Category: Pharmaceuticals

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Pharma Phunnies

From another of my pharma profiles:

In the past year, Takeda made a splash in the U.S. with its surreal commercials for sleep treatment Rozerem. Featuring such elements as Abraham Lincoln and a talking beaver, the spots are supposed to evoke the incredibly embarrassing dream-symbols that insomniacs miss out on. Lucky them.

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Bad Drug Joke

The following was deleted from one of my pharma company profiles: “Dapoxetine was rejected by the FDA in 2005, but if its EU filing gets approval this year, another FDA submission could be coming soon.”

The best part is that the company is Johnson & Johnson.

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I want a new drug

I enjoy writing the big Top 20 Pharma / Top 10 Biopharma report each June. Sure, it’s not what I imagined I’d be doing when I was a brooding, pretentious idiot in college, but it turns out that there’s plenty of fun to be had in researching and writing these profiles.

For one thing, there’s the mystery/police procedural aspect of reading through annual reports and SEC statements and trying to figure out just what certain companies are trying to hide. Maybe it’s awful revenues from a new product (now conveniently reclassified into a group of products, so its figures aren’t broken out), or a diminished product pipeline (“I wonder why [company x] isn’t mentioning any of its late-stage projects”), or a quiet reorganization (last year, a company detailed its layoffs and plant closures, but made no statement anywhere about how much money it hoped to save in the process). It can take some detective work to figure this stuff out; I’m sure if I’d gotten myself an MBA, I could parse it more easily.

And for another thing, there’s the drugs.

I always enjoy reading through these companies’ reports to see about all the neat new therapies, the increased survival rates they bestow, the alleviation of previously uncureable conditions, the lifestyle changes we never thought possible. This, too can take some detective work, because some companies don’t seem to know what they have.

Por ejemplar: Today, I added UCB Group to my Top Biopharmas ranking. The company doesn’t have any biologic-based drugs on the market, but it’s got some in the pipeline, which is better than some of the other companies that I’ve included for years.

As part of its profile, I needed to list UCB’s best-selling drugs and how they performed last year. And that was how I discovered Nootropil, which posted around $125 million in 2006 sales.

“Nootropil?” thought I. “I wonder what that’s for . . . ?” Since I got a masters degree in liberal arts rather than business, I knew that the ‘noo-‘ root means ‘mind’ in Greek, and that left me intrigued.

According to UCB’s annual report, Nootropil’s a “cognitive enhancer.” Well, that begged more questions than it answered! Fortunately, the Internet has plenty of answers! It’s my cognitive enhancer!

Nootropil is known generically as piracetam and, according to this wiki page, it’s “a cerebral function regulating drug which, it is claimed, is able to enhance cognition and memory, slow down brain aging, increase blood flow and oxygen to the brain, aid stroke recovery, and improve Alzheimer’s, Down’s Syndrome, dementia, and dyslexia, among others.” Oh, and it has virtually no side effects.

Now if only I can convince them to send me some samples!

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Utilitarianism

Every summer, when we get rolling on the annual Top 20 Pharma / Top 10 Biopharma report, my trusty associate editor compiles pipeline information for the past year. While I suss out sales figures and try to parse the arcana of accounting, she puts together lists of new drugs that were approved, extensions or new indications for approved drugs, those that are filed and pending approval, those that have lost patent protection, research projects in late-phase or early-phase studies, and those that were canceled or rejected.

That last category, the could-have-beens, is a testament to the enormous risk that drug companies take on. This year’s #1 company, Pfizer, recently had to cancel development of a drug that would have brought in upwards of $50 billion in revenues during its lifecycle. Future revenues are kaput and $1 billion in R&D investment has been flushed away with it.

Fortunately, Michael Moore has a strategy for eliminating this expense and the risk! America needs to regulate drug companies “like utilities since they’re just as important as electricity and water.” That’ll make them more productive and less expensive! Of course!

I mean, outside of the fact that the U.S. power grid is antiquated and prone to collapse, and that the water supply in this house was provided by a well for 35 years, I’d have to say he almost knows what he’s talking about.

I do find it funny when people tell me the pharma industry needs more regulation, and that drugs should be cheaper.

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Regulatory Overkill?

