Hepatitis C drug patent challenged in Europe

A French healthcare campaign group has launched a legal challenge to the patent covering Sovaldi (sofosbuvir), the blockbuster hepatitis C virus (HCV) drug marketed by Gilead. Médecins du Monde (MDM) has told the European Patent Office (EPO) ‘the molecule itself is not sufficiently innovative to warrant a patent’.

HCV infection can clear within a few months. But for about 80% of those infected, it develops into a chronic condition. According to the World Health Organization, 130–150 million people are living with chronic HCV infection.

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Canada: Campaigns launched to promote awareness of and try to prevent Hep C infections in Guelph area

GUELPH—About 300,000 Canadians have potentially deadly Hepatitis C, including 100,000 in Ontario, but up to 50 per cent don't know they're harboring the harmful viral infection, area Hep C Dr. Chris Steingart told a Guelph audience Thursday.

The Sanguen Health Centre executive director said the infection from tainted blood from a variety of sources, which attacks the liver, can cause physical, mental and emotional injury, yet each year more people are infected than seek treatment. 

"The good news is we can do something about that," Steingart told audience members in the health care/harm reduction field at the launch of an information video and color-coded syringes program. He stressed the local availability of effective Hep C testing and treatment. 

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Researchers tackle gaps in hepatitis C treatment

“Do One Thing” seeks to provide screenings, treatment to underserved communities

A program run by University researchers aims to quickly identify and provide comprehensive treatment for medically underserved patients who are chronically infected with the hepatitis C virus, according to a new study published in the Feb. 14 issue of the Journal of General Internal Medicine.

Hepatitis C — a blood-borne disease that inflames the liver — is an “underfunded, understudied and seriously large health problem,” said Amy Nunn, assistant professor of behavioral and social sciences and medicine, who co-authored the study.

“Its magnitude is not to be underestimated and there are at least five to seven times as many people living with hepatitis C than its more infamous counterpart, HIV,” Nunn said. Unlike for hepatitis A and B, there is no vaccination available for hepatitis C. 

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Reallocation; ACOs; ABLE Accounts (Update on Federal Government Actions) Jacques Chambers, CLU

This column normally focuses on benefits issues, not politics; but government actions have a large impact on benefits and the disabled persons who receive them. This month’s article takes a look at three actions by the federal government that directly affect people dealing with disability, namely:

• Reallocation of funds between Social Security trust funds, which could have a dramatic effect on anyone collecting Social Security Disability;
• Accountable Care Organizations (ACOs) under Obamacare which looks to become an effective tool at reducing medical costs; and,
• Enactment of ABLE accounts, a recent federal law which could help disabled persons save money tax-free.

Reallocation of Trust Funds
This is the item that could have the quickest and most severe impact on people collecting Social Security Disability Insurance (SSDI).

A little background: The F.I.C.A. payroll taxes that pay Social Security Retirement and Disability beneficiaries go into two separate trust funds, the Retirement Trust Fund and the Disability Trust Fund. They are split by a formula that has been in effect for many years.

Because the formula does not accurately reflect the payouts from each fund, periodically, the House of Representatives, which initiates budget issues, must “reallocate” funds from one trust fund to the other in order to maintain full payments to both groups of beneficiaries. This is usually a fairly routine procedure and has been done eleven times since 1968 with no opposition or problems, regardless of the political party in control of the House. Due to the age of the allocation formula and the shifts in types of labor, age of workforce, and advancing the retirement age to 67, the reallocation of funds usually has been from the Retirement Fund into the Disability Fund.

If there is no reallocation of money into the Disability Trust Fund from the much larger Retirement Fund, before December, 2016, SSDI benefits will be cut 16 – 20% for the 11,000,000 disabled people currently receiving benefits.

On the first day of the new Congress, the new majority adopted a “rule” about reallocation without consulting the minority party. Instead of simply approving the reallocation as in the past, now a reallocation bill can only be considered if it comes with an accompanying proposal which “improves the actuarial balance” of both funds. In other words, disabled people’s SSDI benefits will be cut by up to 1/5 unless there is a plan on the table to put both Trust Funds into more permanent solvency, i.e., a major rewrite of the entire Social Security retirement and disability system.

Note that this is only a “rule” change, not a law. So it is now in effect; neither the Senate nor the President can do anything to stop it.

