No doubt critics of physician-industry collaboration will be screaming while reading this – but how else are cardiologists supposed to learn about these products?

The products include bedside monitors with early warning systems; a cable-free progressive care monitoring system; home tele-health system; and a remote cardiac service with diagnostic arrhythmia monitoring and additional patient self-testing.

It’s all about connecting the dots: giving cardiologists insight into how their patients fare when they get home.

But it's also about patient education and better communication among patients and providers along the healthcare continuum – make no mistake, it will always be about these two. We doubt this country would be facing this healthcare debacle if we had a handle on the first issue and had never sacrificed the second. 

Thursday, April 28, 2011

The Data Miners' Date With The Supremes

And so it happened: The Supreme Court spent 70 minutes on Tuesday (4-27) hearing arguments about why Vermont’s data mining law should stay on the books, and why it shouldn’t.

This was a big deal – the major media outlets covered this event, all with a different take, which is always welcome and interesting. What we found especially remarkable was that none of them, and we read many stories, interviewed a Vermont physician. It was apparently the doctors themselves who initiated the legislation: When they found out their prescription data were being sold to the likes of IMS, they asked their legislators to write the legislation.

Most of the outlets quoted Justice Antonin Scalia, Chief Justice John Roberts and even Ruth Bader Ginsberg, who questioned the reasoning behind the legislation. They didn’t think it had much to do with protecting the First Amendment rights of the physicians, as Vermont’s legal staff claimed.

“The state is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs,” Justice Ginsburg said, according to the Washington Post. “And if that’s the purpose, why doesn’t that run up against what this court has said — that you can’t lower the decibel level of one speaker so that another speaker, in this case the generics, can be heard better?”

Critics of the law – which include many large physician groups and the New England Journal of Medicine -- contend that data mining “violates medical privacy” a core precept of the physician-patient relationship. They assert the data are private and that the law “advances state interest by closing gaps in medical privacy and protecting the patient-physician relationship from intrusion by sales people, who tend to promote newer, less-tested and more expensive brand name drugs.”

Which is fine: Except that the law also says that a physician can exclude his data, if he wants it that way.

Does pharma use this data to sell? Of course it does. Can a physician shut his door to a drug rep? Of course he can. Let us not forget that the transparency rules are in place.

We find it curious that industry critics have such little regard for physicians’ intelligence and willpower. 

Monday, April 25, 2011

Healthcare Costs: Let the Sadists Rejoice

As politicians and other policy makers try to curb the costs of healthcare, the people who make their living from saving lives are no doubt trying to figure out how not to lose income without looking like heartless jerks. Odds are they also are trying to figure out how to take money from each other.

The folks in the boxing ring: drug makers, hospital owners and insurance companies.

The heavyweight is the hospital owners, even though their slice of the pie has shrunk 10% between 1980 and 2009, to 32.6% from 42.7%, according to the The Cost of Caring: Drivers of Spending on Hospital Care, from the March 2011 American Hospital Association. That’s 32% of $2,330.1 billion. [I BELIEVE THAT’S A TRILLION?]

And, just to complete the reporting, the drug makers’ and insurance companies’ slices have gotten lots bigger: drug makers’ take has doubled, to 10.7% from 5.1%.

As for the insurance companies, “since 1999 [to 2009] premiums have gone up a total of 131 percent, far more rapidly than workers’ wages [up 38% since 1999] or inflation [up 28% since 1999], according to a Kaiser Family Foundation study. 

It’s difficult to see how any of them will lose money. While insurance companies will likely continuing trying to control patient hospital stays, our population is getting older. You know the rest of the story. According to the AHA article, of the Medicare patients who had heart failure and died between 2000 and 2007, 80% were in the intensive care unit during the last six months of their lives. The per-patient bill hovered around $36,000.

Then there are our lifestyle issues. More people are obese, have diabetes, are hypertensive, have cancer …..

And then there is technology, and more and more of it. It may get people back to work quicker, but it also costs money: “The average spending per heart attack case rose from $12,083 in 1984 to $21,714 in 1998.”

And we’ve all read the stories about hospital staffing shortages.

As costs continue to rise, the country’s 1,000+ private insurance companies, let alone self-insured employers, will surely continue to scrutinize every procedure. But hospital administrators aren’t stupid: the losses they incur from patients who don’t pay, as well as from Medicaid, Medicare and the uninsured will be absorbed somewhere: How many hospitals have closed their maternity wings?

A law of physics applies: Every action has a reaction.

Paul Krugman, in his Times Op-Ed column last Friday, (April 22) wrote in support of the Independent Payment Advisory Board, an expert panel that would set spending limits for Medicare. Mr. Krugman says, “We have to do something about health care costs, which means that we have to find a way to start saying no.”

We? There is no we regarding healthcare. For the economic sadists among us, this is pure joy.

Monday, April 18, 2011

Industry-Physician Education: Walking in Patients' Shoes

Some industry critics have railed that any contact between physician and drug makers is akin to a mortal sin; the very thought sullies the purity of medical practice. We think extremism, in any form, shows poor judgment and lack of logical thought. Transparency is excellent, but contact between industry and physician is still necessary for medical advancement.

So we loved the piece we read in Pharmaceutical and Medical Packaging News about the pharmaceutical consulting firm that set up booths at a rheumatology conference which allowed physicians to experience what their RA patients deal with every day. The point: education for all stakeholders, and that includes the use of biologics. A Web-designed program also stresses the need for exercise and the importance of medication adherence.

The booths were equipped with a working faucet and sink; a laundry detergent container; and working taxi cab door. A pharma sales rep guided each physician through the booth, who was asked to turn on the faucet, and so on. The physician, who was measured on how difficult it was to perform the tasks, generally had no problem doing so.

Then the HCP put on specially made gloves (made by folks at George Tech University) that simulated the challenges the RA patient goes through; the physicians' decline in functionality was significant.

The doctors who went through the booth loved it; 92% said they would go through it again – 98% said the demonstration helped them understand what their patients dealt with every day.

Just think: Maybe the consulting firm that developed this tool, OneWorld, can design similar booths for neurologists, so they can appreciate what migraineurs live with, and for pulmonologists, so they can understand what it’s like to live with emphysema.

Thursday, April 14, 2011

The HCC, Its Priorities, and Financial Disclosure

The headline on the Healthcare Channel article reads: Did Merck conceal funding to a vocal advocate of Gardasil?

