1

UK is testbed for mass vaccination with gene therapies, leading to global rollout

Please share this article as widely as you can.


DEFEAT CAPITALISM AND ITS DEADLY SPAWN, IMPERIALISM
ecological murder • endless wars • ingrained racism & social injustice • worker exploitation • incurable via reforms


Editor's Note: No doubt that Hedley Rees is a valuable witness against the global pharma monster, and, for that, we should be grateful. However, in reading his exposés and diverse complaints, it is always necessary to bear in mind that his thinking remains largely and narrowly bound by the capitalist way of looking at things, hence his solutions and proposals always emerge, tortuously, from the maze of liberaloid fixes permitted by the capitalist playbook. In terms of logic, this is like going in circles. It may not occur to Rees, or it may be ideologically unpalatable, to contemplate that most if not all of the issues he denounces so passionately would swiftly vanish under a regime in which the profit imperative was completely removed from the center of healthcare. —PG

Originally
Get the inside track here...

(Tarbell.org)

The first clue

The first clue was confirmed when I had an email from Jonathan Gilthorpe about a Swedish investigative reporter wanting to interview me on GMP. Jonathan is fully awake and we exchange occasional emails as things pop out the woodwork.

I’d been concluding, by dot joining, that the UK was the epicentre of the SARS-CoV2 injections rollout, but the description ‘testbed’ brought instant clarity.

Of course, if they could get away with it in one country with a very ‘friendly’ Regulatory Authority, it would then be EMA, FDA and all around the rest of the world…and here, in the UK, we have the extremely friendly, even ‘enabling’ Regulatory Authority, MHRA.

We spoke about this a few days ago, as below:

Subject: FOI Request—substantial change in 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors: PART IV “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)”

The crux of this is that MHRA changed its Regulations to allow gene therapies, and other advanced medicinal products, to be manufactured without the safety umbrella of there being a proper Quality Management System in place. Dangerous stuff!!!

It takes me back to 2013

For reasons I can’t explain, my mind flashed back to 2013, when I first worked in the gene therapy arena, under the umbrella of my company PharmaFlow.

Then, I consulted to a contract development and manufacturing organisation (CDMO) for gene therapies, named Oxford Biomedica (OXB). The job was on a UK Government funding call, titled the Advanced Manufacturing Supply Chain Initiative (AMSCI) Round 3.

The feedback UKs Office for Life Sciences received was that in the two previous rounds of AMSCI, no life sciences companies were successful. The reason given was they were using a scientific mindset for a challenge that required an engineering and production systems approach. The Office for Life Sciences asked if I could find a company to submit a bid, and steer them through to a successful conclusion.

To cut a long tale short – I found a company and the bid was successful: Oxford BioMedica Wins Significant Funding via a Competitive Award from UK Government’s Advanced Manufacturing Supply Chain Initiative.

You won’t find PharmaFlow on the announcement, even though I had personally recruited Cranfield University and Heart of England NHS Foundation Trust!

That’s often the way I suppose. I felt betrayed at the time, and even more so when they dropped me from the project and fired the Director of Manufacturing who I had been working closely with. That’s business, as they say!

The important bit

Anyway, this is the important bit. That was the last contact I had with the company, but UK Government stayed very much engaged, as I’ve now realised:

Chief Secretary to the Treasury visits Oxford BioMedica

The Office for Life Sciences were hugely impressed by the potential for gene therapies manufactured by OXB in the UK, especially when OXB signed a £100 million agreement with Novartis to supply the viral vector for Kymriah (which they were developing while I was there):

Kymriah approved - royalties to OXB assured

OXB then went on to develop and manufacture the adenovirus vector (Kymriah is a lentiviral vector, very similar) for AstraZeneca:

https://www.oxb.com/news-media/press-release/oxford-biomedica-signs-supply-agreement-astrazeneca-expand-manufacturing

It begins: “Kymriah (tisagenlecleucel/CTL019), for which Oxford BioMedica (OXB) provides the key lentiviral vector component, has been approved by the FDA for the treatment of patients up to 25 years of age with refractory/relapsed (second or later relapse) B-cell acute lymphoblastic leukaemia (ALL). Novartis has announced that the price for the one-off treatment will be $475k (c £370k), an increase over our previous assumption of £300k”

Kymriah has significant side effects of Cytokine Release Syndrome and neurological toxicities, which appear (to the unqualified me) as similar to the AZ side-effects being reported.

Why am I saying all this?

…because the evidence that the UK IS the testbed for gene therapy-based products (especially mRNA) is extremely persuasive.


ADDENDUM

Taming the pharma monster with Hedley Rees

With the aim of re-aligning the industry away from patents and towards patients, Hedley Rees, veteran of the UK pharma sector and now managing consultant at PharmaFlow, spoke to us about the best way to tame and reform the ‘monster.’

During his 40-year stint working in the pharma industry, Hedley Rees realised there was and continues to be something seriously wrong with how medicines come to market; globally drug prices are rising, clinical trial failures are more common than successes and large sums of money are spent on patent litigation.

To correct this and approach modernising the industry, Rees has written a booked titled ‘Taming the Pharma Monster’, and has used his consultancy PharmaFlow, as well as Welsh-led change initiative Friends of Medicines Modernisation to organise a ‘Medicines for the 21st century’ conference.

Rees and his partners are in the middle of composing a White Paper based on the conference’s conclusions, which will be sent to the House of Commons Health and Social Care Committee, as well as organising a non-profit company to support patients and patient advocacy groups in challenging the industry.

 

Allie Nawrat: Why did you describe the pharma industry as ‘a monster’ in the title of your new book?

Hedley Rees: I think there is now a perception that as a system it is similar to the banking system during the 2008 financial crash, and that it is certainly not beneficial to patients or healthcare professionals.

If you take the high profile example of insulin in the US, there are three companies in the US who are charging astronomically high prices for insulin. Patients in the US are dying because they have started to ration their insulin or are not taking it at all.

Other examples are Orkambi and gene therapies; the pharma companies will play hard ball with the NHS, [as] they are holding out until they get the high price they are looking for.

The core issue is that [companies have] patents [,which] create monopolies or oligopolies, so when drugs eventually get to market, pharma companies can basically choose their price based on the [maximum] they think the market will pay.

 

AN: When did this situation emerge and how has it consolidated itself?

HR: We have to go back 40, 50 years to when the industry was vertically integrated – the large pharmaceutical companies owned the facilities for making drugs, they employed the people and they sourced from suppliers in a vertically integrated way. Companies were able to get patents for the process, not just the molecules.

Over the last 40 years that vertical integration has transformed into horizontal integration through a process of outsourcing; the expertise to bring drugs to market doesn’t lay with the big pharmaceutical companies anymore, [now] they have to work with contractors to develop drugs.

This switch originated with a battle between two anti-ulcer drugs in the early 1980s; Smith Kline and French’s Tagemet and Glaxo’s Zantac. Glaxo used the same process as Smith Kline and French, but it made its product a little bit safer for patients, and successfully used sales and marketing so in a few years Zantac was outselling Tagemet by three to one.

Therefore, it looked as if blockbuster revenues came from having a patented drug and [employing] clever sales and marketing, and so the rest of the industry copied that approach.

AN: How do high R&D costs and high failure rates in clinical trials feed into the pharma industry’s negative reputation?

HR: High attrition rates of drugs is also an issue; 95% of drug development ends in failure and 245 out of 250 pre-clinical candidates fail. You can imagine the disappointment of patients and relatives of the patients when they think there is a trial that is going to help them. Then the drug fails, [meaning] thousands and thousands of patients have their hopes dashed.

We are writing a white paper to send to the Health and Social Care Committee, in which we are going to ask really searching questions, such as why is the industry allowed to test its own products – there is no other industry that does that – and why aren’t there post-mortems on failed clinical trials?

There has to be learning in there about what went wrong and what didn’t – but all that is kept secret by the companies. If you compare it to the aviation industry, when there is a plane crash all the information is shared immediately across the industry as to what went wrong and what is being done to put it right.

You have to ask yourself, why doesn’t that happen in pharma? It is because we feel like medicines are different to other sectors, but they are not, there should be an obligation on those companies [like there is in other industries] to investigate failures and explain why they happened.

AN: What can be done to break this negative cycle and bring the industry into the modern era?

HR: I am repeating what people at the coalface – researchers, scientists and physicians – are saying to me. We want the industry to provide more evidence that their molecule could get to market, before the patent was awarded. Unless you take away the incentivisation of the patent, nothing is ever going to change.

There needs to be a consultation of trade bodies, like the BioIndustry Association and the Association of the British Pharmaceutical Industry, facilitated by government, which actually asks these questions around patents. It is about going back 40 years, looking at the benefits of vertical integration and moving back to collaboration.

The work that the FDA’s Janet Woodcock is doing in terms of the Critical Path Initiative, which is part of the agency’s 21st century modernisation framework, could be a starting point; she says ‘don’t fight the system, change the rules’.

AN: Technology is often viewed as a silver bullet. What role do you think emerging technologies can play?

HR: We need to incentivise pharma companies to spend more time at the early stage to invest in predictive technologies, such as in vitro, ex vivo, Insilco technologies and organ on a chip, that really have moved on a long way, but that the industry has not embraced.

There is a lot of hype about AI because the people who have got the technology want to sell it. AI is an enabler, but if you have got a system that is overly complex, clunky, and not properly integrated then AI or machine learning will not doing anything. It has to be supported for the people at the coalface.

ABOUT THE AUTHOR / SOURCE
Hedley Rees is a veteran of the UK pharma sector and now managing consultant at PharmaFlow.

NOTE: The author’s opinions and religious beliefs are his or her own. Greanvillepost.com does not advocate for or against any religion.


Print this article


Unfortunately, most people take this site for granted.
DONATIONS HAVE ALMOST DRIED UP…
PLEASE send what you can today!
JUST USE THE BUTTON BELOW



 

[/su_spoiler]

Don’t forget to sign up for our FREE bulletin. Get The Greanville Post in your mailbox every few days.


Up to You.

^3000US citizens have no real political representation.

We don't live in a democracy. And our freedom is disappearing fast.

I don't want to be ruled by hypocrites, whores, and war criminals.

What about you? Time to push back against the corporate oligarchy.

And its multitude of minions and lackeys.


Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

NOTE: ALL CAPTIONS AND PULL QUOTES BY THE EDITORS NOT THE AUTHORS

Read it in your language • Lealo en su idioma • Lisez-le dans votre langue • Lies es in Deiner Sprache • Прочитайте это на вашем языке • 用你的语言阅读



The great vaccine robbery: Pharmaceutical corporations charge excessive prices for COVID-19 vaccines while rich countries block faster and cheaper route to global vaccination

Our articles depend on you for their effectiveness. Share with kin, coworkers and friends.


PATRICE GREANVILLE


Perfectly reliable, the Russian Sputnik V vaccine has been largely blocked in most EU countries. It is even denounced by the BBC as a "Russian tool of soft power".

More than a year into the pandemic and I still find it hard to locate easily digestible facts for what should be a straightforward question: How much is Big Pharma charging for an average vaccine shot? The leading TV journos have pretty much ignored the topic, as if it did not matter, supposedly (I presume that's their convenient rationale) because the government, as if by magic, is making the jabs free to the public, anyhow. But, friends, without going libertarian, we all know that when the government pays, WE pay, ultimately, because the moneys laid out are our taxes, our money —well so they say. (Contrary to common assumption, the government, which does NOT operate like a household, need not balance the books nor rely on taxes alone for its expenditures).


