EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Wednesday, March 31, 2010

DRUG RESIDUE, MEAT - USA: (NEW YORK)

DRUG RESIDUE, MEAT - USA: (NEW YORK)
************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


Date: Fri 26 Mar 2010
Source: 13 WHAM TV.com [edited]



Federal regulators have cited a dairy farmer in Wyoming [County, NY]
for selling cows with higher-than-permitted residues of antibiotics.

A US District judge in Buffalo issued an order Thursday [25 Mar 2010]
barring Jerald Schumacher from selling his cattle to be slaughtered
for human consumption until he complies with federal limits on
antibiotic residues.

Schumacher owns a farm in Wyoming [County, NY], which sells its dairy
cattle to an auction yard in Pavilion [NY]. A Food and Drug
Administration complaint says he's sold cows for at least a decade
with residues of penicillin and sulfadimethoxine in the animals'
edible tissue, posing a public health risk.

The agency also says Schumacher illegally gave the cows
higher-than-allowed dosages.

The US Department of Agriculture says it has [cited] Schumacher 6
times in the past 10 years and that he violated the law by failing to
keep adequate records of which cows were medicated.

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[Most dairy cattle at the end of their dairy career enter the food
chain as hamburger. It is not usual for a drug residue to be found and
if above the limit, to be acted upon. While USDA is under-manned for
more diligent food inspections, the program for finding antibiotic
residues is reasonably well done. FDA has some very stringent levels
regarding antibiotic residues and they do pursue violators. (Drugs
must be stopped at stipulated withdrawal times before slaughter. -
Mod.JW).

Under the following conditions: 80C for 15 min, sterilized at 134C (3
bar, 20 min.) and dried at 100C (4 hours) penicillin is completely
degraded but sulfamethazine remains 80 percent active. People that
have sulfa allergies/ sensitivities would likely have difficulty with
a rare steak. Most of us do not cook our meat under these kinds of
conditions. Withdrawal times are designed to prevent such reactions
from happening.

What is unusual is that the case has made the media. More often than
not, the media either is not alerted by the proper state/federal
authority or the media does not see these issues as important enough
to cover.

Antibiotic use in animals is appropriate when done properly. It lowers
the cost of our food and keeps the animals healthy. It is not
appropriate to disregard the withdrawal times (before slaughter). It
is those cases the FDA is pursuing. - Mod.TG]

There is an FDA news release at

- Sr.Tech.Ed.MJ]

[The state of New York in the Northeastern US can be located on the
HealthMap/ProMED-mail interactive map at
.
Wyoming County can be located on the map at
. - Sr.Tech.Ed.MJ]

[see also:
2007
----
Drug residue, meat - USA (IL): legal action 20070817.2691]
........................................tg/mj/jw
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Sm. Farmers Win Victory Over Big-Ag Stink, Pollution

Seeger Weiss Delivers $11 Million Verdict to Small, Family Farms Overrun by Corporate Agriculture's Waste
March 4, 2010

Seeger Weiss brought home another victory against giant agro-business Premium Standard Farms, when a Missouri jury awarded $11.05 million to the 15 neighboring owners of small farms today. Co-founder Stephen A. Weiss has led the charge against these giant factory farms, whose careless and illegal disposal of waste products degrades the air and land around them. As co-lead counsel for the farmers’ whose lives and livelihoods had been handicapped by overpowering hog odors, Mr. Weiss proved to the jury, seated in Jackson County, Missouri, that Premium Standard Farms had failed to sufficiently address the problem in the 11 years since the Missouri Attorney General issued an order to do so. This verdict is the largest monetary award against a hog farm in an odor nuisance case.

The Berlin, Missouri factory farm processes roughly 200,000 hogs every year and houses about 80,000 at any given time. Nationwide, the average hog farm houses only 5,000 animals per year. These local farmers are no strangers to the realities of livestock and agriculture, but the staggering mass of bodies and waste contained within the Premium Standard hog farm overwhelmed them. The plaintiffs, some of whom have owned their farms for well over 100 years and spanning five generations, alleged that relentless and extreme odors emanating from defendants' finishing farm – known as concentrated animal feeding operations, or CAFOs – created an unreasonable nuisance. Family members testified at trial that the smell was intense enough to prevent them from venturing outdoors on many days.

Law firms The Middleton Firm, Seeger Weiss LLP and the Speer Law Firm represented the seven households, who filed their case in 2002. After hearing nearly 5 weeks of evidence centering on defendants' land application of massive quantities of liquid hog manure, maintenance of multiple-acre wastewater lagoons, and other odor-producing activities at the Homan farm inGentry County, MO, the 12-person jury agreed. Their verdict was delivered on March 4, 2010, awarding nearly $1 million to each of the 13 farmers who lived next to the Premium Standard facility in Berlin with an another $325 thousand for two additional plaintiffs.

In the early 1990s, Premium Standard Farms bought and leased some 4,300 acres in the community of Berlin, Missouri, to create a "finishing farm," which processes nearly a quarter million hogs per year. Premium Standard Farms is a subsidiary of Smithfield Foods and the privately held ContiGroup Companies (previously Continental Grain). The swine are brought into the facility weighing approximately 60 pounds and are grown to 260 pounds for slaughter. Each hog lives its entire adult life in a single hog pen, with no ability to roam. Berlin is located in Gentry County some 80 miles north of Kansas City.

The odors emanating from the hogs come from multiple sources. The hogs excrete waste into a slatted floor, which collects in basins beneath each barn, where it is evacuated through a piped flushing system that deposits it in four-to-five acre lagoons located across the property. Collectively, the lake-sized lagoons collect some 83 million gallons of hog waste during the course of a year – generating enormous quantities of methane, ammonia and hydrogen sulfide that can be detected for miles. The Berlin facility houses 80 barns, each holding 1,000 hogs at a time.

