Monday, October 15, 2018

Liver Cancer Treatment Paradigm Undergoing Major Overhaul

Liver Cancer Treatment Paradigm Undergoing Major Overhaul
Christine Lehmann, MA
Published Online: Oct 15,2018

Until recently, few systemic therapies had been approved for the treatment of patients with liver cancer, as few agents could demonstrate significant benefit over placebo. Sorafenib (Nexavar) was the first systemic therapy that extended median overall survival (OS) over placebo by nearly 3 months (10.7 versus 7.9 months),1 and, in December 2007, it became the first systemic therapy approved by the FDA for patients with unresectable hepatocellular carcinoma (HCC).

Read the article:

Blog & News Updates: Link between viral hepatitis and liver cancer?

Save The Date
October 16th, 3 p.m. EST
In honor of Liver Cancer Awareness Month we have a few news and blog updates to share with you. On Tuesday, October 16th, join Hepatitis B Foundation for a Twitter chat to discuss the link between hepatitis and liver cancer. Representatives from Hepatitis B Foundation, CDC’s Division of Viral Hepatitis, and NASTAD will co-host the chat at 3 p.m. EST.

In addition check out this years Liver Cancer Awareness Campaign aimed at encouraging individuals with an increased risk for liver cancer to receive ongoing screening, launched by the American Liver Foundation (ALF) and Bayer Healthcare. Find out if you're at risk for liver cancer.

October 23, 2018 2:00 p.m. to 3:00 p.m. EST 

Webinar
Timothy M. Block, Ph.D.President and Director, Baruch S. Blumberg Institute and the Hepatitis B Foundation
Read More

November 29, 2018 (1:00-2:30 pm ET)
Strategies to Eliminate HCV in Veterans Webinar November 29
Join NVHR on November 29, 2018 (1:00-2:30 pm ET) for a webinar to discuss how government and community organizations are working to treat Veterans living with hepatitis C.
Read More

Blog & Journal Updates Around The Web
Oct 15, 2018 
Liver Cancer Awareness Month
• By Lucinda K. Porter, RN
While the incidence of most cancers are declining in the United States, the rate of hepatocellular carcinoma (HCC or liver cancer) is increasing. More than 40,000 people in this country will be diagnosed this year with primary liver cancer, facing a 5-year survival rate of only 18 percent. According to the National Cancer Institute, liver cancer is the fifth leading cause of cancer death. Worldwide, it is the second leading cause of cancer death.
Read More

Oct 14, 2018
VA Continues Hepatocellular Screening, but Study Questions the Value
by Annette Boyle 
SAN FRANCISCO—Although a recent study determined that screening veterans with cirrhosis for hepatocellular carcinoma did not reduce the risk of death associated with liver cancer, the VA has no plans to change its screening practices.

“The VA currently follows the American Association for the Study of Liver Diseases (AASLD) guidelines for HCC screening among patients with cirrhosis,” explained Maggie Chartier, PsyD, MPH, the VA’s deputy director of HIV, Hepatitis and Related Conditions and associate professor at the University of California, San Francisco. The AASLD recommends screening patients with cirrhosis for HCC using ultrasound (USS) with or without serum alpha fetoprotein measurement every six months
Read More

Oct 10, 2018
..positive impact on HRQoL with improvement in mobility, pain/discomfort, anxiety/depression...

Oct 9, 2018
Paul E. Sax, MD
There’s so much going on no one can cover it all, certainly not me. So here’s a sampling of some (emphasis on some) of the interesting research presentations from last week, a “Mini” Really Rapid Review™ of the conference. Use the comments section to chime in with your favorites.

Oct 9, 2018
What support do people with liver cirrhosis and their families need?
People with liver cirrhosis and their families need more information about their condition and prognosis and greater access to palliative care, a systematic review of studies on the needs of people with cirrhosis of the liver has concluded.

Oct 9, 2018
Malnutrition decreases quality of life, social function in cirrhosis
PHILADELPHIA — Malnutrition as measured by subjective global assessment correlated significantly with decreased health-related quality of life in patients with…

Do you know that the liver doesn’t have any nerve cells? Here are some facts about this amazing organ in honor of Liver Awareness Month...

