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  • Karen was one of the kindest, sweetest people.

  • I was able to sit down with her

  • and her husband Tom in-person,

  • and just get to know them a little bit.

  • I remember her talking about her favorite color.

  • She was wearing purple.

  • She had a purple bracelet on, purple sunglasses.

  • She was really excited about the possibility

  • of her and Tom being retired recently

  • and being able to do things,

  • but I think the reality was sort of setting in that

  • some of that travel she had thought about

  • might not be happening because she was too sick.

  • Basically a pretty healthy 70 something year old woman

  • surprised to be diagnosed with liver cancer.

  • That was very aggressive.

  • Her doctors were surprised too.

  • When she received the recall notice from her pharmacy

  • she started to put pieces together.

  • If you are taking heart medication

  • as so many Canadians are,

  • you may wanna double check your label this morning.

  • The FDA has expanded the list of drugs

  • being recalled that contain valsartan.

  • A drug recall over cancer concerns

  • as many patients confused.

  • Researchers have linked that chemical to several cancers.

  • 22 other countries have also already recalled the drug

  • for the very same reasons.

  • Karen had been taking valsartan

  • possibly for as long as four years,

  • she ended up dying recently from cancer.

  • They're testing 100% of the drugs

  • that come into this country,

  • is that how it works to keep me safe?

  • No, and I think a lot of people assume that for sure.

  • Everyone is pushing for cheaper drugs.

  • And what this one example shows is that

  • safety is one of the costs.

  • And we don't even know that we're being asked to pay it.

  • My name is Anna Edney.

  • I'm a health policy reporter at Bloomberg News.

  • I wrote the article titled Tainted Pills, Broken Trust

  • with Susan Berfield,

  • who is also a colleague of mine at Bloomberg.

  • Valsartan was a drug and it's used to lower blood pressure

  • which is something many, many Americans use.

  • I mean, the pills they were used by millions of people.

  • It was found that the drug had carcinogens in it.

  • I had followed issues with drug quality

  • for a really long time.

  • And this was sort of one of the worst ones that I had seen.

  • The chemical that had been found in the valsartan

  • the shorthand is NDMA.

  • It's a chemical that used to be used

  • in rocket fuel production

  • and is also now created through industrial processes.

  • It is created when food is smoked.

  • So that's why there's some concern

  • about eating too much bacon.

  • NDMA is also the reason that secondhand smoke is a problem.

  • It's a probable carcinogen that's created in many ways.

  • People who had been taking valsartan regularly

  • as most people do,

  • there was a concern that there could be some connection

  • to cancer of the liver,

  • in particular we knew the end result

  • was a contaminated medicine.

  • And then we began looking backward.

  • When a company files an application for a new drug

  • to the Food and Drug Administration,

  • they've done very large clinical trials

  • looking at the efficacy and the safety of a drug.

  • And these have lasted months if not years.

  • Generics are different though.

  • Generics are the drugs that have gone off patent.

  • The company that did the research into the drug

  • gets a certain 10, 20 year period

  • where they are the only ones who can sell it.

  • Then after that other companies can make

  • essentially copies of the drug.

  • What they have to show the FDA

  • is just that they work in the same way.

  • So they're not really doing these large clinical trials.

  • They're saying we took your formula

  • and we think ours works exactly the same.

  • So it should be fine.

  • Generics are much cheaper

  • because they don't have to bear the research costs.

  • So it become hugely popular.

  • Almost 90% of the drugs that everyone in America

  • is prescribed are generics.

  • The valsartan is the generic form

  • of a drug that Novartis created.

  • It was enormous success for Novartis.

  • Billions and billions of dollars,

  • among the most popular drugs on the planet.

  • When it went off patent, there were a lot of companies

  • that were rushing to create generic versions of them.

  • Over the past years,

  • more and more are being manufactured overseas.

  • That is largely a financial decision.

  • As we know now, labor and and often supplies

  • can be cheaper overseas.

  • There has been so much pressure on the medical system

  • to approve drugs that can be made more cheaply

  • and then to have them sold more cheaply

  • to American consumers.

  • The FDA tests probably less than 1% of the supply

  • that comes into the US every year.

  • And many of our drugs are coming

  • from particularly China and India.

  • And so not much of it at all gets tested.

  • It's a huge industry and the FDA is not all that big

  • and not all that well-funded.

  • And so they ask that the industry

  • keeps up with quality testing

  • that essentially it's up to them,

  • because they're the ones with their names on the line.

  • In China and India, the FDA has found a lot of issues

  • with quality control.

  • Generics don't bring in a lot of money.

  • So any ability to save something here and there

  • with the type of ingredient that you might use,

  • or the process you might use, the incentive is much higher.

  • And so the quality can suffer sometimes

  • when money becomes the bottom line.

