UK seizure of £15.8 million worth of counterfeit and unlicensed medicines and devices

Today (18 June) The Medicines and Healthcare products Regulatory Agency (MHRA) announced that a staggering haul of fake and unlicensed medicines and devices have been seized across Britain as part of an ongoing global operation.

The huge haul totals around £15.8 million and the seizures represent the biggest to be recorded in the UK. The types of drugs to be counterfeited include massive amounts of the usual suspects that are often imitated; erectile dysfunction and slimming pills, in addition to anaemia and narcolepsy tablets. Fake condoms and unlicensed foreign medicines were also seized.

The MHRA instigated the ‘Operation Pangea VIII’ initiative with INTERPOL, carrying out a series of worldwide drug raids during the week of 9 and 16 June, leading to 156 arrests in numerous different countries.

In news that comes as a delight to Medical Specialists®, after ourselves publishing several articles on how to spot an illegal website/fake ‘pharmacy’, Operation Pangea VIII also involved the shutting down of illicit websites that were duping customers with falsified, counterfeit and unlicensed medicines.  These websites were hit with a closure or suspension by removal of their domain name or payment facility.

Closer to home the MHRA enforcement officers joined forces with local police to conduct raids on known suspect addresses across Britain, addresses connected to the illegal online supply of potentially deadly medicines.

This led to a seizure of nearly 6.2 million doses of falsified, counterfeit and unlicensed medicines in the UK, 15,000 of which were found to be medical devices that had an estimated total value of £15.8 million. Thanks to UK operations, 1,380 websites were shut down, 339 being domestic sites.

MHRA Head of Enforcement, Alastair Jeffrey, said: “Operation Pangea is the global response to internet-facilitated medicines and devices crime. As a result of our intelligence-led enforcement operations we have seized £15.8 million worth of counterfeit and unlicensed medicines and 15,000 devices in the UK alone – which is almost twice as much as we recorded last year, and clear evidence that this is a growing concern that has to be taken seriously.

“Criminals involved in the illegal supply of medical products through the internet aren’t interested in your health – they are interested in your money and are able to get this by selling you a potentially dangerous product, or by stealing your bank details. To protect your health, visit your GP, get a correct diagnosis and buy medicines from a legitimate high street or registered pharmacy which can trade online.”

Most of the products seized in UK were imported from overseas, with India, China, Hong Kong and Singapore being the main countries in question.

With crooks always looking at new means to target potential customers, this has resulted in the MHRA investigating YouTube accounts and videos – leading to over 320 videos being taken off the site.

On a more global scale, regulators and custom officials analysed almost 150,000 packages and seized in excess of 20.7 million doses of unlicensed and counterfeit medicines, worth about £51.6 million.
Alex Lawther, from Border Force’s postal command, added: “Border Force regularly detects and seizes illegal and restricted products imported through the postal system including fake and unlicensed medicines. Our involvement in this operation with the MHRA demonstrates our commitment to combat this form of smuggling. Our message to the public is simple – don’t buy anything online unless you are certain it comes from a legitimate source.”

Quit smoking for 15 years…and it could be like you had never smoked!

All smokers take note: new research has shown that those successfully quit smoking for a sustained period of 15 years, can massively decrease the chance of suffering with heart failure or even dying.

U.S. Scientists made the remarkable discovery that people who stopped smoking almost two decades previously, had a comparable risk to those that had never smoked before.

Despite the findings clearly being a positive for all smokers across the globe, heavier smokers – i.e. those that had gone through at least a packet of cigarettes each day for 32 years or more – still had a slightly increased risk of health problems.

However, lead researcher Dr Ali Ahmed, from the Washington DC VA Medical Center, is pretty clear with the message…people either need to cut down on their smoking, stop smoking as early as they can, or simply never start smoking.

He commented: “While all individuals who quit smoking will benefit from a decreased chance of death, to achieve the full complement of health benefits of smoking cessation of one who has never smoked, smokers need to smoke less and quit early, and for those are not smokers – never start smoking.”

