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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WHO Attack On #Pharma's Ebola Efforts Unfair, Says LaMattina, Former Pfizer Exec

WHO Attack On #Pharma's Ebola Efforts Unfair, Says LaMattina, Former Pfizer Exec | Pharmaguy's Insights Into Drug Industry News |

With the Ebola virus ravaging Guinea, Liberia, and Sierra Leone, one would think that the World Health Organization (WHO) would be very busy doing what it can to help slow this serious outbreak. Yet, it appears that one of the WHO’s priorities is to attack Pharma as part of the problem. Last week, WHO Director-General Margaret Chan assaulted the industry for not taking an interest in developing an Ebola vaccine. Here are some of her remarks.

“Ebola has historically been confined to poor African nations. The R&D incentive (for Pharma) is virtually non-existent. A profit driven industry does not invest in markets that cannot pay.”

Certainly, as an industry, pharma is very profit driven. Actually, all biopharmaceutical companies are profit driven since without revenues and a return-on-investment, investors would look elsewhere with their funds. Furthermore, investments in drug R&D carries a high risk as evidenced by industry consolidation and the high failure rate for biotech start-up ventures. Given this situation, one might understand that a profit driven industry would, in fact, focus on diseases like cancer and heart disease, which impact on both poor and rich around the world, rather than a horrible disease like Ebola which in the last 40 years has arisen sporadically.

However, contrary to Chan’s comments, the pharma industry HAS invested in an Ebola vaccine. Last September J&J announced that, not only had it been working on an Ebola vaccine, but it was accelerating its development. In conjunction with Bavarian Nordic, a Danish biotech firm, J&J hopes to have 250,000 doses of the vaccine available for testing next May. But J&J isn’t alone in seeking Ebola vaccines.

Pharma Guy's insight:

LaMattina should have provided the context for Chan's remarks instead of just providing  a link.

The intro to her remark in the Time article is: "Speaking in Cotonou, Benin, Margaret Chan, the director general of the WHO, wondered rhetorically why clinicians are 'still empty-handed, with no vaccines and no cure' for Ebola, even though the disease first appeared some four decades ago.'

"The answer, said Chan, is at least in part that 'Ebola has historically been confined to poor African nations.' She lambasted drug manufacturers for not taking an interest in an Ebola vaccine until the disease became a threat to non-African countries, including the U.S."

So, in other words, the #pharma industry could have been developing a vaccine long ago, but didn't because no one would pay for it. Now that Ebola is a threat to Western countries, drugmakers are racing to develop vaccines and drugs to address the worst outbreak of Ebola in history. It's unclear who will pay for their products, but companies are betting that governments and aid groups will foot the bill (for more on  that, read this).

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European Plan for Ebola Drug Trials Threatens FDA's "Gold Standard" Approach to Drug Approval

European Plan for Ebola Drug Trials Threatens FDA's "Gold Standard" Approach to Drug Approval | Pharmaguy's Insights Into Drug Industry News |

Medical groups in the U.K. and France say that it would be unethical to hold back experimental Ebola treatments from anyone. U.S. officials say that without control groups getting placebos, it can’t be known whether the drugs are saving lives or killing people.

A consortium including European universities and medical groups plans to give experimental drugs to West African Ebola patients without assigning some to a placebo group, touching off an intense trans-Atlantic quarrel over what is ethical and effective in treating the virus.

Academics and medical groups in the U.K. and France, such as Oxford University, the Wellcome Trust, Doctors Without Borders and Institut Pasteur of France, have decided to give the drugs to sick African patients without randomly assigning other patients to a control group not getting the medicines. They say that in a ghastly epidemic, it is unethical to hold back treatment from anyone.

That has put them at odds with senior U.S. officials at the Food and Drug Administration and the National Institutes of Health. Dr. Luciana L. Borio, FDA assistant commissioner for counterterrorism and emerging threats, told public-health officials at the World Health Organization in Geneva this month she was extremely concerned by the plans to give the medicines to patients without better evidence they work and aren’t highly toxic. “This is too urgent an issue for us not to start out with what we know is scientifically best,” said Dr. Borio. “The fastest and most definitive way to get answers about what are the best products is a randomized clinical trial.”

