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GT Investigates: Big Pharma Greed, Lobbying, Failed Governance and Economic Woes Lead to U.S. Drug Crisis
America’s drug abuse problem — a long-existing thorn in the side of U.S. society — has grown more serious in recent years in the country along with an increasing number of young people turning to drugs due to dwindling economic opportunities and the apparent death of the so-called “American Dream,” analysts said.
The drug problem in the U.S. is caused by an interplay among economic interests, lobby groups, as well as social and cultural factors, an expert in international relations at Fudan University told the Global Times.
While the U.S. federal and state governments keep making pledges to tackle the drug problem, they have failed to take substantive measures due to the lobbying activities of various interest groups, observers said.
Reports showed that large pharmaceutical companies in the U.S. devote large sums of money to peddle narratives such as “opioids are harmless” and push forward drug legalization as well as the promotion of drug sales and prescription of drugs. The lawmakers who receive money from them actively promote bills that benefit Big Pharma.
A Rare Marburg Outbreak Sparks a Race Against Time to Test Vaccines and Drugs
Marburg fever outbreak in Equatorial Guinea is galvanizing efforts to test drugs and vaccines for a virus that currently has none. But every day counts warned experts who gathered virtually on Tuesday to try to chart a course for the work.
The outbreak is believed to have begun in early January, but the confirmation that the Marburg virus was responsible for the growing cluster of people sick with hemorrhagic-fever-like illness was only confirmed on Monday. To date, nine people have died; all were epidemiologically linked. Another 16 people with some symptoms are in quarantine.
There are a number of experimental vaccines and drugs that have been shown in animals to prevent or treat Marburg, a deadly cousin of the deadly Ebola virus family. But finding out if they actually work in people requires an outbreak, and Marburg outbreaks are blessedly rare.
This is the first one Equatorial Guinea has recorded. While there have been four in the past decade in Ghana, Guinea and Uganda (which had two), the last Marburg outbreak with cases that numbered in the double digits was in 2012. And even that one only recorded 15 cases.
Male Birth Control Drug Sees ‘Game-Changer’ Trial in Mice — Here’s What You Need to Know
A new drug was able to quickly and temporarily immobilize sperm in male mice, according to a study published Tuesday in Nature Communications, a discovery that researchers described as a “game-changer” that could pave the way for a male contraceptive pill and could ultimately allow men to share equal responsibility with women for birth control.
The drug is fast-acting — Melanie Balbach, one of the study’s authors and a researcher at Weill Cornell Medicine, said it worked within 30 to 60 minutes — and works by inhibiting an enzyme needed for sperm to function.
It is also temporary, with efficacy dropping to 91% at three hours and fertility returning to normal by the next day.
The study demonstrates proof-of-concept for “safe, non-hormonal, on-demand, male contraceptives,” the researchers said, and while it may work in theory any product will be many years and a great deal of testing in the future.
Gold Standard? 10% of Newly Approved Drugs Were Based on Studies That Didn’t Achieve Goals
One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that weren’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some of the products’ safety and effectiveness.
The FDA’s controversial approval of the Alzheimer’s drug aducanumab prompted researchers to find how often the agency approved drugs despite clinical trials with failed or mixed results.
Bernie Sanders’s New Campaign: Taking on Big Pharma and Starbucks
When I interviewed Senator Bernie Sanders, during one afternoon last week, he’d had a busy day. In the morning, he had presided over his first hearing as the chair of the Senate Committee on Health, Education, Labor, and Pensions, his old-school Brooklyn accent ringing out across the hearing room.
Sanders castigated Big Pharma, noting that, earlier in the day, he had spoken to someone from Finland, who had told him that drug prices in that country were, in some cases, a tenth of the prices in the United States. “So we have to pick on the incredible greed of the pharmaceutical industry, who make huge profits every year and pay their C.E.O.s huge salaries and compensation packages,” he said. “That’s something we are going to go into big time.”
Chairing a Senate committee isn’t new to Sanders, who has been in the Senate since 2007. In 2013 and 2014, he helmed the Veterans’ Affairs Committee, where he worked with the Republican John McCain to successfully reform the healthcare system for veterans.
