Announcement

Collapse
No announcement yet.

The Anti-bacterial Game

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • The Anti-bacterial Game

    There is clearly something wrong with pharmaceutical innovation.

    Antibiotic-resistant infections sicken more than two million Americansevery year and kill at least 23,000. The World Health Organization has warned that a “post-antibiotic era” may be upon us, when “common infections and minor injuries can kill.” Even the world’s tycoons consider the proliferation of antibiotic-resistant bacteria one of the crucial global risks of our times, according to a survey by the World Economic Forum.

    Yet the enthusiasm of the pharmaceutical industry for developing drugs to combat such a potential disaster might be best characterized as a big collective “meh.”

    No major new type of antibiotic has been developed since the late 1980s, according to the W.H.O. From 2011 to 2013, the Food and Drug Administration approved only three new molecular entities to combat bacterial diseases — the lowest rate since the 1940s. “No sane company will develop the next antibiotic,” said Michael S. Kinch, who led a team at the Yale Center for Molecular Discovery tracking the evolution of pharmaceutical innovation over the last two centuries.


    And this is hardly the drug industry’s only problem. Antibiotics, Professor Kinch told me, “are the canary in the coal mine.”

    This is particularly striking at a time when the pharmaceutical industry is unusually optimistic about the future of medical innovation. Dr. Mikael Dolsten, who oversees worldwide research and development at Pfizer, points out that if progress in the 15 years until 2010 or so looked sluggish, it was just because it takes time to figure out how to turn breakthroughs like the map of the human genome into new drugs. The pipeline today, which includes tailored treatments for cancer, newfangled vaccines and therapies for tough diseases like hepatitis C, is robust.

    So far this decade, the F.D.A. has approved drugs at a pace second only to the 1990s. In 2012, the FDA approved 37 new drugs, the most in 15 years.

    But the economics of the drug development, argues Professor Kinch, who in July was appointed associate vice chancellor of Washington University in St. Louis, are not conducive to creating the highest levels of public health.

    More and more antibiotics are going out of circulation every year — either because of bacteria have become resistant to them or because they have been replaced by better or less toxic drugs. The pharmaceutical arsenal against bacterial infections shrank to only 96 different molecules by the end of last year, 17 fewer than at the turn of the century.

    Nevertheless, many of the big drug companies that produced the antibiotic breakthroughs of the past have decided to drop this line of research. And few new entrants are jumping in.

    “It has become very difficult to find new drug classes to fight infections,” Dr. Dolsten of Pfizer acknowledged. “There haven’t been enough incentives for the industry to take on 10 or 15 years of research.”

    Antibiotics face a daunting proposition. They are not only becoming more difficult to develop, but they are also not obviously profitable. Unlike, say, cancer drugs, which can be spectacularly expensive and may need to be taken for life, antibiotics do not command top dollar from hospitals. What’s more, they tend to be prescribed for only short periods of time.

    Importantly, any new breakthrough antibiotic is likely to be jealously guarded by doctors and health officials for as long as possible, and used only as a drug of last resort to prevent bacteria from developing resistance. By the time it became a mass-market drug, companies fear, it could be already off patent and subject to competition from generics that would drive its price down.

    Antibiotics are not the only drugs getting the cold shoulder, however. Research on treatments to combat H.I.V./AIDS is also drying up, according to the research at Yale, mostly because the cost and time required for development are increasing. Research into new cardiovascular therapies has mostly stuck to less risky “me too” drugs.

    Neuropsychiatric diseases, including Alzheimer’s and depression, are the leading cause of disability across most of the industrial world. And they are going to get worse. Yet researchers have underscored a dearth of investmentinto these diseases.

    Instead, pharmaceutical and biotechnology firms are betting on personalized therapies — mostly targeting specific varieties of cancers — and drugs for so-called orphan diseases, which affect very small populations. “More people are studying orphan diseases than have orphan diseases,” Professor Kinch said jokingly. Of the new drugs that the F.D.A. approved in 2013, about 70 percent were specialty drugs — which are used by less than 1 percent of the population, according to the drug benefits manager Express Scripts.

    The problem, of course, lies in the industry’s incentives. The cost of developing a new drug has skyrocketed over the last three decades. A research paper by scientists from Eli Lilly suggested that in 2010, it cost $1.8 billion to bring a big new drug from conception to rollout, through the costly gantlet of clinical trials needed to prove that it is both safe and more effective than existing therapies.

