With the holiday crush nearing its end, PostScript would like to tip its hat (or pen) to the following parties whose bold efforts to help turn the tide against unfettered pharmaceutical marketing may have gone unnoticed in the waning days of 2007. 

UMass Memorial Medical Center – The academic medical center, which also comprises UMass Medical School, announced some of the most stringent conflict of interest policies governing physician-industry relationships in the country. The move follows Boston Medical Center-Boston University School of Medicine’s adoption of equally tough standards earlier this year.

The Prescription Project’s David Rothman called UMass’s policies “gold standard,” citing bans of company meals on and off campus, a requirement that drug samples be delivered to the hospital pharmacy rather than to physicians, and the direction of all industry funds for continuing medical education to the UMass Memorial Foundation as particularly “ahead of the curve.” In the interest of full disclosure and at the risk of sounding like there’s a little horn tooting going on here, the Project provided guidance and feedback to UMass as it developed its policies. But it takes more than a village to bring about such sweeping reforms – it takes strong institutional leadership, the willingness to change the culture of an institution, and the ability to balance the needs of faculty, clinicians and patients with the need to establish fair, effective conflict of interest standards. We hope that in the year ahead, many other academic medical centers will follow suit.

Representative Rosa DeLauro – The Connecticut congresswoman and chair of the subcommittee that funds the FDA added a major speed bump into a federal appropriations bill that effectively puts the brakes on funding for the FDA’s newly created Reagan-Udall Foundation. DeLauro cited concerns about potential conflicts of interest arising from Big Pharma’s funding of the Foundation, a so-called private, independent nonprofit organization created to “advance FDA’s mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”In early December, she sent a pointed letter to FDA Commissioner Dr. Andrew von Eschenbach questioning the appointment of Dr. Tadataka Yamada to the Foundation board in the wake of a Senate Finance committee report that found Dr. Yamada, former chief of research for GlaxoSmithKline, had attempted to intimidate a scientist who raised red flags about the GSK’s blockbuster drug, Avandia. In that letter, DeLauro also made reference to a previous unanswered letter she sent to von Eschenbach concerning the specter of industry influence in the Reagan-Udall Foundation and suggesting that she might rescind funding. Apparently, she wasn’t kidding. Perhaps letter #2 went unanswered, as well… 

Dr. James Orlowski – According to a Dec. 27 profile in the St. Petersburg Times, Dr. Orlowski is the only Tampa Bay-area doctor listed on “No Free Lunch.” (www.nofreelunch.org).

In the article, Dr. Orlowski, Chief of Pediatrics at Tampa’s University Community Hospital and an ardent opponent of pharmaceutical marketing to docs, recounts his days as a struggling med student when plentiful drug company freebie were hard to resist. But Orlowski did. “There was no way I was going to let a drug company gift influence my prescribing,” he said.

Today, Orlowski teaches med students under his guidance to just say “no” to pharma reps and has persuaded the hospital to ban free lunches and sales rep interactions with doctors, students and nurses.

One of PostScript’s 2008 resolutions is to find more Dr. Orlowski’s out there.

Penned-up frustration

The Los Angeles Business Journal documented UCLA’s great pen drop, a symbol of the medical school’s adoption of guidelines to govern vendor relations with physicians and researchers.  According to the Journal, UCLA is one of the medical centers in the UC system to have adopted some of the conflict of interest guidelines promoted by UCDavis, including a ban on gifts.

Instead of digging a little deeper about the UCLA policies and how they stack up to others in California and elsewhere, this reporter asked the question we all secretly wanted to: What happens to all those pens?

“We’ve already approached the art department,” said Dr. Andrew Leuchter, a UCLA psychology professor who sat on the guidelines committee.  “We have some sort of interpretive art exhibit in mind.”

If they don’t care, why should we?

Over at Pharmalot, word of a study of nearly 300 clinical trial participants at George Mason University found that prospective participants were not swayed much by three different stated financial conflicts of interest disclosed by the trial researchers.  The would-be guinea pigs were swayed a little more by the presence of a check.

Ever the journalist, Pharmalot points out that the press release sent out didn’t mention that one of he authors of the study, Jeff Gibb, is a lawyer – whose firm happens to represent several drugmakers.  So what’s his read on the results? Conflicts of interest don’t seem to really change participants’ behavior.  And (wait for it…) “Given that some courts have reached decisions based on their believing that knowledge of a financial stake would actually change people’s behavior,” Gibb said, “his study shows that courts need to rely on facts, not assumptions.”