If Merck tried to, it did a lousy job. Its financial connection to oncologist Maura Gillison, the woman who linked the human papillomavirus with a new type of tonsil cancer, is readily available on the Web. The earliest connection we found goes back to a Forbes story, written in 2009. If Merck tried to keep the connection out of the story, it failed.

There might be an earlier mention, but there’s no date on this disclosure: Dr. Gillison, who also has a PhD, apparently spoke at a webinar for the Association of Reproductive Health Professionals. She disclosed that she “receives unrestricted educational grants from Merck and Digene.” 

If you haven’t guessed already, this is yet another dust-up over financial disclosure. The Healthcare Channel apparently was all aflutter that Dr. Gillison hadn’t listed Merck as a funding source when she published an article in the New England Journal of Medicine in 2010. It notified NEJM; the journal investigated, and it decided that Dr. Gillison HAD NOT violated any of its disclosure rules because the financial arrangement had fallen into a “gray area.”

We don’t know why NEJM let Dr. Gillison slide; but we think this is an example where we need to be careful about the generalizations associated with industry and healthcare practitioners' relationships.

The Healthcare Channel wrote: “The Healthcare Channel has exclusively learned that Dr. Gillison was in fact receiving payments from Merck, going back to 2008 that benefited at the least her laboratory, while she was at Johns Hopkins.” Maybe if its writers had surfed the Web for 15 minutes, they would have found what we found.

This is what the Merck Web page says regarding the information it discloses:

"On March 29, 2011, Merck updated its report on payments to U.S.-based medical and scientific professionals who speak on behalf of Merck about our products and other health care issues. These reports include legacy Merck products prior to the November 2009 merger between Merck and Schering-Plough. The new report covers payments made to speakers for the full year 2010. The report provides data for 2,088 physicians and other health care professionals who, on average, participated in 5.9 programs each and earned an average of $1,659 per program…"

Dr. Gillison is not listed. The presumption: She didn’t speak for Merck during 2010.

We all know there is no uniformity among the current disclosure laws, or among the industry members who are disclosing on Web sites. We’ll all have to wait for 2013 for that to happen.

This is what the Forbes article said about Dr. Gillison and Merck: “Gillison spent three years trying to draw Merck's attention to HPV tonsil cancer. Finally, she is working with Merck to design a study to see if Gardasil can affect HPV infection in the throat. Merck admits studying the problem is ‘challenging’ but says the potential is big.”

Here is a physician who made the connection between HPV, oral sex and a new form of throat cancer. She did the right thing: She worked with industry to try and find a cure. She never hid her connection with industry.

That old expression about throwing the baby out with the bathwater keeps popping into our brains ....

Monday, April 11, 2011

Saving Capitalism and Sunday Dinner

Whatever happened to taking our time? For those of us old enough to remember, a time once existed when virtually all stores were closed on Sundays. Yes, all shopping happened the rest of the week. Sundays were reserved for family and friends; some of us even ate dinner at an earlier hour, and we didn’t dare be late for it, either. Of course, this was a time when computers were the size of tanks and most of us only got three channels on our television sets. 

Life moved at a slower pace.

Now, life moves in nanoseconds. Is it possible to connect today’s freneticism to Dominic Barton’s argument in the Harvard Business Review that for capitalism to thrive, the business world, among other improvements, must start thinking in the long-term –- and that means not in terms of a few months, but in terms of many years?

Mr. Barton’s concern is that unless business leaders fix those problems that were exposed during the Great Recession, Washington and the public will do it for them. 

“There is growing concern that if the fundamental issues revealed in the crisis remain unaddressed and the system fails again, the social contract between the capitalist system and the citizenry may truly rupture, with unpredictable but severely damaging results,” writes Mr. Barton, the global managing director of McKinsey and Company.
He advocates:
  • Adopting a long-term view for success –- at least five years;
  • Convincing typical stakeholders that also serving atypical stakeholders –- customers, creditors, the environment –- is essential to success, and;
  • Converting disengaged board members into engaged, proactive members.
He makes a lot of sense, but we fear his words are too scary for some.
“Analysts and investors are focused on the short term,” he quotes one executive as saying. “They believe social initiatives don’t create value in the near term.” In other words, Wall Street may not like it.

A couple of statistics from Mr. Barton’s story:
  • In 1995, the average CEO stayed on the job for 10 years; now, that tenure has dropped to six years. 
  • In the 1970s, U.S. equities were held for an average of about seven years; now it’s about seven months. 
  • "Hyper-speed” traders account for 70% of all U.S. equities trading. 
When McKinsey and Company broke down the value expectations buried in share prices, it discovered that 70% to 90% of a company’s value was connected to cash flows that were anticipated in at least another three years. If most companies’ worth relies on results that far out, but its leaders are concerned with what’s reportable in the next quarter, then capitalism -- and by default our American culture -- is in trouble, Mr. Barton says.

We think capitalism, Sunday dinner, and a whole host of other valuable traditions  are in trouble.  Maybe we need to focus on what is important and slow down.  

Thursday, April 7, 2011

$4 Generics and Medication Non-Adherence

Let’s face it – the business of healthcare is enough to make anybody nuts.

Take the recent study, conducted in 2007, showing only a handful of people, relatively speaking, who took advantage of their healthcare insurance provision to buy $4 generic drugs. If all the people who could buy $4 generics did so at that time, society would have saved nearly $6 billion. A lot of money, no question. The study included 31,000 people; fewer than 6% bought $4 drugs.

It’s tough to imagine that 93% of these people hated society, so maybe there’s something else going on here. They didn’t know? Perhaps. They don’t like generics? Unlikely. According to the Kaiser Family Foundation, 72% of all scripts written in 2008 were generics, and sales of generics grew 8% from 2005 to 2006. The percentages wouldn’t have changed that much from 2007.

In that same study, “Over half of physicians say they frequently talk with patients about the out of-pocket costs of medicines they prescribe, 62% say they switch patients to less expensive drugs, and 58% say they give patients office samples.”

It's anybody guess why those patients chose to spend more money. But, none of the above is the good-grief part. The following is.

Back in November, the New England Journal of Medicine ran a piece about the possible damage that these $4 generic sales can do to long-term improvements in healthcare.

Normally, when a patient purchases a prescription with insurance, that purchase generates a claims record. The pharmacy sends the claim to the pharmacy benefit manager. These claims can be used for healthcare management, including medication safety, verifying clinical trial results, and ensuring medication adherence.

