I was reading through the FDA website and found interesting that many products have recalls. Many times the company will decide to remove a product that's harmful or defective from the market, or in some instances, this is requested by the FDA. However, some products will still be available in developing countries. I think the reason is most likely to be the lack of law enforcement. Some of the most common drugs that are only available in India are Nimesulide and Furazolidone. They are banned in the US because they have side-effects on the kidneys, liver, and nerve. I think in India there is unawareness, and corruption, as someone mentioned above, it's easier to pay off to officers to get different types of medication.
https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/ucm612550.htm
I don't know much about drugs being banned in different countries but available here in the United States, but I have some experience with ingredients that are banned in certain countries. I work for J&J consumer R&D and when we are developing a new product we have to make sure that the ingredients we use will be considered safe in any country we want to sell the product in. The most common country I have run into issues with is China. They take a long time to qualify and raw materials that J&J has developed in house. I believe that since we are not a dedicated supplier who's only drive is to sell raw materials too companies then they scrutinize our raw materials more closely. This has meant that whilst we can release a product under one formula in North America and Europe we have to change the formula for China.
I think this all comes down to the mentality of the governments. Every government is different and will place different values on the different properties and side effects that certain drugs will have. I also think governments will make choices based on the benefits versus the detriments. Say a company creates a cure for Alzheimer's, and it has the side effect of high blood pressure. Well then I'd like to think every government would approve that because high blood pressure can be easily managed. But if the side effect was highly damaging to another system in your body then it is up to the government to decide whether or not that drug is worth it. I think that is the root cause of why some drugs are allowed in certain countries.
Interesting topic and replies. In my research on this topic, I was surprised that India is one of the countries that still use, sell, buy many medicines that are banned in other countries due to safety and regulation issues. Japan and UAE were the two countries that are very strict in allowing random medicines to enter their countries. I was not able to find a good list of drugs banned in the US but allowed in my country. However, in Saudi, until a few months ago, it was legal and easy for anyone without even an ID to get antibiotics from the pharmacy. It can be sold without any prescription. Recently this rule has been changed. Selling FDA approved Over-the-counter (OTC) antibiotics, that is illegal in the U.S, caused a lot of health issues and complications as in many cases it was unnecessary to take since the bacteria infection is not confirmed yet.
In the 1950s there was a pharmaceutical company (Chemie Grunenthal) created sleeping pills from thalidomide. It was advertised as safe for everyone to use, including pregnant and nursing mothers. The drug gained popularity fairly quickly and spread from West Germany into the UK.
The company also wanted to sell the drug in the US, but Dr. Frances Oldham Kelsey continually denied them. She didn't believe there was enough data to back the claims that the company was making. In the early 1960s, it was discovered that the drug was teratogenic (causes issues in fetal development).
I am perfectly fine with the US not following other countries standards when it comes to allowing drugs to enter the market. I will expand upon jz365 and manolo's point. One of the best examples I can give is Thalidomide as a sleeping pill. Post world war two, sleeping pills became a big hit, for obvious reasons (after seeing unimaginable horrors, it was hard to fall asleep on your own) . It became commonly used all across Europe, and was marketed as being safe for all (including pregnant women). In the US, thalidomide wasn't allowed by the FDA because of Dr. Frances Oldham Kelsey. She wanted more clinical evidence. She stuck to it, even under incredible pressure to allow it on the market. Soon after, a wave of severe birth defects hit the nations who allowed the drug. Thalidomide was found to be the reason why. Over 10,000 children were born with severe birth defects. This is why the FDA needs to have scientists who won't be swayed by pressures, mostly political and financial. More importantly, the FDA needs to be independent from other countries own regulatory agencies. The FDA must run it's own studies and experiments, because trusting that other countries will do it properly is asinine.
[1] http://broughttolife.sciencemuseum.org.uk/broughttolife/people/franceskelsey
I had done some research into oncolytic virotherapy. That is the use of genetically modified viruses to treat cancer. I had come across a story of Ruslan Isayev who traveled to Latvia for a drug called RigVir. He went from having only seven months to live to living at least four more years, to my knowledge. This drug is not approved in the United States and you might ask why? Because the success rate was less than 50% in 2010. With the Capitalism and healthcare in America, a lot of people would have access to this drug and only 50% would survive. While some look at it as "glass half full", the government and the FDA don't.
That drugs are banned in the US but not in other countries does not necessarily make drugs in the US safe. They, in fact, could be downright dangerous. Take the statin drug, for instance, an MIT research scientist has shown that it destroys muscle systems while trying to stop cholesterol production despite the fact that cholesterol is a vital component of particles needed by the body. It has been known to lead to Myocardial Infarction (heart attack). Basically, drugs are actually there to help nurse the coffers of the physician and the drug designer. To get any one of the off-the-counter drugs one must visit a physician - often referred to as MY DOCTOR'. This give the physician the right to bill the patient's insurance company, while the pharmaceutical company makes gains from the sale of the drug; meanwhile, the patient may only derive relieve from use of the drug and then later return to the pharmacy for more drugs. In sum, much money is spent for no cure. To effect cure in any aspect of the body, only natural treatments must be given; I,e by that, I am referring to treatments that will not be rejected by the hormonal system which watches out for safety of the body. No pharmaceutical drugs are tolerated by the immune system; hence, reaction against drugs. In effect, all pharmaceutical drugs should be banned everywhere. Natural cures are known to exist: a physician in New York City effects cancer cures using specially conditioned hormones; Dr. MacMakin in Portland Oregon uses Specific frequency Modulation to address diseases creating problems for tissues of the body; So, all pharmaceutical drugs should be disallowed to enter the sales arena.
