Both Inevitable and Justified

It appears that activists are distributing information that would allow for anyone to make some of the most expensive medications in the world themselves.

A case in point is Sofosbuvir (brand name Sovaldi), which is at this point the only drug which cures Hepatitis C, which sells for $1,000.00 a pill but can be made in a relatively simple home lab for $0.87 a pill, a 114,943% markup.

This means that the treatment regimen can be had for less than $100.00, as opposed to almost $100,000.00.

Drug patents have gotten out of hand, and it needs to stop:

I’ve been video chatting with Mixæl Swan Laufer for about 30 minutes about an exciting discovery when he points out that to date, the best way he’s been able to bring attention to his organization is “the old school method of me performing a bunch of federal felonies on stage in front of a bunch of people.”

I stop him and ask: “In this case, what are the felonies?”

“Well, the list is pretty long,” he said.

Laufer is the chief spokesperson of Four Thieves Vinegar Collective, an anarchist collective that has spent the last few years teaching people how to make DIY versions of expensive pharmaceuticals at a tiny fraction of the cost. Four Thieves Vinegar Collective call what they do “right to repair for your body.”

Laufer has become well known for handing out DIY pills and medicines at hacking conferences, which include, for example, courses of the abortion drug misoprostol that can be manufactured for 89 cents (normal cost: $160) and which has become increasingly difficult to obtain in some states following the Supreme Court decision in Dobbs.

In our call, Laufer had just explained that Four Thieves’ had made some miscalculations as part of its latest project, to create instructions for replicating sofosbuvir (Sovaldi), a miracle drug that cures hepatitis C, which he planned to explain and reveal at the DEF CON hacking conference.

Unlike many other drugs that treat viruses, Sovaldi does not suppress hepatitis C, a virus that kills roughly 250,000 people around the world each year. It cures it.

“Normally you have a virus, and your body fights it off or your body fights it to a standstill and you just have it forever, basically, and hope it remains dormant more or less,” Laufer said. “The holy grail for every virologist is to find a way to drain the viral reservoir, and Sovaldi does this. You take one pill of Sovaldi a day for 12 weeks and then you don’t have hepatitis C anymore.”

The problem is that those pills are under patent, and they cost $1,000 per pill.

“Literally, if you have $84,000 then hepatitis C is not your problem anymore,” Laufer said. “But given that there are other methodologies for managing hepatitis C that are not curing it and that are cheaper, insurance typically will not cover [Sovaldi]. And so we’ve got this incredible technology and it’s sitting on the shelf except for people who are ridiculously wealthy.”

So Four Thieves Vinegar Collective set out to teach people how to make their own version of Sovaldi. Chemists at the collective thought the DIY version would cost about $300 for the entire course of medication, or about $3.57 per pill. But they were wrong. “It’s actually just a little under $70 (83 cents per pill), which just kind of blew my mind when they finally showed me the results,” Laufer said. “I was like, can we do the math here again?”

Our current IP regime, particularly with regard to pharmaceuticals does not work.

Furthermore, it runs counter to the Constitutional requirements of such a system, (Article I, Section 8, Clause 8) "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

This sort of looting and rent seeking does not promote the, "Progress of Science and useful Arts," it promotes corrupt business models.

Patent and copyright are a tax on the rest of us that is provided in order to benefit the public.

Our current IP regime does not do this.

Remember the that Miracle Hepatitis B Cure?

You knwo, the one that costs $1,000.00 a pill, Solvaldi?

Well, it turns out that, in addition to being priced at larcenous expensive, the evidence of its efficacy is simply not there:

The German agency performed this assessment based on a dossier submitted by the drug manufacturer (presumably Gilead).  The assessment found some reason to think the drug beneficial, but that the evidence was sparse, left many questions unanswered, and was inadequate to assess the drug for some important patient populations.  At this point, only a summary is available in English.  It includes links to further information in German.

………

Thus the assessment concluded that the drug company dossier included at best irrelevant data that it tried to pass off as important, and inexplicably left out other data that might have been relevant.

………

Summary

It is even bloodier money if the assumption that the drug is a "well-tolerated and effective cure," which  Dr Huyler held, proves not to be true.  It is clear that most of the money that Gilead is now scooping up in the US is not to pay retrospectively for research and development or drug production. Instead, it seems likely to be supporting marketing, public relations, some investors' profits, and huge executive compensation.  When the public realizes that the money may not be buying miracles, the outrage should increase.  

The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs.

True health care reform would revisit the pact society once made with drug, biotechnology and device companies meant to promote reasonably priced innovation, but now promoting oligarchy; support transparency and honesty in clinical research; and challenge how health care managers can make millions or billions from unproven, and sometimes worthless or dangerous products.

