When Turing Pharmaceuticals jacked up the price of a toxoplasmosis-fighting drug (commonly used by AIDS and cancer patients) to $750/pill (a previous company sold it for $1/pill), CEO Martin Shkreli defended the move, saying the money would be dumped into research for a new and better drug. Of course, this is the usual defense offered by any pharmaceutical company that institutes a rate hike, but these claims are rarely followed through on. (And when they are, the R&D costs tend to be very overstated.)
Daraprim has been on the market since the 1950s and does its job well. The patent has long expired but the FDA's policies make it difficult for anyone to formulate a generic version of this "sole supplier" drug. When there's no competition, it's a seller's market, and Martin Shkreli is making the most of it.
This pirce hike set off a wave of backlash that included several presidential candidates. So, Shkreli hit the airwaves, promising to walk back the price to something more reasonable, whenever he got around to it. What he considered "reasonable" was never explicitly stated and, to date, the price has yet to come down. Now, another company is stepping in to offer patients something much more affordable. (via MetaFilter)
Turing CEO Martin Shkreli became “the most hated man in America” last month after raising the cost of the drug, commonly used to treat parasitic infections in immunocompromised patients, from $13.50 per pill to a staggering $750 per dose, claiming the company’s exorbitant price hike was justified. Now Imprimis will offer their alternative to those who need Daraprim for less than $1 per tablet.
Imprimis is now offering customizable compounded formulations of pyrimethamine and leucovorin in oral capsules starting as low as $99.00 for a 100 count bottle, or at a cost of under a dollar per capsule. Compounded medications may be appropriate for prescription when a commercially-available medicine does not meet the specific needs of a patient.
There's more detail in the disclaimer towards the end of the press release.
Imprimis' finished compounded drug formulations do not have an FDA-approval label for recommended use. Imprimis compounded formulations are not FDA approved and may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.
So, those looking for a cheaper variant of Daraprim will have to find a physician willing to prescribe a drug that doesn't have the FDA's blessing for this particular use. The compound will likely work as well as Daraprim, but it does open doctors up to additional liability. That being said, some doctors may be willing to do this as the only other option for some patients will be no medicine at all.
The other problem is that the FDA could come down aggressively on pharmaceutical companies who market drugs for non-FDA-approved purposes. Imprimis is exploiting a loophole in the system, albeit one much more easily closed than the FDA's loophole-esque sheltering of "sole supplier," off-patent drugs -- the sort that most often see astronomical price hikes post-acquisition.
But for now, it's the market system at work -- the same market system Shkreli used as a justification for raising Daraprim's price. Zero competition led to Turing's $750/pill price. A little competition might push Shkreli to drop Daraprim's retail price lower than he actually wanted to. (And, again, no price drop has been instituted at this point.) But given Shkreli's past use of the FDA as his unofficial partner in stock-shorting moves, it's far more likely he'll be asking the agency to eject his new competitor from the playing field.
We've mentioned before how yeast can produce a bunch of useful stuff, beyond bread and beer. Synthetic biology promises to give us engineered microorganisms that can make almost any specialty chemical or even some biofuels. Brewing medicine might not be too far away, and it might be incredibly difficult to control "controlled substances" in the very near future.
Martin Shkreli -- who became the personification of a deeply-reviled industry thanks to his insanely-exorbitant price hike on a 60-year old drug -- has heard the disapproving roar of the crowd and will do… something… at some point in the future… to make things right. Or at least a bit more right-ish.
“We’ve agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit,” he told ABC News. “We think these changes will be welcomed.”
With nothing else to go on (other than Shkreli's continued assertions that the drug is still underpriced), the public will just have to assume that the new price point, whenever it arrives, will be barely above cost. (Considering it was produced for a $1/pill before Turing's purchase, one would think a significant reduction in price would still leave plenty of room for profits and additional R&D.)
Turing's mini-debacle has damaged the pharmaceutical industry. It has drawn even more heat from legislators and presidential candidates. It has even negatively affected more tangible aspects, like stock prices. Shkreli's actions have also drawn attention to the oft-ignored regulatory procedures that allow companies to fully exploit old drugs and medications, even without the protective power of active patents. Derek Lowe at Science Magazine explains the route to securing post-patent monopolies.
