The Affordable Care Act created some desperately needed means to start controlling ever-rising health care costs. Many — like preventive care or delivery reforms — will take some time to realize savings. In contrast, new anti-fraud efforts look to be paying off right away, in amounts much bigger than expected.

The health reform law provided $350 million over ten years to increase anti-fraud investigation and enforcement resources for the Department of Justice (DOJ) and State Attorneys-General. The goal? Saving $6.4 billion over the next decade. Given that some estimate that fraud and waste cost as much as $60 billion a year, or $600 billion over a decade, saving one percent of that amount seems a pretty modest impact.

But wait! New estimates project that current or pending settlements of drug fraud litigation by the DOJ and the Attorneys-General will top $8 billion in FY2012 alone, according to the group Taxpayers Against Fraud. (See their list below.) This is not the culmination of hundreds of lawsuits; it’s just the eight biggest. So it looks like this anti-fraud effort under the ACA will meet and then surpass this ten-year goal in less than two years!

To be fair, some of these fraud investigations were undoubtedly underway before the increased funding for anti-fraud efforts reached the DOJ and State Attorneys-General offices. But there is little doubt that providing these over-worked regulators with increased resources was a big help in increasing enforcement. DOJ probably has fewer lawyers working on all their pending drug fraud cases than some of the biggest drugmakers hire to defend in just one lawsuit. But despite these disparities, the results show that very modest government investment in fighting fraud, coupled with hard work by government lawyers and whistleblowers, can pay off big.

For example, earlier this week drugmaker Abbott Labs in Chicago settled a civil and criminal investigation of their illegal promotion of the anti-convulsant drug Depakote as an unapproved treatment of dementia in seniors, and of various conditions in children. Abbott pleaded guilty to promoting these unapproved, or ‘off-label’ uses of Depakote, and agreed to pay $1.6 billion – one of the biggest settlements for the illegal promotion of a single drug.

There could be a couple hundred pending whistle-blower lawsuits that are filed under seal and being investigated now by the federal or state regulators. These pending lawsuits may add up to billions of dollars of additional settlements.

Some critics have warned that even billion-dollar fines are an inadequate deterrent when a drug company can profit far more on illegal sales of a drug.

For instance, the $1.2 billion record-breaking settlement with Eli Lilly in 2009 for illegal promotion of their antipsychotic drug Zeprexa was less than 5 percent of Lilly’s gross sales. Yet eight months later, DOJ shattered this record with an even bigger $2.3 billion settlement with Pfizer, which amounted to 14 percent of their gross sales of eight illegally marketed drugs.

Similarly, this month’s $1.6 billion Depakote settlement is nearly 12 percent of the drug’s $13.8 billion in gross sales revenue from 1998 to 2008. Furthermore, DOJ is pioneering two mechanisms to deter future illegal conduct by Abbott, along with this hefty fine.

First, the Depakote settlement places Abbott on probation and imposes a corporate compliance and monitoring program, for five years. If Abbott violates the compliance agreement or significantly violates the law, the government can exclude Abbott, and all their drug products, from federal health care programs. That would cost Abbott billions in lost sales on numerous drugs.

The settlement also aims to hold Abbott’s corporate leadership accountable. Abbott’s CEO must personally certify compliance and the board of directors must review and report on compliance each year. If the CEO or board is lax in these duties, they could be excluded from their positions at Abbott. And if they intentionally lie to the government to cover up any misconduct, they could face personal criminal liability under the federal False Statements Statute.

Sadly, Abbott’s illegal promotion of ineffective and dangerous uses of Depakote has both harmed and put at risk what is arguably the most vulnerable patient population – seniors suffering from dementia, who live away from their families in nursing homes. Undoubtedly millions of seniors were and continue to be given Depakote inappropriately as a result of Abbott’s illegal promotional campaign.

More to come on (1) actions that Medicare and Medicaid can take to address the continuing effects on patients of illegal promotions of off-label use of drugs and (2) how the Arkansas AG fought prescription drug fraud, winning huge fines to plug the state’s Medicaid budget deficit. This blog was also posted on Health Policy Hub.

