Patents promote innovation

The following is the opposing view from USA Today, June 16, 2009. USA Today's view can be found as my previous posting.

Opposing View: Exclusive gene-based rights spur vital research and development

By Jim Greenwood

Can a gene be patented? The easy answer is this: Genes as they exist in nature cannot be patented. No one can patent a naturally occurring gene or protein as it exists in the body.

Here's where it becomes more complicated: Researchers can isolate a protein or DNA sequence that can help treat or potentially cure a disease, like cancer or heart disease, and they can patent this discovery. Many, if not most, human diseases have their roots in our genes. More than 4,000 diseases are suspected to stem from mutated genes inherited from one or both of our parents.

Armed with this knowledge, scientists have developed more than 200 innovative new therapies and vaccines that have helped extend and improve the quality of life for hundreds of millions of patients. Researchers, for example, located the gene responsible for cystic fibrosis, then used that knowledge to create therapies that have extended the average lifespan of a person who has CF from 12 years to more than 40.

Like all other patents, gene-based patents protect the intellectual property of a scientist, researcher or biotech company, spurring investment in research and development. The Patent and Trademark Office has strict guidelines on patents, including the patenting of DNA molecules or genetic material.

Two recent studies, from the American Association for the Advancement of Science and a Department of Health and Human Services advisory committee, both confirm what a prior National Academy of Sciences report concluded: Patents do not hinder biomedical innovation. The HHS panel's study also found that patents are not the cause of access-related issues regarding genetic diagnostic tests, in particular.

Public debate over access to, and use of, genetic technology is a good thing. It requires the consideration of many factors, including coverage and cost, concerns over genetic discrimination and myriad regulatory issues.

Even so, banning patents on gene-related breakthroughs would slow biomedical innovation to a halt — taking away the hope biotechnology offers to patients suffering from debilitating diseases such as cancer, Parkinson's and HIV/AIDS — while doing nothing to address what is really a much more complicated set of issues.

Former representative Jim Greenwood, R-Pa., is president and CEO of the Biotechnology Industry Organization.

Government awards patents for Genes, stiffling research

My mother gave me a USA Today newspaper clipping from June 16, 2009 of the following articles, which we thought were interesteding. This is the view of USA Today and the opposing view will be on my following posting:

Our view: Private interests shouldn’t control rights to features of natural world.

In 2006, Genae Girard, then 36, was diagnosed with Stage 2 breast cancer. She had a lumpectomy and chemotherapy. Then she underwent testing for mutations in the BRCA1 and BRCA2 genes linked to breast and ovarian cancer. Girard tested positive for BRCA2 and elected to have a double mastectomy and then a hysterectomy. As she made these wrenching decisions about her health, she collected second opinions at every step of the way except one — the BRCA test.

The reason: One company, Utah-based Myriad Genetics, owns the patent to the BRCA genes.

(Girard: Couldn’t get second opinion on a cancer test./ACLU)

Say what? Yes, the U.S. government grants patents to DNA sequences, the stuff of life. About 20% of the human genome has been patented.

One consequence of such patents is that only Myriad can test for the BRCA mutations. So, no second opinions. Plus, without competition, Myriad can charge more for tests. At more than $3,000, the tests are prohibitively expensive for many women, and not all insurance companies cover them.

Pharmaceutical companies have long used patent protection to recoup the costs of investment and to make initial profits on drugs. Fair enough. Unlike drugs, though, genes are features of the natural world. The biotech industry argues that by taking genes out of the body and isolating them, scientists are creating something that does not occur in nature and therefore can be patented. This, however, is like arguing that gold can be patented when it has been taken out of a mountain because it's no longer "in nature."

The problem began with a 1980 Supreme Court ruling on the patenting of biological organisms. Since 1982, based on a questionable interpretation of that decision, the U.S. Patent and Trademark Office has granted tens of thousands of patents for human genes and gene-related products.

Many of the patent holders allow virtually unrestricted research. But a few companies are aggressive about prohibiting others from profiting from research on their patented genes. That inhibits scientific inquiry.

Efforts to change the situation are underway in the courts and Congress. The American Civil Liberties Union, along with a non-profit organization, filed a lawsuit last month that challenges the patenting of the BRCA genes. On Capitol Hill, Rep. Xavier Becerra, D-Calif., is promoting legislation to bar gene patenting, which, he says, is "equivalent to patenting water, air, birds or diamonds."

