FDA tries to regulate Health Apps

#FDA works to gain the jurisdiction to regulate health related mobile apps. #HealthApps

FDA works to gain the jurisdiction to regulate health related mobile apps.

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Has Big Pharma hijacked the European Health Research Budget?

Pharmaceutical research is a legitimate use of public money. This is not the first time researchers across Europe have taken issue with the priorities of the European Union’s health research programme

a paper by Michael J Galsworthy, Leonardo Palumbo, Martin McKee

mike galsworthy
Mike Galsworthy: Science by day, poetry by night. Tweets mainly on EU & UK science policy, politics, open data – and occasionally poetry/arts stuff.

The European Commission has just launched its new €80 billion 7-year science fund Horizon 2020. Separately, the Commission has been negotiating five joint-technology initiatives cofinanced by a range of industries. However, the source of matching funds within Horizon 2020 has been unclear.

Now it emerges that one joint technology initiative, the Innovative Medicines Initiative 2 (IMI2), cofunded by the European Federation of Pharmaceutical Industries and Associations, is promised €1·7 billion, not from the Excellent Science (basic research) nor the Industrial Leadership pillars of Horizon 2020, but exclusively from the third pillar, Societal Challenges – specifically the €7·4 billion Health, Demographic Change and Wellbeing stream designed for public health and health services research. An additional €683 million ring-fenced for clinical trials means that 25–32% of health and demographic change research funds are dedicated to drug development.

Pharmaceutical research is a legitimate use of public money. As its name suggests, the IMI2 is the successor to IMI1, which received €1 billion in public funds and was proclaimed as “the world’s largest public-private partnership in health”. However, the source and size of IMI2 funds are alarming. In 2012, the US National Institutes of Health came in for criticism when they decided to divert just 2% of their US$31 billion annual budget on a scheme to speed up drug development. This is not the first time researchers across Europe have taken issue with the priorities of the European Union’s health research programme.

In late 2013, the Commission published its first work programme for health in Horizon 2020. This publication caused immediate consternation, with four of Europe’s leading health organisations expressing, in a letter to the Commissionner, how they were “deeply concerned about the balance of priorities” as the programme focused primarily on biotechnology and personalised medicine, and reiterating the importance of prevention and promotion programmes, tackling social inequalities, providing faster and joined-up services, and improving health-care delivery.

So how did the joint-technology initiatives win these funds without observers of European science policy knowing? First, despite their size, they were never mentioned in the detailed Horizon 2020 breakdowns circulated widely. Second, their finalisation took place separately from the Horizon 2020 negotiations in the European Council, with no meaningful consultation with wider stakeholders. In the same way that hefty donations with strings attached distort spending by WHO,6 the European pharmaceutical industry can use a fraction of its €27 billion annual spend on research and development to leverage public subsidy, seemingly without the wider research community present to offer counterarguments.

Arguments by organisations seeking greater transparency of IMI2 through the European Parliament’s Industry, Research and Energy Committee have been rebuffed because of increases in “administrative burden …undermining competitiveness”. The scale of IMI2 and use of societal challenges funds to pay for it can expect to attract considerable controversy. ”

Sources
  • TheLancet, PDF Downloads, March 19 2014
  • Mike @mikegalsworthy ‘s tweet, 19 Mar 2014

Introducing “Testing Treatments Interactive”

Promoting Better Research for Better HealthCare, 2014

Sir Iain Chalmers explains why fair tests of the effects of treatments can improve healthcare.

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Potential Health effects of Toxic Chemicals in Feminine Care Products

Products intended for use on or in an incredibly absorbent part of a woman’s body are marketed and sold with little to no data assuring the ingredients they contain are safe

image of Chem Fatale Report cover page
The Women’s Voices for the Earth November 2013 Chem Fatale report found toxic chemicals commonly used in feminine care products like pads and tampons.

Feminine care. Feminine hygiene. Personal cleansing products. Intimate care. No matter what you call them, these consumer products are manufactured for and marketed exclusively to women. The purpose of feminine care products is to clean, moisturize, absorb discharge or otherwise treat the sensitive skin and tissues of the vaginal area. Women are told they are necessary for personal hygiene, a “fresher feeling,” or “greater confidence,” and the companies marketing these products imply that this improved cleanliness will promote good health and increase sex appeal.

A closer look at the impacts of these products, and the chemicals they contain, tell a much different story. Products intended for use on or in an incredibly absorbent part of a woman’s body are marketed and sold with little to no data assuring the ingredients they contain are safe. Ingredients are determined “safe,” operating under the premise that they are used on ordinary skin just like other cosmetic products. That means chemicals of concern such as carcinogens, reproductive toxins, endocrine disruptors, and allergens are being used on, or even in, the extremely permeable mucus membranes of the vaginal area. ”

  • Introduction
    • what are feminine care Products?
    • feminine care Products: what makes them special?
    • who uses feminine care?
  • How feminine care Products are regulated
  • Potential HealtH Hazards associated with chemicals found in feminine care Products
    • secret toxic chemicals in fragrance
    • tampons
    • menstrual pads
    • feminine wipes
    • feminine wash
    • douche
    • feminine deodorant
    • over-the-counter anti-itch creams
  • Solutions
    • Personal alternatives
    • recommended federal and corporate Policy changes
  • Appendix : chemicals of concern in feminine care Products

Read the Women’s Voices for the Earth
November 2013 Chem Fatale report

Discover Women’s Voices Earth blogFacebook and Twitter.