The waste is continually pumped out of the lagoons, which the defendants argued was used as fertilizer. "In reality, the jury recognized that the pumping is merely a disguised form of waste disposal – with the farms releasing far more effluent than the land can possibly absorb," said Charles F. Speer, who first started representing PSF neighbors in the mid-1990s. "The odors and flies coming off this farm have devastated the lives of these fine Missouri citizens. For them, it's been a living torment."

"The families who brought this case have been living under a toxic cloud of hog waste produced by Premium Standard for more than 11 years," said lead trial counsel Richard H. Middleton, Jr. of Savannah, GA. "Defendants claimed their operations complied with state environmental regulations – however, this trial showed that PSF produced industrial-scale pollution with complete lack of regard for the extreme toxicity its operation caused for its neighbors, day in and day out."

Co-trial counsel, Stephen A. Weiss of New York City added: "Rather than accept responsibility for their actions like a good neighbor, these defendants continue to deflect blame. We've offered repeatedly to sit down with their representatives to try to forge a fair resolution, but they continue to choose the courtroom over the settlement table. If I were a Smithfieldshareholder today, I'd be none too pleased with their chosen path."

The $11 million verdict represents one of the largest jury awards in Jackson County in the last year. The ruling follows a $4.5 million verdict in 2006 against Premium Standard Farms on behalf of six plaintiffs, a case also won by the trial team of Messrs. Speer, Middleton and Weiss. Premium Standard Farms has lost three of four trials brought against them because of hog odors, and after today’s verdict have been ordered to pay almost $21 million by juries.

"It's time these agri-businesses get serious and start taking care of what continues to be a serious problem with the pollution caused by their factory farm operations," Mr. Middleton added. "Their battalions of high-priced lawyers are not going to make the stench go away."

The three lawyers represent another 250 or so plaintiffs whose cases against Premium Standard Farms are still pending in Jackson County and various counties in northern Missouri.

The case caption is Owens, et al v. ContiGroup Companies, et al.

http://www.seegerweiss.com/news/hog-farm-victory.aspx?gclid=CKCs6IGY4qACFctY2god3C8ZCA

Saturday, March 27, 2010

More Tamiflu Resistant H1N1 Cases

INFLUENZA PANDEMIC (H1N1) (25): OSELTAMIVIR RESISTANCE
******************************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


Date: Fri 26 Mar 2010
Source: PHYSORG.com News [edited]



Rapid development of drug-resistant 2009 H1N1 influenza reported in 2 cases
----------------------------------------------------------------------
Doctors from the National Institute of Allergy and Infectious
Diseases (NIAID) report that 2 people with compromised immune systems
who became ill with [pandemic (H1N1) 2009] influenza [virus
infection] developed drug-resistant strains of virus after less than
2 weeks on therapy. Doctors who treat prolonged influenza infection
should be aware that even a short course of antiviral treatment may
lead to drug-resistant virus, say the authors, and clinicians should
consider this possibility as they develop initial treatment
strategies for their patients who have impaired immune function.

Both patients in the new report developed resistance to the key
influenza drug oseltamivir (Tamiflu), and one also demonstrated
clinical resistance to another antiviral agent, now in experimental
testing, intravenous peramivir, note senior authors Matthew J Memoli,
MD, and Jeffery K Taubenberger, MD, PhD. This is the 1st reported
case of clinically significant peramivir-resistant 2009 H1N1 illness,
say the scientists. The report is scheduled to appear in print on 1
May [2010] in Clinical Infectious Diseases and is now online [MJ
Memoli et al: Rapid selection of oseltamivir and peramivir resistant
pandemic H1N1 during therapy in 2 immunocompromised hosts. Clinical
Infectious Diseases DOI:10. 1086/651605 (2010)]. The people in the
current case report had immune limitations due to blood stem cell
transplants that occurred several years previously. Both recovered
from their influenza infections.

"While the emergence of drug-resistant influenza virus is not in
itself surprising, these cases demonstrate that resistant strains can
emerge after only a brief period of drug therapy," says NIAID
Director Anthony S Fauci, MD. "We have a limited number of drugs
available for treating influenza and these findings provide
additional urgency to efforts to develop antivirals that attack
influenza virus in novel ways."

The pandemic (H1N1) 2009 influenza virus is susceptible to just one
of the 2 available classes of anti-influenza drugs, the neuraminidase
inhibitors. Besides oseltamivir, other neuraminidase inhibitors are
zanamivir (Relenza), which is inhaled, and the intravenously
administered investigational drug peramivir. As the H1N1 influenza
pandemic unfolded, laboratory tests of virus strains isolated from
patients showed that some strains contained a genetic mutation (the
H275Y mutation) that makes the virus less susceptible to some
neuraminidase inhibitors.

The 2 people in the current case study had pre-existing medical
conditions that impaired their immune system function before
contracting 2009 H1N1 flu. Strains of pandemic (H1N1) 2009 virus
containing the H275Y mutation had been reported previously in people
with diminished immune function, but in previous cases the mutation
arose after more than 24 days of continuous therapy. In the newly
described cases, the mutation appeared after 14 days in one
individual and after 9 days in the 2nd. "Although the recommended
length of treatment with oseltamivir is 5 days, it is common for
physicians to continue giving this 1st-line drug longer if the
patient does not improve," says Dr Memoli.

Both people in the current report received oseltamivir for extended
periods but they continued to shed virus in their nasal secretions
throughout treatment. When one patient's condition worsened despite
24 days of oseltamivir treatment, doctors administered peramivir for
10 days. The drug did not reduce viral shedding and the patient
remained ill, demonstrating what the authors described as clinically
significant resistance to peramivir. Next, doctors administered the
only other available flu drug, zanamivir, for 10 days. The person
then fully recovered.