– Wells Wilkinson, Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Projected Drug Fraud Settlements in FY 2012

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

The Food and Drug Administration will soon complete the second stage of a three-phase process to increase public transparency of agency activities and decision making. Last week, the FDA’s new Transparency Task Force concluded a three-month comment period on 21 bold new proposals to expand the agency’s disclosure practices. Community Catalyst, with the support of prominent drug safety experts Drs. Joseph Ross and Aaron Kesselheim of Yale University Medical Center and Harvard Medical School, respectively, filed comments endorsing many of these proposals with respect to prescription drugs, and recommending other improvements to promote public health and empower patients and consumers.

Seeing Clearly Now – The Importance of Transparency

The FDA task forces sees increased transparency as part of new Administration’s Open Government Initiative, and as a means to build public confidence in the FDA by making the agency’s activities and decision-making more accessible and understandable to consumers, providers and other public health experts. These 21 proposals would significantly increase access to information in nearly all areas of prescription drug regulation, from developmental studies to inspections of manufacturing and import procedures to adverse reactions experienced by patients.

Many of these common sense proposals are especially timely in light of the recent revelations about drug makers withholding critical information about drug safety studies and manufacturing problems.

For instance, the FDA recently made public a report summarizing 12 manufacturing violations and other inspection findings concerning a Johnson and Johnson plant in Lancaster, Pennsylvania. This is notable as it was the third Johnson and Johnson plant to be cited for violations this year, the same year in which the company has recalled over 130 million bottles of children’s medication due to possible contamination. A congressional investigation recently found that in June 2009 the company’s McNeil division sent in contractors to surreptitiously buy up potentially contaminated Motrin, rather than issue a formal recall of the product. One new transparency reform being considered by FDA would make information on inspections and violations at manufacturing facilities open to the public. This would inform consumers about when FDA uncovers problems in the manufacturing process—or when a company has a clean record. Increased public scrutiny of problematic industry manufacturing practices will alert consumers when problems arise, and also help force manufacturers to prioritize quality improvement.

Also of great interest to the drug safety and patient community are the proposed disclosures of the status of product applications and the release of summary clinical trial data on drug safety and effectiveness. Such information would notify patients awaiting the development of new drugs on the industry’s efforts and safety concerns and help prescribers make informed decisions. Most importantly, the disclosure would also allow independent researchers to conduct their analyses in order to complement FDA and industry research.

The recent revelations that GlaxoSmithKline withheld studies documenting the cardiac risks associated with their blockbuster drug Avandia, and selectively excluded negative data from other published studies demonstrates the need for full transparency.

GSK’s actions were nearly identical to drug maker Merck’s withholding of studies documenting the cardiac risks of Vioxx, which is estimated to be responsible for tens of thousands of heart attacks. In both cases, lack of access to this data meant that it took years for the health risks of these products to come to light.

Even so, under the current scheme, FDA sits atop a mountain of clinical data submitted with marketing applications that may help identify risks sooner. Had comprehensive clinical trial data on Vioxx and Avandia been available to independent researchers earlier, health risks associated with these drugs could have been discovered and publicized much earlier. Lives could have been saved. The FDA simply does not have the resources to perform all the analyses that independent investigators can.

These safety issues, coupled with recent manufacturing problems that have undermined the integrity of our drug supply chain, demonstrate the need for expanded FDA disclosure of drug approval information and inspection results.

Will it be a Bright Sun Shiny Day?

Aside from supporting the FDA’s bold new approach to increase transparency, we also recommended that the FDA go farther in some areas. For instance, we feel that the FDA’s proposal to disclose the scope and completion of a food recall be expanded to include any recall of prescription drugs, as well.

And while the FDA has proposed future meetings to discuss the disclosure of non-summary (or individual level) data from drug trials, we argued that the need for public access to this data is beyond dispute because it allows independent researchers to more quickly complete objective drug safety analyses that reveal risks and thus sound the alarm on patient safety issues.

