NHS England has lost a major judicial review over the power to commission a preventative HIV drug.
The decision, taken at the Royal Courts of Justice, ensures that the healthcare body will be forced to include pre-exposure prophylaxis (PREP) in its “prioritisation process”.
Mr Justice Green asserted that NHS England had “erred in deciding that it has no power or duty to commission” PREP, and in his judgment the organisation has a “broad preventative role”.
In his summing up statements, Green commented that NHS England had “mischaracterised the PREP treatment as preventative when in law it is capable of amounting to a treatment for a person with infection”, and it any event the body had the power to commission preventative treatments because it supported “the discharge of its broader statutory functions”.
The judge said at its core the judicial review was about “the allocation of budgetary responsibility in the health field”, and explained that NHS England had erred in its responsibilities by blacklisting PREP.
“NHS England says it has no power to provide the service and the local authorities say that they have no money. The claimant is caught between the two and the potential victims of this disagreement are those who will contract HIV/AIDS but who would not were the preventative policy to be fully implemented.”
NHS England has indicated that it intends to appeal against the decision, and has also warned that other medicines could be sidelined if the body is forced to fund PREP.
Nine treatments are apparently under threat as a result of the court verdict.
NHS England have indicated previously that it was impossible for the organisation to fund PREP, as the body did not have the legal power to commission the medicine.
The healthcare organisation instead asserted that the responsibility lied with local authorities.
In response to this assertion, the National AIDS Trust launched the judicial review which has ultimately tesulted in the assertions of NHS England being reversed, pending appeal.
However, despite the court verdict, it is not inevitable that NHS England will commission PREP.
NHS England will instead put PREP through its prioritisation process, which it intends to re-run in October.
Deborah Gold, NAT’s chief executive, commented that the judge’s decision was a “vindication for the many people who were let down when NHS England absolved itself of responsibility for PREP”.
Izzi Seccombe, the LGA’s community wellbeing portfolio holder, was also positive about the prospects for HIV sufferers as a result of the verdict.
“By successfully challenging NHS England’s interpretation of the law, we believe this will provide much-needed clarity around the future roles of councils and the NHS on prevention services.”
The clinical trial of a new drug in France has ended disastrously, with one person brain-dead and another five people in hospital.
Investigations are ongoing into the trial which took place in a private laboratory in the western city of Rennes.
The trial was suspended as soon as problems became apparent, with the oral examination apparently having gone badly wrong.
The French Health Minister Ms Touraine said indicated that she intended to “get to the bottom… of this tragic accident.”
Meanwhile, the Paris prosecutor’s office stated that an investigation had been opened.
The seemingly tragic trial has been carried out by Biotrial; a French company which is a major player in the global pharmaceutical industry.
Indeed, the company has carried out thousands of trials for a wide variety of drugs since being established in 1989.
The accident occurred on Thursday, with the worst of those affected unfortunately being rendered brain-dead.
Meanwhile, five other participants remain in a serious neurological condition.
The study was a Phase I clinical trial according to the French ministry.
Although drug trials remaining critical to developing effective new medicines, such a major and high-profile incident will only contribute to calls to more strictly regulate the industry.
Only recently, German medics had challenged the new regulations put in place by the European Union with regard to clinical drug trials.
There have been suggestions that this new legislation compromises drug trial safety.
This has always been a controversial subject matter, with the ability to attract volunteers for pharmaceutical testing proving problematic at times.
Several individuals have come forward to write books and give recorded accounts of their experiences working in a clinical drug trial environment, despite the nondisclosure agreements that must be signed by any participants.
Before any new medicine can be given to patients, detailed information about how it works and how safe it is must be collected.
And clinical trials are still seen as central to this process, with literally tens of thousands of people participating in such clinical trials on an annual basis.
EU regulations were intended to speed up clinical drug trials, ensuring that testing procedures could be streamlined across the 28 nations that form the European Union.
Yet these latest regulations will not take effect until May, and were certainly too late to save the unfortunate individuals involved in this latest clinical trial error.
With the French investigators continuing to probe with the incidents, there have been conflicting reports about the drugs being tested and the nature of the mistake made by scientists.
Health regulators in the United States have indicated that they have granted approval to an advanced lung cancer medication.
The drug in question is produced by the pharmaceutical manufacturer Roche Holding, and addresses lung cancer in patients with a specific genetic mutation.
Roche Holding will be selling the drug, alectinib, under the brand name Alecensa.
The medication has been approved with the intention of treating patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
Alecensa will be particularly effective in treating those patients within whom this disease has worsened after, or who could not tolerate, treatment with competitor Pfizer’s Xalkori.
There are hopes that the drug will now be approved for wider marketplaces as well, as Roche Holding looks to increase its share of the lung cancer pharmaceutical marketplace.
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, head of the Food and Drug Administration’s Hematology and Oncology Products division, commented in an official statement.
Xalkori was seen as an advance in the field of personalised medicine as it was designed to treat only patients with the ALK genetic mutation.
This is a relatively tiny portion of overall cancer sufferers, with this specific group accounting for only 4% of NSCLC patients.
As competition hots up in this particular area of pharmaceuticals, it has been reported that Pfizer is also developing a drug for ALK.
The pharmaceutical heavyweight has had to acknowledge that many patients have stopped responding to its own products Xalkori, and Pfizer is attempting to develop an alternative remedy.
