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

Yesterday, DPH issued temporary regulations that, unless changed, will gut the state’s drug and device marketing regulations, which were proudly heralded in 2008 as a step toward curbing drug industry marketing abuses and addressing spiraling health care costs. In a shocking capitulation to industry, the DPH regulations go even further than the amendments passed this summer by the legislature, which had weakened the ban on industry providing lavish meals to physicians. DPH would allow drug, device and biotech companies to pay for physician meals outside clinical settings, with no restrictions on the cost of the meals.

A DPH staffer acknowledged that the administration’s Mass Life Sciences Center was consulted about the language— companies meeting down the street at the BioPharm America 2012 Conference must be thrilled. Pharma’s lobbyist, Marjorie Powell, was quoted in the Globe on Thursday,, saying “the Massachusetts law was placing unnecessary restrictions on the industry as it tries to work with health care providers” and she reported meeting with DPH employees who were drafting the regulations. Yet DPH refused to meet with consumer advocates in the Massachusetts Prescription Reform Coalition, nor incorporate any of our written recommendations.

This summer, the Massachusetts legislature repealed the component of the gifts and disclosure law that prohibits pharmaceutical and device companies from giving gifts to Massachusetts doctors, nurses, and other health care providers. The amendment made it legal for the industry to provide “modest meals and refreshments” off-site, at restaurants and other facilities “conducive to informational communication.” DPH was then required to define these terms but it failed to do a credible job, allowing “modest” to simply mean “similar to what a health care practitioner might purchase when dining at his or her own expense.” If that isn’t bad enough, public health experts at the DPH also decided not to address the issue of industry paying for wine or alcohol. Can this possibly be reasonable, given the law’s requirement that payment for meals and refreshments be allowed only in a venue “conducive to informational communication?”

HCFA reports that at yesterday’s Public Health Council meeting to review and approve the regulations “a number of Council members were openly skeptical. One member asked about alcohol. The DPH staffer explained that they saw rationale in the law for barring alcohol. Another Council member asked how the restrictions would be enforced. Self-reporting was the answer. How would DPH know whether the ‘educational’ sessions were truly educational? The DPH replied that it would be up to the drug manufacturer to make its own decisions.”

The gifts ban and disclosure law was an early reform aimed not only at protecting patients but also reducing health care costs—an important goal for sustaining our near-universal coverage in Massachusetts. Numerous peer-reviewed studies show that marketing tactics such as providing meals and gifts influence prescribers to select the latest, most expensive drugs when generics or other lower-cost, equally effective alternatives are available.

Although the gift ban is backed up by sound policy rationales and studies, the politics have been challenging. The pharmaceutical industry teamed up with the restaurant industry and lobbied hard to withdraw the gift ban in 2009, 2010 and 201l. But now they have nearly succeeded in undermining the law, gaining far more concessions from the Patrick administration in these regulations than the legislature allowed.

The DPH regulations would end all disclosure requirements, which under the law apply not just to physicians but to all providers. The DPH regulations dismantle this system as well as the $2,000/company annual fee that supports it. The pretext is the upcoming implementation of the Physician Payments Sunshine Act in Obamacare, which requires industry to report all payments to physicians and teaching hospitals. But the MA law includes disclosure of payments to all providers, including nurse practitioners and physicians’ assistants, key primary care providers in MA who are increasingly the target of industry marketing. Such disclosures are not preempted by the federal law.

Fortunately, Massachusetts medical schools and medical centers have enacted their own policies to shield physicians, researchers, physicians-in-training and other staff from the influence of inappropriate marketing. They have instituted bans on gifts, meals, inappropriate consulting and other marketing, basing their policies on a strong commitment to medical professionalism and good patient care. These institutions acknowledge that relationships with pharmaceutical, device and biotech companies are essential for research and innovation—we all agree with the Mass Life Sciences Center on that. However, these institutions are also committed to erecting firewalls that protect patient care and medical education from industry influence. But they cannot regulate physicians that are not in their systems—the Massachusetts law bridged that gap by creating a blanket policy for all providers.

We call on patients, consumer advocates, legislators, physicians and other providers to join us in reversing the DPH emergency regulations and maintaining the letter and spirit of this important law.

