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. 

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 ....

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.

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.

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.

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.

KOLs, Background Checks, and Unintended Consequences

We look forward to the day when industry members will no longer have knee-jerk reactions to bad press – we just wish we had a reliable crystal ball to tell us when that will be.

Our bemusement stems from some members’ announcement that they now will conduct background checks on physicians – prior to their becoming consultants and speakers. This statement comes in the wake of ProPublica’s original story showing that some industry members hired physicians with tainted backgrounds. In the subsequent story, ProPublica only discusses the relatively serious infractions, like “prescribing unjustified or excessive medications and making serious medical errors.”

The industry members who made this announcement – AZ, Lilly, and Merck – did not provide lots of details on how these checks will be made, other than they plan to review state records. Nor did they discuss what kinds of infractions, if any, would be acceptable. One that comes to mind is failing to keep up with continuing medical education courses.

As we noted in a previous blog, the original ProPublica story found that of 17,700 thought leaders checked out, just 1.4%, or 250, were found to be tainted in some way. Of course, all industry members should have been looking at state and federal records from the get-go. This is something we encourage our clients to do as part of the normal contracting process.

A final thought: Will industry critics be happy with just a state and federal records check? Will they want something more intrusive? If so, we wonder if and how this will negatively impact the practice of medical research. We know this is the right thing to do, but what are the unintended consequences?  How will industry members change how they work with exceptionally influential KOLs?

Let us know what you think.

Patient Bloggers and the "T" Word

What an opportunity for industry to regain the public’s trust – or at least some of it.

We’re talking about industry’s use of social media to promote and market product, an excellent way to bypass mainstream media and hone the message. Even though the FDA is expected this month to present guidelines on how pharma can market medicines on Twitter, Facebook, and the like, the agency really has no say on what individual patient bloggers may say about their relationships with industry members.

To quote Pharma Marketing Blog's John Mack: “FDA cannot enforce transparency -- it has no authority over patients who are free to do and say what they like without mentioning any relationship they may have with pharma companies.”

According to Pew Research, about 61% of adults turn to the web for health information, and no doubt some of those people read those blogs. But do those bloggers disclose their relationship with pharma members, if one exists? We think they should.That is why like Sally Church (@maverickNY) we are going to create a disclosure section of this blog and our web site. Trust can be re-built one brick at a time.

And that goes for industry as well: The pharma member who ensures that the blogger discloses the connection is that much closer to establishing company loyalty among the readership.

It’s the T word, folks.  But stay tuned, because the storm around content creation in the industry is the next chapter in this story.  

The Midei Investigation: Get Your House in Order

Considering all the criticism against industry lately, this is not a good time for companies to be procrastinating about changing some of their business practices. Case in point: What an Abbott Labs division may be doing with Mark Midei, MD.  He is the cardiologist accused of implanting hundreds of more stents in patients than apparently were necessary.

When Dr. Midei was barred from his Baltimore-area hospital last year for allegedly performing the unnecessary surgeries, Abbott hired him as a consultant.

A Senate report -- investigating because of alleged Medicare fraud -- says that Abbott “showered” Dr. Midei with gifts and other handouts, and that he performed more stent surgeries than any other cardiologist in his area, suggesting that the two items are directly related. While we have discussed COI extensively in this blog, the Midei situation is yet another example of how industry needs to continually evaluate and update its contracts with Thought Leaders.


We think a big-name corporation is getting dragged into a situation it did not think was possible, but is becoming more the unintended consequential norm because of heightened scrutiny on the industry. Our advice to clients is get your house in order. Make sure your divisions and affiliates are reviewing their Thought Leader contracts.  Make sure you are taking the appropriate steps to improving your Sunshine Act compliance efforts.

If this is a challenge for you, let us help.

 

Are Tougher Rules the Real Reason Behind Fewer Gifts?

We have a slightly different read on that Archives of Internal Medicine study showing that fewer physicians are accepting gifts or money from industry. 

The study’s author seems to attribute the drop to the tougher rules that hospitals and medical schools have adopted over the past few years regarding such gifts. “The data clearly show that relationships have dropped dramatically,” Eric G. Campbell, director of research at the Mongan Institute for Health Policy, in Boston, told Bloomberg. No doubt, to a certain extent, he’s probably right. There were 1,891 doctors who took part in the survey.

But there could be more to it than just tougher rules.

