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Trials for Type 1 Diabetes Cure
An anonymous reader writes "According to this New York Times article, the pharmaceutical companies and NIH are shunning research for a cure for Type 1 diabetes. There's no money in a cure using medicine with an expired patent. Dr Faustman (researcher/professor at Harvard Medical School) has cured type 1 diabetes in mice and has been approved for Phase 1 clinical trials in humans. The only problem is raising the money, which Lee Iacocca is helping with."
The NYT must be cracking down; the first dozen logins from bugmenot.com didn't work for me.
No problem, I found a copy of the NYT article on Lee Iacocca's page. (Hopefully the server holds up.) Enjoy.
Summary: "If we can't bleed you dry with it, we're not interested in developing it."
I think that's all you really need to know about the current state of play WRT patents and the like. Now how does a little inventor set about getting the protection that patents should have offered him, but don't?
Got time? Spend some of it coding or testing
I will be calling Dr Faustman's office tommorow for more information and a follow up appointment. Even if it means taking a trip to Harvard from Canada. My pet mouse needs the cure desparately.
I've been following Dr Faustman's research since I learned of it a couple years ago, and I have a lot of hope that it will work. However, I've also been aware of the fact that if a cure is found, or a cheaper alternative treatment, there will be many obstacles to getting it to us.
Type 1 diabetics are in the minority, but we're still pretty big cash cows for certain companies. Besides the various types of insulin we need to survive, most diabetics that wish to succesfully manage the disease use additional products like disposeable needles, blood glucose meters and strips (big money), insulin pumps, and more. Potentially, it's many thousands of dollars per person per year and not many companies would want to lose that cashflow.
Google doesn't index user sigs, so stop trying to "Google Bomb" with them.
I can understand how this could happen in the US. My question is: Why doesn't she go to Canada or somewhere else where the health care system is publicly funded. Is such countries the economic factors greatly favor a cure, rather then ongoing treatments.
A Multiplayer Strategy Game for Mac OS X, Windows, and Linux
As an Immunologist - I can't even begin to count the number of times we've cured RA (EAE), GvHD, various forms of cancer, etc. in mice, only to have the 'cure' fail, or even make the disease worse, in patients.
There's no money in a cure using medicine with an expired patent.
This wouldn't be a problem if... uh, there was a truly free market in America. If only Badnarik had won!
Companies are in business to make money. It would be irresponsible for someone at a pharmaceutical company to spend money developing something they couldn't make any money on.
The medical community isn't working in our best interest alone. Scientists work in areas where the best interest of the individual overlaps with the best interest of their employer. There are times when the best interest of the individual does not match up with the best interest of any company and these areas of medicine are horribly neglected (see blueberries vs Lipitor, oxygen therapy vs blood pressure medication, low carb vs the AHA Diet, First Do No Harm). I'm not saying that the doctors are wrong on all these things, I'm saying nobody is putting in the work to check up on them because there's nobody to pay for it.
If the only medical research that gets done is privately funded then the only medical advancements that get made will increase the income of medical companies. If that's the case, the cost of medical care can only go up (unless someone is taking someone else's business but that rarely happens)
I don't think this study is alone. Someone needs to fund this stuff or we'll all be taking out second mortgages because the medical community has convinced us we have to or we'll die.
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The article is mixed up. Nobody is shunning islet-cell transplantation for (IDDM) diabetes. Many people in the field believe that the currently most promising procedure is one developed by surgeon James Shapiro in Canada. It is in human patient trials in more than one country already now. A drawback of course (a big one for some who would otherwise be potential patients) is the need for immunosuppressant therapy after the surgical procedure.
The 'big bad pharmaceutical co' angle is mixed up too. This is a surgical procedure. There is no new pharmaceutical at the centre of it. But if new combinations of immunosuppressants prove specially well adapted to patients who have this procedure, that would quite likely be a new combination of features, and patent protection would likely be available for whatever it turns out to be, anyway.
-wb-
Read the article again till the end.
They found that the treatment/drugs supposed to prepare the mice for transplant actually _cured_ the mice. The treatment was supposed to stop the immune system from blowing away the transplanted islet cells. But after the treatment the islet cells _regrew_ back. So there was no need for a transplant.
""No one had cured them," he said. "Here was this treatment that we thought would get them ready for a transplant but - eureka! - the diabetes was cured.""