It is possible that other solutions exist, short of a complete ban. The scientific world tends to be one of collaboration, not competition. But without strict curbs, for-profit companies such as Myriad — which declined to provide an opposing view to this editorial — too readily can use patents to slow and restrict research as they maximize revenue. (There might be "myriad dollars to be made in Myriad," CNBC's Jim Cramer said on his stock-picking show last week.)

Even though Girard has taken the most drastic steps to prevent her cancer from spreading or returning, the BRCA2 gene runs in her family. If one company continues to have a lock on it, that makes it more difficult to achieve Girard's wish: to make it easier for others, including her niece who might also carry the gene, to make better informed decisions about their own health.

Visit with the pulmonologist

I got in for a follow-up with the pulmonologist yesterday and started with another complete pulmonary function test. The doctor told us my lung function is much better than when he saw me in the hospital over a month ago. My wife said, "yeah, David was really sick back then." The doctor then said, "yes, he was dieing, his lung function was so bad." My wife knew how bad I was in the hospital but I was so out of it that I cannot even remember half of what the doctor had told me. Until recently, I really didn't realize just how serious this bronchial obliterans (BO) is.

So the doctor said I have improved significantly in the past month; however, my lung function is still seriously low. He said I am operating on the capacity of one lung. My air stats are remaining above 90 at rest or slow walk. So he told me I can come off the oxygen when sitting around the house and if exerting myself, such as long walks, hills, stairs, etc., then I need to be back on the oxygen, but at a lower setting than before.

He told us again how the lungs are "stupid" organs that do not respond well to treatment and don't regenerate like other organs do. He advised we contact the Fred Hutchinson where I had the hematopoietic stem cell transplant (HSCT) for a consultation with a lung transplant specialist. He believes the chances of eventually needing a transplant are good and said it is better to be plugged into a system now rather than waiting until the last minute. He told us there is usually a narrow window for a lung transplant between when the lungs are bad enough that a transplant is needed and when the patient is too ill to be able to survive such a procedure.

Seattle Cancer Care Alliance has some interesting information on their website relevant to HSCT recipients with chronic graft versus host disease who are then diagnosed with BO. They state that 30 to 60 percent of HSCT patients develop some kind of lung problems. There is another good article at nature.com that goes into detail the issues of lung problems in relationship with GVHD after HSCT. They say the mortality rate for lung transplant recipients with BO is 61%. And according to Dr. Suckling, our pulmonologist, with BO you are on the clock, with seven years typically being on the optimistic end.

So I am in remission for leukemia but this thing is still trying to beat me down. Although the steroids are making very irritable, cranky, grouchy, and a number of other adjectives my wife tends to use, I am trying my best to maintain a positive attitude and take it one day at a time.

My advice to those of you have had, or are contemplating having, a HSCT, is to make sure when you get home after the procedure, and are being seen by your local doctor, that you are getting pulmonary function tests performed every three months during the first year post-transplant, every six months during the second year, and annually thereafter. If you read the articles I mentioned above then you will find it is very difficult to detect BO until it is severe, which is what has happened to me. Even chest x-rays don't pick it up. I had four of them during the months before I was recently hospitalized and nothing looked abnormal until the chest x-ray done while in the emergency room, which the doctor said the lungs looked elongated, similar to what they might look like if I were asthmatic, which I am not.

Well take care and thanks again for the support and prayers.

David

P.S. If you have anything to share that would benefit other CML or HSCT patients, then please leave your comments via this blog. I often get great emails from people with their own share of GVHD issues, medication side affects, etc. that I think others would love to hear about. So unless your privacy is the concern, please feel free to comment via the blog. I do check them and will respond where needed or requested. Thanks.

O2 Update

I have been home from the hospital now for almost two weeks. I am now on oxygen most of the day and while I sleep. Without it I still get winded walking around the house and especially using the stairs. I am on prednisone steroids again, anti-biotics, and several inhalers. My appetite has improved tremendously because of the steroids and I gained seven pounds in a week. During the first week I was actually getting up at about 1am and eating an entire meal, but I couldn't sleep either. Sleeping a bit better now.

So I am feeling better at the moment but I am still pretty much stuck to the house, needing to drag small oxygen tanks with me if I go out. My insurance company has finally approved home visits from a nurse to monitor my progress. The nurse has also recommended getting me home physical therapy to increase my strength, which I agree will help.

My sister, Lisa, and brother, Stephen, flew out from California to spend some time with me and help out and I have really enjoyed their visit. And my mother-in-law flew out from Ireland for a couple of weeks. It is always great to see Elinor.

I should have another update in several weeks after another pulmonary function test of the lungs. I have received emails, phone calls and cards from so many of you and my family and I really appreciate your kindness.

