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Drug Companies Subpoenaed Over Questionable Charity Connections

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Whenever there is a report of a drug company jacking up the price of a prescription medication, the pharma industry is often quick to point out that there are non-profit charities ready and willing to help patients get these drugs at a more affordable rate. However, those charities may have very close ties to the drug maker that could not only help the company turn a profit, but avoid some tax obligations. In recent months, several large pharmaceutical companies have been subpoenaed as part of an ongoing federal investigation into these connections.

It works like this: Bob’s Drug Company acquires the rights to prescription drug Gleemonex and decides to jack up the price 500%, knowing that some people will not be able to afford the co-pay. However, it’s in the interest of Bob to keep as many patients using Gleemonex as possible, so it looks for ways to make the drug more affordable to those most in need: low-income patients on Medicare.

Now, Bob’s Drug Co. can’t directly fund the co-pay of a Medicare patient. That would effectively be Bob paying Bob, which is an illegal kickback under federal law. What Bob can do is call Sally’s Drug Charity, which will cover the Medicare co-pay on certain drugs.

So Bob makes a sizable donation, which Sally can then use to make Medicare co-pays, meaning patients continue using Gleemonex.

Thing is, while the Medicare patient isn’t having to go broke paying for Gleemonex, taxpayers might be. After all, the co-pay is usually only a fraction of the full amount that Medicare pays to the drug maker. Thus, Bob continues to get the full Medicare payment and enjoy the tax write-off from his donation to Sally’s charity.

Bloomberg BusinessWeek recently published an entire cover story on how the pharma industry uses these charities for their own financial, tax, and public-relations benefit. You should definitely check it out.

Today, Bloomberg published a story on the string of subpoenas issued to four high-profile pharma companies — Valeant, Gilead Sciencse, Biogen, and Jazz Pharmaceuticals — since last fall, mostly by federal prosecutors out of Massachusetts.

The nature of the subpoenas is vague, though they do reference investigations into the companies’ relationships with co-pay charties.

With Medicare on the hook for the balance of these prescription payments, the federal government is taking a particular interest in the possibility that drug makers have exerted too much influence over these charities as donations have grown.

Since 2010, donations to the seven biggest co-pay charities have more than doubled, reaching $1.1 billion in 2014.

Going back to the above fictional example: Under the law, Sally is not supposed to be swayed by Bob or other donors when it comes to which drugs it chooses to cover, which patients to accept, or how much of each drugs co-pay it will subsidize. So if Sally is covers co-pays for a competitor to Gleemonex, she can’t be swayed by Bob’s big bucks to give preferential treatment to his drug.

Recent reports indicate that some charities’ practices may have been motivated by donor money. For example, former employees at one charity told Bloomberg that when patients needed Jazz narcolepsy medication Xyrem, they were processed in a time manner, while patients seeking co-pay help for competing narcolepsy drugs were sometimes steered away or wait-listed if that other company wasn’t also donating to the charity.

The charities have denied allegations of favoritism of bad practices.

Sourced From –  https://consumerist.com/2016/05/27/drug-companies-subpoenaed-over-questionable-charity-connections/

Drug makers spend big to fight California price control referendum

Drug Companies To Pour $100M Into Battle Against California’s Price Control Ballot Initiative

The initiative, likened by one lobbyist to a “grenade being rolled into the conversation,” would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs, and the industry is gearing up to fight back. In other news, Novartis’ heart-failure drug is getting a warmer welcome in Europe than America, and the company is considering its options in selling its stake in Roche.

Politico: Drug Makers Spend Big To Fight California Price Control Referendum

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state. That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C. (Cook and Karlin-Smith, 4/25)

The industry is expected to pour $100 million into an effort to squash the November ballot initiative.

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state.

That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C.

Drug companies are expected to pour $100 million into an effort to squash the referendum in what will be a test of the industry’s strength at a time of growing consumer backlash against drug prices. The initiative would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs — one of the few federal agencies allowed to negotiate drug prices.

