Archives for posts with tag: FDA

According to the Consumer Reports, they may have found some level of arsenic in rice and rice products. In their study, 223 samples of various rice products were tested for arsenic. The samples were localized; store bought items from New York metropolitan area and even online retails. The test results showed that brown rice yielded more arsenic than the white rice. Even though brown rice has a higher nutritious value than white rice, its finding of having higher arsenic levels in brown rice is no surprise. Manufacturing white rice is by removing the outer layer, which may be highly concentrated with arsenic, then the rice is polished to produce the white, pearl-like color which may aid in reducing the arsenic levels. The brown rice retains the outer layer which may be concentrated with arsenic therefore finding that brown rice resulted significantly higher in arsenic levels than white rice. – Consumer Reports 

You can read more about their complete results and findings at their website via PDF file.

The purpose of Consumer Reports finding is to reduce the levels of arsenic in rice and other rice products. Also, the scientists are asking for the following:

  • The EPA should phase out use of pesticides containing arsenic.
  • The USDA and the EPA should end the use of arsenic-laden manure as fertilizer.
  • The FDA should ban the feeding of arsenic-containing drugs and animal byproducts to animals.

DNJ (A Gannett Company) – Reported by Pettus Read titles the article “READ: No need to panic about arsenic in rice supply.” The writer starts the report by reminiscing his childhood eating habits where he was frequently told to finish everything off his plate. He notes that the media is often frenzy “over carcinogens and other chemicals in the foods we consume, without real cause for alarm….  In fact, there are large numbers of carcinogens in every meal we eat, all perfectly natural and traditional, making no human diet completely free of these elements.” The writer also briefly explains the Consumer Reports findings of arsenic in rice. He then refers to 1958 when Congress passed a law to eliminate carcinogens in food products. He further explains that carcinogen tests have been studied with laboratory animals to parallel to the human body. As he finishes the report, leaves the readers to think about how “It is important that we all become educated consumers and dismiss the “carcinogen of the week” scare that is media-hyped. Rather we should study our lessons and recognize the fact that many times all the facts are not reported.”

Huffington Post – Reported by Maria Rodale and written by Sonya Lunder and Dawn Undurraga, of Environmental Working Group. A picture of bowl of rice is at the beginning of the report. The writers state that there are reports from “… U.S. Food and Drug Administration (FDA) and the highly regarded Consumer Reports magazine, and both focused on the worrisome amounts of arsenic in rice and popular rice-based processed foods.” The report is titled “10 Ways to Get Arsenic Out of Your (and Your Kids’) Diet.” Just as the title suggests, the writers list 10 directional ways to reduce and to eliminate arsenic levels. The very first is to limit rice intakes, and suggest other grain items. The remaining nine other items can be found at the website.

Metro – New York – Interview with the registered dietitian Rachel Begun, M.S., R.D.; The report is an interview with the news reporter and the registered dietitian. Rachel Begun briefly summarizes that the Consumer Reporters found arsenic levels in rice. When asked if consumers should stop consuming rice and if there are safer ways to incorporate rice into our diets, she answered “…Eat a balanced diet that includes a wide variety of foods, including a variety of whole grains. This ensures adequate intake of nutrients while minimizing the risk of potential harm from any one food….”

Associated Press – The news report states its findings from the Consumer Reports and also quotes the FDA Commissioner Margaret Hamburg in which she suggests that “…consumers shouldn’t stop eating rice, though she does encourage a diverse diet just in case.” It ends the report with a statement from Professor Jaymie R. Meliker of Stony Brook University that “it’s [arsenic] all a matter of moderation. …In general, in life, you shouldn’t stand out in the sun eight hours a day,” he said. “You shouldn’t eat rice exclusively every meal. You should introduce variety in your diet because there are contaminants in everything. Nothing is completely safe.”

FDA has Q & A layout in their analysis of arsenic in rice and rice products. One of the important things to focus is that they do not agree or disagree with Consumer Reports finding. However, the FDA does state that their preliminary testing is consistent with the Consumer Reports study.

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On June 27, 2012, the Food and Drug Administration submitted a press release for the approval of Belviq (lorcaserin hydrochloride); a drug administered for those with a body mass index (BMI) of 30 or greater, or a BMI of 27 or greater with a weight related problem such as hypertension, type 2 diabetes, or high cholesterol.