(Tune in tomorrow to learn what other consumer advocate, and the drug industry said about these vital transparency reforms.)

– Ian Reynolds, Policy Associate
– Joy Lee, Policy Intern

Yesterday we blogged about comments Prescription Access Litigation and others made to the FDA in support of proposed rules on presenting risk information in broadcast drug ads.

Numerous other consumer and public health groups have commented, and overall offered resounding support for these proposed regs. The Patient, Consumer and Public Health Coalition offered their support for these regulations and stressed that “the goal of DTC ads is to persuade, not to educate, and so DTC ads emphasize the benefits but not the risks of prescription drugs.”

Consumer groups, including the National Consumers League, additionally offered support for the proposed fifth requirement of dual-modality, simultaneous audio and textual presentation. Consumers Union voiced the importance of dual-modality in their comment stating that “[p]roviding an audio warning with other things happening in the background is, no matter how hard one tries, distracting” and, “[p]roviding a text warning while talking about other things is distracting;” “Providing the same, simultaneous audio and visual warning is the single best way to make a lasting impression that will be helpful to patient-consumers.”

Some consumer groups also argued that pre-review of ads should be required. Here’s Public Citizen: “to obtain approval of DTC advertising on broadcast media, a party shall present market research demonstrating that information concerning side effects, contraindications and warnings is comprehensible to the target audience.” A pharmacists group and pharmaceutical powerhouse Eli Lilly also supported the use of focus groups to review and “pre-approve” ads and to pilot test that elements (e.g. font size, color, placement) of an ad.

In addition to these shared themes, AARP also suggested that the FDA rule should specify where in the ad the “major statement” should appear” and that the major statement should not be allowed to be placed in the middle of the ad “where it can be bookended by conveyance of benefit information and is least likely to be retained by consumers.”

The two pharmacist organizations that commented–the American Society of Health-System Pharmacists and the Academy of Managed Care Pharmacy (AMCP)—supported the new proposed rules, as well as dual modality in ads and pre-dissemination review whether by the FDA or by consumer test groups.

Industry against dual modality, for delays
Industry was relatively quiet on these new proposed regulations:  only the Pharmaceutical Research and Manufacturers of America (PhRMA) and four pharmaceutical companies submitted comments so far. Though industry all stressed the public health benefits of DTCA and generally offer their support for the FDA’s action to further clarify the standards, a few common themes of opposition are apparent in all industry comments.

On the whole, industry seems very opposed to the proposed fifth standard of requiring dual modality. Sepracor argues that dual modality “could prove to complicate the presentation for consumers.” PhRMA seconded this argument and said that “dual modality might produce presentations that actually overemphasize risk information.”

Merck further stated that dual modality “does not improve consumer recall or understanding of important risks information.” Though Merck supported this argument with one 2005 study, it went on to mention the limitations of this study and none of the other industry commenters provided any support for their arguments against dual modality, and all of industry’s comments against dual modality ignore the numerous studies that have shown that the technique enhances clarity and recall of information (and which the FDA cited in its proposed rule).

The second overarching theme of the industry comments seems to be an attempt to delay the implementation of these rules. Sepracor, Merck and Eli Lilly all suggest that the FDA do further research and analysis on these standards before implementation. Sepracor argued that the rule should not be made effective until the results of FDA’s study on the impact of distraction can be published and commented on.

This argument reads largely as a delay tactic employed by Sepracor to postpone the inevitable implementation of this rule. Though there is no doubt that the FDA’s study may help them to further understand what elements of broadcast media can be distracting, there’s little debate that the impact of distraction on consumer understanding… is to distract, and that’s hardly a reason for FDA to delay implementing these rules when the public’s health is at stake.

In one of the more head-scratching unsupported assertions, Sepracor stated that up to 70 percent of the time slot of an ad is used to convey safety information for the drug. Anyone who’s ever viewed one of the numerous DTC ads currently on TV knows that this statistic has little foundation in reality.

