FDA First: Agency Approves Video Game Treatment For ADHD, Requires A Prescription

from the dr.-mario-will-see-you-now dept

Way back in 2013, when the world was still a logical and sensical place, we wrote about a group of Finnish doctors experimenting treating those afflicated with ADHD with video games. This certainly must have struck many as an odd path to take, what with my generation being raised largely by parents that insisted that video games were bad for us. Specifically, at least in my household, there was great concern that these games would shorten attention spans and cause us to get ADHD in the first place.

We didn't hear a great deal more on this novel use of video games until recently, but it's still heartening to see that the FDA made a small bit of history recently by approving gaming treatment for those with ADHD. In this case, a game specifically designed to improve cognitive functioning can be prescribed by a doctor.

A new game designed to treat some ADHD symptoms in kids aged 8-12 has been officially approved by the The U.S. Food and Drug Administration, meaning that anyone who wants to attempt treating children with the game needs to get a prescription first. As AP report, it’s not only the first time the organisation has approved the use of “digital therapy” for the treatment of ADHD, but it’s also “the first time the agency has ever authorized marketing of a game-based therapy for any condition”.

The game, called EndeavorRx, uses a combination of sensory and motor challenges to “help the player improve cognitive functioning”.

Now, it should be noted that the game was created by a developer based on a study performed by several doctors who were on the developer's payroll. That certainly sucks. But, still, given that the application of certain games to help cognition in people suffering from ADHD is not entirely new, this probably calls into question the science on how effective this game is, not games in general.

What it doesn't do is call into question what is becoming a more common interest in utilizing engaging gameplaying to address certain medical afflictions. And it isn't just video games, either. In fact, lots of things parents used to worry about are now being used as therapeutics. For instance, Dungeons and Dragons underwent its own infamous moral panic episode, only to be turned years later into a form of therapy.

The real lesson here, or one real lesson, is that we should all beware a trendy moral panic.

Filed Under: adhd, digital therapies, endeavorrx, fda, prescription games, prescriptions, video games
Companies: akili

Over-The-Air Updates Could Turn Millions Of Inexpensive Devices Into Much-Needed Ventilators To Treat Seriously-Ill COVID-19 Patients -- If Manufacturer Helps

from the profits-before-people dept

Last week we wrote about attempts to repair much-needed ventilators for serious coronavirus cases being stymied by manufacturers' refusal to allow hospital technicians to carry out the necessary work. Trammell Hudson, who describes himself as "a programmer, photographer, frequent hacker and occasional watchmaker", has come up with another approach to supplying ventilators to hospitals. It involves taking the inexpensive and widely-used Constant Positive Air Pressure (CPAP) devices typically used for sleep apnea, and turning them into emergency ventilators suitable for COVID-19 patients. These are known as Bi-level Positive Airway Pressure (BiPAP) machines. BiPAP devices are more sophisticated than CPAP ones: they apply higher pressure when the patient tries to breathe in, and lower pressure when they start to breathe out. In investigating the popular Airsense 10 CPAP device manufactured by ResMed, Hudson made a remarkable discovery:

Our work indicates that the actual difference between a low-end CPAP device and a high-end iVAPS [intelligent volume-assured pressure support] device is just a software upgrade. The CPAP machines have many of the same sensors as the more expensive models, and the Airsense 10 CPAP devices include in their firmware all of the other modes, such as iVAPS and BiPAP-ST [spontaneous/timed mode]. When we unlock that mode in software, the CPAP device functions like a much more capable and expensive iVAPS device.

This idea, that the difference between CPAP and BiPAP machines is a software change rather than a hardware change, is at the root of our work. If the common, highly distributed CPAP devices could have a software upgrade that turns them into iVAPS or BiPAP-ST devices capable of ventilating COVID patients, that would be a huge boon to the hospitals and health care workers around the world who are struggling with a lack of ventilators or alternatives to treat the influx of COVID patients.

Following his discovery, Hudson wrote a firmware patch that can be applied to the Airsense 10 CPAP device in order to access its more advanced features. However, he stresses:

We want to be very clear here: this modified firmware should not be flashed on CPAP machines and used to treat COVID patients immediately. The firmware that we've developed is an effective demonstration of the capability, and while it has been reviewed and validated by expert researchers, biomedical engineers, and clinical pulmonologists, it has not yet been put through FDA approval.

