My heart has been crushed and is a bit bruised.
I have not many words to say right now.
(h/t to Lisa Ann for the photo)
In repeated experience, it has taken a full 9 months to fill a laundry bottle 'sharps container' with daily used syringes previously filled with Copaxone. I once tried to stretch it to 10 months but was unsuccessful in the attempt.
Without further ado - drumroll please
The winner of the Trivia Question and the 'Sensational, Sharp, Smart Blogger Award' is Aprilmoon who said it would take one year to fill the container with syringes. Although a 1-year estimate exceeds the actual experimental outcome, it comes closest to the correct answer. Perhaps the syringes used for insulin are a tiny bit smaller than the ones used with Copaxone.
Congratulations and please collect your Blogger Award.
Multiple sclerosis (MS) is a poorly understood disease that affects patients at an early age and, usually, lasts a lifetime. Factors that predispose to the development of MS include genetics, geographic location, sex and birth month, suggesting an interesting nature-nurture interaction in this disease process.
The increased rate of MS at high latitudes has been demonstrated in many studies, with those living in the Northern United States and Canada at a higher risk than those closer to the equator. This geographical influence is most commonly linked to the decreased (UV) radiation in these locations. UV light is a requirement for the production of vitamin D, and it is this effect that is most commonly thought to increase the risk of MS. In addition to affecting bone strength, vitamin D interacts with over 1,000 intracellular pathways, most of which are not well understood. Vitamin D deficiency is documented in patients living at higher latitudes, where MS is more prevalent. Conversely, individuals who work outdoors and have increased sun exposure show a decreased prevalence of MS. Interestingly, the effect of latitude on MS risk is most prominent in infancy in childhood — meaning that moving to an equatorial climate later in life is of limited benefit.
However, a direct link to early childhood vitamin D deficiency and development of MS is lacking, and there are other factors that may cause the same geographical effects. In North America, people of Scandinavian descent are concentrated in the Northern and Western areas, which are the exact locations with the highest MS rates. This suggests the possibility that genetics, in addition to environment, play an important role. Some studies have found South Asian immigrants to Northern climates to have no increased risk of MS, while others find they, or their offspring, to have increased rates of the disease. British migrants to Africa have lower rates than their counterparts who remain in the UK. Clearly there is some interplay between genetic and environmental factors.
There is seasonal variation in the development of MS, based on birth month. Infants born in May have the highest risk, while those born in November have the lowest. This phenomenon may also be explained by exposure to UV light. Women who are pregnant during the winter, and giving birth in late spring, have decrease sunlight exposure compared to those who are pregnant during summer months, suggesting beneficial effects of UV exposure in utero (womb).
Inheritable factors are also present — monozygotic (identical) twins show a higher concordance rate of the disease than non-twin siblings and unrelated persons. In addition to genetic and geographic factors, certain viruses, smoking and female sex are also associated with increased risk of MS.
Clearly we are far from understanding this disease. MS has a variety of seemingly independent factors associated with its development. In addition to the usual suspects — genetics, sex and poor health habits such as smoking — MS is also linked to what appear to be unrelated and uncontrollable factors such as birth place and birth month. The true link underlying all of these factors is currently unknown, but when it is ultimately identified may provide key insights into the pathogenesis and potential treatment pathways of this poorly understood disease.
Reference: Ebers, G. (2008). Environmental factors and multiple sclerosis. The Lancet Neurology, 7(3), 268-277. DOI: 10.1016/S1474-4422(08)70042-5
Scientists have recently pinpointed genes that can predict who is more likely to get Multiple Sclerosis (MS). MS is thought to be an autoimmune disease, meaning the body attacks itself, and to date it affects approximately 400,000 Americans. Every week about 200 people are diagnosed with this potentially debilitating disease in the US alone. Although the most common image of MS is an elderly individual in a wheelchair, the first signs of disease (periods of dizziness, double vision) often appear in the late teens or early twenties, and twice as often in women. The patient may recover completely, partially, or not at all after this first “relapse” episode, and it is a lifelong disease. Most MS patients will get some permanent disability later on in their lives.
