Tag Archives: pharmaceutical

Britain loses medicines contracts as EU body anticipates Brexit

Britain’s leading role in evaluating new medicines for sale to patients across the EU has collapsed with no more work coming from Europe because of Brexit, it has emerged.

The decision by the European Medicines Agency to cut Britain out of its contracts seven months ahead of Brexit is a devastating blow to British pharmaceutical companies already reeling from the loss of the EMA’s HQ in London and with it 900 jobs.

All drugs sold in Europe have to go through a lengthy EMA authorisation process before use by health services, and the Medicines & Healthcare products Regulatory Agency (MHRA) in Britain has built up a leading role in this work, with 20-30% of all assessments in the EU.

The MHRA won just two contracts this year and the EMA said that that work was now off limits. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman.

In a devastating second blow, existing contracts with the MHRA are also being reallocated to bloc members.

Martin McKee, the professor of European health at the London School of Hygiene and Tropical Medicine, who has given evidence to select committees about Brexit, said it was a disaster for the MHRA, which had about £14m a year from the EMA.

The head of the Association of British Pharmaceutical Industry said it was akin to watching a “British success story” being broken up.

Mike Thompson, the chief executive of the association, said: “Clearly we’ve all been incredibly proud of the MHRA’s role over the last few years. They’d established themselves as one of the most respected regulators across all of Europe and industry. It’s been a British success story.”

The EMA said that because of the long lead-time involved in assessing medicines it could no longer award the lead contracts to British people since there was no guarantee they would be part of the EU after March 2019.

It is understood the MHRA bid for 36 EMA contracts this year but were only awarded two, and these were for drugs for which evaluation had already begun.

The situation is a stark contrast to 2016 when the UK was the lead assessor, known as the rapporteur, on 22 applications, and was joint lead or co-rapporteur on 19 multinational applications.

This made it the number one in Europe, with Germany’s regulator behind with 22 lead contracts but only 12 co-contracts.

…..

An MHRA statement said:

“We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. This involves us making sure our regulators continue to work together, as they do with regulators internationally, and we would like to explore with the EU the terms on which the UK could continue to participate in the EMA.”

 

more on this story here

 

 

Trusting the “medical” system?

This five minutes could be the most important for your health & honest statement spoken about the medical “industry”.

 

 

The full two hours debate here

Super session in the 2-hour European Parliament meeting on Thursday – so many issues raised by Dr. Aseem Malhotra, MEP Nathan Gill, Sir Richard Thomson, Professor Hanno Pijl and Sarah Macklin. Now edited with HD footage and clear sound. Let’s get the message out – MEP Nathan Gill and Aseem reckon a million views would be a great goal – only if it gets shared like hell !

To allow doctors to be honest and give best advice for our health, the medical and pharmaceutical industry needs transparency and movement away from profit orientated business and poor medicine.

Over 33,000 prescription tablets recovered from drug disposal bins

Over 33,000 prescription tablets have been recovered in the last year from special drug disposal bins, UTV can reveal.

They have been hailed a major success in the battle against prescription drug abuse.

The huge haul of prescription medication recovered by the PSNI in west Belfast was not through a drugs bust, but safely disposed by members of the public in special drug bins.

The PSNI has hailed the scheme a success.

PSNI Inspector Clare McClelland said: “Ultimately it’s such a danger if these items fall into the wrong hands.

“Anybody who is in possession of unwanted drugs, be that prescription medication or illegal drugs can dispose of them anonymously, these bins are then emptied by ourselves and subsequently the items will be destroyed.”

First set up eight years ago, the bins ensure unwanted prescription tablets don’t fall into the wrong hands.

There are now 25 of them in various locations across Northern Ireland.

Most are in Belfast in places like shopping centres and community hubs, locations with a high footfall to allow for a degree of anonymity.

In terms of how beneficial they have been, the figures speak for themselves.

The latest recovery brings the total number of tablets safely disposed of to over 150,000 since the bins were set up in 2010.

http://www.itv.com/news/utv/2018-07-17/33-500-prescription-tablets-recovered-from-drug-disposal-bins-in-ni/

Starlings on Prozac? Fish on contraceptives!

As drugs – both legal and illegal – pass through us, they enter the UK’s waterways. But can this really lead to a change in the feeding habits, and even the sex, of wildlife?

Most people go to a music festival for the music, the mud and the social scene. But at this year’s Latitude festival Dr John Ramsey and Dr Bram Mizeres have come for the urine.

Bottling up the goods from festival urinals might not sound like cutting edge science, but it can provide a glimpse into our pharmaceutical lives.

The drugs that end up in our urine also make their way out into our waterways, with some startling effects.

Last year over a billion prescriptions were dispensed in the UK, along with a huge number of over-the-counter remedies. More medication is being taken than ever before and with an ageing population this trend is not likely to slow down any time soon.

