Do MDs and hospitals get money for trials?

I know this sounds like a tendentious question, especially coming from a sawbones hater like me. But I really need to know this for very specific reasons. I am being offered participation in certain trials by MDs here in Argentina who are telling me not to do other trials. Their reasoning against the trials they aren't offering aren't very convincing, and I am wondering if they might have a special reason for offering me their particular trial. Like money.

So: can anyone tell me if the hep MDs or their hospitals receive money for signing up patients for trials?

Thanks.

Mike

[WriteItDown]

Yes they do.

[mike716]

I don't doubt it, but can you tell me how you know that? I mean, is it general knowledge, has an MD told you, or have you read it in the news?

[Isobella]

I don't know that they are huge money makers for the hospitals, but they do get reimbursed for their expenses.  That's part of the process...the hospitals and the drug company agreeing on the price/costs,  The studies provide the kits for each visit...meaning tubes for blood draws and shipping materials-stuff like that.  The hospitals provide the people to do the patient care and the massive amounts of paperwork.  Simplistic explanation, I know...but no one does anything for free.

Except for me....I got into my trial just for the free meds =)

Mike, I would say to do your research.  I know you are good at that kind of stuff.  Get into the trial that works best for YOU.  Go to clinicaltrials.gov, post here, ask around.

For me, the trial has worked out well.  UND at 5 months post...free 48 weeks of meds--priceless if I could just get that 6 month SVR....awesome.  But you really have to ask questions and reseach, research, research.

Good luck to ya...please keep us posted.

Isobella

[Trish77]

It's general knowledge, I'd say.  They get given a certain amount of money to be able to administer the trials.  They certainly don't take it out of their own budget. Can you imagine what it would cost a teaching hospital to run a trial?  The bonus is that their patients get access to the trial drug and they get to do research.  

I got paid a small stipend on my trial for that matter, Mike.  I got paid $30 each time I went for an appointment.  It covered my gas, got me a bite to eat and some in my pocket.  And no, I wasn't a drug company lackey as a result, either. :)

In the end, Mike ... it's up to you to read the documentation from the various trials and determine what is best for YOU.  

[mike716]

Hi, Isobella! Thanks for the post. Well, it doesn't sound like they have any real pecuniary interest in the trials, if they are just getting expenses. What I was worried about was if they were making a profit out of it, even just extra money for the hospital. That would explain why these MDs are trying to push me into their trial when there are others maybe more interesting. For example, one hospital offered to put me into a Schering-Plough Phase II PI trial in May, 2010. But that's six more months to wait, and my platelets may be so down by then as to disqualify me. When I brought up the Boehringer-Ingelheim Phase III that's recruiting right now, the MD said she didn't like it. I wondered why she said that.

I'm not very good at making decisions, as you probably guessed. And I'm not getting a lot of help from the hep MDs here. I'm doing a lot of research, but it looks like I missed out on the Telaprevir and Boceprevir Phase IIIs, and I can't find much info on these new PIs that are doing trials.

But I am keeping at it.

Cheers!

Mike

[Rockerforlife]

BIG BUCKS...and i mean big.

[mike716]

Hi, Trish! See my above reply to Isobella re my reasons for this worry. As to documentation, there's hardly anything on the clinicaltrials.gov website, and the news items and company litterature are all but useless. These new PIs are doing Phase II trials before the Phase I results are out, and Phase IIIs before the Phase IIs are published. Everyone's in a big rush, and i lost out because Telaprevir and Boceprevir are done with their trials.

I could wring my hep MDF's neck for talking me into waiting.

But I am facing reality as best I can.

Cheers!

Mike

[mike716]

That's certainly a different POV from isobella and Trish. They say the hospitals are just getting expenses. What's your info?

[Rockerforlife]

Come on,you think the hospitals and doctors are getting taken out for a free lunch and just getting covered just  for expenses?Why do ya think  we in the trials get treated like a king.PCR tests and even resuce drugs are all paid for by the massive drug companies.
I was reading this on a site but i didnt save the info,but its normal anyway,they all want the money,no matter waht business it is,just choose a trail that suits your taste,forget all the money thing.

[Rockerforlife]

The biggest barrier to completing studies is that not enough people take part in them. Fewer than 5% of adults (less than 1 in 20) with cancer will take part in a clinical trial.


http://www.cancer.org/docroot/ETO/content/ETO_6_3_Clinical_Trials_-_Patient_Participation.asp

[newleaf09]

Not exactly.  It's much like the grant process for any good research grant.  The grant from the drug company may provide them salary money for an extra physician's assistant since they will have a heavier caseload with the trial patients.  A certain amount will be provided for overhead costs to the institution that the doctor works for.  All drugs and lab work related to the drugs will be provided by the pharma.  There will be some funding provided for the phlebotomists who draw the blood, and for extra in-house labwork that must be done at the institution (like checking your neutrophils after a neulasta shot).  On some grants, a percentage of the investigator's salary may be paid by the grantor.  It all depends upon how you write the grant and I suspect the pharma decides the terms rather than the participating physician.  It's all part of the scientific research game.  Does the physician get something like $1000 a head for roping them in? NO.  But the monies brought in with the grant do reflect well on the physician when it's time for his annual job performance review (most research scientist/physicians in trials are salaried hospital employees).