Alcohol and Increased Cirrhosis-related Deaths
Many of us are well aware that excessive (particularly long-term) consumption of alcohol is not good for our body — and is especially not friendly to our liver. But a newly published research study might very well convince us that the effects of alcohol on our liver health are even worse than we may have initially imagined. What’s the sobering research finding? The likelihood that increased cirrhosis-related mortality rates from 1999 to 2016 may be due to alcohol abuse and alcohol-induced liver disease...

Hepatitis C affects more than just the liver- it can affect many parts of the body, and mental wellbeing... 

Stress is not good for any of us, it can lead to serious health issues and depression. Stress is the..

In a pilot study from the October issue of Clinical Gastroenterology and Hepatology, colony stimulating factor 3 (CSF3, also called GCSF) improved liver function and increased survival times in patients with severe alcohol-associated hepatitis (AH), compared with standard therapy. Addition of N-acetyl cysteine (NAC) to GCSF did not improve patient outcomes... 

To all of you with gluten intolerance, first, let me say: I’m sorry. You’re looking for good food for celiac and liver disease. I worked in the kitchen and saved my life with The Liver Loving Diet, I had no idea what celiac was....

In The News
HepCBC - Weekly Review
Here's the latest issue of the Weekly Bull.

Oct 15, 2018
Liver Cancer Treatment Paradigm Undergoing Major Overhaul

Oct 15, 2018
Study Casts Doubt on Connection Between DAAs and Liver Cancer Risk
“There are no significant differences between DAA regimens in HCC risk after antiviral treatment,” concluded the authors, led by Elijah J. Mun, MD, of the University of Washington.

Oct 10, 2018
Hepatitis C - Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV
PHILADELPHIA – The direct-acting antiviral Vosevi demonstrated an average sustained virologic response rate of 87% among patients who were “triple-infected” with hepatitis C genotype 3, hepatitis B and HIV, as presented at the American College of Gastroenterology Annual Meeting.

By Nguyen Quy October 8, 2018 
A report by the World Cancer Research Fund International, a leading organization on cancer-prevention research related to diet, nutrition and physical activity, ranks Vietnam fourth among 25 countries with the highest rates of liver cancer this year. The report is based on the latest statistics from Globocan, an interactive web-based platform with cancer statistics from 185 countries....

Mass. General-led study supports ability of regular aspirin use to reduce liver cancer risk
The results of a study led by Massachusetts General Hospital (MGH) investigators support evidence from previous studies suggesting the regular use of aspirin can reduce the risk of developing primary liver cancer – also called hepatocellular carcinoma (HCC). Their report analyzing data from two long-term epidemiologic studies appears in JAMA Oncology and finds that regular aspirin use – taking two or more 325 mg tablets a week for five years or more – led to a significantly reduced risk of developing HCC, which is the second leading cause of cancer death worldwide...

"Compelling" evidence of link between aspirin use, lower hepatoma risk
NEW YORK (Reuters Health) - Regular, long-term use of aspirin is associated with a reduced risk of developing hepatocellular carcinoma (HCC), according to pooled data from more than 133,000 people. "Animal studies have shown that aspirin can block primary liver cancers from developing. Although these studies have been promising, data in humans have been limited," said Dr. Andrew Chan from Massachusetts General Hospital, in Boston.

Scientists use CRISPR to treat genetic liver diseases in neonatal and adult mice
by Arlene Weintraub
The newest issue of the journal Nature Medicine features two animal studies that show progress is being made towards achieving the holy grail of gene editing: the ability to prevent or treat diseases that are caused by gene mutations. In both cases, the researchers used modified versions of CRISPR-Cas9, the most commonly used gene-editing system.

