The Petition text: Dear Mr Wieland Under the current voluntary EU lobby register, too many lobbyists conduct their lobbying secretively and unethically. This does citizens like me, and the public interest, a great disservice. I want to know who is trying to gain influence on EU politics, with what budget, on which issues and on whose behalf. This situation can only be delivered by the transition to a register in which all lobbyists conducting their work in Brussels have to register. It also needs a clear and enforceable ethics code and strong measures to support full transparency while the new register is introduced. As the European Parliament’s Vice-President for Transparency, it is vital that you stand up for lobbying transparency and implement the view of the majority of MEPs who supported the transition to a mandatory lobby register in their vote in May 2011.
Why this is important:
” …Lobbying works in Brussels, partly because it is able to operate in the shadows, and away from the glare of publicity. Thousands of lobbyists boycott the voluntary EU lobby register including virtually all law firms that lobby on behalf of industry clients. Many of the companies and organisations that do sign up, fail to provide comprehensive, accurate and up-to-date information on their activities. And unfortunately, the EU institutions seem happy to let this situation continue.
You can help to change this situation. Right now, the lobby register is being reviewed in a series of meetings (mostly held in secret) between the Commission and MEPs. In November, they will finalise their views and it is vital that we do not lose this unique opportunity to demand change… ”
” …So there I sit, watching a former stripper sing, moments before having my vulva removed. Thoughts boomerang inside me: Every story line on TV revolves around sex. But what about those of us who can’t make love? What if your sex drive is in reverse because in a place that should be divinely pleasurable, you feel pain? Isn’t there anything that defines intimacy beyond throbbing bodies? Everywhere I look makes me feel less like a woman. And yet. I know there is something bigger, something more. My “womanhood” has nothing to do with my vagina, it is in me…”
Publication and reporting of clinical trial results
To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.
Cross sectional analysis
Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009.
PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.
Main outcome measures:
The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.
Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.
Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.
The FDA has put few measures in place to ensure that drugs that are approved based on limited populations are only marketed to those limited groups
New drugs that receive expedited review by the Food and Drug Administration are being tested on fewer patients, leaving many safety questions unanswered even after they are approved, a study released on Monday in the Journal of the American Medical Association found.
It found that expedited drugs underwent a median of 5.1 years of clinical testing before being approved, compared with 7.5 years for those that underwent a standard review. But in many cases safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted, not completed, or not submitted to the FDA.
“The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population with extensive additional testing conducted after approval,” the authors said.
At the urging of patient groups, Congress and the drug industry, the FDA over the past decade has introduced multiple mechanisms for speeding new products to the market. While patient groups and drug companies applaud these measures, saying they get much-needed medication into the hands of patients more quickly, critics say the agency is approving products before they have been fully vetted.
Of the drugs studied by Moore and Furberg in 2008, the FDA required 85 follow-up trials to monitor for safety. By 2013, only 40 percent of those studies had been completed.
The FDA said in a statement that it will review the article in more detail but that on the surface “it shows that the expedited development programs are working as intended by getting promising new drugs to patients more quickly.”
The FDA has traditionally required two controlled clinical trials to prove that a drug is safe and effective. Over time the agency has relaxed the evidence it is willing to accept for certain products.
In some cases the FDA will accept data from a single trial and success may be judged on the basis of a surrogate measure – such as tumor shrinkage – that may or may not translate into a concrete measure such as increased survival.
“In situations of serious and life-threatening diseases with unmet medical need, patients and physicians who treat them have told us repeatedly that they are willing to accept greater uncertainty about risk in order to have access to the hope of improved treatment today,” the FDA said in its statement.
The FDA is discussing additional measures to speed the drug development process, including the use of “enriched” trials that would select patients based on certain demographic or genetic characteristics in order to increase the chance of a trial’s success.
The idea is to direct treatment to patients for whom it will be most effective or who are most likely to respond.
But in a commentary published alongside the study, Daniel Carpenter, a professor of government at Harvard University, said the FDA has put few measures in place to ensure that drugs that are approved based on limited populations are only marketed to those limited groups.
