TIME iran nuclear deal

Iran Nuclear Deal Reaches Key Number of Senate Supporters

A major foreign policy victory for President Obama

Sen. Barbara Mikulski of Maryland announced this morning that she will support President Obama’s nuclear agreement with Iran, giving the administration sufficient support in the Senate to ensure a major foreign policy victory for the president in his final 18 months in office.

“No deal is perfect, especially one negotiated with the Iranian regime,” Mikulski said in a statement released mid-morning in Washington. “I have concluded that this Joint Comprehensive Plan of Action is the best option available to block Iran from having a nuclear bomb. For these reasons, I will vote in favor of this deal.”

Mikulski’s support caps a summer of lobbying by the White House and the State Department in the face of resolute opposition to the deal by Republicans, many of whom criticized negotiations to begin with and argued the deal would empower Iran’s regional ambitions and ultimately enable Tehran to get nuclear weapons.

In weeks of testimony, briefings, letters and phone calls, Obama, Secretary of State John Kerry, and other senior administration officials argued the deal would constrain Iran’s nuclear program, open the door for further diplomatic progress and delay any decisions about a military confrontation with the mullahs for at least a decade.

Mikulski became the 34th Senator supporting the deal, hardly a resounding victory for the administration’s position—it is the bare minimum number of Senators Obama needs to ensure he can deliver on his end of the deal with Iran. If Obama cannot win another seven fence-sitting Democrats before a vote on disapproving the deal later this month he will have to veto that resolution and rely on the Democrats to prevent being overridden by Congress.

But after nearly three years of intense, sometimes secret negotiations that delivered on Obama’s 2008 campaign pledge to try diplomacy instead of military force in the confrontation with Iran, the Senate milestone guarantees him a key legacy victory for his second term, and his presidency.

The administration began its lobbying immediately after inking the deal in July. Secretary of State John Kerry made multiple appearances on Capitol Hill in front of House and Senate committees defending the deal, along with Secretary of Energy Ernest Moniz and Treasury Secretary Jack Lew. President Obama engaged Jewish groups in an attempt to convince them the deal would not endanger Israel. And he and Kerry personally responded to written and other questions from lawmakers in both chambers of Congress.

Republicans came out hard against the deal from the outset. Influential leaders like Sen. Bob Corker of Tennessee expressed early skepticism about the deal’s ability to constrain Iran. But the issue quickly took on a political cast for Republicans, as presidential candidates turned it into a campaign talking-point. Sen. Ted Cruz of Texas said the deal “will make the Obama administration the leading financier of radical Islamic terrorism” because it would lift sanctions on Tehran. Former Arkansas Gov. Mike Huckabee compared the deal to the Holocaust, saying Obama would “take the Israelis and march them to the door of the oven.”

That rhetoric may have been more effective as a way of attracting attention on the campaign trail than in convincing Democrats who were genuinely debating the merits of the deal. While Senators Chuck Schumer and Robert Menendez came out against the deal, in recent weeks centrists like Chris Coons and Bob Casey came out in favor, laying out detailed arguments for their support. The administration likewise won over Democratic House members from heavily Jewish districts in New York and Florida as the summer wore on.

Administration officials say the Republicans ended up undercutting themselves. “It became clear early on that a lot of Republicans were going to oppose the deal without even reading it or understanding the details,” says a senior administration official. “And a lot of the Republican opposition was offensive and truly partisan in nature,” the official says.

The administration framed the debate as a choice between war or diplomacy, with military options still on the table if Iran broke its commitments and tried to go nuclear. The White House argued that the deal was simply a responsible diplomatic effort that put off a war for at least a decade. That argument gained traction with Mikulski, who said Wednesday that “The military option is always on the table for the United States. We are not afraid to use it. But military action should be the last resort.”

In the case of Mikulski, the administration also had an inside line. Before she became a Senator her chief of staff in the House was Wendy Sherman, who was the lead U.S. negotiator for the administration on the Iran deal. Sherman ran Mikulski’s campaign for the Senate. And the current State department liaison to Capitol Hill is also a former Mikulski staffer who traveled to Vienna last month with the Senator for discussions with nuclear arms inspectors over implementation of the deal.

