Tag: big pharma

Landmark Case Means Americans Can Now Sue Big Pharma for Vaccine Injuries

Up until now, the drug companies have been shielded from liability for all the COVID vaccine injuries and deaths that they have caused. They’re protected by something called the PREP Act, which stands for Public Readiness and Emergency Preparedness. A judge in a landmark Michigan case, however, has now ruled that the PREP Act does not shield the Big Pharma companies from liability if their medicines are contaminated.

That’s it. The floodgates are finally open. If you were hurt by a COVID shot or if one of your loved ones died from it, you can now sue the Big Pharma companies.

The Michigan case was brought by Dan Nowacki, an elderly man who was hospitalized with COVID. Mr. Nowacki was treated with Remdesivir, which is a COVID treatment drug made by pharmaceutical company Gilead. Remdesivir is a relatively new treatment, so it’s shielded under the PREP Act.

Mr. Nowacki was treated with Remdesivir intravenously. His attorneys just proved in court that at least two of the vials that Mr. Nowacki was administered were contaminated with shards of glass. It caused him to have two catastrophic strokes in the hospital. He’s now permanently bedridden. About 55,000 vials of Remdesivir were recalled in November of 2021 due to glass contamination.

The judge ruled that the pharmaceutical companies’ liability shielding does not protect them in the case of contamination. If the Big Pharma companies are being protected from being sued, then they still have to meet basic safety standards. They can’t just inject their medicines into people if they know that those medicines are contaminated with shards of glass, arsenic, or… just to name one possible contaminant off the top of our head… cancer-causing monkey viruses.

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OxyContin’s Reformulation Linked to Rising Suicides by Children

In 2010, Purdue Pharma replaced the original version of OxyContin, an extended-release oxycodone pill, with a reformulated product that was much harder to crush for snorting or injection. The idea was to deter nonmedical use, and the hope was that the reformulation would reduce addiction and opioid-related deaths. That is not how things worked out.

The reformulation of OxyContin was instead associated with an increase in deaths involving illicit opioids and, ultimately, an overall increase in fatal drug overdoses. Researchers identified that pattern by looking at the relationship between pre-2010 rates of OxyContin misuse, as measured by surveys, and subsequent overdose trends. They found that death rates rose fastest in states where reformulation would have had the biggest impact. A new study by RAND Corporation senior economist David Powell extends those findings by showing that the reformulation of OxyContin also was associated with rising suicides among children and teenagers.

The root cause of such perverse effects was the substitution that occurred after the old version of OxyContin was retired. Nonmedical users turned to black-market alternatives that were more dangerous because their potency was highly variable and unpredictable—a hazard that was compounded by the emergence of illicit fentanyl as a heroin booster and substitute. The fallout from the reformulation of OxyContin is one example of a broader tendency: Interventions aimed at reducing the harm caused by substance abuse frequently have the opposite effect.

From 1988 to 2010, Powell notes in the journal Demography, the suicide rate among 10-to-17-year-olds fell by 36 percent. That drop was “followed by eight consecutive years of increases—resulting in an 83% increase in child suicide rates.” Based on interstate differences in nonmedical use of OxyContin prior to 2010, Powell estimates that “the reformulation of OxyContin can explain 49% of the rise in child suicides.”

Since “the evidence suggests that children’s illicit opioid use did not increase,” Powell says, it looks like “the illicit opioid crisis engendered higher suicide propensities by increasing suicidal risk factors for children,” such as child neglect and “alter[ed] household living arrangements.” He notes a prior study that found “states more
affected by reformulation experienced faster growth in rates of child physical abuse
and neglect starting in 2011.” And he suggests the suicide rate may also have been boosted by “parental death and incarceration” associated with the shift from legally produced pharmaceuticals to illicit drugs.

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A Threat To Humanity: WHO, Gates, and Big Pharma Make Pandemic Treaty

Intended to form part of international law, preparations for the creation of a World Health Organisation (“WHO”) Pandemic Treaty or Pandemic Accord began in 2001.

Far from strengthening the prevention of, preparedness for, and response to future pandemics as the latest draft of the text claims, its implementation could severely undermine democracy by limiting the ability of national parliaments to make crucial healthcare decisions in the best interests of their citizens.

Aided by proposed amendments to the International Health Regulations of 2005, the Treaty threatens to transform the WHO into a global health dictatorship.

