Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Gilled et al Investigated by Feds for Contributions to Co-Pay Charities

Gilled et al Investigated by Feds for Contributions to Co-Pay Charities | Pharmaguy's Insights Into Drug Industry News |

Federal investigators have launched a number of investigations into how drugmakers might be setting or maintaining high prices on some of their drugs, looking into pricing on generics and relationships with so-called specialty pharmacies. Now three drugmakers have been subpoenaed for information on their relationships with drug charities.

Gilead Sciences ($GILD), Biogen ($BIIB) and Jazz Pharmaceuticals ($JAZZ) have disclosed in filings that they have been hit up by the feds for documents related to their support of nonprofits that assist patients, reports Bloomberg, which has taken a deep look into such relationships.

As the news service points out, drug companies are not allowed to give direct copay help to patients who get treatments paid for by Medicare. That would be deemed a kickback. But they can make contributions to charities that assist Medicare patients to pay for drugs. That is, so long as those donations don’t have any strings attached and charities are not favoring one company’s drugs over another.

Bloomberg reports that drugmakers donated $1.1 billion to charities in 2014, more than double the amount from just four years before. The charities are important because if their support means patients sometimes continue to take expensive drugs instead of less expensive alternatives, meaning drugmakers benefit.

The charities Bloomberg spoke to claim independence. They point out they have no sway over drug prices and that their donors have no say in their operations. But the news service also spoke to a handful of former employees from one charity that claimed patients taking Jazz’s $90,000 a year narcolepsy drug Xyrem got quick help while those taking a competing drug might get waitlisted, a charge the charity denied.

These kinds of relationships came up three years ago when The New York Times reported that the Chronic Disease Fund, the largest copay assistance charity at the time, had put new administrators in place after questions were raised about favoritism towards patients taking Questcor Pharmaceuticals’ H.P. Acthar Gel, a drug that had come under criticism for its $28,000-per-vial price.

Pharma Guy's insight:

Also read “The Real Reason Big Pharma Wants to Help Pay for Your Prescription”;

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How a One Paragraph Letter to the Editor Launched the Opioid Epidemic

How a One Paragraph Letter to the Editor Launched the Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News |

Over the past decade, the US has undergone an opioid epidemic. Prescriptions for opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine have skyrocketed and, with them, the number of overdoses related to opioids.
In 2014, deaths from opioid-related drug overdoses reached a new high of 28,647, according to a January report from the US Centers for Disease Control and Prevention (CDC).

But the trend has been decades in the making.

This explosion in opioid prescriptions began in the early 1990s with "a big push" from medical groups that doctors were under-treating pain, according to Dr. Ted Cicero, a professor of psychiatry at Washington University in St. Louis and an opiate-use researcher.

One of the primary justifications for this increase, used by doctors, pharmaceutical companies, and researchers alike, was a single paragraph printed in the January 10, 1980, issue of the New England Journal of Medicine:


To the Editor: Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients' who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had a history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.

Boston Collaborative Drug
Surveillance Program
Boston University Medical Center
Waltham, MA 02154

The analysis mentioned in the letter, which was authored by Dr. Hershel Jick, was not included.

In the years that followed, the letter was used by pain specialists, nurses, and pharmaceutical representatives in conventions, seminars, and workshops as evidence that opiate painkillers had the low risk of addiction. Specifically, the letter was used to support the assertion that "less than 1%" of opioid users become addicted to the drugs.

Jick's analysis proved no such thing. The study analyzed a database of hospitalized patients at Boston University Medical Center who were given small doses of opioids in a controlled setting to ease suffering from acute pain. These patients were not given long-term opioid prescriptions, which they'd be free to administer at home.

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Obama’s Cancer ‘Moonshot’ vs the Catch-22 of Oncology

Obama’s Cancer ‘Moonshot’ vs the Catch-22 of Oncology | Pharmaguy's Insights Into Drug Industry News |

EVER since Neil Armstrong walked on the moon, American politicians have promised “moonshots” — huge programs, stocked with technology and experts, to solve presumably intractable problems. A common target is cancer: Earlier this year President Obama announced the National Cancer Moonshot Initiative, a $1 billion program led by Vice President Joseph R. Biden Jr.


But cancer isn’t space travel. The growing cancer epidemic is not a problem that medical science is about to solve. In fact, it is a problem we are about to make worse. The better we get at keeping people alive, the older they will get, and the more cancer there will be in the population. How we deal with this paradox will shape the future of society, and our leaders need to understand why.


More people are getting cancer, living with cancer and dying from cancer than ever before. Does that mean that modern medicine has failed — or that we haven’t done enough?


On the contrary, more than a million people have been saved by recent improvements in cancer therapy. General life expectancy has increased, much of it because of better health care, and the United Nations expects the number of people older than 60 to double by 2050. We’re a lot better at fighting cancer. We just can’t cure it.


But what about people who overcome cancer — don’t they prove it is curable? It’s not that easy. Even if they are cured, they live on with an increased risk of getting cancer again. First, cancer cells may still be hiding in their body. And chances are these people have some kind of genetic or environmental predisposition for cancer. The chemo and radiation therapy that saved them may promote cancer later in life. And most important, all their cells are getting older and more prone to going astray. Every time we cure a person of cancer, we produce a person with an increased probability of getting cancer again. It is the Catch-22 of oncology.

Pharma Guy's insight:

There will never be an end to pharma's profits from cancer therapies. So invest now!

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Study: Elderly Women More Likely Than Men To Be Overprescribed Rx Drugs

Study: Elderly Women More Likely Than Men To Be Overprescribed Rx Drugs | Pharmaguy's Insights Into Drug Industry News |

Nearly one in three British Columbia women over age 65 received inappropriate prescription medicines in 2013, according to a University of British Columbia study. One in four men of the same age received similar prescriptions.