–Marcia Hams, Director of Prescription Access and Quality

– Anna Dunbar-Hester, Policy Analyst

This blog was made possible by a grant from the Attorney General Consumer and Prescriber Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

Hopkins bans gifts, drug samples

Johns Hopkins has banned some types of gifts, meals and drug samples from pharmaceutical companies, says the WSJ HealthBlog. The policy, which extends not only to the University’s medical school but also to its affiliated hospital and clinics, also prevents consulting payments without legitimate research aims and keeps sales reps out of patient-care areas.

But wait a second, says fellow blogger Dr. Daniel Carlat, PhRMA already bans its own reps from giving the pens and tchotchkes Hopkins put on the do-not-accept list — it’s in the industry’s new voluntary code on Interaction with Healthcare Professionals. And on closer inspection, the meal limits still allow Hopkins faculty members to eat quite well on a drug rep’s dime (and maybe have a sip of his martini), Carlat says.

FDA calls for safety, efficacy tests of risky medical devices

The FDA announced this week that it will require makers of the riskiest class of medical devices, called Class III devices, to prove their products are safe and effective, though a grandfathering system established before 1976 allowed many of them to be marketed and sold without establishing such evidence. The New York Times has more here.

According to the Times, “The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.”

Sen. Grassley looks into pharma ties of mental health advocacy group

And Sen. Charles Grassley (R-IA) has asked the National Alliance on Mental Illness for information on all funding it receives from pharmaceutical companies or pharma-funded foundations. According to Bloomberg, the group, which calls itself the largest national grassroots organization for those with mental illness, came under fire after 1999 report that it received $11.7 million over 3 years from 18 drug companies, and still has a host of support from high-octane drug makers.

“Destroy them where they live”: email in Vioxx lawsuit reveals company plans to discredit critics

An email from Merck employees released in a federal court in Melbourne, Australia this week reveals a hit list of doctors and researchers who raised questions about the painkiller Vioxx. According to a report in the Australian, the email uses the words “neutralize” and discredit” in reference to those who criticized the blockbuster drug before it was pulled from the market in 2004 for lethal cardiac side effects.

“We may need to seek them out and destroy them where they live,” the email said, according to an excerpt read in court by plaintiff’s attorney.

The email was released as part of a class action lawsuit brought by 1000 Australians who allege they were injured by taking Vioxx between 1999 and 2004.

What DTC, drug labeling does and doesn’t say

The average American watches 16 hours of drug ads on TV each year, reports the Boston Globe in this in-depth look at direct-to-consumer drug ads. The story explores not only the persuasiveness and dangers of the marketing strategy, but a series of proposals from researchers on how to make drug risks and facts clearer in ads and in labeling.

Iowa biotech attacks data-mining bill

The Iowa Biotechnology Association argues in this Des Moines Register column that an Iowa Senate bill to end commercial data-mining would stifle innovation in the state. But the only kind of data-mining that the bill (SF 389) would prevent is marketing: in other words, the use of prescribing records by drug companies to target their sales pitches to doctors – often without the doctor’s knowledge.  For more on prescription data-mining, check out our fact sheet.

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

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

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

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

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

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

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

To read the decision for yourself, go here.

Data-mania!

Eighteen states considered restrictions on commercial use of prescriber data this year, according to this Associated Press story.  But a pending decision in the 1st Circuit Court of Appeals (IMS v. Ayotte) about the legality of the first-in-nation New Hampshire data mining ban has largely frozen the issue, which is earning attention at the federal level, as well.  In the spring, Sen. Herb Kohl (D-WI)  made some inquiries into the American Medical Association’s sale of its prescriber profiles for hefty sums each year.

“We have no privacy issues here,” IMS vice president Randy Frankel told the AP, but many physicians and their advocates (RxP among them) say it goes beyond politesse, and that pharma reps who know covertly doctors’ prescribing patterns are invading the doctor-patient relationship by often pitching the most expensive, least-proven drugs.

Read the RxP fact sheet on data mining here.

Speaking of places where there are privacy issues, this Des Moines Register says that no one has been prosecuted for violating the federal patient privacy law known as HIPAA, the Health Insurance Portability and Accountability Act, even though “38,000 Americans, including 267 in Iowa, have complained of HIPAA violations to the federal Office for Civil Rights” since enforcement began in 2003.  According to the Register, “[m]ore than half of those complaints nationally have been disposed of with no investigation. Until last year, no one nationally ever was prosecuted for violating HIPAA.”