U.S. officials recommend a gold-standard study in which all patients get best possible care; one group also would get a drug, and the other group a placebo. In the case of Ebola, standard care includes aggressively replacing fluids in patients since they can vomit and have diarrhea. Without randomly assigning some patients to the placebo group, scientists say, it can’t be known whether the drugs used to treat the epidemic are saving lives or killing people.

Dr. Piero Olliaro, an infectious-diseases doctor at Oxford University who also works at a WHO-affiliated group, is among the leaders of the European group proposing to give experimental drugs to all patients. Among the drugs that could be used, according to Dr. Olliaro, would be experimental medicines brincidofovir from Chimerix Inc. and one called Avigan, or T-705, from Fujifilm Holdings Corp. ’s Toyama Chemical unit. Doctors from some African countries have joined the efforts of the European coalition.

Dr. Olliaro’s view echoes arguments made in the late 1980s by AIDS activists who wanted access to experimental AIDS drugs. AIDS was then a death sentence, so even an experimental drug was worth trying to some patients. Death rates from Ebola range from 40% to 70% throughout West Africa, Dr. Olliaro said.

Dr. Olliaro says a placebo group is unnecessary because in given villages or clinics, doctors will know roughly what the death rate has been there. They can use that rate as a historical control where patients getting a drug are compared with past experience.

Pharma Guy's insight:

Most commenters support the EU approach. It seems that the the FDA is protecting the interests of drug companies like Johnson & Johnson which is required to follow FDA's methodology if it hopes to get a vaccine on the market and make a profit!

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Drugmakers Bet that Gov'ts & Non-profits Will Pay for Ebola Vaccines, Treatments

Drugmakers Bet that Gov'ts & Non-profits Will Pay for Ebola Vaccines, Treatments | Pharmaguy's Insights Into Drug Industry News |

Drugmakers are racing to develop vaccines and drugs to address the worst outbreak of Ebola in history. It's unclear who will pay for their products, but companies are betting that governments and aid groups will foot the bill.

There are no proven drugs or vaccines for Ebola, in large part because the disease is so rare that up until now it's been hard to attract research funding. And the West African nations hardest hit by the outbreak are unlikely to be able to afford new Ebola vaccines and drugs.

But governments and corporations now are shifting millions of dollars to fight Ebola in the wake of the outbreak that has infected nearly 10,000 people and killed over 4,800. Experts say drugmakers are wagering that international groups and wealthier governments like the U.S. will buy Ebola vaccines and drugs in mass quantities to stockpile them for future use once they're deemed safe.

"The political bet is that the U.S. and World Health Organization have been so embarrassed and burned by this event that they will be willing to change the way they do business," said Professor Lawrence Gostin of the Georgetown University Law School, who studies global health issues.

Drugmakers have benefited from stockpiling before. During the bird flu pandemic of 2009, Western governments spent billions to stock up on drugs and vaccines that mostly went unused. Shelf-life varies by product, but can be as little as a year.

Still, it's unclear who will pay for the Ebola vaccines that are in development, even after a WHO meeting on Thursday that included government officials, drugmakers and philanthropic groups. 

"Something concrete needs to be developed soon," said Dr. Manica Balasegaram of Doctors Without Borders, who attended the meeting.

"This needs to done in tandem for us to prepare for when these vaccines are deployed in the larger scale beyond clinical trials."

Even with the uncertainty, drug companies are rushing to begin testing in patients.

Johnson & Johnson said last week it will begin safety testing in early January of a vaccine combination that could protect against an Ebola strain that is "highly similar" to the virus that triggered the current outbreak.

Pharma Guy's insight:

There's no such thing as a free lunch or a free vaccine, despite the mis-reading of press releases from pharma that tout the amount of money they are earmarking of the "cause."

Alex Dillon's curator insight, October 28, 2014 1:54 PM

Drugmakers are rushing to find a cure for ebola that could be distributed as a vaccine. Due to the largest outbreak of ebola in history, governments have shifted millions of dollars towards research for a cure. Though there is no concrete plan for who will buy these drugs, the makers are certain they will be snatched for either use or stockpile. Most of the current experiments will not be ready for testing on people until 2015. Ebola has changed the way drugmakers think about development and research.


it is imperatove that research is being conducted for a cure for ebola, but January 2015 seems too far away for a company to begin safety testing, and May 2015 for another company to begin large clinical trials. There is a problem now that needs fixed as soon as possible. Later is better than never, but the research still seems too slow.

