Lyman BioPharma Consulting LLC

Advice and Resources for the Biotech Industry

Advice and Resources for the Biotech Industry

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The Judgment of Solomon by Nicolas Poussin (1649)

Biomedical Ethics: Moral Dilemmas with Lives in the Balance

A couple of years ago I had coffee with a young woman with a strong interest in bioethics. She was looking at potential future career paths, with a possible focus on biotechnology. I shared with her my observation that I had never heard of a biotech company actually employing a dedicated bioethicist. The lack of these positions in the industry, however, doesn’t negate the fact that a wide variety of ideological dilemmas are currently front-and-center in the halls of biomedicine. These complex issues call out for the wisdom of King Solomon to help point us in the right direction. Here are just some of the challenges we currently face:

Receiving Good Healthcare Is Now A Patient’s Responsibility

I ran into a few problems with my rental car on a recent family vacation. The “low tire air pressure” warning light came on twice in the first three days, and the car had absolutely no windshield washer fluid. Both problems were solved by visits to a gas station. When I got home I called Avis to complain, expecting an apology and perhaps a small adjustment on my bill. I got neither. Instead, I was told the problem was actually my fault. I was told I should have checked the tire pressure and the washer fluid levels before departing the rental car lot. When I explained that I don’t travel with a tire pressure gauge, and that I expected Avis to provide me with a car that had been checked over thoroughly, I was informed that the responsibility was mine. If I had concerns, I should have asked to have them checked before leaving the lot. Seriously? I actually attempted to do this during a subsequent rental, but my request to the lot attendant was simply met with a look of bewilderment.

HPV Cancer Resources: My New Website for Parents, Patients, Partners, and Healthcare Providers

Today’s blog post is a little different. I wanted to share with you some exciting news about my new website: HPV Cancer Resources. I spent much of the summer putting together this new and very comprehensive website with the following goals in mind:

To spread awareness about HPV, a virus that causes six different types of cancer in people.

To educate parents about, and advocate for, the safe and effective HPV vaccine, which can prevent infection with the virus and thereby block the development of these cancers.

To refute misinformation about the safety and efficacy of the HPV (and other) vaccines by anti-vaccine groups that is, unfortunately, widespread on the Internet.

To share an organized collection of resources specifically curated for HPV cancer patients and their family members.

To provide basic information for all new cancer patients about the different types of scans and cancer treatments, how tumors are staged, how clinical trials work (and how to find one), and much more.

Those were my goals, but who did I design this website for?

Autism in Dogs: People Embrace Conspiracy Theories, So Why Not Junk Science?

The headline in a recent NY Times article was both spellbinding and disturbing:

“No, Your Dog Can’t Get Autism From a Vaccine.”

Autism in dogs? Not a big concern of mine (or even a little one). The fact that someone chose to write about it tells us that some people have actually been worried about this. Is Google being inundated with queries about what autism spectrum disorders might look like in dogs? Maybe these folks developed concerns when their dogs started peeing or slobbering days or weeks after getting their rabies or Bordetella shots. Wait, isn’t that normal behavior for most dogs? Of course it is. What would the symptoms of autism look like in dogs, and how would you diagnose it? Loss of their stick-fetching and squirrel-chasing urges? No longer wanting to be petted? Ignoring that freshly cooked strip of bacon you lovingly placed in front of their noses?

We’ve Got Very Effective Disease Treatments. Too Bad They’re Not Being Used

“I want a new drug, one that does what it should, one that won’t make me feel too bad, one that won’t make me feel too good.” Huey Lewis and the News

Many people were desperately searching for a new drug in April of 1984 when “
I Want A New Drug” reached number one on the Billboard charts. In the midst of the AIDS epidemic, the world was looking for anything that could stop a rapidly spreading, poorly understood disease. It was a cruel diagnosis that, at the time, was tantamount to a death sentence. Drugs capable of successfully combating HIV were eventually discovered, but that hasn’t ended the AIDS crisis. Getting these powerful and expensive medicines in the hands of people who need them has turned out to be an equally daunting challenge.

Biopharma Haiku Round 5

This is my fifth published collection of biopharma haiku. You can access my previous collections on my Previous Op-Ed Articles page. I hope you enjoy them!

Elizabeth Holmes
Next nanotainer: prison
Crook, plain and simple

Holmes and Balwani
Deceitful duo facing
20 years hard time

No due diligence
Theranos fooled investors
Too good to be true


Bias and Self-Delusion Are A Problem In Both Politics and Science

Coarse adjectives get tossed around the political arena as politicians and pundits try to score points with their supporters. This person is a moron, that one’s an idiot, and so and so is such an imbecile. These three adjectives are nowadays used as interchangeable insults, but what most people don’t understand is that these words used to have distinct scientific definitions in the (now discredited) field of eugenics. Eugenics, which was purported over a century ago to be a legitimate science, was later recognized as nothing more than a house of racial and ethnic bias constructed on a shaky foundation of non-rigorously collected “data” that didn’t stand up to careful scrutiny. “Data” were found and adjusted to fit this theory, rather than gathering up facts and then building a concept around them. Bias often lurks at the core of the thought process used by both politicians and scientists. Before going further, let me be crystal clear about one thing: while both groups suffer from biased thinking, it manifests itself in completely different ways.

