Thursday, March 6, 2014

Cure for Hepatitis C: The Politics and Profits behind a Breakthrough

by Nomad

A breakthrough in curing a silent killer, Hepatitis C, should mean that patients will have a new lease on life. But unless they are extraordinarily wealthy or they  live in a state that expanded Medicaid in the wake of the Affordable Care Act, these people will be at the mercy of the profit-driven free market. So for most of the uninsured or under-insured Americans, it will mean no cure at all.

Good News 
Even for researchers who are loathe to use the word "cure," there's no question that the news is very good,

The Denver Post is reporting of a breakthrough drug for hepatitis C in clinical trials at the University of Colorado Hospital. This new anti-viral is being called the blockbuster cure for patients who have long had to endure debilitating treatment for this liver-destroying disease.

Astoundingly, Sovaldi, a daily-dose pill manufactured by California-based Gilead Sciences Inc., has cured about 90 percent of patients in only 12 weeks when used with older drugs, studies nationwide have found.
In other words, it's a very nearly the cure for a killer. Not life-long treatment like the HIV drug therapy, but an actual eradication of the affliction. 
A big big deal.

Silent Killer of the Baby Boomers
This is a disease that infects an estimated 150–200 million people around the world. In the US the majority of the estimated 3.2 million people with chronic hepatitis C virus (HCV) are baby boomer adults. Seventy-three percent of hepatitis C deaths were reported among those 45 to 64 years old.
For every 100 people who contract the virus, 75 will develop chronic infection. About 5 to 20 will develop cirrhosis over the next 20 to 30 years. Between 1 and 5 will die of cirrhosis and liver cancer. Meaning, more than 350 000 people die every year from hepatitis C-related liver diseases. The disease is found worldwide with some countries having chronic infection rates as high as 5% and above.

One of the particularly dangerous aspects of the disease is its insidious nature. Most of those infected with the virus do not know that they have it, which means they could easily be spreading it to others via exposure to blood—or, occasionally, sexual contact. The main mode of transmission in countries with infection rates above 5% is attributed to unsafe injections using contaminated equipment.

"In almost every country it is a significant public health problem, points out Charles Gore, president of the World Hepatitis Alliance, "and, in some, such as Egypt, which has 10% to 15% of its population living with hepatitis C, and Vietnam, where the prevalence of hepatitis B is 15% to 20%, it is simply overwhelming."
So curing this disease is unquestionably a great triumph for science. It's something that the researchers should be proud of. 
There is however one problem.

Now...The Bad News
Sovaldi was approved by the Food and Drug Administration (FDA) last December, but it won't be cheap. Sovaldi costs $1,000 a day and that adds up to staggering $84,000 for a 12-week supply.

Cost considerations have caused private and government insurers to weigh the full implications of coverage criteria for the drug. And that evaluation could take between three to six months.

At present, until the matter is officially settled, the Colorado state Medicaid office has a moratorium on coverage for Sovaldi treatment. On a case by case basis, the department must evaluate whether the patient has an urgent need. 

According to the Denver Post article, this breakthrough could be a game-changer, a new lease on life for the hundreds of thousands of infected patients. For the first time, chronic hepatitis is a preventable cause of premature death. If the results of the clinical trials are valid, then this disease can be treated successful and cured.

And yet, Lorren Sandt, co-chair of the Fair Pricing Coalition points out that particularly for limited-budget programs, including Medicare, Medicaid, AIDS Drug Assistance, the Veterans Affairs and prison systems. the high price for this drug creates barriers to treatment.
For many patients, time is running out. Doctors note that:
"Over time, leaving viral hepatitis untreated can lead to costly care and treatments, and lifetime costs can total hundreds of thousands of dollars. However, early detection and intervention can be cost-effective and save lives."
Now or later makes little difference to the majority of patients. The cost of a cure puts it far out of reach.
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Headquartered and founded in Foster City, California, Gilead Sciences has operations in North America, Europe and Australia. The  biotechnology company that has concentrated primarily on antiviral drugs to treat patients infected with HIVhepatitis B, or influenza.   Gilead Sciences is a star in the biotech industry, becoming one of the first companies to achieve consistent success with its products.
After much success, investors have waited impatiently for results of the promising treatment drugs like Sovaldi to make their through the pipeline. Now they are wanting to see the pay-off.

