Showing posts with label Physician Conflict of Interest. Show all posts
Showing posts with label Physician Conflict of Interest. Show all posts

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. 

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, 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.

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.

Tuesday, December 21, 2010

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.

Monday, December 6, 2010

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.

 

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.

Wednesday, August 4, 2010

Foreign Clinical Trials: Bye Bye, U.S. Trial Investigators

Can we say for certain that industry is conducting more clinical trials overseas because fewer U.S. physicians, who once ran those trials, don’t want to see their remuneration made public?

Probably not, but what we can say is this: It is a factor.

A week before the Inspector General of the Department of Health and Human Services published his report saying that most drugs approved in 2008 were based on trials conducted in foreign countries, Pharmalot published a survey, conducted by the Association of Clinical Research Organizations.


ACRO found that between 2004 and 2007, the number of FDA-regulated trial investigators was dropping in the U.S. and Europe, and climbing in Eastern Europe, Asia, and Latin America. The reasons cited: medical liability, COI rules, and regs that physicians must publish financial relationships – 24% of U.S. investigators were “less likely” to be involved if they had to disclose what they made. U.S. investigators are more interested in making money than their peers in Western Europe – 68% vs. 26%, according to the report.

For those of you who missed the IG’s report: It looked at 121 approved drug applications. Of these, 80% “contained data from foreign clinical trials.” The vast majority of trial participants were not Americans. The vast majority of sites were not FDA-inspected.

This trend is expected to continue, and expand into countries like China. The FDA didn’t inspect sites in countries where political relationships are generally just fine; are we going to get into China? In 2008, the FDA examined .7% of foreign clinical trial sites, and 1.9% of domestic sites. And that, of course, is if the company has even filed an IND. The “FDA may be unaware of some ongoing, early-phase clinical trials because sponsors are increasingly conducting early-phase clinical trials outside the United States without INDs,” the report said.

The agency agreed with the IG’s recommendations to improve the situation, including standardizing electronic data filing and creating inspection agreements with oversees regulatory bodies. Anyone remotely aware of the problems involved with conducting clinical trials these days knows it will take more than the IG’s recommendations to reverse the overseas trend.


Here’s an idea on paying U.S. clinical investigators: Perhaps the solution calls for something like a blind trust. All those industry members conducting clinical trials in a particular year would throw money in a pot, and clinical investigators would be paid from that pot. Their names would be published, but not aligned with any one drug, or industry member.


Is it a dumb idea? Maybe. But we need ideas. Dumb ones can spawn good ones.


Transparency is all well and good, but as we’ve said before, we need to find ways to keep industry and physicians working together, or the medical progress we’ve enjoyed will be compromised. 

Saturday, July 24, 2010

The Nemeroff Affair



The Charles Nemeroff/Tom Insel affair is noteworthy for a few reasons.

1. If there are clear rules, there are no excuses

2. People in high places do really stupid things, so companies need to be concerned about good Thought Leader management practices.

3. Situations like these make it more difficult for companies to navigate the current conflict of interest issue, so understand what is happening in the marketplace around you and have plans to adapt to those conditions.

To recap: If you’ll recall, psychiatrist Charles Nemeroff, former chair of Emory University’s school of medicine’s psychiatry department, left Emory under less than auspicious circumstances. While there, he was receiving NIH funding – but was also getting lots of funding from pharmaceutical companies for speaker services – a major faux pas under NIH regulations. After a U.S. Senate Finance Committee embarrassed Emory with the information, Emory more than slapped Nemeroff’s hands. It told its star M.D. he could not apply for any grants for two years. For his part, Nemeroff claimed the conflict of interest rules were ambiguous.

Enter Insel, the National Institute of Mental Health director, and a former Nemeroff colleague at Emory. Insel received a call regarding Nemeroff from a potential employer, the University of Miami – which obviously wanted a reference. Insel did speak with Pascal Goldschmidt, dean and senior VP of the Leonard M. Miller School of Medicine at UM. But what was said?

Insel’s actions have a lot of people scratching their heads -- considering the current climate --  so much so that Insel wrote about it on his blog. Insel claims that all he did was answer a question about whether Nemeroff could apply for grants – but Goldschmidt easily could have gotten that information elsewhere, and Insel admits that he should have sent Goldschmidt elsewhere for the answer.