The findings were extracted via the most recent data from the Cardiovascular Health Study, which comprised of 2,556 people that had claimed to never smoked, 629 present smokers and 1,297 previous smokers. Every participant in the study was aged 65 or over, and 312 of the previous smokers admitted to heavy cigarette usage – smoking at least one pack daily for 32 years or more.

After a 13 year follow-up evaluation, the proportion of never smokers and previous smokers who had suffered heart failure, was found to be 21% in both groups. Within the group of former smokers that had consumed one pack per day for at least 32 years, nearly 30% suffered heart failure.

Comparison of mortality risks among present smokers and heavy smokers to never smokers was an interesting find. Researchers accounted for factors such as age, sex, race, education, other health conditions and medications, discovering that present smokers were around twice more likely to die from other diseases in comparison to those that had never smoked, and previous smokers were found to be 26% more likely to die compared to the never smokers.

Dr Ahmed told Reuters: “When one smokes, it induces atherosclerosis, or the buildup of plaque in the arteries. However, when one quits smoking, the buildup of plaque and risk of blood of clots decreases, allowing one’s cardiovascular risk to return to normal over time.”

Atherosclerosis is the medical term used when a person’s arteries have become narrower and harderned, usually caused by a high level of ‘bad’ low-density lipoprotein (LDL) cholesterol.
Statins like atorvastatin (Lipitor) and rosuvastatin (Crestor) are currently taken by around 7 million people in Britain, and work to decrease rates of LDL cholesterol by reducing the production of LDL cholesterol inside the liver. It is dangerous to have high rates of LDL cholesterol as this causes the atherosclerosis, resulting in a higher risk of heart attack, stroke and coronary heart disease.

Female Viagra drug Flibanserin on the cusp of FDA approval

Since Pfizer’s male impotence wonder drug Viagra first burst onto the scene an incredible 17 years ago, it was subsequently joined by Eli Lily’s Cialis and Bayer’s Levitra by 2003.

Over the next 12 years the industry has witnessed variations on these such as the lower-strength Cialis Daily tablets for the more ‘active’ male and Levitra orodispersible tablets – especially suitable for men who aren’t comfortable with swallowing pills, wanting to take it with some discretion and without the requirement of a glass of water.

Men also have the options of the newer erectile dysfunction treatment Spedra (Avanafil) or Vitaros cream – ideal for men that have not experienced success with the aforementioned PDE5 inhibitor tablets or cannot take PDE5s for medical reasons.

If all that wasn’t enough choice, men suffering with premature ejaculation have over-the-counter premature ejaculation treatments such as Stud 100 Spray, condoms containing benzocaine like Durex Performa (to prolong climax), whilst there is also prescription medication such as Priligy, which is taken orally and works to prolong a man’s sexual performance by an average of 200% to 300%.
Simply put, men are spoilt for choice when it comes to finding the right treatment option for sexual dysfunction, whether this be for persistent impotence or premature ejaculation problems.

So, what is there for women? If Medical Specialists® Pharmacy were to quiz our thousands of patients to come up with the name of an existing female sexual dysfunction treatment, we’d be surprised if anyone could muster a reply.

In early 2014 Medical Specialists® reported how British pharmaceutical company ORLIBID were developing a drug tentatively titled ‘ORL101’, aimed at boosting a woman’s sex drive, however no further information has been released about ORL101 since then.

However, Medical Specialists® are delighted to announce that a new pill to boost a woman’s libido could be one step closer after US experts gave its endorsement. This will be fantastic news for those that have fought for women’s sex drives to get a similar medical attention to deal put into it as the male treatments.

A panel of Food and Drug Administration (FDA) advisers decided to vote 18-6 in favour of recommending flibanserin, a daily pill nicknamed the ‘female Viagra’ and manufactured by Sprout Pharmaceuticals, who picked up the drug back in 2011 after its initial developer, Boehringer Ingelheim, decided to drop it.

The vote came following a testimony from various women who vigorously persuaded the agency to approve the drug and told of their fear of never being able to have sex again. The final judgement of course will have to come from the FDA themselves, with a verdict on suitability for public use due later this year.

