Later this month, the Supreme Court will hear IMS v. Sorrell, about the right of Vermont and other states to restrict a practice called data-mining – the collection and sale of doctors’ prescribing histories that drug companies then buy and use in marketing to MDs and other prescribers. Vermont’s law banning this practice was struck down in the Second Circuit Court of Appeals, after the First Circuit upheld similar laws. (Both New Hampshire and Maine have standing laws, and Massachusetts is considering a bill this year supported by consumers and the state medical society that would do the same.)

Prescription data-mining is a multi-million dollar business for companies that buy prescription records from pharmacies and physician lists from the American Medical Association, and then match these to produce profiles that they sell to drug companies.  The companies then arm their drug reps with this information to market their drugs to individual prescribers. (Way more about that in the PostScript archives)

Why did the court strike the law? The drug industry trade group PhRMA and the ‘data-mining’ companies, like IMS, who sell this information argued that it was ‘speech’ protected by the First Amendment.

Speech? Are your purchases on Netflix speech?  This seems like a stretch.

The First Amendment protects some kinds of speech more than others, based on the whether the speech has political or cultural value, whether it relates to business and commerce, or whether its part of an otherwise criminal act. The most protected speech is the set of public exchanges that create a thriving free marketplace of ideas – political, social, and economic – which are essential to a vibrant democracy. For instance, the government cannot pass laws preventing the news media from lying. The answer to any lies or untruths in this are is the free flow of opposing ideas – more speech.

However, in the commercial sphere, the government has broader authority to protect people from being deceived or misled. So consumer protections laws can ensure that when a company runs an ad, they have to honor that ad, and not use it to lure customers in for other deals. But since 1976, the Supreme Court ruled that the First Amendment also protects truthful commercial speech from excessive government regulation, because the vibrancy of the marketplace of ideas in a democracy is affected by the free flow of information in the marketplace of goods and services.

That means the First Amendment allows someone affected by a government regulation to ask a court to make the government prove that the government’s regulation of commercial speech ‘directly advances’ a ‘substantial’ state interest, and that the government restriction of speech is not more extensive than necessary to achieve the government’s interest. Lawyers call this “intermediate scrutiny.”

Despite the fact that the First Court of Appeals upheld similar laws in New Hampshire and Maine, the Second Circuit was not convinced that the law banning the use of this data directly advanced the substantial interest of the state (which it acknowledged) in promoting public health and reducing health care costs.

But in its appeal, Vermont maintains that banning the non-consensual sale and use of these doctors prescribing records is “a modest step that protects the traditional confidentiality of the doctor-patient relationship.” Indeed, the state says, it’s not a pharmacy’s free speech right to sell a prescriber’s info that it obtained solely because federal law requires pharmacies to collect that prescriber data in order to dispense prescriptions. (DOJ concurs with this position.) These are undeniably private medical records, the state appealed, and their privacy should be protected as the Court has for other medical records and information.

We have long supported the efforts of Vermont and other states to ban or restrict the sale and use of prescriber data for marketing purposes, since it violates the privacy of the prescriber-patient relationship without conferring any medical (or other) benefit on either party. (The legislation only bans use of this data for marketing, not for legitimate research or quality improvement planning.)  Indeed, in all the hearings and subsequent court cases since New Hampshire passed its first-in-nation data-mining law, no benefit has been established other than that conferred on companies’ marketing campaigns, which are much more effective when a rep knows how much of a competitor’s cholesterol med a doc prescribed last week.

In preparation for the case, Community Catalyst and its Prescription Access Litigation (PAL) project along with more than 32 groups and 35 states (plus DC!) filed amici curiae in support of Vermont’s law. The U.S. Dept. of Justice also weighed in to back the state law.

Drawing on PAL’s experience from several lawsuits, Community Catalyst joined with Health Care for All and AFSCME District Council 37 to highlight how this data-mined prescriber information was used to perpetuate illegal industry promotion. Numerous documents from several lawsuits have shown that data-mined information is an integral part of the drug industry success in its illegal promotion of unapproved uses of prescription drugs like Neurontin, Zyprexa, and Bextra. This illegal promotion not only put consumers at greater risk, it also cost consumers and insurers billions of dollars for ineffective and inappropriate drug treatments.

