Life Science Compliance Update

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June 10, 2010

Consumer and Prescriber Grant Program: Twenty One Million Dollars to Discredit Collaboration

Over six years ago, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws.

A key provision within the agreement included a settlement that provides a $21 million Consumer and Prescriber Education grant program to be administered by a Special Committee of State Attorneys General pursuant to an Oregon Court Order.

The Special Committee selected an Administrator through a competitive selection process leading to a contract for the day-to-day administrative and financial operations of that program. The current Administrator, Harry M. Snyder, who is located in San Francisco, California, takes direction from and reports to the Special Committee. The Oregon Department of Justice is directed by the Special Committee to contract with the Administrator and prescriber program grantees and to disburse funds pursuant to those contracts.

Through the grant program, funds are distributed to programs designed to provide health care professionals and consumers with information relating to prescription drugs, including the way in which drugs are marketed. In order to apply for grant funding, each Principal Investigator must fill out and sign a conflict of interest form up front disclosing all work with the pharmaceutical industry. The Consumer and Prescriber Education program adheres to a conflict of interest policy that prohibits:

  1. Accepting any honoraria, gift or consulting fee from a pharmaceutical company;

 

  1. Accepting compensation from participation on an advisory board to a pharmaceutical company;

 

  1. Accepting a grant for research on a specific pharmaceutical product or on any topic where the grant is funded solely by one or more pharmaceutical companies;

 

  1. Participating in an education program or conference funded wholly or in part by a pharmaceutical company where expenses of more than $25 are paid to the principal investigator; however a principal investigator may participate in an educational program or conference and accept reimbursement of travel, meal and lodging expenses if those expenses are paid for by his or her employer or by another funding source unrelated to a pharmaceutical company.

Accordingly, the first rounds of grants focused on prescriber education, which includes programs that demonstrate ways to of improve prescribing practices by:

-    Educating health professionals at all levels of training about the drug development and approval process;

-    Making health professionals aware of pharmaceutical industry marketing practices and assisting them in developing the knowledge and skills to evaluate those marketing techniques; and  

-    Providing examples and strategies for evaluating existing sources of drug information, and for accessing unbiased sources of information about drugs.

After completing a Request for Application process, the program awarded 28 grants to Academic Institutions and non-profit organizations, and included names like Dr. Jerry Avorn, Dr. Adriane Fugh-Berman, and David Rothman.  Such a concentrated group of anti-industry minded people is troubling.  Are these programs really being funded to educate professionals about drug development and the approval process, or to tell physicians that the drug industry is evil?

 

These grants were awarded to fund the development, dissemination and evaluation of curricula to provide practicing health professionals, and those in training, with the critical skills necessary to evaluate prescription drug information and industry marketing techniques, and to apply this knowledge to their own prescribing practices.

The second round of grant awards focused on consumer education programs that are designed to improve the clinical and economic value of prescription drugs by educating consumers about sound purchasing concepts, reliable sources of drug information and marketing practices of the pharmaceutical industry.

After a Request for Application process, the Special Committee only awarded one grant to the Consumers Union, with Principal Investigator, Doris Peter, PhD, and the following objectives:

  • Enhance public understanding of issues surrounding prescription drug effectiveness, safety and side effects, and costs, and help consumers make informed drug comparisons;
  • Empower consumers to talk with their doctors, pharmacists, and other providers about their prescription drug choices; and
  • Provide consumers with early drug safety alerts and information about off-label use;
  • Improve health outcomes by enhancing drug compliance and treatment adherence.

The work is structured around the following five goals:

  1. Increase the usefulness and use of Consumer Reports Best Buy Drugs by expanding the categories and increasing the frequency of report updates.
  2. Increase public awareness of prescription drug choices and value through a social marketing campaign that aims to enhance public understanding surrounding prescription drug effectiveness, safety, side effects and costs, and helps consumers make informed drug comparisons.
  3. Test the success of dissemination strategies to the target audiences and through web-based technology networks.
  4. Enhance the content distributed by Consumer Reports on drug safety and off-label use to better educate consumers.
  5. Measure the impact of the use of Consumer Reports Best Buy Drugs and specific strategies to educate consumers about their drug choices.

While it is important that prescribers and consumers are both educated about drugs they prescribe and take, $21 million is a lot to spend on educating physicians who are already well versed in literature and materials for a variety of medicines.  In addition, patients are best informed about medication and drugs by their own physicians, not magazines that are published telling them to buy the cheapest drugs.

These funds should be used for more research, clinical trials, and projects in which results can be measured. How will these programs improve patient health? How can a program determine that patients and physicians saw better outcomes in prescribing and medication?

Ultimately, programs receiving grants to tell physicians that alternative medicine is the best option and that any industry funded event or program is biased are problematic.  Any sort of consumer or prescriber education needs to offer all sources of information equally and fairly, including those perspectives held by members who work in the drug and marketing industry.  Since the program itself has a conflict of interest policy, members can disclose their relationships, and offer a balance in the program that will allow individuals and organizations that work with industry to share their perspective about the drug approval and marketing process. 

Programs that give physicians and consumers every perspective will allow patients and doctors to make the best choices together, which will lead to the best outcomes for everyone.

 

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