[Rockerforlife]

Clinical trials are, of course, necessary, but they come with a staggering price tag. On average, pharma companies are spending anywhere between $100 and $800 million per drug candidate. Given this climate, drug companies are looking for cost-saving measures. Sure, pharma companies bring in a lot of money, but they also have to spend a huge chunk of it, too.

CMSInfo, Chesam, UK, reports that national spending on clinical trials in the United States was nearly $24 billion in 2005. Results are forthcoming, but the research institute expects this number to rise to $25.6 billion in 2006 and $32.1 billion in 2011—growing at an average rate of 4.6% per year. The number of clinical trials performed in 2005 was 8,386. BCC Research, Wellesley, Mass., predicts this number will reach almost 10,000 by 2006. At a growth rate of 5.8%, the number of clinical trials performed in 2011 will reach more than 13,000. Research companies are predicting huge growth in this market, but it is clear that life science companies need to find a way to decrease these costs if the industry is to fund all those trials.



http://www.dddmag.com/the-cost-of-clinical-trials.aspx

[foofighter]

Older article, but the info is out there:

http://tinyurl.com/yjcjqn8

Clinical trials of new drugs and medical equipment are rapidly spreading to more medical groups, and is a substantial supplement to the income of many physicians who choose to participate.

"Clinical research is the only way [for a physician in the managed care era] to make a boat payment," quips David Stark, M.D., director of clinical research for the National Institute of Clinical Research in Los Angeles, which administers trials for drug companies.

At 38-physician Doctors Clinic in Veto Beach, Fla., much of the research money ends up in the hands of the physicians who do the trials.

One physician in the practice earns about $100,000 per year from research. "Physicians in this practice definitely supplement their incomes by participating in clinical trials," Kissner says. The specialties most active in research there are primary care, gastroenterology and cardiology.

[Rockerforlife]

Doctor salaries are $250,000 on average anyway,whats anothe 100,000

[newleaf09]

I come from a medical family.  Salaried physicians (those not in private practice) do not make anywhere near $250,000.

[Rockerforlife]

Table 1. Total compensation of Physicians by Specialty; 2002
Anesthesiology $306,964
Surgery, general $255,438
Obstetrics/Gynecology $233,061
Internal medicine $155,530
Pediatrics/Adolescent medicine $152,690
Psychiatry $163,144
Family Practice $150,267

http://hypertextbook.com/facts/2004/TiffanyYam.shtml

[Trish77]

I'm not saying they're JUST getting expenses - I'm saying they HAVE to get money for doing a trial.  I don't know how much they get - I just wonder what would happen if there were no trials.  I'm not sure it's a big fat crime if they don't do trials but it might explain a bit of the competition with your docs if they want to get in good with the drug companies by getting enough patients to be ABLE to run a trial.  You're a hot commodity, Mike.  It comes back to the same thing.  Read the docs.  As for there not being enough information, perhaps it depends what you're looking for.  clinicaltrials.gov tells part of the story and the documentation that you read before you sign on the dotted line comes from the hospital.  That will include also how the hospital itself will run the trial along with the drug company guidelines for the trial.  On the website, it will tell you what the arms are, the dosages, etc.  The documenation from the hospital itself will tell you something else.  You also need to do some research on results of the previous phases of the same trials.

It still comes down to which trial is best for YOU.

[Trish77]

" I'm not sure it's a big fat crime if they don't do trials"  I have no idea what this statement of mine meant.  I don't think it's a big fat crime if they make money from the trials.  There are alot of people who would not have their SVR without them nor have the hope of PI drugs coming without them either.

[mike716]

Hi, Newleaf. That's a rather interesting look at the process. I had no idea it was akin to research grants.

I know zilch about trials, but I was under the impression that all the lab work was done by the pharmaceutical company. Is that not right?

You know, when I read posts like yours I realize what a huge difference there is between hospitals here in Argentina and those in North America and Europe. I can't imagine there being phlebotomists around to draw blood, or specialists to deal with side effects. I think here you're pretty much on your own, unless something major comes up.

I would think that the hospitals here receive the same money that's given to hospitals anywhere else, which for Argentine hospitals will be a lot, as everything here is on a scale of about one third of U.S. prices, costs, and salaries. So even if the hospital just gets (U.S.) costs for personnel and materials, they're doing pretty well.

Are you sure they don't get a certain amount per trial patient?

