Earlier this month, the 2nd Circuit Federal Court of Appeals refused to prosecute pharmaceutical sales representative Alfred Caronia for conspiring to sell a drug “off-label” (without FDA approval for that indication). While Caronia was caught in the act, and the lower court found him guilty of the conspiracy, the majority in this 2-1 panel decision ruled the government was prosecuting Caronia for his First Amendment-protected speech, and vacated the lower court’s judgment. The punishment he avoided was no more than a $25 fine and one year’s probation, yet this case might go all the way to the Supreme Court.

The narrow reading of the court’s ruling is that it hinders the FDA’s ability to prosecute misdemeanor off-label marketing by sales representatives, forcing them to focus their energies on the bigger fish up the food chain, such as sales managers and corporations. The broad reading is that it eliminates the FDA’s power to prosecute for off-label marketing at all. Pro-pharma pundits claim the holding goes so far as to limit the government’s ability to bring a civil suit under the False Claims Act (FCA) for off-label sales. However, we cast a more skeptical eye. While we believe the case was wrongly decided, its impact as a precedent is likely limited to pharmaceutical sales representatives accused of a misdemeanor, not their bosses or the corporation.

Take Two of These and Call Me in the Morning

Here’s how the issues in this case play out. Imagine your doctor gives you a drug because you have insomnia and the bottle says “use as directed,” but the label gives you directions for people with some disease you’ve never heard of. You search for directions for use with insomnia and cannot find them – anywhere. You look closer at the bottle’s Black Box warning and see language that scares you: “This drug is a known drug of abuse. Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Important adverse events associated with abuse of this drug include seizure, respiratory depression…. with instances of coma and death.”

You call your doctor who prescribed the drug, and he assures you that it is “perfectly safe.” He can’t remember where he got the idea, but he’s confident that a half dose should be fine for insomnia.

You take the drug, go to sleep, wake up three and a half hours later sweating profusely, take another dose, go to sleep again and sleepwalk into your neighbor’s yard. In the morning, your neighbor wakes you and invites you in for a much-needed cup of coffee. Luckily, she’s a lawyer. She goes online to find the drug company has been sued for fraud to the tune of $20 million, for marketing to patients, like you, that don’t have the disease indicated on the label. Moreover, the company failed to report 72 negative reactions and ten deaths last spring. As it turns out, your doctor got the idea to prescribe – and those directions – from a sales representative for the drug company, along with a doctor the sales rep recommended.

Who is at fault, here? Anyone? Everyone?

The Facts

This is the question explored in the Second Circuit’s majority opinion, along with a vigorous dissent. In 2002, Xyrem received FDA approval for one very narrow use: the treatment of cataplexy (weak or paralyzed muscles) associated with narcolepsy. The US population suffering from narcoleptic cataplexy is extremely small (between 20,000 and 50,000 patients). To expand its profit potential, Orphan Medical resorted to a marketing strategy designed to promote Xyrem for numerous unapproved indications. This marketing strategy led to $20 million in 2005 sales alone.

Orphan had a policy in place for what sales reps should do when asked by doctors about off-label uses of Xyrem: direct that doctor to fill out a request for information to be sent to the company, for the company to address. Yet, Mr. Caronia recommended prescribing the drug to patients as young as 14 for uses including fibromyalgia, chronic fatigue or chronic pain – even advising on which diagnostic codes to use. We know this because every word was being recorded by his potential “customer” – a doctor working off his plea deal with the government by serving as an informant for the FBI. It turns out Mr. Caronia was hired a few months into the investigation of illegal Xyrem marketing that led its manufacturer to pay a $20 million settlement with the US government in 2007.

The Law

Mr. Caronia’s case went before the 2nd Circuit Court of Appeals just after the Supreme Court’s Sorrell v. IMS decision on data mining. The majority in Caronia’s opinion accepted the sales representative’s interpretation of Sorrell as protecting his First Amendment right to say anything about Xyrem, as long as his statements did not reach the level of fraud, thus invalidating the most compelling evidence for misdemeanor misbranding: his speech. This, despite him calling the drug “perfectly safe” when it holds a black box warning. The majority here protects “truthful, non-misleading” off-label marketing, even if that speech is evidence of a conspiracy to bring drugs to market for unapproved purposes. This is a bad outcome when applied to the facts of this case, but a disastrous outcome when applied more broadly to corporate and individual prosecution under the FDCA.