And then there were two

Though we saw numbers like this earlier this year, now there are Just Two, so here’s a pre-convention update: Going by campaign contributions, Pharma is hedging for Obama, and in a big way. According to a Center for Responsive Politics study, first reported by Bloomberg, presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) has received three times as much pharma moula as presumptive Republican nominee John McCain (Ariz.).

Check it out at The Scientist Blog.

Vioxx papers reveal marketing roots

In a paper published in the Annals of Internal Medicine this week, researchers found evidence in the Vioxx documents that the ADVANTAGE trial was drummed up entirely by the Merck marketing department.

According to the paper:

The trial emerged from the marketing division with a marketing objective; Merck’s marketing division collected, analyzed, and disseminated both the scientific and the marketing data; and Merck did not reveal the marketing purposes of the trial to participants, physician-investigators, and institutional review board members.

For those of us who read Melody Petersen’s book, Our Daily Meds, such news isn’t as surprising as it ought to be, but all the same, we’re glad to see this truth vs. advertising getting into the medical literature.

Now you CMAP, now you don’t

The Dallas Morning News reports that the Children’s Medication Algorithm Project, a preferred drug program for psychiatric medications in Texas, has been halted as part of an ongoing investigation by that state’s Attorney General.  TMAP, the adult precursor, triggered a suit alleging undue pharmaceutical company influence on the selection of the drugs.

According to News, “[a]t least four of CMAP’s key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms.”

“In our country, there’s been a switch from taking care of people to focusing on big corporate money,” Rep. Juan Escobar told the News.  According to the News, Rep. Escobar proposed unsuccessful legislation in Texas last year that “would have banned researchers or government employees funded by the pharmaceutical industry from designing state psychiatric drug protocols.”

Hat tip to Pharmalot.

Deja – vu all over again

Harry and Louise are back, and they’re having some second thoughts about healthcare. Check out the story in the Detroit Free-Press here.

For an industry that regularly tops the charts on profit margins, we weren’t surprised to see the full page ad in the Boston Globe today, signed by the Biotechnology Industry Association, Massachusetts Biotechnology Council, Associated Industries of Massachusetts, Massachusetts High Technology Council, Cambridge Chamber of Commerce, and the Pharmaceutical Researchers of Manufacturers of America itself.  To be honest, we were sort of surprised that they didn’t underwrite an entire special edition of the Globe.

Framed as an epic decision for Massachusetts Gov. Patrick, who must soon take action on the health care cost and quality bill passed by the Massachusetts legislature last week, the full-page humdinger pulls out all the stops. There’s size, of course. Flattery: (“Governors everywhere…have always been extremely envious of the Massachusetts’ Life Sciences sector”).  Matters of Life and Death: “The hope for so many patients, suffering so much, will be diminished.”).  And then, our personal favorite, the good ol’ Pat on the Back: “Is our industry successful, absolutely!”

But it’s hard for us to see why an industry so successful is fearfully baring its teeth at a bill that merely codifies its own code of conduct, which already bans sales reps from giving doctors small gifts and travel. If the industry is as proud as it says about making “products that save thousands of lives every day,” then it shouldn’t be so worried about having to stop treating doctors to dinner. The merits of those products should speak for themselves.

The ad signatories go on to warn of the doom to befall the Bay State if Gov. Patrick signs this bill, which they say will force clinical trials being done in the Commonwealth “elsewhere tomorrow.” “The chilling effect that this will have on the life sciences industry in Massachusetts could not be more obvious,” the ad intones. A less than gracious threat to a state that just committed $1 billion to the life sciences enterprise.

Now, we don’t know much about writing newspaper ads – but we think that when you address the Governor, you should assume he’s read the bill. And for anyone who has read the bill, the claims about clinical trials in this full-page epistle are plainly false – lawmakers explicitly designed it so it would not hinder or interfere with biopharmaceutical research: ( S. 2863 Chapter 111N, Section 2) “The marketing code of conduct adopted by the department shall allow:… 4) compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial.” Furthermore, patients will still be able to receive free drugs during clinical trials, since samples continue to be allowed under the bill.   

“The legislation that awaits Governor Patrick’s decision will significantly curtail, if not end all together, the availability of these last hope clinical trials,” the ad says, because the law would require companies to disclose “the products and areas of research” in which they are involved.

