Problems abound with Eli Lilly’s Strattera
Posted by
Armand RossettiJanuary 30, 2009 11:27 AM
Strattera is the first non-stimulant drug, which the FDA has approved for use in treating Attention Deficit Hyperactivity Disorder (ADHD), and at first glance, that might have been a good thing.
Because, for years, the FDA has ignored evidence that predecessor stimulant drugs used for treating ADHD have been problematic. During those years of seeming FDA complacence, pharmaceutical companies accumulated huge profits by pushing stimulant pills to kids, and for different reasons, to adults as well.
The term “pushing” is a bit sharp, but not totally unwarranted. Because, it is no secret that street side pill peddlers have been selling the same drugs for the past 50 years; i.e., those compounds found in stimulant pills called yellow jackets, uppers, black beauties, and bennies.
Those dangerous and often abused compounds were once the legal diet pills of the 1960s and 1970s. Truckers used them to stay awake. Party goers used them to remain alert to party for days. The same ingredients comprised the weekly “B-12” injections that wealthy patients received; that is, until those injections were banned.
Despite concern for safety, those once prescribed street abused pills did not disappear. Instead, they emerged as prescription stimulants with new identities, for treating millions of children in the United States with Attention Deficit Hyperactivity Disorder (ADHD).
Doctors have been prescribing the following drugs (identified by brand and generic names) for years to children for treating ADHD:
· Methylphenidate (generic Ritalin);
· Ritalin (brand name);
· Amphetamine/dextroamphetamine (generic Adderall);
· Adderall (brand name); and
· Concerta
Consumers taking any of these may suffer one or more of the side effects listed below:
· fast, pounding, or uneven heartbeats;
· feeling like you might pass out;
· fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
· aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
· easy bruising, purple spots on your skin; or
· Dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Because Strattera is not a stimulant, the FDA may have been less critical in 2002, when it approved that drug as being a safe and effective drug for treating ADHD.
Leading up to approval and as part of the FDA approval process, Eli Lilly (Lilly) conducted six placebo-controlled clinical studies over two and one half years. Purportedly, Lilly demonstrated Strattera’s effectiveness in treating children, adolescents and adults with ADHD (stimulant drugs were not effective for treating adults suffering with ADHD). And the Lilly studies prompted the FDA to approve Strattera for use in treating ADHD
While Lilly did obtain FDA clearance to market Strattera in the United States, the pharmaceutical company did not have permission to distribute Strattera in Sweden. Therefore, Lilly had to conduct expensive studies before receiving the go ahead from Sweden to market Strattera.
According to one report, Lilly conducted a preliminary Swedish study and it failed miserably. Before the “disastrous” Swedish study began, the Medical Products Agency in Sweden (MPA) suggested that Lilly use a control group of 20 persons who would take a placebo. However, Lilly refused to include a control group and attempted to enroll 40 adults in the year long ADHD study.
Despite copious newspaper articles, Lilly was able to enroll only 20 persons for the trial. And curiously, 10 of the 20 recruits “disappeared” during the study. An additional 25% of the enrollees had to discontinue participating in the study due to harmful effects from taking Strattera. As a result, only one participant completed the study and there were four additional enrollees who “had still not fallen off,” according to a Lilly spokesperson.
Notwithstanding the poor study results, the MPA allowed Lilly’s Strattera study to continue, this time with 100 children, which included a placebo control group. According Swedish psychiatry investigating reporter, Janne Larsson, Lilly deliberately withheld important information from the children’s parents about disastrous side effects of Strattera. Lilly, however, did mention reports of liver injuries occurring in rare cases.
Nevertheless, Lilly reportedly failed to inform the parents about long known adverse psychiatric effects connected with Strattera that had occurred between November 2002 and June 2005. Ms. Larsson reported the following information about what Eli Lilly knew at the time:
“In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%).
It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.”
This means that Eli Lilly deliberately withheld crucial decision making information from those children scheduled to participate in the study through their parents. It was undeniably evident to Lilly that patients taking Strattera might suffer psychosis and mania, exhibit aggressive and violent behavior, or might commit suicide or suffer heart disorders. And if the 1-10% reporting number is accurate, the 200+ reported adverse effects might have ranged instead from 20,000 to 200,000 affected.
There is evidence that Lilly’s marketing modus operandi included manipulating information for gain. It is evident from publicly available documents that Lilly has openly made a practice of manipulating important facts to suit its quest for profit.
For example, Lilly is on record with the FDA as having promulgated false or misleading information about Strattera’s efficacy and safety. Such was evident in 2005, when Lilly ran a television advertisement entitled “Videogame” for Strattera. According to the FDA, Lilly’s advertisement was false or misleading because it inadequately communicated the indication for Strattera and minimized its associated risk.
The FDA termed the advertisement misbranding, because the commercial suggested that doctors and patients could use Strattera for more than treating ADHD. The details of Lilly’s misbranding begin on page three of the FDA’s Warning Letter to Stacey Holdsworth.
Lilly’s approach to marketing and safety had often ignored the reality connected with consumer safety, while focusing sharply on squeezing every bit of profit out of specific drugs. With only a few new drugs in Lilly’s pipeline emerging from Phase III (many new Lilly drugs are in Phase I or II trials), Lilly has made it a practice to stretch claims for its existing drugs.
As an example, Lilly’s Zyprexa is used to treat bipolar disorder in adults. Nevertheless Lilly pushed Zyprexa to doctors for off label use to control the behavior of “disruptive kids.” It seems as if increased profit was Lilly’s sole motive for suggesting that doctors prescribe such a potent drug as Zyprexa to children who are not suffering from Schizophrenia. Here is an excerpt from Alex Berenson’s New York Times Article on the subject published on March 15, 2008:
“The Zyprexa news is telling because it is indicative of Lilly’s core marketing strategy right now: In the absence of actual new drugs Lilly is attempting to add indications and uses to its existing drugs.
In some cases, the company has stretched claims for its existing drugs so far that people have begun to notice. The FDA slapped the company’s wrists for its marketing of Strattera, saying it had falsely broadened the drug’s indication and wrongly implied that its side effects were transient when, the FDA said, it had failed to present evidence that was the case. Lechleiter himself was accused of this kind of stretching in 2003, when an email surfaced in court that implied he encouraged off-label promotion of Zyprexa.”
Although forty-one reported cases of raised liver enzymes have surfaced (see page 3), a recent search of ClinicalTrials.govfor “Strattera” or “atomoxetine” produced 108 listed trials as completed or in progress, none of which address liver toxicity. It is evident, however, that a majority of the 108 studies concentrate on the expansion of Strattera’s use for treating a host of conditions, such as: Schizophrenia, Autism, Traumatic Brain Injury, comorbid Dyslexia, cannabis abuse, comorbid alcohol abuse, Parkinson’s Disease and insomnia.
Why would any company want to sell, or any doctor want to prescribe, Strattera to children who already might have liver disease from using alcohol or cannabis, especially after the FDA has cautioned that the drug can cause liver damage?