Cracked (16 page)

It appears that when companies research their own products, one way or another they get—or perhaps simply choose to publish—results from which the company stands to benefit. The financial rewards of moving the goalposts, it seems, makes the temptation of doing so perhaps too strong to resist.

5

How does moving the goalposts garner huge financial rewards? The previous editor of the
British Medical Journal
makes it clear that publishing a positive article in a reputable journal is the most effective form of advertising a company can get:

A large trial published in a major journal has the journal's stamp of approval … will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favorable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution. The doctors receiving the reprints may not read them, but they will be impressed by the name of the journal from which they come. The quality of the journal will bless the quality of the drug.

Publishing a positive article in a reputable journal is therefore paramount. But if journal editors know this, why aren't they being more vigilant? After all, the articles discussed above were all published in distinguished medical journals. Smith defends the editors by arguing that, given the growing finesse of company tactics, it's becoming increasingly difficult for editors to spot whether they are “peer-reviewing one piece of a gigantic and clever marketing jigsaw.” Furthermore, Smith also admits there are many financial pressures bearing down on editors to publish companies' trials:

Publishers know that pharmaceutical companies will often purchase thousands of dollars' worth of reprints, and the profit margin on reprints is likely to be 70%. Editors, too, know that publishing such studies is highly profitable, and editors are increasingly responsible for the budgets of their journals and for producing a profit for the owners. Many owners—including academic societies—depend on profits from their journals. An editor may thus face a frighteningly stark conflict of interest: publish a trial that will bring US$100,000 of profit or meet the end-of-year budget by firing an editor.
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In other words, if companies were nonprofits, and if journal editors didn't have to rely upon pharmaceutical revenues for their subsistence, we might well see these dubious research practices disappearing overnight. But these, right now, are just fantastic conditionals. Even in Britain, where treatment is free at the point of delivery, companies are set to make vast profits each year when the right articles appear in the right journals. Companies are very successful at making this happen, since nearly all published psychiatric drug research is in someway industry-funded. Admittedly, psychiatrists still participate in much of this research, but that is no guarantee of its quality.

As the previous editor of the
New England Journal of Medicine
put it, increasingly doctors are used like hired hands, just supplying the patients, collecting the data, and endowing the published reports with their prestigious names and university associations. Most companies now prefer their own employees to design the studies, perform the analyses, write the papers, and decide whether and in what form to publish the results. That way the companies retain control, and therefore make use of the many subtle strategies by which their products can be cast in the best light.
116

Money, then, is at the heart of the issue. It galvanizes companies to find ever more ingenious ways to sell up their pills, it can dull editors' critical sense by the promise of high journal sales, and it can be used to win psychiatric endorsement of a pill, should the price be right.

So let's now focus on this final point. Have psychiatrists been co-opted into supporting the pharmaceutical mega-marketing machine? And if so, in what ways have companies used their financial clout to win psychiatric support for their products?

Before I address this important question, it is only fair I first warn you that if you suffer from high blood pressure, you should probably consult a doctor before reading on.

BUT THEY MAKE US RICH

T
wo days after interviewing Robert Spitzer in Princeton, it was time to make my way to Washington, DC. With each mile I traveled southward, the temperature seemed to rise a corresponding notch on the thermometer. Being in Washington was uncomfortably reminiscent of parboiling in the steam room of my local gym, so I spent my first morning in a local coffee shop, writing, reading, dealing with e-mails, while periodically asking the perspiring staff to please, please turn the air conditioner up.

Once eleven o'clock struck, I puffed my way along Pennsylvania Avenue, so tightly wrapped up in a jacket and tie that I nearly missed the United States Capitol rising up before me like an ancient seventh wonder. That was my cue to turn right down Second Avenue, past the Library of Congress, the Supreme Court, and toward my destination: Hart Senate Building.

The Hart Senate Building is famous for at least four reasons. It's a Senate office building (number one). It's the largest Senate office building (number two). It's where Barack Obama's office was located before he was upgraded (number three). The final reason is hinted at by a wall of JFK-like security booths confronting you as you enter. The building had been on high alert ever since an envelope full of anthrax was posted to Senator Tom Daschle's mailbox in 2001. The whole place had been closed for an entire month while they decontaminated every inch of the place with powerful chlorine gas (number four).

Once I passed through security, I still had twenty minutes remaining before my interview. So I made my way to the vast central indoor courtyard, whose glass-topped atrium vaults an impressive ninety feet into the air, flooding natural light into the corridors and offices below. While sitting there it became clear to me: It was hopeless to pretend I fitted in. My suit was too shabby, my hair too long, and I didn't have a BlackBerry. Senators and their aides were gliding everywhere, literally dripping with technology, with suits so well-tailored and hair so neatly cropped that they looked as slick and polished as the shiny marble floors. What on earth was I, therefore, doing at the US Senate?

