The Supreme Court heard oral arguments yesterday in the prescription data-mining case IMS v. Sorrell, and there’s a whole passel of news stories:

Washington Post

New York Times

Los Angeles Times

Christian Science Monitor

Reports indicate the judges were skeptical of Vermont’s position that preventing companies from buying doctors records from pharmacies – importantly, without the doctors’ consent—was not, in fact, limiting commercial speech.

Two important points that sort of rush by in the Post story. The Post quotes IMS attorney Thomas Goldstein: “If the message is accurate . . . the drug companies can go make their pitch,” Goldstein said. “Vermont can come along and make the opposite pitch. Terrific. So can insurance companies.”

But the accuracy of the message is squarely in question, and at the center of Vermont’s concern. The message is accurate…ly geared to sell drugs. Like all salespeople, those being given doctors’ prescribing data are not obligated to provide complete, accurate pictures about a given therapy class. They are obligated by their job description to sell more of their drug than the next guy.

In some cases “accurate” has been interpreted so broadly that companies promote their drug for uses beyond their approved indication. While physicians should be free to make those prescribing choices within the individual patient-physician relationships, sales-fueled marketing of such uses “off-label” can be dangerous to patients and is therefore illegal. And as we discussed last week, pharmaceutical companies have gotten in big multi-billion dollar trouble with that one. The flagrant scope of this shrugging off of the law and patient safety in favor of profit-motive is one thing Community Catalyst asked the Court to consider as it weighed Vermont’s case for restricting sale of prescriber-identifiable info.

The Post article also says:
“IMS Health and other companies that collect data from pharmacies say it helps law enforcement and public health officials by locating areas where certain illnesses are concentrated and to identify doctors who overprescribe certain drugs, such as narcotics.”

This elides some really important matters at the heart of the case.

Not being in the room, it’s hard to know what exactly was said, but let’s be clear: Drug companies are not spending millions of dollars on this data each year to turn around and share epidemiologic trends with public health officials. One, because spotting disease trends does not require prescriber-identifiable data—knowing the incidence diabetes type II in Stowe, VT is unrelated to knowing which doctors in Stowe prescribe how much tolazamide vs. rosiglitazone. And that’s an important difference, because it’s that second kind of info IMS is making its money selling.  Moreover, Vermont’s law specifically exempts legitimate research and public health uses of the data from its law.

Secondly, neither the pharmaceutical industry nor health-data companies like IMS are in business to out overprescribers. Not their job, and not in their interest. Claiming otherwise before the Court should be a non-starter.

Kate Petersen, PostScript blogger

In the third part of our Supreme Court prescription data-mining review (here’s Part 1 and Part 2) we look at the amicus briefs filed by groups of major physician organizations that represent hundreds of thousands of US physicians and a prominent medical journal.

Since it’s physicians whose prescribing data and identity are being sold to marketers, their interests stand at the heart of this case. Their statements to the Supreme Court demonstrate their powerful consensus that Vermont’s data-mining law protects against harmful intrusion into their clinical decision-making and the foundation of their profession: the confidentiality of the patient-physician relationship.

Vermont Medical Society, New Hampshire Medical Society, Maine Medical Association, Medical Association of Georgia, American Academy of Family Physicians, American Academy of Pediatrics (pdf)

In a brief submitted by groups who represent more than 170,000 physicians nationally, the Vermont Medical Society and other physician groups told the Court that data mining with Prescriber Identifiable (PI) data violates medical privacy, one of the “central tenets” of the patient-physician relationship.

They argue that because the data in question belongs to a physician and patient it is private data, not public, and does not qualify as commercial speech. But they go on to build a case that even it were commercial speech, the Prescriber Confidentiality Law substantially 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.

The law also protects public health, they say, and lowers health care costs that come with the intrusion of salespeople into the medical decision-making—salespeople whose “goals are wholly unrelated to the best clinical treatment for any specific patient.” Studies and millions of marketing dollars have shown that drug company detailing influence the prescribing of newer less-tested, more expensive brand-name drugs when proven lower-cost alternatives exist.

In its decision, they say, the Second Circuit ignored the existing framework of state and federal privacy laws—Vermont’s Prescriber Confidentiality Law fills in those gaps that have allowed data-miners to buy and sell confidential prescriber data.

