More FDA corruption and big pHarma whinning

When I was a kid, if I were told that I’d be writing a book about diet and nutrition when I was older, let alone having been doing a health related radio show for over 36 years, I would’ve thought that whoever told me that was out of their mind. Living in Newark, New Jersey, my parents and I consumed anything and everything that had a face or a mother except for dead, rotting, pig bodies, although we did eat bacon (as if all the other decomposing flesh bodies were somehow miraculously clean). Going through high school and college it was no different. In fact, my dietary change did not come until I was in my 30′s.

Just to put things in perspective, after I graduated from Weequahic High School and before going to Seton Hall University, I had a part-time job working for a butcher. I was the delivery guy and occasionally had to go to the slaughterhouse to pick up products for the store. Needless to say, I had no consciousness nor awareness, as change never came then despite the horrors I witnessed on an almost daily basis.

After graduating with a degree in accounting from Seton Hall, I eventually got married and moved to a town called Livingston. Livingston was basically a yuppie community where everyone was judged by the neighborhood they lived in and their income. To say it was a “plastic” community would be an understatement.

Livingston and the shallowness finally got to me. I told my wife I was fed up and wanted to move. She made it clear she had to be near her friends and New York City. I finally got my act together and split for Colorado.

I was living with a lady in Aspen at the end of 1974, when one day she said, ” let’s become vegetarians”. I have no idea what possessed me to say it, but I said, “okay”! At that point I went to the freezer and took out about $ 100 worth of frozen, dead body parts and gave them to a welfare mother who lived behind us. Well, everything was great for about a week or so, and then the chick split with another guy.

So here I was, a vegetarian for a couple weeks, not really knowing what to do, how to cook, or basically how to prepare anything. For about a month, I was getting by on carrot sticks, celery sticks, and yogurt. Fortunately, when I went vegan in 1990, it was a simple and natural progression. Anyway, as I walked around Aspen town, I noticed a little vegetarian restaurant called, “The Little Kitchen”.

Let me back up just a little bit. It was April of 1975, the snow was melting and the runoff of Ajax Mountain filled the streets full of knee-deep mud. Now, Aspen was great to ski in, but was a bummer to walk in when the snow was melting.

I was ready to call it quits and I needed a warmer place. I’ll elaborate on that in a minute.

But right now, back to “The Little Kitchen”. Knowing that I was going to leave Aspen and basically a new vegetarian, I needed help. So, I cruised into the restaurant and told them my plight and asked them if they would teach me how to cook. I told them in return I would wash dishes and empty their trash. They then asked me what I did for a living and I told them I was an accountant.

The owner said to me, “Let’s make a deal. You do our tax return and we’ll feed you as well”. So for the next couple of weeks I was doing their tax return, washing their dishes, emptying the trash, and learning as much as I could.

But, like I said, the mud was getting to me. So I picked up a travel book written by a guy named Foder. The name of the book was, “Hawaii”. Looking through the book I noticed that in Lahaina, on Maui, there was a little vegetarian restaurant called,” Mr. Natural’s”. I decided right then and there that I would go to Lahaina and work at “Mr. Natural’s.” To make a long story short, that’s exactly what happened.

So, I’m working at “Mr. Natural’s” and learning everything I can about my new dietary lifestyle – it was great. Every afternoon we would close for lunch at about 1 PM and go to the Sheraton Hotel in Ka’anapali and play volleyball, while somebody stayed behind to prepare dinner.

Since I was the new guy, and didn’t really know how to cook, I never thought that I would be asked to stay behind to cook dinner. Well, one afternoon, that’s exactly what happened; it was my turn. That posed a problem for me because I was at the point where I finally knew how to boil water.

I was desperate, clueless and basically up the creek without a paddle. Fortunately, there was a friend of mine sitting in the gazebo at the restaurant and I asked him if he knew how to cook. He said the only thing he knew how to cook was enchiladas. He said that his enchiladas were bean-less and dairy-less. I told him that I had no idea what an enchilada was or what he was talking about, but I needed him to show me because it was my turn to do the evening meal.

Well, the guys came back from playing volleyball and I’m asked what was for dinner. I told them enchiladas; the owner wasn’t thrilled. I told him that mine were bean-less and dairy-less. When he tried the enchilada he said it was incredible. Being the humble guy that I was, I smiled and said, “You expected anything less”? It apparently was so good that it was the only item on the menu that we served twice a week. In fact, after about a week, we were selling five dozen every night we had them on the menu and people would walk around Lahaina broadcasting, ‘enchilada’s at “Natural’s” tonight’. I never had to cook anything else.

A year later the restaurant closed, and somehow I gravitated to a little health food store in Wailuku. I never told anyone I was an accountant and basically relegated myself to being the truck driver. The guys who were running the health food store had friends in similar businesses and farms on many of the islands. I told them that if they could organize and form one company they could probably lock in the State. That’s when they found out I was an accountant and “Down to Earth” was born. “Down to Earth” became the largest natural food store chain in the islands, and I was their Chief Financial Officer and co-manager of their biggest store for 13 years.

In 1981, I started to do a weekly radio show to try and expose people to a vegetarian diet and get them away from killing innocent creatures. I still do that show today. I pay for my own airtime and have no sponsors to not compromise my honesty. One bit of a hassle was the fact that I was forced to get a Masters Degree in Nutrition to shut up all the MD’s that would call in asking for my credentials.

My doing this radio show enabled me, through endless research, to see the corruption that existed within the big food industries, the big pharmaceutical companies, the biotech industries and the government agencies. This information, unconscionable as it is, enabled me to realize how broken our health system is. This will be covered more in depth in the Introduction and throughout the book and when you finish the book you will see this clearly and it will hopefully inspire you to make changes.

I left Down to Earth in 1989, got nationally certified as a sports injury massage therapist and started traveling the world with a bunch of guys that were making a martial arts movie. After doing that for about four years I finally made it back to Honolulu and got a job as a massage therapist at the Honolulu Club, one of Hawaii’s premier fitness clubs. It was there I met the love of my life who I have been with since 1998. She made me an offer I couldn’t refuse. She said,” If you want to be with me you’ve got to stop working on naked women”. So, I went back into accounting and was the Chief Financial Officer of a large construction company for many years.

Going back to my Newark days when I was an infant, I had no idea what a “chicken” or “egg” or “fish” or “pig” or “cow” was. My dietary blueprint was thrust upon me by my parents as theirs was thrust upon them by their parents. It was by the grace of God that I was able to put things in their proper perspective and improve my health and elevate my consciousness.

The road that I started walking down in 1975 has finally led me to the point of writing my book, “A Sane Diet For An Insane World”. Hopefully, the information contained herein will be enlightening, motivating, and inspiring to encourage you to make different choices. Doing what we do out of conditioning is not always the best course to follow. I am hoping that by the grace of the many friends and personalities I have encountered along my path, you will have a better perspective of what road is the best road for you to travel on, not only for your health but your consciousness as well.