Here is a picture of me outside my new favorite place.

Same Journey, Different Path

Thank you to everyone who continues to keep up with me through my blog and email. I am sorry I cannot always respond personally to each email but I do try to.

For the past 18-months or so my chronic myeloid leukemia journey has been more about a journey post stem-cell transplant, which seemed logical enough. I have been doing pretty well overall and have remained in remission since I fully engrafted with my donor's blood shortly after the transplant.

Most of you know I have had a few ups and downs over the past six months or more with fatigue, some dizzy spells, feeling winded after light exertion like walking stairs, etc. I was especially feeling poorly a couple of months ago when it appeared I had picked up some sort of local bug here in Colorado Springs. Well I have been feeling poorly again so my wife brought me into the emergency room last Saturday because I was having difficulties breathing. The ER team placed me on IV and oxygen and began several tests, such as chest x-ray with contrast, CT scan of sinuses, and a high definition chest CT scan. I was admitted into Memorial Hospital that night for observation and more tests the following days.

So the bottom line is I have bronchiolitis obliterans (BO) which I have gotten from graft-versus host-disease of the lungs. Bronchiolitis is inflammation of the bronchioles and obliterans means the inflammation is at least partially obliterating the airways. One form of this is also known as popcorn worker's lungs, which is life-threatening and apparently irreversible.

They have already been talking about a multiple lung transplant and have been in consultation with the organ transplant specialists in Seattle. The doctors at the Hutch said they concur with the assessment of BO but want to wait to see how I do on various additional lung medications (steroids) before returning to talks about lung transplants. I am back home now, on full-time oxygen and taking loads of new medications, inhalers and respiratory lung treatments.

Well nobody promised me a flawless journey without a fair share of bumps along the way. Through this blog, I hope I can continue to inspire patients and caregivers to continue with your CML therapies and treatments with positive outlooks towards success. And of course I will use this blog as a venue for myself to learn the medical and technical aspects of lung GVHD and to share what I learn.

My CML Circle Drug CO-PAY Assistance Program

Hello everyone. Me again.

I wanted to pass on some great news I have just found out about. I was recently contacted, via this blog, by Rachelle L., who wanted to provide information on behalf of Novartis Oncology about a program they have to offer.


The My CML Circle Co-pay Assistance Program provides support for patients throughout their Ph+ CML treatment by providing a co-pay assistance card to eligible patients who are currently taking GLEEVEC (imatinib mesylate) and/or TASIGNA (nilotinib). In addition to receiving co-pay assistance for these treatments, My CML Circle Co-pay Assistance Program also provides regular updates on Ph+ CML treatment and healthy living, along with information on topics like managing side effects and tips for communicating with your doctor.

For more information or to enroll, please visit www.mymclcircle.com or call toll-free at 1-877-966-2745.

The longest cold ever

Well I was able to hold on to that cold/bug for a month and add bronchitis, even with ten days of antibiotics and an inhaler. Last week alone I saw three different doctors, went to five appointments between the Air Force Academy hospital and the oncologist clinic at Rocky Mountain Cancer Centers. I had three chest x-rays, three and a half liters of fluid via IV, three blood tests and one cardio echo gram. Tests were negative so the consensus was that I was tired and winded because of dehydration (I had 8 days of diarrhea too), which was the reason for the fluids.

Anyway, I am starting to feel much better now, thank you for asking. I started feeling better after 8 days on the antibiotics. We figure it has taken so long because of the suppressed immune system. I am still feeling very winded just from walking up stairs to a slight incline on walks with my son to school. That should correct itself with time. And the important bit; I am still in remission. Thank God for all you donors out there, although we could always use more. Tell your friends to sign up and save a life. We recipients appreciate it and so do our families.

So I am now scheduled for a colonoscopy for next Wednesday. It was supposed to be two weeks ago but I had to postpone because of the cold/bug. This procedure is to check for GVHD of the GI tract to make sure I am not flaring up again. The symptoms have been diarrhea and some nausea.

Other than that I have been keeping busy with my graduate studies. It has been difficult with the GVHD of the eyes and fatigue but I am hanging in there. I have already registered for my next course, which when finished will mean a graduate certification in Homeland Security. These credits also go towards the M.S. in Computer Systems Management with concentration in Information Assurance.

Well that's it for now. Thanks for staying updated.