Doing some digging brings up some helpful data, but it is likely the average person won't get a clear picture out of it. For one thing, even though it is usually sourced to nonprofit entities, the data is a bit chaotic and even contradictory. Furthermore, it's obvious that while the Big Pharma mafia is already making a bundle, it expects far juicier profits in the near future, right after the pandemic scare is declared over, when the "Covid long game" scheme is expected to kick in. Yes, those chronic "booster shots" that nary a soul talked about a year ago is where the smart money is at this time, making the anti-Covid jabs a feature of the medical landscape like seasonal flu shots, a habit already widely accepted. (Ironically, one of the reasons why "booster shots" may be recommended and possibly necessary for some people at properly timed intervals is because the main Western vaccines, basing themselves on the mRNA approach that focuses on the virus' spikes, are not capable of ever conferring herd immunity or acting like regular vaccines, but precisely the opposite: they almost guarantee the appearance of increasingly tougher Coronavirus variants). If you're puzzled, read Jim Kavanagh's in-depth analysis of this topic in Danger to Society: Against Vaccine Passports. It will challenge and dispel many notions you currently hold.


Meanwhile, chaos and opportunistic pricing permeate the picture, as they are both inevitable and incurable under capitalism, but there are aggravating circumstances. Since Big Pharma, one of the reigning cartels in North America, can dictate to the US government, the globe's most profitable sphere, the "First World", has been largely declared off-limits to free or much cheaper vaccines (equally dependable if not substantially superior) developed by Russia, China, Cuba and other ethically-minded nations. Russia's Sputnik V vaccine has been denounced by Washington's more commited lackeys (Britain, Poland, etc.) as a "tool of soft power", despite the fact this is a shady art in which the West excels and still holds a considerable lead. The monopoly push is anathema to libertarian purists who still swear by the beneficence of free-market competition, but the neoliberal canon, following its Darwinian DNA, has no respect for delusional constructs. As Calvin Coolidge already warned Americans in 1925, "the business of America is business." Well, folks, apparently nothing has changed in this best of all possible worlds. —PG


The great vaccine robbery: Pharmaceutical corporations charge excessive prices for COVID-19 vaccines while rich countries block faster and cheaper route to global vaccination

Originally published
Origin
View original

 

Vaccine monopolies make the cost of vaccinating the world against COVID at least 5 times more expensive than it could be

The cost of vaccinating the world against COVID-19 could be at least five times cheaper if pharmaceutical companies weren’t profiteering from their monopolies on COVID-19 vaccines, campaigners from The People’s Vaccine Alliance said today.

New analysis by the Alliance shows that the firms Pfizer/BioNTech and Moderna are charging governments as much as $41 billion above the estimated cost of production. Colombia, for example, has potentially overpaid by as much as $375 million for its doses of the Pfizer/BioNTech and Moderna vaccines, in comparison to the estimated cost price.

Despite a rapid rise in COVID cases and deaths across the developing world, Pfizer/BioNTech and Moderna have sold over 90 percent of their vaccines so far to rich countries, charging up to 24 times the potential cost of production. Last week Pfizer/BioNTech announced it would licence a South African company to fill and package 100 million doses for use in Africa, but this is a drop in the ocean of need. Neither company have agreed to fully transfer vaccine technology and know-how with any capable producers in developing countries, a move that could increase global supply, drive down prices and save millions of lives.

Analysis of production techniques for the leading mRNA type vaccines produced by Pfizer/BioNTech and Moderna ―which were only developed thanks to public funding to the tune of $8.3 billion― suggest these vaccines could be made for as little as $1.20 a dose. Yet COVAX, the scheme set up to help countries get access to COVID vaccines, has been paying, on average, nearly five times more. COVAX has also struggled to get enough doses and at the speed required, because of the inadequate supply and the fact that rich nations have pushed their way to the front of the queue by willingly paying excessive prices.

Without pharmaceutical monopolies on vaccines restricting supply and driving up prices, the Alliance says the money spent by COVAX to date could have been enough to fully vaccinate every person in low- and middle-income countries with cost-price vaccines, if there was enough supply. Instead at best COVAX will vaccinate 23 percent by end of 2021.

The Alliance of nearly 70 organisations, including the African Alliance, Oxfam and UNAIDS, says the failure of some rich countries to back the removal of monopolies and to drive down these excessive prices has directly contributed to vaccine scarcity in poorer nations.

Anna Marriott, Oxfam’s Health Policy Manager, said: “Pharmaceutical companies are holding the world to ransom at a time of unprecedented global crisis. This is perhaps one of the most lethal cases of profiteering in history.

“Precious budgets that could be used for building more health facilities in poorer countries are instead being raided by CEOs and shareholders of these all-powerful corporations.”

Winnie Byanyima, Executive Director of UNAIDS said: “Health workers are dying on the frontline all over the world every single day. Uganda alone lost more than fifty health workers in just two weeks. A reminder of the time when millions of people were dying of HIV in developing countries because the medicines that could save them were priced too high.

“I see lives being saved in vaccinated countries, even as the Delta variant spreads, and I want the same for developing countries. It is criminal that the majority of humanity is still facing this cruel disease unprotected because Pharma monopolies and super profits are being put first.”

While some rich countries have started to re-distribute a fraction of their excess doses and have made funding commitments, this charity is not enough to fix the global vaccine supply problems. The People’s Vaccine Alliance is calling on all governments to insist that the vaccine technology is transferred ―to enable all qualified manufacturers worldwide, especially those in developing countries, to produce these vaccines. Governments should also urgently approve a waiver of intellectual property rules related to COVID-19 technologies as proposed by South Africa and India.

The waiver, which has been supported by over 100 nations including the US and France has now entered formal negotiations at the World Trade Organisation that met again this week. But the proposal has been repeatedly blocked by Germany, the UK and the European Union.

Maaza Seyoum, from the African Alliance and People’s Vaccine Alliance Africa, said: “Enabling developing country manufacturers to produce vaccines is the fastest and surest way to ramp up supply and dramatically drive down prices. When this was done for HIV treatment, we saw prices drop by up to 99 percent.

“What possible reason then do the governments of the UK, Germany and EU have to ignore the repeated calls from developing countries to break the vaccine monopolies that could drive up production while driving down price?”

Less than one percent of people in low-income countries have received a vaccine, while the profits made by the companies has seen the CEOs of Moderna and BioNTech become billionaires.

Before the pandemic, developing countries paid a median price of $0.80 a dose for all non-COVID vaccines, according to analysis by the World Health Organization (WHO). While all vaccines are different and the new vaccines may not be directly comparable, even one of the cheapest COVID 19 vaccines on the market, Oxford/AstraZeneca, is nearly four times this price; the Johnson and Johnson vaccine is 13 times; and the most expensive vaccines, such as Pfizer/ BioNTech, Moderna and the Chinese produced Sinopharm, are up to 50 times higher.

It is vital that vaccine manufacturers are forced to justify why their vaccines cost more, but open competition is also critical to bring down prices and increase supply. All vaccines, old and new, only come down in price once there are multiple competitors in the market.

Never in history have governments been buying more doses of vaccines for one disease and the large-scale production should drive down costs, enabling companies to charge lower prices. Yet the EU reportedly paid even higher prices for its second order from Pfizer/BioNTech. Dramatic price escalation is predicted to continue in the absence of government action and with the possibility of booster shots being required for years to come. The CEO of Pfizer has suggested potential future prices of as much as $175 per dose ―148 times more than the potential cost of production. And because pharmaceutical companies anticipate charging such high prices for boosters, they will continue to sell doses to rich countries at the expense of protecting lives globally.

In a briefing note, published today, The People’s Vaccine Alliance highlighted examples of how much both developing and wealthier nations have been potentially overpaying:

  • Pfizer/ BioNTech are charging their lowest reported price of $6.75 to the African Union but this is still nearly 6 times more than the estimated potential production cost of this vaccine. One dose of the vaccine costs the same as Uganda spends per citizen on health in a whole year.

  • The highest reported price paid for Pfizer/BioNTech vaccines was paid by Israel at $28 a dose ―nearly 24 times the potential production cost.

  • The EU may have overpaid for their 1.96 billion Moderna and Pfizer/BioNTech vaccines by as much as €31 billion.

  • Moderna has charged countries between 4 and 13 times the potential cost price of the vaccine and reportedly offered South Africa a price between $30-42 a dose ―nearly 15 times higher than the potential production cost.

  • Colombia, which has been badly affected by COVID, has been paying double the price paid by the US for Modernavaccines. For Moderna and Pfizer/BioNTech combined, the country has potentially overpaid by as much as $375 million.

  • Senegal, a lower-income nation, said it paid around $4 million for 200,000 doses for Sinopharm vaccines, which equates to around $20 a dose.

  • The UK alone has potentially paid £1.8 billion more than the cost of production for the Pfizer and Moderna vaccines ―enough money to pay every worker in its National Health Service (NHS) a bonus of more than £1000.

Maaza Seyoum said: “As long as the pharmaceutical corporations retain their monopolies on the life-saving technology, they will always prioritise contracts where they can make the most excessive profits, leaving developing countries out in the cold.

“With government budgets in crisis the world over, and COVID cases rising in many developing countries, it’s time to stop subsidising corporate fat cats. It’s time to put people before profits.”

Notes to editors

Download a copy of the briefing note "The Great Vaccine Robbery".

Due to lack of transparency of pharmaceutical companies, the exact cost of research and development and manufacturing of vaccines are unknown. Estimates used in this release are based on studies of mRNA production techniques, carried out by Public Citizen with engineers at Imperial College. Their analysis suggests that it could cost $9.4 billion to produce 8 billion doses of the Pfizer/BioNTech vaccine ―$1.18 per vaccine and for Moderna it would cost $22.8 billion to produce 8 billion doses ―$2.85 per vaccine.

The figure that companies have been charging up to 24 times the potential cost of production is based on the reported information that is available. The highest reported cost paid was by Israel. For many countries there is no available data on how much they have paid for these vaccines.

Pfizer forecasts sales of $26 billion in revenue for 1.6 billion vaccine doses, therefore at an average cost per dose of $16.25 (against a potential cost price of $1.18 per dose). Moderna forecasts sales of between 800 million and 1 billion doses, therefore at an average cost of between $19.20 and $24 per dose (against a potential cost price of $2.85 per dose). The total combined forecasted sales income equates to $41 billion above the potential cost of production.

Colombia is reported to have paid $12 per dose for 10 million doses of Pfizer/BioNTech and $29.50 per dose for 10 million doses of Moderna. A potential overspend of $375 million.

Data on vaccine billionaires is available here.

Pfizer/ BioNTech and Moderna have received $8.25 billion dollars in public support for their vaccines between them ―$5.75 billion for Moderna and $2.5 billion for Pfizer/BioNTech. This includes public funding and guaranteed government pre-orders.

COVAX has reported that for its first 1.3 billion doses it paid an average price of $5.20 a dose. Given available reported prices for the vaccines in COVAX’s portfolio it is reasonable to assume COVAX paid less than $5.20 for the Oxford/AstraZeneca vaccine (reducing the average dose price), and likely paid more for the Pfizer/BioNTech (increasing the average dose price). The schemes’ lack of transparency prohibits proper scrutiny.

Gavi reports COVAX will achieve 23 per cent coverage in AMC populations by end of 2021.

Competition drove down first-line regimen HIV medication prices by 99 per cent over a 10 year period, from $10,000 to as low as $67 per patient per year.

Analysis by the People’s Vaccine Alliance has found that just 0.28 per cent of the people in Low Income Countries have received at least a single dose, based on a combined population of 775,710,612, and data from Our World in Data which shows that as of Sunday 2,155,657 had been vaccinated with at least a single dose.

UNICEF procures existing vaccines on behalf on many low- and middle-income countries. According to analysis in The Lancet they pay a median of 0.80 cents a dose for all vaccines.

The Chinese Sinopharm vaccine is being sold for up to $40 a dose (making it 50 times more expensive than $0.80).

The UK is reported to have paid £15 a dose for the Pfizer vaccine and has ordered 100 million doses. For Moderna they are reported to have paid £25 per dose and have ordered 17 million doses. If these two vaccines were produced at the production price estimated by Public Citizen, the UK would have saved £1.8 billion, enough to pay every NHS worker a bonus of £1,012 (based on the NHS having 1.5 million members of staff in England, 140,000 in Scotland, 78,000 in Wales and 64,000 in Northern Ireland).