TIME Hillary Clinton

Hillary Clinton’s Lawyer Readies for Email War

Hillary Rodham Clinton
Jae C. Hong—AP Democratic presidential candidate Hillary Rodham Clinton listens to a home care worker during a roundtable discussion on home care in Los Angeles on Aug. 6, 2015.

Longtime Hillary Clinton ally and lawyer David Kendall is a legal mastermind now entering a highly political arena

Born into a family of Quakers, David Kendall had a birthright claim to be a conscientious objector when the draft was instituted during the Vietnam War. But while he opposed the war, he couldn’t in good faith claim to be a pacifist, those who know him say. So as a student at Yale Law School at the time, he did two things instead: he dove into researching how the draft lottery worked, eventually co-writing a book on the subject, and he enlisted in ROTC, taking a commission as 2nd Lieutenant.

Kendall didn’t end up deploying overseas, but his experience with the draft is as good a place as any to begin understanding the man Hillary Clinton has turned to once again for legal help, this time defending her use of personal email as Secretary of State. Liberal, intellectual and relentlessly committed to the fight, the affable Kendall, who has known the Clintons since their time together at Yale and who defended Bill Clinton during his impeachment, is once again preparing to go to war, whether he has to or not.

Increasingly, it looks as if he will. This week, the Intelligence Community Inspector General told Congress that two of the emails that were stored on Clinton’s unclassified, private email server contain information that should have been classified at the highest level, Top Secret, because they were derived in part from secret overhead eavesdropping platforms like satellites or drones. The IG says there are hundreds of other emails containing classified information in the stash of 55,000 the State department is reviewing from Clinton’s server. Most threatening of all, the hard-headed investigators at the FBI are conducting an inquiry into how classified information made it into unclassified settings. This week, the FBI took possession of both Clinton’s server and thumb drives containing copies of the emails that Kendall had been holding for safekeeping.

For Clinton, the prohibitive favorite for the Democratic presidential nomination in 2016, the developments are a thicket of political, bureaucratic and legal challenges that threaten to stall her campaign and further damage her trust with voters. For Kendall, the challenge is to deliver his expertise in a context where legal fallout is only half the battle.

In one sense, Clinton and Kendall are well matched. Both excelled at law school and they sought out each others’ advice early in their careers. Kendall called her when he needed a contact in Arkansas, where she worked as a young attorney while Bill Clinton pursued politics. And she called Kendall when she needed advice from D.C., where he had joined Washington’s premier litigation firm, Williams and Connolly, after clerking for Supreme Court Justice Byron White and specializing in death penalty appeals at the NAACP Legal Defense Fund in New York.

It was when the Clintons arrived in Washington with the baggage of the Whitewater investigation that they really reconnected with Kendall, however, hiring him to defend them against accusations of improper business dealings. And when Clinton found himself needing to prepare for grand jury testimony in the Monica Lewinsky investigation four years later, it was Kendall who prepared him. “His job was to make sure there was never a criminal charge against the president,” says one member of Bill Clinton’s legal team, and “his preparation [of Clinton for the grand jury testimony] will go down as one of the best ever.”

Legally that is certainly true, but Clinton is dogged to this day by the aura of deceit that settled around his narrow, evasive, answers about his relationship with Lewinsky. “When you’re asked a question in a deposition,” Kendall said later as he defended the president’s narrow testimony in the Lewinsky case, “You ought to respond specifically to the question. You ought not, if asked your name, to give your name and address.” That discipline and control delivered Bill Clinton from the danger of a criminal charge and helped earned Kendall the highest praise from allies and opponents alike in the world of Washington litigation.

But the challenge Kendall faces in representing Hillary Clinton is that the context of her email scandal is not just legal. Her goal of becoming president, and indeed the hopes of the Democratic party for retaining the White House, are piggybacking on her defense in the email case. When it comes to matters unrelated to the law, Kendall is less well-versed. “His lack of being involved in the political process,” says the former member of Bill Clinton’s legal team, and the fact that “he’s never been in government,” are both challenges to his ability to advise Clinton.

