Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.

In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.

The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.

Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.

According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.

The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.

Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.

GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.

In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.

Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.

Pregnant women taking SSRIs for depression face an increased risk that their baby may miscarry, be born prematurely, or have physical or psychological defects.

A major review of published studies of depression in pregnant women has concluded that the use of SSRIs has significant risks but lacks clear benefits.

The review authors expressed particular concern about the implications for women receiving fertility treatment, of whom over 10% report taking SSRIs.

The development of selective serotonin reuptake inhibitors (SSRIs) such as Prozac has seen antidepressant use increase fourfold in the last two decades.

Researchers at three US medical centres (Beth Israel Deaconess, Tufts and MetroWest) found a pattern of risks associated with SSRI use in pregnancy, coupled with a lack of evidence of mental health benefits to these patients.

The risks noted include:

• Higher rates of miscarriage.

• Higher rates of congenital abnormalities – notably cardiac defects linked to use of paroxetine.

• Higher rates of premature birth, which increases the cost of neonatal care and the risk of many health problems.

• Higher rates of pregnancy-induced hypertension and preeclampsia.

• Increased incidence of dangerously low birth weight.

• Increased incidence of Newborn Behavioural Syndrome, delayed motor development, and autistic spectrum disorders.

Lead study author Alice Domar said: “There is enough evidence to strongly recommend that great caution be exercised before prescribing SSRI antidepressants to women who are pregnant or who are attempting to get pregnant.

“Depressive symptoms should be taken seriously and should not go untreated prior to or during pregnancy, but there are other options out there that may be as effective, or more effective than SSRIs without all the attendant risks.”

Prozac and other blockbuster antidepressants have harmful long-term side-effects, according to a Canadian study.

Increasing serotonin levels may elevate mood, the researchers said, but it also interferes with growth, circulation and digestion and can cause strokes.

The study, the first whole-body audit of SSRIs, questions the cost-benefit analysis underlying best-selling brands such as Prozac.

Researchers at McMaster University, Ontario, studied the impact of elevated serotonin levels on all the body processes regulated by the hormone. They found that SSRIs had a range of negative long-term effects:

• developmental problems in young children

• sexual dysfunction and infertility in adults

• severe digestive problems such as IBS

• higher risk of stroke in the elderly.

With regard to the last of these, three studies have indicated that elderly anti-depressant users are more likely to suffer fatal strokes than non-users.

The study authors concluded that the classic argument in favour of SSRI use that it corrects a ‘chemical imbalance’ is false and dangerous.

Paul Andrews, evolutionary biologist and lead study author, commented: “We need to be much more cautious about the widespread use of these drugs. Millions of people are prescribed anti-depressants each year, and the conventional wisdom about these drugs is that they’re safe and effective.”

He emphasised that the evidence of harmful side-effects has been available for a long time, but has been ignored because of the persuasive impact of the ‘chemical imbalance’ model.

“The thing that’s been missing in the debates about anti-depressants is an overall assessment of all these negative effects relative to their potential beneficial effects,” he noted. “Most of this evidence has been out there for years and nobody has been looking at this basic issue.”

A previous study by Andrews and his team had found that SSRIs did not have lasting positive psychological effects: after the cessation of medication there was a strong tendency to relapse.

This finding led to a BMJ article’s statement that SSRIs did not correct any ‘imbalance’, but only created a drug-induced state within which the symptoms of depression were masked.

As the industry adjusts to life after the patent cliff, Maxine Vaccine suggests it may be time to abandon the ‘blockbuster’ mentality and look to a new model of integrated care.

Sometimes the pharmaceutical industry needs a voice. And – regardless of rhyming slang – we could do worse than the ABPI’s Stephen Whitehead. His speech to the trade association’s annual conference this week fired a resounding shot over the bows of the austerity-fixated NHS.

In a week when we learned that the coalition’s austerity policies have plunged the UK economy back into recession, Whitehead commented that the NHS is altogether too smug about its ability to save £3 billion per year by switching wholesale to generics. That’s all well and good, he said, but what happens to that money? If it simply disappears from the NHS budget instead of being reinvested in innovative new treatments, the NHS will be a snake eating its own tail – with the pharmaceutical industry frozen out of the austerity circle.

