Should Drug Reps Know Every Detail of What a Physician Prescribes?

Today we have a guest columnist writing for Question Authority - PharmaSpy:

Should Drug Reps Know Every Detail of What a Physician Prescribes?

Right now they can, down to a single prescription on a weekly basis. They know what percent market share any doctor writes for any drug. They also know how much of the competition that doctor is using.

But they’re not supposed to talk about it, especially with the doctor. It’s ‘proprietary company information’. Drug reps know more about what physicians write than the doctor himself.

Pharmaceutical companies buy pharmacy information from IMS (http://www.imshealth.com/)and other ‘data mining’ outfits as a ‘solution’ to ‘sales force effectiveness’. Here’s how they describe this service:

“One of the most critical success factors for any drug company is the productivity of its sales force. IMS supports sales executives, managers and reps with a range of offerings that empower them to make better, faster, smarter decisions in areas such as: segmentation, and call planning, sales force sizing and deployment, compensation and territory management.”

The word ‘segmentation’ is important here. Big writers are separated from losers. The top guys get all the perks of a drug rep’s attention: speaking engagements, honorarium, research grants, dinner lectures, samples, lunches, CME programs, cupcakes etc. The benefits are piled high to influence their writing habits under the guise of ‘patient health first’.

The good news is that AMA physicians have an ‘opt-out’ program, sort of like a ‘do not call list’ for prescribing data. Simply log onto the AMA website and click on the Physician Data Restriction Program (PDRP) link (http://www.ama-assn.org/ama/pub/category/12054.html ) to go stealth on the drug industry.

FORTUNE: "PETER ROST HAS BECOME THE DRUG INDUSTRY'S MOST ANNOYING - AND EFFECTIVE - ONLINE SCOURGE."

BLOGGING ON DRUGS

Fortune Magazine - Jun. 11, 2007

BOOTED OUT OF A LUCRATIVE CAREER, PETER ROST HAS BECOME THE DRUG INDUSTRY'S MOST ANNOYING - AND EFFECTIVE - ONLINE SCOURGE.

(Click on images to view article in orginal format and full size.)

Peter Rost is worked up about pink cupcakes. The ex--Pfizer senior executive turned blogger believes he has uncovered another instance of unethical marketing by Big Pharma. Today he's taking on AstraZeneca, the British pharmaceutical giant. A group of AstraZeneca salespeople anonymously e-mailed Rost a damning internal newsletter. The handout, among other things, encouraged company salespeople to set up brightly decorated display tables in chemotherapy treatment rooms. In honor of Mother's Day, reps were instructed to give away pink flowers, cupcakes with pink icing, and pink bags filled with information about the company's Arimidex breast cancer medicine. The problem? AstraZeneca's sweet sales event could violate patient privacy laws, American Medical Association guidelines, and the company's own policy of not serving food to patients. "Besides," Rost says with a laugh, "it's a bit cheesy. Patients just finishing up a chemo session are on the verge of vomiting. A cupcake is the last thing they want."

The ridicule comes easy for Rost. In his former life, the 48-year-old physician earned $600,000 a year conjuring up marketing plans for companies like Pfizer, Pharmacia, and Wyeth. That's all behind him. Since Pfizer fired Rost from his post as a vice president of marketing in December 2005, he has been blogging from the basement of his suburban New Jersey home. Rost's blog, Question Authority With Dr. Rost (peterrost.blogspot.com), is one part mocking rant, two parts investigative chronicle. A recent week's headlines included PFIZER, VIAGRA, AND THE MOB; and FORMER U.S. ASTRAZENECA CEO LARS BILDMAN: THE CRAZIEST BIG PHARMA CEO EVER? He has also published an exposé of his years in the drug industry, The Whistleblower: Confessions of a Healthcare Hitman.

[PHOTO: PHOTOGRAPH BY NIGEL DICKSON, UNBLINKING Rost, holding a sculpted lamp, believes he has a mission to shed light on pharma malfeasance.]

Trained as a physician in his native Sweden, Rost has worked in the drug industry for most of the past 20 years. He almost certainly never will again. The blog, then, is perhaps Rost's toughest marketing job ever. The product: Dr. Peter Rost. On the site he also hawks T-shirts, coffee mugs, and postage stamps emblazoned with his own square-jawed Nordic visage. Married with two children, Rost hopes that Question Authority-named after the FORTUNE column in which he was once featured-will help him create a new career. "I'm knitting a parachute," he says, "as I see the ground coming closer and closer."

