Last week, the American College of Physicians (ACP), a 129,000-member group of internal medicine physicians, and second-largest doctors group in the US, called for increased FDA authority and funding to help protect consumers from the risks of newly-approved prescription drugs. Their six recommendations were:
1) increased funding for FDA staff and technological capability to keep pace with the increased workload due to the number and scientific complexity of new products submitted for pre-approval, globalization, and emerging safety challenges.
2) increased FDA authority and capacity to regulate drugs manufactured outside the US;
3) expanded FDA authority and involvement in the design of clinical trials to better evaluate safety and efficacy, through longer trials with larger, more representative target populations;
4) a ban on clinical studies of ‘bundled’ drug products that reduce access to drugs;
5) Improvements that increase reporting of adverse events by doctors and others; and
6) limits on direct-to-consumer advertising in the first 2 years a drug is on the market.
Increased FDA funding:
The ACP report notes that FDA’s “ability to approve and monitor new drugs has been compromised by chronic underfunding, limited regulatory authority, and insufficient organizational structure.” ACP recommends that FDA funding is increased, to improve their “ability to approve and monitor prescription drugs….”
Regulating drug manufacturing overseas:
The ACP should be praised for bringing attention to severe under resourcing at FDA, particularly as it affects the Agency’s ability to ensure the safety of drugs manufactured overseas. Today’s globalized pharmaceutical supply chain has rapidly outgrown FDAs capacity, and FDA is not able to inspect foreign sites with any meaningful frequency. A 2008 GAO study found it would take FDA 13 years to inspect each foreign manufacturing establishment once, while domestic sites are inspected on average every 2.7 years.
ACP points out that a provision for increased foreign inspections were included in a bill (H.R.759) introduced by Reps. Dingell, Pallone and Stupak in January this year. A similar bill (S.882) championed by the late Senator Kennedy and Senator Grassley also seeks to increase foreign site inspections by FDA. Both bills establish new industry user fees to pay for this expanded oversight, but also require annual increases in other appropriations to ensure sustainability. ACP importantly indicates that both types of financial support are needed, and mentions a number of other key provisions in the House bill, including a requirement for dedicated foreign inspection staff.
Facilitating increased physician reporting of adverse events:
The ACP also recommends FDA pursue efforts to “educate physicians on how and when to report an event that is potentially drug-related.” They also proposed streamlining the reporting systems and ensuring anonymity to “facilitate reporting by health professionals.”
DTC advertising of new drugs:
The report acknowledges that direct-to-consumer (DTC) advertising can “dramatically increase [use] of a new drug and … may expose large numbers of people to a drug with undocumented safety concerns.”
The best example of this concerns was seen in the rapid use of the pain-killer Vioxx upon hitting the market. The aggressive DTC advertising and other promotional activities by manufacturer Merck lead to Vioxx’s use by over 20 million consumers, which then lead to 88,000-139,000 cardiac events, and an estimated 35,000-55,000 deaths. Adverse reactions and safety concerns arose with the drugs Zyprexa and Bextra, among many others
To address this concern, ACP recommended that FDA ‘limit’ the DTC advertising of newly approved prescription drugs, and require that labels and ads indicate that data related to the new drug’s “risks and benefits … are less extensive than those [for older] products…”
Prohibiting clinical trials of ‘bundled’ products:
In addition, ACP also makes a recommendation that would help FDA avoid placing itself in the position of helping drug manufacturers introduce ‘bundled’ or combination drug products designed to protect a drug from generic competitors.
For example, the report describes how, in 2005, the drug manufacturer “Pfizer submitted plans to the FDA to begin conducting large trials to test the cholesterol drug torcetrapib in combination with the popular and widely used statin Lipitor.” By allowing clinical trials of the ‘combination drug’ rather than just torcetrapib alone, approval of the new combination drug product would insulate Lipitor from competition. This then puts FDA, in approving the study design, in the awkward position of helping the drug manufacturer avoid anti-trust prohibitions, the report said.
