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Author Topic: Is it a scheme of big pharmaceuticals to make vaccine trial slow and difficult?  (Read 3155 times)

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Offline hahaha

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  • Posts: 123
I guess i must be too depressed about the pace of therapeutic vaccine.
Sometimes I strongly wonder, for those vaccine like Merck's one.   Do they really need to take that much efforts for clinical trial, or they just try to prolong the clinical trial so they can sell more of their drugs?

Big pharm announce they are doing the research, so they may scare off the small company.  When they really have something in their hands, they just keep waiting until their competitors come up with some other matters. So they can earn more on the already marketed drug, dont' they?

Even worse is, I feel that big pharms may "intentionally coordinate and cooperate" to postpone the vaccine's coming by oligapoly. if there are only two or three major player with vaccine candidates in their hand, wiill they just sit down and have undertable agreement not to compete with each other so everybody can take advantage of what they have right now?

I must be out of my mind..... but it seems to be logical...... 
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Offline J220

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  • Posts: 587
Here's the fallacy of your present persepective, IMHO (and your frustration is understandable). "Big pharma" is a misnomer, in that it bags ALL pharmaceutical companies together as if they were all working in collusion. There are literally hundreds, if not thousands, of pharmaceutical companies- big and small - I would seriously doubt that there is some effective conspiracy to delay or prevent the development altogether of a vaccine.

My view is that the reason we have not seen a cure yet is that there is stll much that is unkown about how the virus operates. But as I reiterate in other threads, that is changing. Once we learn that key piece of data necessary to defeat it, it will be done. And remember, the same motivation that ostensibly drives a company to not want a cure to be found (money) drives other companies to try and seek the cure. There is no question that whatever company develops the cure will make billions of dollars. So rest easy, things are moving in the right direction. We'll get there, you'll see! J.
« Last Edit: May 28, 2007, 01:19:55 PM by J220 »
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Offline Jake72

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What I think is so frustrating isn't only the time frame (which can sometimes seem excessively prolonged, with Phase II trials being followed by one Phase IIb trial after another), but also the spotty information, which we've discussed here before.  How many times have concepts seemed to be at least promising, only to disappear without a trace (look at those gene therapy trial results that were supposed to be available in February).  And then there are also delays (wasn't DermaVir delayed for four years before being picked up for a trial? or how about the mystery surrounding the Ensoli vaccine?). 

If it were just the straightforward time frame, it'd be annoying (to say the very least), but understandable since research is obviously needed.  What isn't understandable are the messiness and the sloppy inavailability of a lot of the information.

Offline ronaldinho

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What I think is so frustrating isn't only the time frame (which can sometimes seem excessively prolonged, with Phase II trials being followed by one Phase IIb trial after another), but also the spotty information, which we've discussed here before.  How many times have concepts seemed to be at least promising, only to disappear without a trace (look at those gene therapy trial results that were supposed to be available in February).  And then there are also delays (wasn't DermaVir delayed for four years before being picked up for a trial? or how about the mystery surrounding the Ensoli vaccine?). 

If it were just the straightforward time frame, it'd be annoying (to say the very least), but understandable since research is obviously needed.  What isn't understandable are the messiness and the sloppy inavailability of a lot of the information.

Maybe the the messiness and the sloppy inavailability of a lot of the information is because of faulty coverage of HIV science by the media?? I have already tried to access some medical journals through the net and I have realized that these more specialized sites usually charge the access. So, i am left with sites like aidsmap.com, hivandhepatitis.com, and the like, all sites that only repass information from other sources. 

Offline ScienceGuy25

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  • Posts: 120
Hey Guys

Interesting discussion.  I think the time frame issue (to a certain extent) is out of control of the investigators.  The FDA mandates treating a certain number of patients during each phase of the trial along with investigating safety, dose limiting toxicity etc...  In fact many of you guys know that during a phase I trial the investigators are technically not supposed to be trying to see an effect of the treatment, but merely confirming that it is safe and determining the best dosage (in reality everyone is looking to see if it is having some effect). Only after that can it go to phase II, phase III and then to the public.  This takes time and a lot of money.  Last quote I heard was something like 850 million to take a drug from the bench to the bedside.  So while I don't feel too sorry for big pharma - with that kind of expense you can kind of see why things are so expensive.

Then of course there is the issue of profits. (I work on more rare diseases which big pharma is rarely interested in - not enough of a potential market to make big money, so the academics have to lead the charge in these arenas). With each phase of the clinical trial the cost is exponentially increased.  So if a drug looks somewhat promising but isn't a "home-run" then the cost-benefit ratio may be seen as prohibitive and the company moves on to something else....ahh business..

Offline Matty the Damned

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Hey Science Guy,

You know I could have sworn that Research is a poz only forum and that you're meant to stay in Am I Infected and Off Topic.

MtD

Offline Peter Staley

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Matty -- Research News is techinically NOT limited to HIV+ members.  For instance, we would welcome doctors and researchers here to discuss their latest research.

Peter

Offline risred1

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With these types of questions the concept of restricted access may be viewed as counter productive.

The current process for drug approval is certainly a disciplined one. So the idea that because it is taking so long, the Pharmaceuticals are actually benefiting from this is an interesting conclusion.

When companies are competing against each other, they are actively trying to take market share from each other. So if a company can make a better drug than the other guy, it stands to reason they can take market share away. Actually, I would be more concerned about a company sabotaging another's efforts rather than colluding with them, because if it is about money, then its about protecting your own market share.