Then he delivered the payoff: “Generic medicines do save us money, but it is innovation that saves lives. We have to be careful not to focus on cost saving when we should be focusing on patients. The effective use of innovative new medicines can often reduce costs elsewhere in the healthcare system by reducing the need for expensive primary and secondary care.

“In fact, with diseases like Alzheimer’s placing an increasing burden on NHS resources, the development of new medicines by the pharmaceutical industry will be pivotal in not only fighting disease but ensuring the financial burden they impose doesn’t cripple the healthcare system.”

This statement challenges the NHS and other health systems to match the industry’s commitment to beating the recession through innovative drug development – echoing the recent statements by GSK’s Andrew Witty and Lilly’s John Lechleiter that only robust pipeline development, not austerity measures, can ensure a strong future for their companies.

Whitehead called for more effective partnership between the industry and the NHS to ensure that innovative medicines are seen as part of the solution for a health system struggling with increasing demand and shrinking budgets.

In the same week, the BMJ published an article covering new research that suggests the clinical case for widespread antidepressant use has been overstated by suppliers and clinicians alike. Researchers at Canada’s McMaster University argue that while the therapeutic benefits of long-term antidepressant use are slight, the cumulative evidence of systemic damage is conclusive. Long-term side-effects include increased risk of stroke in the elderly, sexual dysfunction and digestive problems such as IBS.

Prozac was the blockbuster drug par excellence: a ‘happy pill’ promoted as a universal panacea for depression, and prescribed to millions. Side-effects were routinely dismissed as a small price to pay for the correction of a ‘chemical imbalance’ that could not be treated in any other way.

Except that wasn’t true. As another BMJ article explained in 2010, SSRIs do not restore biochemical normality: they create a drug-induced state, comparable to being mildly stoned, in which the symptoms of depression are masked. These days, few doctors persist in the delusion that any drug is an adequate monotherapy for a complex and chronic mental health condition. Medication can be useful for crisis management, but improvement of the patient’s systemic health through behavioural changes, lifestyle management and other medical interventions is the only adequate long-term strategy. The evidence that antidepressants can have lasting and serious side-effects strengthens the case for treating the patient, not the symptoms.

Whitehead’s speech and the debunking of the Prozac myth are two sides of the same coin. The era of the blockbuster drug is over. Innovation is not about seeking the ‘magic bullet’ that treats as many patients as possible. It’s about working with healthcare providers to build complex, flexible solutions for the patient – who is viewed not just as a composite of symptoms but as a living system that changes profoundly over the limited but unique interval we call a human lifetime.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Nursing home residents with dementia who take SSRIs are three times more likely to suffer injuries through falling, according to a new study from the Netherlands.

The study found that the risk of injurious falls increased with dose strength, and concluded that antidepressants should be used with more caution in the treatment of elderly patients.

As falls are a major cause of serious injury and death in nursing home residents with dementia, the study may influence prescription levels in this customer group.

The researchers collected data on 248 nursing home residents with dementia for 2006 and 2007, using prescription and incident records. The results showed that:

• 152 participants sustained a total of 683 falls, amounting to a mean fall rate of 2.9 per person per year. 220 of the falls resulted in injury or death.

• The risk of an injurious fall increased significantly (by 31%) at 0.25 of the Defined Daily Dose of a SSRI, by 73% at 0.5 DDD, and by 198% at 1 DDD.

• The absolute daily risk for an 80-year-old woman not taking an SSRI was 0.09%, increasing to 0.28% with one DDD of an SSRI.

The study authors concluded that there was a “significant dose-response relationship between injurious falls and the use of SSRIs”.

Lead author Carolyn Shanty Sterke from Erasmus University Medical Centre, Rotterdam, commented: “Staff in residential homes are always concerned about reducing the chance of people falling, and I think we should consider developing new treatment protocols that take into account the increased risk of falling that occurs when you give people SSRIs.”