Yesterday, the Massachusetts Attorney-General’s office announced a $24 million dollar settlement resulting from an investigation of pricing fraud in state programs by fourteen different drug makers. This settlement follows a ground-breaking national settlement of a lawsuit filed by the Prescription Access Litigation project at Community Catalyst in 2001, with Health Care For All, Mass Senior Action, MassPIRG and eleven other consumer groups nationwide representing the interests of consumers.

Drug industry pricing fraud became widespread in the mid-1990s, when high but fictitious list prices were used as an incentive to sell products. Doctors or pharmacies made more money using a drug whose actual cost was far less than the amount they were paid by Medicare and Medicaid. This fraud led to our class action lawsuit and a ground-breaking 2007 trial on behalf of Massachusetts consumers and private sector insurers. It was found that AstraZeneca, Bristol-Myers Squibb and Warrick (a subsidiary of Schering-Plough, which was bought by Merck in 2009) had violated consumer protection laws through their deceptive pricing tactics. This victory ultimately convinced 28 different drugmakers to pay over $360 million to settle claims with the private sector health plans and consumers. (See more here.)

And now, on behalf of public programs here in Massachusetts, the Attorney-General has recovered funds from a number of these companies for the same kind of unfair and deceptive pricing. For example, manufacturer Warrick sold an albuterol drug from 1995 to 2003, all the while reporting a list price that was nearly seven-times the actual sales price. The State’s trial in 2010 found that Warrick had cost Massachusetts $4,563,328, and had made 28 false statements in violation of the state’s False Claims Act. After treble damages, 12 percent interest, and legal fees, a $24 million settlement looked like a good deal to Warwick’s new owner, Merck.

How can Massachusetts better protect its public programs from deceptive pricing in the future?

Currently, Massachusetts uses industry-published list prices as a basis to reimburse pharmacies. One option is to adopt the Average Acquisition Cost (AAC) method of paying pharmacies for the drugs MassHealth purchases for its members. The AAC method does not use easily manipulated manufacturer “list” prices (at issue in the court case). Instead, pharmacies are paid based on their actual cost of acquiring the drug from the manufacturer, plus a dispensing fee, thereby reducing overpayment and saving money for MassHealth. This evidence-based pricing method has been adopted by Alabama and Oregon, and it has been recommended by Medicaid headquarters in Washington D.C. And like Alabama and Oregon, Massachusetts could make these regularly-audited drug prices available to the public, so that private insurance plans could also adopt this method and save money, hopefully reducing premium costs. Community Catalyst describes more about AAC in its new Medicaid Report Card.

– Wells Wilkinson, Director, Prescription Access Litigaton, and
Marcia Hams, Director of Prescription Access and Quality, Community Catalyst

Last week, Maine’s governor signed LD719 into law, repealing a series of pharma transparency laws including one that required drug companies to report certain marketing costs, including meals and gifts to physicians. I talked with Maine representative and director of the National Legislative Association on Prescription Drug Prices Sharon Treat (D-Hallowell) to find out what this repeal means for her state, the wider transparency landscape, and what we might expect next.

PS: There’s been a lot of action on the state front again at the end of this budget season. Massachusetts protected its gifts ban from some aggressive repeal threats, and now Maine has repealed its disclosure law. Maine’s move doesn’t seem to reflect a bigger consensus. What do you see happening at the state level?

ST: The new Republican governor and majority in the Maine Legislature have together now repealed not only the state’s gift disclosure law, but nearly every progressive prescription drug policy we have, including our pharmacy benefit manager (PBM) law, and pricing transparency.  This is not surprising as there are very close ties between the pharmaceutical industry and the Republican party in Maine. None of these laws were easy to pass in the legislature even when Democrats had the majority, because the drug industry is very powerful when it comes to influencing politicians.

I don’t think the repeals reflect a change in what the public thinks.  In fact, I doubt if most Maine people have any idea what’s been repealed.  This session a lot of attention was focused on proposed repeals of many of our environmental laws, and in that case the public uproar stopped the rollbacks from going forward.  In the case of the pharmaceutical laws, there aren’t strong consumer advocacy groups in the state that have taken up these issues, partly because so many other social policies are on the chopping block at the same time.

PS: There’s a lot of talk about state Medicaid budgets these days. Why is disclosure an important piece of the cost equation, to your mind?

ST: Maine’s gift and advertising disclosure law was enacted originally because legislators wanted to know how much was being spent by the pharmaceutical companies on promotional activities, since the industry claimed that drug prices had to be high in order to support their R & D activities.