MS is a disease for which we have no cure, because scientists know very little about what causes it. Current treatment options can only modulate the disease or lessen the symptoms. There are generally two streams of thought in the scientific community on what causes the disease: it is either thought to be triggered by the environment, or it is thought that there is a genetic predisposition. Many scientists also propose both factors play a role, given the current evidence. For instance, in Japan, the adoption of a “Western” lifestyle starting in the 1950s has been correlated with a dramatic increase in the incidence of MS. Also, there are statistics showing that the further away from the equator, the higher the incidence rate of MS. It has even been proposed that Vitamin D, which our body produces with the help of sunlight, plays a protective role against MS. It would make sense then, that the sun-intensive equator regions would have a lower incidence of the disease.
Nevertheless, it is now known that genes do play an important role in predicting MS as well. A study spearheaded by researchers from Duke University have found that an important marker in the development and programming of the immune system called the Interleukin 7 alpha receptor (IL-7RA) strongly correlates with MS disease susceptibility. It is now being investigated whether this marker plays a role in causing the disease, providing a valuable clue as to how and why certain people get this illness. Despite the fact that much more research needs to be done, the study provides strong evidence that genetics are an important component, and point the research community in a helpful direction in finding a cure for the disease.
Gregory S et al. IL 7 Receptor alpha chain shows allelic and functional association with multiple sclerosis. Nature Genetics 2007 Sept, 39(9):1083-90.
Broadley SA. Could vitamin D be the answer to multiple sclerosis? Multiple Sclerosis 2007 Aug;13(7):825-6.
Kira J. Multiple sclerosis in the Japanese population. Lancet Neurology 2003 Feb;2(2):117-27. Review
Magnetic Resonance Imaging (MRI) is an important imaging technique used in the medical field to diagnose many diseases and detect abnormalities in the human body non-invasively. In the neurological sense, an MRI is often performed to obtain an inner image of the brain if unusual activity is suspected. For example in the case of multiple sclerosis (MS), abnormal spots called lesions can be detected with an MRI before clinical symptoms occur. MRIs have advantages over other imaging methods because this system is thorough and can be used to detect small subtle changes during the early stages of diseases. One limitation is that the scans usually take several hours to complete.And that concludes the 9th edition of the Carnival.
Now, thanks to dedicated researchers at the University of Illinois in Chicago, the world’s most powerful MRI is ready to be used to help the first patient. The team’s machine received final approval from the Food and Drug Administration (FDA) in the cusp of the 2008 new year. With an entire journal article solely dedicated to the safety of the machine in the Journal of Magnetic Resonance Imaging, the 9.4 Tesla machine will open up a new field in medical imaging, particularly neurology.
Typical clinical MRI scanners have magnetic field strengths of 0.2 to 3 Tesla. At these strengths only the movement of water molecules can be visualized, which limits the observation of metabolic processes in the brain to abnormal cystic or tumor formations and abnormalities in blood vessels or the heart. In 2003 MRIs with magnetic field strengths as high as 8 Tesla were accepted by the FDA, but to date, the 9.4 Tesla scanner is the most powerful clinical scanner that is large enough to acquire images from the human brain.
The 9.4 Tesla MRI allows doctors to visualize molecules other than water. For example, doctors will now be able to perform sodium imaging to determine whether a brain tumor is shrinking, growing, or migrating all in one visit. Previous MRI scanning required that the patient make several trips to the hospital over a period of weeks and sometimes even months. The reason that only one visit is necessary with the 9.4 Tesla scanner is that this high magnetic field strength allows more molecules to be visualized in a shorter period of time in comparison to the lower strength scanners that are currently being used. Imaging technology is now moving towards patient studies such as sodium imaging and towards safety testing for oxygen and phosphorus imaging in humans. Researchers are hoping that this scope can even be extended to other, more rare molecules in the future.
Analyzing a patient’s metabolic pattern after the administration of a therapeutic agent will allow doctors to customize treatment plans as well as determine the optimal type and amount of drugs to prescribe their patients. There are no known harmful side effects of undergoing an MRI besides the exposure to magnetic fields which should be avoided during pregnancy. Patients undergoing an MRI procedure sometimes experience mild nausea or claustrophobia from being inside of a chamber.