Coincidentally, flibanserin, just like the discovery of Viagra, was an unintended find. The drug was firstly developed with the intention of treating depression, but wasn’t as effective for this purpose as expected.

Many of the 11,000 women involved in the trials did note that they were experiencing some rather unexpected side effects from the flibanserin. Increased sexual interest and overall, more satisfying sexual experiences than previous, were being commonly reported.

North Carolina drug maker Sprout Pharmaceuticals, have claimed that their clinical trials have demonstrated that women have experienced a 37% rise in sexual desire in comparison to a placebo. The women reported an average of between 0.5 and one more sexually satisfying events each month, compared to those women taking a placebo. In addition, they had higher scores on questionnaires on desire and scored lower on questions about stress.

The drug – which changes brain chemistry as opposed to Viagra increasing blood flow – isn’t without a chequered history though, with the FDA twice rejecting the drug since 2010, arguing flibanserin’s benefits did not outweigh the risks, which can include low blood pressure and fainting spells.

However, Susan Scanlan, chairwoman of Even The Score, hit back and noted that Viagra can have varying side effects, arguing that the FDA hasn’t approved flibanserin because of their discomfort with women taking control over their sexuality. “The implication is that men can be trusted to make a rational decision of risk versus reward and women can’t,” she said.

The FDA has highlighted female sexual dysfunction as one of 20 priority areas of unmet medical need, and is obviously a major and genuine health problem that needs to be addressed.

Keep checking the Medical Specialists® NHS Pharmacy website for further updates about flibanserin or other female sexual dysfunction products that may become available in the future, and we already have an extension range of male impotence and premature ejaculation treatments, some of which were mentioned earlier.

Lazy Brits are not exercising enough, study finds

New research has painted a damning picture of Britain’s adults…Almost half of us are simply never doing any exercise.

The British Heart Foundation carried out a study and made the alarming discovery that a shocking 44% of adults do not engage in any form of moderate-intensity exercise, meaning British activity levels are shamefully amongst the worst across Europe.

An estimated five million adults are sat down for over a third of the day (8 hours), whilst around one in ten Brits say they are never walking anywhere for more than ten minutes at a time.

Britain is three times less active than our Dutch counterparts over in the Netherlands and overall ranks at a dismal 16^th place in a table of 28 European countries for fitness levels. This means we are on an equal inactive level with Slovakia, Romania and Ireland.

According to the NHS physical activity guidelines, adults aged 19-64 should be aiming for at least 150 minutes (2 hours and 30 minutes) of moderate-intensity aerobic activity per day to stay healthy, which includes cycling or fast walking every week and muscle-strengthening exercises on two or more days each week that are making all the main muscle groups work. However, less than a third of women and less than half of men are actually reaching 150 minutes of the moderate-intensity exercise.

The study has resulted in further warnings about an increasing problem of obesity, which needs to be properly tackled sooner than later.

Catherine Kelly, director of prevention, survival and support at the BHF, commented: “The figures are a worrying indication of the overall picture of our nation’s heart health.

“Alongside funding research into improving outcomes for heart patients, we need to create environments that make it easier for people to better understand and cut their risk of heart disease.

“Research has shown that even making small, more active changes to your daily routine can improve your heart health.

“With the warmer nights and lighter evenings, the summer is the perfect opportunity for people to start making these changes.”

The new worrying statistics were amassed by researchers at Oxford University, who analysed previously conducted national surveys covering exercise levels and sedentary behaviour.

The surveys show that a mere 10% of UK adults are involved in a sport or physical activity on a regular basis or physical activity. This is in comparison to a slightly better rate of 15% in Sweden, Spain and Slovenia. In addition, 9% admitted to never walking for over ten minutes at a time.

In 2014, NHS officials warned that an insufficient amount of exercise could be attributed to around one in six deaths – i.e. fatalities from conditions such as cancer, stroke and heart disease, this is comparable to the death rates from smoking. They stressed that inactive lifestyles are not only to blame for obesity, but for problems such as muscle and joint complaints, depression, high blood pressure, heart disease, dementia, stroke and type 2 diabetes.

