Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, November 21, 2017

Alcoholism: There’s no cure, but there is a test

Addiction and Recovery

By Bob Gaydos
Living in a world in which seemingly anything one might want is just a click away, it’s easy, maybe even natural, to assume there are quick fixes for everything. A robot for every chore. A cloud for every data storage problem. A pill for every illness.
Not yet. Sorry, alcoholics, there is still no pill that cures alcoholism.
It’s not for a lack of trying, to be sure. While research continues to find the magic pill, thus far the U.S. Food and Drug Administration has approved three medications to treat what is referred to clinically as alcohol use disorder or alcohol dependence. The FDA says the medications are non-addictive. According to the National Institute on Alcohol Abuse and Alcoholism, they are:
  • Naltrexone, which is used to treat opioid addiction, but some researchers say can also help people reduce heavy drinking. It is available in pill and long-acting injectable form. Researchers say it acts in the brain to reduce the craving for alcohol in those who have already stopped drinking. However, treatment with naltrexone is not enough on its own. NIAAA says the medication was reported to be effective when combined with counseling, psychotherapy, and alcoholism support groups.
  • Acamprosate, which the Substance Abuse and Mental Health Services Administration (SAMSHA) says makes it easier for some who have already stopped drinking to stay stopped by reducing withdrawal symptoms such as anxiety, insomnia and restlessness, that may follow lengthy abstinence. Of course, counseling, psychotherapy, and alcoholism support groups might help in these cases also.
  • Disulfiram (Antabuse), which blocks the metabolism of alcohol by the body, causing unpleasant symptoms such as nausea, headache, sweating and flushing of the skin. The idea is you will get so sick if you drink alcohol while taking Antabuse you won’t want to drink alcohol. Or, as some alcoholics decide, you won’t want to take Antabuse. It’s the nature of the disease.
There are complications, starting with the fact that each individual is different, meaning some medications might work for some and not others. For example, according to SAMSHA: “Patients with liver damage usually cannot use either naltrexone or disulfiram. However, because acamprosate is not metabolized in the liver, patients with liver damage can safely take the medication.” All the medications have a variety of possible side effects.
Also -- and here’s the major stumbling block for many with a serious alcohol problem -- for each of the treatments the optimal recommended situation is that the person is abstinent at the beginning and is committed to recovery. That may mean detox and, for many, in-patient or out-patient treatment. It also means being honest with your doctor and rehab counselors about your goals, actually being willing to stop drinking and not looking for a quick fix for your problems.
Having a primary care doctor who has more than a cursory understanding of alcohol and drug abuse is an excellent starting point, especially if medication-assisted treatment is to be involved. This doctor must screen patients to determine the level of alcohol use, assess the need for or appropriateness of medication-assisted treatment, develop a treatment plan, choose an appropriate medication and monitor patient progress. If your doctor is unable or unwilling to do all this and you want to try medication-assisted treatment, he or she should refer you to one who is.
But remember, none of these drugs cures alcoholism. They are designed to help manage a chronic disease by discouraging or reducing alcohol intake. That’s obviously crucial, but on its own is not necessarily recovery, which is generally defined as avoiding the trouble associated with drinking as well as avoiding the alcohol itself.
This being a disease of the brain, it is recommended that some kind of counseling or support group accompany the use of these medicines.
It’s also important to know that, while there may not be a magic pill to cure alcoholism, there is a way to help determine a diagnosis of alcohol use disorder. The NIAAA offers a test that you can take:
***
In the past year, have you:
  • Had times when you ended up drinking more, or longer than you intended?
  • More than once wanted to cut down or stop drinking, or tried to, but couldn’t?
  • Spent a lot of time drinking? Or being sick or getting over the aftereffects?
  • Experienced craving — a strong need, or urge, to drink?
  • Found that drinking — or being sick from drinking — often interfered with taking care of your home or family? Or caused job troubles? Or school problems?
  • Continued to drink even though it was causing trouble with your family or friends?
  • Given up or cut back on activities that were important or interesting to you, or gave you pleasure, in order to drink?
  • More than once gotten into situations while or after drinking that increased your chances of getting hurt (such as driving, swimming, using machinery, walking in a dangerous area, or having unsafe sex)?
  • Continued to drink even though it was making you feel depressed or anxious or adding to another health problem? Or after having had a memory blackout?
  • Had to drink much more than you once did to get the effect you want? Or found that your usual number of drinks had much less effect than before?
  • Found that when the effects of alcohol were wearing off, you had withdrawal symptoms, such as trouble sleeping, shakiness, irritability, anxiety, depression, restlessness, nausea, or sweating? Or sensed things that were not there?
Your score: Mild: The presence of two to three symptoms. Moderate: The presence of four to five symptoms. Severe: The presence of six or more symptoms.
Be honest with yourself and -- as the test suggests -- acknowledge your drinking’s effect on others. That’s key, whether you call it alcoholism or alcohol use disorder and whether you use some pill to treat it or not.
bobgaydos.blogspot.com