By various means, old generic compounds have ended up as protected species, and several companies have made it their business to take advantage of these situations to the maximum extent possible. The FDA grants market exclusivity to companies that are willing to take “grandfathered” compounds into compliance with their current regulatory framework, and that’s led to some ridiculous situations with drugs like colchicine and progesterone. (Perhaps the worst example is a company that’s using this technique to get ahold of a drug that’s currently being provided at no charge whatsoever).
Combine this with the bottleneck Turing generously refers to as "distribution" (via a single specialty pharmacy or directly from Turing itself) and you have everything you need to demand any amount you want for a lifesaving drug with a limited market. Everything being said about R&D investment is just smoke until proven otherwise.
Following his short statements promising unquantified price drops at an unspecified point in the future, Martin Shkreli -- who seemed to relish praising himself/insulting his detractors from this social media platform -- took his Twitter ball and went home.
Turns out the market will bear far less than Turing thought, even with the benefits of a tightly-controlled distribution chain and the FDA's assistance in keeping competitors off the playing field. A whole lot of people who will never use the drug managed to nudge the price downward, and all within 48 hours.
Martin Shkreli -- founder of Turing Pharmaceuticals and overnight poster boy for everything that is wrong with the pharmaceutical industry -- spent a lot of yesterday defending his 5000% price hike on Daraprim, a drug that treats victims of toxoplasmosis. That the drug has a nexus with cancer and AIDS sufferers (basically anyone with a diminished immune system) made the price increase seem even more unconscionable.
He claimed raising the price from $13.50/pill to $750/pill was done in the interest of the same people who would likely find it suddenly prohibitively expensive to take the drug.
“With these new profits, we can spend all of that upside on these patients who sorely need a new drug in my opinion.”
Dr. Wendy Armstrong, professor of infectious diseases at Emory University, questions Turing’s claim that, after more than 60 years of physicians using Daraprim, there is a need for a better version of the drug.
“I certainly don’t think this is one of those diseases where we have been clamoring for better therapies,” says Armstrong.
Next, there's the inherent ridiculousness of this assertion, which portrays Turing's plans for Daraprim as a reverse pyramid scheme, in which future "investors" will benefit from the gouging of those who got in on the ground floor.
On top of that, Shkreli claims the drug is still underpriced, despite having been sold for $1/pill before its acquisition by the company Turing acquired it from.
While it's true that drug research and development can be expensive, it is nowhere near as costly as this price hike would indicate. Shkreli tossed out the easily-debunked claim that it costs $1 billion to bring a new drug to market. The actual cost is considerably lower (~$55 million), according to research using the same data drug companies provided to backup their claims of $1.3 billion in R&D costs per new drug.
Data also shows pharmaceutical companies spend far more on marketing than research and development. They have to. Most "new" products on the market aren't actually new. They're just variants on what's already available. It's tough to sell a "new" drug that doesn't outperform a competing product, hence the increased marketing expenditures.
Shkreli also used a variant of "everyone else is doing it" to defend the price jump. He pointed to the existence of other cancer drugs costing "over $100,000" per treatment as justifying Turing's price increase. But being slightly less exortionate than competitors isn't the same thing as being "good."
Shkreli has little interest in being good, no matter what altruistic assertions he makes. His former company -- from which he was ousted over accusations of stock price manipulation -- also jacked up the price on an essential drug just because it could.
When Retrophin acquired rights to Thiola, the drug cost about $1.50 per pill. [Patients take multiple pills per day.] Now, Retrophin has decided to charge more than $30 for the same Thiola pill. Retrophin says it has plans to change the Thiola dose and develop an extended release version of the drug, but I have seen none of those changes yet. To my knowledge, Retrophin hasn't yet done any of this work -- except to drastically increase Thiola's price.
And indeed, Retrophin never did. From a 2015 presentation, it's generating sales for Retrophin, but nowhere in it is any indication the company is actually working towards an extended-release version of the drug.
I asked Shkreli about this and he claimed the company ditched the R&D plans after it ousted him. Maybe this is true, but it doesn't exactly instill any confidence in Shkreli's latest claims that price hikes are being done with an eye on increased R&D spending. Instead, they look like nothing more than the normal deflection performed by drug companies after controversial price increases.