The work analyzed population-based health-care datasets to find out which medical and non-medical factors influence patients' risk of receiving prescription drugs on the American Geriatrics Society's list of drugs that should be avoided for older patients. The biggest non-medical risk factor was an individual's sex.


The authors found that, even when results were adjusted for all other risk factors, women were as much as 23 per cent more likely than men to be prescribed inappropriate drugs.


"Being a woman is double jeopardy when it comes to taking medications," said Dr. Cara Tannenbaum, scientific director of the Canadian Institutes of Health Research's Institute of Gender and Health. "Women metabolize drugs differently than men. Gender roles and social circumstances also place them at risk. However, I expect that by empowering women with knowledge about the harms of sleeping pills and other medications, we can help drive decisions to try switching to safer therapies."


"For men, being married or in a high income bracket reduced the risk of receiving inappropriate prescriptions. These factors had no significant effect for women. On the other hand, being Chinese or South Asian significantly lowered women's risk of receiving an inappropriate prescription, but did not affect men's risks," said Morgan.


The study looked at 660,679 British Columbian residents aged 65 and older in 2013.


Pharma Guy's insight:

I think more women of any age are more likely to be overprescribed Rx drugs! I base this in the DTC advertising that seems to be aimed at women (see here;  There seems to be a proliferation of "real" diseases that "primarily affect middle-aged women." Of course, DTC advertising is not legal in Canada. It would interesting to know, therefore, why more elderly BC women are overprescribed drugs. Can it be due to physician detailing by pharma sales reps?

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No Taxation Without Incentivisation! Say UK #Pharma Re: Anti-Infective Drug R&D

No Taxation Without Incentivisation! Say UK #Pharma Re: Anti-Infective Drug R&D | Pharmaguy's Insights Into Drug Industry News |

We desperately need new anti-infective drugs to avoid life threatening infections. Let’s make that happen by punishing companies who don’t invest in R&D for these specific drugs.


No, this is not a bad joke, but rather a slightly paraphrased recommendation of a UK government-commissioned Review of Antimicrobial Resistance (AMR).


I [Ed Schoonveld is Managing Principal at ZS Associates] certainly agree with the urgency in need for new drugs, but the report is suggesting levying a tax on drug companies that don’t engage in R&D efforts for anti-microbial drugs. It is referred to as “play or pay.” This proposed tax solution is horrifying for many reasons. It may very well cause significant harm rather than address the issue.


Some sort of market entry reward or a guaranteed stockpile order for these critical drugs would indeed create a natural incentive for the pharmaceutical industry to invest in these programs, which would otherwise yield little revenues. But let’s talk about funding because this is where the report is flawed.


It will take additional incentives to motivate a competitive industry to invest in risky discovery and development programs for anti-infective drugs that we hope will only be used sparingly.


Merck CEO Ken Frazier put it very nicely: The drug R&D business is not innovation (like a new iPhone version), it is invention, which is much more complex and uncertain.


This is where the report is horribly flawed. A tax to force invention? Forcing every pharmaceutical company to spend resources on anti-microbial drug development to avoid tax punishment is an equivalent of “the beatings will continue until morale improves!” All this will do is encourage all, rather than only the most talented in AMR, to spend money on anti-microbial research programs, preferably those that qualify for the tax exemption, but still give a relatively low-risk return on investment. It will drain intellectual resources from those companies that are better situated to truly invent new solutions in this space.


Stimulation leads to invention, never taxation.

Pharma Guy's insight:

In the U.S., meanwhile, some manufacturers may be hesitant to enter the Zika vaccine race because of the uncertainty around public funding in the U.S. After the White House requested $1.9 billion, the Senate last week endorsed a $1.1 billion compromise package, and the House of Representatives passed a $622 million plan. The Obama administration, calling it “woefully inadequate,” has threatened to veto the legislation.


“This is not seen as a commercial market, at least for the time being,” said Marie-Paule Kieny, an assistant director-general at the WHO.


Read more here: 

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Like 3-Day Old Fish, AZ's Take it From a Fish Campaign Had Bad Taste

Like 3-Day Old Fish, AZ's Take it From a Fish Campaign Had Bad Taste | Pharmaguy's Insights Into Drug Industry News |

AstraZeneca has suspended its Take it From a Fish campaign, taking down the online creative for a campaign that won the top prize at the 2015 Lions Health festival in Cannes, France.

The campaign website,, the YouTube videos, and the Twitter feed and website are all now inactive.

The unbranded campaign featured two dead talking fish, Sal and Marty, who discussed lowering their triglyceride levels amid jokes about their relationships, eating habits, and big-screen star quality.

“The Take It From A Fish campaign was an innovative pre-launch and non-branded marketing effort that has recently been discontinued,” an AstraZeneca spokesperson said in an email.

Take It from a Fish was the first campaign to win a Pharma Grand Prix at the Lions Health, the healthcare segment of the 2015 Cannes Lions International Festival of Creativity, held each June. Rob Rogers, co-CEO of the Americas for Sudler & Hennessey and the 2015 jury president, last year described the campaign as “an example of a traditionally conservative client doing something really groundbreaking.”

By most industry standards, the campaign was successful. Within three months, there was an 11% increase in searches for high triglycerides and the Twitter feed had the fourth highest follower count among pharmaceutical brands, DigitasLBi claimed.

At the same time, industry executives say it's relatively uncommon for companies to take creative work offline even if it was designed to support an unbranded marketing campaign. Drugmakers traditionally launch unbranded campaigns before moving forward with branded efforts.

There are a handful of reasons why a drugmaker might choose to remove creative content for an unbranded program. One unnamed executive wondered if the removal of the Take It From a Fish creative was more a question of corporate concern about “taste and tone” or if the outcomes of additional clinical trials for other indications were not as promising as initially hoped. Another said that certain pre-launch communications must be amended to promote a product in a branded environment.

