Archive for the ‘FDA’ Category


Monday, November 28th, 2011




Monday, November 21st, 2011
The Wall Street Journal

  • NOVEMBER 19, 2011

A chillingly blunt assertion of regulatory power against a drug for breast cancer.

  • The extraordinary Avastin saga has become a kind of randomized controlled trial, pitting the Food and Drug Administration’s power against potentially life-saving drugs for terminally ill patients. The results are proving that the former is far stronger, with FDA Commissioner Margaret Hamburg’s decision yesterday to withdraw the biologic medicine as a treatment option for women with metastatic breast cancer.

In a 69-page decision, Dr. Hamburg quashed the drug maker Genentech’s last appeal, claiming (in the first person throughout) that FDA approval requires “credible, objective evidence.” But there is no credible or objective definition for that term of art other than what the FDA claims it means at any given time for any given drug, as she goes on to detail. It is merely another way of imposing a blanket government abstraction over the individual choices of a patient and her physicians.

Editorial Board Member Joe Rago on the FDA’s decision to revoke the breast cancer drug Avastin and his interview with John Lechleiter, CEO of the drug maker Eli Lilly & Co.

In 2008, Avastin was initially cleared for breast cancer in combination with chemotherapy under “accelerated approval,” the FDA program that was created in response to the AIDS crisis to speed drugs for incurable illnesses and other medical needs to market. But accelerated approval is despised by the FDA bureaucracy and the New England Journal of Medicine crowd because it uses nontraditional standards to judge medical benefits.

Avastin was first approved on the basis of progression-free survival, or PFS, the time women live without their disease spreading or worsening. In 2009 Genentech applied to convert to full approval, with new studies that also showed PFS improvements, even if they were less statistically robust than the initial trials. At that point cancer drugs chief Richard Pazdur moved to reassert the FDA’s political culture of delay and control, rigging the re-review against Avastin and emphasizing safety risks.


Bloomberg NewsAvastin (more…)



Wednesday, August 10th, 2011
Published on The Weekly Standard (

Time to Stockpile Lucky Charms?

The Obama administration targets food marketed to children.

Kate Havard

August 8, 2011, Vol. 16, No. 44

The Obama administration is after your Lucky Charms, or at least your children’s. The public comment period closed on July 14 for a set of “voluntary” guidelines for the marketing of food to children. If adopted, these rules will transform the advertising of breakfast cereals.

Put forward by an interagency working group, the guidelines will establish nutritional standards that most cereals flunk—and not just those of the “Chocolate Frosted Sugar Bombs” variety. Corn Flakes will not be advertisable to children, along with Raisin Bran, Special K, Rice Krispies, and Wheaties. Plain Cheerios squeak by the proposed 2016 rules but fall foul of the “ultimate goal” for sodium effective in 2021.

While cereals are the most obvious targets of the guidelines, all foods marketed to children will have to meet the proposed nutritional standards. Many don’t. Peanut butter (both smooth and crunchy) has too much saturated fat. Jelly has too much sugar. Forget about apple-cinnamon instant oatmeal and Mott’s apple sauce.

These foods may still appear in grocery stores, but not in brightly colored packages adorned with cartoon characters. Toucan Sam, Cap’n Crunch, and Tony the Tiger will have to retire.

The definition of “marketing to children” is broad. A television show is deemed “targeted to children” if 20 percent of the audience is 18 or under. Any child-oriented theme, like education or parenting or T-ball, cannot be mentioned in the advertising of foods that don’t meet the standards. Frosted Flakes will no longer be allowed to sponsor Little League baseball. The Coca Cola Company will have to give up its Coca Cola Scholars Foundation (which provides $3.4 million a year in scholarships) or perhaps rename it after one of the company’s bottled waters. General Mills’s “Box Tops for Education” program will be barred from kid-friendly cereals. The slogan “Choosy moms choose Jif” will be forbidden as too “targeted.” (more…)



Sunday, July 24th, 2011
The Wall Street Journal

  • JULY 23, 2011

Oncologists vs. the FDA on the breast cancer drug.