    Developing orphan drugs is cheaper. They receive expedited approval from the F.D.A. Clinical trials are inherently less expensive because the drugs are aimed at a small population. And insurance companies are willing to pay $100,000 a year for a drug that few patients will use.

    “Companies are flocking to rare diseases,” said John LaMattina, a former head of research at Pfizer who now writes a blog about pharmaceutical research. “They might only make $500 million in sales a year, but their costs are much lower.”

    Similar considerations have pushed pharmaceutical companies into newfangled biological drugs at the expense of old-fashioned compounds. Standard brand-name drugs lose 80 percent of the market within a year of patent expiration. Biologicals face much less generic competition, protected both by regulation and the fact that it is tough to determine the equivalency of different biological agents.

    The wave of protests over the $84,000 cost per course of Gilead’s blockbuster new drug to treat hepatitis C, Sovaldi, highlights the kind of strain that can be caused when mass market therapies are priced like niche specialty drugs.

    “I’ve seen nothing as potentially harmful as the exorbitant pricing displayed by Gilead,” wrote Dr. Steve Miller, the chief medical officer of Express Scripts. Regardless of whether that is worth it for the individual patient or society at large — which it probably is — the price could bankrupt Medicaid budgets around the country.

    Can drug makers’ incentives be fixed? Some argue that the patent systemgoverning drug innovation is not up to the task, and suggest handing over most drug research and development to the National Institutes of Health, which already spend tens of billions on basic research.

    Tweaking the existing system might be a more feasible proposition, however. Research on new antibiotics could be encouraged by allowing shorter clinical trials for the promising molecules or guaranteeing minimum returns for groundbreaking drugs.

    Patricia Danzon of the Wharton School of the University of Pennsylvania suggests recalibrating the regulatory burden to favor research in drugs with a broader potential footprint. “The decks have been stacked in favor of orphan drugs,” she said.
    At the same time, new mechanisms are needed to constrain prices.

    The National Health Service in Britain may have a bad reputation in the United States, but Americans could benefit from something like the country’s National Institute for Health and Care Excellence, which determines what therapies will be covered, based on their efficacy and their price.

    “There’s a myth in the United States that market forces are working to control prices,” Professor Danzon said. It’s clear that they aren’t. But the market isn’t delivering the innovation we need, either.

    Eduardo Porter

  • #2
    Re: The Anti-bacterial Game

    Frontline did a good show called Hunting the Nightmare Bacteria. That page also has a number of interesting articles, including this:

    Who's Trying to Fix the Pipeline Problem?

    Be kinder than necessary because everyone you meet is fighting some kind of battle.

    Comment


    • #3
      Re: The Anti-bacterial Game

      some salient points in a complex problem:

      Antibiotics face a daunting proposition. They are not only becoming more difficult to develop, but they are also not obviously profitable.

      Unlike, say, cancer drugs, which can be spectacularly expensive and may need to be taken for life, antibiotics do not command top dollar from hospitals.

      What’s more, they tend to be prescribed for only short periods of time.


      any new breakthrough antibiotic is likely to be jealously guarded by doctors and health officials for as long as possible, and used only as a drug of last resort to prevent bacteria from developing resistance.

      By the time it became a mass-market drug, companies fear, it could be already off patent and subject to competition from generics that would drive its price down.


      pharmaceutical and biotechnology firms are betting on personalized therapies — mostly targeting specific varieties of cancers — and drugs for so-called orphan diseases, which affect very small populations.

      Developing orphan drugs is cheaper. They receive expedited approval from the F.D.A. Clinical trials are inherently less expensive because the drugs are aimed at a small population. And insurance companies are willing to pay $100,000 a year for a drug that few patients will use.

      “Companies are flocking to rare diseases,” said John LaMattina, a former head of research at Pfizer who now writes a blog about pharmaceutical research. “They might only make $500 million in sales a year, but their costs are much lower.”


      “There’s a myth in the United States that market forces are working to control prices,” Professor Danzon said. It’s clear that they aren’t.

      But the market isn’t delivering the innovation we need, either.

      Comment


      • #4
        Re: The Anti-bacterial Game

        At least we have a dozen different ED drugs...

        Comment


        • #5
          Re: The Anti-bacterial Game

          Originally posted by Lasher View Post
          At least we have a dozen different ED drugs...
          It's important to have our priorities straight.

          Be kinder than necessary because everyone you meet is fighting some kind of battle.

          Comment


          • #6
            Re: The Anti-bacterial Game

            Originally posted by shiny! View Post
            It's important to have our priorities straight.
            bart used to have a "snare drum rimshot" mp3 file he'd post after remarks like yours.

