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.

 

 

 

TIME global trade

Why Democrats Overcame In-Fighting on Trade

President Barack Obama pauses during a meeting at the White House in Washington on May 1, 2015.
Susan Walsh—AP President Barack Obama pauses during a meeting at the White House in Washington on May 1, 2015.

President Obama’s trade agenda overcame a setback Wednesday in the Senate, showing a blocked vote 24 hours earlier was more of a negotiating strategy by centrist Democrats than a death-blow to the prospects for a trans-Pacific trade deal.

Given the stakes, that’s not entirely surprising: the single biggest factor in how well most human beings live in 20 years will be the economic balance of power between China and the U.S. Figuring out how best to set that balance to America’s advantage is what the Senate debate is all about.

The Trans-Pacific Partnership is being negotiated in secret and few know what is actually in it. But the general purpose is to get 12 countries in Asia and the Americas, which together account for 40% of the world’s production of goods and services, to agree to a broad set of rules for trade and business. Supporters say standardizing those rules would make it easier for Americans to sell things abroad and cheaper to buy things here.

At the same time, China, India and other countries that aren’t part of the TPP talks are trying to cut their own deals to give their companies and consumers an edge. Whoever does it best gets the most benefits, the argument goes.

Opponents of the deal say these so-called “efficient markets” are just jargon for cutting corners on labor, environmental and human rights standards. Competing with China to cut trade deals ends up being a race to the bottom, they say. Instead, they argue that Americans would do better if the Obama Administration set high standards even if that made it harder to compete with other countries.

The problem with that argument is that as China grows ever-more powerful, the world is increasingly happy to ignore high American standards in favor of lower Chinese ones. China’s economy currently produces around $9.24 trillion of goods and services every year; the U.S. weighs in at around $16.7 trillion. Depending on growth rates and inflation, China will likely have the largest economy in the world in a few years and by 2035 it could be way ahead.

That translates into power and influence. Already American allies and enemies alike have shown they will side with China when there is cash at stake. In March, for example, the UK, France, Germany and Italy all defied the U.S. to join a Chinese led development bank.

So how do you set standards and protect American workers while making it easier and cheaper for them to prosper? The centrist bloc of Democrats that stymied Obama yesterday say they want to take a middle path, offering other countries the opportunity to have cheaper trade with the U.S. with somewhat higher standards. The centrists say they’ll vote to pass “fast track” authority if the U.S. also punishes certain kinds of corner-cutting that give countries an unfair advantage in the international markets, such as currency manipulation, lax labor standards and other bad behavior.

Ideologically, that’s not very different from Obama’s position. Which explains why the jubilation on the left after yesterday’s vote was premature. Centrist Democrats reportedly met with the White House to discuss a compromise on tougher standards that would allow “fast track” authority to move ahead. By mid-afternoon Wednesday, a deal had been struck.

Whether that will ultimately keep America competitive with the fast-growing China is another question.

TIME

Clinton Allies Knock Down Donor Allegations, New Questions Pop Up

Hillary Clinton attends the Hillary Rodham Clinton Awards for Advancing Women in Peace and Security at Georgetown University in Washington, DC on April 22, 2015.
Win McNamee—Getty Images Hillary Clinton attends the Hillary Rodham Clinton Awards for Advancing Women in Peace and Security at Georgetown University in Washington, DC on April 22, 2015.

Hillary Clinton’s allies are pushing back against the suggestion in a new book that donations to the Clinton Foundation influenced the handling of the sale of U.S. uranium mines to a Russian-backed company.

The new book, Clinton Cash: the Untold Story of How and Why Foreign Governments and Businesses Helped Make Bill and Hillary Rich, says that Hillary Clinton failed in 2010 to block the purchase of American uranium mines by a Russian-backed company while people with financial and strategic interests in the sale were making millions of dollars of donations to the Clinton Foundation, a philanthropy run by her husband, former President Bill Clinton.

The suggestion of outside influence over U.S. decisionmaking is based on little evidence — the allegations are presented as questions rather than proof. The deal’s approval was the result of an extensive interagency process that required the assent of at least nine different officials and agencies. A former State Department official who participated in the deal’s approval told TIME that Clinton did not weigh in on the uranium sale one way or the other, and her campaign calls the allegations in the book “absurd conspiracy theories.”