But, with the $4 generics, patients often pay in cash. The authors say the pharmacies often do not submit the claim information “since they have no incentive to do so.” The result: patients are classified as non-adherent or non-users. And, because these drugs are often prescribed for chronic diseases, “the consequences of these missing claims are not insignificant.” This is also important to the topic of medication adherence because it already suffers from a lack of awareness. With almost 80% of the prescriptions today being dispensed as generic, medication non-adherence will become more of a silent disease.

The authors, Niteesh K. Choudhry, M.D., Ph.D., and William H. Shrank, M.D., M.S.H.S., aren’t labeling the pharmacies as bad guys – their actions are unintentional, they say. But, as they point out, new systems need to be devised to make sure the claims are filed. 

Monday, April 4, 2011

Pharma Marketers: Smiling Through the Pain

Pharma marketers, it’s little wonder that you aren't happy people these days. The feds have yet again pushed off making decisions about how to regulate social media interaction; your DTC spend has dropped; the Sunshine Act will, indirectly, shift who your customer base is; and your end-users are spending lots of time checking out the goods on the Web before buying. Forgive us for reminding you that patients no longer just blindly take their doctor’s advice on a script.

Your mood is understandable. You need to account for every cent in your marketing budget. We get it.

But may we look at this from another angle? You may not have to recreate your wheel. You can take out a few spokes and replace them.

In other words: Have some fun while you’re miserable.

How? By learning about the game from others in the game. A Medical Marketing and Media article – an oldie but a goodie -- points out that while Pharma companies are learning from other industries’ marketing strategies, they haven’t yet caught on to the value of their own ROI experiences. The article suggests pharma needs “a clear optimization plan…. so that when results come in, everyone can deal with them as opposed to having an academic debate” about what mix works the best.

And then of course, there is keeping track of those Web searches –- not only the searches that patients make, but also those that physicians make. More than 70% of physicians search the Web for drug information, and 30% change the script or treatment course because of information they find on it, according to ThomsonHealthcare.

And more and more, those searches will lead pharma marketing pros to other social media sites like Facebook. For two years in a row, the word Facebook was the top search term on the Web, according to Experian Hitwise.

But waiting for the FDA to make a ruling before industry members are allowed to play the game will lead to many different challenges, not the least of which is disintermediation of their own products. When the FDA finally figures out how it wants industry to conduct itself in the social media world, marketers may not be able to create new spokes for that wheel. We suggest you do some scenario planning to get to those answers.

And hopefully, smile again.

Thursday, March 31, 2011

Being Happy, Being Smart

We have a good friend who has met the financier Warren Buffett. Her description of him: down to earth, interested in people, happy. If you look at his pictures, Mr. Buffett looks like a pleasant individual.

A few years ago, we had the excellent good fortune of meeting E.O. Wilson, the evolutionary biologist and two-time Pulitzer Prize winner—for science writing, no small feat. Our description of him is very similar to that of our friend’s description of Mr. Buffett’s. He too, looks like a pleasant individual.

We forgot to mention, of course, that they’re both brilliant in their respective fields.

Another brilliant man who always seems to have a smile on his face: Bill Clinton.

We combed through Google for all these photos because of a Harvard Business Review blog that talked about whether happy people are dumb. Duh!

The author, a former Harvard teaching fellow, says it is unhappy people who aren’t living up to their potential. We need to release that dopamine to let us enjoy and be happy, and to get the secondary benefits: dopamine turns on the brain’s learning centers. Without the dopamine, it’s tougher for us to learn. The higher the level of positive emotion, the more you learn, the more you create.

“Doctors primed to be positive come to the correct diagnosis 19% faster when primed to be positive as opposed to negative. Salespeople have 37% higher levels of sales when optimistic. … A meta-analysis of employees … reveals that nearly every single business outcome improves when a brain is positive. Happiness is a significant advantage,” author Shawn Achor says.

Being happy isn’t being na├»ve, or ignorant. In fact, the Greek playwright Sophocles said wisdom is the supreme part of happiness.

There’s nothing dumb about that.

Tuesday, March 29, 2011

The Pooled CME Model: A True Gift

Industry members, the American Gastroenterological Association (AGA) has handed you a gift, even though you might be insulted by its recent proposal that you adopt a centrally funded CME model. From our back-of-the-envelope calculations, we can’t figure out how pharma loses with this proposition, only gains from it—including some public credibility.

But first, for those who don’t know what happened recently: The AGA proposed at a recent meeting that its pharma supporters contribute to a general fund for its CME activities. AN AGA education committee would determine the curriculum. But, “If required … AGA would guarantee companies to produce one program in a therapeutic area of interest to the supporter,” according to the Medical Marketing and Media article.

Industry members who heard the proposal weren’t exactly in love with the idea.

But, if they thought about it, they could at least grow to like it. One well known study has shown that physicians aren’t exactly aware of when industry has paid for the CME courses they’re taking, although they seem to be aware of the drug ads in the journals.

If the former is true, and it’s true that industry expects to recoup $3.56 for every dollar it invests in CME, then what difference does it make what the money pays for? Pharma only wins here. It is helping educate physicians, and it can say to its critics, “See, we are supporting well done CME and not involved in influence-peddling.”

Industry shouldn’t fear the change here—pharma should fear that it’s passing up a great opportunity to deal with a meddlesome transparency issue.

ACOs and Fierce Communication

So here’s a question to ponder while you’re reading our carefully honed prose: How do you attract patients to sign up for an accountable care organization?

Last week, Cigna announced that its two ACO pilots were doing, at least preliminarily, what they should be doing: improving patients’ health and saving money. The giant insurer is so happy with the results that it is planning a national expansion of its ACO program this year.

Here’s why they’re happy: At its multi-specialty medical group practice division in Phoenix, the average annual savings per patient was $336; ambulatory surgery was down 11%; preventive care visits, overall, were up 3%, and up 12% for adults. And, its partner in New Hampshire is “closing gaps in care 10% better than the market.”

A few years ago, Cigna jumped on the ACO bandwagon. The goal: “Achieve the ‘triple aim’ of improved quality, lower medical costs and improved patient satisfaction by creating a care model anchored in the principles of the patient-centered medical home that also builds in accountability by rewarding physicians for results.”