Other circumstantial evidence does little for consumer confidence. Not only is Shkreli being sued by his former company for fraudulent behavior, he's previously been taken to court (by Lehman Brothers) for a $2.3 million loss he incurred (but never repaid) when his bet on a market decline went south. The complaint accuses him not only of failing to pay Lehman what was owed, but of pushing through the transaction without actually possessing the funds to cover the original purchase.
Shkreli also has a history of thriving on market failure. He has made money shorting pharmaceutical stocks while simultaneously engaging in questionable behavior. Here's a "treatise" he wrote detailing the negative aspects of one company's research efforts, which clearly states at the top of each page (for legal reasons) that he stands to personally gain if the company's stock price drops.
DISCLAIMER: The authors of this article have a conflict of interest and will benefit financially if the stock price of VTL falls. The authors reserve the right to change their investment if the price of VTL changes dramatically. Please read the Disclosure at the end of this paper for more information.
(This was tracked down from a deleted tweet by Martin Shkreli. Other Twitter users had commented on it, so it was recoverable from Google cache. Here's a screenshot, because the cache won't stay live for long.)
But he's also been accused of actions that are more than simply treading the edge of legality. A heated Twitter exchange implies Shkreli talked the FDA out of a drug approval -- something that hurt the company producing the drug, but paid off for Shkreli's stock short.
Shkreli's history does little to back up his assertions of altruistic goals and a future full of well-funded research and development. Instead, it shows someone who's willing to exploit every last dollar out of something and leave its dessicated corpse behind.
What he has done is anger the "community" he's a part of. Drug prices were already being subjected to the scrutiny of crusading legislators. Now, drug prices are no longer under the Congressional microscope. They're also being projected onto the Jumbotron that is social media. No less than presidential candidate Hillary Clinton offered up her view on the price hike, promising a plan to address the problem.
On top of that, share prices for several drug companies fell the day the Daraprim price hike went viral. That this may have worked out well for Shkreli can't be ignored, considering his prior experience with shorting pharmaceutical companies. Maybe this was part of the plan: Short pharma stocks. Jack price up on newly-acquired drugs. Play the villain while cashing in on the market decline.
That's all speculation, of course. What is certain is that Martin Shkreli is not THE problem. (He's not even "Big Pharma," even though several editorials have placed him in this group.) He's part of the problem, but his specific actions are more about exploiting obscure drugs that competitors aren't interested in. His actions shed little light on the genesis of high drug prices.
The original issue is patents. That has been mostly ignored by legislators and opinion pieces during the most recent push for some sort of drug pricing controls. And it will continue to be ignored because Daraprim's price hike is completely unrelated to patent monopolies. Turing's exclusive license for Daraprim includes only the use of the trademarked name. The patents have expired. Anyone can make it, but no one's been particularly interested in offering an alternative. (Maybe this will change now that a company has a chance to take on the villain du jour…)
But it's patents that make drugs unaffordable in the first place. New drugs are given, at minimum, 20 years of competition-free sales. That's two decades (at least) where drug companies can charge whatever they want because no one else can offer a competing product. Companies -- like Shkreli -- will claim they need this exclusivity to recoup "massive" research and development costs. But this simply isn't true. Pharmaceutical companies enjoy massive profit margins, much more than would be expected if they were faced with meaningful competition. The lie is exposed when patents expire. Prices fall dramatically once the market is opened, including that of the original manufacturer's.
So, if the government really wants to tackle the problem of overpriced drugs, it needs to start with the protections it grants that allow this to happen. But this seems unlikely to happen because drug companies have significant "buying power" when it comes to legislation, no matter how many people come forward to testify about being priced out of essential treatments.
Shkreli, however, is specializing in finding "orphan drugs" -- drugs for rare conditions that are no longer under patent protection (which would raise the acquisition price significantly) but which have seen little to no competitive movement over the years. His decision to implement a 5000% price increase, despite minimal costs (and benefiting from R&D performed 60 years ago), is one he can make because there's no market force in place to stop him. So, he may be the poster boy for everything that's wrong with the pharmaceutical industry, but he's not really indicative of the ongoing problem.
What he is, however, is an opportunist with a hedge fund background and a history of market exploitation. Any claims of altruism or searches for better treatments should be met with intense skepticism.