Rost's many critics would love to be able to dismiss him as an embittered crank. But they can't. The blog has clout. As a conduit for Big Pharma whistleblowers, it has taken some notable scalps. Earlier this spring, for example, Rost's muckraking spurred congressional curiosity; federal investigators are now looking into AstraZeneca for Arimidex-related marketing irregularities. Another series of blog entries resulted in a government probe into Pfizer's marketing activities. And a dispatch on dubious sales practices led to at least one sales director's ouster.

For Big Pharma, whose public image is already battered, blogs are an added nuisance. The problem, says Robert Ehrlich, CEO of DTC Perspectives, a health-care marketing consultancy, is that most pharma companies are ill-suited to deal with the blogosphere. "They are medically oriented and legally oriented," he notes. "But as an industry they are not consumer-oriented." The rise of blogging (see table) also coincides with increasing federal scrutiny into how drugs are sold. From 2000 to 2006, drugmakers paid $5.4 billion in civil and criminal penalties to settle sales and marketing violations; in the ten years before that, the figure was $395 million. To bring such cases, the government relies heavily on tips from company insiders. Whistleblowers and their qui tam lawyers-they work essentially on contingency-initiate some 80% of health-care fraud cases. Tipsters get a cut of any penalty-on average, 16%.

These days, people whose complaints do not rise to the level of a federal case are likely to take their grievances to the web. Last April, for example, Rost received a phone call from an anonymous AstraZeneca employee. The caller claimed that sales reps had been instructed to promote the company's $1.5 billion breast cancer medicine, Arimidex, for uses not approved by the FDA. Marketing such off-label uses is illegal.

"SINCE BEING FIRED BY PFIZER IN DECEMBER 2005, ROST HAS STARTED A NEW CAREER AS A PROFESSIONAL PAIN IN THE ASS."

Rost pressed the caller to back up the charges and within hours received e-mails containing scanned documents from sales representatives at AstraZeneca. On April 5 he posted some of the papers and wrote stories about what he saw as possible ethics breaches and marketing violations.

In an internal publication, Mike Zubillaga, an AstraZeneca regional sales director, encouraged the cancer medicine salespeople to think of each oncology office they visit as a "big bucket of money."

[PHOTO, FOR SALE Among the other items Rost is hawking on his site: boxer shorts, infant bibs, and mousepads]

"Every time you go in, you reach your hand in and grab a handful," Zubillaga continued. "The more times you're in, the more money goes in your pocket." Rost printed the quotations in bright green. A day after Rost publicized the "bucket of money" comments, AstraZeneca fired Mike Zubillaga and issued a statement repudiating the language.

Over the next several weeks Rost continued to pore through the AstraZeneca documents, highlighting questionable practices. The mainstream press caught on, and so did Congress. On April 25, Congressman Pete Stark (D-California), chairman of the House Ways and Means Subcommittee on Health, urged the Department of Health and Human Services to investigate the allegations. Meanwhile, AstraZeneca continued an internal review. Says spokesperson Emily Denney: "We investigated the claims from the group of [insiders who sent the documents] and we found there was some merit to what they were saying. These involve personnel matters, so we aren't sharing information with the public, but we are sharing" it with the government.

In the middle of the AstraZeneca brouhaha, a Pfizer employee sent Rost some internal sales documents and presentations relating to the company's HIV medicine, Maraviroc. The drug is still under FDA review but is considered likely to be approved. Once it hits the market, analysts predict sales of $500 million a year. In this case, the tipster alleged that Pfizer is marketing Maraviroc before its FDA approval. This practice, known as "premarketing," is illegal. Rost received a PowerPoint presentation on Maraviroc, which the informant alleged Pfizer wanted passed along to doctors on a thumb-sized computer storage device. "Rost is on that website everyday, accusing people here of everything from wife beating to God knows what," says Bryant Haskins, a Pfizer spokesperson. "We're just not going to respond to every single allegation." On May 1, Rost wrote that his Pfizer contact had received an e-mail from HHS investigators requesting a meeting.