Currently MRI is the preferred imaging technique in diagnosing and monitoring diseases such as stroke, tumors, blood vessel abnormalities, infections, Multiple Sclerosis, and many other neurological and non-neurological diseases.
Reference: University of Illinois at Chicago (2008) World’s Most Powerful MRI Ready To Scan Human Brain. ScienceDaily.
If the MS patient uses Copaxone, which is a daily injectable, how long does it take to fill that 100oz Tide liquid laundry detergent bottle to the brim with used syringes?Whoever gets closest to the correct answer (as determined by my personal experience) will receive something special from me. Whatever that something special is I haven't decided yet. But hopefully, that will make this challenge all the more interesting.
"Now Tier 4 is also showing up in insurance that people buy on their own or acquire through employers, said Dan Mendelson of Avalere Health, a research organization in Washington. It is the fastest-growing segment in private insurance, Mr. Mendelson said. Five years ago it was virtually nonexistent in private plans, he said. Now 10 percent of them have Tier 4 drug categories."The concept of a 4-tier pharmacy benefit plan is not new and my health insurance policy has had that structure since at least 2000. As a self-employed musician, I purchase my health insurance independently, thus having an individual (non-group) policy with a well-known Blue Cross Blue Shield licensee in the Washington, D.C. area.
"Although MS bloggers have been sounding the alarm for some time, we haven’t seen much in the mainstream press which addresses our concerns. It is important that we keep this issue on the front burner, especially as election time nears."Jeri at Fingolimod and Me - Co-Payment for MS Drugs Going Sky High
"I am terrified about what will happen when this Fingolimod trial ends and I no longer get my medication for free. I strongly believe that the medicine is the reason for this long period of remission that I am enjoying, and the health care system is putting a price on that for me. I know it will be out of my reach once it has gone to market and I am forced to pay for it."Doug at Shoester - In the News: Big Copays for MS Drugs
"Raising copays for a few sick people means many healthier people will pay less (duh), but, as a practical matter, also means the health insurance safety net is getting smaller."Kevin, M.D. - New Tiered Pricing for Drugs
"Patients have been shielded from costs far too long, subsequently leading to an entitlement mentality. Health care is expensive, and people are starting to realize that with the emerging co-payment structure."Peter Zavislak at Medical Pastiche - Solving Moral Hazard: Increase Copayments
"In the long-run, this will decrease prescription-healthcare costs by decreasing the incentives of moral hazard.From March, PhRMA statement on Prescription Sales Growth
Out of control pharmaceutical usage-costs are part of the reason why healthcare is so expensive in this country, and a step such as increasing coinsurance rates is a good way to start reducing overall costs, in the hopes of putting more money elsewhere. It will be interesting to see what effects these changes will have in future healthcare."
“Ultimately, according to CMS, medicines accounted for roughly 10 percent of total health spending in the U.S. in 2006 – the same proportion as in 1960."Vijay Goel at Consumer-Focused Healthcare - Tier 4 Copays: A Flawed Approach to Keeping a Lid on Drug Costs
Richard Eskow at The Sentinel Effect - Tier 4 Drugs: An Industry Response
"It makes sense that payers would want to check the growth in expenditures driven by specialty medications (estimates are the sector will increase from $54B in 2006 to $99B by 2010). Many of these medicines run in the thousands of dollars per month and have no generic equivalents. [see When Will We Have the Option of Generic MS Self-Injectable Drugs?]
Instead, the Tier 4 programs look to limit overall utilization of a helpful drug while not reigning in marginal pricing-- causing significant pain to the people most in need and not changing the incentives of the pharmacos."
"When plan designs are no longer made to change behavior, but simply to transfer high-cost items back to the insured party, that’s risk transfer and not benefit design. As a result, the insurance concept is being subtly modified - and arguably undermined."Editorial in NYT - When Drug Costs Soar Beyond Reach
"The insurers say that forcing patients to pay more for unusually high-priced drugs allows them to keep down the premiums charged to everyone else. That turns the ordinary notion of insurance on its head. Instead of spreading the risks and costs across a wide pool of people to protect a smaller number of very sick patients from financial ruin, insurers are gouging the sickest patients to keep premiums down for healthier people."Whitecoat Rants - Insurance Companies Deny More Care
"Does anyone find it interesting that the same patients who use those medications are the ones that tend to use more medical services in general? This whole Tier 4 pricing scheme is just a way for insurers to discriminate against patients with chronic disease."Dr. Denny at Scholars & Rogues - Seriously Ill? Need Costly Drugs? Go Broke or Die
Mandy at MSMaze - MS and Stress Go Hand in Hand
"The drugs covered by these Tier 4 and Tier 5 categories are expensive. So if these tiers charge a percentage of the cost rather than a flat co-pay, it can become ruinously expensive.
