A pharmaceutical trade group has rated Massachusetts the worst state in which to pursue sales and marketing for the industry, in part because of a new law restricting the activities of sales representatives.
The National Association of Pharmaceuticals Sales Representatives said the new law, intended to help contain health care costs, will act to limit research and product-development initiatives and hamper innovation.
As residents of the Bay State, we here at Prescription Access Litigation wonder what we did to deserve this honor.
Now, what horrific restrictions on “research and product-development initiatives” does the new law impose on the industry?
It requires all pharmaceutical companies to disclose payments they make to health care providers that exceed $50. It requires the state Department of Public Health to establish a statewide code of conduct on marketing and gifts to health care providers. And it creates an evidence-based outreach and education program for prescribers.
That’s it. It doesn’t ban anything, prohibit anything, restrict anything. All it does is require disclosure of gifts to doctors. THAT’s what makes Massachusetts the worst state to pursue pharmaceuticalsales and marketing?
The National Association of Pharmaceuticals Sales Representatives must have forgotten all about the $1 billion gift that the taxpayers of this “worst state” just dropped in their lap back in June, the Massachusetts Life Sciences Initiative:
Governor Patrick signing the Mass. Life Sciences Initiative bill
The $1 billion will go to improve the “life sciences” infrastructure in Massachusetts, including tax incentives, grants, fellowships and other programs to promote research and workforce development that will certainly be beneficial to many of the pharmaceutical and biotech companies doing business in the state.
Here’s the text of the bill that imposed the $50 gift disclosure requirement.
Here’s what Health Care for All, a PAL coalition member and key supporter of the legislation, had to say back in September about pharma’s warning threat that drug and biotech companies would leave the state in response to the law:
Do you remember this phrase: “a direct and immediate devastating impact?” That’s from the full-page ad the biotech industry took out trying to convince the Governor to veto the comprehensive quality and cost bill, that included enforcement of the pharmaceutical and device industry’s own voluntary guidelines. You might also remember the letter from GlaxoSmithKline, threatening to leave the state if the law was passed.
Those of us that support the gift ban thought it was an empty threat at the time – particularly in light of the fact that the state had just pledged $1 billion to the industry.
And, it looks like we were right.
Monday, Governor Patrick will join Genzyme officials to open a $125 million science center, part of $250 million cell culture manufacturing facility. On Tuesday, UMass-Lowell will open its fully automated Massachusetts BioManufacturing Center facility. And last week, a study co-sponsored by the UMass Donahue Institute found that 85% of life sciences employers in the state actually plan to expand their in-state operations over the next two years.
But in NAPSR’s world, a modest disclosure requirement warrants a designation as the worst state in the nation, notwithstanding the $1 billion we just ponied up. Talk about ingratitude!
The National Coalition for Appropriate Prescribing (led by the Prescription Project - a sister organization to us here at Prescription Access Litigation) is working to pass the Physician Payments Sunshine Act, a transparency bill requiring pharmaceutical companies to publicly report their gifts and payments to doctors. The Senate version of the bill is
here and the House version is here.
Pharmaceutical and medical device industry marketing to doctors (well over $30 billion each year) takes the form of gifts, honoraria and other payments. This spending subtly and not-so-subtly induces doctors to prescribe newer and more expensive treatments, regardless of whether they’re better. This in turn drives up drug costs and puts patients at risk, because new and heavily marketed drugs are almost always more expensive, even though they are often no more effective than older, established therapies. Newer drugs may also have unknown side effects.
We believe the public deserves to know how much money individual physicians are accepting from industry. (Disclosure laws in Minnesota and Vermont reveal that many doctors receive industry payments of thousands or tens of thousands of dollars a year.) The Sunshine Act will benefit patients, payers, policy makers and taxpayers alike by creating transparency.
Key provisions include:
Comprehensive and publicly available reporting of information down to the individual prescriber level;
A low ($25) threshold for reporting; inclusion of all payments; and
Yesterday we blogged here (“Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge”) about Zyprexa lawsuits, particularly the state of Alaska’s (seeking to recoup the cost of treating Medicaid patients who took Zyprexa and whom Alaska alleges suffered diabetes and weight gain as a result) and the national class action in federal Court in New York, alleging that Eli Lilly (NYSE:LLY) illegally promoted Zyprexa for unapproved and unproven uses (so-called “off-label marketing.”)
