Big Pharma Inconsistent with Clinical Trial Information

[gerald]

I think we have seen similar articls in the past.  We all see the press releases and the hype about new promising products but we never hear what happens to many of them.  The really dangerous ones is where the edit the clinical data and you don;t hear about the negative side effects in time.

This site shows the negative test results     www.jnrbm.com/
It can be as informative as some of the press releases


-------------------------------------------------
Big Pharma Inconsistent with Clinical Trial Information
11/12/2015
NYU Langone Medical Center / New York University School of Medicine

Despite legal and ethical requirements, information on clinical trials for drugs approved by the U.S. Food and Drug Administration (FDA) varied widely among some of the world's largest drug companies, according to a new study led by a researcher at NYU Langone Medical Center's Division of Medical Ethics in the Department of Population Health.

Although the lack of publicly available clinical trial information has been widely acknowledged as a decades' long problem, the researchers believe this is the first report that ranks specific drugs based on their sponsors' legally-required disclosure of clinical trial information and their ethical obligation to share information. The study, published online in BMJ Open also suggests that U.S. law is both narrow and unenforced in this area.

In the study, the authors debut a solution to help fix the transparency problem: the "Good Pharma Scorecard." The pilot rankings, which will be released annually, score the largest pharmaceutical companies for drugs approved by the FDA in 2012. The authors' goal in releasing this scorecard is to incentivize pharmaceutical companies to strive toward greater transparency.

"Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients," said Jennifer Miller, PhD, an assistant professor of medical ethics in the Department of Population Health at NYU Langone. She led the study, along with researchers from Harvard and Yale Universities.

The findings were sobering. Almost half of all reviewed drugs had at least one undisclosed Phase II or III trial. In addition, the investigators found that only 57 percent of trials per drug were properly registered; only 20 percent of final results were reported on ClinicalTrials.gov (a clinical trial registry and database maintained by the National Library of Medicine at the NIH); only 56 percent were published in academic journals, and; only 65 percent were published or had their results reported in some meaningful way.

Miller also noted that selectively disclosing information violates the rights of human research subjects laid out in the U.S. Common Rule, a rule of ethics that requires that human subject experiments have the potential to contribute to generalizable knowledge.

How the Study Was Conducted

The investigators examined publicly available information for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value. They identified 15 drugs from 10 companies with more than 318 associated clinical trials involving 99,599 research subjects.

Information was gathered from a variety of publicly available documents, including Drugs@FDA, a publicly accessible database containing records of drug approvals and medical and scientific reviews of approved drugs; ClinicalTrials.gov; and journals indexed in Medline.

To aid in their evaluation and reform strategy, the researchers created a "Good Pharma Scorecard," which consisted of five critical elements of transparency for new drugs, including if the trials were publicly registered, if they were reported in ClinicalTrials.gov after FDA approval and if there was adherence with ethics standards established by the World Medical Association's Declaration of Helsinki, the cornerstone document on human research ethics, among others.

Conducting transparency performance audits for new drugs hopefully will incentivize pharmaceutical companies to improve behaviors, give more publicity to best practices, and support the government's monitoring capabilities," said Miller. "The scorecard and rankings have the potential to benefit consumers by helping assure the integrity and completeness of clinical trial information. Full transparency of clinical trials would also strengthen the protection of human research subjects by avoiding their unknowing recruitment into already failed experiments."

Miller and her team will publish this scorecard annually, ranking each new group of FDA approved drugs going forward. A ranking of 2015 approved drugs and their sponsors will be released in 2016.

www.laboratoryequipment.com/news/2015/11/big-pharma-inconsistent-clinical-trial-information

[jim]

Thanks for this Gerald. thumbsupde1

[judi]

Whats this, I read on page 2 that vilanterol was no more effective than salmeterol (in Advair) and neither was any more effective than placebo? The trial was on asthmatics so the results on COPD may differ but it kind of makes you wonder if they fudged that data a little for us. I always breathe better for a little while when I try a new med, I wonder if a lot of people do and thats part of where they get the results showing improvement, our lungs are so bad in many cases anything might help.

I have a sample of Anoro which contains vilanterol and my pulmo said it was very expensive because it was new. Breo Ellipta has it as well. I haven't looked at the research data but even if there was a small improvements will the improvement last over time and is it worth all the money?


I ran across an investment site and they were really pushing COPD drugs as a hot investment and money maker. I like new meds and more choices as much as anyone but I think the amount of money being made is obscene considering how little the meds differ from each other.

I know they aren't very honest about side effects, they tend to use language that while medically accurate is not specific and can minimize what is actually happening. I had very painful burning feet on higher doses of med and the side effects listed 'paresthesia', that is accurate but the term can describe anything from having your foot go to sleep and getting pins and needles to what I experienced. Now I see 'burning' is listed some places but I got diagnosed with 'idiopathic neuropathy' when it happened to me and no one would even consider the med.

[gerald]

I tried Anoro, and 4 or 5 others. At most they worked for a day or so, then stopped working. Some had no affect.

I had an appointment with my respiratory specialist last week. He had just some from a major conference and one of the discussion was around new procedures . drugs etc. He said one of the problems they are encountering is the audience that is used for the trials. In many cases the people have such mild cases of COPD that either anything would show an improvement or nothing would show an improvement depending on what they have as a goal.

This is the same problem with some of the trial procedures / operations / etc that we keep hearing about. I discussed 2 or 3 of them with the specialist and he said they may work. But they trials were done on very very mild cases, so no real proof yet.


If you have a mild case of COPD I would expect Advair would not have much of an affect. But it certainly worked for me, but has some side effects. I switch to Symbicort and it works will.