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

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.

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.

A bill that would allow pharmacies to distribute customers’ information and provide reminder mail about their prescriptions has made it through the California Senate and is waiting for review by the Assembly.  Senate bill 1096, the Confidential of Medical Information Act (CMIA), would allow pharmacies and third-party health information groups to contact patients by mail to remind them to fill prescriptions, a move advocates of patient and prescriber confidentiality worry would open the door for pharmaceutical companies to market in even more direct and personal ways than they do now.

PostScript talked about the bill’s potential reach with New Hampshire Rep. Cindy Rosenwald.  Rosenwald, who chairs the Health, Human Services and Elderly Affairs committee, is the sponsor of New Hampshire’s embattled Prescription Data Privacy Act, which is currently under appeal in the U.S. 1st Circuit Court of Appeals. 

P.S: What would the passage of CA S.B. 1096 mean for patients?

C.R: I think everybody has something to gain, except the patient. The pharmacies have something to gain, by selling the patient’s info.  Second, they have something to gain if that patient fills the Rx. I believe the pharmaceutical industry [has something to gain], because now they know the end end user of their products.

But many people feel that’s another form of marketing.  Because it’s in the pharmacy’s interest to have that patient fill that Rx again. There are many reasons someone might not refill their prescription, not the least of which they can’t afford them.  You may have filled a prescription for one medication, but it didn’t work or you didn’t tolerate it. But if you get a letter from the pharmacy, it’s not hard to see a patient getting confused and filling the wrong prescription, or both.

P.S: Your recent presentation at the National Legislative Association to Reduce Drug Prices (NLARX) in Charleston, West Virginia outlined ways the pharmaceutical industry is getting around HIPAA – is this a case of the pharmaceutical or pharmacy industry getting around a stronger state law?

C.R: HIPAA’s definition of marketing is too narrow. If the communication is related to the individual’s treatment, HIPAA says it’s not marketing.  To me, that’s marketing.

States are not allowed to loosen HIPAA. What the California bill would allow, if passed, is to break through that law, because pharma may be able to sign a business associate agreement with pharmacies.

The business associate is obligated to follow the same laws as the HIPAA–covered entity, but the covered entity is only liable if they knew or had reason to know of violations. There is a huge, huge gaping loophole.

I did hear an example of that happening in New Hampshire. A woman was taking an expensive hypertensive. She stopped filling her prescription because her doctor had given her free samples, and three weeks later she got three letters. One was from her insurer, one was from her pharmacy, and the third letter was from the drug company – which really upset her.

Why is it a drug company’s responsibility to have a patient adhering to a particular medication? It’s the responsibility of the doctor, the patient, and maybe the insurance company.  I don’t even think it’s the pharmacy’s responsibility.

So I don’t see this as a healthcare issue, I see it as a marketing issue.

P.S: Are there characteristics of its passage that suggest this is unique to California and might not happen the same way in say, New Hampshire?

C.R: It looks like the California Senate wanted to allow this.  I’m not sure our data mining ban [New Hampshire’s Prescription Data Privacy Act] would prevent that kind of activity here, if they came to us.  But New Hampshire is fiercely protective of individual privacy. 

I know that [the CMIA] failed narrowly in the California Senate the first time.  And then they brought it back, with an opt out, and then it passed. Between 1 and 3 percent of consumers will opt out.  And then, I believe there’s absolutely no control over what they will do with the information.

P.S: What does this mean for the data-mining legislation, both in California and more widely?

C.R: I know California looked at a data-mining ban, but most of those bans focused only on prescriber identity. The part of the [New Hampshire] law that’s in litigation is only related to prescribers.  So the patient protections are still in force in New Hampshire.

I think if the bill becomes law, that’s not good for patients.  There’s no reason to believe the pharmaceutical companies have the patients best interest at heart.

This week, drug giant Merck is out $671 million in combined settlements in one whopper of a health care fraud case.  Prosecutors for the states and federal government alleged that the maker of Vioxx and Zocor overcharged 49 states and the District of Columbia for four popular drugs, and bribed doctors to prescribe them with kickbacks disguised as consulting fees.

Read AP coverage here.

Row Row Row…Whose boat?

We admit, in the shadow of bribery, fake-rowing seems like a little white lie, but it’s one that may have turned into big bucks for Pfizer, the maker of Lipitor.   A month ago, Dr. Robert Jarvik, the Lipitor frontman that gives millions of primetime viewers the heebie-jeebies during commercial breaks every night, was outed for never having actually practiced medicine.

Now, courtesy of some digging by two Michigan House Democrats, it turns out Jarvik doesn’t row, either, as he’s seen doing in a recent Lipitor commercial (even though his stunt double’s on the team.)

Congress must decide whether the American public was more fooled by Jarvik’s doctorness or his rowing prowess, and why back in 1997 permitting pharma to run TV ads seemed like such a good idea.