Wednesday, March 9, 2016

GMOs: Food fight becomes war of words

The Savvy Shopper

By Bob Gaydos
The non-GMO label is showing up
 on more food products.
The most contentious food-fight on the planet has been transformed into a war of words. Actually, letters. Three of them: GMO. They stand for genetically modified organism.
The battle is being waged in Congress, state legislatures and via social media. The question -- whether food producers should be required to put those three letters on labels of products that have been genetically modified.
Boiled down, the argument goes like this:
  • Producers of genetically modified seeds and companies that use GMOs in the foods they produce say extensive scientific research has shown the food to be as nutritious as non-GMO foods and safe for human and non-human consumption, so there is no need to label them.
  • A diverse coalition, which includes organic farmers, scientists, doctors, Consumers Union, community organizations, and a host of internet sites devoted to nutrition, healthful eating, food safety, and the public’s right to know, say GMO science is still too new to be decreed safe in the long term. Besides, they ask, if it’s safe, why not give consumers a conscious choice in what they eat by labeling genetically modified food?
A lot of money has been spent lobbying members of Congress to  
oppose mandatory labeling of GMOS, and even to prohibit farmers from suing Monsanto, the largest producer of GMO seeds, over its requirement that farmers buy new GMO seeds from the company every year. Last year, the House of Representatives passed what labeling proponents dubbed the DARK Act (Deny Americans the Right to Know Act). Local Reps. Sean Maloney, D-18th District, and Chris Gibson, R-19th District, both opposed the bill, which would have preempted a state’s right to require labeling of GMOs. However, under pressure in December to get a budget bill passed to avoid another government shutdown, the House did not include the GMO measure in its final omnibus budget bill. With the Senate also approving the budget bill and President Obama signing it into law, advocates of GMO labeling took this as a victory in the ongoing battle.
In yet another victory for the advocates of mandatory labeling, Campbell Soups, a major food company, recently announced it would no longer oppose such labeling, It said it has withdrawn from the food industry campaign for voluntary labeling and is urging a national standard, to avoid confusion for consumers. CEO Denise Morrison said the company is not “disputing the science of GMOs or their safety.” But, she added, GMOS have become a major issue with consumers and, “We have always believed that consumers have the right to know what’s in their food.” She said if a federal standard isn’t established “in a reasonable amount of time,” Campbell’s would begin labeling its own products, which include Pepperidge Farm, Prego, Swanson and SpaghettiOs.
Meanwhile, the legal status quo remains and states are free to pass laws requiring labeling of GMO foods. Vermont is the only state to have enacted such a law. Maine and Connecticut have passed similar laws that go into effect when enough neighboring states do likewise. Vermont’s law is scheduled to go into effect in July. Labeling laws are currently being considered in many other states and the issue is also far from dead in Congress.
So, what’s a health-conscious, label-reading shopper to do in the meantime when the label may be no help on GMOs? For one thing, get enough information about the subject. That can help make for more-informed choices at the supermarket or farmer’s market, no matter what the politicians do. The following may help.