The FDA approved drug is to help manage weight problems and is to be used as a supplement in addition to a healthier diet and exercise.

“The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.” – Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research

According to the FDA, there have been three separate experiments conducted in order to research the safety and the efficacy of Belviq. For those who have been treated with Belviq for up to one year have experienced an average weight loss of 3 to 3.7 percent. This drug is not recommended during pregnancy and lists several side effects along with the usage of Belviq.

How Belviq works is by manipulating the serotonin receptors in the brain; specifically activating the serotonin 2C receptor (5-HT2CR). FDA states that the reason why Belviq is constructed to activate this specific receptor is that it “may help a person eat less and feel full after eating smaller amounts of food.” The neurotransmitter serotonin is well known for its key role in maintaining “energy homeostasis” (Marston & Heisler, 2009). In previous research, manipulating the activation or K/O (knock out) of the serotonin receptors in rats, specifically the 5-HT2CR, demonstrated that weight was indeed affected. By inactivating the gene for 5-HT2CR, it “produces hyperphagia and obesity in the mouse (Tecott et al, 1995)” Also by K/O of 5-HT2CR created a blunted response of fenfluramine production which is important in the production of serotonin neurotransmitters (5-HT).

  • On a side-note, neurotransmitters (serotonin) can be analogous as a “key” to one specific lock on a door.
  • A receptor (serotonin receptor) is similar to a “lock” on a door.
  • The door, which separates things from the inside to the outside has to be opened with the right key, unlocking the lock, allowing “things” to be produced and released in/out.
  • Serotonin receptors modulate and influence various biological responses such as anxiety, appetite, mood, sleep, and others. Serotonin receptors are a target of releasing different neurotransmitter which can either excite or inhibit neurotransmission (brain signals).

“Together, these data indicate that the 5-HT2CR is an attractive and tractable potential drug target for the treatment of obesity and/or type 2 diabetes” (Marston & Heisler, 2009).

In result, activating the receptor which allows for the release of serotonin, allows for the brain to be manipulated into “thinking” that a person is full faster. However, it is always tricky to manipulate one specific receptor because there could be unknown side-effects if accidentally interfering with other serotonin receptors. But that is why there are researchers and scientists who investigate those roles.

Yahoo News – Yahoo provides an informative Q & A of the new drug. It lists the reasoning behind why the FDA approved a new anti-obesity drug and how it works. It also provides the readers the biological explanation of how the drug works in response to the activation of serotonin receptor in the brain.

CBS News – There is a video introducing the news report of a woman named Lisa Sutter who participated in a clinical trial of Belviq. The video claims that she has lost approximately 40 pounds which is almost 20% of her body fat in one year. However, she has regained all the lost weight once the clinical trial was over and stopped taking Belviq. In a text report, CBS also provided the fact that FDA had  initially rejected Belviq in 2010. More interestingly, the comments on CBS news are overwhelmingly against the FDA and of its approval for Belviq. Several of the comments are ridiculing the FDA but also providing helpful weight managing tips to other readers by suggesting that they reduce their caloric-intakes and exercising.

Washington Post – Providing a similar video segment from CBS News. Statement such as “…tumors in animal study” could be scary to the viewers.

International Business Times – Below is a video introducing the new anti-obesity approved drug from IBTimes.

References – Marston, O. J., & Heisler, L. K. (2009). Targeting the serotonin 2c receptor for the treatment of obesity and type 2 diabetes. Neuropsychopharmacology,34, 252-253. doi: 10.103

U.S. Food and Drug Administration provides an online search engine for every approved drugs since the 1939. It is called Drugs@FDA. Anyone with access to the internet can search the details of his or her medication. The listed are the following features to the search:

  • Labels for drug products
  • If there are generic drug products for an innovator (“brand name”) drug product
  • Therapeutically equivalent drug products. Drug products that are therapeutically equivalent control a symptom or condition in the exact same way as another drug product.
  • Consumer information for drugs
  • All drugs with a specific active ingredient
  • The approval history of a drugs, including approval letters and review documents

(FDA)

Are you currently on any medication? Do you know the active ingredient of your drug? Check out Drugs@FDA and find out for yourself!

Search engine for approved drugs since 1939.

“Woman dies after drinking 10 liters of Coke a day,” is one of the featured stories in the Health section of Fox News (April 19, 2012). 