Zyprexa’s success was due in large part to the enormous marketing campaign that Eli Lilly put behind it. Lilly’s pharmaceutical salespeople were the cornerstone of that effort. One former “sales rep,” Shahram Ahari, saw the error of his ways and now devotes his time to exposing the wrongs of pharmaceutical marketing and to supporting efforts to curtail that marketing.
Last night, he appeared on New England Cable News, talking about his experiences as a drug rep and what’s wrong with drug marketing:
Many readers may be familiar with Shahram as something of a YouTube celebrity for this clip as well:
There’s a bevy of opinion pieces and articles about drug marketing in the news today, mostly in the wake of the “Jarvik-row-gate,” the scandal concerning Dr. Robert Jarvik, Lipitor pitchman, being neither a licensed physician nor a practicing rower. We blogged on this story here and here.
Here’s a roundup, saving you the time of actually having to go read these pieces yourself. We aim to please here at the PAL blog.
In the Chicago Tribune today, Katie Watson, acting associate director of the medical humanities and bioethics program at Northwestern University’s Feinberg School of Medicine, opines about “a terrible disease — physician addiction to drug money.” She cautions against overfocusing on Dr. Jarvik and his lack of prescribing and rowing credentials, and recommends instead that “Congress should use his Lipitor endorsement as a catalyst for reviewing the larger issues it raises.”
She raises a point that we here at PAL and others have made in the past: That pharmaceutical advertising, nay, medical advertising in general, improperly turns “patients” into “consumers:”
Pharmaceutical advertising is a good place to start. This is typically called “direct-to-consumer” advertising, and the committee’s letter to Pfizer says it’s concerned that “consumers” may misinterpret Jarvik’s health claims. But consumers can’t buy prescription drugs, only patients can. Patients are people who make decisions with expert partners; consumers roam grocery stores picking cereal alone. Once patients were recast as consumers, prescription drugs could be advertised as if they were tennis shoes. It was just a matter of time before a celebrity pitchman turned a drug like Lipitor into Air Jarvik.
The pharmaceutical industry uses advertising to pull patients away from physicians — come in with your mind made up, and your physician is reduced to prescription writer. The industry undermines the other side of the patient-physician partnership by throwing money at physicians. This half of the divide-and-conquer strategy usually happens behind the scenes, but Pfizer’s partnership with Jarvik for mutual profit makes a widespread practice visible.
Business Week hosts a “debate” on the topic of “Halt the Pharma Freebies.” On the “Pro” side to ending pharma trips, meals and gifts is Dr. Philip A. Pizzo, from Stanford University Medical Center. He recounts Stanford’s adoption of policies in 2006 seriously restricting pharma access to doctors in the hospital:
In October, 2006, we enacted a policy across the Stanford University Medical Center campus, prohibiting our faculty members from accepting gifts of any kind, however small, anywhere on the medical campus or at off-site facilities where they may practice.
It also bars industry sales and marketing representatives from wandering the hallways of our two hospitals and our laboratories, and prevents companies from directly paying for meals in connection with educational programs—once a fairly common practice. It requires that those involved in the decision to buy formulary drugs or clinical equipment disclose any related financial interests….
Since our policy went into effect, many other academic medical centers have followed suit. As we train the next generation of physicians under these new standards, we will sow the seed for what could be a wholesale cultural change in the U.S. medical profession.
Our colleagues at The Prescription Project are working with numerous other academic medical centers to adopt policies similar to Stanford’s. They author the very fine blog, PostScript.
On the “Con” side is Ken Johnson, from PhRMA, who has the unenviable task of defending his industry’s positions. Unfortunately, his arguments fail to stray from the now-very-tired PhRMA playbook, and fly in the face of quite a bit of documented evidence.
So, despite what critics say, it’s insulting to suggest that doctors would prescribe treatments based on who gave them a slice of pizza, a pen, or a medical dictionary.