This concern is similar to the claims in the PAL member lawsuit on the drug Norvir, where drug manufacturer Abbott Labs bundle their HIV protease inhibitor cocktail drug Norvir in a new bundled-product-drug Kaletra, in order to increase market share.
ACP recommends that FDA not approve clinical trials which seem to be designed to ‘bundle’ a new drug with an existing brand name drug, and thus perpetuate the patent-protected sales of the new combination product.
Today, the 1st Circuit Court of Appeals issued a decision in IMS v. Ayotte, the case challenging New Hampshire’s Prescription Confidentiality Act, which prohibits the commercial use of prescriber data, including for pharmaceutical detailing. The Court unanimously upheld the law, finding that it did not violate the First Amendment. The opinion weighed in at a hefty 148 pages.
The Act sought to prohibit the practice of “datamining” for the purpose of pharmaceutical marketing: pharmacies sell doctors’ individual prescribing data (what drugs the doctors prescribed, when, and how often) to companies that aggregate such data. Those companies then sell prescribing “profiles” of individual physicians to drug companies, whose salespeople can then use that information to tailor the “pitch” that they use in marketing their drugs to those doctors. For instance, if a doctor has been prescribing a competitor’s drug, they might tailor the sales pitch to talk about why their drug is allegedly superior.
IMS Health, a company that collects and sells pharmacy data on doctors’ prescribing practices, sued the state of New Hampshire before the ink was barely dry on the law. They alleged that it violated their First Amendment rights. In April 2007, the U.S. District Court for the District of New Hampshire agreed, and struck down the law. The State of New Hampshire appealed the decision to the 1st Circuit Court of Appeals, which heard the appeal in January 2008.
Sean Fiil-Flynn, who represented PAL’s parent organization Community Catalyst, as well as AARP, National Legislative Association on Prescription Drug Prices, National Physicians Alliance, New Hampshire Medical Society, and Prescription Policy Choices in filing an amicus brief before the 1st Circuit, gave an excellent analysis of the decision and its ramifications:
The court unanimously upheld the New Hampshire law. The majority found that the act does not regulate speech, but rather regulates only the conduct of health information companies that aggregate and sell prescription records. The concurrence concluded that the Act does affect speech of pharmaceutical marketers, but the regulation is nonetheless justified by the state’s overriding interest in promoting cost containment in the pharmaceutical sector.
This is an important decision for data privacy advocates. 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.”
The 148 pages of analysis exhaustively analyses the voluminous evidence amassed by New Hampshire demonstrating the negative effects on our health care system of allowing pharmaceutical marketers to use prescription record tracking to target their marketing efforts.
The court affirmed that states have a valid interest in regulating the use of prescription records to target marketing to doctors. The court found that the use of such information to identify doctors who prescribe lower cost drugs and target marketing campaigns at them has a demonstrable impact on pharmaceutical spending that states are not disempowered to respond to. Access to individualized prescription data also allows companies to target gifts, consultancies and other perks to their most favored physicians, in effect incorporating prescribers into the commission structure of their sales forces. These practices debase the medical profession and, the more the practices become public, break the chain of trust between doctor and patient.
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
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.
Pfizer’s commercials for Lipitor featuring Dr. Robert Jarvik, “inventor of the artificial heart,” are probably among the most recognized drug ads on TV today. The ads rely on us viewers assuming that because Dr. Jarvik supposedly invented the artificial heart, he must be an authority on cholesterol… Right? The ad above has Dr. Jarvik saying “Just because I’m a doctor doesn’t mean I don’t worry about my cholesterol.”
Hmmm… What if the ads also said that Dr. Jarvik never actually practiced medicine, and in fact never even got licensed to practice medicine? Suddenly, he doesn’t seem like that much of an authority, does he?
Well, apparently that is the case. The Energy and Commerce Committee of the US House of Representatives is investigating “the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials,” according to the Committee’s press release:
Washington, D.C. – Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, announced today that they are opening an investigation into the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials.
“We are concerned that consumers might be misled by Pfizer’s television ads for Lipitor starring Dr. Jarvik,” said Dingell. “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.”
“Dr. Jarvik’s appearance in the ads could influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States,” said Stupak. “Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break.”
