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Why pharma companies are fighting legal marijuana

FewerPillsChart

There’s a body of research showing that painkiller abuse and overdose are lower in states with medical marijuana laws. These studies have generally assumed that when medical marijuana is available, pain patients are increasingly choosing pot over powerful and deadly prescription narcotics. But that’s always been just an assumption.

Now a new study, released in the journal Health Affairs, validates these findings by providing clear evidence of a missing link in the causal chain running from medical marijuana to falling overdoses. Ashley and W. David Bradford, a daughter-father pair of researchers at the University of Georgia, scoured the database of all prescription drugs paid for under Medicare Part D from 2010 to 2013.

They found that, in the 17 states with a medical-marijuana law in place by 2013, prescriptions for painkillers and other classes of drugs fell sharply compared with states that did not have a medical-marijuana law. The drops were quite significant: In medical-marijuana states, the average doctor prescribed 265 fewer doses of antidepressants each year, 486 fewer doses of seizure medication, 541 fewer anti-nausea doses and 562 fewer doses of anti-anxiety medication.

But most strikingly, the typical physician in a medical-marijuana state prescribed 1,826 fewer doses of painkillers in a given year.

These conditions are among those for which medical marijuana is most often approved under state laws. So as a sanity check, the Bradfords ran a similar analysis on drug categories that pot typically is not recommended for — blood thinners, anti-viral drugs and antibiotics. And on those drugs, they found no changes in prescribing patterns after the passage of marijuana laws.

“This provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws,” they write.

In a news release, lead author Ashley Bradford wrote, “The results suggest people are really using marijuana as medicine and not just using it for recreational purposes.”

One interesting wrinkle in the data is glaucoma, for which there was a small increase in demand for traditional drugs in medical-marijuana states. It’s routinely listed as an approved condition under medical-marijuana laws, and studies have shown that marijuana provides some degree of temporary relief for its symptoms.

The Bradfords hypothesize that the short duration of the glaucoma relief provided by marijuana — roughly an hour or so — may actually stimulate more demand in traditional glaucoma medications. Glaucoma patients may experience some short-term relief from marijuana, which may prompt them to seek other, robust treatment options from their doctors.

The tanking numbers for painkiller prescriptions in medical marijuana states are likely to cause some concern among pharmaceutical companies. These companies have long been at the forefront of opposition to marijuana reform, funding research by anti-pot academics and funneling dollars to groups, such as the Community Anti-Drug Coalitions of America, that oppose marijuana legalization.

Read Full Article – https://www.washingtonpost.com/news/wonk/wp/2016/07/13/one-striking-chart-shows-why-pharma-companies-are-fighting-legal-marijuana/

Merck’s patent win over Gilead reversed over false testimony

Merck & Co.’s $200 million jury verdict against Gilead Sciences Inc. was voided in a patent dispute over a breakthrough for hepatitis C because of misconduct by a witness at the companies’ trial.

A federal judge concluded Monday that dishonest and duplicitous testimony by a retired Merck scientist before and during a March trial played into the jury’s finding that the company was responsible for early discoveries that led to the development of Gilead’s Sovaldi and Harvoni medicines.

The scientist “intentionally fabricated testimony” and Merck supported his “bad faith conduct,” U.S. District Judge Beth Labson Freeman in San Jose, California, said in her ruling.

The reversal of the fifth-largest U.S. verdict this year vindicates Gilead in its refusal to share royalties with Merck on the more than $20 billion revenue the hepatitis C drugs generated from 2013 through 2015 in the U.S. The Foster City, California-based company’s sales have started to slow this year as competition for the liver disease market intensifies among drugmakers.

“This is a nice little bump for Gilead who’d already accounted for the $200 million,” said Bloomberg Intelligence analyst Asthika Goonewardene. “But of course, this is a big win and will be beneficial to Gilead and how they can claim ownership of the drug in the long run.”

Merck vowed to appeal Monday’s ruling, saying it “does not reflect the facts of the case.”

“In its decision, the jury recognized that patent protections are essential to the development of new medical treatments,” the company said in an email. “The compounds and methods at issue in this case facilitated significant advances in the treatment of patients with HCV infection, and achieving these advancements required many years of research and significant investment by Merck and its partners.”

Gilead said it “has always believed Merck’s patents are invalid and unenforceable.”

“We are pleased the court has ruled in Gilead’s favor and determined that Merck’s patents are unenforceable against Gilead, and therefore, Merck is not entitled to recover any damages,” the company said in an email.

Labson Freeman re-opened the case in April after Gilead alleged that ex-Merck scientist Phil Durette gave conflicting statements about his participation in a key phone call some 15 years earlier when the drug’s basic composition was first presented to Merck.

Durette initially said in a pretrial deposition he wasn’t on a phone call in which secrets about the compound’s basic chemistry were discussed while Merck was exploring a take-over of Pharmasset Inc., a company that was later acquired by Gilead. When testifying to the jury after checking his notes, Durette admitted to playing a role in the meeting.

“Dr. Durette’s lying at his deposition, recanting that testimony at trial without proper prior notice to Gilead, and further untruthful testimony at trial all support the court’s conclusion that Merck did intend to deceive Gilead and the court,” the judge wrote.

She said Merck’s actions were “even more egregious” because Durette was acting as the company’s patent attorney.

Merck’s victory at trial had set the stage for it to seek future royalty payments from Harvoni and Sovaldi, which sells for $1,000-a-pill in the U.S., before discounts and rebates.

While Gilead continues to dominate the market, the lull in its hepatitis C treatment revenue opened the door to Amgen Inc. retaking its place as the world’s top biotech firm by market capitalization.

