October, 10 2012, 04:42pm EDT
For Immediate Release
Contact:
Sam Husseini, (202) 347-0020; or David Zupan, (541) 484-9167
Meningitis Outbreak "Highlights Failure of FDA"
WASHINGTON
MICHAEL CAROME, MD, via Barbara Holzer [email]
Deputy director of Public Citizen's Health Research Group, Dr. Carome said today: "The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration's regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable.
"The steroid injections, distributed by the New England Compounding Center in Framingham, Mass., have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New England Compounding Center.
"The large-scale production of a drug -- in this case, a drug that is intended to be sterile and injected into patients -- appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce.
"Indeed, prior warning letters from the FDA to the New England Compounding Center and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.
"However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients. By not aggressively enforcing regulations related to drug manufacturing by compounding pharmacies, the FDA has perpetuated a double standard: Traditional drug manufacturers must adhere to rigorous drug-safety standards intended, for example, to prevent the contamination of their products. But so-called compounding pharmacies engaging in large-scale drug production do not. This double standard has resulted in the unfolding public health catastrophe involving hundreds and potentially thousands of patients who received steroid injections for back pain.
"Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible. If current statutes and regulations provided the FDA with authority to prevent this disaster, senior FDA officials should be held accountable. If holes in the agency's existing legal authority are identified, Congress should act immediately to pass legislation to remedy the situation."
In "Comments on a Draft of the Safe Drug Compounding Act of 2007'' (from 2007), Public Citizen noted: "The size of the pharmacy compounding industry is unknown and there is no requirement for compounding pharmacists to report problems with their products to any regulatory authority."
A nationwide consortium, the Institute for Public Accuracy (IPA) represents an unprecedented effort to bring other voices to the mass-media table often dominated by a few major think tanks. IPA works to broaden public discourse in mainstream media, while building communication with alternative media outlets and grassroots activists.
LATEST NEWS
34 US Lawmakers Urge Biden to Pardon Steven Donziger
"We are deeply concerned about the chilling effect this case will have on all advocates working on behalf of other frontline communities, victims of human rights violations, and those seeking environmental justice."
Dec 11, 2024
More than 30 Democratic members of Congress on Wednesday called on outgoing U.S. President Joe Biden to pardon environmental and human rights lawyer Steven Donzinger, who endured nearly 1,000 days in prison and house arrest after successfully representing Ecuadoreans harmed by Big Oil's pollution of the Amazon rainforest.
In a
letter to Biden led by Rep. Jim McGovern, (D-Mass.), 33 House and Senate Democrats plus Independent U.S. Sen. Bernie Sanders of Vermont noted the "troubling legal irregularities" in Donzinger's case, which have been "criticized as unconstitutional or illegal by three federal judges, 68 Nobel laureates, and five high-level jurists from the Working Group on Arbitrary Detention of the United Nations."
Donziger represented a group of Ecuadorean farmers and Indigenous people in a 1990s lawsuit against Texaco—which was later acquired by Chevron—over the oil company's deliberate dumping of billions of gallons of carcinogenic waste into the Amazon. He played a key role in winning a $9.5 billion settlement against Chevron in Ecuadorian courts.
However, Chevron fought Donziger in the U.S. court system, and when the attorney refused to disclose privileged client information to the company, federal District Judge Lewis Kaplan—who was invested in Chevron—held him in misdemeanor contempt of court. Loretta Preska, Kaplan's handpicked judge to preside over Donziger's contempt trial, is affiliated with the Chevron-funded Federalist Society.
Donziger's case drew worldwide attention and solidarity, with human rights experts and free speech groups joining progressive U.S. lawmakers in demanding his release. He was released in April 2022 after 993 days in prison and house arrest.
"Donziger is the only lawyer in U.S. history to be subject to any period of detention on a misdemeanor contempt of court charge," the 34 lawmakers wrote. "We believe that the legal case against Mr. Donziger, as well as the excessively harsh nature of the punishment against him, are directly tied to his prior work against Chevron. We do not make this accusation lightly or without evidentiary support."
The legislators warned:
Notwithstanding the personal hardship, this unprecedented legal process has imposed on Mr. Donziger and his family, we are deeply concerned about the chilling effect this case will have on all advocates working on behalf of other frontline communities, victims of human rights violations, and those seeking environmental justice. Those who try to help vulnerable communities will feel as though tactics of intimidation—at the hands of powerful corporate interests, and, most troublingly, the U.S. courts—can succeed in stifling robust legal representation when it is needed most. This is a dangerous signal to send.
"Pardoning Mr. Donziger," the lawmakers added, "would send a powerful message to the world that billion-dollar corporations cannot act with impunity against lawyers and their clients who defend the public interest."
The lawmakers join more than 100 environmental and human rights groups that have urged Biden to pardon Donziger.
In an April opinion piece published by Common Dreams, Donziger contended that "I need this pardon because I am the only person in U.S. history to be privately prosecuted by a corporation."
"More specifically, the government (via a pro-corporate judge) gave a giant oil company (Chevron) the power to prosecute and lock up its leading critic," he continued. "As a result of this unprecedented and frightening private prosecution, I still cannot travel out of the country and I have been prohibited from meeting with clients I have represented for over three decades. Nor can I practice law, maintain a bank account, or earn a livelihood."
"No matter where one stands on the political spectrum," Donziger added, "we should all be able to agree that what happened to me should not happen to anybody in any country that adheres to the rule of law."
