08/18/17

Public Health Time Bomb

May came and went with the vast majority of people in the U.S.—including me—being totally unaware that it was Hepatitis Awareness month. May 19^th was National Hepatitis Testing Day. Hepatitis-C (HCV) is the most common form of viral hepatitis in the U.S. The number of new HVC infections almost tripled between 2010 (850) and 2015 (2,436). We need to be more aware of this disease and its treatment because it kills more Americans than any other infectious disease, including HIV. Yes, more people than HIV. CDC data indicated nearly 20,000 Americans died from hepatitis-C-related causes in 2015; and the majority of those deaths were people 55 and older.

“Because hepatitis C has few symptoms, nearly half of people living with the virus don’t know they are infected and the vast majority of new infections go undiagnosed.” The highest rate of new infection occurs among 20- to 29-year-old injection drug users. But ¾ of the 3.5 million Americans living with hepatitis C are baby boomers born between 1945 and 1965. They are six times more likely to be infected with hepatitis C and are at much greater risk of dying from the virus. Around ½ of all the deaths from HCV in 2015 occurred within this age range. You can read the three CDC press releases this information was taken from here, here and here.

These press releases highlighted information in report, “A National Strategy for the Elimination of Hepatitis B and C” that suggested a strategy to eliminate both as public health problems by 2030. Immunization against hepatitis B (HBV) can prevent 95% of infections. There is no vaccine against HCV, but there are anti-viral drugs that can cure hepatitis C, but the costs are prohibitive. The introduction of the report said:

There is no longer any reason to disregard these diseases. There is an effective vaccine to prevent hepatitis B, advances in treatment can prevent most deaths in those chronically infected with HBV, and hepatitis C is now curable with a short course of easily tolerated treatment.

CDC data on HCV suggested that 75% to 85% of newly infected adults and adolescents develop chronic infections. From 2000 to 2002 incident rates for acute HCV decreased for all age groups except for persons aged 0-19. Then the rates remained fairly steady from 2002 through 2010. Between 2010 and 2015 rates increased for persons in all but the oldest (<60 years old) and youngest (0-19 years old) age categories. The largest increase was among persons between 20 and 29 years old. See the following graph of the reported CDC data.

The drug companies charge between $60,00 and #90,000 for a 12-week course of treatment. This is way out of proportion to the cost of treatment in third world countries. Eliminating HCV as a public health problem by 2030 would require mass treatment, but none of the direct-acting agents come off patent before 2029. In the long run, HCV treatment is cost-effective, but doesn’t address the upfront costs charged by pharmaceutical companies for their drugs. So the cost of antiviral that cure HCV is a major obstacle.

These drugs have strained the budgets of public and private payers alike. Faced with the unenviable task of allocating scarce treatment, payers gave first priority to the sickest patients, those at most immediate risk of death. Many also imposed sobriety restrictions, fearing the risk of re-infection in active drug users too great to justify the expense of treatment. Such restrictions have met with criticism. Overt drug rationing offends the American public, but it is difficult to know how else to act in the face of such high prices.

One of the recommendations of the report is for the federal government to purchase the rights to one of the direct-acting antiviral treatments for use with neglected populations such as individuals on Medicaid, in prisons and those treated through the Indian Health Services. This would be a voluntary transaction between the government and the pharmaceutical companies providing the antivirals. The company would be guaranteed reasonable compensation and the licensed drug would only be used in the limited markets (noted above) the companies aren’t now reaching.

Calculations show that the licensing rights should cost about $2 billion, after which states would pay about $140 million to treat 700,000 Medicaid beneficiaries and prisoners. By comparison, the status quo would cost about $10 billion over the next 12 years to treat only 240,000 similar patients.

Critics of the strategy suggest it sets a dangerous precedent by having the government negotiating a license for a costly medicine. Actually, it seems that the federal government’s reluctance to interfere with the pharmaceutical industry may have emboldened it to initially set the extremely high prices foe HCV drugs.

The Senate Finance Committee’s 2014 investigation into the pricing of sofosbuvir [Solvadi] concluded that Gilead had deliberately elevated the price in an effort to raise the market floor, ensuring continued high prices for all future hepatitis C treatments. Action now might discourage other companies from pursuing this strategy in the future.