Last but not least: after being vaccinated as a kid I developed asthma, which plagued me all of my life. In 2007 I got exposed to the organic sulfur crystals, which got rid of my asthma in 3 days and has not come back in over 10 years. That, being the tip of the iceberg, has helped people reverse stage 4 cancers, autism, joint pain, blood pressure problems, migraine headaches, erectile dysfunction, gingivitis, and more. Also, because of the detoxification effects by the release of oxygen that permeates and heals all the cells in the body, it removes parasites, radiation, fluoride, free radicals, and all the other crap that is thrust upon us in the environment by Big Business.

For more, please view www.healthtalkhawaii.com and www.asanediet.com.

Namaste!

More FDA corruption and big pHarma whinning

AMA head criticises "demonisation" of big pharma by anti-vaxxers

The president of the Australian Medical Association, Dr Michael Gannon, says it has been disappointing to see a growing “demonisation of pharmaceutical companies” by the anti-vaccination movement in an attempt to promote distrust of proven medicines.

Gannon made the comments in response to the NSW health department recommending reforms that, if implemented, would see parents of high-school students compelled to provide details of their child’s vaccination status, and give public health officers the power to exclude unvaccinated children from high schools during disease outbreaks.

This policy already applies to children in childcare and primary school, but may be extended under the Public Health Act to apply to high schools. A bill reflecting the recommended changes will be drafted and considered by the parliament in 2017.

Gannon told Guardian Australia he supported the changes, which would see unvaccinated children banned from childcare and school for up to two weeks if they come into contact with a child suffering a vaccine-preventable disease — even if they aren’t sick themselves.

“I’m reluctant to make the comparison between anti-vaxxers and climate change deniers, but it almost seems if you can shout louder than the careful, temperate advice from medical professionals and scientists you might get support for your non-scientific views,” he said.

A report from the NSW Child Death Review Team, published on Tuesday, found that in the decade to 2014, 23 child deaths may have been prevented had the children been vaccinated.

Gannon said he believed there was a growing distrust of the medical profession and of big pharma which may be fuelling the anti-vaccination movement.

“Let’s be clear that the pharmaceutical industry is not without sin,” he said.

“But it is disappointing to hear this demonisation of vaccinations as a result of this distrust, and overall the pharmaceutical industry improves and saves tens of millions of lives, without exaggeration, each day.

“The processes by which vaccines get approved and by which the relevant commonwealth government departments decide which medicines to spend tens of millions of taxpayers’ dollars on is very careful, and has to be.

“Vaccines approved have to represent value for money and have to be safe. The idea that big pharma rolls into town and that their latest idea gets approved without scrutiny is ludicrous.”

He said vaccines and their safety were continuously scrutinised and reviewed at a level that “many other things in the community aren’t”.

The director of communicable diseases for NSW Health, Dr Vicky Sheppeard, said that in recent years the incidence of some diseases preventable by vaccine, such as measles, had been higher in high-school-age children than in younger children.

“All recent measles outbreaks in NSW have tended to affect high-school children rather than primary-school children,” she said.

“Since then, catch-up measles vaccination has been offered in all NSW high schools, further reducing the risk of outbreaks occurring in this setting.”

AMA head criticises "demonisation" of big pharma by anti-vaxxers

Antibiotic waste is polluting India and China"s rivers; big pharma must act

Antibiotic-resistant superbugs are a fundamental threat to global health, UN secretary general Ban Ki-moon recently told a general assembly meeting. Failure to address the problem, he said, would make it “difficult if not impossible” to provide universal healthcare, “and it will put the sustainable development goals in jeopardy”.

For pharmaceutical companies the attention on antimicrobial resistance has also brought a focus on one of its key drivers: the unabated environmental pollution of drug factories in developing countries.

In India and China, where a large proportion of antibiotics are produced, the poorly regulated discharge of untreated wastewater into soils and rivers is causing the spread of antibiotic ingredients which cause bacteria to develop immunity to antibiotics, creating superbugs.

A study of drug factories in China found that antibiotic-resistant bacteria were not only escaping purification but also breeding. For every bacterium that entered one waste treatment plant, four or five antibiotic-resistant bacteria were released into the water system, tainting water, livestock and communities.

Superbugs are able to travel quickly through air and water, aboard airplanes and through global food supply chains. By 2050, the total death toll worldwide as the result of contracting an infection that proves resistant to treatment is expected to reach 10 million people (pdf).

Environmental pollution is now a material issue for the pharmaceuticals sector. Global investors such as Nordea and BNP Paribas have raised concern about the potential damage to global health and environment, and are worried that a local factory pollution scandal in India could affect the value of a global pharma company in their portfolio. As the world goes on a global quest to combat antimicrobial resistance, the focus on industry pollution will continue grow.

Last month 13 pharmaceutical companies signed a declaration (pdf) calling for collective action on antimicrobial resistance. They committed to review their manufacturing and supply chains and assess good practice in controlling releases of antibiotics into the environment. They also committed to establish science and risk-based targets for discharge concentrations of antibiotics and to reduce the environmental impact of manufacturing discharges by 2020.

Most global sectors now have a corporate platform where companies seek to tackle intractable sustainability challenges. For pharma companies, the Pharmaceutical Supply Chain Initiative (PSCI) was set up to demand better social and environmental conditions in the communities from where drugs are supplied. However, only 12% of the 140 largest global pharmaceutical companies are members of PSCI according to sector analysts.

Voluntary corporate initiatives are necessary but by no means sufficient to address the industry challenge of environmental pollution. This is partly because not every company signs up and partly because better government policies and law enforcement on the ground are necessary to ensure voluntary commitments are achievable.

The governments where global pharma companies are domiciled – including the UK, US and Switzerland – must play a role. Companies must collaborate with governments to encourage and support a tougher stance on law enforcement in developing counties. At Earth Security Group we call this business diplomacy for sustainable development.

The aid budget of agencies such as the UK Department for International Development could be used to strengthen pollution controls in sourcing countries such as India. This would be a win-win for health in developing countries and for national business interests abroad.

Through the PSCI, the global pharmaceutical industry has called upon governments to collaborate on the threat of increasing antibiotic resistance. PSCI must now also urgently work with governments to achieve the goal of curbing environmental pollution in drug manufacturing.

Ultimately, business diplomacy goes beyond corporate philanthropy and corporate social responsibility, by focusing on the deeper governance failures that threaten progress on sustainable development as well as the license to operate of global companies. Pharmaceutical companies now need to cooperate with governments, to root out pollution from their global supply chains.

Antibiotic waste is polluting India and China"s rivers; big pharma must act

Is Big Pharma To Blame For Soaring Health Costs?

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Drug companies are often demonized for high drug prices. They say it’s necessary in order to create new drugs. Experts at a recent debate take sides.

Is Big Pharma To Blame For Soaring Health Costs?

What Huge Pharma Could Understand From A Craft Beer Brewer

Even though U.S. businesses like Pfizer Pfizer (PFE), Walgreens (WAG) and Medtronic Medtronic (MDT) make noise and grab political consideration by searching at overseas domiciles to reduce tax prices, along comes Tony Magee, brewer of the common Lagunitas IPA from a various college of thought.

