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Underworld

6 Drugs whose dangerous risks were buried so big pharma could make money

New meds are rushed to the market so industry can start making money even before safety has been determined.

When a prescription drug causes risky side effects, the word often doesn’t get out for years, allowing Big Pharma to make money anyway.

The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck’s risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because “the drug potentially provided a significant therapeutic advantage over existing approved drugs,” the FDA said.

Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.

Here are some drugs whose risks did not did not keep them from getting their “patent’s worth.”

You’d think Merck would have learned from Vioxx and Fosamax that aggressive marketing can only hide emerging risks for so long. It didn’t. To sell its asthma and allergy drug Singulair to children, the drug giant partnered with Olympic gold-medalist swimmer Peter Vanderkaay and Scholastic and the American Academy of Pediatrics even as the FDA warned about “neuropsychiatric events” including agitation, aggression, nightmares, depression, insomnia and suicidal thinking.

While Merck marketed Singulair, which comes in a cherry-flavored chewable formulation, to parents with slogans like “Singulair is made with kids in mind,” Fox TV and over 200 parents on the website askapatient reported that children on Singulair exhibited altered moods, depression and ADHD, hyperkinesis and suicidal symptoms. Fifteen-year-old Cody Miller of Queensbury, NY reportedly took his own life days after taking the drug in 2008. Still, Singulair made $5 billion for the company in 2010. After its patent expired in 2012, Australia’s Therapeutic Goods Administration, the FDA’s counterpart, reported 58 cases of adverse psychiatric events in children and teenagers, primarily suicidal thinking. Who knew?

How do you sell a drug that causes 30 percent of users to gain 22 pounds and some to gain as much as 100 pounds? By burying the risks. The antipsychotic Zyprexa was supposed to be Eli Lilly’s followup to its blockbuster antidepressant Prozac even though Lilly knew as early as 1995, according to the New York Times, that Zyprexa was linked to unmanageable weight gain or diabetes. Zyprexa’s side effects of “weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” wrote Lilly’s Alan Breier, who later became chief medical officer, in documents obtained by the Times.

Even as Lilly settled charges that it withheld the drug’s link to high blood sugar levels and diabetes and illegally marketed the drug for dementia, Zyprexa made $5 billion in 2010 and out-earned Prozac. Who says crime doesn’t pay? Zyprexa was especially marketed to the poor and became one of the nation’s top Medicaid drugs extracting at least $1.3 billion of our tax dollars in 2005 alone. In 2008, Lilly settled an Alaskan suit to cover the cost of Medicaid patients who developed diabetes on Zyprexa. Unbelievably, Lilly offered a “free service” to “help” states buy mental illness drugs like Zyprexa as a fox guards the henhouse and 20 states took the bait. Zyprexa’s patent ran out in 2012.

Like Zyprexa, the antipsychotic Seroquel, made by the UK firm AstraZeneca, became a best-selling medication in the US, earning over $5 billion in 2010, despite frequently reported risks. It was so heavily marketed to poor children that in 2007, Florida’s Department of Juvenile Justice’s bought twice as much Seroquel as Advil. Seroquel’s high use in the military for the unapproved uses of sleep and PTSD was also disturbing: reports of veterans’ sudden deaths on the drug, thought to be cardiac-related, surfaced even as use of Seroquel soared 700 percent in the Department of Defense. In 2009, it was the number-two drug at the VA, accounting for $125.4 million in tax dollars.

Months after Seroquel’s 1997 approval, an article in the South Dakota Journal of Medicine raised questions about the drug’s unsafe interaction with 11 other drugs. Within three years, researchers at the Cleveland Clinic were questioning Seroquel’s effect on the heart’s electrical activity. But even as the families of deceased veterans testified at FDA hearings in 2009 and demanded answers from officials and lawmakers, the FDA maintained Seroquel’s safety. Then in 2011, with little fanfare, the FDA issued new warnings that corroborated the swirling suspicions: both Seroquel and its extended release version “should be avoided” in combination with at least 12 other medicines, said the FDA. The drug should also be avoided in the elderly and people with heart disease because of clear cardiac risks. Oops. Seroquel’s patent ran out the following year.

Fluoroquinolone antibiotics are among the biggest-selling drug classes. Many people remember the fluoroquinolone Cipro (given for 9/11-era anthrax attacks) but Pharma hopes we don’t remember the fluoroquinolones Trovan, which was withdrawn for causing liver damage, and Raxar, which was withdrawn for causing cardiac events and sudden death. Johnson & Johnson’s fluoroquinolone Levaquin was the US’ best-selling antibiotic in 2010 with sales over a $1 billion a year but is now the subject of thousands of lawsuits.