The appeal for a Donziger pardon comes amid a
wave of eleventh-hour pleas from lawmakers for Biden to grant clemency to figures ranging from WikiLeaks founder Julian Assange and National Security Agency whistleblower Edward Snowden to Indigenous activist Leonard Peltier—often described as the nation's longest-jailed political prisoner—and federal death row inmates including Billie Jerome Allen, who advocates say was wrongly convicted of murder.
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In Supreme Court Briefs, Biden DOJ Sides With Communities Suing Big Oil
"The Justice Department has affirmed again that communities deserve their day in court to put Big Oil companies on trial for their climate lies and the resulting harms."
Dec 11, 2024
Campaigners and experts on Wednesday welcomed the Biden administration's new briefs urging the U.S. Supreme Court not to intervene in state and local lawsuits that aim to hold fossil fuel giants accountable for lying to the public about their contributions to the climate emergency.
The Tuesday filings in Sunoco v. the City and County of Honolulu and Alabama v. California align with U.S. Solicitor General Elizabeth Prelogar's amicus brief last year, which stemmed from Colorado communities suing Big Oil. Following that filing, the justices declined to hear five appeals from fossil fuel companies trying to shift climate liability cases from state to federal court.
The U.S. Supreme Court—which has a right-wing supermajority—asked Prelogar to weigh in again this past June and October. Her new filings have climate advocates hopeful that the justices will follow their previous path and let the cases against major polluters advance in state court.
"The Justice Department has affirmed again that communities deserve their day in court to put Big Oil companies on trial for their climate lies and the resulting harms," said Richard Wiles, president of the Center for Climate Integrity (CCI), in a statement. "Big Oil companies are desperate to avoid facing the evidence of their deception in a courtroom, but wanting to escape the consequences for your actions is not the same thing as having the law on your side."
"As the solicitor general makes clear, there is no legal basis for the Supreme Court to intervene in these cases."
In Honolulu's case—intended to make companies including BP, Chevron, ExxonMobil, and Shell pay for local climate damages—the Hawaii Supreme Court rejected the fossil fuel industry's argument that "state law claims alleging the deceptive marketing of fossil fuel products were either governed by the federal common law of transboundary air pollution or preempted by the Clean Air Act."
Prelogar made the case that the country's highest tribunal "does not have jurisdiction to review the Hawaii Supreme Court's interlocutory decision" that allowed Honolulu's suit to proceed, "and even if it did, further review at this time would be unwarranted."
For the other case—which involves 19 state attorneys general trying to stop climate deception suits in California, Connecticut, Minnesota, New Jersey, and Rhode Island—Prelogar wrote that "there is no merit to the contention that the federal common law of transboundary air pollution governs (and therefore precludes) the defendant states' claims."
The solicitor general also argued that the attorneys general working on behalf of Big Oil lack standing; "the only interests directly at stake are the interests of private energy companies," not the citizens of each state; and "the very suits that the complaint seeks to enjoin are better forums for resolving the issues raised."
Alyssa Johl, vice president of legal and general counsel for CCI, said that "as the solicitor general makes clear, there is no legal basis for the Supreme Court to intervene in these cases. State and local governments are seeking to hold corporations accountable for lying about their harmful products, and state courts have the authority to hear those claims. The justices should reject these meritless requests and allow communities to have their day in court to hold Big Oil accountable."
Experts at the Union of Concerned Scientists (UCS) agreed. Delta Merner, lead scientist for the group's Science Hub for Climate Litigation, said the new briefs "represent an important step in the pursuit of climate accountability" and "reaffirm that communities have the right to hold fossil fuel companies accountable for decades of misleading the public about the harms associated with their products."
"Research has shown how fossil fuel companies knowingly concealed the dangers of their products while misleading the public—a pattern of misconduct that contributed directly to today's climate crisis," she noted. "These cases seek to give communities the chance to present this evidence in court, shining a light on the broader impacts of corporate disinformation campaigns."
"We applaud the Biden administration's continued support for these lawsuits and urge the incoming Trump administration to continue following science and clear legal arguments."
Kathy Mulvey, director of the climate accountability campaign at UCS, stressed that "communities like Honolulu are bearing the financial burden of addressing climate damages, using public dollars to remediate harms caused by decades of deception by fossil fuel companies."
"A core principle of accountability is timely access to justice through the courts. Honolulu and other communities have already waited years to present their evidence and argue their claims," she added. "We applaud the Biden administration's continued support for these lawsuits and urge the incoming Trump administration to continue following science and clear legal arguments."
Honolulu's suit is just one of dozens that state and local governments have filed against the fossil fuel industry—and Prelogar's brief last year notably represented a departure from the first Trump administration's support for Big Oil. Her new briefs come as the nation prepares for President-elect Donald Trump to return to the White House next month, with a Republican-controlled Congress.
Shortly after the GOP electoral victories last month, Emily Sanders a senior reporter for the CCI project ExxonKnews, spoke with multiple legal experts who framed the courts as key to Big Oil accountability with Trump and Republican lawmakers in power.
"It's not a stretch to say the message coming from the federal executive branch writ large and large numbers of Congress is going to be climate denial and misrepresentations," said Pat Parenteau, an environmental law professor and senior fellow at Vermont Law School. "So these cases and these jury verdicts are going to be even more important to correct the record to the extent you can."
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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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