Although FDA approval could be sought, Hudson points out that by far the best solution would be for ResMed itself to provide the software upgrade -- something that doesn't need FDA permission. There are two other big benefits of taking this route. First, the manufacturer could more easily provide the slightly different patches for the various models of its devices. Perhaps even more importantly, for the majority of machines, the manufacturer could use a built-in always-on cellular connection to upgrade them over the air, without even needing to open them up. Unfortunately, it seems unlikely that the manufacturer will embrace this idea. On its Web site, a FAQ specifically addresses the issue of using a CPAP machine as a ventilator:

CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant rework in order to function as a ventilator.

Hudson's work suggests that is not true: a simple software upgrade is pretty much all that is required. When asked by Ars Technica whether the company would be willing to work with researchers to convert low-cost models to more capable ventilators, a representative wrote: "We are already exploring that option, but our primary focus is to maximize production of our current ventilation devices, masks, and accessories". In other words, rather than helping to save thousands of lives by carrying out over-the-air upgrades of existing machines -- millions of them in the US alone, according to Hudson -- the "primary focus" is on selling more expensive machines. As with the previous story about repairing ventilators, it seems that even during a pandemic, profits are more important than patients.

Follow me @glynmoody on Twitter, Diaspora, or Mastodon.

Filed Under: airsense 10, bipap, covid-19, cpap, fda, hacking, ota, over the air updates, trammell hudson, ventilators
Companies: resmed

Public Pressure Works: Gilead Asks FDA To Rescind Orphan Drugs Designation For Possible COVID-19 Treatment

from the good-to-see dept

Earlier this week, we wrote about the sham orphan drug designation that the FDA gave to Gilead Sciences for remdesivir. As we explained, remdesivir was developed with mostly public funds, and Gilead Sciences already held three patents on it, with a fourth one pending. Orphan drugs designations are supposed to be extra incentives for drug makers to target rare diseases. The issue here was that part of the definition of a rare disease under the Orphan Drugs Act is that it has to affect fewer than 200,000 people in the United States. Ridiculously, the law does not take into account the rate at which the disease spreads -- just how many people have it at the time a drug maker requests the designation. Even worse, the law explicitly says that the FDA cannot remove the designation if the affected group later grows to over 200,000.

Over the last few days, anger continued to grow at Gilead and the FDA -- including with the news that the FDA won't even say when Gilead applied for Orphan Drug status, because that's apparently "a commercial secret." Either way, this morning a ton of public interest groups, organized by Public Citizen, sent a letter to Gilead asking it to renounce its claim for orphan drug status:

We were shocked to learn that your company sought a lucrative orphan drug designation from the Food & Drug Administration for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.

This is an unconscionable abuse of a program designed to incentivize research and development for treatments for rare diseases. COVID-19 is anything but a rare disease. Some estimates suggest that half or more of all Americans may ultimately contract the disease.

We are writing to demand you reverse course and renounce your claim to orphan drug designation privileges for remdesivir.

As you know, Gilead was able receive an orphan drug designation only by rushing to file its application while there were fewer than 200,000 COVID-19 U.S. cases.

The United States most likely will surpass 200,000 COVID-19 reported cases in a matter of days. The real number of people suffering with the new coronavirus likely already has passed this mark. Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.

And here's the crazy thing. It worked!

Almost immediately after that letter was sent, Gilead announced that it has asked the FDA to rescind the designation:

Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.

In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir as a potential treatment for COVID-19. Orphan drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the United States.

The notice tries to give some justification for the orphan designation, suggesting that it would have made approval easier:

Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review.

Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available

So, in the end, public pressure worked, and the right thing was done.

As a side note, I've seen some people point to this article to suggest that because the FDA had only designated remdesivir as an orphan drug for COVID-19, and not yet approved it, that this story was blown out of proportion. This is wrong. The designation almost certainly eventually leads to the approval, and the mere designation creates a massive chilling effect on others working in the space, as it effectively tells them not to go down that path at all. The designation was a big deal, and a terrible scam pulled off by the FDA and Gilead, and it's good to see that Gilead was realizing that it was being seen as a pandemic profiteer and has backed off.