He’s headed to Chicago, the greatest city in the pension-dogged state of Illinois with its unions, higher taxes and multi-billion-dollar debts.

Whilst neither Magee’s tax bill, nor revenue nevertheless rival that of a international health-related device maker like Medtronic or a pharmaceutical behemoth like Pfizer, he says he’s asking for nothing at all in his expansion from northern California to Chicago. And that’s not something most organizations – massive or small – can say when they look to increase, relocate or create jobs.

Magee advised the Chicago Sun-Times editorial board earlier this week that he didn’t want any of the economic incentives provided by Mayor Rahm Emanuel’s Chicago City Hall.

That’s in sharp contrast to the Internal Revenue Services escapes attempted by Pfizer, which attempted to flee U.S. taxes with a British domicile, and Medtronic which this month announced strategies to purchase Dublin, Ireland’s Covidien Covidien for virtually $ 43 billion.

Walgreen Walgreen, also, has been urged by some traders to relocate its headquarters to London exactly where it has a relationship with European pharmacy chain Alliance Boots. And drug maker Abbvie (ABBV), which last year spun off from Abbott Laboratories (ABT), was rebuffed in its try to buy Shire in what many observers say was the latest attempt by a U.S. company to take benefit of a loophole that enables them to keep away from larger corporate taxes here.

But Magee, who is searching to broaden from his base in Northern California to Chicago, would have “none” of the economic incentives offered by the city of Chicago, in accordance to the Sun-Instances report.

“I was like, I really do not want any of it,” Magee advised the Chicago Sun-Instances editorial board.

Magee informed the paper that he’d desire to see the city spend tax income on other things. Magee also seemed to get a shot at other firms that inquire for governmental largess when they do organization, bring in jobs and scout for expansion areas.

“You start realizing you make the globe about you by the decisions you make as you move by means of it and if I really don’t really feel like the government need to be looted [or] whored out for companies … we do not need it … so why request for it?” Magee told the Sun-Times. “I’d rather they have far more midnight basketball and fill potholes. Do not give it to me.”

Magee, who is initially from the northwest Chicago suburbs, sees Chicago as a city with cachet and also likes its geographic spot as a shipping hub to get his brand about the world.  In northern California, Lagunitas has been paying $ 150,000 a month in shipping expenses, Sun-Instances reported.

He told the paper: “If I’m going to sell beer from this brewery in Sweden and the Uk as we do appropriate now … they all know exactly where Chicago is.”

 Wondering how  Big Pharma and the well being business will be impacted by Obamacare? The Forbes eBook Within Obamacare: The Repair For America’s Ailing Well being Care Program answers that question and a lot more. Obtainable now at Amazon and Apple.

Beer (Photo credit: mrwynd)

What Huge Pharma Could Understand From A Craft Beer Brewer

Inquiries stay in excess of source of ITH Pharma little one feed contamination

Kate Hamling, of ITH Pharma, mentioned a single ingredient was thought to be the cause of the infection, but provided no further detail. Photograph: YouTube screengrab/ITH Pharma

Final December, 4 newborn babies died in a hospital in Chambéry, south-east France. They have been in the neonatal intensive care unit, premature and weak, and fed not by mouth but by way of an intravenous drip. It took weeks ahead of it was established that the dietary liquid in the drip was to blame. It was contaminated with bacteria. In January, the French authorities suspended the licence of the company making the product, Marette Laboratories, for six months.

The contrast with events in England in the previous handful of days, the place 18 babies have developed septicaemia from a similarly contaminated drip, could not be better. ITH Pharma, which dispatched the contaminated feed to 22 hospitals, has not stopped production. The only disruption has been the arrival of inspectors from the Medicines and Healthcare Goods Regulatory Authority (MHRA) on Wednesday, followed by a modest group of journalists on Thursday to hear a prepared statement from managing director Karen Hamling. She was obviously disturbed by what she described as the “tragic occasions that have occurred above the previous couple of days” and the media interest. Presently though, the company’s licence stays unrestricted.

It seems that the catastrophe in the United kingdom was handled effectively and that the issue has been resolved swiftly, in contrast to the incident in France. The initial child designed signs of septicaemia – blood poisoning – on Friday at Chelsea and Westminster hospital. Other cases there and in other premature baby units were reported to Public Well being England over the weekend. It was quickly clear from the variety and dispersal of circumstances that this was not any hospital’s fault.

The trail led back to ITH Pharma, which was advised by the MHRA at 5pm on Monday that sick babies appeared to have been offered its items, which are not standardised but made up on the day to suit the requirements of the men and women. One ingredient, created by a supplier to ITH, was frequent to all the cases. That ingredient was contaminated with Bacillus cereus, which is typically in the soil and vegetation and can trigger gut troubles, but in this situation triggered existence-threatening septicaemia due to the fact it went straight into the bloodstream.

In France, the bug was not effortlessly recognized. Scientists spoke of a new sort of enterobacteria. But the reason for the closure of the lab appeared to have a lot more to do with the spacing of the deaths. This was not a single batch from a single day’s production, utilizing elements of which something left is routinely destroyed, which ITH Pharma says was the scenario in Britain.

Hamling stressed the company’s track record. In the past 12 months it had supplied 800,000 products of this variety to individuals, she said. She spoke of “exemplary ratings” from regulators for the good quality and security of the manufacturing approach. The MHRA’s inspectors presumably agree, or they would not let manufacturing to proceed.

Nonetheless, there are unanswered questions. If the incident had not led to the quite emotive sickness of so a lot of newborn infants, not to mention a death, these may well be passed over. When the identical bacterium contaminated a liquid referred to as Viaspan, utilised in the transportation of donor organs, in 2012, there was curiosity, but not the forensic media interest these situations will get.

As it is, the company and the inspectors will want to clarify more. They have so far refused to say what the “ingredient” is and which company provided it. It is also nevertheless unclear how the ingredient came to be contaminated and what measures are currently being place in area to avert that happening once again. ITH Pharma is continuing to use the same supplier. The dietary merchandise is manufactured in aseptic situations, which signifies that the surroundings is strictly managed to maintain out bacteria and other micro-organisms. Workers in what are called the Clean Rooms are not permitted to wear jewellery or make-up. Bacteria monitors are set up, manufactured by the British firm Cherwell, which are checked each day, but they did not display up any issue on Tuesday 27 May, the day the contaminated item was created.

Inquiries stay in excess of source of ITH Pharma little one feed contamination

Time For Pharma To Identify Digital Health Far more Than Just A Fairly Font?

It is easy to get the mistaken impression that digital health is mired in the Gartner Hype Cycle trough of disillusionment.  A latest WSJ post on the health insurer support Oscar, long a media darling, struggled to uncover anything far more enthusiastic to say than “the fonts are amazing.”  Meanwhile, a NYT tech reporter has now confirmed what a NYT overall health reporter wrote in 2013 – fitness trackers are not specially precise.