Why did these people go to Rost with their stories? The AstraZeneca whistleblower tried the New York Times and the Washington Post, but says there was no reply: "Dr. Rost understood the importance of what we sent him," the source told FORTUNE, "and posted about it right away."

Rost also offered empathy: He has been through the mill himself. It all began when he was working in Europe as a head of Nordic regional marketing for Wyeth. In the late 1990s, as Rost tells the story, he noticed that Wyeth was sending bonus checks from the U.S. without withholding the proper taxes. He says he reported the noncompliance internally, to no avail. Rost sued the company in 2001, claiming he was demoted for bringing the tax issues to light. The matter was resolved privately in December 2003. Neither Rost nor the company will comment.

Rost left Wyeth in 2001 and joined Pharmacia, where he became a vice president of marketing, overseeing the company's endocrine products, including Genotropin. Genotropin is a human growth hormone approved to spur growth in children with hormonal deficiencies. Rost became suspicious that Pharmacia drug reps were selling Genotropin off-label as an anti-aging drug. Then, in the summer of 2002, Pfizer bought Pharmacia.

From the moment Pfizer took over, Rost says, he tried to alert his new bosses to the illegal marketing and unethical arrangements he believed plagued the Genotropin marketing operations. Pfizer lawyers listened but were "very hostile," says Rost. "It was disheartening. I thought I was such a hotshot with great results, etc., that I could be the one to change things." Instead, he says, he was marginalized.

His career already damaged, in June 2003 Rost took the final step. He got a lawyer and filed a qui tam suit against the company over its alleged off-label marketing of Genotropin. In 2004 he went public, speaking at conferences where he detailed drug industry transgressions and argued in favor of lower drug prices and cheaper reimported drugs from Canada.

Pfizer has a different story to tell. Ethan Posner, an attorney at Covington & Burling who represented Pfizer in the matter, says Rost presented the company with a list of alleged problems and asked for $12.5 million to "go away." Rost says Pfizer asked for the list, and the $12.5 million figure refers to an estimate the company asked him to provide of damages he might be able to prove in court if he was fired. At any rate, Pfizer fired Rost in late 2005. The proximate cause was that Pfizer was restructuring. Clearly, though, Rost had worn out his welcome, just as he had at Wyeth.

In early April, Rost felt vindicated when Pfizer admitted publicly that its Pharmacia subsidiary had paid doctors to plug Genotropin for unapproved use as an anti-aging medication. The company agreed to pay a $34.7 million penalty. (Because the case was settled as a criminal matter and not as a qui tam suit, Rost got no reward.)

Since leaving Pfizer a year and a half ago, Rost has become a professional pain in the ass. It wasn't long before he got an offer to write for the Huffington Post. But Rost ruffled feathers there too. Last June he found that a frequent heckler posting replies to his blog was actually the website's head technician. When Rost revealed that, he was promptly barred. He began Question Authority last fall.

Is Rost a gadfly looking for a cause? Or is he a guardian, protecting consumers from unethical drug companies? Actually, he is both. His zeal is real; it is also sometimes excessive. Even his critics admit that when Rost is on his game, he is a force to be reckoned with. And he is part of a larger phenomenon that is forcing Big Pharma into a new era of accountability. For better or worse, the drug industry is going to have to get used to Dr. Peter Rost-and others like him.

[BOX]

CRITICAL MASS
Thanks to blogs, no industry can escape from its critics.

PHARMA: corante.com/pipeline Balanced critique of drug science. pharmagossip.blogspot.com Witty Brit takes on drugmakers.

FINANCE: wallstreetfolly.com The URL says it all. dealbreaker.com A Wall Street tabloid.

AIRLINES: planebuzz.com Smart analysis, savvy gossip.

RETAIL: walmartwatch.com/blog Hostile views of America's largest retailer.

TECH: calacanis.com Inside Silicon Valley. fakesteve.blogspot.com Satirical riffs on you-know-who.

Cruella Lustworthy and St. Cupcakes

Another amazing story by Pharma Giles who has returned to blogging.

St. Cupcakes, the internationally-renowned school for would-be pharmaceutical sales representatives, with senior schoolmistress, Ms. Cruella Lustworthy (pictured left).