For other examples of how much developing and wealthier nations have been potentially overpaying on vaccines, calculations and references are available in the briefing note "The Great Vaccine Robbery".

Contact information

Sarah Dransfield in the UK | sdransfield@oxfam.org.uk | 07884 114825
Annie Thériault in Peru | annie.theriault@oxfam.org | +51 936 307 990
SOURCE: https://reliefweb.int/report/world/great-vaccine-robbery-pharmaceutical-corporations-charge-excessive-prices-covid-19

The views expressed herein are solely those of the author and may or may not reflect those of  The Greanville Post. However, we do think they are important enough to be transmitted to a wider audience. 

All image captions, pull quotes, appendices, etc. by the editors not the authors. 
YOU ARE FREE TO REPRODUCE THIS ARTICLE PROVIDED YOU GIVE PROPER CREDIT TO THE GREANVILLE POST VIA A BACK LIVE LINK. 
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License



Up to You.

^3000US citizens have no real political representation.

We don't live in a democracy. And our freedom is disappearing fast.

I don't want to be ruled by hypocrites, whores, and war criminals.

What about you? Time to push back against the corporate oligarchy.

And its multitude of minions and lackeys.


 Don't forget to sign up for our FREE bulletin. Get The Greanville Post in your mailbox every few days. 




Sellling Side Effects: Big Pharma’s Marketing Machine

Please make sure these dispatches reach as many readers as possible. Share with kin, friends and workmates and ask them to do likewise.

By Michelle Llamas
DRUGWATCH.COM


Americans pay more for drugs and medical devices than any other country. Big Pharma follows potential patients everywhere — on TV, in print and online. Companies spend billions advertising to doctors to get them prescribe their brand-name drugs and devices. They also spend billions paying criminal and civil settlements resulting from fraudulent marketing. Do these practices empower patients or expose them to newer, riskier and more expensive drugs and devices?


ABOVE: Jardiance DTC ad, considered by many as one of the most annoying. Like most commercials, Big Pharma ads are intrusive and mendacious, and they make people look stupid, but with their constant reminders about our health vulnerabilities, they also depress our quality of life. Who needs 24/7 reminders about a multitude of diseases lying in wait to ambush us?


“[T]his advertising promotes only the most expensive products, it drives prescription costs up and also encourages the 'medicalization' of American life — the sense that pills are needed for most everyday problems that people notice, and many that they don’t.” —Jerry Avorn, New York Times

[dropcap]C[/dropcap]onvincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record-breaking $5.4 billion on direct-to-consumer (DTC) ads, according to Kantar Media. And it paid off for Big Pharma. The same year, Americans spent a record $457 billion on prescription drugs. The U.S. and New Zealand are the only countries where DTC is legal. Americans also pay more for drugs and devices than any other country.

The bulk of these ads appear on TV at a rate of 80 ads per hour of programming, according to Nielsen. Behind the drug and device ads saturating TV, radio and digital media are hidden costs and devastating side effects that companies don’t advertise, and critics say the ads drive up drug prices and erode the patient-doctor relationship.

With the price of drugs skyrocketing, politicians and health-care providers question Pharma’s DTC spending, which exceeds money spent on research and development. Even presidential hopeful Hillary Clinton called for an end to tax breaks for drug ads and for tougher regulations.


But the money spent on DTC is just one small cog in Big Pharma’s well-oiled marketing machine. Companies spend billions more on getting doctors to write prescriptions for their expensive brand-name drugs or devices for uses not approved by the Food and Drug Administration — a controversial practice called off-label marketing.

The darker side of pharma marketing involves creating clinical trials aimed at influencing doctors and educational courses to showcase expensive drugs for non-FDA-approved uses — even when there is no scientific proof of safety or efficacy.

Big Pharma has paid billions of dollars in criminal and civil settlements over the years because of marketing fraud that cost taxpayers billions and left others with debilitating medical conditions. For example, the Department of Justice accused Johnson & Johnson of spending billions to target children and the elderly for unapproved drug uses, exposing them to serious side effects, including death.

Supporters argue DTC ads educate the public and empower them to make better health-care choices and say the First Amendment protects them. Doctors and other critics say Big Pharma’s sole purpose is to sell expensive products that may have unknown side effects.

The American Medical Association and American Society of Health-System Pharmacists called for a ban on DTC, reigniting the conversation about pharmaceutical marketing. But the facts behind Big Pharma’s tactics show the issue is far more complicated.


The ABCs of DTC

When most people think of pharmaceutical or medical device marketing, they think of the ads they see while watching their favorite TV shows or football game or while browsing a magazine. If it seems as if there are more ads than ever, there are. Over the past four years, the amount of money spent on DTC ads grew 60 percent.

The top four TV networks — CBS, ABC, NBC and Fox — take the majority of the advertising budget, with CBS at the top of the list at $511 million. Ads for erectile dysfunction, arthritis pain and blood thinners dominate the airwaves. Although digital media ads are increasing, older audiences still favor TV. The average CBS viewer is 59, which is the target age for most of these drugs.

DTC ads come in three forms, these are:

Product claim ads
These ads talk about a drug, the condition it treats and its risks and benefits.
Reminder ads
These ads "remind" people about the drug's name, but do not talk about its uses.
Help-seeking ads
These ads talk about a disease or condition without discussing specific drugs.

“And if you’re a pharma company, and you want to reach a lot of people quickly … there’s really no better place to go still than the traditional networks,” Timothy Calkins, a marketing professor at Northwestern University’s Kellogg School of Management, told STAT. “Pharma companies know who they’re going after, and they really focus on reaching those people.”

Though companies spend the bulk of their budget on TV — about $4 billion — magazines follow a close second, with about $1.5 billion spent in 2015, according to Nielsen. Newspapers, radio, billboards, movie theaters and other types of advertising only took up a few million dollars combined.

  Pew Charitable Trusts

Arguments For and Against DTC

DTC has several supporters and critics. Both sides base their argument on a handful of pros and cons.

According to the FDA, DTC raises a few controversial issues, these include:

  • Misleading or false information
  • May threaten public health
  • Not enough info on risks
  • Encourages expensive treatments

Supporters claim DTC:

  • Educates the public
  • Increases communication between physician and patient
  • Reminds patients to take medication

Regardless of the pros and cons, Big Pharma’s motivation comes down to money. Its biggest reason to keep dropping billions on advertising to consumers is that it works. The FDA approved a record 51 new drugs in 2015, and companies are scrambling for market share.

DTC Works

“Drugs with DTC ads had nine times more prescriptions than those that did not.”
—2011 Report by the Congressional Budget Office

 

According to Kantar Media, two-thirds of adults take some kind of action after seeing a drug or device ad, and about 40 percent make an appointment with their doctor. Americans also have a high level of confidence in these ads when it comes to drug dangers, and about 76 percent feel drug companies adequately explain side effects and risks, according to a survey by Harvard and STAT.

“Americans tend to think newer is better. If it costs more, therefore it’s better. If it’s new and it costs more, then certainly it is better,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch. “They sometimes think that the FDA only approves new drugs if they are better. There is no requirement in the law, nor does the FDA require that a new product be better. I’ve heard FDA officials say, ‘We’ve approved this drug. It doesn’t mean we recommend it.'”

In fact, about 43 percent of Americans think only completely safe drugs are allowed to be advertised, according to Pew Charitable Trusts.

They have so much confidence in these drugs’ safety and effectiveness that they ask their doctors to prescribe them. Sales of drugs with DTC ads increased 43 percent versus just 13 percent for all other drugs, according to an article from the Journal of the National Cancer Institute. For every dollar spent on advertising to consumers, sales of prescription drugs rose $4.40.

If you or a loved one were affected by a harmful drug or defective medical device, you could be eligible for compensation. Get a free case review today.
GET HELP NOW

Behind the TV Ad

“Consumer Reports has long held that drug ads should be banned...For one, they encourage patients and doctors to turn to medication when nondrug options might work. And when drugs are needed, ads often promote more expensive options, not the best or safest.”
—Consumer Reports, Can You Trust Drug Ads on TV?

How well do drug ads stand up to scrutiny? According to Consumer Reports, many drug ads are misleading and could encourage patients to seek expensive treatments. It sides with the AMA and ASHP in favor of a ban on DTC. The nonprofit organization cited a 2014 review published in the Journal of Internal Medicine. The data revealed 57 percent of claims in 168 drug ads were potentially misleading and 10 percent were entirely false.

Drug companies tend to pour the most money into advertising newer, more expensive drugs. Consumer Reports published a review of some of the most popular drugs, including costs, risks and benefits. According to the report, newer isn’t always better. All the benefits portrayed in these colorful TV commercials mask hidden side effects and costs the drug companies don’t advertise.

Breaking Down Big Pharma's TV Ad Spending

Viagra (sildenafil) and Cialis (tadalafil)
At $70 for a 10-pill supply of Cialis (Eli Lilly) and $332 for 10 pills of Viagra (Pfizer), these drugs are some of Pharma's staple moneymakers. And the amount of money spent advertising them reflects this. Pfizer and Eli Lilly spend half a billion annually on ads. Millions of men take these medications to treat erectile dysfunction. But they can increase the risk of heart attack, stroke and vision and hearing loss.
Humira (adalimumab)
AbbVie's blockbuster drug for Crohn's disease was the heaviest hitter in revenue spent on ads at $357 million in 2015 — an all-time high for the drug. A month's supply of this drug costs about $5,000. Though research shows the drug works, it also increases the risk of tuberculosis and pneumonia.
Xarelto (rivaroxaban)
These two newer blood thinners reduce the risk of blood clots caused by atrial fibrillation and other issues. Blood clots can lead to strokes. Xarelto had an ad budget of about $106 million in 2015, and Eliquis spent more than double that, at $246 million. Each drug also costs about $300 a month versus warfarin, the decades-old blood thinner. Consumer Reports recommended warfarin over these newer drugs for cost and safety profiles. Xarelto in particular may cause internal bleeding, and without an antidote to stop the bleeds, they can be fatal. Patients have filed thousands of lawsuits against Johnson & Johnson's Janssen unit in courts across the country. Eliquis edges out Xarelto in safety and effectiveness versus warfarin.
Lyrica (pregabalin)
Second only to Humira in dollars spent on ads at $338 million, Pfizer's drug to treat fibromyalgia and epilepsy costs about $260 a month. Yet studies show only a modest benefit in patients who take the drug. Patients also face a wide range of side effects, including suicidal thoughts, liver and kidney problems, blurred vision and swelling. The company agreed to pay $43 million in fines for misleading marketing in 2012. The company faced a number of lawsuits for suicide and other side effects.
Xeljanz (tofacitinib)
Pfizer spends $183 million to advertise this newer rheumatoid arthritis drug. The drug is effective at easing pain but is not as well-studied. Serious side effects can include perforations in the stomach and intestines. The monthly cost is about $2,380. Consumer Reports recommends older generic drugs or better brand-name drugs such as Humira or Enbrel.
Abilify (aripiprazole)
In 2014, Abilify was the top-selling drug in the U.S. and made about $7 billion that year. The drug treats depression and costs about $900 a month. According to the ad, it helps people in whom other antidepressants don't work. But Consumer Reports found that it provides little if any benefit. Scientists aren't even sure how the drug works. The drug is linked to a host of side effects such as compulsive behaviors, heart attack, stroke and involuntary movements. Consumer Reports refused to recommend this drug.

History of DTC Marketing

TV ads are so prevalent that it is hard to believe DTC advertising is a relatively new concept. Before the 1980s, drug and device companies focused on marketing to doctors and pharmacists. But in the 1980s, the FDA relaxed regulations on ads targeting consumers — and Big Pharma seized the opportunity to reach a massive audience. Pfizer and Eli Lilly led the way, and billions of dollars later, the marketing shows no sign of stopping.