These dispatches appear in the context of a broader discussion of entrepreneurship’s limitations, reflected in a thoughtful essay in the New York Occasions magazine (talked about here) arguing startups have a tendency to develop “pat remedies to critical issues,” and in a harrowing account of the startup life in a current Wired (a shortened model of No Exit), also talked about by Felix Salmon (“The Most High-priced Lottery Ticket In The World“).  And of program, there is Mike Judge’s “blistering and affectionate” Silicon Valley, HBO’s “incisive send-up of socially awkward, very intelligent tech insurgents, and also of the eccentric, cutthroat billionaire entrepreneurs who they need to deal with,” as Asawin Suebseang has nicely summarized.

As its worst, the picture emerges of impressionable young grownups manipulated by cynical investors whose enterprise model depends on convincing sufficient eager volunteers to signal up for really higher-chance missions for the guarantee of glory, self-actualization, and shiny Teslas for the number of who make it back.

Nevertheless, the digital health area I see evolving seems appreciably much more hopeful, featuring  increasingly sophisticated, seasoned entrepreneurs, who know how the game is played, and a set of A-checklist traders this kind of as Andressen-Horowitz, Kleiner Perkins, Venrock, Khosla Ventures, and Orbimed, who all (at least by this level) recognize the two the possibility and the difficulties in healthcare, and truly feel compelled to have a critical go at digital well being nonetheless.

I continue to be specially intrigued by the options for digital wellness in pharma, specifically offered how much the sector has been absolutely rattled by the extreme payor pushback to the new generation of hepatitis medication.  If the worth story for these medicines can be challenged, the reasoning goes, how are most other pipeline items very likely to fare?  It’s a non-trivial concern.

Digital wellness technologies could support pharma businesses define and augment the worth story for goods, and also support businesses through the use of sophisticated phenotyping approaches to section sufferers, and as a result streamline merchandise development.

Although many huge pharmas are pursuing digital overall health routines (see this nice evaluation from MobiHealthNews), these efforts strike me as the type of frilly, high-profile demonstration projects that rich businesses pursue as a sort of vanity exercise, to demonstrate their dedication to innovation.  As this kind of, the operate tends to be intriguing sufficient, but not prosecuted with real urgency, as if the company’s long term actually depended on it.

In contrast, I suspect that the transformative second for digital health in pharma will come when a scrappy, smaller sized pharma figures out how to profitable industry a cheap (probably even generic) drug with a sophisticated digital health offering built all around it so it can be sold as a higher-worth resolution to payors, commanding a larger cost than the generic alone by efficiently giving the clinical influence – the outcomes — of a up coming generation, branded merchandise, but at a more desirable value stage.

When big pharmas uncover themselves losing anticipated blockbusters due to this kind of disruptive technique, you can bet they will embrace digital wellness as a aggressive necessity, rather than as an amusing distraction.

Time For Pharma To Identify Digital Health Far more Than Just A Fairly Font?

Big Pharma, my cancer patient and me | Ranjana Srivastava

After failing two varieties of chemotherapy for innovative cancer, my patient knew that her lease on lifestyle was brief, but a cherished family members event stood in the way. “My son is going to propose at the Christmas table, I just want to make it there.” Her son has been her anchor all through her challenge I could see why his engagement mattered so considerably. But Christmas was still some months away, and I feared the feat will be challenging.

“I am not afraid to die but I just want to know that I gave it my all.” This is an all too frequent exchange, unfailingly poignant, frequently heart-wrenching. An totally reasonable answer would be to gently reiterate the lack of meaningful chemotherapy, broach the benefit of excellent palliative care, and allow for regret at the two our ends. Contrary to common belief that mythologizes every patient raging against cancer to the really end, for a lot of this discussion eases the burden of expectation and makes it possible for for a peaceful finish.

But this fairly young mom was merely not prepared however. “I would happily die correct after he proposed” she smileed, reminding me that her goalpost had never ever modified. When a patient like that seems to be you in the eye, it isn’t easy to separate foreboding statistics and human longing into two neat piles and deny hope.

My head said that one more chemotherapy drug wouldn’t make a considerable survival distinction. But my heart urged me to try, if not to enhance survival, then merely to reassure her that she gave it her best shot. Place merely, we both knew that the gesture will be much more therapeutic than the drug itself, hardly a uncommon observation in medicine.

I wrote to a massive pharmaceutical organization for compassionate access to a common chemotherapy that’s not government subsidised for her exact type of cancer (most most likely simply because individuals normally don’t dwell long ample to need to have it). It is a relatively outdated and low-cost drug, importantly with manageable toxicity, and I requested a month’s provide to gauge response. I additional that the patient does not expect recurrent funding in situation she responds to the drug, addressing a legitimate concern. In a planet the place we regularly push the boundaries or prescribe chemotherapy in far more questionable situations, I come to feel comfortable that what I am really carrying out is asking the firm to be my spouse in nurturing hope. Which is after all what every pharmaceutical representative has informed me for as lengthy as I have recognized.

So I merely don’t feel it when my request is declined. Pondering this to be a blunder, I protest further up the chain, pointing out to a senior executive that only not too long ago the organization had provided me conference sponsorship well worth thousands much more than the tiny expense of the chemotherapy. The apologies come rapidly, but the explanations are notably absent.

‘If subsidy looks unlikely, entry schemes are retired, often abruptly’. Photograph: Stefan Wermuth/Reuters

My naive puzzlement slowly turns into the realisation that practically each instance the place a firm has facilitated compassionate access to a item, it has been as a type of marketing and advertising as a indicates of gaining rewarding, government-subsidised listing. In the era of astonishingly pricey blockbuster drugs, government subsidisation is the holy grail of big pharma. The expense of treating a few hundred or even a handful of thousand patients for free (and in the process, securing the backing of doctors), is negligible when the ultimate prize is complete government subsidy. Indeed, men and women and organisations such as the UK’s Wonderful and Australia’s PBS are now questioning the feasibility of subsidising medicines that can cost as much as AU$ 200,000 a year for ambiguous advantage.

Compassionate accessibility schemes for these incredibly pricey medicines may facilitate access for picked patients but they are not genuinely compassionate in the way that the typical person understands. Pharmaceutical companies promote an ethically murky type of hope than what medical doctors and their sufferers might comprehend. The advantage to the firm should eventually outweigh the benefit to the person patient. If subsidy seems unlikely, accessibility schemes are retired, sometimes abruptly. When a commonplace drug is neither vying for market recognition nor fighting for subsidisation, there is no incentive to give it to a patient like mine, whose story would anyway by no means be the things of headlines.

You may possibly request the clear query as to why it would take so prolonged for an oncologist to figure out that a pharmaceutical organization is not a charity. The typical argument is that organizations need to automatically recoup the price of drug growth, as only a small minority realize success in the marketplace.

