Big Pharma announces new drugs. We await to hear about their side effects, and how patients will be harmed by them

MIMS, first published in 1959, claims that it is an "essential prescribing and clinical reference for general practice", and so it is, probably. It is published quarterly, and print copies are sent free of charge to all UK-based GPs. What they claim to be their top 10 stories for 2017 make interesting reading. Here are some of them.

Quinine for muscle cramps linked to increased mortality.
This announces that long-term use of quinine for nocturnal leg cramps, something that doctors have prescribed for many years, has now been found to increase the risk of mortality. The British study was published in the medical journal, JAMA. It is yet another pharmaceutical drug that has been found to be deadly to patients, but as usual, only after many patients have died in order to prove it!

The authors of the study concluded that "the benefits of quinine in reducing cramps should be balanced against the risks" and owing to the poor benefit-to-risk ratio, both NICE and the drug regulator MHRA now (belatedly) advise that quinine should not be considered as a routine treatment for nocturnal leg cramps. However, this does NOT constitute a ban! It can still be considered when self-care measures fail, and cramps cause regular disruption of sleep.

Adjust gabapentin dose to avoid respiratory depression, MHRA advises
Gabapentin, perhaps better known as Neurontin, is a drug used for epilepsy, neuropathic pain, hot flashes, and restless legs syndrome. For many years it has been associated with a rare risk of severe respiratory depression when prescribed with or without concomitant opioids. (Many drug side effects are described as 'rare' to reassure patients and to encourage them to take the drug. But remember, only 1% to 10% of adverse drug reactions are ever notified).

Now the MHRA has issued a drug safety update - which means they were not aware of all the adverse drug effects before, but the damage done to patients is now sufficiently clear to have to come clean!

                "Prescribers should consider whether the dose of gabapentin needs to be adjusted in patients at higher risk of respiratory depression, including patients with compromised respiratory function, those with respiratory or neurological disease or renal impairment, patients taking other CNS depressants and elderly people."

The game of Russian Roulette, played with our health at stake, clearly continues within the conventional medical establishment!

First triple combination inhaler launched for COPD
The other top 10 stories are apparently considered to be good news! Trimbow has been approved as 'maintenance treatment' in adults with moderate to severe COPD "who are not adequately treated by the combination of an inhaled corticosteroid and a long-acting beta2-agonist". It says that as COPD patients deteriorate in time treatment needs to be progressively increased, and patients may have to take several drugs through two or three different inhalers. Trimbow simplifies treatment by providing just one inhaler, and a 'measured' dose.

Nothing about safety, of course. But inhalers are steroid drugs, with serious known side effects. Trimbow apparently enables patients to risk the side effects more efficiently. As as COPD patients 'deteriorate in time' it would appear that they are not entirely effective either!

Liraglutide provides new weight loss option for overweight and obese adults
MIMS tells us that Liraglutide, an anti diabetic drug, is now available as Saxenda - for weight management in obese patients and overweight patients with one or more associated comorbidities. What it does not tell us is that this 'top 10' story concerns a drug that already has a length list of side effects, some of them extremely serious, as detailed in this Drugs.com webpage. MIMS mentions a few of these, but it would appear that any 'new' branding of an old drug constitutes good news for the conventional medical establishment!

Baricitinib: oral rheumatoid arthritis treatment in new drug class
Baricitinib, or Alumiant, is now available to doctors for the treatment of moderate-to-severe active rheumatoid arthritis. More good news! The drug is apparently a 'Janus kinase inhibitor'. No, I don't know either - so let MIMS explain.

               "There are four known Janus kinase (JAK) enzymes. Baricitinib is a reversible inhibitor of JAK1 and JAK2, which are widely expressed and mediate signalling of multiple cytokines implicated in the pathogenesis of RA, including interleukin-6, granulocyte-macrophage colony-stimulating factor and interferons."

Perhaps it is sufficient to say that Baricitinib is another drug that seems to prevent our bodies working normally! So it is a drug that will cause side effects. MIMS does its best to explain what these are.

               "The most frequent adverse events seen with baricitinib during trials were increases in LDL-cholesterol, upper respiratory tract infections and nausea. The risks and benefits of treatment should be carefully considered before initiating therapy in patients with active, chronic or recurrent infections. Lipids should be assessed 12 weeks after starting treatment."

However, as this is a new drug, and if history repeats itself, the full side effects will not be known until patients are prescribed the drug, suffer them, report them, and conventional medicine takes action. This might take several years, during which time lots of patients will suffer!

Tofacitinib: new type of rheumatoid arthritis treatment launches
So, yet more 'good news' for sufferers of rheumatoid arthritis! MIMS says that Tofacitinib, or Xeljanz is a new oral treatment option for patients with moderate to severe active rheumatoid arthritis. It says that it belongs to a new class of therapies called Janus kinase (JAK) inhibitors. I feel that we have heard this before, quite recently! So its a new drug, and the good news is that doctors can now use it. So what about side effects? At least, the side effects currently known after just 3 months of clinical trials?
               "The most common serious adverse reactions to tofacitinib are serious infections, including pneumonia, cellulitis and herpes zoster."