  • 1958 About 90 percent of Big Pharma marketing is aimed at doctors. Its salesmen — called "detail men" — made 20 million calls to doctor's offices, paid for 3,790,809,000 pages of ads in medical journals and sent 741,213,000 pieces of direct mail.
  • 1962 Kefauver-Harris Amendments strengthened the premarket review process and transferred regulatory authority of prescription drugs to the FDA. Drug companies must provide information about contraindications, side effects and effectiveness in all advertisements.
  • 1969 FDA required drug ads be a "true statement of information in brief summary relating to the side effects, contraindications, and effectiveness.” Pharma still targets physicians as its main audience.
  • 1980 FDA relaxes DTC marketing rules.
  • 1982 Pfizer launches "Partners in Health Care” to increase awareness of hypertension, diabetes and depression. Eli Lilly advertises Oraflex to TV networks and radio stations. It emphasizes that the drug might stop arthritis, a claim not approved by the FDA. The drug is pulled five months later because of adverse events.
  • 1985-90 Pharma advertises at least 24 drugs directly to the public. Companies begin branding over-the-counter medications in DTC ads. "Lifestyle" drugs for depression, erectile dysfunction and hair loss became popular.
  • 1992 The AMA says the "era of health care reform" demands "individuals [take] responsibility for their health care, which means they will need more information." DTC prescription medication advertising climbs from $12 million in 1989 to $340 million by 1995.
  • 1999 FDA releases "Guidance for Industry: Consumer-Directed Broadcast Advertisements." The guidance requires that broadcast ads give brief information about the major risks instead of a long summary of risks and warnings.
  • 2005 Pharmaceutical Research and Manufacturers of America (PhRMA) issues "Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines." This guidance adds the "ask your doctor" language to DTC ads.
  • 2007 Advertising by pharma companies to consumers reaches $4.8 billion a year.
  • 2011 Congressional Budget Office releases "Potential Effects of a Ban on Direct-To-Consumer Advertising of New Prescription Drugs." Study finds drugs with DTC have nine times more prescriptions that those that do not.
  • 2014 FDA considers having fewer risks mentioned in DTC broadcast ads.
  • 2015 American Medical Association votes in favor of DTC ban.
  • 2016 American Society of Health-System Pharmacists votes in favor of DTC ban.

Doctors and Pharmacists Support DTC Ban

Doctors and pharmacists favor banning DTC ads altogether. They say the ads drive patients to demand newer, more expensive drugs when more cost-effective choices are available. The practice drives up cost of care and erodes the patient-doctor relationship.

For example, an article in the Journal of Clinical Oncology showed that 94 percent of nurse practitioners had patients ask for a drug they saw advertised, and 74 percent of them had patients request inappropriate drugs. Doctors wrote prescriptions for more than half of these requests.

In November 2015, the American Medical Association’s House of Delegates — its policymaking body of 540 grass-roots physicians — voted to back an advertising ban for prescription drugs and devices.

“The nation’s physicians are concerned that a growing proliferation of commercially-driven promotions is fueling demand for new and more expensive treatments regardless of the clinical effectiveness of less costly alternatives.”

“Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA board Chair Dr. Patrice A. Harris. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

A few months after the AMA voted to ban DTC, the American Society of Health-System Pharmacists followed suit in June 2016. The group’s news release cited a Government Accountability Office report noting that “pharmaceutical companies have increased spending on DTC advertising more rapidly than they have increased spending on research and development” and that “DTC advertising appears to increase drug spending and utilization.”

“For decades, pharmacists practicing in hospitals and clinics have been the leaders in recommending and initiating evidence-based medication therapies in partnership with physicians and other prescribers — and in helping patients achieve optimal and cost-effective medication therapy outcomes,” ASHP CEO Paul W. Abramowitz said in a statement.

The vote to ban all DTC ads is a radical change from the group’s former position that ads be allowed as long as they met certain criteria. According to the GAO report, “FDA’s oversight of DTC advertising has limitations.”

DTC and Its Effect on Drug Costs

“Pharmaceutical companies have been spending money like drunken sailors.”
—Rino Scanzoni, chief investment officer of WPP Plc’s GroupM

The relationship between money spent on marketing and higher drugs costs is difficult to ignore. Though a number of things influence drug prices, Big Pharma’s argument for rising medication costs has long been the idea that it takes a lot of money to bring a drug to market. Companies are quick to say high research and development costs force them to charge higher prices to recoup what they spent.

But the truth is they spend much more money on sales and marketing than on R&D. For example, in 2013, one of the biggest drug companies in the world, Johnson & Johnson, spent more than double its R&D costs on marketing.


Doctors, pharmacists and critics of DTC are quick to point out that the cost of marketing a drug causes the price of the drug to rise. However, few studies exist.

According to a study cited by The New York Times, about 6 percent of rising drug prices are related to marketing. One study published in the Archives of Internal Medicine by Law, M.R. and colleagues followed one of the most advertised and popular blood thinners, Plavix (clopidogrel). The FDA approved the drug in 1999, and its DTC campaign began in 2001.

Researchers studied data from 27 Medicaid programs from 1999 to 2005. From 2001 to 2005, money spent on DTC exceeded $350 million. DTC did not increase number of units sold, but the price of the drug increased by $0.40 after the ads began. This might not seem substantial, but it equated to an additional $40.58 of pharmacy costs per 1,000 patients each quarter.

Spending on DTC ads led to an extra $207 million in pharmacy expenditures for that specific period.

Some lawmakers are sure drug costs increase because of ads. In 2016, House Rep. Rosa DeLauro called for a three-year moratorium on drug ads for new drugs, and Sen. Al Franken introduced a bill that eliminates drug company tax breaks for ad campaigns.

“[Drugmakers are] trying to encourage Americans to buy the most expensive drugs — even when cheaper, equally effective drugs are on the market. … This is just a common sense measure to help cut down health care costs,” said Franken in a statement.

“Proposals to eliminate the tax deductibility of DTC advertising ignore the value of informing patients about their health care and treatment options,” a spokeswoman for the Pharmaceutical Research and Manufacturers of America wrote STAT. “An unintended consequence of eliminating [the tax deduction] may be fewer patients seeking medical care for chronic conditions that could be managed earlier and more cost-effectively.”

Consumer Marketing Encourages Overmedication

Doctors also agree that DTC ads encourage patients to seek out drugs. In fact, 81 percent of doctors surveyed in 2013 agreed that the ads promoted overuse of medications.

For example, take the “Low-T” campaigns for testosterone drugs such as AndroGel, Axiron and Aveed. FDA approved these drugs to treat men diagnosed with clinical hypogonadism, a condition that causes low testosterone. Drug companies billed these drugs as the new fountain of youth, promising increased vitality and sexual prowess.

Millions of men demanded their doctors prescribe these drugs, and many of them did so without a clinical diagnosis. Low-T clinics popped up in strip malls across the country.

“There are a total of 7.5 million prescriptions a year, and in the petition we filed, we only focused on the AndroGel and the patches and the oral drugs — that’s about 5 million,” Dr. Sidney Wolfe of the advocacy group Public Citizen told Drugwatch. “There’s another 2.5 million prescriptions for the injectable form, so it’s a widely used drug. As I said, a majority of the people should not be getting it. They’re not getting any benefit.”

“Obviously, the companies are paying a lot of money for these ads for a reason. They know it affects how many people take these drugs and how many prescriptions are written. And to pretend that they don’t know what the impact is seems disingenuous at best.”
—Diana Zuckerman, President, National Center for Health Research

The problem of over-prescription became so widespread that the FDA released a warning in 2015 stating there was no evidence the drugs were safe or effective for low libido and fatigue — key symptoms of low T featured in drug ads. But that did little to discourage the testosterone therapy craze.

According to Wolfe, millions of men were exposed to a drug with benefits that did not outweigh the risk of potentially fatal heart attacks and strokes. Several studies linked these drugs to increased odds of such cardiac problems. Lawsuits filed by thousands of men who claim the drugs caused a number of health issues soon followed.

Other studies point to the connection between the number of prescriptions and DTC ads. For example, doctors in the U.S. prescribe medication for attention deficit hyperactivity disorder about 25 times more in the U.S. than in the United Kingdom, a country that does not allow DTC. The validity of ADHD diagnosis has long been controversial, as has treating it with powerful antipsychotics. Each year, drug companies make $13 billion in prescriptions to treat it, according to a video report from Wired.com.

Dominick L. Frosch, a professor at the David Geffen School of Medicine at the University of California, Los Angeles, published one of the first studies to analyze overmedication and DTC ads. Frosch and colleagues examined 38 unique TV drug ads for a number of ailments, including high blood pressure, cholesterol and depression.

The study found the ads appealed viewers’ emotions to encourage drug use and had little to do with concrete information.

“We’re seeing a dramatization of health problems that many people used to manage without prescription drugs,” Frosch said in a news release. “The ads send the message that you need drugs to manage these problems and that without medication your life will be less enjoyable, more painful and maybe even out of control.”

The Positives of DTC

"The days of Dr. Kildare sort of being the all-knowing doctor are over. Active, empowered patients who are expected to be very active in their own healthcare lead the culture in our times...it is important for consumers to be a part of the decision-making, to learn about options that are available to them and discuss them with their doctor. [DTC] is all about patient empowerment."
—John Kamp, Executive Director, Coalition for Healthcare Communication

Though DTC has many critics, it also has passionate supporters. Their biggest argument for advertising directly to consumers is the benefit of education and promoting awareness of treatment options.

“Patients who ask about a drug [they see on DTC ads] are more likely to get a better standard of care than those who don’t ask. So the conversation-starting part of direct-to-consumer advertising is a benefit to the patients,” John Kamp, executive director of the Coalition for Healthcare Communication, told Drugwatch.

Based in New York, CHC has been advocating the “free flow of truthful health-care information” for about 25 years. Kamp took the mantle of executive director 12 years ago and was one of the organization’s founders. CHC is an offshoot of the 4A’s — the American Association of Advertising Agencies. His background includes a stint practicing law and teaching constitutional law. Founded in response to an anti-DTC campaign by then-FDA Commissioner David Kessler, the organization ardently defends the right of drug companies to advertise under the First Amendment.

FACT

Nearly 80 percent of people said DTC ads increased their awareness of new drugs, and 73 percent of doctors said their patients asked thoughtful questions regarding DTC drugs ads.

Kamp was critical of the AMA’s stance on banning DTC.

“I find it interesting that the only ones who can prescribe the drug think that the advertising for consumers changes the nature of the situation,” he said. “They are the decision makers. I don’t believe in the dumb or impotent doctor theory that doctors don’t have good conversations with their patients.”

He also says the idea that patients take more drugs just because they see an ad is unfounded.

Some data support Kamp’s assertion. In a 2016 Harvard poll, only 7 percent said they would actually consider taking a drug advertised. A 2007 survey published in Clinical Orthopaedics and Related Research showed 44 percent of patients said DTC ads helped educate them about drugs, medical conditions and treatment options. The ads also appear to affect patient compliance with treatment. In an FDA survey, 18 percent of patients said the ads reminded them to take their medications.

Nearly 80 percent of people said DTC ads increased their awareness of new drugs, and 73 percent of doctors said their patients asked thoughtful questions regarding DTC drug ads.

Critics: Ads Don't Educate

“If the real goal is to educate, they wouldn’t look like this. The goal is to persuade. These ads educate people as much as the ads for the GAP or ads for makeup educate. It is educating you to tell you that this product exists and that it's great.”
—Diana Zuckerman, President, National Center for Health Research

Though patients may feel drug ads educate them about treatments and diseases, there is insufficient evidence that people actually retain helpful information. In fact, findings in studies actually show people’s memories are skewed toward remembering benefits in DTC ads and not the risks.

DTC supporters say drug ads adequately explain risks.

“All you have to do is watch an ad to see that the risks take up one-third to one-half of the ad,” Kamp said. “In no other category [of product] do you get the fair balance that the FDA requires in consumer advertising of drugs.”

That might be true, critics argue, but rattling off a list of side effects actually works in the drug companies’ favor. The litany of side effects is so overwhelming, and most patients don’t pay attention. Most ads don’t discuss findings in clinical trials, either — especially if it’s a serious risk.