Multi-tasking

And over at Health Care Renewal, Roy Poses says it’s another academic’s board nomination with blatant COI implications.   This week Dr. Harry Jacobson, Vice-Chancellor of Health Affairs at Vanderbilt University, was named to the board of Merck and Co.

In the visitors’ dug-out

Pharmastats blogs on how to effectively boost sales in untapped markets using “prescriber-level prescription data.” Citing a Stanford study on the power of medical opinion leaders, the blogger said that two-thirds of surveyed physicians “reported their opinion leaders as other physicians they have contact with in a group or hospital setting. It goes on to estimate that peer effects alone provide a 19 percent lift in the return-on-investment from targeted marketing.”

The pharmaceutical sales reps may not have much science on their CVs, but with the help of the prescriber data, this post shows that selling drugs has truly become a science.

Tiny Tim Health Care

And for those of you who enjoyed yesterday’s Pharmajingle, here’s another seasonal gem: head on over to The Health Care Blog to read Michael Millenson’s rendition of Dickens classic A Christmas Carol.  A good reminder of President Bush’s statement earlier this year in Cleveland that every American has access to health care, all they have to do is go to an emergency room.

Note: The RxP Weekly Reader and PostScript will both be taking the week off next week, and resume posts on Dec. 31.

Happy holidays, Readers –

Here in PostScript country, we’re up to the shins in snow and to the gills with yuletide spirit, so we thought we’d turn all that merriment toward something else that’s on our minds…

 [cues orchestra]

A Data-Mining Carol

[to the tune of Jingle Bells]

Dashing through the wards, with a briefcase in his hand,
The rep signs in and waits, then shakes the doctor’s hand
But this is no plain pitch,
He knows just what to say,
Because he knows just how much Doc wrote
Of Seroquel last May

Oh –

Data sells, the reps can tell
How well their free lunch pays
But docs don’t know how much is shown
On a rep’s handheld display, hey

Prescriptions filled, providers billed,
The rep calls it a day,
Oh how tough his job would be
Without the AMA!

Should this not sate your thirst for health care caroling, click on over to St. Luke’s Health Initiatives The Drift for an ode to Health Reform. A little less snow this time of year out there in Phoenix, but obviously, the spirit of the season is all around us.

Thanks to Envisioning 2.0 for pointing us to Mark Senak’s Eye on the FDA blog.  Envisioning found his breakdown of the presidential candidates’ health care and pharmaceutical platforms super-interesting, and so did we. 

Another interesting blog we’ve recently run across is The HIV/AIDS Shill Factor, http://shillfactor.net (Howard Brody wrote about it here.)

The epigraph is tiny font in parentheses, but the message is bold:

(If you were bringing in an additional $50,000-$100,000 a year with very little effort, shuttling about rich countries extoling the merits of lifelong polypharmacy to clinicians less clever, less compeling than yourself — loads of fancy dinners & hotels, business class travel, furtive financial exchanges, would you stray from the script?)

The rest of the text on the site is a bit small, too, but PostScript appreciates the simplicity of the format and the detail sorted into categories of who: Who controls research, who votes on new drugs, who sets treatment specs, who educates the field on HIV/AIDS….

Though medical conflicts of interest are complex creatures, being up front about them isn’t — it’s essential.

As we browsed through the Arial 10 pt. font lists of “Paid consulting for” “speaking fees from” and ”stock ownership,” we couldn’t help but think: If these guys and gals did this with a word processor and the internet, can’t be too much trouble to ask researchers and doctors to do it, too. 

Two Maine physicians, Drs. Ben Schaefer and Bethanie Picker, threw in their hats Monday for LD4 in the op-ed pages of the Bangor Daily News.  LD4 is a law passed in Maine earlier this year that gives doctors a choice to keep their prescribing data from being sold to the pharmaceutical sales force via a nifty process called “data mining” (more on that here and here).  The law is being challenged by industry and the middle men running the sale, who claim medical data is the ticket to better health care. 

Schaefer and Picker say yes, data matters, but so do the hands it is in, and they think prescribing data in the hands of sales people with a Lipitor quota to hit is hardly a guarantee of better medicine or patient care.

If Dr. Schaefer’s name looks familiar, you might have seen his letter to the editor in the Wall Street Journal on Saturday.

