Historical Perspectives

Summer Reading List 2017: Even More Tales to Inform and Amuse You

It’s time once again for my annual roundup of some of the best books I've read this year. As usual, my focus is on non-fiction tales from the world of science, medicine, and technology. A master list of all books that I recommend can be found here, and you can also check out my previous book recommendations from 2016 and 2015. Here's my latest list:
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So What Did the March for Science Accomplish?

In the words of a wise former colleague, “don’t know, can’t say.”

With this historic event only a week behind us, it’s going to take time to figure out if the March for Science accomplished anything significant. Part of this is due to the fact that its stated goals were rather
diffuse. Data, of course, needs to be collected, sorted, and analyzed, which will happen because the March was studied by a slew of sociologists. Turnouts at the more than 600 marches worldwide were high, with enthusiastic crowds displaying a diverse cornucopia of signs and slogans not usually paraded about in public. As far as I can tell, the marches were uniformly peaceful affairs, with no counter protesters demonstrating in favor of “alternative facts.” I also saw a number of people sharing religious points of view, happily conveying their opinions that one can believe in both God and science. There was even a group of Satanists marching; I didn’t know until visiting their website that they, too, take a pro-science stance.
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Why I’m Joining in the March for Science

If you haven’t heard yet, there's going to be a nationwide
March for Science on Earth Day, April 22nd. This includes a primary March in Washington, DC, as well as “sister” marches around the globe (at least 320 cities have already signed up). I’m planning on marching here in Seattle, and I’m writing this to encourage others to participate in whichever March is most convenient for you to attend. The March for Science is being supported by a number of prominent organizations, including the American Association for the Advancement of Science, the Union of Concerned Scientists, and the NY Academy of Sciences. Not all scientists think the March will be helpful (and some have voiced that it could even be harmful), but I’m not in that camp for the reasons I’ve outlined below.
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BioPharma and Hollywood: Land of the Blockbusters

When you hear the word “blockbuster”, what’s the first thing that comes to your mind?
a) A movie that earns hundreds of millions of dollars at the box office
b) A prescription drug that brings in more than $1 billion a year in sales
c) A bankrupt chain of video stores
d) A large bomb capable of destroying an entire city block

All four of these choices are valid answers, but the focus of this article is on the first two. The parallels between biopharma and Hollywood are strong. Both industries invest huge amounts of money in a large number of projects with the hope that some will turn out to be blockbusters i.e. massive money making machines. Sometimes it works out, but the failure rate is high, with most drugs (and many movies) never recouping their development costs. Both groups also love to develop sequels, which is a simpler strategy than developing riskier independent products that their fickle public may, or may not, embrace.There are many aspects of their businesses that are shared by the pharmaceutical and movie industries. Let’s see how they compare:
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Hollywood and BioPharma: Differentiated by Unique Economic Models

In my previous post, I detailed numerous similarities between the pharmaceutical and film industries. Now it’s time to point out the substantial differences between these two businesses that illustrate their different economic consumption and pricing models.

Production Costs - Big Barriers to Entry in Pharma, but Not Film
Nobody’s producing drugs in their basement that are going to earn them a ton of money. Okay, let me rephrase that. Nobody’s producing legal pharmaceuticals in their basement that are going to earn them big bucks. Creating prescription drugs is a very expensive enterprise. The cost of bringing a new drug to market has been estimated by the Tufts Center for the Study of Drug Development to be about $2.6 billion. That’s a huge hurdle to making money. There’s no getting around extensive research, filing multiple patents, complicated manufacturing steps, expensive clinical trials, and detailed regulatory and FDA filing requirements. How long might it take just to recoup those costs? Let’s return to my previously cited example of a very poor selling drug. Seattle’s CTI BioPharma sold only $3.47 M of their non-Hodgkin disease/B-cell lymphoma drug Pixuvri worldwide in 2015 (all sales were in Europe). If it cost the company the current industry “average” of $2.6 billion to develop it (which it didn’t), it would take about 749 years just to recoup that money, based on 2015 revenues. And that’s without showing a profit. It’s a pretty safe bet this drug will never recapture its development costs no matter what they were.
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The Covenant Between BioPharma Companies and Their Customers