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Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie.

Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie. | Pharmaguy's Insights Into Drug Industry News |
When big pharma blocks essential HIV/AIDS medication to the third world, it is the poor who suffer.

The award-winning documentary Fire in the Blood exposes the challenges NGOs, doctors and activists face in their fight against big pharma and patent laws that prevent millions of HIV/AIDS patients in the developing world from accessing lifesaving drugs.

Oscar winner William Hurt narrates the documentary which was shot in eight countries, across four continents.

The film's contributors include Bill Clinton, Desmond Tutu and Nobel laureate economist Joseph Stiglitz, along with key figures in the struggle to get essential HIV/AIDS drugs to countries of the global south.

Fire in the Blood will screen in two parts on Al Jazeera English on October 31 and November 7, 2014.

Pharma Guy's insight:

I know that pharma companies such as Johnson & Johnson have pledged hundreds of millions of dollars to ratchet up their Ebola vaccine research (see, for example, J&J to spend up to $200 million in push to speed up potential Ebola vaccine development), but there is no pledge that once developed they will donate the vaccine to poor countries in Africa. That's why I ask if history will repeat itself.

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Ebola didn’t have to kill Thomas Eric Duncan, nephew says

Ebola didn’t have to kill Thomas Eric Duncan, nephew says | Pharmaguy's Insights Into Drug Industry News |

On Friday, Sept. 25, 2014, my uncle Thomas Eric Duncan went to Texas Health Presbyterian Hospital Dallas. He had a high fever and stomach pains. He told the nurse he had recently been in Liberia. But he was a man of color with no health insurance and no means to pay for treatment, so within hours he was released with some antibiotics and Tylenol.

Two days later, he returned to the hospital in an ambulance. Two days after that, he was finally diagnosed with Ebola. Eight days later, he died alone in a hospital room.

Now, Dallas suffers. Our country is concerned. Greatly. About the lack of answers and transparency coming from a hospital whose ignorance, incompetence and indecency has yet to be explained. I write this on behalf of my family because we want to set the record straight about what happened and ensure that Thomas Eric did not die in vain. So, here’s the truth about my uncle and his battle with Ebola.

Thomas Eric Duncan was cautious. Among the most offensive errors in the media during my uncle’s illness are the accusations that he knew he was exposed to Ebola — that is just not true. Eric lived in a careful manner, as he understood the dangers of living in Liberia amid this outbreak. He limited guests in his home, he did not share drinking cups or eating utensils.

And while the stories of my uncle helping a pregnant woman with Ebola are courageous, Thomas Eric personally told me that never happened. Like hundreds of thousands of West Africans, carefully avoiding Ebola was part of my uncle’s daily life.

And I can tell you with 100 percent certainty: Thomas Eric would have never knowingly exposed anyone to this illness.

Thomas Eric Duncan was a victim of a broken system. The biggest unanswered question about my uncle’s death is why the hospital would send home a patient with a 103-degree fever and stomach pains who had recently been in Liberia — and he told them he had just returned from Liberia explicitly due to the Ebola threat.

Some speculate that this was a failure of the internal communications systems. Others have speculated that antibiotics and Tylenol are the standard protocol for a patient without insurance.

The hospital is not talking. Until then, we are all left to wonder. What we do know is that their error affects all of society. Their bad judgment or misjudgment sent my uncle back into the community for days with a highly contagious case of Ebola. And now, officials suspect that a breach of protocol by the hospital is responsible for a new Ebola case, and that all health care workers who care for my uncle could potentially be exposed.

Their error set the wheels in motion for my uncle’s death and additional Ebola cases, and their ignorance, incompetence or indecency has created a national security threat for our country.

Thomas Eric Duncan could have been saved. Finally, what is most difficult for us — Thomas Eric’s mother, children and those closest to him — to accept is the fact that our loved one could have been saved. From his botched release from the emergency room to his delayed testing and delayed treatment and the denial of experimental drugs that have been available to every other case of Ebola treated in the U.S., the hospital invited death every step of the way.