A CNN article on the report by Susan Scutti noted the hardest hit areas of the U.S. in terms of new HCV infections are parts of Appalachia and rural areas of the Midwest and New England. Several states, Indiana, Kentucky, Maine, Massachusetts, New Mexico, Tennessee and West Virginia have infection rates that are two times or more than the national average. Ten other states have rates above the national average: Alabama, Montana, New Jersey, Noth Carolina, Ohio, Oklahoma, Pennsylvania, Utah, Washington and Winconsin.

There is a website, HepVu, presented by the Rollins School of Public Health at Emory University, which partnered with Gilead Sciences, the original price gauging pharmaceutical company with its antivirals, Solvadi and Harvoni. The original drug development research into Solvadi was done at Emory. Despite the Gilead partnership, HepVu has some helpful information, including an interactive map by state in the U.S. The home page stated there are an estimated 3.9 million people in the U.S. living with past or current hepatitis C infection. You can look up each state’s individual profile.

For example, within my home state of Pennsylvania, there are an estimated 142,100 people living with Hepatitis C. The HCV mortality rate is 4.952 per 100,000 persons, with 629 hepatitis C deaths in 2014. In West Virginia, there are an estimated 24,400 people living with Hepatitis C. The HCV mortality rate is 5.9 per 100,000 persons, with 110 hepatitis C deaths in 2014. In Ohio, there are an estimated 119,100 people living with Hepatitis C. The HCV mortality rate is 4.9 per 100,000 persons, with 567 hepatitis C deaths in 2014. Go to the site and check out your own state’s data.

The outrageous price of medications to treat hepatitis C illustrates how pharmaceutical companies are feeding off of the problems they had a hand in creating. The rise in hepatitis C infections comes as a result of increased IV drug use, which resulted from the prescription opioid epidemic leading individuals to switch from prescription opioids to heroin. And the public health problems with hepatitis C will only get worse since it often goes undiagnosed for years. It’s a public health time bomb.

The above recommendation to have the federal government negotiate a license for one of the existing Hepatitis C treatments is a good one. It just might deter other companies from trying the same pricing trick in the future with other medications. But the cozy lobbying relationship between Pharma and Congress could prevent it.

For more on this issue, see: “Is There No Balm in Gilead?,” “I Guess I’m a Little Bit Socialist,” “Riding the Hep C Gray Train,” “Impeccable Timing” and “Hepatitis Hostages.” Also see “Pharma Companies Hunt in Packs” for more information on the issues of the high cost of prescription drugs.

06/17/16

Impeccable Timing

Timing is everything—even with medications coming to market. In the last few years new, effective treatments for the Hepatitis C Virus (HCV) have come to market as the death rates steadily climbed. Solvadi (12/2013) and Harvoni (10/2014) by Gilead Sciences; Viekira Pak (12/2014) by AbbVie and Zepatier (01/2016) by Merck are the main ones. They have cure rates over 90% in many cases. Although their prices have been sky high, according to the WHO, the production costs of these drugs are quite low. Harvoni prices were expected to drop, but I haven’t anything much cheaper than $94,500 for 12 weeks of medication. Viekira Pak lists at $83,300 for 12 weeks; Zepatier is the bargain at $54,600.

New CDC data in May of 2016 indicated that HCV deaths for 2014 reached an all-time high of 19,659. The rates have been steadily rising since 2010 when the total was 16,627. The CDC also stated their numbers were most likely a fraction of the deaths attributable in whole or in part to chronic hepatitis C. There are an estimated 2.7 to 3.9 million chronic cases of HCV in the U.S. New acute cases of HCV have also been steadily increasing. In 2014 there were 2,194 new cases of HCV reported, a 300% increase since 2005. The CDC suggested that actual cases are estimated to be 13.9 times higher than the number of reported cases in any year. The following chart was compiled from the CDC data.

	2010	2011	2012	2013	2014
Actual New HCV	853	1,230	1,778	2,138	2,194
Estimated New HCV	11,800	16,500	24,700	29,700	30,500
Cause of Death as HCV	16,627	17,721	18,650	19,368	19,659

A study done on the CDC HCV data found that from 2003-2013 the number of deaths from HCV surpassed the combined total of 60 other infectious conditions. This was despite the improving therapies now available. The HCV death statistics could begin decreasing in the next few years, as the impact of the new drugs is felt in treatment. But the high cost of medications has resulted in health insurance companies prioritizing treatment for the worst HCV cases. So as the heroin and prescription pain medication epidemic rages on, new HCV patients have to wait their turn until their HCV gets serious enough for their health insurance to approve treatment.