Pharma Guy's insight:

Personally, I never saw what was creative about Abbott and Costello channeled as dead fish.

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Annual Healthcare Professional Communication Report 2016

Annual Healthcare Professional Communication Report 2016 | Pharmaguy's Insights Into Drug Industry News |

As the healthcare industry continues to change at a rapid pace, the professionals who provide care are adapting to shifting priorities and new challenges. Reaching healthcare professionals via traditional communication channels may not be as effective as they were previously due to these changes, and the evolving preferences of HCPs as technology advances. This report provides insights on effective communication with healthcare professionals based on responses from our annual HCP Communication Study.

In this report you will discover:

  • How to engage with healthcare professionals the way they want to be reached – study results reveal best methods to communicate with providers
  • The best channels to include in your marketing mix
  • What type of information healthcare professionals want and need
  • The type of support physicians would like to receive from the life science industry
  • Online resources most utilized by healthcare providers
  • Healthcare providers’ opinions regarding direct-to-consumer advertising
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Big #Pharma Reluctant to Develop Zika Vaccine Without Gov't Funding

Big #Pharma Reluctant to Develop Zika Vaccine Without Gov't Funding | Pharmaguy's Insights Into Drug Industry News |

What if a drugmaker spent billions of dollars to create a vaccine -- only to find out humans developed natural resistance to the disease before its product is ready?


That is part of the scenario GlaxoSmithKline Plc and other pharmaceutical giants are weighing in their cautious approach to developing a Zika vaccine.


Large portions of the populations in Zika-affected areas could develop immunity to the virus over the next five to 10 years, slowing its circulation into virgin areas, said Moncef Slaoui, chairman of London-based Glaxo’s vaccines division. That would make it harder to determine the market for a vaccine, which could be just stockpiled for outbreaks rather than used widely during national immunization campaigns.


So far, Sanofi is the only major pharmaceutical company forging ahead with Zika vaccine development. The French drugmaker will begin testing on animals this quarter, and plans to start tests in people next year.


“We have scientists, clinicians, toxicologists, epidemiologists that understand this family of viruses,” said Nicholas Jackson, who heads the Zika vaccine project for Sanofi. “This gives us a great opportunity to move quickly, and quick is needed here.”


While Glaxo, J&J and Merck are among the world’s pre-eminent developers and manufacturers of inoculations, they are absent from the list of companies that have shared details with the WHO on vaccine candidates.


Some manufacturers may be hesitant to enter the Zika vaccine race because of the uncertainty around public funding in the U.S. After the White House requested $1.9 billion, the Senate last week endorsed a $1.1 billion compromise package, and the House of Representatives passed a $622 million plan. The Obama administration, calling it “woefully inadequate,” has threatened to veto the legislation.


“This is not seen as a commercial market, at least for the time being,” said Marie-Paule Kieny, an assistant director-general at the WHO.

Pharma Guy's insight:

So much for pharma's vaulted investment in R&D to meet an urgent medical need! Also read: "When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?";

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De Niro Gets to Have the Anti-Vaccine Discussion He Wanted on Today Show

De Niro Gets to Have the Anti-Vaccine Discussion He Wanted on Today Show | Pharmaguy's Insights Into Drug Industry News |

Robert De Niro on Wednesday defended the notion that vaccines are linked to autism, resurfacing a discredited notion based on false science.


The star appeared on the “Today” show to promote the Tribeca Film Festival, which he helped found. But the segment was dominated by controversy over an anti-vaccination film called “Vaxxed,” which the festival pulled from this year’s program after a public outcry (see here).


The film was directed by discredited scientist-turned-activist Andrew Wakefield. At the time of its removal, De Niro had said that the film would not provide the conversation-starter he had hoped for. But in the interview Wednesday, he admitted that part of him regretted removing the film from the schedule. “As a parent of a child who has autism, I’m concerned,” he said. “And I want to know the truth. And I’m not anti-vaccine. I want safe vaccines.”


“There’s a lot of information about things that are happening with the CDC, the pharmaceutical companies, there are a lot of things that aren’t said,” De Niro said.


Even as Guthrie and cohost Willie Geist pointed out that there is no scientific evidence of a link between vaccines and autism, De Niro dug in his heels. “It’s much more complicated than that. There is a link, and they’re saying there isn’t,” he said.

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Sacré Bleu! French Authorities, CRO & Pharma Blame Each Other for Clinical Trial Death

Four months after a clinical trial in France left one person dead and five others hospitalized, French authorities blamed the clinical research organization and drug maker for various lapses and moved to tighten procedures for testing medicines. The CRO, however, castigated authorities for their findings and blamed the medicine for causing the serious patient reactions.


In a 271-page report released today, France’s social affairs inspectorate, known as IGAS, concluded that Biotrial, the CRO that oversaw the early-stage study, failed to properly manage the testing. Notably, the agency found that Biotrial continued to administer the drug even after one patient was sent to the hospital, and it failed to confirm patient consent before running the trial.


Overall, the CRO failed to “implement the optimal level of protection for volunteers,” the report stated. Compounding matters, the drug maker, Bial, and the CRO were both accused of taking too long to inform French health authorities of the serious adverse events, although the report cleared the National Agency of Drug Safety of wrongdoing.


The drug maker also maintained it did not have access to the patient autopsy in order to investigate possible causes, there was no reason to modify dosing, and that trial protocol was approved and followed. “There were no alerts, or signals in any of the safety parameters collected from any of the previous cohorts that could have anticipated the tragic accident,” the company said.]


For its part, Biotrial issued a scathing statement, saying the company “deplores this situation,” especially since it “respected” the trial protocol that was approved by French health authorities. And the CRO blamed the drug for its “unexpected and unpredictable toxicity, which is at fault for the accident.”