Other notable quotes:

–With unrestricted access to otherwise confidential data, pharmaceutical companies have been able to insert themselves as a third party in the physician-patient relationship in a way that would not be possible without access to PI data. The intrusion on this private relationship is harmful because it calls into question the treatment choices made by physicians and therefore injures the integrity of the physician-patient relationship.

–The law takes appropriately narrow steps to close an unintended loophole in the State’s regulatory system, thereby closing the back door through which data miners buy access to the private patient-physician relationship.

–When salespeople use the prescriptions a physician writes for his or her patients as a basis to “tailor” their pitches, they are actively seeking to exploit confidential treatment information to gain influence and press their advantage over the physician’s subsequent treatment decisions.

New England Journal of Medicine, Massachusetts Medical Society, National Physicians Alliance, and American Medical Students Association (pdf)

By using prescriber-identifiable data without consent of either patient or physician, these groups argue, drug companies and data miners essentially force the doctor and her patients to speak against their will. It detooths HIPAA and other laws that aim to protect private medical info from commercial exploitation, they say, and the Court should not apply advertising cases to what is essentially a medical privacy law. By matching detailed info about a patient’s conditions and treatment, the practice exploits patients and their medical history to publication and exploitation—exploitation the Vermont law seeks to prohibit.

They write:

This case isn’t fundamentally an issue of commercial speech; our view as medical publishers, physicians and medical students is that data miners have wrongfully converted private health information for commercial purposes without consent. Data miners should not have a First Amendment right to use or sell private health information.

The First Amendment does not protect data theft, and the drug companies buying this data without doctors’ consent would not suggest that the First Amendment protects the sale and use of their trade secrets without consent.

Furthermore, the amici write, Vermont’s action only empowers physicians to choose privacy—a choice all physicians should have.

“In a world where privacy is daily being eroded by technological advances,” they write, “Vermont may deem it prudent to slow the dissemination of certain data in order to avoid similar breaches. Federal law has specifically permitted just such a move.”

Other notable quotes:

–One key error in the Court of Appeals below was the failure to appreciate this difference between unauthorized access and subsequent publication. Publishers certainly have First Amendment rights, but not if the data was taken without consent, violating privacy, confidentiality, or intellectual property laws.

–Leave these complex matters of science and health policy in the hands of those best suited to make the decision – the prescribing physicians who are able to discuss these issues with their patients. Let the individual physician decide whether data mining is detrimental or helpful. The First Amendment does not require unconsented disclosure of prescriber-identifiable medical records.

–Kate Petersen, PostScript blogger

As part of our multi-blog review of friend-of-the-court briefs submitted to the U.S. Supreme Court in the prescription data-mining case IMS v. Sorrell, today we look at the amicus briefs filed by major consumer groups and policymakers in favor of Vermont’s law.

Brief of AARP and the National Legislative Association on Prescription Drug Prices (pdf)

AARP and the National Legislative Association on Prescription Drug Prices (NLARx) filed a brief noting how the Vermont law helps protect patient privacy, safeguards the doctor-patient relationship from undue industry influence and misleading marketing, and helps reduce unnecessary and inappropriate prescribing driven by marketing. They note that “the data-mining companies do not meaningfully de-identify the records at all” but only “encrypt the name of the patient . . . [using] an individual identifier to ‘track the patient over time.’”

A recent Wall Street Journal article revealed that TV advertising companies have started to use such so-called de-identified patient data concerning prescription drug purchases to profile discrete individuals for more effective TV advertising. These alarming threats to personal privacy should signal to the Court that protecting the privacy of personal health information is increasingly more important in the data-rich, computer-driven world today. And they offer a compelling argument — that even if data-mined information is commercial speech, this type of private health information, which is never publicly disclosed into the commercial marketplace, is a type of commercial speech that warrants a lower level of protection by the First Amendment.

“The Vermont law directly advances its interest in protecting against disclosure of records containing the most personal of information as well as its interest in protecting individual autonomy in decision making on important personal matters,” said Sean Flynn of American University’s Washington College of Law and counsel to AARP and NLARx in a statement. “Protecting the confidentiality of records advances important goals of our health system, including combating undue influence of in-person pharmaceutical marketing that raises costs and damages public health interests.”