On the legal issues relating to the handling of classified information, Kendall has recent experience. Kendall represented David Petraeus, the former CIA chief, who pleaded guilty in April to a misdemeanor charge of mishandling classified materials and was fined $100,000. The case resulted from Petraeus improperly sharing classified information with his biographer, Paula Broadwell. Kendall led the negotiations that produced the plea deal, which angered FBI agents who thought Petraeus had misled their investigation into the matter.

Hillary Clinton so far appears not to be in the same kind of trouble Petraeus got himself into. But the news that two of Clinton’s emails may contain Top Secret information makes Kendall’s legal defense more complicated. The presence of classified emails does not in itself mean Hillary Clinton broke the law, or even President Obama’s rules regarding the proper protection of classified materials. Generally speaking under the laws criminalizing misuse of classified information, one is guilty only if one “knowingly” removed and intentionally retained secrets improperly. None of the emails contains markings indicating they contained secret information, the Inspector General and other officials have repeatedly said.

But communications intercepted via satellite or other overhead collection means are so closely protected that they have their own law 18USC798, with even tighter rules and higher penalties. That law makes it a crime not just to knowingly mishandle such secrets, but also to use them “in any manner prejudicial to the safety or interest of the United States.” That in turn, says a senior intelligence official familiar with the case, means the FBI’s investigation into the handling of the classified materials “will go way beyond what the intelligence community’s Inspector General ever would do.”

Kendall declined to be interviewed for this article and the Clinton campaign did not return email messages asking for comment for it. The campaign has said her use of a private server and the discovery of classified information on it are being amplified by the political agendas of Republicans on Capitol Hill and on the 2016 presidential campaign trail.

That is no doubt true but it doesn’t make the job of defending her position any easier. Kendall will have his hands full as he attempts to juggle the legal interests of his client and the political reality she has to operate in. “He’s an incredible lawyer, he writes brilliantly, and he works harder than anyone else,” says Kendall’s old colleague from the Bill Clinton impeachment. “Whether he’s successful in the rough and tumble of the public arena is another question.”

TIME Congress

State Department Nomination Blocked Over Clinton Email Inquiry

US Secretary of State Hillary Clinton (R) and Deputy Chief of Staff Huma Abedin arrive for a NATO Foreign Minister family photo in front of the Brandenburg Gate in Berlin April 14, 2011.
SAUL LOEB—AFP/Getty Images US Secretary of State Hillary Clinton (R) and Deputy Chief of Staff Huma Abedin arrive for a NATO Foreign Minister family photo in front of the Brandenburg Gate in Berlin April 14, 2011.

Senator will block nomination over State Department's "contemptuous failures to respond to Congressional inquiries"

Senate Judiciary Committee Chairman Charles Grassley has put a hold on the nomination of a senior State Department diplomat over what he says is the agency’s two-year pattern of “bad faith” in his investigation of Hillary Clinton’s tenure there.

The latest example of that pattern, Grassley says, is the department’s failure to provide copies of thousands of e-mails allegedly sent or received by a top Clinton aide, Huma Abedin, involving the head of a private consulting firm for whom Abedin simultaneously worked in 2012.

Grassley filed a statement in the Congressional record Tuesday evening indicating that he would block the nomination of career foreign service officer David Malcolm Robinson, who has been tapped by Secretary of State John Kerry to be Assistant Secretary for Conflict and Stabilization Operations. Grassley said Robinson was “an innocent victim” of the State Department’s “contemptuous failures to respond to Congressional inquiries.” Grassley said the department “has engaged in unreasonable delay in responding to Judiciary Committee investigations and inquiries” including the Abedin issue.

Grassley’s office says the Senator was tipped by a confidential source to the existence of approximately 7,300 e-mails sent or received by Abedin involving Douglas Band, the head of a global consulting firm, Teneo Holdings, who served as President Bill Clinton’s personal aide for much of his presidency. Abedin had been Hillary Clinton’s deputy chief of staff and in June 2012 shifted jobs to become a “Special Government Employee” at the State Department while also being paid as a consultant by Teneo Holdings. Grassley requested documents relating to Abedin’s unusual employment arrangement in June 2013 and has yet to receive the e-mails, his office says.