This immediately caught my attention. A woman named Natasha Harris, 30, from New Zealand, a mother of eight children, died from consuming 10 liters of coca-cola every day. As you read the article, you could be slightly convinced that all soft drinks are detrimental to your health. Dr. Dan Mornin, pathologists, estimated that Harris had developed severe hypokalemia due to her “excessive consumption of soda.”

  • Hypokalemia is a metabolic disorder resulted from low levels of potassium in the blood

Dr. Mornin also stated that “…she died from cardiac arrhythmia, and that her soft drink habit, along with poor nutrition and too much caffeine, contributed to her death” (Fox News, April 19).

It was just a month ago when an organization, Center for Science in the Public Interest (CSPI), wrote a letter to the Food and Drug Administration to ban the use of caramel coloring agents containing harmful chemicals such as 4-methylimidazole in soft drinks such as Coca-Cola, Pepsi-Cola, Dr Pepper Snapple Group, Dr. Pepper, and Whole Foods’ 365 Cola” (Reuters – reporter Anna Yukhanaov, March 6).

(CSPI petitioned against allowing the use of caramel food coloring containing 2 or 4-methylimidazole to the U.S. FDA.)

According to the FDA spokesman Doug Karas, “A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents.” – Reuters

This “study” can be read in this scientific research paper, “Toxicity and Carcinogenicity Studies of 4-Methylimidazole in F344/N Rats and B6C3F1 Mice,” written by P.C. Chan, G.D. Hills, G.E. Kissling, and A. Nyska.

Through research and investigation using rodents, “4MI is carcinogenic inducing alveolar/bronchiolar adenoma and carcinoma in male and female mice. 4MI may also induce mononuclear cell leukemia in female rats.”

  • adenoma = benign, tumor
  • carcinoma = malignant, cancerous cells
  • mononuclear cell = white blood cells with one-lobed nucleus
Reported in NPR news, “The Center for Science in the Public Interest petitioned the U.S. Food and Drug Administration to ban ammonia-sulfite caramel color….”
 “This is nothing more than CSPI scare tactics, and their claims are outrageous.” -American Beverage Association (NPR, March 7)

“We did have to change these various inputs of temperature, pressure and the various ingredients we’re using in order to change [4-MI concentrations].” -Ted Nixon, CEO of D.D. Williamson (Supplier of caramel color) –NPR, March 7

There are news floating around that coca-cola or the consumption of caramel coloring is hazardous to our body. However, as FDA mentioned in a press release, a person would have to consume a large amount of soda or 2 or 4-MI, in order to show direct effect to the human body.

Dr. Dan Mornin (pathologist of the deceased Natasha Harris, 30 year old female) also stated that “…it was difficult to confirm this [severe hypokalemia] from post-mortem tests, it was consistent with her symptoms of tiredness and lack of strength and other cases of heavy soft-drink consumers, and it was likely her daily vomiting was due to too much caffeine, medically known as caffeine toxicity.” (Otago Daily Times, April 19)

Woah. What is that?

This is a chemical called Roxarsone. It is also commonly known as arsenic-based chemical which is often used in chicken feed to prevent coccidiosis. But it can also be found in other live stock’s feed as well. Roxarsone is most commonly used in chicken feed to inhibit coccidiosis but also to promote growth and stimulate color in poultry meat.

” Coccidiosis is a parasitic disease that infects the intestinal tracts in poultry and can lead to death in poultry.”  –FDA (Product Safety Information)

On June 8, 2011, FDA issued a press release stating that “Pfizer will voluntarily suspend sale of animal drug 3-Nitro.”

“FDA study of 100 broiler chickens that detected inorganic arsenic, a known carcinogen, at higher levels in the livers of chickens treated with 3-Nitro compared with untreated chickens. FDA officials stress that the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro is suspended from the market does not pose a health risk.” FDA Press Release (Stephanie Yao)

This was less than a year ago and now Maryland will be the first state to ban arsenic in chicken feed.

According to reporter Darryl Fears of the Washington Post, “Growers in Maryland, particularly on the Eastern Shore, continued to use stockpiles of the feed after Pfizer suspended it, feeding about 3 million chickens per year, according to Hucker and one of the bill’s supporters, Food & Water Watch.” 