Technically, the ads are supposed to reflect the studies that were submitted to the FDA, but a lot of times they don’t,” Zuckerman said. “For example with Farxiga, people in the clinical trials were five times more likely to be diagnosed with bladder cancer. Who in their right mind would want a diabetes medication that increases your risk of bladder cancer when there are so many diabetes medications?”

In addition, most ads exceed the eighth-grade reading level requirement, according to 2010 review by UCLA’s Frosch and colleagues, making it more difficult for the majority to understand. Experts say this exploits patients and could lead to making decisions based on incomplete facts about a drug or disease. In fact, patients with lower incomes and education levels who are less likely to seek medical care in general were more likely to see a doctor after seeing DTC prescription drug ads.

Studies also showed that risk data on product websites were also more difficult to find, whereas the benefits were on the first page.

“You know every consumer of advertising pays whatever attention they do,” Kamp said. “The information is there if you want to see it… They are not perfect, not everybody pays attention to every part of them, but they are there to warn consumers that every drug has side effects that you should pay attention to. They are not perfect, and no consumer of advertising watches them with 100 percent attention.”

Doctors and other health-care physicians said patients shouldn’t get information from drug ads at all.

“ASHP believes that medication education provided by pharmacists and other providers as part of a provider-patient relationship is a much more effective way to make patients aware of available therapies, rather than relying on direct-to-consumer advertising,” ASHP’s Abramowitz said.

Does DTC Advertising Work?

On June 24, 2016, Drugwatch conducted an online survey via Google Consumer Surveys about DTC advertising. The following results account for 237 responses amongst people age 55 and up.

Some Docs Find DTC Helpful

“What causes doctors to dislike DTC? Well, maybe some of them would prefer to go back to the era... when they were seen as deity and having all the information that anybody needed... I can only speculate. But, I think the recently press has made more of it than there actually is.”
—John Kamp, Executive Director, Coalition for Healthcare Communication

Kamp said the AMA’s decision is unlikely to encompass the views of all doctors. Some actually find DTC helpful.

“A lot of doctors pushed back the proposal to eliminate DTC and didn’t think it was such a good idea,” Kamp.

Some surveys show doctors actually have a positive view of DTC. One from 2013 revealed 64 percent believed ads encouraged patients to contact a health-care professional.

Evidence shows that DTC might also promote general health awareness, not just pill popping. In 2010, a Prevention Magazine survey reported 29 million patients spoke with their doctors after seeing a DTC ad, and the majority discussed lifestyle changes and nonprescription or generic drugs over brand-name medications.

In addition, for every $28 a drug company spends on these ads, doctors get one more patient visit. Ads can also encourage patients with stigmatized conditions such as mental illness —depression in particular — to seek treatment, according to The New York Times.

Though patients with depression are more likely to seek treatment, they do not always get a prescription for the advertised drug. Doctors ultimately control the prescriptions, and sometimes they choose nonpharmaceutical treatments.

Celebrities Spreading Drug Awareness

A large part of pharmaceutical marketing involves celebrities. From famous athletes to actors, Big Pharma has used them throughout the years to help sell a drug or promote awareness of a disease or condition.

One of the more recent ads featuring not one but four celebrities is a TV commercial for the blood thinner Xarelto (rivaroxaban). The ad features celebrity golfer Arnold Palmer, NASCAR driver Brian Vickers, comedian Kevin Nealon and two-time NBA champion Chris Bosh extolling the benefits of Xarelto. These include being able to eat “healthy salads” and not having to check with a doctor for blood tests such as the ones required of patients on warfarin — a decades-old blood thinner.

Noticeably absent from the commercial is the drug’s risk of serious uncontrolled bleedingand lack of an antidote to stop the bleeds, such as vitamin K for warfarin. Bosh missed a number of games and Vickers wasn’t allowed to race while on the drug because of uncontrolled-bleeding concerns.

“This personal connection makes it a very real crusade for these spokespersons. They are armed with information, and they are using their recognizability to educate their fans.”
—Amy Doner, President and Founder of The Amy Doner Group

This ad is a perfect example of a branded ad — meaning all celebrities featured mention the drug by name and are actually taking or have taken the drug. Unbranded ads featuring celebrities raise awareness about a certain condition, such as Cedric the Entertainer talking about Type 2 diabetes on behalf of a drug company without mentioning the name of a drug.

“Unbranded campaigns allow for greater flexibility in my role,” Doner told Drugwatch. “That is to help match the pharmaceutical company with the right spokesperson who has or knows someone with a particular medical condition who then speaks out either personally or on behalf of a family member or friend.”

Doner connects pharma companies with celebrities and worked with actors such as Kelsey Grammer and Rob Lowe and drug companies such as GlaxoSmithKline and Johnson & Johnson. Before founding the Amy Doner Group, she planned events and handled media relations for Big Pharma heavy hitters such as Novartis, Merck, Pfizer, Glaxo and Bristol-Myers Squibb.

“Patient and physician dialogue is key to ensuring patients are better involved in and more informed about what might lie ahead when faced with — or trying to rule out — a medical condition,” Doner said. “Direct-to-consuming marketing can help to create this dialogue, and often a key driver to generating awareness for patients to even consider such a dialogue.”

These tactics work.

One of the first celebrities to raise awareness about erectile dysfunction was Bob Dole. In 1999, Pfizer, the maker of blockbuster erectile dysfunction drug Viagra, paid Dole to talk about ED. In 2000, “Today” show host Katie Couric — whose husband died of colon cancer in 1998 — underwent a colonoscopy on live TV to raise awareness about screening for the disease. Colonoscopy rates jumped 20 percent immediately following the broadcast.

But, although celebrity ads provide some positives, when they promote a dangerous drug, the ramifications can be disastrous.

For example, Bruce Jenner and Dorothy Hamill teamed with Merck to promote the painkiller Vioxx. Then-head of the American Arthritis Foundation Dr. John Klippel appeared on “Larry King Live” with the two Olympians and praised the drug for its lack of side effects.

“That’s one of the important things, Larry: Vioxx was developed to reduce side effects,” Klippel told King. “So if you will … it’s a safer drug to use.”

Four years later, Merck recalled the drug after some people taking it suffered heart attacks. In one of the largest health-care settlements in history, the drugmaker paid $4 billion to settle 35,000 lawsuits filed by people who said they suffered heart attacks.

Is Big Pharma Writing Your Prescription?

"In 2012, the pharmaceutical industry spent more than $27 billion on drug promotion — more than $24 billion on marketing to physicians and over $3 billion on advertising to consumers (mainly through television commercials). This approach is designed to promote drug companies' products by influencing doctors' prescribing practices."
—Pew Charitable Trusts, Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients

Though most consumers have experience with DTC, few know that Big Pharma spends billions more on marketing to doctors. Even the AMA and ASHP don’t address this in their votes to ban DTC. Drug companies employ a wide variety of techniques to reach prescribers. Free meals, speaking fees, and sponsoring educational courses and clinical trials are some of them.

It turns out that it doesn’t take much to sway a doctor. In fact, drug companies can get physicians to prescribe a drug for the price of a sandwich.

A 2016 study published in JAMA Internal Medicine revealed that doctors who accept free meals from Big Pharma tend to prescribe a company’s promoted drugs. Researchers looked at Medicare prescribing information for statins, blood pressure medications and antidepressants. After looking at data from 279,669 physicians, they found that just one free meal equated to higher rates of prescribing heavily promoted drugs Crestor (rosuvastatin), Benicar (olmesartan) and Pristiq (desvenlafaxine).

The study found all it took was a meal less than $20 to increase prescriptions for a branded drug. If the cost of a meal exceeded $20 or a doctor received additional meals, prescriptions rates were likely to go up even more. Authors said that, although the study does not prove a cause-and-effect relationship, there is an association between the two.

But this isn’t the only study to show this relationship between payments and prescribing drugs or devices. A 2016 ProPublica analysis of Big Pharma payments made to doctors also showed an increase in brand-name prescriptions.

“Indeed, doctors who received industry payments were two to three times as likely to prescribe brand-name drugs at exceptionally high rates as others in their specialty,” ProPublica found.

A spokesperson for Pharmaceutical Research and Manufacturers of America, the industry trade group, told ProPublica that many factors affect doctors’ prescribing decisions.

“Working together, biopharmaceutical companies and physicians can improve patient care, make better use of today’s medicines and foster the development of tomorrow’s cures,” she wrote. “Physicians provide real-world insights and valuable feedback and advice to inform companies about their medicines to improve patient care.”

Top 10 companies in Doctor Payments

COMPANY

NUMBER OF PAYMENTS

PAYMENT TOTALS

Genentech, Inc. 6,486 $388 million
DePuy Synthes Products LLC 2,565 $94.7 million
Topera Inc. 298 $93.1 million
Stryker Corporation 120,404 $90.8 million
AstraZeneca Pharmaceuticals LP 968,562 $90.7 million
Medtronic Sofamor Danek USA, Inc. 45,180 $85 million
Pfizer Inc. 738,451 $82.5 million
Zimmer Holding Inc. 47,417 $70.5 million
Allergan Inc. 343,906 $69.9 million
Arthrex, Inc. 15,152 $58.9 million

Marketing Campaigns Disguised as Clinical Trials

“Some company-sponsored trials of approved drugs appear to serve little or no scientific purpose. Because they are, in fact, thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company, they are often referred to as 'seeding trials.”
—David A. Kessler and colleagues, New England Journal of Medicine

Seeding trials are thinly veiled pharma attempts at marketing drugs to doctors and probably some of the most insidious forms of marketing.

“In an age of for-profit clinical research, this is the new face of scandal,” wrote Carl Elliott in The New York Times. “Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naively sign up, unaware of the ways in which they are being used.”

These supposed clinical trials have a few distinguishing characteristics. They employ physicians that are frequent prescribers of competing drugs of the drug being studied, are poorly designed and pay high fees to the physicians participating in the trial who prescribe the drug.

The true purpose of seeding trials remains hidden until court documents surface in litigation against pharma companies. Companies do not disclose the purpose of these trials to review boards, physicians or patients, and little information is available in the public domain on the practice.

“This practice — a seeding trial — is marketing in the guise of science. The apparent purpose is to test a hypothesis,” wrote Drs. Harold C. Sox and Drummond Rennie in an editorial in the Annals of Internal Medicine. “The true purpose is to get physicians in the habit of prescribing a new drug.”

One of the most famous examples of a seeding trial surfaced during legal proceedings against Merck for its pain reliever, Vioxx. The trial, named ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), was supposed to assess the gastrointestinal safety of the drug. Results of the trial even appeared in peer-reviewed medical journals, according to a review published in the Annals of Internal Medicine by Dr. Kevin P. Hill and colleagues.

“This practice — a seeding trial — is marketing in the guise of science. [...] The true purpose is to get physicians in the habit of prescribing a new drug.”
—Drs. Harold C. Sox and Drummond Rennie in an editorial in the Annals of Internal Medicine

But doctors or researchers didn’t actually design the trial.

According to internal documents, Merck’s marketing team designed the trial to reach “a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class and gather data important to this customer group.” Merck even nominated the marketing team for its Best Physician Program Award. Merck later pulled Vioxx from the market after a large number of patients taking the drug suffered heart attacks.

Parke-Davis, now a part of Pfizer, conducted another example of a seeding trial on its seizure drug Neurontin. Inexperienced investigators and a flawed study design led to disastrous consequences. Not only did it not yield much useful information, but 11 study participants died and 73 experienced serious adverse events.

Pharma's Addiction to Off-Label Marketing

“Desperate to maintain their high profit margins, pharmaceutical companies have increasingly engaged in illegal activities, such as dangerous, illegal promotion of drugs for uses not approved by the FDA — a practice commonly referred to as 'off-label promotion.'”
—Dr. Michael Carome, Director, Health Research Group at Public Citizen

One of the most controversial practices in pharma marketing is so-called off-label promotion: the marketing of a drug to doctors for a use not approved for the FDA. Though it is legal for health care providers to prescribe a drug for an off-label use, it is illegal for a drug company to encourage it because the FDA has not received data showing the drug is safe or effective for that use.

