Head to Headby John CastellaniPresident and CEO, Pharmaceutical Research and Manufacturers of America [PhRMA]British Medical Journal. 2013 347:f1881.Clinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients. Biopharmaceutical companies are committed to the continuous improvement of clinical trials to bring innovative medicines to the patients who need them. This includes protecting the safety of study participants, overcoming barriers to greater participation, and fostering new medical discoveries. The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. In the process of drug development, companies routinely publish their research, collaborate with academic researchers, and disclose clinical trial information at the time of patient registration, drug approval, and for medicines whose research programs have been discontinued. In addition, PhRMA has set out voluntary principles to fortify biopharmaceutical companies’ commitment to the highest standards for ethics and transparency in the conduct of clinical trials. PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results are designed to help ensure that clinical research conducted by biopharmaceutical research companies continues to protect patients and provide meaningful medical research results to healthcare professionals and patients.
The biopharmaceutical sector may provide more information about its research and products than any other industry. As expected by the healthcare professionals that prescribe innovative medicines, the current biomedical research system includes wide sharing of trial results with government regulators, academic and medical communities, and physicians through submissions to the US Food and Drug Administration [FDA] and other international regulatory bodies, presentations at medical conferences, and publication in peer reviewed journals. Information on clinical trials for potential new medicines is already required by US law to be posted on ClinicalTrials.gov, the publicly accessible clearing house maintained by the National Institutes of Health [NIH]. As of May 2013, ClinicalTrials.gov has information on 146 213 studies in all 50 states and in 185 countries. NIH reported last year that ClinicalTrials.gov “receives more than 95 million page views per month and 60 000 unique visitors daily.”
While these efforts are working, the biopharmaceutical industry is engaged in a dynamic ongoing process to improve on all aspects of clinical trials and is committed to taking part in a multi-stakeholder dialogue to advance responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research. We are reaching out to groups such as the Institute of Medicine, the Harvard Multi-Regional Clinical Trial Center, Project Data Sphere of the CEO Roundtable on Cancer, and the European Alliance for Personalized Medicine. Processes for data sharing or disclosure must take account of patients’ informed consent and the reality that re-identification of patients based on anonymized information is possible. Threats to patient privacy will jeopardize patient willingness to participate in clinical trials, which would delay the availability of new therapies.
Dumping millions of pages of clinical trial information into the public domain without providing appropriate scientific and clinical context or guidelines for meta-analysis could lead to second guessing of the expert decisions of national regulators worldwide, undermining patient trust and confidence in the safety and effectiveness of approved medicines. Mandatory public disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries. Without appropriate protection for intellectual property to incentivize the enormous investment risk involved, biopharmaceutical companies will be discouraged from investing in the next generation of new medicines, leading to patients and physicians being deprived of innovative therapies to tackle the serious and life threatening diseases of the 21st century.
The modern clinical trial system and associated sharing of information led to more than 340 new medicines approved by the FDA over the past decade, with 39 new medicines in 2012 alone. It contributed to over 30 new medicines approved for HIV in the past three decades—based on the work of 2400 completed trials—turning what was once a death sentence into a treatable, chronic condition. Since 2000, PhRMA member companies have invested about $550bn [£330bn; €390bn] in research and development, including clinical trials, in the search for new treatments and cures. No government or academic institution has the resources or multidisciplinary expertise to conduct the clinical trials needed to develop the new medicines patients need. Only the biopharmaceutical industry can take on this considerable risk at such a scale, and only a carefully balanced regulatory and competitive environment can foster the future investments in this research necessary to produce new treatments to benefit current and future patients.
Frank Herberts classic, Dune, is the all-time best selling science fiction novel in which the ruling Houses fight for control of the desert planet Arrakis, the only source for the Spice – a drug derived from the giant worms that roam the planet. The Spice is the most valuable substance in the universe – the organizing principle of politics, science, commerce, and religion. The one truth never questioned in the novel is that "the Spice must flow." I think of that novel when I read something like this treatise from PhRMA which sounds like life reproducing art to me – particularly when it comes to psychiatric medications. Unfortunately, I also think of that novel when I read Dr. Lieberman’s article in the Psychiatric News discussed in the last two posts [all better now?…, the wrong we…]. His logic is very similar ["the Spice must flow"]. It’s the music of both articles. And Castellani’s article needs some music, because his words make no sense. Data transparency offers no real challenge to subject anonymity. There are no proprietary secrets at stake. There’s just the truth about the efficacy and the adverse effects of the medications, at least as much truth as short clinical trials can reveal. And if we know that truth about efficacy and adverse effects, we’ll prescribe less, and patients will take less medication. Castellani’s article contains a threat. If we restrict industry by making clinical trial results available for independent evaluation, they’ll stop pouring money into research and the medical enterprise. That will create a genuine and difficult problem. It already has. But it’s one better dealt with directly than by creating an unholy alliance with the pharmaceutical industry.