Rumsfeld and the Pandemic
A little more research in the company's history uncovered a familiar face.
Donald Rumsfeld. That's right Bush's Secretary of Defense one of the key planners of the United States' response to the September 11, 2001 attacks, which included two wars, one in Afghanistan and one in Iraq.
Rumsfeld has been a board member of Gilead since 1988 and in January 1997, was appointed Chairman of the company. He left that position in order to become Secretary of Defense. (And we all know how well that went.) 
According federal disclosure documents, Rumsfeld owned between US$5 million and US$25 million in Gilead stock.

Gilead Sciences held the patients for a famous anti-viral drug called Tamiflu, the only approved drug for fighting influenza. Gilead receives a royalty from Roche, which is in charge of manufacturing the drug, equaling about 10% of sales.

In late 2005, headlines warned that a global influenza pandemic was "imminent" and could kill "up to 150 million" according to the UN officials that was in charge of coordinating a worldwide response. At that time, at least 65 people in Asia had already died and scientists were warning that the H5N1 virus could mutate into a deadly threat.

So it must have been Rumsfeld's lucky day  when on November 1, 2005, President Bush urged Congress to pass $7.1 billion in emergency funding to prepare for a feared bird-flu epidemic. The president announced:
It's my responsibility as the president to take measures now to protect the American people from the possible that human-to-human transmission may occur. So several months ago I directed all relevant departments and agencies in the federal government to take steps to address the threat of avian and pandemic flu.
A full $1 billion of that funding was dedicated to the purchase and distribution  of two drugs supposedly equipped to fight the virus. One of those was Gilead's Tamiflu.  
Even at the time, some insiders noticed the conflict of interest. Fortune quoted analyst Andrew McDonald of Think Equity Partners in San Francisco in an article saying:
'The prospect of a bird flu outbreak may be panicking people around the globe, but it's proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences."
Who were those politically connected investors? Hard to say for sure but we can get an idea from the board of directors.  We see some familiar names like George P. Shultz and not so familar names like, Carla A. Hills,  Étienne Davignon.  In order to appreciate the connections, one can look at an attempt to map the power network.  Admittedly, realizing the impossibility of covering his connections, Rumsfeld seemed to make every effort to stay out of the decision-making process when it came to Tamiflu.

Even then, when it came to Tamiflu, there were questions about the drug effectiveness against the H5N1 threat.  According to an article in the Sunday Times in the UK, one doctor, Dr Nguyen Tuong Van, who ran an  intensive care unit at the Centre for Tropical Diseases in Hanoi and has treated 41 victims of H5N1 called the bird flu drug "useless." He was quoted as saying:
“Tamiflu is really only meant for treating ordinary type A flu. It was not designed to combat H5N1"
He had found that, despite following the World Health Organization guidelines on Tamiflu on infected patients, the drug had no effect. Other doctors suggested more effectiveness if the drug were used a preventative treatment rather than on already infected patients.
Another drug derived from black elderberries. Van alleged, he alleged, had proved to be much more effective (at least 99% effective against the Avian Fku virus H5N1).
In the end, the pandemic never materialized. Of the  649 cases since 2003, a total of  385 deaths have been reported worldwide. To put that in perspective, compare the number of fatal drug overdoses in the US: over 100 persons die per day

Every nation should be prepared, of course, but as far as a global crisis it was something of a flop. Nobody's complaining about that. Still, the way it turned out could hardly have been any better for Rumsfeld and his friends.

A Matter of Business
It's important to remember that, despite the questionable morality, Gilead is simply following the industry practice of pricing its wonder drug as high as the market will allow. Morality and charity play no part in it. This is how our system is supposed to work, we are told.
That doesn't stop advocacy organizations and physicians from expressing outrage and decrying what they see as "a brazen and greedy" move.

