Dietary supplements are not controlled in the same way as medicines. The lack of oversight in people puts the health of the consumers at risk. People ought to be a little careful when taking dietary supplements.
This is because all dietary supplements available in the market are not safe. Proper idea is necessary to take the right supplement at the right time. This will not put the life of an individual at risk.
Calvin Jimmy Lee-White was very small. He took birth on 3rd October 2014 and was two months premature. He weighed just 3 pounds and was hardly the size of a butternut squash. Treating infants this small requires adhering to certain standards.
Doctors at the Yale-New Haven Hospital, Connecticut followed these standards for treating the baby. The doctors placed the baby in an incubator for regulating the temperature of his body. The incubator also kept germs away.
They offered surfactant medicines to promote the lung development of this premature infant. However, right from the first day of Calvin’s life, the doctors also gave the infant a regular probiotic.
Probiotics are liquids, pills or powders made of live bacteria. They help maintain the natural balance of the body’s gut microorganisms. There are many NICUs or neonatal intensive care units that offer probiotics to preemies in the recent years.
They do this based on the fact that they can be of good help in warding off dangerous intestinal diseases. There are many doctors who are concerned about this trend. Probiotics do not have to be held to the same regulatory standards as OTCs or prescription drugs.
This is because probiotics can serve in the form of dietary supplements. The producers do not have to obtain the approval of FDA or Food and Drug Administration for selling their products. Their facilities are also not policed in the same way as the pharmaceutical firms.
The NICU at the Yale-New Haven Hospital chose a safe product. The product was manufactured by a seemingly popular and large company. It was marketed especially for children and infants and was available at all drugstores throughout the country.
Anyways, Calvin struggled a lot. He developed bulges in his abdomen. Surgery revealed that Calvin’s intestines were infected by an uncommon fungus. This infection quickly spreads from his intestine to the blood vessels causing multiple blockages.
The infection reached his aorta and resulted in clotting. He dies on 11th October, just 8 days old. Post this event; the government authorities conducted a sorrowful investigation. What was the root of the fungus? How did the fungus get into Calvin’s premature body?
The answer to the above question is that the probiotic given to Calvin was contaminated. Tests were conducted by FDA on the unopened containers of the same batch of probiotic offered to Calvin. The tests suggested that the probiotics in the containers had the same fungus that infected Calvin’s intestines.
Several lots of this product called an ABC Dophilus Powder were brought from drug stores and pharmacies through the US. These were made by Solgar- a reputable supplement manufacturer. The Lee-White’s filed a court case against Yale-New Haven Hospital and Solgar.
They claimed that Calvin had been poisoned repeatedly and they were not warned about the risks connected with probiotics. The family’s lawyer, John Naizby says, “As offered, the dietary supplement did not just fail to eliminate a dangerous intestinal infection. It actually caused a dangerous intestinal infection.
Through email, Solgar reported to the Consumer Reports that it carried out a complete investigation on the matter. The investigation also included the Centers for Disease Control and Prevention (CD) and the FDA.
Solgar reported that it did not find any complaints in the supply chain. The contaminated samples were found in the ones delivered to the FDA from the pharmacy of the Yale-New Haven Hospital. The hospital did not comment on this. However, concerning baby Calvin’s death, the FDA came up with a statement advising the doctors.
The statement advised the doctors to be extra cautious when using supplements that contain live bacteria. This goes especially when such dietary supplements are used in people with weak immune systems. It further said that evidence for the safety of that particular approach was inadequate. Further clinical trials were necessary for this field.
The issue is not related to just one contaminated probiotic. Supplements- minerals, vitamins, botanicals, herbs and other natural substances have come from the vitamin aisle. They have migrated into the mainstream medical industry. Hospitals are no longer including dietary supplements in their list of approved medicines.
They are into opening their very own supplement stores online and on-site. Doctors are also practicing the same method. As per the Gallup review of around 200 physicians, 45% have suggested herbal supplements. 94% have advocated minerals and vitamins to patients. However, there are 7% physicians suggesting supplements and even selling them in offices.
People are buying these products in large number. As per the Nutrition Business Journal, the sale of supplements has increased by around 81% in the last ten years. This is because supplements are easier to purchase in comparison to prescription drugs.
Apart from this, supplements also carry the image of being safer and more natural. They come with labels promising to tackle health problems. They serve as easy solutions for many problems.
There is Garcinia Cambogia for a smaller waistline. Yohimbe is better for improved sex experience. Creatine would offer bigger muscles and Omega-3 fatty acids are for boosting the brain. There is ginseng for increased energy levels.
It is quite difficult to say what amount of these products are risks to the users. The GAO or Government Accountability Office conducted a study in 2013. This report suggests that from 2008 to 2011, the FDA received around 6, 307 cases of health issues from dietary supplements.
This included a large number of life-threatening problems and 92 deaths. It also included over 1000 serious illnesses and injuries. The GAO suggests that because of underreporting, the real number of such problems might be greater.
The real tally might probably be smaller in comparison to the portions of supplements purchased and used. However, there is no reliable method of telling whether a particular supplement is completely safe. Thus, the fact remains that the supplements are not being controlled the same way as medicines.
Peter Chen, MD, an assistant professor of medicine at Harvard Medical School says, “The promoted ingredients of various supplements are dangerous.” He has extensively studied supplements and has even written papers on this problem. He is the view that supplements are dangerous because of the way they are regulated.