Amgen joined forces with the Centers for Disease Control and Prevention and the CDC Foundation to launch a three-year initiative to provide resources and educational tools for cancer patients, their caregivers, and healthcare professionals about the risks and impact of infections. 

Announced on Wednesday, the program was spurred by a new Harris Interactive survey that revealed that a quarter of patients interviewed had experienced an infection in the past 12 months while receiving chemotherapy. Additionally, 22 percent of patients with infections said that it took four weeks or longer for the infection to clear up, and more than half had to go to the emergency room for treatment.

The poll also revealed that more than 90 percent of specialists are worried that patients are resistant, or are building resistance to antibiotics used to cure infections. 

Amgen markets, Neulasta, a treatment for the reduction of infection caused by neutropenia, the decrease in white blood cells brought on by chemotherapy. However, the biologics firm made it clear that this campaign is unbranded, and was created with the sole purpose of educating patients. 

There are two main components to the new program: an evidence-based curriculum for clinicians on infection control for patients, as well as appropriate antibiotic management; and an interactive online tool for caregivers that will provide tailored educational messaging on how to best manage an infection. 

“At the end of the day, we want to make sure that all three of these audiences know how best to prevent an infection, and how to best manage if they get an infection,” said Ashleigh Koss, spokesperson for Amgen.

According to Koss, cancer patients have a weakened immune system, either due to the cancer itself or because of treatments such as chemotherapy. “If you have a low level of white blood cells and you have had a low level for some time, it puts you at a greater risk of infection,” Koss said. “Cancer patients undergoing chemotherapy must do everything possible to prevent an infection that can impact their overall treatment.”

While this is the first time Amgen has teamed with the CDC to fight infections, it isn’t its first major marketing foray into patient education around the disease. In 2002, Amgen picked actor Rob Lowe to be the face of its “By My Side: Taking Control of My Cancer Treatment” campaign, which offered a bevy of touch points for patients, including a Web site and phone hotline.

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News Analysis

Cancer patients worry not only about their disease, but also the side effects of the drugs they take to treat it. Now the Centers for Disease Control and Prevention and biologics firm Amgen are partnering on a multi-prong program to get patients to pay attention to another, related, danger: chemo-related infections.

Amgen and CDC to Spearhead Anti-infection Campaign

Pharmaceutical companies no longer have an excuse if they receive a warning letter from the feds citing them for failure to present balanced risk and benefit information in ads. On Tuesday, FDA released draft guidance highlighting exactly what kind of risk information it is looking for in pharmaceutical and medical device advertising. From the size of the font used in television commercials to the amount of white space in text advertising, the agency detail exactly what it approves or disapproves in drug and device marketing material. 

In effect, pharma and device ads must avoid any false or misleading claims, reveal all facts both positive and negative regarding the drug being advertised, and depict information about the benefits and risks in an equal manner. FDA also made it clear that it doesn’t approve of fast-moving imagery or loud music that can distract consumers from absorbing risk and benefit information. 

According to the guidance, all ads will be reviewed based on the perspective of the “reasonable consumer,” a standard accepted by the Federal Trade Commission for consumer advertising. It states: “We examine the practice from the perspective of a consumer acting responsibly in the circumstances. If the representation or practice affects or is directed primarily to a particular group, the Commission examines reasonableness from the perspective of the group.”

The guidance even goes into specific details about signals or font size and headlines. For example, pharma companies cannot place risk information in a smaller font size than benefit information, or display it below a benefit statement. The same guidelines go for spoken language, with particular emphasis placed on language used and vagueness of statements. 

Placement of risk information is also described at length. FDA recommends that side effects be mentioned at the beginning or end of television or radio ads to maximize recall, while risk info should be placed at the top of print ads, as people are less likely to read something at the end. 

, FDA spokesperson Karen Mahoney stated that the draft guidance does not change any of the rules that have previously applied to prescription drug and device promotion (guidance documents are intended to describe FDA's current thinking on a topic, rather than introducing new regulatory requirements). FDA's rules and the basis for its enforcement actions remain the same-the Appendix to the guidance describes the applicable legal provisions in detail.  

“What this guidance document provides is an in-depth look at the factors FDA considers when it evaluates promotion for compliance with these longstanding rules and regulations, along with recommendations on effective communication techniques,” Mahoney wrote. “Our aim is to aid companies in effectively communicating risk information in their promotion.”

The guidance is subject to comment for 90 days before being approved or altered. 

You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."

Pharmaceutical Executive-05-28-2009

Amgen and CDC to Spearhead Anti-infection Campaign

FDA Releases Guidance on Risk in Ads