NCI Board Nixes Pharma Plan To Fund Research
14 CommentsBy Ed Silverman // June 27th, 2008 // 4:57 pm
A research program shot down by National Cancer Institute scientific advisors earlier this week was unlike any other, according to The Cancer Letter. The NCI proposed using $5 million in pharmaceutical industry money to pay for up to three R01 (investigator-inititated) grants to study the tumor promotion potential the ESA drugs, which are sold by Amgen and Johnson & Johnson.
And the money would be contributed by those same companies, and floated through the Foundation for the National Institutes of Health, which the newsletter notes is a non-profit created by Congress to raise private funds to help support biomedical research.
Confronted with the proposal for a Request for Applications at its June 23 meeting, members of the NCI scientific advisory board were troubled by the ethics of the funding arrangement and an overly broad research plan. “However you say it - whatever way this money has been laundered - the fact is that the money has come from the company,” board member Robert Schreiber, professor of pathology at Washington University School of Medicine, tells the newsletter. “This is basically contract research.”
After a contentious discussion, the advisory board voted to defer a decision on the proposal and appointed a committee to sort through the ethics and the science. (Here is the transcript).
But at a time when NIH finds itself under scrutiny over conflicts of interest in its intramural and extramural programs, The Cancer Letter notes that the ESA proposal points to a previously new tpe of conflict - the role of the NIH Foundation in allowing drugmakers to affect the institute’s scientific priorities. The newsletter notes that the Foundation does not have a uniform policy on conflicts.
“It is a huge ethical no-no to try and cheapen the currency urrency of the R01s either by undercutting the peer review process that gives them their prestige or simply by trying to target them from a particular funder,” Art Caplan, director of the University of Pennsylvania Center for BioEthics, tells the newsletter.
“The whole point of the NIH R01s is that it is peers and peers alone who determine the value of the work. The reason the NIH R01s are so prestigious is that they kept us free from politics and influence from commercial interests as reasonably can be done. This undercuts that.”
By proposing a Request for Applications, NCI officials were in effect stating that research on ESA
tumor promotion is a high-priority topic that needs urgent attention, according to the newsletter, which notes that grant applications submitted in response to RFAs go through special peer review committees set up by NCI, bypassing the normal NIH peer review system.
This is a lengthy story and so you’ll have to contact The Cancer Letter for the rest.
Pam Parker
Thank GOD someone has finally started to question the use of grant monies from pharmaceutical companies (and their “non profit” foundations) for research for which the conclusions, of course, are reached in favor of the drug of the pharmaceutical company funding the research. Now, how do you undo the damage that has already been done by the greedy pHARMas? I think they should all be investigated, especially those who use their “non profit” (what a joke) foundations who also own stock in the pharmaceutical company. They’ve bought their way and bought laws that benefit them financially and their stockholders with their artificially inflated stocks. It’s a sin, truly a sin and the bad thing is that they’ve damaged the credibility of “science” for the sake of their greed. Italy recently had some new residents added to their prisons. This is all going to backfire on you greedy, unethical pharmaceutical companies..companies who hide information on drugs that harm and kill…companies who try to buy negative internet websites…and when this comes crashing down on all of you, you’ll be dropped like a hot potato. Big pHARMa makes big tobacco look like Mother Goose. Everyone you think is in your corner will act like they’ve never met you. You’ll be all alone. And I’ll be reading every article I can on the topic.
History Buff
Actually I think the biggest CANCER on this earth IS the pharmaceutical companies. What a bunch of schemers.
Greg Pawelski
Instead of NCI spending that money on three grants to study the tumor promotion potential of ESA drugs, perhaps they should just pay the Weizmann Institute of Science to do the research. I believe the Institute already has found the mechanism behind the growth factor of these drugs.
Nathan
Maybe I’m missing something: Pharma companies sponsor research all the time. Why would they want to sponsor it via the NCI? Why not just sponsor it directly?
Dr. Sal Giorgianni
Nathan. Who knows why decisions are made. But I can tell you, having been in on a few such discussions about similar scenarios, the view at PhARMA was/is that funding through an unimpeachable source (i.e. a government lab) provides a secure safe-harbor that will insulate the trial from the usual “but industry funded it” sniping.