Despite enthusiasm for the new curative, brief (12-week), all-oral antiviral treatments for hepatitis C virus (HCV) infection, the continued health burden and increased mortality for HCV-infected patients in the United States remain underappreciated.

A CDC press release indicated the greatest HCV burden falls on baby boomers, born between 1945 and 1965. A study published in The Lancet Infectious Diseases in 2016 suggested injection and blood transfusion technologies were not as safe as they are today, so many boomers may have been unknowingly living with HCV for many years. Jonathan Mermin of the CDC said: “Why are so many Americans dying of this preventable disease? Once hepatitis C testing and treatment are as routine as they are for high cholesterol and colon cancer, we will see people living the long, healthy lives they deserve.” The outrageous price for HCV medications may be part of your answer, Dr. Mermin.

A Live Science article on the CDC study noted that HCV is primarily spread today through people sharing needles, syringes or other equipment used when injecting drugs. “But before 1992, when the U.S. began screening the blood supply for the virus hepatitis C was also commonly spread through blood transfusions and organ transplants.” The following chart from Wikimedia Commons, composed by Opigan13, was compiled from CDC figures. It shows data on hepatitis C infection by source.

HCV can be a “silent illness,” with people having no symptoms for decades. This allows the disease to progress unnoticed. Hepatitis C is “a different beast” from other liver infections that have more symptoms or are shorter in duration, according to Dr. Raymond Chung, director of hepatology and the Liver Center at Massachusetts General Hospital. Dr. Chung thought the increase in HCV deaths could continue for five more years or longer.

Amy Nunn, an associate professor of behavioral and social sciences at the Brown University School of Public Health said the rise in HCV deaths was alarming. About 85 percent of individuals who are infected with HCV don’t know they have it. Most people are not routinely screened for the virus. Nunn also pointed to the high cost of the new hepatitis C drugs as one reason that some people are having trouble getting access to them in the early stages of the disease.

A report by IMS Health for 2015 indicated that nearly 250,000 new patients received treatment for HCV in 2015. Added to the 170,000 new patients in 2014, the past two years have seen 5 times the number of patients than the previous three years combined. The majority of patients were treated by Medicare (50%); followed by commercial insurance (28%) and Medicaid (19%); 3% paid cash. Non-discounted spending over the past two years for the newer HCV drugs was $31.0 billion. “The discussion continues over the price of these medicines and the criteria for determining patient access and insurance coverage.” See chart 10 in the report for this data.

Spending on HCV went from so small an amount in 2013 that a figure couldn’t be shown in chart 8, to 12.2 billion in 2014 and 18.8 billion in 2015. Looking at the top medicines by spending in 2015, Harvoni was #1 with $14.3 billion. Solvadi dropped to 19th with $3.0 billion spent. In 2014 Solvadi had been tied for 1st with Humira at $7.8 billion in spending.

The World Health Organization (WHO) estimates that 130 to 150 million people globally have chronic hepatitis C infection. Around 500,000 people die yearly from HCV-related liver diseases. The most affected regions are Africa, Central Asia and East Asia. Populations at risk of HCV include: people who injects drugs, people who have used intranasal drugs, people who have tattoos or piercings, people with HIV, prisoners or previously incarcerated individuals, and children born to mothers with HCV.

The incubation period for hepatitis C ranges from 2 weeks to 6 months. After the initial infection, 80% of people do not show any symptoms. Individuals who are acutely symptomatic could exhibit “fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, grey-coloured faeces, joint pain and jaundice (yellowing of skin and the whites of the eyes).” The WHO said:

Recently, new antiviral drugs have been developed. These medicines, called direct antiviral agents (DAA) are much more effective, safer and better-tolerated than the older therapies. Therapy with DAAs result can cure most persons with HCV infection and treatment is shorter (usually 12 weeks) and safer. Although the production cost of DAAs is low, the initial prices are very high and likely to make access to these drugs difficult even in high-income countries.