But the book’s dark suggestions reflect the growing problem Clinton faces in her run for the White House in 2016 as more and more details of the foundation’s fundraising activities present the appearance of impropriety and lack of transparency during her time as Secretary of State.

One chapter of the book, written by conservative author Peter Schweizer and obtained by TIME, focuses on an obscure deal that had been years in the making. Schweizer says Secretary Clinton failed to block the Russian State Atomic Nuclear Agency (Rosatom), a Kremlin-controlled nuclear agency, from purchasing a controlling stake in an American Uranium mining concern, Uranium One. The company’s chairman, Ian Telfer, was a major donor to the Clinton Foundation. Several other Clinton Foundation donors stood to gain from the agreement as well.

Because the proposed sale involved the transfer of potentially strategic U.S. assets, the Uranium One transaction was subject to approval by the Committee on Foreign Investment in the United States (CFIUS), an interagency panel that comprises powerful federal agencies. In prior years, Clinton had urged the committee to take a hawkish view of deals involving U.S. strategic assets, and Schweizer says that should have inclined her against the Rosatom purchase. “Despite a long record of publicly opposing such deals Hillary didn’t object,” Schweizer writes in the version of the chapter obtained by TIME. “Why the apparent reversal? Could it be because shareholders involved in the transaction had transferred approximately $145 million to the Clinton Foundation or its initiatives? Or because her husband had profited from lucrative speaking deals arranged by companies associated with those who stood to profit from the deal?”

The State Department’s role in approving the deal was part of an extensive bureaucratic process, and the chapter offers no indication of Hillary Clinton’s personal involvement in, or even knowledge of, the deliberations. State has just one vote on the nine-member committee, which also includes the departments of Defense, Treasury and Energy. Disagreements are traditionally handled at the staff level, and if they are not resolved, they are escalated to deputies at the relevant agencies. If the deputies can’t resolve the dispute, the issues can be elevated to the Cabinet Secretary level and, if needed, to the President for a decision. The official chairman of CFIUS is the Treasury Secretary, not the Secretary of State.

Before purchasing a controlling stake in Uranium One, the Russian conglomerate also had to get approval from the Nuclear Regulatory Commission, an independent agency outside of the State Department’s purview, as well as Utah’s nuclear regulator. It also received the sign-off of Canada’s foreign investment review agency. The deal itself was the outgrowth of a diplomatic initiative launched by the Administration of George W. Bush to expand trade opportunities between Russia and the U.S., including in the area of nuclear power.

One official involved in the process said Clinton had nothing to do with the decision in the Uranium One case. Jose Hernandez, who as former Assistant Secretary of State for Economic, Energy and Business Affairs was the State Department’s principal representative on the committee, rejected the notion that Clinton’s foundation ties had any bearing on the deal. “Secretary Clinton never intervened with me on any CFIUS matter,” he told TIME. A spokesperson for Hillary for America, Josh Schwerin, also attacked the suggestions made in the book. The transaction “went through the usual process and the official responsible for managing CFIUS reviews has stated that the Secretary did not intervene with him,” Schwerin says, “This book is twisting previously known facts into absurd conspiracy theories.”

Throughout the new book, Schweizer suggests that Clinton used her authority as Secretary of State to intervene on behalf of companies that donated to her family’s foundation. Clinton has sought to distance herself from the charges on the campaign trail, calling the GOP claims “distractions.”

Even if Clinton was not involved in approving the deal with the Russian company, the book does raise more questions about the Clinton Foundation’s transparency regarding its donors and shows that the issue will continue to dog her candidacy. The book reports that Telfer, the Uranium One chairman, donated $2.1 million to a Clinton Foundation subsidiary through a charity he controls around the time the purchase was being finalized, an assertion TIME has verified through a review of public records. Those donations do not appear on the foundation’s disclosure of donors. Telfer is listed for smaller donations he made directly to the parent foundation.

In 2008 the Clinton Foundation and President Barack Obama’s transition team signed a memorandum of understanding about the foundation’s activities to allay congressional concerns over potential conflicts of interest stemming from its donors as Clinton was preparing to become Obama’s Secretary of State. “In anticipation of Senator Clinton’s nomination and confirmation as Secretary of State, the foundation will publish its contributors this year,” the agreement states. “During any service by Senator Clinton as Secretary of State, the foundation will publish annually the names of new contributors.”

