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.

Thursday, January 20, 2011

The FDA and Social Media: The Industry Needs Guidelines

If you love irony, you’ll love the following.

Respondents to a Deloitte study said social media likely could improve clinical trial efficacy in two ways: one, by supplying data to quicken reporting results, and two, to determine the correct patient reported outcomes.

But of course, these respondents aren’t likely to investigate whether these presumed efficiencies would actually work, because the FDA has put off, yet again, its guidelines on how industry can use social media.

Social media is already proving some success, says FierceBiotech, in recruiting and retaining clinical trial subjects.

It’s a head-scratcher. Facebook has more than 500 million users; half of them log on every day. The average user has 130 friends. As for Twitter – and these are older stats – it has more than 105 million Tweeters, yours truly included.

Do we need to list the problems that clinical trial researchers have had over the years in conducting quality trials, in trying to meet all the rigorous criteria? Remember the media attention the FDA’s report received last year regarding the lack of monitoring of overseas trial sites? That report showed that “between 40 percent and 65 percent of clinical trials investigating FDA-regulated products are conducted outside the United States.”

We can take an educated guess as to why the agency is putting off publishing its guidelines – the unknowns are enormous. More than half of the 208 Deloitte study respondents say there will be confusion – in interpreting the guidelines, in administering the guidelines -- after the FDA publishes them.

We say, that’s okay. At least we’ll have something on paper and a place to start. The agency can redact as we move forward or modify moving forward. But just like the internet in general, the world is moving to more adaptable, amorphous content built by communities.  The FDA and other regulators around the world need to appreciate that fact.

As things are now, many industry members are willing to take risks, and spend money on social media innovations, but, as Deloitte points out, innovation is developing slowly, as members wait for the agency’s lead. We think there needs to be another approach. Again: The agency should develop regulations that are progressive, adaptable, and modifiable.
But industry members could get restless, and venture into unchartered areas, as Novartis did last year – and got its wrist slapped for it. Is that fair? No, it isn’t. The technology is here, possible solutions to major problems are here, and the agency, in our opinion, should pick up the pace.

Monday, January 17, 2011

Nurse Practitioners: Should the Sun Shine, or Shadows Fall?

The other day, we wrote about a medication adherence study that ran in the American Journal of Managed Care. Pharmacists, the authors said, were second only to nurses – in the right milieu – in getting patients to stick to their medication game plan.

We bring this up because a second study in the same journal is also talking about nurses. But here, the study’s focus is on nurse practitioners. And the study’s topic is nurse practitioners and industry influence.The study’s authors are concerned that NP's see no conflict of interest with drug reps promotions.  The respondents to this study see no problem with handing out samples, learning about new drugs at industry-sponsored dinners, attending industry-sponsored CME, and so on.

The authors suggest, “Future research should assess influences of evidence-based academically sponsored continuing education programs on NP prescribers’ beliefs and practices.”

The researchers’ fears are based on the fact that these professionals are going to become more prominent in the delivery of patient care going forward. The number of physicians planning to enter general internal medicine is significantly dropping. Nurse practitioners, who now number at least 150,000 in this country, are allowed to prescribe most drugs in every state.

And now the reason we bring the med adherence study into this blog. Back in 1993, the Gallup people polled patients about their willingness to see a nurse practitioner. The results: 86% said yes, we like them. Why? Their communication skills and the way they promote health. Considering the scarcity of doctors and the little time they can give to patients -- there is no reason to presume that the 86% figure has decreased since then.

According to the nurse practitioners' study, the industry directed 20% more of its marketing efforts between 2004 and 2006 to these ancillary HCPs. We advise folks to proceed with caution here.  We believe that these healthcare professionals should be treated as the educated, intelligent individuals that they are.

And industry critics need to be careful here as well. The unintended consequences of taking away all industry-provided tools could be detrimental to patients’ welfare.

Friday, January 14, 2011

Talk to a Pharmacist: It's Good for Your Health

If pharmacists are up to the task, they could help save the U.S. healthcare system a lot of money – about $300 billion a year, to be exact.

Why? A recent study showed that of all the ways to try and get people to stay adherent to their medicines, pharmacists – talking to patients in the store – is the way to get the job done.

The runners up? Nurses – talking to patients who are leaving the hospital. Did everyone note that the words ‘talking to patients’ are in both paragraphs?

PMP News recently ran a story about a study in the American Journal of Managed Care. The study's researchers culled more than 6,000 articles before focusing on 168 of them.  The results: Of the 168 articles, 51 were reviewed and met the inclusion criteria for their analysis. Here is a summary of what the data suggest when there is person-dependent intervention:
  • 83% of interventions done at the pharmacy, in-person with a pharmacist, are the most effective.
  • 67% of interventions done at the time of hospital discharge with a trained professional were effective.
  • 47% of interventions done at the clinic were deemed effective.
  • 38% of interventions done over the phone were effective.
The researchers also found that “electronic interventions” – faxes, e-mails, and so on – can work too, but not as well. Among person-independent interventions, 56% of these types were successful, with electronic interventions being the most successful sub segment, representing 67%.

Obviously, people want meaningful contact – the opposite of what many patients may get in our country’s health care system.

We couldn’t agree more. The question is: What, if anything, will be done with the study’s results?

A look on Google showed that no major media outlet picked up on the study, which tells you that med adherence just isn’t sexy enough for the paparazzi, even with a $300 billion price tag. But it is for CVS.

A look at the company’s web site shows that medication adherence is a topic near and dear to its heart. Sure, for obvious reasons. But it’s also funding studies – check out the web site – to try and find answers to this huge issue. Which is more than others are doing.

We ask that you share these results with your colleagues, and consider developing an adherence initiative that motivates patients to adhere to their prescribed regimens. 