"Additional, larger studies are needed to further refine our
findings," says Dr Memoli. "But these cases of rapid appearance of
drug-resistant 2009 H1N1 influenza in immune-compromised patients are
worrisome and should prompt clinicians to reconsider how they use
available flu drugs."

The mutation that allows the pandemic (H1N1) 2009 influenza virus to
resist oseltamivir also significantly reduces the virus's
susceptibility to peramivir. If a relatively short course of
oseltamivir causes a mutant flu strain to emerge in a particular
patient, that person may not respond to peramivir. Zanamivir might be
a good choice if a patient does not respond within a few days to
oseltamivir, Dr Memoli says. However, because zanamivir must be
inhaled, patients who are very ill and whose breathing is
mechanically supported cannot be given zanamivir.

"As clinicians, we should carefully consider our treatment options
and use all the drugs available to us wisely. This is especially
important in a patient with prolonged infection or when an antiviral
drug fails to cure the patient after the recommended course of
treatment," says Dr Memoli.

--
Communicated by:
ProMED-mail


[Previously it was reported that a kidney transplant patient in
Western Australia developed resistance to oseltamivir and ultimately
the patient's infection was cleared by zanamivir treatment (Medical
Journal of Australia, 11 Jan 2010;
).

Although both oseltamivir and zanamivir are inhibitors of the
activity of the influenza virus neuraminidase protein, the
oseltamivir-resistance (His274Tyr) mutation does not confer
resistance to zanamivir. The interesting feature of the NIAID report
is the rapidity of appearance of oseltamivir resistance and the lack
of response to another antiviral agent, now in experimental testing,
intravenous peramivir, which presumably has the same site of action
as oseltamivir.

One patient's infection was ultimately cleared by zanamivir
treatment. It is not recorded if the patient's virus remained
zanamivir sensitive. - Mod.CP]

[see also:
Influenza pandemic (H1N1) (04): Australia (WA), i/v zanamivir 20100111.0127
2009
----
Influenza pandemic (H1N1) 2009 (77): Taiwan oseltamivir resistance
20091027.3725
Influenza pandemic (H1N1) 2009 (50): oseltamivir resistance 20090917.3260]
....................................sb/cp/mj/dk

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Friday, March 26, 2010

Pfizer faces $142M in Neurontin damages

Pfizer lost its bid to escape a multimillion-dollar racketeering verdict when a federal jury ruled that the drugmaker's marketing of the epilepsy drug Neurontin violated federal and state law. Now, Pfizer faces damages of up to $142 million in the case.

Kaiser Foundation's health plan and hospitals had sued the drugmaker, claiming that it had spent more money than necessary on Neurontin because of Pfizer's marketing of the drug for off-label uses. Not only did the drugmaker push the drug for those unapproved indications, but Pfizer knew the drug didn't work for those uses, either, Kaiser claimed.

Kaiser calculated that it had overpaid for Neurontin on five unapproved uses--to the tune of about $90 million. The jury, however, set damages at just over half of that: $47 million. Under the racketeering law, those damages are automatically tripled; hence the $142 million total. "We hope this decision will send a message to the medical community and pharmaceutical industry that manufacturers must adhere to high ethical and legal standards in their research and marketing of drugs," Kaiser says in a statement.

Pfizer says it disagrees with the ruling--and will fight it. "We are disappointed with the verdict and will pursue post-trial motions and an appeal," spokesman Christopher Loder says in a statement (as quoted by Dow Jones). "The verdict and the judge's rulings are not consistent with the facts and the law."

- get the statement from Kaiser
- see the WSJ piece
- check out the Reuters story

Related Articles:
Pfizer defends Neurontin as trial winds down
NEJM: Studies unduly flattered Pfizer's Neurontin
Witness woes in another Neurontin trial





Pfizer faces $142M in Neurontin damages



Pfizer lost its bid to escape a multimillion-dollar racketeering verdict when a federal jury ruled that the drugmaker's marketing of the epilepsy drug Neurontin violated federal and state law. Now, Pfizer faces damages of up to $142 million in the case.

Kaiser Foundation's health plan and hospitals had sued the drugmaker, claiming that it had spent more money than necessary on Neurontin because of Pfizer's marketing of the drug for off-label uses. Not only did the drugmaker push the drug for those unapproved indications, but Pfizer knew the drug didn't work for those uses, either, Kaiser claimed.

Kaiser calculated that it had overpaid for Neurontin on five unapproved uses--to the tune of about $90 million. The jury, however, set damages at just over half of that: $47 million. Under the racketeering law, those damages are automatically tripled; hence the $142 million total. "We hope this decision will send a message to the medical community and pharmaceutical industry that manufacturers must adhere to high ethical and legal standards in their research and marketing of drugs," Kaiser says in a statement.

Pfizer says it disagrees with the ruling--and will fight it. "We are disappointed with the verdict and will pursue post-trial motions and an appeal," spokesman Christopher Loder says in a statement (as quoted by Dow Jones). "The verdict and the judge's rulings are not consistent with the facts and the law."

- get the statement from Kaiser
- see the WSJ piece
- check out the Reuters story

Related Articles:
Pfizer defends Neurontin as trial winds down
NEJM: Studies unduly flattered Pfizer's Neurontin
Witness woes in another Neurontin trial





Click on title above for original article w/ working links;
http://www.fiercepharma.com/story/pfizer-faces-142m-neurontin-damages/2010-03-26?utm_medium=nl

Wednesday, March 24, 2010

NIMH chief wants psychiatry to 'clean up' its act

Is the new Journal of the American Medical Association a special issue on reform? It doesn't stop with its demands for new publication standards (see related article). It's also showcasing a rallying cry from National Institute of Mental Health Director Dr. Thomas Insel, who calls on his fellow psychiatrists to "clean up our act."