  • What are GMOS? GMOs are seeds whose genes have been altered in a laboratory to change certain properties. Generally, proponents of GMOs say they are more resistant to extreme weather and pesticides, are able to produce a higher yield in smaller acreage and have a longer shelf life. The Food and Drug Administration has approved a GMO apple that supposedly won’t turn brown when sliced and a potato that resists bruising. These are not in wide use. (The FDA also recently approved a GMO salmon. See sidebar.) Opponents say they are concerned about GMOs contaminating nearby conventional crops or posing serious health problems since they contain the chemical pesticide to which they have been made resistant. They also say GMOs allow for wider use of pesticide spraying of crops.
  • How much of our food is genetically modified? Lots. Maybe 90 percent of the corn and soybeans grown in the United States are genetically modified. Other major GMO crops are cotton, squash, canola, papaya and sugar beets. Since several of these crops are common ingredients in packaged foods, it’s estimated that 75 percent or more of processed food products in the U.S. contain GMOs. More food companies have begun to voluntarily include “Non-GMO” or other similar information on their labels.
  • Do other countries require labeling of GMO foods? Yes. Australia, Russia, most of Europe, Iceland, Saudi Arabia and Turkey have stringent labeling laws, according to the Center for Food Safety. Others that have labeling requirements include  Brazil, China, Japan, South Africa and South Korea.
  • How do I tell what’s true about GMOs and what’s not if I check on the Internet? Good luck. This debate changes every day, with major corporations spending millions of dollars in advertising, lobbying and research grants to scientists to bolster their arguments and organic food organizations and consumer groups spending considerably less money, but no less energy, in an effort to counter them. This is why labeling has become the focal point of the controversy.  
Maire Ullrich is the go-to GMO person at Cornell Cooperative Extension in Middletown, N.Y. As agriculture program leader, she offers interested groups a 40-60 minute talk on GMOs. She says the agency takes no position on GMOs. “There’s no good data that says it’s not safe,” she says, “but you still have a choice to be an educated consumer. People need to be really wise to the back of the package, not just read the labels on the front” if they want to know what they’re eating,
For example, she cited a product label boasting of non-GMO oil. But that oil was only 5 percent of the oil in the can. The other 95 percent was canola, which was modified.
Ullrich says most of the produce at local stores and farmers markets is non-GMO (“there are no GMO onions”) because of “the pushback from consumers.” She says farmers are more reluctant to grow GM crops. “Of course, if it’s labeled organic, you know it’s not GMO.”
“Part of what I teach is that if you want to use labels, you have to be scientific in your argument,” she says. “Is it your right to know growing practices and ingredients? Argue for consumer knowledge and transparency. If you don’t like the economics behind GMOs, it’s OK to say so.”
As for that GMO potato, “It’s been an abject failure,” she says. “McDonald’s wouldn’t buy it.” The non-bruising GMO apple? Ullrich says, “If McDonald’s won’t buy a GMO potato, do you think they’ll buy a GMO apple for a kiddie meal?” Both will wind up being processed for other, less obvious, uses.
Meanwhile, the food fight continues.