I really don't care if they make money, you know. I just wonder how much the money may be influencing their decisions, like telling me the other trials (the ones their hospital is not involved in) are no good.

Mike

[mike716]

Thanks for the article!

[Rockerforlife]

Telling you the other trials are no good ?  this is not the norm for a hospital to bad mouth another trial and say theis is better.i think caution would be in order, this doctor who told you this,ask him why its no good>

[mike716]

How can I trust these hep MDs who are participating in trials to give me truthful information on the relative merits of the various trial drugs if they are in competition with each other?

Like I said, on Friday one hep MD told me she could put me into a Phase II PI trial in may, and when I asked her about the BI201335 Phase III trial that's recruiting now (in New York, but not in Argentina) she told me she didn't like the drug. I didn't understand the reason. Sounded like scientific double-talk to me. If she didn't want me to do the BI trial now for her own selfish motives, whether it be money or something else, then I am being manipulated against my own health interests.

I can't figure out all this trial stuff by myself, it's just too complicated and there's too little info available. You have to read the research articles in the professional journals to get real lowdown on the trial drugs, and even then you don't always get the real skinny. I know how to read those articles because i used to do biomed bibliographic research. But when they are starting trials before publishing the previous trial's data, what the h**k is a person to do?

I mean, do I paste up the names of all the trial drugs on the wall and throw darts at them?

Mike

[WriteItDown]

Mike, if you can afford it, why not come to NYC, find a doctor you trust (there are some very good doctors out there -- such as Dr. Deiterich and Dr. Jacobson in NYC), and do your tx, whether a trial or a personally designed program, in NYC. That way you wouldn't have to decide for yourself, you could let a doctor you trusted do it for you.  I think good doctors recommend trials that they think will work for their patients, regardless of money. Many times the trial has more people wanting to do it than there are available slots, and there's no need to convince anyone; in fact, a good doctor gets their patients "in." It might be worth it in the long run.

[Trish77]

The documentation they give you is like a legal document, at least the ones in my trial and others I've seen.  It lays out the procedures they will follow in greater detail and both they and you need to sign it.  Surely at least one of them have given you an agreement to look over?  At my hospital, the Board of Ethics had to look over the trial details and approve it.  Then there was a whole document of a number of pages that I had to read over and chew on.  Before you get your shorts in too much of a knot, you aren't committing to anything until you've read that agreement.  Now...in Argentina, maybe things are different.  The documentation from the hospital goes into far greater detail.  

You do have to do a little digging sometimes and get the skinny on the previous trial results, the scuttlebutt so to speak.  If you don't trust the docs at the hospital you're dealing with to be upfront with you on the results of previous trials or known side effects then perhaps you shouldn't go with them.  That's for you to decide.  

Yes, you might be being manipulated by this doc.  It's not exactly unheard of.  That may help you with your weeding out process.  What you still need to do is gather as much information on each trial as you can and make a decision.  With my own trial, I read their documentation, asked them what questions I had out of reading the docuementation they gave me to read over and sign and I posted the details here and I got very good feedback....and then took my own factors and priorities into account and came up with a decision.

Try to calm down a little, Mike.  You'll think much clearer that way.  Honestly.  Maybe this doc is on the level about this BI trial.  Maybe she's not.  Just start looking into both of them and see what you find out.  What does the doc of the other trial have to say about the one this doc is wanting you to go into in May?  Just take it a step at a time, Mike.  It's a BIG decision to decide to do a trial or not and yes, it can be confusing.  Just break it down into little chunks instead of looking at the whole big thing all at once.  Start with getting the documentation.  Make a list of questions you have as a result of reading the documentation.  Google on the past trial and see what you come up with.  I came across scuttlebutt on past trials that way sometimes.  This one isn't until May so you have a bit of time to sort through it all.  You're not the first and you won't be the last to go through this process.  Just try to stay calm and, again, break it out into chunks and take it through each step at a time.  Maybe you make a list of what your priorities are  and see how each trial matches up to that and see which trial shakes out the best in the end according to YOUR priorities.

[mike716]

Look, everyone, I don't give a d**n if doctors are making a lot of money in their practice or getting rich on trials. Makes no difference to me at all. What worries me is that I seem to be getting a con every time I talk to a hep MD, and I wonder what their motives are.

For example, the MDs at my own hospital have made a complete mess of my case, missing my blood indicators in 2006 and not ordering an HCV test, then in 2008 diagnosing me as F1 non-progressor and telling me I could wait for approval of the PIs, and now that I'm F3/F4 one year later the offer me SOC. So, was it all just error? Or did maybe the cost of the meds have something to do with it?

Now I go around to another hospital. What do they tell me? To wait another six months for the trial of a PI (Nex-2) that I can't find anything about on the web, and bad-mouthing a trial that I could probably join this week in New York (BI201335).

Who do I believe? I've been misdiagnosed and lied to so much at this point that my head's spinning.