Check out the PAL blog’s ideas for Jarvik’s replacement.

Industry-free CME at Sloan-Kettering: a case study

The Carlat Psychiatry Blog found this article in Medical Meetings Magazine on how Sloan-Kettering Memorial Cancer Center in New York cut industry out of its CME curriculum.

Some seemingly simple steps were taken to make up for the 25 percent of industry funding the center turned back:  Conference organizers used more cancer experts already in-house, moved the meetings from hotels to the conference center on campus, cut out catered lunch, and reduced advertising in mailers and medical journals. According to officials at the world-renowned cancer hospital, response has been positive and attendance steady. 

Vanderbilt gets on gift-ban bandwagon

Vanderbilt University Medical Center has banned gifts from pharmaceutical and devicemakers, an announcement that comes in the wake of news that the vice chancellor of health affairs was appointed to the board of Merck.

According to the Fairview Observer, the policy does not affect researchers, only clinicians, and there is no provision for oversight or penalties.

[Yeah, but who wants to anger Commodore Cornelius?]

Between the lines

Gooznews had his reading glasses on for this one:  a sentence in a New York Times story about spine device researchers who invest in the technologies they test.  Count me in, says Goozner, among the “few [who] would argue that doctors should never be allowed to invest in new technologies.”

“Why draw the line at research?” Goozner writes. “Is it okay that the doctor prescribing a particular drug has a huge hunk of his or her retirement portfolio in the stock of the company that makes that drug?”

What Would Nightingale Do?

Without much formal conflict-of-interest training or guidelines, nurses are prime targets and perhaps the next frontier for pharmaceutical detailing, according to this new article in PLoS Medicine.

Portrait Gallery

A nice profile on RxP ally, AMSA PharmFree coordinator, and Tar Heel of the Week Anthony Fleg appeared this week in the Chapel Hill News and Observer.

And the New Jersey Business Journal interviews state Attorney General Anne Milgram.  There are ten questions, but they all fall under the general category : “Why you gotta be so mean to pharma?”

State Round-up

This Charleston Gazette piece looks at the debate around a law recently passed in the West Virginia legislature that would require pharmaceutical companies to disclose all gifts to physicians to a state-wide board.

Pharmalot reports that New York State Senator Tom Morahan has asked the state health commissioner to look into a report that NY Medicaid spent $82.8 million on psych drugs for kids in 2006, many of which were off-label.

The Vermont legislature still stands behind the prescription data confidentiality law it passed last spring, according to a vote on a motion to repeal the embattled law at the state house this week.

Vermont was sued by health information companies who sell the data and awaits a trial in May.  A similar 2006

New Hampshire law was overturned by a district court judge and awaits decision by the  U.S. Court of Appeals.

From the Oops department… Covetous reporters, critics of pharma and all those ever bested by office culture had a good laugh this week after the leak of top secret documents related to Eli Lilly’s high-stakes Zyprexa negotiations to a lucky New York Times reporter was linked back to an error by a Lilly lawyer who used the auto-fill in his email headings one too many times. The docs were supposed to go to Bradford Berenson, Esq., but the unintended recipient was none other than Times pharmaceutical reporter Alex Berenson. Pharmalot has more here.

From the Let the Good Times Roll department…

Comes a good post from the New Orleans-based National Physicians Alliance doc, alias KidShrink, who made a point of speaking up and saying ‘not cool’ to a pharmaceutical Rep-Elf stuffing physician mailboxes with branded trinkets. Queen of England and King cake, all in one post.

Yesterday, PostScript visited the John Joseph Moakley courthouse in Boston.  After getting a wee bit lost, we made it safely into the U.S. Court of Appeals, which heard the appeal of a decision by the First District Court in New Hampshire last April overturning that states’ ban on the sale of prescriber data for marketing purposes.

PostScript has not minced words about the practice of data–mining (for proof, look here). As a matter of tradition, we didn’t mince much here, either. 

In the case IMS inc. v Kelly Ayotte, Judges Lipez, Selya and Siler heard arguments in support of the overturned law from state counsel Laura Lombardi Esq., and Sean Flynn Esq., legal consultant for the Prescription Project, which filed an amicus brief alongside the New Hampshire Medical Society, NLARX, NPA, AARP, PPC.  (See end for acronyms – it’s like a crossword.)

Counsel for the defendants, three data-mining companies that buy the information from the pharmacies and sell it to the drug companies, argued that the overturned prescriber data confidentiality law amounts to content discrimination, privileging payors who want to reduce drug costs with data while restricting sellers (pharma companies) from the same data sets.

IMS counsel argued also that the state had brought no evidence that the sale of prescriber data had led to sub-optimal prescribing. This is a sticking point. After all, you can show that NH doctors have been prescribing lots of brand name drugs, and you can show they prescribed ones that had sub-optimal effects – Vioxx, say.  But it’s hard to compare that to what doctors would have prescribed if detailers had not been snooping around in their prescribing data.  Would reps have used other tactics?  Would those have sold less or more brand-name drugs? No one knows.

