by Gwen Olsen
and friendship,
He learns to find love in the world.
13
A Betrayal of the Public Trust
“The world is a dangerous place, not because of those who do evil, but because of those who look on and do nothing.”
—Albert Einstein
It is no small coincidence that, before I could even complete or publish this book, the press started reporting on the outrageous conflicts of interest existing between the FDA and the pharmaceutical industry. In recent months, several inside whistle-blowers from the FDA have come forward, exposing the intimidation of investigators who try to alert the public to potential risks affiliated with new drugs. Dr. David Graham, a twenty-year veteran investigator with the FDA, is one such champion. Dr. Graham questions the viability of a regulatory agency funded largely by the industry it regulates and has called the attention of Congress to several new drugs he considers to be potential time bombs.
Most people would be surprised to learn of the close financial ties between the FDA and the pharmaceutical industry. Thanks to the Prescription Drug User Fee Act of 1992, Congress allowed the FDA to collect user’s fees from the pharmaceutical companies to help fund the approval of new drugs. This fee is up to $300,000 for each new drug application.
Before 1992, the FDA had a fairly unfriendly reputation in the industry as being too strict and bogged down by bureaucracy. However, since the introduction of the user’s fees, the FDA has approved an unprecedented number of new drug applications in record speed. In fact, Total Approval Times, the time from the initial submission of a New Drug Application to the issuance of an Approval Letter, was cut from an average of twenty-three months to twelve months. Fast- tracking of priority applications was also cut in half, reduced from an average of twelve months to six months (Strand 36).
This appeared to be the perfect solution for the government. Pressure was mounting from special interest groups such as AIDS and cancer patients, who needed to acquire new drugs, and whose growing numbers startled Americans. It cannot be denied that the accelerated approval process may have saved the lives of thousands of patients desperately in need of these new drugs (Strand 41—42). However, the end result has been that a large number of dangerous chemicals, which in essence were “me too” drugs and provided no major advantages over existing therapies, have been unleashed on an unsuspecting American public without adequate testing and scientific data.
In the FDA approval process, a drug can fail numerous times in clinical trials to show efficacy (to be effective) and still be approved, as long as two or more studies show a statistical superiority over placebo. Drug companies carefully select patients and researchers to improve the probable outcomes of their trials (Breggin, Talking Back to Prozac, 47).
Remember, less than fifty percent of the serious adverse reactions to a new drug are identified by the FDA before its release on the market. The FDA relies largely on post-marketing surveillance to identify all of a new drug’s adverse reactions. Even then, the FDA estimates only one to ten percent of all adverse reactions are reported. Only sixty-five full-time employees work at the FDA’s office of Post-Marketing Drug Risk Assessment, and they monitor the 8,000 plus drugs that are currently on the market. Conversely, more than 1,400 employees staff the approval of new drugs (Strand 74). The result is that the American population has become the largest Phase IV clinical trial population on the planet. The ramifications of this imbalance will not be known in its entirety for some time yet to come.
This gross betrayal of the public trust undermines more than the health of select individuals. It subterfuges the entire health care system and diminishes one’s belief/faith in his or her doctor and the remedies prescribed to heal him or her. If a patient is skeptical to begin with about the doctor’s knowledge and/or motivations or is concerned about the safety of a drug prescribed, then healing is more elusive. After all, the gold standard, placebo comparison in clinical trials exists because the body and mind can heal themselves. This is an accepted fact among medical professionals. There is simply no other way to explain the miraculous recoveries and remissions that occur in some people with the mere suggestion they are receiving treatment. Inactive placebos are sugar pills…nothing more.
(It should be noted that Phase IV clinical trials are largely conducted for marketing purposes as well. For Phase IV trials, the doctors, rather than the patients, are carefully selected by the pharmaceutical manufacturer. Companies want influential doctors to get immediate exposure to their new drugs, so they pay doctors to enroll patients in their practices into Phase IV trials. The incentive paid is usually several hundred dollars per patient. You can see how a monetary incentive like that might sway a doctor to use a new drug rather than an older one for his patient. Quite frankly, the results of these Phase IV trials are rarely conducted under strict clinical guidelines, and most are never reported to the FDA) (Goozner 230, 238).
Follow the Leader
In all of my years working with doctors, I have never met one whom I felt would do intentional harm to a patient. Prescribing habits among physicians are varied (and believe me, poor prescribing is common), but this can be attributed to the fact that doctors receive little, if any, unbiased training about drugs following their residency. Nearly every educational opportunity or event they attend thereafter is funded or provided by the pharmaceutical industry.
Continuing Medical Education (CME) is a huge commercial enterprise. Currently, the Accreditation Council for Continuing Education accredits more than 100 for-profit companies. Medical education service suppliers receive nearly three-quarters of their income from pharmaceutical companies. These companies provide CME formerly available only in academic medical centers and medical schools. The rapid advance of medicine in recent years has forced large numbers of practicing physicians back into the classroom in order to keep up with the times (Kassirer 16).
Pharmaceutical companies eagerly support CME for the marketing opportunities they provide. In 2003, drug companies spent more than $1,500 per year on CME for each doctor in the United States. Their contributions represented seventy percent of all continuing education for doctors (Abramson 119). The CME companies are very savvy and know exactly what it takes to change a practicing physician’s prescribing habits—deference to the recognized experts. In other words, doctors follow their leaders.
Medical education suppliers hire professional experts from either medical academic settings or community thought leaders, also referred to as key opinion leaders (KOLs). It is widely acknowledged that most of the top medical authorities in this country—and virtually all of the top speakers on medical topics—are employed in some capacity by one or more of the country’s pharmaceutical companies (Kassirer 15—19). This is particularly true in the incestuous world of biopsychiatry.
As the press caught wind of the outlandish marketing excesses employed by the pharmaceutical industry in the late 1990s, CME became an even more important marketing tool. All of a sudden, for expense purposes, huge entertainment budgets were now shifting into continuing education. The excesses did not stop. They were just accounted for differently, that is, politically correctly. In 2002, under increasing public scrutiny, Pharmaceutical Research and Manufacturers of America (PhRMA) voluntarily imposed guidelines for permissible, modest offerings. These guidelines are poorly adhered to.
In addition to CME courses, doctors routinely attend medical conferences and other meetings in which pharmaceutical companies sponsor the affiliated symposia. Drug companies pay handsomely to have elaborate displays of their products at these meetings. Doctors meander through the display halls during their breaks, visiting with reps and stuffing large bags full of promotional trinkets and other goodies. It never ceased to amaze me how greedy some of these doctors could be. A particular example that comes to mind was a popular social event that was provided to doctors at medical conferences for years by one of my former employers, Syntex Laboratories. It was called “All Things Chocolate.”
> “All Things Chocolate” was by invitation only and consisted of a banquet hall full of the most decadent chocolate desserts and treats imaginable. Every- thing—chocolate mousse, cookies, ice cream, cheesecakes, and giant, chocolate candy sculptures—was served on dozens of help yourself banquet tables.
As a specialty rep, I was often requested to work conventions and medical conferences. I had been warned about the chaos that “All Things Chocolate” had provoked in the past. My colleagues referenced the event as a feeding frenzy, and I soon found out why.
Doctors and their wives would do anything to sneak into this event, telling elaborate stories to doormen about their lost invitations. Once inside, women would literally open their handbags and scoop handfuls of expensive chocolates and other treats off the tables into them. I witnessed one Indian woman who opened her sari, fashioning it to serve as a tote. With one fell-swoop of her forearm, she took a complete display of Godiva chocolates. Her husband stood by nervously, acting as though he hadn’t seen her. It was outrageous!
