Archive for fda

Senators Trying To Practice Medicine Without A License

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senators

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.

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As children suffer, meningitis cases confirm need for FDA reform

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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.

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Rep. Steve King Is Trying To Kill Us

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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?

HuffPo:

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.

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The FDA Is Afraid Of Home DNA Tests

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pregnancy test

One of the largest selling over the counter items to come along in the past ten years is the home pregnancy test. It's simple, safe and for the most part, accurate. Without doubt, there are false negatives and certainly false positives. Regardless of that fact, women who want the test can drop on down to the drug store and pick up a kit. And for many, when they discover that they are with child, they seek immediate medical attention. They leap right into healthy pre-natal care or address the pregnancy in other ways. But the simple point is that the home test started them on a path toward better care and attention.

USA today reports a startling story about another kind of home testing -- done with a simple swab. It's the home DNA test.

WASHINGTON (AP) — The Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is backed by science.

In a warning letter posted online, FDA regulators say the Silicon Valley company is violating federal law because its products claim to identify health risks for more than 250 diseases and health conditions.

23andme test kit

I can't say that I have ever found need for a DNA test. But I'm sure there are many who do -- it's almost a staple test on Jerry Springer, Dr. Drew, Dr. Phil, and Maury Povich. Yet seemingly there's a large number of people who are using these home tests.

 The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy science.

So the FDA is claiming that DNA is flimsy science. Tell that to the people in jail or freed from it because of that flimsy science.

Here's where the wheels of doubt and suspicion start working like the cogs at an old steampunk factory. Who's really against this and why?

The FDA warning takes issue with a number of claims the company makes for its saliva-based test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care.

Let's look at that for a second. You test positive for a possible disease and you're not going to follow up on it? I would think not knowing you had an illness would contribute more to complications and lack of care than knowing. And now with Obamacare and more  people having health coverage, it's as important as ever to have an idea you may be carrying something that can be cured so you'll seek out medical attention.

23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.

Isn't no result (not being tested) worse than a false result? Early detection is key in curing. This FDA argument is a bogus one at best. What doctor is going to accept a home test result and operate on someone or give them radiation treatments without doing their own followups? If they do, they don't deserve to have a license.

The FDA's concern with 23andMe appears to center on its commercial approach, which sidesteps doctors and health professionals.

The test also claims to predict how patients will respond to popular drugs, including the ubiquitous blood thinner warfarin, which is used to prevent blood clots. The FDA warns that an inaccurate reading there could "have significant unreasonable risk of illness, injury, or death to the patient," if they don't receive the appropriate drug dose.

Once again, it's time to apply some common sense here. Sometimes one doctor prescribes something and another doctor prescribes something else which in combination could cause a conflict. Don't we as patients want to know that so we can contact our physicians and ask.

Center For Disease Control:

In 2011, drug misuse and abuse caused about 2.5 million emergency department (ED) visits. Of these, more than 1.4 million ED visits were related to pharmaceuticals.

An educated and cautious patient is a good thing. Just accepting meds on face value is the real danger. Doctors should welcome this potential heads up. At the very worst, the patient can call the doctor and tell him/her what their home test revealed. Lives could be saved, not lost.

Why doesn't the FDG have the same problem with home pregnancy tests? It seems perhaps the FDA is showing signs of corruption. If they don't get their bribe, their payoff, they don't give their approval. It might be time for an investigation, a home test, on the FDA and see what kind of maladies they're suffering from.

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Did You Have Tyson Bacon With Your Breakfast Today?

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baby pigs

Cooking for many is a passion. For others, it's an obligation. For even others, it's an elusive skill. But one thing that we all have in common is we enjoy a good meal. It's even made more special when it's a home cooked dining experience. Somehow a well made home meal, despite the fact that it can take a lot of planning and preparation (compared with the relatively short time it takes to devour) makes everyone, especially the cook, feel good.

Maybe the least likable part of the making the special meal is shopping for ingredients, yet it's perhaps the most important. You can't make an omelette without eggs, and meat loaf is hard to cook without some ground beef.

There's a lot to consider along with just figuring out the menu. There's the freshness of components, the price of the items you'll need and the time the entire shopping process takes. If you're going to be preparing and cooking for hours, convenience always enters into into consideration as well. Many times we'll consider partially prepared elements so we only have to add them to the process and not actually make them from scratch-- things like a prepared pie crust, a prepared spaghetti sauce or a pre-cooked chicken to add to our "home made" chicken pie. It's okay. All cooks do that from time to time. Time is precious and we look for convenience.

What we don't spend enough time on though is the consideration into the brand or how a particular company chooses and prepares it's product before our purchase and use.

We grab a container of eggs without giving the method of collection much thought. We have the FDA to make sure the product is clean and safe. We buy chicken, beef and now that we're approaching Thanksgiving, turkeys figuring they're humanely raised and slaughtered, done under clean and the safest methods possible. All that most of us think about is the bottom line -- the price.

Actually, there's more to think about if we're going to be responsible shoppers. And that's how the products are raised, harvested and delivered. It's important though to consider how humanely this process was handled.

Despite the price, wouldn't you boycott an item if you knew it as using sweatshop labor, child abuse or slaves to manufacture the item-- some jeans, shirts, shoes or other fashion item? We speak out for these victims by refusing to buy the products that are made with substandard labor.

Well, what about with food? Isn't it time we avoid blatantly abusive companies that don't stand up to industry standards? Those that routinely torture the animals used for products?

