Innovation is the foundation of America, and since 1790, entrepreneurs have been able to claim patents on their inventions so that copycats can't profit off their work. But some companies have found a controversial use of the American patent system, derisively referred to as "patent trolling." The practice refers to when a company buys broad patents for technology that it doesn't make—or partners with inventors who don't actively use their patents—and brings legal claims against other companies that use the technology. The price of stealing someone's work in the United States is mind-blowingly expensive—in the millions of dollars—and even if the accused company wins, it still faces high legal costs. Often, a company violating a patent will pony up a few thousand dollars for licensing fees rather than face off in court.
"There are hundreds of thousands of crappy, vague, overly broad patents out there, and all you have to do is scoop up one of these patents and threaten to sue. No one is going to defend themselves, because it makes no financial sense," says Julie Samuels, a senior staff attorney for the Electronic Frontier Foundation (EFF), which is running a database of patent troll claims. "It's totally legal, and very lucrative, and absolutely shady."
Bryan Farney, an attorney for a MPHJ, a company that has accused multiple businesses of using its patented office-scanner technology without permission, takes issue with the characterization of companies that sue others over patents they don't use. "Obviously, patent trolling is a pejorative term…" he tells Mother Jones. "A more accurate term is Non-Practicing Entity."
Earlier this month, Sen. Claire McCaskill (D-Mo.) called these kinds of companies "scam artists" and "bottom feeders" who "work in the shadows." Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and Sen. Mike Lee (R-Utah) introduced a bill this month that specifically takes aim at them by making it harder and more expensive to make these claims and allowing targeted companies to get their legal fees back. The bill has support from the White House. This week, a group of inventors—including Facebook's and Twitter's cofounders—sent a letter to the House and Senate Judiciary Committees arguing that "broad, vague patents covering software-type inventions—some of which we ourselves are listed as inventors on—are a malfunctioning component of America's inventive machinery."
But companies that oppose the legislation say that it shouldn't matter whether or not they use their own patented technology because big tech companies are taking advantage of their inventions. "Almost all inventions seem obvious after they have been invented,'" wrote Katharine Wolanyk, president of Soverain Software, in a November 18 letter to the House Committee on the Judiciary. (Wolanyk's company owns patents that governs online shopping cart technology and lost one of its claims in the US Court of Appeals for the Federal Circuit. Soverain is now trying to bring the case to the Supreme Court.) "The current system forces patent owners to defend, over and over again, the validity of their patents."
Without further ado, here are eight inventions you thought were patent-free but could get you sued:
1. Magic Missiles on Dungeons and Dragons
Dungeons and Dragons
In October 2012, Treehouse Avatar Technologies filed a patent infringement lawsuit against Turbine Inc., better known as the company that makes the online version of the popular role-playing game, Dungeons and Dragons. According to the suit, Turbine violated Treehouse's patent—which it acquired a few months before—by including a feature that allows the game system to "tally" how often gamers pick certain video game character attributes, such as hair color, eye color, weapons and clothing, to determine which are the most popular. Stephen Roth, a legal representative for Treehouse, tells Mother Jones that "Treehouse Avatar Technologies is not a 'patent troll.' In fact, that term could be seen as offensive by some; just as calling an injured person seeking redress as greedy, or a person defending their rights to free speech as a left-wing liberal." The inventors of this particular patent partnered with Treehouse to help enforce their licensing, he says, but they are not presently operating any technology with the patent. He says that the company has "numerous" claims out with other gaming companies, but the licensing fees it's asking for are "confidential."
2. Internet Routers in Local Coffee Shops
Starting in 2011, Innovatio IP Ventures, a nonpracticing entity, sent more than 8,000 demand letters to targets in 50 states claiming violations of patents it owned on equipment found in common wifi routers. Rather than only targeting the companies that made the routers—which had greater financial means to fight the patent claims—Innovatio went after local hotel chains and coffee shops that couldn't afford lawsuits and had to pay up to $5,000 a pop for licensing. Some big-name router companies, like Cisco, threatened to sue Innovatio, alleging that it was engaged in a racketeering scheme against its customers, but the allegations were ultimately thrown out. Ray Niro Sr., a lawyer who has worked on behalf of Innovatio, told Chicago Lawyer in April that the letters aren't trolling, because inventors get a portion of the recoveries in most cases. "What's so bad about that?" he asked.
