Saturday, March 2, 2019

WALL STREET PLUNDERS! - BIG GOV CRAWLS IN BED WITH BIG PHARMA TO LOOT AMERICA

US Senate hearings on drug prices provide “friendly warning” to pharmaceuticals

On Tuesday, executives from seven leading pharmaceutical companies appeared before the Senate Finance Committee to testify about drug prices. While some of the members of the committee occasionally posed as industry critics, the Senate hearing made it clear that no serious action will be taken to rein in high drug prices.
The CEOs of AbbVie, Bristol-Myers Squibb, Merck, Pfizer and AstraZeneca appeared before the committee, along with an executive VP at Johnson & Johnson.
This was the first high-profile congressional hearing since Heather Bresch, CEO of Mylan, went before the House Oversight Committee in 2016 to face questions about the skyrocketing price of EpiPens, which are used to treat severe allergic reactions.
The tone of the hearing was respectful, in contrast to the grandstanding of past hearings, such as when disgraced former Turing Pharmaceuticals CEO Martin Shkreli provided testimony.
At Tuesday’s hearing, Merck CEO Kenneth Frazier admitted that poor patients were the hardest hit by drug prices.
“The people who can least afford it are paying the most,” Frazier said. “We have a system where the poorest and the sickest are subsidizing others.”
“The system itself is complex and it is interdependent, and no one company could unilaterally lower list prices without running into financial and operating disadvantages,” Frazier added.
Democratic Senator Bob Menendez, noting that the drug companies represented at the hearing had spent $40 billion in stock buybacks after the Republican tax cuts passed, asked if any of the drug companies represented had used their savings to lower drug prices. A couple responded yes, while the rest gave a variety of excuses or struggled to provide an answer.
This line of questioning was largely posturing by Menendez, who opened his comments by praising the drug companies in New Jersey, his home state, and framing his comments as a “friendly warning” to the industry.
According to a report released by Senator Cory Booker in April of last year, none of the top 10 drug companies planned to use their savings from the Trump tax cuts to lower drug prices.
Despite warnings from Senators that they not try to shift the blame, the executives trotted out the usual arguments used by the industry to justify high drug prices. They emphasized their investments in research and development, pointed the finger at pharmacy benefits managers and insurers as sharing part of the responsibility, and threatened that innovation would be harmed if the industry were forced to lower prices (i.e., the drug industry would refuse to produce life-saving medicines if it was not allowed to price-gouge patients).
Republican Senator Bill Cassidy tried to shame Johnson & Johnson Executive Vice President Jennifer Taubert for selling a drug, Duexis, a combination of generic Pepcid and ibuprofen, for $2,300 for a 90-day supply, only to learn that the drug is sold by a different manufacturer not represented at the hearing, Horizon Pharma.
Democratic Senator Maggie Hassan questioned Taubert about the role of Jassen Pharmaceuticals, which was acquired by Johnson & Johnson in 1961, in creating the opioid epidemic. Taubert attempted to downplay the responsibility of the company by stating that “opioids represent less than 1 percent of our products.”
The Senate Committee also probed other unscrupulous behaviors of the drug industry, such as refusing to provide drug samples to generic manufacturers, which can slow down the approval time of a generic competitor, which must prove to the FDA that its generic version is bioequivalent to the branded version.
All of the CEOs stated that their companies did not engage in the practice. However, Stat News notes that an FDA database showed both Pfizer and AstraZeneca were accused of the practice.
The tepid nature of the current proposals to lower drug prices was indicated by the fact that the drug executives largely endorsed the reforms proposed by the senators, with the exception of allowing Medicare to negotiate drug prices.
These include the Trump administration’s proposal to ban the use of rebates by drug manufacturers to pay insurers, and a version of the CREATES Act, which would ban the practice of drug manufacturers refusing to sell drug samples to potential generic competitors.
In addition to allowing Medicare to negotiate prices, other minor reforms proposed by Democrats, such as Senator Hassan, include legislation permitting Americans to import cheaper drugs from Canada. None of the proposals would in any way threaten the power or profit prerogatives of the US drug industry, which, unlike in other advanced industrialized countries, is allowed to price drugs as they wish.
The pharmaceutical industry knows that it has nothing to fear from the political establishment, which it regularly bribes with large campaign donations. Concerned about the growing rhetoric surrounding drug prices, the pharmaceutical and health products industry has stepped up its lobbying efforts, spending a record $280 million in 2018 alone, according to the Center for Responsive Politics. The industry’s trade group, the Pharmaceutical Research and Manufacturers of America, spent a record $28 million in 2018.
2018 Lobbying by Pharmaceuticals and Health Products
Political donations by the drug industry are a bipartisan affair. In fact, according to the Center for Responsive Politics, the top four senators who received the most money from the pharmaceuticals and health products sector were Democrats—Bob Casey, Pennsylvania ($532,859); Heidi Heitkamp, North Dakota ($309,997); Joe Donnelly, Indiana ($259,395); and Jon Tester, Montana ($244,073).
Casey, who received the most money from the industry, sits on the Senate Finance Committee. Others on the committee who received drug industry money in 2018 include Democrat Robert Menendez, New Jersey ($188,763); Republican Bill Cassidy, Louisiana ($156,000); Democrat Tom Carper, Delaware ($143,550); and Republican Mike Crapo, Idaho ($131,800).
Some senators have even closer relationships with the industry. For example, Joe Manchin, a Democrat from West Virginia who received $123,672 from the industry in 2018, is the father of Mylan CEO Heather Bresch.
Little affected by the public outrage over skyrocketing costs, drug manufacturers raised prices on more than 250 prescription drugs at the start of the year.
Drug prices continue to rise well above the rate of inflation. A recent report by the American Association of Retired Persons (AARP) found that the prices of 768 widely used prescription drugs rose 50 times higher than the rate of inflation.
As a result of the current system, Americans pay more for prescription drugs and other medical interventions than other advanced industrialized countries, in some cases ten times as much.
While drug companies highlight their research and development costs to help justify high drug prices, this claim is contradicted by the fact that they generally spend more on marketing and sales than research and development—often much more.
Number of companies spending more on M&S than R&D
In 2016, the Institute for Health and Socio-economic Policy (IHSP), the research arm of the California Nurses Association, released a report that found that of the top 100 pharmaceutical companies in 2015, 89 spent more on marketing and sales (M&S) than on research and development (R&D). Forty-three of the companies spent five times as much, while 27 spent 10 times as much.
The report emphasizes the increasing role played by shareholders represented by finance capital who have placed pressures on pharmaceutical companies for a high return-on-investment in the short term, leading to a strategy where R&D is increasingly ignored, while the industry aggressively markets the drugs it has already produced.
The rise in the number of mergers and acquisitions among pharmaceutical giants has also undermined support for R&D as significant cuts to R&D programs typically take place after a company is acquired. The report notes that when Pfizer acquired Wyeth in 2009, they had a combined R&D spending of $12 billion, but just a year later R&D spending was cut in half to $6.5 billion.