It also turns out that the study was not double blind.

So the wonder drug may not be any more effective than existing drugs, and it costs a lot more.

What, You Mean $1000.00 a Pill is too Expensive?

A few months back, I wrote of push-back from an NGO about the price of Gilead Sciences’ Hepatitis C drug Sovaldi.

Well the World Health Organization and the pharmacy benefits management company Express Scripts are pushing back as well.

While the WHO is engaging in fairly typical hand wringing:

Gilead Sciences' new hepatitis C drug, Sovaldi, will cost $84,000 for a 12-week treatment plan, rounding out to $1,000 a day. Bound to cause a whirlwind among investors and the healthcare world, the World Health Organization has stepped in.

The drug is facing protests in the United States because of the excessively high price that Gilead Sciences set for their new product. Despite its potential effectiveness - it is projected to cure 90% of the targeting hepatitis C patients - its gross income will exceed that of every other pharmaceutical drug if a majority of 150 million hepatitis C patients purchase it.

As a result, the World Health Organization is urging Gilead Sciences to make the drug cheaper and more accessible to help those in dire need of the medication and to avoid creating tremendous problems for insurance companies and investors. But pharmaceutical companies argue that they need to charge high prices on new effective drugs because they need to cover the expensive cost of development.

Express Scripts is playing some serious, and very well deserved, hardball:

Express Scripts Holding Co. (ESRX), a pharmacy benefit manager that handles more than 1 billion prescriptions annually in the U.S., is ratcheting up its effort to force Gilead Sciences Inc. (GILD) to cut the $84,000 price of its new hepatitis C pill Sovaldi.

Express Scripts plans to ask its clients, composed of national employers, health insurance plans and government agencies, to join a coalition that would stop using Sovaldi once a rival medicine is approved for the U.S., expected next year, said Steven Miller, chief medical officer of the St. Louis-based company. Express Scripts said in December it may block reimbursement for Foster City, California-based Gilead’s pill once other new hepatitis C therapies are on the market.

“What they have done with this particular drug will break the country,” Miller said in a telephone interview. “It will make pharmacy benefits no longer sustainable. Companies just aren’t going to be able to handle paying for this drug.”

Cara Miller and Amy Flood, Gilead spokeswomen, didn’t return phone calls yesterday seeking comment. The company has previously justified the price for Sovaldi by saying it would pay for itself by avoiding future complications from the virus.

(emphasis mine)

Note that Sovaldi has been granted a breakthrough designation by the FDA, which allows the drug to hit the market faster, for which the US government, and the taxpayers got a consideration of ……… nothing at all.

Basically the declaration of "breakthrough" status, and that is the term the 2010 law uses, is a subsidy to the manufacturer, both extending the time available to Gilead under exclusivity, and reducing capital costs by allowing revenue to start earlier.

Maybe the FDA should include a "reasonable and justifiable pricing" clause to things like this.

Pushback on Drug Pricing

The AIDS Healthcare Foundation is lobbying to keep the $1000.00 a pill Sovaldi out of Medicaid formularies.

I wholeheartedly agree enough is enough:

In a series of letters to be sent to state Medicaid directors starting today, AIDS Healthcare Foundation (AHF) President Michael Weinstein will ask the state directors to block Gilead Sciences’ new $1,000-per-pill Hepatitis C drug Sovaldi (sofosbuvir) from inclusion on their respective state Medicaid and other drug formularies. The drug was approved by the F.D.A. on December 6, 2013 and Gilead immediately announced that it would price the drug at $84,000 for a twelve-week course of treatment—or $1,000 per tablet—making it one of the most expensive drugs ever marketed. Suggested treatment guidelines also require that Sovaldi be used with another drug, ribavirin (a nucleoside inhibitor), further adding to the cost of the prohibitively expensive course of treatment.

“When is enough, enough? At $1,000-per-pill, Sovaldi is priced 1,100% more than Gilead’s most expensive AIDS drug, Stribild, its four-in-one AIDS drug combination, which was priced at $80 per pill a year ago when it came to market,” said Michael Weinstein , President of AIDS Healthcare Foundation. “At that time, Stribild’s price was 35% more than Atripla, the company’s best selling combination HIV/AIDS treatment, and made Stribild the highest priced first-line combination AIDS therapy. Now, Gilead has set a new benchmark for unbridled greed with its outrageous price for Sovaldi—a price that some pharmacy industry sources suggest represents a retail markup of 279,000% over the cost of actually producing the drug.”

In his letter to state Medicaid directors, Weinstein wrote, “Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).1 This represents a retail markup of over 279,000%.

Enough is f%$#ing enough.

This sh%$ needs to stop.