In January of this year, Personal Audio LLC brought claims against some TV networks and podcasters—including individuals, like comedian Adam Carolla—for using technology it patented that covered "media players that have the capability to receive playlists." This could potentially apply to any podcaster that allows users to scroll through different episodes. EFF is presently challenging Personal Audio on the basis that it didn't create the technology and "people were podcasting years before Personal Audio first applied for a patent." James Logan, the founder of Personal Audio, told Slashdot that even though his business is considered a nonpracticing entity, "I did try to build a product…I spent $1.6 million of my own money trying to realize our vision of a custom listening experience that ended up, at the end of the day, being implemented in the form of a cassette tape product, and not the digital player system we envisioned and patented."
4. Office Scanners
In 2012, MPHJ Technologies began to send letters to companies for violating five patents it purchased relating to office scanners. As the company explained, "A good example of an infringing system, and one your company likely uses, is an office local area network which is in communication with a server, employee computers having email software such as Outlook…and a [scanner] which permits the scanning of a document directly to an employee email address." MPHJ does not produce products related to these patents. For an annual license, MPHJ wants around $90 per company employee, per year. For a permanent license, MPHJ wants $900 per employee. State attorneys general in Vermont, Nebraska, and Minnesota have spoken out against MPHJ's claims. That hasn't stopped MPHJ: In response to Minnesota's recent order that the company not file patent enforcement claims in the state, Bryan Farney, the company's attorney, tells Mother Jones, "The Minnesota AG does not affect in any way the ability of MPHJ to file suit for patent infringement against anyone…MPHJ believes federal law is clear that its actions were lawful, and that the actions taken by the attorneys general have largely been based upon lack of knowledge of US patent law."
5. iPhone Apps
In 2011, Lodsys LLC started making claims against small independent app developers, on the basis that the developers were violating patents it purchased that cover a broad swath of internet technology (one patent was purchased as recently as 2010). Specifically, these patents affected services that allow users to report errors, get online help and customer support, interact with online ads, and renew their subscriptions online, among other things (one of the patents dates back to 1992, and is intended to be used for fax machines). An app developer named Eugene Kaspersky fought Lodsys' $25 million infringement claim in court over a period of 18 months. Lodsys ultimately withdrew its lawsuit, and Kaspersky claimed that it was evidence that "patent trolls can be resisted and defeated." In a blog post on its website, Lodsys wrote, "If you are a Developer, it's about knowledge about the scope and risks of your own business. Lodsys has only one motivation: we want to get paid for our rights."
6. Publishing Messages Online
EasyWeb Innovations LLC owns patents on online messaging publishing. In 2011, EasyWeb sued Facebook and Twitter for violating these patents. TechCrunch has called EasyWeb an "obscure patent troll looking to score coin by suing companies that actually innovate, rather than building and selling something." John D. Codignotto, the owner of EasyWeb, planned to put his ideas into practice, "but financial resources were not available to enable its commercialization," according to the Facebook court document. EasyWeb also has patents concerning online photo uploading, which it has accused more than a dozen companies, such as SmugMug, of violating, according to Law 360.
7. SSL Encryption
In 2006, Texas-based firm TQP purchased a 1989 patent that covers transmitting encrypted data over a "voice-grade telephone line." Since then, the company has used the patent to make claims against companies that use SSL encryption—the most commonly used form of internet security. The company gives a percentage of the licensing revenue back to the inventor. According to Forbes and Law360, TQP has settled with multiple big-name companies. Additional cases brought against major credit card companies and social networks are still spending. TQP's owner, Erich Spangenberg, told Forbes that he's not bothered by the fact that his company doesn't use the SSL encryption patent: "If you buy a hundred-foot lot in the middle of Manhattan, you’re not required to develop it…Companies have the right to protect their IP dollars.”