Unfortunately, off-label promotion happens more often than the American public knows. In some parts of medicine, such as pediatrics and psychiatry, there is more off-label than on-label use. Supporters say drug companies should be allowed to discuss it.

“The drug sponsor, the company that manufactures the drug, is usually in the best position to talk about off-label because they know more about the safe and effective use of their drug than any other institution,” Kamp said. “If Einstein were among us, the last thing we would want to do is say everybody can talk about the theory of relativity, but we won’t let Einstein talk about it because he’s the one that came up with the idea.”

FACT

Since drugs are often FDA-approved for very limited uses, pharma companies are quick to exploit off-label uses to pad profits — often, at the expense of patient safety.

In some cases, patients may get access to lifesaving treatments off-label. For example, this is often the case with experimental cancer treatments. Patients with rare, terminal diseases may also benefit. But the intentions of drug companies might not be as noble.

Because drugs are often FDA-approved for very limited uses, pharma companies are quick to exploit off-label uses to pad profits — often at the expense of patient safety. Officially, they damn the practice as illegal. Unofficially, they incentivize sales reps and even coach them on tactics to sell off-label uses to doctors, hospitals and other health care facilities, such as nursing homes. For some reps, bringing up ethics could mean getting fired.

One of those former sales reps was Melayna Lokosky. She worked for venture-funded startup Acclarent, now part of Johnson & Johnson’s Ethicon division, which bought Acclarent in 2010. Before that, she worked for Bristol-Myers Squibb and Schwarz Pharma.

“I’m living proof [of this practice],” Lokosky told Drugwatch. “When I started challenging that behavior at then-Johnson & Johnson’s Ethicon’s Acclarent, I was wrongfully terminated.”

Lokosky filed a whistleblower complaint in Los Angeles Superior Court in 2015 accusing Acclarent of off-label promotion of its Relieva Stratus MicroFlow Spacer for an unproven drug-delivery use. According to the complaint, J&J is liable for millions of dollars in damages stemming from insurance companies paying for medically unnecessary, misbranded Acclarent devices marketed to physicians for unproven off-label use.

William Facteau, who was CEO, and Patrick Fabian, who was vice president of sales — two former top Acclarent executives — face fraud charges in Massachusetts. A federal grand jury indictment said they marketed Acclarent’s Relieva Stratus MicroFlow Spacer off-label for delivering steroids. The FDA only approved the device for opening sinuses.

“Reps now, from recent rulings, can sell off-label if what they are saying is factual,” Lokosky said. “The problem with FDA giving the industry an inch, to sell off-label, is that they’ll take a mile, as we’re now seeing with the Johnson & Johnson Acclarent case.”

Off-Label Use Leads to More Side Effects

Using drugs off-label can also spur an increase in side effects. Of the top five drugs prescribed off-label, about 80 percent did not have strong scientific evidence for off-label use, according to a 2015 study in JAMA by Tewodros Eguale and colleagues.

The study looked at 151,305 prescriptions. About 7.6 percent of patients suffered adverse effects from the drug, but when the same drug was used off-label, the rate of side effects was 44 percent greater.

Marketing an Antispychotic to Children and the Elderly

One of the most publicized cases of off-label marketing in recent years centers around Johnson & Johnson’s off-label promotion of its antipsychotic drug Risperdal (risperidone). Originally, the FDA only approved the drug in 1993 to treat schizophrenia in adults. However, that didn’t stop J&J from marketing the drug to treat ADHD, anxiety, sleep difficulties, depression and hostility in groups at high risk for dangerous side effects — in this case, children and the elderly.

In early J&J trials, researchers found the side effects of the drug in children and the elderly were substantial, according to Steven Brill’s investigative piece “America’s Most Admired Lawbreaker.” Despite this, J&J’s Janssen unit exploited these two profitable groups.

“Risperdal is indicated for the management of manifestations of psychotic disorders,” Lisa Stockbridge, then of the FDA’s Division of Drug Marketing, Advertising and Communications, wrote to Janssen’s director of regulatory affairs. “However, Janssen is disseminating materials that imply, without adequate substantiation, that Risperdal is safe and effective in specifically treating hostility in the elderly.”

Of considerable concern to Stockbridge and the FDA was the large number of unexplained deaths from heart-related issues and strokes in elderly patients taking Risperdal. In fact, the agency denied J&J’s request for Risperdal approval for use in the elderly in 1999 because of safety issues. In particular, J&J “failed to fully explore and explain what appeared to be an excess number of deaths.”

The side effects of the drug for children and the elderly were substantial

One of the most controversial side effectsinvolved young boys and men growing breasts, a condition called gynecomastia. Court documents say J&J knew of the risk. But in the 1990s, Risperdal made about 20 percent of its revenue from sales to children — even if the FDA had no proof it was safe or effective in this group. J&J marketed it heavily for ADD and ADHD and paid reps heavy bonuses to promote it to doctors as safe.

“At the same time, the company focused on rounding up respected academics who could aid the cause by touting the results as they came in and make Risperdal the prime choice for pediatricians regardless of what the FDA label said,” wrote Brill in his article.

Lawsuits filed by parents and young men who suffered gynecomastia they say Risperdal caused poured into state and federal courts across the country.

In 2015, Austin Pledger won the first Risperdal jury trial. Pledger developed size 46DD breasts when he was a teenager after he started taking the drug at age 8. The jury awarded him $2.5 million after determining J&J failed to warn about the risk of gynecomastia.

Pharma Spends Billions on Marketing Fraud Fines

The Department of Justice collects billions of dollars in fines from drug companies routinely breaking the law. So far, the biggest settlement in American history belongs to GlaxoSmithKline. The company paid $3 billion to resolve criminal and civil charges related to illegal promotion of drugs and failure to report safety data. The drug at the heart of the controversy was its popular antidepressant Paxil. The pharmaceutical giant pleaded guilty for pushing the drug as a treatment for children younger than 18, though the FDA never approved it for this use.

“Off-label promotion can be prosecuted as a criminal offense because of the potential for serious adverse health consequences to patients from such promotional activities,” Dr. Michael A. Carome, director of Public Citizen’s Health Research Group, told Drugwatch.

According to a March 2016 Public Citizen study, “Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015,” federal and state governments and pharmaceutical manufacturers reached a total of 373 settlements totaling $35.7 billion.

“Many of the infractions, and the single largest category of financial penalties, stemmed from the practice of off-label promotion of pharmaceuticals,” Carome said.

Fines Won't Stop Big Pharma

Regardless of hefty DOJ fines, experts say pharma won’t curb off-label promoting anytime soon — there is just too much money to be made. Lack of oversight from federal authorities and the medical community allows drugmakers to find loopholes in the laws, Forbes reported.

“Despite the gaudy sums, however, it’s unlikely that the industry will curb its reliance on off-label prescriptions. The practice is simply too lucrative to pass up.”

Off-label prescriptions bring in about $40 billion each year or about 20 percent of all revenue, according to a report from Cozen O’Connor’s Life Sciences Practice Group. With figures such as these, Big Pharma is willing to sacrifice a few hundred million for a one-time fine.

In the case of Risperdal, for instance, off-label prescriptions accounted for 75 percent of sales in 2002. According to court documents, it was J&J’s second-best-selling drug, and off-label marketing catapulted the drug from sales of $172 million in 1994 to $1.7 billion in 2005.

The DOJ didn’t reach a $2.2 billion settlement until 2013 — that’s almost two decades’ worth of profit from off-label use.

Biggest Marketing Fraud Settlements

COMPANY

AMOUNT

DRUGS

YEAR

GlaxoSmithKline $3 billion Paxil, Wellbutrin, Avandia 2012
Pfizer $2.3 billion Bextra, Geodon, Zyvox, Lyrica 2009
Johnson & Johnson $2.2 billion Risperdal, Invega, Natrecor 2013
Abbott Laboratories $1.6 billion Depakote 2012
Zyprexa $1.4 billion Zyprexa 2009
Merck $950 million Vioxx 2011
Serono $704 million Serostim 2005
Purdue Pharma $634.5 million OxyContin 2007
Allergan $600 million Botox 2010
AstraZeneca $520 million Seroquel 2010
Bristol-Myers Squibb $515 million Abilify 2007

Courses Designed to Sway Doctors

Wining and dining doctors isn’t the only way to influence prescriptions. Another way pharma and device companies reach health care providers is through continuing education programs. The law requires doctors to take continuing education courses to keep their licenses in 45 states. And pharma doesn’t have to disclose the money it spends on these programs.

Big Pharma has always been a big contributor when it comes to funding these courses, many of which are free for doctors. In 2014, course providers reported $2.7 billion in income, and about $676 million came from device manufacturers and drug companies, a Milwaukee Journal Sentinel and MedPage Today investigation found.

Tighter regulations requiring doctors to disclose funding and universities refusing drug company money led to pharma’s hiring third-party companies. These companies created materials, hired instructors and put on the courses.

“Consider it the dark money of medicine.” —John Fauber, Coulter Hones and Kristina Fiore, Testosterone Courses Downplay Risks, Lead to Overuse in Older Men

“These companies want to get more money from industry, and they’re certainly not going to put on a course that doesn’t appeal to industry,” Paul Lichter, who heads the University of Michigan’s clinical and educational conflict of interest committee, told the Journal Sentinel “They know where their bread is buttered.”

The Journal Sentinel and MedPage Today reviewed 75 Big Pharma-funded courses for testosterone replacement therapy found half the faculty received drug payments, and 65 course instructors had ties to a company that makes or markets these products. And these courses focus on off-label uses.

Course materials often use studies funded by the drug industry or studies with dubious information. For example, one study only involved 13 men. Several studies show testosterone can contribute to prostate cancer, yet Abbott — the maker of AndroGel — promoted its use in men with active, low-grade prostate cancer. FDA-approved labels for the drug also say men with known or suspected prostate cancer should not use the drug.

The FDA's Role

“The FDA has written policies that sound good, but the reality is very different from the written policies.”
—Diana Zuckerman, President, National Center for Health Research

Contrary to what the public believes, the FDA has not deemed as safe all drugs that are advertised. In fact, the FDA sees the ads at the same time the public sees them. In the meantime, an unsuspecting public risks exposure to harmful drugs. In fact, the agency that many consumers rely on to provide oversight in all things drug- and device-related seems to be doing a poor job.

Only 33 percent of Americans think the FDA does a “good” job of regulating new drugs, according to a poll by Harvard and STAT. More than half think it does a fair or poor job.

So what does the FDA actually do when it comes to reining in pharma marketing? It turns out, very little, and any of the FDA’s guidelines for drug companies are voluntary.

“In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used,” the FDA says on its website. “Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away.”

The FDA’s drug company letters are getting fewer, too.

From 1997 to 2001, the agency sent an average of 111 letters per year, according to Public Citizen. But this number dropped to 29 a year from 2010 to 2014. The agency has also had the authority to issue an actual monetary penalty to manufacturers for illegal ads since 2007. Public Citizen asked the FDA in 2015 whether it ever assessed such a penalty, and it had not.

“The FDA is responsible for regulating drug marketing and promotion. Unfortunately, the agency does a poor job of monitoring DTC advertising,” said Public Citizen’s Carome. “Therefore, the FDA needs to be more vigilant in monitoring DTC advertising, dedicate more resources to the oversight of pharmaceutical company marketing, and take more aggressive enforcement actions against companies that engage in misleading advertising.”

Other FDA critics took an even tougher tone.

In 2002, critics slammed AstraZeneca’s print and broadcast ads for tamoxifen, saying they overstated the benefits and understated the risks. The FDA approved the drug for healthy women at high risk for developing breast cancer. The drugmaker’s ad boasted a 47 percent reduction in new breast cancer incidence after five years of therapy and minimized serious risks such as uterine cancer and blood clots.