Don’t want to wade through all those other legal briefs yourself? Don’t worry, we did! In the next week we will be blogging a sort of viewer’s guide that summarizes key points and quotes from other amici, including state medical societies, lawmakers, the New England Journal of Medicine, and major consumer groups. Check back in next week for those.

–Wells Wilkinson, Community Catalyst and Kate Petersen, PostScript blogger

Three headlines that caught our eye over the weekend:

FDA report suggests it’s not quite time for J&J to cut the ribbon on its brand-recovery campaign. The New York Times looks at the most recent inspection report the agency filed on J&J’s troubled Puerto Rico plant, which documents “distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.” The report goes through early November; earlier this month, more manufacturing problems led the company to make another huge wholesale recall of more than 9 million bottles of liquid Tylenol, 4 million packages of Benadryl, as well as Motrin and Rolaids products.

As concerns of nationwide counterfeiting problems grow, India commissions a feasibility study on a federal computerized distribution system to better track drugs through the supply chain. In addition to this survey of stakeholders, India’s drug regulatory agency, DCGI, is also encouraging smaller drug companies to use national subsidies to help with set-up costs of a barcoding system. “Both developments tie in with recent initiatives by the Indian government to try to improve the transparency of India’s pharmaceutical sector – a critical supplier of essential generic medicines for countries around the world – and shake off its image as a hub for counterfeit and substandard drugs,” Securing Pharma writes.

And American Medical News, the online news arm of the American Medical Association, sees a significant drop in doctors’ financial ties to drugmakers. Using follow-up survey data on commercial CME, meals, and samples in a recent Annals of Internal Medicine article, the AMN suggests the last five years have seen a sea-change in the way industry markets to doctors (or conversely, the way doctors accept industry’s advances.)

But though there may be a trend here, recent payment data from Massachusetts’ disclosure law and aggregators like PharmaShine and ProPublica suggest that hundreds of millions of dollars are still going from industry marketing budgets to physicians’ pockets each year.

The future federal sunshine law, as well as state and other AMC public disclosure regs (which barely got a paragraph here) are key: not only as potential driving factors in the trends that AMN is pointing to, but as sources of data that suggest the drop off of physician-industry coziness may not be quite as simple as the AMN suggests.

The article also gives a lot of space to the voluntary PhRMA conduct code and AMA’s own code, both of which are relatively weak and unenforceable compared to many academic medical center policies, and which were, chronologically, responses to pressure for system reform rather than drivers of such change, as the AMN article implies.

–Kate Petersen, PostScript blogger

Data-mania!

Eighteen states considered restrictions on commercial use of prescriber data this year, according to this Associated Press story.  But a pending decision in the 1st Circuit Court of Appeals (IMS v. Ayotte) about the legality of the first-in-nation New Hampshire data mining ban has largely frozen the issue, which is earning attention at the federal level, as well.  In the spring, Sen. Herb Kohl (D-WI)  made some inquiries into the American Medical Association’s sale of its prescriber profiles for hefty sums each year.

“We have no privacy issues here,” IMS vice president Randy Frankel told the AP, but many physicians and their advocates (RxP among them) say it goes beyond politesse, and that pharma reps who know covertly doctors’ prescribing patterns are invading the doctor-patient relationship by often pitching the most expensive, least-proven drugs.

Read the RxP fact sheet on data mining here.

Speaking of places where there are privacy issues, this Des Moines Register says that no one has been prosecuted for violating the federal patient privacy law known as HIPAA, the Health Insurance Portability and Accountability Act, even though “38,000 Americans, including 267 in Iowa, have complained of HIPAA violations to the federal Office for Civil Rights” since enforcement began in 2003.  According to the Register, “[m]ore than half of those complaints nationally have been disposed of with no investigation. Until last year, no one nationally ever was prosecuted for violating HIPAA.”