8. 3-D Printing
While claims against 3-D printer innovators haven't yet become widespread, six companies are currently applying for patents that could be applied towards the technology. EFF says it has filed a challenge of the patents on the basis that they're overly broad and could be used by patent trolls to make claims against small developers. One of these patent applications is for "Additive Manufacturing System and Method for Printing Customized Chocolate Confections"—which was issued in 2001 and applies to technology that molds chocolate into specific shapes. Whether this can be used to sue the guys printing 3-D guns remains to be seen.
When I voted last year in downtown Washington, DC, I was able to walk down the street, cast my ballot, and get back to the office in less than 30 minutes. But according to a new report by two voting rights groups, the Advancement Project and OurTime.org, plenty of American voters weren't so lucky. According to their research, African Americans, Latinos, and millennials in Virginia and Florida—two key battleground states—faced significantly longer wait times than older white voters in 2012. This was largely because the former groups are more inclined to utilize early voting, which was restricted in both states last year. And according to the report, this new "time tax"—along with other voting obstacles, like strict ID laws—will likely continue to dampen voter turnout among these groups in 2016.
In 2012, Florida cut early voting from 14 days to 8 days, and lines were so long, more than 200,000 Florida voters gave up and went home, according to data collected by the Orlando Sentinel. The Advancement Project and OurTime.org report focused on 5,196 of the 6,100 voting precincts that were used last November in Florida—which faced some of the longest voting lines in the country—and found that young voters spent a disproportionately longer time waiting to vote. For example, in Orange County, which has the highest percentage of voters younger than 30 in the state (22 percent), precincts closed an average of 86 minutes after the 7 p.m. deadline, with one precinct closing five hours late. The report found that in Orange County, the trend indicated that the more voters under 30 there were at a certain precinct, the later the closing time.
"Regarding the number of people willing to wait in line to vote in 2012, there were others who didn't vote, and there is no guarantee that voters will always be able to wait so long to exercise their fundamental rights," says Katherine Culliton-González, director of Advancement Project's Voter Protection Program. The report makes the case that young voters have less flexibility with their work schedules, and when early voting days are cut, as they were in Florida, lines get longer. Millennials (defined in the report as people between the ages of 18 and 29) are also more racially diverse than the rest of the population, meaning that there is often an overlap between young voters and voters of color. This 2013 MIT report found that voters of color are also more likely to wait in line than white voters:
The conservative Heritage Foundation maintains that African Americans face longer voting times than white voters because they "tend to be concentrated in large urban areas" and "the most populous areas had longer wait times than those living in areas with fewer voters." But Culliton-González, from the Advancement Project, tells Mother Jones that her group's study disproves this, since their research found that there wasn't a clear correlation between longer lines and precincts with dense populations. She says that, in Virginia, for example, "unless a voter can prove they are sick, otherwise disabled, or have to travel for work on Election Day, all voters must vote on the first Tuesday in November. These limits are probably what caused the disparities, as due to socioeconomic factors, many young voters of color have less flexibility in their work schedules." Voting rights groups argue that all states should offer flexible early voting—but some states have done the opposite: North Carolina, for example, is restricting early voting from 17 days to 10 days, starting in 2014.
Culliton-González adds, "We are concerned about 2014, but even more concerned about 2016," since Florida and other states will likely not have enough early voting time so that voters can avoid long lines. (The Advancement Project didn't find evidence of the "time tax" in the state elections earlier this month, partly because voter turnout was so low.)
But even if early voting is taken care of, young voters of color are also more likely to be turned away from the polls because of identification requirements. This was true in 2012, even in states that didn't have voter ID requirements on the books (see chart below). In the state elections that occurred earlier this month, numerous voters complained of being unable to vote because of real or perceived voter ID laws.
According to data collected by the Black Youth Project, an activist group that does research on issues that affect African American youth, only 67 percent of Latino youth and 71 percent of black youth possess driver's licenses, compared to 85 percent of white youth. Additionally, three times more young black voters than white voters said that lack of an ID was the reason they didn't vote in 2012. The Advancement Project and OurTime.org have submitted their report to the Presidential Committee on Election Administration, President Obama's group that is tasked with finding ways to improve voting.