When my uncle was first admitted, the hospital told us that an Ebola test would take three to seven days. Miraculously, the deputy who was feared to have Ebola just last week was tested and had results within 24 hours.

The fact is, nine days passed between my uncle’s first ER visit and the day the hospital asked our consent to give him an experimental drug — but despite the hospital’s request they were never able to access these drugs for my uncle. (Editor’s note: Hospital officials have said they started giving Duncan the drug Brincidofovir on October 4.) He died alone. His only medication was a saline drip.

For our family, the most humiliating part of this ordeal was the treatment we received from the hospital. For the 10 days he was in the hospital, they not only refused to help us communicate with Thomas Eric, but they also acted as an impediment. The day Thomas Eric died, we learned about it from the news media, not his doctors.

Our nation will never mourn the loss of my uncle, who was in this country for the first time to visit his son, as my family has. But our nation and our family can agree that what happened at Texas Health Presbyterian Hospital Dallas must never happen to another family.

In time, we may learn why my uncle’s initial visit to the hospital was met with such incompetence and insensitivity. Until that day comes, our family will fight for transparency, accountability and answers, for my uncle and for the safety of the country we love.

Pharma Guy's insight:

This is truly a sad story. And it has relevance for the many poor U.S. citizens who suffer from Hepatitis C or cancer and cannot afford the new medicines that cost as much as a median family house (read The Top Ten Most expensive Drugs).

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While Some Nurses are Quarantined, Others Plan Protests Over Lack of Preparedness in US Hospitals

While Some Nurses are Quarantined, Others Plan Protests Over Lack of Preparedness in US Hospitals | Pharmaguy's Insights Into Drug Industry News |

National Nurses United, which has repeatedly warned that nurses are unprepared to handle patients with the deadly Ebola virus, will holdprotests in at least 14 states and the District of Columbia to demand tougher Ebola safety precautions in U.S. hospitals.

"With the refusal of hospitals across the country to take seriously the need to establish the highest safety precautions for when an Ebola patient walks in the door, and the failure of our elected leaders in Washington to compel them to do so, America's nurses say they have to make their voices heard a little louder," NNU Executive Director RoseAnn DeMoro said.

The union scheduled the day of protests for Nov. 12, the same day that Health and Human Services Secretary Sylvia Mathews Burwell and Homeland Security Secretary Jeh Johnson will testify before the Senate Appropriations Committee on the government's Ebola response, The Hill reports. Ron Klain, President Barack Obama's newly-appointed "Ebola czar," is not scheduled to testify.

"The hospitals are willing to gamble with the lives and safety of RNs and other health workers. But we are not," said DeMoro. "If registered nurses, the people who will be caring for Ebola patients and are at the most risk, are not protected from the Ebola virus, no one is protected. Stopping Ebola in our hospitals is the only way to stop Ebola in the U.S."

Pharma Guy's insight:

It seems to me that states should be more concerned about being prepared to treat Ebola patients than with quarantining health workers exposed to Ebola patients.

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Can You Believe This? Wall Street Analysts Predict Ebola Vaccine Will Be Next Blockbuster Drug! Cuz You're Afraid & Gov't Will Stockpile It!

Can You Believe This? Wall Street Analysts Predict Ebola Vaccine Will Be Next Blockbuster Drug! Cuz You're Afraid & Gov't Will Stockpile It! | Pharmaguy's Insights Into Drug Industry News |
Drug makers stand to make $1 billion in federal contracts to develop stockpiles of Ebola vaccines and treatments for the U.S. government, says investment bank Credit Suisse.
Pharma Guy's insight:

Didn't we learn anything about stockpiling vaccines from the shameful Tamiflu stockpiling scandal?: The British Medical Journal (BMJ) has alleged that pharmaceutical giant Roche is deliberately hiding clinical trial data about the efficacy of oseltamivir (Tamiflu) in patients with influenza. The journal says global stockpiling and routine use of the drug are not supported by solid evidence and alleges that Roche concealed neurological and psychiatric adverse events associated with the neuraminidase inhibitor drug. See here.