It might be insulting, but it doesn’t make it not true. Numerous studies document that even small gifts affect prescribing. (See, e.g. Physicians and the Pharmaceutical Industry- Is a Gift Ever Just a Gift? in JAMA from 2000. See also here for many more studies documenting this.) This is not a conscious quid pro quo (“Gee, that pizza the drug rep brought sure was good. I think I’ll prescribe her drug to the next patient I see.”) but rather a subconscious engendering of good feeling and goodwill. We are all prone to it, whether we went to medical school or not.
What’s more, there are regulations and a comprehensive industry ethics code to help make sure information about new treatments provided by America’s pharmaceutical research companies is accurate and well-substantiated.
To which I can only say, Ha. One need only browse the boards at CafePharma to read numerous tales of the thwarting, skirting and even outright ignoring of said regulations and codes of ethics.
Existing federal law is very clear: Pharmaceutical research companies and their technically trained representatives, including some health-care professionals, must not give physicians anything of value in exchange for the doctors writing prescriptions for their medicines. The companies must also ensure that information they convey to physicians is consistent with pharmaceutical product labeling approved by the Food & Drug Administration. The fact is, federal and state authorities, including the FDA, the Justice Dept., and state Attorneys General are closely monitoring for improper activities.
And guess what? That monitoring, and the work of brave qui tam whistleblowers, has brought to light countless examples of widespread improper activities in the past few years. Which suggests that perhaps, methinks, compliance is not fully robust.
For its part, the Pharmaceutical Research & Manufacturers of America (PhRMA) sponsors ethical guidelines to keep communications between its member companies and physicians focused on proper use of medicines and the needs of patients. The PhRMA ethics code says all forms of entertainment are inappropriate and only modest meals—such as sandwiches—should be provided when doctors meet with pharmaceutical research companies. Additionally, our code says items given to physicians should not exceed $100 in value and should be things, including stethoscopes and medical dictionaries, that benefit patients or support a medical practice.
Ah, voluntary guidelines, the pharmaceutical industry’s favored method to forestall true regulation and enforcement. These guidelines are not binding (except in California, which by legislation adopted them as state law), and there’s no enforcement for violations. PhRMA and their members liked these unenforceable physician gift guidelines so much that they used the same approach for drug advertising in their “”Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines.” These guidelines earned PhRMA one of PAL’s coveted “Bitter Pill Awards” in 2006: The Fox Guarding the Henhouse Award: For Pushing Toothless “Guiding Principles” on Drug Advertising.
In the end, it’s clear pharmaceutical research companies have the most extensive information about new medicines. After all, they devote 10 to 15 years and spend nearly $1 billion to develop just one new medicine in a process that generates thousands of pages of scientific data.
They also have the greatest incentive to “spin” their drugs, by withholding negative information and clinical trial results (ahem, Zetia/Vytorin anyone?), by pushing on doctors medical journal articles that show their drug only in the most favorable light, etc. And PhRMA, please stop trotting out the tired $1 billion figure for new drug development. Merrill Goozner handily refuted that myth in his book The $800 Million Pill (back when PhRMA was only claiming it cost $800M for a new drug) and continues to do so on his excellent blog GoozNews.
Over at HOI-19 News (an ABC affiliate), there’s a story called “Drug Pitch Police.” It begins by reciting, mostly unquestioningly, PHrMA’s claims about drug marketing and the costs of drug development, but then gives a description of the Independent Drug Information Service (IDIS), a program that is providing “counter-detailing” or “academic detailing” to physicians in Pennsylvania. These “academic detailers,” mostly nurses and pharmacists, provide a vital counterbalance to the self-serving and slanted messages of the drug company sales reps. They provide doctors in PA with information about the true effectiveness and cost-effectiveness of various drugs, in order to both reduce costs to Pennsylvania’s Medicaid program and improve treatment.
The Roanoke Times has an editorial today calling on Congress to “Pull the Plug on Drug Ads.” It talks about the House Committee on Energy and Commerce looking into Dr. Jarvik’s bona fides and says, among other things:
The committee is compiling information and will most likely head on down the rabbit hole of “celebrity endorsements.” Instead, it ought to be looking at the bigger picture: It is unwise to allow pharmaceutical companies to continue direct marketing to consumers whether they feature Jarvik or a next-door neighbor…The House committee should be persuaded to go much further than looking at deceptive marketing and, instead, renew the ban on marketing to consumers.”