So pharmaceutical companies like Gilead Sciences, AbbVie and Merck are making enormous profits from their HCV treatments and will continue to do so for many years (see “Riding the Hep C Gravy Train”). The low production cost for HCV drugs is also an explanation for why Gilead Sciences was so willing to offer steep discounts to countries like Egypt (See “Is There No Balm in Gilead?” and “Hepatitis Hostages”)—it’s good PR and they either still make a profit or buy a lot of goodwill for a nominal cost. As Amy Nunn said, “This is an epidemic of enormous magnitude.” And it looks like it will be around for awhile longer. Gilead, Merck and AbbVie, your timing for drug development was impeccable.

05/20/16

Riding the Hep C Gravy Train

12992431_s — © Jiri Markalous | 123rf.com

Gilead Science launched its revolutionary drug, Solvadi to treat hepatitis C in December of 2013. At $1,000 per pill, a twelve-week course of treatment costs $84,000. Combined with some other necessary medications, the cure rate was projected to be over 90%. Then on October 10, 2014 Gilead launched Harvoni, a combination of Solvadi and ledipasir, which meant that only one pill taken daily for twelve weeks was needed. Gilead priced Harvoni at $95,000 per 12-week treatment. Patient cure rates for Harvoni were in the mid-to high 90% range. Gilead justified its price for Harvoni and Solvadi by pointing to longer-term savings on costly complications from hepatitis C, such as liver transplants, liver cancer and repeated hospitalizations for advanced cases of Hep C. Then the company booked a ride on the gravy train.

Drawing on the annual financial reports noted in the company’s press releases, Gilead Sciences grossed $10.3 billion in sales for Solvadi in 2014; $8.5 billion of which was in the U.S. Harvoni sales in 2014 grossed $2.1 billion; $2 billion of which was in the U.S. Solvadi sales for 2015 dropped to $5.3 billion; $2.4 billion of which was in the U.S. This was likely because of the huge sales for Harvoni in 2015, $13.9 billion; $10.1 billion of which was in the U.S. Full year product sales for Gilead Sciences for 2013 was a respectable $11.2 billion, an increase of 15% over 2012 product sales. In 2014, full product sales were $24.5 billion, an increase of 137 percent. And in 2015, full product sales were $32.2 billion, an increase of 31 percent.

This was enough of a sales boost for Gilead Sciences to jump from the 21st ranked pharmaceutical company by global sales in 2013 to the 9th ranked company by global sales in 2014. This means that Gilead Sciences had an estimated 95% share of the U.S. market for hepatitis C treatment, where 3.2 million people are infected. AbbVie, the 11th ranked pharmaceutical company in 2014, launched its own hep C drug treatment, Viekira Pak, in December of 2014. There wasn’t much of a discount, as it was priced at $83, 320 for a 12-week treatment, according to Hanna Ishmael for Bidness ETC.

Express Scripts, the U.S.’s largest pharmacy benefits manager, secured a discount from AbbVie for Viekira Pak and announced it was dropping coverage for Gilead’s treatments, except under certain medical conditions. The Chief Medical Officer for Express Scripts said the discount put it in the range of Western European levels for Gilead’s hepatitis C treatment, between $51,000 and $66,000. That is correct. Gilead negotiated a better deal for its treatments with countries outside the U.S. “The dynamic will save Express Scripts customers $1 billion in 2015, with a total of $4 billion in savings across the United States when all payers and employers are included.”

In response to the deal between Express Scripts and AbbVie, Gilead began offering discounts that averaged 46% off its listed price for Solvadi and Harvoni, meaning they cost would $45,360 and $51,300 respectively. However, some payers continued to restrict access to Gilead’s drugs, so in return, Gilead began to limit enrollment in its patient assistance program for hepatitis C drugs. These programs help patients obtain Solvadi and Harvoni treatments when they don’t have the finances or sufficient insurance coverage to get the medicines. Beginning on July 1, 2015, Gilead announced that patients who were insured, but did not meet their payers coverage criteria would no longer be eligible for Gileads Patient Assistance Program. Ed Silverman said: “The drug maker is taking this step after finding that some payers, despite receiving discounts in recent months, have continued to restrict patient access to its hepatitis C medicines.”