Supporters of this new rule have frequently tried to portray SSDI as too easy to get and claim almost anyone can walk in and get it. Any disabled person who has gone through the application and appeal process will have no problem appreciating the total inaccuracy of that.

One senator maintains that over half the recipients are either anxious or have a sore back, saying, “Join the club. Who doesn’t get up a little anxious for work and their back hurts.”

In 2011, the last year for when numbers are available, all types of mood disorders plus all types of musculoskeletal issues comprised less than 45% of total worker beneficiaries, which includes far more conditions than anxiety and a “sore back.”

The reason for the new rule, according to its supporters, is to push Congress to address the inadequacy of current revenue and benefits payouts and stop “kicking the can down the road.”

Those opposed to the new rules, which include virtually all of the disabled community and its advocates, accused the House of holding the disabled hostage. Who is correct?

While the supporters focused on anecdotes, the Government Accounting Office (GAO) performed an audit of improper SSDI payments and issued its report in 2013 (GAO13-635). It concluded only 0.4% of beneficiaries received overpayments, or payments for which they were not able–not even 1% of the total benefits paid.

The proposed budget recently issued by The White House specifically calls for a reallocation into the Disability Trust Fund, but that is only a proposal at present.

There is a possibility that, if pushed, the majority in the House may postpone this rule, however, that risks the rule or something like it being brought up in future years similar to other issues such as expanding the debt limit or threatening to cut successful, popular, and necessary programs. At present the rule is in place, and, if not changed or postponed, SSDI beneficiaries will see a large cut in their benefits by the end of 2016.

Accountable Care Organizations (ACOs)
One of the provisions of the Affordable Care Act (aka Obamacare) created ACOs in an attempt to control the rapidly rising medical costs. An ACO is a group of doctors, hospitals, and other health care providers who come together voluntarily to give coordinated high quality care to their patients. This would save costs by avoiding unnecessary duplication of services and prevent medical errors.

The goal of coordinated care is to ensure that patients, especially the chronically ill such as those with HCV and HIV, get the right care at the right time. When an ACO succeeds both in delivering high quality care AND spending health care dollars more wisely, it will share in the savings it achieves.

This may sound a little like the HMO model for health care, and the goals are definitely similar in that it attempts to move away from paying by the treatment provided (fee-for-service) and tie payment more to health outcomes. What separates an ACO from an HMO is the patient is not locked in to any set of providers or hospitals where they must go for treatment. Beneficiaries can still go to any doctor or hospital. 

Under the terms of Obamacare, the ACO will be responsible for all the care needs for a group of patients and will be paid based on those patients’ health outcomes, satisfaction, and costs.

At present, ACOs are primarily being tried with beneficiaries who are on original, (or fee-for-service) Medicare. Private insurance companies are watching closely and are also starting to work with it on a smaller scale. Kaiser Health News reports that Medicare ACOs are already serving over one million Medicare recipients with promising results. For an interactive map showing current Medicare ACOs, see the site below: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/
ACOs-in-Your-State.html

By having the various medical providers working together more closely, health outcomes will be improved, there will be less wasted dollars from duplicate and unnecessary procedures being performed, fewer and shorter hospital stays, and greater patient satisfaction. The indications so far are good.

ABLE Savings Accounts
In December, 2014, Congress passed and the President signed the Achieving a Better Life Experience (ABLE) Act. Similar to the tax-sheltered 529 College Savings Accounts, it allows people with disabilities to establish a tax-sheltered fund to assist with expenses.

To qualify, a person must have been diagnosed by age 26 with a disability that results in “marked and severe functional limitations;” those receiving Social Security disability benefits would also qualify. Note that there is no age limit to establishing the fund, but diagnosis of the condition must have occurred while the disabled beneficiary is age 26 or less. While this would eliminate anyone diagnosed with HCV after age 26, it could be a significant tool for those who are eligible.

The beneficiary, family, and friends could set up and fund a tax-free at financial institutions, depositing up to $14,000 per year. Funds could be used for housing, health care expenses, transportation, education, employment training, personal support services, financial management, and administrative services. The contributions would be with after-tax dollars but earnings would grow tax-free.

The maximum amount of the fund would be the same as each state’s maximum for the 529 Education Tax-Free Funds. A major advantage is that as long as the fund remains below $100,000, the beneficiary would still be eligible for Supplemental Security Income (SSI) benefits. Regardless of the fund size, eligibility for Medicaid would continue.