Tyson, a company you've undoubtedly heard of and seen in your local grocery chain is one such violator of animal cruelty laws.  And the attached video is all you need to see, if you can stomach it. None of this kind of behavior is proper, necessary or legal. But yet we support Tyson with our purchases of their products.

If this disgusts you as much as it does me, seek out an alternate. Don't tell Tyson this is okay by just turning your back on the animals that are sacrificed to bring us our daily meals. I'm not saying you should become a vegan. I won't. I love my meat products, but I will avoid any company that won't humanely treat their livestock while raising them, or harvest them as painlessly as possible when their time comes.

Caution -- extremely disturbing footage:

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Welcome To The Explosive World Of Vaping

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eCigs

A week ago, three U.S. congresspersons,  Reps. Henry Waxman (D-Calif.), Diana DeGette (D-Colo.) and Frank Pallone Jr. (D-N.J.) wrote in a letter to the Food and Drug Administration. They complained that e-Cigarette companies are taking advantage of a “loophole” in current regulations that allows them to escape the type of oversight given to the rest of the tobacco industry.

Really. The tobacco industry is getting nervous. That can't be all bad. Remember, these are the peddlers of cancer sticks they call tobacco cigarettes.

What this trio of representatives is really complaining about isn't regulation of the product based on contents, health, or dangers. It's competition. Commerce. They're doing their dirty deeds under the guise of trying to protect children from vaping -- using eCigs.

First, I don't want to see kids smoking. Certainly not cigarettes. Yet the health hazards equated to eCigs and related vaporizing devices, according to the Daily Consumer Alert are not all that drastic.

A few of the benefits claimed from using the electronic cigarette:

No tar, tobacco, carbon monoxide, or ash.
Get the same amount of nicotine as a regular cigarette.
Each cartridge costs less than $2 and is equivalent to an entire pack of cigarettes.
Average consumer can expect to save over $1,000 each year.
You won’t “smell” like a smoker any longer.
Different flavors are available.
No more second-hand smoke.

bloomberg reports on eCigsYet because there is no tobacco in these products, they don't fall under the strict guidelines the FDA has set up for tobacco products. One of those restrictions has to do with access to anyone under 18.

Will kids start taking up eCig usage and vape? You bet, just like with regular cigarettes. But is this healthier for them? Probably, but that's what research is for.

Then the question becomes, before a product is deemed needing regulation, do kids need extra protection, just in case? Hesitantly I say, maybe. But I'm not sure yet of the motives of the people trying to bring parity with the tobacco industry regulations. I've got questions as to who's bidding these congresspeople are doing. Are they interested in the children, or is this a lobbyist attempt to help out what could be a dying cigarette industry?

Maybe if they want to bust open their books and return any money they've received in contributions in the past or currently, I might be inclined to be less dubious of their putting some "sin" in sincerity.

If vaping grows as rapidly as it looks to be doing, there's cause for tobacco to worry. Cigarettes won't die out forever, but they may becomes yesterday's news.

A year ago I didn't know anyone who had tried an eCig. Today I know a few. And those are all people used to smoke cigarettes. They don't anymore. I've asked if they enjoy the experience and unanimously they say yes.

Formerly, the cigarette smoker's clothes and even their bodies reeked of old cigarettes. Their breath wasn't fresh, and when they'd  taken a hit or two in my presence, I got a headache from the smoke smell. Not now. With the eCig usage I noticed nothing more than a light waft of soft, fragrant aroma. It's less than passing by mid-summer, night-blooming jasmine.

So maybe these congresspeople should cool their jets. Do some research. If eCigs require more regulation, it'll come. But after research.

Until then, check out the newest advertising for eCigs. An adult campaign isn't going to get kids to want to give vaping a try. See for yourself.

Hmm. You know what I wrote up above -- Never mind.

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Coming Soon, Epidemic of Lettuce Smokers -- Congressman Buyer

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insane asylum

Oh, boy, where to start? When the nuts in the crazy house start bringing up analogies, you're sure to have some outrageous statements that only serve to reinforce why we need to clean house in Congress. For too long, we've been committing the insane to the big domed building on Capitol Hill and not the institutions for the mentally challenged or handicapped in their own state. And they shouldn't mind. With the ACA, pre-existing conditions will now be covered.

Take Rep.Steve Buyer, R-Ind. With a name like Buyer, you might think this guy was a dope dealer. Only half right. The first half. He's a dope.

Steve Buyer

In debating whether or not eCigs, the tobacco-less smoking vaporizing devices are harmful and should be regulated as tobacco, Buyer goes off on a tangent that only someone high on Marijuana could make sense of. I'm not saying he's a pot head -- I'm just saying his logic is about as sound as someone who's been on a non-stop Kush smoking binge for a few days --  if not since college.

I'm neither for nor against eCigs. But when you take to the floor of Congress to fight for one side of the other, don't some unprepared. It shows.

Buyer's argument harkens ineffectively to guns don't kill people, people do. In his argument cigarettes don't kill, only people who smoke them do. Of course he forgets the thousands, if not millions who've died from second hand smoke. But Dealer isn't all that bright and his arguments would give an aged Swiss Cheese a run for it's money in the content holes department.

So he goes on -- not quitting when he had half a valid argument to go on. His amped up argument reaches to smoking lettuce.

smoking lettuce

LETTUCE. That green, leafy stuff you make a salad with. He's proposing that drying and smoking lettuce is analogous to smoking marijuana or tobacco.

See for yourself. This real Congressional moment wouldn't need a bit of punch-up to become a classic SNL sketch. It's right up there with the Sarah Palin parodies and the "more cowbell" sketch with Christopher Walken.

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