DRUG BUST Alan Cassels

It is time the nation woke up and realized that it’s not the armed robbers or drug dealers who cause the most economic harm; it’s the white collar criminals living in the most expensive homes who have the most impressive resumés who harm us the most.
– Harry Markopolos

AN OLD SAW in investing states that if something sounds too good to be true, it probably is. Had it been taken, that advice would certainly have helped those investors who, eager for quick and substantial profits, shovelled their money to Bernard Madoff. With as much as $65 billion US having been flushed away through Madoff’s infamous chicanery – the biggest Ponzi scheme apparently ever foisted on the public – his fame was secured not by the uniqueness of the scheme, but by its size.

Yet compared to the $900 billion generated annually from prescription drug consumption globally – an empire built on confidence, belief, trust and not a little bit of hubris – Madoff’s Ponzi scheme looks like a mere schoolboy’s trick.

You see, the same sort of confidence that kept the investors flocking to Madoff is at work keeping people returning to a healthcare system where the alleged highest returns seem to be generated from people ingesting pharmaceuticals. Let’s face it; the claims you hear in drug ads promising simple, chemical cures for profound illnesses are more often than not too good to be true.

A Ponzi scheme pays investors not from any real profit, but with the contributions of previous investors. By pointing to incredible rates of return, Madoff’s scheme was able to entice more and more investors (even some famous ones who should have known better) to give him their money. Essentially, as long as people believe in the scheme and news spreads of the wonderful returns (to attract new investors), the scheme can last forever – or at least until the shell game is revealed and the whole enterprise collapses. The prescription drug world is buoyed by a Madoff-style belief system that underpins much of what is keeping this Ponziceutical scheme afloat.

I consulted an expert on these affairs. Harriet is a professor of social science at York University in Toronto and an anthropologist with a shrewd inside take on the Ponziceutical business. Along with Danielle Allard, she is co-author of the paper Evidence for Caution: Women and Statin Use, which, in my estimation, offers some of the best, current information about cholesterol-lowering drugs. While Rosenberg is currently writing a paper on Ponziceuticals, she points to David Lee, a graduate student in communications at the University of South Florida, as being the first person to coin the term. Excerpts from our conversation follow:

Alan Cassels: What is it about the term “Ponziceutical” that captured your imagination?

Harriet Rosenberg: The idea is that there is a willingness to believe in something too good to be true. In terms of what’s happening in the economy, I started watching how the messaging system works, reading about Ponzi schemes and Madoff. I noticed the language of economic meltdown, the discussions of “toxic assets,” the “health” of the economy and so on. There are many parallels to healthcare. You don’t want to overstate things, but the language around the economic meltdown provides a compelling perspective on how to view the pharmaceutical industry.

AC: What led you to make these parallels?

HR: My main interest stems from the research I have done on cholesterol-lowering drugs. You need to know about what happened with Vytorin. This is a newer cholesterol-lowering drug that combines simvastatin and ezetimibe and it was exceptionally effective in lowering cholesterol. It was widely prescribed in the US. It was studied in a trial called the “Enhance Trial” to see if it could stop plaque from expanding in arteries, but the trial results were mysteriously delayed for 18 months causing somewhat of an uproar. Basically, they eventually found that the plaque regression was not statistically significant.

AC. They basically proved the drug didn’t work. What happened next?

HR: Carrie Smith Cox, CEO of Schering-Plough, which made Vytorin, is alleged to have dumped 900,000 of her company’s shares, worth $28 million, before the results were published.

AC: Like what happens in a real Ponzi scheme, she got out right before the trick was up, right? Ponziceutical indeed.

HR: Yes and this led to a congressional investigation and a lot of discussion about insider trading. Is this not an example of where the two discourses intersect?

AC: You mean, she would have been hyping the asset, like confidence men such as Ponzi or Madoff, but then got out when the going was good?

HR. And consider this: the recent purchase of Wyeth, one of the world’s largest drug companies, by Pfizer, the world’s largest drug company, is significant because the $22 billion needed to do this deal is in part coming from the very financial institutions being bailed out by federal money – taxpayer money, that is. So what are the implications here?

AC: Now you’ve written about the cholesterol-statin hypothesis, discussing the weak evidence base, aggressive marketing and inattention to harm when prescribing statins to women. Would I overstate things if I said your hypothesis that lowering cholesterol with drugs is a massive Ponzi scheme?