As Benjamin Ryan, writing for Hep magazine, explains:
The pharmaceutical giant stands to reap a colossal reward for its investment in hep C therapeutics. Analysts with BMO Capital Markets expect Sovaldi’s 2014 revenue to come in at around $1.9 billion. Matthew Roden, an analyst at UBS, has said that the drug’s annual sales could eventually climb higher than the $13 billion brought in by Pfizer’s cholesterol-lowering Lipitor (atorvastatin) in its biggest year. 
That's quite a motivation for being brazen, especially with investors breathing down your neck.

The costs of this drug- which could potentially mean life or death for the millions of hepatitis patients- could easily tax the US health care system. In those states that have no intention of expanding medicaid, it's quite certain that Sovaldi treatments will be out of the question.

Is it possible to cut the costs? Perhaps. One UK medical study has suggested that costs for other anti-viral drugs for a 12-week course could be as little as $100 to $250 a person. But it's hard to see how that will ever happen in the US.

The worst part of it all is that, even before this latest announcement, anti-viral treatments really are bringing down the numbers of people dying from this disease. We are on the right track, clearly.
A government survey found that the number of Americans with hepatitis C fell 16 percent to 2.7 million over almost a decade. Most doctors think this is a result of new, more effective treatments.  By combining these treatments with a practical way to provide clean needles for addicts and that number could fall much further.
But given the cost of the new drugs, that seems an unattainable goal for the last superpower.
The number of people living with viral hepatitis who will be eligible for Medicaid in 2014 will vary by state. However, the Supreme Court’s decision in June of 2012 greatly limited the ability of the federal government to enforce the ACA’s Medicaid expansion, creating a question of whether and when every state will comply with the coverage expansion. In states that do not opt to expand Medicaid in 2014, the status quo continues for people living with viral hepatitis.
Status quo is not a good thing for a patient looking for a cure.

Third World Texas
Let's turn to one state and see the effects of the one-two punch of high prices and the rejection of Medicaid expansion.

One study found that 387,395 Texans (1.79%) are infected with the hepatitis C virus. Chronic hepatitis C is common in Texas and will result in an increase in complications of cirrhosis in coming years. Incarcerated individuals may have a higher prevalence of infection than the general population.
In addition, prevalence rates were generally highest in border counties where there is a concentration of extremely low-income communities. These communities are called colonias and Texas has the largest number of any state; 1,400 in all. Lacking the most basic facilities - water, sewerage, electricity, paved streets and sidewalks these poor communities have been compared to the shanty towns of Third World cities. Not unexpectedly, the people who live in these areas are also uninsured.

One report from the University of Texas in Austin notes that hepatitis is only one of many common life-threatening diseases found there.
Not surprisingly, the colonias have much higher incidences of disease than any other part of the state. Hepatitis A, salmonellosis, dysentery, cholera and tuberculosis occur much more frequently in the colonias than elsewhere. This problem is compounded by a lack of medical services: shortages of primary care providers, resident difficulties in accessing health care because of long distances to travel, fear of losing wages for time spent away from work, lack of awareness of available care, and no health insurance.
That medical study referenced above also noted that all the data points to the need for aggressive anti-viral treatment for infected patients- especially the uninsured poor.
However, prescriptions for antiviral therapy in the state have averaged about 3000 per year since 1998, so we can safely assume that only a small percentage of patients are currently being offered such therapy.
Nor they will be as long as politicians refuse to take seriously the problem of poverty and disease, preventative health and insurance for the poor.

That's only in Texas. Multiply those numbers and those outcomes in every state that has refused medicaid funding, such as, Georgia, Missouri, North Carolina, Virginia Louisiana, Oklahoma and Wisconsin. Then factor in other treatments that will come for other diseases. All of them life-changing and most of the unaffordable to most Americans, (not to mention the rest of the world).
*   *   *   *
In the end, it makes no moral sense for researchers to develop breakthroughs if corporations refuse to price the wonder drugs reasonably. The treatments must be available to both rich and poor- even if that means extending the length of patent rights five more years before they become generic. It makes no sense to have dedicated scientists idealistically making wonder drugs when politicians deny their own citizens affordable access to them.
Between these two policies for healthcare, one economic and one political, Americans will be reduced to living in a nation hardly better than your average Third World country.