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Only 6% of U.S.- based Infection Specialists in Acute-Care Hospitals Say Their Facilities Prepared for Ebola

U.S. hospitals don't have the necessary infection prevention staff and departments are stretched beyond capacity to handle the Ebola virus, according to a new survey conducted by the Association for Professionals in Infection Control and Epidemiology released during International Infection Prevention Week.

APIC Chief Executive Officer Katrina Crist said the survey highlights the short shrift many hospitals give to infection prevention. "The Ebola outbreak illustrates why facility-wide infection prevention programs are critical and require adequately trained, staffed and resourced infection control departments. The unique skill set of the infection preventionist is needed to get out in front of this outbreak and prevent the next public health issue from escalating to a crisis."

Pharma Guy's insight:

Meanwhile, some MDs are suggesting that Ebola patients be treated at home from retro-fitted UPS trucks! See this LinkedIn post: ER Doctor: What Scares Me Even More Than Ebola

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ObamaCare Brought EHRs to Physicians, But the Technology is Not Ready to Combat Ebola!

ObamaCare Brought EHRs to Physicians, But the Technology is Not Ready to Combat Ebola! | Pharmaguy's Insights Into Drug Industry News |

United States citizens have followed the Ebola outbreak in West Africa for nearly 6 months, with concern mounting about the disease arriving on US shores, apparently for good reason. The readiness of the health care system for Ebola was challenged by the very first case. The press in part focused on whether the electronic health record (EHR) contributed to the missed diagnosis, but the right question to be asking is how a modern computer system should perform in this circumstance.

What should the public expect from the $48 billion appropriation to promote health information technology (IT) adoption made under the HITECH provisions of the American Recovery and Reinvestment Act? One goal is greater adoption of EHRs. That is happening. The expenditure, multiplied many-fold by investment of dollars and time across health care, has prompted more than half of physicians to use EHRs—up from 5% in 2008. However, EHRs purchased under the meaningful use program are not yet nimble enough to rearrange the display of health information based on either patient or public health context and they do not communicate with public health. Five years after the enactment of meaningful use, public health officials still reach clinicians and hospitals through traditional dispatches and media alerts. Not emphasizing the most salient data under an extenuating circumstance may ironically distract a busy clinician from an urgent task at hand.

Compounding the problem is that public health, largely absent from the table in defining requirements, remains mostly locked out of the point of care, barely able to exploit the newly deployed health information technology (HIT) infrastructure.

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The Economics of Ebola (and other antibiotic) Drugs

The Economics of Ebola (and other antibiotic) Drugs | Pharmaguy's Insights Into Drug Industry News |
James Surowiecki on the economics of Ebola drug development. The lack of a treatment is disturbing but predictable. What will persuade pharmaceutical companies to develop unprofitable drugs?

It’s not just developing nations that the system disserves, however.

So how can we get the drugs we need without magically transforming the industry that develops them? The key is to reward companies for creating substantial public-health benefits. And the simplest way to do this would be to offer prizes for new drugs.

Prizes aren’t a new idea—in the seventeen-hundreds, the British government successfully used a prize to find a method for measuring longitude at sea. But, in the past couple of decades, they’ve become more common, with prizes being offered for things like innovations in private space flight.

Pharma Guy's insight:

In a BMJ articled titled "Pharmaceutical research and development: what do we get for all that money?",  the authors' promote a NEW business model for the pharmaceutical industry:

"We should consider new ways of rewarding [drug industry] innovation directly, such as through the large cash prizes envisioned in US Senate Bill 1137, rather than through the high prices generated by patent protection," said the authors.

I was intrigued to learn that a US Senate Bill has been proposed -- although long tabled -- that actually seriously proposed getting rid of patent protection for new drugs as an incentive for innovation. Here's how the BMJ authors describe what SB 1137 proposes:

"The bill proposes the collection of several billion dollars a year from all federal and non-federal health reimbursement and insurance programmes, and a committee would award prizes in proportion to how well new drugs fulfilled unmet clinical needs and constituted real therapeutic gains. Without patents new drugs are immediately open to generic competition, lowering prices, while at the same time innovators are rewarded quickly to innovate again."

The authors assure us that the approach advocated by SB 1137 "would save countries billions in healthcare costs and produce real gains in people’s health."


New Pharma Business Model: Prizes, Not Patents, for Innovative Drugs
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