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Thursday 10 October 2019

10 CATASTROPHIC FAILURES OF THE PHARMACEUTICAL INDUSTRY


Catastrophic Failures of the Pharmaceutical Industry
By Justin Crockett,
Toptenz, 9 October 2019.

We place our lives in others’ hands every time we see a doctor or have medicine prescribed for us. It’s an unspoken agreement we’ve entered into, and we’re okay with it. After all, most of us don’t know how to do medicine, unless you’re some kind of village shaman.

We’re also seemingly okay with all the side effects that modern medicine creates. You take a pill for depression, and it can cause suicidal thoughts and…depression. You take a new medication for arthritis and it makes your jaw dislocate. It’s unfortunate but, again, are you going to create a new wonder drug in your bathtub? Probably not. Oddly enough, some pharmaceutical companies have released products that not only seem like they were created in a bathtub, but that were just unsafe to give to human beings. Here are some of the worst offenders.

10. Heparin recall


Heparin is a blood thinner that’s commonly used in dialysis, and to keep veins and arteries free of blood clots. It’s also partially made from pig intestines, so there’s also that. One problem that arose during production of the usually-very-helpful drug was that there wasn’t enough heparin in the United States, so much of it was brought in from China.

Too bad some of it was incredibly contaminated. After quite a bit of investigation, it was found that a Chinese company sent tainted batches to the U.S., causing up to a hundred deaths. What’s particularly disturbing is that the contaminated items passed through several stringent quality checks. Scientists are trying to find a better way to make a kind of synthetic heparin, as the world relies on China for up to 70 percent of the world’s heparin.

9. Elixir antibiotic (led to creation of FDA) - 100 dead


In 1937, President Franklin Roosevelt received a letter from a mother whose child had died after receiving a dubious medication called Elixir Sulfanilamide. It was touted as one of the world’s first true antibiotics. The problem was that there was a poison contained within the mix, called diethylene glycol.

Almost immediately, patients began experiencing everything ranging from nausea to kidney failure, to even comas. 107 patients died from consuming Elixir Sulfanilamide. The man who created it took his own life two years later, devastated from the death toll. If one good thing came about because of the tragedy, it was that a precursor to our modern day Food and Drug Administration was established soon after.

8. 2012 meningitis outbreak from epidural steroids


A Massachusetts compounding facility that made a steroid called methylprednisolone acetate was at the center of a horrific series of events that took place in 2012. The Framingham-based pharmacy put out contaminated product that was used in steroid injections, and at first owned up to knowing about it, putting out a recall on their own in September that year.

That’s when the extent of their culpability became known. They created a $100 million fund the following year to pay victims for their tainted product. 20 states around the U.S. reported contaminated steroids, and over 750 cases of meningitis were reported, directly tied to the drug. 64 people died from the outbreak of the disease. The owners of the pharmacy were among 14 people arrested, and some were even charged with second degree murder. This was after the company filed for bankruptcy and even claimed their cleaning company had a hand in poisoning the batches of medication.

7. Panama uses antifreeze for cough syrup


It was seemingly a noble move for Panama’s Social Security agency to distribute cough syrup to the country’s poor population. But at least 20,000 were passed out to folks without being tested, and a simple mistake of not reading an ingredient could have avoided disaster.

During mixing of the cough syrup, an ingredient called diethylene glycol was added, when the drug makers thought they were using a simple sugar substitute. What they were actually mixing in was a component of antifreeze. Which, most doctors say, is terrible for a cough. And for staying alive. Anywhere between 60 and 300 people died because the makers of the cough syrup mistakenly ordered a wrongly-labeled bottle. And again, all of this could have been avoided if even rudimentary testing had been done on the medication in the first place.

6. The Bextra settlement


Bextra was an anti-inflammatory drug put on the market by Pfizer. The painkiller didn’t last long, though, as people quickly began experiencing heart problems, and there were even reports of a fatal skin condition called Stevens-Johnson syndrome. In 2005, the FDA made the drug maker remove Bextra from stores. But that wasn’t the end of the matter, at all.

Pfizer ended up paying out one of the largest settlements in history for the Bextra fiasco. $4.85 billion for patient injury claims, as well as having to shell out more for fraudulent marketing and other class-action cases. They paid out the mammoth settlement without ever having to admit any wrongdoing, so there’s that.