If you’re suffering from the relapsing-remitting (RRMS) form of multiple sclerosis, you may be taking Copaxone to reduce the relapse rate. The drug may cost nearly $2,000 a month. Your co-pay might have been a flat-fee $25 a month in a three-tiered plan. Under Tier 4 or 5, the co-pay may be a percentage of the whole cost.
At 25 percent of Copaxone’s cost, your co-pay could hit $500 a month (unless capped at a specific amount). That’s a life-altering 1,900 percent increase."
"I have no choice in pharmacy for these precious injectable drugs. Insurance company allows but one, and they are an unpleasant group at best. They still wanted to charge me more than my maximum monthly out-of-pocket [which is $500 per script]. Interestingly, they wanted to charge even more than the previous month."From February, Dr. Gross at Health Central - MS and Like Diseases Get Short Shrift in "Health Care" Debate
"We must have universal affordable specialty care for all patients with MS...a big-ticket item for seriously ill people, afflicted with a disorder whose onset had nothing to do with life style."Merrill Goozner at Gooz News - High Biotech Drug Prices = A Failed Industrial Policy
"Insurance companies are charging many patients thousands of dollars a month in co-pays for very expensive drugs, the New York Times reported this morning. A quick glance of the list of drugs that the insurance industry funneled onto this so-called "Tier 4" co-pay list are recombinant proteins, products of the nation's biotech industry.
About half of the one dozen drugs highlighted in the graphic accompanying the article are made by Amgen and Genzyme, two of the nation's leading biotech companies. But rather than re-exploring the failures of these biotech industry giants, let's look at Copaxone for multiple sclerosis, which was the drug featured in the lead anecdote in the story and is made by Teva Pharmaceuticals, an Israeli company whose original claim to fame was as a maker of low-cost generics.
From the FDA Orange Book, we learn that the Food and Drug Administration approved this drug in 1996. From the nation's public registry of clinical trials, we learn that the primary approval trial for Copaxone (copolymer 1, a combination of four recombinant proteins) involved about 250 patients with relapsing MS, half of whom were randomized to placebo.
This trial, according to the government, was conducted at the University of Maryland on a National Institutes of Health grant with information provided by the Office of Rare Diseases at the Food and Drug Administration. In other words, taxpayers like you and me paid for the seminal research that brought this drug to market.
According to this website produced by a Brit with MS, we learn that Copaxone reduced the rate of relapses among patients taking the drug by about 29 percent. Subsequent trials, funded by Teva, showed that it was slightly superior or equal to the other drugs for the condition that are on the market (Betaseron by Bayer and Avonex by Biogen, both of which are recombinant forms of interferon). Most of these trials involved just a few hundred patients, and often did not have the statistical power to prove anything in these head-to-head comparisons.
Teva continues to fund research. Again, a quick glance at Clinicaltrials.gov suggests most of these trials compare Copaxone to other drugs for the condition. There are also a few companies seeking to get approval for their own brands of interferon to fight MS, undoubtedly attracted by the high prices set on Copaxone. The government is also still involved. The National Institute of Neurological Diseases and Stroke (NINDS) has financed Dr. Fred Lublin of Mt. Sinai Medical School to test 1,000 patients randomized to either Copaxone, Avonex or placebo. Unfortunately, that trial, which began in 2005, won't be completed until 2012, just two years before Copaxone goes off patent.
Now let's follow the money. A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients.
The only justification for the high prices slapped on this government-funded discovery is that it would generate research into new drugs and significant therapeutic insights. Consumers, who paid the tab through their insurance premiums, got neither for their investment. And the government, which could have used that money and much less of it to get started earlier in funding definitive trials, now must come with another huge infusion of cash (a 1,000-person trial will cost at least $10 million) to sort out the mess.