But what is the fate of these drugs as they travel beyond our toilets?

Intersex fish

At Brunel University, Prof Sumpter has been studying the effects of pharmaceuticals in our waterways ever since intersex fish – male fish exhibiting female traits such as egg production – were first spotted in UK rivers in the 1990s.

He and his colleagues wondered what was in the water that could be causing such radical change.

“At a biochemical, molecular level, a fish is extraordinarily similar to you and I,” he explains.

“So almost every drug target in a human – receptors, enzymes, ion channels – is present in fish. And they do the same thing.”

As drugs – both legal and illegal – pass through us, they enter the UK’s waterways. But can this really lead to a change in the feeding habits, and even the sex, of wildlife?

Most people go to a music festival for the music, the mud and the social scene. But at this year’s Latitude festival Dr John Ramsey and Dr Bram Mizeres have come for the urine.

Bottling up the goods from festival urinals might not sound like cutting edge science, but it can provide a glimpse into our pharmaceutical lives.

The drugs that end up in our urine also make their way out into our waterways, with some startling effects.

Last year over a billion prescriptions were dispensed in the UK, along with a huge number of over-the-counter remedies. More medication is being taken than ever before and with an ageing population this trend is not likely to slow down any time soon.

But what is the fate of these drugs as they travel beyond our toilets?

Intersex fish

At Brunel University, Prof Sumpter has been studying the effects of pharmaceuticals in our waterways ever since intersex fish – male fish exhibiting female traits such as egg production – were first spotted in UK rivers in the 1990s.

He and his colleagues wondered what was in the water that could be causing such radical change.

“At a biochemical, molecular level, a fish is extraordinarily similar to you and I,” he explains.

“So almost every drug target in a human – receptors, enzymes, ion channels – is present in fish. And they do the same thing.”

As studies into intersex fish developed, researchers soon amassed evidence that hormones from the contraceptive pill in the effluent from sewage treatment works were responsible.

Two decades on, our wastewater treatment has improved and most scientists suggest the majority of intersex fish can still breed without difficulty. But the contraceptive pill is not the only pharmaceutical making its way to our waterways.

Starlings on Prozac

Prof Sumpter now focuses on the effects of anti-depressants on fish.

Like synthetic sex hormones, anti-depressants dissolve in fat rather than water. As a result, they enter the bloodstream of organisms exposed to contaminated water.

This can affect other wildlife too, including birds. Dr Kathryn Arnold from the University of York has been studying the effect of Prozac on starlings, a number of which feed on the worms, maggots and flies found at sewage treatment works.

These creepy crawlies, living happily on the abundance of food found at the treatment works, contain high levels of pharmaceuticals, especially Prozac.

To study the effects this might be having on starlings, Dr Arnold and her team confined wild birds to aviaries and fed them on Prozac-laced worms, with the research to be published in October. They found that these birds ate less overall, snacking throughout the day instead of having full meals.

“And it’s all these small, very subtle effects that build up and potentially compromise an animal in the wild,” Dr Arnold says.

As yet, the science is at an early stage. Although the evidence seems to be mounting that laboratory-controlled, environmentally-relevant levels of micro-pollutants can have behavioural effects on fish and birds, only a small number of studies have tried to look at these changes in animals in the wild.

Dr Arnold and her team intend to start measuring the levels of Prozac in wild starlings’ blood this winter.

“So we’ve done what many researchers in this area have done, we’ve kind of tried to do things in a controlled environment, in the lab,” Dr Arnold explains.

“I guess the question that a lot of us are asking is, well, what does it mean for a normal healthy bird or fish in the wild to be consuming anti-depressants, or anti-psychotic drugs?”

Monitoring disease outbreaks

Such emerging evidence makes it all the more important that we know what is actually in the water.

Dr Barbara Kasprzyk-Hordern, an analytical chemist at the University of Bath, uses urine samples to provide near real-time data into levels of drug use.

“In the case of MDMA,” explains Dr Kasprzyk-Hordern “there will be spikes during the weekend because it is a club drug. While, when we look at heroin, its use will be stable throughout the week because it’s a very addictive drug.”

Dr Kasprzyk-Hordern thinks this technique will also be able to monitor populations for outbreaks of disease.

“Usually when we test for certain diseases we use urine,” she explains. “Why do we have to collect urine from every individual, why not look at wastewater?”

Just as an individual’s urine can help assess their risk of developing certain forms of cancer, Dr Kasprzyk-Hordern hopes that by analysing a wastewater treatment plant it may be possible to identify areas with a greater incidence of cancer and target them with increased patient screening.