Since the influence of gifting and relation-building on prescribing behavior is well-documented, the state thinks – and we agree — that docs would generally prescribe less brand name and more proven older drugs if detailers weren’t hanging around so much.  But without another state to look to (New Hampshire was the first one to pass a data mining ban like this), the evidence is inferential, even common-sensical – but not documented yet.

The IMS counsel also warned the court that without accessing to individual prescribing records, pharmaceutical companies would have to increase their marketing force. But with the R& D pipeline tapped, generic prescriptions on the rise, and frequent news of pharma layoffs and an ongoing round of executive musical chairs, how much bigger can the sales force reasonably get before they run out of things to sell?

Attorney Flynn made rebuttal for the state, noting that if the district court’s decision is allowed to stand, a healthy handful of really good laws prohibiting the release or use of consumer data would be threatened, including the Driver Privacy Protection Act, Video Privacy Protection Act, Stored Communications Act, Electronic Communications Privacy Act, and Fair Credit Reporting Act.

Judge Lipez asked why, if the New Hampshire law affects the conversation in the doctor’s office between a detailer and doctor, the plaintiffs contend the case is not about commercial speech.  “They’d know a lot less about that doctor than they did before,” Lipez said. To PostScript and a lot of docs out there, that doesn’t sound half-bad.

Flynn emphasized that the law does not impinge speech but rather access – access to information created by the doctor and the patient.  If there were any grounds for a speech restriction argument in this case, Flynn added, it would be that the sale of this prescriber data to salesmen and -women impairs doctors’ right not to speak. 

“It’s the doctors and patients who are speaking,” Flynn said.

For more information, see the Prescription Project fact sheet on data-mining, Flynn’s legal memo on the New Hampshire decision, and www.reducedrugprices.org.

acronyms: NLARX = National Legislative Association to Reduce Drug Prices; NPA = National Physicians Alliance; AARP = American Association of Retired Persons; PPC = Prescription Policy Choices

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.

Prescription drug problems have hit the presidential radar screen. With an announcement of a plan to rein in the pharmaceutical industry this weekend at a campaign stop in Laconia, NH, John Edwards became the first major 2008 presidential candidate to take on the drug companies.  Here’s coverage in the Associated Press and Concord Monitor. Check out the full Edwards platform here on the campaign website.  Though much of it’s pulled from measures stripped from the FDA reauthorization bill passed earlier this year, Edwards’ proposal, which includes provision for a comparative effectiveness drug-testing center, full disclosure of safety and comparative effectiveness information on drug labeling and ads, empowering the FDA to go after drug companies that run misleading ads, and a two year moratorium on consumer ads for new drugs, is smart, and represents a leap forward in the candidates’ health care conversation.

On one hand, the fact that pharmaceutical marketing and industry reform is showing up in the presidential platforms only now is curious.  After all, talk of health care reform is as ubiquitous on the presidential campaign trail as American flag lapel pins, and the cost of prescription drugs is an issue that has emotional resonance with a pharmacy nation like ours.  Conventional (or perhaps campaign) wisdom has led candidates to focus on coverage, access and Medicare—how to cover more people without charging anyone else—these are the big ticket items. Catch is, conflicts of interest and undue marketing influence on prescribers have the power to affect the cost of those items, and recent reports indicate that they have.

On the other hand, it’s no surprise: health care groups, pharma included, have been some of the most aggressive lobbyists and generous contributors to presidential contenders, according to the Wall Street Journal Health blog, which has done a good job of keeping track.  And today the New York Times reported that health care groups have given $6.5 million to Democratic candidates and $4.8 million to Republicans so far. 

Pfizer has been the pharmaceutical company with the deepest pockets, giving the most to Hillary Clinton ($12,150), followed by Rudy Guiliani ($8,600).  Predictably, Edwards has received the least health care sector contributions to date (the Health blog points to his career as a plaintiff’s lawyer as explanation.)

So far, the headlines have focused on Edward’s DTCA moratorium, and the Monitor piece makes clear why: On the stump, it’s easier to lampoon the endless Flomax ads during the World Series or summon, as Edwards did, goofy images of allergen-free skipping fields. That’s fine—a two-year hold on ads for new drugs certainly won’t hurt matters, and may even decelerate the dubious consumer-marketing machine pharma’s driving.

But voters and the media should remember that DTCA is just a portion of a bigger problem—companies spend nearly twice as much in direct-to-physician marketing each year.  A candidate committed to these issues should address the rough reality that drug ads are just the tip of a really big iceberg: the potential for conflict of interest spills into academic medical centers, university research, continuing medical education, and physician marketing.  We must address those areas, too, if we are to truly tackle our nation’s prescription problem.