Simply put, I was there to find out more about a malady afflicting most of medicine today, but especially psychiatry. It relates to the fact that pharmaceutical companies are paying physicians for a variety of different reasons, and not all these payments are transparent. The issue is so important because although many years ago psychiatrists did not have extensive financial links with the pharmaceutical industry, in the last twenty years the industry has become a major financial sponsor of psychiatry both in Britain and the United States, having unprecedented influence over psychiatric practice and research.

The facts are telling: Many heads of psychiatry departments now receive departmental income from drug companies, while at the same time receiving personal income.
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Also, nearly all research into psychiatric drugs—antidepressants, neuroleptics, tranquilizers—is now pharmaceutically financed (e.g., nearly 90 percent of all clinical trials in the UK are conducted or commissioned by the industry
118
). Furthermore, most consultants and academic drug researchers now also receive research funding, consultancy fees, and honoraria from the industry—a fact graphically illustrated by how many members of the
DSM-IV
and
DSM-5
committees have strong financial ties to the drug industry.

A recent study from the University of Massachusetts, for example, worryingly showed that of the 170 panel members of
DSM-IV
, a full ninety-five members (56 percent) had one or more financial associations with the pharmaceutical industry.
119
And for the diagnostic categories for which drugs are far and away the first-line form of treatment (such as for the “mood disorders,” “eating disorders,” “psychotic disorders,” and “anxiety disorders”) an average of 88 percent of all
DSM-IV
panel members had drug-company financial ties.

This trend has continued with the writers of the new edition,
DSM-5
(due May 2013). Of the twenty-nine taskforce members writing the manual, a full twenty-one have received honoraria, consultancy fees, or funding from pharmaceutical companies, including the chair of the taskforce, Dr. David Kupfer, and the vice chair, Dr. Darrel Regier.
120
As Spitzer said to me in an interview almost apologetically, “Today it is very difficult to find somebody or a large number of people who have not had some pharmaceutical support.”

So the question that brought me to Washington is one that should concern us all: Are these financial entanglements corroding the independence of the psychiatric profession itself?

2

The person I wanted to help me answer this question was Senator Chuck Grassley, a senior member of Congress who supports intensified regulation of the mental health industry. His story is compelling. He began life as a farmer in Iowa, never intending to reach high political office. But once his local reputation spread as a spokesperson for “the ordinary struggles of ordinary folks,” he was drawn into local politics, then into state politics, before securing a place in Congress. He has now been a senator for over thirty-two years and is still a man with a mission: the moral reform of corporate America.

His reputation in Washington for countering corruption is so solid that the US Justice Department now refers to him as the “federal government's best weapon against fraud.” Little has escaped his attention: corrupt tax practices, lax regulation of government agencies, the financial irregularities of corporate elites, and, more pertinent for us, the misdemeanors of psychiatry.

I was excited to meet Grassley. His communications director, Jill Kozeny, welcomed me warmly and led me rather ceremoniously down a long corridor toward his office. Jill gave a gentle tap on the senator's door before gently pushing it open. Senator Grassley was poised ready in the middle of the room—tall, lean, senatorial, commanding. He strode toward me confidently, and with a handshake like a quarterback's boomed with a smile, “So you're from England, huh? Well, come on in then, take a seat, we've got a bit of time.”

I was becoming accustomed to grand offices. Grassley's didn't disappoint. The seating area to the right was comprised of antique chairs and elegant Chesterfield sofas, all encircling a large, mahogany coffee table. To the left rested an intimidatingly large writing desk, flanked ceremoniously by flags—the Stars and Stripes on one side, the flag of Iowa on the other. Against the wall behind me were rows of dark, wood cabinets filled with books and federal files, and directly opposite the door warmly ticked a grandfather clock atop the soft, maroon carpet. The office seemed more like a museum exhibit than a place of work, and I struggled to appear nonchalant despite an incredible urge to take a picture.

It was clear that Senator Grassley and I would not be alone. The communications director and a senior assistant, who were busily arranging various folders and notebooks as we sat down, would join us. These assistants, as I would later discover, would be very much part of our meeting—fact-checking, jumping in with additional information, and sometimes qualifying what Grassley said.

What I wanted to know first was how Grassley became interested in the relationship between psychiatry and the pharmaceutical industry. So once a few preliminary pleasantries were past, I put the question directly to him.

“I was chairman of the finance committee here in Washington,” answered Grassley coolly, “and this committee pays for all of the Medicare and Medicaid medicines in the US. This gave us jurisdiction over the Food and Drug Administration [the FDA], which is the agency responsible for ensuring that prescription drugs are efficacious and safe for the public to use.”