–Emily Cutrell, Prescription Access Litigation

As Cephalon joins the ranks of pharmas disclosing payments to physicians or health care entities under corporate integrity agreements, John Mack at the Pharma Marketing Blog and Eric Milgram over at Pharma Conduct have good posts on the importance of the format in which companies have posted data about who’s getting what.

In a distinction Mack describes as translucent vs. transparent, Cephalon’s payments are posted in FlashPaper, a format that does not allow the data to be copied and is hard to search. So are Eli Lilly’s, which began disclosing under a similar agreement late last year. Merck and GlaxoSmithKline, who began disclosing some payments (these were not court-ordered disclosures) last month, publish the data in PDFs, which are unsortable and hard to search, but at least allow data to be extracted.

All the companies fall short in that they provide little or no additional detail on the nature or purpose of the payments. Merck only reports payments to U.S.-based health care professionals who speak on behalf of Merck or its products through Merck Medical Forums, presumably excluding payments to providers who provide other types of services.  And no companies have provided complete disclosures that include all those paid for clinical trials and every type of research, although GSK plans to begin reporting compensation to research investigators in 2011.

Eric Milgram’s checklist for what details make disclosure data usable and valuable to the public is a great place to start. He says at minimum, disclosure data should include a provider’s name, specialty, main hospital or practice affiliation, and a brief description of the reason for payment.  And he says that companies shouldn’t only have to disclose those payments made to physicians, but to all health care providers.

The lesson in all this? When it comes to disclosure, details matter. The program Cephalon and Lilly have used to date make searching difficult and copying impossible. There are easier programs out there: it’s time to use them. Without useful markers—(it’s not as helpful to search for a doctor by the letters in her name if you can’t also search by state, specialty, or practice location)–it’s difficult for consumers and researchers to use the data to make informed decisions or analyze trends in industry-physician relations—arguably the very reason such disclosures are part of court settlements.

These first disclosure attempts provide good lessons for courts that wish to make meaningful disclosure a part of future settlements, as well as state and federal regulators who are developing or may have to plan for uniform disclosure databases such as those proposed in the Physician Payment Sunshine provisions and bills being introduced in several states this year.

As a postscript, it’s worth remembering that despite the good publicity some pharmas have gotten for putting this data on their websites “voluntarily” (see: Eli Lilly), half of the companies that have disclosed payments so far (and more than half, if you count medical device companies) have done so by order of a court because they settled on charges of systematic inappropriate marketing – cases that have yielded enlightening documents about company marketing practices and their sway over company research, authorship, and publication.

–Kate Petersen, PostScript blogger

Massachusetts reached a significant milestone today in the effort to both measure and manage the extent of pharmaceutical and medical device marketing to prescribers.  The state’s Public Health Council today passed strong regulations that limit gifts and payments to prescribers, and disclose others, completing the  state’s enforceable code of conduct passed last summer.  The code, required to be at least as strong as the PhRMA and AdvaMed voluntary codes, is arguably the strongest in the nation; Minnesota’s first-in-nation gift ban does not apply to medical device companies; Massachusetts’ does. And unlike Minnesota’s standing law, the disclosure info will be posted on a public and easily-searchable database for consumers and researchers.

Among the highlights of the final regulations:

-DPH included trainees in the ban on direct payments for scholarships, CME, and other travel payments. This is a good news for the state of unbiased medical education at Massachusetts many academic medical centers.

-The Council had a good debate on prescription drug samples, and will do further study of the issue of samples as marketing tools and revisit the issue next year.

-DPH interpreted the $50 limit as a floor, meaning gifts under $50 not expressly banned in the law would not have to be disclosed. Since pens, pads, and tchotchkes are banned, this means that a lot of in-office drug lunches will fly under the radar.

-Bona fide payments to investigators for research will not have to be disclosed, but those payments for trials with marketing purposes, such as seeding trials, must be.

Seeding trials, if you’ll recall, are clinical trials whose scientific purpose is tenuous at best: “a marketing trial with a marketing objective,” in the words of the authors of a paper on the Vioxx ADVANTAGE seeding trial. Unlike other, scientifically rigorous clinical trials, seeding trials are primarily designed and carried out by marketing departments with the goal to get doctors to start using their drugs — kind of like beta-testing for gadgets and computer programs, or the little bags of free granola that come wrapped in the Sunday paper. Except with powerful, sometimes lethal pharmaceuticals.

