Cytogen Quadramet Promotions Cited In FDA Ad Division Warning Letter

A radio ad, website and patient video for the cancer pain therapy overpromise benefits and minimize risk to “a very sick and vulnerable population,” FDA says. The warning letter follows a 2001 “untitled” letter for Quadramet that also objected to unsubstantiated efficacy claims.

Ads for Cytogen's radioactive therapy Quadramet (samarium) overstate efficacy and minimize risk for a particularly vulnerable population, FDA's Division of Drug Marketing, Advertising & Communications says in a July 18 ^FDL-1 warning letter to the company.

A broadcast radio ad, patient testimonial video and website "overstate the effectiveness of Quadramet and fail to reveal and minimize important risk information associated with the use of Quadramet," the DDMAC letter states.

"These violations are extremely concerning from a public health perspective because they overpromise the benefits and minimize the risks of Quadramet to a very sick and vulnerable population."

Quadramet is indicated for "relief of pain in patients with confirmed osteoblastic metastatic bone lesions."

The video and website overstate the pain relief Quadramet demonstrated in trials or clinical experience, FDA says.

"The patient video and website misleadingly imply that patients receive immediate pain relief from Quadramet, overstate the extent of the pain relief from Quadramet, and misleadingly imply that patients will not need to use other analgesics (such as narcotics) after treatment with Quadramet."

The agency cites the video and website statements that "treatment takes just one minute and can provide pain relief for 16 weeks in responding patients."

Patients who respond to treatment will not experience relief until a week or more after receiving a Quadramet injection, the letter notes.

The patient video also implies that Quadramet provides a therapeutic benefit in treating cancer, FDA says.

The statement "Quadramet doesn't make you lose your hair, it targets the cancer and that is what is so great about it," explicitly and implicitly suggests "that Quadramet is a cancer therapy that can provide a therapeutic benefit other than pain relief," FDA says.

"This misimpression is reinforced by such statements on the website as 'Now I have time to enjoy life,' which can be construed to mean that patients on Quadramet can be expected to live longer," the letter states.

In addition, the promotional materials imply that "patients will be able to resume their normal daily activities as a result of using Quadramet."

A testimonial on the video describes one patient as "ambitious and walking around" and able to "do her daily things" after receiving Quadrament.

"The patients for whom Quadramet is indicated are suffering from a serious (and eventually fatal) underlying disease that Quadramet does not treat (metastatic bone lesions), which may in ways other than through bone pain prevent them from engaging in normal activities," the letter states.

The radio ad includes no Quadramet-specific risk information, while the video "minimizes the one risk it does present," on bone marrow suppression. The website also "misleadingly minimizes the risks associated with Quadramet," FDA said.

The July 18 warning letter follows a 2001 ad division "untitled" letter for Quadramet that also objected to unsubstantiated efficacy claims.

"We are very concerned that you are continuing to promote Quadramet in a violative manner," FDA stated.

FDA requested that Cytogen immediately discontinue dissemination of the promotional materials and respond to the agency by Aug. 2 with a plan to distribute corrective messages.

- Elizabeth Walker