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Pfizer ‘Knowingly Distributed’ Adulterated Drugs to Children: Lawsuit

Pfizer and one of its partners distributed a medication to children despite having knowledge that the drug was adulterated, according to legal action unsealed on Nov. 20.

Pfizer and Tris Pharma distributed Quillivant XR, a drug for children aimed at treating attention-deficit/hyperactivity disorder (ADHD), even though the companies knew the drug did not meet federal standards, the lawsuit from Texas Attorney General Ken Paxton says.

The U.S. Food and Drug Administration (FDA) approved Quillivant in 2012 but soon after its approval, the drug failed quality control tests, according to the suit.

Instead of investigating the root cause, as required by federal rules, Tris repeatedly changed testing methods allegedly to try to generate positive results, Mr. Paxton’s probe found. Tris was “under financial pressure” to “rapidly increase production” and did ramp up production but “without adequate controls,” the suit states.

Quillivant comes in powder form and is reconstituted by pharmacists with water.

The medication is a schedule II controlled dangerous substance, and suppliers are required by the FDA to ensure display of a black box warning about abuse and dependence, and the potential side effects which include nausea, vomiting, and insomnia. It was developed by Nextwave Pharmaceuticals, and was acquired by Pfizer in May 2012.

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Why Is the FDA Still Requiring Human or Animal Testing For New Drugs?

Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.

The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NH). Its goal was to speed up the drug approval process, and to let scientists experiment with approaches methods that are more humane than testing on live subjects. Reason‘s Elizabeth Nolan Brown aptly summarized the bill’s achievements, noting that “previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won’t have to.”

And yet the Food and Drug Administration (FDA) has not taken action to update the agency’s regulations.

“The FDA’s regulations related to animal testing no longer fully conform with applicable law,” writes Paul in a letter to FDA Commissioner Robert Califf.

Paul’s letter, obtained exclusively by Reason, was co-signed by Booker and several other senators from both parties. It notes that the FDA has previously spoken positively about moving away from animal testing. But companies currently submitting applications for drug approval still have to deal with FDA requirements that stipulate human or animal testing—at least on paper.

“These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible,” writes Paul.

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Free the Meds: 5 Drugs You Should Be Able To Buy Over the Counter

The Food and Drug Administration (FDA) approves not only which drugs can go to market but also whether they require a prescription from a doctor. The agency gets this power from the Durham-Humphrey Amendment of 1951. Meant to protect patients, the law has turned into a license to make life difficult. Here are five low-risk drugs that the FDA could make available over the counter today.

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GOP Congressman Worries That Moving Marijuana To Schedule III Could ‘Allow Big Pharma To Control It’

A Republican congressman says he’s concerned that if the federal government doesn’t “go further” than simply moving marijuana to a lower drug schedule—as the top health agency has recommended—large pharmaceutical companies might be able to overtake the cannabis industry.

On Monday, Rep. Matt Gaetz (R-FL) filled in for a Newsmax host and led a segment that featured attorney John Morgan, who spent millions to put a successful medical cannabis initiative on the ballot in Florida. The two discussed recent reporting that the U.S. Health and Human Services (HHS) is advising the Drug Enforcement Administration (DEA) to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).

Morgan criticized the status quo that currently lists marijuana in the same schedule as drugs like heroin, and he accused the alcohol and pharmaceutical industries of wanting to block research into cannabis because such studies could support the idea of substituting marijuana for the more dangerous drugs that they market.

“Well, I totally concur with the assessment that marijuana reform is often blocked by Big Pharma because they want the opportunity to control it,” Gaetz, who also pressed the DEA administrator on the status of the scheduling review last month, said. “My concern is that if we don’t go any further than moving marijuana from Schedule I to Schedule III, that could potentially allow Big Pharma to control it.”

The congressman also suggested that the Biden administration may have been moved to recommend rescheduling after seeing research showing that legalization is associated with reduced opioid-related hospitalizations and lower rates of child foster case cases due to substance misuse. And he then asked Morgan if he felt the HHS Schedule III recommendation is “sufficient.”

Despite certain concerns about a potential power grab by the pharmaceutical industry if marijuana is rescheduled, Morgan said that it represents “a step in the right direction,” echoing recent remarks made my numerous congressional lawmakers who back marijuana reform. “It has to happen,” he said.

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