In its press release Cigna says its collaborative ACO model is big on communication. Its doctors and nurses speak frequently with its customers’ doctors and nurses, “to help with coordination of patient care.” Cigna’s program also includes disease management programs and lifestyle management programs, including stress management.

Cigna doesn’t say how its customers reacted to the idea of participating in an ACO. That notion is even more interesting for Medicare patients. How will Medicare—by law, mandated to start pilot programs by next January—attract its seniors, normally an independent, privacy-loving lot? According to the new healthcare law, the pilot ACOs will take care of all the healthcare needs of at least 5,000 Medicare patients for three years, minimum.

FierceHealthcare says the success of these ACOS will require “fierce communication strategies,” like physicians doing things they don’t normally get paid for—contacting patients by e-mail, instant messaging and so on.

But as usual, it comes down to communication. We somehow doubt that it will matter what the medium is: word of mouth, Twitter, radio, smoke signal. If the ACO healthcare providers are communicating among themselves, sharing information about a patient’s well-being, and that patient’s health is improving, along with his quality of life, then that patient will spread the word.

And that can be pretty fierce, don’t you think?

Friday, March 25, 2011

Patience and Effective Disease Management Programs

The McKinsey Quarterly recently did its usual fine job, explaining in detail how other countries are running effective disease management programs. McKinsey says a successful disease management program has these common denominators: many participants; simple rules to follow; is patient-focused; has clearly defined measures; and aligned incentives. Sounds doable, right?

And then it got to the kicker.

“Any group thinking of sponsoring a disease management program must also realize that a large program takes years, not months, to get completely off the ground. It took Germany more than six years to fully implement its program for type 2 diabetes.”

Kind of dooms the notion of a successful disease management program happening in this country. Americans are not exactly the most patient of people.

Need proof? In a survey published Jan. 21, 2009, 79% of Americans were “optimistic” about this country’s future under the leadership of its new president, Barack Obama. By July 30, 53% said they didn’t like how Mr. Obama was handling the economy. Four months later, his job approval rating had fallen below 50%.

If we’d gain a little patience and let providers develop some effective disease management programs, can you imagine what the savings to lives and the bottom line would be? Isn’t that worth a little patience?

Maybe if we thought of a disease management program as a bottle of fine wine, aging to a perfect maturity....

Saturday, March 19, 2011

The VA Shouldn't Hold Its BREATH

What a mess. In 2009, the Department of Veterans Affairs abruptly halted a study called the BREATH study, designed to help 413 veterans manage their advanced COPD, because of unspecified safety concerns.

Apparently the deadly type of safety concerns.

The VA, keeping mum about what happened until it publishes in a peer-reviewed journal, had all the right intentions. It wanted to help the sick vets cope with this chronic lung illness by teaching them how to manage it–-with the hope of then keeping them out of the hospital.

But apparently the trial backfired. While the study’s researchers wouldn’t give details, one told the Pittsburgh Tribune-Review, “If someone were to start a disease management program, I would suggest they probably not do it just yet, until the information is available," said Dennis Niewoehner, a pulmonary doctor in Minneapolis, a co-chair for the trial.

Forgive us, Dr. Niewoehner, but we disagree. One, the VA should tell healthcare providers now what happened. There may be a clinical trial going on that could benefit from your knowledge. And two, stalling the start of a disease management program until a paper is published is not right. For those with chronic diseases, every minute has got to be torture.

What is ironic is that maybe the VA should have waited to start its study. Just recently, a review was published in Current Opinion in Pulmonary Medicine on COPD and older adults. The researchers looked at various areas, including comorbidities and disease management.

Older adults with this disease have an average of nine other comorbidities, including depression, cardiovascular diseases and chronic renal failure. What they found was that research suggests that “aging is a determinant of the progression of disease and that management of this population requires different metrics and strategies.” According to the summary information of the VA study, the study group received an education program, an “action manager," plus care. They also received telephone calls. The control group received standardized care.

Since we have no clue as to what went wrong with the study, we can only speculate, but the take-away message is that patient monitoring and management could have potentially signaled these problems sooner. While we think publishing what goes wrong is as important as publishing what goes right, we also believe the use of monitoring technologies like MedAdherence can help providers manage patients with many comorbitities remotely, and possibly better.

Let us know what you think.

Tuesday, March 15, 2011

Adopting EMRs: Can Challenges Be Overcome?

A recent Wall Street Journal article talks about the biggest challenges that electronic medical record (EMR) adoption faces: the physicians and HCPs using the system. One challenge that's easy to understand is finding the necessary funding -- $7.5 million of a $250 million investment is allocated for training.  Man, that is a lot of money!

Is there a better way?  We think so, but the real issue is the change that needs to occur in the training of medical personnel.  It also requires a perception change that may make the practice of medicine even less desirable today.  The WSJ article quotes one consulting firm that compares "the switch to the commercial airline industry's move from analog to digital flight decks because both involve highly skilled professionals learning a new technology quickly."  Maybe that is why the cost is so high, but does it have to be?

The Healthcare Channel (HCC) highlighted this point in one of its recent blog posts and suggested that physicians not be paid until they document moving forward. While HCC suggests in a harsh manner that it is physicians' incompetence, we think it is really a fear of the unknown.

We believe EMRs can offer significant advancement in medical care. It is clear that gaps in medical care are caused by events or issues between visits, episodes or conversations. We think technology can positively change care and as HCC suggests, accountable care organizations will need to use EMRs to achieve business objectives and margin targets.

In the end, change is often difficult. When people are faced with change or proving why they should not, most people get busy with the proof.

Friday, March 11, 2011

Getting Patients and Physicians to use EMR's & PHRs

Physicians are missing an amazing opportunity to help ensure that their patients maintain their treatment regimens. That opportunity, of course, is online. Their patients are online; many of these patients want their doctors online; but their doctors, for various reasons, continue to resist.

According to a story in FiercehealthIT, meaningful cyberspace connections aren't happening between patient and physician, regardless of the Web tool – patient portal or personal health record.

Patient portals, according to the article, are primarily used administratively, paying bills and requesting appointments. As for personal health records-–few people have them--but a survey by the California HealthCare Foundation found that more than half of those queried said they’d like a PHR provided by their doctor. Which means they want real data in their files. Which means they’d need to get it from an electronic medical record ….

A report from the business technology consultant CSC says that’s not likely to happen, because EMRs are “the least prevalent” sources of data available today.