The case is Gilead Sciences Inc. v. Merck & Co., 13-cv-04057, U.S. District Court, Northern District of California (San Jose).

Full Article – http://www.theindianalawyer.com/mercks-patent-win-over-gilead-reversed-over-false-testimony/PARAMS/article/40559

New Xarelto Claim That J&J and Bayer Lied

Posted by Shezad Malik MD JD
March 8, 2016 7:03 AM

According to bombshell revelations in the New York Times, did two major pharmaceutical companies, in an effort to protect their blockbuster drug, Xarelto, intentionally mislead editors at one of the world’s most prestigious medical journals?

Several thousand injured plaintiffs have filed personal injury and product liability claims against Johnson & Johnson and Bayer over the safety of its anti-clotting drug Xarelto.

Now plaintiffs claim that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University deliberately left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies provided the very same data to regulators in the United States and Europe.

The New York Times article suggests that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.

Defective Medical Device Results Flawed

The heart of the controversy alleges that a key medical device that measures the levels of blood thinner in patients involved in the study was defective and that those running the clinical trial knew it, but failed to reveal that information.

The New York Times reports that documents produced by the drug makers during Xarelto lawsuits suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.

It is now confirmed that the measuring device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin.

Flawed Xarelto Medical Studies?

The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.

The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. An INRatio recall has since been issued after it was discovered that the device may show results that were falsely low.

The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.

The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism since Xarelto was approved, as the drug has been linked to a shocking number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have been unable to stop serious bleeding problems that occur, increasing the risk of severe injury or death.

Xarelto Lawsuits Over Bleeding Problems

Xarelto (rivaroxaban) is a new class of blood thinners released in recent years as a replacement for warfarin, which had been the gold standard blood thinner treatment for the past 60 years. Xarelto was approved in 2011, this new-generation treatment has been prescribed instead of warfarin to reduce the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Xarelto lawsuits allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. But, independent studies published after Xarelto was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

Undue Big Pharma Influence

Big Pharma is the nickname given to the vast and influential pharmaceutical industry and its trade group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars every year by selling drugs and medical devices.

Pharmaceuticals are HUGE business and these Big Pharma” companies stand to reap billions of dollars over the life span of a block buster drug. Big Pharma industry influence has led to the concealment of critical unfavorable data or ghost written medical articles (written by industry insiders) — when crucial clinical data went missing from journal articles, leading to embarrassing corrections and ethics policies to limit the influence of drug companies on medical literature.

Xarelto Billion Dollar Block Buster

Xarelto, is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace warfarin.

Last week, lawyers in the case against Johnson & Johnson and Bayer filed a legal brief in federal court in New Orleans, asking a judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

Read Full Article – http://fortworth.legalexaminer.com/fda-prescription-drugs/new-xarelto-claim-that-jj-and-bayer-lied/

Drug company leaders should face prosecution, Oregon official says

William Theobald, USA Today 12:12 p.m. PST February 23, 2016

WASHINGTON – Drug company executives should be prosecuted for improper actions that contribute to the growth of opioid addiction, an Oregon assistant attorney general told a Senate committee Tuesday.

“We have to have more personal accountability of the executives who make these decisions,” David Hart testified at a hearing of the Senate Finance Committee on the opioid addiction epidemic. “They can’t walk away with their stock options and their salaries.”

Hart, head of the Oregon attorney general’s health fraud unit, has led several investigations into improper marketing and promotion practices by pharmaceutical companies that make the highly addictive painkillers.

In response to questions from Sen. Ron Wyden, the ranking Democrat on the committee, Hart also said the companies should be required to forfeit the profit they earn from their improper actions.

“We need to have these companies help clean up the messes they make,” Hart said.

He cited the state’s investigation of Insys, the maker of a painkiller called Subsys. Investigators alleged the company provided “improper financial incentives” to doctors to increase prescriptions, promoted the drug to doctors not qualified to prescribe it, and deceptively promoted its use for mild pain.

The company agreed to a voluntary settlement last August that included a $1.1 million payment, which Hart said amounted to two times its sales of the drug in the state of Oregon. The money is being used to fight opioid addiction.

Hart also was involved in a 2007 settlement among Oregon and 26 other state attorneys general and Purdue Pharma, after the company was accused of misrepresenting OxyContin’s risk of addiction.

Wyden said one common theme he heard during public meetings in Oregon last week on opioid abuse was a phenomenon he dubbed the “prescription pendulum.”

In past years, he said, doctors were criticized for not being aggressive enough in prescribing medication to manage severe pain. Now, the issue has swung the other way and doctors are being criticized for overprescribing pain killers.

Oregon ranked fourth among states in the rate of abuse of prescription painkillers, according to a 2013-2014 survey by the federal Substance Abuse and Mental Health Services Administration. That’s down from first among the states in the same 2010-2011 survey.

Between 2000 and 2013, there were 2,226 deaths in Oregon due to opioid overdoses. While the overdose death rate has dropped in recent years, in 2013 it was still nearly three times the rate in 2000.

“This epidemic is carving a path of destruction through communities all across the country,” Wyden said.

He said he worries policymakers are splitting into opposing camps: one focused on increasing enforcement and the other favoring more resources for treatment.

“What’s needed is a better approach that includes three things: more prevention, better treatment, and tougher enforcement,” Wyden said. “True success will require all three to work in tandem.”

The committee is expected to take up legislation soon that would allow for people in the Medicare program who are identified as at-risk for opioid addiction to be placed in a special program under which all of their prescriptions would be handled by one doctor and/or one pharmacy. Opioid abusers often will obtain multiple prescriptions for the painkillers.

In 2013, 3.6 million prescriptions for opioid painkillers were dispensed in Oregon, enough for nearly one prescription for every resident.