This past Wednesday, the Prescription Project, a sister project to PAL at our parent organization, Community Catalyst, filed four petitions with the FDA raising concerns about online advertising of medical devices and drugs on YouTube.com. The petitions cited ads posted on YouTube by Abbott Laboratories (NYSE: ABT), Medtronic (NYSE: MDT) and Stryker (NYSE: SYK).

Within hours, the two videos about Medtronic and Stryker’s devices cited by the Prescription Project were removed, and the remaining videos about an Abbott Laboratoriess device were labeled with safety information, and removed from public access the next day.

The Prescription Project’s petitions have gotten widespread media attention, including articles in the Wall Street Journal, Associated Press, Crain’s Chicago Business, Chicago Tribune, Minneapolis Star Tribune, and Pioneer Press.

The Prescription Project’s press release on the petition is here.

Here is the entry from PostScript, the Prescription Project’s blog, about the request for FDA action:

Devicemakers’ bypass marketing rules on YouTube
December 3rd, 2008

Today the Prescription Project filed a series of citizen petitions with the FDA asking that six YouTube videos be removed immediately from the self-broadcast internet supersite because they appear to have been posted by medical device manufacturers, but do not contain the federally-mandated warnings or provisions required of medical device advertisements.

The videos include four posted by Abbott Laboratories about its XIENCE-V drug eluting stent, one for Medtronic’s Prestige® Cervical Disc, and one for Stryker’s Cormet™ Hip Resurfacing Technology. Here they are.

The Prescription Project is petitioning the FDA, which is charged with regulating the marketing of approved medical devices as well as prescription drugs, to require the makers to remove the ads from YouTube immediately and to post “curative” ads that contain the proper risk information. In addition, the Project calls on the FDA to:

• Advise all major prescription drug manufacturers and medical device manufacturers that online/Internet drug and device advertisements and promotions are subject to the same requirements as drug and device promotions in other media, and recommend that they review their online advertisements for compliance.

• Issue a Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet to clarify how federal law and FDA regulations apply to online drug and device promotions.

But who watches YouTube for info about health, anyway? Well, it seems that number is growing rapidly. According to a 2007 survey conducted by the Pew Internet and American Life Project, somewhere between 75% and 80% of internet users have looked online for health information. And a Manhattan Research poll about physician online habits released just last month found that 83% of physicians watch video clips online, as compared with 34% of all US adults.

So statistically, these ads are being seen by both patients and doctors. And without the proper risk information that’s required in other broadcast drug device advertising, that’s a problem.
In fact, we think it’s an even bigger problem because consumers injured by medical devices can no longer sue device manufacturers for failing to warn them about known but undisclosed risks, a result of the February 2008 Supreme Court decision in Riegel v. Medtronic. And consumers injured by prescription drugs may well lose that same right if the Supreme Court issues a similar ruling in Wyeth v. Levine, a case argued before the Court last month.

To read the petitions and view the videos, go here.

Prescription Access Litigation’s parent organization, Community Catalyst, is also home to The Prescription Project, which works to eliminate conflicts of interest created by pharmaceutical industry marketing by promoting policy change among academic medical centers, professional medical societies and public and private payers. Rob Restuccia, the Prescription Project’s director has an excellent op-ed in today’s Atlanta Journal-Constitution, Let public see doctors’ ties to drug companies.

Here it is:

What is the appropriate relationship between the medical profession and the drug industry? Last month, Dr. Charles Nemeroff stepped down as chair of Emory University’s psychiatry department after a Senate investigation exposed his failure to report hundreds of thousands of dollars in industry consulting and speaking fees, including payments from Glaxo-SmithKline, whose drug he was also studying using taxpayer dollars from the National Institutes of Health.

Last week in this newspaper, Emory economist Paul Rubin defended Nemeroff and accused Sen. Chuck Grassley (R-Iowa), who led the investigation, of leading a “war on pharmaceuticals” (“If politician’s war on drugs continues,” @issue, Oct. 28). Rubin argues that Nemeroff’s presence on 21 pharmaceutical payrolls is evidence that he is conflict-free, for how could he possibly favor the product of one company over the other 20? It’s a fallacy of the first order.

Physician-researchers play an important role in evaluating new drugs. But many physicians are also involved in helping the industry market its products. NIH guidelines do not prevent collaboration with industry (as Rubin suggests), but they do require that financial interests of more than $10,000 a year be reported and that conflicts of interest be managed so that publicly-funded science is not colored by industry support. Documents released by Grassley suggest that Nemeroff misled university officials about the extent of his financial relationships.