Bob Gaydos is a freelance writer. He can be reached at rjgaydos@gmail.com

Is it really a salmon?
The $1.1 trillion budget bill passed by Congress in December also contained another significant victory for proponents of GMO labeling. In it, Congress instructed the Food and Drug Administration to prohibit the sale of GMO salmon until the agency creates labeling guidelines and a program to disclose to consumers whether a fish has been genetically altered. The FDA in November approved salmon as the first genetically modified animal safe for human consumption. It required no labeling of the Atlantic salmon produced by AquAdvantage.
The salmon contains a growth hormone from a Chinook salmon and a gene from the ocean pout. The modification reduces the time required for the fish to grow large enough for consumption to 18 months instead of the usual three years. The fish is also considerably larger than the average salmon.
Critics of the product and commercial fisherman raise the same questions posed about GMO vegetables and fruits: Is the fish safe to eat and what might happen if the fish escapes from its breeding tanks into the environment and mates with wild salmon?
AquAdvantage says the fish are safe to eat, are all sterile females and its land-based breeding areas are secure.
While it is unclear when the fish might be ready for sale, some food chains, including Whole Foods, Target, Trader Joe’s and Aldi, have said they will not sell it. Sen. Lisa Murkowski, R-Alaska, who fought for the labeling language, said, "There's a question as to whether this fish should even be called a salmon. The FDA made no mandatory labeling requirement. Instead, they said it could be labeled voluntarily. But no manufacturer of a 'Frankenfish' is going to label it as such. ... At least now people will have the opportunity, the chance, to know what it is that they are purchasing."

More info
To schedule a talk on GMOs, Maire Ullrich, agriculture program leader at Cornell Cooperative Extension, Orange County, can be reached at:

-- (845) 344-1234

Tuesday, September 1, 2015

E-cigs: Way to quit smoking or new way to get hooked?

Addiction and Recovery
By Bob Gaydos

Is it a Catch-22 or a smoke screen? Are e-cigarettes the most promising product to come along to help smokers quit their nicotine addiction, or are they a clever, new way to get non-smokers hooked? Or, are they both?
At this point, no one can say for sure, but there appears to be an informal and growing consensus that electronic cigarettes represent a real health benefit for longtime smokers. That’s because e-cigs do not contain tobacco and the many harmful substances that are released and inhaled when cigarettes are smoked. At the same time, there is concern that too little is known about possible negative health effects on e-cig users and bystanders of chemicals that are released when their vapor is inhaled.
That is an important health issue, but the purpose of this column is to discuss addiction. In that regard, again because of the newness of the product, there is too little information to know if e-cigs, as widely touted, can actually help smokers break their nicotine addiction. Even more significantly, as the Food and Drug Administration says on its web site, “It is not known whether e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.”