In 2012, a year after Levaquin’s patent expired, a cascade of side effects began to emerge with Levaquin and the whole class of fluoroquinolones that casts doubt about their safety. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis. The New England Journal of Medicine reported the same year that Levaquin was linked to an increased risk of cardiovascular death, especially sudden death from heart rhythm disturbances.

While the FDA warned of tendon ruptures on fluoroquinolones, especially Achilles’ tendons in 2008, and added a black box warning on the label, it had a serious new warning two years after Levaquin went off patent. In 2013, the FDA warned about the “the serious side effect of peripheral neuropathy” in fluoroquinolones, a type of nerve damage in which sensory pathways are impaired. Peripheral neuropathy caused by fluoroquinolones like Levaquin can “occur soon after these drugs are taken and may be permanent,” warned the FDA. Fluoroquinolones are also linked to Clostridium difficile, also called C. Diff, a serious and potentially deadly intestinal microbe.

Before its patent expired in 2009, the seizure drug Topamax made Johnson & Johnson a billion a year and it still made $538 million a year after its patent expiration. Topamax was such a favorite for pain conditions in the military it was given the nickname “Stupamax” for the way it slowed reaction times and impaired motor skills, attention and memory, according to Army Times. Not too great for combat.

A year before Topamax went off patent, the FDA warned that it and other seizure drugs are correlated with suicide and asked their manufacturers to add label warnings. Four patients on the drugs killed themselves versus none on placebo reported the FDA after reviewing clinical trials. Then, in 2011, the FDA announced that Topamax can cause the birth defects cleft lip and cleft palate in babies of mothers who take the drug. “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional,” the FDA warned, though the risks did not stop the FDA from approving a new diet drug containing Topamax’ generic drug in 2012.

Purdue Pharma’s Oxycontin is the granddaddy of drugs that make money despite lethal side-effects. Along with other prescription opioids, it accounted for an astounding 17,000 deaths last year – four times that in 2003. “The increase [in use] has been fueled in part by doctors and pain advocacy organizations that receive money from drug companies and make misleading claims about the safety and effectiveness of opioids, including that addiction is rare,” reported the Journal Sentinel.The American Geriatrics Society used Pharma-linked experts to rewrite clinical guidelines in 2009, says the Journal Sentinel, which specified opioids for all patients with moderate to severe pain as opposed to Aleve or Advil. Ka-ching.

Oxycontin, because it is a long-acting formulation, was supposed to reduce toxicities and addictiveness – at least until its crush, snort and shoot potential made it more popular than cocaine on the street. (All the pill’s 80mg could be taken at once.) In 2010, responding to the addictions, overdoses, deaths and diversions associated with the drug, Purdue rolled out a tamper-resistant Oxycontin and began to push for state and federal laws requiring opioids to be tamper-resistant in 2012. Purdue said public health was its main concern but many are asking why that concern only surfaced as Oxycontin’s patent was expiring. Its patent expired in 2013.

Martha Rosenberg is an investigative health reporter and the author of Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Random House).

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Underworld

Havana Syndrome again? CIA officers are mowed down by a mysterious disease

A CIA officer in Moscow experienced symptoms of the so-called “Havana syndrome” in 2017. This became known to The New York Times with reference to sources in diplomatic circles.

CIA officer Mark Polimepulos, who helped lead covert operations in Russia and Europe, complained about the manifestation of mysterious symptoms. According to the newspaper, in December 2017, he felt severe dizziness, which later developed into a prolonged migraine, forcing him to retire. At that time, Polymerpoulos was 48 years old.

It is noted that such a case was not the only one. Similar symptoms were experienced by the staff of the American ambassadors in Cuba and China in 2016-2018. However, the exact number of cases and the place where this happened is not named. It is alleged that the US diplomats have tried to influence in a similar way around the world.

At the same time, the US State Department was unable to establish an unambiguous reason that caused the “Havana syndrome.” Among other things, it was assumed that the diplomats may have been exposed to an unidentified sound effect.

In 2017, it was reported that, beginning in late 2016, American diplomatic officials and their relatives in Cuba began to complain of symptoms such as hearing loss, nausea, headaches and balance disorder. 

The Associated Press received audio footage of the attack and described the harassing sounds as “the high-pitched sound of crickets combined with fingernails scratching on a board.” Then the American government suggested that Russia or China could be the culprit.

Many victims are still undergoing rehabilitation. Specialists from the University of Pennsylvania performed magnetic resonance imaging and revealed visible changes in the structure of the brain in the diplomatic missions.

Differences were found in 23 men and 17 women who complained of health problems while on diplomatic duties in Havana. Scientists have yet to figure out what causes the unusual symptoms.

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Underworld

How Russia and the United States nearly started a nuclear war in 1995

The Norwegian meteorological rocket incident remains the only time in history that the Russian president has activated his nuclear briefcase.

