Tag: FDA

Closing Thought–05Jan24

Do you take pills….if so then your meds are probably expensive especially if you fighting off some disease like Diabetes.

I know Biden has brought of insulin down and to that I say ‘bless his heart’…..but what about other drugs?

Well the FDA has just made a ruling on drugs…..

Americans are known to head across the border into Canada to buy their prescription drugs at cheaper costs. Now, for the first time, a state government has received approval to do the same thing on a much larger scale. In a decision described as historic, the Food and Drug Administration has granted Florida’s request to import drugs in bulk from Canada, reports the New York Times. The pharmaceutical industry is expected to file a legal challenge before that happens, but if the move goes through, expect other states to follow suit. Details:

  • The impact: The development has the potential to “change the way Americans obtain prescription medicines and could reduce their cost,” per the Wall Street Journal. Several other states already have applications pending to the FDA, including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin.
  • However: Canada is only so big. “There are real constraints on Canada’s ability to even do this—they would basically be giving up drugs that are meant for their population to subsidize drugs for people in Florida,” Stacie Dusetzina, a health-policy professor at Vanderbilt, tells the Journal. More tellingly, a spokeswoman for Health Canada agrees: “Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette tells the Times. “Bulk importation will not provide an effective solution to the problem of high drug prices in the US.”
  • Context: The Washington Post notes that the decision comes as Big Pharma appears to realize something has to give on drug prices. Eli Lilly, for example, said this week it would make its diabetes and weight-loss drugs available via telehealth, and CVS is in the midst of a major revamp of its pricing that takes effect in 2025. Both moves could result in lower prices. Politically, Florida Gov. Ron DeSantis could gain bragging rights over this, as could former President Trump, whose administration pushed the importation law ahead, and President Biden, whose FDA signed off on it.
  • First drugs: Florida plans to import drugs initially for the treatment of HIV, AIDS, diabetes, hepatitis C, and mental illness, per CNN. They would be used for Medicaid patients, inmates, and other patients served by state entities, and the FDA would have to approve any such purchases after vetting them for safety and to verify savings. However, it could be awhile before all the legal hurdles get sorted out.

Something needs to be done to slow down the slugs at Big Pharma…..soon you would have to be Bezos to afford your meds.

Please do not fall the con of a Medicare Advantage Plan….it is a rip-off.

I Read, I Write, You Know

“lego ergo scribo”

More Covid News

Are you sick of the daily updates yet?

Sorry to say I have one more…..

All the hoopla around the ‘jabs’ and then the booster….well there is one more piece of news….Merck has had a breakthrough….a pill….and no it is not a horse laxative or bleach……

The makers of what could be the first antiviral pill for COVID-19 said Friday that they will request emergency use authorization in the US as soon as possible. An independent board of experts monitoring the clinical trial of molnupiravir from drug-maker Merck and Ridgeback Biotherapeutics recommended it be halted early after the drug was found to reduce the risk of hospitalization and death due to COVID-19 by almost 50%, reports the Washington Post. The trial involved unvaccinated people with COVID-19 (including variants gamma, delta, and mu) who had at least one risk factor for severe disease.

Some 385 participants took molnupiravir within five days of symptoms while 377 took a placebo, per USA Today. Among the first group, 28 people (7.3%) were hospitalized within a month, compared to 53 people (14%) in the placebo group, eight of whom died. The safety board decided it would be unethical to enroll another 750 participants, half of whom would receive a placebo, as planned. One standout observation: The head of Merck Research Laboratories says the results suggest molnupiravir is more effective against SARS-CoV-2 than Tamiflu is against the flu.

If emergency use authorization is granted, molnupiravir would join remdesivir as one of two approved early treatments for COVID-19; as with approved monoclonal antibody therapies, remdesivir must be administered intravenously, reports the AP. With molnupiravir, a person who tests positive for COVID-19 could take two small capsules twice per day for five days. The pill works by messing with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. As molnupiravir is designed to keep the virus from replicating, it may also prevent mutations.

The drug has been licensed to five Indian drug manufacturers to hasten availability to moderate- and low-income countries, with the Post noting it could be crucial in those places, where vaccination rates are low and it’s tougher to make widespread use of drugs that have to given by IV. Merck, which plans to produce 10 million courses of treatment by the year’s end, says there will be a “tiered pricing approach,” with higher-income countries paying more and lower-income countries paying less. The US government has already committed to pay $1.2 billion for 1.7 million courses, or around $700 each, if approved.

Personally I like the idea of a pill over a ‘jab’…..but that is just me.always consult your medical professional before making any decisions.  Your favorite talk show host of some rabid pastor are not qualified to dispense medical advice.

I Read, I Write, You Know

“lego ergo scribo”

But

Another Covid-19 Treatment

I try to keep my readers up-to-date on the news around the Covid-19….some of it good….most not so…..like 5.7 million cases and 177,000 deaths…..like I said not so good……

Well we all know that social distancing works and masks help stem the flow of germs…..and Donald the Orange has offered several ways to help prevent even cure this virus……first was some drug that was used to treat Malaria….then we had the drinking of bleach….next was the UV light thing…..then followed up by extract of the Oleander plant…….and now we have yet another treatment to be approved by Trump’s FDA……

President Trump plans to announce the FDA’s approval of a COVID-19 treatment Sunday night—but whether it’s big news or hot air remains open to debate, the Washington Post reports. The treatment is blood plasma from recovered COVID-19 victims. More than 70,000 patients have already received it, and there’s evidence it lowers death rates. But the Trump administration’s praise of the treatment—including the phrase “major therapeutic breakthrough”—is getting a dose of cold water from medical experts. FDA commissioner Scott Gottlieb said Sunday on CBS‘ Face the Nation that the antibody-rich product is “probably beneficial” for people with COVID-19 but is already “widely available,” so FDA approval will make an “incremental” difference.

A New York City specialist went so far as to tell USA Todaythat plasma “has not yet been shown to be effective in COVID-19.” On the bright side, STAT reports that plasma is being widely tested and got a moderate thumbs-up from the Mayo Clinic, which saw a small but noticeable impact on COVID-19 death rates. But that study’s lack of a placebo group made the results less clear. There’s also intense political pressure on the FDA amid a fiery federal election. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

A miracle waiting to appear?

This could prevent deaths of those that have contracted the virus….but we are still looking for that magic vaccine to prevent people from actually contracting the virus.

I Read, I Write, You Know

“lego ergo scribo”