Recommended reading

Evidence does not support statin use for conditions other than heart …
Despite studies suggesting benefits for conditions beyond cardiovascular disease (CVD), the evidence does not support revising current statin …

Early liver disease detection during pregnancy key for improved outcomes
October 7, 2018
PHILADELPHIA — Early detection of liver-related complications and hepatic diseases in patients who are pregnant leads to reduced risks and improved outcomes for…

NAFLD has ‘bidirectional’ course in patients with type 2 diabetes
October 8, 2018
PHILADELPHIA – Nonalcoholic fatty liver disease may have a “bidirectional” nature in patients with type 2 diabetes as NAFLD regressed in 2.2% of patients without any NAFLD-specific interventions despite increase in the prevalence of risk factors, according to a presentation at the American College of Gastroenterology Annual Meeting.

Obesity, Weight Gain Linked to Fibrosis Progression in NAFLD
Medscape Medical News 
October 4, 2018
Obesity and weight gain are independently associated with an increased risk for fibrosis progression in patients with nonalcoholic fatty liver disease (NAFLD), a large cohort study has found. Weight loss was negatively associated with fibrosis progression...

At-Risk Teens and Young Adults Overlooked During Opioid Crisis Too Few Tested for Hepatitis C, Research Suggests 
SAN FRANCISCO – Teens and young adults who have injected drugs are at risk for contracting hepatitis C, but most aren’t tested and therefore don’t receive life-saving treatment, according to a national study being presented at IDWeek 2018. The study of more than 250,000 at-risk youth found only one-third of those with diagnosed opioid use disorder (OUD) were tested for hepatitis C...

NEW YORK (Reuters Health) - The risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB) treated with tenofovir is lower than in those treated with entecavir, according to a nationwide study from South Korea. "Patients with CHB have about 1% risk of developing HCC," Dr. Young-Suk Lim from the University of Ulsan College of Medicine, in Seoul, told Reuters Health by email. "Once diagnosed with HCC, the overall prognosis of the patients is very poor, with 5-year survival rate of less than 30%. Therefore, prevention of HCC is of utmost importance in the management of CHB patients."

Healthy You
October 13, 2018
Dietary Supplements Can Contain Viagra, Steroids, or Worse
October 13, 2018
You know those sexual enhancement dietary supplements for sale at gas stations and markets across the country? Beware, they might actually be viagra. Or steroids. Or an antidepressant. Many supposed dietary supplements for weight loss, erectile dysfunction, and muscle building may contain actual pharmaceuticals—but you likely have no way of knowing what's in them...

October 13, 2018
Weekend Reading - Baby Boomers and the Flu
Did you know that you are more susceptible to flu-related complications if you're over 65, living with chronic liver disease, or viral hepatitis?

Recommended Reading
How Many Cases of Drug-Induced Liver Injury Are Caused by Herbal and Dietary Supplements?
September 2018
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses
Read more

Recent Updates
Online learning activity
Screening and Diagnosis of Hepatitis C Infection
Topics; HCV Transmission FAQs, Risk Factors for Acquiring HCV, HCV Disease Burden and more...

Twitter Updates
Open To All
Watch the open access webcasts from #EASL #NAFLDsummit on : https://bit.ly/2NsZkzZ 

Check back for updates!
Tina

Study Casts Doubt on Connection Between DAAs and Liver Cancer Risk

Study Casts Doubt on Connection Between DAAs and Liver Cancer Risk
OCTOBER 15, 2018
Jared Kaltwasser

“There are no significant differences between DAA regimens in HCC risk after antiviral treatment,” concluded the authors, led by Elijah J. Mun, MD, of the University of Washington.

The finding is significant because it suggests that hepatocellular carcinoma risk does not need to be a determining factor in which DAA a physician prescribes. However, the authors say the takeaway from the study can extend even beyond the question of whether any particular DAA therapy is worse than another when it comes to cancer risk. They argue their study suggests DAAs broadly don’t increase the risk of hepatocellular carcinoma

On This Blog
Sift through current Liver Cancer and Hepatitis C research articles

Liver Cancer After Treatment For Hepatitis C:
Research demonstrates that while SVR markedly reduced liver-related complications and liver cancer, some long-term risk for liver cancer remained in those who were cured of Hepatitis C. But after direct-acting antiviral therapy does the risk of developing liver cancer increase? Research is saying no, check out an index of articles here..... 