Brief of Public Citizen, The Center for Science in the Public Interest, Consumer Action, Public Good, U.S. PIRG and New Hampshire PIRG (pdf)

These groups argue that if the Second Circuit’s ruling were to stand, it would jeopardize a slew of federal and state consumer-protection laws around privacy of information such as financial data, emails, and health and education records, and would unleash a landslide of litigation from companies who would profit from selling private consumer data the law now requires them to protect.

“The information being sold, highly detailed prescribing data, belongs to a doctor just as other private data such as bank and health records do,” they maintain.

“Such information is confidential under state law, and drug companies have no more right to access it than they have to access a doctor’s private bank records,” they write. They worry that the Second Circuit’s holding would give advertisers First Amendment cover “to surreptitiously track the websites that users visit and sell that data, complete with identifying information, for a profit.” They also point out that the Court has before acknowledged states’ need for “broad latitude” in experimenting with ways to protect their citizens’ privacy.

Notable quotes:

“Laws limiting certain uses of private information reflect the common-sense judgment of federal and state governments that consumers who supply their private information for a specific purpose—such as applying for a driver’s license or a credit card—do not expect that information to be sold to mass marketers.

“That problem is essentially the one that Vermont sought to address here—doctors writing private prescriptions for their patients do not expect that information to come back to them in the form of drug-company marketing efforts. Because [such data-mining laws] do not restrict what anyone can say or to whom they can say it, federal and state governments should be free to make such judgments with the same ‘broad latitude’ that the Court has given to other essentially economic regulations.”

–Kate Petersen, PostScript blogger

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

Having revealed that more than 250 physicians with serious sanctions against their medical licenses are on the speaking circuit of some of the nation’s top drug companies, ProPublica and a series of news outlets around the country have put the question to the companies: When it comes to speakers bureaus, who’s keeping the gate?

One company said that they had a previous plan for gatekeeping.  So what happened to it?

These are not nitpicky violations we’re talking about—a CME credit here or there, unpaid dues. One doctor listed in the ProPublica database, Kenneth Fisher, is paid by GlaxoSmithKline and two other companies despite having been on probation for nine years in the state of Arizona for a series of serious misconduct charges, including sexually violating HIV patients.

This is the sort of thing that makes landlords do background checks. And if landlords can do them, why not drug companies spending millions to have certain doctors talk about their finely-tuned brands?

“Let’s be honest, they do a lot of very complicated things very well,” Hastings Center bioethicist Josephine Johnston told ProPublica. “These are the people who have figured out how to get prescription data for individual doctors so they can send drug reps to target particular doctors in particular ways.”

Good point. Data-mining isn’t exactly a simple (or transparent) marketing strategy, but the industry has it down, spending millions each year to buy individual prescriber records and pairing them with prescribers’ names so that they can tell how much Lipitor Dr. Doe is writing, and how many more scrips she’s likely to write (more on data-mining here). But complicated things in service of marketing that works, and complicated things that might make effective marketing harder are two different matters (although one wonders if there aren’t easily 250+ blemish-free docs willing to step in to fill vacancies on the speaking circuit).

Perhaps the failure to do background checks—the casualness it conveys—underscores just how big these marketing budgets are. That the $7.1 million these seven companies gave the sanctioned docs in the last two years isn’t enough to inspire thorough background checks suggests the sums don’t make industry’s reputation radar. Pharma has been cutting sales rep jobs for awhile now, but let’s not mistake that for cutting marketing spending—doctor-to-doctor talks work, and they are still going strong: The ProPublica aggregator totaled up $282 million in speaking fees from seven companies between 2009 and 2010.  And there are more than 70 drug companies in marketing in the U.S., meaning there’s potentially a lot more money on the table that we will learn of when state disclosure laws and the federal Sunshine laws kick into effect.

None of the seven companies whose payment data was reported offered an official to speak with ProPublica (a sign as a reporter that you’re on to something). But among the general statements they did make, we couldn’t help our jaw from dropping a little as we read the range of reasons companies gave for not doing background checks on their speakers:

Pfizer and Glaxo noted that some of the physicians listed no longer speak for them.

Pfizer also noted that none of its doctors had been banned from participating in federal health programs.

Merck & Co. said it had “previously initiated” plans to conduct more frequent background checks and “is exploring additional capabilities.” The firm would not be more specific.

Johnson & Johnson, Glaxo and Cephalon each said that they are always looking for ways to enhance their selection of speakers.