I think this quote from Lieberman’s 06/25/13 article in Psychiatric News about his experience at the White House Mental Health Conference says it all:
Don’t get me wrong: the conference represented, to my mind, the most important and significant presidential effort on behalf of mental health care since Rosalynn Carter’s White House Conference on Mental Illness over 30 years ago. But there were things about it that gave me pause. The tenor and content of the meeting were not as medically oriented or scientifically based as I would have liked. The presentations and discussions got a little too “touchy feely” at times, and the overall focus seemed more on social-science approaches to mental health care than biomedical or neuroscience perspectives.Sigh. When the biomedical perspective on mental health is all you have, how can you avoid turning to pharma?
Mr. Castellani has mastered the art of humbug. The turgid prose style has a numbing effect even on alert readers… he takes an awfully long time to say very little. And my eyebrows shot up at the same 2 deceits that you specifically called out: the fear mongering about patient privacy and the preposterous reference to damaging disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials.
On the first issue Mr. Castellani is being richly ironic, considering how PhRMA has treated patients in clinical trials like disposable commodities for so long. You signed an informed consent? You believed your altruistic participation would generate knowledge to benefit society? Well, we didn’t like the results so we suppressed or manipulated the data, and society be damned. Glaxo Study 329, anybody?
On the second issue, the chemical structure of the tested drug is already known, there are no proprietary scientific methods in clinical trials, and the only commercial information that PhRMA wants to keep confidential is the unvarnished complete truth about the results. Glaxo Study 329, anybody?
Big Pharma is not going to stop pouring money into R&D. If they do, they’ll have no new products to market. We really need to start calling their bluff.
Psychpractice, thanks for the charts on your blog showing APA finances.
Clearly, one of APA President Lieberman’s tasks is to drum up new business.
This was written by someone’s marketing department, what a load.
Many decades ago all the rage was mission statements, and who wrote mission statements? Marketing! The result is a lot of the doublespeak we see in this waste of time and ink.
Pharma is nothing more than a marketing group that would sell another product if the margins were as good.
Steve Lucas
“While these efforts are working, the biopharmaceutical industry is engaged in a dynamic ongoing process to improve on all aspects of clinical trials and is committed to taking part in a multi-stakeholder dialogue to advance responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research.” John Castellani
Frank Herbert had a wicked sense of humor though, this compund that all of the factions were fighting over-spice. Was comprised of …worm dung.
Great comments all!
a-non
Herbert’s sense of humor is legend, and the comparison isn’t lost on us either. But notice how they are trying to morph data transparency into data sharing. We want the former to check their work and put a stop to their sheenanigans. They want to give us the latter, which makes them the great and generous and evades Ben’s and the rest of our point that pharma’s days of deceit are over and done.
The science fiction story that keeps coming back to me lately is from The Star Diaries, the exploits of the great cosmonaut Ivon Tichy as told to Stanislaw Lem. Tichy lands on a planet whose rulers are gradually submerging it in water. As the water levels rise higher, they tell the inhabitants that their glorious destiny is to evolve into fish people. With enough effort and the right attitude, they’ll all grow gills. Rulers and subjects alike are all contorted with rheumatism from the damp, and everyone pretends not to see everyone else secretly bobbing up for air. Tichy lands in a re-education camp alongside a newspaper editor whose only crime was to write that “water is wet.”
It turns out the ruling bureaucracy is descended from an Irrigation Department that long ago saved the planet from drought. When there was finally plenty of water, however, they just had to hang on to power. So they pushed what they had to offer, which was water, and forced the citizens to consume it. It’s a great satire of the Soviet bureaucracy that Lem chafed under in Poland, of course … but it works at least as well for capitalism, which Lem understood pretty damn well. If Eli Lilly were selling water, the APA could be counted on to proclaim Mankind’s March towards Fishification.
Well, I think a lot of people are either afraid or just minimizing the criminal element that is going on by a select but powerful few in the profession. Frankly, at this point in my life, I have been so often ostracized and marginalized by the corrupt and their lackies in the indifferent, let them choose to want to come after me again, who cares. Let those who are passive and indifferent get what they deserve by inaction and lack of concern.
As said by the main protagonist to Batman during his training in the movie “Batman Begins”, “the criminal is not complicated”, and I truly believe that. They are driven by basic instincts of addiction, power, control, and mayhem. And that seems to sum it up for me what drives the leaders of the APA and much of academia these past 20 years. One more wonderful quote from the movie, again by Ra’s al Ghul, “criminals thrive on the indulgence of society’s understanding”. Because doctors get the pass that by having the “MD” after their name, they have to be good.
Antisocial personality disorder does not discriminate in levels of race, gender, socioeconomic status, profession, even societies. And to see it and ignore it or dismiss it, well, more power to them, eh?
God, this man has only been the president of the APA for what, 2 months, and I am already sick of reading and hearing about him!
My compliments on your choice of post title.