Wait six months, when I'm F3/F4 now and my platelets are down to 120k and my crioglobulins are positive? Will I even be able to get into a trial, any trial, six months from now?

Do I kiss off what the hep MD told me Friday, leave my apartment here unattended for 12 months, grab a plane to NYC, and sign up for a trial I know virtually nothing about?

This is utter madness, guys.

Mike

[Rockerforlife]

You have basically 3 choices

1.protese inhibitors
2.polymearse inhibitors
3.SOC

CHOOSE

[mike716]

I've got no health insurance in the U.S. I don't even have a social security pension, as I worked all my life as an independent journalist. I live on a small private income that barely pays for my apartment, food, and dental bills. How am I going to do what you suggest, in New York, where medical costs are the highest in the world?

[mike716]

I'm calm, Trish. Who wouldn't be on 6 mg of Lorazepan a day?

I don't expect anyone here to solve my problems for me. I know that I've got to deal with them myself. I really just wanted to get this question of trials vs. money straight in my head.

Sorry if I've been sounding a little hysterical. It's probably more due to the bad canned music they're playing in this ciber cafe, and the fact that the wi-fi keeps dropping out on me.

Anyway, tomorrow's another day, right? And as my old hep MD used to say, "if you don't have bleeding varices you're still ahead of the game."

How's that for black humor?

Mike

[Rockerforlife]

Forget the going to USA,find a trial where you live now, they are free ,just get ready for the next one and go for it,this was my strategy.I think your are in denial.

[Trish77]

I just took a look at your trial.

Two arms.  One arm is 24 weeks with the trial drug for 12 weeks.  The other arm is 48 weeks with the trial drug for 48 weeks.  That means you get trial drug no matter what.  I agree that this information is scarce.  They don't list dosages and if you'll be doing 12 weeks IF you go RVR or if it's 12 weeks regardless.  However, that's a question you can ask.

They will likely do a biopsy as I doubt they'll accept the results of your Fibroscan for various reasons.  The trial sponsor themselves will likely insist on it. You'll find out once and for all what your status is for sure at no cost to you. You will get excellent care on this trial, I would think as well.  Your drugs and your tests and everything will be free.  

As for no results from the previous trials, that's not at all true.  There appears to be plenty of information on the outcome of the previous trial - did you look?  That's why I'm telling you to calm down...break it down into a "to do" list and check out the information.  Here's some info that was presented at AASLD in 2008:

Safety and Antiviral Activity of BI201335, a New HCV NS3 Protease Inhibitor, in
Combination Therapy with Peginterferon Alfa 2a (P) and Ribavirin (R) for 28 Days
in P+R Treatment-Experienced Patients with Chronic Hepatitis C Genotype-1 Infection.
M. P. Manns1; M. Bourliere2; Y. Benhamou3; M. Schuchmann4; D. Haussinger5;
S. Pol6; M. Bonacini7; G. Steinmann8; D. B. Huang8; J. Mikl8; G. Kukolj8; J. O. Stern8
1. Medizinische Hochschule Hannover Zentrum Innere Medizin, Hannover, Germany.
2. Hopital Saint Joseph, Marseille, France.
3. Hopital Pitie Salpetriere, Paris, France.
4. I. Med. Klinik und Poliklinik, Mainz, Germany.
5. Universitätsklinikum Düsseldorf, Düsseldorf, Germany.
6. Hopital Cochin, Paris, France.
7. California Pacific Medical Center Research Institute, San Francisco, CA, USA.
8. Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
BACKGROUND: BI201335 is a HCV NS3 protease inhibitor (EC50 of 3-6 nM). A multiple rising dose
study evaluated the safety and antiviral activity in P+R treatment-experienced patients (pts) with chronic
hepatitis C genotype-1 infection for 28 days as combination therapy with P + R.
METHODS: 19 pts (France, Germany, Spain, USA) with a Metavir fibrosis score of 0-3, who experienced
previous virologic failure with P+R combination therapy, were assigned to receive BI201335 once-daily
(qd) doses of 48 mg (n=6), 120 mg (n=7), or 240 mg (n=6) in combination with P (180ug/wk)+R (weight
based) for 28 days. All patients were monitored for safety and tolerability of study drugs. The primary
endpoint was a ≥2 log10 reduction in HCV viral load (VL) from baseline at any time up to Day 28. Plasma
HCV-RNA levels were measured using the Roche COBAS TaqMan assay (LLOQ 25 IU/mL).
RESULTS: 19 pts were white, 11 were male, mean age was 48±9 years, mean body weight was 81±15
kg, and median (range) baseline VL was 6.9 (5.9-7.4) log10. There were no significant demographic
differences between dose groups. BI201335 was well tolerated and no serious or severe adverse events
(AEs) were observed among pts in this study. AEs were typical for P + R. 1 subject discontinued
treatment due to an AE (anxiety). A rapid, dose-related decline of VL was observed in all pts. All pts
treated with BI201335 + P +R achieved > 2 log10 VL decline with triple combination therapy. Median
(range) maximal decline in VL during 28 day combination therapy for 48 mg, 120 mg, and 240 mg dose
cohorts was 4.8 (3.4-5.9), 5.2 (3.9-6.0), and 5.3 (4.8-6.1) log10, respectively. Virologic rebound during
treatment was observed during the first 28 days of BI201335 + P + R dosing in 2/6 pts in the 48 mg and in
1/7 pts in the 120 mg dose groups. In these patients, population sequencing of the NS3/4A protease at
baseline and at viral rebound during treatment revealed selection of variants in the NS3 protease domain
shown to confer in vitro resistance to BI 201335. No rebound during treatment was seen in the 240 mg qd
dose cohort: 5/6 pts had VL < 25 IU/mL at Day 28. The sixth pt had a 4.7 log decline in VL from baseline
on Day 28 and VL was < 25 IU/ml at next visit, Day 42.
CONCLUSION: BI201335 given once-daily in combination therapy with P + R for 28 days was well
tolerated, and induced a strong and rapid antiviral response. The results support further study of
BI201335 as a potent protease inhibitor for P+R treatment-experienced HCV patients.