“Frankly,” he wrote, “I am tired of hearing Big Pharma complain. There may be a crisis looming, but it is largely a self-made crisis and not even close to the one faced by patients who haven’t been able to afford their medicines in recent years.”  If you are a subscriber, go here.  And he and Picker have been in the op-ed pages before in support of stopping the sale of prescriber data for marketing purposes.

What to make of Dr. Schaefer’s rising word count? Well, the conversation around conflict of interest is certainly not a new one, but one could argue (and we will) that the debate is heating up. PostScript takes it as a good sign that doctors are joining in as vigorously as Picker and Schaefer have. 

After all, medicine is not just practice but an idea, an ethic, and a critical, if broken, social contract.   Healing patients is good, yes, but healing them and also thinking about how it’s done and how it could be done better – in this case, without the over-the-shoulder help of the pharma’s sales team – is even better. 

Schaefer and Picker are both members of the National Physicians Alliance, a great group of docs and ally of the Project.   Other NPA docs in print (and online) are Daniel Carlat,  Howard Brody, and NPA blogger Chris McCoy.  But the common thread here is not the newsprint, but their self-made roles as citizen MDs.

Let’s be clear; we’re not talking about the long-standing tradition of the doctor-writer, the William Carlos Williams way of putting down the art and science of medicine in poems, or of Atul Gawande, who writes with a definite audience in mind (readers of The New Yorker, for one). 

Instead, Schaefer, Picker, and other physician-advocates like Carlat, Brody, Joshua Sharfstein and Roy Poses, to name just a few, are writing because they believe there are things that need to be said, opposed, and fought for.  As those practicing medicine, they have the twin right and responsibility to do it. And, let’s face it, the letters behind their name to get heard.

Psych task force issues primer on industry influence

A task force at the American Psychological Association assigned to look at the role of external funding on the profession’s mission  came back this week with a serious report and tough recommendations on how to break free from pharmaceutical influence as more states begin to grant psychologists prescribing privileges.

Some of the recommendations include :

• that the APA adopt a “consistent and meaningful conflict of interest standard” in the APA code of ethics and creating educational material to educate members and vendors about the standard.
• that the association never use external funding for operating budget or budget shortfalls
• that the APA adopt ”a policy on disclosure of funding sources and potential conflicts of interest for all individuals and entities seeking APA approval for CE presentations” and considering “not offering CE credits for industry-funded courses.”

And some creative out-of-the-box types, too, including

• a proposal that academic journals “should have a disclaimer about the accuracy of claims made in advertisements.  A significant portion (perhaps 25%) of selected industry advertising revenue should be set aside to support data-based perspectives (possibly through scheduled debate or other continuing education [CE]) that might otherwise be stifled in those areas in which one industry dominates the advertising agenda.”

This primer is a must-read.  Good blog posts on the report at Pharma Marketing Blog and Pharmalot. Whether it’s heeded going forward? Well, that’s another question, says the blogger at Clinical Psych.

Safe Rx Act of 2007 squeaks by in first council vote

A bill that would license detailers, prohibit prescription data–mining and outlaw deceptive marketing of prescription drugs passed the first vote in the D.C. city council this week by a margin of 7-6.

The Safe Rx Act of 2007 was brought by councilman David Catania, the president of the National Legislative Association to Reduce Drug Prices and would, if passed, make the District the first U.S. region to license detailers.  A second and final vote will be held Jan. 8.

Check out the NLARX website for more coverage.

“No Longer Under the Radar” for parents

The Kaiser Family Foundation and NPR released a survey that shows parents don’t all know about the recent FDA vote that over-the-counter could and cough meds are neither safe nor effective for children under age 6, and those that do are divided in how to proceed.

According to the Kaiser Daily Health Policy Report, the survey showed 86 percent of parents had heard about the safety concerns, and 34 percent had stopped using the drugs with for their children, at least temporarily. Still, 23 percent considered the drugs to be very safe.

And Dr. Joshua Sharfstein, the pediatrician who led the charge to get those drugs off pharmacy shelves, coauthored this perspectives piece in the New England Journal of Medicine. Tracking the October hearings and the dismal lack of safety of efficacy data for this type of drugs, the authors conclude:“Although the FDA does not need to follow the recommendations of its advisory committees, we believe that it should immediately ask companies to remove these products from store shelves and begin legal proceedings to require them to do so.”

