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Sunday, February 27, 2011

Inside Information

When you think of disgruntled employees you think of crazy people. The kinds who come back to work with guns and mow down their old colleagues. But there are other kinds. Some people are good and the company management is lacking.

Here is what a high ranking former employee at a small biotech had to say about the management:

I thought they had some good technology..., however, the leaders had no clue how to develop ethical pharmaceuticals and they weren't folks that I could respect. It was really unfortunate as they hired good people but really didn't allow themselves success due to incompetence at the top.

Will those four clowns at the top every get rich like they want?

For the record, the leaders went on to make a rather lucrative deal with Big Pharma. The Big Pharma company wanted a large amount of the drug to start their own research. Little Biotech company had about 2% of what the Big Pharma company asked for. What they did have did not pass the bioburden test. So how did they get the positive data that attracted Big Pharma?

Overseas, third world country testing! Unethical? Yes. Could the leaders "develop" pharmaceuticals? No. They haven't made one molecule that could be used in the US or Europe. Did they get rich? Yes. The "clowns" at the top have multiple houses and new cars and all of the things a greedy person would cherish.

Could we blow the whistle on this company? I don't think so. Overseas testing is legal. Incompetence in medical research is subjective. Unethical conduct can be argued against by claiming ignorance to the rules. They could claim that they had to go outside the US and Europe because they are small and can't afford the rigorous process in the modern world. Once again medical science has designed in flaws that select for the bad guys.

But this is the kicker today. Our history is rotten to the core. Human beings can't be trusted. Testing dangerous drugs on human subjects is decidedly bad. Now we know better. Right?

The new test subjects have to take "medicine" that would not pass muster in the US or Europe. Once again, we've lowered our standards and found people whom we have less fear of. They are not protected as Americans and Europeans. The prisoners and mentally ill were not protected either. How far have we come in our humanitarian ways?

The "clowns" at the top of this little biotech are not evil. They are greedy and they want to be powerful players in the business. They are a small and dangerously desperate company.

Thursday, February 17, 2011

Biotech Inc.

I took my latest lab tour after a 2 hour interview for a 5 week temp job. It was a small space with all of the usual things. Hoods, gel apparatus's, incubators, shakers, PCR machines... It was merely a satellite branch of Biotech Inc. Sometimes I think biotech is all one big secret corporation (Biotech Inc.) whose mission is to collect money from gamblers (biotech investors). Each branch has a twist to the usual story. They cure disease with big brain ideas that no one really understands. The idea needs money to work. In reality, Biotech Inc. needs money. Invitrogen, GE Healthcare, BioRad, Pall, Millipore and companies like these have made a fortune off selling to Biotech Inc. As a result each lab looks the same. The tour I took yesterday was short. I'd seen it all before.

Rumor has it that this particular company is looking to sell itself off for a quick profit for investors. I was interviewing for a 5 week job at the bottom, once again. I was informed of the temporary status of the job half way through the interview. During the lab tour I knew I was looking at an entire group of temps. They had more benefits and longer contracts than an admitted temp, but they didn't have long to go. The company is looking to be sold. If they can't pull it off they will shut it down. Either way, the laboratory staff had short futures with a small company.

Big Pharma has tired of wasting their time and energy trying to develop drugs. Big Pharma has made the claim that the small biotechs will become their feeding ground. They will let the innovation take place on someone elses dime and snatch up the winners. The Biotech Inc. lab space that previously had taken up real estate in Pfizer and Merck is fading away. The Biotech Inc. space moved to small dangerously desperate companies. Like a dishonest post-doc who needs data to fall in his/her favor in order to advance his/her career, the desperate small biotech gets the kind of results that go over well in a meeting. Easily understandable stories that put dollar signs in wealthy peoples eyes are what people want.

A fair amount of money had to be spent on the company work space. Besides the Biotech Inc. lab, there was a nice reception/office/cubicle space. All of the colors matched on the carpet, walls and tile. It was a nice theme. The management comes from The University. They have higher degrees in science than the lab staff so they get to spend some time developing color schemes and picking out carpet. This job could not be done by people earning the same as the lab staff. The difference in salary is an indication in importance of daily work. Although The University tends to teach things that would be most useful in the lab, the money from the investment pool can be used to hire the best biotech architects and interior design experts. In the end it looks as though the high ranking members of Biotech Inc. have really done a good job. You can look at the end result.

The end result of the laboratory work is a different story. The laboratory looks the same before and after major accomplishments. Each worker has the same white lab coat supplied by the same white lab coat company. Their Invitrogen DNA preparation kits look the same stacked up in their Thermo 4 degree refrigerator. Their Eppendorf pipettes look the same. The chemical cabinet, the hood, the tips, the gel boxes all look the same. But these tools of the trade are powerful when used properly. The laboratory staff can create molecules. They can alter a molecules shape, size and chemistry. But ultimately, it is the decisions of those who pick out the carpet and wall colors who decide what to do with the products created in the laboratory.

Biotech Inc. is not just a collection of Cargo Cults. There are many useful people in the corporation. You have to break it down to components and people are the indivisible component that separates the Cults from the companies.

Sunday, February 13, 2011

The People

In 2001 I was working at a little biotech company in East Los Angeles. The founders were two professors at the USC Med School. The company had a pipeline of 4 antibodies against "denatured" collagen. The idea behind them was that they would prevent blood vessels from forming around tumors and thus kill them. The company was funded by an angel investor. The goal was for us to obtain some data that could be used to sell the company off and make our investor some money.

The experiment consisted of three groups of bald mice. Each group had 10 mice. There was a positive control group, treated with Rituxan. Rituxan is a monoclonal antibody that binds to VEGF. There was a negative control group, treated with PBS. There was an unknown group, treated with one of our antibodies. Day one we injected cancer cells subcutaneously on the backs of the mice. Each day the mice were injected with a large dose of the drug or PBS shot into their belly. In a couple days tumors began to grow, which we measured with a caliper.