FDA however assures the public that “…the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro® is suspended from the market does not pose a health risk.”  –FDA

Arsenic is dangerous if it is consumed in an inorganic form, which is potentially cancerous. However, the approved 3-Nitro (Roxarsone) arsenic is in its organic compound. Both organic and inorganic arsenic are naturally-occurring chemicals. They can be found in water, soil, and air. Many argue that chemicals that we breathe in and even the water we drink could be potentially cancerous and dangerous to our health.

“Banning roxarsone in chicken feed would not eliminate all arsenic from chickens or the environment…But banning the additive in feed would eliminate a substantial portion of arsenic from the human food chain and some of the arsenic in drinking water.” –Chemical & Engineering News (April 9, 2007)

Check out these two different, opposing opinions. What do you think?

“What does all this mean for consumers? The study looked only at feathers, not meat, so we don’t know exactly what chemicals reach the plate, or at what levels…My take is that the business model of industrial agriculture has some stunning accomplishments, such as producing cheap food that saves us money at the grocery store. But we all may pay more in medical costs because of antibiotic-resistant infections.” – Arsenic In Our Chicken? by Nicholas D. Kristof

“So why all the hullabaloo? Most likely because arsenic, like the ammonia-infused pink slime recently exposed in school and grocery store hamburger meat, does not sound like something we’d like to eat…But every substance is poisonous in the right dose – even water.” – Arsenic In Chicken, or Just Feathers? by Paul Frysh

The U.S. Food and Drug Administration issued a statement on April 3, 2012 warning the public and medical practices of the purchased counterfeit drug, “Altuzan.”

“Medical practices that purchase and administer illegal and unapproved foreign medications are putting patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous.” –FDA

Key information about Avastin and Altuzan:

  • They are both the “same” drug; contains the same active ingredient (Bevacizumab) – FDA Drug Report
  • Avastin is the FDA approved brand name drug containing the active ingredient. Altuzan is the brand name drug of Avastin in Turkey.
  • “The only Avastin that can be legally purchased by wholesalers in the United States is FDA approved Avastin manufactured by Genentech.” – Charlotte Arnold (Associated Press reporter Matthew Perrone via The Examiner)
  • “Avastin is a prescription-only medicine that is a solution for intravenous infusion.” – Genentech
  • Intravenous infusion – a method in which a drug is administered directly into the vein using a syringe to slowly inject the medication with a combination of fluid. This other “fluid” administered with the drug is usually an electrolyte solution. This is one of the most effective ways to deliver a drug or chemical into the body because the drug is administered straight into the bloodstream and most likely travel rapidly to the brain.
Avastin is an effective drug that can tremendously help save cancer patients. However, FDA issued a report recently of finding fake Avastin, named under the Turkish name, Altuzan, circulating within the medical practices in the United States. According to report from CBS News Armen Keteyian, “As many as 19 medical practices in the U.S. purchased a version of Avastin that turned out to be from outside this country and contained no active ingredients. Some vials had little more than salt and starch.”
How could fake drugs enter the United States so easily and potentially create danger to already vulnerable patients?
“According to British authorities, 82 of the counterfeit vials were shipped to the U.S. by River East Supplies, located in the U.K. and owned by Canadian businessman Tom Haughton. Haughton is currently under federal investigation for shipping counterfeit Avastin into the U.S., offering Avastin for about $2,000 a vial — some $400 less than the manufacturer’s price.” – CBS News
“U.S. practices bought Altuzan and “other unapproved products” from foreign sources, particularly Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), the agency said.” –USA Today
 According to my readings, the mass media reported accurate information concerning about the fake cancer drug, Avastin. The press release and safety reports about fake Avastin was issued from FDA on April 3rd.
Check out the video below from CBS News for a summary report of the fake cancer drug.

CBS News
http://cnettv.cnet.com/av/video/cbsnews/atlantis2/cbsnews_player_embed.swf

Reporter Susan Jones from CNS news writes, that “The law said all cigarette packages must carry one of the nine new warnings starting in September 2012.”

I then checked the U.S. Food and Drug Administration website to see that they have listed a timeline of when they think this law can be implemented.

“September 22, 2012* – Cigarettes for sale or distribution in the United States can no longer be manufactured or advertised without the new cigarette health warnings” —FDA

But wait, did you see the asterisk next to the date? Clearly, I have overlooked at the little “star” that is next to “September 22, 2012*” From my previous post and from several other news such as Thomas Reuters, I had undeniably overlooked at the asterisk on the FDA website.

