PhRMA Statement About Accessing Online Health Information

PhRMA Statement About Accessing Online Health Information

Washington, D.C. (March 9, 2010) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President David E. Wheadon issued the following statement regarding patients’ access to reliable health information online:

“PhRMA member companies are committed to providing patients and healthcare professionals with truthful and scientifically accurate information about the life-saving and life-enhancing medicines they research, develop and manufacture. To that end, PhRMA is proposing that the Food and Drug Administration (FDA) issue new guidance detailing how biopharmaceutical research companies may use social media to help patients and to improve public health; the guidance eventually could be adopted as regulations.

“PhRMA and its member companies remain committed to working constructively with the FDA to help develop these Internet-specific standards.

How should doctors receive education about new drugs?

We have seen so many new drugs and even new classes of drugs emerge over the last ten years. How do most physicians learn about new drugs? Many (certainly not all) community practitioners would say they learn what they need to know from the drug reps. Others indicate continuing medical education or CME activities as their main source of information regarding new drugs. Back in the "old days," docs would also attend many promotional/marketing dinners and social functions to learn about new medications. Those days are ending as PhRMA code regulations get stricter.

So what is the most effective way for physicians to learn about new drugs? They are so busy and easily overwhelmed by their workload that many have a difficult time keeping up with the latest science, the latest medical news, or even urgent FDA alerts and warnings.

Most of the clinical studies evaluating new drugs are performed by the drug manufacturer. Most of the CME activities that include any information related to new drugs are often underwritten by pharmaceutical companies, but the educational content is developed independently to be fair-balanced and is not influenced by industry. You won't see certified-CME activities that focus only on a single drug (maybe the only exception is when that's the only drug that's out there for a specific condition).

If a new drug comes out, do doctors really know how to use it safely and effectively? How can they accomplish this unless they receive fair-balanced education that highlights the clinical utility of such new agents? This becomes especially important when we're talking about brand new classes of drugs that have entirely new mechanisms of actions and pharmacological profiles.

There has been a lot of talk recently about industry-supported CME (certified continuing medical education). Some think that it's a bad idea for industry to support CME. Others feel that the lack of industry support may have a significant negative impact on physician continuing education. Why? Because the availability of fair-balanced educational programs may shrink considerably. What would happen if physicians only get exposed to marketing/promotional messages about new drugs and they don't get exposed to fair-balanced continuing education about those same products?

PhRMA to find $80 billion in discounts

Our country needs healthcare reform. What's the pharmaceutical companies doing about it? How are they contributing?

PhRMA members are pledging to find $80 billion in discounts. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies. This may include reducing drug prices by 50% to seniors in the Medicare Part D “donut hole” coverage gap. The complete details of this plan are still in process and it won't be finalized until the plan is scored by the Congressional Budget Office.

At at a press conference with AARP officials, President Obama made the following statement: “The agreement by pharmaceutical companies to contribute to the health reform effort comes on the heels of the landmark pledge many health industry leaders made to me last month, when they offered to do their part to reduce health spending $2 trillion over the next decade... We are at a turning point in America's journey toward health care reform. Key sectors of the health care industry acknowledge what American families and businesses already know - that the status quo is no longer sustainable. The agreement reached today to lower prescription drug costs for seniors will be an important part of the legislation I expect to sign into law in October. And to do that we're going to have to work together to root out waste and inefficiencies that may pad the bottom line of the insurance industry, but add nothing to the health of our nation. To that end, the pharmaceutical industry has committed to reduce its draw on the health care system by $80 billion over the next 10 years as part of overall health care reform."

Tons of Pharma Freebies on Ebay

So, now with the new PhRMA code, we've seen the last of pharma pens, cups, and note pads, right? Look on eBay and you'll see tons of people selling items that list: Exforge, Viagra, Bystolic, Lexapro, Lipitor, and much more. I still have some pens that say Vioxx, Zelnorm, and Propulsid (these drugs are no longer available in the USA).

If you have pharma freebies, are you hanging on to them with the hopes that they may someday become very valuable collectibles? Or, maybe you can show them to your grandkids and tell them what you used to receive "back in the day."

The World of Medical Education

The world of medical education can be broken down in so many different ways.

First: professional vs. consumer health education

If professional, then: promotional vs. certified continuing education (or certified CME/CE)

Let's talk a bit more about professional health education since we all know about WebMD and Revolution Health.

The world of promotional education is governed by strict FDA guidelines. Plus, don't forget the PhRMA code. There is no off-label discussion within a promotional activity. Also, speakers are recruited directly by the pharma/biotech/device company. The content does not need to be fair-balanced and there is no governing body that certifies those activities for any type of continuing education credit.

In the world of certified CME/CE, the rules are completely different. Here, you can discuss off-label use of medications. As a faculty speaker, you are to have no communications with the pharma/biotech/device company. Also, you don't get paid directly from a drug company. The educational content must be fair-balanced and the ACCME acts as a governing body to provide rules and regulations regarding certified CME (the CE for nurses and pharmacists are governed by other bodies). The PhRMA code has rules regarding CME.

Surprisingly, many healthcare professional are not aware of the distinction between non-certified medical education and certified medical education. Since the rules are constantly changing, it's important to stay updated on the latest guidelines and codes. The PhRMA code just got revised and the ACCME guidelines are constantly in flux.

Center for Communication Compliance (CCC)

Have you heard of the Center for Communication Compliance (CCC)? The CCC now offers certification programs for professionals working in either healthcare advertising companies or in promotional medical education companies. Please note, this is NOT something for medical education companies that focus on certified CME/CE activities. Promotional medical education is entirely different from certified CME.

New 2009 PhRMA code will be effective at the beginning of 2009. Gone are the days of pharma pens, trinkets, notepads, and all those freebies. I wonder if the prices of Viagra pens will go up on eBay.