Saturday, October 13, 2018

Weekend Reading - Baby Boomers and the Flu



Baby Boomers and the Flu 
Did you know that you are more susceptible to flu-related complications if you're over 65, living with chronic liver disease, or viral hepatitis? Yep, I knew it too. 

Currently information on this blog is aimed at people living with or treating hepatitis C, for the most part that is the baby boomer generation; born between 1946 to1964. 

Speaking of baby boomers, if you haven't read the CDC's eye- opening report on last years flu season, it was reported 80,000 flu-related deaths occurred in the US, the highest in 40 years. The death rate among young baby boomers, aged 50 to 64 were shocking as well; 
"Death rates were highest in the over-65 age group, which is typical, but the second most affected group comprised those aged 50 to 64 years old; normally, the second highest death rates occur in children, from birth through age 4 years. The ferociousness of the flu season overall, combined with above-average impacts on younger baby boomers, made 2017-2018 one for the record books."

Liver Disease & The Flu
As we age our immune system is less effective in fighting infections, and new infections can have a severe impact on the liver. This can be especially serious for liver transplant recipients and people who have cirrhosis. Flu-related complications could develop into bronchitis or pneumonia, which in rare cases can also be fatal.

Even though the flu vaccine won’t keep everyone from getting sick, it helps prevent serious flu complications. For instance people over 65 who were vaccinated had a lower rate of flu-related death, according to a 2017 study, found on the CDC's website.
"Flu vaccination reduced deaths, intensive care unit (ICU) admissions, ICU length of stay, and overall duration of hospitalization among hospitalized flu patients; with the greatest benefits being observed among people 65 years of age and older."
In The News
Last Year, The Flu Put Him In A Coma. This Year He's Getting The Shot
October 14, 2018
"I figured [the flu] was something that's dangerous to the elderly and the young, not somebody who is healthy and in their 30s," says Hinderliter, who is 39 and the director of government affairs at the St. Louis Realtors association
"Turns out, I was wrong," he says
Read the article, here.....

Should I or Shouldn't?
September 27, 2018
"People say they never had the flu until they got the shot. That argument doesn’t hold water. Either you got your shot too late, you got a strain of the flu that isn’t covered by the vaccine, or you had a one-day immune response which may make you feel like crap for the day, but isn’t anywhere like having the flu. If you are over 65, high dose flu shots are recommended, and some people feel a bit low and fluish the next day. This is not the flu – it is an immune system reaction"
Read the article: The Flu Shot Debate, written by HCV advocate Lucinda Porter.

CDC Information
People 65 years and older should get a flu shot and not a nasal spray vaccine.
They can get any flu vaccine approved for use in that age group with no preference for any one vaccine over another. There are regular flu shots that are approved for use in people 65 and older and there also are two vaccines designed specifically for people 65 and older:
High Dose Flu Vaccine:
The “high dose vaccine” contains 4 times the amount of antigen as a regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production). Results from a clinical trial of more than 30,000 participants showed that adults 65 years and older who received the high dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose flu vaccine. The high dose vaccine has been approved for use in the United States since 2009.
Learn more about high dose flu vaccine here.

Adjuvanted Flu Vaccine:
The adjuvanted flu vaccine, Fluad, is made with MF59 adjuvant an additive that creates a stronger immune response to vaccination. In a Canadian observational study of 282 people aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots. There are no randomized studies comparing Fluad with Fluzone High-Dose. This vaccine was available for the first time in the United States during the 2016-2017 season. Learn more about adjuvanted flu vaccine here.

For Adults with LIVER DISEASE: Important information about a dangerous infection
If you have chronic liver disease, you are more likely to have serious complications if you get pneumococcal disease

Get pneumococcal vaccines 
People who are 65 years of age and older should also be up to date with pneumococcal vaccination to protect against pneumococcal disease, such as pneumonia, meningitis, and bloodstream infections. Talk to your doctor to find out which pneumococcal vaccines are recommended for you. Pneumococcal pneumonia is an example of a serious flu-related complication that can cause death. 