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Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies

Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies | Pharmaguy's Insights Into Drug Industry News |

The revenue growth opportunity in vaccines looks far more promising when compared to the overall market for pharmaceuticals. Revenues earned by vaccines manufacturers worldwide reached $27.6 billion in 2015 according to Kalorama Information, up 11% from $24.7 billion in 2014, as sales in all segments expanded. This is, by Kalorama’s estimate, at least five to ten times the revenue growth rate of the overall pharmaceutical market in recent years. The world vaccines market is predicted to increase at a compound annual rate of 7.6% during 2013–2022, reaching $45.1 billion in 2022 as new product introductions continue and usage of current products expands further.


The world vaccines market is dominated by four major competitors: Sanofi Pasteur, GlaxoSmithKline, Merck & Co., and Pfizer. Pfizer and Merck hold 45% of the market. As the market leader in 2015, Pfizer’s vaccine sales exceeded $6.4 billion on strong growth of its Prevnar family, giving the company 23.3% of the market. Pfizer was followed by Merck with $5.9 billion.

Pharma Guy's insight:

Also read: "When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?"; 

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Another #Pharma Film About Psoriasis Awareness - This Time by Celgene

Another #Pharma Film About Psoriasis Awareness - This Time by Celgene | Pharmaguy's Insights Into Drug Industry News |

Celgene has released a fictional film to raise the profile of the physical and social challenges people living with psoriasis and psoriatic arthritis face every day.

The short film - Millefeuille (A Thousand Leaves) - tells the story of Élodie, a Frenchwoman who was forced to give up her career as a pastry chef due to her struggles with the effects of psoriasis and psoriatic arthritis.

Lee Heeson, vice president of inflammation and immunology at Celgene EMEA, said: “We believe that 'coping' is not good enough and that patients deserve more.

“It is our hope that using an approach which goes beyond the 'standard' definition of disease information - and uses fiction to bring the message to life - can help those who are less motivated or not seeking psoriasis education, to challenge the status quo and live better lives.”

Pharma Guy's insight:

This is not the first psoriasis film produced by a pharmaceutical company. Back in 2007, Centocor produced Interspace, which focused on rheumatoid arthritis (RA), Crohn's disease, and psoriasis. Here's how the film is described in Centocor's press release:


"...a first-of-its-kind documentary providing insight into the 'inner states' of three everyday adults facing chronic, life-altering inflammatory diseases. As they confront daily challenges and life's experiences, they tell the emotional stories of their journeys toward living 'normal' lives in a film that is sure to touch the hearts of all viewers, including the millions of Americans who suffer from these conditions."


Learn more about this film and how I got invited to a private screening here: 

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The Real Reason Big Pharma Wants to Help Pay for Your Prescription

The Real Reason Big Pharma Wants to Help Pay for Your Prescription | Pharmaguy's Insights Into Drug Industry News |
Fueled almost entirely by drugmakers’ contributions, the seven biggest copay charities, which cover scores of diseases, had combined contributions of $1.1 billion in 2014. That’s more than twice the figure in 2010, mirroring the surge in drug prices. For that $1 billion in aid, drug companies “get many billions back” from insurers, says Fugh-Berman.
“Drug companies aren’t contributing hundreds of millions of dollars for altruistic reasons,” says Joel Hay, a professor and founding chair in the department of pharmaceutical economics and policy at the University of Southern California. The charities “don’t ever have to scrounge for money. It falls right to them.” Both Hay and Fugh-Berman have served as paid expert witnesses in lawsuits against drug companies.
When Turing bought Daraprim and sought to boost its annual revenue from $5 million to more than $200 million, the use of patient-aid funds was considered essential, internal company documents show. Last May, as the company did its due diligence before the purchase, one executive warned in an e-mail that new, high copays would force toxoplasmosis patients to seek alternative drugs.
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Most UK HCPs OK with Revealing #Pharma Payments to Docs, But...

Most UK HCPs OK with Revealing #Pharma Payments to Docs, But... | Pharmaguy's Insights Into Drug Industry News |

In a poll of more than 500 UK healthcare workers carried out for the Association of the British Pharmaceutical Industry, 87 percent believe payments from pharma companies to individually named healthcare professionals should be transparent, with around two thirds (64 percent) saying that this information should be publicly declared.


However, a significant chunk - 26 percent - felt disclosure of payments to individually named HCPs is unnecessary, and 24 percent feared the move would adversely affect medical innovation, while 26 percent also felt their relationships with pharma companies would change as a result.


The ABPI is just weeks away from publishing details of payments and benefits in kind made to UK HCPs and healthcare organisations on an online, publicly searchable database under its drive to improve transparency and trust in the industry.


Nevertheless, while being largely supportive of the move, 69 percent of respondents did express concerns about the process. The biggest concern is potential misrepresentation of data (49 percent), closely followed by possible negative perceptions among the public (44 percent), data protection (43 percent) and potential media coverage (35 percent).

Pharma Guy's insight:

I bet the poll did not ask docs if revealing payments should be mandatory. For more on that, read: "Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?"; 

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Mom to Bayer: "Would You Implant This in Your Mother...?"

Mom to Bayer: "Would You Implant This in Your Mother...?" | Pharmaguy's Insights Into Drug Industry News |

The following is a letter from E-Sister Brianne Savino:


Dear Bayer,

I find myself writing this with no expectation that this will be read by anyone at your company that holds any merit. However, I hold onto a small vestige of hope that this will not only be read but also understood. You are a very large and successful corporation. Your company has offered many products that have helped countless lives and there is something to be said for that.

Nonetheless, you have made a mistake. As children we are taught that mistakes are allowed as long as we learn from them and correct ourselves. You bought and distributed a product known as Essure. You successfully promoted it and it is now widely known and used. For some this product has been wonderful and others it has become a living nightmare from which we cannot wake. Many of us are suffering and what I want to know is ‘do you care?’ I understand that a large corporation must pay heavy attention to their bottom line but I urge you to look below that. We are not numbers and statistics. We are human beings.