An Internal Merck slide outlined the lead role of Merck’s marketing department in the ADVANTAGE trial:
•    Design protocol and oversee execution of trial
•    Select investigator sites
•    Run investigator meetings
•    Choose and manage CRO
•    Perform data analyses
•    Prepare publications

Historically, drug companies have not been upfront about what a clinically valuable trial and what is a seeding one – after all, what doctor or patient would sign up for a clinical trial that she knew was designed only to create product loyalty? The Council showed a good understanding of the complexity of the issue, and made it clear it that DPH and the Attorney General’s office will be actively seeking signs of such illegitimate trials and sanction companies that don’t disclose them.  And reports today of a Massachusetts-based investigator who fraudulently published 21 clinical trials on the use of painkillers like Celebrex for post-operative pain – studies funded by Pfizer – highlights anew the public interest in knowing a clinical trial’s legitimacy and money trail.

Requiring companies to report all research payments is the failsafe way to ensure such marketing-based trials are recognized and disclosed, and we would have liked to see the Council stand by that original standard. Still, we are encouraged by the Council’s recognition that the corporate marketing aims of seeding trials undermine safe and effective drugs for state residents.

As we prepare for the regs to go into effect July 1, we’ll explore, along with others, ways to identify seeding or other questionable trials in a way that is valuable to regulators who will be protecting Bay State patients by monitoring drug and device payments to doctors.

In a week where spending your taxpayer dollars on bad investments suddenly sounds like a ‘rescue plan,’ read this: the FDA spent a chunk of their not-so-spare change  (OK, so $300,000 is a lot less than $700 B) to hire a PR firm to “create and foster a lasting positive public image of the agency for the American public,” the Washington Post revealed this week. Instead of issuing the request for bids required for federal government work, a former public affairs executive for a medical-device firm now working for the FDA orchestrated a no-bid contact through Alaska Newspapers, Inc, which isn’t subject to government bidding requirements because of its special status. 

So are we more enraged at the fact the agency went the good ol’ boys route and circumvented the rules process to find the best and lowest-cost bidder, or that even as the chronically under-funded agency was asking Congress for more dollars to shore up its crumbling safety and oversight divisions, it was working this hard and shelling out this much to shine up the story in tomorrow’s social studies books? Right now, we’d say it’s a coin toss.

Putting ADHD drug ads in timeout

The FDA has warned five drugmakers about false or misleading advertisements of five ADHD drugs, according to the Bureau of National Affairs Health Care Daily Report. “The FDA sent letters to Eli Lilly and Co., Mallinckrodt Inc., Novartis Pharmaceuticals, Johnson & Johnson, and Shire Development.” One of them was a video testimonial by Extreme Celebrity Home-giver Ty Pennington for Shire’s Adderall XR, an unapproved ad the FDA says overstates efficacy but which company officials claim was never supposed to leave the Shire website, where the side effects, dosage and indications were plain for all to see.

The pre-emption question

As the Supreme Court’s November date with pre-emption case Wyeth v. Levine nears, this Boston Globe editorial argues the evidence has shown that the FDA approval process requires “insufficient proof” of drugs’ safety “and then does not recognize their harmful effects quickly enough.” The Globe continues: “the Supreme Court has no business depriving patients of their recourse to courts.”

Pharmalot’s Ed Silverman has made his site the one-stop shop for all things pre-emption. Check out his syllabus here.

Media matters

And in this week’s Journal of the American Medical Association, researchers from Harvard Medical School and Cambridge Health Alliance look at news reports on industry-funded pharmaceutical studies in the mainstream media and found that about 40% of 300 major news stories failed to mention the source of the study’s funding. 

Of course, reporters aren’t alone – recently, major medical journals have been discovered to have missing disclosure statements from industry-funded authors, and Congressional queries have found giant gaps in payment disclosures by university researchers. When it comes to disclosure, these researchers seem to be asking that the fourth estate go first.