The information gathered showed that advertising and promotion outspent R & D.  It helped make the public case for reducing high drug prices.  Then, as the data was collected, more public attention was paid to conflicts of interest and the role of gifts and payments in driving prescribing of the highest priced branded drugs.  It helped open peoples’ eyes to larger issues of safety and appropriateness of prescribing.

Maine also had a law, also just repealed,  that directly collects drug price data from the pharmaceutical companies and requires a person with authority to certify the truth of this data. This independently collected information was a direct help to the state in negotiating very favorable rebates and limiting pricing fraud under the Medicaid “best price” requirement (nationally major drug pricing fraud cases are common).  Maine gets a return on average of about 50 percent of its Medicaid drug spend back in rebates, and having this check on drug company pricing reports has helped avoid fraud and keep our Medicaid prescription drug budget in line, with minimal increases over the years.

PS: Your colleague, physician Linda Sanborn, also supported the Maine transparency law, and state physician groups have supported similar bills and laws elsewhere. Have you heard from Maine physicians on the repeal, and next steps?

ST: Dr. Sanborn spoke eloquently in the floor debate about the need to have public disclosure of the clinical trials data- another law that was repealed.

Fortunately, federal laws will eventually pick up the slack on both the clinical trials database and reporting on gifts and payments, but the Legislature’s majority did not support even linking our state website to the federal databases.  All of the Democrats on the Health and Human Resources Committee strongly supported these laws and spoke to the issues.

The physician groups were most active trying to prevent the repeal of the academic detailing program, which they are now very involved with implementing.  Although the funding was reduced, this program did stay alive in part because of their advocacy.

In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor.  If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.

I was actually shocked that so many legislators who ran for office on platforms of preventing fraud and abuse passed two laws that repealed effective anti-fraud laws– the PBM law repeal and the pricing disclosure law. These repeals will hike the costs of the Medicaid program (as confirmed by the Legislature’s fiscal office in the fiscal note on the legislation).

PS: Transparency of industry marketing relationships with prescribers isn’t going away. Taking the long view, what can we expect next?

ST: I think we will see a more active media in Maine looking into the federal doctor payment databases and the financial links between big pharma and Maine politicians.  I expect that there will be more awareness going forward about these conflicts of interest.  My hope is that this awareness will once again lead to taking action with public support and a more receptive legislature and governor.

–Interviewed by Kate Petersen, PostScript blogger

This week, I talked by email with physician and researcher Dr. Joseph Ross about the importance of using unique identifiers in pharma disclosure data, and other ways to take the guess work out of the Physician Payments Sunshine database.

PS: Last week, a commentary in JAMA (Carpenter/Joffe) suggested that unique investigator identifiers should be used in the Physician Payments Sunshine database to make the data most usable, accurate, and suitable for cross-reference with other databases.

You’ve spent a lot of time with data collected under similar disclosure laws in Minnesota and Vermont. From your point of view as a researcher, what aspects of an identifier are important or helpful to looking at these data?

JR: From our experience examining the data in Minnesota and Vermont, I can only say that some unique identifier is necessary. Neither the Minnesota or Vermont data that we used included a unique identifier, just the name of a physician, clinician, or hospital/clinic that accepted the payment from the pharmaceutical company.

We found that trying to determine exactly who accepted which payment was virtually impossible, because one could not be sure whether a “Dan Smith” in Minneapolis was the same or a different “Dan Smith” in St. Paul, for example. Without a unique identifier, doing research to examine which physicians or clinicians are accepting payments can only be done in the aggregate, not at the individual level.

However, what is most interesting about Carpenter and Joffe’s proposal is not the unique identifier in itself, but the development of an identifier that could be used across databases, linking payment disclosure data, to grant applicants, to manuscript submissions and publications, to service on NIH or FDA committees. I could imagine this identifier being an expanded use of the NPI (national provider identifier), or another number, but it would certainly make identifying potential conflicts of interest far simpler.

PS: One of the reasons these authors suggest a unique identifier is to capture payments made to non-physician investigators. Did you deal with this issue in your work with the Minnesota and Vermont data?

JR: Yes, examining the data in Minnesota and Vermont, there were a substantial number of payments made to non-physicians, although these clinicians were not necessarily investigators. I agree that if the PPSA is broadened to include payments made to non-physicians, an alternative identifier to the NPI might be necessary. NPIs are required by all health care providers, including non-physicians who bill insurance companies or write prescriptions. But some non-physicians who receive payments from industry may not fall into this category.

However, to me, the real issue is a shortcoming of the PPSA, which requires companies to include physicians’ NPIs in their annual submissions, but prevents these numbers from being made publicly available.

