A Vermont federal district court gave good news to advocates of a VT law to ban the use of prescriber information for marketing by the drug industry. Our friends at the Prescription Project posted the following blog [available at http://blog.prescriptionproject.org/?p=626] on this victory:

Vermont District Court upholds data-mining law

[On Thursday, April 23, 2009] the Vermont District Court upheld a 2007 law banning the use of prescriber-identifiable information to market prescription drugs. In his opinion, Judge J. Garvan Murtha affirmed the Vermont Legislature’s findings that the use of data-mining as a pharmaceutical sales tactic promotes the overuse of more expensive, less-tested drugs, and that banning the practice for marketing purposes protects public health and contains costs.  Importantly, the decision explicitly deferred to the legislature to decide how to rein in rising health care costs.

The Court’s decision supports a unanimous November 2008 ruling by the U.S. First Circuit Court of Appeals to uphold a similar law in New Hampshire that bans the use of prescriber-identifiable information for marketing purposes, and is a strong signal for other states that are currently considering data-mining restriction laws, including Connecticut and Massachusetts.

A Healthy Blog, part of the coalition supporting the Massachusetts data-mining bill, found inspiration in Vermont Attorney General William Sorrell’s response to the decision: “It is a testament to our Legislature and to the courage of this small state that we continue to lead the way on important public health issues,” he said.

Here’s the full decision [at http://www.prescriptionproject.org/tools/solutions_resources/files/0040.pdf ].

And to commemorate the World Malaria Day this past Saturday, we bring you a post by Sonia Shah, a guest blogger on international human rights and drug policy on the PAL blog.  She posted this interesting history of the role of malaria in the growth of the US nation, a reminder of how much we have in common with the developing nations struggling with this contintuing health threat.  See it at http://www.zcommunications.org/zspace/commentaries/3843

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.

Other resources:

• The 1st Circuit’s decision is here
• An Associated Press article on the decision is here: NH prescription privacy law upheld
• The 1st Circuit Amicus Curiae brief of Community Catalyst and others is here.
• The District Court Amicus Curiae brief of Prescription Access Litigation and others is here.
• See also what PostScript, the blog of our colleagues at The Prescription Project, had to say about the decision.

The Prescription Access Litigation Blog has been on summer vacation recently, sunning itself at the beach, drinking iced tea, and playing volleyball with other blogs at Blog Camp. It’s now back, tanned, rested, and ready to deliver an ice-cold cup of refreshing pharmaceutical news and outrage to you, our thirsty readers.

And its first post-summer-break item is a dispatch straight from the Department of Unbelievably Evil & Greedy Schemes:

Business Week ran a special report yesterday (July 23, 2008), with the frightening title:

“They Know What’s in Your Medicine Cabinet: How insurance companies dig up applicants’ prescriptions—and use them to deny coverage”.

Here’s the rub:

That prescription you just picked up at the drugstore could hurt your chances of getting health insurance.

An untold number of people have been rejected for medical coverage for a reason they never could have guessed: Insurance companies are using huge, commercially available prescription databases to screen out applicants based on their drug purchases.

This is one of the latest revelations concerning the practice of pharmaceutical datamining. There’s a fact that few people know, but that should be printed on huge signs at every pharmacy:

Pharmacies sell information about the prescriptions they fill to companies that then sell that information to health plans, pharmaceutical companies and others that use it for marketing purposes.

The use of this information that’s most widely known is for drug company marketing. Companies like IMS Health and Verispan buy data from pharmacies detailing the prescribing records of doctors. That data is supposed to have any details about individual patients removed, or “scrubbed.” These companies then turn around and sell this information to drug companies. The drug companies give this information to the sales people, who then descend on doctors’ offices, armed with the details of exactly what drugs the doctor has prescribed, and how that’s changed over time. They can then tailor their pitch accordingly.

That practice is bad enough, and a number of states have passed or are trying to pass laws outlawing this “datamining.” (And datamining companies have sued to block these laws in every state in which they’ve been passed — we at PAL joined a “friend of the Court” brief defending Maine’s law. Read more about that here.) It’s an issue that the Prescription Project and the National Legislative Association on Prescription Drug Prices are working very hard on.

But, as the Business Week report describes, an even more nefarious use of this prescribing data is emerging. A few choice excerpts and factoids from that article:

• “Traditionally, applicants have been asked to provide insurers with a description of past illnesses. About 30% are deemed uninsurable because of their histories, according to industry veterans. Prescription profiles could add another hurdle, making it especially difficult for the 47 million Americans who lack insurance to acquire coverage.”
• “Most consumers and even many insurance agents are unaware that Humana, UnitedHealth Group , Aetna (AET), Blue Cross plans, and other insurance giants have ready access to applicants’ prescription histories. These online reports, available in seconds from a pair of little-known intermediary companies at a cost of only about $15 per search, typically include voluminous information going back five years on dosage, refills, and possible medical conditions. The reports also provide a numerical score predicting what a person may cost an insurer in the future.”
• “drugs for depression and other mental health conditions are often red flags to insurers.”