Additionally, drug companies rely upon the billions of dollars of government funding that goes into medical research, such as funding from the National Institutes of Health, which is then commercialized by biotech and pharmaceutical companies, effectively subsidizing their R&D budgets and allowing them to select promising drug candidates discovered with federal funding, rather than fund the uncertain outcomes involved in basic research.

San Diego City Attorney sues drug makers, alleging deceit behind nation's opioid epidemic

https://www.sandiegouniontribune.com/news/courts/sd-me-san-diego-opioid-sackler-purdue-lawsuit-20190228-story.html

 


Pauline Repard
The San Diego City Attorney’s Office on Thursday filed a federal lawsuit against major manufacturers of prescription painkillers, alleging company officials knew they were stoking the country’s opioid crisis.
“Opioid manufacturers have profited handsomely from the human suffering they intentionally inflicted through manipulation and deceit,” City Attorney Mara Elliott said in a statement.
“While San Diego will long deal with the destructive consequences of their greed, we intend to hold them accountable for funding drug treatment and education programs that will protect the health and safety of San Diegans.”
Thousands of cities, counties and states, hospitals and individuals across the nation have been filing similar lawsuits for years.
More than 1,000 of the cases have been consolidated as multi-district litigation overseen by an Ohio federal judge.
Elliott’s statement notes that the city’s lawsuit is expected to become part of the consolidated case.
San Diego is going after the makers and distributors of powerful painkillers, such as Purdue Pharma’s OxyContin.
The Centers for Disease Control and Prevention reported that in 2016, 42,249 people fatally overdosed on illicit and prescription opioids.
Most of the death toll was attributed to illicit fentanyl, a potent synthetic heroin widely spread in the street market. Prescription drugs were involved in an estimated 34 percent of the deaths, the CDC reported in 2018.
The city alleges Connecticut-based Purdue, its billionaire owners the Sackler family and other major companies created a public nuisance and used deception to market the drugs.
Robert Josephson, a spokesman for Purdue, said the company denies allegations it acted improperly and noted the U.S. Food and Drug Administration has approved OxyContin as safe for its intended use.
“We share the city’s concern about the opioid addiction crisis.” Josephson said in an emailed statement.
“While Purdue Pharma’s opioid medicines account for less than 2% of total prescriptions, we will continue to work collaboratively with the city and state to help bring meaningful solutions forward to address this public health challenge.”
Elliott is seeking damages to fund drug treatment and education programs, return allegedly unlawful profits and recover the city’s costs in responding to the opioid crisis. The prosecutor also alleges the companies ran an ongoing conspiracy in violation of the federal Racketeer Influenced and Corrupt Organizations Act — know as RICO.
Defendants in the city’s lawsuit include Rhodes, Teva, Janssen, Allergan, Actavis, AmerisourceBergen and McKesson pharmaceutical companies.
The suit specifically names eight members of the ultra-rich Sackler family. Brothers Mortimer, Raymond and Arthur Sackler, all now deceased, founded Purdue Pharma, which later developed OxyContin.
Forbes estimates the Sackler family’s worth at $13 billion. Family members are known for worldwide philanthropy, especially directed toward museums and galleries including the Metropolitan Museum of Art in New York, the Sackler Museum in Beijing and the Royal Academy in London.
Speaking for Purdue, Josephson said, “We have strong defenses against these allegations, and believe we will prevail once the full facts are presented.”
He added, “it is inappropriate to substitute the judgment of the city (of San Diego) for the judgment of the regulatory, scientific and medical experts at FDA.”
Josephson said the complaint disregards basic facts about Purdue’s prescription opioid medications, including that OxyContin, as a Schedule II drug, is highly controlled by the Drug Enforcement Administration.
Also, he said the FDA-approved label for OxyContin bears a prominent “black box” warning for healthcare providers about the risks of addiction and overdose.
“Purdue promoted its opioid medications based on the medical and scientific evidence in the FDA approved label and did so to licensed physicians who have the training and responsibility to ensure that medications are properly prescribed,” Josephson’s statement said.
Further, he said the lawsuit omits that in 2010 the FDA approved a reformulated version of OxyContin with properties intended to deter abuse.
The allegations also omit key facts about FDA’s regulation of opioid medications:
“Purdue worked for over a decade to develop the new formulation, and it was the first FDA-approved opioid with abuse deterrent properties;” Josephson said.


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