Filed Under: covid-19, exclusivity, fda, greed, orphan drugs, pandemic, patents, public pressure, remdesivir
Companies: gilead sciences

FDA Won't Say When Gilead Applied For Orphan Status On COVID-19 Treatment, Calling It 'Secret'

from the oh-come-on dept

Update: Facing tons of public pressure and ridicule, Gilead has agreed to give up the orphan designation.

I'm still pretty ticked off about the FDA's absolute bullshit decision to grant remdesivir "orphan drug" status for COVID-19 status. As I explained in the post yesterday, orphan drug status is supposed to be for rare diseases, in order to create an extra incentive for drug makers to find and deploy drugs to treat those diseases with a smaller than usual market. It would be ridiculous to argue that COVID-19 fits the bill. However, as the law in the US currently stands, the definition of a "rare" disease, is one that effects fewer than 200,000 people. The problem -- and the loophole that Gilead Sciences is exploiting here -- is that there's no concept of time and infection rate. The law was written with an idea that the rate of a disease would be relatively constant, so if you apply for orphan drug status at under 200k possible cases, it would remain that way.

Gilead, instead, is exploiting this loophole by basically rushing to the FDA before we'be even tested COVID-19 enough to know how widespread it is, and before we have enough real data or understanding of how wide it has spread. However, given what's happening around the country and the globe, to argue that this is a small market drug that needs extra protections is obviously ludicrous. Even worse, under the law, having the disease later impact more than 200k people is not a reason that the FDA can remove the status.

When a drug has been designated as an orphan drug because the prevalence of a disease or condition... is under 200,000 in the United States at the time of the designation, its designation will not be revoked on the ground that the prevalence of the disease or condition (or the target population) becomes more than 200,000 persons.

So, basically, rushing to the FDA works wonders. Meanwhile, Claire Cassedy from Knowledge Ecology International, wrote to the FDA to ask for clarification on just why Gilead got the orphan drug status, and was told (of course) that it was because of the "fewer than 200,000 people" criteria. She also asked exactly when Gilead applied for the designation and was told that was a "commercial secret."

What the actual fuck? How is that a commercial secret? We publish when patent, copyright and trademark applications are made. How could this possibly qualify as a secret?

Of course, the much bigger what the fuck is why would the FDA go along with this obvious abuse of process? At the very least, Congress needs to close this loophole so that the next big, fat, and happy drug maker can't abuse it for the next pandemic as well...

Filed Under: covid-19, fda, orphan drugs, remdesivir, secrecy, transparency
Companies: gilead sciences

Why Is The FDA Giving A Potential COVID-19 Treatment 'Orphan' Status?

from the we-don't-need-no-more-exclusives dept

Coming up with a treatment for COVID-19 is obviously incredibly important, and I'd be perfectly content if whoever did so got filthy stinking rich for basically saving the world. But we should be pretty damn careful about what kinds of incentives we set in place, and how that might lead to a ridiculous monopolistic, exploitative situation. Unfortunately, it looks like one pharma giant -- with a hopefully promising approach -- is already abusing the regulatory process to make sure it can extract monopolistic rents for a potential treatment.

It's good and exciting that various companies are pulling out all the stops to try to come up with some sort of treatment for COVID-19 (though it's incredibly dangerous and frustrating that the President of the United States seems to be regularly suggesting drug treatments based on basically no evidence of their effectiveness, and without regard to the safety -- or lack thereof -- to desperate people willing to listen to his unscientific snake oil nonsense).

One of the most promising offerings, though, has been remdesivir, from pharma giant Gilead Sciences. It's an anti-viral drug that has been in testing for other viruses, such as ebola, and there were some early suggestions that it might work against COVID-19. It's promising enough that NIH clinical trials for using remdesivir to treat COVID-19 started back in February (funded by NIH, not Gilead). And, over the last few weeks, Gilead has been facing rapidly increasing demand for the drug and has been offering it under "compassionate use" rules -- though it just put a halt to that program (though it claims it is creating a better process).