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Did you know you can occasionally find people discussing narcotics on the Internet? Russian Internet regulator Roskomnadzor (the Kremlin's "Federal Service for Supervision in the Sphere of Telecom Information Technologies and Mass Communications") is pretending to have only recently figured this out, and is working tirelessly to purge this naughty behavior from the Internet. Of course, they're ingeniously doing so in a way that breaks the Internet for everybody else, often taking entire websites offline simply because of one yahoo's heady pontifications on dope.
The country recently thought it would be a great idea to ban all of Reddit because of one thread on growing hallucinogenic mushrooms. Reddit complied and was unbanned after deleting the content, since complying with country-by-country censorship requests (sometimes reasonable, sometimes not) is something Reddit's ok with these days. This week, Russia briefly banned all of Wikipedia as well because of one entry on charas (an Indian version of hashish). Instead of censoring the entry in question (like Reddit), Wikipedia refused and only changed the URL of the entry so it technically adhered to Russian law:
"Wikipedia refused to comply with the request and instead made a small change to the URL of the charas hashish article, technically putting it in compliance with Russian law. The old page now features a list of seven different Wikipedia entries on the various meanings of the word “charas,” while the original text about charas hashish is completely intact, but is now accessible at a new URL on the encyclopedia's website."
As of yesterday, Roscomnadzor wasn't satisfied, saying it would (re-)ban all of Wikipedia. Unless, of course, the site was willing to make one notable change:
"Roscomnadzor's press-office also said they didn't intend to block the whole website, and would be able to only block the offending content and pages, provided Wikipedia's management “cooperated” and removed the HTTPS encryption protocol that puts the whole website in danger of being blocked."
So yeah, this isn't just another government being stupid and filter happy. Russia is filtering these websites under the authority embedded in a 2012 censorship law, whose purpose was purportedly to protect the children from the Internet's naughty bits. The bill's real purpose, of course, was to create an intentional, obfuscated slippery slope, designed specifically to aid in expanding control over the Internet. So Russia's sudden interest in playing pointless drug content Whac-a-mole is actually an attempt to reduce the overall use of encryption and make snooping easier:
"This is an important case because it’s part of the general offensive against https. Roskomnadzor and the FSB [security services] don’t know what to do with it,” said Andrei Soldatov, a journalist and author of Red Web, a book about the Russian internet. Soldatov said SORM, the system Russia uses for internet surveillance, does not work with the more secure https protocol, also used by sites such as Facebook and Gmail...
Soldatov speculated that the move against Wikipedia could be part of a test of another strategy: by threatening the site with bans over single pages, the site could be forced off https to ensure that the whole site is not affected when only one page is banned. Soldatov said: “There are two options for https: the first is to have access to the data before encryption, which explains the demand to store servers in Russia. The second is to try to force services to give up on https, which is what is happening with Wikipedia.”"
So basically, the Russian government is assaulting encryption, expanding Internet surveillance power and cracking down on critics -- under the pretense of protecting the children from bonghits. Remember, though, killing journalists, encouraging violent homophobia and pumping the Internet full of propaganda twenty-four hours a day are still on the recommended hobbies list in Putin's Russia.
Getting a shot isn't the worst thing in the world, but it's not exactly enjoyable, either. Early phlebotomists used leeches to draw blood from patients, but doctors don't generally recommend that anymore -- and sterile hypodermic needles are far more commonly used. However, if you've ever had one of your veins pierced (sometimes multiple times due to human error), you may have wondered why needles can't be as painless as a mosquito bite. Well, maybe they can in the near future -- it might cost a little more, though.
As we're in the middle of crunch time for the final TPP negotiations, New Zealand's Prime Minister John Key has finally admitted what many experts have been saying for years -- that under the TPP, drug prices will undoubtedly rise, because it extends monopoly protections on important medicines. Key tries to play this off as no big deal, because it's the government paying for the medicine so the public won't notice (leaving aside the fact that it's their tax dollars). However, folks who actually understand basic economics note that, when the price goes up, access to drugs gets more difficult even in New Zealand, where it's noted that some key life saving drugs have not been made available because they're too expensive. One doctor in New Zealand talked about how other expensive drugs are not available:
He said 300 people died of malignant melanoma each year. Patients would benefit from using the new drug but it cost $100,000 to $200,000 annually for each person. In total that would cost the drug-buying agency Pharmac $30 million to $60 million a year.