With all the negative reports that you have flooding in I would like to ask each one of you that continue to market and promote this product, ‘Would you implant this is your mother, sister, wife, or even your daughter?’ That’s what we are, we are not complaints or negative press. We are mothers, sisters, wives and daughters. Every one of us owns one or more of those titles. How do we get through to you? If not by a moral compass than what?

Many of us, myself included, have no means to get help with this. I am a single mother to 5 children whom I support and take very good care of. I find myself in quite the predicament with healthcare. I make too much to get any help from a state agency and yet I make too little to get any help from the marketplace. You have spent millions in incentives to have doctors push your product and yet you are doing nothing to help the people that your product has hurt. Will you not do as we are taught as children?

Apologize and make things right. I suggest that you do some reading on the very large mistakes that GM has made, not only morally but financially as well. They were in a scenario much like yours. They had the information and the resources to correct the poor decisions that were made but they chose not to. Financially this has hurt them more in the long run than it would have if they had corrected it in the beginning and has sufficiently warped their reputation. Precious lives were lost because they were afraid of the financial aspect. Will that example open your eyes?

I beg you to see me, the real me. Not the case number or complaint number that I have been issued. Me, the person, the daughter, the mother that you have hurt. I may be just one measly person in the world to you but to my five children, I am the world. You are at a crossroads right now.

You can become the company that cares for profit margins only or you can become the company that cared enough to make things right. Very little comes before the almighty dollar these days, I am very well aware of that fact.

That being said, I know who I am and who my mother raised me to be. I would never put a price on a human beings life. To those that love us, we are priceless. I will ask one thing of the Bayer CEO, all the executives and employees that continue the fight to keep Essure as a safe, effective and permanent birth control before I close this letter.

When you lay your head on your pillow tonight, close your eyes, keep in mind all the hard evidence and facts of injury that have come before you with this product, now think of your mother wherever she may be.

Lastly, ask yourself one question…’Would she be proud of you and the decisions that you’ve made?’

Pharma Guy's insight:

Re: Essure It's a Flint, Michigan moment: Drink your own Kool-Aid and prove it's safe!

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Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?

Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory? | Pharmaguy's Insights Into Drug Industry News |

Pharmaceutical firms currently pay about £40m every year to healthcare professionals, including doctors and pharmacists. These payments could be for anything from expert advice to sponsoring a healthcare professional’s medical education. Now, the Association of the British Pharmaceutical Industry (ABPI) has created a central database, going live in June, on which its member companies, and others that have signed up to comply with the ABPI code of practice, will disclose who these payments are made to, and for what.


[For comparison, pharma has made over $6 Bn in payments to physicians in the U.S. in 2014. $3.2 Bn of that was for research – see chart above.]


How will this new transparency affect the complex matrix of relationships between health professionals, pharmaceutical firms, the NHS and, most importantly, patients? That was the underlying question under discussion at a seminar hosted by the Guardian and sponsored by the ABPI.


Sarah Boseley of the Guardian kicked off the discussion by pointing out that the ABPI database has already come in for some criticism: the Academy of Royal Medical Colleges says it doesn’t go far enough. But should disclosure be mandatory? Only 69% of healthcare professionals say they would agree to have their relationships with pharmaceutical companies disclosed on the publicly searchable database.


Ash Soni of the Royal Pharmaceutical Society agreed that disclosed payments need to be seen in the right context to be of value. “It’s important that there is an ability to respond and react to some of this disclosure.”


The panel members were in broad agreement that increased transparency is a good thing, whether it’s disclosing payments or publishing clinical research data – but, like Soni, Nikki Yates of GlaxoSmithKline (GSK) stressed the need for education around its issues. “The way I’ve embraced it [disclosure and transparency issues] is to take a step towards ensuring that whoever we are working with has a full understanding of why this is an important thing to do,” said Yates. Since 2014, she said, GSK has had a disclosure clause in its contracts. Thus far, it has had more than 90% agreement for disclosure of trial results. “And we’ve gone a bit further and said if we can’t agree on disclosure, then we won’t work with those individuals.”


[GSK has pledged that it will no longer pay doctors to promote its products. For more on that, read “GSK ‘Sunshine Blocks’ Outside Docs: No More $ For You!”;]


But GP Dr Margaret McCartney pointed out that talking about shared goals, partnership and collaboration is all very well – but what are the shared goals and who decides what they are? She cited the pharmaceutical researcher who had approached her practice to do clinical research. When McCartney asked him if results would be published no matter what they showed, she was told no, and that McCartney herself would not be allowed to make them public. “How can I trust a leadership that says it will not guarantee published results, no matter what they show?” she asked.

So should disclosure be required by law? McCartney said she was pleased with GSK’s advances in making clinical data public, but believed that the process has to be “enshrined in law”. Others were not so sure: Jackson was concerned with “over-sterilisation” of the system. “… if we legislate, and go too far, then we could end up stifling the system by not allowing it to breathe.”


Transparency in the interest of patients

But times are changing, said Soni. “The industry did have a very bad reputation and there is no doubt that it earned it. Some of the things it did were not in the interests of patients or for the best interests of care. However, the industry has changed – it’s had to. It had to realise some of the things it was doing were not of a suitable standard. And I think this is helping us to move further and further in the right direction.”


George Freeman, minister for life sciences took up this theme in his keynote address… “We have a choice between historically justifiable conspiracy theory, distrust and legislation as the only solution – the law or the threat of law, which I think drives defensiveness – or an approach based on mutual respect for others’ perspectives. [That approach] will accelerate us into this landscape of a more transparent healthcare ecosystem, which I think is genuinely in the interests of all of us.”