From a link off Dr. Faustman's webpage: "The source of the funding for the clinical research activities in the MGH Diabetes Center has come almost entirely from NIH and foundation grants. This funding is ear-marked for specific projects and protocols, allowing little flexibility or opportunity to fund the type of innovative clinical research that the Diabetes Center aims to conduct and provide hope of significant advances. Flexible funds to foster new initiatives, to support researchers who need the funds to pursue innovative approaches and research, are critically needed. Many of the exciting breakthroughs that occur in clinical research and lead to the development of new therapies require this type of initial backing, which is almost never available from government, corporate or foundation sources. Your support can make the difference."
It appears that some of her funding does come from the NIH, although she may want it to be more flexible or something.
Why? This statement is 100% false. For many diseases and disorders there is more than one method of treatment. For cancer, there is chemotherapy and radioation. Both work. Same thing for diabetes, if one method works, why not another?
Stem cell research can result in a cure for diabetes. The same thing can be true for Dr. Denise Faustman's treatment.
I'd have to say NYT either is biased against stem cell research or they just repeat another's bias.
Again... why capitalism and science doesn't mix.
...and the human race dies off because the bureaucrat couldn't make the buck... what a wonderful system.
Chemist/Pharmacist: Look! We found the cure for cancer, AIDS, and all forms of nerve injury!
Manager: Who cares? The patent's expired.... just throw it away...
I would like to suggest that this opinion of drug companies is, in some ways too generous; Its not their fault, its the economics and laws which we set up to drive pharmaceutical research and profits.
Similar outcomes different goals?: Illegal Drug dealers induce a dependency by pushing a prohibited substance, targeting any easy mark. Drug companies discover dependecies by hiring "researchers" to find substances which alleviate or "manage" pre-existing common diseases, targeting any sick person.
These "no-cure" drugs temporarily alleviate the symptoms of the diseases, and even extend the patients life (and thus profits), while, "unfortunately", rarely managing to fundamentally cure anything. When was a drug as useful as penicillin last discovered?
The really clever people are in marketing, its carefully created to spin the appearance of dedicated people attempting to find cures. I find that laughably naive, clearly the economic pressure precludes that from happening. However, I suspect many of the scientists and 'caring professionals' in the field prefer to believe that comfortable fallacy and self image.
To me this focus on researching pushable drugs, versus practical cures, is a natural outcome of allowing the humanitarian medical sciences to be solely driven by raw capitalism and simple greed.
The pharmaceutical companies, will grow wealthier, and the poignant marketing campaigns, and "real soon now cures", will be glossy, slick and convincing, for as long as the hypocrisy continues.
Note: Where there are funds for any cure oriented research, it will typically be in areas where there is a huge PR payback in company image and good will factors.
We, the public, are the addicts, we pay the taxes, fund the basic research, and then have to drink their coolaid and swallow the bitter and expensive pills, just so we can feel better... for a while.
IMHO, there is no cure for this chronic disease of legalized "no-cure" drug pushing, except by radical surgery on the NIH and our health research laws.
There is no god; get over it already! Never exchange a walk on part in the war, for a lead role in a cage.
From reading the article I wonder if anyone knows why the Juvenile Diabetes Research Association is funding an independent researcher but not providing any funds to the person if started the research? Of course from reading some of the other discussion, it is possible the article is simply underreporting the funding to make the issue more sensational (or is that too cynical?)
I make my face look like this and concerned words come out.
So what? There are tons of philanthropic organizations that would love be known as the organization that funded the cure for diabetes. Do you have any idea the kind of prestiege (and donations) that would bring them? Free market solutions win again!
Years ago, CBC's "Quirks & Quarks" science program
had at least 2 items (the later on a follow-up) on
transplating Islets from healthy donors into Type 1 diabetes sufferers.
[ Research was from University of Alberta ]
Trials have been going for years already, with
over 90% success rates. Not good enough?!?
What's the latest on this treatment...?
This was the study published by Baystate Medical Center in 1999.
No Cure in people. Not even a rise in insulin levels, but it's a promising avenue of research.
Effect of Bacillus Calmette-Guerin vaccination on new-onset type 1 diabetes. A randomized clinical study.
Allen HF, Klingensmith GJ, Jensen P, Simoes E, Hayward A, Chase HP.
Baystate Medical Center Children's Hospital, Springfield, MA 01095, USA.