It’s not surprising that Pfizer chose Dr. Jarvik as its spokesperson. In the past three years, we’ve seen a stampede of white coats in drug ads — either actual doctors or actors dressed up like doctors. The white coat conveys authority and gravity to the ads.
But there’s something very bothersome about using a “Doctor” who has no license to practice medicine, and who in fact apparently has never done so, to advertise Lipitor. And that is the fact that particularly when it comes to cholesterol medications, the prescribing details matter. The decision of whether to prescribe a statin (such as Lipitor, Crestor, Zocor, Pravachol, etc.) and which statin to prescribe are ones that require a fair amount of knowledge and experience on the part of the doctor — different patients need different statins, different statins have different side effects. So who should use Lipitor -versus another statin or even versus just changes to diet and exercise – are complicated questions requiring doctors to know a fair amount. Yet Pfizer has Dr. Jarvik, who can’t even practice medicine, advising consumers to take Lipitor!
It’s a measure of what Pfizer thinks of us lowly consumers that they use a celebrity doctor spokesperson who can’t even prescribe the product they’re endorsing.
What with the recent flap over Montel Williams, PhRMA’s patient assistance spokesperson, threatening to “blow up” a high school student, and now the revelation about “Doctor” Jarvik, it makes us wonder whether celebrities are the best choice for drug ads…
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.
The FDA Division of Drug Marketing, Advertising, and Communications has issued one of its increasingly rare enforcement letters, calling Eli Lilly (NYSE:LLY) to task for overstating the efficacy of its drug Cymbalta in a “professional mailer” sent to physicians. The letter said:
This mailer is false or misleading in that it overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use. Therefore, the mailer misbrands the drug in violation of Sections 502(a) and 201(n) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations.
Sending so-called “untitled” letters, like this one, and the theoretically more serious “warning letters” have traditionally been the FDA’s only power to do anything deceptive drug advertisements and promotional materials. Under the FDA Amendments Act of 2007 recently signed by President Bush, the FDA has gained the power to impose monetary “civil penalties” for violations of the regulations concerned drug ads — up to $250,000 per violation, (“up to” being the operative words here) maxing out at $500,000 for a single company in a three year period. Arguably these fines, if the FDA ever actually musters up the gumption to impose them, are a slap on the wrist.
But will the FDA use them? The FDA’s number of enforcement letters has dwindled to a trickle over the past 8 years. This year, letters have hit an all-time low: While the FDA has issued 14 letters so far in 2007 concerning promotions to physicians, here’s how many they’ve issued to drug companies regarding direct-to-consumer ads:
One!
That was a slap on the wrist for Takeda Pharmaceutical’s ad for the sleep aid Rozerem — and even calling it a slap on the wrist is perhaps overstating it — the ad had a “back to school” theme (i.e. August/September) – and the FDA’s letter was issued in March!
Perhaps the fees that the FDA is now able to collect from drug companies for reviewing drug ads (a power also gained under the recently-enact FDA Amendments Act) will permit the FDA to hire more advertisement reviewers (right now they are woefully understaffed, given the 50,000+ promotional materials filed with the FDA every year). That in and of itself will not mean that the FDA will use its new powers… Only political will can do that, and so far there’s precious little evidence of that at the FDA…
Here’s the FDA’s letter: Here’s the promotional mailer they were concerned about.
P.S. The mailer asked Physicians receiving it to fill it out a survey — in exchange for which they’d receive this handsome simulated leather letter tray! Classy… And oh so “practice related.”
Great post up on Slate right now, “Under the Influence? Drug companies, medical journals, and money,” by Kent Sepkowitz. In it, Dr. Sepkowitz describes the disclosures that medical journals require their authors to go through regarding any financial relationship with or interest in the company about whose products they’re writing. But, he points out, what’s lacking is a little disclosure from the journals themselves, which reap significant sums of cash from drug company advertising, purchases of “reprints” of favorable articles to hand out to doctors, and non-peer-reviewed “supplements” sponsored by advertisers.