            Comment


            • #7
              Re: The Anti-bacterial Game

              Originally posted by jk View Post
              bart used to have a "snare drum rimshot" mp3 file he'd post after remarks like yours.
              :-)

              Where is Bart, btw?

              Be kinder than necessary because everyone you meet is fighting some kind of battle.

              Comment


              • #8
                Re: The Anti-bacterial Game

                Originally posted by shiny! View Post
                :-)

                Where is Bart, btw?
                http://blog.nowandfutures.com/

                Comment


                • #9
                  Re: The Anti-bacterial Game

                  Originally posted by shiny! View Post
                  :-)

                  Where is Bart, btw?
                  eye have seen him (his login anyway, in the 'thread info' line near the bottom of the page) here n there occasionally/lately - apparently hasnt been posting tho...

                  Comment


                  • #10
                    Re: The Anti-bacterial Game

                    Just to focus on another model for making things related to health...
                    Weekend Edition July 25-27, 2014
                    Share on facebook Share on twitter Share on google More Sharing Services 8



                    The Threat of Good Example
                    Socialist Cuba Exports Health Care, Gains Important Recognition

                    by W.T. WHITNEY, Jr.
                    In Cuba recently press conferences and new reports celebrated the ten-year anniversary of Operation Miracle, known also as “Mision Miracle,” which occurred on July 8. This internationalized project aimed at restoring vision on a massive scale took shape within the context of ALBA, the Bolivarian Alliance for the Peoples of Our America.
                    Cuba and Venezuela launched ALBA in late 2004. Latin American and Caribbean nations belonging to ALBA engage in mutually beneficial trade-offs of educational and medical services, scientific projects, even commodities. They are referred to as solidarity exchanges. ALBA exemplifies Cuba and Venezuela’s central role in promoting regional integration.
                    Under Operation Miracle, Cubans and Venezuelans benefit from surgical eye care, as do tens of thousands of foreign nationals who’ve traveled to Cuba for treatment. Cuban ophthalmologists serving in Venezuela took the lead in establishing 26 eye care centers throughout that national territory. Staff consisting of eye surgeons, nurses, technicians, and other physicians have served Venezuelans and also vision- impaired people from 17 Latin American countries plus Italy, Portugal, and Puerto Rico. More recently organizers established centers in 14 Latin American and Caribbean nations. Ten years after its start the project operates in 31 countries, some in Africa and Asia.
                    Those receiving diagnosis and treatment through Operation Miracle had gone without eye care because of poverty and/or geographic inaccessibility. The most common cause of reduced vision the teams deal with is cataract. They provide treatment also for glaucoma, strabismus, retina problems, and abnormal ocular growths. Corrective lenses are provided. Services are available for patients at no personal cost, as are transportation and accommodations.
                    Operation Miracle reportedly has improved or restored vision for 3.4 million individuals. That measure of the project’s reach takes on additional meaning through World Health Organization data showing that 39 million people in the world are blind. These figures are within reach of one another, especially because most visual impairment – 80 percent – is preventable or curable.
                    So it seems that two formerly colonized, dependent nations have taken giant steps toward addressing a major cause of human disability. But who, one asks, knows this story of human betterment? Writing recently for Cuba’s La Pupila Insomne web site, journalist Jose Manzaneda charges that international media ignored this “spectacular news.”
                    He highlights the Spanish El Pais newspaper as a purveyor of anti-Cuban bias. Recently El Pais writer Mauricio Vivent reported on international assistance to Haiti, but failed to mention Cuban efforts to fill Haiti’s health-care vacuum. In fact, according to Manzaneda, 11,000 Cuban health workers, mostly physicians, have served in Haiti for more than 16 year, and 700 of them are there now. They’ve cared for 20 million patients, performed 373,000 surgical operations, and delivered 150,000 babies. Over1300 Haitian young people, recipients of Cuban government scholarships, have graduated from Cuban universities Currently 322 Haitians are studying medicine in Cuba.
                    Why the reticence on the part of the world’s dominant media? Historian Aviva Chomsky speculated in 2000 that Cuba is suspect because of its “threat of a good example.” She was writing about Cuban health care achievements.
                    The recent visit to Cuba of Dr. Margaret Chan, Director – General of the World Health Organization, elevated that threat to high alert. On July 16, while participating in the inauguration of a new structure in Havana that will house a center for bio-pharmaceutical development and another for clinical trials, she observed that Cuba “is the only country I have visited with a [health] system tightly connected with research and development in a closed circle … The objective of science is to serve health care and health and in this, Cuba is an example.” Chan lauded “the Cuban purpose of benefiting not only the health of Cubans but also of the citizens of Latin America and the rest of the world.”
                    Writing in the new guest book, Chan congratulated one center “for its great achievements over 25 years. This has been possible through the vision of leaders like Fidel and Raul Castro who think strategically, for the long term, and established the bases for the success we see today. I congratulate them for their contribution to the improvement of the health of people in Cuba, in the region, and in the world. The Pan American Health Organization and the World Health organization will always be your good and trustworthy friends.”
                    In a 2008 letter explaining his decision no longer to serve as Cuba’s president, Fidel Castro stated that, “My only wish is to fight as a soldier in the battle of ideas.” Indeed, medical outreach to Haiti, Operation Miracle, ALBA, and the centers that Dr. Chan praised are themselves ideas that Cuba has advanced, in struggle. The overarching idea, however, is “Patria es Humanidad” (homeland is humanity) which was pronounced by Cuban national hero Jose Marti. Surely, as demonstrated by down –to- earth, people – centered instances of international solidarity, Cuba’s revolution remains true to its Martian roots.
                    W.T. Whitney Jr. is a retired pediatrician and political journalist living in Maine.

