Litigation Challenging Regulation of Data Mining
Sean Flynn
March 31, 2008
There is a battle brewing in the federal courts over the rights of
states to adopt the same prescription data privacy regulations that now
exist in Europe and much of Canada. In those countries, pharmaceutical
companies are not permitted to buy and sell prescription records that
identify the prescribing habits of specific health care professionals,
but rather can only access aggregate prescription data showing, for
example, the number of prescriptions issued for a particular drug in a
broad geographic area.
New Hampshire, in passing its Prescription Confidentiality Act , was the
first state in the nation to ban the trade in prescriber-identified
prescription data for marketing purposes. On April 30, 2007 a Federal
District Court Judge in that state ruled that the law violated the First
Amendment rights of pharmaceutical corporations to engage in commercial
speech. That decision was followed by the passage of laws in Vermont and
Maine that attempted to more narrowly tailor the data restrictions by
giving physicians the right to control the subsequent use of
prescription records identifying them. These laws have also been
challenged in federal court, and the New Hampshire decision has been
appealed to the Court of Appeals for the First Circuit.
Defending the Legality of Data Mining Regulation
The New Hampshire District Court that New Hampshire’s ban on the
marketing related uses of prescription data violated the First
Amendment. The Judge found that (1) the trading of targeted marketing
lists compiled from prescription records is a form of commercial speech
protected by the Constitution, and (2) banning the trading and use of
prescription data did not adequately advance any legitimate interest of
the state. The court specifically found that there was insufficient
evidence that data mining contributed significantly to harassing sales
practices by pharmaceutical markers or that its regulation would advance
the state’s interest in containing health care costs or promoting
evidence-based prescribing practices. It also criticized New Hampshire
for not including legislative findings supporting the legislation.
I don’t agree with the New Hampshire District Court’s decision that
trade in prescription data for marketing purposes is protected
commercial speech. My views in that regard are canvassed in the enclosed
article. More importantly for your purposes, there are compelling
justifications for the regulation of data mining that should overwhelm
any speech interests of the corporations engaging in this behavior.
Judging from the New Hampshire Court’s decision, it may be wise to make
express legislative findings on what these interests are and include in
the record of the bill citations to the research in this area
demonstrating these interests.1
State Interests in Regulating Data Mining
The Act Prevents Undue Influence in Pharmaceutical Marketing
States have a paramount interest in combating undue influence of
pharmaceutical marketers over prescribing decisions.
Nearly all direct to prescriber marketing is one sided because only the
most expensive and profitable medicines, i.e. branded blockbuster drugs,
are marketed through in person detailing. Access to prescribing data
aggravates the negative impacts of this one sided information market by
permitting branded medicine marketers to observe and reward favored
prescribing behavior. Ninety four percent of all doctors routinely
receive gifts of significant value, such as meals, branded office
supplies, and free drug samples, which create powerful psychological
urges to reciprocate. Prescriber data is used to guide this gift giving,
so that the most profitable prescribers receive the highest rewards. The
most favored prescribers can receive hundreds of thousands of dollars in
payments from drug companies for speaking engagements, research, and
sitting on various advisory boards.
The extensive medical and scientific training that health professionals
receive does not insulate them from being unduly influenced by
pharmaceutical marketers. Doctors, particularly primary care physicians,
are overworked and overwhelmed by the volume of medical news, creating a
system where pharmaceutical marketers become the easiest source of
information on new drugs, delivered with lunch directly to the office.
When this is combined with a pharmaceutical representative’s ability to
extol the benefits of their drug in specific, if biased, comparison to
the one the physician is currently prescribing, even physicians
conscious of the marketing pressure are commonly influenced.
Numerous studies and investigations have documented a significant,
measurable, and increasing influence of direct to physician marketing at
convincing doctors to adopt prescribing practices that are contrary to
clinical guidelines and the weight of objective scientific evidence. An
exhaustive data synthesis from over 500 published studies found
conclusive evidence that pharmaceutical detailing guided by access to
prescribing data “impact[s] the prescribing practices of residents and
physicians in terms of prescribing cost, nonrational prescribing,
awareness, preference and rapid prescribing of new drugs, and decreased
prescribing of generic drugs.” The same study concluded that meetings
with pharmaceutical representatives had a direct relationship to
physician requests to add drugs to a formulary that had “little or no
therapeutic advantage over existing formulary drugs.”
Studies have also shown that physicians and other health care
professionals are not well qualified to filter through misleading and
skewed presentations by sales representatives. Despite the volume of
evidence showing that pharmaceutical marketing is effective at shifting
prescribing habits away from the best evidence based practices, most
physicians deny that pharmaceutical marketing has any affect on their
prescribing practices (while reporting that marketing does affect their
colleagues). Further, they generally trust the messages delivered by
pharmaceutical representatives, and are very poor at detecting false and
misleading messages within sales pitches.
The Act Reduces Costs and Promotes Public Health
Undue influence by pharmaceutical marketing results in enormous costs to
society that states have a compelling interest in restraining. These
costs are measured not only in dollars, but in the degradation of public
health that flows from increased prescribing of drugs that are less
effective, and sometimes harmful, to patients.