He recommends:
And so I have a modest suggestion: In addition to requiring authors to post conflict-of-interest statements when they publish an article, medical journals should tell readers how much revenue they themselves have received in the previous year from the company producing the drug or device under discussion. The total sum should include not just advertising pages purchased, but also the other ways that industry money can slip into journal pockets, by buying reprints and journal supplements. Show us the actual dollar (or euro or pounds sterling) amount. And if a professional society sponsors the journal, tell us about its financial dealings with the drug companies as well.
Such disclosures would take work, annoy scads of people (most of them honorable), and be completed under protest. But they’re worth it, to help assure the integrity of medical literature. Just as compromised relationships are unusual among researchers, they are likely, in the end, to be unusual among medical journals. But it is naive to think that only authors are influenced by who is writing the checks.
An excellent op-ed ran this week in the San Francisco Chronicle, “Prescription mining raises millions for doctors’ group.” It highlights the American Medical Association’s sale of physician profiles and data to drug companies, to help those drug companies convince doctors to prescribe the most expensive brand-name drugs over cheaper and often equally effective older and generic drugs.
As the op-ed points out, most doctors aren’t even aware that their information is sold — not just by the AMA, but by pharmacies as well. When one of the 100,000 drug salespeople that blanket the country enters a doctor’s office, they know exactly how many prescriptions the doctor has written for their drug and for those of their competitors. And they know how the doctor’s prescribing habits changed since their last visit — so they can figure what messages worked, and didn’t work, with that particular doctor.
If most doctors aren’t aware of this, you can be sure that most patients aren’t aware of it either. Drug companies try to portray their salespeople as providing an “informational” and “educational” service, but that’s a red herring. The goal of the salesperson to sell their drug — not to educate the doctor on the most effective and cost-effective treatment.
It’s high time that doctors kicked the drug salespeople out of their offices and instead relied on independent information about drugs. Some doctors and medical centers have done just this. Getting Academic Medical Centers to adopt better policies about drug salespeople is one of the goals of the Prescription Project, whose director, Rob Restuccia, is one of the authors of this op-ed. (The Prescription Project is a project of Community Catalyst, which is also PAL’s parent organization)
No Free Lunch now has a directory of doctors who refuse to see drug salespeople — go here to check to see if your doctor’s name is in it. If he or she isn’t, why not ask them to take the no-drug-salespeople pledge at your next appointment?
Here’s the op-ed that ran this week:
Prescription mining raises millions for doctors’ group
Robert Restuccia and Lydia Vaias
Wednesday, July 25, 2007
Drug companies care about what your doctor prescribes just as much as you do – and they’re paying big money to find out. They are paying so much, in fact, that even though the vast majority of physicians disapprove of the sale of their personal prescribing data for marketing purposes, the American Medical Association persists in selling detailed physician information to the pharmaceutical industry. This data must be used for legitimate public health research – not brand promotion.
Drug ads cover doctors’ offices, coating everything from wall calendars and paperweights to stethoscopes and prescription pads. The numbers show that these advertisements work: doctors are prescribing more brand-name, higher-cost drugs than ever before.
One of the less obvious but more intrusive marketing tools is the drug rep’s hand-held computer, which contains a detailed profile of your doctor’s prescribing history. Armed with the knowledge of each doctor’s individual prescribing habits, pharmaceutical sales representatives tailor their pitches to each physician. This strategy has resulted in new, costlier drugs replacing established medications that have proven histories of safety and effectiveness. Industry profits swell, as do the nation’s health care costs.
Few people recognize the role the AMA plays in making physician information available to companies that use it for pharmaceutical marketing purposes. The AMA sells information from its physician “Masterfile” to health information organizations that pair the identifying information with prescribing records from pharmacies and sell the whole package to pharmaceutical companies, a practice commonly called “prescription data-mining.”
The AMA profits handsomely from this agreement. In 2005, the AMA made more than $44 million from the sale of database products, approximately 16 percent of its budget. It comes as no surprise, then, that the sale of prescriber information failed to make the formal agenda when AMA delegates met in Chicago last month.