In Insel's estimation, psychiatry has grown too close to drugmakers. All the money flowing from pharma to psychiatrists and psychiatric researchers has created a "culture of influence," he says, and psychiatrists need to rise above all that. He wants all financial ties between drugmakers and psychiatry to be disclosed, and for psychiatrists to take a step back from branded meds in favor of generic drugs and non-drug treatments such as talk therapy.

This is far from the first call for change in psychiatry. Over the past three years, congressional probes have repeatedly highlighted influential psychiatrists' financial relationships with industry. In some cases, payments from drugmakers went undisclosed even though researchers were obliged to report them to their universities.

- read the JAMA extract by clicking on to the title above;
http://www.fiercepharma.com/story/avandia-inspires-jama-call-reform/2010-03-24?utm_medium=nl

Related Articles:
Is APA treatment advice tainted by pharma ties?
APA phases out industry-supported events
Psych journal discloses financial ties
Study: Psychiatrists choose drugs over therapy





http://www.fiercepharma.com/story/avandia-inspires-jama-call-reform/2010-03-24?utm_medium=nl

Tuesday, March 23, 2010

Pig virus contamination halts GSK Rotarix use

March 23, 2010 — 9:12am ET | By George Miller

Contamination has led to a temporary halt in the use of a childhood vaccine and to a separate drug recall expansion.

GlaxoSmithKline's oral rotavirus vaccine Rotarix has been temporarily shelved in the U.S. due to a pig-virus contamination. Researchers stumbled on DNA from porcine circovirus type 1--believed nonthreatening to humans--while using new molecular detection techniques. More work is being done to determine whether the whole virus or just DNA pieces are present.

Additional testing has confirmed presence of the matter in the cell bank and seed from which the vaccine is derived, in addition to the vaccine itself. So the vaccine has been contaminated since its early stages of development.

GSK says it is now reviewing how best to replace the cell bank and virus seeds used in making the vaccine, but it will continue Rotarix production using current methods. The FDA, for its part, says it is assessing current vaccine testing methods.

Separately, The Medicines Company has added four lots to the 11 lot recall initiated last December for IV blood pressure medication Cleviprex. Members of the quality team spotted particle contamination during an inspection, prompting the recall. The visible contamination comprises sub-visible stainless steel particles, the company says.

The contamination could "theoretically" reduce blood flow in capillaries, damage tissues, or cause inflammatory reactions, according to the recall notice. The company asks that treatments from the affected lots be returned via wholesaler or distributor.

Click on title above for working links to the below articles;

- here's the Cleviprex recall announcement
- see the FDA's Rotarix announcement
- here's GSK's statement
- see this Rotarix recall article

Related Article:
FDA tells doctors to temporarily halt Rotarix shots



Read more: http://www.fiercepharmamanufacturing.com/story/pig-virus-halts-gsk-rotarix-use/2010-03-23?utm_medium=nl&utm_source=internal#ixzz0j1ZvfWEu



http://www.fiercepharmamanufacturing.com/story/pig-virus-halts-gsk-rotarix-use/2010-03-23?utm_medium=nl

Monday, March 22, 2010

Monsanto's dominance draws antitrust inquiry

Patented seeds are go-to for farmers, who decry their fast-growing price

By Peter Whoriskey
Washington Post Staff Writer
Sunday, November 29, 2009

For plants designed in a lab a little more than a decade ago, they've come a long way: Today, the vast majority of the nation's two primary crops grow from seeds genetically altered according to Monsanto company patents.

Ninety-three percent of soybeans. Eighty percent of corn.

The seeds represent "probably the most revolutionary event in grain crops over the last 30 years," said Geno Lowe, a Salisbury, Md., soybean farmer.

But for farmers such as Lowe, prices of the Monsanto-patented seeds have steadily increased, roughly doubling during the past decade, to about $50 for a 50-pound bag of soybean seed, according to seed dealers.

The revolution, and Monsanto's dominant role in the nation's agriculture, has not unfolded without complaint. Farmers have decried the price increases, and competitors say the company has ruthlessly stifled competition.

Now Monsanto -- like IBM and Google -- has drawn scrutiny from U.S. antitrust investigators, who under the Obama administration have looked more skeptically at the actions of dominant firms.

During the Bush administration, the Justice Department did not file a single case under antimonopoly laws regulating a dominant firm. But that stretch seems unlikely to continue.

This year, the Obama Justice Department tossed out the antitrust guidelines of its predecessor because they advocated "extreme hesitancy in the face of potential abuses by monopoly firms."

"We must change course," Christine Varney, the Obama administration's chief antitrust enforcer, said at the time.


Of all the new scrutiny by Justice, the Monsanto investigation might have the highest stakes, dealing as it does with the food supply and one of the nation's largest agricultural firms. It could also force the Obama administration, already under fire for the government's expanded role in the economy, to explain how it distinguishes between normal rough-and-tumble competition and abusive monopolistic business practices.

Monsanto says it has done nothing wrong.

"Farmers choose these products because of the value they deliver on farm," Monsanto said in a statement. "Given the phenomenally broad adoption of these technologies by farmers, such questions are normal and to be expected."




Click on title above for rest of story;
http://www.washingtonpost.com/wp-dyn/content/article/2009/11/28/AR2009112802471.html

Sunday, March 21, 2010

Friday, March 19, 2010

Safety Alert Issued for Ready To Eat Deli Meat Products

Washington, DC: The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert due to illnesses possibly associated with ready-to-eat (RTE) deli meat products that may be contaminated with Listeria monocytogenes.