There are many examples of the successes of our super-charged
pharmaceutical marketing system at shifting massive amounts of
prescriptions toward newer, more expensive drugs that do not benefit
patients. One study, referenced in the New Hampshire legislative
history, showed that using highly marketed branded medicines for high
blood pressure instead of less expensive generic therapies rated as more
effective by national treatment guidelines increased U.S. health costs
by $3 billion in 1996. Another study found that approximately forty
percent of Pennsylvania Medicare patients on antihypertensive therapy
were being prescribed medications at odds with clinical guidelines at a
cost of $1.2 billion per year in that state alone. A similar effect can
be seen in the incredible marketing push and resultant prescription
surge for Vioxx, Celebrex, and other COX 2 inhibitors, despite the lack
of any conclusive medical evidence that they were more effective than
older pain medications, or that the reduction in gastric side effects
were significant for most patients. And in the case of Vioxx, aggressive
marketing using prescriber data helped facilitate the widespread
adoption of a drug that was far more dangerous to patient health than
existing alternatives or than the company’s marketing messages admitted.
The aggregate financial costs to society of undue influence by
pharmaceutical marketers is enormous. Nearly a third of the five fold
increase in U.S. spending on drugs over the last decade can be
attributed to pharmaceutical marketing efforts that shift doctors’
prescribing from existing, effective, and lower cost (often generic)
therapies to new and more expensive treatments. A significant amount of
these irrational are enabled by pharmaceutical marketers knowing that an
individual doctor is favoring the less expensive treatment and mounting
a campaign in response to convince the doctor to switch treatments.
The Act Maintains Standards in the Medical Profession.
Many physician organizations advocate an end to prescriber-identified
data trading for marketing purposes because the practice threatens the
ethical standards of the profession and jeopardizes their relations with
patients.
There may be no greater affront to the ethical basis of the medical
profession than permitting pharmaceutical companies to give pecuniary
rewards to medical professionals based on their prescribing habits.
Prescription data mining provides the key tool for pharmaceutical
companies to literally pay prescribers with meals, gifts, vacations,
high value low work “consultancies,” and board appointments for the use
of their products. High prescribers and influential specialists can
receive tens and even hundreds of thousands of dollars for consultancies
and lectures each year, a cycle that not only rewards high prescribers,
but also uses those physicians’ prominence to influence other doctors=
prescribing choices. This incorporation of prescribers into the
commission structure of pharmaceutical sales debases the medical
profession and, the more the practice becomes public, breaks the chain
of trust between doctor and patient.
The Act Protects Doctors Against Vexatious Sales Practices
Doctors are pushing many of the reforms in this area in part because a
substantial number feel harassed by the increasing frequency and
aggressiveness of detailing forces fueled by the use of prescribing data
to track prescription writing and calculate sales bonuses.
There are a host of federal and state laws that combat harassing and
frequent marketing calls on consumers by limiting marketers’ access to
identifying information. In the case of medicines, it is doctors who
make the purchasing decisions for the ultimate consumers of the product,
and therefore they receive the large majority of all marketing efforts.
Although marketing to doctors has long been a key focus of
pharmaceutical company marketing budgets, the availability of digitized
prescribing data beginning in the early 1990s made the practice more
profitable and invasive. Access to prescribing data has stoked a massive
increase in spending and sales force size for individualized marketing
that has become harassing in its sheer volume. In 2004, the industry
spent $27 billion on drug marketing, more than any other sector in the
U.S., on its sales force or media advertising. Over eighty five percent
of pharmaceutical marketing budgets are targeted at doctors. In the
decade after IMS unveiled its flagship prescriber tracking program in
1993, spending on detailing increased by nearly three hundred percent,
doubling the number of pharmaceutical sales representatives to over
100,000. There is one pharmaceutical sales representative for every four
to five office based physicians in the nation. But because low
prescribers often do not receive sales attention, it has been estimated
that the effective ratio of sales representatives to targeted doctors is
closer to one for every 2.5 doctors. The average primary care physician
in 2004 interacted with a staggering 28 sales representatives each week.
In addition to being harassing by its sheer volume, access to prescriber
detailing increases the prevalence of coercive marketing practices in
individual sales calls. Sales representatives use this data in
increasingly obnoxious ways to hold prescribers “accountable” for their
marketing messages and gifts, including by telling prescribers that they
are being monitored and that the free lunches and gifts will dwindle if
they do not meet the marketers’ expectations.
The Act Protects Patient Privacy.
There can be no doubt that patients have the strongest possible interest
in not having their treatment histories subjected to surveillance and
lobbying by pharmaceutical companies. But this interest cannot be
protected by the removal of patient names alone.
Patient de-identification is not complete with the removal of names and
addresses. The data can still be used to track an individual patient,
identified with a unique numerical identifier that carries forward
through time. The problem with this is twofold. It weakens the
protection of privacy for patients in situations where knowing treatment
history and physician identity can allow re-identification of a patient.
It also allows pharmaceutical companies to target an individual patient
for sales efforts, even name unknown. With access to prescriber
identities and “anonymized” patient data, a pharmaceutical company can
not only observe a specific treatment event for a particular patient,
like the switching of a prescription, but can respond with an
individualized marketing campaign at the prescriber to change that
patient’s treatment. This insertion of the pharmaceutical company into
the monitoring and influence of the patient’s treatment is an invasion
of privacy of the most odious kind: one that directly affects the
treatment course of the patient for the pecuniary interest of another
through a breach of confidentiality that is nearly impossible to detect.