Artificial Intelligence? I'd Settle For The Real Thing!

It’s great when societies take on new initiatives and challenges. Back in the early 1960’s, President John F. Kennedy declared in a speech to the nation, “We choose to go to the Moon in this decade and do the other things, not because they are easy, but because they are hard….” Examples these days of other difficult technical challenges might include developing self-driving cars, and figuring out ways to enable artificial intelligence to help solve many of our most pressing technical problems. Having said that, working on hard things shouldn’t give us a pass on failing to do easy things properly. Or to put it another way, artificial intelligence shouldn’t give us a pass on using real intelligence. The simple stuff really and truly matters.

As John W. Gardner put it, “The society which scorns excellence in plumbing as a humble activity and tolerates shoddiness in philosophy because it is an exalted activity will have neither good plumbing nor good philosophy: neither its pipes nor its theories will hold water.

The HPV Vaccine: Preventing Cancer Beats Treating It

You don’t have to be an oncologist to know that fighting cancer is tough. Nearly 1.7 million Americans will be diagnosed with cancer this year, and about 600,000 will die from the disease. But here’s some good news: overall U.S. cancer deaths have been in a steep decline for over 25 years. Much of this reduction is tied to a decline in smoking, along with early detection of some cancers (e.g. colon), and more effective cancer therapies. While treatments against some particular types of cancer have advanced greatly, it’s still a disease no one wants to face. Fighting an opponent that you can never be really sure you’ve defeated challenges both the physical strength and mental fortitude of those who’ve been diagnosed. I know because I’ve been there.


Data Irreproducibility: The "Waste, Fraud, and Abuse” of Scientific Research

Waste, fraud, and abuse. We’ve heard the phrase a million times. Politicians tell us the key to making things better in our society is to simply eliminate this unholy trio of troubles. They never bother to detail specifically what they’re referring to, for attempting to do so might set their lips ablaze. Their declarations always elicit feelings of déjà vu. Where, precisely, is the waste located, and how much of it is there? Who, exactly, are the specific groups or individuals that have committed fraud? What types of abuse are we talking about? Is the problem really widespread, or limited to just a few cases? If you’ve really identified the root cause of these problems, what’s it going to take to eliminate them? And since this expression is uttered so frequently, why haven’t these problems been fixed by now? Sadly, this meaningless catchphrase is trotted out whenever the speaker has no real solutions to offer but pretends to have deep insights that are never actually enunciated.


Is Pharma Really Facing Its Demise?

A widely reported
op-ed piece recently predicted the upcoming financial demise of the pharmaceutical industry. Some have opined, “there’s nowhere to go but down.” While it’s true that the industry faces strong headwinds (many of its own making), I don’t think it’s going to fold anytime soon. Reports of its upcoming demise are, as the saying goes, greatly exaggerated. There’s been an uptick in drug approvals in 2017 (the highest in over a decade), and some of the newest drugs cost upwards of half a million dollars or more. Global sales of biopharma medicines jumped 45 percent from 2006 to 2015. Cancer drug sales in particular are soaring. New biomedical innovations, such as CAR-T immunotherapies and gene modifications using the CRISPR-Cas9 system, appear promising to help treat mankind’s ills.

Let’s take the long view: how has the industry expanded and flourished over the past century? I was recently reading the centennial issue of Forbes, which listed the top 50 U.S. companies (ranked by market cap) from 1917, 1967 (the magazine’s 50
th anniversary), and 2017 (100th anniversary). Comparing these time points provides a fine illustration of just how financially successful the pharmaceutical industry has become over the past one hundred years.

What to Read To Get the Latest BioPharma/Healthcare Info

One question I’m frequently asked: what do you read to keep up with developments in biopharma? My recommendations are below, but keep in mind that my needs may be different from yours. It depends on an individuals background, their interests, how they plan to use that information, and how much they want to spend. Most people will give disparate answers to this question, and that’s just how it should be.

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Illustration: Josh Lyman

Non-Compete Agreements: Dangerous Liaisons

I was recently contacted by outside counsel for a large biopharma company about doing some consulting work for them. We discussed the general scope of the project by phone, and quickly reached agreement that I would be able to help them with their task. The next step was to sign a consulting agreement, which was par for the course. When I was emailed the form I was pleasantly surprised to see that the agreement was only one and half pages long. Many of the consulting contracts I’ve signed for other organizations are typically eight to ten pages. They force me to carefully step through a minefield of minutiae to ensure that the agreement is fairly written for both parties. This one, I thought, would be easy to review and sign.

Then I read it…