Conclusion

Mr. Caronia’s case should not serve as precedent for a change in the way US courts interpret the FDCA. Drug companies have overwhelming incentives to maximize sales before patents run out, and sales representatives are under the gun to deliver those profits however possible. As products liability lawyer Bill Cash opines: “[d]rug sales representatives are low-level employees, often with little or no medical training, who have only one function: to push pills.” Given the vast difference in culpability between a sales representative and those at the top that knowingly apply the pressure to their own ends, the case is a poor choice for SCOTUS review of the breadth of the FDCA. Individual violators should be prosecuted when appropriate, but more importantly, companies should be held both criminally and civilly liable for the dangerous practice of off-label marketing. Any threat to that is a threat to consumers, to the intent of the FDCA and to the purpose of the Food and Drug Administration.

– Khadijah M. Britton, JD, Program Associate, Prescription Access and Quality

On June 28, the Supreme Court made its momentous decision upholding the Affordable Care Act, a major win in the effort to ensure that all Americans can go to a doctor when they get sick and receive high-quality, affordable care. The ruling paved the way for the law to be fully implemented to benefit the American people. It means that insurance companies can no longer deny care to people when they get sick or if they have a pre-existing condition, benefit expansions such as closing the Medicare prescription drug “donut hole” for seniors and people with disabilities are secure, and new coverage programs for those without insurance can be implemented.

And the decision means many other innovations and consumer protections in the ACA will go forward, including the Physician Payment Sunshine provisions, which Community Catalyst, the Pew Prescription Project and others have championed for many years. The Sunshine provisions mandate that all payments to physicians and teaching hospitals made by makers of drugs, medical devices and biological products be reported to the government, and then disclosed to the public. This broad transparency program is intended to improve quality of care by reducing the incidence of fraudulent or unethical promotions to prescribers and the resulting wasteful costs to patients and public programs.

Fraudulent and highly unethical industry payments to medical professionals have led to lawsuits against virtually every major drug and device company. Just this month, a new record-breaking settlement of $3 billion with Glaxo-Smith-Kline revealed that GSK salespeople paid or compensated doctors through illegal kickbacks related to seven different drugs: Avandia, Paxil, Wellbutrin, Imitrex, Lotronex, Flovent and Valtrex.

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,” said Carmen M. Ortiz, U.S. Attorney in Massachusetts.

This is fresh on the heels of last month’s shocking revelations about Abbott’s payments to professionals at nursing homes to promote the over-use of Depakote to treat the elderly.

Congress included the Sunshine provisions in the ACA out of concern for such practices and their impact on patient care and medical professionalism. Now industry will be required to report all payments made to doctors and teaching hospitals on a public website. This will allow patients, researchers, Medicare, Medicaid, private health plans, medical schools and academic medical centers can continually monitor these financial exchanges and evaluate whether they could be leading to bias in prescribing or medical education.

Now that the Sunshine provisions are clearly the law of the land, the Obama administration should finalize the regulations promptly so that industry reporting and public disclosure can proceed.

 – Marcia Hams, Director, Prescription Access and Quality

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

Drugmaker Genentech’s new promotion to get eye doctors to use the expensive injectable drug Lucentis for macular degeneration offers rebates to top-prescribing practices based on bulk and rate of increased use, the New York Times reports, despite little evidence that the drug works better than another far less-costly drug, Avastin.

The rebates may be designed to win or keep prescribers from Genentech’s Avastin, a similar drug indicated for cancer that some physicians say works equally well and costs about one percent of what Lucentis does.  A head-to-head trial between the two drugs is underway and some suggest the Lucentis promotion is a way of creating customers for the more expensive drug in the lead-up to the trial results.

The Lucentis rebate to physicians is based on volume but also increase in use—something that sounds all right enough for a coffee customer card, but disturbing for a drug. The program is a top-users club to begin with, only offered to the top 300 using practices in the country. Even with lattes, there’s a finite number of espresso shots one can or should have in a day/week/month, and reward for increase in use is a problematic model because it suggests a curve of infinite consumption.

More disturbing? The company has been explicit in keeping the program a secret. The Times reports that “doctors who have signed up for the rebates are not allowed to acknowledge even the existence of the program, let alone to talk about the specific terms,” in accordance with a company-proffered contract that practices must sign. That’s definitely not how they do the coffee cards.

Lucentis and Avastin are injectables, meaning a doctor must administer the doses rather than a patient going to a pharmacy to get a drug, and as with other injectables, Medicare reimburses doctors for buying the drugs. A rebate or bulk discount program offered by a drug company such as this one boosts the potential money a doctor can make and ties physician payment directly to frequency and volume of a drug used, which is one reason for the federal anti-kickback statute.