Yet among physicians there is a growing and vigorous debate about the appropriateness of this practice and its enhancement of pharmaceutical marketing. Despite representing less than 30 percent of all U.S. doctors, the AMA keeps identifying information on all licensed physicians – and sells it all. Even so, only 60 percent of physicians surveyed by the Kaiser Family Foundation were aware of the sale of their information. Once told, 74 percent disapproved. Even a survey by the AMA itself found a 66 percent disapproval rate.
A number of policymakers, physician groups and medical societies have come out against this practice in recent years. Leaders include the National Physicians Alliance, the American Medical Student Association, the Vermont Medical Society and the New Hampshire Medical Society. Unfortunately, the AMA has a financial incentive to keep selling this information without regard to how it is being used or the impact it has on patient care and health-care costs.
A growing number of states have taken measures to end data mining because the AMA will not. Maine and Vermont recently passed legislation banning the sale of information detailing what drugs doctors are prescribing their patients while New Hampshire, the first state to pass such legislation, saw the data mining companies challenge the law. A federal court overturned the law banning the sale of prescription information “on free speech” grounds and the case in now being appealed by New Hampshire.
Last year, in response to this growing pressure, the AMA created an “opt-out” measure, called the Prescribing Data Restriction Program. Difficult to navigate, poorly publicized, with only a quarter of physicians are aware of it, and used by less than 1 percent of doctors, the opt-out program is a step toward reform, but a small and inadequate one. The program does not bar the sale of prescriber information to pharmaceutical companies; it merely requests and then relies on the industry to prevent the transmission of this data to its sales teams.
By continuing to profit from the sale of physician data, the AMA has shown itself to be at best, slow-to-act, and at worst, opportunistic at the expense of professional boundaries. The AMA should put medical ethics before profits and stop licensing its Physician Masterfile for pharmaceutical marketing purposes.
Robert Restuccia is the executive director of the Prescription Project, a national initiative supported by the Pew Charitable Trusts to end conflicts of interest created by the pharmaceutical industry’s marketing to physicians. Lydia Vaias serves as president of the National Physicians Alliance and is a board-certified general surgeon on staff at Kaiser Permanente Hospital in Bellflower (Los Angeles County).
A major victory occurred today in the massive Average Wholesale Price lawsuit in the U.S. District Court for the District of Massachusetts. PAL’s press release on this is below. To learn more about this case, go here.
Federal Court Rules Against Three Drug Companies in Average Wholesale Price Case
Judge finds Astra Zeneca, Bristol-Myers Squibb and Warrick acted “Unfairly and Deceptively”
BOSTON, MA – Today, Prescription Access Litigation (PAL) and Hagens Berman Sobol Shapiro LLP announced a landmark victory in a prescription drug lawsuit brought by members of PAL and others. Judge Patti Saris, of the U.S. District Court for the District of Massachusetts, found that AstraZeneca (NYSE: AZN), Warrick (a subsidiary of Schering-Plough (NYSE: SGP)) and Bristol-Myers Squibb (NYSE: BMY) violated the Massachusetts consumer protection act, Chapter 93A, by reporting false “Average Wholesale Prices” for a number of prescription drugs, including physician-administered drugs for cancer.
The “Average Wholesale Price,” or AWP, is a benchmark figure reported by drug manufacturers to commercial publications that publish compendia and electronic databases of prescription drug prices. Health plans, government health programs such as Medicaid and other “third party payors” use these AWP figures to determine how much to pay doctors and pharmacies for drugs which are given to their members and insureds.
The lawsuit is part of a much larger case, In re Pharmaceutical Industry Average Wholesale Price Litigation. Dozens of defendants, including the largest drug companies in the U.S., are alleged to have reported inflated and inaccurate AWPs for drugs covered by Medicare Part B, in order to increase sales of their drugs. Until 2003, Medicare reimbursed doctors for these drugs using a formula based on the AWP. However, the amount it cost doctors to purchase these drugs was much lower than the amount Medicare reimbursed them. Doctors profited from the difference, known as the “spread.” The defendants in this suit are alleged to have “marketed the spread” by artificially inflating the AWP so as to increase the amount the doctor would keep as profits by purchasing that company’s drug as opposed to a competitor’s.