I suppose even that safe-harbor has been destroyed by the storm of public opinion. (Pretty good, gotta try and remember that one).
Remember folks, a lot (if not the lion’s-share, if I remember my stats correctly) of NIH money is targeted to basic research. Those who have tried to change that culture (such as the esteemed Dr. Bernadine Healy) have been raked over the coals. So, to get government labs to do this sort of important ongoing work (I presume that most here would agree that studying these products is important work) PhARMA has to pony up the money.
If NO study that receives PhARMA funding (in full or in part) regardless of WHO or WHAT LAB does it is allowed to proceed or given appropriate scientific credibility then how will research continue? Do folks here feel that the Federal Government will fund this? Do they think it will be through non-profits?
This is a pretty savvy and engaged group of folks so I am just curious – A Question for you all: IF PhARMA WERE BARED FROM FUNDING COMMERCIAL RESEARCH, WHO SHOULD FUND PRODUCT DEVELOPMENT WORK ON PHARMACEUTICAL AND BIOTECH PRODUCTS? SHOULD ALL PhARMAs BECOME GOVERNMENT RUN, LIKE THE MILITARY? (Sorry, Ed, I know you usually ask the questions on your site, but this intrigues me a lot.)
anonymous
So Pam and History,
I take it this means that on ethical grounds, should either one of you acquire a disease that can be treated with pharmaceuticals, you will eschew the use of any drugs? After all, they are a “cancer” and virtually all of the drugs we currently have have been largely researched and developed by Pharma. Let’s see you put your money–and your health and lives–where your big fat mouths are.
Laurie
I think we all know that most research is done by the pharmaceutical industry.
All I want to see is disclosure of that funding source to be laid out and easily accessible to those reading those studies. Not three “organizations” removed from the company that is actually funding the specific study.
Oh, and accurate data collection and interpretation.
Virgilk
In the case of bans on smoking you will, if you look deep enough, find a bias as has never been found before in science. This does not mean all science is a fraud. Without real science we are lost, but smoking studies funded by the RWJF through the ACS for the profit of J&J is far from real science. Even the Surgeon General was affected. He got his marching orders and he didn’t like doing it.
In 1998, when I first started my research into smoking and second hand smoke, I found that all of the largest most comprehensive studies by the ACS,WHO and all the rest, came to the exact same conclusion. They found no connection of Cancer to SHS/ETS and the same for Heart Disease. The WHO even found that children raised in smoking families were 22% less likely to contract cancer.
After the Robert Wood Johnson Foundation was formed by the Johnson & Johnson drug company, science took a nosedive into biased science to promote their smoking cessation products. Looked at closely, it is nothing but a marketing program for the sales of Smoking Cessation Products.
It started full force when Mr. Bill and Hillary got the EPA into the act with their non-study of the supposed 3,000 deaths caused by SHS/ETS.
If a study funded by the ACS,WHO,J&J was not found to be heading for the preconceived conclusion, the funding was dropped and the study had to find other funding or it was stopped.
Without fail all studies funded by the above will be found to be totally biased and even pure fraud done by those with no or very little scientific background.
A Federal Judge, Judge Osteen, found against the EPS Report as being a complete fraud in that they reported the findings before the report was started. They used only the studies that would conform to their agenda and had to adjust those figures upward to make their findings fit the risk factors needed. Judge Osteen worked for four years with, independent scientist, before his decision.
To date, not one death has been proven to be caused by SHS/ETS.
The RWJF has funded smoking bans with grants in the millions and contributions to Political parties. They fund so called grass roots groups in every State and County that have passed a Smoking ban.
Since they started their funding of Smoking Bans, their profits have increased 40%+.
They have caused small businesses to close Nation and World wide. Job losses unequalled in every instance. Tax losses to government. Smuggling and even deaths caused by the products they sell. Their products have caused more health problems than SHS/ETS will ever cause.
This is not a condemnation of real science. It is a condemnation of fraudulent Smoke studies.
