The Tiny Lab Finding Danger in Your Medicine Cabinet
Summary
TLDRこのビデオスクリプトでは、アメリカの食品医薬品局が再評価を呼びかけた75ブランドの手消毒剤のrecallについて触れています。独立した検査機関であるValisureが、FDAが承認した製品と実際の販売されている製品の間に驚くべき不一致を発見し、多くの問題を明らかにしています。彼らは、検査不足を補うために独自の検査を行っており、多くの問題を発見しています。彼らの発見は、製品のrecallや訴訟につながり、今後も多くの研究と発見が行われる見込みです。
Takeaways
- 🚨 FDAは約75ブランドの手消毒剤をリコールしている。
- 🔍 Valisureという小さなラボが、安全な製品と実際の販売商品のギャップを埋めるために注目されています。
- 🛑 FDAは医薬品の承認面に重点を置いているが、製品品質の実際のテストは独立したテストが行われることが少ない。
- 🏥 Valisureは、独自のテスト方法を公開し、高影響の学術誌で発表しています。
- 💊 Valisureはオンライン薬局に関連付け、独立して検証された医薬品の販売を始めました。
- 📈 Valisureの収益は過去数年で大幅に成長しており、現在は1000万ドル未満から1000万ドル未満に増加しています。
- 🧪 Valisureは、Zantacという薬剤に発がん物質NDMAが含まれていることを発見し、市場からの撤回を促しました。
- 💼 SanofiはZantacの撤回に伴い3億8800万ドルの損失を計上しました。
- 🔄 Zantacは市場から戻ってきたが、活性成分が変更され、PepcidのFamotidineを使用しています。
- 🤝 Valisureは、医薬業界や規制当局とのより協力的な関係を望んでおり、安全問題を解決するためです。
- 🧴 Valisureは、サンスクリーンやドライシャンプー、止汗剤などの個人用品において発がん物質ベンゼンが検出されたことを報告しています。
Q & A
なぜFDAは手の消毒剤の75ブランドを回収するよう指示していますか?
-FDAは、手の消毒剤に安全でないと考えられる化学物質が含まれていると判断したため、これらのブランドを回収するよう指示しています。
Valisureというラボはどのような役割を持っていますか?
-Valisureは、独立したテストを行っていて、医薬品や個人用品に潜む危険な化学物質を検出しています。彼らの研究は、製品の品質管理の欠陥を明らかにし、製品の回収や改良につながっています。
FDAは医薬品の品質をどのように管理していますか?
-FDAは医薬品の臨床品質を担当していますが、実際の製品品質や製造品質は、企業側が自己申告しています。
Valisureが行う独立したテストとはどのようなものですか?
-Valisureは、医薬品や個人用品のサンプルを化学分析し、有害な化学物質の存在を検出する独立したテストを行っています。彼らはその結果を公開し、時にはFDAに報告しています。
Valisureが検出した有害化学物質の例としてあげられるものはありますか?
-はい、Valisureは医薬品のZantacにNDMAというおそらくがんを引き起こす化学物質を検出し、それが市場からの回収につながしました。
Zantacが市場から回収された背景にはどのような問題がありましたか?
-Zantacに含まれる活性成分Ranitidineが、体内でNDMAというがんを引き起こす化学物質に変化することがValisureによって検出され、それが回収の背景にあります。
Valisureの独立したテストが行われる理由は何ですか?
-医薬品の供給チェーンには、独立したテストの欠如があり、Valisureはそのギャップを埋めるために設立されました。彼らのテストは、製品の安全性を高めるために重要な役割を果たしています。
Valisureのテスト結果がFDAに報告されると、どのようなことが起こるでしょうか?
-Valisureのテスト結果がFDAに報告されると、FDAはその情報を基に製品の安全性を評価し、必要に応じて製品の回収を指示することがあり、実際の回収につながることがあります。
Valisureは今後どのような分野で研究を拡大する予定ですか?
-Valisureは、医薬品だけでなく、サンプリングやその他の個人用品を含む、より多くの製品の分析を拡大する予定です。彼らは今後も継続的に新しい研究結果を出す予定です。
Valisureが検出したべンゼンという化学物質は何ですか?
-べンゼンは、血液がんなどと関連しているとされる非常に強いがん物質です。Valisureは、サンプリングやその他の個人用品でべンゼンの存在を検出しています。
Valisureの活動はどのようにして評価されていますか?