I went to public high school in Montana, where at least once a year we were shuffled into the gymnasium for lectures from abstinence-only educational speakers on how to make "good choices." Young, sprightly twentysomethings, who often resembled Ken and Barbie, would dance around the auditorium playing Christian rock and trying to convince us that having sex wasn't cool. In between all the jokes and music, I learned that condoms cause cancer and that sex is a bad deal for women. Turns out, I wasn't alone. Across the the United States, public schools—even ones that teach comprehensive sex education—invite religious abstinence speakers to come in to talk to students about sex, and sometimes spread information that is factually inaccurate in the process. Here are five such speakers, many of whom have generated local headlines for their controversial presentations. And they might be coming to a school near you—they're all still active on the sex-is-bad circuit.
Justin Lookadoo: "God made guys as leaders."
Lookadoo is a spiky-haired Christian lecturer who bills himself as a "professional Speaker who CONNECTS with the audience." He is on the road 200 days a year and on his website, he lists his age as "legal in every state." Lookadoo's presentations can be paid for "under many federal programs, including Safe and Drug Free Schools, Campus Improvement, Title I [and] Title IV." Last week, he caused controversy at Richardson High School in Texas when he gave a presentation for teenagers in which he said: "Girls, the reason it's so hard for you to succeed these days is not because of guys…You're doing it to yourselves," according to the Dallas Morning News. His online dating recommendations have also drawn ire from students and parents: "Men of God are wild…They keep women covered up" and "dateable girls know how to shut up." The Richardson High School principal apologized to students and parents, promising that "we will not invite this speaker back to RHS." Responding to the widespread media criticism, Lookadoo wrote on his Facebook page that "the complaints are based on relationship stuff [posted] on a website that I don’t even talk about in schools."
Jason Evert: "Girls...only lift the veil over your body to the spouse who is worthy."
Evert has two theology degrees and tours the country promoting abstinence with his wife, Crystalina Evert, with whom he runs the Chastity Project. According to Evert's bio, he speaks to over 100,000 teens each year. Evert tells Mother Jones he speaks to "lots of public schools" and his upcoming schedule shows that he's speaking next month at several in Texas. He says, however, that he removes all religious content from his public school presentations and is not paid personally for these events. Half of his honorarium for each event is spent on giving the students free copies of his pro-abstinence books and CDs.
Evert is passionate about women dressing modestly (or as he puts it, "Girls...only lift the veil over your body to the spouse who is worthy to see the glory of that unveiled mystery.") In this 2008 YouTube video, he says: "A culture of immodest women will necessarily be a culture of uncommitted men." He elaborated on those remarks for Mother Jones, saying that "true feminine liberation isn't about having the 'freedom' to dress like Miley Cyrus" and that that his views "could be judged as misogynist, but I think this would be an unfair assessment." He adds, "It's a joke to think the girl needs to be the chastity cop...but to reach [a] level of mutual respect in society, I don't think Daisy Duke shorts are going to expedite the process." Evert also maintains that birth control pills cause abortions. (In reality, they prevent conception, and if an egg is fertilized, they make the uterine lining inhospitable for implantation. The Code of Federal Regulations and the American College of Obstetricians and Gynecologists define pregnancy as beginning at implantation.)
Pam Stenzel: "If you take birth control, your mother probably hates you."
Stenzel is a lecturer who, according to her bio, "provide[s] a structured and unambiguous message of abstinence that will mobilize and empower adolescents to make responsible choices" and claims to speak in-person to about 500,000 young people annually. She makes about $4,000 to $6,000 per appearance and has an extensive line of DVDs. She was also consulted for President George W. Bush's abstinence programs. This April, at George Washington High School in Charleston, West Virginia, a public school, she allegedly made some female students cry by "slut-shaming" them. According to the Charleston Gazette, she said, "If you take birth control, your mother probably hates you" and claimed she could tell which teenagers are promiscuous by looking at them. Stenzel told LifeSiteNews that she never said those things, but acknowledged that her presentation was "a little tough." In her YouTube videos, Stenzel tells students that sex is worse for girls (because they "are much easier to infect and easier to damage"). She also asserts that the HPV vaccine "only works on virgins," and that chlamydia—even when treated—is likely to make women infertile, with a 25 percent chance of infertility the first time it's contracted and a 50 percent chance the second time. Her HPV claim is 100 percent false, and her chlamydia statement is mostly false. (Of women with chlamydia who go untreated, about 10 percent will develop pelvic inflammatory disease, which in some cases may cause infertility.)