The ABLE Fund would have significant advantages over the Special Needs Trust, currently used to maintain eligibility for needs-based public programs. They are much less expensive to set up, and they do not have the significant limitations on the use of the funds.

For more information contact a financial planner or a banker. States may also set up funding plans as they do with the Education Accounts.

http://hcvadvocate.org/news/newsLetter/2015/advocate0215_mid.html#4

Texas needs needle exchange program

A needle exchange program to help reduce the spread of HIV and hepatitis C may finally be a reality for Bexar County.

The launch of what is sometimes referred to as harm reduction programs was first attempted in 2008. At issue was vagueness in the wording of the law that exposed participants in the program to possible prosecution under state drug laws for possession of drug paraphernalia.


Rep. Ruth Jones-McClendon, D-San Antonio, has introduced HB 65, which would allow for pilot needle exchange programs in Bexar, Dallas, El Paso, Harris, Nueces, Travis and Webb counties. It provides for the the exchange of needles and syringes, education about communicable diseases such as HIV, hepatitis B and hepatitis C, and helps program participants access substance abuse and treatment and bloodborne disease testing.

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The Five: Sleep and Insomnia —Alan Franciscus, Editor-in-Chief

A good night’s sleep is a critical component of living healthy especially with hepatitis C.  As any insomiac will tell you, getting a restful night’s sleep may be one of the most difficult goals to achieve, but man when you get one it’s like achieving nirvana! 

Recently, the National Sleep Foundation released new recommendations for Americans of every age.  While these are recommendations, there are always reasons why people may require more sleep than recommended.  For instance, if you have an illness or are being treated for hepatitis C your body needs more sleep than recommended to heal and recover. 

1. The National Sleep Foundation recommends the following hours of sleep every day: 

• Newborns (0-3 months): 14-17 hours
• Infants (4-11 months): 12-15 hours
• Toddlers (1-2 years): 11-14 hours
• Preschoolers (3-5 years): 10-13 hours
• School-age children (6-13): 9-11 hours
• Teenagers (14-17):  8-10 hours
• Young  Adults & Adults (18-64): 7-9 hours
• Older Adults (65+): 7-8 hours

2. Causes of insomnia: There are many causes of insomnia or sleeplessness including:  

• Living with hepatitis C and the uncertainty of life with a potentially deadly illness
• People who are on HCV treatment may worry about being cured
• Sleep Apnea (a medical condition that interferes with people’s breathing while they sleep)
• Certain prescribed and over-the-counter medications
• A sleeping partner who snores or is restless (including pets)
• Too much alcohol, nicotine, caffeine,  too little or too much food before bedtime
• Change in work schedule
• Traveling long distances, travel across time zones, and many, many  more reasons 

3. Complications of Insomnia:

• Anxiety and depression
• Slow reaction times and poor work performance
• Irritability
• Increased risk for high blood pressure, heart disease, and diabetes
• Substance use
• Overeating and obesity that could lead to fatty liver

4. Self-Help Tips:

• Limit caffeine, soda, tea, chocolate
• Avoid or cut back on alcohol and tobacco especially too close to bedtime
• Go to bed the same time every night.  Have a consistent routine when preparing for bed—brush teeth, read a book—this tells your mind and body you are ready for bed
• Make sure your bed/pillow  is comfortable
• Don’t go to bed hungry, but don’t eat a large meal too close to bedtime
• Use earplugs and eye masks to block noise and light if needed. 
• Turn off your mind when going to sleep—try  relaxation techniques and tapes
• If you cannot sleep, get up do something boring and go back to bed. 

5. Medical care:  There are many over-the-counter and prescription medications that can treat chronic insomnia.  People who suffer from chronic insomnia can benefit from a sleep study to determine if they have sleep apnea or another sleep disorder.  A symptom of sleep apnea is being tired during the day—the same symptom that is the most common symptom of hepatitis C.  Treating sleep apnea can improve everyone’s quality of life especially those with hepatitis C.

Don’t live your life full of sleepless nights—practice self-help strategies and get medical help as needed to live life to the fullest.  No one should live a life full of sleepless nights and days full of being tired.  Get tested. Get treated. Get Cured. 

Check Out These Sleep and Insomnia
Fact Sheets

• Easy C Facts: Sleep
• Easy C Facts: Side Effects – Insomnia
• HCSP Fact Series: Sleep

http://hcvadvocate.org/news/newsLetter/2015/advocate0215_mid.html#3

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