Writes FiercehealthIT: “The common denominator between the situation with patient portals and PHRs is that most doctors and hospitals still are not making much clinical data available to patients."

A Health Affairs study might add some insight. In a national survey of physicians conducted in 2008 and 2009, 64% said they hadn’t used a patient’s electronic personal health record. The reasons: patients’ privacy concerns, data accuracy and liability issues, and lack of payment for reviewing or using the records.

Legitimate concerns, but concerns that should be worked out. These records, if maintained accurately, could lead to better health–-at least that’s what the California HealthCare Foundation found. Physicians would have more holistic pictures of their patients.

Can we all agree that would make sense?

Monday, March 7, 2011

Pharma: Know Thine Enemy

Mindless habitual behavior is the enemy of innovation. 
Harvard Business Professor Rosabeth Moss Kanter 

Might we suggest that pharma begin thinking about investing serious money into healthcare that does not only involve drugs? We keep tripping over stories and studies of how non-traditionalists are stepping into the healthcare space using social media.

We found this interesting.

One group of researchers has published two papers on smoking cessation; both papers involved the same number of subjects, 27. Another group took a look at the 47 apps, designed to help smokers quit smoking, all of which are currently sold for iPhones only.

The two groups of researchers found different results.

In the first paper  the researchers first used fMRIs on the subjects, all heavy smokers, to learn which parts of the brain were fighting, or giving in, to the urges to smoke. Their description of this battle: “A war that consists of a series of momentary self-control skirmishes.”

The researchers theorized that by mapping the brain areas where these skirmishes are fought, they could predict which of the subjects would have more success at quitting–-because these brain areas were more active. The motivation they used on these subjects was text messages, eight messages a day for three weeks.

“We are really excited about this result because it means that the brain activation we see in the scanner is predictive of real-world outcomes across a much longer time span than we thought,” said one researcher. “The tasks that we use in the laboratory are simplified models of these real-world processes–-but they seem to be valid models.”

In the apps paper, the researchers checked out the 47 smoking cessation apps, just to see how effective they might be. They looked at how each app approached smoking cessation and its adherence to the U.S. Public Health Service's 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence.

The conclusions? The apps had “low levels of adherence to key guidelines in the index. Few, if any, apps recommended or linked the user to proven treatments such as pharmacotherapy, counseling, and/or a quitline.”

What an opportunity for pharma; it’s tailor-made.

Friday, March 4, 2011

Can the NIH Innovate Faster than Industry?

So it’s come to this: The federal government plans to entice industry with basic bench, and maybe even clinical trial results, to spur drug development.

Concerned that so few promising drugs are in the pipeline, that let alone meet FDA standards, the NIH is setting up a new research shop. Anticipating that penny-pinching Republican House members may give him a hard time about his idea, NIH chief Frank Collins is willing to “cannibalize other parts of the health institutes to bring more resources to the new center,” says the Times.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he told the Times. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For those who need a recount: The FDA approved 21 drugs in 2010, 25 in 2009, and 24 in 2008. No drugmaker, says Fiercebiotech, had more than one drug approved last year. The approval rules are getting tougher: We all saw what happened with the obesity drugs. Collins said in the Times article that industry’s “productivity has been declining for 15 years.”

It doesn’t look like many drugs will be approved this year: The Street said in January that 26 were in the queue and one’s already been rejected: Contrave, the obesity drug.

Industry is all tied up in what it considers a bad situation. While profits are increasing for some members, companies choose to focus on patent expirations, tough regulators – on both sides of the Atlantic – the new U.S. health care reform, and no doubt myriad other issues.

Fiercebiotech penned the apt phrase: A wave of impatience has crashed over the drug development and discovery business.

How did we get here? Another phrase is apt: The perfect storm.

Pharma’s past behavior forced overregulation, which added more costs to R and D. And since no one in discovery appears willing to give up its quest for innovation – read blockbuster – the costs of discovery continue to rise. So mergers and acquisitions make sense, which in our experience has drained talented R and D personnel.

So, academic researchers and advocacy groups may be the ones who drive new innovation, but it's doubtful they'll have enough funds to see any product through all the regulatory challenges. It appears to us no one is reconciling the priorities with the limited dollars available.

In our opinion: Drug research is too inefficient.

Industry critics continue to scream that pharma spends way too much on marketing and has no reason to cry poor mouth. This may be true: But the fact remains that collaboration in pharma is still a business, and pharma must answer to a board of directors, shareholders and its own future. As for the NIH, do we have evidence that research dependent on the federal government for basic bench research is the way out of this mess?

We believe both parties can find new ways to conduct research and conduct clinical trials. We just began working with a company that's ready to break down some of those challenges. We suggest this type of communication, knowledge management and performance measurement tool can help all parties involved in research. 

A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.

His suggestion: Pharma should use more computer-based mechanistic disease modeling.

Monday, February 28, 2011

Pharma: It Must Invest in Improving Health Outcomes

If you're a businessperson and you see an opportunity, don't you take it? Especially if the opportunity is in a business that doesn't seem particularly interested in protecting its territory.

The territory we’re talking about: the quest for improving health outcomes. In a new Ernst and Young report, the authors say that non-traditional companies are investing in projects designed to improve health outcomes. To be sure, some of these partners are traditional, like Apple and Abbott Labs.

The non-traditional investments far outweigh those of Big Pharma. The non-traditionalists have spent $20 billion since 2006; Big Pharma’s figure was not given, but it wasn’t close to that, according to a Bloomberg story.

The authors say that Big Pharma has no choice but to invest in improving health outcomes, and for two reasons: the current health care system is not sustainable -- but new technologies can make it so. These technologies, the writers say, can drive behavioral change.

Examples of these projects include the insurer UnitedHealth Group, the YMCA, and Walgreens, which are working together in a diabetes management program. Others, according to Bloomberg, include GE, Telus Corp, a wireless carrier, and IBM.

One company, called PharmaTrust, based in Toronto, is creating a device called MedHome that dispenses the appropriate amount of medicines to patients in their homes. At the same time, it communicates with providers and caregivers about patients’ compliance, according to the report.

And Qualcomm, the mobile technology company, is hoping to increase compliance and health outcomes with its “connections:” an Internet-connected pill bottle cap designed to increase compliance and also lets patients refill prescriptions by pushing a button on the underside of the cap; and a “connected” blood glucose meter that tracks how often patients are testing themselves and reminds them when they are running low on supplies. They can even reorder from the device.