Medicare Part B pays 80% of the cost of drugs that are administered in a doctor’s office as well as a small number of self-administered drugs, such as asthma drugs used with a nebulizer. The remaining 20% is paid by individual Medicare recipients or by supplemental insurance, known as “Medigap” plans. Today’s ruling benefits health plans and consumers in Massachusetts who paid part or all of that 20%, as well as health plans that paid for these drugs for patients not enrolled in Medicare.
“Today’s decision rights a great wrong that was done by these three companies against some of our society’s sickest and most vulnerable patients,” said Alex Sugerman-Brozan, director of Prescription Access Litigation. “What could be more outrageous than taking advantage of cancer patients in the name of profits?” One of PAL’s coalition members, Pipefitters Local 537 Trust Fund, is a plaintiff in the case.
The Court found that the three defendants caused the publication of false and inflated Average Wholesale Prices for seven drugs:
• Astra Zeneca: Zoladex
• Bristol Myers Squibb: Taxol, Vepesid, Cytoxan, Blenoxane and Rubex
• Warrick: albuterol sulfate
“Prescription drugs are one of the fastest growing cost drivers in health care,” said John McDonough, Executive Director of Health Care For All, a Massachusetts advocacy group which is a member of the PAL coalition and a plaintiff in another part of the AWP case, “This decision puts drug companies on notice that they can’t get away with burdening the health care system by illegally and artificially increasing those costs.”
Although government programs (including Medicare Part B and Medicaid) are abandoning AWP, virtually all private health plans and insurers still use it. Today’s Court decision and a settlement in another lawsuit will help push these third party payors towards other benchmarks. In October 2006, a separate case brought by two PAL coalition members against First Databank, the main publisher of AWPs, was settled. In that settlement, First Databank agreed to roll back the AWP spreads on hundreds of drugs, and to stop publishing AWP data within two years of the settlement becoming final.
“This Court decision is yet another nail in the coffin of Average Wholesale Price,” said Sugerman-Brozan. “The day is long overdue for our health care system to pay for drugs based on real and accurate data, rather than on fictitious figures made up by drug companies that are more concerned about profits than patients.”
This summer, trials begin in another phase of this massive AWP litigation, with a trial set to begin in July against Bristol Myers Squibb on behalf of a nationwide class of individual Medicare beneficiaries. Steve Berman, lead attorney in the case and managing partner of Hagens Berman Sobol Shapiro LLP, said “We are looking forward to continuing the prosecution of this case against the remaining defendants who perpetrated similar if not identical wrongs against patients and insurers nationwide. We view this ruling as a big win that should serve notice to all defendants that they will be called to account for their wrongdoing.”
About PAL
Prescription Access Litigation (PAL) (www.prescriptionaccess.org) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups in 35 states and the District of Columbia fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. Since 2001, PAL members have filed 28 sets of lawsuits targeting such practices. News about PAL’s cases and public education efforts is published regularly on the PAL Blog at www.prescriptionaccess.org/blog
About Hagens Berman Sobol Shapiro LLP
The law firm of Hagens Berman Sobol Shapiro LLP is based in Seattle with offices in Chicago, Cambridge, Los Angeles, Phoenix and San Francisco. Since the firm’s founding in 1993, it has developed a nationally recognized practice in class-action and complex litigation. Among recent successes, HBSS has negotiated a pending $300 million settlement as lead counsel in the DRAM memory antitrust litigation; a $340 million recovery on behalf of Enron employees which is awaiting distribution; a $150 million settlement involving charges of illegally inflated charges for the drug Lupron, and served as co-counsel on the Visa/Mastercard litigation which resulted in a $3 billion settlement, the largest anti-trust settlement to date. HBSS also served as counsel in a $850 million settlement in the Washington Public Power Supply litigation and represented Washington and 12 other states in lawsuits against the tobacco industry that resulted in the largest settlement in the history of litigation. For a complete listing of HBSS cases, visit www.hbsslaw.com.
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