Category Archives: FDA

Do You Want to Know That You Will Be an Alzheimer Patient in Two to Six years?

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Yesterday The New York Times reported a medical breakthrough: “the development of a blood test that can  accurately  diagnose Alzheimer’s disease, and even do so years before truly debilitating memory loss.”

Well, “accurately” may be a bit of a stretch. As the Times explained, the test is about “90 percent accurate in distinguishing the blood of people with Alzheimer’s from the blood of those without the disease” and “about 80 percent accurate in predicting which patients with mild memory loss would go on to develop Alzheimer’s disease two to six years later.”

Then, the Times acknowledged, there is one other problem with the test:  “At present, treatments for Alzheimer’s disease are not very effective.”

So why exactly would I want an early warning that would give me two to six years to contemplate what it will be like to observe my mind dissolving? (Of course I could comfort myself with the fact that the test is only 80 percent accurate, but somehow I suspect that would only compound my anxieties.)

“There are people who want to know what their future holds so they can plan their estates and lives,” Dr. Sam Gandy, a professor at Mount Sinai School of Medicine in New York who is chairman of the medical and scientific advisory council of the Alzheimer’s Association, told the Times.

Right, this is an estate planning tool.

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Inside the FDA

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I was speaking to a source inside the FDA recently and he explained that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.

“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he adds, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

We also talked about direct-to-consumer advertising and why many in the pharmaceutical industry resisted the suggestion that they wait two years before trying to sell a new drug directly to the public. “There is a saying in the industry,” he confided, “[that] you want to get doctors accustomed to using a new drug while it still ‘works’—while it’s still the latest and the greatest.”

In other words, drug-makers want doctors to begin using the drug before everyone discovers that it is not quite the miracle cure that some hoped it would be. Knowing that it takes time to discover the risks of a drug, doctors might not be so quick to take up the absolute newest thing on their own. That’s why companies like to go to consumers who they hope will push their doctors into trying the new products before all the risks are known.

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

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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.

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

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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.

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Wall Street, Cancer and the FDA: A Cautionary Tale

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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

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