“Pharma is significantly behind the medical device industry in thinking about connectivity and using its power for productivity and business model innovation,” wrote one Qualcomm exec.

All we are suggesting is that innovation may quickly become the domain of others. What are the unintended consequences of this lack of pharma innovation? 

Thursday, February 24, 2011

Investing in Health Outcomes: Does Pharma Get It?

A new Ernst and Young report on what it calls Pharma 3.0 – the industry’s migration from its sole focus on selling medicines to the inclusion of improved health outcomes – reminds us of the tale of the Big Three. Yes, we mean Detroit.

We’ll get to that analogy in a minute.

“In Pharma 3.0,” the authors write, “companies will succeed or fail based not on how many units of a drug they sell, but on how well their market offerings improve health outcomes.” Considering that this report included roundtable discussions and more from numerous Big Pharma execs, it’s safe to say it has lots of industry buy-in.

The report says that some pharma members are investing in such programs. By the authors’ count, 220 programs were launched between 2006 and 2010, with the lion’s share, 44%, coming last year. The authors say nearly all the top pharma houses “are active in the Pharma 3.0 space” with a few, such as Pfizer, Novartis and Roche “leading the charge” with more programs. (Pharma 1.0 is how business was conducted; Pharma 2.0 is considered Pharma’s pursuit of blockbuster drugs and is now coming to an end.)

The report doesn’t talk about how big the programs are, or how much money industry has spent.

But it does mention how much money other companies – non-traditional organizations like Apple and IBM – are spending: $20 billion.

And counting. The writers aren't pleased with industry's skimpiness.

“Pharma is still focused on investing in drug innovation,” says a Johnson and Johnson exec. “We’re not making the kinds of investments in Pharma 3.0 that many non-traditional entrants are making.”

And now for that Big Three connection.

For those of us old enough to remember, do you recall when Toyota and other foreign automakers seriously started selling their cars on American soil? The Big Three ignored their fuel efficiency, their smaller size, their better performance – until it was nearly too late.

The article authors make a similar connection.

“It is important, however, for pharma companies to recognize that they may have a limited window of opportunity. Today’s non-traditional entrants, though unfamiliar with the health care business, could prove to be quick learners, and the advantages that the pharma companies have because of their domain knowledge could shrink in a few years.”

Tomorrow: what those non-traditional entrants are doing.

Tuesday, February 22, 2011

Elected Officials: Poor Profiles of Courage

A while back I started to receive an e-mail newsletter from an organization called The Healthcare Channel.  Much of it covers topics relevant to healthcare, particularly in Washington D.C. My reason for raising awareness about its work is a recent article below, which concerns the unlikely confirmation of President Obama's pick for Medicare chief, Donald M. Berwick, M.D.

My take: This article encapsulates a huge problem we have in this country. Our elected officials, on both sides of the aisle, need to wake up and realize this country is dysfunctional because they lack the courage to make difficult decisions.

While this blog has never been overtly political, we have discussed politically created unintended consequences, such as the Physicians Payments Sunshine Act. I think what is happening here as part of Dr. Berwick's confirmation process is a travesty that will have a negative impact on our country's ability to solve our healthcare crisis. I know the qualities of a man like Dr. Berwick's and believe this is someone we need to help us create change. His willingness to do what is in the best interests of the country has always been one of his hallmark traits. While I am sure his presumed replacement, Marilyn B. Tavenner, a nurse, has many great qualities, I am not sure Congress has really given Dr. Berwick a fair shot to try and make change happen.

As always, I am interested in knowing your thoughts.

Rising Calls to Replace Top Man at Medicare
By Robert Pear
The Healthcare Channel

WASHINGTON — Members of Congress, including Democrats, have urged the Obama administration to search for another Medicare chief after concluding that the Senate is unlikely to confirm President Obama’s temporary appointee, Dr. Donald M. Berwick.

Dr. Berwick’s principal deputy, Marilyn B. Tavenner, has emerged as a candidate to succeed him. Lawmakers of both parties said Monday that Ms. Tavenner, a former Virginia secretary of health and human resources with extensive management experience, could probably be confirmed.

In a letter to the White House last week, 42 Republican senators urged Mr. Obama to withdraw the nomination of Dr. Berwick to head the Centers for Medicare and Medicaid Services, which runs insurance programs for more than 100 million people. If those senators stick together, they could block confirmation.

Mr. Obama bypassed Congress and appointed Dr. Berwick while the Senate was in recess last July. The appointment allows him to serve to the end of this year.

The president has nominated Dr. Berwick three times, most recently in January. No confirmation hearings have been held, and none are scheduled.

Reid Cherlin, a White House spokesman, said the president would not withdraw the nomination. “The president nominated Don Berwick because he’s far and away the best person for the job, and he’s already doing stellar work at C.M.S.,” Mr. Cherlin said.
It is not clear whether the White House will fight for the nomination or press the Finance Committee to hold a confirmation hearing, which could provide Republicans another opportunity to criticize the new health law.

Dr. Berwick, a pediatrician and a health policy expert, was hired to run Medicare and Medicaid. In recent weeks, the White House has expanded his portfolio to include federal regulation of private insurance.

As a co-founder of the Institute for Healthcare Improvement, a nonprofit organization in Cambridge, Mass., Dr. Berwick advised hospitals on how to save lives by upgrading care and reducing medical errors.

He became caught up in the partisan battle over the new health law. Republicans challenged him to explain comments in which he had discussed the rationing of health care, praised the British health care system and urged health care providers to reduce the use of ineffective procedures near the end of life.

At a hearing of the House Ways and Means Committee last month, Dr. Berwick said, “I abhor rationing.” Representative John Lewis, Democrat of Georgia, told Dr. Berwick, “I love your testimony, not just like it but I loved it.”

Republicans were hostile.“In your testimony, I see nothing but platitudes,” Representative Charles Boustany Jr., Republican of Louisiana, told Dr. Berwick.

Representative Geoff Davis, Republican of Kentucky, said Dr. Berwick’s answers bordered on equivocation. And Representative Tom Price, Republican of Georgia, told him: “You missed your calling. I think you would make a great lawyer.”

Several people who work with Dr. Berwick at the Medicare agency said they were disappointed that the White House had not done more to promote him. “Everybody here admires Don and the work he’s done, but he is not going to be confirmed,” a supporter said. “That’s inevitable. The Republicans will block him. There’s not a lot of optimism that the White House can do anything about it.”