PS: Why is that a problem?

JR: This is a problem because, as it stands, the payment disclosure data cannot be confidently attributed to an individual without using the NPI as a unique identifier. Our prior experience suggests that individual physicians will appear in the disclosure data multiple times, potentially with different spellings of their names, different practice addresses and so forth. It becomes a bit of guess work to determine if a payment to Daniel Smith from Lilly in September should be combined with the payment to Dan Smith from Lilly in April.

PS: In your 2007 JAMA article, you wrote about difficulty you had obtaining the Vermont/Minnesota data, and the poor quality of the information once you received it. Out of this experience, what should some of the priorities be in developing Sunshine systems and payment categories to produce a meaningful public disclosure scheme?

JR: Well, we’re still more than two years away from seeing how the PPSA plays out in practice. The legislation was fairly specific in terms of what information is to be collected.

Of all the categories pre-specified, the “nature” of the payment is most subject to interpretation.

My hope is that they interpret it as specifically as possible, so that, for instance, its disclosed when a payment is for a) speaking at a ACCME accredited educational event, b) speaking at a non-ACCME accredited educational event, c) attending a ACCME accredited educational event, or d) attending a non-ACCME accredited educational event. If the “nature” of a payment is disclosed vaguely, all four of those activities could be listed under the umbrella of “education.”

Otherwise, I agree with the Carpenter/Joffe commentary: Something needs to be done to ensure that a unique identifier is required for disclosure by companies and made available to the public. Without this, these payments may be misattributed, particularly within larger markets, limiting the effectiveness of this law within those communities.

Joseph S. Ross, MD, MHS, is an Assistant Professor in the Section of General Internal Medicine at the Yale University School of Medicine in New Haven, CT. He holds a medical degree from the Albert Einstein College of Medicine, Bronx, NY, and completed his post-graduate training in primary care internal medicine at Montefiore Medical Center in Bronx. As a fellow in the Robert Wood Johnson Clinical Scholars program at Yale University, Dr. Ross earned a Master’s degree in health sciences research. Using health services research methods, Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations, evaluating the impact of state and federal policies on the delivery of appropriate and higher quality care, and issues related to conflicts of interest, medical professionalism, and drug safety.

Interviewed by Kate Petersen, PostScript blogger

This Pharma With a Chance of Meatballs site is making the rounds, and it’s a great illustration of the issues on the Massachusetts gift ban we touched on yesterday.

(The site’s author clearly has a knack for story-booking policy issues. We can’t help wondering what an animated version of academic detailing or the Physician Payments Sunshine Act would look like…)

–Kate Petersen, PostScript blogger

When it comes to pharma meals, MA medical centers have already spoken

In its aggressive push to repeal the state’s gifts and meal ban, the Massachusetts restaurant industry (and pharma, the presumptive cooks in the kitchen behind this lobbying blitz) are hoping legislators will think the issue of doctors and drug companies is still, well, on the table. Since Bay State restaurant numbers don’t seem to have suffered from the law, these groups are betting that lawmakers will be willing to open the old and fundamental question: Should prescribers who are responsible for their patients’ best interests be letting pharma pay their way for meals, liquor and other perks?

But the question’s closed: Academic medical centers in Massachusetts have spoken loudly, and they’ve said that physicians and drug companies should work together at the lab bench, not the dinner table (or the bar). They’ve done this by developing and strengthening policies around industry marketing over the last four years, many of which set the bar nationally for rethinking conflicts of interest in the clinical setting, while protecting innovation.

UMass, Boston Medical Center, Tufts and Harvard Medical School have all demonstrated national leadership and done big work in setting ground rules to keep pharma’s marketing dollars out of doctors’ training, practice, and professional development. The American Medical Student Association scorecard, which evaluated conflict policies at all U.S. medical schools, recognized this leadership with top grades.   Specifically, all of these institutions received perfect “3s” on gifts and meals, meaning that “all gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”

So, if Massachusetts’ flagship medical centers have done this, why all this hubbub over at the State House?

In 2008, lawmakers heard the message from these clinical centers about keeping medicine separate from marketing, and they realized that what’s good for patients and providers at UMass or Harvard is good for patients and providers outside the academic medical centers—on the Cape, or in Waltham, or Deerfield. Tchotchke-free waiting rooms and unbiased clinical care should be the norm everywhere in the state, and that could only be addressed by a state law. And so they passed a law limiting the kinds of gifts and meals drug and device companies could give docs—including the ‘educational’ wine-and-dines at some of the state’s priciest restaurants.