The U of M says it will keep an eye on Nemeroff. “There will be particular scrutiny of his activities to protect him and the institution and to [make] sure there is no bias in his work,” said Goldschmidt.

The take-home lessons here: Industry needs to manage its Though Leader relationships much closer and adapt to what will certainly be an ever-changing set of rules, regulations, and market conditions.

Friday, July 16, 2010

Is the Conflict of Interest Tide Turning?

Though we want to imagine physicians as mild-mannered healers, we can’t help but think that some medications would have helped at the recent meeting between folks at the ACCME and the AHA – the one where the ACCME kinda, sorta didn’t reverse its public stance about not letting industry scientists speak at CME-accredited AHA meetings.

Though they won’t admit it.

"We have definitely not reversed course," Murray Kopelow, chief executive of the ACCME, told the Milwaukee Journal Sentinel.

One week industry scientists can’t speak at an accredited event, two weeks later, they can? What happened in between? What should have been happening since the conflict of interest issue first reared its head – a conversation among doctors, on both sides of this debate. Up until now, it’s been the purists’ voices who have dominated the conversation. But after the ACCME announced its decision a few weeks ago, people like Francis Collins and Clyde Yancy objected.

“It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector,” said Collins, who runs the NIH.

It was Yancy, president of the AHA, who met with Kopelow after the ACCME’s sweeping announcement in mid-June. According to Medical Marketing and Media, Yancy told the ACCME that his group had its own “independent peer-review process and procedure for accepting abstracts.” Apparently, that was good enough for the ACCME. The ACCME now will allow industry scientists to speak at accredited events, as long as the accreditor – the AHA, whoever – has control of the information being discussed.  Yancy brought up another interesting point in the MM and M article – he said industry abstracts presented at meetings are far and few between. “Over the last three years, only about one-half of one percent of abstracts at AHA's annual confabs have been presented by industry scientists. … which is pretty interesting when you consider all the hand-wringing that's taken place as of late.”

Did the ACCME cave to big-name pressure? Maybe, maybe not. What this scene reveals is that those physicians who are not happy about being labeled guilty until proven innocent should say so. It also reveals that when some physicians say, “hey wait a minute, let’s use some common sense,” others might actually agree with them.

Monday, July 12, 2010

It’s Time to Give Up This Ghost

We’re very puzzled by this ghostwriting business.

If industry has anything to do with a journal article, from conceiving it, creating content matter, finding the author, writing the article, editing the article, producing the article – anything at all – it should say so, in black and white, for all to read.

Ghost of a chance, you say? We are not that naive to know that is not how it works.

So we'll ask: Has industry been dishonest in the drug creation? In conducting the clinical trial? In gathering the data? In presenting its findings to the FDA? We do not believe so.   Thought Leaders validate their work, test their processes, and publish their articles with points of view to create debate. That is the value of the current system. We often talk about the unintended consequences of increased scrutiny on this subject.  Our concern is that innovation and science will suffer.

No doubt, the temptation to massage the data can be overwhelming, so keep this in mind: Some journals are now demanding that industry-sponsored trials must be independently tested. After JAMA imposed its regulation in 2005, some folks did a study, comparing industry-submitted articles from 2002 and 2008 – and found there was a 21 percent fall in submissions. Innovation occurring at the expense of gains in medical breakthroughs is one thing, but are companies really so profit-focused they forget why they are in the business?

Are we seeing the impact of this transparency and will there be a positive outcome?  More to follow on the subject I am sure.

Thursday, July 8, 2010

Pharma’s Achilles’ Heel

So, how are you doing on determining your company’s fair market value calculations?

Say it ain’t so – you’re still not putting it off, are you?

Okay, as a public service, we’ll rant again. A couple of quotes to set the appropriate tone:

“The trend is clear: Enforcement activity will increasingly focus on holding individuals responsible for the legitimacy of relationships between pharma companies and the physician-consultants they engage.”

“The states are using new codified rules ‘to close their budget gaps…there is a continuing trend of enforcement actions.’”

Friends, do not ignore what is happening here: Federal and state legislators want industry to “legitimize” its relationships with Thought Leaders. Industry will literally pay the price if it does not. The old ways are out: Lawmakers want, in writing, the reasons you paid Dr. Smith, Dr. Jones, Dr. Miller, and so on, those particular fees for the particular service they provided. And they better be justified. The new motto may as well be “consistency in fee determinations.”