                    Comment


                    • #11
                      Re: The Anti-bacterial Game

                      dangerous ideas, grab the crosses and the garlic . . .

                      (thanks for posting)

                      Comment


                      • #12
                        Re: The Anti-bacterial Game

                        ​(further) notes on Big Pharma's business model . . . .

                        A new drug for the liver diseasehepatitis C i — it’s generally heralded as a genuine medical breakthrough — but costs $1,000 a pill and about $84,000 for a typical person’s total treatment.

                        But maybe we are looking at the costs of Sovaldi in the wrong way. One reason it is causing such angst among insurers and state Medicaidofficials is that treatment costs are coming all at once.

                        First of all, there is pent-up demand. There are a lot of people with hepatitis C — an estimated 3.2 million in the United States — many of whom have been waiting for a good treatment. Second, unlike drugs for most chronic diseases, like diabetes or H.I.V./AIDS, for which treatment continues over many years, Sovaldi can cure most patients’hepatitis in just a few weeks, with the bill soon to follow. The lifetime cost of treating someone with an H.I.V. infection is around $380,000, according to estimates from the federal Centers for Disease Control and Prevention, but the annual bill is much smaller.

                        Think about AIDS treatment as paying a mortgage. Sovaldi is like buying a house with cash.


                        The United States health insurance system works better for costs that are spread out and predictable.

                        That does not mean that our health care system is not expensive — it is — but we are more used to costs that pile up slowly over time.

                        Research on the cost-effectiveness of Sovaldi is still in the early stages, but it appears that use of the drug has the potential to actually save money over the long run. Data from the C.D.C. suggest that more than 60 percent of people with hepatitis C will end up with chronic liver disease — and as many as 20 percent will end up with cirrhosis. Treating those diseases is costly. A liver transplant, the most expensive option for the small group of patients with end-stage disease, costs nearly $600,000.

                        Because the drug cures around 90 percent of patients who take it, public health researchers believe it has the potential to reduce the spread of the disease to others, eliminating the future costs of treating their disease and any complications.

                        “If it is cost-effective from a societal standpoint, it is not necessarily going to be cost-effective from a health plan standpoint,” said Dan Mendelson, chief executive of Avalere Health, a health care consulting company. “I think some of the friction here results because the societal value is not reflected in the health plan operations.”


                        But for all the panic, the crisis may soon wane. New, effective drugs are about to enter the market to compete with Sovaldi, offering other options with high cure rates and low side effects. And a more competitive market is likely to drive down the drug’s price, once payers can choose to cover only the drug that is the best deal.

                        The pent-up demand of patients who have been waiting for a cure will work itself out over the next few years. The PricewaterhouseCoopers estimates show big costs for treating hepatitis C over the next two years, then a sharp decline as the untreated population dwindles.

                        Comment


                        • #13
                          Re: The Anti-bacterial Game

                          how profitable would ebola be in the US?

                          just wonderin'

                          Comment


                          • #14
                            Re: The Anti-bacterial Game

                            No money in vaccines for Ebola?

                            http://www.cnbc.com/id/101887615?__s...story|&par=msn

                            Comment


                            • #15
                              Re: The Anti-bacterial Game

                              the above posts suggest it's the magnitude of profitability that decides the issue.

                              Comment

                              Working...
                              X