Unfortunately, reporting for FiercePharma, Emily Wasserman said there have been reports of serious liver injuries tied to Viekira Pak, which led to changes in the meds’ labels warning doctors against using them for the sickest patients. AbbVie countered by saying that its drugs are safe for the vast majority of patients. The risk of serious injury is only for 3% to 5% of patients with the most serious stage of the disease.

The FDA and Gilead announced in March of 2015 that a serious slowing of the heart rate (symptomatic bradycardia) can occur when Harvoni or Solvadi is used in conjunction with the antiarrhythmic drug amiodarone. Nine patients had had serious reactions and one of the nine died. Three others had to receive pacemakers. Gilead said the mechanism of the potential interaction is unknown. “Gilead said that 6 cases of symptomatic bradycardia happened within 24 hours of starting one of the drugs and the other three in two to 12 days.”

Now their the competition is expanding. Johnson & Johnson has its own next-generation hep C treatments in the pipeline and Merck just had its hep C drug, Zepatier, approved by the FDA in January of 2016. Like Harvoni, Zepatier is a once-daily single-tablet of two drugs. The new drug is priced at $54,600 for a 12-week regimen, which Merck said puts it in the range of discounts for other competing hep C treatments like Harvoni and Viekira Pak.

Reportedly, Zepatier also has a better safety profile than Solvadi. Advera Health Analytics looked at the clinical trials data for all three drugs and concluded it was less risky than Solvadi. “The general conclusion is that Zepatier looks safer than Sovaldi, just based on clinical trial information.” Gilead, of course, disagrees. They said the analysis was “deeply flawed.” It wasn’t based on a head-to-head comparison of the three drugs. There wasn’t consideration given for the underlying condition for which patients were taking Harvoni or Solvadi. Nor was there adjustment made for the drugs given along with Solvadi, which have their own serious side effects.

The first-generation hepatitis C treatments take longer, have more known adverse side effects and don’t have as high of a patient cure rate. The second-generation treatments, like Solvadi and Harvoni will save lives. But patients in the U.S. are at a financial disadvantage as they are forced to pay a much higher cost for their treatment. See “Hepatitis Hostages” and “Is There No Balm in Gilead?” for more on this topic. It is getting better, but the initial gravy boat of profits launched Gilead into the top ten of pharmaceutical companies in global sales for 2014. When the dust settles from all the above noted concerns, the bottom line is that the pharmaceutical companies, especially Gilead Sciences, will make a huge profit off their hepatitis C treatments. There is a balm in Gilead, but it’s going to cost you.

12/10/14

Hepatitis Hostages

In September of 2014, Gilead Sciences announced a deal with seven Indian drug companies to produce less expensive generics for their blockbuster Hepatitis C drug, Sovaldi. Gregg Alton, an executive vice-president for Gilead said: “This announcement is a game-changer. . . . The great thing is we are making this medication available to millions of people around the world.” Alton also said: “Gilead is working to make its chronic Hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible.” The medication could be on the market in India by the third quarter of 2015. The licensing deal will cover 91 countries, which have an estimated 100 million people living with Hepatitis C. But the cost to Americans and the profits to Gilead for Sovaldi are through the roof.

Through the third quarter of 2014, Gilead has made $8.6 billion in profit from Sovaldi (see info here, here, and here.)—most of it from American sources. It is on schedule to exceed $10 billion in sales for 2014. This is largely because of the extreme cost differential of Sovaldi to Americans. The charge to US patients is $1,000 per pill; $84,000 for a full 12-week course of treatment with the drug. In June of 2014, Forbes contributor Robert Glatter reported that Gilead was offering Sovaldi at a 99% discount to countries like Egypt and India. The production cost for Sovaldi is somewhere between $130 and $150 per pill. Gardiner Harris of the New York Times reported that Gilead will introduce the drug in India for around $10 per pill.

Rohit Malpani, of Doctors Without Borders, observed that: “Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 percent of people with hepatitis C live today.” Gregg Alton said that Gilead would provide middle-income countries with discounted prices for Sovaldi. “Pricing for Thailand, Mexico or Brazil will be very different than the U.S. price.”