Where the suppression idea has some legs, however, is within a company. I'm am relatively certain the profitability of a drug line may in fact influence corporate decisions regarding the development pipeline of drugs that are essentially competing against itself. However there is a bigger picture of competition that actually drives most companies regardless of these manipulations. If they don't actively develop these newer better treatments, which include vaccine, others will. Either you have a stake in the game or there is a potential the game will be taken from you.

In the industry which I work, telecom, it is the same concept. A new company shows up with a new product, and the entrenched ones have to respond with their own offering or loose market share. I can assure you the idea of conspiracy of collusion in that business really doesn't fly. Some would claim that in fact it is the government that has a larger interest of dampening the market in order to create stability and ubiquity of telecommunications services.

In this case of Pharma, the government's regulatory bent is not on suppressing innovation, but rather proving efficacy and safety of drugs. What you are witnessing is the legacy of an industry that would choose to release drugs sooner in order to gain market share quicker if it could, but now must move more cautiously and carefully in order to keep their profits from being diluted by potential product litigation. If you look at the history of regulation development in the Pharma world and FDA, you will see ever more stringent criteria being applied on trials to prove efficacy and safety because of past problems such as, and these are off the top of my head:

Vascular problems with Fen Phen.
Vascular problems with VIOX.
Suicide potential from anti depressants.

And the grand daddy of all the problems:

Birth Defects due to Thalidomide.

Thalidomide alone has probably been the biggest reason for today's regulations regarding drug trial processes, to the point where they currently have now FAST track authorization as an exception, which creates the legal framework for a company to release a drug before it is fully evaluated for safety.

The standards are high for a reason. Are the standards too strict? I'll just say I understand the frustration from a patients point of view.

The system isn't perfect, but my feeling is that how we got here today has more to say with the idea that companies needed to be regulated in the pharma industry that gives the appearance of collusion. When in fact, there is vigorous competition. Currently there are well over 100 HIV drugs in development, including vaccines. HIV is a stubborn beast.
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Offline Jake72

  • Member
  • Posts: 145
You have to think...if the current FDA red tape had been around in the early days of Salk's polio vaccine, we might not have had a polio vaccine available until about 1965 or 1970 instead of the mid-'50s. Think of how much more misery and suffering would have resulted!

If you look at how the polio vaccine was handled, it'd never have been deemed acceptable by today's standards.  The field trials for the vaccine involved 1.8 million schoolchildren!  Yet it is considered one of the medical miracles of the 20th century.   

 

Online Miss Philicia

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If it were just the straightforward time frame, it'd be annoying (to say the very least), but understandable since research is obviously needed.  What isn't understandable are the messiness and the sloppy inavailability of a lot of the information.

I think that's more an issue of the information being more accessible, in our newly digitized world, on the internet.
"Iíve slept with enough men to know that Iím not gay"

Offline ScienceGuy25

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  • Posts: 120
Hey Science Guy,

You know I could have sworn that Research is a poz only forum and that you're meant to stay in Am I Infected and Off Topic.

MtD

Sorry I didn't know that was the rule? I thought this would be an interesting place for discussion as I'm nearing completion of my PhD in immunology and cell and gene based vaccine research. Was my post offensive?

Offline Esquare

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  • Posts: 237
Matty -- Research News is techinically NOT limited to HIV+ members.  For instance, we would welcome doctors and researchers here to discuss their latest research.

Peter

I'm glad to hear that.

Offline JPinLA

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  • Posts: 148
  • Cheers!
Hi all...

I work for what would be considered a large biopharma company as an analytical scientist in the department of clinical immunology.  We do not develop vaccines, that's not our business, but I would like to comment on some of the discussion happening here. 

Obviously I have a skewed perspective but I would like to reiterate that development of any therapeutic takes a large amount of time and money.  Any type of biological therapetuc (be it a mere peptide, protein or attenuated organism like with some vaccines) requires careful study of its efficacy but equally important is its safety in patients.  The study of safety and efficacy can take a good deal of time and with higher risk products like some forms of vaccines, even more time.  In the case of vaccines like the polio vaccine, while the process for approval was somewhat different, there were still federal guidelines surrounding the saftey of vaccines.  As we learned more and more about vaccines we further discovered that 1. Salk's was better than Sabin's since it was "dead" comapred to alive and 2. the production method prior to the late 1990s early 2000s was questioned due to possible contamination with a simian virus 40 (SV40, the virus for the vaccines was produced in monkey cells).  Vaccines are especailly tricky because they often use whole or parts of microorganisms that could poteintially have sideeffects of actually causing the disease in question or have other effects such as cancers (gene vaccines) or transmission of other contaminates from the manufacturing process.

I guess my point is that federal agencies require careful testing and assurances that these therpaeutics are safe and effective for a reason.  Companies have to follow these requirements and are actually committed to ensuring this safety.  Now, I am not saying that companies are not in it for the money because they are and as one person already stated if the potential target for the therapy does not reprsent a large unment need (i.e. have potential for large market capital) then it is economically not in the company's interest.  That is where I have the most difficult time working in business driven science but in most cases I am happy that my work helps to provide effective therpaetuics for unmet medical needs.  Pricing and politica aside.

It's not that the companies are trying to make these trials slow and diffcult.  They are being cautious and sure that the therpaies they are developing have been studied well enough that they can say something abut thier safety and that that actually work effectely to make a difference.  This requires sometimes large and long clincal trials that can make approval wait for 10 years or more costing companies millions of dollars. Couple that with competitive markets, wonky healthcare policies and business driven science and it can certainly appear that compnaied are all bad.  In the cases of clinical trials, however, I assue that they are long for a reason.

JP
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