Tuesday, December 04, 2007

"Food Cop" cops it

The chief governmental agency standing between consumers of food, medicine and medical products and the marketers and manufacturers of those consumed things is hogtied by lack of funding from those folks who normally pork barrel away.

Some people refer to the FDA and certain of its supporters, and not sympathetically, as the "food cops":
"The food cops are at it again, this time calling on the Food and Drug Administration to limit how much salt manufacturers use in prepared meals. Instead, they should demand that shoppers read labels....

Americans know salt is unhealthy in great quantities, and go right ahead and choose taste and convenience over what they know is good for them.

The American Medical Association has joined the nanny chorus....

The food industry would rightly prefer a voluntary effort and letting market demand dictate ingredients....

Education and public awareness are better solutions than the government messing with manufacturers' recipes.

We would like nothing more than to see our embarrassingly overweight nation slim down, but not at the expense of businesses and consumers being able to make their own choices. Manufacturers wouldn't sell salty foods if people didn't buy them.

Now go each your vegetables - before the government makes you."
Of course, if your veggies have e. Coli contamination, who's to help you?

The problems at the FDA are highlighted in this report from Reuters:
FDA science dearth puts public health at risk by Kim Dixon

"Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is under funded, a panel of advisers to the agency said at a public meeting on Monday.

Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA's ability, the report by a subcommittee of the agency's Science Board said.

[The subcommittee panel was] chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co. (LLY.N: Quote, Profile, Research), and representatives from Genentech Inc (DNA.N: Quote, Profile, Research) and Wyeth (WYE.N: Quote, Profile, Research), among others....

The agency regulates products from drugs to food and cosmetics representing about $1 trillion, or a quarter of every dollar spent in the United States, according to the report.

The U.S. Congress passed more than 100 laws expanding the FDA's authority since 1988, but has not increased the funding appropriately"
USA Today breaks down some of the report's findings and elaborates:
"The report details a "plethora of inadequacies" in the agency, including:

•Inadequate inspections of manufacturers, noting that foodmakers, for example, are inspected about once every 10 years.

•A "badly broken" food-import system and food supply "that grows riskier each year." In the past 35 years, FDA inspections of the food supply have dropped 78% due to soaring numbers of products and inadequate FDA funding.

•A depleted FDA staff, which is about the same size as it was 15 years ago despite huge growth in agency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.

•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.

•An "obsolete" information-technology system.

The report echoes concerns put forth before by others, including the Institute of Medicine; the Government Accountability Office, the investigative arm of Congress; and congressional committees.

The advisers traced the long list of ailments to chronic underfunding and a continual expansion of FDA duties. While the FDA regulates 80% of America's food, it receives about one-third of the nation's food-safety budget; the U.S. Department of Agriculture gets the rest."
The Cato Institute notes this about the Department of Agriculture:
"The U.S. Department of Agriculture (USDA)
* Will spend $89 billion in 2007, or $774 for every U.S. household
* Imposes 84 million hours of paperwork burdens on Americans

* Agricultural Subsidies. The USDA provides up to $30 billion annually in cash subsidies to farmers of corn, cotton, rice, soybeans, wheat, and other commodities. It also funds an array of support activities for farmers including research, loans, and insurance.

* Agricultural Regulations and Trade Barriers. The USDA regulates the markets for sugar, milk, and other products with respect to pricing, production, and distribution. The government also imposes tariffs and quotas on numerous farm commodities.

* Rural Subsidies. The USDA operates a range of subsidy programs for businesses and individuals in rural areas.

* Food Subsidies. Most of the USDA’s budget is devoted to food welfare activities, including the food stamp and school lunch programs.

* Forest Service. The Forest Service controls 193 million acres of forest and provides subsidies for businesses and state governments."
The Heritage Foundation has disclosed this about the Department of Agriculture:
Another Year at the Federal Trough: Farm Subsidies for the Rich, Famous, and Elected Jumped Again in 2002

"Taxpayers funding Washington's $20,000-per-household budget have long known they are not getting their money's worth. Farm subsidies are among the most wasteful uses of taxpayer dollars. The budget-busting $180 billion farm bill enacted before the 2002 elections not only encourages the crop overproduction that depresses crop prices and farm incomes, but also undermines trade and encourages other nations to refuse American exports.