As early as the spring of 2014, concern was that the cost of Sovaldi in the U.S. would lead to a huge rise in healthcare costs. There are over 3 million potential customers with Hepatitis C in the U.S. PharmExec.com reported in April that a large insurer, United Health Group, reported a decline in its first-quarter earnings, in part because it spent more than $100 million on hepatitis C treatments. In July, the Senate Finance Committee informed Gilead it was launching an investigation into the pricing of Sovaldi.

Given the impact Sovaldi’s cost will have on Medicare, Medicaid and other federal spending, we need a better understanding of how your company arrived at the price for this drug.

Gilead defends the price, citing the eventual cost savings over time. “The value of a cure … is underestimated in terms of the overall advantage that the health care system receives from it.” Yet some organizations are suggesting that treatment be withheld until the condition is more serious. The problem with that is determining how far Hepatitis C has progressed can be difficult. And there is evidence that early treatment means there is a better chance of curing Hepatitis C. Also, early treatment can avoid damage to the liver from the virus.

Withholding treatment is already a reality in the California prison system. The chief pharmacy officer of San Francisco’s Public Health Department said that if they used their entire drug budget for the year, they could only treat 24 or 26 of the 108 inmates estimated to be infected with Hepatitis C. “It’s crazy. It’s just insane. And that’s where this whole conversation about price becomes important, because at what cost?” Nationwide, at least 500,000 inmates have chronic Hepatitis C. The net costs of their treatment alone could exceed $30 billion.

Now Gilead Science has had a new treatment for Hepatitis C approved—Harvoni. It is a combination of Solvadi and the NS5A inhibitor ledispasvir. Harvoni is “the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.” The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation because of its potential to offer a major advance in treatment over available therapies. Nezam Afdhal, a principle investigator in the Harvoni trials said: “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”

The cost of Harvoni will be $94,500 for a full 12-week course of treatment. But that is roughly in line with the previous cost of Sovaldi and the drugs used with it. “Many patients should be able to take Harvoni for only eight weeks, at a cost of about $63,000.” The shorter time period can be considered for treatment-naïve patients without cirrhosis.

But the cost is still too high for many insurance companies and Medicaid programs, who are restricting the use of Sovaldi to the most seriously ill patients. Some are requiring patients to demonstrate they have not abused alcohol or illicit drugs for a number of months or limiting the treatment to “once-in-a lifetime.” Dr. Steven Miller, the chief medical officer of Express Scripts, which manages pharmacy benefits for employers and insurance companies, said: “Their budgets just are not going to be able to tolerate it.”

The small population argument justifying a high cost of drug treatment (to motivate the drug’s development) like that used for drugs like Acthar and Soliris doesn’t apply to Sovaldi and Harvoni. If every American with Hepatitis C was treated with Sovaldi, the cost would be $250 BILLION! Treating everyone on the planet would cost $14.28 TRILLION. “To put those numbers in perspective, the U.S. spent about $381 billion on prescribed medicine last year.” Gilead defended the cost of the medicine, saying: We believe the price of Harvoni reflects the value of the medicine.” The Motley Fool suggested that Harvoni could generate as much as $12 billion in its first full year on the market.

Even when factoring in the negative impacts of competition, shortened treatment durations, and the need for additional approvals, Harvoni should still double the marijuana industry’s 2018 revenue forecast by this time next year.

Gilead Sciences announced its third quarter financial results for 2014. Gilead’s total revenues for nine months ending on September 30th was $17.25 billion. This compared to $7.76 billion for the same period in 2013. $7.33 billion of the $8.6 billion in sales of Sovaldi for 2014 was made in the U.S. market.

Plain and simply, the American health care system and Americans with Hepatitis C are being held hostage by Gilead Sciences. In their pursuit of record-breaking profits from Sovaldi and Harvoni, Gilead is creating a health care crisis by refusing to negotiate a more reasonable cost to Americans. See my previous articles, “Is There No Balm in Gilead?” and I Guess I’m a Little Bit Socialist,” for more on Gilead Sciences and Sovaldi.

07/16/14

I Guess I’m a Little Bit Socialist

a hepatitis virus rbhavana / 123RF Stock Photo

Aaron (not his real name) walked into my office and said he needed my help. We were the two therapists scheduled to work that weekend with the inpatient adolescent unit at a drug and alcohol treatment center. He had been in an individual session with a sixteen year-old Hispanic girl who was always getting into trouble; usually from losing her temper. For weeks he’d been trying to get her to open up and talk about what was behind her anger. And she finally decided to tell him—she had witnessed the ritual killing of an infant.