5. DES estrogen drug


A synthetic type of estrogen that was sold to women in the mid-1900s. Up to 10 million females took it during their pregnancies, in the belief that it would help curb miscarriages. Diethylstilbestrol was touted as a miracle drug to help women carry their babies to term, but instead the estrogen invaded everything, including the blood of the fetuses themselves.

Upon birth, many of these children would have abnormalities in their reproductive organs. Many would turn out to be infertile, and would end up way more likely to develop various forms of cancer. Above all, the very thing DES was created for (to decrease miscarriages) instead increased chances of miscarrying. Armed with this knowledge in 1958, the FDA let the drug be used for another 12 years. They would ban its other use, fattening chickens, before they would take it off the market from human use.

4. Defective breast implants in France linked to cancer


Poly Implant Prosthesis designed and manufactured breast implants out of their France facility, and in fact was one of the world’s leaders in such production. It was when they started cutting corners in their work that the extent of their laziness for an entire decade was discovered.

30,000 women in France and surrounding countries were found to have received defective implants during that time. Instead of medical-grade fillers inside the breast implants, the company had been using industrial silicone, which saved them millions of dollars annually. That same silicone is normally used for computer parts and electronics. Their “savings” also led to ruptured casings which may be causing cancer.

3. Bayer HIV crisis


Hemophilia is a condition where a person’s blood does not clot normally, leading even a tiny injury to turn into a bloodbath. So a medication that helps prevent that would be a godsend. When pharmaceutical company Bayer (try their aspirin!) developed a drug for that purpose in the early 1980s, it looked like it could have been a game-changer.

Unfortunately in the early ’80s, there was also a mystery illness known as HIV spreading around. Bayer found out that the drug had at some point been contaminated with the HIV virus, so in 1984, they began heat-treating the medication to kill it. Thing is, they still had a bunch of tainted medication just laying around. Instead of doing the super humane thing and destroying it with fire, they opted to sell the rest off to poor countries in Latin America and Asia. At least a hundred hemophiliacs in Asian countries wound up with full blown AIDS, and thousands more around the world contracted the HIV virus from the contaminated product. Bayer and others paid out around $600 million for their troubles, but swear they’re “ethical” and “humane.”

2. Fen-Phen


There was a diet pill craze that took place in the ’80s and ’90s, which the FDA kind of silently ignored. The makers of the pills would have to passively state that their products didn’t have the FDA seal of approval, and everyone allowed the ruse to continue.

Fen-Phen was a little different. It promised to end obesity. Doctors went absolutely nuts-butts for the stuff, cranking out 18 millions prescriptions for the drug in 1996. The drug fen-phen simultaneously decreased appetite and made the body burn calories at a faster rate. The trade-off, we found out, was that people’s heart valves became defective. Which is way better than being fat, obviously. The makers of the drug, American Home Products, had to cough up $3.75 billion dollars. 175,00 claims in all were filed against AHP, thought who knows how many actually got paid. And this wasn’t even the company’s first time in hot water with legal settlements and class action suits: they had to pony up $54 million the same year as the fen-phen settlement because of defective birth control devices they sold that had unknown side effects.

1. Thalidomide drug in 1950s and ’60s


You may have heard the buzz word “thalidomide” bandied about when you’ve come across your crazy anti-vax aunt engaged in a Facebook discussion. One key theory in the anti-vaccine movement is that something in the vaccines given to babies causes them to grow up with autism. Thalidomide is often pointed to as one of those ingredients. It’s all also incredibly reckless and untrue, and usually based on the “results” of one discredited gastroenterologist.

Thalidomide itself was actually used in the 1950s and ’60s, as a cure for morning sickness in pregnant women. Whether it worked or not isn’t nearly as important as the fact that it stunted blood vessel development at a key stage for the fetus. Five to nine weeks into the pregnancy is usually when the expectant mothers would take thalidomide, and in tens of thousands of cases, it resulted in astonishing birth defects in the brain and limbs of their born babies. It wasn’t until 1961 when thalidomide was finally discontinued, yet the damage had already clearly been done. If only there was a vaccine to keep drug companies from putting out harmful product to human beings.

Top image: Thalidomide effects. Credit: National Institutes of Health/Wikimedia Commons.

[Source: Toptenz. Top image added.]

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