OBJECTIVE: We undertook this study to test whether Bacillus Calmette-Guerin (BCG) vaccine preserves beta-cell function and increases the remission rate in children with new-onset type 1 diabetes. RESEARCH DESIGN AND METHODS: This was a randomized double-blind placebo-controlled trial offered to children referred to the Barbara Davis Center for Childhood Diabetes or the Baystate Medical Center with a diagnosis of new-onset type 1 diabetes. There were 94 children aged 5-18 years who received either BCG or saline intradermally within 4 months of onset of symptoms and who were then evaluated at 3-month intervals for 2 years. The primary end point was remission, defined as insulin independence for 4 weeks. Secondary end points were C-peptide levels (fasting and in response to a mixed meal challenge), insulin dose, and HbA1c. RESULTS: Of the patients, 47 were randomized to each arm; 7 in the placebo group and 9 in the BCG group did not complete 1 year of the study and are not included in the analysis. One patient from each group achieved remission. Fasting and stimulated C-peptide levels did not differ by treatment arm but declined in both groups and were lower initially and during the entire 2-year period in younger children. Insulin requirements and HbA1c levels did not differ in the two groups. CONCLUSIONS: Vaccination with BCG at the time of onset of type 1 diabetes does not increase the remission rate or preserve beta-cell function.
to err is human, to forgive is divine, to forget is... umm...
But stem cell research is *much* more important than just for diabetes.
So why do the bleeding-purple-heart liberals focus only on research with new lines of embryonic stem cells? What about umbilical stem cells or bone marrow stem cells?
What happens when a person with type 2 DM goes on a low-carbohydrate, low-calorie diet to help reduce the secretion of excess insulin into the bloodstream?
Yes, our only choices are "no patents, too much unfair competition" and "bad patents, not enough fair competition". That crazy Constitution, with its quaint notions of "securing for limited Times" monopolies "To promote the Progress of Science and useful Arts". Now that feudal monarchy is in the past, we need monopolies to keep the social contract.
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make install -not war
Let's get to brass tacks here. The issues we are talking about here is the effect of the American patent system & American capitalism/Democracy on research. The example of Dr. Faustman's lack of ability to continue to do research on an unexpected tangent, simply because it is not authorized by the funding, is yet another example of the increasing flaws/perversion in both systems. Reasoning: 1. Life/fulfillment/freedom is a right of every individual, (treatment/medicine to maintain your life should necessarily follows that premise.) (Individualism) 2. I think we can all agree in our hearts that the pursuit of money/wealth is not a righteous endeavour. We do it out of necessity obviously, and our acceptance of it varies in degrees of acceptance relative likely to where we are in society/personal belief system. 3. American Capitalism (American dream, American Democracy) is based on the pursuit of wealth and maintaining it, with health and happiness a by-product of it, not a result from the pursuit. (Capitalism/American style Democracy) 4. When it comes right down to it America is not run by government; its course/policies are made by lawyers, as they interpret and create the doctrine America lives under. Who do the lawyers represent? Business...very simple. The people that speak loudest/most influence in government are those represented by lawyers...Who do the lawyers represent?.. Business... I think there is a pattern there. (Obviously I am generalizing, and generalizations are never totally correct. :) Please give me some leeway in accepting these generalizations, as this is a discussion, and that involves listening and understanding another's view, not just stating your own)
If you can understand/believe these assumptions you quickly realize that the patent system and research in medicine walk a fine line at the best of times in America. Obviously the more Rightwing-Capitalistic/"Republican" America becomes, the more the scale of society tips towards #3 and less towards #1. The patent system may have been created to protect an inventors idea from being copied and efforts being rewarded justly, but it has been bastardized/perverted by lawyers/big business to now mean protection in the market, and the resulting ability to make money. Again the scales are being tipped from #1 towards #3. Capitalism/American Democracy does not promote individual freedoms; it promotes its own growth. It is directly at odds with that premise.
So how does America remove the shackles of the laws it has entangled it's self with? Elect better judges to the Supreme Court, to vote virtuously and in favour of the individualism and not to side with capitalism/Americanism. Hmm.. Who recently got elected .. and which type of judge do you think he will elect to the Supreme Court? The world needs is more rebels... more individuals standing up for people and #1. What a rebellious thought...(In this case it is Lee Iacocca stepped up to the plate.)
BCG is not a drug, it's a vaccine against TB. Faustman is using it as an adjuvant to modify the immune response.
Since BCG is already on the market, any physician can prescribe it to you for any reason they like. It doesn't have to be proven to work for your disease yet. This is called "off-label use". In other words, not only is there not a conspiracy to deny you this drug, but you can have it today if you and your doctor want it. Me, I think I'd wait for the clinical trial. Autoimmune diseases are complicated.
If you want to support Dr. Faustman's research, you can donate online through the Reach For the Cure web site. The money goes directly to Dr. Faustman's project.
EAE = experimental autoimmune encephalomyelitis
RA = rheumatoid arthritis
GVHD = graft-vs-host disease