It took the FDA six months to respond, a lag exposing millions of women to a potentially dangerous side effects and incomplete evidence of efficacy.

“The FDA regulations are drafted and enforced in such a way that encourages drug companies to cross the line — with a lack of resources to identify violations and enforcing these regulations,” said Barbara Brenner, executive director of Breast Cancer Action, in 2002. “They do not have the resources to monitor drug ads prior to publication, so the burden of monitoring these ads then falls on the public.”

Instead of Banning Ads, Demand Transparency

The call to ban DTC ads is years old. Unfortunately, the AMA, ASHP and countless consumer groups are unlikely to get such a drastic decision passed by Congress. The truth is drug advertising and its supporters are protected by the Constitution. Not only that, powerful lobbyists protect them. With DTC gone, a lot of organizations stand to lose billions. This includes advertisers and media that accept such ads.

"We have seen versions of this legislation before, and it’s not surprising that it rears its ugly head again in this campaign season," said Kamp. "But the premise and the public policy are just plain wrong. ... Laws that ban truthful messages are a violation of the First Amendment."

Instead of an outright ban on DTC, Kamp suggested the FDA and other regulators focus more on what really matters: making sure companies tell the truth.

“I think it is time for FDA to take a leadership role and to take this more in the direction of false and misleading, because false and misleading advertising is never allowed,” he said.

Part of the truth should include a demand for more transparency. For instance, drug companies should be required to submit specific information about DTC and other advertising expenditures. The Physician Payments Sunshine Act requires drug companies to report their payments to doctors, for example. This change in legislation makes physicians think twice before accepting money from Big Pharma. It also lets consumers know of possible conflicts of interest.

“You know that the current US Supreme Court has ruled that corporations are people and that money may speak as people, so don't hold your breath.”
—Dr. George Lundberg, At Large at Medscape

If the ads are here to stay, improve them. What consumers really want to know are the costs, harms and trials as well as benefits. For example, simple tables with this information should be featured in print and TV ads. One study in the American Journal of Public Health found even consumers of lower education levels understood information presented in a quantitative table.

Other advocates suggest a drug scorecard from the FDA. The card might feature comparative data of new drugs and older ones with information on cost and clinical trials, reported The New York Times.

When dealing with drugs and medical devices, patients shouldn’t have to wonder whether they will suffer a serious side effect, be disfigured or even die as a result of lack of information or misleading advertising driven by profiteering companies. Unfortunately, when it comes to many of these products, it is a case of “buyer beware.”

Though a ban is unlikely, signing petitions and reaching out to Congress are still good ways to speak out and raise awareness.

“Even if you think of it as a free speech issue, there is the problem of yelling ‘fire’ in a crowded movie theater,” said Zuckerman of the National Center for Health Research. “When can you say, ‘This has such a negative effects that it shouldn’t be allowed’? Many of us think we’re there.”

Were you or a loved on harmed by side effects from a drug or defective medical device? You could be eligible for compensation.
FREE CASE REVIEW

WRITTEN BY  Michelle Llamas. Senior Writer

22 Cited Research Articles

  1. FDA. (2015). Women in clinical trials. Retrieved from https://www.fda.gov/science-research/womens-health-research/fda-research-policy-and-workshops-women-clinical-trials
  2. FDA. (2015). Women's health and research. Retrieved from https://www.fda.gov/science-research/science-and-research-special-topics/womens-health-research
  3. FDA. (2015). Office of women's health. Retrieved from https://www.fda.gov/about-fda/office-commissioner/office-womens-health
  4. Laan, E. & Tiefer, L. (2014, November 13). The sham drug idea of the year: 'pink Viagra.' Los Angeles Times. Retrieved from https://www.latimes.com/opinion/op-ed/la-oe-laan-tiefer-pink-viagra-20141114-story.html
  5. CDC. (2015). About DES. Retrieved from https://www.cdc.gov/des/consumers/about/history.html
  6. Weinberger, A.H. et al. (2010). Inclusion of women and gender-specific analyses in randomized clinical trials of treatments for depression. Journal of Women's Health. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936499/
  7. Feeley, J. (2012, June 19). Pfizer paid $896 million in Prempro settlements. Bloomberg. Retrieved from https://www.bloomberg.com/news/articles/2012-06-19/pfizer-paid-896-million-in-prempro-accords-filing-shows-1-
  8. Carome, M.A, et al. (2011, August 25). Petition to ban surgical mesh for transvaginal repair of pelvic organ prolapse. Retrieved from https://www.citizen.org/wp-content/uploads/petition_to_ban_surgical_mesh_for_transvaginal_repair_of_pelvic_organ_prolapse.pdf
  9. Consumer Reports (2012). Dangerous medical implants and devices: Most medical implants have never been tested for safety. Retrieved from https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm
  10. Schiebinger, L. (2013, October 1). Women's health and clinical trials. The Journal of Clinical Investigation. Retrieved from https://www.jci.org/articles/view/19993
  11. Kwiatkowski, K. et al. (2013, May 14). Inclusion of minorities and women in cancer clinical trials, a decade later: Have we improved? Cancer. Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.28168
  12. Prout, M.N. & Fish, S.S. (2001). Participation of women in clinical trials of drug therapies: A context for the controversies. Medscape General Medicine. Retrieved from http://www.medscape.com/viewarticle/408956
  13. Fraser v. Wyeth et al. (2012, March 6).Ruling on Motion for Summary Judgement, United States District Court of Connecticut, Civil No. 3:04cv1373 (JBA). Retrieved from http://www.gpo.gov/fdsys/pkg/USCOURTS-ctd-3_04-cv-01373/pdf/USCOURTS-ctd-3_04-cv-01373-0.pdf
  14. Pearson, C. (2015, June 8). I’m a feminist. Here’s why I don’t support the ‘female Viagra.’ Washington Post. Retrieved from https://www.washingtonpost.com/posteverything/wp/2015/06/08/im-a-feminist-heres-why-i-dont-support-the-female-viagra/
  15. Jim Cooper, Congressman. (2015). Cooper bill ensures equality in medical research. Retrieved from https://cooper.house.gov/researchforallpress
  16. NovaNext. (2014, May 15). U.S. Government will require sex equality for lab mice. Retrieved from https://www.pbs.org/wgbh/nova/article/u-s-government-will-require-sex-equality-for-lab-mice/
  17. FDA. (2015). FDA Activities. Retrieved from https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-essure
  18. Sterman, J. (2013, November 8). FDA rule means Essure patients with complications can't sue. Retrieved from http://www.abc2news.com/news/local-news/investigations/fda-rule-means-essure-patients-with-complications-cant-sue
  19. Gilger, L. and Tomasch, M. (2015, April 1). FDA responds to petition to recall Essure permanent birth control; agency will investigate. ABC 15. Retrieved from http://www.abc15.com/news/local-news/investigations/fda-responds-to-petition-to-recall-essure-permanent-birth-control-agency-will-investigate
  20. Levitz, J. (2015, August 7). Members of congress call on GAO to investigate surgical tool. Wall Street Journal. Retrieved from https://www.wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884
  21. Washburn, V. (2015, August 10). From hospital bed, cancer patient presses device suit that blames N.J. doctors, manufacturer. Retrieved from http://www.northjersey.com/news/from-hospital-bed-cancer-patient-presses-device-suit-that-blames-n-j-doctors-manufacturer-1.1390275?page=all
  22. Wolfe, S. (2015, August 19). FDA's big mistake: Expect flibanserin to be pulled from the market in a few years. Public Citizen. Retrieved from http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5620


ABOUT THE AUTHOR

Michelle Llamas ( mllamas@drugwatch.com ) has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member

  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates

  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

ALL CAPTIONS AND PULL QUOTES BY THE EDITORS NOT THE AUTHORS

black-horizontal




Pharma Companies Win Case Against Drug Price Transparency

Please make sure these dispatches reach as many readers as possible. Share with kin, friends and workmates and ask them to do likewise.


Wendell Potter


Scumbags = 1; The People = 0

Pharma Companies Win Case Against Drug Price Transparency

July 14, 2019


One of the Trump administration’s promises leading up to 2020 is to reduce prescription drug prices, but the plan has stalled after a big court loss, and other blows to Trump's grand healthcare plan. Wendell Potter discusses the implications.

JACQUELINE LUQMAN Hi. This is Jacqueline Luqman with The Real News Network.

 One of the Trump administration’s key campaign promises leading up to 2020 is to reduce prescription drug prices. The idea is really popular among even GOP voters who are just as opposed to giant pharmaceutical companies price gouging prescription drugs as the progressive left is, but Trump has had some trouble getting his much-touted plans off the ground as of late. And that might be an inroad for the Democrats to seize on in 2020. So joining me now to talk about this is Wendell Potter. Wendell is a former health insurance executive, serving as head of corporate communications for Cigna before leaving in 2008 after a crisis of conscience. And now, he’s a consumer advocate and author. His newest project is Tarbell.org, which examines how money and politics impacts millions of Americans. Wendell, thank you for joining me.

WENDELL POTTER My pleasure, Jacqueline. Thank you.

JACQUELINE LUQMAN So let’s talk about Trump’s plan for transparency in prescription drug pricing because that’s what he called it. What was this plan, and what would it have meant for consumers?

As Churchill once quipped, "Americans always do the right thing after trying everything else." So its is with healthcare and its major felon, the pharmaceutical companies. Eventualy the nation will have a rational and equitable healthcare system, but the delaying tactics of Big Pharma and their corrupt allies on Congress will have exacted unnecesary enormous penury and even death from tens of millions of people. —The editor

WENDELL POTTER Well among the various things that he said he would be doing along the lines of transparency, one was to require drug companies in their TV advertising to list the prices of those medications, and that’s not going to happen. There’s been a ruling that says that drug companies don’t have to do that. It’s not constitutional to require them to do that. And so, it’s not going to happen. It would have been probably meaningless in the first place. I think there’s some merit certainly in us knowing how much drug companies are charging for their medications, but the reality is that we pay varying amounts. There’s no one charge. There might be an ultimate list price for some medications but regardless of—Because so many of us have different kinds of health insurance plans. Some of us have to pay a lot out of our own pockets before our coverage kicks in. Some of us are uninsured. It’s almost a meaningless number anyway, but it’s not going to happen. That’s one thing.

JACQUELINE LUQMAN So basically, this plan that Trump touted that would drive prescription drug prices down—And as a matter of fact, he said, or one of his Health and Human Services Department officials said, that forcing pharmaceuticals to publish their prescription drug prices would shame the pharmaceutical companies into reducing their prices. So you’re saying that wouldn’t have happened, even if this ruling went in Trump’s favor?

WENDELL POTTER Oh, absolutely not. Again, there is merit in transparency and knowing how much they actually are trying to get away with and gouge us. But the reality is, they could have done it in a way that—Say for example, you actually need a medication that’s being advertised, and you want to make sure that you’re presumably getting the best medication that’s available for your treatment. A lot of people would say, well, that one that cost $50,000 is better than the one that cost $20,000. Well, I want that $50,000 drug. So, you know, we just have to keep in mind the psychology of so-called consumers or patients. So I’m not sure it would have had the intended effect. In fact, it could have been counterproductive, to tell you the truth.

JACQUELINE LUQMAN Counterproductive in what way?

WENDELL POTTER In that, they could do the advertising in such a way to say, look, our new drug or this new version of a drug, it may cost a lot of money, but it’s far superior than a competitor or a generic. And so people would probably then go to their doctor and say, look, I want the high-priced Cadillac drug, if you will, because it’s my health and my life’s on the line. So I’m not sure that that would actually serve to bring prices down, and I don’t know that—You know, the drug companies have demonstrated they’re not shamed. They can’t be shamed all that much. We’ve seen them get away. There’s been a lot of publicity about the money that they’re taking in, and the prices they’re charging for drugs that just have no bearing in reality in terms of value. It’s just, they just price them based on what they think the market can bear. So there’s been no shortage of publicity. It’s one of the reasons why Americans are outraged, but that outrage hasn’t translated into any changes in terms of pricing by the big drug companies.

