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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 of the doctor’s and patient’s right to privacy.  The data mining companies then sell it to the pharmaceutical companies.  This practice has gone on for decades.   Vermont and later Maine 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 the 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 ruling is another example of the political reality that we live in a corporatist state.  Or as Teddy Roosevelt said that, they are the “shadow government.”

 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 include 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 phase 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.[1]  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 this 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 .[2]  For psychiatric drugs off-label usage runs as high as 94%.[3]  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 to over 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 of data mining cause a detrimental impact on public’s health and increases in prescription drug costs.[4]  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 of perks and thus upon prescribing practices and the lectures of thought leaders.   In the UK and other EU countries, because of the lower profit margin on drugs, the perks are less, but still effective.  Data mining and its use 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 to 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.  

http://www.imshealth.com/portal/site/ims/menuitem.5ad1c081663fdf9b41d84b903208c22a/?vgnextoid=79e65890d33ee210VgnVCM10000071812ca2RCRD

Prescription Data Restriction Laws

U.S. Supreme Court Strikes Down Vermont Prescription Data Restriction Law



[1] 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.   

[2] For a complete account of the uses of phase IV studies, Dr. Marcia Angell, The Truth About Drug Companies, Chapter 9. 

[3] 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.”  

[4] 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 to be 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 save lives.”

  • [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 Restriction Law

  • [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

Background

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

Supreme Court opinion http://www.imsfreespeech.org/resources/Supreme-Court-Opinion1.pdf

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