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European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System
The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent. A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that ...
Source: CardioBrief - May 20, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes ace inhibitor Angiotensin II receptor antagonist European Medicines Agency food and drug administration hypertension Source Type: blogs

Bringing trial data out of the shadows
All sectors have their own mood music, unobtrusive much of the time, but occasionally brought to startling effect into the foreground, dominating all else. The pharmaceutical industry is no different, and at present there is one insistent theme: transparency.And if there is one area of this debate behind which chords are starting to swell loudly it is the availability of clinical trial data. Unflattering or disappointing trial outcomes have been routinely unpublished, pharma's critics claim, which means patients taking part in trials can be exposed to ineffective or even dangerous products because previous negative researc...
Source: PharmaGossip - May 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

AllTrials update
Dear Friends Yesterday the European General Court issued an injunction stopping the European medicines regulator from releasing information from clinical trials conducted by two pharmaceutical companies at the request of those two companies. The ruling pertains to two particular cases but it has ramifications for all. The Court’s decision puts the European Medicines Agency into conflict with its own stated policy to proactively release clinical trial data for all medicines being used in Europe. More importantly it puts it into conflict with patient’s interests. We need to let the EMA know how much support there is fo...
Source: PharmaGossip - May 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information
via ema.europa.eu Posted via email from Jack's posterous (Source: PharmaGossip)
Source: PharmaGossip - April 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Alex Lomas says to Abbvie "Show me the data"!
Personal View I’m a patient: show me the trial data BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2336 (Published 16 April 2013) Cite this as: BMJ 2013;346:f2336 Article Related content Article metrics Alex Lomas, patient, London alex@alexlomas.com The patient Alex Lomas is taking a biological drug for Crohn’s disease, and he wants to know why the maker is trying to prevent disclosure of trial data that may well affect him I have an obsession with data. I have instruments in my house so I know how hot each room is and to warn me i...
Source: PharmaGossip - April 19, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

FDA Let Drugs Approved on Fraudulent Research Stay on the Market
On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide. Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former employee's allegation that the company had tampered with records and manipulated test data. When Stone explained the gravity of the inquiry to Chinna Pamidi, the testing facility's president, the Cetero executive made a brie...
Source: PharmaGossip - April 16, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Diane-35: Geen Reden tot Paniek!
Dear english-speaking readers of this blog. This post is about the anti-acne drug Diane-35 that (with other 3rd and 4th generation combined oral contraceptives (COCs)) has been linked to the deaths of several women in Canada, France and the Netherlands. Since there is a lot of media attention (and panic) in the Netherlands, the remainder of this [...] (Source: Laika's MedLibLog)
Source: Laika's MedLibLog - March 12, 2013 Category: Medical Librarians Authors: laikaspoetnik Tags: Dutch Gynecology & Obstetrics Harm & AE Pharmaceutical Industry Researchblogs Acne vulgaris anticonceptiemiddel Bayer Canada Combined oral contraceptive pill Cyproterone Diane Diane-35 European Medicines Agency Food and Drug Ad Source Type: blogs

Niacin
theheart.org is reporting today that The European Medicines Agency (EMA) will be launching a review of all niacin (nicotinic acid) agents. This is due to new data from a soon to be reported trial at the ACC in San Francisco, HPS2-THRIVE. It is being reported that a combination of niacin and another agent (which was supposed to reduce the flushing of niacin) "failed to show that the combination reduces the risk of major vascular events (such as heart attack and stroke), and a higher frequency of non-fatal but serious side effects was seen in patients taking the combination." The EMA is launching the review t...
Source: Dr Portnay - March 8, 2013 Category: Cardiology Authors: Dr Portnay Source Type: blogs

FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment
Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding ideas stakeholders and the public may have for combating drug shortages. As noted on FDA’s own blog, the agency believes that despite the progress made over the last year, even more can be done and is therefore turning to the American public for advice. Comments due by Thursday, March 14, 2013. The Docket Number is FDA-2013-N-0124. Background As we previously wrote this summer, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. ...
Source: Policy and Medicine - February 27, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Roche Peels Back The Curtain On Clinical Trial Data
In response to enormous criticism over its handling of Tamiflu clinical trial data, Roche announced a new plan to increase access to such information and its approach mimics steps begun recently by GlaxoSmithKline. Specifically, Roche will work with an “independent” group of “recognized experts” to evaluate and approve requests to access patient-level data and will also support the release of case study reports for all of its licensed medicines. The move comes after Roche found itself in a heated row with researchers at the Cochrane Collaboration, who two years ago complained they were repeatedly st...
Source: Pharmalot - February 26, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Avandia BMJ Clinical Trials Cochrane Collaboration GlaxoSmithKline Phrma Roche Tamiflu Source Type: blogs

Is Evidence-Based Medicine Only an Illusion?
By Kristina Fiore, Staff Writer, MedPage Today Published: February 23, 2013 In a system where half of all clinical trials never see the light of publication, doctors are merely "imagining that we're practicing evidence-based medicine," says Ben Goldacre, MBBS, a British physician and science journalist. Goldacre is among the most vocal critics of drugmakers who refuse to hand over complete clinical trial data, making it impossible for doctors and patients to get the full picture on most of the medicines widely used today. He decries the industry's behavior in his new book, Bad Pharma, which in itself is a review of the e...
Source: PharmaGossip - February 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Doctor Can Finally Tell Fresenius: ‘I Told You So’
Last year, we wrote that Fresenius Kabi got into a tussle with a Danish professor after he and several colleagues published a paper in The New England Journal of Medicine that concluded its hydroxyethyl starch treatment for sepsis may cause kidney failure and hemorrhages that may lead to patient death. The drugmaker reportedly threatened a lawsuit after the professor told ScienceNordic the treatment should not be used for sepsis (back story). The spat between the drugmaker and the professor may not have normally generated much notice had the spector of litigation not been raised. Although Fresenius later denied threatening...
Source: Pharmalot - February 20, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Fresenius Kabi Joachim Boldt Sepsis Source Type: blogs

The European Medicines Agency Mitigating Drug Shortages in Europe
The European Medicines Agency (EMA) recently released a proposal for how it can help mitigate potential and real drug shortages stemming from manufacturing problems, reported FiercePharmaManufacturing. The six-page proposal notes that “Recent unexpected disruptions to the manufacturing supply chain due to manufacturing/GMP (good manufacturing practices) compliance problems have resulted in acute and chronic shortages of important medicinal products in the European Union (EU) requiring changes to prescribing information, and initiation of patient allocation programs.” The Reflection Paper is concerned with public h...
Source: Policy and Medicine - February 13, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Avandia - Glaxo resists UK claims despite settlement with victims in US
Families face battle with GSK over dangerous diabetes drug Tuesday 29 January 2013 21.04 GMT Sarah Boseley, health editor Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US. The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems. A scientist with the Food and ...
Source: PharmaGossip - February 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Is there a cure for corporate crime in the drug industry? - BMJ Editorial
Effective enforcement of regulations requires more resources and determination to impose robust sanctions Nearly 30 years ago, Braithwaite’s Corporate Crime in the Pharmaceutical Industry showed that unethical and corrupt behaviour was endemic in the sector. Sadly, there is growing evidence that little has changed. Recent research suggests that violation of the law continues to be widespread. Most new medicines offer little or no therapeutic advantage over existing products, so promotion plays a huge role in achieving market share. In a crowded and competitive marketplace the temptation for companies to resort to mislea...
Source: PharmaGossip - February 8, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs