There is a line from Lilly and FDA in 1991 through to Louis Appleby in 2012 (see Platonic Lies) that runs through Pfizer in 2001.
A few nights poor sleep before meeting Bill Clinton
In November 1998, Victor Motus, a prominent member of the Filipino community in Southern California, had a few nights of poor sleep. He owned an architectural firm, was president of the local school district board and had just launched his campaign for a seat on the Cerritos city council. He was due to go to Washington to receive an award from President Clinton for work done for the local school. With his wife Flora he owned numerous rental properties, an antique store, and held an 80% ownership interest in two restaurants. Even without all this, a few nights of poor sleep were hardly surprising in a 51-year-old man.
When he developed problems sleeping, Flora made an appointment with a general practitioner, Dr Trostler, for her husband to obtain sleeping pills. During the visit, mention was made of financial problems with one of his restaurants, and even though there was no prior medical history to point to depression, and little wrong clinically, educated by companies like Pfizer to think that sleep difficulties commonly pointed to a depressive disorder, and should be treated with antidepressants rather than hypnotics, Trostler gave Victor a sample pack of Zoloft – something unlikely to help his sleep. The Motus’ were told that Zoloft might take several weeks to work.
The drug is making me crazy
Victor took Zoloft as instructed over the next six days. His family later said that for the first day he thought the drug was helping him. By the third day, he told his sister it didn’t suit him, and his wife noticed he was pacing and sleeping even less at night. On the fourth day, he had become shaky. On the fifth day, his birthday, he told Flora “I don’t feel like myself”, “the drug is making me crazy”, and “I want to kill myself”. She urged him to continue taking the drug because the doctor had told them that it might not work for another week.
He was due to fly to Washington the next day, the sixth day of treatment. When his brother arrived to take him to the airport, Victor was not there. He was found in his car several blocks away, dead behind the wheel from a single gun shot to his head.
In 2001, Flora took a legal action alleging that Pfizer
“negligently… failed to adequately warn the medical community, the general public and (her husband)… of the dangers, contraindications and side effects… of Zoloft.”
Troy & horse
Malcolm Wheeler, the lead attorney for Pfizer, had previously come up with the idea that Matt Miller had died from auto-erotic asphyxiation (see Notes on a scandal). On this occasion he contacted the new Chief Counsel of the FDA, Daniel Troy. Troy had joined the Department of Justice the year before, from a legal office that had done over $358,000 worth of business with Pfizer that year. Troy filed an Amicus brief in the Motus case. In order to file such a brief, he had to have clearance from the Solicitor General in the Bush government, Paul Clements, a former partner in King & Spalding, the main law firm representing GlaxoSmithKline, who were also faced with a series of suicide cases involving Paxil.
Troy’s brief argued that the California court had no jurisdiction in the case. FDA is responsible for the labeling of drugs and if Pfizer had warned the drug could cause people to become suicidal it would have broken the law. Troy was firing a shot across the court’s bow to ensure it did not do anything that would “undermine the agency’s authority to protect the public health”.
Warnings would frustrate the purpose of Federal regulation
When considering warnings, according to Troy, FDA has to take into account the risks posed by the untreated illness – depression.
“Under-utilization of a drug based on dissemination of scientifically unsubstantiated warnings, so as to deprive patients of beneficial, possibly life saving treatment could well frustrate the purpose of federal regulation”.
This was an extraordinary and unprecedented move. This was not the conventional company argument that juries cannot decide on the science of an issue such as whether a drug might cause suicide. Troy was arguing that this case was not about whether Pfizer should warn but about whether FDA gets to decide who lives and who dies and a jury had no place in such a case. The company could not be prosecuted provided it had followed the directives FDA had given it, regardless of whatever effect the drug had or had not on Victor Motus and even though federal law obliges companies to warn if there are hints of a problem – not just on the basis of proof of a problem.
If pharma made cars
The idea of using a federal agency to pre-empt legal action in a state court was Malcolm Wheeler’s brain child. He had used it first when defending the Honda Motor Company in a 1980 case in which a plaintiff argued the company should have installed airbags, even though federal regulations didn’t at the time require them. This case went all the way to the Supreme Court who, noting that the car contained many other safety features such as seat-belts, sided with Honda.
In the case of cars and butter, it is not the job of the regulator to even begin to think about whether people should be driving cars or using butter. In the Motus case, however, the argument from Pfizer was that the FDA should be not only thinking about whether drugs should be used but attempt to ensure that they would be, and that in this light, warnings might put a chill on this use. This opens up an extraordinary vista.
When I turn the ignition key to start a car, wires have to connect to a starter motor and there has to be a flow of both oxygen and gasoline for the act of driving to become possible. For a physician to practice medicine, having a drug that works is helpful but often not essential. From time immemorial, good medical practice has been held to be much more likely where there is detailed knowledge about the hazards of any drug used. Semi-automatic prescriptions have never been regarded as good practice.
In arguing about the merits of safety warnings, Wheeler and Troy portrayed the issue as being the equivalent of having airbags in a car, when in fact they are arguing against a need to have the ignition wires properly connected to the starter motor, or letting people know that, in some instances, the ignition wires might default to the petrol tank (an instance of immediate-onset side effects), or, in a case of later-onset adverse effects, faulty brake linings that would give way after 6 months. Safe starting connections and functioning brakes have never been optional extras to a car in the way airbags once were; they’re integral to its basic operation.
All of the major pharmaceutical companies made use of this “pre-emption” argument to get hundreds of cases against them thrown out between 2001 and 2009. Given the origins of the defense, this was very much a case of auto-asphyxiation of medical care. And curiously appropriate that it originated with the man prepared to run an auto-erotic asphyxiation defense in the case involving the suicide of a 13 year old boy (see Notes on a Scandal). The Supreme Court finally rejected the argument in 2009 – see Pharmageddon.
A perpetrator-less crime
Pfizer in fact got the Motus case thrown out on the basis of the prescription-only status of Zoloft. In a pre-trial deposition, Dr Trostler testified that no matter what the warnings were on Zoloft, he would have gone ahead and prescribed it anyway. If a doctor testifies in this way, any case against a pharmaceutical company on the basis of failure to warn about the risks of a prescription drug collapses. Victor Motus, like almost everyone who dies unnecessarily on a prescription only medicine, was the victim of a perpetrator-less crime.
The service that pharmaceutical companies get from doctors goes well beyond what other industries get from their doctors. Not only can companies depend on doctors not to rock the boat, but they can palm any legal responsibility for injuries caused by exposure to chemicals on to the doctors who do the prescribing. Complain about or investigate a problem and the doctor knows he is in for a rough ride from the company and his colleagues. But faced with a problem that turns up later, the company gets off Scott free because the doctors refuse to accept that the chemicals have caused the problem – or like Louis Appleby justify it on the basis of all the other lives they are saving.