But for each dollar spent on study, nearly twice is spent on lobbying and advertising – and it is also this cost that organizations want to recover. From the time they are students, physicians are exposed to relentless marketing that massive pharma is their companion in healthcare. The glory days of marketing noticed doctors supplied egregious varieties of largesse, from conferences hosted in ancient castles and on cruises to lavish dining and enjoyment. Then there have been the rivers of pens publish-it notes, pressure balls and cute toys to influence prescribing. Regulation is a lot tighter these days, but there is still a lot of income in sponsorships, paid speaking excursions, including one’s credible title to journal content articles, and just selling a drug to one’s peers, specifically if you are anointed a key viewpoint leader.

Drug firms believe practically nothing of sending a representative to wait for three hours in a clinic to invest five minutes with a medical professional. Unlike other folks, these folks never ever express aggravation at the ludicrous wait and are unfailingly courteous. They request subtly about you, your family and your holidays. They probe your prescribing habit and tell you why your peers choose their drug. They routinely inquire what would make it even less complicated for you to prescribe their drug. It is impossible to navigate the discussion in the direction of price or what makes for the greater societal great.

And to be honest, it is unseemly to be something but polite in the direction of someone who has waited hours to see you, appears genuinely nice, and from whom you may want a favour for your up coming patient. These favours are unusual but the younger you are, the much more impressionable. No wonder many medical colleges and hospitals have banned pharmaceutical representative visits, hopefully signalling to medical doctors that the sandwiches have a hidden value.

Ultimately, I tell my patient that my request for compassionate entry was denied. Crushed, she asks if she wasn’t important adequate. “That is not real”, I say unconvincingly, “it’s just the way it is.” She dies, with a number of weeks to go prior to Christmas, leaving me to wonder whether or not the drug may possibly just have bridged the modest gap. I will in no way know, but feeling morally compromised by the whole exchange, I inform the drug company that I will not see its representatives in potential.

I did not assume an acknowledgment but when it came, it sounded like a thinly veiled warning that the visits have been an vital prerequisite to getting favours. An incredulous representative exclaims, “you would genuinely do that, quit seeing us due to what occurred with that a single patient?”

But “that a single patient” represented the human encounter of what occurs when the interests of a patient and the pharmaceutical firm do not align. That 1 patient’s crushed hope felt no much less essential than the renewed hopes of yet another. What took place with that a single patient ultimately opened my eyes to what has gone just before.

It looks only right to start by paying tribute to my patient, even though acknowledging my complicity in the thorny tangle of physicians, individuals and drug organizations.

Big Pharma, my cancer patient and me | Ranjana Srivastava

What the Tamiflu saga tells us about drug trials and big pharma

These days we located out that Tamiflu isn’t going to operate so properly right after all. Roche, the drug business behind it, withheld essential information on its clinical trials for half a decade, but the Cochrane Collaboration, a worldwide not-for-profit organisation of 14,000 academics, finally obtained all the details. Putting the proof together, it has found that Tamiflu has tiny or no impact on complications of flu infection, this kind of as pneumonia.

That is a scandal since the United kingdom government invested £0.5bn stockpiling this drug in the hope that it would help prevent significant side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding important details on how well its drug performs. In reality, the approaches and benefits of clinical trials on the medicines we use these days are even now routinely and legally currently being withheld from medical professionals, researchers and individuals. It is straightforward poor luck for Roche that Tamiflu grew to become, arbitrarily, the poster child for the missing-information story.

And it is a excellent poster kid. The battle in excess of Tamiflu properly illustrates the want for total transparency all around clinical trials, the relevance of entry to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is created on transparency and openness to criticism, since the saga of the Cochrane Tamiflu review began with a easy on-line comment.

In 2009, there was widespread concern about a new flu pandemic, and billions had been getting spent stockpiling Tamiflu around the planet. Due to the fact of this, the Uk and Australian governments exclusively asked the Cochrane Collaboration to update its earlier critiques on the drug. Cochrane reviews are the gold-common in medicine: they summarise all the information on a provided treatment, and they are in a continual review cycle, simply because proof modifications above time as new trials are published. This need to have been a quite every day piece of work: the previous evaluation, in 2008, had discovered some evidence that Tamiflu does, indeed, minimize the rate of problems such as pneumonia. But then a Japanese paediatrician referred to as Keiji Hayashi left a comment that would set off a revolution in our knowing of how proof-based mostly medication ought to operate. This was not in a publication, or even a letter: it was a basic on-line comment, posted informally beneath the Tamiflu evaluation on the Cochrane site, nearly like a blog comment.

The United kingdom government invested £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its good conclusion was driven by information from just one of the papers it cited: an market-funded summary of ten preceding trials, led by an writer referred to as Kaiser. From these ten trials, only two had ever been published in the scientific literature. For the remaining eight, the only offered data on the approaches utilized came from the short summary in this secondary source, developed by business. That is not reputable adequate.

This is science at its greatest. The Cochrane assessment is readily available on-line it explains transparently the approaches by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand exactly where the conclusions came from. Cochrane offers an simple way for readers to increase criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 evaluation. He realised immediately that he had created a blunder in blindly trusting the Kaiser data. He said so, with out defensiveness, and then set about receiving the data necessary.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they had been told that this staff no longer had the files: they must contact Roche. Right here the troubles began. Roche said it would hand more than some info, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tough: Cochrane critiques are built close to showing their functioning, but Roche’s proposed contract would call for them to preserve the data behind their reasoning secret from readers. More than this, the contract explained they have been not allowed to talk about the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the strategies and outcomes of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of men and women all around the planet, and on which governments had invested billions. Roche’s demand, worryingly, is not unusual. At this stage, a lot of in medication would both acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was required. He never ever obtained a reply.

Then, in October 2009, the firm modified tack. It would like to hand in excess of the data, it explained, but yet another academic evaluation on Tamiflu was being carried out elsewhere. Roche had provided this other group the study reports, so Cochrane could not have them. This was a non-sequitur: there is no purpose why numerous groups must not all operate on the exact same question. In truth, because replication is the cornerstone of very good science, this would be actively desirable.

Then, a single week later, unannounced, Roche sent 7 paperwork, every single all around a dozen pages prolonged. These contained excerpts of inner firm paperwork on each and every of the clinical trials in the Kaiser meta-evaluation. It was a begin, but nothing like the details Cochrane needed to assess the benefits, or the charge of adverse events, or totally to recognize the design and style of the trials.

Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters

At the same time, it was swiftly becoming clear that there had been odd inconsistencies in the info on this drug. Crucially, distinct organisations around the globe had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) explained it gave no advantages on complications this kind of as pneumonia, although the US Centers for Ailment Management and Prevention stated it did. The Japanese regulator manufactured no claim for problems, but the European Medicines Agency (EMA) explained there was a benefit. There are only two explanations for this, and each can only be resolved by full transparency. Both these organisations noticed different information, in which situation we need to have to build a collective list, add up all the trials, and work out the results of the drug all round. Or this is a close call, and there is realistic disagreement on how to interpret the trials, in which case we need total accessibility to their methods and outcomes, for an informed public debate in the healthcare academic community.