Cancer Statistics: the Difference between Survival and Mortality Rates

How do we measure our ability to prevent death?

Almost every time someone wants to proclaim the US to be the “best in the world” in health care, they point to survival rates. The metric people should be using is mortality rates…

  • Survival rates refer to the percent of people who live a certain amount of time after they’ve been diagnosed with a disease. But there are real problems in using survival rates to compare the quality of care across systems.
  • When we compare mortality rates, we don’t look nearly as good. Why is this important? Aaron E. Carroll answers in this video by NHS Commissioning Board, 15 Dec 2013.

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Why ALL data from ALL drug Trials MUST be released

Why researchers MUST publish ALL results of clinical trials

Why the data on all drug trials must be released
Hidden pharma trials lead to bad treatment decisions, waste of time, money and effort

Results of thousands of clinical trials remain unreported – leading to bad treatment decisions and duplicated research effort.

Despite the fact that hidden and unregistered trials are compromising patient care, change is still being blocked or slowed by bodies that say it’s too complex and hard to police.

Read Why the data on all drug trials must be released
by Síle Lane, The Guardian, 17 Sept 2013.

Related posts:

Chemotherapy alternatives: new Cancer Tools allow Patients to reconsider harsh Cancer Treatments

Combination of new technology and more-targeted cancer drugs

A development stage biotechnology company is leading the way to a new approach to cancer treatment, adding years of survival and doing so without toxic side effects at lower cost than pricier new cancer drugs.

  • Video by IBTimesTV, Published on 2 May 2013

Find out more

  • After decades of using one-size-fits-all therapies to combat cancer, doctors are using new tools to help decide when their patients can skip chemotherapy or other harsh treatments. An approach to oncology that has been in place for decades is beginning to yield to an arsenal of long-term clinical studies, genetic tests and novel drugs that target cancer cells and their infrastructure.
  • Read Skip Chemo? New Cancer Tools Allow Patients To Reconsider Harsh Cancer Treatments
     HuffPost Healthy Living, 15 May 2013.
  • More posts on Cancer and Chemotherapy.

2013 Revolutionary Research on Pancreatic, Ovarian and Lung Cancer Detection

My 3 Cents on Cancer: Jack Andraka at TEDxSanJoseCAWomen

Jack is a fifteen year old freshman in high school. He developed a paper sensor that could detect pancreatic, ovarian and lung cancer in five minutes for as little as 3 cents. He conducted his research at John Hopkins University. This research could change the face of cancer and promote early detection. He has been selected as the Intel 2012 ISEF winner and has won awards at multiple national and international math competitions. Jack is on the national junior whitewater kayaking team and enjoys playing with his dog and folding origami.

  • Jack’s method is 168 times faster, 26000 times cheaper, 400 times more sensitive and has a 90% success rate.
  • In the spirit of ideas worth spreading, TEDx is a program of local, self-organized events that bring people together to share a TED-like experience. At a TEDx event, TEDTalks video and live speakers combine to spark deep discussion and connection in a small group. These local, self-organized events are branded TEDx, where x = independently organized TED event. The TED Conference provides general guidance for the TEDx program, but individual TEDx events are self-organized.
  • Video by TEDxTalks, Published on 15 Jan 2013
  • DES Videos in English – Diethylstilboestrol video channel DES Diethylstilboestrol's channel on YouTube

Pacific Cod Fish Protein should be a promising antimetastatic Agent for various Cancer Treatments

The use of natural dietary products with anti-tumor activity is an important and emerging field of research

New Study: Fish Protein may Slow Down Cancer MetastasisResearch published in Proceedings of the National Academy of Sciences (PNAS) claims that protein derived from Pacific cod fish may suppress Prostate Cancer and perhaps other cancers from spreading. The research carried out by the researchers at the University Of Maryland School Of Medicine. ”

Read New Study: Fish Protein may Slow Down Cancer Metastasis , DNA, 20 Mar 2013.

Scientists find evidence of unreported Prescription Drug side Effects via Search Engines before FDA

Web-scale pharmacovigilance: listening to signals from the crowd

Unreported Side Effects of Drugs Are Found Using Internet Search Data, Study FindsUsing data drawn from queries entered into Google, Microsoft and Yahoo search engines, scientists at Microsoft, Stanford and Columbia University have for the first time been able to detect evidence of unreported prescription drug side effects before they were found by the Food and Drug Administration’s warning system. ”

Read Unreported Side Effects of Drugs Are Found Using Internet Search Data, Study Finds by John Markoff.

Abstract

Adverse drug events cause substantial morbidity and mortality and are often discovered after a drug comes to market. We hypothesized that Internet users may provide early clues about adverse drug events via their online information-seeking. We conducted a large-scale study of Web search log data gathered during 2010. We pay particular attention to the specific drug pairing of paroxetine and pravastatin, whose interaction was reported to cause hyperglycemia after the time period of the online logs used in the analysis. We also examine sets of drug pairs known to be associated with hyperglycemia and those not associated with hyperglycemia. We find that anonymized signals on drug interactions can be mined from search logs. Compared to analyses of other sources such as electronic health records (EHR), logs are inexpensive to collect and mine. The results demonstrate that logs of the search activities of populations of computer users can contribute to drug safety surveillance.

Web-scale pharmacovigilance: listening to signals from the crowd, jamia, 1 May 2013.