It’s likely that other classes of drugs are red flags as well — anything that suggests a “preexisting condition,” particularly a serious or chronic one, might make an insurer lean towards denying a consumer coverage. So drugs for diabetes, arthritis, HIV/AIDS and any number of conditions might raise similar flags.

What’s particularly troubling about this is that, because of the nature of prescription drugs, there’s no way for consumers to be “anonymous” in the way that they can be in virtually every other product they buy. For instance, let’s say you go to the drug store to buy something that you’d rather not call attention to – be it diarrhea medication, contraceptives, or the latest issue of Us Weekly. You just pay cash and don’t use your store “frequent buyers card” (like the CVS ExtraCare card). Voila – anonymity.

But you can’t do that with a prescription drug. You need a prescription from your doctor, which identifies you, and your information gets entered into the pharmacy’s computer system. What’s ironic about this is that one can argue that there’s a greater interest in having your prescriptions kept private than in having your other purchases kept private.

How can pharmacies disclose my prescription information? Isn’t it private?
This data is private, and is protected from disclosure by HIPAA, the Health Insurance Portability & Accountability Act. UNLESS you give someone PERMISSION to access that information. And that’s exactly what millions of consumers are doing, without realizing it, when they apply for health insurance. As Business Week says:

When applying for insurance, individuals routinely sign paperwork allowing providers to review their medical history. To comply with the privacy provisions of the federal Health Insurance Portability & Accountability Act, most insurers have now added a reference to prescription history in the lengthy fine print consumers are instructed to read.

The FTC forced the industry to begin disclosing the use of prescription information under a different federal statute, the Fair Credit Reporting Act. Insurers now are required to tell applicants the address of the company that assembled the data. Copies of prescription reports are supposed to be available to consumers at no charge under federal law.

But these disclosures are typically buried and never read by the overwhelmingly majority of consumers that are “agreeing” to them by signing that health insurance application. And there’s likely nothing you can do about it either — if you refuse to allow the health insurer access to your medical records, in all likelihood, they can and probably will just turn down your application. I believe that’s what they call a Catch-22, or perhaps being caught between a rock and a hard place.

Now that the practice is coming to light, hopefully privacy advocates and those working to make insurance easier to access will begin raising a hue and cry about this, and get the attention of legislators and regulators. In the meantime, it cant hurt to read the fine print when you apply for health insurance and ask your pharmacy what they do with your prescription records and whether it’s possible for you to “opt out” of whatever programs they have that sell that information.

Over at A Healthy Blog, our friends at Health Care For All (a member of the Prescription Access Litigation coalition) report today on the fight that is brewing in the Massachusetts legislature over a proposed ban on pharma gifts to physicians. They quote an article from yesterday’s State House News Service:

Pharmaceutical companies are attacking Senate President Therese Murray’s effort to block their firms from providing gifts, meals or trips to doctors, calling it an anti-business policy that would hobble efforts to deliver cutting-edge drugs to patients. In a letter to the chairs of the Legislature’s Economic Development and Emerging Technologies Committee, executives from Pfizer, Amgen, Abbot Bioresearch Center, Genentech, all of which have facilities in Massachusetts, ripped the gift ban as counter to Beacon Hill’s painstaking efforts to lure the life sciences industry, highlighted by Gov. Deval Patrick’s nearly year-old $1 billion incentives plan headed for legislative approval.

It’s somewhat odd to cast a gifts and lunches to doctors as being on par with a $1 billion state incentive plan — unless perhaps the gifts and trips and meals are worth more than $1 billion to the industry — after all, Massachusetts has dozens of teaching hospitals and a new health care law that means more and more people with health insurance. The prescriptions written as a result of a modest investment in gifts and trips and meals could easily garner more than a billion in new sales.

To learn more about the proposed gift ban, go visit the Massachusetts Prescription Reform Coalition.

In 2006, New Hampshire became the first state to prohibit pharmacies from selling information about what drugs doctors prescribe. Pharmacies routinely collect and sell information on what drugs individual doctors write prescriptions for, and sell it to companies like IMS Health and Verispan. Those companies then sell that data to drug companies. Drug company salespeople use that information to tailor the sales pitch that they make to doctors during visits to doctors’ offices. IMS Health sued the state of New Hampshire, arguing that the new law violated the company’s “free speech” rights.

Prescription Access Litigation’s parent organization, Community Catalyst joined AARP, AFL-CIO, AFSCME, Center for Medical Consumers, Community Catalyst, National Women’s Health Network, and New Hampshire Citizens Alliance in submitting a “friend of the Court” (amicus curiae) brief in support of the law. Unfortunately, the U.S. District Court for the District of New Hampshire struck down the law. The state of New Hampshire appealed, and last week, there was a hearing at the U.S. Court of Appeals for the First Circuit, in Boston, MA.