Pfizer has established itself as one of the 50 largest corporations in the world according to Forbes magazine, with a market capitalisation in excess of $200 billion.
The pharmaceutical lobby is famously one of the most influential groupings in the United States, and indeed the industry spends more on lobbying government than any other comparable industrial sector.
While the United States pharmaceutical industry unquestionably produces many valuable medicines, the country has also been criticised for its reliance on responding to illnesses with drugs, as opposed to addressing the cause of problems.
Indeed, the US has something of an addiction to popping pills, with the country one of only two in the world that allows the television advertising of drugs (the other being New Zealand).
The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence of clinical benefit.
A confirmatory study is required to verify the benefit of Alecensa for it to gain full approval, the agency revealed.
There are an estimated 158,040 deaths from lung cancer annually in the United States (86,380 in men and 71,660 among women).
AstraZeneca has just had a new lung cancer drug approved by US regulators, in what will be seen as a major coup for the British pharmaceutical manufacturer.
The drug in question is AZD9291, which will be ultimately go on sale under the brand name Tagrisso.
Notable for targeting the genetic mutation known as T790M, Tagrisso effectively usurps existing cancer medication which is unable to deal with this problem.
The drug is intended to specifically target advanced non-small-cell lung cancer; the most common form of lung cancer.
Having passed US regulatory measures, the drug will now be made available to patients in the United States as soon as possible.
Although pricing has yet to be publicised, AstraZeneca have stated that they will reveal the price early this week.
It was stated by a spokeswoman that the pricing will ultimately be comparable to existing cancer treatments.
Lung cancer is the leading cause of cancer death among men and women, accounting for one-third of cancer deaths, more than breast, prostate and colorectal cancers combined.
So this drug breakthrough could be excellent news for cancer sufferers all over the world.
This latest treatment has been developed in Cheshire, and is one of several drugs that AstraZeneca is currently developing.
The company has recently been targeted by American rival Pfizer, the maker of Viagra, but AstraZeneca chief executive Pascal Soriot has cited this drug and other products in a defence against this prospect.
AstraZeneca estimates that Tagrisso could bring in sales of $3bn (£2bn) annually, which is greatly needed by the corporation considering that sales of older drugs are diminishing, and therefore losing patient protection.
The move by AstraZeneca is indicative of a scramble of drug companies to enter the immunotherapy market.
Experts believe that immunotherapy could eventually be worth in the region of £26 billion annually in sales.
Thus, Tagrisso could be an extremely valuable commodity for AstraZeneca, particularly as the drug performed so admirably in trials.
According to Richard Pazdur of the FDA’s centre for drug evaluation and research, the Tagrisso tablet had a “significant effect on reducing tumour size in over half of patients who were treated.”
The approval of the drug is a step in the right direction for AstraZeneca, with the company continuing its odyssey of creating and marketing six new cancer treatments to patients by the end of the decade.
This latest decision follows the previous launch of Lynparza for ovarian cancer in the US.
Tagrisso was first tested on humans just 30 months ago.
It had received breakthrough status in the US and has also received accelerated assessment in the EU following its filing in the summer, as well as priority review in Japan.
A new drug that has a significant influence on the likelihood of being infected with HIV is being strongly promoted by experts.
Pre-exposure prophylaxis (PrEP) is being heralded as a massive breakthrough in treating HIV and AIDS, after researchers in a UK-based study found that it decreased infections by 86 per cent among gay men at high risk.
Scientists involved in the study opined that the NHS simply “cannot afford to ignore” this HIV treatment.
Having carried out a trial at 13 sexual health clinics last year, researchers involved in the test have now published results in The Lancet.
The initial tests were accelerated as it became clear that the drug was extremely effective.
Results indicate that one case of HIV could be prevented for every 13 men taking PrEP, which is considered to be an outstanding result.
The pill in question is referred to as Truvada, and it is already widely available in the United States. The NHS is now examining whether offering this drug free to high risk groups is feasible.
Although the early results regarding this pill are extremely positive, that decision on its availability is not expected until early in 2016.
However, it seems that prescriptions of PrEP may offer not only medical benefits but financial savings to the NHS as well.
The potential decline in HIV infections caused by the drug suggest that PrEP could save the NHS a considerable amount of money in the medium to long-term.
Researchers for the Lancet-published review were led by Professor Sheena McCormack of the Medical Research Council clinical trials unit at University College London (UCL).
The group concluded that “National health services are under financial constraints, but they cannot afford to ignore the results of PROUD and [separate PrEP trial] IPERGAY, which strongly support the addition of PrEP to the current standard of prevention for men who have sex with men at risk of HIV infection.”
This latest pill arrives in the context of the battle against HIV having read something of a logjam.
The number of new HIV infections in UK has remained static for 10 years, with around 3,250 new cases in 2013.
However, despite the current efficacy of this treatment, decisions about cost-effectiveness will have to encompass the significant cost of treating HIV infections.
This figure can rise as high as £11,000 per year, while clarification on the criteria for qualifying for a free PrEP prescription also needs to be agreed.
Dr Ian Williams, Chair of the HIV clinical reference group for NHS England, commented positively on the Lancet study “We want to see reductions in new transmissions of HIV infection and are already investing in programmes to achieve this. These findings add to existing international evidence on preventing infection, and consideration is already being given to how best to make further progress.”
As PrEP is a specialist HIV drug, a final decision on the pill will be made by NHS England, as opposed to the National Institute of Health and Care Excellence.