Weekend Reading

I’ve been trying of late to get a grip on the huge American pharmaceutical business, without much success. It’s very big and the machinations and maneuverings and political intrigue involved in bringing a drug to market overwhelm me. But here is what I have gleaned so far:

The FDA is largely compromised these days, and has given into pharmaceutical demands for streamlined drug approval at the expense of safety and efficacy.

Drug testing is largely done under the control of the companies that produce the drugs. They are held to low standards, having only to show that new drugs are better than a placebo, and are not tested against existing drugs that are often cheaper and more effective.

The heart of big pharma is the TV ads they run, which they use to push their worst products – the ones that do little and cost much. Only the United States and New Zealand allow such advertising, and doctors, who are marketed to separately on the other end, are very susceptible to it.

Much of what passes for new drugs on the market are actually “me too” drugs that imitate other drugs. Other drugs that come to market are actually given to us in response to conditions created by the drug manufacturers to create a market for their product. (“Acid reflux syndrome” (heartburn) is one.) Drug manufacturers are not very interested in finding remedies for non-chronic conditions or for things that afflict only a few hundred thousand people (for which they have to be subsidized.) Widespread and deadly diseases, like malaria, are low priority because the people that get these diseases are poor and cannot afford expensive treatments.

Much of what is patented or licensed for exclusive marketing are merely cosmetic changes in dosage or color and shape of existing drugs to extend their patents. Pharmaceuticals spend billions of dollars in court cases to keep generic drugs off the market and even more in research to make non-substantive changes to medications.

Drug companies spend far more money marketing their products than they do on research and development. Most research is done by the National Institute of Health (NIH) and on campuses and universities. Breakthroughs usually come from that source and small startups, and are then bought up by the big pharmaceutical companies, who pay small royalties in return for the right to market these products. There’s very little new coming down the pipeline, and precious little of that from the big companies. That’s not what they are about.

Drug companies are the most powerful lobby in Washington, and can virtually write their own ticket, as they did with Medicare D, in which legislators like our Senator Max Baucus were convinced that Medicare should not be able to bargain with drug companies to lower prices. Baucus still stands by that ludicrous proposition.

So powerful is the pharmaceutical lobby that the simplest of laws, such as allowing reimportation of cheaper drugs from abroad to lower prices here, cannot be passed.

The following link is to an interview done by Jake Whitney of Guernica Magazine with Dr. Peter Rost, a whistleblower who once worked for Pfizer and has since attempted to make his career as author and expert witness. He runs a website that focuses on pharmaceutical issues, but also has a wide variety of interesting subjects.

Here are a few quotes from the interview:

Guernica: You’ve described the pharmaceutical industry as mob-like. What did you mean by that?

Peter Rost: It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry—which has been proven in different cases. You could go though a 10-point list discussing similarities between the two. The difference is, all these people in the drug industry look upon themselves—well, I’d say 99 percent, anyway—look upon themselves as law-abiding citizens, not as citizens who would ever rob a bank. Not as citizens who would ever go out and shoplift. And the individuals who run these companies would probably not do such things. However, when they get together as a group and manage these corporations, something seems to happen. Just look at all of these billion-dollar fines—Schering Plough, I think is in the lead now with $1.2 or $1.3 billion in fines; and number two is Bristol-Myers Squibb. It’s pretty scary that they’re committing crimes that cause [the government] to levy those enormous amounts of fines against them. So there’s something that happens to otherwise good citizens when they are part of a corporation. It’s almost like when you have war atrocities; people do things they don’t think they’re capable of. When you’re in a group, people can do things they otherwise wouldn’t, because the group can validate what you’re doing as okay.

Guernica: You said one similarity between the drug industry and the mob was that in both the side effects are “killings and deaths.” As that pertains to the drug industry, I’m assuming you mean in unintentional deaths resulting from unforeseen side effects—unlike the mob, which intentionally kills people.

Peter Rost: Clearly, the drug industry doesn’t want to kill people. But at the same time, I’m not sure if it’s always completely unintentional. Yeah, they don’t want to kill people because it’s bad for business, right. But if you look at a number of these cases where people inside the company knew they had problems. If you look at Merck with Vioxx, for example; if you look at Bayer and the lipid-lowering drug they had that caused liver failure, Baycol. Those guys knew that these drugs were causing major problems. And they knew these problems resulted in serious side effects, including death. Yet they kept on selling the drugs. So is that intentional or not?

Guernica: In your 2007 book, Killer Drug, you have a character named Torrance who’s the head of security at a fictional drug company called Xenal. Torrance is an extremely shady character who won’t hesitate to murder enemies of the company. The book is a novel, of course, but did you come across anyone in your career who gave you the feeling that he could possibly act like Torrance?

Peter Rost: The book is fiction. But it is using some of what I’ve seen and experienced, and taking some of the different people and putting them in a thriller environment. I’m not aware of individuals conducting themselves the way Torrance does. At the same time, I am aware that the kind of background he has is very common in the drug industry for someone who is heading up security. Pfizer has a former FBI agent, John Theriault, heading up its security department. And he has lots of law enforcement officers working under him. We have to recognize that these big companies are all building small paramilitary organizations inside the companies that answer to no one except the company itself. Look at Hewlett Packard, how they abused security consultants by getting phone records and information about journalists… and you know we only know a tiny fraction about what really happens—we only find out when these companies happen to get caught. It shows that there aren’t really any limits to what big companies—in the drug industry and others—will do.

It’s an interesting interview if you have time and interest. Discouraging for me was Rost’s statement that he doesn’t think there will be any significant change in the U.S. health care system for thirty or fifty years, since so many people from doctors to pharmas to lawyers to insurance companies are making gadzillions of dollars on it. Do you think that a Democratic Administration will change things? Think again. As Rost notes, Pfizer’s new CEO Jeff Kindler and the incoming stream of executive appointments are all Democrats. As Dr. Alan Grant said of the velociraptors and Captain Jean-luc Pecard of the Borg, “they’re adapting”.