I find numerous examples in research where big name academic psychiatrists, who bring in millions of research dollars from drug companies to there universities, publish articles where they dramatically puff-up their findings to try to make the manufacturer's medicine much more useful that the actual findings suggest. This is unethical. We are not selling used cars. We are duty bound to the patients we treat to be impartial and honest. Spin doctors do not deserve to be in the profession.
Harvard, Pittsburgh Researchers Push Modafinil for Drug Company Despite Study Documenting Very Little Benefit: In a large multicenter 8-week DB PC study of 311 patients with major depression and only partial responses to SSRI therapy after at least 8 weeks, half were given the expensive brandname stimulant modafinil 200 mg/day, an "orphan" drug approved only for the treatment of narcolepsy. There was no significant improvement in 31-item or 17-item HAM-D depression scores, Epworth Sleepiness scores, Fatigue Severity scores, Brief Fatigue Inventory scores, or MADRS depression scores. More side-effects occurred with modafinil (nausea and jitteriness). The only significant finding favoring modafinil and only at final visit, modafinil improved patients' overall clinical condition compared with placebo on the basis of Clinical Global Impressions-Improvement scores (p = .02). The authors claim, that based on their study, "these findings suggest that modafinil is a well-tolerated and potentially effective augmenting agent for SSRI partial responders with fatigue and sleepiness." A multicenter, placebo-controlled study of modafinil augmentation in partial responders to selective serotonin reuptake inhibitors with persistent fatigue and sleepiness. Fava M, Thase ME, DeBattista C. MGH-Harvard and University of Pittsburgh. Ed: The company manufacturing modanifil has a long history of funding very brief, even single dose studies, to irresponsibly push its drug. This study actually has a good research design and found nothing. The CGI is the most unreliable of all research measures. It could easily be influenced just by the fact that patients like the little amphetamine like surge you get after taking modafinil. That doesn't mean its good for you. Harvard and the University of Pittsburgh have long histories of cranking out studies for drug companies.
High Dose Atorvastatin (Lipitor) Made Absolutely No Difference on Rate of Death; May Even Increase Death: But Spin Doctors Says Its Great: In a massive 4.9-year DB PC study of 10,001 patients with clinically evident coronary heart disease and LDL cholesterol levels of less than 130 mg, but no history of a heart attack, there was no difference in the rate of death between those on 10 mg or 80 mg of atorvastatin per day. The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal heart attack, resuscitation after cardiac arrest, or fatal or nonfatal stroke. LDL cholesterol levels dropped to 77 mg/dl with 80 mg of atorvastatin and 101 mg/dl with 10 mg of atorvastatin. Persistent elevations in liver enzymes occurred in 0.2% with 10 mg and 1.2% with 80 mg of atorvastatin (P<0.001). "Major cardiovascular events" occurred in 8.7% receiving 80 mg vs. 10.9% with 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2% (P<0.001). Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease. Larosa JC, Grundy SM, et al. N Engl J Med. 2005 April 7.
Ed: The number of patients needing to take the high dose for 5 years to prevent one non-fatal event was 45. That means that $95,000 extra Lipitor had to be taken to prevent one non-fatal event. The news coverage of this study made it sound like the treatment was great and saved lives. The people behind this study slyly lumped together the fatal and non-fatal events, then headlined the word "died" ("died or suffered a stroke, heart attack or other major problem") to the news media as part of the events that were decreased by 22% without ever saying that fatal events weren't decreased at all! In fact, deaths, especially cancer deaths, were actually non-significantly higher with the high dose treatment! Also, a 22% decrease sounds like a lot. In fact, only an extra 2% of the people over the 5 years were helped by the high dose. Only such a huge study was able to tease out such a small difference.
The Associated Press said, "The risk of strokes and heart attacks was cut more impressively than expected." Since the impact was so small, I wonder what had been expected. The PRNewswire-FirstCall, like AP, made no mention of the fact that deaths were not decreased. It used the same wording as AP so as to leave the reader with the misimpression that lives were saved. Dr. Joseph Feczko, Pfizer's chief medical officer, crowed, “TNT is the very first study to demonstrate even greater cardiovascular benefits of lowering LDL beyond recommended guidelines with Lipitor 80 mg." He claims "outstanding benefits" and that this study was "critical new information" in Medical News Today which also made no mention of death rate. Only Healthday News told the lack of benefit on death and, even then, it was buried in the fluff. No one bothered to calculate the money that would have to be spent on all that Lipitor. www.WebMD.com made no mention that deaths were not reduced by Lipitor and gave readers the same misimpression. Only, investment sources, like www.Forbes.com mentioned the problem with the increased death rate and shareholders dropped the value of the stock.
If all of the work, expense, benefit, and side-effects of high dose Lipitor occurred to the same person, the doctor would be telling the patient, "Now, high dose Lipitor is really great. If you will just take 80,000 pills and spend an extra $95,000 for them, I absolutely guarantee that they will prevent one non-fatal heart attack. You will only have a 50% risk of getting high liver enzymes and a non-significantly higher risk of dying. Is that great or what?" I think that most patients would ask if there were something better. Is America corrupt, or what?