On the local level, sales reps also provide funding for journal clubs, staff meetings, grand rounds, and other educational opportunities in hospitals. The rep generally brings food and is given an opportunity to display and promote his or her products in return. There is always a quid pro quo expected in this industry, which, in essence, translates to “you do something for me, and I do something for you.
Several doctors in private practice take advantage of these relationships by requiring reps to see them by appointment only over lunch. This policy routinely provides food and drinks for their staff. Toward the end of my career, I started to exclusively use a catering service because of the sheer number of appointments that required meals to be carried in. Many offices offer both breakfast as well as lunch appointments. I once saw a local employment ad that listed “meals provided by pharmaceutical reps” as a benefit for a medical receptionist position. The competition among different reps is not limited to their drugs either. It would irk me something fierce when office personnel would pit me against other sales reps by saying, “so-and-so brought Olive Garden last week.” in order to drop the name of a major competitor. As a cardiology specialist, I often spent $200+ for a luncheon that might provide me a two-minute opportunity to talk with the doctor. if I was lucky!
“Shadowing” the Opinion Leaders
The sun was just starting to rise as I raced through the parking garage into the hospital operating room (OR). The previous day, I had accompanied one of my cardiologists in the cath lab (where many cardiac procedures are performed) of the same hospital to “shadow” him and learn about the various procedures. This was a popular way for reps to win time and establish rapport with influential specialists that might not see pharmaceutical reps otherwise. For the mere cost of an anatomical heart model ($400), a cardiologist would allow me to spend a half- day or so observing him interact with patients. A cardiovascular surgeon, who was known by all the female reps for his machismo, had stuck his head in to provoke my instructing cardiologist and invited me to come and see a “real doctor at work.” He had given me instructions to meet him the next morning in the OR for an aortic valve replacement.
I was a little apprehensive about how I would handle the whole thing. I don’t have a very strong stomach and have never been able to tolerate even the sight of my own blood without fainting. However, my numerous years of “surgery over lunch” with graphic films depicting bloody procedures had desensitized me somewhat to the blood of others.
The surgical team and anesthesiologist arrived before the surgeon and began prepping the patient for surgery. The elderly woman having the procedure looked frail and frightened as they prepared her for anesthesia. The nurses spoke reassuringly as they inserted her IV line. I was instructed to take my place behind the patient drape with the anesthesiologist, and I was given a stool to stand on so that I could overlook the patient’s chest cavity. As soon as the patient was under, I was struck by the marked change in demeanor among the surgical team. They started laughing and making crude remarks about the old woman’s mastectomy and other physical traits. Under the circumstances, it seemed irreverent. I was grateful when the surgeon finally arrived and the nurses, all in a flutter, broke off their antics.
This was a fascinating educational experience. It was unlike any I have had since. I watched in awe and amazement as the chest of this eighty-four-year-old woman was cut open with a saw and her ribs were pried apart with a spreader in order to access her heart. I stood mesmerized in that position for nearly five hours, just observing this medical miracle.
The surgeon removed material from the woman’s aorta that resembled tooth enamel. I heard it clunk as he dropped it onto the instrument tray for me to view. The doctor openly flirted with me as the hours of the procedure passed by. He would raise his eyebrows suggestively. He would then look up with a wink and a nod each time he instructed the surgical technician to remove blood from the chest cavity by commanding her to “Suck.” So, as soon as the doctor started to close, I hightailed it out of the operating room with the excuse I had a lunch meeting to attend. I wanted to avoid any additional uncomfortable exchanges or comments.
I would always wonder after that just what was being said and done without my knowledge when I was put under with anesthesia. This experience had certainly shaken my confidence in the professionalism of medical personnel. There was seemingly no sanctity in medicine, and no respect for the vulnerable. That saddened me.
Public Service for Maximum Profit
Another way in which pharmaceutical companies manipulate the market is through the support and financial backing of public service campaigns. Many nonprofit organizations that promote lowering cholesterol to reduce cardiovascular risk or inform you about the oppressive symptoms of social anxiety disorder (SAD) (not to be confused with another SAD, seasonal affective disorder) are doing so with funds donated by pharmaceutical manufacturers. Why? Because this type of advertising is highly effective with consumers who feel their best interests and improved health are the motivation behind these campaigns.