Abedin’s employment by the State department and Teneo Holdings came after her maternity leave from the government, when she was living in New York with her husband, former Congressman Anthony Weiner. Abedin was given the unusual job designation, “Special Government Employee” which is normally reserved for employees being hired from the private sector or elsewhere in government with unique expertise.

In a July 2013 response to Grassley, the State Department said Abedin was retained as “a senior adviser/expert” under the SGE designation, which allowed her to serve other clients or entities and to keep her security clearance. In a July 5, 2013, letter from Abedin to the department included in its response to Grassley, Abedin said the birth of her son “led me to decide to spend the bulk of my time in New York City” and that she had received approval for the arrangement from the department’s legal staff and human resource officials.

Abedin’s lawyers said that while they, like Grassley, have not seen the emails involving Band, they suspect based on the volume of email and the wording in the Senator’s letter that they are mass mailings of schedules or press clips on which both Abedin and Band are copied. In her July 5 letter to the State Department, Abedin said she “provided strategic advice and consulting services to the firm’s management team, as well as helped organize a major annual firm event.” She said she wasn’t asked to undertake any work on Teneo’s behalf with the State Department, and didn’t provide “insights about the Department, my work with the Secretary, or any government information” to Teneo.

Band has built Teneo’s business around the network he established as President Bill Clinton’s personal aide at the White House and during his post-presidency. He has been the target of criticism from some Clinton allies for leveraging that network for personal advancement, most notably in a Sept. 2013 New Republic article. A spokesman for Teneo did not immediately return a messages requesting comment for this story.

The State Department has provided five letters since 2013 in response to Grassley’s inquiries about everything from its use of SGE designations to Clinton’s use of a private e-mail server. But Grassley says those letters have been incomplete and that the department has willfully withheld responsive materials, demonstrating “a lack of cooperation and bad faith in its interaction with Congress.”

Grassley says Abedin’s employment by both State and Teneo raise concerns about potential conflicts of interest. Abedin also worked for the Clinton Foundation during the period she was working for Teneo. Grassley has also alleged that Abedin may have improperly received payment from the department while on leave.

A State official says the Department will be providing a response to Grassley “in the very near future.”

TIME Hillary Clinton

The Legal Question Over Hillary Clinton’s Secret Emails

Secretary Hillary Clinton speaks to voters at a town hall meeting in Nashua, New Hampshire, on Tuesday, July 28, 2015.
The Washington Post—The Washington Post/Getty Images Secretary Hillary Clinton speaks to voters at a town hall meeting in Nashua, New Hampshire, on Tuesday, July 28, 2015.

Two key questions: Did she know material was classified and did she act negligently handling it?

Is Hillary Clinton in trouble for having government secrets on her private email server?

Last week, the inspector general for the U.S. intelligence community concluded that some of the emails Clinton and others exchanged on her private server while she was Secretary of State contained classified information.

But the consequences of that revelation were muddied early on by erroneous reports of a request for a criminal inquiry from the Justice Department and by official disagreement over when and whether the information in the emails was actually classified.

Legally, the question is pretty clear-cut. If Clinton knowingly used her private server to handle classified information she could have a problem. But if she didn’t know the material was classified when she sent or received it she’s safe.

There are several laws that make it a criminal offense knowingly to reveal or mishandle classified information. The main one, 18 USC 1924 reads:

Whoever being an officer, employee, contractor, or consultant of the United States, and, by virtue of his office, employment, position, or contract, becomes possessed of documents or materials containing classified information of the United States, knowingly removes such documents or materials without authority and with the intent to retain such documents or materials at an unauthorized location shall be fined under this title or imprisoned for not more than one year, or both.

Clinton has explicitly and repeatedly said she didn’t knowingly send or receive any classified information. “The facts are pretty clear,” she said last weekend in Iowa, “I did not send nor receive anything that was classified at the time.” Intelligence Community Inspector General I. Charles McCullough III, disagrees, saying some of the material was in fact classified at the time it was sent. But in his letter last week to Congressional intelligence committee leaders, McCullough reported that, “None of the emails we reviewed had classification or dissemination markings.” And there has been no indication Clinton knew she was sending and receiving anything classified.