Pharma Guy's insight:

It seems to me that only mandatory laws requiring full disclosure of payments to physicians is the only way to go to achieve the type of "full transparency" that was bandied about by this panel. Recall that before the Sunshine Law took effect in the U.S. only a few pharma companies disclosed payments and only because they were required to do so by law. But more telling was the fact that the disclosures themselves were not transparent - several different data formats were used and some datasets were impossible to download for independent analysis and were not easily searchable (for more on that, read "Transparency Vs. Translucency in Reporting Physician Payments"; The Sunshine Law changed all that!

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Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?

The maker of the pain pill OxyContin filed an appeal on Monday of a Kentucky judge’s decision to unseal records related to how the drug was marketed and what company officials knew about the addictive properties of the potent opioid.

The notice of appeal by Purdue Pharma, filed in Pike Circuit Court in eastern Kentucky, triggered the beginning of the appeals process and did not contain any legal arguments challenging the judge’s decision. After a month to six weeks of procedural matters, it is expected both sides will begin arguing the case in briefings to the Kentucky Appeals Court. That process could take up to five months. The appeals court, consisting of three judges, will then decide to either conduct oral arguments on the case or rule on the matter based only on the briefings.

Pharma Guy's insight:

You might also like to read these:


Judge Orders Release of Secret Purdue #Pharma OxyContin Marketing Documents - But Don't Hold Your Breath!;


Iraq War Veteran Lawmaker Calls for Scrutiny of Purdue Pharma's Role in Opioid Abuse Epidemic;


OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It;


The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic;

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Are Pharma Marketers Really Responsible for "Patient Centricity/Engagement?"

Are Pharma Marketers Really Responsible for "Patient Centricity/Engagement?" | Pharmaguy's Insights Into Drug Industry News |

For the last few years, most pharma companies have discovered (or is it rediscovered?) the healthcare consumer — putting patients at the center of their businesses with patient-centric thinking.


But who understands and represents the patient in big pharma? Marketers do [says David Anderson, managing partner at Insight NZ, a healthcare brand advertising agency. See my insights].


Marketers have a unique opportunity to be “the voice” of the patient within their organizations. What does this mean in practice?


1) Get into the patients' shoes. Understand their world. Understand their commonality and their diversity. Understand their journey from illness to wellness. What motivates them? Why do they make the decisions they make?


2) Include patients in the conversation. Make sure they're involved in their health, which means talking to them in a language that they can understand. Health literacy is low for many chronic conditions — so don't use “dyspnea” when you can say “shortness of breath.” And it's the flu, not influenza, no matter how much the medical team may hate that abbreviation.


3) Support physicians by augmenting the clinical information they have, so that they can deliver a more holistic healthcare solution.


4) Advocate for the patient in your organization. Patient needs should come first in all levels of your organization. At every opportunity advocate for your patients and share what you know. This will help others make patient-centric decisions in their roles.

Pharma Guy's insight:

The author of this piece, David Anderson, is a managing partner at Insight NZ, a healthcare brand advertising agency. He argues that, by definition, marketing is "patient centric": 

The UK Chartered Institute of Marketing defines marketing as: "… the management process responsible for identifying, anticipating, and satisfying customer requirements profitably."


"Profitability," however, often trumps (with a small "t") putting patients' interest first. If it weren't so, I would never have anything to write about! 


For an alternative view, read this: "Are #Pharma Medical Departments Responsible for 'Patient Engagement?'"; After reading that you will see that Mr. Anderson completely ignores the medical research side of the business, which marketers don't fully understand until after the fact it seems.

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Looking on the "Bright Side" of Metastatic Cancer Survival

A paper by Dr. Patricia Steeg of the National Cancer Institute (NCI) published in a prestigious journal, Nature Reviews Cancer calls out an “alarming” but debatable decline in survival in other advanced cancers, including ovarian, prostate and uterine tumors, and a general lack of progress against metastatic disease.


From 2000 through 2010, median survival for U.S. women with metastatic breast cancer increased from 22 to 30 months.


From 2000 through 2010, the 5-year relative survival for women with metastatic breast cancer rose, from 25.9% to 32.6%, This increase was statistically significant (confidence intervals: 24.9 – 27.0%, and 31.6 – 33.6%, respectively).


What this means, first, is that in the five years before 2000, half of women with stage 4 breast cancer lived for 22 months or longer; by 2010, half lived 30 months or longer. These findings are based on data in a public database (SEER 11), collected in the periods 1995-2000 and 2004-2010, respectively. As explained in a handy SEER glossary, “relative” 5-year survival indicates how long the cancer patients live compared to age and sex-matched controls in the population.


The low numbers might upset someone who is not aware of the fact that–despite so much progress against early-stage, local and “regional” breast cancers–metastatic breast cancer remains incurable. That most women with metastatic disease die within three years of diagnosis, still, or at least until 2010, is a very sad statistic.


On the bright side: Survival has gone up, and measurable progress was evident by 2010. I’d go as far to say that most likely, and almost certainly, survival continued to improve from 2010 and 2015. If you consider all the new drugs that have come out since 2010, particularly for estrogen-positive, hormone-sensitive breast cancer, the most frequent forms, and for Her2 positive cases, for which there are, now, quite a few helpful agents (there were none in 2000), and better diagnostic testing for tumor subtypes, that these medications can be prescribed sensibly, the outlook should be better now, in 2016. And by 2020, who knows?

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#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease

#Pharma Drug Repurposing: How Drugs Spread from Disease to Disease | Pharmaguy's Insights Into Drug Industry News |

While drug development is typically thought of as the disease-centric process of finding a drug that can treat a disease, much effort goes in the reverse, drug-centric direction of finding a disease that can be treated by a drug. The diseases for which a drug is intended can change over the course of its development and post-marketing. During pharmaceutical development, new diseases can be selected or dropped at every stage of the pipeline on the basis of pre-clinical and clinical results. When a drug starts to show signs of success with a particular disease, additional diseases are sought to broaden the drug’s therapeutic and commercial appeal. Once a drug has been approved by regulatory agencies, its use may not be restricted to the diseases for which it was approved, as medical practitioners may prescribe it off-label. Indeed, a drug’s efficacy against certain diseases may only become fully apparent once it is consumed by a large number of patients or made widely available for scientific experimentation. New findings about a drug’s efficacy can prompt the original drug developer to seek supplemental indication approvals or pursue life-cycle management strategies such as combining the drug with other new or existing drugs.