Another article caught our eye. It seems that more doctors are getting out of traditional private practice. They’re entering the highly lucrative concierge business, or becoming hospitalists.  The reasons for entering either specialty are plentiful – and we believe a contributing factor is that physicians are not happy with the excessive scrutiny their profession and medical practices has come under.

Unintended consequences: We think there is a fundamental shift in medical practice back towards the hospital-based model.  Doctors now will be willing to live "under the protection afforded by hospitals." It is no longer prudent or profitable to practice medicine in the ambulatory setting. Care in these settings will be delivered by allied health professionals, who we think are very competent. 

But what does this mean for industry marketers?  Focus your development efforts, if your product, device or service, is a niche/specialty product, on the physicians.  If your product, device or service is ambulatory based, focus on the PAs and NPs.    

Pharma’s Wake-Up Call: More Individuals, More Often

Today’s topic of conversation: Why the DOJ has begun focusing on pharma execs -- and not just their companies.

Just recently, the feds announced they don’t want pharma executives doing business with the U.S. government if their company has been convicted of ripping off Medicare -- which is above and beyond existing legal restrictions.

According to the Washington Post, the new DHS guidelines say executives can be barred from doing business with the federal government from the time they knew about the fraud, or if the inspector general determines the executive should have known about the fraud.

And, in an unrelated, highly unusual move, the DOJ charged a former GSK attorney of various counts of fraud, alleging that she lied to federal authorities about what she knew regarding off-label promotion of Wellbutrin SR.

Let’s look at the numbers. According to these attorneys, who specialize in representing whistleblowers, “Over the past two years, the Department of Justice has collected over $2 billion from big pharmaceutical companies in fines, damages and civil penalties for defrauding Medicare and other health care programs funded with tax payer dollars.”
 That’s just the companies. Just think what the DOJ could collect if it also went after the execs. Think Jeff Skilling, Bernie Madoff, Michael Milken – who paid $600 million in fines for his financial sins.

According to the whistleblower attorneys, the DOJ doesn’t have to get personal. Under the False Claims Act, the offending pharma company could be forced to pay a $10,000 penalty for each script written under the offending scheme.

That’s certainly a lot of money – but it doesn’t have the same impact as being personally charged with a crime, or crimes.

"The current administration is feeling that they want to increase enforcement in this area, and they're of the belief that monetary settlements aren't sufficient, and they need to charge individuals to deter the conduct," Jeffrey Senger, former acting chief counsel with the FDA, told the Washington Post.

“The theme of [a] drug-law industry conference last month was ‘more individuals, more often,’” wrote the New York Times.

For those industry members who aren’t reading the writing on the wall, it’s either time to get new glasses or a very good translator.

Reporters, Pharma-Sponsored Seminars: Keep the Brick in the Wall

From the should-we-create-another-shade-of-gray department: Are journalists who attend seminars underwritten by corporate sponsors still objective?

Some journalists say yes, some say no. What do we think? We think a good friend, a first-rate journalist, hit it on the head: If it’s a trade association, then that would be okay. Why? It’s an amorphous group, she says. You know what you’re getting, you know what the agenda is. If it’s a sole company, “you don’t know what they have in mind.”


The sole company that’s raised the stink in the blogosphere is Pfizer.


Here’s the background. The National Press Foundation offered a four-day seminar to a small group of journalists to learn about covering cancer. It’s the second year that the seminar’s been offered. Pfizer, one of NPF’s sponsors, underwrote the seminar both years. According to the NPF’s Web site, the foundation’s mission is to educate journalists about complex issues. It has numerous corporate sponsors, including Toyota, Gannett, Allstate, Merck and Pfizer – the latter donating $100,000 plus. (Prudential Financial, another sponsor, underwrote a seminar on retirement, but we were hard-pressed to find any media stink about that seminar.)


Politics Daily argued the ethical dilemma that such a connection creates; the NPF, on the other hand, argued that newsrooms are stretched for cash so that training journalists in these difficult topics isn’t taking place. NPF controls the agenda, it said, so it is confident that church and state, so to speak, are kept in their respective corners.


We can appreciate what the NPF is doing. A conscientious journalist who doesn’t have a solid background in writing about cancer will be frustrated in dealing with this topic. And attending pharma-underwritten seminars is one way to become educated.We just think it is importance that independence of educational content be refereed by NPF. 

This operating principal helps NPF and journalists feel confident the "firewall" is trustworthy. Maybe we’re naïve, but it seems we are very concerned these days with assuming people/situations are guilty until proven innocent.