According to a calculation by the Times, the volume rebates combined with the increased usage rebates on offer could net a practice meeting the minimum requirements in the biggest rebate category $58,000 per quarter. U.S. sales of Lucentis went up nearly 30 percent in the first three quarters of 2010, to $1.1 billion, and though Medicare reimbursed for less fewer Lucentis injections in 2008, it paid a whole lot more for them: $537 million that year compared to $20 million for Avastin.

Whether these types of rebates violate anti-fraud and anti-kickback laws may depend both on whether they were properly disclosed to government payors, and on how they were promoted to providers. But putting that question aside, news of the program is worrisome from a medical standpoint. Here is a company promoting its (very costly) medicine based on some hybrid of the Starbucks/Costco philosophy—the more and more frequently you buy, the more you save!—and not on the efficacy or merits of the medicine, or on clinical trials and guidelines that demonstrate superiority to comparable drugs or optimum treatment regimens. And where is the patient in all this? Eyes open, and paying the bills.

–Kate Petersen, PostScript blogger

Newly-released court documents gathered as part of a court case against Wyeth (now part of Pfizer) brought by patients who developed breast cancer while taking its Prempro hormone replacement therapy (HT) illustrate how ghostwriting was used to distort or hide scientific evidence and lend clinical credibility to company marketing aims in medical journals and presentations. In “The Haunting of Medical Journals” in this week’s PLoS Medicine, Georgetown physician, researcher and expert witness Adriane Fugh-Berman examined the documents. She found that where company-funded trials and clinical findings are concerned, the marketing tail is still vigorously wagging the dog.

DesignWrite, a medical education and communication company (MECC) was hired by Wyeth to produce large quantities of “authored” papers that touted unproven benefits and later downplayed risks of HT proven in large randomized control trial (RCT) studies. Between 1997 and 2003, Wyeth hired DesignWrite to produce drafts of more than 50 peer-reviewed publications, including at least four primary publications on a Wyeth-funded Prempro trial.

DesignWrite’s ghostwriters also helped “manage” clinicians and thought leaders, ensuring marketing messages remained front and center in published papers, and planned CME events and journal supplements.

“Even though a 1997 DesignWrite proposal admitted that ‘HRT continues to be a drug in search of a disease’” Fugh-Berman writes, “my examination of the available documents indicates that the lack of evidence regarding the prevention and treatment of cardiovascular disease, dementia, and other diseases proved no deterrent to Wyeth/DesignWrite’s promulgation of numerous marketing messages positioning HT as a panacea.”

While this lines up with mounds of other evidence that show companies’ marketing goals running the scientific show, the casualness of the counter-science that was done to keep physicians prescribing HT is newly shocking.

When in 2002 the Women’s Health Initiative, a large RCT, disproved purported cardiovascular benefits previously associated with HT and showed increased risk of breast cancer and stroke, Wyeth commissioned the ghostwriters at DesignWrite to write papers casting doubt on hormone therapy’s role in breast cancer. One Wyeth employee suggested that a journal supplement falsely state that breast cancer associated with the treatment was less virulent. That year, Wyeth management “charged the Publication Committee with increasing the number of positive HRT/Premarin-related publications. They have asked us to publish at least 1 study per month.” The company also flooded medical publications with mini-reviews, editorials, comment, and other booster pieces that did not have to be peer-reviewed, but still packed a clinical punch with physicians.

Physicians, it’s clear from the documents, were only as valuable to Wyeth and DesignWrite as their prescribing pen and their generic credibility. As “authors” who lent their names to ghostwritten pieces, the companies saw them as interchangeable: “I moved Dr. Creasman as an author to the patient ed piece (with Blackwood, Weiss, & Speroff) and left Horwitz and Boman on the basic science manuscript,” one document stated.

This should be insulting to physicians. As a marketing tool, ghostwriting has been implicated in the physician recruitment campaigns around Vioxx, Neurontin and other high-profile drugs stripped of their mystique and safety profiles by sound science.  But as Fugh-Berman and these documents illustrate, the use–and manipulation–of medical journals and clinical evidence to support marketing aims may have become so routine that in some cases, the most reaction Wyeth’s antics stirred was confusion on the part of the token author:

“From what you have written, I would be more of an ‘editor’ rather than the major writer—that is, you guys would be writing the versions—with me ‘altering, editing, etc.? Is that correct?’”

And if this is an outrage to physicians, so should it be to the rest of us. The following is a response from Wyeth’s Gerald Burr to a ghostwriter about whether manuscripts could be reused.

“‘You can’t just put another name on the article, but you can plagiarize the way we did when we wrote papers in college. What you need to do is give your potential authors Karen’s version of the article before the author modified it. Then have your authors modify it for publication under their name. Wyeth owns Karen’s draft, not the final publication.’ Burr supplied five drafts but asked that [a DesignWrite supervisor] Karen Mittleman be notified of the plans for reuse ‘so she can advise if we are going to piss off any of the U.S. authors.’”