In an e-mail, Glaxo spokesman Kevin Colgan added that disciplinary actions alone shouldn’t be the basis for excluding a potential speaker or consultant.”

Glaxo and Lilly each made payments to more than 100 of the 292 sanctioned docs ProPublica identified.

After reading about Dr. Fisher’s record, we’d be interested to see the criteria GSK does use to exclude a potential speaker or consultant.

–Kate Petersen, PostScript blogger

Earlier this month, the U.S. Court of Appeals in Boston (First Circuit) upheld Maine’s 2007 data-mining law, which bans the commercial use or sale of data showing what health practitioners prescribe to their patients. Over on Health Policy Hub, Ian Reynolds blogged about what the decision means in the context of earlier court cases:

The Maine law is nearly identical to laws in New Hampshire and Vermont that have also survived challenges by industry…

For those keeping score, we now have three variations of data mining laws in three states. We’ve got the total ban, the “opt-in” and the “opt-out.” Each of the states has also been given the go-ahead to implement its law, though we’re still waiting for the outcome of the final appeal on the Vermont statute.

The First Circuit ruling is another win for prescription privacy and public health advocates. But the ruling may be most significant because there isn’t really anything remarkable about it. It feels like we’ve been here before, heard many of the same arguments and had similar results. Even though these three laws differ slightly in how they go about it, they all have the same intent: to limit drug reps’ access to prescriber-identifiable data. The legal and public health arguments for limiting data mining are clear, and that’s been shown time and again. Last week’s ruling in Maine cited many of the same findings from Vermont and New Hampshire decisions: the statute is constitutional, does not infringe on free speech guarantees, stands to protect public health and will save public dollars.

Maybe this was strike three. Or maybe the final appeals court ruling on Vermont’s law will be strike three. Sooner or later it will come and advocates can focus on developing programs and systems that use prescription information to improve patient care, rather than simply defending against its use for marketing practices that drive up costs. With the passage of the new health law, we need smart strategies like these to make the health care system more sustainable while improving quality.

Read the full post here.

-Kate Petersen, PostScript blogger

New Jersey is responding to widely-shared concerns about physician-industry financial relationships with a mix of both tested and newer reforms, and its move toward greater transparency is consistent with national trends.

In a report this week, the state’s Division of Consumer Affairs calls on state agencies to ban pharma meals to physicians, require physicians to disclose industry payments totaling more than $200, and restrict the use of commercial data-mining of prescriber data, one of the main tools in the pharma industry’s marketing arsenal.

New Jersey’s Board of Medical Examiners has been exploring these issues seriously and comprehensively for some time, holding public hearings on pharma issues like gifting, conflict of interest policies at academic medical centers, and industry-backed continuing medical education. (The Prescription Project testified before the Board on industry marketing in Nov. 2007.)

In general, we favor measures that put the compliance requirements on the industry, rather than on physicians. Because New Jersey puts the onus on doctors, it is possible that its approach will do more than existing laws in other states to discourage certain problematic relationships. However, it may also be more difficult to ensure compliance. In the main, though, New Jersey is to be congratulated for these innovative efforts to curb inappropriate influence on prescribers.

We’re going group!

After two years, PostScript is graduating to a group blog. There’s more about Rx policy than we can say ourselves, so from time to time—starting next week—we’ll open this space to other voices on pharmaceutical issues.

Stay tuned…

–Kate Petersen, PostScript blogger

Today the First Circuit Court of Appeals unanimously upheld New Hampshire’s Prescription Confidentiality Act, which prohibits the commercial use of prescriber data, including for pharmaceutical detailing.

The practice, commonly known as “data-mining,” is a key tactic used by prescription drug companies to tailor their marketing campaigns to individual doctors. The New Hampshire first-in-nation law was struck down by a district court in April 2007 on the grounds that the use of that data by health information companies, pharmacies, and drug companies constitutes commercial speech. The state appealed, and IMS Health v. Ayotte was heard by the First Circuit Court of Appeals in Boston in January of this year.

In its 148-page decision upholding the law, the Court said “the portions of the law at issue here regulate conduct, not speech” and even if they qualified as protected speech (the Court held they did not), New Hampshire’s restrictions on the use of prescription data would pass “constitutional muster” in regulating that speech.

