DailyDirt: Killing Those Tiny Germs

from the urls-we-dig-up dept

The overuse of antibiotics may be leading us into the "post-antibiotic era" where we'll face numerous bacteria that are resistant to our most advanced drugs. We may need to develop different strategies for identifying antibiotics or try various phage therapies to fend off antibiotic-resistant superbugs. Here are just a few links on finding new antibiotics and using bacteriophages in medicine.

• If we really met the end of antibiotics without any medicines to fight bacterial infections, it would be horrible. If you think Ebola is scary, just read up on MRSA and KPC-Oxa 48. [url]
• Tweaking antibiotic drugs can still produce some variants that may extend the usefulness of these pharmaceuticals by several years. A chemically-modified vancomycin has been discovered with 10-100 times the potency of the native compound. [url]
• The strategy of looking for new antibiotics in natural products has provided diminishing returns as researchers discovered they were finding the same compounds again and again, but new ways to genetically identify microbes could help refine the screening process and avoid redundant targets. Compiling a database of known genes could help identify potentially new antibiotics by highlighting the strains that might be more fruitful for novel drug targets. [url]
• Viruses are not evil. Bacteriophages actually keep us healthy by infecting and killing off disease-causing bacteria. Phage therapy could be a viable alternative to using antibiotics, but using viruses to fight off infections is not a widely used procedure in Western medicine (yet). [url]

If you'd like to read more awesome and interesting stuff, check out this unrelated (but not entirely random!) Techdirt post via StumbleUpon.

Filed Under: antibiotics, bacteria, bacteriophages, biotech, drug discovery, health, kpc-oxa 48, medicine, microbes, mrsa, phage therapy, pharmaceuticals, superbugs, vancomycin, virus

More Abuse Of The Orphan Drug System: Taking Treatment From Free To $80,000 A Year

from the regulatory-loophole dept

Last year, we wrote about a disturbing abuse of the orphan drug system in the US, which is designed to encourage the development of treatments for rare diseases, but which in practice can allow companies to increase prices hugely. Here's another example, reported by Adam Feuerstein in The Street, that is in some ways even worse. It concerns a company called Catalyst Pharmaceutical Partners, which has just reported what seems like good news for those suffering from Lambert-Eaton Myasthenic Syndrome (LEMS), a progressive, muscle-weakening disease. Catalyst has announced positive results from a final phase trial of a drug called "Firdapse." As The Street article reports, analysts believe that once approved by the US Food and Drug Administration, Firdapse could cost between $60,000 and $80,000 per year if it is designated an orphan drug, which brings with it seven years of marketing exclusivity. That might seem the going rate for new drugs, but there's a nasty twist in this tale, as Feuerstein notes:

Firdapse is not a new treatment for LEMS. The active ingredient in Firdapse is a compound known as 3,4-Dap, which has been available in the U.S. for more than 20 years. Doctors treating the small numbers of LEMS patients in the U.S. can obtain inexpensive 3,4-Dap from compounding pharmacies. It's even given away for free to doctors and patients by a tiny New Jersey drug maker, Jacobus Pharmaceuticals.

That means that Catalyst took no risks with Firdapse. Indeed, it didn't really do anything at all, as Feuerstein explains:

The company did no development work, made no effort to improve the drug's efficacy, safety or convenience for patients.

And yet despite that fact, it stands to profit handsomely:

For the zero work done by Catalyst, LEMS patients and their insurance companies will be paying as much as $80,000 for the exact same drug they use now for a fraction of the cost, if not gratis.

Derek Lowe, writing on Corante, puts it well:

I can think of no possible reason, no public good that comes from taking a drug that was easily available and working exactly as it should and have someone suddenly be able to charge $80,000 a year for it. This is not a reward for innovation or risk-taking -- this is exploitation of a regulatory loophole, a blatant shakedown, or so it seems to me.

What makes things worse, is that just a few weeks before, Lowe had described exactly this behavior from another company, Retrophin, which bought the marketing rights to a drug called Thiola. Here's what happened next:

Retrophin hasn't done any new trials, and they haven't had to. They've just bought someone else's old drug that they believed could be sold for twenty times its price, and have put that plan right into action. No development costs, no risks whatsoever -- just slap a new sticker on it and put your hands over your ears. This is exactly the sort of thing that makes people go into fist-clenching rages about the drug industry, and with damn good reason. This one enrages me, and I do drug research for a living.