At this point, it's worth pausing a second to give some of the background on remdesivir. While everyone refers to it as coming from pharma giant Gilead, as with most drug breakthroughs, the reality is that most of the work in discovering remdesivir actually came from academic institutions, using US taxpayer money from NIH, including a recent influx of $37.5 million in taxpayer funds to the University of Alabama at Birmingham, which developed remdesivir with some help from scientists at Vanderbilt University and UNC. Gilead's role, was as a partner of UAB to handle the clinical trials -- which are certainly expensive. But, the fact is that this drug was not "developed" by Gilead, but by a public university using public money. Still, Gilead, as is often the case, is the one running around getting all the patents for remdesivir. In the US, it has applied for four patents, three of which have already been approved. It appears that those three patents will grant Gilead exclusivity over remdesivir until October 29th, 2035.

You might think that would be enough for Gilead. You'd be wrong. On Monday, Gilead was able to get the FDA to designate remdesivir as an orphan drug for the treatment of COVID-19. This is the part that's bullshit. The Orphan Drug Act was designed to give extra incentives to drugmakers to develop drugs for which there is a very small market, such that it's unlikely that (even at inflated monopolistic prices) the market can compensate them adequately for the development to treat those rare diseases.

So, uh, can someone at Gilead or the FDA explain how the fuck COVID-19 should qualify?

Basically, it looks like Gilead is pulling quite the scam. To get orphan designation according to the law in the US, you need to be targeting a "rare disease," with that being on the basis of it affecting 200,000 people or less in the US:

The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year

Now, technically, this remains accurate at this moment in the US where "official" cases in the US are still at 33,404 (Monday evening as I write this... I expect it will be higher by the time this is published). But that does not mean that the disease is "rare." First, we've barely got any testing infrastructure in place, so the actual number of patients is obviously much, much higher in the US. Second, the whole reason we've shut down much of the country is because many, many, many millions of people are at risk of getting the disease.

Calling COVID-19 a "rare" disease in order to get special benefits is bullshit.

But the fact that Gilead was able to do it here, and the FDA (ridiculously) approved it, means that we're likely to see this "loophole" exploited much more frequently. Any pharma company with a potential treatment for any new disease, just needs to get their orphan status request in before too many people are infected, even if everyone recognizes that something is highly contagious and will likely spread to millions of people before this is over.

So, what kind of "benefits" does this new status give Gilead? It gives the company extra exclusivity regardless of the validity of Gilead's patents. The FDA will not allow others to use the same chemical for seven years -- again, no matter the status of Gilead's patents. On top of that, Gilead can potentially get a 25% tax credit.

So, to sum up: it's a very good thing that remdesivir might be a useful treatment for COVID-19. And, frankly, I'd be totally fine if the US government just handed over a giant check if it proves to be effective. But, the fact is that this drug was developed with taxpayer funds at public universities, and the COVID-19 clinical trials are being done again with taxpayer funds by the NIH. Gilead already has three patents on it and will likely get its 4th. So why the fuck are we giving it extra exclusive rights and extra ability to block competition, by using a provision of the law that is explicitly designated for diseases that will impact a small percentage of the population?

The whole thing appears to be blatant abuse of the system by Gilead to get an extra boost at the expense of the public on what may be the most promising treatment for COVID-19. The FDA should answer why it approved this designation, despite it obviously being an abuse of the process -- and, at the very least, Congress should close this loophole, or we're going to see drug makers getting this designation on basically every new disease, no matter how widely it will target the population.

Filed Under: covid-19, exclusivity, fda, orphan drugs, remdesivir
Companies: gilead sciences

FDA, Homeland Security Issue First Ever Recall, Warnings About Flimsy Pacemaker Security

from the your-heart-attack-has-an-IP-address dept

We've well established that the internet of things (IOT) market is a large, stinky dumpster fire when it comes to privacy and security. But the same problems that plague your easily hacked thermostat or e-mail password leaking refrigerator take on a decidedly darker tone when we're talking about your health. The health industry's outdated IT systems are a major reason for a startling rise in ransomware attacks at many hospitals, but this same level of security and privacy apathy also extends to medical and surgical equipment -- and integral medical implants like pacemakers.

After a decade of warnings about dubious pacemaker security, researchers at Medsec earlier this year discovered that a line of pacemakers manufactured by St. Jude Medical were vulnerable to attacks that could kill the owner. The researchers claimed that St. Jude had a history of doing the bare minimum to secure their products, and did little to nothing in response to previous warnings about device security. St. Jude Medical's first response was an outright denial, followed by a lawsuit against MedSec for "trying to frighten patients and caregivers."