[Trish77]

Cont....

Based on the information presented at the AASLD, I would ask what the dosages are.  The response appears to be good, particularly at the higher dosage.  The information I'm reading so far also indicates there are no adverse effects as a result of higher dosages of this drug either.  Again, ask the dosages on this trial.

It does appear that, for SOME people, there is a resistance to the drug for some people. You will find out rather quickly if that is you and the resistance decreases as the dosage increases.  Again - ask the dosage.

[Trish77]

Okay, in that first post I said trial drug for 48 weeks and SOC drugs for 48 weeks.  Mistype.  It's either trial drug for 12 weeks and SOC for 24, or trial drug for 24 weeks and SOC for 48.

[newleaf09]

Excellent posts, Trish.  

Mike, there are not tons of info on Phase 1's because their purpose is to determine safety and potential activity of the drug on a small group of patients.  Phase 2's generally are aimed at finding the most effective dosage and length of treatment.  The fact that this one even has an arm that is shorter than 48 wks while still in phase 2 indicates that they have a suspicion that the drug can work effectively in a shorter time period (one of the current goals of HCV research).  Phase 3's usually deal with the correct dosage (determined by results of the phase 2's) and prove their assumptions that were based on the results of the phase 2 results.

Trish also talked about the informed consent, the document you sign when you agree to participate in a trial.  It will list all of the side effects of all of the the drugs (that they know of).  I agree that you should ask for a copy of the informed consent to take home and read at your leisure.  That may not be common practice; I know they gave me mine, left it with me for half an hour to read, then gave me my own copy after I signed.  Mine clearly says that you may leave the study at any time without penalty and without prejudicing the institution against you for any future research opportunitites.  They just suggested that you discuss the decision to leave with the study doctor before dropping out.  Even if you were to drop out they would continue to follow up on your response later.

On your other question, the pharma assigned a cooperating lab in Indianapolis to process all of the bloodwork.  Samples were overnighted to Indianapolis on Monday, results were faxed back to doctor on Thurs or Friday of the same week.  All being processed by the same lab gave them reassurance that there would not be random mistakes because of handling in different labs.

[WriteItDown]

Mike, that's why I included the words "if you can afford it" in my post.  It was only a suggestion and I'm sorry if it's not a viable one for you.

[Trish77]

Mike, on a trial, all your costs are covered.  I don't think you'd have to pay for any care in NY on a trial.  They'd do your biopsy, your screening tests, etc. all at their cost.  The drugs would be covered by the trial.  The only cost to you might be rescue drugs but I've learned that some trials cover the cost of those too.  You can ask.  So...if you still have that pad in NY and living expenses are reasonable, it might be worth investigating this trial in NY with doctors who have known expertise in the field.  Just a thought.

Sorry if I've overwhelmed you with info. Which I'm about to do further perhaps.  Some questions, I'd recommend:

On this trial, ask if the 24 week regimen is if you go RVR at 4 weeks.  That's the only way I can see them stopping anyone at 24 weeks so I expect that's the case but I would ask to be sure that's the case.

Ask what the dosages are in each arm.

Ask about rescue drugs, their attitude about them - if they will administer rescue drugs rather than reduce dosage and who pays for them.

The trial results I posted went to 28 days.  That's 4 weeks.  That's long enough to know how many went RVR.  I would ask that.  The docs should have that information, I would think.

That would be a good start, I think, Mike.  Hang in there.