  • Zhejiang Huahai was manufacturer of what's called

  • the active ingredient in the valsartan.

  • So they need essentially the part of the drug

  • that has the effect,

  • and then they would sell it to other manufacturers

  • who would kind of finish it with inactive ingredients

  • and the coding that you see so that you can take it.

  • Huahai was founded in 1989

  • and has been committed to supplying high quality medicine,

  • active pharmaceutical ingredients,

  • and advanced intermediates for our customers.

  • Huahai decided to use a solvent that was cheaper

  • than the one Novartis had been using.

  • They wanted to save money however they could.

  • They changed it to a solvent that's called DMF.

  • When Huahai changed the solvent

  • it said that it wasn't a huge change

  • and it landed the FDA but it said

  • that it wasn't a critical change.

  • Just that rephrasing was very important

  • because it would invite less scrutiny

  • and suggested that it was a pretty ordinary change

  • that was done for reasons

  • that were really very crucial to the process.

  • And both of those things proved untrue.

  • It was critical because the ingredients in it

  • reacted with ingredients in valsartan to form the NDMA.

  • One of the hardest parts with reporting the story

  • is that the FDA inspection process is very secretive.

  • So it can be difficult to get the documents.

  • Once you do get them through the FDA,

  • they're heavily redacted.

  • What we found in particular with Huahai is that

  • there had been inspections.

  • And the inspectors had found problems

  • like rusty and old machinery,

  • but more important than that discovered that

  • Huahai had found impurities,

  • essentially kind of in their testing.

  • When a company does quality testing,

  • some of the readouts sort of look like an EKG,

  • like a heart rhythm, they're waves going up and down

  • that are indicating what's in the drug.

  • And so the inspector found these peaks

  • that weren't supposed to be there.

  • The management at Huahai called them ghost peaks,

  • and he indicated that he never heard of that before.

  • He didn't know what that meant.

  • And later it was found out that that ghost peak,

  • what was indicating there was NDMA in the drug.

  • The inspector was worried enough

  • that he recommended the FDA issue

  • what's called a warning letter.

  • And that is the most extreme measure that the FDA can take.

  • And it essentially says putting company on notice.

  • The FDA decided not to do that when it came to Huahai.

  • And again, they said, we've noticed this problems,

  • we'd like you to fix them and report back to us.

  • And essentially nothing was done at that point.

  • So Huahai did not move immediately on the issue.

  • Novartis ordered valsartan active ingredient

  • from Huahai in 2018.

  • The company that had originally made the brand name

  • blood pressure medication was also making generics

  • and had bought 45 metric tons of the active ingredient.

  • It arrived in Switzerland and they began what we understand

  • to be routine testing of it.

  • And discovered some impurities, these peaks.

  • This peak that Huahai had seen, but ignored,

  • and Novartis that didn't look right.

  • And so they ended up trying to identify it

  • and they were able to identify that it was NDMA.

  • Novartis notified Huahai of the problem.

  • They notified the European drug regulators and the FDA.

  • They began recalling the valsartan

  • that was produced by Huahai.

  • At the same time, they started to test other suppliers

  • and began discovering that the problem existed

  • beyond just Huahai.

  • The FDA has expanded its recall

  • of a common blood pressure medicine due to cancer concerns.

  • Potentially millions of prescriptions

  • could be affected by this wide recall.

  • The recall began in the summer of 2018.

  • As we closed the story, the end of 2019,

  • there had been 52 separate recalls.

  • And that's because the testing was ongoing.

  • The recalls continue for other drugs

  • that have NDMA in them.

  • And that's something I think that is not going away.

  • The FDA ultimately developed its own test.

  • The FDA issued a warning letter to Huahai.

  • At the same time are trying to allay consumer's concerns

  • about the risk of developing cancer.

  • Repeating that though the levels of NDMA

  • in the valsartan were high,

  • they weren't really high enough to be concerned.

  • They said like everyone should not be checking

  • to see if they have cancer.

  • And yet there are many, many, many lawsuits

  • that are now in the courts for that exact reason.

  • We know there was this problem.

  • We know there are these people

  • who took the drug who are sick.

  • How closely we can make those connections

  • is something that probably will need to be answered

  • both by medical experts and in the courts at this point.

  • Millions of people took these drugs.

  • The impact I think, will be seen for a long time.

  • Safety concerns obviously there, but they came second.

  • To a lot of people that we spoke to they said,

  • well valsartan and the NDMA that we found in it,

  • that's probably just one example.

  • It's a terrible example because it's a probable carcinogen,

  • but it's probably not the only drug that's contaminated

  • or that will be contaminated,

  • because the system has vulnerabilities.

  • Those vulnerabilities will likely be exploited.

  • And you know, the consequences will be borne

  • by the people who have the least say

  • in how any of this happens.

Karen was one of the kindest, sweetest people.

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