FSIS was informed by the Canadian Food Inspection Agency (CFIA) that products subject to recall in Canada may have been exported to the United States. This public health alert was initiated after positive test results and an investigation by CFIA in response to a listeriosis illness outbreak. At this time, no confirmed linkage has been made between the products subject to recall and the reported illnesses. This is an ongoing investigation and as more information becomes available, FSIS may proceed with a recall action.

Implicated products produced by Siena Foods LTD, a Toronto, Ontario, establishment, include, but are not limited to, "Cacciatore Salami, Mild," "Coppa," "Prosciuttini," "Prosciuttini Hot," and "Prosciutto Cotto." The individually wrapped products have variable weights and a "Best Before" date through June 22, 2010, as well as the establishment number "Est. 212" inside the CFIA mark of inspection. However, the original brand and/or best before dates may not have been transferred at the deli counters to consumer packages. Persons who may have purchased any of these products and do not know original brand and code are advised to check with their retailer or supplier to determine if they have the affected product.

Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy.

Click on title above for original article;
MAR-17-10: FSIS Issues Public Health Alert For Ready-To-Eat Deli Meat Products [USDA: NEWS & EVENTS]

NOCARDIOSIS, UNLICENSED INJECTION-INDUCED - USA: (NEW JERSEY)

*************************************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


[1]
Date: Sun 7 Mar 2010
Source: The Newark (NJ) Star-Ledger [edited]



Officials said 6 women from the Essex County (NJ) area who wanted
fuller bottoms ended up in hospitals after receiving
buttocks-enhancement injections containing the same material
contractors use to caulk bathtubs.

The women checked into hospitals in the county after their
procedures, apparently administered by unlicensed providers, went
horribly wrong, state health officials said. The women underwent
surgery and were given antibiotics. No arrests have been made.

Different from medical-grade silicone, the substance used in the
botched procedures was believed to be a diluted version of non
medical-grade silicone.

"The same stuff you use to put caulk around the bathtub," said Steven
M Marcus, executive and medical director of the New Jersey Poison
Information and Education System, who learned about the bizarre
procedures through a committee he sits on that monitors outbreaks in
the metropolitan area.

Gregory Borah, chief of plastic surgery at Robert Wood Johnson
University Hospital in New Brunswick, also president of the New
Jersey Society of Plastic Surgeons, said the botched procedures
underscore the need for patients who seek augmentation to have it
administered by a licensed professional in a sterile setting. A
plastic surgeon doing buttocks augmentation would make an incision to
develop a pocket underneath the muscle and shape the buttocks with
inert medical-grade silicone, Borah said. He noted it is a relatively
uncommon procedure in most practices and that he has done only 2 in
his 24-year career.

By the time he tells patients of the potential risks, from
anesthesia, scarring, and silicone shifting when patients sit down,
they often change their minds.
Breast and cheek augmentations are the most common procedures, he
noted. Borah said buttock augmentation is more popular in some
cultures than others.

The state Department of Health and Senior Services did not identify
the women or release any details about their ethnicity. It also did
not say where the "unlicensed medical provider or providers"
performed their procedures.

"Fortunately, these women are being treated and are recovering," said
Tina Tan, the state epidemiologist. "But there is the potential for
more serious complications if these infections are not treated early
and properly."

Investigators have not determined if the 6 cases, which began to be
reported in mid-February 2010, are related, but they have stoked
concern among officials that such injuries are more common than
previously thought. Health officials issued an alert to state
hospitals and doctors about the cases and the potential for more
victims.

[Byline: Rohan Mascarenhas, Mike Frassinelli]

--
Communicated by:
ProMED-mail


******
[2]
Date: Wed 10 Mar 2010
Source: New York City Department of Health and Mental Hygiene [edited]



The New York City Department of Health and Mental Hygiene (DOHMH) has
been notified of 6 cases of cellulitis/subcutaneous abscesses in New
Jersey residents who received injections of unknown substances into
the buttocks for cosmetic purposes. There have been no cases reported
among New York City residents, but 1 patient from New Jersey reported
receiving her injections in a private residence in New York City.

All of the cases occurred in young women who received the cosmetic
injections between November 2009 and February 2010. The 6 patients
presented with buttock cellulitis and abscesses requiring incision
and drainage approximately 2 to 4 weeks following their injections;
all were hospitalized. No deaths have been reported, but some
patients have required long-term outpatient antibiotic therapy.

The New Jersey Department of Health and Senior Services and local
health officials in New Jersey are actively investigating the cases,
and preliminary information suggests the injections may have been
performed by unlicensed individuals. _Nocardia_ spp. has been
identified in cultures obtained from abscesses from 3 of the 6 New
Jersey cases; cultures are pending still for the other cases.

Previous incidents of infections associated with cosmetic procedures
performed by unlicensed providers have occurred in New York City,
though with different organisms. The NYC DOHMH investigated a cluster
of cutaneous _Mycobacterium abscessus_ infections in 2002 and a case
of cutaneous _Mycobacterium fortuitum_ infection in 2005.

_Nocardia_ include a number of species normally found in soil,
organic matter, and water. Although health care providers evaluating
individuals with infections following cosmetic injections should
consider typical organisms such as streptococci and staphylococci,
atypical organisms such as _Nocardia_ spp. and _Mycobacterium_ spp.
also should be included in the differential. These atypical organisms
can present with more indolent skin lesions and may not respond to
usual empiric antimicrobial regimens. Strong consideration should be
given to consultation with an infectious diseases specialist when
managing patients infected with _Nocardia_ spp. and other atypical
organisms.

