No, that's not 'ole Hank pontificating -- that's the Editor of JAMA, Catherine DeAngelis.
This is a great editorial in a major scientific journal -- so grab a chair and pay attention.
While on vacation recently, I had the opportunity to contemplate the sometimes unethical influence of money on medical science, a very serious issue, which has become more evident over the past year or so...
Unethical influence of money?!!? Hmm, I thought you scientice-types wuz only interested in the evidence, facts and truth?
....it is important to discern the necessary and honest interests of for-profit companies from the potentially corrupting influence of commercial interests.
You mean "corrupting-influence" in the sense that certain big powerful companies control and distort the studies that will determine whether or not their drug will receive FDA approval?
Two basic goals of for-profit companies are the discovery, testing, and production of products (the scientific goal) and the sale of products to garner profits, thereby generating returns to the shareholders (the marketing goal). Profits are a logical expectation of the companies that fund the discoveries. Ideally the products discovered, tested, and produced will be beneficial to many individuals for whom the products will be prescribed and who will purchase them, returning a healthy profit for the company.
That don't seem so unreasonable in theory, does it? We don't mind folks making a profit of selling, say, insulin, for diabetics, do we? But, here's where it gets ugly.
Now comes the potential problem. In some instances, the marketing goal of a company dominates the scientific aspect of the company-funded research. There have been a number of high-profile examples of such research irregularities involving for-profit companies, such as the refusal to provide all study data to the study team, reporting only 6 months of data in a trial designed to have 12 months of data as the primary outcome; incomplete reporting of serious adverse events; and concealing clinical trial data showing harm.(footnotes omitted)
Refusing to provide data? Reporting only half the data? Ignoring serious adverse events? Concealing harmful data?
Well, blow me over with a feather. I didn't think science was such a ....contact sport. These folks sound like politicians --- or worse, lawyers!
And it ain't just the pharmaceutical companies -- even some of the doctors and scientists get in on the action:
Individual clinicians or medical scientists may also exhibit inappropriate or unethical behavior perhaps influenced by money or other factors. All would agree that it is dishonest for clinicians and medical scientists to falsify data or data analysis; to provide negative peer reviews of other's submitted but not yet published manuscripts because they do not want to be "scooped"; or for an editor of a medical journal to participate in the editorial review and decision to publish a review article authored by himself or herself and for which financial imbursement from the sponsor was obtained. These are obvious problems, but in other situations, the concerns about potentially unethical financial influence on individuals are more difficult to identify.
Anyhoo -- the DeAngelis piece is a great wake-up call for some of you naive types on what's at stake here. Again, it isn't that science is somehow innately corrupt or misguided. That just ain't true. We love science -- the art of deduction from evidence. We maintain that it is the best means devised by man to ascertain the truth. But, currently -- like the steroid problem in baseball -- we're in a 30 year rut, where politics, money and systemic greed is crowding out good, honest science.
We intend to change this. Read the whole piece. And, don't be shy about letting Dr. DeAngelis know about some specific, ahem, examples of this scientific rot.
Dr DeAngelis is Editor in Chief, JAMA ([email protected] ).
You are right about DeAngelis' tireless efforts to raise standards in scientific journals. I probably don't go (nearly) as far you, Mr. Barnes, but so much rides on favorable outcomes of drug trials, that commercial interests do tend inch their way into controlling the process.
But, what's the solution?
Posted by: Jeffrey Cooper | August 25, 2006 at 12:44 PM
Seems to me that the problem here lies more with the government than with the drug companies.
I wouldn't expect ANY company (science based or not) to necessarily look out for my best interests. The reality of making money works too much to the contrary. I do expect government agencies to do their jobs and DEMAND that the research either backs up the claim or the company is sent back to the drawing board.
Fortunately, a lot of science that gets to the consumer is not life/death or even health related. But when it is, ESPECIALLY, we have to expect some rigorous investigation prior to it being made available. What's a doctor to think when the government has given it's righteous Seal Of Approval to a drug for X disease and a patient suffering from X comes to him in need? He/She will prescribe the drug. If His/Her annecdotal experience is that it was perscribed 5 times and worked each time then that, along with the Seal Of Approval, makes it "certain" that it is a good protocol for future such cases.
