From the Director

Next week the U.S. Supreme Court takes up Sorrell v. IMS Health, with oral argument on Vermont's appeal of the 2d Circuit decision invalidating its prescription records confidentiality law scheduled for Tuesday, April 26.  NLARx and AARP have jointly submitted an amicus brief and plan to be at the Court for the argument - check out our next newsletter for a full report.  Read the article below for more on the Supreme Court case and prescription privacy issues.   

In other news, this past week, our letter to the Federal Trade Commission about ongoing conflicts of interest involving giant PBM-pharmacy chain CVS-Caremark and the need for the FTC to order divestiture as a remedy got some attention in the N.Y. Times and elsewhere.  More on CVS Caremark and PBMs below.   

State legislative sessions are focused intently on budgets, which have spelled drastic cuts for many prescription drug programs, especially those helping seniors.  We report below on the latest state developments.  Of interest, state insurance commissioners, prosecutors and comptrollers have joined the fight to lower drug prices, while it seems state legislators are fighting a rearguard action just to preserve the programs they currently have in Medicaid and providing discounts to seniors.   We also include  a roundup of other pharmaceutical news we think is especially newsworthy. Be sure to join us on Facebook for more up-to-the-minute posting of news and resources. 

Sincerely, Sharon Treat    

NLARx Calls on FTC to Split Up CVS Caremark to Address Conflicts of Interest and Other Concerns 

US Supreme Court Hears Argument April 26 in Vermont  Prescription Record Privacy Case

Legislators in Vermont, New Hampshire and Maine are closely following the Sorrell v. IMS Health case pending before the US Supreme Court that will decide the fate of prescription record privacy, or "datamining," laws in each of the states. Although the Maine and New Hampshire laws have been upheld by the 1st Circuit Court of Appeals, Vermont's law has been overturned by the 2d Circuit, and that decision is on appeal to the US Supreme Court.  NLARx has submitted an Amicus Brief in support of the Vermont law and we will be attending the argument next week.  We believe the Court should recognize the overriding interests of Vermont and other states in regulating the confidentiality of prescription records. The Vermont law directly advances the State's interest in protecting against disclosure of records containing the most personal of information as well as its interest in protecting individual autonomy in decision-making on important personal matters.  Protecting the confidentiality of records advances important goals of our health system, including combating undue influence of in-person pharmaceutical marketing that raises costs and damages public health interests.

Our brief argues that the Court should not apply the First Amendment to Vermont's Prescription Confidentiality Law, and should overturn the 2d Circuit decision which we believe improperly applied the First Amendment free speech protections to the commercial use or private-channel distribution of confidential data in purely private settings that do not inform or contribute to the public sphere. We also assert that the data in question is a secondary use of information where the government requires the initial disclosure. It is thus governed by cases in which the Supreme Court has affirmed a right of governments to restrict access to government held or mandated information. 

Kate Petersen blogs in Community Catalyst's PostScript that since it's physicians whose prescribing data and identity are being sold to marketers, their interests stand at the heart of this case. In a brief submitted by groups representing more than 170,000 physicians nationally, the Vermont Medical Society and other physician groups argue that because the data in question belongs to a physician and patient it is private data, not public, and does not qualify as commercial speech. But they go on to build a case that even it were commercial speech, the Prescriber Confidentiality Law substantially advances state interest by closing gaps in medical privacy and protecting the patient-physician relationship from intrusion by sales people, who tend to promote newer, less-tested and more expensive brand name drugs. For more, read the Medical Groups' Amicus Brief submitted by the Vermont Medical Society, New Hampshire Medical Society, Maine Medical Association, Medical Association of Georgia, American Academy of Family Physicians, American Academy of Pediatrics. 

Community Catalyst and its Prescription Access Litigation (PAL) project along with more than 32 groups and 35 states (plus DC) also have weighed in supporting Vermont's law. The U.S. Dept. of Justice also is backing the state law. Community Catalyst joined with Health Care for All and AFSCME District Council 37 to highlight how data-mined prescriber information was used to perpetuate illegal industry promotion. In their blog Postscript, they point to numerous documents from several lawsuits showing that data-mined information is an integral part of the drug industry success in its illegal promotion of unapproved uses of prescription drugs like Neurontin, Zyprexa, and Bextra. This illegal promotion not only put consumers at greater risk, it also cost consumers and insurers billions of dollars for ineffective and inappropriate drug treatments. Prescription data-mining is a multi-million dollar business for companies that buy prescription records from pharmacies and physician lists from the American Medical Association, and then match these to produce profiles that they sell to drug companies.  For more background on datamining and prescription privacy issues, check out the PostScript archives and the NLARx advertising & marketing web page.