*The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir.).

The date is uncertain because of the continuous battle between the tobacco companies and FDA. Reporter Brett Norman from POLITICO states that “The Justice Department has appealed both rulings, and oral arguments on the injunction are scheduled for April 10 before the D.C. Court of Appeals.”

Cincinnati Federal Appeals Court ruled on March 19th that warning labels on cigarette packages does not violate the U.S. Constitution’s free speech reported by Bloomberg and TIME. You can also read about it in Joe Palazzolo’s blog (The Wall Street Journal).

The U.S. Food and Drug Administration announces that starting in September of 2012, the FDA will be allowed to post warning labels by printing pictures onto the cigarette packages. You can view the final selection of nine images on the FDA website that will be soon to be seen on cigarette packages starting September this year.

In order to refresh your memory about cigarette warning labels, check out the video posted below for a quick summary of what the U.S. Food and Drug Administration is trying to accomplish. This youtube video is presented by Associated Press. The content of the video is informative and correctly outlines the beginning stages of implementing warning labels on cigarette packages. You can also refer to one of my first posts about the warning labels HERE.

Now that you have a general idea of what the Food and Drug Administration is trying to accomplish, the video below is another brief clip reported by NewsyScience in regards to the current situation of the warning labels. The NewsyScience youtube channel accurately describes and informs the viewers the present state of what is happening to the warning labels. The proposed idea of printing gruesome images onto the cigarette packages was blocked by U.S. District Judge Richard Leon in District of Columbia on February 29, 2012,. He explains to TheHuffingtonPost that “federal mandate to put the images, which include a sewn-up corpse of a smoker and a picture of diseased lungs, on cigarette packs violates the free speech amendment to the Constitution.” However, this case is being pending before the U.S. 6th Circuit Court of Appeals in Cincinnati.

The graphic warning labels on cigarette boxes the FDA had proposed is still a hot topic within the media and in particularly within the local media. Let’s examine the three local news coverage just in the month of November.

An editorial, “Gross is good,” published in Buffalo News is in favor of the proposed graphic warning labels on the cigarette packages. The article explains that this is necessary in order to reduce the bad smoking habits in America. This idea can be clearly seen just by the title. The first sentence begins by giving their negative views on cigarettes in general. The editorial continues with the skepticism by criticizing how ineffective the current warning labels on the cigarette boxes. The article explains that even our neighboring country, Canada, has graphic warning labels on their cigarette packages. Several other countries have followed their footsteps because of the positive results that they have observed in encouraging smokers to be cautious of their addiction. The article fully supports the labels and even says that the United States has some catching up to do compared to the other countries in promoting the warning labels positively but effectively in order to reduce the increasing number of tobacco smokers.

Reported from Richmond, VA, WSOCTV has an article on their website titled, “Feds Proposes Graphic Cigarette Warning Labels written by an Associated Press tobacco writer Michael Felberbaum. To point out few of things I’ve noticed in this article is that the writer has embedded a video for the readers to easily have the access to the pictures of the cigarette boxes with graphic warning labels on them. Right below the video, the writer provides other related stories and links such as a slideshow of the pictures of the proposed warning labels, national smoking rates, and etc. As Buffalo News has mentioned (paragraph above), writer Michael Felberbaum also agrees that the warning labels will help reduce the numbers of smokers. He also gives additional evidence that the pictures will have a strong impact on the consumers by quoting a credible source such as David Hammond. He is a behavior researcher in Canada who also helps the FDA with designing their warning labels. This is very important that the writer cited a credible source in convincing the readers that the change committed by the FDA is a good thing.

The Columbus Dispatch presents similar news written by Bill Bush titled “New cigarette warning labels to be graphic.” The idea and the tone of the article is very similar to the two previous local news coverage discussed above. However, an interesting thing to notice in this particular report is that writer Bill Bush uses the local’s opinions to support his favorable views on the warning labels. Instead of citing credible sources such as researchers or government officials, the writer interviews the local people about their views on the warning labels of cigarette packages. He interviews a select range of people: a working class male on his usual smoke break, owner of an advertising company, and even the owner of a tobacco shop. He uses the opinions of the people in his report in order to get the message across to the readers that “everyone else” is agreeing to the warning labels and that it is normal to do so.

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