Herbal Supplement Crackdown —Alan Franciscus, Editor-in-Chief

On February 3, 2015, the New York State Attorney General’s office announced that four major chains (GNC, Target, Walmart, and Walgreens) were selling herbal supplements that could not be verified to contain the labeled substances in the listed ingredients.  Worse yet, many of the substances tested and found were not listed on the labels.  The letters sent out by the State Attorney General ordered the retailers to immediately stop selling the supplements. 

What most people do not realize is that herbal supplements are not regulated to protect consumers.  New York state is introducing a bill to regulate herbs and supplements.   

In the brands tested only 21% had verified ingredients that were listed on the product label. The remaining 79% contained other fillers that included rice, beans, pine, citrus, asparagus, primrose, wheat, houseplants, wild carrot, and other fillers.  These could be potentially dangerous to people with allergies to these substances.  Of note, one sample contained only 4% of the particular ingredient that was listed on the label.

The bigger question is:  How is a person to know what herb or supplement to trust?  There are a couple of options—some require a paid subscription.  But the cost could well be worth an investment to make sure that the herbs and supplements are of stated potency and dollar value: 

• Consumerlabs.com is a useful resource for herbs (paid subscription required).
• The German E Commission has information about the safety of herbs.  However, it has not been updated since 1994, but some still consider the information valid. 
• American Botanical Council is a resource for herbs in general and houses an English version of the German E Commission as well as an expanded version issued in 2000 (paid subscription required).
• HCV Advocate has an Herbal Glossary and Fact Sheets that we are in the process of updating.
• Amazon.com sells many books on herbs that provide some information about drug-drug interactions.

Always tell your medical provider of any supplement or herb (prescribed or over-the-counter) that you are currently taking for potential drug-drug interactions.

The Full Prescribing Information for a particular Food and Drug Administration (FDA) approved drug lists all the possible drug-drug interactions.  For instance, St. John’s wort (a common herb) should not be taken when people are being treated with HARVONI or VIEKIRA PAK.  All of the ‘Labels’ can be found on our website  http://www.hcvadvocate.org/hepatitis
/treatment.asp#FDAPI

While the tests were conducted just in New York State (in 13 regions) it is likely that the same ingredients are similar to store brands found in other states.  The tests were conducted using a DNA testing technique performed by Dr. James A. Schulte II of Clarkson University in Potsdam, N.Y. on samples purchased at the stores from across New York State. 

I have copied the information from the New York Attorney’s press release about the herbal preparations tested.  

GNC:

• Six “Herbal Plus” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from four locations with representative stores in Binghamton, Harlem, Plattsburgh & Suffolk.
• Only one supplement consistently tested for its labeled contents: Garlic. One bottle of Saw Palmetto tested positive for containing DNA from the saw palmetto plant, while three others did not. The remaining four supplement types yielded mixed results, but none revealed DNA from the labeled herb.
• Of 120 DNA tests run on 24 bottles of the herbal products purchased, DNA matched label identification 22% of the time.
• Contaminants identified included asparagus, rice, primrose, alfalfa/clover, spruce, ranuncula, houseplant, allium, legume, saw palmetto, and Echinacea.

Target:

• Six “Up & Up” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Valerian Root, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Nassau County, Poughkeepsie, and Syracuse.
• Three supplements showed nearly consistent presence of the labeled contents: Echinacea (with one sample identifying rice), Garlic, and Saw Palmetto. The remaining three supplements did not reveal DNA from the labeled herb.
• Of 90 DNA tests run on 18 bottles of the herbal products purchased, DNA matched label identification 41% of the time.
• Contaminants identified included allium, French bean, asparagus, pea, wild carrot and saw palmetto.

Walgreens:

• Six “Finest Nutrition” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Brooklyn, Rochester and Watertown.
• Only one supplement consistently tested for its labeled contents: Saw Palmetto. The remaining five supplements yielded mixed results, with one sample of garlic showing appropriate DNA. The other bottles yielded no DNA from the labeled herb.
• Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 18% of the time.
• Contaminants identified included allium, rice, wheat, palm, daisy, and dracaena (houseplant).