Monday, January 10, 2011

The Facebook Audience: Can Pharma Maximize Its Potential?

Like everyone else, we're intrigued about the science of Facebook marketing. Dan Zarella (Dan suggested in this PowerPoint presentation that pharma Facebook pages are some of the least liked pages. Why is that?

Source: Hubspot 101 Marketing Charts-Graphs-
Science of Facebook-Slide 61

While this information could be dismissed as ho-hum, we think you should pay attention to the important points about social media. We believe Facebook represents 67% of the "bell curve" that is your market. Our assertion is that if pharma publishes Facebook pages for its products, disease states or its patient tools, the content must meet the needs of this audience -- and currently it doesn't.  But can it really meet those needs?  

Looking at the rest of this presentation, we see that much of the Facebook audience is looking for interaction with others. What facebookers tend to value is more entertainment-oriented sites. So the next question about this social medium is: Should pharma even be in this space?  While many in e-marketing groups want to answer that question, our point of view is yes, but only if they are willing to create an interactive relationship with Facebook "friends" on the "friends' " terms. Building interactive games and apps that help facebookers learn or interact, is the key.  If not, they shouldn't waste their time, because the price of entry is steep.

It is this concept we believe industry marketers need to grasp. For years, the industry has been able to buy a seat at any table it chooses, but the game is changing!  In the past, industry would change the rules and today people are choosing not to let industry play in their game.

So what are we suggesting here?  Industry leaders need to change their expectations and must realize they may not be able to call the shots. But data show, like in Facebook, if you believe this is your target market, there is opportunity to market your products -- just realize the game is not set up to meet industry's needs.

So what is your next step?  Ask us -- we have some ideas.

Friday, January 7, 2011

Medication Adherence: A Glance At PubMed

Do you need proof that certain treatment adherence programs can work?

Just plug in “patient adherence” and “cell phones” into PubMed. You'll likely see two Lancet articles on mobile phone use and HIV treatment adherence.  In the Chi and Stringer article, these researchers found that weekly text messages sent to HIV patients in sub-Saharan Africa improved adherence -- 62% versus 50% for the control group – and allowed for better rates of virological suppression (57% vs 48%). Patients who didn’t respond to the text message within 48 hours received a follow-up phone call.

Chi and Stringer raise interesting points in their article. They recognized that the calls were too spread out to actually remind patients to take their antiretrovirals; they speculated that “[p]ossibly the SMS [short message service] intervention worked by improving communication and rapport between health providers and patients.”

Two other points of discussion:  One, the cost. Chi and Stringer write that SMS costs less than $8 per patient.  “This intervention might prove cost effective, particularly when one considers the cost and complexity of second-line therapy. However, this aspect still requires formal analyses.”

The second point the researchers raise: Can cell phones be used to help other patients with other types of chronic diseases?  Chi and Stringer might find the answer to that question in other PubMed articles. In India, at the L.K. Diabetes Centre in Lucknow, diabetes specialists use videos made with mobile phones for diabetes education. They call them “mobi-films.” These mobi-films are used in multiple ways: patient to patient communication, doctor to doctor communication, doctor to patient communication, and patient to doctor communication. As to whether these films have helped improve patient care, the authors write, “Over the years, we have seen a sea change in the knowledge and day-to-day diabetes care skills of people visiting our center and benefiting from our diabetes education films.”

Some physicians are experimenting with cell phones for patients with hypertension; other researchers have seen success with patients with malaria.
And, by the way, Chi and Stringer aren't the only researchers who found that HIV patients are adherent when prompted with cell phone messages; a literature review by other researchers found similar findings.

To us, the travesty of patient non-adherence is that solutions to the problem exist and that people in this country are not adhering to physician recommendations. What is reassuring: That studies are suggesting that innovation can occur anywhere.

Tuesday, January 4, 2011

Patient Adherence: Money Can't Change Everything

Even if providers slash medication prices, some patients are not adherent. To wit: Patients’ decision not to get vaccinated during the current flu season.

It seems that some major retailers, like Rite Aid and Kroger, and smaller venues, like doctors’ offices, are awash in flu vaccine, and cutting vaccine prices to salvage their losses. The WSJ reports there aren’t enough takers for this year’s 163 million doses of flu vaccine.

Last year, there were 110 million doses manufactured, not enough to cover the demand for the potentially fatal H1N1 viral strain. Pharma ramped up production this year, hoping that the public’s demand would be the same as in the prior flu season, and because the CDC now says all people over six months old should get the shot.

During last year’s epidemic, in which 12,000 people died and millions were sickened in this country, you couldn’t turn to a media outlet without hearing about H1N1, the CDC, WHO, problems with the vaccines, and so on. If you’ll recall, there was even a huge stink involving the WHO and conflict of interest. This year, stories about the flu season have been perfunctory, found essentially on medical web sites.

But the general feeling about last year’s flu season was that the medical community, including pharma, cried wolf. One of the comments to the WSJ article was that “H1N1 was an overblown marketing effort for the most part.”  Said another: Of course it was overblown."  Comments such as these certainly help explain the public’s ambivalence to getting their flu vaccine – and to those in public health in trying to accurately forecast the reach of the flu.

This year's flu season is still early, January is just starting. It will be interesting to see what happens in the waning months of the winter. Imagine the public's outcry if the flu season gets really out of hand.

Which raises this point: Will industry and public health officials pay attention to how patients are reacting this year to getting their shots? We think that people choose not to  get vaccinated because there is no immediate value to them in doing so. We believe that focused efforts on adherence to medical evidence, providing reminders for vaccinations via text messages can help overcome the delicate balance of supply and demand for vaccines.

This is important public health work.  We believe those who are casting aspersions on the industry need to be educated to the real challenges industry faces in forecasting this often fatal disease.