Friday, October 29, 2010

With Patient Non-Adherence, Use a Little Psychology

My mother always said to get resistant people to do what you want, use a little psychology. That’s exactly what MicroMass Communications says in a recent white paper that discusses patients with chronic diseases and their unhealthy habits. MicroMass says if you want these patients to lose weight, take their medications, adopt positive attitudes, and so on, then it’s essential to find what will motivate them to do just that.

In their white paper, called “Understanding and Changing the Metabolic Mindset” researchers at MicroMass interviewed 1,500 patients with type 2 diabetes, obesity, high cholesterol and hypertension. They started out wanting to know the differences among the patients, so they could understand how to sell to them more effectively. But in the interviews, MicroMass researchers began seeing similarities among these people – the patients’ barriers to changing their behaviors were not all that different.

The researchers organized the patients into four groups: those on cruise control; those who take charge; those who are disengaged; and those who are overwhelmed. The last group is the largest; in a video, MicroMass’s director of behavioral services says patients in this group lack confidence to do what they need to do -- healthcare providers often mistake this lack of confidence for indifference. Encouraging the completion of baby steps is important here, she says.

Healthcare providers who can identify which group their patients belong in will see more success with those patients, MicroMass says. “Programs built around behavioral models have been successful.”

Nobody in this reading audience needs the dollars lost to patient non-adherence repeated here. A few pilot studies certainly seem in order.  To my friends at Micromass, Great Work! Others in your business should be making similar investments in their marketing strategy recommendations as well.

Thursday, October 28, 2010

Pharma Ethics: It’s Time for Constructive Ideas

The criticism of pharma continues. One of the latest salvos: “White Coat, Black Hat: Adventures on the Dark Side of Medicine,” by Carl Elliott, MD, professor at the Center for Bioethics at the University of Minnesota. In an interview with Pharmalot, Dr. Elliott spoke about industry ethics, and said that industry money has undermined trust. “The difficulty with the way things are done now is that you don’t know if you can believe what’s in the medical literature anymore,” he said.

His views on transparency: “I don’t think disclosure solves the problem. That seems to be the approach and I think it’s totally misguided. The more doctors who do it and the more widely known people know about it, the more widely it will be done and the practice will become normalized and nobody will feel any compunction about taking money from industry anymore.”

I think Dr. Elliott is right -- maybe time can correct some of these problems. Maybe some of the recently implemented regulations and the court proceedings will change poor behavior. 

But, friends, the criticism leveled at industry hasn’t been exactly constructive. What's needed are suggested solutions. We still do not have answers, we need operational leadership on where to go from here. We continue to suggest that we all move beyond the "industry/HCP relationship is dirty."  We suggest that you cannot highlight a problem unless you also offer a solution going forward.

Monday, October 25, 2010

Pharma: Is It Time To Answer the Critics?

It’s a question that’s begging to be asked: How can pharma get its groove back? Bad news, much of it self-inflicted, continues to besiege it. There’s the Pharmalot DOJ whistleblower’s story, which said that eight of the ten largest healthcare fraud cases involved drug makers. Says Pharmalot: “The scrutiny has been eating away at pharma’s reputation and gradually forcing changes in business practices. But attorneys say many more lawsuits are in the pipeline and the willingness of the federal government to pursue them - selectively - remains unabated.”

Then there is the ProPublica story. Reporters at ProPublica used industry-compiled databases containing the names of physicians and other thought leaders who have spoken on behalf of pharma and checked them out. What they found: Not all the thought leaders are worthy of the job. Some weren’t board certified. Others had “serious sanctions."

It sounds ugly. But if you do the math, it’s a small percentage: of 17,700 thought leaders checked out, 1.4% -- 250 — were found to be tainted in some way. (The story says more than 250, but doesn’t give a specific number.)

On the one hand: Some industry members interviewed by ProPublica reporters admitted that they didn’t do the background checks that they should have.

On the other: That 1.4% wasn’t in the story, but it doesn’t matter. The PR damage continues to be inflicted -- from within, and without.

In 1970, an American man or woman could expect to celebrate a 71st birthday. In 2003, that person could expect to live another 6 years or so. Pharmaceutical, Biotech & Medical Devices are a huge reason for those extra years. But few people – including pharma itself – seem to acknowledge that truth. Kinda of like some in Congress & the administration who do not take pride in the Healthcare Reform act. While Americans do not like this large entitlement program, in general we believe overall healthcare of the US population will be more improved.

Maybe it's time for pharma and others to speak up? Maybe. Being silent sure hasn’t helped the industry (or even the Democratic Congress for that matter).

Thursday, October 21, 2010

Financial Disclosures and Journal Authors: Enough Rhetoric

When President Obama signed the healthcare reform act into law, part of the legislation package included the Physicians Payment Sunshine Act. We’re all familiar with it. Sometime soon, Industry will have to make public its financial transactions with industry consultants.