The drug is also known to cause headache, respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension. Nothing too serious there, then. No wonder the drug regulator approved them! And I am sure that doctors will, right now, be treating their arthritis patients in the hope that they won't contract any of these conditions, or indeed any of the other adverse drug effects not yet known to conventional medicine.

So it must have been an exciting 'good news' year for MIMS, with these warnings about the new side effects of old drugs, and the new drugs with unknown side effects!. Perhaps what this really demonstrates is more 'good news' - that there is absolutely no 'good news' coming out of conventional medicine at the moment.

Sick people need to understand that conventional medicine has little to offer patients. There are no good new drugs coming through the pipeline, and plenty of bad new about old, failing drugs. Time for everyone to check out alternative medicine before conventional medicine fails completely.

Diabetes. Are patients better with, or without these conventional drugs?

Anyone suffering from Diabetes, and in Britain, about 2.5 million people do, must be wondering whether they are better off with, or without the drugs they are prescribed by their NHS doctor. 

A Channel 4 Dispatches programme, broadcast on 10th June 2013 set the scene. It linked certain diabetes drugs (it mentioned Januvia, Victoza and Byetta) with Pancreatitis and Pancreatic cancer. Despite these concerns, the programme said that the Big Pharma drug companies were

     (i) refusing to release data they had gathered on the drugs,
     (ii) but they were interested in using the drugs for the growing problem of Obesity.

This is quite typical of what is happening in the Conventional Medical world. On the one hand, a complete lack of transparency when it comes to responding to concern about serious adverse reactions to drugs. But, on the other hand, a desire to use drugs in other, more lucrative areas of ill-health.

In both cases, the patient appears to be the last to be considered.

As always, when discussing the disease-inducing-effects (DIEs) of pharmaceutical drugs, a question is posed by the conventional medical establishment. Do the benefits of the drugs (in this case, for the treatment of Diabetes) outweigh the risk (in taking drugs that cause Pancreatitis and/or Pancreatic cancer).

One of the drugs concerned, Januvia, has apparently been found to double the risk of developing acute pancreatitis. This was the result of a study, published in the Journal of the American Medical Association (JAMA), in February 2013. The study found that in most cases, hospital admission for pancreatitis happened within the first 60 days of patients taking Januvia.

The makers of Januvia, Merck, have long rejected any link between Januvia and pancreatitis!

The link with pancreatic cancer is even more serious, as it is a disease that kills 80% of people within the first year of diagnosis. There is research, published in 2011, indicating that Januvia could increase the risk of of pancreatic cancer (by 172%) and thyroid cancer too (by 48%).

Equally, what cannot be denied is that Januvia is a money-spinner, one of Mercks best-selling drugs, earning an estimated $4.1 billion in 2012.

So what are the drug regulators doing? Not, it would seem, very much. The FDA announced in March 2013 that 'it will investigate' the risks associated with Januvia. Yet, in the meantime, there is little evidence that any move has been made to inform patients, or that there is much concern about those people who might contract pancreatitis, or pancreatic cancer, during the time it takes to investigate the drug. Not much urgency there, it would seem!

Yet this cannot be considered to be a new linkage. As Agora Health stated in their 'Daily Health eAlert  (June 2013), the FDA were aware of the dangers of Januvia as early as 2006, as between October 2006 and February 2009, the FDA received reports of 88 cases that linked this drug with pancreatitis.

It would seem that being diabetic, not an easy one at the best of times, is being made far worse by the drugs the Conventional Medical Establishment gets them to take.

Victoza, another diabetes drug, was introduce in 2012. Even at the testing stage, animal studies indicated that it cause thyroid tumours, and human studies indicated that it caused pancreatitis. So why was it approved? Only the drug regulators know. But despite the evidence, the drug was uncompromisingly heralded as a 'breakthrough' in the treatment of type-2 diabetes! Other drugs, of the same type, are called Byetta, Exenatide, Liraglutide - and of course, Januvia.

Dispatches reported that the British Medical Journal (BMJ) had looked at all the evidence concerning this drugs, and had concluded that the manufacturers (including Merck, Novo Nordisk and Amylin Pharmaceuticals) may have been trying to hide the potential harmful reactions the caused. Dr. Deborah Cohen, from BMJ, is reported saying that whilst the evidence of the trial "may seem inconclusive",

          "When considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug".

So, are diabetes patients better off with these drugs, or without them?

Remember the diabetes drug, Avandia? Some people dubbed it as 'the killer drug' - although it must be said that Avandia has many rivals to this claim! Recall that it was banned throughout Europe in September 2010, as it was found to significantly increase the risk of heart attacks? Yet Avandia was marketed from 2000, and for 10 years it was allowed to cause heart attacks and strokes - whilst it was being 'investigated' by the drug regulators.

Will it take as long for these 'new' drugs to be banned? Will the drug regulators allow pharmaceutical companies to profit from drugs that are causing death whilst they 'investigate' the problems? How long will it take before the needs of patients come before the profits of drug companies?

One thing that every diabetes sufferer can do is to challenge their doctor, challenge the NHS, challenge the Department of Health, challenge their MP - and demand safer medicine. We all need to ask the question. Is the need to treat diabetes worth risk of getting acute pancreatitis, and pancreatic cancer? Do the benefits of these drugs really outweigh the risks?