Grassley's relationship with the FDA was initially smooth, until one rainy afternoon a whistle-blower from the agency entered his office with a barrage of disturbing revelations. “We learned that the scientific and regulatory processes within the FDA weren't working properly,” said Grassley with a growl. “They were being compromised by a lot of people at the FDA who had too close a relationship with the pharmaceutical companies. The FDA was approving drugs for public use which some in-house scientists knew were dangerous. And when these scientists tried to speak out, the FDA put enormous pressure on them to shut up.”

Just in case you have forgotten, we encountered the FDA back in chapter 4. Like its equivalent in Britain (the MHRA), it's the organization that merely requires a company to show in just two clinical trials that their antidepressant is more effective than a placebo. If this can be shown, then no matter how many negative studies there have been, the drug will be approved for public use.

But this issue of “discarding the negatives” was not the problem Grassley was now referring to. He was, rather, alluding to a scandal concerning a drug called Vioxx made by the pharmaceutical giant Merck. The scandal unfolded in this way: A scientist at the FDA called David Graham decided to go public about how the agency had ignored warnings that Vioxx was killing people by causing heart attacks and strokes (as many as 140,000 heart attacks, according to Graham). Furthermore, even before Vioxx was sent to the FDA for approval, it was clear there were questions at Merck about the drug's safety. Graham's point was that not only should the FDA have never approved the drug for public use, but that Merck should never have even submitted the drug for approval. Once Grassley got wind of these problems, his suspicion of the dealings at the FDA was ignited—a suspicion that has in no way abated.

“Whenever I get the heads of the FDA in here,” said Grassley, leaning forward intently, “I ask them all the time whether things have been put right. Every one of them sits there and promises that things are going to be changed. But we never really know until there is another scandal.” Grassley then paused momentarily, as if recalling something important. “Actually, I don't know if we've had any recent scandals or not.”

“We do!” supplied one of Grassley's spritely assistants. “There was another group of FDA whistle-blowers that had come to see Senator Grassley. The FDA got wind of it, so they hacked into these scientists' personal e-mail accounts to monitor the discussions they were having with Senator Grassley.”

“And that reminds me,” boomed Grassley, banging the chair with his fist, “we are going to get the FDA director in here to pursue that, right? Because they aren't even answering our mail yet. So what have they got to cover up?”

These struggles with the FDA led Grassley to turn his attention more specifically to the doctors themselves, especially those who work as academic researchers within universities. This group is crucial to the pharmaceutical industry because they have the power and influence to alter the opinions and prescribing habits of the wider community of practitioners. When a university professor or leader in the field speaks up on behalf of a drug, other doctors listen. And this is why companies actively and aggressively recruit their services: doctors simply trust them more than they do company reps.

The companies themselves even have a term for these influential doctors: KOLs (Key Opinion Leaders). But given the potential conflicts of interest involved in being both a psychiatrist and a KOL, psychiatrists who work in universities are expected to report any income they receive from pharmaceutical companies for research, speaker's fees, or work on advisory panels. Grassley was interested in whether this reporting system was working within the universities. Were doctors accurately reporting their industry income? He undertook an investigation to find out.

What Grassley first discovered was that when financial disclosures were being made, they were usually kept secret. As he put it in a speech delivered to the Senate floor in 2007: “If there is a doctor getting thousands of dollars from a drug company—payments that might be affecting his or her objectivity—the only people outside the pharmaceutical industry who will probably ever know about this are the people at that very university.”

A further and more serious problem he encountered was that the universities were terrible at keeping track of who was being paid what. “The reason why the universities weren't checking things,” said Grassley to me heatedly, “was because the National Institute of Health wasn't paying much attention to how the universities were conducting their affairs. This meant that the only people who knew whether the reported income was accurate or not were the actual doctors receiving the money.”

This problem first became apparent after Grassley sent a letter to the University of Cincinnati asking about how much money the drug companies had been paying to one of its psychiatrists, Dr. Melissa DelBello. Grassley had become interested in DelBello ever since her work on bipolar disorder in adolescents had been discussed in the
New York Times
. Her study, which was funded by pharmaceutical company AstraZeneca, showed that Seroquel (yes, Seroquel again) was particularly effective for treating bipolar disorder in children. This study, which helped put Seroquel on the map, led to DelBello being hired by the company to deliver promotional talks to other psychiatrists about the virtues of the drug. When Delbello was asked by a reporter at the
New York Times
how much she'd received for this promotional work, she replied curtly, “Trust me, I don't make much.”

But Grassley wanted to know
how
much. So he contacted her university to find out. The university disclosed that a year after DelBello's influential study was published, AstraZeneca paid her over $100,000 for lectures, consultancy fees, travel expenses, and service on advisory boards. In the year after that, she received a further $80,000 for the same services. In subsequent years (between 2005 and 2007) DelBello was also paid a further $238,000 by AstraZeneca. The problem was that for that same period she had only reported earnings of $100,000 to her university. As DelBello had not been reporting her industry income accurately, were other doctors doing the same? Grassley cast his net further to find out.