Dr Fitzharris said that under TPP it was likely getting access to these new, more effective drugs would be delayed even further.
Medicines New Zealand says the most recent OECD report shows New Zealand comes last out of 20 countries when it comes to access to new medicines.
Back in the US, even a bunch of Congresscritters who voted in favor of giving the USTR fast track authority appear to be having a bit of buyer's remorse as they've asked the USTR to explain why it appears the current draft of the TPP will make drugs more expensive rather than less.
We are concerned that the TPP would fail this scrutiny if it does not meet or exceed the standards set under the May 10th Agreement, reached by House Democrats and the Bush White House in 2007, with respect to timely access to affordable medicines in developing countries.
Specifically, AARP objects to intellectual property provisions in the draft TPP agreement that unduly restrict competition by delaying consumers’ access to lower-cost generic drugs. These anticompetitive provisions include extending brand drug patent protections through “evergreening” drug products that provide little to no new value and prolong high prescription drug costs for consumers, linking approval to market generic or biosimilar drugs to existing patents in a way that protects only brand drugs, and increasing data exclusivity periods for biologics that further delays access by other companies to develop generic versions of these extremely high-cost drugs. These provisions are all designed to ensure monopoly control by brand-name drug companies.
How can the USTR and the Obama administration continue to insist that the TPP is in the public interest when it's abundantly clear that it's in the pharmaceutical companies' interests instead?
Over the last few years, we've seen leaks here and there of the various chapters of the TPP agreement, but generally ones that are quite out of date. The latest public leak of the "intellectual property" chapter that I'm aware of was done last October by Wikileaks and was the version from the previous May (2014). Now, Politico claims that someone has leaked the May 2015 version, though Politico has not published the document (which, frankly, is pretty lame for a journalism property). But, based on Politico's report, the agreement still looks to be what everyone's been saying it would be: a huge gift to giant corporate special interests, such as Big Pharma:
The draft text includes provisions that could make it extremely tough for generics to challenge brand-name pharmaceuticals abroad. Those provisions could also help block copycats from selling cheaper versions of the expensive cutting-edge drugs known as “biologics” inside the U.S., restricting treatment for American patients while jacking up Medicare and Medicaid costs for American taxpayers.
“There’s very little distance between what Pharma wants and what the U.S. is demanding,” said Rohat Malpini, director of policy for Doctors Without Borders.
In response, the USTR falls back on its standard lame reply, about how draft texts are not "final." But this is why it's actually important to post these draft texts publicly, because what the draft Politico saw appears to show is that, whether or not it gets it, the USTR is fighting for policies that would harm poor, sick people, and massively benefit giant pharmaceutical conglomerates.
The highly technical 90-page document, cluttered with objections from other TPP nations, shows that U.S. negotiators have fought aggressively and, at least until Guam, successfully on behalf of Big Pharma.
That bit of information seems rather important in determining whose interests the USTR is truly representing in these negotiations. Remember, that while the final agreement will be posted publicly, the negotiating texts (which show what each side argued for) are being kept secret for four yearsafter ratification -- by which point the staff at the USTR will likely have turned over greatly, and whoever is there now can pretend they had nothing to do with the negotiating positions that the US is now locked into.
And, of course, now that fast track is the law, Congress can't even step in to fix it. They'll only be allowed an up/down vote on the entire agreement -- with tremendous pressure on them to approve the whole thing, even if there are dangerous provisions mixed in the overall agreement.
Of course, we all know that this is why the agreement is secret. It's not politically feasible for the US government to publicly show that it's fighting against the health interests of the public and in favor of pharma profits. But it appears that's exactly what's happening behind closed doors. And that seems... wrong.
Genetically engineered organisms already produce some highly valuable products for us. Insulin used to be harvested from the pancreases of pigs, but now stockpiles of human insulin can be made using a fermentation process with bio-engineered bacteria. Various kinds of yeast can produce different kinds of breads and beers, but if we can modify these tiny organisms at will, yeast could produce an incredibly wide variety of products. Just check out these links on the versatility of yeast.
