Healthy Skepticism Library item: 12079

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Glaxo hyped breast cancer drug, FDA says
CNNMoney.com 2007 Nov 27
http://money.cnn.com/2007/11/27/news/international/glaxo_fda.ap/index.htm?source=yahoo_quote

Full text:

London-based drug company scolded by federal regulators for downplaying cancer drug risks, playing up benefits in promotional materials.

WASHINGTON (AP) — Government regulators have criticized GlaxoSmithKline for downplaying the risks of its breast cancer drug Tykerb, while exaggerating the benefits, in letters to doctors.

The Food and Drug Administration scolded Glaxo (Charts) over “misleading” promotional materials urging physicians to prescribe Tykerb, a daily pill for patients with advanced breast cancer. FDA posted the Nov. 21 warning letter to its Web site Monday.

Regulators said Glaxo hasn’t adequately alerted physicians to Tykerb’s risks, including reduced pumping action of the heart’s lower left chamber. The drug’s label instructs doctors to monitor patients’ heart strength before and after starting treatment with Tykerb, but FDA says that information was left out of Glaxo’s marketing letters to doctors.

The FDA says London-based Glaxo also omitted precautions and warnings to pregnant women and patients with liver disease.

Regulators also cited Glaxo for exaggerating the effectiveness of Tykerb. The drug was approved based on two studies: one that showed a 43 percent decrease in patients’ risk of tumor growth and another that showed a 28 percent decrease. However, the materials from Glaxo only mention the study with the 43 percent reduction.

The FDA has asked Glaxo to stop distributing the letters and to outline a plan for correcting its marketing message by Dec. 6. FDA warning letters are not legally binding, but the agency can take companies and individuals to court if the warnings are ignored.

A spokeswoman for Glaxo said the promotional letters were first issued after Tykerb’s approval in March, but could not confirm whether they are still in use.

“We will work with the agency to address its concerns,” said spokeswoman Sara Alspach.

Shares of GlaxoSmithKline plc fell 60 cents Monday to close at $50.19.