He's probably not alone in being enraged, but this kind of abuse is so lucrative for the companies prepared to take this route that we're probably going to see more of it until this particular loophole is closed.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Filed Under: drugs, firdapse, monopoly rents, orphan drugs, pharmaceuticals
Companies: catalyst phamaceutical partners

FTC Finally Sues Pharma Companies Over 'Pay For Delay' Deals

from the and-what-about-all-those-overpayments? dept

For some time now, Techdirt has been following the "pay for delay" scandal, whereby a big pharma company buys off manufacturers of generics so that the former can continue to enjoy monopoly pricing long after its patents have expired. As we've reported, the authorities have finally started to clamp down on this abuse of the patent system. At the end of last year, two drug companies were fined by the European Commission, and now it looks like the FTC wants to follow suit, as the Wall Street Journal reports:

For the first time since the U.S. Supreme Court ruled last year that so-called pay-to-delay deals may be subject to greater antitrust scrutiny, the U.S. Federal Trade Commission has filed a lawsuit charging drug makers with violating anti-trust laws and hurting consumers in their collective pocketbooks.

Specifically, the agency charged several drug makers -- including AbbVie, Abbott Laboratories, which spun off AbbVie, and Teva Pharmaceuticals -- for striking deals that delayed the availability of the widely promoted AndroGel testosterone replacement therapy, a $1 billion seller.

The article includes some details on how the "pay for delay" deals worked:

In its lawsuit, the FTC charges that AbbVie, Abbott and Bevins Healthcare filed “sham” patent litigation against potential generic rivals, including Teva, and then entered into an allegedly illegal patent settlement in order to thwart competition.

Although it's great that the FTC is finally tackling this problem, it's regrettable that it had to wait so long for that ruling by the Supreme Court (pdf) to give it the legal basis for pursuing pharma companies:

The FTC had spent years trying to convince Congress and the courts that pay-to-delay deals hurt the economy. The agency, in fact, regularly released reports estimating the deals cost consumers dearly. In the last such report, which was issued in early 2013, the agency estimated the deals cost Americans $3.5 billion annually and contributed to the federal deficit.

The delay in bringing these cases doubtless means that the companies engaging in this behavior have made some serious profits as a result -- and that the public has been forced to pay billions of dollars unnecessarily.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Filed Under: androgel, drugs, ftc, patents, pay for delay, pharmaceuticals
Companies: abbott laboratories, abbvie, bevins healthcare, teva, teva pharmaceuticals

EasyDNS Tries To Balance Bogus Requests To Take Down Legit Foreign Online Pharmacies Against Truly Rogue Pharmacies

from the not-an-easy-balance dept

We've written a few times about domain registrar/hosting company EasyDNS, which has been pretty vocal about how law enforcement and industry groups have recently started targeting registrars and hosting comapnies as "the soft underbelly" for censorship and coercive control. While we've covered this issue frequently as it relates to things like copyright, the real ground zero for this may be around online pharmacies. The online pharmacy space is a bit complicated -- because there are really a few different kinds. There are US-based accredited/approved pharmacies, there are overseas accredited/approved online pharmacies... and then there are flat-out rogue pharmacies dealing in illegally obtained or counterfeit medicines. Obviously the last one is in a different category altogether from the first two, but US drug companies like to conflate legal foreign online pharmacies with the rogue ones.

For years, there have been fights over the issue of "gray market" and "re-imported" drugs. The most common case involves Canadian pharmacies, which are perfectly legitimate, selling into the US, but at prices much cheaper than the drug companies would like (undercutting the prices charged by American pharmacies). Fake and dangerous drugs from rogue pharmacies are a real (if relatively small) problem. Legitimate foreign pharmacies selling into the US at cheaper prices are a made up problem by US drug companies. But those US drug companies like to take the "small" problem, and blame it on any non-US pharmacy in an attempt to block out the competition. This has been going on for years, but has ramped up recently.

We've written about how the big drug companies recently got control over the .pharmacy domain, and the indications are that they're planning to use it to block out legitimate foreign pharmacies by arguing that only online pharmacies with a .pharmacy domain are "legit" and then banning legitimate foreign pharmacies from getting the domain. Earlier this year, we also wrote about the lobbying group, the National Association of Boards of Pharmacy, telling registrars that if they complain about a site, it must be taken down.