This wasn’t radical: This was the next step on ground cleared by AMCs and the industry itself (whose own code of conduct Massachusetts used as a template for its law).

The drive to preserve this law will be decided in the next few weeks.  The House voted to repeal the gift ban, but the Senate Ways and Means budget, released yesterday, does not include mention of repeal. Senate President Therese Murray championed passage originally as part of the effort to eliminate unnecessary health care spending, including that driven by drug company marketing.  And as for that claim that these meals are necessary educational opportunities for docs: What caliber of education do we really believe happens in the function rooms of Boston’s finest restaurants over a $40 cut of Kobe sirloin and a few bottles of a nice reserve cab?  (Dr. Carlat talks menus here.) Remember, the law doesn’t prevent companies from catering a legitimate program in the hospital, but that wouldn’t include liquor and elaborate meals.

So as the debate heats up again, let’s remember that we’ve already had this one—and physician leaders have said clearly that gifts, food and booze don’t have a place in the medicine being practiced our prestigious academic institutions.  We hope these leaders will take the opportunity to remind the public in the coming weeks why they took a stand for reforming the relationships between the industry and physicians, and why their new institutional policies and the Massachusetts gifts and disclosure law are important to upholding the state’s reputation for clinical excellence and medical education.

–Kate Petersen, PostScript blogger

As you may have read by now, the Massachusetts House has voted to repeal a chunk of its first-in-nation gift and meal ban, spurred on by cries from the state restaurant lobby. The law, which bans drug companies from treating Bay State physicians to some gifts and restaurant meals, aims to check the potential for conflict of interest inherent whenever pharma picks up the tab.

No matter that state numbers show restaurant revenues are up nearly 10 percent over last year (see here), or that drug companies are moving their operations into town (see here and here and here). Or that despite the ban, new state payment data suggests drug companies didn’t seem to lose face time with Massachusetts docs – companies paid individual docs $16.4 million in the last half of 2009 alone.

“The only thing that’s being hurt is the ability of the drug industry to market their high-priced drugs by wining and dining doctors at our expense,’’ Health Care for All’s Brian Rosman told the Boston Globe.

But a concerted push by the Massachusetts restaurant industry seems to have swayed House lawmakers, who, by a wide margin, voted last week to repeal the part of the law that prevents drug, device and biotech companies from footing physicians’ bill at restaurants. (Companies are still permitted to bring docs lunch in their offices for “educational” presentations.)

An editorial in the Globe yesterday says the legislature shouldn’t chip away at the law. It’s not just that such meals are medically unnecessary. “But there’s also an unsavory conflict of interest in doctors being feted by drug companies and then turning around and prescribing the companies’ drugs to their patients. Are the prescriptions really necessary? Are the drugs really the most effective treatment?”

Many doctors insist their professional judgment cannot be bought with fancy meals. But if wining and dining didn’t work, the drug industry wouldn’t spend $6 billion a year on direct marketing to physicians. The Legislature should send the repeal amendment and similar attempts to weaken the gift ban back to the kitchen.

In characteristic color, Newburyport psychiatrist and blogger Daniel Carlat agrees.

Yes, commoners escape workplace demands by going home at 5 or by taking a stroll through a park during lunch. But doctors need raw oysters and wine after a hard day of work—plenty of it, free, and with fawning pharmaceutical reps complimenting them on their knowledge of vintages.

Hopefully the State Senate will realize that Massachusetts doctors have stronger ethical compasses than Massachusetts politicians, who since 2009 have been barred from receiving anything of value from lobbyists. Lawmakers are, indeed, vulnerable to inappropriate influence from meals and other gifts. But physicians would never prescribe more Abilify after enjoying a steak dinner funded by Bristol-Myers Squibb. After all, they’re doctors!

The Massachusetts Senate is due to vote on its budget later this month. For more on industry-physician interactions visit Community Catalyst’s resource page and the Physician Payments Sunshine guide.

–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

An investigative outfit’s consolidation and analysis of payments that drug companies made to doctors has refocused attention on state efforts to shine light on the financial ties between doctors and drugmakers.

Currently three states—Minnesota, Massachusetts, and Vermont—require drug companies to disclose payments to prescribers and make some of that data public. While each of these states takes a different approach to collecting and making the payment data available to the public (more on that here), information from all three have been extremely valuable in demonstrating the dimensions and scope of these marketing relationships. And now a new value to the state data has emerged: demonstrating that pharma isn’t keeping very good track of who it’s been paying what.

The ProPublica report in Monday’s Minnesota Star Tribune and here online found a series of big discrepancies between what a company said it paid a doctor on its website and what it told the state of Minnesota it paid the same person. Right now, ProPublica can only crosscheck the seven companies that have posted payments on their own websites.

