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Medicine: Made in the USA
Joanie at her latest open-heart surgery
“The supreme art of war is to subdue the enemy without fighting.” –Sun Tzu
I am blessed to have four of the brightest, cutest, most fun-loving nieces God had the mercy to bestow upon me. But one – I’ll call her Joanie – holds a particularly special spot in my life. Joanie was born with a genetic defect that affects her heart. My brother and his wife knew before her birth she had a very serious heart defect. She had a faulty valve and a hole in her heart’s wall that required surgery immediately following birth.
After being in Neonatal Intensive Care for the first months of her life, she came home and slowly grew — as did her heart. She underwent two more open-heart surgeries to ‘upgrade’ the artificial valve as she outgrew it. Each time she bounced back like only a capital ‘T’ troublemaking, rambunctious child could. She proves the adage that boisterous, unruly kids are payback to their parents for their own childhood bad behavior (of which I know my brother is guilty).
I bring up Joanie because I saw the anguish and fear in her parents’ faces as she underwent yet another surgery, another trip to the hospital, and again this past week when she went to the emergency room due to coughing up blood during a bout of pneumonia. As scary as it is for this small child to undergo these serious procedures, it brings into focus how fortunate we are to have advanced medicine and talented, knowledgeable doctors to save the life of this child who, only decades earlier, would not have survived infancy. But what if the life-saving drugs and vaccines we rely on were compromised – or worse – disappeared at the hands of a malicious foreign power?
Over the last few decades, America’s foreign policy has dealt with many grave threats: Cold War Russia and the Communists, radical regimes in the Middle East, terrorists in Africa and South America, Russia (again). But the nagging threat that lurks menacingly like a Cheshire cat is China. The Communist regime made bold headlines recently for its brutal suppression of pro-Hong Kong demonstrators and the leaking of documents detailing the horrors of underground prisons and “reeducation camps” for minority groups, and is even suspected of harvesting organs.
China’s military is seeking control over the South China Sea through development of thousands of acres of reclaimed islands. Chinese nationals have been caught and convicted of stealing intellectual property and, on January 6, two Chinese national students studying at the University of Michigan appeared in the US District Court of Southern Florida for entering Sigsbee Annex Naval Air Station in Key West to photograph defense installations.
Between trade wars and diplomacy skirmishes are the things the Cheshire cat hides behind his smile. It’s millions of Americans being held hostage by the thousands of life-saving drugs made in China. With the rise of globalization, drugs such as the anticoagulants my niece relies on for her heart surgeries, antibiotics, antidepressants, cancer drugs, blood-pressure medication, even birth-control pills have essential ingredients made in China and sold in the United States.
A new report from the US-China Economic Security Review Commission stated that China’s pharmaceutical industry is “not effectively regulated by the Chinese government,” putting the American public at risk of exposure to contaminated and dangerous medicines. This nightmare became reality as documented by Rosemary Gibson in her book China Rx, a clear-eyed but terrifying look at pharmaceutical manufacturing in China.
A contaminated batch of heparin made its way from unregulated factories in China to hospitals all over the country including children’s hospitals like the one where Joanie was treated. Reports poured in of life-threatening drug reactions. Due to quick actions of the CDC and FDA, the toxic batch of heparin was identified, but not before hundreds of injuries and four deaths.
Gibson recounts the episode:
Heparin, a blood thinner, is used in kidney dialysis, surgery, and critical care to prevent blood clots that can trigger a heart attack or stroke. Twelve million seriously ill people need it every year, and [Illinois-based Baxter Healthcare Corporation] controlled about 50 percent of the market. “We wondered what we were going to do if all of it was recalled,” Dr. Edward (infectious disease specialist at Children’s St. Louis) said. “We looked at each other, and the blood drained out of our faces.”
We have a grave situation in which a nation who is at best a cunning foe in the fight for supremacy in our age of globalization and, at worst, a maleficent enemy actively undermining the United States and our allies in a quest for global domination. When such a force floods the market with medicine we need to survive, shouldn’t we be concerned with the quality of that medicine? Shouldn’t we demand to know where the active ingredients in our drugs are manufactured and by what standards? Shouldn’t we have the means to ensure we don’t rely solely on a nation that means to do us harm to provide vaccines to citizens and our military men and women? We talk a lot about energy independence, what about pharmaceutical independence? It would be nice if my husband could rest assured the infusion he needs every eight weeks at the VA to treat his Crohn’s Disease was both available and safe.