Trish

[copyman]

doctors are compensated $10k to 20k for each PI participant. Although it would be nice to think they were doing it for the good of man kind of course they are not. It is all about the money. The pharma companies say one of the main reasons that their drugs cost so much is because of  research & development and cost of trials.

[GreatBird]

My trial did not pay for my biopsy and does not include any reimbursements or payments to me as a patient. However, they have paid for the SOC and trial meds and the procrit.

I also paid for visits to the eye doctor to find out what was going on. It's possible they would have referred me to someone but since I'm a three hour drive away, I preferred to see someone local.

[Trish77]

Interesting how each trial is a wee bit different.  My trial did NOT pay for the procrit/eprex or neupogen -  I was put on very strong antibiotics that cost $700/bottle and my doctor negotiated for Roche to pay for those since the reason was the adverse effect of the trial drug. I tend to think that the payment to trial participants was something done by our own trial center as the trial was subject to review by the hospital's own Board of Ethics before proceeding but perhaps not.

[Andiamo1]

A well run trial levels the playing filed.  If individual doctors or hospitals did things independently, then the results could be skewed. For example, if one center paid for rescue drugs and another did not, the center that paid would likely have fewer drop outs than one that did not.

When a company files with the FDA for a trial, they stipulate all the rules and payments.  Medical centers are chosen for the trial and the center decides if it will participate.  It is not at all similar to applying for a grant: those are done with discrete applications.  Trials keep everything as uniform as possible.  There is some variability for cost adjustments in high expense areas.

I think, but I have no confirmation, that the Vertex trial cost Vertex about $100,000 per participant.

[susan400]

I have no proof, just my opinion.  I believe that the centers/doctors do get paid for their participation in the trial.  If you look at some of the research doctors reports..., don't want say where I saw it, you'd be surprised at how many of the drug companies are 'paying' them.  I looked up one of them and saw that Roche, Schering, Vertex..., etc., were listed under his name on one of the papers he wrote at the bottom under 'conflicting interests'.  Made me wonder about that...   Like I said, I have no proof.  Just an opinion.

Susan400

[katherine2009]

Doctors make alot of money on depositions, testifying, it can get very expensive and then you also have the expense of an experty witness to evaluate monetary damage.  

