Policy and Medicine

IMS vs. Vermont: Free Speech but only in the Interest of the Government

Free Speech but only in the interest of the Goverment.

This is exactly what the NLARX has stated in their press release about the filing of the “Friend of the Court Brief” for the IMS versus Vermont Case:  That the law “serves substantial governmental interests”.

The Vermont law S. 115 restricts the sale of prescription drug information that identifies prescribers and patients; services like IMS, Versipan and Walters Kluwer, Health sell this information to manufactures to assist in targeted marketing.  The Vermont Law is a similar law to one struck down earlier this year by the First Circuit Court in Boston. The law has been temporarily repealed until 2011 or until the courts decide on the constitutionality of the law (for more information).The date for the court hearing is July 28^th in Brattleboro, VT.

On Monday, June 23^rd several organizations sent in their “Amicus” Friend of the Court Briefs including the Coalition for Healthcare Communications.

In the Coalition Brief they point out “that Vermont cannot ban one class of speakers from the marketplace of ideas and information while at the same time allowing other speakers without violating the First Amendment.” That this bill was hastily put together to undermine the courts’ decision in the New Hampshire Case.

They also point out that this information is used for research and to develop information regarding the safe uses of drugs and serves the public interest.

The statue if not overturned, government will resort to tactics used here to restrict the data and communication of other commercial speakers.   

“If the Government is capable of violated free speech by selectively releasing its own data, surely it violates free speech by regulating the manner in which third parties release theirs.”

In the brief created by NLARX and Community Catalyst, they use language like societal justifications (code for if they market drugs and devices governments spend more money), and governmental interests (code for saving money).  They go on to describe marketing practices that “promote irrational drug selection” (code for branded drugs versus cheep generics). 

It is interesting to note that government is always looking to save money and not necessarily in the best interest of patients.  The groups that will be most affected by these types of legislation are those who live in rural areas like Vermont, New Hampshire and Maine (which passed these laws) who’s physicians are least likely to learn of new and more effective medications without access to industry.

The courts have been right in their protecting the first amendment, it is in everyone’s interest for as much information on medical therapies to get into the hands of physicians and patients.  The competition of ideas about what is best for patients in fought on a level playing field, and is more important than the governmental interest of saving dollars.  Our patients deserve more informed healthcare professionals not those who have only been spoon fed what the government thinks is important for us to know.

Regulating CME: States Attorney’s Join in the Act

The States Attorney Generals have joined in the act of regulating CME.

On May 20th, Merck settled with States Attorney Generals on Vioxx litigation.  As part of the settlement, Merck agreed to restrictions on a variety of topics that include promotional claims, DTC advertising, drug safety monitoring boards, manuscript authorship, clinical trial posting, and CME.

For CME Merck Agreed to Three things:

A)   Merck shall comply with ACCME Standards for Commercial Support:

Merck will include in their promotional speaker contracts a pledge that if the speaker has worked for or received compensation from Merck in the therapeutic category the program concerns in the last 12 months, the speakers will:

Disclose to participants orally and to the CME provider for inclusion in the written materials:

                                                  i.    The existence

                                                ii.    Nature

                                               iii.    Purpose of their arrangement with Merck

                                               iv.    Type of promotional work engaged

B)   Merck shall not fund a CME program if at the time of funding decision they had knowledge that a speaker had also been a promotional speaker in the last 12 months at a Merck-sponsored promotional event related to the class of drugs to be discussed in the activity.

C)   The agreement in respect for CME:

a.    Shall remain in effect for 9 years.

b.    Shall only apply to speakers’ contracts entered into, amended to extend the contract period, or renewed after the date of this Agreement.

The attorney generals understand that disclosure is important.

As CME funders and providers strive to eliminate and reconcile conflicts of interest, it is important to remember that we are under tremendous scrutiny and must work to do an excellent job at this piece of the puzzle.

Press the link for copies of the Download merck settlement may 20 2008 cme section full settlement and analysis.

Minnesota Doctors: No Ice Cream for You

This weekend at the ASCO (American Society of Clinical Oncology) meeting in Chicago at least two booths had signs telling doctors from Minnesota that to comply with state law please don't take our ice cream.

This is according to a report in Fortune News Feed at both the Eli Lilly and Novartis booths had signs asking doctors from Minnesota and some government employees not to indulge in their small give aways. (Novartis a soap dish, and Lilly frozen yogurt)

This is a classic example of how utterly ill thought out these gift bans-limits are.   Please, name me one other industry that has these types of restrictions, even at FOSE(the government computer show) there are no shortages of trinkets or ice cream,.  Yet now states are in the act (more each year), to make it so doctors have no incentive to stop by an exhibit booth to learn from a rep. 

Please help me understand how these bans help patients or save anything, but potentially embarrass doctors from those states.  Does anyone think for a minute that a doctors judgment is forever impaired because they stopped by a booth and got ice cream or a soap dish.... please....