And for dessert, Doc?

It seems a Merck rep who didn’t make the sale on a shingles vaccine at a dinner for some Illinois doctors may have sent anonymous letters to two of the docs in attendance smearing their wives.

The docs and their lawyers hypothesize that the anonymous letter may have been meant to silence the docs’ questions about the vaccine; both physicians, Carl Lawyer and Paul Smelter, have threatened a defamation lawsuit.

Here’s a report in the Springfield Journal-Register, and an editorial arguing that the episode serves as a lesson for doctors who go to dinner to get ‘educated’ on drugs.

“Consider this analogy: If you wanted to research a new car purchase, would you turn first to the car salesperson?,” the editorial board writes.  “The answer is obvious. And it is obvious that fancy dinners are not about educating doctors; they are about influencing them. Doctors should just say no to drug reps.”

Get the blogword from Howard Brody’s Hooked and Pharmalot.

Blogorama

A bit more from the blogs we read this week…

The thread Dr. Carlat pulled over Eli Lilly’s deployment of a risk management firm to counsel doctors on risky antipsychotics without fear of litigation just keeps unraveling.  He links to an Indianapolis Star story on the matter in this post.

Besides the Springfield fiasco, Howard Brody also posted interest tidbits on the American Medical Student Association and the FDA draft guidance on marketing for off-label uses .

And David Harlow over at Healthblawg has just issued the latest Health Wonk Review, the bi-weekly round up of all things health care.

When I spoke with him last week, Ed Silverman was in transit, taking the train into midtown for a meeting.  I asked Silverman, the man behind the pharmaceutical news megablog Pharmalot, if he usually blogs on the train, and he said yes, when the signal permits – and then admitted he’s been known to take his laptop with him to the hospital. 

PS: Before being editor for Pharmalot, you were a reporter for the Star-Ledger of New Jersey.  Was pharma your first beat?  Your dream beat?  How did you get here?

ES: I was at New York Newsday until it closed in 1995, and then I went over to the Star-Ledger.  I’ve been a business journalist my whole life, so when I got to the Star-Ledger, I was assigned the pharma beat, and I did that ten solid years, part of the time covering it all on my own, part of it with someone else.  I got a great education, covered all sorts of things, but by the 10-year mark, we were all at a crossroads, me, the paper. 

I suggested something like Pharmalot to the editor, who liked the idea as a vehicle to grow into the future.  So I spent 2006 talking, planning, and pitching to folks.  The Newhouse family, who owns many media outlets, the Star-Ledger biggest among them, really liked the idea. 

PS: For such a new media idea, why did you need old media backing?

ES: I didn’t have to go out on my own, which meant I was able to keep my health benefits and retirement benefits from the paper.  I have tech support and the legal support (I haven’t needed that, but it’s there) of a big paper.  It also gives me a certain credibility that is harder to attain and maintain on my own in what is still, for the moment, an old media world.  I am journalist with a large newspaper, and I can still trade on that cache.  It’s easier to establish yourself that way. 

But I’m no longer a cog in a wheel.  What I’m doing is challenging, fresh and unique, and I’m kind of my own boss.  I don’t have anyone looking over my shoulder, I do answer to someone, but I have an opportunity to grow a business that I wouldn’t have had if I’d remained in the newsroom.

PS: How did you conceptualize Pharmalot when you were pitching the idea?

ES: I envisioned something that looked in different ways at different things about the pharma industry.  It didn’t have to smell like or look like a blog, it just had to be some sort of launch pad. 

PS: Do you have more access to stories than you did as when you were a reporter? Less?

ES: It’s a funny thing.  The Star-Ledger is a big paper, by the numbers, but it’s right across the river from New York, and has always been overshadowed by the Wall Street Journal and the New York Times when it comes to business news. 

Even though we’re right in the heart of the pharma industry, geographically, physically, it’s harder to compete with reporters in Washington.  For instance, if you are working for the FDA, you check two papers:  the Washington Post and the WSJ.  There are a few go-to places based on what you do and where you are. 

It’s taken months, and I’ve spent a lot of time on the phone, introducing myself to people, sometimes again.  But the influence and reach [of Pharmalot] is growing in ways I never could have at the Star-Ledger.  I have more readers in Europe, and a growing number of readers in India. 