Ultimately, the FDA was forced to issue its first ever warning about the security of a pacemaker earlier this year, though the agency somewhat downplayed the potentially fatal ramifications:

"The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient's physician, to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks."

Inappropriate, indeed. St. Jude Medical has since been acquired by Abbott Laboratories, and back in April the FDA sent a warning to Abbott that it needed to design a comprehensive plan to fix the flaw (first revealed in August of last year) within fifteen days. That was followed up with a formal, voluntary recall notice issued by the FDA regarding the impacted pacemaker, believed to be the first such warning of its kind. In its warning, the FDA urged the estimated 400,000 owners of this pacemaker model to schedule a physician appointment for a firmware update, lest they find themselves quite literally hacked.

The FDA's alert was also joined by a warning by the Department of Homeland Security outlining the problem as such:

"The pacemaker’s authentication algorithm, which involves an authentication key and time stamp, can be compromised or bypassed, which may allow a nearby attacker to issue unauthorized commands to the pacemaker via RF communications....The pacemakers do not restrict or limit the number of correctly formatted “RF wake-up” commands that can be received, which may allow a nearby attacker to repeatedly send commands to reduce pacemaker battery life."

Comforting. Many security experts have been quick to point out that this may be the turning point at which companies finally begin taking these sorts of problems more seriously. But the lengths it took to bring us to this point are downright comical, involving MedSec going so far as to at one point short St. Jude stock to bring necessary attention to the problem. Hopefully, the entire saga is a shot over the bow that other security-apathetic medical impact manufacturers will wisely heed.

Filed Under: cybersecurity, dhs, fda, pacemakers, security
Companies: st. jude medical

After Lawsuits And Denial, Pacemaker Vendor Finally Admits Its Product Is Hackable

from the digital-wetworks dept

So we've noted how the lack of security in the Internet of Things is a bit of a problem. Initially, many of us thought that easily hacked smart tea kettles and smart refrigerators were kind of cute. Then we realized that this same, paper-mache grade security is also apparently embedded in everything from automobiles to medical gear. Then, more recently, we realized that all of these poorly-secured devices were being quickly compromised and used in botnets to help fuel massive, historically unprecedented, new DDoS attacks. The warnings were there all along, we just chose to ignore them.

For more than a decade people had been warning that the security on pacemakers simply wasn't very good. Despite these warnings, many of these devices are still vulnerable to attack. This week the FDA was forced to issue a warning, noting that security vulnerabilities in the St. Jude Medical implantable cardiac device and corresponding Merlin@home Transmitter could be a serious problem. It's notable as it's the first time we've seen the government publicly acknowledge this specific type of threat.

The St. Jude Medical Merlin@home Transmitter uses a home monitor to transmit and receive RF signals wirelessly to the pacemaker. But the FDA found that this transmitter was vulnerable to attack, with the press release politely tap dancing around the fact that said vulnerability could be used to kill:

"The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient's physician, to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks."

According to the FDA, they have no evidence of anybody dying because of the vulnerability yet. They're also quick to note that St. Jude Medical issued a patch on January 9 that fixes this vulnerability. St. Jude Medical was quick to issue a statement patting itself on the back for patching its systems against "highly unlikely medical device cyber risks":

"There has been a great deal of attention on medical device security and it’s critical that the entire industry continually enhances and improves security while bringing advanced care to patients,” said cyber security expert Ann Barron DiCamillo, former director of U.S. CERT and advisor to St. Jude Medical’s Cyber Security Medical Advisory Board. “Today’s announcement is another demonstration that St. Jude Medical takes cyber security seriously and is continuously reassessing and updating its devices and systems, as appropriate."

Granted St. Jude Medical had previously received a bit of a nudge, and this isn't the first time the company's name has appeared in lights for the wrong reason. Security startup MedSec resorted to some creative tactics last year when it began shorting St. Jude Medical stock to try and highlight the company's abysmal security, after the traditional vulnerability reporting process failed to get the company's attention. At the time, MedSec Chief Executive Officer Justine Bone stated that the company consistently did little to nothing when vulnerabilities were reported:

"As far as we can tell, St. Jude Medical has done absolutely nothing to even meet minimum cybersecurity standards, in comparison to the other manufacturers we looked at that have made efforts," Bone said. There are steps St. Jude can take relatively quickly to protect patients, including changing the programming of implanted pacemakers and defibrillators through a method that would involve a doctor’s visit, she said."

