After waging battle for months, Vermont has decided to amend a new law that would ban data mining companies from gathering physician-prescribing information. The announcement comes after similar legislation in 

Companies such as IMS Health and Verispan resell the data to pharmaceutical companies and government agencies. According to the three states, the new law would help curb rising healthcare costs, but so far they have had a hard time proving it in court.

Rather than lose the battle, Vermont is modifying the law as follows:

The state will delay the law until September 2008, so that opt-in forms can be sent to physicians with normal licensing forms. 

A provision will be deleted that required manufacturers to provide physicians who opted in to the system with evidence-based information about other products in the same therapeutic class.

Minor language changes were suggested to bring a cause if a manufacturer receives a warning letter from FDA.

"They don't seem to be able to implement the law," said Randy Frankel, VP external affairs at IMS Health. "They don't seem to be able to support it in the courts and are obviously trying to adjust to the situation."

The judges in both the New Hampshire and Maine cases  indicated that the data was valuable. One judge indicated that patient care would be compromised and another said that the data is valuable.

"I believe these amendments are intended to bolster their position, although we don't believe any of the amendments they are suggesting in any way change the outcome," Frankel said. "These laws are misguided and will cause more harm than good, in respect to patient care. We would welcome a repeal of these laws and would much rather work with [the states] than have to deal with this situation in the court."

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News Analysis

After watching similar legislation barring data mining for Rx info get shut down in Maine and New Hampshire, Vermont changes tactics and amends its law.

Vermont Amends Data Mining Law

New written prescriptions (NWRx) of Vytorin have taken a nose dive since Merck and Schering-Plough reported the 

 of their study that found that the drug worked no better at reducing arterial plaque than lower-cost alternatives.

According to new data from ImpactRX, market share of Vytorin stumbled from 17 percent at the start of the year to 4 percent as of last Wednesday. Meanwhile, new prescriptions of generic simvastatin, the market leader, have spiked from 30 percent to 44 percent share in that same period.

NWRx refers to treatment starts, add-ons, and switches and not renewals of existing prescriptions. Information is gathered at the doctors' office, unlike NRx, which tracks prescriptions refilled and new scrips being dispensed at the pharmacy.

The prescription volume drop is being compared with that of GSK's embattled diabetes drug, Avandia?even though there is no reported clinical safety issue in the case of Vytorin. "If there is any issue with Vytorin?whether it be efficacy issues or not?doctors know that they have a perfectly effective alternative in simvastatin, and they are switching," said Patrick Angelastro, senior vice president, strategic development at ImpactRx.

Avandia lost approximately two-thirds of its NWRx share, eventually leveling off, but never rising. "This is similar to what we are seeing in Vytorin," Angelastro said. 


As new scrip writing has dropped, the number of requests by physicians for sales details has spiked since the Vytorin story broke. Between Jan. 13 and 21, Vytorin's share of details had increased from 28 percent to 39 percent, rivaling the amount of detail being done for Lipitor.

"It seems as if the doctors are providing the Vytorin reps more access than they had previously because they want to know more about what these ENHANCE results mean," Angelastro said. "This is not unlike what we saw after both the Avandia and the Vioxx situations. After Vioxx was withdrawn, we saw the drug's share of attention spike upwards because docs wanted to know what was going on?they were detailing a product that was no longer on the market."

In the wake of the ENHANCE study, new prescriptions of the cholesterol-lowering drug Vytorin are dropping drastically, but calls to sales reps by physicians are on the rise.

Pharmaceutical Executive-01-30-2008

Vermont Amends Data Mining Law

Vytorin Scripts Plummet