Mixed in with all of this is the somewhat questionable setup of an operation called "LegitScript," which is an organization that claims to verify which pharmacies are legit. The history of "LegitScript" is extremely sketchy, involving a former White House official who specifically worked to block legitimate Canadian pharmacies from sending drugs to the US, and who then immediately went off to form LegitScript as a competitor to PharmacyChecker -- a similar service that verifies online pharmacies including Canadian pharmacies. Oh, and the "immediately" in the last sentence may be inaccurate as the guy, John Horton, appears to have registered the domain for LegitScript while he was still a federal government employee... Either way, the US pharma industry has worked hard to make LegitScript the standard while pushing back on PharmacyChecker.

Back to EasyDNS: the company has been fighting off these demands to shut down sites repeatedly, saying that it will only do so with a court order. After getting into a fight with the US's Food and Drug Administration (FDA) over demands to take down a bunch of domains, EasyDNS finally agreed to take down a site, after being provided with evidence that it was truly a rogue pharmacy, and someone had died from taking drugs ordered from that site. Because of this EasyDNS has adjusted its policy, saying that if you are selling drugs, you have to prove to EasyDNS that you have a license to do so, or be approved by either LegitScript or PharmacyChecker (meaning that it will allow legitimate foreign pharmacies to exist). EasyDNS is still standing up to bogus requests (including new ones from the City of London Police) to take down websites, but is being more proactive when an online pharmacy has no signs of being legitimate.

While some people complained about EasyDNS's new policy, the company's CEO Mark Jeftovic explained it as follows (after referencing the latest copyright takedown demand from the City of London Police):

So in one case we have people allegedly pirating Honey Boo Boo reruns and on the other we have people dying. We don't know where exactly, but the line goes somewhere in between there.

We have always done summary takedowns on net abuse issues, spam, botnets, malware etc. It seems reasonable that a threat to public health or safety that has been credibly vetted fits in the same bucket.

As a private company we feel within our rights to set limits and boundaries on what kinds of business risk we are willing to take on and under what circumstances. Would we tell the US State Department to go to hell if they wanted us to take down ZeroHedge? Absolutely. Do we want to risk criminally indicted by the FDA because of unregulated drug imports? Not so much.

He also notes, as we did, how Fedex was recently indicted over deliveries from questionable online pharmacies, and notes that it's only a matter of time until criminal charges are filed against a registrar or hosting company as well.

These are not easy decisions for anyone -- though, I have to imagine that truly "rogue" pharmacies are increasingly moving to the darknet and underground markets anyway. However, while some may disagree, there does seem to be a reasonable argument for why a registrar like EasyDNS decides it really doesn't want to be involved with clearly rogue pharmacies.

Filed Under: domain registrars, fda, grey market, online pharmacies, pharmaceuticals, reimportation, rogue pharmacies
Companies: easydns, legitscripts, pharmacychecker

Ebola Cure Not Fully Developed Because Big Pharma Not Interested In Saving Lives Of Poor People In Africa

from the back-burner dept

As you may have heard, there's been a somewhat scary Ebola outbreak in western Africa. You may have also heard about what some are calling a "secret miracle serum" that effectively stops the impact of the virus for those who catch it. It's an experimental drug that hasn't undergone human clinical trials yet, but it was apparently given to a couple of Americans and appears to be working. There's some indication that it would take a couple months to produce a larger number of doses -- though, again, the lack of testing here means that people really aren't sure if it will work (or if there are serious side effects).

That said, as one article notes, a big reason that there hasn't been much testing on this is because treating poor people in Africa just isn't very profitable for the drug companies:

“These outbreaks affect the poorest communities on the planet. Although they do create incredible upheaval, they are relatively rare events,” said Daniel Bausch, a medical researcher in the US who works on Ebola and other infectious diseases.

“So if you look at the interest of pharmaceutical companies, there is not huge enthusiasm to take an Ebola drug through phase one, two, and three of a trial and make an Ebola vaccine that maybe a few tens of thousands or hundreds of thousands of people will use.”

While some may question whether or not Bausch's statement is just from frustration from where he is, Big Pharma execs more or less confirm his claims. Remember that it was just a few months ago that we wrote about Bayer's CEO claiming directly that they make drugs for rich people who can afford it:

Bayer Chief Executive Officer Marijn Dekkers called the compulsory license "essentially theft."