You can learn all about this place over at Pharma Giles.

Click here to go there.

Congressman Pete Stark, speaking out against AstraZeneca's Pink Cupcakes?

Anyone who reads this blog knows that AstraZeneca has a Pink Cupcake-Gate on their hands. Just check prior posts.

What you may not have realized is that this may be the straw that breaks the camel's back.

Congressman Pete Stark, Chairman, Ways & Means Subcommittee on Health has already sent a letter to Daniel Levinson, Inspector General, Department of Health and Human Services, questioning AstaZeneca's behavior; link here.

But there's more, it turns out Pete Stark is also a strong opponent of drug company cupcakes. Below is his most recent speech on this. Anyone want to send my Pink Cupcake posts to him?


Statement by Congressman Pete Stark
Introducing the Prescription Drug Safety and Affordability Act
February 7, 2006

Mr. Speaker,

I rise today to introduce legislation that will bring some sanity back to prescription drug marketing, and help bring down the astronomical costs of prescriptions drugs. The Prescription Drug Safety and Affordability Act will force manufacturers to educate physicians instead of spending billions of dollars wining and dining them.

As Congress begins to investigate its own ethics, we should also shed some light on the immoral relationships between the pharmaceutical industry and physicians. Golf trips and lavish meals aren’t just for Members of Congress. Though its hard to imagine, physicians may actually get more lobbying perks from the drug industry than Members of Congress do.

For far too long, the pharmaceutical industry has jeopardized patient safety and inflated prescription drug prices by using tax-deductible dollars to underwrite their so-called “physician education” efforts. According to a recent report in the Journal of the American Medical Association (JAMA) there is a clear conflict of interest when doctors become too cozy with pharmaceutical companies.

Drug companies annually spend about $10,000 on every single physician in the United States trying to entice doctors to prescribe their drugs. That adds up to nearly $8 billion in annual spending by drug companies marketing their products to physicians. It is not unusual for doctors to receive lavish meals, all expense paid “educational” trips to posh resorts, and lucrative consulting deals from pharmaceutical manufacturers. Every single dollar spent on these unnecessary gifts is tax deductible for the drug industry as a general business expense.

The Pharmaceutical Research and Manufacturers of America (PhRMA) pretended to discourage these improper marketing ploys by issuing conflict-of-interest guidelines in April 2002. After announcing the guidelines with fanfare, they then paid the American Medical Association to “educate” their members on these guidelines—that is, they gave doctors financial incentives to promote ethical guidelines that called for an end to financial incentives! It is obvious that PhRMA is not serious about ending the practice of giving financial incentives to doctors.

Regardless of what PhRMA may say, the marketing tactics are still working. It is clear from the JAMA study that self-policing won’t work. “Although physician groups, manufacturers, and the federal government have instituted self-regulation of marketing…current controls will not satisfactorily protect the interests of patients.”

Doctors swayed to prescribe a certain drug because of their financial ties to drug companies put their own personal interest above the health and safety of their patients. This must stop now. My legislation will curb unnecessary spending physician gifts to the benefit of all patients.

The Prescription Drug Safety and Affordability Act is a simple way to ensure pharmaceutical companies’ behavior matches their rhetoric. This bill eliminates the tax-deduction that pharmaceutical companies currently receive for spending on physician gifts. The bill specifically exempts free drug samples, as that is often the only means by which uninsured patients can get medications.

Unnecessary physician gifts from the drug industry unduly influence prescribing, increase drug prices and corporate profits, and endanger patients who get the wrong prescriptions for the wrong reasons. By removing incentives for pharmaceutical companies to lavish gifts of dubious public value on physicians, I hope that pharmaceutical companies will either redirect those funds toward research and development of lifesaving drugs or reduce the prices of prescription drugs for seniors and all Americans.

The American Medical Student Association has endorsed the Prescription Drug Safety and Affordability Act. This group of future doctors--not yet beholden to the drug industry--recognizes the importance of this bill and the problems physician gifts cause in the doctor-patient relationship. I am pleased to submit their attached letter of support for inclusion in the Congressional Record.