So, as much as you’d rather do another project, you need to set aside copious amounts of time to get a fair market system plan in place. You need to talk to departments you normally don’t deal with – you’ll be amazed at how many departments use physician consultants in myriad ways -- and gather data from far and wide, inside and outside your company.

Hiring a consultant, someone well schooled in FMV determinations, is probably a good idea. Relying on the Office of the Inspector General is no help – “they advise only that the method must be ‘reasonable.’ And remember – you are now required to post all those fees on the Web in several of the states.

Let us know how we can help you!

Friday, June 25, 2010

Medtronic and Transparency: Well Said, Mr. Hawkins

Recently, Medtronic announced that it too, would begin posting online the dollar amounts, above $5,000, that it pays its physician-consultants, joining the ranks of other medical industries that have begun listing their KOL payments. The new health care reform law will require Medtronic to do this in 2013, but Medtronic is smart to do it now.

What caught our attention is how succinct Medtronic Chairman and Chief Executive Bill Hawkins put the need for KOL involvement in product development, whether it’s medical devices or a drug. He told the Wall Street Journal that his field is very technical and highly dependent on collaboration between Medtronic engineers and outside consultants.

"I'm hard-pressed to think of any innovation we've had that didn't come from Medtronic working with physicians,” he said. 

Industry, while acknowledging that transparency has its place, needs to stress the value of industry-physician collaboration, and the good that has come of it.

We certainly believe that the two need to exist, and now even some journal editors believe that too. We think these arrangements can be appropriately structured to ensure the transparency everyone requires while not going overboard by gutting private investment in medical science.

Tuesday, June 22, 2010

Transparency and the Advertising $$$ Free-Fall

The transparency trend is firmly in place now, and its impact is beginning to be felt. One significant tremor: Industry spending on advertising revenue in medical journals. The WSJ Blog reported recently that those dollars plummeted to $626 million last year, from $865 million in 2005.

To refresh your memories: A March article in Medical Marketing and Media said only one journal, NEJM, had an increase in pages – a whopping .9%, for 2009. JAMA was down 12.8%.

The WSJ article, which focused its piece on industry revenues lost by the American Psychiatric Association, ($7.5 million over the past year), said that industry is cutting back from advertising in the APA’s journals, “in part because the industry faces its own pressures to avoid potential conflicts of interest.” 

The impact of this lost revenue and a bad economy are impacting everyone.  But what do less articles published, less research presented at conferences, less private investment in health really mean?

Did anyone think of the unintended consequences this push for transparency would bring?

Up until this point, physicians and KOLs have been fairly quiet about the COI turmoil. But recently, some medical association heavy hitters took a stand.

That's what this issue has lacked all along: A real conversation between physicians who think there is a conflict of interest in earning a living from industry, and those who don't. Maybe they can make sense of all this, and establish workable rules that make real sense.

We'd like to believe the pendulum is swinging the other way and industry's model of interacting with healthcare professionals will continue to change.  We hope for the overall improvement in healthcare, but we also know we are a long way from really knowing.  In the meantime, the economy is affecting all of us.  Make sure your CV/Resume is up to date. 

Tuesday, June 8, 2010

The Transparency Band Wagon Gets More Crowded

As more medical professionals jump on the conflict of interest band wagon – the Council of Medical Specialty Societies (as reported in Fierce Pharma) being the latest – maybe it’s time to be less myopic and examine this situation from 30,000 feet up.

So far, the exam yields nothing but questions.
  • What will be the effect of all this transparency?
  • Should the separatists, (those who believe that industry money is too much of a lure to keep physician consultants honest), get most of what they want, then what will happen to real research and development?
  • Can anyone deny that collaboration has not yielded excellent results?
  • What will be the effect of all this finger-pointing on physician and student education? Will all presenters be looked upon with mistrust? What about CME? Will it survive? Who will pay for it?
  • Will physicians avoid becoming NIH researchers, not wanting to see their name on a Web site?
  • Will physicians stop working with industry, for the same reason?
All of this seems to suggest that healthcare professionals working with industry are guilty until proven innocent!  It is clear that the former model must change and adapt; our message is that some may be trying to throw the baby out with the bathwater. Good, clearly structured contracts can help make this process more organized and disciplined -- which is what many are really saying anyway.