May, 04 2016, 04:15pm EDT
Nine Years of Anti-Regulatory Fiction
Statement of Amit Narang, Regulatory Policy Advocate for Public Citizen’s Congress Watch Division
WASHINGTON
On Tuesday, the Competitive Enterprise Institute (CEI) for the ninth time released a previously discredited report on the costs of federal regulations.
Statement of Amit Narang, Regulatory Policy Advocate for Public Citizen's Congress Watch Division
The Competitive Enterprise Institute's discredited report on federal regulations belongs in the fantasy section of the bookstore, next to "Star Wars" and "Game of Thrones." When asked about its nearly identical report in 2015, CEI admitted that it used "back of the envelope" calculations and that no one should assume households actually pay anything in regulatory costs.
In addition to the numerous and serious methodological flaws in the report, it wholly ignores the benefits that regulations provide to the public. CEI admits it made no attempt to compute the benefits of the regulations it scrutinized or compare those benefits to costs. This is akin to grocery shoppers deciding to buy no groceries because they cost money. Deceiving the public, the press and lawmakers by hiding regulatory benefits is unacceptable.
The report is full of fictitious figures that cannot withstand even the most basic scrutiny. For example, the total cost figure in CEI's report includes more than $300 billion in transfer payments totally unrelated to regulatory costs, such as Medicare benefits. Another $316 billion of the cost figure is made up of tax compliance costs, which also have nothing to do with any sensible tally of regulatory costs.
In claiming that "economic" regulations cost roughly $400 billion per year, CEI's report relies on a notorious report on the impact of federal regulations commissioned by the U.S. Small Business Administration (SBA). That SBA report has been thoroughly debunked by independent experts and received so much criticism that the SBA eventually disavowed it.
CEI should disavow this report instead of republishing it year after year.
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
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Big Pharma Drug Patent Abuses Cost Medicare Billions: Report
"As CMS negotiates the prices Medicare will pay for top-selling drugs, it should take into account the billions we've already lost due to these patenting tactics," said one researcher.
Dec 11, 2024
When the Inflation Reduction Act became law in 2022, it included a historic provision that gave the Centers for Medicare and Medicaid Services (CMS) the ability to negotiate maximum fair prices for select drugs. This means that CMS now has an important tool to resist high prices imposed by pharmaceutical companies and lower the cost that Medicare recipients pay for their drugs. So far, Medicare has negotiated the maximum fair prices for 10 drugs, which will go into effect January 1, 2026.
But according to a report released Wednesday by the watchdog group Public Citizen, the manufacturers behind these drugs are able to rely on another method to protect their profits: patent abuses and evergreening tactics.
The report defines "evergreening tactics" as the practice of "patenting trivial and/or obvious modifications of existing medications to lengthen exclusivity on branded medicines."
The makers of the drugs Eliquis, Imbruvica, Jardiance, Farxiga, and Entresto, for example, obtained patents on what constitute trivial or minor changes to earlier patent claims, "such as crystalline forms of drug compounds which would be discovered and managed during routine testing that is part of the drug approval process," according to Public Citizen. These new patents allow the manufacturers to extend their monopoly on these drugs.
"Big Pharma patent abuse is cheating Medicare enrollees of more affordable drugs and costing taxpayers billions," said Public Citizen Access to Medicines program researcher Jishian Ravinthiran in a statement.
"Patent abuses enable Big Pharma companies to unfairly extend their monopolies and keep prices artificially high. As CMS negotiates the prices Medicare will pay for top-selling drugs, it should take into account the billions we've already lost due to these patenting tactics," he added.
The report makes this same point, arguing that the agency's initial offers on pharmaceuticals should take into account how long-monopoly drugs have been able to obtain longtime exclusivities on medicines by manipulating patents.
This is paramount, Public Citizen argues, given the scope of lost savings. The group estimates that Medicare will lose somewhere between $4.9 and $5.4 billion in savings that should have accrued to taxpayers if four out of the 10 drugs did not take advantage of patenting tactics, and therefore would have faced greater competition prior to negotiation.
"These lost savings are nearly as much as what Medicare is expected to save if negotiated prices go into effect on all of the selected drugs in the first year of the program ($6 billion)," according to the report.