David

The Nasty Common Cold

Since my last posting, I received lab results from the doctor in Internal Medicine. He phoned to tell me my iron levels were low so I am now taking iron supplements. He also ordered a colonoscopy, which was supposed to have been last Friday, except that I have a cold so they postponed the procedure until the 18th March. I have had this terrible cold for over two weeks now and just haven't been able to shake it, despite several days in bed. So today I went to the Air Force Academy to be seen in the Acute Care clinic. I am finding that where most people would be given cold meds and sent home, I have been tested and prodded a bit more, just to be safe. So another chest x-ray and blood work didn't indicate anything out of the ordinary. My blood pressure was very low though, which the doctor contributed to dehydration. I have had diarrhea for the past three days and I have been so tired, to the point it can be hard to breath. After a liter and a half of fluids in an IV and I felt better. That is until this evening when I deposited that liquid as quickly as I took it in. Anyway, the doctor has given me an anti-biotic and an inhaler for the cold and wheezy chest. I hope to feel their benefits within a day or two.

I have my monthly oncology appointment scheduled for this Thursday so I will discuss the possibility that the chronic gvhd is coming back to my gut. I think it fits because just a week ago I finished the taper off of Budesinide, which is a steroid that helps the lower GI system.

My mouth sores have been hurting a lot lately as well. No help from the suppressed immune system which has been squashed even more with the cold. But for some good news, it would appear that my eyes are getting a bit better. Maybe the increase in tacrolimus is helping combat the gvhd.

I hope you are all well.

David

Them bones, them bones, them - my bones

Yesterday I paid a visit with my primary care manager at the US Air Force Academy hospital. I really like this doctor in Internal Medicine. He is so knowledgeable, thorough and takes the holistic approach. We discussed my problem with trying to gain weight and he referred me to a cancer rehabilitation program. We discussed my chronic sniffles, he said my nostrils are real inflamed and he prescribed a new nasal spray, which seems to already be doing the trick. We discussed my mental health and he has prescribed me with Remeron to take along with the Lexapro I am already taking. The added side affects are drowsiness and increased appetite.

Finally, we discussed the Fred Hutchinson's suggestion that I repeat a bone density (DEXA) scan in about three months because of my previous results. The doc reviewed my numbers and recommended we begin treatment for osteoporosis now with a follow-up DEXA scan in a year. He has prescribed Fosamax plus D, which he said I would need to stay on for two to five years. And Fosamax requires plenty of calcium in the body so I need to continue with the calcium and vitamin D supplementation.

While at the hospital for my appointment I also went in to immunizations for my two-month booster shots, two per arm. Polio, HiB, Tetanus-Diphtheria, and Hep B. They had to use a baby needle because of my puny arms. And my right arm is soooo sore.

As far as how I am feeling these days, I have been in a bit of a slump lately, feeling especially tired and winded. So I have been trying to get out for more walks with our new toy poodle, Molly. I am also convinced that once I begin working with a cancer rehabilitation training specialist and begin to gain some muscle and weight, then I will begin to feel better. Meanwhile, I am still dealing with graft versus host disease (GVHD) of my mouth, eyes and maybe a little skin. Except for my eyes, I am not really bothered too much by it. It is difficult to see sometimes, especially with my left eye. If I don't see improvement soon I'll need to get eye glasses to help me read. In a week I am starting back with my graduate studies, picking up where I left off almost two years ago. But this time the Department of Veteran Affairs is picking up the tab.

Happy Birthday To Me, Happy Birthday To Me

Hello my loyal followers. Yes, today is really my first birthday of my stem cell transplant and my wife, children and I celebrated with a nice cake. I cannot believe how fast this past year has gone by. Thanks again to all my dear family and friends who have supported my family and I. We really do appreciate it.

I hope you all enjoyed your long Thanksgiving weekend (at least those of you Americans who celebrate the occasion). As always, my wife cooked us a fabulous traditional turkey dinner and I am sure I did put on some much needed pounds. In fact my mother said she hoped I put on a good ten pounds. Sorry to tell you Mom but if I did then those pounds are now gone.

Nothing much has changed since my last blog except that I did go into the Air Force Academy hospital to get another PSA blood test done, which thankfully came back negative for signs of prostate cancer. So I am continuing with my increased dose of the immuno-suppressive medication, tacrolimus, and the meds for my mouth. I am also now taking calcium and vitamin D supplements, hoping for better bone density results in a few months.

Well it has been a long day and I am off to bed. My wife is very good to let me sleep in when I can and because of the 24-hour snow fall we have just experienced, the children have a two-hour delay for school in the morning. Yes! More sleep. Good night all. I still have to get up in the morning to shovel snow.