The next generation of killer drugs approved by FDA

As Overdose Deaths Soar To Record Highs, FDA Approves New Painkiller That's 1,000X More Powerful Than Morphine

ZeroHedge,

3 November, 2018

Purdue Pharma and other pioneers of powerful opioid painkillers probably felt a twinge of regret on Friday when the FDA approved a powerful new opioid painkiller that's 10 times stronger than fentanyl  - the deadly synthetic opioid that's been blamed for the record number of drug overdose deaths recorded in 2017 - and 1,000 times more powerful than morphine, ignoring the objections of lawmakers and its own advisory committee in the process. 

After all that trouble that purveyors of opioids like Purdue and the Sackler family went to in order to win approval -doctoring internal research and suborning doctors to convince the FDA to approve powerful painkillers like OxyContin despite wildly underestimating the drug's abuse potential - the agency might very well have approved those drugs any way? And opioid makers might have been able to avoid some of the legal consequences stemming from this dishonesty, like the avalanche of lawsuits brought by state AGs.

What's perhaps even more galling is that the FDA approved the drug after official data showed 2017 was the deadliest year for overdose deaths in US history, with more than 70,000 recorded drug-related fatalities, many of which were caused by powerful synthetic opioids like the main ingredient in Dsuvia, the brand name under which the new painkiller will be sold.

 

Dsuvia is a 3-millimeter tablet of sufentanil made by AcelRx. It's a sublingual tablet intended to provide effective pain relief in patients for whom most oral painkillers aren't effective. The FDA's advisory committee voted 10-3 to recommend approval of the drug, a decision that was accepted by the FDA on Friday. The agency justified its decision by insisting that Dsuvia would be subject to "very tight" restrictions.

"There are very tight restrictions being placed on the distribution and use of this product," said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency's approval of Dsuvia. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia."

Still, some of the agency's actions looked to critics like attempts to stifle internal criticism. For example, the agency scheduled the advisory committee vote on a day where the chairman of the committee, who was opposed to approval, could not attend - while circumventing its normal vetting process, despite the fact that the member in question had notified the agency of his unavailability months beforehand.

But the FDA rejected any and all criticisms related to Dsuvia being sold as a street drug by insisting that the risk of diversion (when doctor-prescribed drugs are illicitly sold on the black market) was low because the drug would only be prescribed in hospital settings, and wouldn't be doled out at pharmacies. But critics said that, given its potency, Dsuvia would "for sure" be diverted at some level. They also rejected the FDA's argument that Dsuvia satisfied an important need for pain treatment: offering rapid, effective relief for obese patients or others lacking easily accessible veins.

While a niche may eventually be found for Dsuvia, "it's not like we need it...and it's for sure, at some level, going to be diverted," said Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. "Do we really want an opportunity to divert another medicine?"

Fortunately for Dsuvia's manufacturer, AcelRx, these public health risks pale in comparison to the enormous profits that the company stands to reap from sales. The company anticipates $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

It goes without saying that cancer patients and others suffering from life threatening illnesses have a legitimate need for effective pain relief. But when the FDA says Dsuvia is needed in the hospital setting, it probably isn't telling the whole story. Because, as the Washington Post pointed out, the medication's development was financed in part by the Department of Defense, which believes Dsuvia will be an effective treatment for emergency pain relief on the battlefield - like when a soldier gets his legs blown off after accidentally stepping on an IUD.

Meanwhile, the Department of Justice's Jeff Sessions-backed war on medical marijuana continues despite President Trump's token resistance.

The International Narcotics Trade

International bank system needs Afghan drugs to live

Pravda.Ru,

16 November, 2011

The situation with the production of drugs in Afghanistan has reached a critical level. The States, having spent huge amounts to combat drug trafficking in Afghanistan, contributed to the opposite effect (many believe that Washington wanted exactly that). The Russian Federation suffered most from it.

The latest UN report says that the production of opium in Afghanistan has increased by almost 50 percent over the last year. According to the report, released Wednesday by the UN Office on Drugs and Crime (UNODC), the total square of ​​agricultural land that is used in Afghanistan for poppy cultivation, increased by 36 percent in 2012 compared to 2007. The total production of opiates reached 5,500 tons, which was almost 50 percent more than last year (3,700 tons).

Afghanistan has long become a leading producer of opium in the world (75 percent of global production last year, according to UNODC). The Taliban became the biggest beneficiary, senior Afghan government officials, corrupt commanders of the army and officers of law enforcement agencies are no less involved in the business.

