Archive for fda

Letter: Monsanto Roundup impacts food, also poisons bees, butterfilies, soil, air, water


stop monsanto roundup

Monsanto is a name that has been in the news and on the Internet a lot recently, and not in a good way. CREDO, an organization that "fights hard to enact progressive change and defeat regressive policies," sent me this email about stopping Monsanto from using the herbicide Roundup. You may have received the same one:

Tell the EPA and FDA: Immediately suspend Monsanto's Roundup herbicide.

Petition to EPA Administrator Gina McCarthy and FDA Commissioner Margaret Hamburg: 

Evidence is mounting that the massive use of glyphosate, the primary ingredient in Monsanto's herbicide Roundup, is making us sick at alarming rates. Immediately suspend the use of glyphosate.

In case you weren't sure yet if the massive use of the herbicide glyphosate - the primary ingredient in Monsanto's Roundup - was cause for concern, here's the sobering takeaway from an MIT senior researcher who just conducted a review of the stuff...

And then they linked to their petition along with more information about the toxic herbicide used in Monsanto's Roundup.

But there's more, right here in today's Los Angeles Times letter to the editor, because our voices matter:

Bioengineered Seeds of Destruction

So much of the current debate on labeling foods containing genetically modified organisms (GMOs) focuses on the health impacts of eating that food. ("The legal nightmare of labeling GMOs," Letters, May 10)

While this is the immediate issue for many people, it's important to take a step back and look at why Monsanto and other producers of modified seeds are pushing farmers to plant their patented crops: because it enables farmers to spray their fields with herbicides such as Roundup without fear that this will kill off the crops.

The aggressive use of herbicides is destroying bee and butterfly habitats (the monarch butterfly population has been decimated by the use of Roundup and similar products on milkweed) and is polluting our air and water.

When we purchase GMOs, we are supporting a way of farming that maximizes the use of toxic herbicides. The issue of GMO foods isn't just about what we're putting on our tables, it's about what we're putting in our soil, air and water.

Mara Sperling

Los Angeles



Senators Trying To Practice Medicine Without A License



Here is part of the Food and Drug Administration's (FDA) mission statement from their website:

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

Who makes up the FDA? Scientists, doctors and experts in related fields.

Who does NOT make up the FDA? Corporate sponsors, Big Pharma, groups or organizations which benefit from rulings AND elected officials.

The last one is why this post exists. It seems there are some in Congress who feel they, despite lack of any scientific facts, research or background education and training in medicine, know more about pharmacology than the experts do. Being elected for office requires no educational background and we've certainly seen way too much proof of that. So why should they be telling the FDA what's safe and what isn't? When they're sworn in, do they get a diploma from Dufus U. School of Medicine?

Dunderheads like Todd Akin, Steve King and others just don't get it. Now we can add a few more names to this list of non-doctors telling licensed medical practitioners what medications they can and cannot be prescribing.

This, from The Hill:

Sen. Joe Manchin (D-W.Va.) plans to introduce legislation in the coming days that would push back against the Food and Drug Administration (FDA) for approving a controversial prescription drug, his office confirmed Wednesday.

Manchin is working with several other senators on a bill that would target the FDA's approval process, after the agency gave the green light in October to Zohydro, which critics say is a highly-addictive and easily-abused painkiller.

Those several other senators include the Madam's boy,  David Vitter (R-Louisiana) and the ever increasingly neurotic Charles Schumer (D-New York). Each of them sent letters to Health and Human Services Secretary Kathleen Sebelius this month, demanding she step in and force the FDA to reverse its decision. She has jurisdiction over the agency.

What is this horrible drug that needs to be halted before it can be sold?  Zohydro. It's the first FDA-approved drug that uses pure hydrocodone to treat chronic pain. In lay terms, is amped up Vicodin. One tab of Zohydro would take the place of six to ten Vicodin. So, instead of two pills every two to four hours, you'd take one pill once or twice a day. It's cheaper, its more effective and would aid people in chronic pain. It's been tested, researched and successfully made it through the numerous, stringent studies involved with any new medication.

How is that so awful? According the the Manchin gang, it could lead to abuse and overdosing. Well, Senators, so can Vicodin and other pain meds. According to GEN (Genetic Engineering and Biotechnology), the most abused medication today is Oxycontin. Hydrocodone is only number 17. So maybe you should be looking into the 16 medications that are abused in greater numbers than Vicodin. They include Xanax, Ativan and Valium.

Oh, that's right, those are the pills you might already be using to deal with the anxiety and pressures of your new responsibilities as resident doctors in the Senate chambers.

Let's not always look at the worst case scenario. There will always be people who abuse medications. Let's not punish those who are really in need because of a small percentage of abusers. It's doctors who should be the ones either prescribing a drug or withholding it from a patient. But the choice should be left to experts, not politicians. They have trouble walking and chewing gum. Maybe they should stick to improving those skills. Then they can work their way up to walking and talking while making sense.

That's wishful thinking, I know. Maybe there's a pill for that.


As children suffer, meningitis cases confirm need for FDA reform



You may have read about meningitis outbreaks at college campuses, in some instances resulting in deaths . Today's guest post is by someone whose name you may very well recognize, Dr. Julianne Malveaux. She makes a good case for urgent FDA reform:

Meningitis Cases Confirm Need for FDA Reform
by Dr. Julianne Malveaux

Julianne Malveaux is a Washington, D.C.-based economist and writer. She is President Emerita of Bennett College for Women in Greensboro, N.C.