This is not to say that drugs are created ex nihilo. They are generally designed with an intent rooted in biological rationale, such as to inhibit a disease-causing gene. However, the interconnected nature of human biology and of pathological mechanisms, the steady advance in our understanding of diseases and the potential lack of target selectivity means that drugs designed for a specific purpose can end up having different or additional applications. Once a drug is created it can fail with diseases for which it was designed and succeed with unanticipated diseases. Thus, drugs hold an intrinsic value based not only on their proven therapeutic effect but also on their therapeutic potential, both suspected and unsuspected.

Because the process of pharmaceutical drug discovery is long and uncertain, a central part of a drug’s suspected therapeutic potential is the drug’s prospects to treat multiple diseases. Challenges to a drug’s development may come from faster-advancing competing drugs that can become standard of care and discourage further work on other drugs. They may also come from business vagaries such as department closures in pharmaceutical companies that lead to re-alignment of internal drug portfolios. Thus, having multiple potential applications increases the likelihood that a drug will be able to navigate the development process.

The unsuspected therapeutic potential of a drug is illustrated most clearly by the field of drug repurposing. Drug repurposing has drawn attention in part due to the commercial interest of pharmaceutical companies possessing an abundance of safe drugs that have failed to show sufficient efficacy in any disease. The “poster child” of drug repurposing success is that of a safe but abandoned drug that is discovered to be efficacious with a previously unsuspected disease. While drug repurposing focuses on late-stage and post-marketed drugs, the search for unsuspected diseases for existing drugs can be undertaken at any point in a drug’s history.

Pharma Guy's insight:

A good example is Botox. Read "Botox: Pharma's Answer to Duct Tape"; 

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Discount Rx Drug Coupons Lower Price of Drugs, But Not How You Think They Do

Discount Rx Drug Coupons Lower Price of Drugs, But Not How You Think They Do | Pharmaguy's Insights Into Drug Industry News |

Consider [Rx drug] coupons. Over the past several years, drug makers have used these to entice consumers to fill their prescriptions, since coupons defray or eliminate copay costs. In 2009, coupons were available for fewer than 100 prescription medicines, but the number exceeded 700 by last year, according to the analysis released on Tuesday by the Tufts Center for the Study of Drug Development. The study was funded by Pfizer.


Drug makers contend coupons help consumers who might otherwise have difficulty affording their medicines as insurance requires them to shoulder a greater share of the cost. This “can be a real barrier to patient access to medicines, and coupons can help break that barrier down,” the Pharmaceutical Research and Manufacturers of America, the industry trade group, wrote in a 2012 blog post on its web site.


Studies have shown, however, that coupons are a mixed bag.


A 2013 analysis in The New England Journal of Medicine found that 62 percent of coupons were available for brand-name drugs for which lower-cost options existed. But a 2014 study in Health Affairs found coupons reduced consumer costs for expensive specialty drugs to less than $250 a month, suggesting patients may be less likely to forego their medications.


Pharmacy benefit managers, which negotiate deals with drug companies and manage lists of covered medicines called formularies, argue that coupons are a ruse. As Tufts notes, pharmacy benefit managers and insurers believe coupons are increasingly used by drug makers to negate the exclusion of certain drugs from formularies, and other efforts in order to weed out less effective drugs and to lower costs.


So over the last few years, the nation’s two largest pharmacy benefit managers have been excluding more drugs from their formularies. CVS Caremark excluded 124 drugs in 2016, a 63 percent increase since 2014, while Express Scripts excluded 80 drugs in 2016, a 67 percent rise since 2014, according to Tufts. Significantly, coupons were available for more than 90 percent of the drugs that were excluded.


“The leverage gained by pharmacy benefits manager, by way of exclusions, puts downward pressure on prices of (certain) drugs,” said Joshua Cohen, a health economist at Tufts who coauthored the analysis.

Pharma Guy's insight:

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." (read "Drug Ads & Coupons"; Also: "Rx Drug Coupons: Lower Costs at First, But You Pay More Later"; 

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Pfizer Blocks the Use of Its Drugs in Executions. Some States Resort to FIRING SQUADS!!!!

Pfizer Blocks the Use of Its Drugs in Executions. Some States Resort to FIRING SQUADS!!!! | Pharmaguy's Insights Into Drug Industry News |

The pharmaceutical giant Pfizer announced on Friday that it had imposed sweeping controls on the distribution of its products to ensure that none are used in lethal injections, a step that closes off the last remaining open-market source of drugs used in executions.


More than 20 American and European drug companies have already adopted such restrictions, citing either moral or business reasons. Nonetheless, the decision from one of the world’s leading pharmaceutical manufacturers is seen as a milestone.


“With Pfizer’s announcement, all F.D.A.-approved manufacturers of any potential execution drug have now blocked their sale for this purpose,” said Maya Foa, who tracks drug companies for Reprieve, a London-based human rights advocacy group. “Executing states must now go underground if they want to get hold of medicines for use in lethal injection.”


The obstacles to lethal injection have grown in the last five years as manufacturers, seeking to avoid association with executions, have barred the sale of their products to corrections agencies. Experiments with new drugs, a series of botched executions and covert efforts to obtain lethal chemicals have mired many states in court challenges.

The mounting difficulty in obtaining lethal drugs has already caused states to furtively scramble for supplies.