"We did not develop this medicine for Indians," Dekkers said Dec. 3. "We developed it for western patients who can afford it."

As we noted at the time, it's worth comparing that statement to what George Merck, the former President of Merck said many decades ago concerning the pharma industry:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

It seems that we've come a long way from those days.

Filed Under: africa, clinical trials, drugs, ebola, economics, pharmaceuticals, serum

Even The Onion Is Mocking Big Pharma's Focus On Patents Over All Else

from the truth-in-humor dept

For many years, we've been pointing out that the big pharmaceutical industry has become so focused, and so reliant, on patents that they've lost sight of the plot. They don't even consider other potential business models or, you know, keeping people healthy. These days, everything is about getting and extending patents, allowing them to charge exorbitant markup rates on drugs around the globe. It's now reached the point that even The Onion is deftly mocking big pharma's patent focus, with a story titled: "New Pfizer Breakthrough Miraculously Extends Lifespan Of Near-Death Patents." Here's a snippet:

“At Pfizer, patents always come first. Our primary goal is, and always will be, keeping them alive and healthy for as long as possible. And that’s why we couldn’t be happier to announce this wonderful development.” Hilty added that nothing causes Pfizer officials more distress than seeing a once robust patent expire at a young age, a “terrible tragedy” that allows dozens of generic manufacturers to copy it and offer pharmaceuticals to customers far more cheaply.

It's both funny and depressing at the same time, because it's pretty damn accurate. It's disappointing just how far the pharmaceutical industry has gone over the years. Back in 1929, one of the leaders in the pharmaceutical industry, George Merck, declared:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

That's a noble position to take. That's not how the pharmaceutical industry acts today. At all.

Filed Under: humor, patents, pharmaceuticals
Companies: the onion

Following Backlash, White House Realizes Guy Who Opposed Obama's Own Patent Reform Plan Shouldn't Lead The Patent Office

from the how-did-it-even-get-that-far? dept

A little over a week ago, it came out that President Obama was on the verge of appointing a former pharmaceutical industry exec, who had spent years fighting against the very kind of patent reform that President Obama supported, to be head of the USPTO. It was a little odd how the news came out -- as it seemed to be clearly "leaked" to a few folks in the press that Phil Johnson was likely to be the nominee. However, the move was pretty quickly condemned, and now the same folks are saying that the White House has changed its mind, and will not offer the position to Johnson.

At the very least, that suggests that the "leak" of his name was something of a trial balloon, to see how it would go over -- and the vocal rejection (including by big patent reform supporter Senator Chuck Schumer) made the White House realize that it would be in for a pretty angry fight over the nomination. Hopefully, the next nominee isn't someone who has vocally fought against the President's own position on patent reform...

Filed Under: director, patent reform, patent trolls, pharmaceuticals, phil johnson, uspto
Companies: johnson & johnson

Big Pharma Companies Happy To Use The US Government To Push Industry Agenda, Not So Happy To Pay US Taxes

from the hardly-fair dept

Big pharma companies exert considerable influence on US trade policy. Research by the Sunlight Foundation shows that the pharmaceutical industry has been lobbying for the measures it wants in TPP longer and more consistently than any other sector. For example, one of the most important -- and contentious -- chapters of TPP is about keeping drug prices artificially high. Big pharma has also been vocal in calling for the European Union to be put on the Special 301 Report's "Priority Watch List" for daring to require that basic safety data about drugs be made available. Given this wide-ranging support from the US government, you'd think that pharmaceutical companies would be only happy to pay back in the form of taxes, say, but as Quartz points out, that's far from the case:

Pfizer's bid to purchase AstraZeneca failed, but the company's attempt to move to London in an effort to avoid US corporate taxes has inspired a new round of commentary on America's corporate tax system. Perhaps it should also spur a look at America's commitment to raising drug prices around the world.

The US taxes the global income of its companies, which has lead many of the largest to keep profits overseas indefinitely to avoid paying Uncle Sam, and even shift US profits overseas to avoid public levies. So-called “inversions” -- reverse mergers where a US company buys a foreign one and assumes their jurisdiction, as Pfizer proposed -- have also become more popular. Four US pharmaceutical companies have used the tactic to go overseas in the last year, and four more are considering similar moves.