This law wouldn’t do that at all.  And much information about clinical trials is already public record – by law, drug companies seeking FDA approval are required to register those data about all clinical trials on clinicaltrials.gov.  The only way the new law would affect clinical trials is to disclose the amounts paid to investigators.  And if the industry is as proud as it claims to be for creating life-saving products, then viable payments for legitimate services should be no problem – and are certainly no trade secret. 

“These are your family members, friends, neighbors,” the ad goes on. Precisely. This act, as part of the larger cost and quality bill, would serve those very people by making sure their doctors have the unbiased information on the safest, most effective drugs, and by letting them see whether their doctors take money and gifts from the companies who make the drugs they’re prescribed. 

Governor, this bill means good medicine for your family members, friends, and neighbors, and we urge you to sign it.

A bill, introduced today in both House and Senate, would have the federal government go head-to-head with the pharmaceutical industry’s 100-thousand-or-so sales reps.

The Independent Drug Education and Outreach Act of 2008 provides grants for the creation of unbiased educational materials for doctors. And another set of grants funds pharmacists and nurses to take that good information to the doctors in their offices.

Office calls work. That’s why they are the preferred sales tactic of industry. So it makes sense that governments and others who actually foot the cost of prescription drugs should adopt the same tactic, albeit with the goal of encouraging the use of the best, safest, most cost-effective drugs.

This idea, sometimes called “academic detailing” has been around for at least 20 years. Programs are well established in other countries and in several states. Australia and Pennsylvania have model programs. Kaiser Permanente has its own long-established initiative. The evidence shows that such programs not only improve patient outcomes, they also produce net savings – by one estimate two dollars is saved for every dollar invested. See our related Senate testimony here.

But it is also important to note that these programs are not mainly about cost savings; they are about providing good information. Sometimes that even means encouraging more use of pharmaceuticals. And doctors who have a chance to participate generally appreciate having a source of information they can trust.

IDEA is being sponsored in the Senate by Sen. Herb Kohl (D-WI), Sen. Edward Kennedy (D-MA), Sen. Richard Durbin (D-IL) and Sen. Robert Casey (D-PA), and in the House by Rep. Henry Waxman (D-CA) and Rep. Frank Pallone (D-NJ). Both the Prescription Project and the National Coalition for Appropriate Prescribing support passage of this bill.

The IDEA Act allows for public payors and non-profits – those free of pharmaceutical industry funding – to apply for grants. That means a new potential source of funding for state programs, such as the one Massachusetts is likely to pass today [tune in tomorrow for more on that]. The Congressional Budget Office should score this bill. The House and Senate should pass it quickly. We have neither time nor money to waste.

PhRMA announces changes to marketing code

The main trade association of the drug industry, Pharmaceutical Researchers and Manufacturers of America, announced today it is revising its voluntary code ‘Interactions with Healthcare Professionals’ to ban small gifts such as pens, mugs, stethoscopes, and impose bigger suggested limits on support for travel, Continuing Medical Education, and consultants. [For you seeing-is-believing types, check the revised code out here.]

According to the New York Times, the new code “provides no definite limits on the millions of dollars spent on speaking and consulting arrangements that drug makers have forged with tens of thousands of doctors. Nor does it ban the routine provision of office breakfasts and lunches, or the occasional invitation to educational dinners at fancy restaurants.”

Though the industry’s Code till now has been unenforceable and vague, the announcement of the change, a day after the UK drugmakers association adopted new provisions, may change the game for state lawmakers considering a ban on gifts to physicians. Such a ban is currently under review by Massachusetts state lawmakers, and is already on the books in Minnesota.

“A voluntary restriction on the small gifts used by pharmaceutical companies to curry favor with doctors is a step in the right direction, ” said Rob Restuccia in a Prescription Project statement on the Code revisions, and added that the change “is an important complement to efforts by state and federal policymakers to limit industry marketing.”

And it’s time to get your own pens, docs, says the droller Wall Street Journal Health Blog.

Salesforce in the Green Mountain state grows

Pharmalot’s Ed Silverman sums up the latest numbers from Vermont’s pharma payment disclosure law: “A total of 84 drugmakers spent more than $3 million dollars in Vermont in fiscal 2007 to influence sales, a 33 percent increase over the previous year and a 42 percent jump from two years ago, according to a report issued by the state’s attorney general.”  Four out of the five of the top marketed drugs in the Green Mountain State are used to treat ADHD or depression, according to the report.