The public doesn’t yet know the content of the classified emails, and the State Department and the inspectors general have tens of thousands still to review. If evidence emerges that Clinton knew she was handling secrets on her private server, “She could have a problem,” says William Jeffress, a leading criminal trial lawyer at Baker Botts who has represented government officials in secrecy cases. Barring that, says Jeffress, “there’s no way in the world [prosecutors] could ever make a case” against her.

Clinton also has to worry about government rules for handling secrets. In December 2009, President Obama signed Executive Order 13526, which renewed the long-running rules for classifying information and the penalties for revealing it.

Under that order, agency heads like Clinton are responsible for keeping secrets safe throughout their departments. And all officers of the government can be suspended, fired or have their security clearance revoked if they “knowingly, willfully, or negligently” disclosed secrets or broke the rules in any other way.

Was Clinton negligent in setting up her private email server and communicating with State Department staff exclusively on it? Says Steven Aftergood, a secrecy expert at the Federation of American Scientists, “The material in question was not marked as classified, making it very hard or impossible to show negligence.”

With 16 months until the 2016 presidential election, Clinton’s opponents will certainly try. And with tens of thousands of emails still to be reviewed, they’ll have plenty of material to work with.

TIME Greece

Greek Debt Crises Haunted by Balkan History

Greece Eurozone
Yves Herman—Reuters German Chancellor Angela Merkel, Greek Prime Minister Alexis Tsipras, European Central Bank President Mario Draghi, French President Francois Hollande and European Commission President Jean Claude Juncker take part in a euro zone EU leaders emergency summit on the situation in Greece in Brussels, on July 7, 2015.

Lives are at stake in the final push for a Greek deal

Things can always get worse, and few places prove it like the Balkans. Twenty years ago this week, President Bill Clinton’s national security team was struggling to come up with a plan to save or replace the failing three-year-old United Nations “peacekeeping” mission in Bosnia. On July 6, 1995, Serb forces overran the UN-protected “safe-haven” of Srebrenica and slaughtered more than 8,000 men and boys in the worst European massacre since World War II. Even now, some 1,200 people remain missing in the scattered mass graves of eastern Bosnia.

Today’s Balkan crisis in Greece is not nearly so acute. A last ditch effort to avoid chaos is afoot as European creditors and the self-described radicals now ruling in Athens race towards a Sunday deadline for a deal to avoid economic collapse. A deal looks increasingly likely, but with some on the right still looking to teach Greece a fiscal lesson and others on the left urging Athens to rebel against its creditors, it is worth remembering there is plenty of room for more pain.

Banks remain closed and runs on products that can retain value have begun. If there is no deal by Sunday and Greece is forced to drop the Euro to pay its international and domestic bills, food and medicine shortages and fast-rising inflation are likely. In that event, says former U.S. Ambassador to Athens, Charles Ries, “You’ll see further hardship in the middle and lower classes, incomes will be worth less and household income will go down.” With little credibility left for the Greek government on the world markets, printing money may be the only way to fund public payments and rapidly rising inflation could further impoverish the country.

Where economic collapse leads the way, political unrest sometimes follows, and scared Greeks rightly worry that social order and stability are in danger. Greece, for all its historical claims as the font of western democracy has a more checkered recent political past. A civil war between the Greek government and communists backed by Yugoslavia and Albania followed World War II, and a right wing military coup took power from 1967 to 1974, relinquishing control only after the debacle of the Turkish invasion of Cyprus. A radical left-wing terrorist group, November 17, attempted for years to violently overthrow successive democratically elected governments.

To be sure, Greeks have a strong national identity and sense of their own history, and view their country as integrally tied to Europe. Both Ries and another former U.S. ambassador, Nicholas Burns, see prospects for a deal to avoid a Greek exit from the Euro increasing, and both think political collapse is unlikely. But the recent referendum over whether to accept a European bailout showed “a country very badly divided,” says Burns. “I don’t think the state will break over this,” he says, but Greeks “do have a tradition of demonstrations and angry political discourse” that “could really roil the politics.”