Read the full article here.

–Kate Petersen, PostScript blogger

For those who haven’t read it, Ed Silverman over at Pharmalot has a great interview with former FDA associate chief counsel and former Pfizer senior counsel Arnie Friede, about the new “BadAd” program that FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) rolled out yesterday.  The program gives doctors and health care providers a way to report misleading or illegal drug promotion to the agency, which has not, until now, had a mechanism for reviewing promotion that happens in the doctor’s office, off the page or TV screen.

When Silverman asked how an already resource-strapped FDA would follow up on every report, here’s what Friede said:

On balance, the FDA probably feels there’s a lot of violative behavior they simply can not monitor with limited resources. To some extent, yes, many of these reports may reflect a doctor’s misunderstanding of what was actually said. That’s certainly a possibility and, hopefully, the FDA willl find a reasonable way to separate the wheat from the chaffe. But if the objective is compliance and not enforcement, then this is an additional incentive for a company to closely monitor and control communications by their sales people. For an enforcement agency, I think it’s an understandable, perhaps even brilliant move…

Read the whole thing here.

-Kate Petersen, PostScript blogger

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

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.

The Prescription Project, National Physicians Alliance, Prescription Access Litigation (PAL) and US PIRG have submitted public comments opposing an FDA Draft Guidance that would allow drug companies and their salespeople to distribute reprints of medical journal articles discussing off-label uses to physicians.

The groups outline numerous reasons why the distribution of reprints by pharmaceutical representatives does not facilitate evidence-based decision making and could jeopardize patient safety and public health. They urge the FDA not to issue the Draft Guidance in its current form and to hold public hearings on industry marketing of products for off-label purposes.

Off-label prescribing, the prescribing of drugs for non-FDA approved purposes, is legal. However, the marketing of drugs by pharmaceutical companies for off-label purposes is not legal. Currently, pharmaceutical companies can provide medical journal articles discussing off-label uses to physicians only if the physician asks for the information. The FDA guidance would loosen that restriction.

Ghostwriters…

The big story from the Pharm Country this week is ghostwriting, in the wake of reports that some of the papers published about Vioxx were penned by Merck but attributed to physician authors.  If you haven’t seen the story, you need not look very far — it’s everywhere.  The Baltimore Sun and CNN here, plus some more in an earlier blog post.

Sen. Chuck Grassley (R-IA), sponsor of the Physician Payments Sunshine Act, wasted no time writing Merck a letter.

As FDA deadline approaches, so do lobbyists

And as the deadline for public comment on the FDA’s proposal to loosen restrictions on off-label marketing materials, pharma lobbyists descend on Washington.  The story is in the Wall Street Journal.  The approaching guidance would allow pharmaceutical salespeople to distribute journal articles about off-label uses of their drugs to doctors – but this review of Neurontin off-label use (spoiler alert: it’s dismal) is a good case study in why some worry about the legalization of such off-label promotion.

Massachusetts Senate cost control bill moves to House

In Massachusetts, the state Senate has passed a comprehensive cost-control bill that includes a gifts ban and academic detailing provision.  Now it moves on to the House.

But not before veteran pharma champion and biotech director Thomas Stossel MD of Harvard Medical School and co-writer and Harvard doc Dennis Ausiello MD got their word on the gift ban in.

“We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps,” Stossel and Ausiello wrote in the Boston Herald.

Hmm.  A call for more interaction among all stakeholders + a state shortage of primary care docs = Perhaps the reps could see patients themselves, to help the docs out?

We thought we were just poking fun, till we saw this post on Pharmalot – it’s almost happening! In Australia, medical practices have started to ask pharmaceutical companies to help with payroll for their staff.   A total pigs-on-the-runway moment for PostScript.

Pharmalot and the HealthBlog are really good about pointing out relevant ties to industry that may color the opinion columns and letters of pharma’s more prolific defenders like Stossel, which is good, because it seems the original publisher of those pieces rarely get disclosure of his industry ties right on the first try….

The Vytorin Connections

Part of Schering-Plough’s clean-up team for the Vytorin mess is on the board of the New York chapter of the American Heart Association,  as is one of S-P’s compliance officials, reports Pharmalot.  While consumer groups like the AHA taking funding from pharmaceutical companies is nothing new, Pharmalot says there are an awful lot of dots to connect in this picture.

On the street where you live

All politics are local, and now so are drug ads, like this Zyrtec pull-away flyer.  Streetcorner DTC? From what we know about the size of pharma’s marketing budget, we’d say this is cutting more than a few street corners.