I urge my colleagues to join me in support of the Prescription Drug Safety and Affordability Act. Prohibiting the drug industry from lavishing unnecessary gifts on physicians is a nonpartisan issue that should receive bipartisan support. If we can clean up Congress there is no reason we shouldn’t clean up health care. It is time to stop using taxpayer dollars to fund marketing campaigns that put profits above patients.

AstraZeneca's pink cupcakes cause cat fight. According to John Mack.

John Mack has his unique take on this story; the fight between the "Black Kitty" who didn't like what Christiane Truelove over at MedAdNew wrote.

John's comments are here.



John calls this a kitty fight . . . the fight even inspires him to write a pink cupcake post called Guidelines for Gifts to Patients.

Meanwhile, Jack over at PharmaGossip has his own take on Christiane's own drug rep story . . .

Doesn't look like AstraZeneca policy allows pink cupcakes to patients . . .

Here are the guidelines.

Am I missing something?

Or isn't the AstraZeneca's Pink Cupcake campaign, which is taking place RIGHT NOW for Mothers Day, violating AstraZeneca policy?

Read yourself:

According to the guidelines, meals can be provided to health care providers and staff only & all attendees must be listed on an expense report. Patient listings on AZ expense reports would be a serious HIPAA violation.
-------------------------------------------------

AstraZeneca Policy:

Standards for Providing Meals in Conjunction with Product or Informational Discussions

5.2 Attendees

5.2.1 Who can attend?

Onsite: Health care providers and staff who would benefit from the educational information being provided may be invited to attend. Because of the educational focus of these programs, spouses, other family members, and/or GUESTS MAY NOT ATTEND these discussions.
--------------------------------------------------------------------
Expense Reimbursement Policy

11. Meals

Meals must be charged on the AMEX card whenever possible. Employees must use good business judgment and not incur lavish or extravagant expenses. Questions regarding this policy must be directed towards your line manager first, then, contact the Expense Reimbursement Department.

11.2 Business Meals

A business meal occurs when it takes place with clients, prospects, associates, or AstraZeneca employee(s) and a specific business discussion takes place. The most senior level AstraZeneca Employee in attendance must record the expenditure.

The IRS REQUIRES A COMPLETE LIST OF ATTENDEES, business relationship, and the business purpose in order to demonstrate the business nature of the expense. This documentation supports both the deductibility of the expense for the Company and the non-taxability of the reimbursement to the employee. This information must be included on the expense report form. The Original, itemized transaction receipt showing all items purchased must be included with the expense report. Tear tabs are not to be used as a receipt.

Expenses incurred for program meals or meals that are served at a company-sponsored event, such as a "Lunch and Learn," are reimbursable. These meals are considered business meals, and should be recorded as such.

MedAdNews "Pharma Blogs: Week in Review"

I'm enjoying this weekly summary more and more . . .:




The aftershocks of the Zubillaga saga won't go away and may turn into even more powerful earthquakes. Right before Easter, AstraZeneca fired oncology regional sales manager Michael Zubillaga over an unapproved internal newsletter after his crass comments referring to doctors' offices as a "big bucket of money" hit the blogs and even the mainstream media. Then an anonymous group of AstraZeneca employees shared internal sales documents with blogger Dr. Peter Rost at Question Authority, alleging that AstraZeneca was engaged in illegal off-label marketing of the breast cancer drug Arimidex against Novartis' Femara. Specifically, the employees claimed that confidential training tapes used by AstraZeneca show reps how to raise doubts over the results of trials of Femara, and then switch back to discussing Arimidex's own positive trial data. Dr. Rost says he believes the tapes prove that AstraZeneca is operating illegally.

This prompted a request from California Democrat Rep. Peter Stark to the Office of the Inspector General to investigate FDA's oversight of pharmaceutical marketing to physicians.

The April 25 letter from Mr. Stark was not unexpected. At Pharmalot, Ed Silverman's sources told him earlier in April that the Congressman was curious and wanted to know more about the off-label allegations. In his letter, Mr. Stark says he is "concerned about industry greed leading to clinical decisions not based on sound medical science." He goes on to say, "If this is happening at one company, it's likely happening at most drug manufacturers."