Nemeroff is in a group of influential doctors the industry refers to as “thought leaders,” prominent researchers that drug companies use to help promote their products among other physicians. A copious body of research over the past 20 years shows the link between industry marketing and physician prescribing.

The success of that marketing is at least part of the reason that U.S. doctors are so quick to adopt new and often unproven drugs. Yet news headlines warn us that new drugs —- Vioxx, Paxil, Avandia, Vytorin —- aren’t necessarily better drugs. In fact, the Food and Drug Administration’s own numbers show that in a recent five-year period, only 14 percent of drugs approved represented true therapeutic advances.

This is why there is a clear public interest in understanding the financial ties between physicians and drug companies. If disclosure of those ties discourages one physician from accepting NIH funding, there is no shortage of other highly qualified researchers who will step in to take his or her place.

Grassley understands that innovation does not stand at odds with transparency; it is strengthened by it. That’s why he and Sen. Herb Kohl (D-Wis.) have introduced the Physician Payments Sunshine Act, which would require drug and medical device companies to disclose all payments to physicians on a publicly accessible Web site, a critical step toward better, safer, more transparent medicine that Congress should pass in 2009. Patients are certainly better off for Congress’s recent efforts to shed light on conflicts of interest in medicine.

Robert Restuccia is executive director of the Prescription Project, a national initiative created with The Pew Charitable Trusts and led by Community Catalyst to ensure safe and effective drugs for consumers.

A drug advertising pitchman?

Recently, the FDA requested comments on direct-to-consumer (“DTC”) advertising, and its effects upon subsets of the general population, such as the elderly, children, and racial and ethnic minority communities.

PAL and our sister organization, the Prescription Project (www.prescriptionproject.org ) weighed in on the relationship between DTC advertising and the risks and costs of prescription drugs. Our assessment overall was that

“direct-to-consumer advertising produces no proven public health benefits and likely plays a role in driving unnecessary use of pharmaceuticals. Manufacturer-sponsored television advertisements, in particular, are ill-suited to effective communication of risk-benefit information about prescription drugs. Elderly consumers, the less-educated and those with English as a second language may be at particular risk for misunderstanding the potential risks and benefits associated with advertised drugs.”

First, we noted that there is evidence that DTC ads prompt people to discuss advertised conditions and treatments with their doctors – in short, DTC ads work. Why else would the drug companies spend increasing billions each year on drug ads. But, more importantly, we point out that there is no evidence that what ‘works’ to sell drugs is of any benefit for patients. To the contrary, there is abundant evidence of the harm and cost of DTC advertising to consumers.

Populations at risk.
Drug companies tend to focus their advertising on new drugs, with the hopes of finding the next billion-dollar block-buster. When successful, ads drive a rapid increase in prescribing that can expose a large number of the public to the health risks and previously-unknown side effects associated with the new drug. (Clinical trials of new drugs that drug companies run as part of getting FDA approval usually involve only a few thousand participants for a short time, usually less than two years. Therefore side effects that are rare, or that emerge only after patients have used a drug for a longer period of time, may only become obvious once the drug is on the market for a while and being taken by millions of people.)

Vioxx: The Poster Child for Drug Usage Driven by Advertisements
Developed as a daily-use pain reliever, Vioxx was no more effective than ibuprofen (Advil) or naproxen (Aleve). Its only established improvement over these older, time-tested (and much cheaper!) medicines was a decreased risk of stomach bleeding and ulcers. However, no more than 2-4% of patients are at risk for developing these stomach problems. As a result of the substantial DTC advertising and other aggressive promotion, Vioxx use soared from 1999 until its recall on September 30, 2004. Our comment notes that the rapid explosion of Vioxx use, made possible in part by DTC advertising, was

“responsible for an estimated 88,000 to 140,000 cases of serious coronary heart disease and an estimated 38,000 to 61,000 deaths in the USA.”

Even without these risks, DTC advertising drives up health care costs. DTC advertising promotes medically unnecessary prescribing that offers “little or no meaningful clinical benefit for many patients….” This is true of cholesterol lowering agents, allergy medications, antidepressants, and many other types of heavily advertised drugs.

For instance, we noted one study in which actors went to doctors offices posing as patients, and specifically asked for Paxil after supposedly seeing an ad. Doctors wrote prescriptions for Paxil in very high percentages even when the purported condition was one for which there was little evidence (minor depression), or even no evidence (social adjustment disorder) that Paxil was an effective treatment. This illustrates how DTC advertising helps fuel medically inappropriate use.

