Editorial: Should Black-Box Warnings be Dispensed with Commercial Prescriptions? Should "Percent Effectiveness" Information be Provided to Patients? Buyer Beware?

When you purchase many items today you get:

• A money-back guarantee if not satisfied
• A reasonable expectation of what that item will do
• Reasonable assurance that the item is safe
• Reasonable assurance that the item is functional and effective
• An opportunity for litigation if required
• Reasonable recourse in the event of litigation...

When you buy a prescription drug product, the patient gets:

• NO assurance that the drug is going to be effective for them
• NO assurance that the drug will take care of their problem
• NO information on the likelihood the drug regimen will be successful
• NO money-back guarantee
• NO, or very little, information on the dangers associated with the drug (one is counseled with warnings that they may experience side effects)
• Possibly NO opportunity for litigation (if pre-emption is made into law)
• A medication they do not select (as the prescriber selects the therapy)

1. Request that the President not enact pre-emption rulemaking. Allow patients to sue pharmaceutical companies if they are injured by the drugs they are prescribed; the same as they can with other products. Limit attorneys' legal fees instead of patients' legitimate damages.
2. Require "Black-box Warning" stickers on all prescriptions so patients will know the potential dangers associated with their therapy. (These stickers can be provided by the manufacturers in the package for pharmacists to affix to the dispensing container.) This allows the patients to be more fully informed on what they are taking/using.
3. Require that a "Percent of Effectiveness" statement be made available to the patients to enable them to accept or reject their treatment. If a drug is 5% effective, 25% effective, 50% effective, 70% effective, 90% effective, etc., the patient needs to know. As it is today, patients have no idea how effective their drug is. Patients often get a Percent of Effectiveness statement regarding surgery, etc.

Think about the following from a patient's and taxpayer's point of view:

• Don't the patients have a right to know this information?
• Why should the patient pay for ineffective or marginally effective treatment?
• Why should the government and insurance companies pay for drugs that are not effective and that cause further harm and even death? If a drug is only 60% effective, think about all the money that is wasted and taxpayers are being charged!
• Do prescribers not have a responsibility to be aware of all this information instead of just listening to marketing representatives?
• Do pharmacists have any responsibility to make patients aware of all the information discussed in this editorial? If so, what would be the prescriber's response?

Neurontin Study
Results from a large European study were suppressed that suggested that the drug was ineffective for chronic nerve pain. Pfizer executives privately strategized about how to silence a British researcher who wanted to publicize the data. During this same time period involving several years, Pfizer Inc. promoted the purportedly positive findings of a smaller Neurontin study it had published in a major medical journal in an advertising blitz. This widespread promotion resulted in generating more than $2 billion a year in U.S. sales for Pfizer before a competitor drug entered the market in 2004. Neurontin was the fourth fastest growing blockbuster drug in the world. The findings of the European study were never published as a stand-alone paper but were combined with results from several other Pfizer studies and published in a minor journal in 2003.

Pfizer is being sued for consumer fraud and unjust enrichment saying the company promoted Neurontin for medical conditions and doses for which it knew the drug was not effective.
http://www.boston.com/news/local/articles/2008/10/08/e_mails_suggest_pfizer_tried_to_suppress_study_on_drug/

Rule Changes Could Block Product-Safety Suits
Administration officials are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states. The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine.

This year, lawsuit-protection language has been added to10 new regulations, including one issued October 8 at the Department of Transportation that limits the number of seatbelts car makers can be forced to install and prohibits suits by injured passengers who didn't get to wear one.

These new rules can't quickly be undone by order of the next president. Federal rules usually must go through lengthy review processes before they are changed. Rulemaking at the U.S. Food and Drug Administration, where most of the new pre-emption rules have appeared, can take a year or more.

The U.S. Chamber of Commerce's Institute for Legal Reform supports pre-emption as part of its campaign to "neutralize plaintiff trial lawyers' excessive influence over the legal and political systems," according to its Website.

Mr. Lefkowitz said the administration decided not to press its pre-emption agenda in Congress, where it might lose. "There was already authority within federal government statutes and regulations to start the reform process without legislation," he said. "Using that and legal briefs, we proceeded."
http://online.wsj.com/article/SB122403828537735379.html?mod=dist_smartbrief

Dietary Supplements Pocket Companion
Grayslake, IL: Pharmaceutical Press; 2008
$39.95 www.pharmpress.com

This great pocket-size handbook is designed to provide busy healthcare professionals with a quick reference text drawn from the reference work Dietary Supplements. It contains 88 monographs on specific food supplement ingredients and has new monographs on arginine, dong quai, 5-HTP, hydroxycitric acid, multivitamins, and pumpkin seed. It contains the latest evidence summarized in a tabular format for quick reference and ease of use.

The Compounding Around the World program sponsored by the International Society of Pharmaceutical Compounding and the National Community Pharmacists Association was excellent! The speakers presented the material in a very entertaining way, including video clips, to the attendees and many eyes were opened to what is going on around the world!

E-mail Marketing
Use e-mail for marketing special groups of patients! Set up different "mailing lists" by patient disease state/drug therapy and provide them a periodic newsletter when anything related to their drug therapy comes up, especially news clips, etc. This works great for diabetic, BHRT, pain management and other patient groups in your pharmacy. Be sure to set the lists up so there can be no HIPPA infringements.