Joi Wasill: "According to your health textbook, and all of the medical textbooks, and science textbooks, and biology texts, conception is when life begins."
Wasill is the founder and executive director of Decisions, Choices & Options, Inc., a Tennessee-based organization with strong Christian and Republican ties that has provided educational programs that have reached about 40,000 high school students (her organization is currently available for public school bookings.) For speaking gigs outside of the Nashville area, the organization charges for travel fees and a per diem. In May, she spoke at Hillsboro High School, a public school in Nashville, Tennessee, along with Beth Cox, a presenter for Wasill’s organization. One student recorded her presentation and leaked it to the press. RH Reality Check, a daily publication covering sexual health, noted the talk included a host of inaccurate information.
The speakers claimed that condoms have holes in them and a failure rate of 14 percent (it's actually less than 3 percent); that first-trimester abortions can cause infertility (the National Abortion Federation says they're one of the "safest" medical procedures); and that the morning-after pill is a "chemical abortion" (nope, it delays and prevents ovulation). They also said that "according to your health textbook, and all of the medical textbooks, and science textbooks, and biology texts," life begins at conception. Wasil tells Mother Jones that her curriculum is "based upon information obtained from the Center[s] for Disease Control, SEICUS [Sexual Information and Education Council of the United States], National Center for Health Statistics, the health textbooks adopted by the state, and other sources such as these." Teaching "sexual risk avoidance" is in accordance with the law, she says, adding, "the avoidance of the risky behavior that leads to infection, disease, and teenage pregnancy is the best outcome for all students and enables them to live healthy, productive and successful lives."
Pro Life in TN
Shelly Donahue: "Girls are more feelings-oriented, and boys are more facts-oriented."
Donahue is a speaker for the Colorado-based Center for Relationship Education, an abstinence-only education program that works with students in 42 states and has received millions in federal funds. In 2006, Donohue caused controversy at Natrona County High School, a public school in Casper, Wyoming, when she gave a religious-themed abstinence presentation. According to the Casper Star-Tribune, she asked students, "Do you get closer to your God or do you get farther away when you have sex?" (The answer she wanted: "Farther away.") She also said that boys are "wired" to like math, science, and numbers, and girls are wired to be more feelings-oriented. She held up a bag of noodles to indicate that girls "are like spaghetti, with their feelings about parts of their lives entangled," according to the Star-Tribune. (She told the paper: "The outpouring and the positive was so much greater than this one kid's complaint.") In a training video posted by the Denver Westword in 2011, Donahue tells students that if a guy gets sperm anywhere near a girl's vagina, it will turn into a "little Hoover vacuum" and she will become pregnant. (No. Vaginas don't vacuum sperm off the couch.) In another 2011 video, she says, "the boys want to love and respect these girls, and the girls won't let them. The girls are backing up the booty, the girls are being assertive, these girls are emasculating these boys." She continues to conduct sex-ed training programs for teachers on public Title V funds and is holding one this month in Greeley, Colorado.
Not a month goes by without former National Security Agency contractor Edward Snowden dropping another explosive bombshell about the US government's vast surveillance programs. In response, lawmakers have proposed a flurry of bills that aim to clamp down on NSA spying. But tech companies aren't just sitting on the sidelines—the latest lobbying disclosure forms filed by Google, Facebook, Yahoo, and Twitter reveal that their lobbyists are keeping an eye on a number of these anti-NSA bills. And although most of the companies won't say which specific bills they support or oppose, some new bills have popped up on their lobbying forms just as the companies are publicly demanding surveillance reform.
The lobbying disclosure forms cover the period from July 1 to September 30, the months immediately following the first Snowden disclosure about the PRISM program in June. Bills introduced after those dates, such as the tech industry-backedUSA Freedom Act proposed by Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and Rep. Jim Sensenbrenner (R-Wis.), aren't included. There are also some bills that were introduced pre-Snowden.