  • The humanitarians urging the Food and Drug Administration to withdraw Avastin for women with terminal breast cancer claim there is no other choice: The evidence shows Avastin doesn’t work, so too bad. But how to square that view with the highly respected medical group that—reading the same evidence—recommends preserving Avastin as a treatment option?

The National Comprehensive Cancer Network is a consortium of 21 leading U.S. oncology programs that issues practice guidelines on the basis of “sound, evaluative clinical information,” according to its mission statement. Last week, the NCCN’s breast cancer panel reaffirmed its position that Avastin is “an appropriate therapeutic option” for some patients in combination with chemotherapy. The vote was 24 in favor, with one abstention. No members were opposed.

The FDA’s expert panels have now reviewed Avastin three times. All three have rejected it, though the first vote was overruled by the FDA leadership in 2008 to give the biologic drug provisional approval. Cancer division chief Richard Pazdur moved to revoke approval last year after a negative re-review of the evidence, and a final decision is now pending following an unprecedented appeal hearing last month by Avastin’s maker, the Roche subsidiary Genentech.

Yet the NCCN has now reviewed Avastin for breast cancer four times since adding it to the compendium in 2005, and each time it has reaffirmed its support. One reason for the group’s divergence with government is that it fields practicing oncologists from institutions like Dana-Farber/Brigham and Women’s Cancer Center at Massachusetts General Hospital, the University of Texas’s M.D. Anderson and Memorial Sloan-Kettering in New York. They understand the benefits that Avastin can provide to some (but not all) women in controlling their disease, and the NCCN’s advice is appropriately qualified.

The FDA, by contrast, favors statistical purists who think in the abstractions of controlled trials, and its conflict-of-interest rules are meant to exclude doctors who have experience treating specific cancers in the real world. For the FDA, believe it or not, being an expert in breast cancer fatally compromises your objectivity in ruling on a breast cancer drug. The oncologists also don’t carry Dr. Pazdur’s political agenda to increase his agency’s power over cancer drug approvals.

Genentech is merely asking for Avastin to remain available for metastatic breast cancer while it conducts an additional trial to add to the evidence about which patients Avastin does help. FDA Commissioner Margaret Hamburg hasn’t said when she’ll make a final decision. If you were a patient, would you rather trust a federal regulator or some of the best cancer doctors in the country?



Tuesday, June 21st, 2011
The Wall Street Journal

  • JUNE 20, 2011

What the late Stephen Jay Gould could teach the FDA.

On June 28, the Food and Drug Administration (FDA) will hold a hearing to decide the fate of Avastin, a drug taken by thousands of women fighting late-stage breast cancer. Many of these women have pleaded for continued access to the drug, which they consider a matter of life and death.

But this case is really about what will guide decisions on treatment options—the best judgment of doctors and their patients, or the policy preferences of the FDA.

Last year, the FDA began the process of revoking Avastin’s approval for breast cancer. Some leading oncologists applauded the decision, arguing that, for the average patient, Avastin doesn’t work very well and has significant side effects.

Patient advocates and thousands of women who credit their survival to Avastin argue that it’s unfair for the FDA to remove one of the few available options for patients diagnosed with terminal cancer. They’re right.

Avastin originally hit the market in 2004 to treat other cancers, and in 2008 the FDA conditionally approved it for breast cancer. Initial testing showed that, on average, Avastin didn’t lengthen patients’ overall survival time. But it did slow tumor growth, giving many patients a longer “progression-free” survival. What this means is that dying patients get a precious few extra months of quality time they can spend with family and friends, travel rather than being confined to a bed, or get their personal effects in order.

Scientist Stephen Jay Gould lived another 20 years after being diagnosed with lung cancer.





Friday, January 21st, 2011
  • The Wall Street Journal
    • JANUARY 19, 2011

    Obama’s Rules Revelation

    The era of big regulation is over. Or is it?