Since the invasion of Afghanistan in 2001, the U.S. has spent nearly $7 billion to combat the production of opiates through the eradication of poppy fields, allocation of subsidies for alternative crops and incentive payments to the population of opium-free regions. However, the recent UNODC report shows that the opium trade has gone deeper in the real sector of the Afghan economy, becoming the leading sector of production.

UNODC Executive Director Yury Fedotov described the results as "sobering." In the foreword to the report, written in collaboration with the head of the branch of Afghanistan, he wrote that the persistent opium "virus" threatened to further destabilize the country after the withdrawal of ISAF international forces. In an interview with Reuters, Fedotov said that Afghanistan could soon become a "full-fledged narco-state" unless the international community gave the country appropriate support. "An integrated, comprehensive response to the drug problem is required," said Fedorov.

Who will propose a specific plan and who will implement it? The Americans, in an anticipation of the withdrawal, wrap up all operations. What kind of operations were they? There were so-called "response teams" organized to burn poppy fields. But, according to UNODS, eradication efforts reduced this year by 24 percent, after attacks on those teams became more frequent: 143 deaths vs. 102 in 2012. The Afghan army refused to escort the teams. The Americans preferred to raid villages in search of Taliban fighters rather than expose themselves to dangers in combat actions on the border with Pakistan - the stronghold of the Taliban and the main center of poppy cultivation. As for the promotion of alternative crops, it was complicated with incomparable prices (much higher on opium) and complete uncertainty of the future of Afghanistan. And this uncertainty has been growing.

The withdrawal of international forces, the core of which is U.S. soldiers (about 10,000 people), is scheduled for the end of 2014. An agreement is being developed between the U.S. and Afghanistan on how bilateral relations should be built after the withdrawal. Experts suggest that with the departure of Hamid Karzai, who has served his two presidential terms, another person will come, who will most likely become US-oriented in the next few years. Civil war scenarios are also possible. The deteriorating level of security will affect economy; GDP is to decline this year by ten percent, according to World Bank forecasts. U.S. analysts say that agricultural infrastructure was destroyed during the war against the Soviet Union. They also indicate an increase in the use of drugs in Afghanistan (the consumption of opiates between 2005 and 2009 doubled; the consumption of heroin has increased 140 percent). Supposedly, this is the reason why many farmers turned to growing poppy, Amar Toor wrote in The Verge.

However, according to the Russian Federal Service for Drug Control, under the Taliban (before 2001), the opium poppy production was minimal. It increased dramatically - nearly 40 times - with the deployment of American troops in the country. Today, "four million farmers are engaged in the cultivation of opium poppy. A third or a half of the population of Afghanistan is involved in the production of drugs," Chairman of the State Anti-Drug Committee, the head of the Russian Federal Drug Control Service, Viktor Ivanov, said on November 11 at a press conference. According to Russian security services, there are about two thousand heroin laboratories in Afghanistan, and more than four million people are involved in the process.

Ivanov sees completely different reasons for such a sad state of affairs. "The drug industry is needed for many thousands of drug addicts. The international bank system needs it as well, because it is the bank system that eventually absorbs income from this industry," said Ivanov. According to him, more than $1 trillion was invested in transnational crime of selling heroin. "Those wars that take place in Afghanistan are the wars between drug cartels. The international community needs to fully accept responsibility for the situation in Afghanistan," said Ivanov.

"The crowning effort in Afghanistan is to curb drug trafficking by motivating specific countries, unions and companies," military expert Boris Podoprigora, former deputy commander of the joint group from the North Caucasus, told Pravda.Ru. In his opinion, it goes about Russia, the countries of the SCO and the CSTO.

"We need to work with the north of Afghanistan, where Uzbeks and Tajiks live. We should boost their economy and give those people alternative employment. This is the only way to protect Russia from heroin and opium drug trafficking."

On October 28, a two-day meeting of the heads of anti-drug agencies of Central Asian anti-drug quartet finished in Islamabad. The group includes Afghanistan, Pakistan, Russia and Tajikistan. The meeting considered the implementation of the "road map" (2012 - 2017) of the four states in the field of anti-drug cooperation. The group of four is to have another member - Iran, that shares more than two thousand kilometers of land border with Afghanistan and Pakistan. According to the UN, Iran takes the lead in the struggle against drugs.

Lyuba Lulko

Pravda.Ru