In total, during this period, Facebook spent $1.44 million on lobbying, Yahoo spent $630,000, Google spent $3.37 million, and Twitter spent $40,000. The forms don't break down whether a company poured thousands of dollars into lobbying for one bill, or had one brief conversation about it with a lawmaker or an aide. Nor do the forms reveal whether companies have lobbied for or against a given bill. And for now, most US tech companies are keeping their positions about specific bills secret, so they can present a unified front against NSA spying and keep their options open.
Representatives of the most important tech companies have, however, made public statements indicating that they're likely to support bills that allow them to shed more light on government surveillance. "I was shocked that the NSA would do this—perhaps a violation of law but certainly a violation of mission," Google Executive Chairman Eric Schmidt told CNN last week, in response to an October 30Washington Postreport that the NSA was tapping into Google's servers without the company's consent. "From a Google perspective, any internal use of Google services is unauthorized and almost certainly illegal." Niki Fenwick, a spokesperson for Google, said that the company doesn't comment on whether it supports specific bills, but Bloomberg News reported last week that the company, which has bulked up its lobbying presence on Capitol Hill, "seeks to end National Security Agency intrusions into its data."
"Defending and respecting the user's voice [is] a natural commitment for us and is why we are so committed to freedom of expression," Colin Crowell, Twitter's vice president for global public policy, tells Mother Jones. A Twitter representative noted that the company is actively supporting two of the bills below, S. 607 and HR 1852, which require law enforcement to obtain a warrant before accessing private emails. "For the others, at any given moment, bills are in a state of change so it is rare to emphatically state that we formally support or oppose any given bill until it is nearer a point of final passage," the representative added.
Without further ado, here are eight pro-transparency bills that some of the biggest names in tech are watching:
"If you approve this pill, you surely will be signing a death sentence for thousands of people, especially young kids," Avi Israel, a father whose 20-year-old son committed suicide after becoming addicted to doctor-prescribed hydrocodone, told FDA officials at the December hearing.
The FDA's advisory board, an appointed group of medical experts who evaluate drugs used in anesthesiology and surgery, voted against Zohydro 11-2 last December. As several board members noted, most opioid painkillers on the market also include acetaminophen, the main ingredient found in Tylenol, a combination that is less likely to lead to addiction. But like OxyContin, the "Hillbilly Heroin" the Drug Enforcement Agency has blamed for hundreds of deaths in a single year, Zohydro includes a high dose of its main opioid ingredient undiluted by acetaminophen. That could lead to higher rates of abuse, the FDA's medical advisers warned.
The Centers for Disease Control and Prevention has released data showing that painkillers are essentially the worst drug epidemic in US history, killing 16,000 people in 2010 alone. Painkillers that include hydrocodone and its cousin, oxycodone, are widely abused by users who crush, snort, or inject the drugs, seeking a high. Zohydro is made from high-dose hydrocodone undiluted with acetaminophen; OxyContin uses undiluted, high-dose oxycodone. "Oxycodone and hydrocodone are very similar drugs and Zohydro (extended release hydrocodone) is similar to OxyContin (extended release oxycodone)," Andrew Kolodny, chief medical officer at the Phoenix House Foundation, a nonprofit drug and alcohol rehabilitation center, tells Mother Jones. "This drug will almost certainly cause dependence in the people that are intended to take it," Judith Kramer, a professor at Duke University Medical Center who voted against the drug, testified in December.
Among the advisory board's other objections: Zohydro's manufacturer, Zogenix, disregarded FDA recommendations that opioid painkillers include a gel-like plastic preventing them from being crushed and snorted; the drug is meant to be used by cancer patients, but was never widely tested on those patients; and during the study's trial run, 2 of 575 test subjects are believed to have committed suicide, one by hoarding the drug and overdosing after the study was over.
The FDA says that making painkillers less likely to be abused is a "public health priority." One such abuse deterrent, now standard in OxyContin, involves injecting the pills with a gel so that they can't be crushed and snorted. But Zohydro doesn't come with that measure. On November 4, Zogenix entered into a $750,000 agreement with a Montreal-based company, Altus Formulation Inc, to help it come up with an abuse-deterrent formula—but it's not clear how long that will take, or whether it will be ready before Zohydro hits pharmacy shelves in four months. Zogenix did not respond to multiple requests for comment.