As public health campaigns against tobacco products have
sharply reduced sales of tobacco products in the United States, e-cigarettes have quickly blossomed into a $2-plus billion industry that shows no signs of slowing down.
Cities and states have scrambled to pass laws regulating where e-cigs can be used. New York City bans using them wherever smoking is banned. (You must be 18 to buy them.) In an effort to provide uniformity to the law, the FDA is poised to extend some or all of its regulations for tobacco products to electronic cigarettes. That has a lot of smokers upset, saying the government shouldn’t make it harder for people trying to quit smoking by vaping -- the term for using e-cigarettes.
E-cigs use a battery to heat and vaporize nicotine that is mixed with water, flavoring and a base (two types) to carry the mixture. Unlike traditional cigarettes, cigars and pipes, there is no combustion -- the source for the health problems. For e-cig users, it’s more like inhaling fog, with a shot of nicotine (in varying doses), while enjoying the same hand-to-mouth, tactile experience of lighting up. Smoking without the smoke.
Again, that sounds like a sensible way to help longtime smokers avoid the serious health risks associated with using combustible cigarettes, while still getting their nicotine fix. It says nothing about that fix -- the addiction to nicotine. Some studies have raised concerns about the addictive power of the nicotine used in e-cigs, even at lower doses.
Meanwhile, many anti-smoking groups and health experts pose this question: If e-cigarettes are being sold as a way to reduce the harm of smoking tobacco for longtime smokers, why are they also being marketed in such a way as to attract thousands of young users who have never smoked traditional cigarettes? (It is worth noting that big tobacco companies are also big sellers of e-cigarettes.)
The fear, cited by the FDA as well as public health advocates, is that electronic cigarettes may act as a gateway product, luring young users into trying tobacco products.
A recent report in the Journal of the American Medical Association lends weight to that fear. The report noted that, in a recent study, 16 percent of 10th-graders reported using e-cigarettes. The study said that the group of teenagers included those who had smoked before (43 percent) and those who had not and that, in follow-up studies, the teens who had never smoked before were more likely to try smoking traditional cigarettes after trying e-cigs. Curiosity? Suggestibility? Peer pressure? Being a teenager?
Among those who suffer from it and those who treat it, there’s a saying: Addiction is a disease of more. In other words, if I can feel this good with just a little nicotine, how good can I feel with even more? Or, if this is such a cool experience -- making believe I’m smoking even though I’m not inhaling any nicotine -- how cool can it be with the real thing?
Sukhwinder Singh and his wife, Satnam Kaur, own Smokers Heaven, an e-cigarette shop in the Town of Wallkill in upstate New York. He says 75 percent of his customers are trying to quit smoking. “They’re trying to go from smoking thousands of chemicals, to one, nicotine.” He says many have been advised by their doctors to switch to e-cigs.
Singh says he only sells flavorings made in the United States (not China) because there are more controls on the ingredients, another concern for the FDA. “I don’t push nicotine on anyone,” he adds, saying that he tries to steer younger non-smokers who are curious about the product to non-nicotine mixtures. He and his wife sample the choices of hundreds of appetizing-sounding flavors -- without nicotine -- so they can tell their customers what they are like.
The fact that e-cigs are also cheaper than combustible cigarettes -- many more puffs per buck -- adds to the argument that they are a sensible, harm-reduction, health product.  But the FDA says there is as yet no proof of that. If they came under FDA control, e-cig makers would have to pass scientific muster to gain approval for sale. That could be expensive and time-consuming.
But even if producers eventually do offer scientific evidence of harm reduction, e-cigs are still delivery devices for a highly addictive substance -- nicotine. For this reason, the FDA is being urged, at the very least, to make e-cigarettes subject to the same regulations that prohibit companies from advertising and marketing tobacco products in ways designed to appeal to young consumers.
Are e-cigs safer for some? Maybe so. Time will tell. But even time won’t erase one question: If there’s no addiction to quit (no harm to reduce), why risk creating one?




E-cigarettes and the FDA
Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user. Most e-cigarettes are manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble everyday items such as pens and USB memory sticks.
Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research. Currently, the FDA Center for Tobacco Products regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.
FDA has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes.

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm




Wednesday, August 12, 2015

So, what does it mean to be labeled 'organic'?

The Healthy Shopper

By Bob Gaydos
Illustration of the USDA organic sealThe most important information on food product labels is in the fine print of the ingredients rather than in the big, splashy words used to sell the product. That has always been the case and today it’s truer than ever.  With major food companies trying to capitalize on the growing interest in eating healthfully, it is increasingly important for consumers to know what the words on the product really mean.
This series has discussed food labeled “gluten-free” and “natural” and the confusion built into such labeling by companies taking advantage of what many describe as nebulous FDA regulations.
Confusion also exists about the term “organic,” even though it has been around for a long time. In fact, until around the 1920s, all farming was organic, with farmers using strictly natural methods to treat the soil and to fight pests. With the introduction of industrialized farming -- notably the development of DDT after World War II as a means to control pests -- the widespread use of chemicals became the rule and organic farming the exception.
But today, DDT is banned and more than 40 million Americans say they buy organic food. Sales last year topped $40 billion, according to the Organic Food Industry, and the organic movement is growing steadily. Still, millions of shoppers remain unclear about why those products in specially designated sections of the supermarket are different from the rest. What makes them “organic” and why does it matter?
In this case, there is at least no official confusion. The U.S. Department of Agriculture has set specific standards for food to be certified “organic.”  Producers who sell less than $5,000 a year in organic foods are exempt from certification, but are still required to follow the USDA's standards for organic foods.
The standards:
  • Prohibit the use of chemical fertilizers, synthetic substances, irradiation, sewage sludge, or genetically modified organisms (GMOs) in production.
  • Prohibit the use of antibiotics and synthetic hormones in organic meat and poultry.
  • Require 100 percent organic feed for organic livestock.