“The current system of accelerating drug approval in the United States can be described as a growing hodgepodge of exceptions to the rule of rigorous premarket review,” he said.
The FDA said it has a “robust program for postmarketing surveillance and ensuring the completion of required post-approval trials.”
“We believe that we have set the bar for the balance between pre-approval testing and early availability of promising new drugs to treat serious and life-threatening diseases in the right place.”
” Mammography screening is one of the greatest controversies in healthcare, and the extent to which some scientists have sacriﬁced sound scientiﬁc principles in order to arrive at politically acceptable results in their research is extraordinary.
In contrast, neutral observers increasingly ﬁnd that the beneﬁt has been much oversold and that the harms are much greater than previously believed.
This groundbreaking book takes an evidence-based, critical look at the scientiﬁc disputes and the information provided to women by governments and cancer charities. It also explains why mammography screening is unlikely to be effective today. ”
Systematic review and meta-analysis of observational studies
Abstract: Objectives: To evaluate whether the stage distribution among women diagnosed as having breast cancer differs between those who have received breast implants for cosmetic purposes and those with no implants and to evaluate whether cosmetic breast augmentation before the detection of breast cancer is a predictor of post-diagnosis survival.
Systematic review of observational studies with two meta-analyses.
Systematic search of the literature published before September 2012 conducted in Medline, Embase, Global health, CINAHL, IPAB, and PsycINFO.
Study selection Eligible publications were those that included women diagnosed as having breast cancer and who had had augmentation mammaplasty for cosmetic purposes.
The overall odds ratio of the first meta-analysis based on 12 studies was 1.26 (95% confidence interval 0.99 to 1.60; P=0.058; I2=35.6%) for a non-localized stage of breast cancer at diagnosis comparing women with implants who had breast cancer and women without implants who had breast cancer. The second meta-analysis, based on five studies, evaluated the relation between cosmetic breast implantation and survival. This meta-analysis showed reduced survival after breast cancer among women who had implants compared with those who did not (overall hazard ratio for breast cancer specific mortality 1.38, 95% confidence interval 1.08 to 1.75).
The research published to date suggests that cosmetic breast augmentation adversely affects the survival of women who are subsequently diagnosed as having breast cancer. These findings should be interpreted with caution, as some studies included in the meta-analysis on survival did not adjust for potential confounders. Further investigations are warranted regarding diagnosis and prognosis of breast cancer among women with breast implants.
Internal financial documents show that ACSH – The American Council on Science and Health “nonprofit organization that debunks junk science health claims with science-based evidence and common sense” – depends heavily on funding from corporations that have a financial stake in the scientific debates it aims to shape, say Andy Kroll and Jeremy Schulman in their report. The ACSH – Pro-Industry Science Group? – also directly solicits donations from these industry sources around specific issues. ACSH’s financial links to corporations involved health and safety controversies highlighted in the past – such as Bisphenol-A (BPA) and pesticides.
Alok Jha, Science correspondent at the Guardian and BBC TV presenter, speaks at length with Campaigner, Writer, Dr Ben Goldacre about his investigation into the pharmaceuticals industry and his book Bad Pharma.
Endometrial Stromal Cells of Women with Recurrent Miscarriage Fail to Discriminate between High- and Low-Quality Human Embryos
More than ten percent of clinical pregnancies end in miscarriage. Recurrent miscarriages (RM), defined as three or more consecutive miscarriages, is experienced by 1–2% of couples that try to conceive. Since the prevalence of RM is higher than what would be expected by probability alone, it is likely to indicate specific aetiologies in affected women. Known causes include fetal genetic abnormalities, uterine abnormalities, antiphospholipid syndrome and thrombophilic disorders. However, in more than 50% of cases, no cause is identified.
Increasing evidence suggests that some women may experience RM when ‘super-receptive’ endometrium allows embryos of low viability to implant, presenting as a clinical pregnancy before miscarrying.