Are Your Medications Safe Just Because They Are Scientific?
Posted on Friday 21 August 2015 and filed under Health: Drugs & Chemicals , Health: General , Highlights , Silambarasu Karuppiah , . You can follow any responses to this entry through theRSS 2.0 . You can leave a response or trackback to this entry from your site
(hla) NO
MATTER how stringent the regulations are for ensuring the safety and effectiveness
of medication, there are always loopholes used by pharmaceutical companies to
mask potential regulatory concerns. Many have the impression that every
medication consumed is safe and effective just because they have undergone many
scientific studies are being overseen by regulatory bodies. However, most drugs
are created to maximise the generation of profits for pharmaceuticals.
For example, Reuters reported that in 2013, Ranbaxy
USA Inc. (a subsidiary of the Indian generic pharmaceutical manufacturer
Ranbaxy Laboratories Limited, India) pleaded guilty to felony charges related
to drug safety and was fined $500 million for selling substandard drugs and falsely
representing various data to the FDA about manufacturing practices at its
plants. It was deemed the largest
drug safety settlement to date with a generic drug manufacturer.
FDA responded by banning import of drugs from all
of Ranbaxy's India-based plants, which is the largest supplier of generic
medicines to the United States, under a wide scrutiny of the country's $15
billion pharmaceutical industry.
Ranbaxy USA admitted to introducing into US certain
batches of adulterated drugs that were produced at its Indian plant in 2005 and
2006. Former Ranbaxy executive Dinesh Thakur blew the whistle on the company's
activity in 2007 when he found Ranbaxy's drugs were made for Americans with "bioequivalence" data that did not
exist or made up. Generic drugs are supposed to prove that they give the same
effect as the brand name. This is known as "bioequivalence".
What this means for the public is that medications can
be potentially harmful products. Imagine taking Ciprofloxacin, an antibiotic
given to treat infections, that is substandard in quality and that it not only does
not treat the infections effectively but even worse, it can lead to resistant
strains of bacteria that will not respond to Ciprofloxacin in the future. This
creates a domino effect. The harm does not stop here! Resistant strains will be passed down to the
future generations as well just because of such unethical practices!
It is not surprising that the said company had
other potential safety problems as well. In 2012, Ranbaxy issued a recall after
finding glass particles in raw ingredients for generic Lipitor. A recall is
when a particular batch(es) of products are removed from being sold to the
public due to potential safety concerns. In the same year, FDA inspectors found
faulty cleaning records and a failure to investigate problems in another
Ranbaxy facility.
Such unethical practices do not stop with Ranbaxy.
Other major pharmaceutical companies have also been found guilty to such
unethical misconducts. How many other pharmaceuticals out there are unethical
and use various loopholes to place profits first? How many have directly or
indirectly died due to such unethical lapses?
There is certainly a need to improvise the system
in the pharmaceutical industry so that such unethical lapses are prevented. The
safety of medications are not truly guaranteed and properly represented despite
their scientific claims and support. It is not uncommon for negative data to be
played down so that they meet the stringent requirement established by
regulatory bodies to proceed with production. Consumers need to be aware of how
such unethical lapses can lead to even their death if it is not contained.
Copyright © 2015 Sandhya Maarga Holistic Living Resources
Holistic Living Annex (AUGUST 2015)
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