petersenbook

“Our Daily Meds"

Yes, we knew that the pharmaceutical industry has been creating new diseases for at least four decades (recall how menopause became a hormone-deficiency disease curable by taking estrogen for the rest of your life). But the author of Our Daily Meds, a new book by journalist Melody Petersen, shows that one drug company, Pharmacia, was not shy about acknowledging it publicly.

Overactive bladder was created by Pharmacia in the mid-1990s in order to sell its new drug Detrol. (See TV ads with this obnoxious voice-over: “Gotta go, gotta go, gotta go right now.”) Petersen, then a business reporter for The New York Times, describes how she covered the 2003 Pharmaceutical Marketing Global Summit in Philadelphia, where Neil Wolfe, Pharmacia’s vice president, outlined the steps taken to make Detrol into the $3 billion a-year-product it is today. The first slide of his presentation: “Positioning Detrol (Creating a Disease).”

Detrol was initially intended as a treatment for urinary incontinence, but the market for this condition was too small, and a cheap alternative drug was already available. Besides, doctors weren’t keen on prescribing drugs for what was seen as a normal part of aging. Pharmacia’s first step in overcoming these obstacles was to hire doctors judged to be knowledgeable opinion leaders (KOLs) as “consultants,” fly them to medical meetings, including two symposia in London, where they were expected to come to a consensus about the definition and treatment of this new disease called overactive bladder.

While being expensively wined and dined, the doctors heard from other doctors hired by Pharmacia about the “disabling” consequences of having to go to the bathroom more than eight times in a 24-hour period. If any KOLs objected to such an absurd notion, no such comments made it into the dozens of articles that Pharmacia paid to have written for medical and lay publications about the benefits of Detrol, writes Peterson. “And another disease was born.”

After a new disease is identified, the next step is creating buzz in the media. Of course, there’s no story unless the disease is perceived as extremely prevalent. No problem, the necessary statistics are generated by Pharmacia-financed surveys and passed on by a credulous media, including publications that should know better. (Consumer Reports lists Detrol as one of its “Best Medicines for Less 2008” along with this statistic: “overactive bladder affects some 15 to 20 million people in the U.S.”)

The standard formula for disease creation is complete once the drug maker saturates the airways, print media and medical journals with ads for Detrol. (Pfizer took over this role when it bought Pharmacia in 2002.)

Fast forward to the fall-out now that Detrol has been on the market for nearly a decade. New adverse effects have come to light—hallucinations and memory impairment, severe enough to be mistaken for Alzheimer’s disease. Oh, and there’s that question hardly anyone seems to ask (and not addressed in this book): How good is Detrol at reducing the number of trips to the toilet? The 12-week trial that won FDA approval showed that people taking Detrol LA (long-acting) had one less “episode” a week than those taking a placebo. Detrol costs $4 to $6 a day, depending upon where it is purchased.

The story of Detrol is but one of many jaw-dropping nuggets of information from Our Daily Meds. Here are a few more:

-Prescription medicine is one of the leading causes of death in the U.S., estimated to kill 270 people a day.

-Americans spent $197 billion on prescription drugs in 2003—up from $12 billion in 1980.
-It can take a hundred years before all the risks of a medicine are known, said FDA’s Janet Woodcock, in a 2005 presentation to a panel of experts reviewing the safety of the nation’s drugs.
-Once, the most successful pharmaceutical companies were those with the brightest scientists searching for cures. Now the most profitable and powerful drugmakers are those with the most creative and aggressive marketers.

-The pharmaceutical industry spent more on lobbying between 1998 and 2004 than any other industry. It has won new laws that have allowed the companies to profit from medical discoveries made by taxpayer-funded scientists. And when these new measures boosted the drug companies’ profits, other laws gave them tax credits so lucrative that as a group they pay far lower taxes on average than other major industries.

-The public is told that high profits are needed due to the high cost of innovation, but in fact the true cost of developing a new medicine is actually closely guarded secret. What’s more, the industry hasn’t come up with many innovative drugs in the last 20 or so years.

-“Copycat drugs” are the money-makers. It’s much easier to cash in on a competitor’s blockbuster with a “new” drug that is virtually the same, simply by making doctors and consumers think it is better or has fewer annoying side effects.

The most troubling aspect of the industry’s marketing practices is the extent to which they have corrupted medical research. Over the course of the last 25 years, drug companies have been using clinical trials and medical journals to market their products. This trend was described as “the marketing approach to research” by Richard Daly, senior VP , Takeda Pharmaceuticals, at a 2002 breakfast meeting in Manhattan of executives from the largest pharmaceutical companies and advertising companies that work with them. The marketers aren’t working with test tubes and injecting patients, Petersen explained, “Instead they are standing besides the scientists, telling them what studies to do, what research questions to ask, what data to gather.”

Withholding data about serious adverse reactions from drug trials has become so widespread that there’s even a medical term for it—“selective reporting” of trial results, otherwise known as cherry-picking only the results the drug company wants made public. No one knows how many pharmaceutical studies have been kept secret after they showed a drug does not work or caused harms, write Petersen, but several reviews have found that at least 50% of pharmaceutical trials were never published. Thus, a complete picture of a drug’s harms is unknown.

Prescribing physicians can no longer trust the information published in medical journals. And the doctor-patient relationship itself has become severely compromised by drug marketing. It is nearly impossible for most people to know whether their doctors are prescribing on the basis of the best available scientific evidence or the best available marketing scheme.

Petersen put it this way: “The pharmaceutical companies have become so wealthy and powerful that the whole medical system has become unbalanced. Inside hospitals and medical offices, corporate marketers are now calling the shots. They decide how patients will be treated and the doctors follow along. How else can you describe a system where doctors now prescribe a pill called Detrol for a disease called overactive bladder.” .