Walmart:

• Six “Spring Valley” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three geographic locations with representative stores in Buffalo, Utica and Westchester.
• None of the supplements tested consistently revealed DNA from the labeled herb. One bottle of garlic had a minimal showing of garlic DNA, as did one bottle of Saw Palmetto. All remaining bottles failed to produce DNA verifying the labeled herb.
• Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 4% of the time.
• Contaminants identified included allium, pine, wheat/grass, rice, mustard, citrus, dracaena (houseplant), and cassava (tropical tree root).

Press Release:
A.G. Schneiderman Asks Major Retailers To Halt Sales Of Certain Herbal Supplements As DNA Tests Fail To Detect Plant Materials Listed On Majority Of Products Tested.
http://www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests

http://www.hcvadvocate.org/hepatitis/
factsheets_pdf/CAM_herbs_&_hepatitis_C.pdf

http://www.hcvadvocate.org/
hepatitis/factsheets_pdf/
CAM_Complementary_and_Alternative_
Medicine_Resources.pdf

http://hcvadvocate.org/news/newsLetter/2015/advocate0215_mid.html#2

Legislature making progress against heroin plague

"The bill also allows local communities to choose to establish needle exchanges"

During the next few weeks, members of the Kentucky House and Senate will try to hammer out an agreement on a bill to address growing heroin abuse in Kentucky. Each chamber has passed its own measure.

The version that emerges will reflect whether legislators see the heroin epidemic as a criminal problem or a public health crisis, the term used by House Judiciary Committee chairman John Tilley, sponsor of the House bill.

Tilley, D-Hopkinsville, made an eloquent, informed and impassioned case that unless it's treated as a public health crisis, "we'll be digging ourselves out of this until we're all dead and gone."

Read more...

Could This Be The Biggest Advance in Hepatitis C since Gilead Sciences' Sovaldi?

Tiny biotech stock Achillion Pharmaceuticals (NASDAQ: ACHN ) reported what could be pretty big news for hepatitis C patients this week. The clinical stage biotechnology company released data showing that combining its ACH-3102 with Gilead Sciences' (NASDAQ: GILD ) Sovaldi achieved 100% cure rates in as little as six weeks of treatment. The success of that combination is prompting Achillion to launch a study of the two drugs over an even shorter 4-week dosing period. If that study pans out, it could be the biggest advance in hepatitis C treatment since Sovaldi won approval in 2013.

Read more....

Weekly Special Topic: Transmission and Prevention of Hepatitis C

Learn about how hepatitis C is transmitted and more importantly how to prevent transmission of hepatitis C with our newly updated fact sheets:

Transmission and Prevention of Hepatitis C.

   

Click Here

The Global Spread of Genotype 1 —Alan Franciscus, Editor-in-Chief

The origin of hepatitis C (HCV) is unknown.  The current theory is that it may have originated in horses, but while the virus found in horses is similar to the hepatitis C virus the scientific evidence linking it to hepatitis C is far from clear.   Where the virus originated is on more solid ground—it is believed to have originated in West Africa.  Hepatitis C is spread by direct blood-to-blood contact.  So how did it develop into such a huge problem with an estimated 130-150 million people infected worldwide?  How did genotype 1 become the most common genotype worldwide?  The answer to both questions is well-known—blood transfusions and unsafe injections. 

In the study “The Global Spread of Hepatitis C Virus 1a and 1b:  A Phylodynamic and Phylogeographic Analysis,” by G Magiokinis et al., the authors used a complicated system of analysis with various models (molecular clock & the Bayesian skyline demographic).   The model tracked how genotype 1a and 1b spread throughout the world.  First it was found that genotype 1a had a steady rate of expansion from about 1906 through the 1960’s.  Moreover, it was found that from the 1960’s through the 1980’s it dramatically expanded.  This corresponds to the increase in injection drug use from the 1960’s through the present day. 