Ms. Tavenner, a nurse, worked for more than two decades at the Hospital Corporation of America, first as a nursing supervisor, then as a hospital executive and eventually as president of the company’s outpatient services group.

Thursday, February 17, 2011

Can Pharma See Wisdom in the Sell-Off?

The Street is pushing Big Pharma members to sell off their non-core assets. Why? To keep stockholders happy, of course. Even the media-deprived know that last year was not a stellar year for pharma, finance-wise or any other wise.

The Street people are arguing that some Big Pharma members are worth more dissected than they are whole. If Abbott Labs, for example, were torn asunder and its various pieces sold off, it would make a handsome profit, and its stock price could jump 30%, according to an analyst quoted in Barron’s.

Obviously, that money could be used for what’s needed: R and D.

FiercePharma brings up the point, and it’s a good one, that such dissection would run counter to what pharma members have been trying to do with all these mergers and acquisitions, and that is survive – a sophisticated way of hitting the mattresses, if you will.

Our two cents: We’re with the Street, but not for the same reason. We think it’s time for pharma members to get back to their roots, and that is Research and Development, 24/7. If discovery, trials, regulatory, and so on were the same as they were 30 years ago, it would be one thing, but they are all much tougher today. The amount of focus and concentration needed is exceptional.

Too many divisions cause too many distractions, too many worries.

Barron’s is right: Bigger is not always better. In fact, it can be a real burden.

Monday, February 14, 2011

Telehealth: Simple Is Beautiful

One challenge with healthcare is figuring out when people alone can produce the best healthcare outcome for the patient, or when technology can do the job better.

Or a combination of the two.

We present, as an example, a three-year Department of Defense study involving pediatric care in the Pacific Rim. The DoD wanted to see if physicians who consulted with pediatric subspecialists online regarding consultations, treatments and so on, could improve health outcomes for young patients while saving the DoD money. The conclusion: Yes on both counts.

The study, conducted between 2006 and 2009, looked at more than 1,000 tele-consultations in community hospitals from the area, including Guam and South Korea, often in areas where pediatric subspecialists are not available. Most of the tele-consultations, 75 percent, came from these areas.

Because the doctors spoke, the diagnosis and/or treatment plan was changed for 74 percent of the children – preventing patient transfers to other facilities between 12 percent and 43 percent, saving American taxpayers between $208,283 and $746,348 each year – not to mention saving the children and their families unnecessary expense and concern. The study authors said the number of “tele-consultations has grown significantly since 2006.”

It didn’t take long for the Twitter world to react to this study. One tweet [Feb. 8, 8 p.m.] asked if healthcare pros who don’t use telemedicine are negligent; another [same time] said Alaska and Hawaii are teaming up to extend telehealth to remote locations in those states.

The straightforwardness of this study, and its convincing outcomes, dispels the healthcare challenge this particular problem presented. That is why we wanted to bring it to your attention.  If only all things were this simple.

Thursday, February 10, 2011

Medication Adherence: Two Views

We have a friend who’s done a lot of research on medication adherence, and he says that healthcare professionals fall into two camps regarding how they see patients and their capacity to maintain their treatment regimens. In the one camp, he says, are those who think patients can't motivate themselves for their own betterment. It’s the doctors who have the answers, not the patients.

Those in the other camp think just the opposite. They say patients are smart enough to know they need to maintain their prescribed regimen – they just need a little help to stick with the program.

Is it possible both camps are right? A study of hypertensive Medicaid patients who used a pill phone app on their cell phone reminding them to take their meds is pointing that way. It was a small study – 50 patients -- so we’re loathe to do more than surmise.

In a nutshell, the 50 patients accepted the idea, and used the app throughout the seven-month study. The patients were “generally satisfied” with the software, and patients continued to have their scripts refilled. But – once the study was over, there was a “decrease” in refills “after the application was discontinued.”

So, the study’s sponsors and researchers, including George Washington University Medical Center, appreciated that the participants were smart enough to be taught how to use the technology. And these patients used it for the study's duration. But once they no longer had the phone, they stopped.

Why? It would be good if the researchers asked some follow-up questions of these study participants. Any insight into how patients feel about maintaining their treatment regimens can only help.

Monday, February 7, 2011

Invest in Healthcare, But What Exactly?

A recent Wall Street Journal piece regarding why pharma is having problems producing effective product caught our eye. The Feb. 9 op-ed article, called “Health-Care Investment: The Hidden Crisis” [subscription-only access] lays out ways that Washington “can remove some of the barriers to growth in medical research.” Its author: Michael Milken.

He argues that “improved public health translates directly into greater national productivity, which underpins all economic growth.” He cites figures showing how life-expectancy gains have added to America’s prosperity, and expresses concern that cuts in NIH funding “will cause some younger medical scientists to either change careers or take their work to places like Singapore” which welcome researchers.

The barriers he talks about are the usual suspects: anticipated patent expirations, regulatory issues, qualms about litigation exposure, and high U.S. taxes on repatriated overseas earnings.

Mr. Milken is on point linking ROI and extended lifespan. The study he cites –- that gains in life-expectancy since 1970 have added $3.2 trillion per year to "America's national wealth" – is impressive. We further argue that if more attention were paid to medication adherence, then that figure would be even more impressive.

Mr. Milken also argues that the FDA needs more resources to “keep up with the pace of innovation in such areas as medical-device development and regenerative medicine.” Agreed – let alone with inspecting clinical trials on foreign soil.

But let’s also consider this: The FDA needs resources to find different ways to solve their medical information problems. While the FDA guards public health, the FDA doesn’t produce good guidance on medical information and as a result industry may not provide good medical information to the patients using its products. A few years ago, the public didn’t have access to this information, but now it does. And the public will be talking about this information on social media sites. We believe the FDA isn’t moving quickly enough on its social site regulations or being adaptive enough about the content it regulates. It needs the time and resources to define flexible policies, not to apply additional funds to enforcement.

To our way of thinking, the FDA should become less regulator, and more healthcare-outcome policy initiator and promoter.

Thursday, February 3, 2011

EMRs and Pay for Performance: Stay the Course

Consider: When people must choose between changing an ingrained behavior, or proving why they don’t need to change their behavior, they will put their energies into the latter. Depending on what that behavior is will determine how much conflict there will be, and how uncomfortable the situation will get.