St. Jude Medical's first response was an outright denial, followed by a lawsuit against MedSec for "trying to frighten patients and caregivers." Fast forward a few months, and St. Jude Medical is now trying to hold itself up as the poster child for proactive security and accountability. But the reality is that publicly shaming companies that can't be bothered to prioritize user security (even when human lives are at risk) appears to pay notable dividends.

Filed Under: fda, iot, merlin@home, pacemaker, security
Companies: st. jude medical

Antitrust Suit Alleges Pharma Company Rubbished Its Own Product In Order To Stave Off Competition From Generics

from the commercial-motives-played-no-part dept

Techdirt has written a number of stories about how Big Pharma is never content with the patent bargain -- that, in return for a time-limited, government-enforced intellectual monopoly, products will afterwards enter the public domain. Instead, companies have come up with various schemes to extend the life of that monopoly -- and thus to cheat the public of the low-cost generic versions of the drug in question that should have appeared. The Daily Beast points to an antitrust lawsuit brought by 35 states and the District of Columbia against the makers of Suboxone, a prescription drug used to treat opioid addiction, over the alleged use of one such scheme, known as "product hopping". That's where:

a company makes modest changes to a product to extend its patent protections so that other companies cannot enter the market and offer less-expensive generic alternatives.

In this particular example:

Reckitt Benckiser Pharmaceuticals, Inc. -- now known as Indivior PLC -- and MonoSol Rx are accused of conspiring to switch Suboxone from a tablet version to a film, which dissolves in the mouth, in order to prevent or delay generic alternatives and maintain artificially inflated profits.

...

Over time, the states allege that Reckitt converted the market away from the tablet to the film through marketing, price adjustments and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market.

The "other methods" are particularly interesting. In September 2012, Reckitt announced that it was going to "voluntarily discontinue the supply of Suboxone tablets", because it was worried they might be dangerous for children:

The company received an analysis of data from U.S. Poison Control Centers on September 15, 2012 that found consistently and significantly higher rates of accidental unsupervised pediatric exposure with Suboxone Tablets ... than seen with Suboxone Film ... The rates for Suboxone Tablets were 7.8-8.5 times greater depending on the study period.

Curiously, though, Reckitt didn't mention that the study had been commissioned by itself, as the Guardian noted in an article at the time. Quite why Reckitt would want to pay for and then publicize a study that showed one of its own products was dangerous became clearer just a few hours later, when it submitted a "citizen petition" to the Food and Drug Administration:

urging the US regulator to ban any future competitor pills to its suboxone tablets that were insufficiently "child resistant".

In other words, Reckitt effectively wanted the FDA to ban any generic versions of its own tablets, now out of patent, while leaving its patented film formulation on the market to enjoy a new monopoly. As the Guardian reported:

A company spokesman has insisted commercial motives played no part in Reckitt's decision to withdraw suboxone tablets from the market. However, Martin Deboo, an analyst at Investec Securites said: "We view these moves as consistent with Reckitt's strategy of protecting the suboxone franchise by hastening migration to [strip] and raising barriers to entry to generics."

The new antitrust lawsuit will doubtless explore these moves in detail, and the harm they might have caused, both financial and in terms of patient suffering. The plaintiffs allege:

that federal and state healthcare programs, including Medicaid, as well as consumers and other purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion and, since then, rates of opioid abuse in Connecticut and across the country have increased significantly.

That's a useful reminder that pharma patents are not just about monopolies and money, but also about people and pain.

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

Filed Under: disparagement, fda, monopolies, patents, pharmaceuticals, suboxone
Companies: indivior, monosol, reckitt benckiser

AstraZeneca Tries To Use 'Orphan Drug' Designation To Extend Patent Life Of Top-Selling Pill

from the evergreen-desire-to-hang-to-intellectual-monopolies dept

At the heart of copyright and patents there is -- theoretically -- an implicit social contract. People are granted a time-limited, government-backed monopoly in return for allowing copyright material or patented techniques to enter the public domain once that period has expired. And yet copyright and patent holders often seem unwilling to respect the terms of that contract, as they seek to hang on to their monopolies beyond the agreed time in various ways.