As an example, the drug etanercept, which is marketed as Enbrel, is on the list of 10 drugs that will be subject to a negotiated cap come January 2026. Etanercept's maker Amgen did not contribute to the original research and development of etanercept, per Public Citizen, it just acquired the original maker of the drug, Immunex, in 2002.
Immunex's patent of etanercept was set to expire in 2019, but "by using abusive patent practices" Amgen was able to extend the patent protections through 2029, according to Public Citizen. Amgen was able to evade competition of two potential "biosimilar" competitors, Erelzi and Eticovo, which received FDA approval in the 2010s.
Referencing analysis done in a separate report, Public Citizen estimated "that biosimilars could have entered the market after August 2019 were it not for Amgen's unwarranted patent exclusivities, and we calculated Medicare would have spent $1,891,500,836 less on a net basis had enrollees been able to use lower-cost alternatives by the time negotiated prices go into effect on January 1, 2026."
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Survivor of US Atomic Bombing Makes Plea to World With Nobel Acceptance Speech
"Let us all strive together to ensure that humanity is not destroyed by nuclear weapons, and to create a human society where there are no nuclear weapons and no war," said Terumi Tanaka.
Dec 11, 2024
Accepting the 2024 Nobel Peace Prize on behalf of the grassroots Japanese anti-nuclear group he co-chairs, Terumi Tanaka warned on Tuesday night that the world is moving in the opposite direction than the one hibakusha—survivors of the U.S. bombings of Hiroshima and Nagasaki—have demanded for nearly seven decades.
Tanaka is a co-chair of Nihon Hidankyo, an organization founded in 1956 by survivors of the bombings that had killed an estimated 140,000 people in Hiroshima and 70,000 in Nagasaki, with the death toll continuing to rise in later years as people succumbed to the effects of radiation.
The group accepted the Nobel Peace Prize in Oslo, with the Nobel Committee honoring Nihon Hidankyo "for its efforts to achieve a world free of nuclear weapons."
The organization aims to maintain a taboo around the use of nuclear weapons, which have only been used in combat by the U.S. in Japan in 1945.
Tanaka warned that there are currently 12,000 nuclear warheads in the arsenals of the U.S., Russia, China, and six other countries, and 4,000 of those "could be launched immediately."
"This means that the damage that occurred in Hiroshima and Nagasaki could be multiplied by hundreds or even thousands," said Tanaka, who is 92. "Let us all strive together to ensure that humanity is not destroyed by nuclear weapons, and to create a human society where there are no nuclear weapons and no war."
"It is the heartfelt desire of the hibakusha that, rather than depending on the theory of nuclear deterrence, which assumes the possession and use of nuclear weapons, we must not allow the possession of a single nuclear weapon," he added.
"I hope that the belief that nuclear weapons cannot—and must not—co-exist with humanity will take firm hold among citizens of the nuclear weapon states and their allies, and that this will become a force for change in the nuclear policies of their governments."
Tanaka said that "the nuclear taboo threatens to be broken," as evidenced by Israeli Heritage Minister Amihay Eliyahu's recent comment that a nuclear attack on Gaza would be "one way" to defeat Hamas.
"I am infinitely saddened and angered" by such statements, said Tanaka.
He described his experience as a 13-year-old when the U.S. bombed Nagasaki, just a couple of miles away from his family's house, which was crushed by the impact.
He said he later found the charred body of one of his aunts and saw his grandfather close to death from the burns that covered his body.
"The deaths I witnessed at that time could hardly be described as human deaths," Tanaka said. "There were hundreds of people suffering in agony, unable to receive any kind of medical attention."
"I hope that the belief that nuclear weapons cannot—and must not—co-exist with humanity will take firm hold among citizens of the nuclear weapon states and their allies, and that this will become a force for change in the nuclear policies of their governments," said Tanaka.
The International Campaign to Abolish Nuclear Weapons (ICAN) applauded Nihon Hidankyo and the hibakusha "for their resilience and willingness to share their stories over and over again, so that the world may learn and come together to say 'never again.'"