    • President Obama took to these pages yesterday to announce a new executive order to restore “balance” to federal regulation and root out rules that impede job creation and economic growth. If he means it, this will be one of the great policy walkbacks in American history. The rest of us should stay in a Missouri state of mind.

    Substance aside, Mr. Obama’s new order is a significant symbolic concession. The White House is admitting that after an historic voter rebuke due in part to its regulatory overkill, it must show some willingness to pull back the throttle. The President is gradually conceding the conservative and business critique of his first two years, even if the concessions so far are mostly in style and rhetoric.

    This rules rethink is akin to the Democratic Congress’s vote to extend all the Bush-era tax rates while being forced to admit that raising them would hurt the recovery. Liberals have spent years dismissing warnings that their agenda created uncertainty and harmed the economy, and then they wake up to find their leader on the Wall Street Journal editorial page disowning “unreasonable burdens on business—burdens that have stifled innovation and have had a chilling effect on growth and jobs.”

    The real test will be how Mr. Obama defines “unreasonable.” The executive order he signed yesterday instructs federal agencies to weigh the costs and benefits of proposed rules and choose the least burdensome alternative. Yet that merely reiterates an executive order President Clinton signed in 1993 and that was supposed to be governing the Obama Administration all along. Mr. Obama also ordered a “retrospective analysis” of all rules to streamline or repeal the damaging ones.

    1regs (more…)



    Sunday, November 28th, 2010

    New Zeal Blog

    Who Benefits? The Food Safety Bill Will Centralize and Regulate Food Production

    Posted: 24 Nov 2010 10:06 PM PST

    “If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” – Thomas Jefferson.

    This Founding Father would be rolling in his grave if he knew of the draconian measures to restrict food production the Senate is seeking to bring in. Under the deceptive title of the “FDA Food Safety Modernization Act“, the bill if passed into law will crack down not only on large corporations, but also on “small businesses and entities that sell directly to consumers”, and will give authorities power to further regulate “growing, harvesting, sorting, packing, and storage operations, minimum standards related to soil amendments, hygiene, packaging, temperature controls, animal encroachment, and water”.

    The Food Safety Bill (S. 510) is being heralded as more dangerous than even the Health Care Reform which passed earlier this year. Section 404 makes it clear that the bill seeks to conform to the requirements of the World Trade Organization and grants new authority to the Department of Homeland Security to oversee food production. Here’s the key catchphrase from the proponents of this bill, responding to criticisms that the bill will cripple small-time farmers. This comment from Sandra Eskin of the Pew Charitable Trusts:

    “Rather than telling peo­ple they don’t have to meet these basic safe­ty re­quire­ment that will be scale and size ap­pro­pri­ate, rather than ex­empt­ing them we think you should be giv­ing as­sis­tance in help­ing them meet the re­quire­ments of the law.” (more…)



    Saturday, November 20th, 2010
    Morning Bell
    Does The FDA Really Need More Power?

    Our long national nightmare is over. Phusion Projects, the makers of Four Loko brand caffeinated malt beverages, announced yesterday that it will remove the caffeine from its products. Phusion’s decisions came just one day after Senator Chuck Schumer (D–NY) pushed the Food and Drug Administration to ban “these dangerous and toxic drinks.”

    Unfortunately Schumer never explained what exactly makes these drinks “dangerous and toxic.” For now, Americans are still free to buy malt beverages. And for a limited time they are also still free to buy caffeinated drinks like coffee and Red Bull. So please, nobody tell Schumer how easy it is to buy alcohol and caffeine and mix them together. Because then Schumer might pressure the FDA to take away your morning coffee and table wine, too.

    The reality is that there is little known medical evidence that caffeinated malt beverages are less safe than other alcoholic drinks. But that fact is no defense against current FDA power to ban products it deems unsafe for the American people. And now Senate Majority Leader Harry Reid (D–NV) wants to grant the FDA even more unaccountable administrative authority. Specifically, he is pushing for passage of the FDA Food Safety Modernization Act in the lame duck session that opened this week. (more…)

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