SYPHILIS STRIKE BACK – The problem of medicines

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As the world continue to find better ways to treat disease conditions, a study by a group of health professionals, published in the journal ‘Nature Microbiology’ has shown that Syphilis, a sexually transmitted Disease (STD) could be impossible to treat with key antibiotics due to a new drug resistant strain.

Although, Syphilis in times past was regarded as a death sentence, it has become curable with penicillin injections, but a new aggressive strain of the infection has been observed, according to the study, putting concerns on the effectiveness of the known treatment substances.

Syphilis is a highly contagious disease, spreading primarily by sexual activity, including oral and anal sex. Occasionally, the disease can be passed to another person through prolonged kissing or close bodily contact.

While it could also be spread from sores, the vast majority of those sores go unrecognized, as the infected person is often not aware of the disease, and unknowingly passes it on to his or her sexual partner.

Studies have also shown that pregnant women with the disease can spread it to their babies.
This disease, called congenital syphilis, can cause abnormalities or even death to the child.

Of all the sexually transmitted infections, syphilis typically falls pretty low on the list of concern.

HIV/AIDS, HPV, and drug-resistant gonorrhea grab more headlines than an infection most of us consider a relic of history.

You don’t often hear sex ed teachers warning students about a disease believed to have stricken the likes of Vincent Van Gogh and Al Capone.

But syphilis is making a comeback, according to government health officials.

Syphilis is divided into three stages of disease, with the primary and secondary stages being the most infectious.

In 2015, the U.S. experienced the highest number and rate of reported primary and secondary syphilis cases in more than 20 years, according to the CDC.

While Maine’s rate is likewise on the rise, at 2.1 cases per 100,000 residents in 2015 we rank a respectable 44th in the nation for the prevalence of syphilis.

Rates are higher among men, particularly gay and bisexual men, the CDC reports. But the disease is increasingly afflicting women, both in Maine and nationally.

Researchers haven’t pinned down exactly why syphilis is returning.

But men who have sex with men face a combination of factors than can lead to higher levels of STI’s, including barriers to testing such as lack of access to quality health care and stigma, the CDC states.

One CDC epidemiologist told The Atlantic that people might be less vigilant about safe sex now that the threat of HIV/AIDS is less immediate, or that the precautions they are taking aren’t as effective for syphilis.

Condoms, for example, reduce the chances of contracting syphilis, but only when they cover the area where the infectious sore has broken out.

Syphilis is easily treated with antibiotics if caught early, but diagnosing the disease can be tricky.

Known historically as “the Great Imitator” for its ability to mimic other diseases, syphilis begins as a painless sore where the infection has entered the body, often on the genitals or anus or in the mouth.

But it can take up to 90 days after the infection for the sore to appear, so people often don’t know they have it until after they’ve infected others.

In the second stage, a skin rash and other symptoms develop, including a fever, fatigue and sort throat.

A rash caused by syphilis. Source: U.S. CDC

Those symptoms disappear in the third, latent stage of the disease.

If left untreated, syphilis can reemerge decades after the initial infection, leading to brain and muscle damage, blindness, and even death.

Pregnant woman also can transmit syphilis to their unborn babies, a dangerous situation that can lead to stillbirth.

What is the problem ?

Just four companies produce the active ingredient for penicillin – a drug that changed modern medicine 76 years ago – and because the medicine offers little profit, those companies keep production levels low.

As penicillin has been used to treat diseases, such as syphilis and rheumatic heart disease, which disproportionately affect poorer countries, the extent of the demand for the drug also isn’t always clearly captured.

“There is a market failure in the penicillin sector: there is a demand, but it comes from the poor,” explains Ganesan Karthikeyan, a cardiologist at the All India Institute of Medical Sciences in New Delhi, India.

India has the highest number of deaths caused by rheumatic heart disease, with 111,000 fatal cases in 2015, according to WHO Global Health Estimates.

But, despite the number of people affected, the supply of penicillin, the drug that can stop the disease, has been irregular in the country for the past 15 years.

In the case of syphilis, 5.6 million people are infected around the world every year, but that “is a small market from a pharmaceutical point of view,” explains Andy Gray, a consultant pharmacist and senior lecturer in pharmacology at the University of KwaZulu-Natal, South Africa.

The WHO has estimated that a shot of penicillin could have saved more than 53,000 babies from 30 countries who died from syphilis acquired in the womb in 2012.

Another factor that contributes to shortages is the fragmentation of the production process. Most pharmaceutical companies source the raw materials and the core drug ingredient – called API – from other companies, then formulate the final medicine, package and sell it worldwide. So a disruption in one company in this chain can impact the global supply.

Why aren’t more manufacturers producing penicillin?

Three of the four companies that still produce the active pharmaceutical ingredient for benzathine penicillin G are located in China.

These are North China Pharmaceutical Group Semisyntech Co. Ltd, CSPC Pharmaceuticals Group Ltd. and Jiangxi Dongfeng Pharmaceutical Co.. The fourth company is Austria-based Sandoz GmbH.

Risultati immagini per vial of benzathine penicillin G

These companies produce only 20 percent of what they could because benzathine penicillin G is “off patent, offers little profit and because demand data is extremely limited,” according to the WHO.

The medicine’s cheap selling price also makes manufacturers disinclined to enter the market.

With so few producers, drugmakers say they do not have many options when it comes to sourcing the drug’s ingredients.

Two years ago, while Portugal was struggling with a shortage of benzathine penicillin G, Portuguese drugmaker Laboratorios Atral SA turned to China after its former European supplier changed the presentation of the active substance – which Atral says made it incompatible with its formulation process.

Atral says none of the companies they evaluated in China had the full set of documents demanded by the the European Union, such as a certificate of suitability or the Active Substance Master File (ASMF), where a producer details its manufacturing process.

But, with no other options, the European drugmaker assisted the manufacturer in bringing together a package of information in line with EU legislation. Atral says it has audited the Chinese manufacturer, whose name it hasn’t disclosed, to ensure their standards.

“It is not easy. There are a few producers and, of those that are in the market, one is banned and the others don’t have complete documentation,” says Eduardo Oliveira, regulatory affairs director of Atral.

The company’s penicillin brand Lentocilli S is sold to at least five other countries.

South Africa last year also sourced more than 242,000 vials of unregistered benzathine penicillin G from North China Pharmaceutical Group Corp (NCPC), the parenting company of Semisyntech, through an emergency scheme.

Even India, a leading pharmaceutical producer, outsources almost all production of penicillin G to China, according to the Indian Drug Manufacturers’ Association (IDMA). “India became unviable as China’s price is too low to compete with,” says Ashok Kumar Madan, executive director of IDMA.

Global reliance on a few manufacturers can compromise stability of supply as manufacturing delays or failure in one of these sites can affect several countries and millions of patients at once.

Shortages mean sick people are sometimes treated with less efficient and more expensive drugs. According to a 2015 survey with European hospital pharmacists, half said patients were given inferior drugs during shortages.

More than a third said stock outs led to medication errors.

And stock outs are not rare.

“Hospital pharmacists in Europe will usually face difficulties in sourcing a medicine that is not immediately available in their country,” notes Steve Glass, chief commercial officer of Clinigen for North America and Europe, a company that supplies hospitals with medicines.

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