You can get the pneumococcal vaccine your provider recommends when you get the flu vaccine.

CDC - Got Questions?
Flu vaccines recommended this season.

Detailed flu and flu vaccine information specific to the current flu season

If you have HIV, you are at high risk of serious influenza-related complications and should get an injectable influenza vaccine (a flu shot). 

Stay healthy!
Tina

Friday, October 12, 2018

Dietary Supplements Can Contain Viagra, Steroids, or Worse

In Case You Missed It
How Many Cases of Drug-Induced Liver Injury Are Caused by Herbal and Dietary Supplements?
September 2018
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses
Read more

In The News - Wired 
You know those sexual enhancement dietary supplements for sale at gas stations and markets across the country? Beware, they might actually be viagra. Or steroids. Or an antidepressant. Many supposed dietary supplements for weight loss, erectile dysfunction, and muscle building may contain actual pharmaceuticals—but you likely have no way of knowing what's in them.

Between 2007 and 2016, the FDA issued warnings about unapproved pharmaceutical ingredients in 776 dietary supplements, according to a new report in JAMA Network Open. Of those, less than half received voluntary recalls. The authors compiled their data from the FDA’s own warning website. Known as the Tainted Products Marketed as Supplements List, it catalogs any time the FDA reports finding unapproved pharmaceutical ingredients in supplements. The hundreds of offending supplements the FDA found during that nine-year period traced back to 146 companies. These represent only a small fraction of the potentially hazardous supplements on the market.


JAMA - Original Investigation 
Public Health
October 12, 2018
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings
Jenna Tucker, MPH1,2,3; Tessa Fischer, DVM, MPH2,3; Laurence Upjohn, PharmD3; et al David Mazzera, PhD3; Madhur Kumar, MS, PhD3
Key Points Question
What are the trends across adulterated dietary supplements associated with a warning released by the US Food and Drug Administration from 2007 through 2016?

Findings
In this quality improvement study, analysis of the US Food and Drug Administration warnings from 2007 through 2016 showed that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements, with 157 products (20.2%) containing more than 1 unapproved ingredient.

Meaning
Potentially harmful active pharmaceuticals continue to be identified in over-the-counter dietary supplements.

Abstract
Importance Over half of adults in the United States report consuming dietary supplements. The US Food and Drug Administration (FDA) has warned of numerous dietary supplements containing undeclared, unapproved pharmaceutical ingredients. These FDA warnings have not been comprehensively analyzed for recent years.

Objective 
To summarize trends across adulterated (containing unapproved ingredients) dietary supplements associated with a warning released by the FDA from 2007 through 2016.

Design, Setting, and Participants In this quality improvement study, data were extracted from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a 6-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning. Data analysis was conducted from February 2017 to June 2017.

Results
From 2007 through 2016, 776 adulterated dietary supplements were identified by the FDA and 146 different dietary supplement companies were implicated. Most of these products were marketed for sexual enhancement (353 [45.5%]), weight loss (317 [40.9%]), or muscle building (92 [11.9%]), with 157 adulterated products (20.2%) containing more than 1 unapproved ingredient. The most common adulterants were sildenafil for sexual enhancement supplements (166 of 353 [47.0%]), sibutramine for weight loss supplements (269 of 317 [84.9%]), and synthetic steroids or steroid-like ingredients for muscle building supplements (82 of 92 [89.1%]). There were 28 products named in 2 or 3 warnings more than 6 months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once. In recent years (2014-2016), 117 of 303 adulterated samples (38.6%) were identified through online sampling and 104 of 303 (34.3%) were identified through the examination of international mail shipments.

Conclusions and Relevance
Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.
Full-text: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496

Invited Commentary
JAMA Network
2018;1(6):e183329. doi:10.1001/jamanetworkopen.2018.3329
The FDA and Adulterated Supplements 
Pieter A. Cohen, MD1,2
The US Food and Drug Administration (FDA) plays an essential role in ensuring the safety of vitamins, minerals, botanicals, probiotics, amino acids, and glandular extracts sold as dietary supplements in the United States. While the FDA does not assess the safety of supplements prior to market, the agency is tasked with identifying and removing adulterated and hazardous supplements from the marketplace.