In 1991, when then Secretary of Health and Human Services Louis Sullivan was hauled before Congress to explain why it was paying so much money through the Medicare program for Amgen's Epogen, which is used in dialysis patients, he testified that it was to show Wall Street that this new exciting industry -- biotechnology -- would generate generous returns if it came up with innovative products. Isn't it time to call a halt to this failed industrial policy, especially when it comes to drugs brought to market with taxpayer support? Surely the patients like those now paying 25 percent of the cost these drugs in Tier 4 co-payments deserve better."
I am a baker. I love to cook. It is one of my passions, and I can say that I am pretty good at it too. I make a mean loaf of Challah and Kickin’ Chickin’ Stew. I still cream the butter and sugar together by hand, I tirelessly whip the egg whites and knead the bread dough with tiny pearls of sweat clinging to my young brow. It can take me an extra 30 minutes to mix up a batch of muffins because my arm weakness requires I take a rest between adding ingredients blueberry and flour; sure, it’s daunting but I do it anyway.
Why have I done it this way for what seems like forever? There has been something missing from my kitchen all these years. That’s why.
I know. I deal with things in a strange way, All this excitement, and all the acceptance was overwhelming I guess. My hunny kept asking me “Aren’t you going to use it?!” Like I was crazy. Well I was crazy. I really did not want have to use it.
I am proud to say that the love I put into my food still shines through, even when it assisted by [the mystery item]. The best part is my arms are saved, born again. I am free to enjoy what I make now vs being to tired to enjoy it from making it!
I am thinking about my commitment to swim again and I can't wait... I won't be able to swim until I get my ear plugs that will arrive about two weeks from yesterday. Being deaf and wearing hearing-aids, I can't afford to have ear infections that I often get when swimming, so ear plugs are great investments.
I have flexible spending accounts (FSAs) which allow me to pay for prescription drugs and doctor visits with pre-tax dollars. I want to use this for [YMCA] membership and according to the benefits list, I am eligible only if my doctor prescribes for me to exercise. In 2001, the IRS released its Revenue Ruling 2002-19, which states that certain health club service fees, not including health club dues, may qualify as tax-favored medical expenses. Such services must be prescribed by a physician for the treatment of a disease, including, but not limited to, obesity, heart disease, hypertension, high cholesterol, counseling for weight-reduction, nutrition, cholesterol, or hypertension, and type 2 diabetes. Physical inactivity are associated with 23% of health plan charges and 27% of national health care charges. I say, I need help to find ways to stay active that is financially affordable. Anyway, I am going to check with my doctor and see if she could prescribe for me to join YMCA.
Sex is a topic that always seems to be talked about anonymously on the MS Society message boards and seems to be something people can be worried about talking about or ashamed. I understand why in most cases but I thought I'd share my experience seeing as it is a fairly common problem for people at some stage or other of their MS.WHOA: We stop this important broadcast for the following announcement. The steamy contents of Vicky's Sex post from this point on have been omitted to spare the innocent, but you can certainly read all the good stuff in its entirety here. Subjects include a tongue, a pet Rabbit, naughty text messages, nookie, afternoons, orgasms, and most importantly SEX.
Originally my problems were isolated to the left side of my torso and my lower legs. Then one morning I woke up and the numb feeling was all the way up to my bum and I was having to check with my hands that I was sat on the loo seat properly, I also felt like I had a permanent 'wedgy' which was really, really annoying!
I realised, having been to the loo that although I could feel the area around my genitals it was not a normal feeling - interesting I thought - but possibly not good. I went to the Dr shortly after this and was referred to a neuro - lucky me, no faffing, no 'its stress' just, go see a neuro.
I'm not sure when my other half and I next had sex but I am a big fan of getting my pleasure in - and I am not that easy to please! [...]
There is a sin even greater than [speaking lashon hara], and one which is more widespread, i.e., the sin of refraining from informing another about a situation in which one can save him from being victimized—all out of concern for lashon hara… One who behaves in this manner, his sin is too great to bear and he violates, "You shall not stand by the blood of your brother." - Pithei TeshuvahIn "When the Disease Eludes Diagnosis," Dr. Barron Lerner discusses one of his longtime patients, Lucy, who feels she has a neurological ailment which has not been adequately diagnosed.