--
Communicated by:
ProMED-mail


[Nocardiosis is generally seen in humans when an alteration in the
normal immune state is present especially following solid organ
transplantation or with chronic granulomatous disease. Despite the
severe cellular immunosuppression in end stage HIV infection,
nocardiosis seems underrepresented in the spectrum of infection seen
in this cohort.

An aerobic gram-positive bacillus that is also partially acid fast
and be initially confused with mycobacteria, _Nocardia_ can also
cause a cutaneous infection reminiscent of the disease caused by
sporotrichosis, an environmental fungus. - Mod.LL]

[The state of New Jersey can be located on the HealthMap/ProMED-mail
interactive map of the US at
.
Essex County can be located on the map at
. - Sr.Tech.Ed.MJ]

[see also:
Anthrax, human - UK (06): (Scotland) 20100310.0780
2009
----
Anthrax, human - UK: (Scotland) heroin users 20091217.4270
Mycobacterium fortuitum, breast implant - Brazil: (SP) 20090112.0121
2007
----
Tetanus, injection-related - USA (NY) ex Dominican Republic (03)20070613.1927
Tetanus, injection-related - USA (NY) ex Dominican Republic (02) 20070612.1915
Tetanus, injection-related - USA (NY) ex Dominican Republic 20070611.1904
2004
----
Mycobacterium abscessus - USA ex Dominican Republic (03) 20040621.1650
Mycobacterium abscessus - USA ex Dominican Republic (02) 20040504.1225
Mycobacterium abscessus - USA ex Dominican Republic 20040501.1200
2003
----
Mycobacterium abscessus - USA (New York) 20030116.0137]
...................................ll/mj/lm

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thereon, are not guaranteed. The reader assumes all risks in
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Wednesday, March 17, 2010

Tuesday, March 16, 2010

Big-Ag Gets BioFuel $$$ = Small Farmers "0" Gain

USDA funds available for biofuel, bioenergy production
Posted March 15, 2010, at 8:15 a.m. CST

Agriculture Secretary Tom Vilsack announced March 12 that Fiscal Year 2009 funding is available again through three USDA programs to promote increased production of biofuel and bioenergy. The programs are authorized under the Food, Conservation and Energy Act of 2008 (Farm Bill).

• Applications for remaining FY 2009 funding under the Biorefinery Assistance Program (Section 9003), which uses loan guarantees to develop, construct, and retrofit commercial-scale biorefineries, must be received by June 1, 2010.

• Applications are also being accepted for remaining FY 2009 funding under the Repowering Assistance Program (Section 9004), which provides for payments to biorefineries (that were in existence when the Farm Bill was passed) to replace the use of fossil fuels in their operations with renewable energy from biomass. Biorefineries interested in obtaining funding must apply by June 15, 2010.

• Those producers eligible under the Bioenergy Program for Advanced Biofuels (Section 9005) may also apply to receive payment from remaining FY 2009 funds. Applications must be received by May 30, 2010. During the first round, the Department awarded funding to 123 recipients in 34 states to


Article Continues After Advertisement
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accelerate the production and usage of advanced biofuels.

"The Obama Administration is working aggressively to give our nation's rural communities, farmers, ranchers and producers of biofuels the financial tools they need to help bring greater energy independence to America," Vilsack said. "This funding will help the nation's advanced biofuel industry produce energy from sustainable rural resources, and in doing so create jobs and stimulate rural economies across the nation."

Under Section 9005, the Bioenergy Program for Advanced Biofuels, payments are made to eligible producers in rural areas to support and ensure an expanding production of advanced biofuels. Payments are based on the amount of biofuels a recipient produces from renewable biomass, other than corn kernel starch. Eligible examples include biofuels derived from cellulose, crop residue, animal, food and yard waste material, biogas (landfill and sewage waste treatment gas), vegetable oil and animal fat. Information on how to apply for payments can be found in the March 12, Federal Register. Information on how to apply for funding under Sections 9003 and 9004 is also available in the March 12 Federal Register or by going to http://www.access.gpo.gov/su_docs/aces/fr-cont.html#Rural%20Business-Cooperative%20Service. Funding for these programs is not provided through the American Recovery and Reinvestment Act.

The producer payments are intended to help eligible producers to support and ensure an expanded production of advanced biofuels necessary steps toward meeting the nation's energy needs. The following is a list of biofuels producers that have already received funding under USDA's Bioenergy Program for Advanced Biofuels. Recipients of payments less than $500 are not listed.