Perhaps worst of all, farm subsidies are not distributed to the small, struggling family farmers whom lawmakers typically mention when defending these policies. Rather, most farm subsidies are distributed to large farms, agribusinesses, politicians, and celebrity "hobby farmers." This paper analyzes how Washington distributed farm subsidies in 2002 and illustrates that farm subsidies continue to represent America's largest corporate welfare program.

Farming may be the most federally subsidized profession in America. The persistence of farm subsidy programs results from the popular misconception that they stabilize the incomes of poor family farmers who are at the mercy of unpredictable weather and crop prices. Yet a recent U.S. Department of Agriculture report concluded that, "On average, farm households have higher incomes, greater wealth, and lower consumption expenditures than all U.S. households."1 This statement can be broken down into three parts:

* Higher incomes. In 1999, the average farm household earned $64,437--17 percent more than the $54,842 average for non-farmers. Incomes were even higher among the 136,000 households with annual farm sales over $250,000--and who also receive the largest subsidies. Their 1999 average income of $135,397 was two-and-a-half times the national average.2 (See Chart 1.) Farmer incomes are not only high, but also quite stable from year to year, despite agricultural market fluctuations.

* Greater wealth. The average farm household had a net worth of $563,563 in 1999--well above the $88,000 national average.3

* Lower consumption expenditures. Farm households have fewer costs than other households because (1) the cost of living is lower in rural America; (2) farm households need to purchase less food from outside sources; and (3) mortgage and utility bills are often classified as business expenses. Consequently, the average farm household spent only $25,073 on goods and services in 1999, which is $11,000 less than the average non-farm family.4

Because farmers are relatively wealthy, alleviating farm poverty would not be very expensive. Just $4 billion per year would guarantee every full-time farmer in America a minimum income of 185 percent of the federal poverty level ($34,873 for a family of four in 2004)

Eligibility for farm subsidies is determined by crop, not by income or poverty standards. Growers of corn, wheat, cotton, soybeans, and rice receive more than 90 percent of all farm subsidies: Growers of nearly all of the 400 other domestic crops are completely shut out of farm subsidy programs. Further skewing these awards, the amounts of subsidies increase as a farmer plants more crops.

The number of farms receiving over $1 million in farm subsidies in one year increased by 13 percent to a record 78 farms in 2002. Riceland Foods, an Arkansas co-op, topped the list by amassing a staggering $110 million in farm subsidies for its members--more than subsidies to every farmer in Nevada, West Virginia, Vermont, Maine, Delaware, New Jersey, Massachusetts, Connecticut, New Hampshire, Alaska, Hawaii, and Rhode Island combined.

Large farms are grabbing all of the new subsidy dollars because the federal government is helping them to buy out small farms. Specifically, large farms are using their massive federal subsidies to purchase small farms and consolidate the agriculture industry. As they buy up smaller farms, not only are these large farms able to become more profitable by capitalizing further on economies of scale, but they also become eligible for even more federal subsidies--which they can then use to buy even more small farms.

The result is a "plantation effect" that has already affected America's rice farms, three-quarters of which have been bought out and converted into tenant farms.8

This farm industry consolidation is not necessarily harmful. Many larger farms and agribusinesses are more efficient, use better technology, and can produce crops at a lower cost than traditional farms. Additionally, not all family farmers who sell their property to corporate farms do so reluctantly.

The concern is not consolidation per se, but whether the federal government should continue to subsidize these purchases through farm subsidies and whether multimillion-dollar agricultural corporations should continue to receive welfare payments. When President Franklin D. Roosevelt first crafted farm subsidies to aid family farmers struggling through the Great Depression, he clearly did not envision a situation in which these subsidies would be shifted to large Fortune 500 companies operating with 21st century technology in a booming economy.