Although I hope to make further progress on her case, I have also told her that there may never be a definitive answer. Not surprisingly, she is feeling pretty frustrated with me.Barron H. Lerner teaches medicine and public health at the Columbia University Medical Center.
Why do doctors and patients often approach the diagnosis of disease so differently? Part of the answer lies in the concept of triage... [...]
Patients’ frustration may rise even more when their conditions are especially obscure. I once had a patient who complained of persistent drenching sweats that forced her to change her bedclothes several times a night.
Upon learning of this problem, I first went into triage mode, ruling out possible dangerous causes, including tuberculosis, a thyroid abnormality and rare tumors that release hormones. I referred her to a gynecologist on the chance that she was getting hot flashes decades after her menopause.
When all the tests were negative, my patient was understandably upset, even angry. “No doctor that I have spoken to has been able to tell me what it is,” she said, as I remember. She even called a doctor on a local radio show for his opinion.
I recalled this story when I learned recently that my longtime patient Lucy’s new neurologist was questioning whether she had multiple sclerosis, a diagnosis she has carried for more than 25 years. Since I have known her, Lucy has had painful and weak legs that necessitate a walker.
Rather than simply corroborating her existing diagnosis, this doctor had thought outside the box, noting that Lucy’s relatively stable condition — and her lack of brain lesions on an M.R.I., a test not available at the time of her initial diagnosis — warranted a new perspective.
At first, Lucy was excited too. After all, being told you may not have a serious disease like multiple sclerosis is surely good news.
But while the neurologist had correctly questioned the diagnosis, she had a harder time finding a new one. Lucy became discouraged. “I want to know,” she told me. “I point-blank asked the neurologist, ‘What is it?’ And the only answer she can give me is: ‘I don’t know. I’m not sure.’ ”
Eventually, the neurology team decided that Lucy had an atypical form of multiple sclerosis, one that caused unusual neurological symptoms and was present in the spinal cord but not the brain. Yet the doctors admitted that this diagnosis generated more questions than answers about Lucy’s prognosis and her future treatment.
While trying to be as sympathetic as possible, I find myself reminding Lucy of the limits of certainty in medicine. Despite enormous advances in technology, some diagnoses may remain elusive. I also told her that it was highly unlikely her doctors missed diagnosing a disease that could have been successfully treated. But she remains convinced that she deserves to know exactly what she has.
So we will continue to search.
I had given little thought to the possibility that records related to (and unrelated to) my blog might be subpoenaed for any legal reason. It somehow indicates the increasing power and influence which individual bloggers are gaining in the world of citizen-journalism.
Legal thuggery is sure to make a medical blogger's heart stop. Eric Turkowitz over at New York Personal Injury blog links to the buzz created by New Hampshire blogger Kathleen Seidel of Neurodiversity.com, and her remarkable post entitled "The Commerce in Causation." Ms. Seidel is a level-headed, well-researched citizen-journalist who has tirelessly investigated the pediatric medical research conducted by Rev. Lisa Sykes, Mr. Clifford Shoemaker, and their colleague Dr. Mark Geier; their efforts to compel removal of mercury-containing antimicrobials from FDA-approved vaccines; and their "judicial advocacy" campaign.
After sharply criticizing Shoemaker's legal incentives, she received a subpoena within four hours from Mr. Shoemaker, the plantiffs' council, demanding "bank statements, cancelled checks, donation records, tax returns, Freedom of Information Act requests, LexisNexis® and PACER usage records. The subpoena demands copies of all of my communications concerning any issue which is included on my website, including communications with representatives of the federal government, the pharmaceutical industry, advocacy groups, non-governmental organizations, political action groups, profit or non-profit entities, journals, editorial boards, scientific boards, academic boards, medical licensing boards, any 'religious groups (Muslim or otherwise), or individuals with religious affiliations,' and any other 'concerned individuals.'...."
Not intimidated, Ms. Seidel subsequently filed this well-targeted motion to quash the subpoena. It's an incredible story exposes the underbelly of a potential new legal tactic that could be imposed against bloggers anywhere: issuing malicious subpoenas to quell bloggers' free speech.
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