In the case of copyright, this has been through repeated extensions of copyright's term, even though there is no economic justification for doing so. In the realm of pharma patents, a number of techniques have been employed. One is "pay for delay." Another is the granting of "data exclusivity." And a third is the use of "evergreening." Techdirt wrote about the last of these a while back, so it's no surprise that companies have continued to "innovate" in this field since then. For example, AstraZeneca is trying to use a variant of evergreening for its anti-cholesterol pill Crestor. As a New York Times article explains:

Crestor is the company’s best-selling drug, accounting for $5 billion of its $23.6 billion in product sales last year. About $2.8 billion in sales were in the United States, where the retail price is about $260 a month, according to GoodRx.com.

Here's how AstraZeneca hopes to hold on to that lucrative market, even though its patent on the drug is now coming to an end, and it should be entering the public domain:

The company is making a bold attempt to fend off impending generic competition to its best-selling drug, the anti-cholesterol pill Crestor, by getting it approved to treat [a] rare disease. In an unusual legal argument, the company says Crestor is entitled to seven years of additional market exclusivity under the Orphan Drug Act, a three-decade-old law that encourages pharmaceutical companies to develop treatments for rare diseases.

In May, AstraZeneca won approval of Crestor to treat children with the rare genetic disease of homozygous familial hypercholesterolemia (HoFH ). That gives it an additional seven-year patent on the drug, but only for that particular -- very small -- market. However, the designation means that detailed prescription information about using Crestor to treat children in this way must not be included on the label. AstraZeneca's clever lawyers are trying to turn that into an extended patent for all uses of the drug:

AstraZeneca immediately petitioned the F.D.A., arguing that if the correct dose for children with HoFH could not be on the generic label, then it would be illegal and dangerous to approve any generic versions for any use at all. That is because doctors might still prescribe the generic for children with HoFH and choose the wrong dose, posing "substantial safety and efficacy risks."

Needless to say, AstraZeneca was only asking for generic versions to be kept off the market for another seven years for safety reasons, not because doing so would bring it billions more in exclusive sales to the general population. Of course.

The New York Times article goes into more detail about the fascinating legal background to AstraZeneca's argument here, and notes that other drug companies have tried the same approach in the past, without success. Even if this particular ploy does fail again, we can be sure that pharma companies will be back with other sneaky ways of extending their patent monopolies -- implicit social contract be damned.

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Filed Under: blocking, competition, crestor, evergreening, fda, generics, new uses, patents
Companies: astrazeneca

DailyDirt: Adulteration Of Foods May Not Be What You Expect

from the urls-we-dig-up dept

Some food additives can be dangerous to public health -- such as adding melamine to infant formula. So understandably, government agencies policing food safety should focus on health issues related to food additives and food poisioning. But there are perfectly safe food additives that are just aimed at increasing the profits of food distributors, and it looks like Americans might want to research their cheese suppliers a bit more closely.

• The FDA found that Castle Cheese Inc wasn't selling 100% real parmesan cheese -- just a lot of fillers (e.g., cellulose) and cheaper cheddar cheese. It's not unsafe to eat, but an estimated 20% of hard Italian cheeses in the US could be deceptively labeled. [url]
• Cellulose is a common food additive, so if you saw headlines of "wood pulp in cheese" -- it's nothing new, really. It's not sawdust, and food scientists have tried to source cellulose from non-wood plants, but it's not as easy to get. Cellulose has been used as an anti-clumping agent in baking, and the food industry claims it provides a healthy source of dietary fiber. [url]
• The adulteration of food stuffs has been a tempting way to increase profits since forever. Olive oil was once the most adulterated agricultural product in the EU in 1997-1998. Olive oil is easy to dilute with cheaper oils and has been tampered with as far back as ancient Greece, and adulteration can be difficult to detect -- even with modern chemistry. [url]

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Filed Under: cellulose, cheese, dietary fiber, fda, food, food additives, food safety, olive oil, parmesan, wood pulp
Companies: castle cheese