"It was their courage that enabled the [Treaty on the Prohibition of Nuclear Weapons] to be adopted, which represents the first progress on nuclear disarmament in decades," said Melissa Parke, executive director of ICAN, referring to the treaty that's been ratified by 73 countries.
"Listening to Mr. Tanaka describe the horrendous effects on his family and city when the Americans dropped their atomic bomb should convince world leaders they have to go beyond simply congratulating the hibakusha of Nihon Hidankyo for this award. They must honor them by doing what the hibakusha have long called for—urgently getting rid of nuclear weapons," said Parke. "That is the only way to ensure that what Mr. Tanaka and the other hibakusha have been through never happens to anyone ever again. As long as any nuclear weapons remain anywhere, they are bound one day to be used, whether by design or accident."
Jørgen Watne Frydnes, chair of the Nobel Committee, condemned the nine nuclear powers for "modernizing and building up their nuclear arsenals."
"It is naive to believe our civilization can survive a world order in which global security depends on nuclear weapons," Frydnes said. "The world is not meant to be a prison in which we await collective annihilation."
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US Ambassador to UN Slammed Over 'Right to Food' Rhetoric as Israel Starves Gaza
"She is on a shamelessness tour," journalist Jeremy Scahill said of American diplomat Linda Thomas-Greenfield.
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The U.S. ambassador to the United Nations is facing backlash after delivering a speech earlier this week touting the universal "right to food" as the Israeli military—armed to the teeth with American weaponry—fuels widespread and increasingly deadly hunger in the Gaza Strip.
In remarks Monday at a gathering of U.N. and civil society leaders focused on global food insecurity, Thomas-Greenfield called hunger, starvation, and famine "man-made tragedies" that "can be stopped by us."
"Let me be clear: Every human being, everywhere, has the right to food," she continued. "For the United States, this is a moral issue. And it's an economic and national security issue."
Thomas-Greenfield's speech sparked derision given the Biden administration's continued military support for an Israeli government that has been accused of wielding starvation as a weapon of war in Gaza, where—according to the latest U.N. Food and Agriculture Organization assessment—food aid has reached an all-time low under Israel's suffocating blockade.
"Hunger is a man-made tragedy that you helped make in Gaza."
Oxfam and other human rights groups have said that by arming the Israeli military as it obstructs humanitarian aid, the Biden administration is complicit in the starvation of Palestinians in Gaza and Israel's repeated attacks on aid workers attempting to feed the enclave's hungry.
"She is on a shamelessness tour in her final weeks as U.S. ambassador to the U.N.," journalist Jeremy Scahill wrote Wednesday in response to Thomas-Greenfield's speech. "She presided over numerous cease-fire vetoes as part of an administration that facilitated Israel's starvation policy against the Palestinians of Gaza. Listen to her remarks on 'hunger' in that context."
Yesterday, @USUN brought together humanitarian leaders to discuss solutions to the global food insecurity crisis.
Hunger is a man-made tragedy. But if it caused by man, that means it can be stopped by us, too.
Every human being, everywhere, has the right to food. pic.twitter.com/zczlerRHEc
— Ambassador Linda Thomas-Greenfield (@USAmbUN) December 10, 2024
Middle East scholar and analyst Assal Rad, wrote that Thomas-Greenfield's vetoes at the U.N. "have helped Israel continue its genocide and deliberately starving people."
"Hunger is a man-made tragedy that you helped make in Gaza," Rad added.
Despite Thomas-Greenfield's insistence that addressing global food insecurity has long been a priority for the world's wealthiest and most powerful nation, the U.S. and Israel were the only two countries to vote against a U.N. committee draft on the right to food in 2021.
On Tuesday, the Biden administration welcomed to the White House former Israeli Defense Minister Yoav Gallant, who—along with Prime Minister Benjamin Netanyahu—is facing an arrest warrant from the International Criminal Court for "the war crime of starvation as a method of warfare," among other crimes.
"Today is Human Rights Day—a date chosen to honor the UN’s adoption of the Universal Declaration of Human Rights in 1948," the Institute for Middle East Understanding Policy Project wrote Tuesday. "Biden's White House is dishonoring this day by hosting a confirmed war criminal who conducted a genocide, and starved and targeted Palestinian civilians."
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