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Total 35 results found since Jan 2013.
Boehringer Kept Pradaxa Analysis From FDA, Records Show
Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.The F...
Source: PharmaGossip - February 26, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Statins - John P. A. Ioannidis writes
The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on assessment of cardiovascular risk1 and on treatment of blood cholesterol, which included recommendations for primary prevention with statins,2 came under intense criticism immediately with their release. Main concerns focused on flawed methods (problems with the risk calculation),3 ethics (conflicts of interest),4 and inferences (too many people offered treatment).The ACC and the AHA are among the most experienced organizations in medicine that develop guidelines. Their processes are meticulous, including transparent r...
Source: PharmaGossip - December 3, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Congress Writes CMS To Change Sunshine Rule For Textbooks
A bi-partisan group of more than two dozen members of Congress has written the US Centers for Medicare & Medicaid Services to demand the agency modify the reporting requirements of the Sunshine Act, so that medical textbooks and peer-reviewed journal reprints are excluded from the data that must be collected by drug and device makers.
The move comes one month after dozens of national and medical societies - including the American Medical Association, the American Academy of Family Physicians, the American College of Cardiology and the American Society of Clinical Oncology - made the same request and threatened to file ...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Doctors Say Heart Drug Raised Risk of an Attack
Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead.The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year.“Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday.Dr. Nissen was the senior author of a report on the d...
Source: PharmaGossip - November 20, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
By The Numbers? Flawed Cholesterol Calculator May Boost Statins
The latest by-the-numbers approach for assessing cholesterol and cardiovascular risk apparently does not add up. The new online calculator that the American College of Cardiology and American Heart Association last week recommended for determining treatment apparently overestimates the risks and, as a result, may mistakenly suggest that millions of people should be taking statins.
The problems were actually noticed a year ago by a pair of Harvard Medical School professors, when the National Institute of Health circulated the proposed guidelines, according to The New York Times. However, their findings apparently were never...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Statin Insanity
The medical student was confused. "Well, that's not good."He was seeing, in black and white, the benefits and harms of statin medicines. After years of systematic inculcation about the power of cholesterol reduction, this was the first time he had seen the numbers."I don't get it. I thought cholesterol was the big player in heart attacks."Not really. Three-quarters of people having a first heart attack, for instance, have normal cholesterol levels."Seriously?"Indeed. In fact, 50 years ago during the Framingham Heart Study, researchers first suggested that cholesterol may be a weak risk factor for heart disea...
Source: PharmaGossip - November 16, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
The Cholesterol Guidelines Panel And Conflicts Of Interest
Earlier this week, the American Heart Association and the American College of Cardiology released new guidelines that will dramatically change the calculus for prescribing cholesterol-lowering medicines. And while there is debate about the extent to which prescribing habits will change quickly, the big winners are expected to be drugmakers that sell statins, since other types of pills were not recommended (back story).
However, here is an interesting note. Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medicati...
Source: Pharmalot - November 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Cholesterol Guidelines Are Changed, But Will Prescribing Rise?
In a move that will greatly alter the use of the cholesterol-lowering pills known as statins, the American Heart Association and the American College of Cardiology have released new guidelines that change the calculus for prescribing these medicines. To the extent the changes will generate more prescriptions and, therefore, more revenue for the pharmaceutical industry, however, is unclear.
The biggest change dispenses with the idea that people with a specific cholesterol level should automatically be given treatment and puts an end to the notion of treating patients until their cholesterol level is lowered to a specific ta...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
What The Probe Into The Brilinta Trial May Mean For AstraZeneca
The drumbeat of investigations launched by this or that government agency into a big drugmaker is often shrugged off, at least by investors, who play wait-and-see since the outcome of such probes can amount to nothing. However, the news that the US Department of Justice is investigating a key trial for the Brilinta bloodthinner sold by AstraZeneca prompted a cautious response from one analyst.
What are the feds looking at? As we wrote last week, the inquiry is focused on the PLATO trial, which was used to win FDA approval. There were no other details, but the disclosure came six months after a small group of researchers ra...
Source: Pharmalot - November 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Not So Brilliant? Feds Probe AstraZeneca Over Brilinta Trial Data
Six months after a medical journal raised troubling questions about the reliability of a key study that was used to win approval for its Brilinta bloodthinner, AstraZeneca (AZN) says that the US Department of Justice has recently opened an inquiry into the trial, according to a filing with the US Securities and Exchange Commission. The disclosure was made in the most recent earnings report that was released today (see page 28).
An analysis last April in The International Journal of Cardiology found a host of disturbing issues with the so-called Plato trial. Nearly three years ago, the FDA questioned aspects of the study an...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
How brilliant is Brilinta?
AstraZeneca US drug trial queriedAstraZeneca's chief executive Pascal Soriot says he is very confident in the findings of the clinical trial of heart drug Brilinta. Photograph: Lynne Cameron/PAAstraZeneca is being investigated by US authorities over a clinical trial that was used to win marketing approval for its heart drug Brilinta, casting fresh doubts over the medicine.Brilinta sales have been a disappointment since its launch two years ago, although AstraZeneca has recently stepped up marketing efforts and hopes that further clinical tests will underscore its value in preventing heart attacks.The British drug...
Source: PharmaGossip - October 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Doctors To HHS: Exclude Textbooks And Reprints From Sunshine Act, Or Else
As drug and device makers begin collecting data to comply with the Sunshine Act, dozens of national and medical societies are asking the US Department of Health & Human Services to modify the reporting requirements so that medical textbooks and peer-reviewed journal reprints are excluded. And if HHS refuses to comply, the groups are considering seeking help from Congress and, possibly, filing a lawsuit.
The Sunshine Act, you may recall, establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organiz...
Source: Pharmalot - October 29, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Novartis says sorry!
Novartis has apologised to patients in Japan over the alleged manipulation of data in five trials of its blockbuster blood pressure drug Diovan.
After meeting health minister Norihisa Tamura in Tokyo, the head of Novartis’ pharma division, David Epstein, said: “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry.”
In comments reported by Reuters, he went on: “We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion.”
There is no detail on what sanctions...
Source: PharmaGossip - September 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Blink Of An Eye: Chosterol-Lowering Drugs Linked To Cataracts
Can statins cause cataracts? Over the years, there has been confusion owing to mixed results from different studies. Yet another study, however, finds that such a link may exist – those taking a cholesterol-lowering drug had a 9 percent higher chance of developing a cloudy lens over the eye.
There was no definitive cause-and-effect proof and this was an observational study, although the findings were obtained by using propensity matching, a statistical technique that attempts to estimate the effect of a treatment. And this was the first time this approach was used in examining the subject, suggesting the study may resona...
Source: Pharmalot - September 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Blink Of An Eye: Cholesterol-Lowering Drugs Linked To Cataracts
Can statins cause cataracts? Over the years, there has been confusion owing to mixed results from different studies. Yet another study, however, finds that such a link may exist – those taking a cholesterol-lowering drug had a 9 percent higher chance of developing a cloudy lens over the eye.
There was no definitive cause-and-effect proof and this was an observational study, although the findings were obtained by using propensity matching, a statistical technique that attempts to estimate the effect of a treatment. And this was the first time this approach was used in examining the subject, suggesting the study may resona...
Source: Pharmalot - September 20, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