Debunking drug industry propaganda that DTC advertising promotes public health
In our comments, we took the opportunity to review the many other submissions to the FDA by drug companies which claimed that DTC advertising promotes public health. We noted that most of their purported ‘proof’ were ‘opinion surveys’ of how doctors or patients felt ads helped lead to needed diagnoses or treatment. Only one cited study looked at how often ads lead a patient to seek diagnosis. But we noted that there were no studies proving that DTC ads actually lead to objectively measured, medically necessary and appropriate care.

DTC advertising is not balanced
Under federal regulations, promotional materials for prescription drugs must achieve a ‘fair balance’ between showing the benefits of a drug, and its risks. Also, promotional materials must provide adequate warning of the possible risks or adverse side effects.

The heart of the problem with direct to consumer advertising is that it does not achieve this ‘fair balance.’ DTC ads have been shown to focus more on the benefits, and to downplay or undermine the viewer’s understanding of risks. As a result, one study found that patients can accurately describe the benefits of drugs 80% of the time, but can only understand the risks 20% of the time. This is because drug ads spend more time describing a drug’s benefits, using easier language, with frequent repetition. In contrast, drug risks are often presented more quickly, in more difficult language, with other audio and visual distractions.

Our conclusion
We recommend that FDA closely examine whether DTC ads can or do achieve a ‘fair balance’ between benefits and risks, given the ads representation of, and the public’s perceptions of, these risks. In addition,

“it must be remembered that DTC advertising drives attention to conditions chosen for their return on investment, not their importance in improving the public health.”

PAL’s and Prescription Project’s comments are here.

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
• penalties for companies that don’t report.

Sign this petition today to ask your members of Congress to support these bills: http://www.thepetitionsite.com/1/sunshine

For more information:

• To learn more about industry payments to doctors click here
• For factsheets on the Sunshine Act House and Senate bills click here
• To see the organizations that are members of the National Coalition for Appropriate Prescribing click here

Sign the petition

We write frequently on this blog about “off label” marketing — that’s the practice of prescription drug & medical device companies illegally promoting their products for uses or conditions that are not approved by the FDA.

Here’s the “elevator” version of what off-label marketing is and why it’s illegal:

Before any prescription drug can be sold in the U.S., the Food and Drug Administration must find that the drug is “safe and effective” for the conditions that the company wants to sell it for and at the dosages that it seeks to sell. However, once it’s on the market, a doctor can prescribe it for any condition or purpose or type of patient, regardless of whether the FDA approved it for that or not.

In some specialties (particularly oncology), off-label is very common and is the so-called “standard of care.” Important new uses for drugs have at times been found through off-label prescribing. Since many drugs are not tested on children as part of FDA approval, much (possibly most?) pediatric prescribing is off-label.

So off-label prescribing is perfectly legal (as long as it doesn’t go so far afield that it constitutes malpractice) and is not regulated by the FDA. However, off-label marketing is very much illegal – it’s considered “misbranding” under section 502(a) of the Food Drug and Cosmetics Act (FDCA). In other words, a drug company cannot promote a drug for off-label purposes — because the off-label use has not been shown to be safe and effective, is an end-run around the FDA’s approval process, and eliminates the drug company’s incentive to submit an application to have the off-label use approved.

Back in February, the FDA published its Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices and requested public comment on its proposed rules.

Today, we at Prescription Access Litigation, along with our colleagues at The Prescription Project, National Physicians Alliance, and US PIRG submitted our comments, calling on the FDA not to issue the Draft Guidance as a final Guidance. The FDA’s Draft Guidance would make it much easier for pharmaceutical companies and their salespeople to distribute reprints of medical journal articles discussing off-label uses to physicians.

It is ironic that the FDA is working to make it easier for drug companies to market drugs for off-label purposes when there have been so many revelations and allegations of egregious illegal off-label marketing in the past few years, including off-label marketing of Pfizer’s Neurontin (which resulted in a $430 Million settlement with the U.S. Attorney and state Attorneys General), and of Eli Lilly’s Zyprexa.

Among the reasons we cite for why the FDA’s draft guidance is a bad idea:

“Distribution of single studies by pharmaceutical representatives is not an effective way to facilitate evidence based decision making and thus does not prioritize patient safety or public health. Specifically:

• Early evidence is often contradicted.
• Single trials can be misleading and may not adequately assess drug effectiveness or
  safety.
• Statistically, any individual study has a good chance of coming to the wrong
  conclusion.
• Trials stopped early for benefit are found to be less striking on further review.

The Draft Guidance would allow drug companies to distribute journal articles from any peer-reviewed medical journal. However, as we point out in our comments:

“The FDA drug approval process requires review of all data regarding a drug, both published and unpublished. In contrast, the editorial review processes employed by peer reviewed journals do not. Journal review processes vary widely and publication in a peer reviewed journal is not in and of itself a guarantee of quality.

• FDA approval requires access to full data.
• Journal reviewers only have access to what has previously been published.
• Published studies may lack appropriate controls, design or statistical analysis.
• Industry has the potential to fund and publish individual studies with substantial bias.
• Industry-funded trials and reviews are more likely than independent evaluations to be
  favorable toward the sponsor’s drug.
• Publication bias means negative studies are less likely to be known by reviewers.
• Industry, motivated to sell more product, could selectively choose to distribute studies
  that show its products in a favorable light.
• Industry has frequently been shown to play an invisible role in funding and even
  “ghost writing” published studies that are published under the names of academic
  physicians.
• FDA lacks resources to review all distributed studies and ensure they meet a high
  standard.

To see our comments in their entirety, go here.

To see the other comments that have been submitted and the full text of the draft guidance, go here.

The New England Journal of Medicine ran a terrific “Sounding Board” piece just last week on this topic by Drs. Jerry Avorn & Aaron Kesselheim of Brigham & Women’s Hospital: Pharmaceutical Promotion to Physicians and First Amendment Rights (subscription required)

The Boston Globe today ran “A line between docs and drugs,” an editorial that featured our colleagues at the Prescription Project. The editorial lauded academic medical centers that are implementing policies restricting the “freebies” and other marketing thrown their way in drug company attempts to influence their prescribing. Kudos to the Prescription Project for helping usher in these changes and to the Boston Globe for highlighting this growing trend!

A line between docs and drugs
February 25, 2008

Third in a series
PRESCRIPTION drug companies develop, manufacture, and sell powerful medicines. Academic medical centers treat patients and train physicians. Both the drug industry and the teaching hospitals play essential roles in modern medicine, but their functions need to be kept separate, as they will be under a policy recently unveiled by UMass Memorial Medical Center in Worcester.

Health insurance companies and state governments have encouraged physicians to prescribe generic products, and the rate of prescription drug inflation has diminished significantly. But keeping inflation down is a constant battle in healthcare. Academic medical centers, as shapers of physician opinion, ought to lead the way in protecting physician education from marketing by drug companies and their companion industry, the manufacturers of medical devices.

The UMass Memorial policy, up for final approval Wednesday, would prohibit hospital physicians from receiving gifts or meals from drug companies. Doctors wouldn’t be able to accept drug samples, which would instead be distributed by the central pharmacy. Donations to physicians for educational programs would be banned. Companies could contribute to a hospital fund for education or direct money to a department, but administrators would determine the content of the program.

This policy goes against a tradition of drug company largesse, but hospitals around the country are realizing that they can no longer serve as marketing adjuncts. In Massachusetts, a nonprofit coalition under the umbrella of the Prescription Project is shaping opinion to a strict standard. Last summer, Boston Medical Center adopted a policy similar to UMass’s, although physicians can partake of free food off campus if they “use discretion.”

Elsewhere in Boston, Tufts-New England Medical Center bans gifts, and, assisted by the Prescription Project, is working on a comprehensive policy. The Partners network imposes restrictions, but many can be waived by a department chief. Drug companies can offer informational meetings, with a meal if the food costs less than $20 per person and the chief approves. Samples can be accepted, if the program or department allows them, as can gifts worth less than $100. At Beth Israel Deaconess, a company can pay for food at seminars as long as the department approves. Doctors can get samples (for poor patients), and gifts, too, up to an annual $300 limit.

Partners, at least, is working on a tougher policy. Dr. Daniel Podolsky, its chief academic officer, cautioned, “We want doctors to know what is the best state-of-the-art care.” Drug and devices companies spend billions of dollars on marketing, and they’ll get their message out one way or the other. Hospitals need to make sure the information is not tainted by even a tiny bit of physician self-interest.

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 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.

Our friends at The Prescription Project have announced the launch of Postscript, their new blog on pharmaceutically-related medical conflict of interest issues:

PostScript, a blog from the Prescription Project, adds another dimension to the Project’s goal of raising awareness around the medical conflict-of-interest issues that are created when drug companies open their wallets to influence prescribing. The Prescription Project Weekly Reader, an e-newsletter that highlights relevant news stories of the week, will continue its regular circulation. You can sign up to receive the Weekly Reader at the Prescription Project website, www.prescriptionproject.org, where you can also find project news, press releases and media resources, and information on upcoming events.

We wish them the best of luck! Welcome to the pharmablogosphere!

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).

http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/07/25/EDPRR6D571.DTL

This article appeared on page B – 9 of the San Francisco Chronicle