I know being manufactured in America doesn’t guarantee safety, but I would like to be informed about the origins of the drug, perhaps on a label. The FDA finds room for every warning that can fit in a lawyer’s pocket, surely they can fit “Manufactured in ____.” A few years ago, there was a massive recall of tainted pet food that was manufactured in China and sold in the United States by American companies. Hundreds of pets died from the food. I work at a small pet store (not my ideal, but if I was smart and talented enough, I’d be writing every day instead) and still get questions about where food, treats, and toys are made. “Not China” is the desired answer — and for good reason.
If we are this concerned about our pets’ well-being, shouldn’t we also be about the health of our parents, spouses, and children? We demand to know where dog food is made and if it will be available when we need it. We should be more so about the drugs and medicines that keep our families alive, especially when the supply we rely on comes from a country whose actions signal hostile intent.
Published in Healthcare
Drug ingredients from China is a frightening thought. There are very few I take, but I’d like to know that I’m not at risk of dying. Best wishes for little “Joanie.” It must be so hard for all of them–and you.
All the more reason to disengage from China until they resolve their ethics problem in manufacturing.
My middle daughter has visited China several times and has friends there, or did. On one visit they went out for breakfast in Shanghai. Her friends advised her to avoid the fluffy looking muffins she was eyeing. The bakers put detergent in them to make them that fluffy.
We’d need to resurrect our defunct drug manufacturing operations. I assume it is a monopoly situation in which the Chinese drug manufacturers make the drugs cheaper than American manufacturers. I don’t know that that is something consumers have any control over no matter how many times we ask for U.S.-made drugs.
To change this, it would have to start in the halls of the insurance companies and the offices of Medicare and Medicaid.
Are there American-made alternatives to these drugs?
I wonder what alternatives exist.
Generally, consumer reports and reviews (reputation) are sufficient quality control. If a company sells bad or even harmful products, and consumers learn of that, then the company loses its customers.
A century ago, that company could just move to a new market and sell its faulty product with a fresh reputation. But today information abounds.
Minus regulation, a company can afford to offer an unproven product and appeal to more daring consumers who, for want or need, are willing to take a greater risk for something new (hope) or cheaper.
Regulation adds expense (which is translated into higher consumer prices) and time (meaning, for example, someone desperate to try a new medicine might not get that chance) to development, let alone distribution and sale.
You raise an important dilemma. But I’m not sure regulation is the solution. It might be that such drugs could be made more reliably and cheaper in America if regulations didn’t increase the costs. Or China might simply have natural resources we don’t, in which case the American corporations importing the drugs could take responsibility for verifying quality.
There will be lapses of quality control with private companies. But government isn’t perfect either. At least the former is subject to repercussions.
Is India also a malicious foreign power?
India is the largest global supplier of generic medicines, exporting over 60% of its bulk pharmaceuticals, mostly to Russia and the US. India’s industry has had some quality-control issues, but its affordable products overall seem to do a lot more good than harm, and India pharma manufacturers are open to FDA inspection. Some argue FDA inspection in India has become lax, though if so, fixing that is not a problem outside US control.
Are you interested in where the finished pharmaceutical was assembled, or on the provenance of every ingredient used in the manufacturing process? The latter is considerably harder to track and label than the former.
The American FDA has played a role in stifling drug development and manufacturing. The Clintons destroyed the vaccine industry in the US. Hillary, in one of her thoughtless interventions nationalized vaccines and that result is still being felt in price and shortages.
It’s almost impossible to get decent info on vaccines on the internet, as hysteria ahs pretty much gtaken over, but the Clintons, probably Hillary, established a national program that drove most US manufacturers out of the business. Here is a web site with some of the info but you have to ignore the autism GMO nonsense.
https://eraoflight.com/2019/05/06/bill-clinton-clinton-foundation-hillary-clinton-vaccines-pharmaceuticals-measles-masterminds-millions/
I can’t clip the unbiased parts of the article but the info on the national vaccine program is pretty accurate.
This should be Easy to fix. Really, reaaaaally easy.
Just forbid the importation of drugs except from, say, Switzerland and Israel, effective 1/1/2021. By November we will have a new generic industry.
But don’t let Senator Manchion get involved.
Thank you @susanquinn J is a little spitfire and my hope is the first 6 years of her life are by far her most challenging!