It's probably too much to hope that the US government will abandon its unquestioning support for the pharmaceutical industry, but if more drug companies do relocate overseas to avoid paying US taxes, the public outcry against it doing so may grow.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Filed Under: drugs, pharma, pharmaceuticals, taxes, tpp, trade, ttip

European Medicines Agency Unexpectedly Waters Down Draft Policy On Sharing Drug Safety Data

from the surely-not dept

For some time, Techdirt has been reporting on the attempt to open up critical drug safety information in Europe. Despite fierce opposition from the pharmaceutical industry, in April the European Parliament adopted the Clinical Trials Regulation by a huge majority -- 547 in favor and 17 against. Needless to say, that's not the end of the story. Here's what's happened recently, as reported by the AllTrials site, which has led the campaign for access to this information held by the European Medicines Agency (EMA):

The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible.

The policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.

It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.

The EMA's draft policy also asks researchers to agree that the companies who produced the trial data can take legal action directly against the researchers if the trial sponsor considers the researchers broke any of the conditions, introducing a new and unpredictable risk of high legal costs into routine academic work.

Clearly, that's a far cry from the unfettered access that researchers have been seeking, and which the European Parliament has mandated, but which does not come into force until 2016. As a result, the AllTrials groups wrote an open letter to the head of the EMA, explaining why the watered-down draft policy would be "all but useless to independent researchers" because of the unreasonable constraints placed upon their use of the clinical trials data. The EMA chief replied with his own letter (pdf), but as the AllTrials blog politely put it:

his letter does not leave us in a satisfactory place.

A letter was also sent to the EMA by BEUC, an umbrella organization of 41 national consumer groups in Europe. It makes the following important point regarding clinical trials data [pdf]:

The volunteers who take part to clinical trials put their own life at risk of unexpected adverse drug reactions. They do so to contribute to scientific progress for the benefit of society. Therefore the results of the trials belong to them and to society at large . Everybody has the right to access the evidence used by EMA scientific committees to determine the benefits and risks of medicines.

Despite that public-spirited risk-taking by volunteers, pharmaceutical companies are trying to claim the resulting data as "commercially confidential information" that belongs exclusively to them, not to society. The BEUC letter ends by posing an interesting question:

we take this opportunity to ask you to clarify the impact -- if any -- of the settlement with AbbVie on the definition of the new policy.

This refers to the rather mysterious decision of the US pharmaceutical company AbbVie to drop its legal action against the EMA, in which AbbVie had sought to prevent the agency releasing information from clinical trials of its drugs. By an amazing coincidence, the other company suing the EMA, InterMune, has this week also cancelled its own lawsuit. BEUC wonders whether there might be some connection between AbbVie's move and the EMA's unexpected decision to bring out a new -- and neutered -- draft of its data sharing policy. Surely not....

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Filed Under: alltrials, clincial trials, data, drugs, ema, eu, european medicines agency, medicine, pharmaceuticals, transparency

Harry Reid Bows Down To Trial Lawyers And Big Pharma In Killing Patent Reform

from the same-old-story dept

Tuesday evening, I had a discussion with a friend who was working on patent reform efforts. I said that the reform effort was dead, but my friend insisted that it was being negotiated as we spoke, and that the folks working on it wouldn't be doing so if it died. But, of course, by Wednesday morning it really was dead, and basically everyone who had been working hard on it pointed their finger at one person: Harry Reid. Within minutes of Leahy announcing that patent reform was dead, a whole bunch of people reached out to all say it was Reid's fault. And, that story got out fast. Basically everyone is saying that Harry Reid called Leahy and told him to kill the bill after trial lawyers and the pharmaceutical industry complained to Reid. Reid, fearing a loss in donations from those groups that often support Democrats in an election year, killed the bill.

Most of the reports said that Reid told Leahy he wouldn't allow the bill to come to the floor, but we heard a slightly different story: Reid didn't want it to come to the floor, and if it passed out of the Senate Judiciary with strong bipartisan support, he would be forced to bring it to the floor. That's why it was killed before it even had the chance, and Leahy had to pull it off the agenda without even allowing the Judiciary Committee to vote on it.

This is politics as usual. The same groups killed patent reform efforts in 2004, and basically every two years after that until they got a watered down bill in 2011. Unfortunately, if the same pattern holds, we may not see patent reform until 2021, by which time it too will likely be useless. And all the while actual innovation and our economy suffers.

Filed Under: harry reid, leadership, patent reform, patent trolls, patents, patrick leahy, pharmaceuticals, senate, trial lawyers