Big pharma has been caught off-guard again. Like the reports earlier this fall that hundreds of sanctioned doctors were still making cash on the side with speaking gigs, some companies seem not to know who they are paying what. Despite spending billions of dollars to develop and manufacture drugs, and spending other billions to market them to prescribers and armchair prescribers (i.e. consumers), the folks who brought you Lipitor, Effexor, Zyprexa and that one that will send this to your spam folder, don’t seem to know what they paid docs to give PowerPoint presentations.

The report also gave some doctors the opportunity to say strange things:

Dr. Randy Shapiro, one of the doctors whose take was under-reported to Minnesota told ProPublica that if anything, patients should want to see their physician among the speakers on these payment lists. “If their doctor is not on the list,” he said, “maybe they should look for a different doctor.”

That’s…an interesting take. We’re not aware of any links between participation on speakers bureaus and clinical excellence or bedside manner. Based on some earlier findings (we’re thinking of the Risperdal, Biederman, and all these folks) we’re not sure that would be our prescription. (In fact, based on the mounds of evidence about the influence of even small gifts, we tend to think finding a pharm-free physician or one who is engaged on clinical projects she’s happy to tell you about, and not just the PowerPoint circuit, is the way to go).

And the top-paid physician in Minnesota, Dr. Todd Hess, a pain specialist in St. Paul who made over $364,000 last year, told ProPublica that the media is unfairly lumping these educational talks with the old pharma ways.

“This is a mountain-molehill thing,” Hess told ProPublica. “I know the problems of the past. I know what pharma has done to change those. People just can’t get over the past.”

Maybe he knows something that we don’t know, but it might not be a problem of a press corps with a too-long memory. Recently, awkward chuckles went up through the pharma news sphere when word of Abbott’s celebratory pig roast for a Maryland doc who managed to implant 30 stents in one day showed up in a Senate Finance report.

That wasn’t back in the high-flying, anything-goes 90s depicted in the recent pharma-flick “Love and Other Drugs.” It was two years ago. Teachers are warned not to grade 30 papers in one day (and this blogger can vouch for that advice). We’re pretty sure, like the Senate Finance Committee, that 30 stent operations in a day is an even worse idea.

Despite what headlined docs and pharma spokespeople say, there is still a lot of money changing hands for things of questionable clinical value. The thing about the ProPublica data is: it’s current. The stories about hundreds of millions of dollars going to sanctioned docs, the Massachusetts reports that just came out–those payments are all from 2009-present. And now we see it isn’t being recorded very well. Maybe some of these companies really did believe no one would bother to look.

“If all the reports are true I’m outraged,” Maryland delegate and physician Dan Morhaim told the Baltimore Sun.

According to the Sun, “Maryland’s General Assembly has explored limiting financial relationships between doctors and drug or device makers, but no laws have come from it,” but Morhaim said ‘it’s a continuing topic of interest’ in the next legislative session.”

While there are real and beneficial relationships between academic medicine and industry, Pew Prescription Project Allan Coukell told a Memphis paper this week that “patients deserve to know if their doctors are receiving money from drug companies.”

And patients and state lawmakers are right to be concerned about what add up to significant financial exchanges between industry and doctors willing to pitch drugs to their colleagues. We wouldn’t be surprised to see more states explore ways to keep track of or limit the types of payments industry makes to doctors. Regardless, pharma should take this opportunity to get its house in order so everyone’s on the same—accurate—reporting page by the time Physician Payments Sunshine kicks in.

–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

Drug and device companies paid Massachusetts physicians more than $16 million in the second half of 2009, the Bay State’s newly-unveiled disclosure database shows (for those of you ready to bookmark: http://mass.gov/dph/pharmamed/). Health Care for All’s got first impressions over at A Healthy Blog:

“While other states have come out with data,” they write, “Massachusetts’ is the first database that is fully searchable by provider name, company name, or payment category, and is the nation’s most comprehensive.”

Massachusetts joins Vermont and Minnesota among states that publish pharma payments made to doctors, and as researchers, journalists and consumers begin to comb the data, more pieces of the picture about industry marketing payments to health care providers will fall into place. The data and, importantly, the database itself–its organization, user-friendliness, design and maintenance–offers one working draft for the designers of the federal Physician Payments Sunshine database to copy, improve on, or tweak as they build the federal version, and we’ll be looking at the database with an eye toward its blueprint-ness in the coming weeks and months.

On your mark, get set, download…

–Kate Petersen, PostScript blogger