From the industry’s perspective, California could set a dangerous precedent. Besides having an economy the size of many small countries, the liberal bastion is often a laboratory for new ideas that take root and then spread east. That’s even more likely given that the presidential front-runners are pushing the federal government to negotiate drug prices for Medicare.

“This is the crack in the door” on drug pricing, said Jamie Court, president of Consumer Watchdog, a California nonprofit devoted to consumer protection issues. “If any Democrat in America wants bulk purchasing in Medicare, it will start with bulk purchasing for the most liberal state government in America.”

Which is precisely the intention of the initiative’s sponsor, Michael Weinstein, CEO of the Los Angeles-based AIDS Healthcare Foundation. “If we win, we hope it will start a national prairie fire,” he said.

Weinstein pursued the ballot measure after years of in-your-face activism on AIDS and after watching the California state legislature fail to do anything about drug prices — a big concern to people with HIV/AIDS who may be taking costly drugs for the rest of their lives.

Read more: http://www.politico.com/story/2016/04/drug-makers-california-referendum-222334#ixzz471Q9mg4k
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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, like http://sideeffectsofxarelto.org/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.

Time for J&J to pay up in $124M Risperdal case as SCOTUS deflects final appeal

January 11, 2016 | By

Johnson & Johnson ($JNJ) fell short Monday in its final effort to escape a Risperdal marketing penalty in South Carolina. The U.S. Supreme Court declined to take up J&J’s last appeal in the case, putting the company on the hook for a $124 million penalty.

J&J had cited the Eighth Amendment in arguing against the penalty, saying it qualified as an “excessive fine.” As Reuters notes, the U.S. Chamber of Commerce had backed the drugmaker in seeking Supreme Court review.

J&J’s Janssen unit has been fighting South Carolina’s deceptive trade practices court win since 2011, when a jury ordered the drugmaker to pay $327 million for Risperdal marketing violations. The company succeeded in lowering the judgment twice, first to $136 million and then, last year, to the final $124 million.

The lawsuit centered on promotional materials Janssen used to market the antipsychotic drug. Key to the case was a letter sent to South Carolina physicians, which overstated Risperdal’s benefits compared with other drugs in its class and downplayed side effects, the jury found. The trial court judge ordered Janssen to pay about $4,000 for each of the more than 7,000 letters mailed.

The original $327 million judgment dwarfed other similar rulings in drug-marketing lawsuits, including sizable decisions and settlements in other Risperdal-related litigation, but it fell far short of a $1.2 billion verdict in Arkansas. The Arkansas Supreme Court struck down that judgment in March 2014, and the company later negotiated a settlement of $7.5 million.

The South Carolina decision survived that state’s top court in a ruling last year, in which Justice John Kittredge backed the decision at trial, but lowered the $327 million penalty to $136 million.

In affirming the judgment against the company, Kittredge echoed the trial judge’s “profit-at-all-costs” characterization of Janssen’s marketing efforts. “Janssen’s desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law,” Kittredge wrote in the February 2015 ruling.

Janssen had argued that it did not intentionally deceive doctors with the now-notorious “Risperdal letter” that has featured in several state-court lawsuits. The drugmaker also contended that South Carolina’s attorney general didn’t prove patients were actually harmed by the drug. It was on that point that Kittredge lowered the judgment.

The “Risperdal letter” lawsuits compose only part of the mountain of litigation J&J has fought over the antipsychotic drug. The company agreed to pay $2.2 billion in a marketing settlement with the U.S. Justice Department and a group of states.

And the litigation isn’t over yet. The company now faces more than 1,000 lawsuits over Risperdal’s ability to trigger breast development in boys. J&J lost the first court battle last February, as a Philadelphia jury ordered J&J to pay almost $2.5 million to a young man who developed breasts while using Risperdal. In November, another jury awarded $1.75 million in a similar case.

Read Full Article – http://www.fiercepharma.com/story/time-jj-pay-124m-risperdal-case-scotus-deflects-final-appeal/2016-01-11