[Isobella]

~~~The pharma companies say one of the main reasons that their drugs cost so much is because of  research & development and cost of trials.~~~~

I would imagine the trial I was in with 1050 participants was very expensive for the drug companies....especially if the cost per patient to them was $100,000. So even if the docs don;t get a big payoff....trials are pricy for big pharma.

But I honestly don't have a problem if my trial doc got paid 10K-20K for taking care of me for 72 weeks.  Worth every penny....even more so as they weren't MY pennies =)

[franke566]

I believe you were not asking about trial Tx.  When I agreed to Tx over 4 years ago
my Insurance paid for everything "BUT" my Hepatologist got a lump sum of 6K from
Schering-Plough for referring me.  I was and still am a "saw bones" skeptic.  It took
alot of digging to get the answer.  I actually stumbled upon it because I was going
to so many doctors trying to get an answer to "why" I wasn't clearing the Sxs and
my Neurologist told me flat out that Hepatologists are given a "bonus" for their referrals.  I do not believe any physician would treat a patient unless he or she
met the criteria but having said that; worse things have happened.  Greed is a powerful influence; isn't it?

[Rockerforlife]

Who cares what they get paid to have me in the study,as long as i am taken care off and i SVR....BUT..let us not forget its us  taxpayers who end up paying the bill in the long run as usual.

[FlGuy]

"BUT..let us not forget its us  taxpayers who end up paying the bill in the long run as usual."


How do you figure that?  Unless, you are speaking of Canada this time?

[franke566]

So when you go to a bar and you ask a lady to dance (if I were single) you usually end up buying the lady a drink.  You go to a drs office and you pay for the exam, the tests, the medications, treatment etc. and the Dr gets a bonus.  Now if it isn't wrong to tip the bartender why is it wrong for the dr to get a tip from the pharmaceutical co.?
Because the Gov't says it's okay.  But if I went to a Dr and said look doc.  I'll give you 6k on the side to treat me-that would be against the law if he took it.
When a Bill passes I wonder how many Heppers are going to get treatment?
Hope this isn't too political for this forum.  Or maybe it will be all lollipops and sugarplums.  Everyone dances for free!  Yeah right.

[Rockerforlife]

Where does the salary the doctors get come form?....the person who goes to the doctor,where does that person get the moneyfrom to pay the doctor?...from working and paying insurance premiums or out of pocket....is this the way the heath system works inthe USA?...in canada we just go to the doctor and  say fix me up...no questions  asked,except ,lets see your health card and all is covered .but its taken out of our pay check in th form of taxes....any way you slice the pie...the working jack or jill pays

[FlGuy]

There is a differerence if Jack and Jill want to have the choice to pay or not.  So, for now, it is consumers who decide if they will purchase insurance or drugs or medicines or doctor visits.  It's not accurate to say that taxpayers pay for it in the form of taxes - not yet anyway.

[Trish77]

Actually, in Canada doctors doing trials potentially save the taxpayer money.  A goodly chunk of the treatment expenses would be covered by the trial sponsors - the drug companies - instead of coming out of the source, the taxpayers who fund the system.  In the U.S., I suppose it's the insurance companies who reap the benefits and sometimes the taxpayer if treatment would have been funded otherwise in some way by medicare or VA.

Correct?

[franke566]

No truer words have ever been spoken!  Freedom to choose my doctor and his or her freedom to choose me as a patient.  

[FlGuy]

If a person uses a trial the costs are covered by the sponsoring drug maker, true.  If this person who would have pursued treatment in the normal course of care his private (or employer) insurance would cover the expenses, subject to the insurance coverage limitations (80% for example).  So the insurance company by not paying out for the benefits gets benefit of a trial.  For those people who would normally get their care from a government entity (Medicar or VA) but participate in a trial, the government entity gets the benefit by avoiding a taxpayer funded expense.
In that respect, same as Canada.
My point to Rocker was that "taxpayers" really don't pay for doctor visits or medicines.  Those are paid out of pocket by "consumers" or by insurance coverage, or both.  Although taxes and private insurance premiums are both paid by Jack and Jill I look at them very differently.  One is voluntarilly and the other liberty-sapping governmental seisure. And of course these statements are not to be construed as political in nature.  It's as different as going to a doctor for a tonsil exam and saying "aaahhhh' and going to a doctor for a rectal exam and saying 'ooowww'.  Similar actions, much different in essence.

[Trish77]

Not touching that with a ten foot anal probe .. uh .. pole. ;->

[Rockerforlife]

Its so difficut to discuss health topics with politics being invloved in some way,seems like politics can discuss us but we cant discuss them....maybe this post is agains the rules?
Sometimes i wish i was living on the top of a mountian,gettm fed up with the feds.

[FlGuy]

That's a good observation.  And depending on what happens down south of you the difference between politics and healthcare may, in fact, be indistinguisable--if it isn't already.

[Bill1954]

I typically read through these posts without telling you how much I appreciate your humor; seems this is a good time to say it… so thanks :o).

Bill

[mike716]

Thanks for the info, Trish. It is all a little overwhelming, but I'm gonna try and sort it out as best I can.

I got a message from Lou, who is in the BI201335 trial. He wrote:

"group one is  120 mg of BI 201335NA combined  with peg.  riba.  for  24 weeks..potentially followed  by an add. 24 weeks of treatment **

group two is 120 mg of BI 201335NA combined  with peg.  riba.  for 12 weeks..potentially followed  by an add. 24 weeks of treatment **

** after 4 weeks if your are  und. at 4 weeks.....you will discontinue all treatment after week 24
if your  viral load is measureable at anytime after 4 weeks..you may continue  with  soc to  48  weeks"

If Lou is right, some people don't have the chance to do 48 weeks (the 12 + 24 arm). But then the second part contradicts this.

It's all too confusing for me. This is why I give up. I can't handle the information/misinformation overload.

I also can't find the trial sites from the clinicaltrials website, and no one answered my email to the company. Gee, this is almost as much fun as shooting myself in the foot.