Exempt from that relationship were an array of Clinton Foundation subsidiaries, including the Clinton Giustra Enterprise Partnership, a Canadian-based charity that works to establish “social enterprises” in the developing world. Telfer is one of three directors of a charity called the Fernwood Foundation, according to Canadian tax records dug up by Schweizer and verified by TIME. Fernwood has donated $2.1 million to the Clinton Giustra Enterprise Partnership, which at one point passed through as much as 88% of its donations to the main Clinton Foundation, Schweizer writes. Schweizer alleges that Telfer had 1.6 million shares in Uranium One and profited hugely off the deal, a claim that couldn’t be independently verified.

The Clinton Giustra Enterprise Partnership is listed as having given contributed more than $25 million to the foundation according to its online disclosures, but the foundation does not list any of the Giustra Partnership’s individual donors. When contacted by TIME, a spokesman for the Clinton Foundation deferred comment to the Clinton Giustra Enterprise Partnership, which didn’t immediately respond to requests for comment.

Without a full account of donors to the foundations, allegations like the one in Schweizer’s book will follow Clinton’s candidacy even as she seeks to remain above the fray. The campaign, for its part, will continue to do its best to discredit Schweizer’s book and distance itself from Republican attacks.

“While Republicans focus their efforts on attacks, Hillary Clinton is going to continue to focus on how to help everyday Americans get ahead and stay ahead,” the Clinton campaign said in a memo circulated Tuesday night. “That’s what her campaign is about, and no book — especially one as discredited as this one — is going to change that.”

Read next: How New Hampshire’s Women Paved the Way for Hillary Clinton

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TIME Foreign Policy

The 5 Keys to a Final Nuclear Deal With Iran

The details of the agreement are only part of it. Here's what else matters.

The U.S., Iran, the European Union, Russia and China announced that they had “reached solutions on key parameters” to a nuclear deal April 2 after more than a week of tough negotiations in Lausanne, Switzerland.

Speaking at the White House, President Obama called the deal “historic” but also said that it was only a “framework” that depended on a final written agreement being set to paper in coming weeks.

In principle, the deal traded limits on the Iranian nuclear program and broad but unspecified international inspections in exchange for the lifting of U.S. and E.U. sanctions and conditional removal of United Nations sanctions. Obama said that until the written agreement was signed, “our work is not yet done” and that if Iran backslid, “there will be no deal.”

Five things will determine whether the U.S. and Iran can ultimately reach a signed, sealed agreement.

  1. What the deal says. Iranian acceptance of intrusive international monitoring of its nuclear program, and the ability of the U.S. and others to reimpose penalties if Iran cheats on a deal are the most important parts of any agreement for the Obama administration. The April 2 statement includes some specifics of the inspections, but leaves others open. Iran has apparently agreed to inspections of all parts of the Iranian nuclear program from mining and milling uranium to suspected nuclear weapons research facilities, and is “required to grant access” to suspicious sites. But the details of that access, its frequency and any limits Iran might try to impose are unclear. If the inspectors, or Western spies, turn up evidence of cheating, the U.S. wants to be able to reimpose the tough economic sanctions that forced Iran to the negotiating table without engaging in lengthy diplomatic wrangling at the U.N. The April 2 agreement speaks of removing some UN sanctions, maintaining others and says a “dispute resolution process” will be put in place.
  1. How Obama handles Congress. The March 31 deadline that drove the current round of talks was actually just a way for the administration to get the U.S. Congress off its back. The real deadline is the June 30 expiration of the Nov. 2013 interim agreement which froze Iran’s nuclear program in return for freezing Western sanctions. Many in Congress believe, rightly, that tough U.S. sanctions helped force Iran to sign that interim agreement to begin with, and now Republicans and some Democrats want a say in whether those sanctions get lifted. Some want to take action to force Iran to agree to concessions in writing. Congressional action could backfire and undermine the April 2 statement before a final deal is written down and signed. The administration is negotiating the terms of any Congressional action, and the outcome of those discussions is unclear.
  1. How Obama handles the international coalition. The greatest downside to the recent talks in Lausanne, from the U.S. perspective, was the appearance of fractures in the international sanctions coalition. Russia and China’s agreement to squeeze Iran through U.N. sanctions was another key to Iranian concessions over the last few years. At one point in the lengthy talks in Switzerland, Russia seemed to side with Iran over whether a deal had been agreed even as the U.S. and France said one hadn’t, raising the danger of a split. If Iran can divide the U.S. and the E.U. from Russia before signing a final deal June 30, it could escape sanctions without having to follow through on the April 2 concessions it provisionally agreed to.
  1. What happens in Iran and Saudi Arabia’s proxy war. Our magazine story this week details the region-wide proxy war between Saudi Arabia and Iran that is the urgent regional context for the nuclear issue. The Obama Administration is struggling to reassure allies in the Middle East that a deal with Iran doesn’t mean Washington is looking to help Iran’s ascendancy in the new, post-Arab Spring Middle East order. In his White House statement April 2, Obama said he would convene a conference with Saudi Arabia and other Gulf Arab powers this spring as part of that effort. But the worsening violence in Yemen, Syria and Iraq, where Iranian and Saudi proxies are battling it out, could have an unexpected effect on the effort to reach a final written agreement.
  1. How long everyone talks. If the U.S. and Iran can’t get a final written deal by June 30, an ultimate agreement would depend on whether the two sides agree to keep talking, and writing, anyway. Some administration officials have argued it would be better to keep the talks going than to see a complete collapse. Under the terms of the Nov. 2013 temporary agreement, Iran’s program is frozen and the sanctions are in place. But keeping Congress onside, the sanctions coalition together and the Iranians at the table may be impossible after the next deadline.
TIME Foreign Policy