And then there were two

Though we saw numbers like this earlier this year, now there are Just Two, so here’s a pre-convention update: Going by campaign contributions, Pharma is hedging for Obama, and in a big way. According to a Center for Responsive Politics study, first reported by Bloomberg, presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) has received three times as much pharma moula as presumptive Republican nominee John McCain (Ariz.).

Check it out at The Scientist Blog.

Vioxx papers reveal marketing roots

In a paper published in the Annals of Internal Medicine this week, researchers found evidence in the Vioxx documents that the ADVANTAGE trial was drummed up entirely by the Merck marketing department.

According to the paper:

The trial emerged from the marketing division with a marketing objective; Merck’s marketing division collected, analyzed, and disseminated both the scientific and the marketing data; and Merck did not reveal the marketing purposes of the trial to participants, physician-investigators, and institutional review board members.

For those of us who read Melody Petersen’s book, Our Daily Meds, such news isn’t as surprising as it ought to be, but all the same, we’re glad to see this truth vs. advertising getting into the medical literature.

Now you CMAP, now you don’t

The Dallas Morning News reports that the Children’s Medication Algorithm Project, a preferred drug program for psychiatric medications in Texas, has been halted as part of an ongoing investigation by that state’s Attorney General.  TMAP, the adult precursor, triggered a suit alleging undue pharmaceutical company influence on the selection of the drugs.

According to News, “[a]t least four of CMAP’s key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms.”

“In our country, there’s been a switch from taking care of people to focusing on big corporate money,” Rep. Juan Escobar told the News.  According to the News, Rep. Escobar proposed unsuccessful legislation in Texas last year that “would have banned researchers or government employees funded by the pharmaceutical industry from designing state psychiatric drug protocols.”

Hat tip to Pharmalot.

Deja – vu all over again

Harry and Louise are back, and they’re having some second thoughts about healthcare. Check out the story in the Detroit Free-Press here.

Feds Put AMA on the Hot Seat

This week, Senators Herb Kohl (D-WI) and Richard Durbin (D-IL) sent a letter to the American Medical Association requesting information about its prescriber data opt-out program. According to the BNA Health Care Daily Report, “the letter asked for information related to the AMA’s Physician Data Restriction Program (PDRP), which allows doctors to protect their prescribing information. The letter also requested information regarding the type of outreach the AMA conducts to physicians to educate them about the program, the number of physicians who currently participate, and how the AMA ensures that pharmaceutical companies are appropriately responding to and adhering to the program.”

“To say the least, we are troubled by any attempt to persuade physicians to prescribe a drug for any reason other than the patient’s condition and the drug’s effectiveness in treating it,” said Kohl and Durbin in a statement this week. “Without question, it is very important for physicians to be able to protect the privacy of their prescriber numbers and prescribing patterns.”

What’s it all about? In a (hyphenated) word, data-mining. While the sale of the Masterfile brings home a bundle for the AMA annually ($44.5 million in 2005), the AMA’s opt-out program doesn’t have quite the same cache —few physicians know about it, and even less have opted-out. Some who’ve done it say it’s a rigmarole, and one which must be done every three years to stay “opted-out.” Even then, an opted-out doc’s prescribing data can still be sold – the purchasers must only agree not to share it with individual sales reps. We’re glad to see it’s getting some attention on the Hill.

And this just in, from the On the Dotted Line Dept...

If you haven’t already, check out RxP’s consumer petition for the Physician Payments Sunshine Act, a national disclosure bill backed by the National Coalition for Appropriate Prescribing and gathering steam among members of Congress (including Sen. Kohl, who co-sponsors with Sen. Chuck Grassley.)

For more on the Sunshine Act, go here.

And if you’ve already signed up, thank you.

Using court documents from lawsuits over Merck’s Vioxx, a study in this week’s Journal of the American Medical Association found that Merck often wrote first drafts or commissioned for-profit ghostwriters to write academic articles on the pain drug, then paid academic thought leaders for claiming primary authorship. Half the time, those doctors did not disclose that payment in publication, and often the corporate ghostwriter was not listed among authors at all. 