In January, he wrote to Moderna and rebuked the company for raising the price of its COVID vaccine.
Florida Patient Sues Maker of EzriCare Eyedrops Linked to Bacterial Infections
A woman in Florida filed a lawsuit late Thursday against the maker of EzriCare artificial tears and Walmart after suffering a bacterial infection that she said was caused by the eye drops.
Houston-based Lange Law Firm, which is representing the woman, Teresa Phillips, 60, of Bradford County, said the lawsuit is the first nationwide over injuries related to eyedrops linked to a drug-resistant bacterial infection called Pseudomonas aeruginosa.
Phillips had to have surgery to remedy some of the issues related to the infection and still has symptoms, according to the firm.
The EzriCare artificial tears have been linked to at least 56 cases of bacterial infection in 12 states. Five of those people so far have had vision loss. One person died when the bacteria entered the bloodstream. Doctors say there could be more cases.
Alcon to Pay Johnson & Johnson $199 Million to Settle Eye-Laser Cases
Alcon Vision LLC (ALCC.S) will pay Johnson & Johnson‘s (JNJ.N) J&J Surgical Vision Inc. $199 million to settle legal battles over intellectual property related to the companies’ laser eye-surgery devices, Alcon said in a press release on Sunday.
Alcon said the one-time payment would resolve “various worldwide intellectual property disputes” and that the companies had reached a cross-licensing agreement.
A copyright trial was set to begin this week in Delaware federal court over claims that Alcon stole software from J&J’s iFS Laser system, used for LASIK vision correction and other surgeries, and utilized it in Alcon’s LenSx system to treat cataracts. A J&J expert had argued that the company was entitled to at least $3.1 billion in damages.
The ‘Extreme’ Story of How Two Game-Changing Cancer Drugs Came to Market — New Book by Former Forbes Senior Editor Pulls Back the Curtain on Drug Development
In his new book, For Blood and Money, Nathan Vardi provides deep insights into how blockbuster drugs are developed — particularly, how strongly the investment community and the science are intertwined.
Vardi tells the “extreme” story, as he calls it, of the development of two Bruton’s tyrosine kinase (BTK) inhibitors that changed the way doctors treat chronic lymphocytic leukemia (CLL). Part of what makes the story extreme is its wild cast of characters, which includes two hard-charging investors, Bob Duggan and Wayne Rothbaum.
That story ends with the sale of Duggan’s company, Pharmacyclics, to AbbVie for $21 billion, and Rothbaum’s company, Acerta Pharma, to AstraZeneca, for almost $7 billion.
Sun Pharma Recalls Generic for High Blood Pressure After Failed FDA Lab Test
In a recent FDA enforcement report, the agency said the firm is pulling more than 34,000 bottles of generic diltiazem hydrochloride because the drug batch failed “stability testing and failed dissolution testing” at an FDA laboratory.
The drug is used to treat high blood pressure, chest pain and certain heart rhythm disorders.
Sun Pharma made the pills at its Halol manufacturing plant in Gujarat, India. The pills were distributed nationwide.
The company started the recall on Jan. 13, but the agency classified it as a Class 2 recall earlier this month. Class 2 recalls cover situations that “may cause” temporary health consequences or a remote chance of serious health outcomes.
The PBM Transparency Act Will Not Lower Drug Prices
While members of Congress agree on the need to try to rein in the prices of prescription drugs, there is less consensus as to how this might be accomplished. Unfortunately, some of the ideas currently being considered would have the unintended consequences of reducing competition in the marketplace, and ultimately raising drug prices even higher.
One such misguided idea is a bill the Senate Commerce Committee will consider this week that would give the Federal Trade Commission the authority to limit the ability of pharmacy benefit managers (PBMs) to negotiate lower drug prices from drug companies. If passed, it would serve to increase drug costs and worsen health outcomes for many people who take prescription drugs.
A summary of academic research that we published last year showed that efforts to limit the power of PBMs would increase drug costs by tens of billions of dollars every year, and research from the Congressional Budget Office and the Government Accountability Office has shown that hindering PBMs’ negotiating power against big drug companies carry a high price tag for patients and taxpayers.