Pharma, COI, and Principled Interactions

One thing’s for sure: Pharma members are going to need scorecards to keep track of what kind of industry-thought leader interaction each academic institution allows. For example, the University of Iowa does not permit the distribution of drug samples, nor can its faculty use ghostwriters. They can’t appear on speaker bureaus, either.

In Boston, physicians who work for Partners Healthcare – Brigham and Women’s Boston, Massachusetts General -- face similarly strict rules. If you recall, one Brigham faculty member resigned in protest over the fact that he could no longer earn money, speaking on behalf of pharma. But its rules on CME aren’t as stringent as those at Stanford University, or at Memorial Sloan Kettering, according to this same Globe article.

But at Yale, leadership there has adopted a more nuanced approach to dealing with perceived conflict of interest issues and interaction with industry.

“We rejected the idea that all interactions [with industry] are wrong and the notion that any relationship is a conflict of interest,” Ronald Vender, MD, chief medical officer for the Yale Medical Group and associate dean for clinical affairs for the Yale School of Medicine told Medical Marketing and Media. “[I]t's not that we are promoting interactions. But if one is going to have [them], we are promoting the concept of ‘principled interactions.'”
Well, what do you know -- a realistic approach. At Yale, these principled interactions require that faculty pay attention to the rules. Yale has established an “enforcement mechanism,” MM and M says.

Yale faculty must follow the rules regarding speakers’ bureaus, gifts, meals, interactions with sales reps, and so on. The one COI area that Yale put its foot down about is ghostwriting – it’s not allowed. Good for the Bulldogs. As we’ve said in this blog before, ghostwriting in this business is wrong. If a researcher needs an editor – and all writers need editors -- give that person credit at the end of the article.

About those scorecards. With academic institutions everywhere adopting new COI rules, the wise pharma member will want to know which institution requires what before making any contact with any institution. But who has time to get all that information? Maybe BioPharma Advisors can help you.

CBI KOL Management Conference-Princeton, NJ

We are attending the CBI KOL Management Conference in Princeton, NJ.  Click link for the agenda, follow our tweets by hashtag #kolmtg. 

We are part of Workshop presentation on Centralized KOL Management.  Send us an email if you would like a copy of that presentation

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.

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).

The FDA, Transparency, and Reality

As we have stated in this blog many times, transparency, as in nearly all matters, can be a good thing.

So by all means -- a 21-gun salute for the FDA’s 21 proposals that allow the public a better view at what transpires between the agency and industry, including summary safety and efficacy data from pre-approval and marketing applications.

Why the touch of tone? Because what the FDA wants to do will cost money and eat up valuable time. And skeptics might ask: Will these new rules really improve the public's health?

We actually think so! But, industry insiders may not be looking at it that way. In our view, transparency will uncover those issues in which the agency and industry have differences -- now, those problems will get thrashed out, but usually during the time compressed approval process, when conflict avoidance is the word of the day and if conflict occurs is usually not a positive outcome.

We all know consensus is not reached without significant debate -- and that typically does not happen quickly. Why does industry panic?  Is it because these business constraints seem to happen only at critical moments in their business cycle?  It seems like the age old going to the gym argument. Maybe if we went to the gym and worked out before we needed to desperately do it, maybe the change would not be so hard. 

Because we live in a sound-bite world, a full explanation of these problems will rarely be published, digested, and carefully considered, and most likely will be misconstrued. Does this help improve public health? Not likely, because again the presumption is that medicines are generally safe and people may not care until after the fact. 

No man-made system works perfectly – who isn’t shocked when something goes off without a hitch?

While it seems like each party should fight for its point of view, people just want their various afflictions solved.

We just think this transparency issue needs to be moved forward. These 21 proposals are not perfect, but they do begin that process. Please engage in discussing the solutions.  

Is Conflict of Interest Pushback Begining to Happen?

Is it possible that physicians and clinical researchers are beginning to push back against their Conflict of Interest (COI) critics? We'd like to think so.

The proof? The Association of American Medical Colleges (AAMC) and other university associations recently asked the National Institutes of Health to loosen up its proposed financial reporting requirements, which have few exceptions. The AAMC et al essentially said that the NIH’s proposed transparency rules are unnecessarily strict. This new opinion differs from the AAMC’s earlier support.

In its letter to the NIH, the AAMC said:

“There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.”