On the reverse side, one drug banned in other countries but not the US is Soma (carisoprodol). It's a muscle relaxant that treats pain and stiffness from muscle spasms. While it's still prescribed in the US today, in Europe (especially in Norway) it is banned as it started to be used recreationally. The urgency in banning it was due to how addictive the drug is and how strong the withdrawal effects are, which could often be compared to the addictiveness of Oxycodone as well as its withdrawal effects. Nowadays however, in light of this, most people are prescribed other muscle relaxants that are less general and more specific to the actual pain areas.
Levamisole is a medication used to treat parasitic worm infections, and more recently, colon cancer. While it is on the World Health Organization's List of Essential Medicines, it has been discontinued in the US since 1999 for unknown reasons. One reason may be as a result of its use as an cutting agent for cocaine, mostly in the US. The majority of illicit cocaine seized by the DEA is laced with the medication, and found in most cases of seizures resulting from an overdose. I believe this was the case of the government responding to a humanitarian issue with a ban and crackdown of the drug, which has also limited further research of the other potential medical uses of the drug.
This response is somewhat related to the question above but to change perspectives a little bit. Why do you think in the majority of countries drugs that are meant for ADHD are banned(Korea and Japan to name a few). To be more specific Korea is known for having a high ban on drugs if it has a little bit of addictiveness regardless of the medical effectiveness. Do you guys think that if the drug has high medical effectiveness but one of the side effects is addictiveness does it actually out way the risk? Also, this could be vice versa is that some drugs are banned in the US wherein other countries they are used to treat other medical conditions that are known to be effective. Let me know what you guys think.
There are many such drugs like that. For instance, DISPRIN( a non-steroidal anti-inflammatory drug) is banned in US since 2002 as it can lead to severe vomiting and drowsiness, medically known as Reye’s syndrome. But the drug is available in India and is used very commonly as painkiller primarily for headaches. There are many more drugs like that which are banned in the US but available in other countries, eg, Vicks VapoRub, Thioridazine, etc.
My concern here is not drugs banned in the US but used in other countries. Instead, it's drugs banned in other countries but in wide-use here, like Ritalin and several opioids. In terms of restrictions and safety protocols, the FDA in the US appears to be the gold standard in ushering in products to the market that do not pose significant risk to consumers. However, that appears to be changing, because there are an increasing number of drugs and food additives that other nations have banned, but are still commonly used in the US.
Although its approval process is the most stringent, many argue that the FDA is slow to act when a product has adverse side effects until a significant number of people die. Many have also argued that the FDA is tainted by a conflict of interest when its directorship and key board members are filled with former executives from big Pharma who they are supposed to be regulating. (I for one who be more comfortable with the majority of this body being comprised of scientists, sprinkled with end users and consumers.) The argument basically contends that the FDA is reluctant to pull products, because it is more concerned with the profitability of industry giants than with the well-being of consumers.
Apparently, with most OECD-member countries, they may be slower on approvals and less administratively sound, but they seem to be more proactive in responding to consumer concerns. Specifically with food additives, genetically-modified products and popular psychotropic drugs and opioids, Europe, Canada and other parts of the world have banned many categories of products that are commonly accepted in America. Interestingly, India is NOT an OECD member, which might partly explain why it is considered "rogue" with allowing some drugs that are banned in the US.
The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services . India has its own Enforcement agency called The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices .As we saw in the video the regulatory rules are different in different countries .And also there is India FDA office to overlook the import of drugs from India .The above drugs may have gotten approval from the Indian enforcement agencies but have not passed the US regulatory rules .
https://core.ac.uk/download/pdf/190389524.pdf
The study linked above explores drugs withdrawn in the US versus other countries and found that out of 151 drugs the authors studied, 67% of them were banned in the US compared to 79% banned internationally. Reasons for this discrepancy may include differences in US policy, monetary benefit that drug companies/government get from keeping a drug on the market. An example of a drug banned in the US but available outside the US is pergolide (Permax), which is a dopamine receptor agonist used to treat Parkinson's disease. It was removed from the US market in 2007 due to increased rates of vavular dysfunction that were associated with using the drug. However, Pergolide is still used in the UK and Australia to treat Parkinson's disease.
Yeah, absolutely, some countries have have regulations that are more strict than the US and for that reason some drugs or devices banned in other countries are actually deemed safe in the US. For example: Sudafed is available in the US but banned in Japan.
Just a small interesting story: I had interesting experience with the Korean FDA. After a successful audit, one of the auditors noticed a fly trap near the entrance of our building. At the end of their audit, he recommended we keep track of the bugs caught in the trap and look for a trend. While it was not an official recommendation, it was interesting that of all of the auditing bodies, the Korean FDA was the one to ask about a trend analysis and then to recommend it. 🙂