I'm not a huge fan of the government, but it has it's uses - or it SHOULD! Focus on the monetary connection between those in science and industry and those in politics. There lies your problem.
Posted by: Johnny B. | August 25, 2006 at 03:29 PM
Richard re-appeared today after being out of touch for a few days and I sent him to the thread, which I now see is closed. Can we start a new thread? Who is going to interview Richard? He has offered to tape record an interview and even transcribe it. Then it could be posted here.
Any volunteers? Is Mark still with us? Dan? Have we agreed it would be best to have the interview conducted by a gay man? I certainly think so.
Posted by: Celia Farber | August 25, 2006 at 06:08 PM
This is really none of my business - I'm just curious. WHY does it have to be a gay man? And of all the people who show up at Barnes-ville, isn't Celia Farber the most qualified person to do an interview? If you're too busy to entertain me, I quite understand. Again, just curious.
Posted by: Johnny B. | August 25, 2006 at 08:01 PM
I think Celia is an obvious choice for an interviewer. Although it would be interesting to compare histories, experiences and perceptions from the "early days".
Posted by: Dan | August 25, 2006 at 09:09 PM
Thank you. It's nice to think one's skills are wanted. I'd be quite happy to interview Richard but he is my close friend and we have been TALKING on and off tape for like 20 years. Part of me wanted somebody who hasn't been hearing all this amazing stuff and complexity enter into it. I said gay man because I wanted to avoid the possibility that a straight person wouldn't be as attuned? But Richard and I have many great talks and could easily have another one.
If I am elected, I will do it. I guess it's up to Mr. Barnes. Maybe HE should do it?
I'm a tired old mule, you know.
Posted by: Celia Farber | August 25, 2006 at 09:19 PM
Welcome, Jeffrey Cooper!
"But, what's the solution?"
Good question. One proposed solution would be to hyper-scrutinize and even stigmatize all studies done by manufacturers of their own products. That should be a huge red flag. There should be an extra, extra, burden for those studies to pass muster.
That would be a good start.
Hank
Posted by: HankBarnes | August 25, 2006 at 10:22 PM
It's weird to read the interest in interviewing me. Seems like only yesterday when graphic details about my sex life were reported on a gay cable TV show in an attempt to silence me after my first AIDS article appeared. When the truth makes gay men look bad, just design a flattering new one! Anyone with an open mind, and an appetite for human disaster, will do. Looking forward....
Posted by: Richard Berkowitz | August 25, 2006 at 11:07 PM
Yes, Celia. I nominate you and Hank. Either one would be a good choice. Hank is not gay, but he is definitely attuned. Men with Gay-dar might even get a false-positive reading on him! :)
Posted by: Johnny B. | August 25, 2006 at 11:43 PM
Johnny B, your assessment that the problem is with the government is correct, it's what is known as quality control. In the 60's we had a problem with this at our naval shipyards that is why we lost one of our nuclear submarines on a test run and all who were aboard.
The navy realizing that it had a serious problem, wisely instituted a quality control problem or an independent, inspection team which is in effect to this day. Since that time, the navy, nuclear program has one of the best safey programs in history.
Until the government gets serious and we insist better from our representatives the status quo will stay in effect. What do you think would happen if 200,000 Americans were killed by nuclear power plants? Wow, everyone of them would be closed. Why is not a second though given to the Vioxx scandal and so many more?
Because, the drug manufacturers can get away with it. There is no independent oversite, we have the fox guarding the hen house.
Posted by: noreen martin | August 26, 2006 at 08:34 AM
Ni Hao!
With the help of Big Pharma and the Demican and Republicrat party lines under different what they like you to think are opposing sermons (liberal v. conservative), the masses are right where Cord Meyer’s CIA planned for us to be—stoned, narcissistic, passive and supplicant to the masters: http://www.markriebling.com/leary.html
It’s integrated into the culture and the world’s economies: http://www.correntewire.com/america_the_stoned
Like it’s labor force, America’s running on a mixture of legals and illegals, other countries on mostly illegal production for export (Columbia, Afghanistan, etc.), or welfare gifts (African countries).
MOTYR
Posted by: Mouth of the Yellow River | August 26, 2006 at 11:59 AM