European Medicines Agency (EMA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Big Pharma’s data sharing principles “weak and filled with loopholes”
Campaigners for greater transparency of clinical trial data for medicines have criticised a set of principles published by the pharma industry aimed at improving access to study information.Led by pressure group AllTrials, numerous critics have said that the commitments, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US' Pharmaceutical Research and Manufacturers of America (PhRMA), go nowhere near far enough in allowing independent researchers to determine if a drug is as effective as its manufacturer claims.Among the most damning comments were those from AllTrials c...
Source: PharmaGossip - July 26, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Pharma Adopts Data Sharing Plan, But Critics Deride 'Caveats'
In response to the heated debate over disclosing clinical trial data, the two largest trade groups representing the pharmaceutical industry have released voluntary guidelines outlining steps that drugmakers are willing to become more transparent. However, critics say the effort falls short of sufficient disclosure because there are caveats that could ensure data is kept behind closed doors. Specifically, provide patient-level and study-level data; full clinical study reports and protocols for medicines approved in the US and European Union will be provided to “qualified” scientific and medical researchers upon request,...
Source: Pharmalot - July 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity
I had guessed that this sort of thing was going on all the time, but being kept very well hidden. Now we have some more evidence.An article in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against suppression and manipulation of clinical research. In summary,The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.More specifically,The strategy was drawn up by two large trade groups, the Pharmaceutical Res...
Source: Health Care Renewal - July 23, 2013 Category: Health Medicine and Bioethics Commentators Tags: PhRMA deception health care corruption manipulating clinical research patient advocacy groups public relations suppression of medical research conflicts of interest Source Type: blogs

Pharma Enlists Patients To Prevent The Release Of Clinical Trial Data
The pharmaceutical industry is quietly working on a concerted, behind-the-scenes effort to prevent the release of clinical trial data, a flashpoint of controversy in recent years over allegations that negative information is being withheld. Trade groups in the US and Europe have so far enlisted patient advocacy groups to discourage regulators from allowing the data to become public, The Guardian reports. However, their plan also calls for reaching out to scientific organizations and businesses about the risk of releasing or sharing confidential data, and possibly creating a network of academics across Europe to act as spok...
Source: Pharmalot - July 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

AllTrials contd. Which patient groups are in Big Pharma's pocket?
The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials. Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies' claims about the safety and efficacy of drugs. Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that sh...
Source: PharmaGossip - July 21, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Bayer Drug, The EMA And Transparency... Or The Lack Thereof
In yet another instance in which transparency involving pharmaceuticals has been questioned, the head of the Swedish organization that assesses health care products has criticized the European Medicines Agency for its closed-mouth approach to allowing physicians to resume use of a controversial Bayer drug that had been suspended several years ago. In a letter published in The Lancet, Mans Rosen complains the EMA refused to make available the scientific information that was the basis for its recommendation last year to lift a suspension for Trasylol, which is used to control bleeding during heart surgery (see the EMA statem...
Source: Pharmalot - July 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Are Clinical Trial Data Shared Sufficiently Today?
On bmj.com yesterday [Tuesday 9 July 2013] two authors debated the issue of publicly sharing clinical trial data. This will also be the subject of this week's reader poll on bmj.com. Ben Goldacre, research fellow at the London School of Hygiene and Tropical Medicine, says we need all the evidence to make informed decisions about medicines. The lack of progress on transparency has been startling, he writes. Current estimates suggest that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be published. There is legislation manda...
Source: PharmaGossip - July 10, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Castellani vs Goldacre
Are clinical trial data shared sufficiently today? YesThe AllTrials campaign asks for all trials to be registered and their results published. Ben Goldacre (doi:10.1136/bmj.f1880) says we need the evidence to make informed decisions about medicines. John Castellani says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the informationClinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients. Biopharmaceutical companies are committed to the conti...
Source: PharmaGossip - July 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Tamiflu saga continues - NYT. By Katie Thomas
Breaking the Seal on Drug ResearchPETER DOSHI walked across the campus of Johns Hopkins University in a rumpled polo shirt and stonewashed jeans, a backpack slung over one shoulder. An unremarkable presence on a campus filled with backpack-toters, he is 32, and not sure where he’ll be working come August, when his postdoctoral fellowship ends. And yet, even without a medical degree, he is one of the most influential voices in medical research today.Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companie...
Source: PharmaGossip - June 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? - BMJ
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3680 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3680Article Related content Article metrics Deborah Cohen, investigations editor Author Affiliations dcohen@bmj.com Incretin mimetics have been called “the darlings of diabetes treatment” and they may soon also be licensed for treating obesity. But a BMJ investigation has found growing safety concerns linked to the drugs’ mechanism of action. Deborah Cohenasks why patients and doctors have not been told. They’ve been touted as th...
Source: PharmaGossip - June 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Psst! Former Biotech Exec Pays $616K Fine For Insider Trading
Yet another instance of insider trading by a pharmaceutical industry employee. This time, the US Securities and Exchange Commission says the former InterMune finance vp and controller Bruce Tomlinson has agreed to pay $616,000 after the agency filed a lawsuit accusing him of tipping a friend and former business associate about the progress of a drug for which approval was sought in Europe. Here’s the background, according to the lawsuit: In March 2010, the drugmaker filed paperwork with the European Medicines Agency for its idiopathic pulmonary fibrosis treatment. Seven months later, Tomlinson e-mailed his friend that th...
Source: Pharmalot - June 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Dr Sidney Wolfe retires with a bang!
Avandia: A Drug That Should Be BannedStatement of Sidney M. Wolfe MD, Founder and Senior Adviser, Public Citizen’s Health Research GroupJune 6, 2013Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779Note: Dr. Sidney Wolfe is testifying today before two FDA advisory committees that are meeting to consider a range of actions on the dangerous diabetes drug Avandia (rosiglitazone), from lifting restrictions to banning it. Dr. Wolfe’s testimony is available at http://www.citizen.org/hrg2134.According to U.S. Food and Drug Administration-acquired marketing data, since late 2010, when the diabetes drug Ava...
Source: PharmaGossip - June 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Lone Voice Raises Alarms on Lucrative Diabetes Drugs - NYT
LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.“I said, I’m not interested in your money, go away,” Dr. Butler recalled.Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9...
Source: PharmaGossip - May 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Sacre Bleu! European Agency Rebuffs French Regulator Over Bayer Acne Pill
Now what will French authorities do? After months of debate, the European agency that coordinates regulation of medicines on the continent has decided that the controversial Diane 35 acne pill sold by Bayer, which is also widely prescribed as a contraceptive, is safe to use so long as steps are taken to minimize the risk of blood clots. The decision was announced this morning. The overwhelming 26-to-1 vote by the Coordination Group for Mutual Recognition and Decentralised Procedures, which is overseen by the Heads of Medicines Agencies, endorsed the recent position taken by the European Medicines Agency (read statement h...
Source: Pharmalot - May 30, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Januvia and the pancreas
Merck's juggernaut diabetes drug Januvia now faces renewed scrutiny five years after an endocrinologist found that lab rats given the medicine were more susceptible to pancreatic cancer, according to a report in The New York Times. After followup studies by the same doctor, Peter Butler, the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on Whitehouse Station-based Merck's Januvia and other drugs in its class, according to The Times report. In March, the FDA also said it was reviewing unpublished findings by a group of academic researchers tha...
Source: PharmaGossip - May 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs