Closing arguments are scheduled today in Brattleboro, Vt., capping a weeklong federal bench trial that pits the state of Vermont against the pharmaceutical industry and its supporting cast of data-miners.
It is the third trial in New England in which state attorneys general have attempted to defend laws passed by their state legislatures intending to control rising prescription drug costs by limiting pharma access to prescriber-identified prescription drug data.
In the past 15 months, slightly different laws with similar aims in Maine and New Hampshire have been struck down by federal trial court judges who saw in them unconstitutional abridgements of corporate free-speech rights.
In January, New Hampshire state attorneys argued before the 1st U.S. Circuit Court of Appeals in Boston that a trial court erred in April 2007 when it struck down a state law there on free-speech grounds. The appeals panel has yet to rule in the New Hampshire case.
Plaintiffs in the New Hampshire lawsuit are data-miners IMS Health and Verispan, which was sold this week to privately held data-miner SDI. Filing friend of the court briefs in the New Hampshire case in support of the data-miners were the eHealth Initiative, the National Alliance for Health Information Technology, the National Association of Chain Drug Stores, SureScripts and Wolters Kluwer Health.
In August 2007, IMS Health, Verispan and data-miner Wolters Kluwer filed lawsuits in Vermont and Maine to block the two states from enforcing their laws, both of which were to take effect Jan. 1, 2008. The data-miners in those cases again say the state laws would prevent important healthcare information from being used and cite constitutional protections of free speech and interstate commerce.
An appeal of the Maine case has been stayed pending the outcome of the appeals court decision in the New Hampshire case, since both courts are in the 1st Circuit, a spokesman with the Maine attorney generals office said.
According to a 2006 report by Vermont Attorney General William Sorrell, which is referenced in the Vermont law, pharmaceutical companies made direct payments of almost $2.2 million to Vermont prescribers in 2005 for consulting fees and travel expenses and spent $10 million or more on marketing of drugs to prescribers, excluding free samples and direct-to-consumer advertising.
Prescriber-identified data, which the law seeks to control, allows pharmaceutical companies to track the prescribing habits of nearly every physician in Vermont, a preamble to the law says. The data enable the pharmaceutical companies to monitor physician prescribing practices and their sales representatives to assess the impact of various gifts and messages on a particular physician to help them select the most effective set of rewards and to employ manipulative practices, tailoring their presentations to individual prescriber styles, preferences and attitudes.
The Vermont law would require physicians to opt in to allow their prescription data to be mined by signing up for a prescriber data-sharing list to be kept by the Vermont Health Department and the states Office of Professional Regulation.
The Maine law would require physicians to opt out of data-mining in that state.
The New Hampshire law, the broadest of the three, stipulated that records relative to prescription information containing patient-identifiable and prescriber-identifiable data shall not be licensed, transferred, used or sold by any pharmacy benefits manager, insurance company, electronic-transmission intermediary, retail, mail order or Internet pharmacy or other similar entity, for any commercial purpose, except for the limited purposes of pharmacy reimbursement; formulary compliance; care management; utilization review by a healthcare provider, the patients insurance provider or the agent of either; healthcare research; or as otherwise provided by law. The New Hampshire law defined commercial purposes as advertising, marketing, promotion, or any activity that could be used to influence sales or market share of a pharmaceutical product, influence or evaluate the prescribing behavior of an individual healthcare professional, or evaluate the effectiveness of a professional pharmaceutical detailing sales force."
In Vermont, the state agencies are to solicit the prescribers consent on licensing applications or renewal forms and shall provide a prescriber a method for revoking his or her consent.
The state is saying, effectively, that this is not unconstitutional, said Caroline Earle, an assistant attorney general in Vermont. There are different levels of speech and commercial speech can be regulated by government bodies and legislatures.
Kate Duffy, the lead attorney handling the trial for the Vermont attorney generals office before U.S. District Judge Garvan Murtha, said that Vermont could fare better than Maine and New Hampshire by, oddly, the addition in the Vermont case of Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerful trade group for the prescription drug industry that joined the data-miners as a plaintiff after the lawsuit was initially filed.
The entry of the drug manufacturers group enabled Vermont to obtain court-ordered depositions from drug company officials, Duffy said, testimony that challenged the commonly heard arguments of data-miners that the prescription-drug data are put to numerous public health uses.
I think whats different with our case, weve been able to get access to more information in the discovery process than in the other cases, Duffy said. PhRMA had not been involved in the other two suits, so we were able to subpoena some of the records of their members. What we asked them about is how they used the data and how they train their sales reps to use the data.
The data-miners maintained that their data are used by drugmakers to identify prescribers and more efficiently direct their sales forces, but its more than that, Duffy said. They divide doctors into deciles and determine high prescribers. They also use it to tailor the message they give them and then they can look to see afterward if it works. It can lead to undo influence that physicians are totally unaware of. We were able to get information and the sales techniques that they use, and it is a sales tool to increase business, but not the educational tool that they said.
Data-miners also claim the prescription data could be used for clinical trials, Duffy said, but through discovery the state obtained testimony from drugmakers that the data had limited current usage for that purpose.
The state obtained some testimony that data might identify a cluster of doctors using a specific product that might be helpful in a clinical trial, Duffy said, but another said they dont use it for that and even one said it would be unethical to use it for that.
They said they need it for use for drug recalls, but they dont, because when they give out the drug samples, they have the physicians signature on a receipt for the samples, she said.
Its funny, because it was the health information organizations that were making these claims that were often contradicted by the manufacturers, according to Duffy.
Although patient privacy was not the lead issue for legislators in passing the Vermont law, it is implicated by data-miners obtaining access to the prescription-drug data stream, according to Earle, the Vermont assistant attorney general, and Duffy.
Duffy said the information obtained by the data-miners from pharmacies and the like is stripped of the patients name, but data-miners will be provided the patients age, gender and some location information using ZIP codes.
Even in selling this limited data set, We think there is a violation and intrusion of patient privacy, Earle said. AIDS drugs are only prescribed for the AIDS virus, but if you have a doctor in Rutland, a pretty small town, I think there is a real potential there of the privacy of the patient being compromised. Their name may not be attached, but this is intensely personal information that is being shared to a national organization and other information that is being shared for marketing.
IMS Health, Verispan and Wolters Kluwer were contacted and asked for comment. By deadline, only Verispan responded by releasing via e-mail a brief written statement saying that the trial was under way, that Verispan, along with other plaintiffs, has testified, and that a ruling is expected within 60-90 days.
A Wolters Kluwer executive designated to comment is attending the trial, a spokesman said. The executive was unavailable at deadline.
Duffy, too, said she doesnt expect a decision for a few months. No matter what happens this is going to be appealed. -- by Joseph Conn