That’s it, folks, a busy day for those holding forth on drug marketing. What do you think? Good points? Bad points? Beside the point? Let us know in the comments.
A new study conducted by Harvard University researchers at Cambridge Health Alliance bucks an important piece of conventional wisdom about prescription drug samples: They don’t primarily go to low-income and uninsured people — in fact the study found the opposite: “Most free drug samples go to wealthy and insured patients and are not used to ease the burden of the poorest nor the uninsured,” said the press release on the study (below).
Most doctors and even most patients think of drug samples as benign, and even beneficial. After all, what’s wrong with getting your prescription drug, even the first few days’ or a month’s supply, for free? But this ignores several key facts:
Drug samples are almost always for the newest, most expensive brand-name drugs. They are a way to introduce doctors to these newer, costlier drugs, even if they don’t offer any advantage over older, less expensive drugs, especially generics. Newer drugs have less of an established record of safety than older drugs – One of the authors of the study says in the press release below “we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy.”
Drug samples are primarily a marketing tool. They are part and parcel of the overall sales pitch aimed at doctors — a pitch delivered by the same drug salespeople who drop off the samples, provide free lunches for the staff, invite the doctor to a “continuing medical education seminar” at a fancy restaurant, and ply the doctor with reprints of medical journal articles casting the company’s drug in the most positive light possible.
Drug samples affect prescribing. Doctors tend to continue patients on drugs that are working for them. If the patient starts on Expensive Brand Name Drug X because that’s the sample that was in the Doctor’s cabinet, and it works for them, then they’re likely to continue on that drug, even if Inexpensive Generic Drug Y would have worked just as well. Brand-name drug companies know this, and that’s why they spend billions a year providing samples to doctor’s offices. It’s not feasible for generic drug companies to provide samples, because they can’t guarantee that the patient would get their particular version of the generic when they later fill a prescription at a pharmacy. So drug samples lead to overuse of expensive brand-name drugs and millions in unnecessary spending.
Doctors often justify allow drug salespeople into their offices because of drug samples, and justify accepting drug samples on the notion that they help their needy or uninsured patients. Today’s study undermines that justification, at least on an aggregate basis.
Interestingly, the study pointed to differences in health access and insurance coverage to explain why wealthier and insured patients get more drug samples:
“Free sample receipt was consistently higher among those with better access to medical care. Non-Hispanics, English-speakers and Whites were all more likely to receive free samples than were members of ethnic, linguistic or racial minorities. Receiving medical care in an office and taking more medications also increased an individual’s chances of receiving free drug samples.”
NPR did a story on the study today, and interviewed a representative from PhRMA, the brand-name drug industry’s trade association. That PhRMA rep was quick to point out that drug companies don’t consider samples to be a way to help low-income or uninsured patients — and instead pointed to drug company patient assistance programs as serving that purpose.
There are some moves afoot to put generics on a more equal footing with brand-name drugs at the doctor’s office. More and more health plans are charging their members zero copayments for generics. In our 2006 Bitter Pill Awards, we gave a “Real Deal Award” to MedVantx, a company that places “generic sample cabinets” in doctors’ offices. Doctors are able to give a patient an initial supply of a generic drug, and thus have an alternative to the marketing-oriented brand-name samples that drug companies ply.
Here’s the press release from the researchers who performed the study:
Most Free Drug Samples go to the Wealthy and Insured
-First of its Kind Study from Harvard Medical School Researchers at Cambridge Health Alliance Finds Few Samples Distributed to Poor and Uninsured-
Cambridge, MA……Most free drug samples go to wealthy and insured patients and are not used to ease the burden of the poorest nor the uninsured, according to a study by physicians from Cambridge Health Alliance and Harvard Medical School. The study, which is the first to look at free drug samples nationally, will appear in the February 2008 issue of the American Journal of Public Health.