JACQUELINE LUQMAN And, you know, one of the three large pharmaceutical companies put out a statement after this ruling came out in their favor, saying that they were happy with the ruling and that what they were going to do now was to focus on the real problem, which was making sure that American consumers who can’t afford their medications are able to afford their medications. But they said they would do it in a way that sounds interesting to me. They said that they’re going to work with their stakeholders to address this issue. Now, we’re talking about pharmaceutical companies here, Wendell. Who are their stakeholders? And how is the pharmaceutical company working with their stakeholders going to help Americans who can’t afford the prescription drugs able to afford them? That’s confusing to me. Is it a little bit confusing?

WENDELL POTTER No, it is. And as a former corporate executive I can tell you that their number one stakeholder is their shareholder, or their shareholders plural. These companies are in the business to make money. They happen to make medications or drugs— in many cases, lifesaving drugs— but their number one priority is to make money, to enhance shareholder value. So that’s stakeholder number one. Who knows who they really have in mind when they’re talking about stakeholders? The ultimate stakeholder, of course, is the patient. But it also involves employers because many of us get our coverage, our health insurance coverage, through our employers. It includes insurance companies, it includes policy makers, so who knows? It’s just one of those words that really hasn’t a lot of meaning. It just is a nothing statement, a nothing word to use, a word that some politicians have sometimes used that signifies absolutely nothing. It just means that they’ve gotten a bit more time to baffle us with BS.

JACQUELINE LUQMAN [laughs] Now it’s worth noting that among the events of this week that seem to be kind of full of setbacks for the Trump administration in regard to his prescription drug plan that he had pretty laid out with a lot of fanfare, it’s worth noting that the ACA was also in court—Is also in court right now this week as arguments are being heard again as to the constitutionality of the ACA because of the ruling of the unconstitutionality of the individual mandate. So we’re waiting for a ruling on that. We don’t know how long it’s going to take for that ruling to come out.

 But also, the Trump administration was pretty much backed into a corner and forced to withdraw their plans for a rule that would end negotiating, or that would end rebates for prescription drugs. And when that rule, or the withdrawal of that rule was announced, health care providers’ stocks skyrocketed in the stock market. What does all this mean for the Trump administration’s prescription drug plan? And what does all this mean for consumers who need these lifesaving drugs, and millions of Americans cannot afford them, and there doesn’t seem to be much relief for them in sight?

WENDELL POTTER What it means is our so-called free market in health care is just completely out of control and pretty much immune to what the Trump administration and Republicans in Congress have come up with as ideas for how to bring prices down. Now there are some bipartisan efforts to try to address prescription drug prices, but the reality is that most of what has been proposed are just completely ineffectual. And what we’re seeing here in this this particular thing is a contest between powerful lobbyists in Washington. On the one hand you’ve got the drug manufacturers. And on the other, you’ve got the insurance industry and this other middleman.

 Insurance companies are middlemen, but there’s another one called pharmacy benefit managers that work closely with drug companies and employers to theoretically try to bring the price of medications down. Because they’re middlemen, in many cases, there’s no way of knowing whether they do that at all, or if they’re just adding to the total cost of health care and prescription drugs. But anyhow, at the end of the day, what happened was that the insurance companies and the pharmacy benefit management companies prevail. It was sort of a setback for the drug companies. It’s almost obscure to try to explain exactly what happened to, you know, a regular person because our system is so complicated. But the bottom line is, we’re getting no relief. This is not something that the administration is able to pull off. And so, it’s kind of back to square one.

JACQUELINE LUQMAN So you mentioned the bipartisan legislation that is being introduced or that’s been drafted to address this issue. Is any of that legislation, do you see any of that legislation making headway in this administration? Do you think Trump is more likely now that he’s suffered some setbacks in this area to work more with the Democrats to advance some of that legislation? What do you see happening?

WENDELL POTTER I’m not very optimistic that you’re going to see anything that gets through Congress. I may be wrong, and I hope I am wrong because it is, I guess, conceivable that Republicans and Democrats could agree on something that might be of relief to patients. There is agreement broadly that drug prices are too high and that there should be some bipartisan effort to do that. There have been hearings. There has been agreement among Democrats and Republicans on the broad strokes of legislation, but broad strokes don’t result in actual legislation. You have to have details and the devil is in the details. When you start adding the details, that’s when you start losing support on one side of the aisle or the other, and that’s why I’m a little skeptical.

JACQUELINE LUQMAN So last question, as we wrap this up. Now, Bernie Sanders has been a longtime advocate for addressing or challenging, really holding accountable the big corporate interests, including the pharmaceutical companies in this country. He has been very pointed in saying that he is going to address the prescription drug crisis. He went so far as responding directly to a tweet that President Trump recently tweeted out— probably, you know, during one of his morning tweet storms— saying that, and this was in January, that in 2018, the price of prescription drugs were at their lowest point in 50 years, [laughs] I think he said. And Sanders’s response was pointedly to tell Trump that that’s a lie. Well, to tell his supporters, his followers on Twitter that that’s a lie. And then Sanders went on to say that when we win, we are not going to wait for the pharmaceutical companies to reduce their prices; we’re going to reduce their prices for them. Wendell, how likely is it that Bernie Sanders, or anybody else who is president, is able to get the pharmaceutical companies to reduce their prescription drug prices if it’s been so difficult up to this point?

WENDELL POTTER It’s going to take, kind of, a sea change. Certainly, the current leadership in Washington is not going to make this happen. Bernie Sanders does have some solid and bold ideas. He advocates for moving us to an improved and expanded Medicare program in which all of us would be covered by Medicare, and allowing the Medicare program to actually negotiate with drug companies for lower prices. We should have that. The drug companies and the insurance industry lobbied against that and have successfully kept Medicare from being able to do that. That’s going to change. One reason it’s going to change is that business leaders are beginning to step up to the reality that they’ve been sold a bill of goods by insurance companies and by pharmaceutical companies over many years. So there’s going to be growing support. There is growing support for what Bernie Sanders is advocating, what Congresswoman Pramila Jayapal on the House side is advocating. Which is, expanding the Medicare program to cover all of us and getting that program, which has been around for 50 years, the authority, the ability to really do something to bring costs down.

Every other country in the developed world has a system like what Sanders and Congresswoman Jayapal are advocating. We will get there, but it is going to have to come from government. These companies, these industries are not interested in changing from within. It’s got to be bold change. And that’s going to require Democrats hanging on to control of the House, taking over the Senate and the White House. No easy lift, but that’s what’s going to be required, and I frankly am optimistic it’s going to happen. And I think, as I said earlier, one of the new things I’m doing is leading an effort to bring the business voice into this work. To get business leaders who are already outraged in the game and say, enough is enough. We want the solid kind of change that Senator Sanders and Congressman Jayapal and many others in Congress are advocating.

JACQUELINE LUQMAN Well, this is really an interesting turn of events for the Trump administration in this particular issue with the claims that he is going to reduce prescription drug prices— something that even his base voters desperately want and desperately need. And we will continue to watch how this issue plays out not just for this administration, but for whatever administration we have in 2020. But in the meantime, we have to leave this discussion right here. Thank you so much, Wendell Potter, for joining me today.

WENDELL POTTER My pleasure, Jacqueline. Thank you very much.

JACQUELINE LUQMAN And thank you for watching. This is Jacqueline Luqman with The Real News Network in Baltimore.


 

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

ALL CAPTIONS AND PULL QUOTES BY THE EDITORS NOT THE AUTHORS

black-horizontal




Homeopathy is ‘pseudoscience’ – Russia’s top science body

horiz-long grey

HELP ENLIGHTEN YOUR FELLOWS. BE SURE TO PASS THIS ON. SURVIVAL DEPENDS ON IT.

Homeopathy is ‘pseudoscience’ – Russia’s top science body

The memorandum on homeopathy was released by the Commission to Combat Pseudoscience and Falsification of Scientific Research, a part of the Russian Academy of Sciences, the Russian chief scientific body, on Monday.

“The treatment with ultra-low doses of various substances used in homeopathy has no scientific basis,” the commission statement said, adding that the principles of such treatment contradict all known “chemical, physical and biological laws.”

“Patients spend a lot of money on ineffective drugs and neglect treatment with proven effectiveness. This can lead to adverse outcomes, including death of the patient,” it said, stressing that the use of homeopathy thus contradicts all principles of the Russian health care system.

“Homeopathic diagnosis and treatment should be qualified as pseudoscientific,” it concludes.

Homeopathy, a system of alternative medicine, was created back in 1796 by Samuel Hahnemann, and is based on his principle that a substance that causes symptoms of an illness in healthy people would cure similar symptoms of this illness in sick people.

For example, a fly agaric, which produces hallucinations if people eat it, should be used in small doses to treat hallucinations, according to homeopathy, although there is no sufficient scientific data proving that this mushroom has any medicinal qualities.

“Homeopathy was created in an era when the most important principles of the chemistry and biology of the molecule properties and existence of microbes had not yet been accepted,” the report states.

The commission, however, calls on people not to confuse homeopathy with phytotherapy, a use of plants and its extracts for therapeutic purposes. Unlike homeopathy, phytotherapy involves the use of plants with proven medicinal qualities for treatment of relevant diseases.

It calls upon the media not to present homeopathy as a useful type of treatment.

“[We call on the media] to present homeopathy as a pseudoscience together with magic, healing and psychic practices,” the report states.

The issue of homeopathy has been long disputed worldwide. In 2009, the World Health Organization said that it did not support homeopathy for a range of diseases, including HIV, tuberculosis, malaria, influenza and infant diarrhea.

The practice is reportedly widely applied in France – in 2010 some 27 million French people used homeopathic medicines, according to the data from the National Syndicate of Homeopathy.

In 2015 the National Health and Medical Research Council of Australia said that there is no evidence that homeopathy is effective for treating conditions, adding that people who choose this treatment put their health at risk.

In 2015 Spanish University of Barcelona scrapped a homeopathy program because of its "lack of scientific basis." The decision followed a death of a six-year-old boy whose mother, a physical therapist at a homeopathic clinic, refused to get him vaccinated for diphtheria that has not been seen in Spain since 1986.

UK is one of the countries that have several homeopathic hospitals whose status is as yet unclear. These institutions include Bristol Homeopathic Hospital, Royal London Hospital for Integrated Medicine and Glasgow Homeopathic Hospital


“Homeopathy was created in an era when the most important principles of the chemistry and biology of the molecule properties and existence of microbes had not yet been accepted,” the report states. The commission, however, calls on people not to confuse homeopathy with phytotherapy, a use of plants and its extracts for therapeutic purposes. Unlike homeopathy, phytotherapy involves the use of plants with proven medicinal qualities for treatment of relevant diseases.

 Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.




News

^0America's Goal...

Make every homeless tranny

gender comfortable!

By subscribing you won’t miss the special editions.

Parting shot—a word from the editors
The Best Definition of Donald Trump We Have Found

In his zeal to prove to his antagonists in the War Party that he is as bloodthirsty as their champion, Hillary Clinton, and more manly than Barack Obama, Trump seems to have gone “play-crazy” -- acting like an unpredictable maniac in order to terrorize the Russians into forcing some kind of dramatic concessions from their Syrian allies, or risk Armageddon.However, the “play-crazy” gambit can only work when the leader is, in real life, a disciplined and intelligent actor, who knows precisely what actual boundaries must not be crossed. That ain’t Donald Trump -- a pitifully shallow and ill-disciplined man, emotionally handicapped by obscene privilege and cognitively crippled by white American chauvinism. By pushing Trump into a corner and demanding that he display his most bellicose self, or be ceaselessly mocked as a “puppet” and minion of Russia, a lesser power, the War Party and its media and clandestine services have created a perfect storm of mayhem that may consume us all. Glen Ford, Editor in Chief, Black Agenda Report