Alabama
• Athens Biodiesel, LLC, $2,262.11
Arizona
• Pinal Energy, LLC, $1,337,529.99
Arkansas
• FutureFuels Chemical Company, $544,785.84
• Pinnacle Biofuels, Inc., $20,085.18
California
• Energy Alternative Solutions, Inc., $4,269.21
• Imperial Valley Biodiesel, LLC, $1,999.57
• Imperial Western Products, Inc. $55,105.91
• Yokayo Biofuels, Inc., $8,308.57
Florida
• Agri-Source Fuels, LLC, $7,103.50
• Biofuel Consultants of North America, $2,004.77
Georgia
• Alterra Bioenergy of Middle Georgia LLC, $530.98
• Down To Earth Energy LLC, $1,062.62
• Nittany Biodiesel, $196,949.91
• The Edge Group, Inc., $8,167.17
• U.S. Biofuels Inc., $106,208.25
• American Proteins, Inc., $32,935.57
Hawaii
• Pacific Biodiesel, Inc., $8,655.92
Idaho
• Coeur D'alene Fiber Fuels, Inc., $203,769.40
Illinois
• Blackhawk Biofuels, LLC, $258,309.90
• Nova Biosource Fuels, Inc., $239,740.09
• Valley Energy, Inc., $4,717.00
Indiana
• E Biofuels LLC, $165,980.73
• Indiana Flex Fuels, LLC, $5,164.00
• Kingsbury Energy Group, $17,861.00
• T and M Limited Partnership, $30,702.24
Iowa
• Central Iowa Energy, LLC, $114,239.69
• Iowa Renewable Energy, LLC, $216,592.82
• Maple River Energy, LLC, $9,742.32
• Renewable Energy Group, Inc., $727,132.93
• Riksch Biofuels LLC, $10,401.22
• Sioux Biochemical, Inc., $13,961.87
• Western Dubuque Biodiesel, LLC, $253,695.87
• Western Iowa Energy, $298,475.92
Kansas
• Arkalon Ethanol, LLC, $663,270.50
• Bonanza Bioenergy, LLC, $266,261.11
• East Kansas Agri-Energy LLC, $34,500.65
• Emergent Green Energy, Inc., $1,700.79
• ESE Alcohol, $17,688.56
• Healy Biodiesel, Inc., $5,281.14
• Kansas Ethanol, LLC, $690,080.67
• Nesika Energy, LLC, $104,104.40
• Prairie Horizon Agri-Energy, LLC, $ 824,692.23
• Reeve Agri Energy Inc., $150,398.26
• Trenton Agri Products LLC, $130,867.50
• Western Plains Energy LLC, $848,999.36
Kentucky
• Griffin Industries, Inc., $17,278.36
Maine
• Corinth Wood Pellets, LLC, $176,855.44
• Maine Woods Pellet Company, LLC, $231,291.84
Michigan
• Hillside Farms, LLC, $793.50
• Michigan Biodiesel, LLC, $1, 372.22
• Scenic View Dairy, LLC, $10,219.43
Minnesota
• Cargill Inc., $269,307.51
• Chippewa Valley Ethanol Coop LLP, $8,560.08
• Corn Plus LP, $182,421.73
• Fumpa Biofuels, $25,793.57
• MN Soybean Processo, $565,695.38
• Riverview LLP, $3,993.54
• West River Dairy, LLP, $4,874.74
Mississippi
• Greenlight Biofuels, $18,732.10
• Scott Petroleum Corporation, $106,190.64
Missouri
• Global Fuels LLC, $13,748.25
• Mid-America Biofuels, LLC, $538,101.79
• Natural Biodiesel Plant LLC, $26,909.55
• Prairie Pride, Inc., $133,712.70
• Show Me Energy Cooperative, $35,813.38
Montana
• Earl Fisher Bio Fuels LLP, $586.66
• Huls Dairy, Inc., $1,041.68
Nebraska
• AG Processing Inc., $120,115.61
• Chief Ethanol Fuel Inc., $1,345,588.16
• Northeast Nebraska Biodiesel, LLC, $9,264.65
Nevada
• Bently Biofuels Company, $2,144.76
New York
• MST Production, LTD, $82,410.75
• TMT Biofuels LLC, $1,728.06
North Carolina
• North American Bio-Energies, $4,149.60
• Piedmont Biofuels Industrial, LLC, $7,710.29
• Triangle Biofuels Industries, Inc., $9,148.67
North Dakota
• Archer Daniels Midland Company, $385,062.16
Ohio
• American AG Fuels, LLC, $923.99
• Arlington Energy, LLC, $1,699.77
• Bridgewater Dairy, LLC, $2,028.39
Oklahoma
• Ecogy Biofuels LLC, $85,057.55
• High Plains Bioenergy, LLC, $329,457.85
Oregon
• Green Fuels of Oregon, $643.33
• Stahlbush Island Farms, Inc., $735.50
Pennsylvania
• Middletown Biofuels LLC, $17,510.92
• Soy Energy, Inc. dba Custom Fuels, Inc., $3,382.39
Tennessee
• SunSoil, LLC, $2,811.54
Texas
• Beacon Energy (Texas) Corporation, $69,453.37
• Double Diamond Energy, Inc., $8,711.97
• New Energy Fuels, LLC, $5,424.50
• Levelland/Hockley County Ethanol, LLC, $432,305.71
• Texas Green Manufacturing LLC, $558.14
Vermont
• Audet's Cow Power, LLC, $757.59
• Berkshire Cow Power, LLC, $2,107.69
• David and Cathy Montagne, $586.29
• Green Mountain Dairy LLC, $918.17
Virginia
• Chesapeake Custom Chemical Corporation, $12,438.66
• Red Birch Energy, $6,583.85
• Virginia Biodiesel Refinery LLC, $23,341.53
Washington
• Farm Power Rexville LLC, $1,115.41
• FPE Renewables, LLC, $6,987.32
• GDR Power LLC, $16,162.98
• Imperium Grays Harbor LLC, $195,671.27
• Inland Empire Oilseeds LLC, $8,012.82
• Qualco Energy, $1,558.79
• Standard Biodiesel USA Inc., $3,219.96
• Whole Energy Fuels Corporation, $10,661.75
Wisconsin
• Badger Biodiesel, Inc., $193,237.25
• Best Biodiesel Cashton, LLC, $6,149.62
• Bio Blend Fuels, $1,976.11
• Buckeye Ridge Renewable Power LLC, $10,518.57
• Clover Hill Dairy, LLC, $1,371.50
• Green Valley Dairy LLC, $5,733.51
• Grotegut Dairy Farm, Inc., $1,066.92
• Holsum Dairies, LLC, $6,891.98
• Norm E Lane, Inc., $2,264.82
• Norswiss Digester, LLC, $11,535.15
• Pagel's Ponderosa Dairy, LLC, $2,045.72
• Quantum Dairy, LLC, $1,718.79
• Stargest Power, LLC, $11,636.27
• Statz Brothers, Inc., $1,464.80
• Walsh Bio Fuels, LLC, $6,656.94
• Sun Power Biodiesel, LLC, $9,050.39

USDA, through its Rural Development mission area, administers and manages more than 40 housing, business, and community infrastructure and facility programs through a network of 6,100 employees located in 500 national, state and local offices. These programs are designed to improve the economic stability of rural communities, businesses, residents, farmers and ranchers and improve the quality of life in rural America. Rural Development has an existing portfolio of more than $130 billion in loans and loan guarantees.