So, why are the media still acting like every undisclosed transaction – especially ones that are years old -- between physician and industry is like an unheard-of immoral outrage? Case in point: the 2007 study showing that 25 of 32 consultants to medical device companies didn’t reveal their connections in published journal articles. Those connections were worth millions, the Times says.

A constant critic of the industry-thought leader connection was quoted as saying that the study was “one more indication of the widespread corruption of the medical profession by industry money.”

It’s not clear from the article how many journals were involved in the study. The study apparently doesn’t name individual doctors or their articles. Two journal editors were quoted, each saying that yes, they must get stricter on disclosures. We’re not sure how these journals are funded, but if those sources are medical device companies, it won’t be easy biting the hand that feeds them.

We support transparency – our blog readers know this.

We do not support incomplete journalistic reporting – a check on even some of these journals in 2008, 2009, and 2010 would have rounded out the story. What were their disclosure records then? Did disclosure improve, stay the same, get worse? Is there a basis for comparison? If this record check did happen, it’s not mentioned in the Times article.

The article quotes the study’s author as saying he didn’t “know how often the journals required disclosures in 2008, but he said the lack of results showed ‘a broken system’ regardless of who was to blame.”

Physicians have battled over the question of financial disclosure for years – this NEJM editorial is from 1993.

Again, the unintended consequences of this constant, where-is-this-getting-us criticism: The effect on physician education! Physicians need to be educated in the latest research, newest drugs, newest medical devices. Industry use to be a trusted source of that information. Could we tone down the rhetoric, and begin a conversation?  We have to figure out solutions that improve healthcare overall and continue to recognize the value of medical innovation.

Monday, October 18, 2010

Ghostwriting and Full Disclosure: When the Critics Get Caught

A friend and I were discussing the problem of ghostwriting in industry – she was lamenting its demise. My friend, a journalist by profession, didn’t see a conflict of interest problem – she saw a conflict with clarity problem. She had worked for one of the major pharma houses, and one of her jobs was helping a researcher with writing his papers. Scientists generally can’t write, she said.

Anybody who writes for a living who’s seen what a researcher can do to the English language will agree with her. By definition, a ghostwriter is someone who writes for another – he or she doesn’t alter thoughts, tone, meaning, wit. The ghostwriter just makes the prose clear. BioPharma Advisors even uses ghostwriters for some of its own work.

Which brings us to the Wyeth, Prempro, Adriane Fugh-Berman, PLoS Medicine, conflict-of-interest drama. Wyeth (now part of Pfizer) is being sued by women who took the HRT Prempo and contracted breast cancer. The drug maker recently was slammed by Fugh-Berman in PLoS for hiring a communications firm, DesignWrite, to “ghostwrite” articles that touted Prempro’s benefits and smoothed over the risks. These documents – more than ghostwritten -- had been released as part of the court record.

But it was no coincidence that Fugh-Berman wrote the piece, and that PLoS published it. Fugh-Berman, at the time her article was written, was on the payroll of the plaintiff’s law firm. That fact wasn’t disclosed in the article. Another hidden bit of info: PLoS had sued Wyeth for the DesignWrite documents.

Fugh-Berman told Pharmalot that she had never made a secret about her status as an expert witness, and would clarify her position. PLoS editor Ginny Barbour told Pharmalot, “We intervened in the Prempro case solely because of our interest in unmasking this [ghostwriting] practice. We have no professional, financial, legal or other relationship with the plaintiffs or their lawyers in any of the cases that Wyeth is defending, or in any other past or ongoing legal case." Checking Google, very few media outlets covered this part of the story, compared to the splash the PLoS article made. We continue to lament the media’s current lack of parity in covering industry.

The DesignWrite articles ran between 1997 and 2003. Did Wyeth do the right thing? No. Are there reasons that nearly all crimes have a statute of limitations? Yes.

Pharma has said that ghostwriting, as done in the past, will stop. And it should in the context in which it is currently practiced, for at least two reasons: One, it’s not completely transparent. Two, as long as pharma continues to make itself a target, it will be guilty until proven innocent, and its research will continue to be viewed skeptically, and that affects us all.

But please, pharma members – for your researchers who can’t write, hire an editor, and give the guy or gal credit at the article’s end for work done.

Monday, October 11, 2010

Pharma and University Collaborations: On the Rise

Pharma members and university researchers have increasingly formed collaborative partnerships to develop new medicines, according to a Business Insights report.

But you don’t need a report to tell you that. Just one media account, like this FierceBiotech story – about AstraZeneca and the University College of London --
tells you there are many other collaborations right behind it. AZ and University College signed a three-year deal to create drugs that use stem cells to mend the damaged eyesight of those with diabetes. GSK also has a deal with University College. 

A quick rundown of reasons for these partnerships: Pharma needs fast and furious ways to beat patent expirations; all the low-hanging, cheap developmental fruit’s been picked; and the remaining developmental fruit is costing, and will continue to cost, huge amounts of money. As for why the universities are signing on, they need cash too – endowments are down, public financial support is down. Both sides have good reasons to partner up. 