The USDA currently allows foods that are “100 percent certified organic” (fruits, vegetables, eggs) to display the green USDA Organic seal. Use of the seal is voluntary, but its presence is key. It means the producing farm has passed muster from a trained inspector.
Food products that contain more than one ingredient (cereal, for example) may also use the seal if 95 percent of the ingredients are organic. Then the product may be labeled “organic.”
Products made with 70 to 94 percent organic ingredients may not use the USDA seal, but may say “made with organic ingredients.”
Whatever the percentage of organic food ingredients -- whether the product is labeled “100% organic,” “organic,” or “made with organic ingredients” -- none of the ingredients may be produced from genetically modified organisms. That means products “made with organic ingredients,” while only requiring 70 percent of the ingredients to be organic, must nonetheless be 100 percent non-GMO.
This is a key regulation today, with a major debate under way in Congress and many state legislatures on whether to require food producers to list genetically modified organisms on the label. That’s the subject of a future article.
It should also be noted that it’s not just a desire to avoid food that has been produced with the aid of chemicals that motivates many consumers today. Increasingly, more Americans are buying locally produced foods. The fruits, vegetables, eggs, beef, etc. go directly from local farm to local supermarket or kitchen table. This offers fresher foods while also using less fossil fuel for transportation. And the money spent at a local farmers market is more likely to stay in the community. A win/win/win situation.
But again, the key is to check for the green label. Not all food sold at farm stands or farmers’ markets is organically grown. If no label is shown and the vendor is advertising “organic” produce, ask to see the certification. It should be no problem.
Some people question whether eating organic is worth the added difference in price (largely a result of the government’s heavy subsidization of the conventional food system). That’s a personal decision. The goal of this series is to provide information to help shoppers make more-informed decisions on what they buy and what they eat.
In that regard, the facts are that: 1) food certified as organic must meet strict, transparent government standards (no chemicals, no hormones, no antibiotics, etc.); 2) more consumers are choosing to buy organic food every year; and 3) price is becoming less of a factor in making that decision.
Next: The debate over GMOs.

IMG_0461.jpg
Organic produce sections are growing steadily in supermarkets.
Photo by Bob Gaydos

Getting certified
A common perception among consumers is that organic farming is old school. Basic stuff. No artificial ingredients. Period.
Not really, says Liana Hoodes. “Organic farming today is definitely not your grandfather’s organic farming," says Hoodes. She says organic farmers today are using computers, new technology and new techniques to improve the quantity and quality of their products. She only wishes the USDA would provide more than 2 percent of its funds for research to speed the development of 21st Century organic farming.
Hoodes, of Pine Bush, is policy adviser to the Northeast Organic Farming Association and to the National Organic Coalition, an organization she helped found and which she served for years as executive director. The NOC is both an advocate for and a watchdog to protect the integrity of organic farming. NOFA certifies organic farmers.
Certification does not come easily. A farmer must lay out a plan, with maps of every field, every year. Crops must be rotated. Changes must be noted. Materials used must be USDA-approved. A yearly inspection by an independent inspector must be passed.
Hoodes says there’s not a lot of cheating going on among farmers looking to get the green USDA seal and the inspectors are good at spotting those few who do try. For example, an inspector might see some blue barrels tucked behind a barn, the kind of barrels chemicals come in. Or, the cows at a dairy farm may not look so healthy. A request to use the bathroom in the house provides an opportunity to discover antibiotics prescribed by a veterinarian, obviously not intended for humans and prohibited for organic cattle.
Even on non-scheduled inspection days, the farms are under scrutiny. One inspector wondered how a field full of weeds could produce so many organic tomatoes. A surprise check of the property revealed the “farmer” was buying boxes of tomatoes at the supermarket and selling them as organic.
While such behavior may be uncommon among organic farmers, a food industry that promotes itself as imposing strict, transparent standards needs to live by those standards. That’s why the USDA seal is stressed by organic producers.