Saturday, May 21, 2011

Help the Avastin ladies

Background: Avastin is an anti-cancer drug that blocks blood flow to tumors. In 2007, the FDA granted accelerated approval for the use of Avastin for treatment of metastatic breast cancer. It was clear from the Avastin studies then that while many women would not benefit from the drug, a significant minority could live longer and with less pain.

The FDA asked Avastin researchers to evaluate the drug’s risks and benefits on a larger group of patients with the same standards used to approve the drug in the first place. The study confirmed the 2007 results showing benefit to specific groups of women. But the FDA revoked Avastin’s approval for breast cancer treatment because it didn’t extend life on average.


I hereby urge the President of the United States of America, the Congress of the United States of America and the Commissioner of the Food and Drug Administration to act immediately to protect women with metastatic breast cancer (MBC), an incurable disease that kills 40,000 women per year.

We the People petition you to grandfather access to the drug Avastin for the current 17,500 patients, as well as protect their private insurance and Medicare coverage for Avastin. Without Avastin, women will die and without keeping their coverage intact through private insurance or Medicare, the drug will be unaffordable for most.

We further insist that you find ways to keep Avastin on the market for all patients who can benefit from its safe usage. We beg you to allow further trials for Avastin following FDA guidelines and to encourage further research to determine genetic markers for women who might benefit from Avastin.

We also implore you to explore ways to improve the FDA's drug approval process without reducing the safety of drugs reaching market. The quicker patients have access to safe drugs, the more they can be helped.

We appeal to you to adopt common-sense approaches to allowing drug companies to donate drugs to people in need on a compassionate use basis. Drug companies are restrained in donating on a compassionate use basis because of uncertainty of corporate and personal liability. This uncertainty must to be removed to help the needy.

We are a civilized society that values life. We also cherish individual freedom and the right of a patient to choose her medical options with her physician. By acting on this, you will confirm our belief that Life, Liberty and the Pursuit of Happiness is an inalienable right for all, including the seriously ill.

Petition here

Federal Food Police Against Business and Science

Late last month a host of government agencies including the Federal Trade Commission and the Agriculture Department proposed what the media described as "tough'' but "voluntary" new standards for food companies that advertise to children, designed to pressure the businesses into incorporating much lower amounts of fat, sodium and sugar in foods aimed at a young audience.

Barely a week later the Journal of the American Medical Association published new research which suggested that lowering sodium consumption not only doesn't benefit most people, it may actually increase risk of heart attacks for some. The research was apparently so disturbing to government regulators that some felt the need to step out and criticize the results in the media, something that they rarely do.

If you've been following the latest research on diet in the scientific journals, you would understand why the regulators appeared so defensive. Increasingly, some of the basic assumptions about nutrition that have formed the core of the government's recommendations on what Americans should eat are being questioned by studies which suggest the advice is not merely ineffective but may be counterproductive, contributing among other things to the rise in obesity which the White House decries.

Rather than be humbled and made cautious by such research, however, government regulators are simply plowing ahead with a conviction that their ideas about nutrition are correct. Businesses are expected to fall into line, regardless of the implications for their products.

The sodium controversy is a good example of how distorted the arguments have become. The regulators dismissed the new study by suggesting that the results were unusual because the research was flawed. But this was not the first time that a peer-reviewed study had cast doubt on the idea that most of us consume too much sodium. Indeed, more than a decade ago Science Magazine highlighted the controversy with a piece entitled "The (Political) Science of Salt" which noted that, "Three decades of controversy over the putative blood pressure benefits from salt reduction are demonstrating how the demands of good science clash with the pressures of public health policy."

More recently, in a February, 2010, article in the Journal of the American Medical Association, Dr. Michael Alderman, a leading hypertension expert, reviewed the relevant recent research and found a disturbing lack of consistency in the results of a dozen studies on the relationship of salt to our health, which prompted him to observe in the New York Times that any potential population-wide government requirements or recommendations on sodium reduction would amount to a giant uncontrolled experiment with the U.S. population with potentially unintended consequences.

The legacy of the government's dietary guidelines may turn out to be a disturbing list of unintended consequences, including possibly the current obesity epidemic. Since the 1970s, the government's food recommendations have largely been aimed at cutting our consumption of cholesterol and fat, especially saturated fat, to reduce cardiovascular disease and stroke and the conditions that might lead to them, including obesity.

The guidelines, first produced by Sen. George McGovern's Select Subcommittee on Nutrition and Human Needs, were controversial from the start because there was no conclusive evidence at the time that diet was a major contributor to heart disease. But the committee and its scientific advisers proceeded because, they argued, there were no risks in "eating less meat, less fat, less saturated fat...more fruits, vegetables, unsaturated fats and cereal products." Over the years this has become a mantra of the public health establishment about diet, namely that even when the research is inconclusive, what could possibly be the harm in consuming less of things like meat and salt?

With the federal bureaucracy behind them, the guidelines became widely accepted even though subsequent research often questioned them. Two of the government's principal studies on diet and heart disease, published in the 1980s, were intended to offer reassurances, but instead produced results that were inconclusive, at best.

The science has only gotten more troubling since then, as researchers have begun to wonder if the obesity epidemic is in some way related to the change in diet prompted by the guidelines. A 2008 article in the American Journal of Preventive Medicine argued that Americans have actually followed the government's advice, reducing intake of fat and increasing the proportion of our calories from carbohydrates. The result had been a rise in overall calorie intake, leading the authors to wonder if, "the U.S. dietary guidelines recommending fat restriction might have worsened rather than helped the obesity epidemic." They criticized the government for relying on "weak evidentiary support" in the guidelines.

In April of last year Scientific American reviewed the mounting number of studies contradicting the governments point of view in a piece entitled, "Carbs Against Cardio: More Evidence that Refined Carbohydrates, not Fats, Threaten the Heart." And in October of 2010 the journal Nutrition weighed in with a piece by five researchers entitled "In the Face of Contradictory Evidence: Report of the Dietary Guidelines for Americans Committee," which cited dozens of peer-reviewed studies questioning the science at the foundation of the guidelines.

None of this has deterred the government. The new, 2010 guidelines, for instance, ignored the contrary evidence and recommended significantly lowering salt consumption for everyone over age 50. As in the past, the food regulators seem to have little concern for the unintended consequences of their untested theories. Food companies have argued, for instance, that the sodium goals set by the government are so low that they will make some foods like prepared soups unpalatable to kids. We have no idea what other foods kids will turn to instead.

More than three decades of government involvement in dietary recommendations have led to a situation our grandparents and great-grandparents would have found unthinkable: people turning to government for advice on what to eat. In the interim a whole industry of nutrition writers and diet books has emerged to interpret the Washington diet to us, or contend against it. Not surprisingly, some Americans are confused.

If the federal government unleashed a Pandora's Box of unintended consequences more than three decades ago, it's going to be awfully hard to undo much of what Washington has done. We haven't even begun trying yet.


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