[Excerpted from this month’s From the Editor column at my magazine.]

In last June’s From the Editor page, I wrote about a scandal involving Chinese “innovation,” namely a rip-off that literally involved scraping a western company’s name off of cell-phone chips and painting a Chinese company’s name on them. I received some guff for that editorial, and have been told at numerous conferences in the past year that China will dominate the 21st century, because the world is bowl-shaped or flat or somesuch.

I maintain that the country’s poverty-level population (800 million), out-of-balance birthrates (in the 1990s, some provinces peaked at 32 male births to one female, thanks to advances in portable sonograms), and catastrophic environmental record are going to yield so much unrest as to counter its “economic miracle.” Those of you who’ve had the misfortune of listening to me expound on this subject know that I believe China’s one-party dictatorship makes it impossible for the nation to truly accommodate itself to the western world; instead, it does a passable impression of capitalism. But when it breaks down, it breaks down critically.

Let’s take China’s role in exporting chemicals, a major economic driver. Those exports have made plenty of news lately, after

  1. an ingredient (or two) used by Chinese livestock-food suppliers to falsify protein tests led to the deaths of a number of pets in the U.S., and
  2. a counterfeit ingredient in cough syrup supplied by a Chinese company poisoned at least 100 people n Panama.

These problems don’t only plague China’s exports; the same ingredients have led to deaths within China, too. Perhaps we should envision these as growing pains, a result of China’s crash course in modernizing the SFDA and bringing its drug supply under regulation. If anything, that would mark these events as symptoms of the country’s attempt to join the international community.

That reading might be a valid one, given that the toxic ingredient in the cough syrup happened to be diethylene glycol. After all, the Food, Drug and Cosmetic Act was passed in the U.S. in 1938 after the use of diethylene glycol in “Elixir Sulfanilimide” led to the deaths of more than 100 Americans.

Seventy years ago, there was no requirement for tox-tests for drug formulations. The manufacturer’s lab tested for flavor, appearance and smell, but not toxicity. So this elixir shipped, and the death followed. At the time, the agency was simply fortunate that the product was called an “elixir.” According to an FDA article, if it had been called a “solution” instead, “FDA would have had no legal authority to ensure the recovery of the drug and many more people probably would have died.” As it was, agents had to fan out across the country to help in the recall of the elixir. All told, 234 out of 240 gallons of the toxic product were recovered.

Following the diethylene glycol disaster, the FDA was given greater authority to regulate drugs, and evolved into the agency we know today, for better and worse.

Nowadays, we hold congressional hearings about tougher standards for Advisory Committees. Concerned about conflicts of interest, our representatives debate regulations stipulating that no one who is an expert enough about a subject to get paid for it should be responsible for evaluating it. (Hey, it’s my reductio and I’ll ad absurdam if I want to.)

As it turns out, China — and that one-party system of theirs — has also developed new regulations to deter conflicts of interest. In their case, a court recently ordered the execution of the former head of the SFDA.

In May, Zheng Xiaoyu was convicted of taking more than $832,000 in bribes in cash and gifts during his tenure. According to a state newspaper, “Under his watch, six types of medicine approved were fake and pharmaceutical companies got away with using false documents to apply for approvals.” Oh, and an antibiotic produced under not-so-aseptic conditions looks to have killed at least 10 Chinese patients.

The government has already taken the occasion of the sentencing to announce a new food-recall system; we’ll see how it overhauls the drug process. I’m all for creative destruction, but I’m hoping it won’t take too many more of these episodes before we see China adopt some semblance of global standards. I’m not optimistic about this, of course.

Fortunately for Mr. Xiaoyu, if the method of execution is lethal injection, then there’s always a chance he’ll come out of this experience just fine.

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Cause? Effect?

According to ESPN.com, Ricky Williams tested positive for pot again. Obviously, that’s not news. The only reason I’m posting about it is because of this unintentionally funny paragraph from the story:

“Falling off the wagon is part of rehab,” a source said. “Based on the medical evidence in Ricky’s case, the doctors say it’s too early to come back. He had the positive test last month. Remember, he’s been diagnosed with social anxiety disorder — that’s a real disease and a good percentage of those folks self-medicate with substances like marijuana, often at the moment they are about to have a high level of social interaction.”