Some states have used straw buyers or tried to import drugs from abroad that are not approved by the Food and Drug Administration, only to see them seized by federal agents. Some have covertly bought supplies from loosely regulated compounding pharmacies while others, including Arizona, Oklahoma and Ohio, have delayed executions for months or longer because of drug shortages or legal issues tied to injection procedures.


A few states have adopted the electric chair, firing squad or gas chamber as an alternative if lethal drugs are not available. Since Utah chooses to have a death penalty, “we have to have a means of carrying it out,” said State Representative Paul Ray as he argued last year for authorization of the firing squad.



Lawyers for condemned inmates have challenged the efforts of corrections officials to conceal how the drugs are obtained, saying this makes it impossible to know if they meet quality standards or might cause undue suffering.


“States are shrouding in secrecy aspects of what should be the most transparent government activity,” said Ty Alper, associate director of the death penalty clinic at the University of California, Berkeley, School of Law.


Before Missouri put a prisoner to death on Wednesday, for example, it refused to say in court whether the lethal barbiturate it used, pentobarbital, was produced by a compounding pharmacy or a licensed manufacturer. Akorn, the only approved company making that drug, has tried to prevent its use in executions.


Pfizer’s decision follows its acquisition last year of Hospira, a company that has made seven drugs used in executions including barbiturates, sedatives and agents that can cause paralysis or heart failure. Hospira had long tried to prevent diversion of its products to state prisons but had not succeeded; its products were used in a prolonged, apparently agonizing execution in Ohio in 2014, and are stockpiled by Arkansas, according to documents obtained by reporters.

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Lobbyist Argues DTC Ad Tax Deduction is as American as Cheeseburgers

Lobbyist Argues DTC Ad Tax Deduction is as American as Cheeseburgers | Pharmaguy's Insights Into Drug Industry News |

Limiting direct-to-consumer advertising, outright banning it, or eliminating its deduction as a business expense are not new ideas. However, a potential end to the business advertising tax deduction for DTC is more real than ever, Jim Davidson, chair of the the Advertising Tax Coalition, cautioned marketing executives.

Drugmakers can currently write off money they spend on advertising and marketing as a tax deduction. In March, Sen. Al Franken (D-MN) proposed a bill, which is called the “Protecting Americans from Drug Marketing Act,” that would end the tax deduction.

“The tax [deduction] will be one of the hardest things to defend,” Davidson told attendees at the Coalition for Healthcare Communication's Rising Leaders Conference on Healthcare Policy. He noted that tax reform will likely be a focus for the next president's agenda — a process that could begin as soon as 2017 — and added that the DTC advertising tax deduction could be seen as a major revenue offset in negotiations. Democratic candidate Hillary Clinton has said she would end tax breaks for DTC. Donald Trump has also generally expressed support for tax reform.

Colucci quipped that the pharmaceutical industry “has as much right to advertise as alcohol [companies] and McDonald's. I just want to be treated with the same respect as a damn cheeseburger.”

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#Pharma Disease Awareness Ads Scare You, Branded Drug Ads Reel You In With Calm Music

#Pharma Disease Awareness Ads Scare You, Branded Drug Ads Reel You In With Calm Music | Pharmaguy's Insights Into Drug Industry News |

I [Bob Ehrlich] was a strong supporter of the Novartis heart failure disease awareness ad. This was the one with the man in the room with water pouring in and filling up the room. It was criticized by some doctors for being alarmist. I never thought so myself, as heart failure is about as serious cause for alarm as there can be.



The disease ad was a precursor to a branded ad for Entresto, which I can’t stop thinking of as Ernesto. This ad is the polar opposite in tone to the disease education campaign. While the message of preventing heart failure is the same, the branded ad takes an uplifting approach.


The ad uses the song from Annie, “Tomorrow” which I guarantee you will sing for at least 24 hours after seeing it. It is a series of patient vignettes where the actors sing parts of the song. The message is that Entresto will help make more tomorrows possible.


The disease ad really stopped you in your tracks alerting viewers that heart failure is something to watch out for and act on. While deadly serious in tone, I think it was entirely appropriate. They could have used the same idea for the branded ad but they smartly chose to play up the positives. It is better to promise in the branded campaign hope about living longer than warning about early death.

Pharma Guy's insight:

"What was necessary in the disease ad to get your attention was not the best approach in the branded ad," Ehrlich says. This seems to be a mantra of the drug industry. Boehringer, for example, produced a couple of scary, dark disease awareness videos (read "Another Dark Disease Awareness Youtube Video from Boehringer";


Meanwhile, Novartis hopes uplifting TV ads may sell more Entrestro (read, for example, "Tomorrow, Tomorrow, After DTC, Sales Will Come for Entresto, Bet Your Bottom Dollar!";


Entresto sales'll come tomorrow
Bet your bottom dollar that tomorrow there'll be sales
Just thinkin' about DTC tomorrow
Clears away the cobwebs and the sorrow till there's none
When I'm stuck with a day that's gray and lonely
I just stick out my chin and grin and say
The sales'll come tomorrow, after DTC
So you got to hang on till tomorrow, came what may!
Tomorrow, tomorrow, I love you, tomorrow
You're always a DTC ad away
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1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge!

1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge! | Pharmaguy's Insights Into Drug Industry News |

Public Citizen released additional data on pharmaceutical industry criminal and civil settlements, stemming from its March report tallying all settlements with both federal and state governments from 1991 through 2015. The new data provide company-specific totals for the most recent 10-year period (2006-2015), which demonstrate that, for most companies, the vast majority of penalties were paid out in those 10 years since 2006. During the 10 years from 2006-2015, 21 companies entered into two or more settlements with the federal government.

The Challenge: Can you rank the Top 10 of those companies in terms of the amount paid over those 10 years? Click on "Read More" to see how well respondents did.

Forty-three brave souls took the challenge. Only one person was able to put all the companies in the correct order.


Click here for more...

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Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See