On January 25, 1995, Doomsday could have come in the world: the Russian Federation was preparing to launch a nuclear strike on the United States. How did it come about that the states that left the confrontation of the Cold War in the past and had just normalized relations with each other found themselves on the verge of mutual destruction?

The beginning of the war?

The cause of the crisis was an ordinary Norwegian meteorological rocket. Its launch from the small island of Anneia at 7 am local time (10 am Moscow time) towards Spitsbergen caused a stir in Russia. 

Black Brant XII.

Black Brant XII. Legion Media / ZUMA Press

Equipped with scientific equipment to study the aurora borealis, the Black Brant XII was similar in size to the nuclear-powered American Trident D-5 ballistic missile, intended for launch from submarines. In addition, it flew along a trajectory along which, as the Russian Defense Ministry believed, American missiles would fly in the event of a nuclear war. 

In December 1994, Norway informed 28 states, including Russia, about the planned launch, but did not give a specific date, limiting itself to specifying the period: from January 15 to February 10 of the next year. Due to bureaucratic delays, this information did not reach the Russian Missile Warning System, which sounded the alarm.

Decisive minutes

An emergency meeting with the country’s top political and military leadership was convened in the Kremlin. Defense Minister Pavel Grachev, Chief of the General Staff Mikhail Kolesnikov and President of the Russian Federation (as Supreme Commander-in-Chief) Boris Yeltsin had three strategic missile forces control terminals activated – the so-called nuclear suitcases.

Vladimir Sayapin / TASS

The military believed the lone missile could have been fired to create an electromagnetic pulse that knocked out Russian radars and communications systems. Following it, a massive blow could be expected.

For several tense minutes, as leaders watched it flight, it was decided whether Russia would launch a nuclear strike against the United States. 

“Little is known today about what Yeltsin said at the time, given that it could have been some of the most dangerous moments in the entire history of the nuclear era,” The Washington Post journalist, David Hoffman wrote three years after the incident : “They make it clear that the Cold War nuclear readiness system continues to operate, and how catastrophic its consequences could be, despite the fact that the feud between the great powers is already over.”   

The situation was discharged only when it became clear that the rocket had gone towards Spitsbergen (not far from which it fell into the ocean). The nuclear cases have been deactivated. Russian President Boris Yeltsin (center) and Russian Defense Minister Pavel Grachev (right).

Russian President Boris Yeltsin (center) and Russian Defense Minister Pavel Grachev (right). Igor Mikhalev / Sputnik

The incident with bringing Russia’s Strategic Nuclear Forces to combat readiness, soon became the property of the world community. When, four years later, the Norwegians were about to repeat their launch of Black Brant XII and reported this to the Russian Foreign Ministry, the US additionally warned all key Russian military departments about it through their channels. As a result, this time there were no unpleasant surprises. 

Source: rbth.com

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Underworld

Germany conducted exercises in case of nuclear war

Bundeswehr / Birthe Brechters

The Bundeswehr with partners in the North Atlantic Alliance ( NATO) trained in operations in a nuclear war.

The German army, together with Italian, Belgian and Dutch colleagues, conducted exercises in the event of a conflict with the use of nuclear weapons.

The location of the exercise “Steadfest Noon” was chosen airbase “Nörfenich”, where the tactical squadron of the Luftwaffe 31 “Boelcke” is located. Together with the Luftwaffe of the Bundeswehr, the air forces of other NATO countries, in particular, Italy, the Netherlands and Belgium, took part in the exercises.

According to a report by Bild, the exercise scenario involved training procedures for safely removing nuclear weapons from storage, delivering ammunition and installing them on aircraft. The training flights took place without nuclear weapons, and in parallel with the aviation exercises at the Büchel airbase, where the tactical squadron of the Luftwaffe 51 Immelman is located, the Resilient Guard air defense systems were trained to protect the airfield from air attacks.

The training sites for the Luftwaffe of the Bundeswehr were not chosen by chance, since the Nörfenich airbase is a reserve storage site for the B61, a hydrogen bomb that forms the basis of nuclear weapons of the US strategic nuclear forces. 

Some of this ammunition is stationed at NATO bases in Europe. The exact number of hydrogen bombs that are stored at European sites and which ones are not reported. In Europe, the B61 is carried by Panavia Tornado fighter-bombers (pictured) and General Dynamics F-16 Fighting Falcon fighters.

Recall that the B61 thermonuclear bomb is the main weapon of the US strategic nuclear forces, although it entered service in 1968. Since 2012, a new guided version of the B61-12 has been under development, which will replace all B61 and B83 bombs that have been in service since 1983. It can be used both on strategic bombers and tactical aircraft. About two billion dollars were spent on the development of the 12th modification of the aerial bomb.

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