Genotype 1b on the other hand expanded at a steady rate from 1922 to the late 1940s.  Then from the 1950’s until the 1980s it showed the greatest expansion.  Thus, the highest rate of expansion of genotype 1b was ~16 years before genotype 1a.   An interesting observation was that early on in the hepatitis C epidemic it was thought that genotype 1b led to more cases of liver cancer.  A possible explanation of this is that people with genotype 1b were infected longer and were more likely to have had more disease progression.   As the authors pointed out, the connection between genotype 1b, liver cancer and the earlier spread of genotype 1b needs to be validated  in future studies. 

To validate their findings of the earlier expansion of genotype 1b, however, the authors pointed to other evidence: 

• All US military recruit samples from 1948-1955 were genotype 1b.
• Older HCV-infected individuals are “systematically” or consistently genotype 1b.

Back to why genotype 1 is the most common genotype.  The most likely reason is that genotype 1 was introduced into developed western countries and spread by the introduction of blood transfusions, plasma pooling and unsafe injections (reuse or improper needle sterilization) of medicines to treat many diseases.  In the late 1920s through the present day the epidemic of injection drug use and sharing needles and drug preparation tools is another reason for the spread of HCV genotype 1.  

One has to wonder how different it would be if genotype 2 had been ‘the genotype’ that had been the one that had greatly expanded instead of genotype 1.  Treatment of genotype 2 produced very high cure rate early on in the history of treatment.  Still with current treatments we have the potential to eradicate hepatitis C in a lifetime. If only we could increase treatment access for everyone with hepatitis C. 

Facts about genotype 1:

• Genotype 1 is the most common genotype worldwide at 83.4 million (46.2%) people.
• Genotype 1 is the most common genotype in the United States at 70% of the population with HCV.
• Genotype 1a and 1b are the most common subtypes; subtypes 1c, d, e, f, g, h, i, k and l have been identified but are uncommon.
• The current standard of care for the treatment of hepatitis C can cure 90 to 100% of people who take the medications (HARVONI and VIEKIRA PAK).  Treatment durations are usually 12 weeks but vary from 8 to 24 weeks.

http://hcvadvocate.org/news/newsLetter/2015/advocate0215_mid.html#1

Depression not linked to insulin resistance in patients with diabetes, HCV

Depression was not associated with peripheral insulin resistance among a cohort of patients with diabetes and hepatitis C virus infection, according to a study data published in the Journal of Viral Hepatitis.

Researchers enrolled 74 patients with diabetes (non-type 2) and HCV (mean age, 48 years) in the cross-sectional study and evaluated data after extensive comprehensive, clinical, histologic and metabolic testing to determine whether insulin resistance was associated with depression. Insulin was appraised through an insulin resistance test that measured steady-state plasma glucose and logistic regression analyses was used to evaluate predictors associated with depression, according to the research. 

“Depression was not associated with [insulin resistance] in our HCV-infected cohort,” the researchers concluded. “With the introduction of highly effective direct-acting anti-HCV treatments, the burden of HCV is anticipated to decrease significantly. However, considering the multifactorial nature of depression, interventions directed at other modifiable risk factors in at-risk individuals in this population are warranted.”

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Study: Door-to-door campaign linked hepatitis C patients to care

Effort overcame the many hurdles to specialized treatment for Philadelphia's medically underserved

PROVIDENCE, R.I. [Brown University] -- In Philadelphia, as in many cities, neighborhoods with high rates of hepatitis C virus (HCV) often also have limited access to screening and treatment. A new study in the Journal of General Internal Medicine shows that when expert advocates made a focused effort in a medically underserved area, they were able to help vulnerable patients leap each of the many hurdles that often keep people out of care.

"This study demonstrates the importance of community-based testing for HCV in identifying previously undiagnosed individuals and re-engaging those aware of their diagnosis but not currently in care," Trooskin said. "We learned that a comprehensive approach to nonclinical testing is critical and must integrate immediate access to confirmatory testing as well as intensive patient navigation to effectively link patients to care. Although hepatitis C is now a curable disease, we identified new barriers to care such as the need for a referral to subspecialty care and challenges obtaining medication approval for patients, particularly those covered under Medicaid."

Read complete release here....