We fear that those who see no future in health IT or pay for performance will use lots of energy to convince others. One analysis study published in the Archives of Internal Medicine, one IT survey from Thomson Reuters/HCPlexus, and one pay for performance study published in BMJ suggest that physicians have no need to change behavior.

“Don’t spend any more money on this foolishness,” they are saying.

In our mind, is the question about the technology, or about change management?

In the Archives study, researchers from Stanford University pored over 255,402 non-hospital patient visits that occurred between 2005 and 2007 to non-federal treatment facilities. The authors looked at the role of electronic medical records (EMRs) and clinical decision support software (CDS) in assessing whether patients received better care, using 20 quality indicators as benchmarks. EMRs and CDS only exceeded one benchmark, the authors concluded.

"These results raise concerns about the ability of health information technology to fundamentally alter outpatient care quality," they wrote.

In the IT study, 3,000 MDs were queried as to whether EMRs would help patients: 39 percent said yes, 37 percent said there would be no effect, and 24 percent said the effect would be detrimental.

But could it be that some doctors aren’t tech-savvy, or that they just don’t have the time to learn how to use the system? We do not think the former, but it's true EMRs will likely,at least in the beginning, take them away from their patients. But over time, that should pass. 

Maybe it's all in the way IT is approached.An analysis study highlighted in FierceHealthIT showed that using IT, along with clinical guidelines, cut down on imaging studies for lower back and headache MRIs, and hence the costs. Yet another study in the same article noted that improvements came about when “healthcare organizations wholeheartedly embraced the technology and customized it to maximize performance.”

The operative word here: wholeheartedly.

Writes FierceHealthIT: “Physician complaints about computers detracting from patient encounters show that many doctors don't yet know how to use EHRs properly. …While today's health IT leaves much to be desired, doctors must make the effort to meet computers halfway if they expect the technology to help them improve care.”

In the BMJ pay for performance study, the researchers chose 470,725 hypertensive patients to follow between 2000 and 2007. The point: to see if their physicians could improve their patients’ numbers, earning money if they did. Nada.

“Pay for performance had no discernible effects on processes of care or on hypertension related clinical outcomes,” the authors wrote. “Generous financial incentives, as designed in the UK pay for performance policy, may not be sufficient to improve quality of care and outcomes for hypertension and other common chronic conditions.”

It’s very possible the researchers chose the wrong disease. After all, hypertension doesn’t have any initial symptoms. Patient adherence could have been an issue.

On his blog, KevinMD writes that health reformers need to “be careful about overstating the benefits” of IT and pay for performance. “The data isn’t there yet,” he says.

Our point exactly. These studies have older data. Let's see what newer data can tell us before hardline decisions are made.

Monday, January 31, 2011

KOLs: Here's Another Reason to Get Your House in Order

So, the pharma reporting errors are beginning. For a few years members have disclosed to the state of Minnesota how much they pay physicians for services they provide, but now they must also report those numbers on their own sites as well.  So what happens when the figures on the company's web site are different than the figures reported on a state's website?

Are these honest mistakes, or is there real deception involved? We can’t really tell from the following story.

ProPublica compared its database, compiled from the seven industry sites that have gone public with their financial relationships, to the database maintained by Minnesota, the first state to mandate disclosure, and found “multiple” examples of mismatched figures.
ProPublica didn’t provide exact numbers, but said some dollar amounts didn’t match.

Anyone even remotely connected to the business knows that a database containing the names of physicians who have represented these companies must be fairly large: Pfizer’s web site alone has 4,850 “entities” paid between July 1 and December 31, 2009. Is it possible that a few misreports could happen? One would think -- especially if different departments use the same KOL -- and didn't share the information.

Without the exact data, we can only guess. Either way, the reporting is incomplete. More robust reporting would be helpful, but frankly, the real need is for everyone to realize this financial reporting will likely have unintended consequences -- for starters, less informed physicians, because fewer physicians will want to act as speakers. They won't want to undergo this kind of public scrutiny.

There is no question that pharma needs to get its house in order regarding KOL payments. This is why we believe KOL selection, contracting monitoring and management must be done from a centralized unit. We have written extensively on this subject, and are expert in guiding members in how to coordinate, manage, and maintain KOL relationships.

The sooner, the better.

Sunday, January 23, 2011

Transparency and Health Advocacy Organizations

The release of the American Journal of Public Health study [here’s the abstract ] showing that the vast majority of health advocacy organizations (HAO) did not reveal that they had received grants from an industry member raised the predicable media ruckus. The industry member was Lilly, and only because Lilly was the first member to disclose its HAO contributions. The study year was 2007 – four years ago.

According to the study, only 25 percent of the 161 groups – mainly mental health organizations -- acknowledged receipt of the money on their Web sites, and 10 percent admitted that Lilly was a sponsor. The concern, of course, is that the Sunshine Law only requires that industry members make public its financial arrangements with physicians –- not with nurses, not with HAOs. You can find the groups here.

We’ve decided to present another side of the picture, one other press outlets didn’t mention, at least that we could find.

Thomas Sullivan, who writes the blog Policy and Medicine, says the study is essentially skewed: it was funded, he says, by organizations and individuals he considers industry critics – the Pew Charitable Trusts, George Soros, the Rudin Family Association – who want to present this data “in a negative light."

Industry, he says, already has adopted transparency via the Sunshine Law. Forcing HAOs to do the same is wasting money and time. What is needed is more collaboration between industry and HAOs “to focus their research and development budgets on diseases and new breakthroughs.”

“While transparency is important and it should certainly be feasible for HAOs to disclose their corporate grants, the information and data must not be used to discredit the organizations or programs… that help improve health care for patients,” he writes. “However, that is exactly what Rothman’s [AJPH] article attempts to do.” The study asserts that the HAOs’ lack of transparency is “disappointing because [the grantees] ‘pursued activities that promoted the sale of Lilly products.’ But this claim is overstated.”

He continues. “What is really disappointing is that the authors use their anti-industry bias to present the HAO programs as marketing endeavors, when in reality, these programs taught patients and physicians how to treat deadly and chronic diseases, create a strategy to end breast cancer, and to utilize the latest breakthrough in medical science."

As we’ve written time and again, all industry-initiated financial transactions should be made public. What we hope for, but doubt is happening, is that all parties involved here -- industry, its critics, and so on -- are mindful of the unintended consequences of these actions.