Adulteration of dietary supplements typically involves 1 of 2 patterns: economic adulteration, in which a less expensive ingredient is used in place of a more expensive ingredient listed on the label, or pharmaceutical adulteration, in which an active drug is included in a purportedly botanical supplement, for example, sildenafil in a “natural” sexual enhancement supplement. The FDA maintains a public database listing the brands of supplements it has identified as adulterated with drugs and the actions, if any, it has taken to remove the product from commerce.

An analysis of the FDA database of pharmaceutically adulterated supplements is the focus of a new study by Tucker and colleagues.1 The authors found that between 2007 and 2016 the FDA identified 746 brands of supplements adulterated with pharmaceutical agents. The adulterants included prescription medications such as sildenafil and fluoxetine, withdrawn medications including sibutramine and phenolphthalein, and unapproved drugs including dapoxetine and designer steroids. Twenty percent of the adulterated supplements contained 2 or more undeclared drugs, for example, weight loss supplements containing both an anorectic and a laxative. Most supplements adulterated with drugs were marketed as weight loss, sexual enhancement, or sports supplements—the same categories that epidemiologists have found to be responsible for a disproportionate number of the estimated 23 000 emergency department visits attributed to dietary supplements each year in the United States.2

Given the potential public health risks of inadvertently ingesting unknown quantities of pharmaceutical drugs, once an adulterated supplement has been identified by the FDA, the agency frequently requests that the responsible firm voluntarily recall the product and, if the firm agrees, the agency publicizes the recall through email alerts and postings on its website. However, the effectiveness of voluntary recalls for supplements has been questioned.3,4 In one study, investigators found that many supplements previously subject to recalls remained on sale and were still adulterated with pharmaceutical drugs, sometimes years after the initial recall.3 In another study, consumers of a supplement subject to a voluntary recall were not aware of the recall and continued to purchase the product following the recall.4

Despite their limited effectiveness, voluntary recalls are the most common approach used by the FDA to remove adulterated supplements from commerce. In the current study, the agency discovered 746 distinct supplements to be adulterated but announced voluntary recalls for only 360. Only 360 of 746 (48%) were recalled, leaving the majority of adulterated supplements, more than 350 products, available for sale.

The database does not provide information as to why the FDA fulfilled its responsibilities less than half of the time, but it is possible that some firms might have refused to voluntarily recall their products. Warning letters may be used to nudge firms to recall supplements. In the current study, however, more than 140 firms were involved, but the FDA issued only 7 warning letters. The agency has other enforcement tools at its disposal when a firm does not agree to a voluntary recall, including mandating a recall (authority available since 2011 under the FDA Food Safety Modernization Act) or making a referral to the Department of Justice. Tucker and colleagues1 found that the agency seldom uses these enforcement tools: the FDA reported no mandatory recalls and only 1 Department of Justice investigation in response to the 746 brands of adulterated supplements.

This new evidence is consistent with prior research that has highlighted major deficiencies in the FDA’s regulation of supplements. In a similar study published in 2013, Harel and colleagues5 found that the FDA identified 332 brands of supplements adulterated with pharmaceutical agents during the 9-year period from 2004 to 2012 but only 222 brands (67%) were recalled.5 In another investigation from 2013, the FDA’s analytical chemists uncovered a mixture of synthetic compounds, including an amphetamine analog, β-methylphenylethylamine (BMPEA), in weight loss and sports supplements.6 The FDA did not inform consumers or issue warning letters. An independent study describing the FDA’s inaction was published 2 years later,7 and only then did the FDA begin to take steps to remove the supplements containing BMPEA from the market.

This pattern is currently repeating itself—the FDA has not warned consumers about additional stimulants discovered in weight loss and sports supplements. My colleagues and I informed the FDA in early 2017 that we had identified 2 experimental stimulants, 1,4-dimethylamylamine and octodrine, in dietary supplements.8 One stimulant has never been approved by the FDA for use in humans, and the other was approved for use by inhalation in the 1940s but has since been removed from the US market. Neither stimulant has ever been FDA approved for oral consumption. Our research has since been confirmed by FDA-funded investigators,9 yet as of September 2018 the FDA has not taken any regulatory action to remove these synthetic stimulants from commerce or warn consumers about the novel adulterants.