I guess I'll have to try and call them long distance tomorrow (if the telephone number works!).

Why is this all so difficult? Why am I having so many problems? Is the big fella in the sky telling me that it's time to pack it in?

And to think that I spent my whole life avoiding involvement with officialdom and the squares, and now I have to chase after them. I really wonder if it's worth it. I find myself wishing I'd never been diagnosed. I could have just lived out what was left of my life as i wanted, until the pain got too bad, and then bye-bye. Now I have to dedicate every day to things I hate doing, like talking to doctors and searching for anbiguous or unrelaible information on government (oh, horror of horrors!) websites.

Enough of that!

Thanks again for all your help. Everyone. I love you all.

Mike

Mike

[mike716]

I seem to have woken up a hornets' nest with my thread question about MDs and money. I really only posted it because I can't figure out if what I'm being told by the hep MDs here in B.A. is true (like that the B201335 trial now recruiting is no good), or if they only want to get me into THEIR trial for economic reasons. And although there hasn't been a simple answer to this, I think the consensus is that ya can't trust 'em. But then we knew that already, didn't we?

I have an unusual problem. I get physically ill when I have to deal with morally degenerate people or situations. I get like nauseous and dizzy, the blood rushes to my head, and I have a compulsion to lash out in all directions. I guess it's rage. Rage against all those like MDs and drug companies and government bureaucrats and for-profit hospitals and the myriad other powers that are destroying my miserable existence.

So far I'm asymptomatic from the hepatitis virus. But I think I'm dying from the anguish of trying to deal with it.

Mike

[Rockerforlife]

You dont need to worry about all the different arms and stuff,you have no control over those anyway,once you choose a trail,you only got 2 choices the polymearse inhibitor or the protese inhibtor....whats so complicated about that...go do the trail...you have an 80% to full chance of getting the real drug...

[Rockerforlife]

Have you been accepted to do a trial yet?

[mike716]

Are you kidding? I can't even figure out how to apply!

[Rockerforlife]

are you close to texas?
the ph # is  888-662-6728  

Contact: Please reference Study ID Number: NV20536 888-662-6728  ***@****




http://www.clinicaltrials.gov/ct2/show/study/NCT00869661?term=RO5024048&rank=2&show_locs=Y#locn

[Rockerforlife]

Ive spoke with these people for my brother.

[Rockerforlife]

Puerto Rico
Recruiting
SANTURCE, Puerto Rico, 00909  



http://www.clinicaltrials.gov/ct2/show/study/NCT00869661?term=RO5024048&rank=2&show_locs=Y#locn

[mike716]

How do you find out the study site from that location name (SANTURCE, Puerto Rico, 00909)?

[newleaf09]

Easy, you google it.  It's a barrio in the most congested part of San Juan.  Here's a list of Hospitals online: http://www.theagapecenter.com/Hospitals/Puerto-Rico.htm
Check out the most likely ones in San Juan.  Several are VA hospitals.  Look for a teaching hospital attached to a medical school.

Also go to the Hoffman-LaRoche site.  They may have contact info for people intersted in trials (I think Vertex did).

Rocker, any other ideas?

[mike716]

Good try, hon, but actually I'm nowhere near Puerto Rico. I was just trying to find out how to decipher the clinicaltrials.gov website.

For the BI201335 Phase II trial, the website gives this for the New York site:
1220.40.007 Boehringer Ingelheim Investigational Site   Recruiting
New York, New York, United States

Any idea what this means? (1220.40.007 is obviously not a postal code. And there are more than 100 hospitals in New York City.)

Mike

[FlGuy]

http://www.anmat.gov.ar/

Assuming you speak the language, see if you can get in touch with a department that has information regarding clinical trials.

[KniteWolf]

might be a long shot  but  googled  this info
U.S. Headquarters Contact Information:

Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
P.O. Box 368
Ridgefield, CT 06877
[phone]
[phone]

maybe a call there would steer you in the right  direction ;0

[newleaf09]

Sorry, I thought there was some reason that Rocker mentioned Puerto Rico.  Not a terrible idea for you.  You should have the language skills and it's a cheaper cost of living than the US.  I looked at the trial and it seemed okay to me.  No exclusions for cirrhosis, 4 out of 5 chance of getting the PI.

[Rockerforlife]

How do you find out the study site from that location name (SANTURCE, Puerto Rico, 00909)?\



1-888-662-6728  

[mike716]

Interesting website, but I couldn't find anything on it about trials. There is also no contact email address (typical of Argentine websites!).

[mike716]

I've given up on that trial (BI201335). There's just no way to find out the sites. The company is totally unresponsive. They don't want to deal with patients, apparently. i have a short fuse these days, and trying to contact them has made me furious. I really don't know what's going on with this trials dance, and the gov is not helping by having such a user-unfriendly website. Once again, the sick are at the bottom of the heap.

Mike

[mike716]

Thanks, but I don't think I could deal with Tx and a new country at the same time. It's New York or Buenos Aires for me. I don't look forward to Tx-ing in NY either, frankly. No family or friends left there, no car, two hours from manhattan, etc.

I suppose I sound negative about all this. Sorry. I do appreciate everyone trying to help me. Very much. But shooting off into the unknown is not my cup of tea right now. I can hardly deal with life as I know it [grin].

(I'm going to reply to your 10/18 message as soon as I get the chance, hon.)

Mike

[Trish77]

This information from clinicaltrials.gov - hope it helps.

Contact: Boehringer Ingelheim Study Coordinator   1-800-243-0127   [e-mail]

http://www.clinicaltrials.gov/ct2/show/study/NCT00984620?term=BI201335&rank=1&show_locs=Y#locn

[KniteWolf]

mike
  reconsider       bro  and     be persistent and patient   i'm  und   in the  B! trial  at  two weeks  

[mike716]

Unfortunately, Trish, none of that is helpful. The website doesn't specify locations except to give the city (there are over 100 hospitals in and around New York!), no one is replying to that email address, and when I called that number I got a nightmarish run-around that ended up with "If you aren't an MD, get stuffed."

[mike716]

I'm happy for you and only wish I were in a position to do the trial too. But I've plumb run out of leads. There's a limit to what one can do from a third-world country in the Southern Hemisphere, and tracking down trials that don't want to be found is apparently beyond that limit. (Begin music from The twilight Zone...)

M.