-Valisureの活動は、医薬品や個人用品の安全性を高めることに貢献しており、業界や規制当局にとっても重要な役割を果たしています。しかしながら、FDAとの間で調整が必要とされる場合もあるため、コラボレーションが求められています。
Outlines
🧪 Valisureの独立した薬品検査とFDAとの関係
この段落では、Valisureという独立した検査ラボが、FDAとは異なる立場から薬品の安全性を検証していることを紹介しています。FDAは主に医薬品の承認に注力しており、製品品質は自社から報告されるため、独立した製品検査が欠けていると指摘しています。Valisureは、大学で行われるべきだと思われる研究や探偵のように、多くの領域で問題を見つけており、その結果として多くの製品がリコールされています。Valisureは独自の検証方法を公開し、高い影響力を持ち学術誌に発表しています。また、オンライン薬局に関連付け、独立して検証された医薬品の販売を始めたと紹介されています。
🛑 Valisureが発見した医薬品と個人用品の汚染問題
2つ目の段落では、Valisureが医薬品や個人用品(サンスクリーン、ドライシェンプー、止汗剤)において発見した汚染物質について触れています。特に、ベンゼンという強い致癌物质がサンスクリーンなどで検出されたことを強調しており、これは血液癌のような重篤な健康リスクを持つと警告しています。Valisureは、FDAとの間で検証方法に関する議論や訴訟を経験しており、FDAはValisureの独立した検査に協力することを拒否したこともあります。Valisureは、製品に含まれるべきでないベンゼンの検出につながる独自の検査方法を開発し、FDAによるリコールにつながる情報を提供しています。
Mindmap
Keywords
💡食品医薬品局(FDA)
💡Valisure
💡自己報告
💡独立したテスト
💡NDMA
💡ザンタック(Zantac)
💡ベンゼン(Benzene)
💡市民請願(Citizen Petition)
💡医薬品不足
💡独立した検証
💡法的紛争
Highlights
The FDA is recalling 75 brands of hand sanitizer due to safety concerns.
Valisure, a Connecticut lab, is frequently involved in identifying unsafe products on the market.
The FDA primarily focuses on drug approval, with the industry funding much of their operations.
There is a significant gap in the pharmaceutical supply chain regarding independent product testing.
Valisure conducts research and detective work that is typically expected from universities.
Valisure has discovered chemicals known to cause cancer in consumer products.
Valisure's independent testing led to the discovery of the probable carcinogen NDMA in the drug Zantac.
Zantac was taken off the market, leading to a $388 million impairment loss for Sanofi.
Sanofi attempted to reintroduce a safe version of Zantac but ultimately discontinued Ranitidine.
Valisure's testing methodology involves using solvents and heating samples to detect volatile compounds.
Benzene, a potent carcinogen, was found in personal care products such as sunscreen and dry shampoo by Valisure.
Valisure's findings often lead to product recalls and further regulatory actions.
There is a contentious relationship between the FDA and Valisure over testing methodologies.
Valisure aims to add a new layer of independent testing to the pharmaceutical supply chain.
The company is continuously expanding its analysis to cover more products and contaminants.
Drug shortages in the U.S. are at record levels, primarily due to quality issues.
Valisure's mission is to ensure safe and high-quality products for consumers.
Transcripts
You may want to check your bathroom cabinet.
The Food and Drug Administration is recalling 75 brands
of hand sanitizer.
There's a surprising disconnect between what regulators
and manufacturers in the US say is a safe product
and what actually ends up on store shelves.
And in recent years as some potentially dangerous products
get taken off of those shelves,
the name of one tiny lab in Connecticut keeps popping up.
A lab called Valisure.
Now the company Valisure says...
Valisure.
From Valisure, God **** heroes.
The Food and Drug Administration heavily focuses on the
approval side of drugs.
They are funded largely on the drug side by the industry.
And the pharmaceutical industry pays user fees, millions
of dollars, to file a new application to get a drug approved.
There's a huge missing element in the pharmaceutical
supply chain of independent testing.
The actual testing of the product.
The FDA is responsible for the clinical quality
of a product, but the actual product quality,
the manufacturing quality is self-reported.
It's sort of the kind of research
and detective work that I would expect
to be at universities, but it's not very sexy science.
We were quite surprised to see
that we were finding these issues in so many areas.
We're not just talking about chemicals of potential concern,
but chemicals that have been known to cause cancer,
that have been known to cause injury
to patients, to consumers.
I first discovered Valisure about six years ago.
There are labs, say, at universities
and other labs that do work for pharmaceutical companies.
This was different because Valisure was doing it
more independently.
We publish our methods, we publish a lot of details.
We publish in citizen petitions.
We publish in peer-reviewed academic literature of
very high-impact journals because the science is the key.