It is virtually impossible to get Democrats and Republicans to agree on anything healthcare related these days. Even issues that everyone can agree on - like covering Americans with pre-existing conditions and keeping young adults on their parents' health plan - become political footballs.

But while Congress continues to debate healthcare policies, they are missing opportunities to genuinely effect Americans' health. There is common ground to be found, including ensuring our nation is properly expediting life-saving vaccines for a deadly disease.

Recent scares at Princeton University and the University of California Santa Barbara (UCSB) have highlighted a sluggish, reactive approach to disease prevention and that the consequences of this leadership vacuum, particularly at the U.S. Food and Drug Administration, could be deadly.

Last spring, a Princeton University student was diagnosed with Meningitis type B (MenB), a highly contagious and life-threatening bacterial infection known to strike college campuses. By November, officials made national headlines by confirming an eighth case.

Just as Princeton was taking steps to protect its students against this deadly disease, UCSB confirmed that MenB had stricken four of its students. One young man – a lacrosse player, Aaron Loy – had to have the lower portion of both legs amputated.

As a former college president, I can assure you that no university is prepared for this kind of crisis. This is particularly true because many college administrators believed they had protected their campuses by requiring incoming freshmen to be vaccinated against meningitis. But it turns out that immunizations cover every meningitis type except for MenB, which accounted for more than 30 percent of meningococcal cases last year.

Because FDA has not approved a MenB vaccine for use in the U.S., the Centers for Disease Control and Prevention (CDC) has been scrambling to respond to public health crises like those at Princeton and UCSB. Rather than proactively immunizing susceptible college students before or immediately after a meningitis outbreak occurs, the CDC can only administer “Bexsero” – a MenB vaccine that is currently in use for all ages in European Union, Australia, and Canada – weeks after students have already fallen ill.

FDA’s ad hoc approval for Bexsero means that it takes months for the vaccine to reach college students, rather than days. In the case of Princeton, CDC and FDA launched a vaccination program more than two months after university officials requested special permission to administer the vaccine. Just last week UCSB began immunizing students, some three months after the first case of MenB was confirmed. As one CDC official told CNN, “You don't go online and order 10,000 doses and get next-day delivery of this vaccine. It takes time.”

That statement underscores the need for full U.S. approval of Bexsero -- quickly. A country that has long been the world leader in developing and deploying life-saving medicines should not have to depend on partners in the EU or Canada.

Moreover, other college campuses should be afforded the opportunity to vaccinate their students proactively, well before a disease like MenB strikes their campus. But this option for college administrators, state health officials, and parents is not possible so long as Bexsero remains unapproved in the U.S.

If Congress isn’t yet convinced that there is an urgent problem, perhaps they should listen to the parents of affected students.

"It's absolutely devastating to have Aaron, in the prime of his life, be stricken,” Mike Loy said. “We hope that Aaron's horrific illness brings increased awareness and rapid approval by the FDA of the vaccine.”

I've also heard one mother whose healthy daughter contracted MenB at college and she died within 30 hours of entering the hospital with a headache. She said the FDA would be moving a lot faster if they had to watch their children suffer the way she did.

Improving efficiency at FDA is an issue that should find bipartisan support on Capitol Hill. Our system’s continued failure on the MenB vaccine is just one example that illustrates that there’s too much at stake for FDA reform to turn into the partisan fight du jour, or worse yet, be ignored by Congress altogether.


Rep. Steve King Is Trying To Kill Us


diseased food animals

Eat diseased food, you'll get sick or even worse, you'll die.

That's why we have Federal food inspectors who keep the chances of disease ridden food from making it to our shelves. As least we have it now, but if Republican Steve King has his way, that won't be the case much longer. And if you're like me, you become suspicious when a committee's findings are are being kept hush-hush. Fruther that suspicion when a silent amendment is being sought. You start wondering what it is that the Tea Party extremist Steve King is afraid we'll all find out? Could it be he favors animal cruelty, substandard food quality, sick and diseased animal bi-products being used, tainted ingredients, unregulated chemical content, unsafe food handling -- or all of the above?


A group of law professors have written to the House and Senate blasting a controversial amendment to the farm bill currently undergoing negotiations.

In it, they reportedly criticize the Protect Interstate Commerce Act introduced by Rep. Steve King (R-Iowa), an Amendment that seeks to limit states’ power to supervise their own farming standards. If passed, the amendment would ban states from requiring agricultural and livestock conditions that are stricter than those in other states, so long as the products are intended for out-of-state sale.

The experts allege that the amendment is a food safety risk, writing that there is “a significant likelihood that many state agricultural laws across the country will be nullified, that public health and safety will be threatened, and that the amendment could ultimately be deemed unconstitutional.”

Fortunately, there are hundreds of protesters to this bill. And coming out against this heinous lack of restrictions are a bi-partisan group on Capitol Hill: 23 Senators and 169 Congresspeople. But it's not just shaking the foundations in Washington. This absurd, dangerous self serving bill by Steve King is being fought by hundreds of other organizations. I highly recommend you look over this list to find out who is supporting us by bashing Steve King and his Republican cohorts as they wish to flood the market with tainted food. Click here for the list.

Keep your eyes open. If King and his Tea Party people have their way, they'll literally kill you.