UMN ponders new stronger COI policy

Minnesota Public Radio revealed leaked recommendations by a University of Minnesota medical school task force on new conflict of interest policies. The recommendations called for health care providers to disclose to patients any interest they have in companies whose products they prescribe them, developing a conflict of interest website, a complete phaseout of industry funding for continuing medical education, and a requirement that all physician-industry relationships be disclosed (currently, only payments above $10,000 are required to be reported). The University received a D on the American Medical Student Association scorecard for its current policies earlier this year. Here’s the AP follow-up.

Cephalon settlement calls for disclosure

As part of $444 million in settlements of whistleblower lawsuits related to illegal off-label marketing, Cephalon is the first drugmaker to enter into a corporate integrity agreement that will require it to disclose prominently payments to physicians and amounts on its website; the move comes a week after Eli Lilly and Merck announced they will voluntary disclose such payments beginning next year; two years ago, five medical device makers began to disclose such payments under a similar settlement agreement to Cephalon’s.

Find out more at Marketwatch and Wall Street Journal Healthblog.

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.

The unconventional thank you note: GSK exec demonstrates

Yesterday Chris Viehbacher, head of GlaxoSmithKline’s U.S. Division, sent a wouldn’t-it-be-a-shame note to legislators considering a Massachusetts bill that would ban pharmaceutical vendors from giving gifts to physicians.  In the letter, Viehbacher expressed his displeasure at the prospective law and reminded them of Glaxo’s recent job creation in the Bay State. Considering that the same legislators have proposed $1B to help boost the state’s biotech cluster, we wonder just how much Viehbacher wants before he’d be content ditching the bribes to physicians and sticking to the science.

Here’s the original story in the Boston Herald, and today’s follow-up, which includes interviews with two legislators who weren’t amused. We were, though, to read that state Sen. Mark Montigny (D-New Bedford) called the letter ‘baloney.’

Speaking of the Boston broadsheets, Pharmalot says supporters of physician/industry relations have enjoyed some column inches lately on the op-ed pages of the Herald and Globe. Chief of medicine at Mass General Hospital Dennis Ausiello, M.D. coauthored both, in which he calls for “more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.”

When last we checked, that engagement was happening at every stage of the process – and look how good Vytorin turned out.

We’d like to hear from you

Today, Big Pharma goes to the Hill, but not for lobbying (ok, well maybe for that too.) The House and Energy Oversight and Investigations subcommittee will be hearing from Pfizer, Johnson & Johnson, Merck, and Schering-Plough about direct-to-consumer advertising.

The baby in the bathwater, and Texaco treats at school:

A doc–off over AAMC recommendations

Over at MSNBC, Art Caplan Ph.D., a renowned bioethicist at University of Pennsylvania squares off against Cornell surgeon Edward Craig M.D. M.P.H.  about why the new AAMC recommendations are a good thing – or not.

Caplan writes:

Business has no business selling or promoting in the middle of classrooms or other academic settings. Academic medical centers, if they want to teach their students how best to think about the medicines they prescribe and to retain the trust of the American people about evaluating them objectively, should do everything they can to keep the marketing, sales pitches, promotions and bribes — large and small — away from campus.

Craig, however, says that the prescribed ban, which includes things as big as foreign travel and as small as pens, lacks subtlety, and insults hungry doctors.  “When was the last time you were bribed by a piece of pizza or a logo pen with five days worth of ink?” Craig writes.

Ah, the old if-it-were-you argument.  More than a few fables and aphorisms have been written to warn us against that reasoning, but perhaps Jane Austen did it best in her novel, Persuasion: “How quick come the reasons for approving what we like!”

(And we like the pens a lot.)

Airing on the side of secrecy

Slate.com reported on some undisclosed industry relationships on the airwaves.  Neither the hosts nor the medical experts interviewed during a program on the depression meds SSRIs announced the experts’ consultant and advisory capacities for makers of the drugs.  More here.

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

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

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