Sean Flynn, Associate Director of the Program on Intellectual Property at Washington College of Law at American University, was there and argued on behalf of a number of “amici curiae.” Sean reports on that hearing, in the PAL Blog’s first-ever “guest blogger” post. Here’s his dispatch from the hearing:

___________________________________________

On Wednesday, the First Circuit heard arguments in IMS v. Ayotte, involving New Hampshire’s appeal of a district court ruling striking down a first-in-the-nation law prohibiting prescription data mining.

Prescription data mining occurs through “health information companies” like IMS purchasing information from pharmacies on what drugs were prescribed by whom. This information, which is provided without the consent of either the doctor or the patient, is sold to pharmaceutical companies who use it to tailor the marketing of drugs to physicians. Using prescription information identifying prescribers enables drug companies to send a salesperson into a doctor’s office with an individually tailored pitch as well as to identify and reward their best prescribers with gifts, paid consultancies, prestigious board appointments, expense paid “educational” trips and other perks.

According to some estimates, drug companies spend as much as $34 billion a year marketing to doctors. Evidence in the case showed that the average physician sees at least five drug company reps a day.

In 2006, New Hampshire became the first state to outlaw prescription data mining for marketing, and was immediately challenged in court by the major drug information companies. Last May, the law was overturned by the a U.S. District Court, which agreed with the companies that the law violated the First Amendment guarantee of free speech because it “limits both the use and disclosure of prescriber-identifiable data for commercial purposes.”

At the hearing before the First Circuit on Wednesday, the judges appeared very critical of the data mining industry’s assertion that collecting and selling prescription records amounted to protected speech under the First Amendment. Judge Selya, who wrote an important opinion holding that advertising consulting services between companies are not 1st Amendment speech, asked the New Hampshire attorney “if there is any effect on commercial speech, isn’t it just incidental?”

All of the Judge’s questions were focused on the degree to which states can regulate economic conduct with an ‘incidental effect’ on commercial speech rather than whether the law itself was narrowly tailored. The court never asked either side for detailed arguments on whether the law was ‘narrowly tailored’ to meet its objectives, a possible indication that they believe that the law does not regulate protected speech.

The judges were much more critical of IMS’s argument. Judge Lipez asked skeptically whether NH had to have a “Turner record” (three years of congressional hearings used to justify regulating cable speech) for this law. The IMS attorney seemed not to take the hint, responding that NH needed more because this law was akin to regulating the core of the 1st Amendment and therefore required strict scrutiny.

I gave the rebuttal argument on behalf of the public interest amici in the case. The core of my argument was that the First Amendment’s commercial speech doctrine is about protecting the rights of companies to speak to consumers about their products. It does not protect any right of companies to monitor their consumers to see whether their pitches are successful. This law, like many others, regulates the latter by cutting off access to identifying information rather than regulating the substance of what marketers say. It is thus similar in particulars to

• Driver Privacy Protection Act (upheld by Reno v. Condon)

• Video Privacy Protection Act (video rental information)

• Stored Communications Act (internet)

• Electronic Communications Privacy Act

• Fair Credit Reporting Act (upheld by Trans Union v. FTC)

The DPPA is particularly relevant since that law was passed in part to cut down on harassing sales tactics by lawyers searching accident records for potential clients.

We argued that a gift ban would not meet the state’s interests because the monitoring of prescriptions is used to target a host of reinforcements of favored prescribing behavior — including consultancies, educational seminar invitations, prestigious board appointments and even targeted expressions of appreciation — that are difficult or impossible to regulate under gift bans.

I am optimistic about the chances for a favorable ruling. If the First Circuit overturns the ruling striking down New Hampshire’s first in the nation law regulating prescription data mining, several states and the District of Columbia are expected to quickly enact similar laws. Washington State and New York look primed to move soon, possibly without waiting for the ruling. The First Circuit’s ruling will also affect current litigation in Vermont and Maine that passed data mining restrictions soon after New Hampshire.

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

Great article in today’s Washington Post: “Doctors, Legislators Resist Drugmakers’ Prying Eyes”. The article discusses the now-hot issue of whether the data of what drugs Doctors prescribe should be private, or whether drug companies should be able to purchase that data from pharmacies.

The article features the National Physicians Alliance, which has a new campaign on this issue (featured in our recent blog entry, “Doctors: Big Pharma is watching you!”)

In that entry, we raised the issue of whether doctors know that their prescribing data is being sold. All indications are that many if not most doctors are not aware of this. But how would most Doctors feel if they knew that the American Medical Association was selling their information to drug companies? As the article points out:

The American Medical Association, a larger and far more established group, makes millions of dollars each year by helping data-mining companies link prescribing data to individual physicians. It does so by licensing access to the AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors.

After complaints from some members, the AMA last year began allowing doctors to “opt out” and shield their individual prescribing information from salespeople, although drug companies can still get it. So far, 7,476 doctors have opted out, AMA officials said.

It’s not abundantly clear on the AMA website how physicians go about opting out, but this page appears to be a likely candidate.