Exclusive: Netanyahu Canceled Intel Briefing for U.S. Senators on Iran Dangers

Israel's Prime Minister Netanyahu attends cabinet meeting in Jerusalem
Gali Tibbon—Reuters Israel's Prime Minister Benjamin Netanyahu attends the weekly cabinet meeting at his office in Jerusalem March 8, 2015.

Israeli spy chief warned Congress might blow up talks on Iranian nuke program

Israeli Prime Minister Benjamin Netanyahu tried to cancel a January briefing for U.S. Senators by his nation’s intelligence service that warned Congress could damage talks aimed at constraining Iran’s nuclear program, according to sources familiar with the events.

Tennessee Republican Bob Corker, the head of the Senate Foreign Relations Committee, had requested the Jan. 19 briefing for six of his colleagues traveling to Israel so that the intelligence agency, Mossad, could warn them that a Senate proposal might inadvertently collapse the talks. After Netanyahu’s office stripped the meeting from the trip schedule, Corker threatened to cut his own Israel trip short in protest.

Netanyahu relented after the personal intervention of Israeli ambassador to the U.S., Ron Dermer, and allowed the briefing to go forward, sources say. Attending were Corker, Republican Senators John McCain, Lindsey Graham and John Barrasso, Democratic Senators Tim Kaine and Joe Donnelly, and Independent Senator Angus King.

At issue was the fate of a Nov. 2013 agreement between Iran, the U.S. and five other international powers. That temporary agreement promised no new economic sanctions on Iran in exchange for a freeze of Iran’s nuclear program, new international inspections of Iran’s nuclear sites and the removal of nearly all medium-enriched uranium from Iran’s possession. Both sides have stuck to the interim deal while talks on a long-term deal to constrain the Iranian nuclear program have dragged out.

The controversial but popular bill proposed by Republican Mark Kirk and Democrat Robert Menendez would have imposed new sanctions on Iran if it didn’t agree by June 30 to a long-term deal. U.S. intelligence officials had concluded that the Kirk-Menendez bill risked collapsing the talks and taking with it the 16-month-old agreement, according to a report by Eli Lake and Josh Rogin of Bloomberg View. Corker wanted the Mossad briefing to bolster the U.S. assessment.

During the Mossad briefing, the agency’s chief, Tamir Pardo, warned that the Kirk-Menendez bill would be like “throwing a grenade” into the U.S.-Iran diplomatic process. After some of the contents of the briefing were first reported by Bloomberg View, Pardo released a statement saying he had used the phrase not to oppose new sanctions, but “as a metaphor” to describe the effect derailing current talks might have.

A spokesman for Netanyahu declined to say why the Prime Minister acted to prevent the Senators from receiving the briefing from Pardo. Since the Mossad briefing, Corker has rallied support for an alternative measure to replace the Kirk-Menendez proposal, support for which has faded. Corker’s bill, which has broad support and potentially could receive enough votes for a veto-proof majority, would only impose new sanctions if Iran walked away from the Nov. 2013 agreement.

