Drug-Maker’s Direct-to-Consumer Advertising—“Half-True”?

Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .  information currently being advertised could mislead the public.”

But “don’t get too excited that the U.S. Food & Drug Administration has regained its sanity,” says blogger Bill Sardi.

“This is the FDA in Thailand,” he explained. (Sardi picked up the news in the Bangkok Post)

Before taking a closer look at precisely why Thailand’s health officials  are concerned about Merck’s ads—and why our own FDA isn’t raising a red flag-- let’s step back and review our own government’s policy on drug ads that are beamed directly to you and me.

Screening for Prostate Cancer: Before Medicare Pays, Patients Need to Know More About Risks

Roughly two-thirds of all men on Medicare are screened for prostate cancer. Most feel they have no choice. After all, this year more than 27,000 American men are likely to die of the disease. When men are asked about their fear of cancer, a survey from the Harvard Risk Management Foundation reveals that prostate ranks at the top of the list. Colon cancer, which kills roughly as many men in the U.S. each year, ranks number seven. There is something about prostate cancer that pushes buttons. No wonder so many men sign up for the “PSA” test which measures levels of prostate-specific antigen in the blood. But the truth is that current research offers no proof that widespread screening and early diagnosis saves lives. What we do know is that patients who are tested and treated may suffer life-changing side effects that outweigh the uncertain benefits of early detection.

In June the National Cancer Institute made its position clear: “Screening tests are able to detect prostate cancer at an early stage, but it is not clear whether this earlier detection and consequent earlier treatment leads to any change in the natural history and outcome of the disease.” The U.S. Preventive Services Task Force agrees.

Wall Street, Cancer and the FDA: A Cautionary Tale

Only in America do physicians who evaluate new drugs need bodyguards. You may have read about the brouhaha surrounding Provenge, a vaccine designed to extend the lives of men suffering from late-stage prostate cancer. In March, a Food and Drug Administration (FDA) advisory panel voted 13 to 4 to recommend approval. The next day, shares of Dendreon, the drug’s sponsor, doubled. But shareholders did not celebrate for long. Two of the dissenting votes were cast by the panel’s two prostate cancer specialists: Sloan-Kettering’s Howard Scher and the University of Michigan’s Maha Hussain. And they did not just vote “no”—following the hearing, both wrote to the FDA arguing that Dendreon offered no solid evidence that Provenge works.
   
The FDA listened. And in May it told the company it wouldn’t approve the drug until it had more data. That is when the two oncologists began receiving threatening e-mails, phone calls, and letters. Many were anonymous