HR: Lately, there has been lots of public questioning of the cholesterol hypothesis and it’s clear that the edifice is starting to crumble. There is a paradigm shift underway. Maybe it started with the January 2008 cover story in Business Week and a long article that said that cholesterol drugs weren’t doing any good for most people who did not have heart disease. Recently, Matthew Herper at Forbes magazine pointed out that the “cholesterol hypothesis” is being contested by the inflammation hypothesis.

AC: What do you mean?

HR: The newest cholesterol drug on the market, AstraZeneca’s Crestor, does lower cholesterol, but it is being positioned as being effective for its anti-inflammatory properties. In my mind, there are lots of ways that pharma marketization of bio-medicine looks like Ponziceuticaliztion. This is characterized by market expansion driven by fear mongering and an endless increasing of primary prevention targets. The recent JUPITER trial essentially said that healthy people should be taking statins if they have high CRP (c-reactive protein) and all of these things are feeding the need for relentless system growth. The conflicts of interest in that trial are often ignored by the press. This is an industry-sponsored trial and the lead investigator has a patent on the CRP test.

In addition, the benefit is very modest but was described in extravagant boosterish language and the risks have not been sufficiently aired. It would take 243 people to be treated by this drug to prevent one heart attack. Yet for every 167 exposed to the drug, there would be one new case of diabetes. Wouldn’t diet, exercise and quitting smoking be a better option?

AC: But new uses for drugs means even more capital entering the pharma system. Does that not seem to add weight to the Ponziceutical hypothesis?

HR: Yes and there is this incremental sense that everything is fine. A Ponzi scheme is a confidence game and part of that confidence is to assume that the industry and regulators are looking after you. Terence Young’s new book, Death by Prescription, talks about his daughter who died at 15 from taking Prepulsid, a popular heartburn drug. He poignantly illustrates that caution and protection are no longer high priorities of our regulators.

AC: Do we have enough people who can see behind the hype and who can expose wrongdoing?

HR: In the case of Bernard Madoff, there was this one guy Harry Markopolos who did the math and said what Madoff was selling was actually too good to be true. He kept going to the SEC saying something is wrong here. Nobody would listen to him. Everyone wants to believe in the structure. Terence Young is like Markopolos – documenting the harm that comes from aggressive marketing, overstating benefits and failing to make harms of drugs understood by patients. These whistleblowers are exposing compromised regulatory systems like Health Canada and the FDA in the US – agencies that are in terrible conflicts of interests because they depend on industry user fees. There is the comparable experience of under-regulation despite warning after warning and the cumulative moral compromises that have allowed the system to reproduce. There is the confidence racket nature of it all, taking advantage of the aura of legitimacy to make excessive benefit claims without risk seem plausible, inevitable, natural.

AC: Will something burst the bubble of the pharmaceutical business?

HR: It’s hard to know because what’s interesting in the way the bubble burst with the financial meltdown is that nobody seemingly knew it was going to burst. None of the pundits predicted it. Where was the business press? And now, where is the health press? Why aren’t reporters looking more deeply into this? Are they cheerleaders or are they asking the hard questions?

AC: Just like with the financial system, people are harmed by undersight. Is the potential harm of drugs getting the attention it deserves?

HR: Not at all. Look, we have a system in Canada that captures less than 10 percent of the population’s experience with Adverse Drug Reactions. When you don’t make collecting drug safety data a priority, you add measurably to the idea that drugs must be safe. And you get a situation like Terence Young’s where a non-essential heartburn drug is found to cause deaths, but it is not immediately removed from the market. We need vigilant, proactive oversight for pharmaceutical drugs and medical devices to protect us from the very real “Toxic Assets” that these products are and to protect us from the confidence schemes that now dominate.

AC: Amen to that.

Alan Cassels is a drug policy researcher at the University of Victoria and author of The ABCs of Disease Mongering: An epidemic in 26 Letters. For a further dose of skepticism, he recommends MP Terence Young’s new book Death by Prescription: A Father Takes on his Daughter’s Killer – The Multi-Billion-Dollar Pharmaceutical Industry. The book details Young’s battle with Big Pharma after the death of his daughter Vanessa due to a prescription drug. A federal Conservative, Young is currently introducing a motion in the House of Commons to create an independent drug safety agency in Canada

cassels@uivic.ca