The Times of London named Pharmalot one of the best 50 business blogs last year, which was very flattering and completely out of the blue.  When I was writing for the Star-Ledger, no one but the one guy I know in London knew what Ed Silverman wrote last week.  And now I guess they do. 

PS: With so many readers and such a wide story base, are you accused of having a bias?

ES: Sometimes I’m accused of being pro-pharma by people, and sometimes I’m accused of being anti-pharma by other people.  The reality is that I’m a journalist.  This is an industry that’s going through enormous change and challenge, and as journalist, I follow the tension.  I don’t feel the need to inject myself — the site is not about me. 

PS: On average, how many posts do you make per day?   Do you have a number you shoot for, or does it vary a lot? 

I do about 8-10 posts per day, and that’s a strategic number.  You should do several things a day that add up to the most interesting blog.

A lot of people think of blogging as sounding off, but I don’t necessarily do that in every post; it’s a mix of news and views.  As Bob Dylan said, if there’s an original idea out there, I’d sure like to hear it.

I have experience, but in the end, I’m still just a journalist, I’m not the executive at a pharma company.   So, if we’re going to have a site people want to go to, it has to be more than commentary. 

On the other hand, if you are just regurgitating news and linking to other places, that’s only useful up to a point.  This is a brave new media world, and there’s always a new aggregator out there.  To get people to think about something everyday, you have to give them something everyday. 

PS: How many visitors do you get per day?

ES: We started in January 2006, so we’re closing in a year.  I can’t be specific, but several thousand a day.  We haven’t advertised — it’s all viral and word-of-mouth.  By three measures — RSS feeds, email subscribers, and daily visitors — Pharmalot is growing incrementally and steadily.

PS: What are the pressing issues you see facing the industry and its consumers?

ES: Safety-patents-pricing-generics-advertising-lobbying-litigation.  And it just goes on.

PS: When you write about the leaves falling outside your window, is that actually happening?  When you do the pharmalittle coffee break, do you actually get a cup of coffee, or change the wash? 

ES: I didn’t have time to put something on my site that I’ll be on a train to Manhattan this afternoon, but sometimes I’ll do that.  When I say that the dog has pooped and the kids are off at school, that’s accurate.  Or if I’m going to a lunch meeting, I’ll put a picture of the type of food we’re going to have, just a hint.  It’s all a little tongue in cheek.

PS: Some reporters have a book in the drawer, or a book they aspire to write.  Do you?

ES: No.  Actually, in my previous life, I did have an agent and one book proposal out, but I have not pursued anything since then.

Of all the books out on the pharmaceutical industry in the past two years, and most of them that I know of are good, none of them have gone anywhere commercially.  I just wonder how much appetite there is for reading that material in that kind of detail.

PS: Does it bother you when you read the phrase “tipping point”? I hear and read it everywhere now, but what were people using to describe this phenomenon before 2000? 

ES: Nah, I see so much jargon, it all goes by me.  So long as I know what people are saying when they write, I’m fine. 

And there were bad ones before.  “Pushing the envelope.”  Remember that one? That was terrible.   

Ta-da!

The Prescription Project Weekly Reader,  a weekly email of pharma/conflict-of-interest news in review, is moving to PostScript, where it will appear every Friday,  rain or shine.

If you have been receiving the Weekly Reader by email, we invite you to subscribe to PostScript in the right-hand column, and every friday, the Reader will arrive in your inbox, just like the old days.

And if you are just passing by, we hope you’ll subscribe, too, or stop back on Fridays to catch up.

No shortage of news, though, so let’s start in.

Putting off-label studies on the table

Yesterday we posted here about the FDA’s draft guidance on permitting drug marketers to use off-label studies, but coverage abounds in the Washington Post, WSJ Healthblog, and Kaiser Health Policy Daily Report, to name a few.

and speaking of detailing…

This AP report says that physicians are spending less time with drug reps and more time with online detailers.  According to the report, a research firm recently found that just one-quarter of sales visits actually involved an in-person encounter with the good doc.

“Patients are watching, medical students are watching and it’s just become harder and harder to justify these interactions,” online pharma marketing executive David Kramer told the AP.

Weighing the pros and conflicts

Doctors don’t always adhere to the high ethical standards they hold their profession to, according to a new study in the Annals of Internal Medicine this week.  Though 90 percent said that incompetent colleagues should be turned in, 45 percent said they hadn’t always done so, according to this AP report.