U.S. and Iranian officials are entering a tense phase of negotiations in Switzerland this week as they attempt to reach a political deal to extend and expand the Nov. 2013 agreement for at least 10 years. As the challenges of reaching the longer-term deal have increased, some in the U.S. are trying to ensure the interim agreement that has frozen the Iranian program isn’t undermined in the process.

Some members of the Senate oppose the ongoing talks with Iran. Freshman Republican Senator Tom Cotton last week issued an open letter with 46 other GOP Senators warning the Iranian leadership that Congress could reverse parts of any deal the talks produce. Corker did not sign that letter; his bill provides for partial Congressional approval of a deal.

Cotton has said that rather than negotiate with Iran, the U.S. should adopt a policy of regime change and should arm Israel with bombers and bunker busting bombs with which it could attack Iranian nuclear sites. Authorities in both parties, including Obama’s first Defense Secretary Robert Gates, have worried that an Israeli attack could draw the U.S. into a military confrontation with Iran on unfavorable terms.

Supporters of Kirk-Menendez argue it would increase pressure on Iran to make concessions that would more effectively limit its ability to get a nuclear weapon. Republicans are concerned that the Obama administration is too eager to do a long-term deal with Iran and is making too many concessions in the current talks. Secretary of State John Kerry arrives for talks in Geneva Sunday ahead of a self-imposed Mar. 24 deadline for the political framework for a long-term deal. Final terms of a comprehensive agreement would not be worked out before June.

Netanyahu is seeking re-election in a tough vote Tuesday, with his Likud Party trailing his strongest competitor, Zionist Union, by four points in recent polls.

TIME Foreign Policy

Why Republicans Wrote to the Ayatollahs

Senator Tom Cotton speaks during a news conference with members of the Senate Armed Services Committee about arming Ukraine in the fight against Russia in Washington, D.C. on Feb. 5, 2015.
Samuel Corum—Anadolu Agency/Getty Images Senator Tom Cotton speaks during a news conference with members of the Senate Armed Services Committee about arming Ukraine in the fight against Russia in Washington, D.C. on Feb. 5, 2015.

Two words: Regime change

The 47 Republican Senators who wrote to the leaders of the Islamic Republic of Iran yesterday did so, they said, “to bring to your attention two features of our Constitution” which the Senators said limit how much President Obama can commit to in nuclear negotiations between Tehran, the U.S. and its five allies.

But to judge by his past statements about those negotiations, the letter’s primary author intended it not so much to edify the Iranians about the American system of government as to completely undermine the talks themselves.

Freshman Sen. Tom Cotton of Arkansas strongly opposes the nuclear talks and believes they should stop immediately. In January, he told the Heritage Foundation “the ongoing nuclear negotiations with Iran … started out as an unwise policy [and have] now descended into a dangerous farce.”

In his Heritage speech, Cotton suggested that Obama might have cut a quiet deal to push off Iranian nuclear weapons capability until after the end of his second term. Cotton said that the President, in writing to Iran’s supreme leader over the last several years in pursuit of a diplomatic solution to the nuclear impasse, had behaved “like a love-struck teenager.”

By contrast, Cotton informed the Iranian leaders in his letter Monday that any deal Obama cut with them might not last. “We will consider any agreement regarding your nuclear weapons program that is not approved by the Congress as nothing more than an executive agreement,” Cotton and his fellow Senators wrote. “The next president could revoke such an executive agreement with the stroke of a pen and future Congresses could modify the terms of the agreement at any time,” the Republican Senators added.

Cotton has thoughts on what an alternative policy should be. In his Heritage speech, he said the U.S. should focus first and foremost on bringing down the regime in Tehran. “The goal of our policy must be clear: regime change in Iran,” Cotton said. To that end, Cotton said, the U.S. Congress should offer to transfer bombers and 30,000 pound bunker busting bombs to Israel for use should Israel decide to attack Iranian nuclear sites.

Not all the Republicans agree with that policy. Seven Republican Senators did not sign the letter, although they have not all stated their reasons. Former Defense Secretary Robert Gates has previously argued that Israeli military strikes against Iran could draw the U.S. unprepared into war. Cotton served in Iraq and Afghanistan, but after two long and costly wars few politicians are willing publicly to embrace policies that could drag the U.S. into another Middle East conflict.

Which may explain why Cotton and his fellow signatories ended their letter to the Iranians by saying only that, “We hope this letter enriches your knowledge of our constitutional system and promotes mutual understanding and clarity as nuclear negotiations progress.”

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