In the States... A Roundup of News  

WISCONSIN SENIOR GROUPS OFFER COMPROMISE TO SAVE DRUG PLAN ASSISTANCE FOR ELDERLY

[Wisconsin State Journal, April 13]  "Advocates for older adults are proposing a way to help people enrolled in SeniorCare continue to have coverage for prescription drugs without signing up for Medicare Part D, as required under Gov. Scott Walker's proposed budget. The idea, by the Coalition of Wisconsin Aging Groups, involves the state getting more money from drug company rebates, issued only when the state pays part of the cost of prescription drugs. Under the proposal, the state would split medication costs with enrollees up front instead of making them pay pay their full deductible first, followed by small co-pays for each prescription, said John Hendrick, government affairs director of the coalition." More 

NEVADA STATE OFFICIALS INVESTIGATE PAYMENTS TO DOCTORS 

[NY Times: Inquiry Into Payments By Device Maker, APRIL 5]  Nevada state officials have begun an investigation to determine if payments to cardiologists there by a little-known heart device company were legitimate consulting fees or inducements to the doctors for using its products.  More  

NORTH CAROLINA LAWMAKERS WEIGH BILL TO RESTRICT DRUG SAFETY LAWSUITS  

[Pharmalot, March 24] Legislation in the North Carolina General Assembly would protect drugmakers and and those selling medications from liability in lawsuits so long as the med was approved by any state or federal government agency. Opponents of the bill maintain the provisions are among the most restrictive in the nation and would, effectively, prevent state citizens from recovering damages from any harm. Only Michigan currently has a law that bars such suits.  The only exceptions contained in the proposed North Carolina legislation refer to those who continue to sell a med after a government agency ordered a withdrawal or alter the med in a way that would have avoided an alleged injury, intentionally withheld or misrepresented info that led to approval by a government agency, or bribed a government official in order to obtain product approval. More 

KENTUCKY CONSIDERS RESTRICTING 3 CANCER DRUGS IN MEDICAID

[McClatchy / The Lexington Herald-Leader, March 28 ] Kentucky health officials are considering restrictions on the number of cancer-fighting drugs Medicaid patients may receive without prior approval, a move designed to contain costs in the health care program for the poor and disabled. The possibility of creating a non-preferred list of oral oncology drugs - pills that replace intravenous chemotherapy drugs - that Medicaid won't pay for without prior approval has raised questions from patient advocates and those who treat cancer patients. More 

TENNESSEE PROSECUTOR FOCUSES ON HEALTH CARE FRAUD 

"... As he closes in on his first year in office, [Jerry] Martin has decided to make the prosecution of health-care fraud cases a top priority in the 32-county district. He has doubled the number of prosecutors in the civil division who handle such cases - partially at the expense of his criminal division. "When you have as much health-care industry as we have here in the Middle District of Tennessee that regularly bill Medicare for billions of dollars annually, then health-care fraud and waste and abuse ought to be a top priority of the U.S. Attorney's Office," Martin said." Read more 

CALIFORNIA LAWSUIT ACCUSES BRISTOL MYERS OF BRIBING DOCS

[Amed News, April 4] California's insurance commissioner is suing pharmaceutical giant Bristol-Myers Squibb Co., accusing the drug company of bribing physicians using an assortment of kickbacks to prescribe the company's drugs. According to the lawsuit, physicians deemed "high prescribers" by Bristol-Myers received trips to basketball camps, free concert tickets, autographed basketball merchandise, liquor, golf outings and other rewards to boost prescriptions. Low-prescribing doctors were warned by drug reps that they would not receive free samples or event invitations, the suit said.High-prescribing physicians were compensated with expensive gifts by Bristol-Myers, the suit alleges, but the drugmaker says the allegations have no merit. MORE   

CALIFORNIA COMPTROLLER ASKS DRUGMAKERS TO LOWER AIDS PRICES

[Pharmalot March 29] California State Controller John Chiang sent letters to nine drugmakers, asking each of them to lower the prices on their AIDS meds and also extend supplemental agreements that were reached last year to relieve financial pressure on the AIDS Drug Assistance Programs around the country. In each case, Chiang wrote that California's ADAP program has experienced a 257 percent increase in AIDS drug spending since 2000, more than three times the rate of client growth over this same period. The state is "faced with either racheting down access to ADAP or cutting other vital health services to offset the cost of ADAP," he wrote the drugmakers, adding that supplemental agreements with several drugmakers expire this year, contributing to the financial pressures on the states. More 

SUPREME COURT RULES ONLY FEDERAL GOVERNMENT CAN SUE TO ENFORCE 340B PRICING

[Pharmalot March 29] The US Supreme Court ruled March 29 that Santa Clara County cannot proceed with a lawsuit alleging its hospitals and clinics were overcharged for prescription meds by various drugmakers, which failed to offer discounts as part of what is known as the 340B program. This offers access to discounted drugs to healthcare entities certified by the US Department of Health and Human Services. The 8-to-0 decision overturned a federal appeals court ruling of a lawsuit filed in 2005 against Pfizer, AstraZeneca, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Merck and Sanofi-Aventis, among others. The county had filed suit after the HHS Office of Inspector General found the drugmakers had violated pricing ceilings between 2001 and 2005. More