According to the Congressional Quarterly, the request from Mr. Stark has stirred the Office of Inspector General (OIG) into looking into the allegations. Meanwhile, AstraZeneca says its own internal investigation into the anonymous allegations has yielded disciplinary action. Mr. Silverman says, "there were no details provided about the number of people involved, their employee rank, or the specific violations uncovered. So for the moment, there is no way to verify the extent to which the company has actually taken action."

As an aside, BrandweekNRx claims that the Zubillaga saga marks a turning point in the coverage of pharma. "The Bucket of Money scandal, with a few exceptions, has unfolded almost entirely on blogs," BrandweekNRx says. "It marks a real turning point in Big Pharma's relationship with the media, if only because these whistleblowers have turned to Rost rather than Alex Berenson at the Times. I mean, how many other Congressional inquiry demands have been based on blog coverage?"

AstraZeneca is not the only company dealing with allegations of illegal marketing based on the leak of internal sales documents from an anonymous employee. On Monday, Dr. Rost revealed that a whistleblower, whom he calls Jane Roe, claims that Pfizer used the HIV sales force to illegally promote the AIDS drug maraviroc before its approval. The allegations came after an FDA advisory committee voted unanimously to recommend the accelerated approval of maraviroc, a CCR5 inhibitor, for use along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1. If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade. Discovered by Pfizer scientists in 1997, maraviroc works by blocking viral entry to human cells. Rather than fighting HIV inside white blood cells, it prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

Jane Roe claims that she and other representatives were given an unapproved slide set for maraviroc in 2006 and were asked to slip the slide set onto memory sticks and give them to doctors that the company trusted. Allegedly, the sales representatives were asked to promote an expanded access trial for maraviroc. The reps were allegedly used as liaisons to help medical affairs enroll new research sites and promote the trial.

In a thread on Cafe Pharma, Jane Roe allegedly speaks up about why she went to Dr. Rost to get the news out about her complaint. "I tried going to Pfizer, hired a lawyer, and called the OIG," she says. "I finally decided I wanted to do the right thing and going [to] Rost was my best option for getting out the truth. He does have a bias against Pfizer but I asked him and he agreed once he knew the story and saw the evidence. He was willing to do what everyone else was not. I am on my way out as it is just a matter of time before they put it all together. I know many will blame me for doing this just remember I didn't initiate the wrong I witnessed it and tried to tell Pfizer. Once I told them they iced me out and have made my life pretty stressful. I am looking at it now and thinking its kind of comical in [a] wierd [sic] way. I just wanted to do my job and be treated fairly and trust me if you ever complain that will not happen."

Where does it begin?
When I first learned about the Pfizer employee and AstraZeneca employees' allegations, they sounded hauntingly familiar to me because of an e-mail inquiry I received months ago. As editor of Med Ad News, marketing and advertising executives occasionally ask me for an opinion or advice on tracking down a bit of information. In this particular case, an advertising executive was doing research for a direction for a campaign that they were going to propose to a client. The executive asked me, "Is there a precedent for a brand doing competitive advertising that references the generic name of a product that is not approved in the U.S., but is branded and approved in other countries?"

Did this set off alarm bells in your head like it did in mine? In my reply to the executive, I stated that FDA would probably look askance at any materials developed on this concept as they would not offer U.S. physicians a true comparison - the competing drug referenced is not available in the United States and the doctors wouldn't have any clinical experience with it.

The executive agreed that the tactic would not fly with FDA and that it would probably not even get past the client's legal and regulatory departments. The agency was "just curious" if there was a precedent.

This may have been just an extreme case of brainstorming, but I do wonder if all the oxygen gets sucked out of the room by all the talking done during marketing sessions. I also wonder what kind of strategy the agency (who I will not name) went with for that particular client and brand (which was not named by the agency). And if this tactic was too extreme to go with, why look into it in the first place?

It seems to be human nature to push right up against firmly drawn lines, and if there is a gray area, to dance around in it. Logic seems to have nothing to do with it - like the person in the horror movie who has to check if the axe-wielding psychopath is still lurking just outside the door because they haven't heard him in five minutes.

BrandweekNRx sees another parallel between the AstraZeneca and Pfizer sales representatives' complaints. According to BrandweekNRx, the whistleblowers highlight an unresponsive OIG. In both instances, the whistleblowers claimed to go to OIG first and had not gotten any response, so they then went to Dr. Rost. "Clearly, the lesson here is that if the OIG could just respond to emails and faxes a little quicker - even just a note to say 'Thanks! We're on it! We'll get back to you as soon as we can!' - neither of these people would have gone anywhere near Rost," BrandweekNRx says.