I have information on over 150 studies in which only three found a risk factor of 3 to 4 was found. All the est found little risk, if any and some found a benefit.
It is all about Profit in the Billions and has never been about Health.
I have over 260 attachments indexed and ready to send to anyone who needs help fighting this fraud. All you have to do is ask. I am totally self funded and depend on my retirement income. I charge nothing for my services.
I can be reached at 502-727-4747 I will also send a CD with the indexed information. I ask only for postage and that can be sent after you receive the CD if you feel it is worth the cost.
Virgilk
Oops. EPS should have been EPA. I’m not that good of a Typist. If anyone asks, the groups I work with are not funded by any organization. We are funded out of our own pockets and hate to see Freedoms lost because of lies.
Pam Parker
http://ethisphere.com/whats-ailing-johnson-johnson/
http://www.nytimes.com/2008/04/14/opinion/14mon2.html
Does THIS seem like a drug company from whom YOU’D want a precription?
And I WAS on one of their drugs, TOPOMAX for pain management. Worst trip of my life. I could not remember, while driving to work, what I had seen when I looked to the right at a stop sign nor what I’d seen to the left when I looked right again. The only warning on the drug bottle? Use care when operating machinery. I repeated myself constantly. My personality became so altered that my 2 best friends approached me about stopping taking the drug which was an easy decision since, after taking my 200 mg. once a day dosage I would become doubled over in pain.
Johnson & Johnson uses their “non profit” foundation to funnel money (they call it “grants”) to pay for laws, such as smoking bans, so they profit and their stockholders profit from artificially inflated stocks because guess who sells Nicoderm, Nicoderm CQ, Nicorette? And guess who owned, as of December, over 40 MILLION SHARES of JnJ stock? Of course, their “non profit” foundation, the Robert Wood Johnson Foundation. Does no one see anything wrong with the fact they profit from the laws they pay for? They’re dumping major money into obesity. Gee…wonder who owns Splenda?
anonymous
Pam,
Perhaps you should have a word with your prescriber, rather than attacking the company. In the realm of pain, Topamax is only indicated for migraine prophylaxis, and not at 200 mg qd. If I recall correctly, the migraine dose is 50 mg. At that dose, Topamax usually doesn’t cause cognitive impairment. At doses over 100 mg/day, Topamax indeed becomes, for some people, Dopamax. And if there was a warning on the bottle, did you pay attention to it? Or did you blow it off? A prudent individual might take a drug with that warning on a morning when they don’t have to drive anywhere–see what happens.
Your physician knows quite well, I am sure, that Topamax can cause cognitive impairment at higher doses. He should have warned you about that. Additionally, you should have gotten a patient information sheet from the pharmacy which described the common side effects, including cognitive dysfunction.
J&J is not responsible for warning individual patients about their products’ side effects. That would be your physician’s job–and as I noted above, every single physician who uses Topamax regularly knows dopiness is a problem.
I don’t work for J&J and never have. I don’t take Topamax. But it is a great drug when used correctly. You make the usual error here on this site of science-by-anecdote.
And if you think pharma is the only industry that profits from the laws for which they lobby, you must have just fallen off the turnip truck. K Street is full of lobbyists for all sorts of special interests–including groups like the Sierra Club, the ACLU, the Trial Lawyers Association and Greenpeace–who push for laws that will benefit them (read increase their power and profit). Where is your indignation with all these other groups and industries?
Jane
Horuscat, your writing style speaks volumes, do you really think we don’t know you as anonymous?
alijane
It is the lobbyist of K Street who run the country, not the talking heads we send to Congress. They are bought and sold on a daily basis and the people who elected them are mere pawns in a big game of keep seats in
Congress and that takes $$$. Re-elect no one and help change the status quo.
The lobbyist only have power if they have paid for the inside track. We need term limits now more than ever.
HorusCat
Sorry to disappoint you, Jane, but I started my own blog and have been to busy to post here. Ed just emailed me to tell me I stood accused. Whatever. I am also occupied at the moment with a very sick child who hasn’t stopped vomiting for more than 5 minutes at a time in the past 4 hours, so I’ve had more important things to do.
Cheerio!