Safety of Medicines

To say that medicines as they relate to public health aren't safe is an obvious statement.
But to avoid the howls of justifications from many quarters, particularly the
pharmaceutical companies, it would be useful to outline one's concerns. The right of
access to modern medicines is also obvious, particularly since our generation has seen the
emergence of sophisticated scientific developments, that can and do make a real
difference to the quality of our lives. Indeed, there are many people who wouldn't be
alive today, had it not been for the availability of modern medicines.

Individuals can rightly expect, to live to an old age, and have access to all of the current
facilities for which they pay, all of their working lives. The public has an absolute right to
expect the highest standards attainable, where matters relating to their health and welfare
are concerned. Why should the public suffer poor controls in drug innovation,
manufacture, and administration? When a patient is treated by the medical practitioner,
it's only to be expected that the medication is appropriate, properly researched, properly
manufactured, and properly tested for safe use. Patients should accept no less than to be
confident that substances being administered have been approved by recognized bodies,
and prescribed by properly trained personnel. It's the professions that cause the problems
that periodically flare up.

The problems that arise seem to stem from a multitude of human factors, that manifest
themselves in all sorts of ways. It appears that commercial pressures upon the
pharmaceuticals occasionally force companies to launch products on the market before
they're fully tested, or in spite of evidence that there are ambiguities or omitted protocols.
Indeed, it's everyday practice for manufacturers to make and sell medicines, knowing that
they can do harm patients.

One can accept that from the commercial point of view, the manufacturers will release
products they produce as soon as they can satisfy the specified criteria. But from the
patient's point of view, nothing but the fullest range of safety tests will do. The individual
is the recipient of the product, and all is well for the majority of patients who show no ill
effects from the administered medicine. But for those that are mutilated, maimed, or
murdered by the medication, any procedure that could have prevented the injurious
effects is essential practice.

The number of medicines that are being produced for consumption is very large. Even as
a student of chemistry, it was difficult to understand how the tens of thousands of
products that are being churned out by the chemical industry, and used daily by the
population, can be properly tested and ascertained 'safe for use'.

It's distressing to hear of underhanded commercial pressures being applied, by the

pharmaceutical companies. These companies make enormous profits, and the commercial
bribery that is said to go on boggles the mind. Most doctors seem to be fed up with the
constant stream of commercial inducements to specify this medicine, rather than that. The
pharmaceuticals' policy of bombarding doctors with advertising literature, gifts, and
incentives to prescribe given medications, is driven by greed to make more money rather
than good practice. Extensive publicity is given to drugs that have emerged from research
facilities, and vast sums are spent upon advertising pharmaceutical products.

It does seem that substantially more money is spent on business consolidation of new
medications, rather than upon research, development, and testing. Most certainly, patients
who have to pay for their medications don't welcome the ever increasing cost of
medicines that they must have, in order to maintain their quality of life. Not many
patients would begrudge paying a sensible overhead for the development of medicines,
but to be paying for the commercialisation of innovated medications causes a great deal
of resentment.

To deprive whole populations of the benefits of modern medicine, by raising the price of
medications in order to cover commercialisation costing, is unacceptable. It's not clear
how companies can continue to justify prohibitive cost. Poor societies will no doubt
simply copy the formulations and make their own, because theft of intellectual property is
not a criminal offence. The business of protecting intellectual property rights on a global
scale is a nightmare quagmire, that only the financially secure venture into. Policing theft
of formulations will be almost impossible.

Doctors say that all medicines have side effects, but the pharmaceutical industry remains
undeterred, and continues to release medicines that at times have devastating effects upon
patients. From thalidomide and antidepressants, to the cox-2 inhibitors, the trust that
patients put into professional standards can result in individuals paying a huge personal
cost

For professionals to adopt practises that are manipulated by commercial pressures is

deplorable and there is a case for preventing pharmaceutical companies from having
direct contact with the prescribers of their products. Prescription guidance should come
from authorities that have independent facilities, to trial and assess medicines. Only then
should prescribers be advised of the merits of any given medication.

For small research facilities, with restricted resources, the release of new information is
almost impossible. My own research into enterococcus faecalis, first encountered some
30 years ago in a histology lab, is typical of a small, under-funded project that had neither
enough money to test the initial findings nor the contacts to independently test the work
in hand. The work was abandoned, restarted, abandoned, and restarted again on several
occasions. No journals accepted the meagre research for publication, and disturbingly, it
was still possible only quite recently to buy yoghurt in supermarkets to which
enterococcus faecalis was added at the production stage.

Enterococcus faecalis is a microbe that causes long term inflammation of tissues and
therefore must weaken the immune system but the possibility that it might actually
succeeding in transferring its genetic material to host cells during an inflammatory phase,
generates immense interest. The most surprising thing about this coccus, is the speed with
which it adapts to antibiotics. Some years ago, a severe gastroenteritis was treated with a
new antibiotic called ciprofloxacin, 500mg three times daily for five days. The infection
causing the food poisoning was eradicated, and the worst of the symptoms cleared up,
leaving a disgruntled alimentary system that was on two separate occasions diagnosed as
irritable bowel syndrome.

Not knowing the cause, the specialist gastroenterologist shrugged their shoulders, and
sent the patient home. Two years of private follow-up investigation resulted in the
microbiologists identifying a heavy contamination of enterococcus faecalis, that was
resistant to ciprofloxacin. As far as the patient was concerned, the treatment for the
original food poisoning was the one and only time that the patient had been exposed to
ciprofloxacin, which meant that the enterococcus faecalis become resistant to this new
antibiotic in one five-day exposure to this medicine.

In retrospect, the antibiotic was the treatment of choice for the gastroenteric problem,
correctly prescribed by the doctor. Eventually, the enterococcus faecalis was eradicated,
the gut settled down, and the irritable bowel syndrome was no more.

Science should take a close look at the genus enterococcus and its isolates because it is
capable of pathogenicity and depending on where in the body it is hosted, as to the
symptoms. The battle to reclassify enterococcus faecalis as a pathogen goes on to this
day.

This example demonstrates how dangerous medications can be, and clearly exemplifies
the need for an urgent reappraisal of prescription procedures. It seems that the medical
profession is, above all other agencies, the greatest culprit in the emergence of multiple
antibiotic resistant strains of microorganisms. And it seems that existing treatment plans
are, in effect, the cause of the explosive spread of multiple-resistant microbes.
Medications specified by the pharmaceutical manufacturers for treating a given factor
create problems that, in the long term, promote the evolution of organisms that kill
patients.

A serious problem exists, and what's needed is a separate body that specifies use of
emerging, for example, antibiotics, and will take into account exposure to microbes
known to be quickly adaptive to environmental factors. Prescribing treatments at the
expense of creating multiple-resistant strains of known pathogens is counterproductive,
and administering medications in the presence of contaminants that have a longer lifespan
than the treated microbes, promotes the evolution of drug resistant strains. Administration
of medications is a complex business requiring extensive effort to prevent the
development of multiply antibiotic resistant strains of microbes.

(Contribution to a discussion on why the Enterococcus Faecalis should be reclassified as

a pathogen).