Pink cupcakes
On the lighter side, there has been some note made of AstraZeneca's breast cancer drug marketing initiatives centered around Mother's Day. Dr. Rost posts AstraZeneca's directive to to sales representatives . The May and Mother's Day-centered initiative promotes MUMs (Mothers United for Mammograms), which AstraZeneca's Missy Moran of the Mid-Atlantic Sales Team says offers the company an opportunity to not only support breast cancer education, but "can also be leveraged to enhance our presence in key accounts . . . Utilize this campaign to gain access and enhance selling opportunities for Arimidex, Abraxane, and Faslodex with your key accounts." The idea is for sales representatives to set up tables in waiting rooms and other areas ("chemo areas can be successful") and distribute pink flowers, information in pink Arimidex bags ("They will also be highly visible throughout the entire office"), and pink-iced cupcakes ("Refreshments and food will help attract patients to the table.").

The bloggers writing about this gave the impression that they think this initiative is tacky. They're also all men. Quite frankly, if I were a breast cancer patient and some cheerful people are handing me flowers and cupcakes on my way out of chemo, I'd be very happy about that (and having had a breast cancer scare in the past, this is not a topic far from my mind at times). I'm also enough of a cynic to understand that the flowers and cupcakes are not being given out just to make me feel happy. I realize that other people might not think the same way, though, and might ask their doctor about treatment with Arimidex even if it's not right for them.

But I don't think this initiative is truly tacky. Truly tacky is the tale that I heard once of an initiative by a sales representative from a top 10 pharmaceutical company - I am leaving out the company name and the name of the drug to protect the innocent in this admittedly anecdotal tale. If the tale is true (it was passed on to me from someone at the University of Pennsylvania Center for Bioethics), then this beats pink cupcakes all out. It seems that the rep went into the doctor's office with a tarp, a beach backdrop, and a sunlamp. She spread sand on the tarp, stripped down to a bikini, and sunbathed. The sign on the backdrop read, "[Our SSRI] is like a day at the beach." Allegedly this was a hit with the doctor, and the rep's idea, published in the department newsletter, got her a nice cash bonus that month.

This incident happened during the early '90s, I was told. Sales behavior like this seems to have been curbed over the years, as scrutiny of pharma has become more intense. I don't expect to see a sunbathing rep in the waiting room anytime soon, but let's hope tacky doesn't make a comeback, and that more internal and external policing of marketing departments will fend off borderline unethical sales tactics.

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AstraZeneca's Pink Cupcakes May Violate AMA Guidelines and HIPAA law

A few days ago I brought the story "AstraZeneca's Secret Oncology Plans: Sell Cancer Drugs to Patients with Pink Cupcakes" to you.

According to AstraZeneca's secret sales plan, the company planned to use the Chemo Injection area to serve pink cupcakes to patients.

AstraZeneca wrote, "Refreshments and food will help attract patients to the table. Cupcakes are easier for patients to handle and less messy than a cake. Have them made with pink frosting."

They also wrote, "Provide the small pink Arimidex bags for patients to fill with information. They will also be highly visible throughout the entire office."

There is only one problem with the pink cupcake program; not only do patients who get chemo feel nauseous and would rather vomit than eat pink cupcakes, the entire sales program may also violate the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and certainly violates American Medical Association (AMA) guidelines, unless patients sign a written authorization.

According to AMA guidelines, a sales representative may not willy-nilly sit in on any patient's exam or treatment: "A sales representative may sit in on a patient's exam or treatment only if the patient has signed a valid authorization expressly allowing the sales representative to do so."
And that's just not likely to happen. Here's why:

This is what a chemo treatment area looks like. It can often have ten or twenty patients getting treatment at the same time.

Anyone thinks the AstraZeneca rep is getting authorization from all these patients before serving cupcakes?

Ain't very likely.

And, according to the HIPAA Act, "covered entities must first obtain an individual's specific authorization before disclosing their patient information for marketing." Like "here is Mrs. Smith and she's getting chemo treatment." Can't disclose that. No way. Big violation.