There’s every reason to think that good outcomes can happen. Consider the trove of information -- all being shared -- recently uncovered about Alzheimer’s disease when academia, government, and pharma researchers collaborated. 

But on second thought: We shouldn’t be too hopeful. It’s likely just a matter of time before pharma critics start complaining about these collaborations. 

For what legitimate reason? We've no idea.

Friday, October 8, 2010

Pharma and the Travails of Social Media

What a world. One of the most regulated industries on earth – pharma – is trying to learn how to communicate with its “new” customers – patients – on the anything-goes media, the Web. According to a PharmExec blog, industry is hiring all kinds of Web gurus to teach them about the “minefields” of YouTube and Facebook.

One – Novartis – already has gotten burned. The FDA said the company permitted conversation to occur about its leukemia drug, Tasigna, on Facebook and sent Novartis a warning letter about it. Jonathan Richman, founder of Dose of Digital, said in response to the PharmExec blog that Novartis was encouraging people to comment about content that it knew wasn’t compliant and to share it. According to Dose of Digital, industry has 50 sponsored pages on Facebook.

It begs the question: In a business as heavily regulated as this one, in which the DOJ publicly announced its attentions to investigate it for alleged off-label violations – and then did so – would industry be more cautious about inviting more trouble?

Maybe because it has no choice. Pharma’s customers are interacting in this world in the ways the FDA did not even think possible.  Is this foray into the cyber communications minefield an unintended consequence of the heavily regulated world of medical communications? We think so.

Next question: How does this impact public safety? More to follow. 

Wednesday, October 6, 2010

Clinical Trials: Is Full Disclosure Necessary?

Here’s a hypothetical: Your 85-year-old mother, who has Alzheimer’s, has the chance to enter into a clinical trial for a new Alzheimer's disease drug. Possible dilemma: The type of drug your mother will receive is similar to one that just failed in another trial – in fact, it caused harm. Do you want to know about that failed trial? Is the trial sponsor under any obligation to tell you about it?

The New York Times, which recently discussed the pros and cons concerning full disclosure in clinical trials, said Alzheimer's disease patients and their caregivers may be different than other patients. Cancer patients may want to know all details if a trial is stopped; Alzheimer's disease caregivers, too tired from the daily grind, may not. Certainly, we’re talking about different diseases here: People can survive some cancers. For Alzheimer's disease, there is no cure.

The basis for the article was Eli Lilly’s decision to stop its huge trial on semagacestat because patients showed worse cognitive functioning than those on placebo, and increased skin cancer risk. According to the article, Lilly's drug disrupted gamma secretase, but was an older generation of this drug class. The newer disrupters, the article said, may be safer.

Of course, trial participants sign consent forms. They acknowledge that the drug may not help; there may be side effects; they may not get better -- or even worse. But our point is that industry members could help themselves in the court of public opinion if they take a few more steps to notify trial participants about why a trial was canceled. Leaving this to the clinic that recruited the patient initially is one of its responsibilities, but it should not fall just on that clinic.We encourage industry to consider this approach as a way to invest in its depleted "trust" bank account with patients. 

Monday, October 4, 2010

A “New” Venue for MDs, Sales Reps

Talk about unintended consequences. Even though some physicians and medical institutions may not welcome industry sales reps into their offices during business hours, they seem to have no problem getting together at educational events.

A recent survey found that 71% of those who shut their doors to sales reps while they are working will meet with them at these live events.

Pri-Med conducted the survey, which comprised 1,100 doctors who attended seven medical education meetings nationwide. Pri-Med says it’s about choice. Sam Bishop, director of research for Pri-Med, told Medical Marketing and Media that “[the physicians] have personally chosen to come to this event. If industry is there, the majority will choose to opt in. If they are in their practice, working with patients, struggling through the day, typically they don't want to be intruded on” in reference to the current rep calls that take place.  

Okay, maybe it’s about choice. But maybe it’s also about the need for physicians to learn about the R&D that industry is up to. And, maybe physicians don’t want to be hassled with new rules governing a rep in their office. Or, maybe they just want to chat with business associates who have become friends.

Humans are funny. If they don’t like a rule, they’ll find a way to work around it. The question is then, does industry still need more than 65,000 sales representatives in the U.S. detailing these doctors? 

Friday, October 1, 2010

Internet Marketing: The New Line Item

“I believe every brand team should have a dedicated Internet marketing person assigned to them.” So writes Richard Meyer, of Online Strategic Solutions.

All we can say is: We wish we had said it first.

A recent House episode featured a 105-year-old-patient, who told the crusty Dr. House that he had searched the Web for something or other. At first, it seemed odd that a centenarian would be comfortable with the Web, and then on second thought, it didn’t.

There are internet marketing professors. There are people who teach about the history of the Internet.

Our point? The Web is as much a part of our lives as cars, toothpaste, and Thanksgiving. The Web, and any subsequent versions of it, are here to stay. Having marketing specialists in this medium makes absolute sense. We don't need to tell you where patients are turning to get their medical information.

To us, having dedicated Internet marketing personnel assigned to each brand team is a business necessity!