This is particularly crucial, considering that there can often be shortcomings in the style of a clinical trial, which suggest it is no longer a honest test of which therapy is best. We now know this was the situation in numerous of the Tamiflu trials, exactly where, for instance, participants have been often really unrepresentative of true-planet patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient need to be in a position to tell whether they’re obtaining a placebo or the real drug – the active and placebo pills have been distinct colours. Even much more oddly, in virtually all Tamiflu trials, it would seem a diagnosis of pneumonia was measured by patients’ self-reporting: a lot of researchers would have anticipated a clear diagnostic algorithm, probably a chest x-ray, at least.

Because the Cochrane team have been even now becoming denied the data required to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make total review reviews accessible. For four many years, they then failed to do so.

Throughout this time period, the global medical academic neighborhood started to realise that the short, published academic papers on trials – which we have relied on for a lot of years – can be incomplete, and even misleading. A lot more detail is obtainable in a clinical study report (CSR), the intermediate document that stands between the raw data and a journal report: the exact program for analysing the information statistically, comprehensive descriptions of adverse occasions, and so on.

By 2009, Roche had shared just little portions of the CSRs, but even this was sufficient to see there have been problems. For example, looking at the two papers out of ten in the Kaiser review that had been published, 1 explained: “There were no drug-relevant severe adverse occasions”, and the other isn’t going to mention adverse occasions. But in the CSR documents shared on these identical two research, 10 critical adverse occasions were listed, of which 3 are classified as currently being possibly relevant to Tamiflu.

Roche HQ in Basel, Switzerland. Photograph: Bloomberg/Bloomberg through Getty Photos

By setting out all the identified trials side by side, the researchers were capable to identify peculiar discrepancies: for example, the largest “phase three” trial – a single of the big trials that are accomplished to get a drug on to the market – was in no way published, and is seldom described in regulatory documents.

The chase continued, and it exemplifies the frame of mind of industry in the direction of transparency. In June 2010, Roche advised Cochrane it was sorry, but it had imagined they already had what they needed. In July, it announced that it was worried about patient confidentiality. By now, Roche had been refusing to publish the examine reviews for a year. Abruptly, it started to raise odd individual worries. It claimed that some Cochrane researchers had created untrue statements about the drug, and about the organization, but refused to say who, or what, or exactly where. “Specified members of Cochrane Group,” it said, “are unlikely to strategy the overview with the independence that is both necessary and justified.” This is difficult to credit, but even if correct, it ought to be irrelevant: poor science is often published, and is shot down in public, in academic journals, by people with excellent arguments. This is how science works. No organization or researcher must be permitted to choose who has access to trial data. Even now Roche refused to hand in excess of the examine reports.

Then Roche complained that the Cochrane reviewers had begun to copy in journalists, including me, on their emails when responding to Roche personnel. At the very same time, the business was raising the broken arguments that are eerily acquainted to anyone who has followed the campaign for higher trials transparency. Important among these was 1 that cuts to the core of the culture war between proof-based mostly medicine, and the older “eminence-primarily based medicine” that we are supposed to have left behind. It is merely not the work of academics to make these selections about advantage and threat, mentioned Roche, it is the job of regulators.

This argument fails on two fronts. Very first, as with many other medication, it now appears that not even the regulators had witnessed all the information on all the trials. But more than that, regulators miss things. Several of the most notable problems with medicines in excess of the past number of many years – with the arthritis drug Vioxx with the diabetes drug rosiglitazone, marketed as Avandia and with the proof base for Tamiflu – weren’t spotted largely by regulators, but rather by independent medical professionals and academics. Regulators never miss factors because they are corrupt, or incompetent. They miss issues because detecting signals of chance and benefit in testimonials of clinical trials is a difficult company and so, like all hard inquiries in science, it positive aspects from obtaining numerous eyes on the issue.

Although the battle for accessibility to Tamiflu trials has gone on, the planet of medication has begun to shift, albeit at a unpleasant speed, with the European Ombudsman and many British choose committees joining the push for transparency. The AllTrials campaign, which I co-founded last 12 months, now has the help of practically all health-related and academic skilled bodies in the United kingdom, and numerous much more around the world, as effectively as far more than 100 patient groups, and the drug business GSK. We have noticed new codes of carry out, and European legislation, proposing enhancements in accessibility: all riddled with loopholes, but enhancements nonetheless. Crucially, withholding information has grow to be a headline concern, and much much less defensible.

Final yr, in the context of this wider shift, underneath ceaseless questions from Cochrane and the British Health-related Journal, soon after half a decade, Roche lastly gave Cochrane the details it essential.

So does Tamiflu function? From the Cochrane examination – totally public – Tamiflu does not decrease the number of hospitalisations. There wasn’t ample information to see if it minimizes the amount of deaths. It does decrease the variety of self-reported, unverified circumstances of pneumonia, but when you search at the 5 trials with a comprehensive diagnostic type for pneumonia, there is no important advantage. It may possibly assist avert flu signs and symptoms, but not asymptomatic spread, and the evidence here is mixed. It will consider a couple of hrs off the duration of your flu signs. But all this comes at a important value of side-results. Given that percentages are hard to visualise, we can make those numbers more tangible by taking the figures from the Cochrane review, and applying them. For example, if a million people consider Tamiflu in a pandemic, 45,000 will encounter vomiting, 31,000 will expertise headache and 11,000 will have psychiatric side-results. Don’t forget, although, that individuals figures all assume we are only giving Tamiflu to a million folks: if issues kick off, we have stockpiled ample for 80% of the population. Which is fairly a great deal of vomit.

Roche has issued a press release saying it contests these conclusions, but providing no motives: so now we can last but not least allow science get started. It can shoot down the details of the Cochrane overview – I hope it will – and we will edge in direction of the truth. This is what science seems like. Roche also denies currently being dragged to transparency, and says it merely did not know how to react to Cochrane. This, once more, speaks to the tempo of modify. I have no thought why it was withholding details: but I rather suspect it was simply simply because that’s what individuals have usually completed, and sharing it was a hassle, requiring new norms to be produced. That’s reassuring and depressing at the identical time.

Must we have invested half a billion on this drug? Which is a tough query. If you picture your self in a bunker, viewing a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade oneself that Tamiflu may well be really worth getting anyway, even understanding the hazards and positive aspects. But that final clause is the important. We often pick to use treatment options in medication, realizing that they have limited advantage, and significant side-effects: but we make an informed choice, balancing the dangers and rewards for ourselves.

And in any case, that £500m is the tip of the iceberg. Tamiflu is a side present, the one particular spot exactly where a single crew of dogged academics stated “enough” and the firm caved in. But the benefits of clinical trials are nevertheless being routinely and legally withheld on the medicines we use right now and absolutely nothing about a final reply on Tamiflu will assist plug this gaping hole.

Star anise offers the principal component of Tamiflu. Photograph: Adrian Bradshaw/EPA

A lot more importantly, for all that there is progress, so far we have only sentiment, and half measures. None of the alterations to European legislation or codes of carry out get us entry to the information we need, since they all refer only to new trials, so they share a loophole that excludes – remarkably – all the trials on all the medicines we use nowadays, and will proceed to use for decades. To take a single concrete and topical illustration: they would not have made a blind bit of distinction on Tamiflu. We have observed voluntary pledges for higher transparency from several person companies – Johnson &amp Johnson, Roche, GSK, now Roche, and a lot more – which are welcome, but similar promises have been given before, and then reversed a handful of many years later on.