“This is an important decision for data privacy advocates,” said Sean Fiil-Flynn, Counsel for the public interest amici in the case, and with whom the Prescription Project filed a friend of the court brief. “The ramifications of giving companies a First Amendment right to sell data on all of our purchases, travel and activities would be staggering.

“The First Circuit ruled on the side of consumer privacy, admonishing that the First Amendment does not protect every exchange of information from traditional social and economic regulation. It refused to apply the First Amendment to the trading of prescription records for marketing purposes where ‘information itself has become a commodity.’ The court explained that applying the First Amendment to such trade in prescription data ‘stretches the fabric of the First Amendment beyond any rational measure.’”

Flynn is the Associate Director of the Program on Information Justice and Intellectual Property at the Washington College of Law, American University.

The Court wrote: “We believe that in moving to combat the novel problems presented by detailing in the information age, New Hampshire has adopted a form of conduct-focused economic regulation that does not come within the First Amendment’s scope.”

To read the decision for yourself, go here.

This week, House Energy and Commerce Committee Chair John Dingell (D-Mich) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) sent a letter to the FDA asking about just how and why the agency chose non-profit EthicAd to partner on the creation of the “Be Smart About Prescription Drugs” website, launched last month to help consumers navigate drug ads.

In September, we had some questions of our own about EthicAd’s mysterious funding sources and close ties to Shaw Science Partners, a pharmaceutical marketing company with a long list of Big Pharma clients.  We broke news of Shaw Science Partners and EthicAd’s office- and phone-sharing arrangement here on Postscript, and look forward to hearing of the agency’s reply. 

And the latest joint probe of the Senate Finance Committee and the Special Committee on Aging, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments received by Columbia University cardiologist and stent entrepreneur Martin Leon and other Columbia researchers at the Cardiovascular Research Foundation.  The probe seems to center around the CRF’s industry–sponsored device conference, Transcatheter Cardiovascular Therapeutics, and Leon’s ties to the sponsoring companies.

Here’s more at Bloomberg.

But it’s only the latest investigation, and if history’s any guide, won’t be the last. With the troubling discovery of piles of undisclosed industry payments an Emory University psychiatrist took from a company whose drug he was testing on the government’s dime, and new revelations about the wag-the-dog marketing tactics used to push Neurontin, editors of the New York Times and Atlanta Journal-Constitution write this week that all this coziness between drug companies and doctors “underscores the need for Congress to pass a bipartisan bill, sponsored by Senators Chuck Grassley and Herb Kohl, that would require drug companies and other medical manufacturers to publicly disclose payments to physicians that exceed $500 a year.” (10/11, New York Times).

The Journal-Constitution went further in its recommendation, saying passage of the disclosure bill – also known as the Physician Payments Sunshine Act – is a “bare minimum,” and that the “culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing,” including a “temporary reduction in the amount of money going into research and continuing physician education.”(10/12, Atlanta Journal-Constitution)

And another editorial in the Arizona Republic this week takes a puzzling non-stand on the PPSA: First they were against, then they were for it? In the end, we’re not really sure. Just like the writers don’t seem very sure whether or not doctors are influenced by pharmaceutical marketing. The verdict?  “Probably not.” Sure, we’d heard the West is a place of fewer words, but this is taking it too far.

The first two editorials were no doubt spurred by the controversy around Dr. Nemeroff’s busy speaking schedule. News came this week that he’s about to get a little less busy – the National Institutes of Health have hit pause on the 5-year, $9.3 depression grant that Nemeroff was heading up at Emory. The AJC says despite his freed up schedule, Nemeroff is still turning down interviews.

And over at A Healthy Blog, RxP’s Kathy Melley looks ahead at what we’ve all been waiting for. Our 401Ks back? Ok, the other thing we’ve been waiting for – the decision from the U.S. Court of Appeals on prescription data-mining bellwether case, Ayotte v. IMS Health.

“The court ruling could have the effect of ratcheting up or down state legislative activity on data mining,” Melley writes, but that “regardless of where the court comes down, there’s a good chance the U.S. Supreme Court may be the final arbiter on this issue.”

Medical students and local physicians will rally at the Harvard Medical School campus today, urging their adminstrators to create better conflict-of-interest policies around pharmaceutical marketing.  According to a press release from the American Medical Student Association, which is capping its National PharmFree Week at the Longwood medical campus in Boston, “Students are asking for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.”

Check out the AMSA scorecard rating medical school COI policies here.

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.