"This is a colossal mistake on the FDA's part," David Jurrlink, a scientist with the Sunnybrook Research Institute at the University of Toronto, tells Mother Jones. "Because this isn't tamper-resistant like OxyContin, there is a real concern that it will be preferentially sought by people who want to abuse it. It boggles the mind." Liscinsky, a spokesperson for the FDA, confirmed to Mother Jones that Zohydro "is not abuse-deterrent," but noted that "FDA does not believe it is feasible at this time to require that all new solid oral-dosage form opioids have abuse-deterrent properties."
Before approving Zohydro, the FDA examined one study of the drug's effectiveness. In that, study, researchers gave Zohydro to about 1,500 patients. One phase of the study, which weighed the drug against a sugar pill, showed that subjects taking Zohydro for chronic lower back pain reported less pain than those who received the placebo over a 12-week period. The study definitively showed that Zohydro "was superior in controlling pain," Stephen Farr, the cofounder, president, and chief operating officer of Zogenix, told the FDA. But the results were not dramatic enough for some members of the FDA's advisory panel.
"I am concerned that there's a very modest change in the pain scores. With a lot of methodologic reworking, it is convincing as a study, but not that convincing," Jeanmarie Perrone, the director of the division of medical toxicology at the University of Pennsylvania, said during the December hearing. "I have my doubts." She went on to vote against the drug's approval.
In another part of the study, researchers gave Zohydro to with a variety of chronic pain conditions to test for possible side effects over a period of six months to a year. The main side effects reported by the test subjects were non-life-threatening symptoms like nausea, fatigue, headache, and dizziness. But a few subjects reported more serious side effects, including "mental impairment." According to Liscinsky, the FDA spokesperson, of 575 subjects in the chronic pain population who were given Zohydro, 5 died. The first four deaths—one of which was a completed suicide, by carbon monoxide poisoning, and another which was caused by drug toxicity from other painkillers—"were unlikely [to be] related to study medication." The fifth death was "an apparent suicide" by a patient who "hoarded study medication" during the study and died from an overdose of the drug about a year after the study was over, Licinsky says.
"If we had this issue arise of diversion and potential abuse in a closely monitored situation with multiple professionals, then how do we control this substance in the larger marketplace where we don't have the same controls underway?" Rodney Mullins, the national director for Community Health Advocates and the consumer advocate on the FDA advisory committee, asked at the December hearing. He, too, went on to vote against the drug.
Panel members also raised concerns about Zogenix's marketing strategy. Cancer patients will be eligible to take the drug, but only five cancer patients took it during testing. "You're asking us for an approval that will be used much more broadly," said Kramer, who also noted that Zogenix sales representatives will be compensated, up to a certain point, based on the number of Zohydro prescriptions they can convince doctors to write during the drug's first year on the market.
"In Texas, I have six pain clinics that in a 15-month period wrote between almost 24,000 and 43,000 scripts…Those guys are still in operation. So we need to be very aware that these people who are into making the money, just because you call [Drug Enforcement Agency] doesn't mean things are going to happen quickly," Jane Maxwell, a senior research scientist at the Addiction Research Institute who voted against the drug, said at the hearing.
Farr, Zogenix's president, testified at the hearing that the company believes it can control abuse of the drug by limiting its availability and focusing on the patients who need it. The FDA is not allowing any prescription refills with Zohydro, and notes that there will be stringent recordkeeping, reporting, and physical security requirements for the drug. But James Breitmeyer, the chief medical officer at Zogenix, acknowledged, "There's an unfortunate linkage between opioid abuse and suicide. And that will be an important part of the training that we do."
The two panel members who voted for the drug argued that Zogenix has met the FDA's safety standards and posed no greater risk than current painkillers on the market. The FDA agrees. "FDA has concluded that the benefits of Zohydro ER outweigh its risks when used as provided in the approved labeling," Licinsky, the FDA spokesman, tells Mother Jones.
But at the December vote, some doctors weren't willing to take that risk. "I happen to live in the real world," said Alan Kaye, a doctor who chairs the anesthesia department at the Louisiana State University School of Medicine, explaining why he was voting against the drug. "I certainly feel there would be quite a bit of morbidity and mortality that would result."