Male impotence drug Viagra makes it hard for Malaria to spread

The hugely popular erectile dysfunction medication Viagra (sildenafil citrate) has been taken by men all around the world for over 15 years to help stiffen erections for sex, and it seems this very stiffening prowess has been found to be the key element in aiding a decreased risk in the transmission of the mosquito-borne malaria parasite Plasmodium from humans to mosquitoes. In turn, this would then prevent a further passing of the virus to other people.

The findings have been laid bare in a study conducted by the London School of Hygiene and Tropical Medicine in collaboration with the CNRS, INSERM, Université Paris Descartes at the Institut Cochin and the Institut Pasteur.

How the malaria transmission can be blocked through then use of Viagra was explained by study co-author David Baker, Professor of Malaria Parasite Biology at the London School of Hygiene and Tropical Medicine.

He said: “In this new study we show that Viagra, a drug shown to be safe in humans, can make the sexual forms of the malaria parasite stiff.

“This causes them to be inactivated in the spleen and so prevents transmission of the sexual malaria parasites to mosquitoes. This is an interesting proof of concept which gives us hope that new drugs could be developed that specifically target the malaria parasite phosphodiesterase enzymes and block malaria transmission,” he added.

Plasmodium falciparum is one of the parasites that triggers the infectious, and sometimes deadly disease malaria. This parasite isn’t always easy to treat, with experts believing the single celled organism is evolving to become more resistant to the most commonly prescribed antimalarials. It is this reason why researchers continually look for other ways to fight the disease.

The parasite develops in a person’s red blood cells, which are emitted by bone marrow into the blood stream. Should a mosquito bite somebody that is already infected, it will extract some of the parasites within the blood and there is a risk that the mosquito could then infect another person by biting them.
As the blood circulates, stiff, old or abnormal blood cells are taken in by the spleen, with the healthier normal cells left to travel around. With the Viagra though, the infected red blood cells are taken in by the spleen – meaning they are not available for mosquitoes to get after biting someone. Sildenafil maintains a signalling pathway within the red blood cells, which results in the molecule cAAMP becoming more concentrated and the cells stiffening.

So far, tests have only been conducted using test tubes and there will need to be carried out with animals. If those show signs of success the next trials will need to involve humans before any medication can be approved for the use of malaria prevention.

Obesity crisis could be worsened by our drinking habits

The European Parliament will decide in the future if all alcoholic drinks should be sold bearing the calorie content of the drink printed on its label.

Experts have argued that many drinkers are completely unaware of the amount of calories in the drinks they are consuming, and that the listing of calorie content on all drink labels is vital to try and put a halt to the increasing problem of obesity.

Calorie content for food items is already printed on labels, but most alcoholic drinks are currently from this policy. Any drinks that contain over 1.2% of alcohol by volume are currently exempt from EU regulations on nutritional labelling that came in to force in 2011 covering all food and soft drink.
However, later today MEPs will deliberate on the issue and come to a conclusion on whether or not calorie labelling for alcohol drinks should be implemented or abandoned. If the proposals are voted in favour of, it could still be several months or even years before such proposals become fully-fledged legislation.

Glenis Willmott, MEP for the East of England, is strongly supporting the plans for mandatory alcohol labelling, highlighting the fact that many European countries are amongst the heaviest drinkers in the world.

She said: “Europe is still the heaviest-drinking region in the world but many people don’t realise that a large glass of wine contains the same number of calories as a slice of cake.

“In order to reduce the burden of alcohol-related harm, we must make sure people are given clear information to enable them to make informed choices.”

The debate on labelling calorie content on alcoholic drinks comes in the same week a study was published in the British Medical Journal (BMJ) on the connection between alcohol intake and obesity.
Professor Fiona Sim, chairman of the Royal Society for Public Health, argued that a recent growing trend of places such as bars and restaurants of serving much bigger glasses of wine and drinks comprising of a higher alcohol content is hindering the efforts to control an ever-growing obesity epidemic.