SOURCE: USDA











http://www.biomassmagazine.com/article.jsp?article_id=3562

USDA Exploring Ways 2 Let Big-Ag Off Pollution Liability Hook & Get Paid as Well (Planting Trees)

USDA's Vilsack: proper carbon bill to help farmers
Mon Mar 15, 2010 11:07pm GMT

* Vilsack says well-crafted bill could avoid costs

* USDA studying ways to improve carbon offsets



WASHINGTON, March 15 (Reuters) - The U.S. agriculture secretary told a farm group on Monday that a well-designed climate bill would provide opportunities for farmers and ranchers to make money in contracts for carbon offsets.

The U.S. Department of Agriculture "is committed to helping Congress design and implement a carbon offsets market that will provide significant income opportunities to America's farmers and ranchers," Secretary Tom Vilsack told the National Farmers Union convention in South Dakota on Monday.

Climate bill opponents, such as the 6 million member American Farm Bureau Federation, have said higher fuel and fertilizer costs resulting from the legislation would outweigh revenue from contracts to offset greenhouse gases by planting trees and crops that capture carbon.

USDA chief economist Joseph Glauber said in a memo released by the department on Monday that "some actions to mitigate greenhouse gas emissions can reduce commodity output." He said converting bare or cultivated land into forests, or afforestation, was one example of where that can occur.

Glauber is working with the Environmental Protection Agency to study ways to improve agricultural carbon offsets. Offsets would allow polluters to invest in clean agriculture projects such as afforestation and techniques to store carbon in soil, rather than cut their own emissions.

"USDA and third-party analyses, as well as our experience in implementing conservation techniques, make it absolutely clear that properly structured legislation will avoid unintended consequences and provide enormous benefits to our agricultural economy, and our environment," Vilsack said.

Senators John Kerry, a Democrat, Lindsey Graham, a Republican, and Joe Lieberman, an independent, are working on a compromise climate bill. They could outline the bill next week, but the legislation faces an uncertain future on opposition from lawmakers from energy-rich and agriculture states. [ID:nN15216776] (Reporting by Timothy Gardner; Editing by Marguerita Choy)


Click on title above for original article;

http://uk.reuters.com/article/idUKN1513896520100315

Thursday, March 11, 2010

North Las Vegas Company Under Fire Over Contaminated Equipment

NORTH LAS VEGAS, Nev. - A North Las Vegas company is being blamed for a nationwide recall that affects more than 100 types of processed food. 8 News NOW has also uncovered disturbing details about how long company representatives knew they had problems with salmonella contamination.

The Food and Drug Administration announced Wednesday that Basic Food Flavorings knew about the contamination of its equipment back in January, but continued to ship its flavor-enhancing ingredient until mid-February. The ingredient, hydrolyzed vegetable protein or HVP, is used in processed foods such as taquitos, seasoned snacks and dips.

Rylee Gustafson knows the dangers of food contamination. She was a victim of it several years ago. At age nine, she was hospitalized for more than a month after eating spinach contaminated with E. coli. "My organs started to shut down," she said. "I developed diabetes, and I went through psychosis. It was really crazy." Since then, Gustafson has become an advocate for food safety. She has testified before Congress and lobbies for better food safety laws.

Watch Rylee Gustafson's Testimony Before Congress

"(Basic Food Flavorings) need(s) to be interested, because this is a really big deal," she said. "If we are questioning, ‘Is this going to be good for me to eat,' it's kind of scary." Federal officials say Basic Food Flavorings conducted a major recall of its products. So far, no illnesses have been tied to the recalled products.

Regardless, Gustafson hopes laws are soon in place to stop outbreaks and recalls before they happen. "You are losing a lot of consumers, and you need to think of others, not just your company," she said.

8 News NOW tried to contact Basic Food Flavorings, but our calls and e-mails were not returned. There are also reports the company may be closing for good.





Click on title above for more detailed article;

http://www.fda.gov/Safety/Recalls/MajorProductRecalls/HVP/default.htm

Monday, March 8, 2010

Infections and deaths force Biogen, Roche to suspend blockbuster program

By John Carroll

In a significant setback, Biogen Idec and Roche have suspended the troubled development program of ocrelizumab for rheumatoid arthritis, and analysts are already questioning if work related to multiple sclerosis may soon follow.

The companies made their move after an independent safety board said that the risks outweighed the potential benefit from the experimental therapy, noting that serious and opportunistic infections had afflicted patients taking the therapy, some of whom died. Safety concerns had already forced researchers to halt two clinical trials for rheumatoid arthritis and lupus.

"The news wasn't completely unexpected since some trials were on hold before," notes Birgit Kulhoff, an analyst at Rahn & Bodmer. "However, with the obvious fatalities the drug has a high likelihood of not being approvable.. I would expect that the MS trials will be stopped as well."

"Patient safety is of the utmost importance in all of our drug development programs," says Roche's Chief Medical Officer Hal Barron. Kulhoff had projected blockbuster sales if the drug had gone on to an approval for all three indications.

- see the companies' release
- here's the MarketWatch report
- here's the story from Bloomberg

Related Article:
Roche's RA drug posts blockbuster results in Phase III
Arbitrator sides with Biogen in Rituxan dispute
Roche/Genentech - Biotech Market Share Report

Read more about: ocrelizumab, Roche, Biogen Idec

Friday, March 5, 2010