Your Personal Prescription information is public--Supreme Court rules
The First Amendment of the US Constitution establishes
freedom of speech and the 4th
Amendment a right to privacy for
citizens (no mention of corporations).
The Supreme Court decided on June 4, 2011 the conflict between the corporations’
right to personal information (speech) and citizen’s right to privacy. Data mining companies buy from the pharmacies
the prescription practices of doctors, which include the patient’s name, age,
sex, and drugs. It is a violation
doctor’s and patient’s right to privacy.
The data mining companies then sell it to the pharmaceutical
companies. This practice has gone
decades. Vermont and later
attempted to protect the privacy of doctors and patients concerning their
prescribing practices, and at the same time limit the mischief done with this
information. This legislation in
public’s interest has been shot down in favor of free-speech & information
gathering rights of corporations because it promotes corporations’ financial
interests (explained below in detail).
The Supreme Court ruling among other things incongruously holds that it
is in the public’s interest that Pfizer should know what your doctor
prescribes. The Supreme Court ruling
favoring data mining by extension
entails all other information of commercial value: corporation come before the Right to Privacy
Clause of the Bill of Rights. That
is another example of the political reality that we live in a corporatist state. Or as Teddy Roosevelt said that, they are the
Data mining has
consequences that affect prescribing practices. Assume Doctor Jones is prescribing an SSRI
made by Merck; the Pfizer sales rep thus informs him about their latest
patented SSRI. Other enticements
free samples of Zoloft and free trip with accommodations to attend a Pfizer
sponsored carnival-like continuing-education classes on depression.
Pfizer hires thought leaders who will, while
discussing depression during classes, inform Dr. Jones about the benefits of
sertraline (Zololft), zipraidone (Geodon) and other Pfizer neuroleptic
drugs. The thought leader will use
IV studies to convince the audience that Zoloft besides the approved treatment
for depression is the best for off-label treatment of premenstrual dysphoric
disorder, social phobia, post-traumatic
stress, depression in the elderly, obsessive-compulsive disorder, generalized anxiety disorder, eating
disorders, premature ejaculation, disorder, must emotional disturbances,
seizures, schizophrenia , muscle relaxant,… No mention
will be made of the 40% drop out in
the phase III trials or effects upon libido. A year later based
upon Dr. Jones’ increased
prescribing of Pfizer’s drugs, his sales rep will offer lucrative perks. Dr. Jones will be asked to recruit patients
for a phase IV study of Zoloft. For
he will be paid $1,000 per patient he recruits, and additional $5,000 when he
has recruited 6, and over $22,000 for monitor those patients, and signing his
name to the journal article ghost written by Pfizer . For psychiatric drugs
off-label usage runs as
high as 94%. In the US phase IV
studies (often of the
lowest standards) are used to funnel funds for services to favored
doctors. These perks can amount
a $100,000. The perks are strong incentives for a physician to select just
Pfizer’s pharmacopeia of drugs when possible.
Without data mining Pfizer could not know with confidence which doctors
to favor with perks. The impact
mining cause a detrimental impact on public’s health and increases in
prescription drug costs. Data mining plays
an important role in recruiting
doctors to preferentially prescribed Pfizer’s drugs. This is one mischief of the marketplace which
Vermont and Maine tried to limit in their states.
Data mining plays an important role in the distribution
perks and thus upon prescribing practices and the lectures of thought
leaders. In the UK and other
countries, because of the lower profit margin on drugs, the perks are less, but
still effective. Data mining and
provides an incentive for mergers.
Mergers permit a company like Pfizer to acquire a full-line of patented
drugs for loyal physicians to prescribe.
A full line makes it more likely for physicians to choose Pfizer as the
company of choice. The marketing
physicians of a larger product line is the most profitable advantage of
mergers-- not the excuse of lower costs through merging. For a book on how bad it is, read (or listen
to Dr. Ben Goldacre Bad
Pharma. Its main
theme is that with junk science doctors can’t know what is best to prescribe--jk.
Prescription Data Restriction Laws
Court Strikes Down Vermont Prescription Data Restriction Law
From uses listed at http://en.wikipedia.org/wiki/Zoloft.
Zoloft in 2011 was the 2nd most prescribed antidepressant
(37,800,000 prescriptions US. Zoloft
replaced Neurontin which went
off-patent in 2004.
For a complete account of the uses of phase IV studies, Dr. Marcia Angell, The
Truth About Drug Companies, Chapter 9.
 Warner-Lambert’s marketing increased
off-label sales from 15
percent of all Neurontin prescriptions in 1994, its first year on the market,
to 94 percent of Pfizer’s Neurontin sales in 2002, according to federal
government court filings. Posting Bloomberg article published Dec 9,
2013 at http://healthfully.org/rep/id8.html, on court settlement, calling Neurontin “snake oil of the 20th century.”
 See Brief of AARP & NLA Rx Ass'n,
supra note 24, at 24-25. And also David Orentlicher, Prescription Data Mining
and the Protection of Patients' Interests, 38 J.L. MED. & ETHICS
74, 76 (2010), and Michael G.
Ziegler et al., The Accuracy of Drug Information from Pharmaceutical Sales
Representatives, 273 JAMA 1296, 1296 (1995).
U.S. Supreme Court
On June 23, 2011, the United States
Supreme Court ruled that states may not prohibit the use of information about
physician healthcare practices in the marketing of medicines. The court’s
decision in Sorrell v. IMS Health holds
that a Vermont statute violates the
First Amendment by banning the voluntary exchange of information on a matter of
public importance – improperly restricting the rights of others from using
information about physicians’ prescribing practices.
In the 6-3 decision rejecting
the Vermont law, the majority stated that, “the First Amendment directs us
especially skeptical of regulations that seek to keep people in the dark for
what the government perceives to be their own good.” Further the majority writes that the “free flow of commercial speech…has great
relevance in the fields of medicine and public health where information can
[article at this link is in error, for it misses
provision of law, and argues that this information can be used to warn
physicians about drugs they prescribe, or should prescribe for a
condition. The law bars passing the
information on to drug companies, but allows other users and uses such as the
FDA and researchers. This point was made
by dissenting opinion on pages 38 & 39 of luc.edu article, link below.] Press
Release re: the U.S. Supreme Court Strikes Down Vermont Prescription Data
[Link to current
issue of newspaper] Privacy
Not At Issue
[Another article which makes IMS Inc. seem like
a night on a white horse serving the public to find healthful drugs and drive
down costs. The record of pharma
indicates there use of prescribing practices information; it is used with the
mind-set of American Tobacco Inc.] Supreme
Court Case is about Patient Care
In July 2006, New Hampshire
became the first state in the nation to pass a law banning the commercial sale
of prescriber-identifiable data. Proponents said the law would help constrain
healthcare costs by slowing down the use of new medicines. Opponents, including
IMS, said the law would harm patients, reduce transparency and the free flow of
information in healthcare, and was a violation of the constitutional protection of free speech.
Since New Hampshire
passed its law, more than 100 similar bills have been introduced in state
legislatures across the country, yet only two were passed into law and none
since 2007 when Vermont and Maine joined New Hampshire.
The existing laws in
New Hampshire and Maine are likely to be declared unconstitutional or repealed
in light of the Supreme Court decision in Sorrell v. IMS Health.
More will be known in the coming months.
Here is a Timeline of the legislative and legal events and
milestones of the past five years surrounding the data restriction laws.
For an excellent in
depth account of Sorell
v. IMS Health Inc.
Links on Bad Pharma, well
researched, good reading. http://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1007&context=annals
Court opinion http://www.imsfreespeech.org/resources/Supreme-Court-Opinion1.pdf