This is a pivotal second in the background of medicine. Trials transparency is ultimately on the agenda, and this might be our only opportunity to fix it in a decade. We can’t make informed choices about which remedy is ideal although details about clinical trials is routinely and legally withheld from physicians, researchers, and sufferers. Any person who stands in the way of transparency is exposing sufferers to avoidable harm. We want regulators, legislators, and expert bodies to demand total transparency. We need to have clear audit on what data is missing, and who is withholding it.

Finally, far more than anything at all – simply because culture shift will be as effective as legislation – we need to do some thing even a lot more difficult. We want to praise, encourage, and support the companies and folks who are beginning to do the correct issue. This now consists of Roche. And so, paradoxically, right after everything you have read above, with the outrage fresh in your thoughts, on the day when it feels more difficult than any other, I hope you will join me in saying: Bravo, Roche. Now let us do better.

• Ben Goldacre is a physician and the author of Poor Pharma.

What the Tamiflu saga tells us about drug trials and big pharma

IBS – No Remedy or No Massive Pharma Cure?

IMAGINE HAVING A CONDITION with symptoms so severe that you can’t leave the house, yet your doctor calls it a “functional,” or “psychosomatic,” disease — meaning that it’s all in your head.

But it’s a very real problem for the 60 million people — that’s 20 percent of Americans — who have irritable bowel syndrome (IBS). These people are plagued by uncomfortable and often disabling symptoms like bloating, cramps, diarrhea, constipation, and pain.  We have been told that there is no way to stop the pain.

That is NOT the answer.  Big Pharma just doesn’t have a pill they can sell you yet. 

Some doctors believe food allergies may be a trigger of IBS for some people. The most common food allergens are dairy products, wheat, soy, eggs and fish.

Your health care provider may recommend an elimination diet, where foods that are suspected of causing an allergic reaction are eliminated from your diet, then gradually added back to see which food trigger symptoms.

Eating a healthy diet that includes mainly fruits, vegetables, and whole grains may help. If gas is a problem, you may want to avoid beans, cabbage, broccoli, cauliflower, apple juice, grape juice, bananas, nuts, and raisins. These tips may also help:

• Avoid refined foods such as white breads, pastas, and sugar.


• Eat fewer red meats and more lean meats


• Use healthy cooking oils, such as olive oil or vegetable oil.


• Take fiber supplements to help reduce pain, cramping, and gas.


• Drink 6 – 8 glasses of filtered water daily.


• Exercise 30 minutes daily, 5 days a week.

Eliminating dairy and wheat from your diet is not a major concern.  However, fish contain omega-3’s that are essential for maintaining a healthy lipid profile and reducing overall inflammation.  This means a fish allergen could be a double whammy!  Not only could you be in gut wrenching pain, but your body needs the Essential Fatty Acids (EFA’s) that come with fish, like the omega-3 EPA.  Omega-3’s have shown amazing reductions in inflammation throughout the body.

We suggest trying the only proven alternative to fish oil, PhytOriginal.  PhytOriginal is made of the plant-like phytoplankton that fish eat to build up their omega-3 reserves.  It is produced from cradle to grave in the United States with only the highest grade ingredients.

IBS – No Remedy or No Massive Pharma Cure?

IBS – No Remedy or No Massive Pharma Cure?

IMAGINE HAVING A CONDITION with symptoms so severe that you can’t leave the house, yet your doctor calls it a “functional,” or “psychosomatic,” disease — meaning that it’s all in your head.

But it’s a very real problem for the 60 million people — that’s 20 percent of Americans — who have irritable bowel syndrome (IBS). These people are plagued by uncomfortable and often disabling symptoms like bloating, cramps, diarrhea, constipation, and pain.  We have been told that there is no way to stop the pain.

That is NOT the answer.  Big Pharma just doesn’t have a pill they can sell you yet. 

Some doctors believe food allergies may be a trigger of IBS for some people. The most common food allergens are dairy products, wheat, soy, eggs and fish.

Your health care provider may recommend an elimination diet, where foods that are suspected of causing an allergic reaction are eliminated from your diet, then gradually added back to see which food trigger symptoms.

Eating a healthy diet that includes mainly fruits, vegetables, and whole grains may help. If gas is a problem, you may want to avoid beans, cabbage, broccoli, cauliflower, apple juice, grape juice, bananas, nuts, and raisins. These tips may also help:

• Avoid refined foods such as white breads, pastas, and sugar.


• Eat fewer red meats and more lean meats


• Use healthy cooking oils, such as olive oil or vegetable oil.


• Take fiber supplements to help reduce pain, cramping, and gas.


• Drink 6 – 8 glasses of filtered water daily.


• Exercise 30 minutes daily, 5 days a week.

Eliminating dairy and wheat from your diet is not a major concern.  However, fish contain omega-3’s that are essential for maintaining a healthy lipid profile and reducing overall inflammation.  This means a fish allergen could be a double whammy!  Not only could you be in gut wrenching pain, but your body needs the Essential Fatty Acids (EFA’s) that come with fish, like the omega-3 EPA.  Omega-3’s have shown amazing reductions in inflammation throughout the body.

We suggest trying the only proven alternative to fish oil, PhytOriginal.  PhytOriginal is made of the plant-like phytoplankton that fish eat to build up their omega-3 reserves.  It is produced from cradle to grave in the United States with only the highest grade ingredients.

IBS – No Remedy or No Massive Pharma Cure?

New Examine Ranks Johnson & Johnson #1 In Pharma For Social Media Engagement

The use of social media within healthcare has undoubtedly been slower than other industries, but it is generating progress. Many healthcare specialists and institutions have been active on the internet for many years and at 1 of the key healthcare business events – HIMSS – Twitter Co-Founder Biz Stone gave the opening keynote deal with in 2012 to an audience of about 8,000 (right here).

Later on following month, the Chairman, CEO and President of Aetna Aetna, Mark Bertolini is scheduled to provide the opening keynote at this year’s HIMSS in Orlando. Mr. Bertolini is personally lively on Twitter and created national information in 2012 when he employed the service to chat with an ASU student suffering from stage four cancer. Throughout the 2-day chat, Mr. Bertolini committed to covering all of the college students medical expenses (which had eclipsed their lifetime cap of $ 300,000). The student has because succumbed to the cancer, and (under Obamcare) the lifetime caps are history, but Mr. Bertolini did what he felt was correct at the time – in a very public and social media way.

Social media on the element of the pharmaceutical industry, nonetheless, has been a lot slower and much more tentative largely due to regulatory risk.