Moreover, a quarter of respondents said they’d refer a patient to an imaging center in which they had financial stake without revealing the conflict of interest.  Our favorite part: The AP reported that 21 doctors cashed the $20 survey incentive check without sending back the  survey.

Here’s coverage at the Boston Globe, Washington Post, Health Care Renewal and Pharmalot, too.

What sort of asssistance is Montel offering, anyway?

Montel Williams pitched critics of PhRMA’s marketing machine (and matching tour bus) a softball this week when he threatened a high school intern who asked whether pharmaceutical companies would conduct as much research if profits were restricted.  In the age of YouTube, this story is even juicier.  Read all about it at Prescription Access Litigation blog, Pharmalot, or WSJ Healthblog.

Osh Kosh, My Gosh

The Oshkosh Northwestern points a finger at Oshkosh orthopedist Dr. Jeffrey McLaughlin, who received $600,000 last year in payments from medical device makers, 45 percent of Wisconsin’s take and the most among state docs and healthplans.

The balance sheets are part of an anti-kickback settlement with the federal goverment earlier this year in which five medical device-makers were required to post payments to doctors and providers in online public databases.

The Kennebec Journal – Morning Sentinel looks again at the prescription data-mining issue. Hearings from a challenge to the law restricting the sale of doctors’ prescribing data through an ‘opt-out’ provision have begun, and the health information organizations that aggregate the data and pair it with pharmacy records are looking for an injunction to the law.

Old and off-label

In a follow-up to last week’s summary of an earlier St. Petersburg Times story, the Wall Street Journal looks at the growing use of atypical antipsyotics in nursing homes and connects it with the 1987 law President Reagan signed that restricted restraint tactics that could be used in eldercare facilities. Sen. Chuck Grassley (R-IA) has begun an investigation.

FDA isn’t tilting at windmills for this one

At least, that’s the word from a new report by the Center for Science in the Public Interest that said finding conflict-free experts isn’t as hard as the FDA said it was last month, when it released the results of its own report on the feasibility of assembling conflict-free expert panels.

In an open letter to FDA commish Andy von Eschenbach, CSPI joined with the National Physicians Alliance, Consumers Union and the Union of Concerned Scientists to call on the FDA to create conflict- free panels as opposed to the patchwork of COI waivers that currently compose the committees. Healthcare Renewal, The Scientist, and Pharmalot all weighed in.

Too different to disclose? drugs vs. devices in MN

In a follow-up to last week’s question about why Minnesota’s drugmaker gift disclosure laws don’t cover device makers, Howard Brody over at Hooked has a few ideas.

“I don’t need a drug rep on site to show me how the patient is supposed to swallow a capsule,” Brody writes.  “Virtually all the information that I need to know about how to prescribe a drug could be provided to me in writing. For many devices this is not true.”

A banner year for safety breaches, and a bad one for pharma

Hats off to Pharmalot for pointing out this “Top Ten Drug Warnings and Recalls of 2007″ from FiercePharma.

And it this makes you nostalgic, here’s a new WSJ report on an old refrain: Big Pharma’s prospects are drooping as economic, management and regulatory models shift. Bonus gloom and doom: you may need a subscription to read this one.

This week, the FDA issued a draft guidance that could, if adopted, change the contents of the drug rep’s briefcase.  It will free up the industry to distribute studies of drugs for off-label indications.  That’s a concern.

Of course, many off-label uses are medically appropriate. Once a drug is on the market, there is nothing to stop a clinician for prescribing it for any indication he or she sees fit. Providing there is good evidence to support those prescriptions, we support that. But do we really want pharmaceutical marketing mavens pumping up the volume?

Right now, drug reps are prevented from promoting drugs for off-label uses. So whatever the quality of the information they provide, we at least know that the FDA has established that this particular use of the drug has some merit.

The argument for changing the system, presumably, is that companies can play a role in “educating” doctors about peer reviewed studies. But peer review is no guarantee of quality.

As a general rule (very, very general), the most important, best-designed studies show up in first- and second-tier journals. But a slew of minor peer-reviewed rags exist to snap up the remaining vast quantity of unbelievable rubbish. We’re talking about studies that are badly designed, lacking appropriate endpoints, outcomes, comparators, randomization, blinding, follow-up, analyses and conclusions – sometimes all at once. The good news is that nobody reads most of this junk. It gets published in minor journals and serves mostly to pad out CVs and grant applications.