It was extremely inhumane because no one had a painless way of doing this. The mice were horrified when the lights came on. I tagged along to write down the readings. I watched as each mouse was held upside down and a large needle was injected into a non-distinct region of their underbelly.

The experiments were done over and over. That is because we had to get the set of data that our superiors wanted. The investor had decided that the antibodies were a great idea and he sank millions into making a profit from them. The lab people needed to get the results. The problem was that we our antibodies didn't work. The Rituxan worked great. No tumors. The other two groups were statistically the same. But this would not do. We were sent back to have a graduate student from one of the founders lab show us how to "properly" use the caliper to make the measurements. She spoke as she measured, instructing us. As she instructed she was clearly favoring the hoped for measurements. Using a caliper is not a skill. When she had finished getting the data to look "better" and she ended her lesson on measuring tumors.

I had just one question. I handed her a mouse that she had already measured. She asked, "what is this?".

Me: It's a mouse with a tumor. Can you measure this one?

Her: Didn't we measure it?

Me: Yes, if you are measuring accurately you should get the same tumor size.

She measured again and was off by 30%. This number of course was not written down. It was for my own assessment. That was my N-Rays moment. I knew in my heart that they had been playing these games. The new measurement didn't count. I knew I was in a Cargo Cult.

The graduate student and the boss needed to show a reduction in tumor size. Somehow by measuring the mice again, they did not feel that they were simply fabricating data. After all, they had performed the measurements. To me, this was fraud. To the boss and the grad student, this was survival. They needed the data as much as anyone else.

My entire biotech career is littered with this ilk. They are good people until the data doesn't go their way. They convince themselves that these things are simply little white lies. They don't matter. In the big picture they know their drugs work and they'll be vindicated later. The little experiments where data is cherry picked is no big deal. It's one or two slides in a presentation that tells a much more interesting story. And the story is what sells. Investors open their pocket books and bigger companies start listening.

Thursday, February 10, 2011

Oh Pfizer Again

Good thing they have lots of money. Pfizer is once again shelling out hundreds of millions to pay for covering up the danger of their drugs.

I posted last week about Pfizer being sued for 142 million for promoting their drug off label knowing it was potentially dangerous.

Paying out money is a lot better than going to jail. But actual human beings made these bad decisions. They are allowed to hide behind the corporate logo?

Saturday, February 05, 2011

Who Likes Bad Science?

I used to joke with my friends in the physics community that if you want to cleanse your discipline of the worst scientists in it, every three or four years, you should have someone publish a bogus paper claiming to make some remarkable new discovery — infinite free energy or ESP, or something suitably cosmic like that. Then you have it published in a legitimate journal ; it shows up on the front page of the New York Times, and within two months, every bad scientist in the field will be working on it.
Gary Taubes

The quote brings self doubt into the mind of the CCS. Are the people in the laboratories attracted to bad science? Is it just easier to get a degree in a bio science than a harder science such as chemistry or physics? Would it behoove the Biotechnology industry to insist on stronger math skills?

Let's look at a couple jobs and their requirements for the industry:

Entry level research associate: Education; A B.S. or B.A. in Molecular Biology, Biochemistry or Chemistry or an Associate’s Degree in Biotechnology.

A bachelors degree in Chemistry = an associates degree in Biotechnology?

A protein science temp job: QUALIFICATIONS; Ph.D. or equivalent industry experience.

A PhD? A PhD in what?

And these come from Craigslist. Would an executive recruiting company use craigslist? Why are biotech scientists subjected to a craigslist ad?

Bad businessmen and bad scientists are attracted to bad science. They hire their scientists from Craigslist ads. Critical positions that can cost the company millions in delays getting a drug through the approval process are left up to temps. The businessmen and those applying for the jobs don't know or they don't care. They are in it for the short term.

In The Big Short there was a Cargo Cult Science taking place in the financial industry. A handful of people became aware of it and they bet that the sh*t was going to hit the fan. They found the way to make money off of it. The biotech professionals who have bet their careers can do the same. Be aware of bad science and stay away. There are places to go where the science is real. Seek out good science. It won't be as easy as you think. If you find yourself in the pool of bad scientists who Gary Taubes described above, get out. Leave that RNAi company. Don't apply to that PhD temp job. Work harder and get where you need to be. The Cargo Cult Airports are very tempting. They pay the same and they look the same. But they are not long term winners. Career professionals need to work for the longterm. A resume of short term bets will not be very satisfying.

And so I don't think that working in biotechnology is just a bunch of bad scientists who are attracted to bad science. There are good places, even inside bad companies. Seek them out. Look for long term options that make sense.

So I have just one wish for you--the good luck to be somewhere
where you are free to maintain the kind of integrity I have
described, and where you do not feel forced by a need to maintain
your position in the organization, or financial support, or so on,
to lose your integrity. May you have that freedom.


Thursday, February 03, 2011

Huge Airport Shutting Down

This isn't like shutting down that quaint little coffee shop you thought would be a good idea to buy so you quit your job and sank your life savings into and ended up staying up late at night counting up your daily losses until finally you had to file for bankruptcy... Whew! I'm just saying... that would be a bad idea.

Pfizer and Merck won't be facing an end to their dominance in the drug pushing business. But they have different ways of facing their future. Pfizer sees their massive R&D campus as a Cargo Cult Airport and they are tired of not getting the cargo.
Merck maintains their faith in their airport.

Since we at the CCS believe that most drug success stories are random events it will be interesting to see how these two companies fare. Does it matter if a major drug company shuts down a major scientific research center?