Crucial to stability in the event of a worsening economic crisis are the leaders of the far-left alliance, Syriza, and that is the primary cause for worry, says Burns. Prime Minister Alexis Tsipras has “driven the country into a ditch,” but is taking no responsibility for his actions, says Burns. Syriza’s leadership, “Strike me as highly ideological [and] quite inexperienced,” says Burns, “And I just worry that they haven’t shown the kind of sophisticated, calm leadership that you’d want in a real national crisis.”

Some observers in Greece see signs of the fraying of liberal political consensus in the current disarray. Prosecutors in Athens have launched an investigation into coverage of the recent referendum by local media, and statements by Syriza leaders, including the Interior Minister Nikos Voutsis, have further fanned concerns. Nor do the nationalist sympathies driving much of the outrage against austerity necessarily fall naturally on the side of pluralist democracy: right wing political groups, including followers of “Golden Dawn,” have been arrested for violent attacks on members of the political left in recent years.

With the possibility of economic collapse imminent, it seems Syriza’s leaders and Greece’s international creditors may be able to reach a deal. It is certainly the most reasonable course of action. But as the world pauses to remember the dead at Srebrenica, it is worth remembering that especially in the Balkans, many have died assuming that things couldn’t get any worse.


Here’s the Trickiest Part of the Iranian Nuclear Talks

Foreign Minister of France Laurent Fabius (R) talks with U.S. Secretary of State John Kerry during the nuclear talks between the E3+3 (France, Germany, UK, China, Russia, US) and Iran in Vienna, Austria on July 06, 2015.
Thomas Imo/photothek.net Foreign Minister of France Laurent Fabius (R) talks with U.S. Secretary of State John Kerry during the nuclear talks between the E3+3 (France, Germany, UK, China, Russia, US) and Iran in Vienna, Austria on July 06, 2015.

How inspections and verification would work

After more than 18 months of talks, the U.S. and Iran are within striking distance of a nuclear deal. But diplomats familiar with the talks say the hardest issue negotiators have struggled with from the start remains unresolved: the nature and extent of international inspections to monitor the supposedly peaceful nuclear program Iran gets to keep under the agreement. Which means the final push for a deal is probably the most important.

The heart of the interim “political framework” that the U.S. and Iran agreed to on April 2 was a step-by-step-lifting of economic sanctions on Tehran in exchange for its commitment to allow international monitors to verify tough limits on its nuclear program. But the outline left unresolved just how much access the monitors would get and what would happen if there were a disagreement. “The interim deal was largely silent on verification conditions,” says David Albright, a former arms inspector and the president of Institute for Science and International Security.

What kind of access the IAEA gets makes all the difference in part because Iran has a history of cheating on nuclear deals. A signatory to the Nuclear Non-Proliferation Treaty, it committed to monitoring by the International Atomic Energy Agency (IAEA). But twice in the past twenty years it secretly built nuclear facilities that were only uncovered by aggressive intelligence work by the U.S., France, the United Kingdom and Israel. And Iran has never explained the research into nuclear weapons that the international community uncovered over that time.

Since the April deal, Iran has sent mixed messages on how much access inspectors would get to suspected nuclear sites around the country. On May 20, Iran’s supreme leader, Ayatollah Ali Khamenei, ruled out inspections of military facilities. But Iranian officials suggested to reporters last week in Vienna that the country would accept additional, intrusive inspections proposed by the IAEA. Getting those additional measures is key to U.S. and Western confidence in a deal. “The IAEA has to get better cooperation from Iran,” says Albright.

Even if Iran agrees on paper to the additional IAEA inspections, though, skeptics worry that in practice Tehran will block monitors. The U.S. negotiators have pushed for a system to resolve disputes quickly so that Iran couldn’t hide evidence at a suspect site before inspectors got there. How that system would work and whether Iran will agree to it are still unknown.

The final question is what happens if the IAEA and international powers actually catch Iran breaking the agreement. The U.S. has insisted that sanctions must be reimposed automatically if the IAEA finds violations Iran can’t or won’t explain them. While details are thin, sources familiar with the talks say both sides have made progress on that issue in recent days.