Acronym Soup

This Inside Higher Ed article looks at the path toward greater federal regulation of conflicts of interest among academic researchers, some pending legislation on the Hill that might change the laws around financial disclosure of those funded by NIH grants, and some of the milestones (and Senators) that got us here.

From the glad-someone-caught-it dept.

Howard Brody over at the Hooked blog spotted this exchange between former NEJM editor Marcia Angell and the Manhattan Institute’s Benjamin Zycher in the pages of the Wall Street Journal. When Mr. Zycher opinioned in the Journal that Big Pharma is an indispensable piece of the research machine, Dr. Angell cries foul on industry credit-taking for what she writes is often publicly-funded university research that gets licensed (and profits) later.

It’s a slugfest, and Brody is the best sort of bystander, polite but not deferent, someone who knows a ball from a strike before the umpire moves, and doesn’t spill nachos on your feet in the fourth.

AMSA applause

And a few RxP allies at the American Medical Student Association got a tip of the hat and a little cash to boot for their notable work in AMSA’s PharmFree program, in the form of The Medical Letter-AMSA PharmFree Scholarships. Congratulations Jonas, Gabe, and Lekshmi.

Keep on keepin’ on – the Lipitor bump

And in a predictable industry find, the good folks who bring you Lipitor found in a study published in the July issue of Current Medical Research and Opinion – surprise! – patients are more likely to stay on Lipitor than its competitor class of  (cheaper) simvastatins. The text: good news for patients and doctors, because medicine adherence is key to managing disease. The subtext: good news for Lipitor, because once you’re on it, you stay on it, even though recent studies dispute its artery-clearing powers against a placebo.

We’re waiting for someone to do an adherence study comparing a drug and nothing-at-all. PostScript bets it’s easier for folks to remember to take the pill you don’t have to.

This, of course, is only a hypothesis.

A couple of weeks ago, GlaxoSmithKline Chief Chris Viehbacher tried out the bully pulpit on Massachusetts lawmakers considering a gift ban for physicians.  Too early to tell, but it may have done more harm than good.  So now pharma companies are trying a different tactic – have the caterers plead their case for them.

The caterers who make all those physician lunches certainly have a horse in this race – Kevin Abt, Founder of RestaurantstoYou.com, a corporate catering service in Stoughton, Mass., estimates that pharmaceutical reps drop $40 million on food in for docs in the state every year. Hardly chump change.  And because of this, he’s asking Massachusetts representatives to strike meals from the list of gifts that would be banned under proposed bill S.B. 2660.

We know that pharma has long found ways to get what it wants by talking through others – physicians, say, or advisors for the FDA. But a tip to the letter-writers of the world: if you don’t want to look like you were put up to something, don’t parrot information you probably couldn’t get doing your job. 

The petitioner from RestaurantstoYou moves quickly from entreating to indignant: “How could we think “the most educated people in the world, Doctors, could be manipulated by the offer of a ham sandwich and chips from a pharmaceutical or medical device company sales agent?  Instead, the opposite is true. Doctors routinely ask these reps to go do more research for them, at no cost to the doctor, so that they can have additional information for their individual analysis that they will use to make decisions regarding their patients.”

Abt knows this because he says to better understand his clients, he has watched from the back of the room in admiration as the reps performed their lunch and learns. Fine.

But if you are the one making the sandwiches, do you really want to sound like you are reading off the same talking points as the state policy director for the PhRMA trade association? PostScript has been to enough hearings to know those talking points when we hear them. Sales reps with no background in science are providing valuable information about drugs that physicians can’t get anywhere else? And pasta salad.

Yep. 

No doubt: $40 M is a lot of money to spend on food every year – but if that number tells Massachusetts lawmakers anything, it’s the sheer scale of investment these companies have made in wooing physicians, evidence that it’s probably time for the marketing machine is to be reined in.

If nothing else, it’s intriguing to see pharma moving the mouths of both Ivy League physicians who are recruited to speakers bureaus where they use marketers’ slides to pitch their drugs for them, and those of the blue collar catering drivers from Stoughton: “The food we deliver is wholesome and delicious, but it is not flashy or expensive.”  We have to hand it to them: The chemical pushers have become deft chameleon puppeteers.

But in another sense, pharma has found authentic common ground with the simple ham sandwich makers of the world – they’ve got mouths to feed, starting with the shareholders.

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.