New York Governor Jumps on the “Gifts to Physicians” Ferry

Governor Paterson of New York announced he is introducing a ban on gifts to physicians.  Though the bill is not available couple of key points:

A)   Ban gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year

B)   Require practitioners who make presentations at Continuing Medical Education (CME) events to disclose any financial relationship they have with drug companies

C)   Require pharmacy benefit managers (PBMs) to disclose information to health plans, doctors and patients.

a.    the actual utilization of drugs by the health plan’s participants;

b.    every policy or practice of the PBM that presents an actual or potential conflict of interest with the health plan;

c.    Any increase in the net price to the health plan for a covered drug and the reason for the increase;

d.    all contracts and agreements entered into by the PBM with a network pharmacy and with any pharmaceutical manufacturer. To prevent PBMs from switching patients to more expensive drugs without the patient’s knowledge and without providing adequate information to the practitioner, the bill requires notification to patients and the provision of relevant clinical and financial information to prescribers before drug switches can be made.

This bill was endorsed by the New York, AARP, Consumer Union, Business and Labor Coalition, and Citizen action.   It is worth noting that the bill is designed to fix problems already addressed:  For CME disclosure it is a ACCME requirement to disclose your relationships. From our expierence it is working, doctors take disclosure very seriously. 

For PBM’s, I don’t know of a single instance where pharmacists are switching patients to brand drugs without their knowlege, but stories every day of un notified switches to gernerics.  This morning, I recieved an email, outlining how it was almost impossible to get a brand drug,  the pharmacist kept switching all his prescriptions to generics.  Even when the doctor writes medically necessary on the prescription, often the pharmacy will not have the branded drug in stock, so they will fill with generic. 

The ban on gifts is also suspect in that the definition for gifts almost always includes services and consulting. 

If you want to read more here is the Reuters Article

So here we go again…..

Connecticut: Just Information for Now

Connecticut Attorney General Richard Blumenthal, Brother of David Blumenthal and both

potential Clinton/Obama appointees, delivered strong rhetoric for a prohibition against drug company gifts and other benefits provided to doctors under the grounds that gifts may improperly influence health care decisions.

Blumenthal testified April 21 before the Connecticut State Public Health Committee "Marketing of Prescription Drugs" Informational Forum,  (Legislative staff made it clear this was simply an information forum not a hearing) that The pharmaceutical industry, hospitals and physicians groups have adopted "codes of ethics" to prevent conflicts of interest - but Blumenthal said these codes are virtually unenforceable and meaningless, and must be made law.

"We must stop improper impacts and influence of money on health care providers from the pharmaceutical drug companies," Blumenthal said. "Shocking recent disclosures about Merck's widespread ghost-writer reports - with payments to prestigious health care providers - vividly demonstrate the audacity of pharmaceutical drug company monetary influence.

He proposed the following recommendations be turned into Connecticut State Law:

• Prohibit any gifts, scholarships or other items in exchange for prescribing products, a commitment to continue prescribing products or to otherwise interfere with the independence of a health care provider's prescribing practices;
• Prohibit any gifts for the personal use of a health care provider;
• Prohibit any gifts to a health care provider for business use except for items of minimal value such as post-its, note pads, etc;
• Limit gifts for patient benefit to free samples of prescription drugs and items valued under $100;
• Prohibit any gifts or payments to health care providers for attending conferences but allow financial sponsorship of such conferences if the benefit of the sponsorship is distributed evenly among all attendees through reduced conference fees;
• Regulate payments to health care providers to serve as consultants, requiring written contracts, documentation of the criteria and the selection process for such consultants, articulation of the legitimate need for such consultant services; and
• Require all recipients of scholarships and other financial educational assistance to be selected by the participating academic or training institution and not the pharmaceutical company.

California Dreaming

Last week the California State Assembly delayed AB 2821 (actually it was defeated on April 1, then offered for reconsideration, and the new hearing last week on April 15^th was canceled by the bill sponsor. I hope you got all that)

AB 2821 Bans all gifts greater than an aggregate $250.00 to physicians and requires disclosure filing annually of all gifts over $50.00 and the first annual report will be due December 31^st 2010.  CME is excluded as a gift, along with reasonable honorarium and faculty expenses.

It is interesting to note that in the sponsors presentation he has the miss-understanding that doctors still get gifts -- like trips, gift certificates, and parties.  And that today physicians are paid to attend CME events. (see public hearing analysis)

AB_2821_Text of Bill

AB2821  Bill Status

AB2821_Public_Hearing_Analysis 

CAL-PIRG (California Public Interest Research Group is the prime supporter of this bill in the California Legislature -- PIRG was founded by Ralph Nader)  All this commotion is in response to companies now filing compliance documents with the State of Californa to meet the guidelines of SB1765 which is now law in the state of california).

CalPirg_AB2821_Letter to Chairman

CalPIRG Report on Gifts to Physicians  (includes a chart by company of limits for gifts in California)

California Progress Report PIRG