Ultimately a nuclear deal with Iran is only as strong as the inspections that verify its implementation. The question now is whether Iran will actually accept intrusive monitoring and if not, will U.S. negotiators have the fortitude to walk away after a year and a half of talks have brought them so close to a deal.


TIME opioids

FDA Warned Drugmaker About Pain Pill Injection

Endo Pharmaceuticals Opana Drug Pain Killer
Tripplaar Kristoffer—Sipa/AP A logo sign outside of a facility occupied by Endo Pharmaceuticals in Malvern, Penn. on May 30, 2015.

A new form of pain killer could be driving addicts to inject the drug, hastening the spread of HIV

As officials in Indiana scramble to contain a fast-spreading HIV outbreak, TIME has learned that government officials warned one company that the newest version of a drug it manufactured could be driving behavior that is contributing to the crisis.

In May 2013, federal regulators from the Food and Drug Administration told Endo Pharmaceuticals, the maker of the widely used prescription pain pill Opana, that a new form of the medication could be driving abusers to inject the drug intravenously instead of snorting it.

The HIV outbreak in southern Indiana, which has ballooned from 8 cases in January to 166 as of June, is the result of addicts dissolving and injecting Opana, according to the Centers for Disease Control and Prevention (CDC) and local officials in Scott County, where the outbreak is centered. 96% of those who tested positive for HIV and were interviewed by the CDC said they were injecting Opana, according to an April health alert by the agency.

In 2012, Endo introduced a new version of the drug that it said was designed to be abuse deterrent. Where a previous version of the drug could be easily crushed and snorted or dissolved and injected, the new version had a special coating that supposedly made doing so more difficult. Endo removed the previous version from the market and asked the FDA to rule that it had been unsafe. Such a ruling would have prevented other drug makers from introducing generic versions of the pill.

The FDA denied Endo’s request, rejecting the company’s claims about the new coating’s ability to deter abuse. While the new formulation made it harder to crush and snort the drug, the FDA found, “it may be easier to prepare OPR for injection.” That raised, the FDA said, “the troubling possibility that the reformulation may be shifting a non-trivial amount of Opana ER abuse from snorting to even more dangerous abuse by intravenous or subcutaneous injection.”

Officials in Scott County say abusers discovered they could cook down the abuse deterrent version of the pill, dissolving it and preparing it for injection. Officials say addicts prefer the drug to heroin, even though it is more expensive, and the high doesn’t last as long. Addicts in Scott County have transmitted HIV to each other by sharing needles as they shoot up, sometimes as often as 20 times a day.

Endo, a Pennsylvania-based company that specializes in pain medications, earned $1.16 billion in revenue from Opana from 2008-2012. The company has denied Opana is at the heart of the outbreak and has suggested generic versions of its drug that didn’t have the “abuse deterrent” coating might be at fault, as discussed in the current cover story of TIME on opioid abuse in America:

In April, Endo held a conference call with public-health officials in Scott County. The Endo officials “thought it was a mistake,” says [Scott County public health nurse, Brittany] Combs, who was on the call. Around the same time, [Scott County Sheriff Dan] McClain says an Endo security official called him and offered to help investigate the source of the pills. The Endo official told him the drug being abused couldn’t be Opana because it had been reformulated to be “abuse deterrent.” McClain was skeptical. “I’ve got an evidence room full of Opana over there right now, and I don’t have any generic forms of that pill that are being purchased off the street,” McClain says.

Endo officials declined repeated requests to be interviewed for this article. In response to questions emailed to the company regarding its marketing of Opana and its response to the crisis in Scott County, Keri Mattox, senior vice president for investor relations, said, “Patient safety is a top priority for Endo,” and the company has “an ongoing, active and productive dialogue” with the FDA regarding Opana’s “technology designed to deter abuse.” Mattox says the company supports “a broad range of programs that provide awareness and education around the appropriate use of pain medications” and has reached out to the CDC, Indiana state officials and Scott County health and law enforcement officials, among others.




Your browser is out of date. Please update your browser at http://update.microsoft.com