We started off building out the laboratory
of over a few years
and eventually we were able to attach it
to an online pharmacy that was the first to dispense,
independently validated and tested batches of medications.
A few years ago,
the revenue was less than a million dollars,
and now they're at less than $10 million.
They're growing. I think they want to keep expanding
and keep working with companies like Kaiser Permanente.
That's a big purchaser of drugs.
I would love to have Valisure satellite sites
and laboratories all around the United States, all
around the world potentially.
I've done a few articles on Valisure
and one of the biggest ones was they found a probable
carcinogen called NDMA in a drug called Zantac,
which was taken off the market.
Pharmacies should immediately remove the drug from shelves
and people should stop taking the
medication and throw it away.
This drug was created by GlaxoSmithKline
but by the time it was recalled 40 years later, Sanofi,
a French drug maker, had the rights to sell it.
And so in 2020, Sanofi in their annual report said
that they took a $388 million impairment loss.
Which basically means they could write that much off.
When Zantac was first recalled,
it wasn't just the brand,
it was also all the generics: Ranitidine.
Because the medicine itself forms this NDMA,
everything had to come off the market.
So Sanofi was trying to see if they could bring Zantac back
to the market in some safe way.
And essentially determined, no, we can't do that.
So they brought Zantac back, but they got rid of Ranitidine.
The active ingredient is now Famotidine,
which is the same exact thing in Pepcid.
So they've put out Pepcid and put it in a Zantac box.
It's like nothing I've seen in my
drug-coverage before.
A recall isn't just taking it off the shelves,
but there were people that really feel like they were harmed,
that they have cancer because they took Zantac.
There are a lot of lawsuits weaving their way
through the system currently.
I would hope that at the end of the day, industry
and regulators are grateful at the opportunity
to clean up serious issues that were found.
These are scientific truths.
These contaminations, these safety issues are very real
and that's why there's been a lot of follow up and actions.
We hope that it'll continue to be more collaborative
as opposed to combative in the future.
They also have been doing some testing
of personal care products, so in sunscreen, dry shampoo,
antiperspirant, they found a, actually very potent carcinogen
called benzene, which has been linked
to blood cancers like leukemia.
Now, when Valisure has findings
that they've determined are dangerous potentially
to the public, they usually have them tested
by another lab as well.
Often they've used equipment at Yale.
And then they compile all the information in what's called a
citizen petition. In doing this testing,
they've run into issues at times with the Food
and Drug Administration.
Even when the Defense Department was trying
to get a steady up and running to work with Valisure,
that was another point with the FDA
that caused some contention.
My understanding from sources is that the DOD,
when they were getting this project up
and running, the FDA, did not want them to work with Valisure.
There ends up being a lot
of discussion over specific methodologies.
There ends up being a lot of litigation.
Vast majority of the time, testing is done
by the manufacturers, not by the FDA.
And so we decided we're going to add a new layer
of independent testing to the supply chain.
And that was the very core of Valisure.
The interesting issue with the FDA
and Valisure is when Valisure has submitted information
to the agency that there's something contaminating products,
that's usually followed by recalls.
Alright, so we're going to go through testing
for benzene contamination in hand sanitizers.
We add a standard amount of solvent.
That basically allows the sample to be homogenized.
And then a mixing step.
We call it vortexing.
Make sure that it's a nice and homogeneous mixture.
So when the machine takes the sample vial,
it will heat it up in an oven to 130 degrees.
Then anything that's volatile should go into the head-space.
So we're waiting for the benzene peak to come out. There it is.
This is our benzene peak right here. Yeah.
The source of contamination is benzene and
benzene should never be there.
There is no benzene
that should be allowed anywhere in any product
that you typically consume or apply to your body.
Valisure is always continuing to expand what we analyze for
and the various products that we investigate.
And we do anticipate that there are going to continue
to be studies and findings in the coming months
and potential years.
And we're actually ending up in a situation lately
where there are record levels
of drug shortages throughout the United States.
And the number one cause
of drug shortages are quality issues.
To have realized that there could be some very serious
vulnerabilities in the systems that just weren't addressed,
it was extremely surprising to us as a company
and as individual consumers.
I have five kids.
We use a lot of consumer products like sunscreens,
hand sanitizers, over-the-counter medications,
behind-the-counter medications.
Everybody's mission here is to have safe,
high-quality products for patients
and consumers to use, whether that's industry
or the regulators or Valisure
looking at this from an independent standpoint. I hope
that there will be a lot more collaboration on this into the
future because these are serious issues.
تصفح المزيد من مقاطع الفيديو ذات الصلة
5.0 / 5 (0 votes)