Let’s look at the numbers. In its letter, and we’re essentially quoting, the AAMC says it represents 150 U.S. and Canadian medical schools; about 400 teaching hospitals and health systems; and 89 academic and scientific societies. That’s 125,000 faculty members and 106,000 resident physicians. And that’s only the AAMC. The Association of American Universities represents 61 research universities.

You get the point. That’s a lot of physicians who have chosen a life of medical research or is the place where they develop their medical training. It’s possible that those physicians raised a concern about what the NIH was proposing – and the AAMC leadership listened. A good example of a group listening to what its constituents want for policy and not letting someone in government dictate their way of life.

And maybe that’s the way this COI crisis will resolve itself. Not in a public forum, for all to hear, but in back rooms, away from glaring eyes and media attention. It happened earlier this summer, if you remember, with the AHA and the ACCME drama.

It’s not how we would like it – the unintended consequence is that the public is not hearing the full-throated discussion, but we also think that not everyone cares about how this "sausage" policy is made, but that these COIs do not harm or cause inappropriate care to be delivered.

But at least, if we're right, physicians on both sides of this issue are talking to one another, thrashing this whole thing out.  The next question is how those talks will impact industry collaboration.

The Foreign Corrupt Practices Act and Industry

As promised last year -- the Department of Justice is following where industry members conduct their business. At last count, [that we know of] the DOJ had notified at least 12 industry and device manufacturers that they were under investigation for possible violations of the Foreign Corrupt Practices Act. The feds want to know if these 12 tried to influence how physicians would determine the results of industry members’ overseas trials on any drugs that came back to the U.S. market. (To get the Lexocology article about the investigation, you'll need to register.)


Getting specifics on what the DOJ has found hasn’t been easy: As this WSJ story on Merck points out, Merck wasn’t charged with anything. The Financial Times reported that the DOJ "was looking at whether pharma companies had ignored a 'systematic risk' inherent in the global drugs business and ignored obligations under local and US anti-bribery law."

What ostensibly rattled the DOJ’s proverbial cage was that report this summer from the Inspector General of the Department of Health and Human Services. You all saw it – the one that said 80% of all FDA approved drugs in 2008 were based on trials conducted in foreign countries. And of course, the FDA had conducted very few inspections of those sites.

We say ostensibly because of what the DOJ said last year. The feds said they were interested in looking at industry through the legal lens of the FCPA. In that speech [second paragraph], the assistant AG talked about how much money the department made in other cases it had tried -- $1.6 billion in one, $579 million in another. The assistant AG mentioned that the department has brought more prosecutions since 2005 (58), than between 1977, when the FCPA was passed, and 2005.


We think the DOJ will continue to examine industry practices in a manner that will make it more difficult to operate, cost more to complete innovative drug research, and challenge or change the way the industry conducts business. Maybe it’s time to say, enough.

WHO's H1N1 COI Dust-Up: It’s Time for Cooler Heads to Prevail

The waiting is over, the list is out. Of the 15 or 16 flu experts who served as advisers to WHO during the swine flu epidemic, five had prior, or current, financial connections to industry while the board was discussing how to handle the spread of H1N1.

A brief recap: BMJ reported a couple months ago that Margaret Chan, secretary-general of the WHO, would not release names of members of an important committee with industry ties. This committee decided when to announce the pandemic, and BMJ, among others, wanted to know if committee members’ decisions helped put money in vaccine makers' pockets, namely Roche and GSK.

According to BMJ, industry made about $7 billion because the committee wrongly predicted how large the pandemic would be, and so countries stockpiled the antivirals. H1N1 didn’t spread as rapidly, and wasn’t as deadly, as was expected. Conspiracy theorists unite!

According to a story in the Ottawa Star, “The WHO said all ties were disclosed to the committee, which decided they did not constitute conflicts of interest.” This board apparently made its decisions together about how extensive they thought the pandemic would be; how many people it would affect; how long it would last; and so on.

But think about it: If eight of the 15 advisers had active KOL contracts with industry members that made flu vaccines, one could say, “Yeah, there’s a conflict. We need to rethink this.” But that wasn’t the case here. Unless we missed something, five out of 15 is a third, which does not make a quorum -- it’s a minority of the board. Fingers were pointed, charges were leveled. The unintended consequence? KOLs are considered guilty by association.

As a result the solutions to solve problems will be colored by the implication of motivation and greed, but what would have happened if nothing had been done, what would have been the outcry from maybe some of these same critics had people perished as a result of these vaccines not being available?

When will those with cooler heads show their leadership?