However, the truth is, although the nonprofit organization may indeed mean well, pharmaceutical companies are not charities. They are looking for a return on their investment. Overall, these programs are just well-disguised marketing campaigns designed to increase consumer awareness, thereby increasing drug sales for that disease.
The success of the latest marketing ploy of promoting diseases in lieu of drugs is self-evident. A perfect example of this emerged at the start of the psychophar- macological era, when Merck marketed the concept of depression along with amitriptyline “by buying and distributing 50,000 copies of Frank Ayd’s book on recognizing and treating depression in general medical settings” (Healy, The Antidepressant Era, 181). In a similar manner, just as Eli Lilly was poised to launch Zyprexa, the nonprofit, consumer organization known as the National Alliance for the Mentally Ill (NAMI) began a massive campaign to educate the public about the prevalence of untreated mental illness. Booklets, pamphlets and other media were widely distributed to increase consumer awareness. What the public did not know was who was bankrolling this marketing effort and what they stood to gain financially. Reportedly, in a three-and-a-half-year period from 1996 to 1999, NAMI received $11.7 million in funding from drug companies. The largest donor during that time was Eli Lilly, who contributed $2.87 million. Eli Lilly’s support also included an Eli Lilly executive who worked on loan at the NAMI headquarters, but whose salary was paid entirely by Eli Lilly (Levine 2).
Another such example is the 1999 Paxil Public Service Campaign. According to the Diagnostic and Statistical Manual of Mental Disorders—Fourth Edition (DSM IV), social anxiety disorder (SAD) is “an extremely rare condition” (Abramson 163). However, this public awareness campaign sponsored by Glaxo- SmithKline through three different nonprofit organizations—the American Psychiatric Association, Anxiety Disorder Association of America, and Freedom from Fear—helped get the word out about soci
al anxiety and increase Paxil sales by twenty-five percent between 1999 and 2000. The initiative also won the distinction of Best P.R. Program of 1999 awarded by the New York chapter of the Public Relations Society (Abramson 163).
Direct-to-Consumer (DTC) Advertising
On any night of the week, count the number of pharmaceutical ads on television during prime time. Or, open your favorite magazine on any given subject. Count the ads. It is overload to say the least! “Ask your doctor about this…consult with your doctor about that.” Nice, slick Madison Avenue ads feature happy, smiling faces of the medically challenged. What the pharmaceutical companies really mean is they want you to pressure your doctor into giving you their new drug. That way, they can influence his prescribing habits—yet once again—through you. A study conducted by the FDA in 2002 concluded that patients get prescriptions for drugs they requested more than fifty percent of the time. A Prevention magazine study printed in 1999 reported an even higher request rate of nearly eighty percent of the time (Abramson 156).
Now, a study that appeared in the Journal of the American Medical Association on April 27, 2005, documents just how effective DTC advertising is in influencing patients to request particular antidepressants. The authors note that “antidepressant medications consistently rank among the top DTC advertising categories” (Kravitz). The study was designed as a randomized trial using standardized patients. The objective was to ascertain the effects of DTC-related requests on physicians’ treatment decisions in patients diagnosed with depressive symptoms. The 152 doctors that participated were recruited from the San Francisco, California, and Rochelle, New York areas. The patients were middle-aged, white, and nonobese women. Most had professional acting experience. They were trained to present randomly to the doctors’ offices between May 2003 and May 2004, portraying six different roles. The various scenarios included patients telling the doctor they had seen an ad on TV for Paxil and asking for the drug by name. Another might tell their doctor they had seen a show on depression and wondered if medication might be right for them. The researchers chose the SSRI Paxil because it is one of the higher-priced, more widely promoted antidepressant drugs.