Outrageous drug price increases have been a hot-button news story for most of the year. Even those who work in the industry know that drug pricing is incredibly complicated, tied to all sorts of group discounts, bundles, and a system of rebates (which are themselves tied to market share of the drug) that benefits both drug companies and pharmacy benefit managers. What was once explained by industry wags as the unfortunate actions of just a few exploitative bad actors (e.g. Turing and Valeant) has continued to expand to more firms. Generic drug maker Mylan (seller of the EpiPen) and Taro Pharmaceuticals have now been caught up in the contretemps, as has newcomer Novum Pharma. Venture capitalist Bruce Booth wrote a nicely detailed commentary comparing “innovator” vs. “exploiter” companies, but I’m not so sure that it’s easy to quickly distinguish one from the other. Many of the companies categorized as innovators (meaning they actually do R&D, and generate new products that meet unmet medical needs), are also responsible for some of these outrageous price hikes. These include companies that make drugs for multiple sclerosis and those who peddle high priced insulins.
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Can Changing A Biotech Company’s Name Really Alter Its Fortunes?

Shakespeare tells us that a rose, by any other name, would smell as sweet. Its alluring fragrance is a quality independent of what we call it. Is the same thing true in the land of biotech? Would changing its name really free a biotech company from an established reputation as a substandard performer? Or is changing the name of a company simply pretending to solve a problem, equivalent to putting air in one of the tires when the check engine light comes on?
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Summer Reading List 2016: More True Tales to Inform and Amuse You

Following an enthusiastic response to my summer reading list from last year, I decided to once again recommend a number of non-fiction, bioscience and medicine based books that I read this past year. The majority of these were recently published, although some are “oldies but goodies” that contain nicely written stories that are well worth your efforts to track them down. Here’s the list:
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Which Bush Had The Greatest Impact On American Science?

Was it George W. Bush? His administration is best known for putting limits on the use of embryonic stem cells for research, for its continued support of space exploration (remember the proposal for the mission to Mars), and for questioning the science of global warming. This latter position contributed (at least in part) to the U.S. not supporting the Kyoto protocol to reduce greenhouse gas emissions. He did fulfill a commitment to doubling the NIH budget during the early years of his administration. Unfortunately, funding of the NIH became static at that point, and in inflation-adjusted dollars, is now about 20 percent lower than it was in 2003. George W. Bush also called for the doubling of certain research programs via the American Competitiveness Initiative, but Congress never funded it. His administration was repeatedly accused of being anti-science by adding politically correct appointees to various science panels, and for censoring reports that conflicted with his administrations views.
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Cancer Immunotherapy: It’s (Almost) All About the Combo

In the early days of cancer chemotherapy, doctors quickly realized that the single agents they were testing were not only highly toxic, they were simply ineffective at curing their patients. Initial discussions about combining some of these drugs were met with heated opposition by the medical community. As former NCI Director Vincent DeVita Jr. stated in his recent memoir The Death of Cancer (2015), “Using more than one drug at a time to treat something was, as a general rule, considered sloppy medicine.” The first effective cancer treatments evolved to include combinations of four chemotherapeutic drugs. This pattern is now repeating itself in the field of cancer immunotherapy.
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Drug Pricing: Lack of Transparency and Trust Compound the Problem

The latest attack on drug industry pricing has calmed down a little now, although the subject is sure to reignite as the 2016 Presidential election race heats up. Hillary Clinton, despite being the leading recipient of campaign contributions from drug industry insiders, recently issued a call to regulate drug pricing (and Bernie Sanders has actually co-sponsored new drug pricing legislation). These calls elicited the expected responses from PhRMA and BIO, with both trade organizations suggesting that such a move would restrict patient access and inhibit the development of new medicines. Read More…