Tag: big pharma

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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How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

In trials, brexpiprazole failed to provide a clinically meaningful benefit and it increased mortality, but the FDA fast tracked its approval and the sponsor predicts $1bn in annual sales. Robert Whitaker investigates the first licensed antipsychotic for treating agitation in elderly patients with dementia

For years, health officials have tried to rein in the prescribing of atypical antipsychotics to elderly patients with dementia. The practice has been entirely “off label” yet widespread. The US Food and Drug Administration reports that around 60% of patients with Alzheimer’s dementia in residential care have received an off-label prescription for an antipsychotic, benzodiazepine, antidepressant, or anti-epileptic drug. After a 2005 FDA warning that cited a 60-70% increased risk of death associated with antipsychotic drug use, the US Centers for Medicare and Medicaid Services established the National Partnership to Improve Dementia Care in Nursing Homes, a public-private collaboration that sought to “reduce the use of antipsychotics” and “enhance the use of non-pharmacological approaches.”1

But a May 2023 FDA approval of the antipsychotic brexpiprazole for agitation in patients with Alzheimer’s dementia may reverse all of this. At a cost of around $1400 (£1102; €1280) a month, the manufacturers Otsuka and Lundbeck, which jointly brought the “first in class” approval to market, are forecasting an additional $1bn in annual sales of Rexulti.2

Serious questions remain, however, about the harm-benefit balance of Otsuka and Lundbeck’s drug. The drug carries a “boxed warning”—the FDA’s most serious type of warning, informing prescribers of increased mortality. And among four efficacy evaluations across the three prelicensure clinical trials, the highest efficacy observed was a 5.3 point improvement over placebo on a 174 point scale. In the two trials that assessed quality of life, no benefit for either the patient or the caregiver was demonstrated.

“The small benefits do not outweigh serious safety concerns,” said Nina Zeldes, health researcher at the consumer advocacy organisation Public Citizen, addressing the FDA’s advisory committee at its 14 April meeting before the approval.3 “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”4

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Medical Marijuana Improves Military Veterans’ Quality Of Life And Reduces Prescription Drug Use, Study Finds

Over 90 percent of U.S. military veterans who use medical marijuana say that it improves their quality of life, with many using cannabis as an alternative to over-the-counter and prescription medications, according to a new study.

Researchers at the University of Massachusetts, University of Utah and cannabis research institutes looked at self-reported survey data from 510 veterans who said that they consume marijuana, seeking to better understand the purpose and experiences of their usage.

A majority of the respondents (67 percent) said that they use cannabis daily. And about one-third (30 percent) said that they consume marijuana to reduce the use of other medications, including anti-depressants (25 percent) and non-steroidal anti-inflammatories (17 percent). Another 21 percent said that cannabis has allowed them to reduce their use of opioid-based medications.

Overall, 91 percent of the veterans said that cannabis improved their quality of life.

“Veterans who were Black, who were female, who served in active combat, and who were living with chronic pain were more likely to report a desire to reduce the number of prescription medications they were taking,” the study says. “Women and individuals who used cannabis daily were more likely to report active use of cannabis to reduce prescription medication use.”

“Medicinal cannabis use was reported to improve quality of life and reduce unwanted medication use by many of the study participants. The present findings indicate that medicinal cannabis can potentially play a harm-reduction role, helping veterans to use fewer pharmaceutical medications and other substances.”

The observational study, which was published last month in the journal Clinical Therapeutics, has several limitations—including the fact that data was self-reported and several cannabis friendly media outlets and companies promoted recruitment or provided funding for the research initiative. But the findings are generally consistent with other studies that have focused on marijuana as a potential alternative to prescription drugs.

There’s particular interest in studying the possibility of cannabis as a treatment option for veterans, as the population disproportionately suffers from post-traumatic stress disorder (PTSD) and high rates of suicide.

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All Birth Control Pills, Not Just One, Should Be Over the Counter

On July 13, the Food and Drug Administration (FDA) finally allowed women to access one birth control pill over the counter. The FDA signaled in May that this was likely to happen after an advisory panel recommended that the agency approve over-the-counter marketing of the progestin-only oral contraceptive Opill, manufactured by the Dublin-based Perrigo Company. Progestin-only oral contraceptives have been around since 1973. Dubbed the “mini pill,” these contraceptives have their limitations.

For example, women must take the pill at the same time every day, within a three-hour window. If they miss the window, they must discontinue the pill and begin again with the next cycle. With standard birth control pills that combine estrogen and progesterone, women who miss a daily dose can double up the next day. Women who take progestin-only pills have a slightly lower risk of developing blood clots that can break off and travel through the body (venous thromboembolism, or VTE) than they do with combination pills. But the American College of Obstetricians and Gynecologists (ACOG), which has for decades advocated making all hormonal contraceptives available over the counter for women of all ages, states the risk of VTE “with combined oral contraceptive use is small compared with the increased risk of VTE during pregnancy and the postpartum period.”

ACOG is not the only medical professional organization calling to free the birth control pill. It is joined by the American Academy of Family Physicians and the American Medical Association. And most reproductive health care providers surveyed in 2016 favored over-the-counter birth control pills. These medical experts, who get paid to evaluate women and prescribe hormonal contraceptives, have the financial incentive to argue for maintaining the status quo. When they repeatedly assert that women do not need their services to obtain birth control pills, regulators should take notice.

The FDA approved over-the-counter emergency contraception, the so-called morning-after pill, for women of all ages in 2013. These pills (for example, Plan B) usually contain high progestin levels. But standard birth control pills can also be used for emergency contraception. The required dose is 8-10 pills. The FDA denies women over-the-counter access to contraceptives with one-eighth to one-tenth the potency of over-the-counter emergency contraceptives.

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