We knew she had been a runaway with a guy in his forties and thought we had a pretty good guess of what her past trauma issues were. But we were way off. Aaron and I were friends and part of the same bible study. I‘d heard his testimony and knew that his commitment to Christ came after the accidental drowning of his young son. When he heard what the Hispanic girl had to say, all his past grief and loss came back to him.

He took me back to his office and he told her why I was there; he was just too close to his own loss to help her just then. We listened to her story of being forced to witness the ritual killing and I helped her as best I could with the memories and feelings she expressed. She kept crying and repeating how bad she felt for the baby; the baby. In closing the session, I told her that Aaron and I would pray for the dead infant and she could too if she wanted. We were not Roman Catholic, but knew that the girl was. So the prayer was intended to give her a time of closure with what she had just shared with us. We prayed; and she did also, asking God to protect and care for the dead baby.

The girl was placed on suicide watch; we told other staff about what she had disclosed. In a day or two there was a treatment review of the incident by the newly hired treatment director and newly appointed facility administrator. Our center had been recently bought by a much larger corporation. Aaron said later that everything went fine with the review—until he told them of the closing prayer we had done. Then our new bosses suddenly wanted to go over the whole thing again with a fine-toothed comb.

We had been therapeutically on the money. There wasn’t anything that could be said to be clinically wrong with what we did. But Aaron and I were told in no uncertain terms to never pray with anyone ever again. I distinctly thought that if they could have pointed to anything out of order, it would have been used to fire us on the spot. I’ve always thought that one of the greatest ironies of this was that the administrator was a former minister. It was after this incident that I began to think it was time for me to move on and I did. I went to seminary.

I didn’t stay in touch with Aaron over the years. But I ran into a mutual friend at a Christian counseling conference last year. The friend had taught the bible study Aaron and I were part of. He also had been the former director of treatment let go at our facility. The new corporate owners came in with their new treatment direction and he hadn’t been part of their plans. We caught up on what had been happening in each others lives and I began asking about other people from that time. My friend told me that Aaron had died a couple of years ago because of complications from hepatitis C. Even though we hadn’t been in touch, I still felt the loss.

Recently I posted two links on Facebook about an outrageously expensive treatment for hepatitis C, Sovaldi, which is listed to cost $1,000 per pill. Both times I received comments justifying the cost by pointing to the right of the drug company Gilead Science to charge what they consider a competitive market price; that the company has to recoup its research and development costs, etc. The first time I was upset enough to impulsively delete the person’s comments. That led to me being “unfriended.” The second time, I responded by posting links indicating how drug companies have been shown to carry out a misleading campaign to justify their profits to fund expensive, “risky” research and development. Here the organization, Public Citizen, was noted to be in favor of government control of the economy and therefore socialist.

A Yahoo News report indicated: “An estimated 15,000 people died from hepatitis C in the U.S. in 2007, when it surpassed AIDS as a cause of death.” Health care costs related to hepatitis C are expected to increase 1,800 percent by 2016. Additionally, more than a dozen European countries are joining forces to negotiate a lower rate for the drug treatment. And two U.S. senators have written to the Gilead chief executive, saying: “the pricing had raised serious questions about the extent to which the market for this drug is operating efficiently and rationally.”

So I guess when it comes to Hepatitis C treatment, I’m a little bit socialist. Either that or I take profiteering by drug companies personally. Probably both. Rest in peace Aaron.

Also read, “Is There No Balm in Gilead?”

07/14/14

Is There No Balm in Gilead?

15326843_s — balm of Gilead in an olive wood scoop. marilyna / 123RF Stock Photo

I’ve always felt there was great irony in the fact that my favorite concert memory turned out to be a way of enabling David Crosby’s drug habit. When David Crosby and Kenny Rankin came to the Syria Mosque in Pittsburgh, I made sure I had tickets. Kenny Rankin sang his cover of the Beatles song: Blackbird. David Crosby came on stage with just his acoustic guitar and went through many of his hits with CSN&Y (Crosby Stills, Nash and Young for those born after the Boomer generation). It was great. Then I read in a magazine about David Crosby’s cocaine problem. In the article, Crosby described how he arranged quick solo acoustic concert tours when he was running low on drug money.