Since 1995, lawmakers have received subsidies averaging 46 times those received by the median farmer. Five of the nine lawmakers also sit on the House or Senate agriculture committees overseeing these programs.

Other notable farm subsidy recipients, include:

* David Rockefeller, the former chairman of Chase Manhattan and grandson of oil tycoon John D. Rockefeller, who received 99 times more subsidies than the median farmer;
* Scottie Pippen, professional basketball star, who received 39 times more subsidies than the median farmer;
* Ted Turner, the 25th wealthiest man in America, who received 38 times more subsidies than the median farmer; and
* Kenneth Lay, the ousted Enron CEO and multi-millionaire, who received 3 times more subsidies than the median farmer."
Programs run by the Department of Agriculture include:
Commodity Loans and Loan Deficiency Payments
Dairy Indemnity Program
Dairy Market Loss Assistance Program
Milk Income Loss Contract Program
Direct and Counter-cyclical Payments Program
Farm Ownership Loans
Farm Operating Loans
Farm Storage Facility Loans
Farm Labor Housing Loans and Grants
Livestock Compensation Program
Tobacco Transition Payment Program
Market Protection and Promotion
Food Stamps
Special Milk Program for Children
Senior Farmers Market Nutrition Program
Intermediary Relending Program
Business and Industry Loans
Homeland Security - Agricultural
Empowerment Zones Program
Rural Abandoned Mine Program
And on and on. You can find all of them, with links to the details of each program, here.

Meanwhile, back at the FDA, in a continuing move to discard duties is just can't get around to, the FDA is considering reducing oversight of so-called "off-label" marketing from its functions.

Off-label uses refers to the use of something in a manner for which it hasn't been proven effective or safe. Guambat recalls Mrs Guambat buying some direct-marketed fragrance spray to keep the mossies away, "but they aren't allowed to say that because they haven't got the OK to say so."

Off-label uses of products by doctors can be a very useful function. Guambat recalls, vaguely, some anecdotal events, such as a therapeutic use of thalidomide, for instance.

But what is at stake here is the increasing use of marketing by big pharma to con the hypochondriacs. The following article originated in the Washington Post, but Guambat found it here:
FDA may alter 'off-label' marketing By CHRISTOPHER LEE

Under a draft "guidance" prepared by the FDA, drug and medical device manufacturers could distribute unabridged reprints of peer-reviewed research from reputable medical journals as long as the articles were not written, edited or otherwise "significantly influenced" by the manufacturers or people with financial ties to them. No other promotional materials could be attached to the reprints, which would have to be labeled as describing uses for the product that have not been FDA-approved.

The proposal would be a break with the FDA's prohibition on the marketing of drugs and medical devices for unapproved purposes, which dates to 1938.

In 1997, Congress created a temporary exception allowing companies to distribute reprints so long as they submitted them to the FDA for advance review and had formally asked the FDA to approve the new use. That exception expired in 2006. In recent years, the marketing restrictions have been the subject of legal challenges on free speech grounds.

ep. Henry A. Waxman, D-Los Angeles, chairman of the House Committee on Oversight and Government Reform, said ... the draft guidance "would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."
The WSJ added this to the discussion:
On the other side, courts have pressured the FDA to avoid restricting companies' free-speech rights. "Off-label prescribing is very often the standard of care," and companies should be able to give doctors "truthful, non-misleading information" about such uses, said Daniel Troy, a former FDA chief counsel who previously helped argue against the agency in a major suit over restrictions on off-label promotion. Mr. Troy now represents drug companies and others in private practice.

The FDA's draft proposal seems to try to strike a middle ground, allowing companies to distribute information about off-label uses but setting limits on the practice. Among other restrictions, the draft suggests that letters to the editor of a medical journal wouldn't quality and that the scientific articles would have to be peer-reviewed. In addition, if the conclusions in a particular article have been disputed, it would have to be distributed along with another article showing the opposing view.

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