But what if America’s 100-thousand-or-so drug reps were to load up the trunks of their cars with these studies and start driving around, handing them out to doctors? That would be bad — especially if they were using these studies to promote off-label uses of their drugs (that is, indications that the FDA has not reviewed or approved). And yet, that is precisely what the FDA’s new draft guidance is proposing to allow.

What on earth would prompt the guardians of the nation’s drug safety system to invite industry to reach into the Pandora’s box of crap studies for unapproved uses and, well, start selling?

That’s the question that Representative Henry Waxman is asking. We await the answer.

On Wed., Nov. 20, as many readied their turkey dinners and packed the car, one Joseph Conn, staff writer for Modern Healthcare, wrote an article detailing the first week of hearings in the Maine prescriber data-mining case.  Little could Mr. Conn know what he had started.

On Wed. Nov. 26, one Mr. Terry Nugent, Vice President of Marketing at Medical Marketing Services, which buys physicians’ data from the AMA and pairs it with pharmacy records to make primo detailing food for pharmaceutical companies, wrote a letter.  This letter. 

Today, Mon., Dec. 3, not wanting to bring the French Revolution to the pages of Modern Healthcare any more than was necessary, we write back to Mr. Nugent here.

In response to Joseph Conn’s “Data-miners unite in Maine to block ‘opt-out’ Rx law”, Mr. Terry Nugent (Letters, Nov. 26) writes that the “law of unintended consequences” is reason to continue to allow prescription data-mining, or the sale of physicians’ data to pharmaceutical marketers.

But the pharmaceutical industry’s invasive sales scheme operates instead on the law of intended consequences; the industry spent $7.2 B in marketing to physicians last year alone because they know it changes prescribing patterns.  Mr. Nugent threatens that ending prescriber data-mining would cause marketing costs to “increase and inevitably be passed on to the patients and taxpayers of America,” but it’s a hollow threat because it’s already here.  That $7.2B and the $18B more spent in samples is exactly why brand-name drugs are priced radically higher than their generic equivalents, and consumers and payers are the ones stuck with the bill.

Mr. Nugent calls laws such as Maine and Vermont’s prescriber privacy acts “a waste of taxpayer dollars.” On the contrary, laws restricting the sale of prescriber data to pharmaceutical marketers bring down health care costs by ensuring that doctors base prescribing decisions on science, not biased marketing, and by making more room in their schedules for patient care and continuing education.

Though he calls legislators seeking to protect this patient-physician relationship “liars”and “leftist politicians,” Mr. Nugent’s strangest name calling comes just words later, when he likens the opponents of this invasive marketing tactic to Marie Antoinette. It’s an odd analogy, as the mythology of the French queen—a spendthrift leader whose excesses came at the expense of her subjects—calls more readily to mind the pharmaceutical industry, which lavishly gifts doctors, even as it violates their most important obligation to care for patients by buying their prescribing data and raising drug costs for the public.

Update: Dr. Narayanachar Murali, a gastroenterologist from South Carolina writes to Modern Healthcare, thanking Mr. Nugent for educating him on the AMA’s sale of doctors’ data for marketing, and intimating that if more doctors knew about this  practice, the professional medical association might have a suit on their hands.

Second update: Mr. Nugent writes back. This time he brings Adam Smith and fall of the T-model Ford to the defense of his middle-man industry.

His middle-man industry: The MMS homepage trumpets that as “the first company franchised to manage the AMA Physician list,” it has “developed a proprietary, multidimensional, identification process to convert data into perfect prospects. Translation? When it comes to selling out doctors to pharma, we’ve got it down to a science.  Check out the company website here, including the montage of doctor portraits across the top. Did they all agree to their data being sold to Big Pharma? [And is that Dr. House on the right?]

Excerpt: “Murali prescribes ‘iron-fist’ regulation of the pharmaceutical market; my second opinion is the ’invisible hand’ of the market, which has guided our nation to worldwide economic pre-eminence.”

We still have unanswered questions: Where are the Modern Healthcare referees?  When Dr. Murali wrote about the iron-fist, was he alluding to despotic regulatory tactics, the Marvel superhero, or the heavy metal album?  We may never know.

And so, unable to channel either Adam Smith or Joseph Stalin, PostScript has declined to respond to Mr. Nugent’s second letter.

But we’ll be sure to keep watching the data-mining hearings in Maine and the pages of Modern Healthcare for more on this issue.