In a Rolling Stone interview, David Crosby reflected on his unlikely survival: “‘I don’t know why I’m alive and Jimi isn’t and Janis isn’t and Mama Cass isn’t and all my other friends,’ says Crosby. ‘I have no idea why me, but I got lucky.’” Well he hasn’t been as lucky with his health. He had hepatitis C and needed a liver transplant in 1994. Phil Collins paid for his transplant.

Typical treatment for hepatitis C is 6 to 12 months of a drug cocktail consisting of interferon and ribavirin plus a protease inhibitor. Interferon treatment has both physical and psychiatric side effects. Physical side effects can include flu-like symptoms (41 to 70%), nausea (29 to 46%), anorexia (21 to 32%), and diarrhea (22%). Psychiatric side effects can include: depression (22 to 36%), irritability (24 to 35%), and insomnia 37 to 40%). Suffice it to say that treatment is not very pleasant.

When I heard the announcement about Gilead Science’s new drug Sovaldi being approved in December of 2013, I was pleased and encouraged. Sovaldi sounded like a real medical break through. It blocks a specific protein needed by the hepatitis C virus to replicate. When Sovaldi is used in conjunction with existing hepatitis C medications such as ribavirin and peginterferon-alfa, a study showed that 12 weeks after the end of the 12 to 24 week treatment regimen, 91% of untreated hepatitis C patients tested negative for hepatitis C!

This is simply amazing. Many of the people I’ve known that began interferon treatment stopped at some point because of the side effects. They simply can’t go on with their daily lives because of the medications. If Sovaldi can cut the treatment time in half and provide a 90% “cure” rate, more people will get and complete treatment.

So it seemed Gilead Science was attempting to live up to its name. Gilead Science’s name and logo intentionally uses the Biblical reference to the balm of Gilead. Gilead was a mountainous region east of the Jordan River that was famous for it healing ointment. The chorus of a classic spiritual, “There is a Balm in Gilead,” goes:

There is a balm in Gilead,

To make the wounded whole;

There is a balm in Gilead

To heal the sin-sick soul.

The existing cost for standard hepatitis C treatment (combination interferon and ribavirin therapy) before Sovaldi was steep, between $10,000 and $12,000. Maybe Sovaldi was going to be the “Hep C balm from Gilead”—or not. I was outraged to see that Gilead was charging $1,000-a-pill for Sovaldi. A full course of Sovaldi costs $84,000. The full treatment for Hepatitis C will cost over $90,000! And get this—Sovaldi costs about $130 to manufacture.

Other industrialized countries are paying roughly half of the $84,000 cost for Sovaldi. Third world countries like Egypt and India get a 99% discount. According to Dr. Steve Miller on Forbes.com, “Hepatitis C patients in the U.S. are mostly uninsured, underinsured and/or incarcerated. Medicaid, the VA and our prison system bear the brunt of the cost impact, and by extension so do all of us as taxpayers.” So it would seem that in the U.S. there is a balm from Gilead—but you’re going to pay through the nose for it.

Is there no balm [for hepatitis C] in Gilead?

Is there no physician there?

Why then has the health of the daughter of my people

not been restored? (Jeremiah 8:22)

Yes, there is a Hep C balm in Gilead; and yes, there are physicians there to oversee the treatment. But the health of the daughter of your people will not be restored if she doesn’t have good health insurance, or someone like Phil Collins able and willing to make up your financial shortfall.

By the way, first quarter total sales in 2014 for Gilead’s Hep C balm was $2.27 BILLION. It was the fastest drug launch on record. The Senate Finance Committee is inquiring about the drug. They have requested information for documents related to research and development costs of Sovaldi. Karen Ignagni, chief executive of the trade group America’s Health Insurance Plans, noted that treating all hepatitis C patients would cost $268 billion, which is $5 billion more than was spent on all prescription drugs in 2012. “This pricing, which Gilead attempts to justify as the cost of medical advancement, will have a tsunami effect across or entire health-care system.”

Also read, “I Guess I’m a Little Bit Socialist.”

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: hepatitis C