Full article

https://www.bbc.co.uk/news/health-29108330

further reading

https://www.health.harvard.edu/newsletter_article/drugs-in-the-water

Adverse drug reactions – (NICE)

Assessment

  • Assess the nature and severity of the reaction.
  • This will determine whether urgent action is required or whether the person can be managed in primary care. For example, a cough due to an angiotensin-converting enzyme inhibitor can be troublesome but not life threatening, but an anaphylactic reaction is a medical emergency.
  • The nature of the presenting condition may strongly suggest that it is an adverse drug reaction (ADR). For example, the following conditions are often ADRs:
  • Acute dystonias
  • Blood dyscrasias
  • Skin reactions, such as Stevens–Johnson syndrome and toxic epidermal necrolysis
  • Neuroleptic malignant syndrome
  • Take a history of the presenting symptoms, including:
  • When it started:
  • The time from when use of the drug was started to when the reaction develops may be characteristic of the reaction (for example anaphylaxis usually develops within a few minutes of parenteral drug administration).
  • If the drug was stopped, the time it took for the reaction to abate will often be related to the known duration of action of the drug.
  • Relationship to dose:
  • ADRs are often dose related and may be minimized by reducing the dose of the drug.
  • If the symptoms resolve when the drug is withdrawn, they may have been associated with the drug, although it could still have been coincidental.
  • If a drug is reintroduced and symptoms recur, the drug is most probably responsible for the adverse reaction. However, deliberate re-challenge is only very rarely justified (clinically and ethically) after serious ADRs, because of the risks involved.
  • Other possible causes:
  • The symptoms may be a manifestation of the person’s underlying illness or another disease.
  • Other medications (including self-medication and herbal remedies) could be responsible.
  • Consider the possibility of drug interactions (including with food and drinks).
  • Consider the drug history, and review any history of allergy or previous ADRs.
  • Take a complete drug history, including when the drug was started, what dose is being taken, what other drugs are being taken, and whether the person is also taking over-the-counter (OTC) or herbal medicines.
  • Check whether the person has ever had similar symptoms or presentation in the past with other drugs (from the same or a different drug class) or has a history of atopy or of ADRs with different presentation(s).
  • Be aware that even if a drug was stopped some time before the ADR, it may have been responsible if it has a very long duration of action (for example amiodarone).
  • Review the adverse effect profile of the drug and consider:
  • Whether the signs and symptoms are in keeping with the documented adverse effect profile of the drug.
  • Whether the ADR been reported before. This can be checked in the readily available sources of information, including:
  • The British National Formulary (BNF).
  • The electronic Medicines Compendium (www.medicines.org.uk).
  • Interactive Drug Analysis Profiles(iDAPs) — a complete listing of suspected ADRs for individual drugs that have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card scheme by health care professionals, members of the public, and pharmaceutical companies.
  • Regional and district medicine information services. Details of regional centres and other useful contacts can be found in the front of the BNF and BNF for Children (or online). Local services can found by contacting the medicines information department or the hospital pharmacy in major hospitals.
  • How common the suspected adverse reaction is.

More

The Top Pharmaceutical Drugs Causing Cognitive-Related Damage

Pharmaceutical drugs pushed by the mainstream medical establishment are notorious for causing countless side-effects leading to even more problems. In fact, the average drug label contains 70 negative side-effects on average, with many drugs reaching the 100’s. Helping to make up the outrageous amount of side-effects caused by pharmaceutical drugs are brain-related side-effects, known to be causing serious damage to many prescription drug users.

Top Pharma Drugs Linked to Cognitive Damage

Collecting data from the FDA Adverse Event Reporting System, a company known as AdverseEvents, Inc. conducted a survey of pharmaceutical drugs potentially causing brain-related side-effects. In their quest, the company found more than 50,000 individual adverse event case reports linking to “common brain-related side-effect categories” such as:

  • Memory loss (amnesia)
  • Loss of libido
  • Compulsive behaviors

After analyzing the data collected, the company found which top drug culprits cause the greatest adverse impact on the brain. Used by thousands of individuals to ‘treat’ insomnia, a drug known as Ambien CR was the top drug linked to memory loss-related side-effects. Interestingly enough, it was recently reported that consuming sleep medication not only completely ignores the underlying problem of what is causing sleep issues, but also leads to an increased risk of cancer and premature death.

With about 41 percent of adults diagnosed with insomnia turning to prescription drugs, it is imperative to pass along this information. The top drug shown to lead to the most side-effects, causing inhibition of libido and more, is a hair loss medication known as Propecia. Other drugs making the top 25 count were commonly used antidepressants. Ingested by more than 1 in 10 Americans, antidepressants have also been shown to cause your arteries to thicken 400 percent more than aging.

These pharmaceuticals, as shocking as it may sound, have even been shown to worsen depression and cause suicidal thoughts. As for causing the greatest amount of side-effects related to compulsive behavior, a Parkinson’s medication called Mirapex won the gold trophy. Instead of resorting to this medication, brain exercises have been shown to provide significant relief to Parkinson’s patients. In addition, tai chi can improve balance and lower the risk of fallsin those suffering from mild or moderate Parkinson’s disease……

full article