And there's more:

HIPAA Violations and Enforcement: Failure to comply with HIPAA can result in civil and criminal penalties (42 USC § 1320d-5).

Criminal Penalties

In June 2005, the U.S. Department of Justice (DOJ) clarified who can be held criminally liable under HIPAA. Covered entities and specified individuals, as explained below, whom "knowingly" obtain or disclose individually identifiable health information in violation of the Administrative Simplification Regulations face a fine of up to $50,000, as well as imprisonment up to one year. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five years in prison. Finally, offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain or malicious harm permit fines of $250,000, and imprisonment for up to ten years.

Of course, I'm not sure how this will be interpreted, but doctors who let sales reps serve pink cupcakes to patients during treatment would appear to set themselves up for trouble.

You may wonder what's the difference between the chemo area and a waiting room. Well, in the waiting room you don't know for sure the patients' treatment, which is confidential information, per HIPAA.

Here's the guidance doctors get on how to follow HIPAA in the waiting room, per AMA:

"May a physician use a sign-in sheet? Call out names in the waiting area? Place charts outside a patient's room while the patient is waiting to see the physician?

Yes. To the extent these activities result in other people learning a patient's name or other information, the disclosure would be considered "incidental" to the physician's treatment of the patient, and therefore acceptable under HIPAA.

Physicians should take appropriate precautions to limit the amount of information that might be incidentally disclosed in this manner. For example, physicians should not ask patients to list "reason for visit" on a sign-in sheet. With respect to placing charts outside of an examination room or the patient's hospital room while the patient is waiting to see the physician, the physician should take precautions such as turning the front of the chart towards the wall so others do not have the opportunity to read the front page while walking past the room."

So, at a minimum, having any sales rep present in the Chemo Injection area, would appear to create the possibility for several violations. With or without pink cupcakes.

And, uh, one more thing-this program is ongoing right now, according to the AstraZeneca group of 7 whistleblowers.

THEY ALL HAVE TO DO FIVE OF THESE CUPCAKE PROGRAMS. THIS IS WHAT ASTRAZENECA WRITES: "TARGET AT LEAST 5 KEY ACCOUNTS" WITH THE PINK CUPCAKE PROGRAM.

AstraZeneca Wrap-Up? Or Not.

Jim Edwards over at Brandweek has the story and the timeline. Check it out, outstanding reporting.

And since AstraZeneca announced the end of its probe more documents have been revealed, like these ones: AstraZeneca's Secret Oncology Plans: Sell Cancer Drugs to Patients with Pink Cupcakes.

We'll see if this is really over when Congress and OIG are done with their part . . .

AstraZeneca's Secret Oncology Plans: Sell Cancer Drugs to Patients with Pink Cupcakes

AstraZeneca has had a lot of problems in the oncology area lately. Such as ZubeGate.

And now Question Authority can reveal how the company plans to "gain access and enhance selling opportunities for Arimidex, Abraxane, and Faslodex with your key accounts."

They'll use Mother's Day and unabashed selling direct to patients. Kind of like a Tupperware party or Avon cosmetics. Only AstraZeneca will use pink cupcakes to sell cancer drugs directly to patients in chemo treatment rooms.

Below are the secret selling plans, "for internal use only."

Here are a few selected quotes that say it all:

"MUMs, a unique breast cancer awareness campaign Mothers United for Mammograms"

"The MUM's Campaign can also be leveraged to enhance our presence in key accounts . . . Utilize this campaign to gain access and enhance selling opportunities for Arimidex, Abraxane, and Faslodex with your key accounts."

"Coordinate with all key account members in planning your programs/celebrations . . . Physicians, RNs, Social Workers to aid in patient involvement and leverage for future business opportunities."

"Display table location is key . . . Chemo area can be highly successful. Waiting rooms can restrict access to RNs and MDs."

"Refreshments and food will help attract patients to the table. Cupcakes are easier for patients to handle and less messy than a cake. Have them made with pink frosting. Coordinate with the office for refreshments. Some offices provide waiting patients with coffee and sodas."

"Provide the small pink Arimidex bags for patients to fill with information. They will also be highly visible throughout the entire office."

All of this from AstraZeneca Oncology, with luuuuve.