The study found that use of free prescription drug samples is widespread. More than one out of every ten Americans received one or more free drug samples in 2003. Among Americans who take at least one prescription drug, nearly one out of five got free samples.
Few free samples went to the needy. Insured Americans and those with higher incomes were more likely to report receiving at least one free sample. More than four-fifths of sample recipients were insured all year. Conversely, less than one-fifth were uninsured for all or part of 2003, and less than one-third had low family incomes (under $37,000 for a family of four).
Free sample receipt was consistently higher among those with better access to medical care. Non-Hispanics, English-speakers and Whites were all more likely to receive free samples than were members of ethnic, linguistic or racial minorities. Receiving medical care in an office and taking more medications also increased an individual’s chances of receiving free drug samples.
Author Sarah Cutrona, a physician at Cambridge Health Alliance and an Instructor of Medicine at Harvard commented: “The distribution of free samples has become very controversial. Evidence shows that free samples may influence physicians’ prescribing behavior and cause safety problems. For instance, we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy.”
Dr. David Himmelstein, senior author of the study, a physician at Cambridge Health Alliance and an Associate Professor of Medicine at Harvard adds: “We know that many doctors try to get free samples to needy patients when those patients come into the office. We found that such efforts do not counter society-wide factors that determine access to care and selectively direct free samples to the affluent. Our findings strongly suggest that free drug samples serve as a marketing tool, not as a safety net.”
“Free drug samples are not the solution to the disproportionately low amount of health care resources going to the poor and uninsured; they are part of the problem,” said Dr. Steffie Woolhandler, a physician at Cambridge Health Alliance, Associate Professor of Medicine at Harvard, and study co-author.
The study used data on 32,681 US residents from the Medical Expenditure Panel Survey (MEPS), an annual federal survey. Dr. Cutrona’s work on the study was supported under a National Research Service Award.
Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis published in American Journal of Public Health http://www.ajph.org/ February 2008, Vol 98, No. 2. Authors: Sarah L. Cutrona, MD, MPH, Steffie Woolhandler, MD, MPH, Karen E. Lasser, MD, MPH, David H. Bor, MD, Danny McCormick, MD, MPH, and David U. Himmelstein, MD.
Our friends over at PostScript, the blog of the Prescription Project, got in to the holiday spirit last week with a Christmas Carol about the joys of drug sales people pitching their drugs to Doctors, with the aid of data and information sold to them by the American Medical Association (AMA). Here it is. Enjoy!
Here in PostScript country, we’re up to the shins in snow and to the gills with yuletide spirit, so we thought we’d turn all that merriment toward something else that’s on our minds…
[cues orchestra]
A Data-Mining Carol
[to the tune of Jingle Bells]
Dashing through the wards, with a briefcase in his hand,
The rep signs in and waits, then shakes the doctor’s hand
But this is no plain pitch,
He knows just what to say,
Because he knows just how much Doc wrote
Of Seroquel last May
Oh –
Data sells, the reps can tell
How well their free lunch pays
But docs don’t know how much is shown
On a rep’s handheld display, hey
Prescriptions filled, providers billed,
The rep calls it a day,
Oh how tough his job would be
Without the AMA!
A recent and welcome addition to the pharmaceutical blogosphere is PostScript, the blog of The Prescription Project (a sister project of Community Catalyst, which is PAL’s parent organization). PostScript has been featuring a series of fascinating interviews with various medical professionals, on the topic of medical ethics and interactions with the pharmaceutical industry. The latest is “How Hooked Happened: a conversation with Howard Brody, M.D.” Dr. Brody is author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Have a look. Here’s a good quote from that interview. I’ve bolded the particularly juicy parts:
Reform has to be a two-pronged thing. First, a professional level of reform: individual physicians growing a certain underdeveloped piece of anatomy….we need our professional spines to be strengthened. And the second piece is regulatory reform: We need to take back medical research from the pharmaceutical industry. There’s got to be some accounting for the bennies [ed: benefits, that is] that these contract research organizations and investigators get from the drug companies.
The public simply cannot demand further tax cuts unless they confront the fact that they are selling medical integrity to the hands of private industry. I think that means we are going to have to pay so that science remains a public good, and not property of the commercial outfits.
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