In the report published in the BMJ, Professor Sim says that for adult drinkers, roughly 10% of their daily calorie is derived from alcohol.

In the BMJ Dr Sim commented how a recent survey by the Royal Society discovered that around 80% of the 2,117 adults involved in the survey were clueless to the calorie content in most of the common drinks at pubs.

Moreover, the majority of those quizzed didn’t actually know that alcohol was included in the total amount of calories they consume, but positively, most agreed with calorie content being shown on drink labels.

However, it is clear that alcohol is certainly playing an important role in our increasing waistlines, and Dr Sim says: “Hardly anyone interviewed seemed to know much about the calorie content of alcoholic drinks, and most wanted more information. It is impossible to ignore our failure to deal with obesity. Daily, in clinical and public health practice, we see its cost to individuals and society. Drinking alcohol is common and, in excess, harmful. To what extent do the calories consumed in alcohol contribute to the obesity epidemic?”

Viagra gang who netted £10 million are given massive prison sentences

A counter drug gang consisting of twelve people managed to rake in a staggering fortune in excess of £10 million, a court heard earlier this week.

Under the guise of a nationwide mail-order fishing tackle company, the gang – which comprised of six people alone from northern Lincolnshire – flogged suspiciously low priced male impotence pills, apparently offering them either over the internet or selling them in person.

The phony pills could have resulted in “catastrophic damage” to the public due to the fact that fake Viagra tablets have previously been found to contain a variety of toxic substances such as acid, brick dust and road paint, Judge Charles Wide QC told the Old Bailey as he sentenced the gang.

A former married couple seemed to be the pioneers behind the operation, with a northern branch ran by the Thailand-based husband and his wife in control of the daily UK operation. Members of their family were also hired to successfully continue the illicit dealings.

A number of ‘front’ companies were formed that claimed to be selling items such as jewellery, fishing tackle and cosmetics in order to take-in electronic transactions, and the crooks then laundered the money through over 100 different bank accounts. In total, the exact amount of laundered money or that obtained by fraudulent means was undetermined, but estimates pit the proceeds at more than a staggering £10 million – raking in as much as £60,000 each week.

Prosecutor Gillian Jones told the Old Bailey: “This case is not about wanting to distribute good medicines cheaply, but rather the motivation was greed, with an utter disregard for patient safety.”
The court was told that the illegal dealings spanned for eight years from 2004, with those behind the scam carrying on even after being arrested on September 20, 2011. The arrests came after an investigation by the drugs regulatory body, MHRA (Medicines and Healthcare Products Regulatory).
“The medicines that were seized which were purported to be Viagra and Valium, in fact, turned out to be counterfeit,” said Miss Jones.

“This was big business. The proceeds of the supply of these medicines, via websites which have been traced to various merchant facilities, is in excess of £10 million – that is not the real figure. Not all bank accounts have been identified.”

The money was transferred into bank accounts ran by those either directly involved in the conspiracy or members of their family, and was then either withdrawn in cash or put back into the business to keep it running.

Miss Jones continued: “They purported to be trading fishing tackle, cosmetics or jewellery, but they were just a front to hide the real merchandise which was unlicensed medicines. As demand grew, the customer database widened to countries including Sweden, France and Germany.”

After the banks began raising questions about transactions going through the accounts, the gang then craftily opened accounts offshore in Belize and Panama.

Last Monday, the crooks paid the penalty however for tricking the public by selling the dangerous fake erectile dysfunction drugs, and drugs for other apparent purposes.

A 42-year-old man from Brighton was given a massive 17-year prison sentence for being the main man in the scam and found guilty of offshore money laundering. The judge also jailed a 45-year-old man from Crayford, Kent, to four years, describing him as the middle man of the operation. He was found guilty of money laundering, conspiracy and selling or distributing counterfeit goods. Other members of the gang were also slapped with sentences totalling several years between them, proving that crime doesn’t pay and will catch up with everybody eventually.