Important information. And I think you strike on a crucial point: all the information hidden from us-the end users of these drugs. And I’m not surprised in the least that a Clinton could have a hand in hiding information… 😉
It would do us well to at least know where the raw materials for pharmaceuticals are coming from. The heparin example I draw from stemmed from lax oversight of pig slaughter needed for the drug. I think if faced with the choice of a life-dependent drug or vaccine coming from China or say India, people would be more likely to choose to latter, and hopefully over time pharmaceutical companies would pick up on that.
Here’s the problem – the FDA does inspect foreign factories, but it has no power there. As Midge noted, you need good manufacturing not just of the medication, but of the ingredients involved in the process of making the medication and turning it into something edible.
For example, lots of chemistry students make aspirin. This would need high quality salicyclic acid and acetic anhydride, along with a safe synthesis of Aspirin. Now you need high quality pharmaceutical grade inert ingredients to make it into tablets.
Sourcing all of those safely is a challenge, to say the least.
Is this the WV senator Manchin? I don’t know of his involvement, can you point me to some sources?
Thanks
So we can put a man on the moon, and bring forward computer advances no one thought possible 60 years ago, but cannot reliably know if the drugs we take are safe or not.
Somehow I am not buying that. If there was an actual will inside Big Pharma, there would be a way.
I never said it was impossible, Carol. It’s just not as easy as just saying where the pills are made. You need even more detailed recordkeeping for each component of the pill, and where the stuff you used to make that came from. Inferior Chinese replacement parts that fail to meet spec are a problem for national laboratories and NASA, by the way.
And please drop the Big Pharma conspiracy line – the expensive, brand-name drugs that are still under patent are generally made under tighter controls, since losing a major cash cow to a recall is a big loss, and they are the only group making the compound. Even if they are driven solely by profit, they are driven to help us get good quality drugs by the one-two punch of regulation and profitability. Big Pharma is actually more vulnerable to lawsuits than Chinese and other foreign drug manufacturers.
I’ve been thinking about this post: it can’t be a good thing for us to be dependent on foreign countries for most of our life-saving pharmaceuticals. I had no idea how much of our pharmaceutical supply was imported. It seems to me that that’s a whopping vulnerability in terms of national security.
Can I say something that sounds a bit harsh, even if I don’t mean it to?
Many of us Americans dependent on life-saving pharmaceuticals, including those made overseas, aren’t really vital to national security: should the supply chain be interrupted and our deaths result, that would be tragic, of course, but not really a national-security threat.
Yes, America would lose some productivity, though probably not as much as would be lost by the death of completely healthy Americans, since even the wonders of lifesaving medical care can’t usually make those who need care to survive and function as productive as they would be if they were completely healthy. American security doesn’t require saving all of us, if it came to that. If we get to the point where international supplies were totally cut off (and even in war that’s an extremity, since we have allies), then hopefully America would still have the backup capacity to manufacture the medicines necessary to keep functional the military and intelligence personnel who’d be dead or incapacitated without them. But the rest of us? Our plight would be more a tragedy than a threat.
Absolutely. It would not be a threat to national security for one or a few people to die because their medicine was tainted or suddenly unavailable. But on a large scale, it would be.
My daughter is a veterinarian, and when she was in vet school, there was a major pet food recall that hit every single pet food company in the United States. That was because all of the pet foods contained an ingredient that all of them obtained from a single supplier in Canada. It was a minuscule component of the pet foods, but it was in all of them.
Carrie and I explored the idea at that time of writing a book together on how to make your own pet food. We never did anything with it, but I learned a lot while I was getting a tentative outline together. :-) Most importantly, I got to thinking about the human food supply.
I would feel better if there were some American companies still in operation that were making medicines. I am uncomfortable having our populace so dependent on foreign countries’ good feelings toward us. :-)
This has always been an argument against monopoly–that monopolies make consumers dependent on them. This is why it has never been a good idea to export all of our manufacturing to foreign countries. We really need to know how to build a car and have a facility in which to do so.
Sure, but I was making the stronger point: that even on a fairly large scale, civilian deaths may be a tragedy and a cost to productivity, but still not a national security threat.
Obviously, if the large scale is large enough, civilian deaths would threaten national security, too. But it’s possible to imagine large-scale, tragic civilian death that’s still not much of a national-security hazard.
It could be a war-instigating issue. I don’t know where the tipping point is, where wars start because one country killed a large another of another country. Is it 4,000 or 5,000? I hope someone at the Pentagon is making such calculations for worst-case scenarios.
There’s also just the pure dependency issue. If their factories go out of business for some reason, it would be nice to think Americans still had a few medicine factories to work with. There’s expertise and experience needed that I would like to think we still have.