In a companion editorial, JAMA editor-in-chief and RxP advisory board member Catherine D’Angelis M.D. decries the practice, writing, “it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors.”  The lead author of the paper, Dr. Joseph Ross of Mount Sinai School of Medicine in New York, is a member of the National Physicians Alliance, a partner of the Prescription Project.

Read more in the Washington Post, the Boston Globe, and the New York Times.

Well, the RxP Weekly Reader is back and ready for a busy year of news and comment on pharma and medical conflicts of interest. But there’s a few things that happened at the end of the last one that need mention before we dive fully into 2008…

UMass Medical Center clamps down on industry ties

UMass Memorial Medical Center (UMMMC) just introduced tough conflict-of-interest policies to limit industry influence on faculty working at the Worcester campus.

The new rules, which the Prescription Project helped the medical center develop, prohibit faculty from accepting all gifts, including vendor-bought meals on and off-campus, from participating in speaker’s bureaus for industry, and from serving on the hospital’s P&T committee if they have a financial relationship with a drug or device company.  The policies are being lauded as some of the toughest in the nation.

Read more in the Boston Globe, Medical Marketing and Media, Health Care Renewal, and this editorial in the Springfield Republican.   To read more about the Project’s recommendations for academic medical centers, go here.

Alms for the poor, but samples?

Not so much. That’s the contention, at least, of a forthcoming study by researchers at Harvard Medical School and Cambridge Health Alliance, who found that the overwhelming majority of free samples go instead to wealthy or insured patients.

The study, based on a survey of 33,000 Americans, found that just 28 percent of those who reported receiving samples from their physician were poor, and only 18 percent were uninsured for part of the year, statistics that work against the myth that samples primarily aid poor or underinsured patients. The study will be published in the February edition of the American Journal of Public Health.

Read more at USA Today, The Boston Globe, Modern Healthcare (subscription required), Prescription Access Litigation blog and Kaiser Daily Health Policy Report.

“The Cost of Pushing Pills” in PLoS

This analysis in PLoS Medicine uses a new source of industry data to estimate that pharmaceutical companies spend twice as much on marketing as they do on research and development.  The metric, which combines data from IMS Health and research group CAM, is bolder than previous numbers compiled from IMS data that have also suggested that when it comes to pills, the free pen is mightier than the pipette.

In this week’s American Medical News, there’s an excellent ethics opinion piece on physician disclosure and whether it would solve conflicts of interest in medicine.  A researcher and physician each take their turn; one argues that voluntary physician disclosure of gifts to patients would improve patient confidence; the other says disclosure is a false fix for a plainly unethical practice, and anyone who does accept gifts is a “compromised healer.”

District Court strikes down Maine’s data-mining law

As newsrooms emptied and shopping malls filled before Christmas, Bangor district court judge John Woodcock struck down that state’s law, which permitted physicians to opt-out of their prescribing records being sold for marketing purposes.  Despite the timing, here’s copy in the Bangor Daily News and the Wall Street Journal.  And RxP director Rob Restuccia talks to iHealthbeat about the practice.

Next week, the U.S. Court of Appeals in Boston will hear New Hampshire’s appeal of an earlier district court ruling that struck down its prescription data-mining ban in April 2007.

DSM disclosure dismal, says U.S News and World Report

U.S News and World Report takes a closer look at the disclosure ordered up for members of the current DSM update panel – and found less-than-rosy results.  All but eight of the 27 panel members charged with writing the manual that defines what’s a mental health disease and what’s not have financial ties to the pharmaceutical industry, and the news journal found disclosure of those relationships vague and incomplete, despite the APA’s claim that they are a great marker of transparency. Thanks to Pharmalot for the tip.

Miscellany Rx

The Grey Lady finally digested the survey on medical professionalism released in the Annals of Internal Medicine in early December and has this to say about physician professionalism and its bearing on cost and quality.

And here’s the latest on activists taking on the FDA over Provenge, after the regulatory agency flip-flopped on approval of the prostate-cancer drug by Dendreon.  Advocate groups, some of which accept pharma money and others that do not, claim that some of the dissenting advisory board members had conflicts of interest, including a lead investigator on a competitor drug to Provenge.

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.

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.