To counter the perception of regulatory inertia, FDA officials have emphasized their work to eliminate the stimulant 1,3-dimethylamylamine (1,3-DMAA) from supplements. The sympathomimetic 1,3-DMAA was originally introduced by Eli Lilly & Co in the 1940s as a nasal decongestant to compete with amphetamine marketed by Smith, Kline and French.10 By the 1970s, 1,3-DMAA had been withdrawn from the US markets, but it reappeared in the 2000s as a replacement for ephedra in sports and weight loss supplements; by 2012 the stimulant was available in more than 200 brands of supplements.10 The World Anti-Doping Agency banned the stimulant in sport in 2009. In 2011, Health Canada banned 1,3-DMAA from supplements and the US Department of Defense removed 1,3-DMAA supplements from military bases due to safety concerns. The stimulant received prominent media attention as potentially contributing to strokes and deaths of US troops. Only in 2012 did the FDA finally begin to use its full enforcement powers, including warning letters, product seizures, and mandatory recalls, to remove the stimulant from supplements.

More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market. Congress would need to reform the Dietary Supplement Health and Education Act of 1994. One practical change would be to require firms to register supplements with the FDA prior to sale and Congress could provide the FDA with more effective enforcement tools such as immediately revoking a product’s registration if a supplement is found to be adulterated with pharmaceutical drugs. In the meantime, the process that the FDA is required to follow to remove supplements from the marketplace will remain cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.

Article Information
Published: October 12, 2018. doi:10.1001/jamanetworkopen.2018.3329

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Cohen PA. JAMA Network Open.

Egyptian experience, achievements and limitations towards HCV elimination

Recommended Reading
New York working to eliminate Hepatitis C BUFFALO, N.Y. 
New York is establishing a Hepatitis C Elimination Task Force that will advise the state on a plan to eliminate the infection...

Rochester health care leader named to state hepatitis C task force
Rochester has a representative on a task force working on what Gov. Andrew Cuomo says is the state’s first strategy to elimin…

In The Journals 
World J Gastroenterol. Oct 14, 2018; 24(38): 4330-4340
Published online Oct 14, 2018. doi: 10.3748/wjg.v24.i38.4330

Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations
Dalia Omran, Mohamed Alboraie, Rania A Zayed, Mohamed-Naguib Wifi, Mervat Naguib, Mohamed Eltabbakh, Mohamed Abdellah, Ahmed Fouad Sherief, Sahar Maklad, Heba Hamdy Eldemellawy, Omar Khalid Saad, Doaa Mohamed Khamiss, Mohamed El Kassas

Worldwide, more than one million people die each year from hepatitis C virus (HCV) related diseases, and over 300 million people are chronically infected with hepatitis B or C. Egypt used to be on the top of the countries with heavy HCV burden. Some countries are making advances in elimination of HCV, yet multiple factors preventing progress; remain for the majority. These factors include lack of global funding sources for treatment, late diagnosis, poor data, and inadequate screening. Treatment of HCV in Egypt has become one of the top national priorities since 2007. Egypt started a national treatment program intending to provide cure for Egyptian HCV-infected patients. Mass HCV treatment program had started using Pegylated interferon and ribavirin between 2007 and 2014. Yet, with the development of highly-effective direct acting antivirals (DAAs) for HCV, elimination of viral hepatitis has become a real possibility. The Egyptian National Committee for the Control of Viral Hepatitis did its best to provide Egyptian HCV patients with DAAs. Egypt adopted a strategy that represents a model of care that could help other countries with high HCV prevalence rate in their battle against HCV. This review covers the effects of HCV management in Egyptian real life settings and the outcome of different treatment protocols. Also, it deals with the current and future strategies for HCV prevention and screening as well as the challenges facing HCV elimination and the prospect of future eradication of HCV.

Full-text article-