“When you appear across the healthcare landscape – most of the core leadership at large healthcare institutions are embracing the energy of social – the electrical power of pull. Pharma has been the lone and notable exception. But it is inevitable so it’s encouraging to see the public and really visible indications that it’s changing.” Howard J. Luks, M.D. – Orthopedic Surgeon and Advisory Board Member of Mayo Clinic Mayo Clinic’s Center for Social Media (here)

That modify is reflected in a new report today by the IMS Institute for Healthcare Informatics (IMS Overall health). It’s an encouraging 1st seem into real metrics around the social media actions of some of the biggest pharmaceutical brands.

Amid the prime 50 pharmaceutical businesses, half do not engage with buyers or sufferers on healthcare-associated subjects through social media, and only ten organizations utilized all three assessed channels. Twitter is utilized by 22 of the 50 companies studied, followed by YouTube which is utilised by 17 organizations, and Facebook is utilised as a channel by 15 firms. Engaging Individuals By way of Social Media – IMS Wellness Report (January, 2014 – 47 pages – free but registration needed right here)

Employing the leading three social media channels – Facebook, Twitter and YouTube – IMS Overall health ranked the ten pharmaceutical companies by a Reach Index, a Relevance Index and a Connection Index (every single of which utilised likes, shares and re-tweets). Of the ten pharmaceutical firms that were lively across all 3 channels, Johnson &amp Johnson Johnson &amp Johnson came out on prime – by a broad margin.

As suggested earlier, much of the hesitation can be attributed to the lack of regulatory guidance, but that also transformed final week when the FDA announced draft social media recommendations for the market (here).

Noticeably absent from the IMS Well being evaluation are some of the other consumer and enterprise oriented social media channels like Google Google, Pinterest or LinkedIn (to identify a few of the bigger ones), and that is also what’s helps make FDA guidelines so tough to bake. They have to be broad adequate to encompass all the various channels each and every of which have their own distinct nuances and strategies of communications. The interest to move quickly into social media (at least by some) was also plainly evident in the report.

Organizations are starting to deal with the lack of regulatory transparency by publishing their personal tips (e.g. Roche and AstraZeneca AstraZeneca). AstraZeneca’s guideline summary revolves around a set of principles with suitably broad definitions of what social media is and what behavior they count on from workers to cover most situations. However, even with these safeguards in place AstraZeneca was forced to pull a Twitter campaign in August 2013 from the Related Press’ Twitter feed. This was simply because it was pointed out that they had incorporated a reference to Nexium in the attached link of the tweet, which is accessed by pressing “View Summary.” This solution title was integrated with no the necessary safety information, placing it in breach of laws. Engaging Patients Via Social Media – IMS Health Report

 The report also cited many outside sources for crucial social media statistics as a way to frame the value of their findings.

* Use of social networking web sites has grown from eight% of all adults on the internet in 2005, to 67% in late 2012 and up to 72% of U.S. adults on-line in Might 2013.

* In 2009, 70% of Canadians turned to the web for wellness-connected data, and 92% of people utilized the search engine Google, rather than a health portal to gather this info.

* Facebook is reported as the fourth most popular source of wellness information in the U.K.

* Physicians on regular devote 3 hrs per week viewing on the web videos for professional functions and cite Medscape and YouTube followed by pharmaceutical firm sites as the most crucial sources of video.

* In the U.S., curiosity in certain conditions receives the best sum of consideration in social media relating to healthcare, followed by way of life changes, well being insurance coverage specifics and security info.

One more part of the report went into significant detail all around the prevalent use of Wikipedia which the authors recommend “is the foremost single supply of healthcare details for sufferers and healthcare pros.” They researched the prime a hundred pages by condition topic and presented this chart relative to the leading 25 (“English” language page – globally).

For healthcare in particular, sufferers are concerned about the validity and neutrality of the data they look for out, and Wikipedia increasingly meets this need, providing supplemental details to that which they obtain from clinicians. IMS Report

It could not be an Oscar, a Grammy or a Golden Globe, but it is obviously a sizable lead and visible win for JNJ in the globally important social media group for healthcare.

“We see that pharmaceutical companies acknowledge that patients increasingly are using some form of social media to obtain info, exchange views and look for suggestions regarding their healthcare. They consequently need to be present, energetic and engaged in these channels to be patient-centered.” Murray Aitken – Executive Director, IMS Institute for Healthcare Informatics

New Examine Ranks Johnson & Johnson #1 In Pharma For Social Media Engagement

South African pharma firms accused of arranging to delay patents law reform

Patents on new medicines may possibly be bypassed in South Africa if adjustments to intellectual home law go ahead. Photograph: Krista Kennell/ZUMA/Corbis

Drug firms in South Africa have been accused of preparing a covert, properly-funded campaign to delay the introduction of laws that threaten their earnings. Leaked paperwork demonstrate that pharmaceutical firms planned a $ 450,000 campaign, involving a high-profile consultancy primarily based in Washington, DC, against modifications to intellectual house laws that would allow their patents on new medicines to be bypassed in the interests of public health. This would permit the manufacture of less costly copies of their medicines.

Campaigners accused the global drug giants of trying to derail existence-saving legislation. The trade entire body IPASA (Modern Pharmaceutical Industry Association South Africa), which was coordinating the campaign, explained on Thursday the programs have been no longer going ahead – though it was legitimate for drug organizations to advertise their views in this way.

One particular of the leaked paperwork is an e-mail dated 10 January from a member of IPASA’s executive to representatives of most of the large-name drug businesses operating in South Africa. As agreed in December, it says, “we have moved ahead in identifying a large-calibre consultancy group to work with us”, naming Washington-based mostly Public Affairs Engagement (PAE).

The second document is the proposed PAE approach, involving the creation of an alliance of businesspeople and academics, the placement of prominent editorials in newspapers, and a bid to “distract” access to medicine campaigners “from their personal aggressive campaign”.

The document later names Médecins Sans Frontières (MSF) and the Therapy Action Campaign (TAC), calling them a “coalition that was formed to pressure the government into making [the draft IP policy] in the initial location”.

The stakes are high, says the document. “South Africa is now ground zero for the debate on the value of robust IP protection. If the battle is misplaced right here, the results will resonate. Clearly MSF and related NGOs understand that … With no a vigorous campaign, opponents of strong IP will prevail – not just in South Africa but eventually in much of the rest of the developing world.”

Campaigners mentioned they had been shocked. “What is surprising to us is that it is done so subversively,” stated Julia Hill of MSF. “We have really made an effort to be really transparent. It is disappointing that this is currently being carried out in secret and that this kind of an extraordinary volume of funds is getting spent to interfere with the democratic method.”

Lotti Rutter, a senior researcher at TAC, stated: “We have received substantial concerns in excess of what seems to be fairly a covert and well-funded atempt from foreign sector to delay an essential law reform method happening here in South Africa.”

Val Beaumont of IPASA said the discussions had taken spot but the PAE proposal had not been accepted. “It is a really, quite essential situation to us and it will be to any of the knowledge-primarily based organisations,” she stated. “There was a large concern that it would be rushed.” It was Ok for an organisation to have a PR company to support place across its views, she said.

South African pharma firms accused of arranging to delay patents law reform