Sunday, 23 June 2013

Adopting the HIV model

What can we learn from HIV and HIVers? #MSBlog #MSResearch

"Can studying the history of the HIV/AIDS epidemic and the scientific response to the epidemic teach us anything and help MSers with their plight when it comes to accessing effective DMTs early in the course of their disease?"


"The following is a must read open-access perspective article from the New England Journal of Medicine."


Allan Brandt. How AIDS Invented Global Health. N Engl J Med 2013; 368:2149-2152




Excerpts:


.... The rapid development of effective antiretroviral treatments, in turn, could not have occurred without new forms of disease advocacy and activism. Previous disease activism, for example, had established important campaigns supporting tuberculosis control, cancer research, and the rights of patients with mental illness. But AIDS activists explicitly crossed a vast chasm of expertise. They went to Food and Drug Administration meetings and events steeped in the often-arcane science of HIV, prepared to offer concrete proposals to speed research, reformulate trials, and accelerate regulatory processes. This approach went well beyond the traditional bioethical formulations of autonomy and consent. As many clinicians and scientists acknowledged, AIDS activists, including many people with AIDS, served as collaborators and colleagues rather than constituents and subjects, changing the trajectory of research and treatment. These new models of disease activism, enshrined in the Denver Principles (1983), which demanded involvement “at every level of decision-making,” have spurred new strategies among many activists focused on other diseases. By the early 2000s, AIDS activists had forged important transnational alliances and activities, establishing a critical aspect of the “new” global health.....

"Where are the MS activists? Why are you not camped outside the EMA with banners stating 'enough is enough'? How many more unemployed MSers do you need to see? How many more divorces, suicides, walking sticks, wheelchairs, falls, fractures do you need to see for us to convince you that we need highly active DMTs early in the course of our disease? Did you know the main burden of MS in the early stages are cognitive impairment, fatigue and depression? Do you want  the next generation of MSers to dement before you allow us access to these treatments?" 

..... HIV has also attracted remarkable levels of private philanthropy, most notably from the Bill and Melinda Gates Foundation. HIV funding led to new public–private partnerships that have become a model for funding of scientific investigation, global health initiatives, and building of crucial health care delivery infrastructure in developing countries. These funding programs have fomented contentious debates about priorities, efficiency, allocation processes, and broader strategies for preventing and treating many diseases, especially in poorer countries. Nonetheless, they offered new approaches to identifying critical resources and evaluating their effect on the burden of disease. The success of future efforts will depend on maintaining and expanding essential funding during a period of global economic recession, as well as new strategies for evaluating the efficacy of varied interventions....

"We need more MS Philanthropy. We need wealthy donors to fund MS prevention studies. We need to shift the paradigm away from treating too late to treating as early as possible. Did you know that since highly-active anti-retroviral therapies (HAART) were launched HIVers can now expect a near-normal life expectancy? Some say this is a miracle. It is not. It is what hard work by the community and a remarkable partnership between HIVers, scientists, politicians, regulators, funders and charities can do. Why does it seem like everything is such a fight in the field of MS? Why don't the regulators (EMA & NICE) see that all we are trying to do is give MSers with active MS the equivalent of HAART? Why are there so many therapeutic nihilists in the neurology community? Why are we so patronising towards MSers and assume that they can't make decisions about risk? HELP!"



"I suggest we adopt the term highly-active from the field of HIV to describe the next generation of DMTs. Aggressive is the wrong adjective to describe DMTs; aggressive has too many negative associations."

HIGHLY-ACTIVE DISEASE DISEASE MODIFYING THERAPIES (HA-DMTS)

"Did you know that in most developed countries guidelines suggest that if your are HIV positive you should start HAART as soon as you receive a diagnosis. Why wait for the virus to start slaughtering your immune system before starting treatment? Sounds obvious; it is also backed-up by class 1 evidence from clinical trials. In MS we have similar evidence but the regulators are so concerned that we will expose MSers with benign disease to risks associated with these therapies that they err on the side of being overcautious and deny everybody, except a minority of highly-active MSers, access to these therapies as first-line agents.  Most HIV clinicians try and suppress the HIV virus to levels that the virus is undetectable, i.e. no detectable viral activity. Sound familiar? NEDA - no evidence of disease activity. We are we so behind the curve with adopting these concepts that some are referring to us being dinosaurs? MS is a brain shredder why accept anything less than complete suppression of the disease?"




A CALL TO ARMS:
  1. WE NEED MSER ACTIVISTS - the more militant the better.
  2. WE NEED MSER ADVOCATES TO RAISE THEIR HEADS ABOVE THE PARAPET - neurologists, nurses, health economists, politicians, scientists, etc, where are you? 
  3. WE NEED PHILANTHROPISTS - as a start the community needs several million pounds to kick-start an MS prevention programme.
  4. EDUCATION - we need to get MSers and their healthcare professionals educated about these concepts.
CoI: multiple

45 comments:

  1. A fantastic post. I am not sure everybody will agree with you, but I am up for it. What can we do to help? Maybe we should all write to our MPs? Are you referring to Campath when you talk about HADMTS?

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  2. Thank you for taking the effort.

    Does the EMA hold open meetings? Is there timetable you can send us?

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  3. What a provocative post; have you spoken to MS Society about your call to arms? For example, they should lead the EMA protest. With all your conflicts you will labelled as having Pharma's interest at heart.

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  4. Unfortunately, some of the slow progress must fall at the feet of the MS researchers. 60 years of research and the world experts can't tell us the cause, whether it's an primarily an inflammatory disease or a neuro- degenerative disease etc. etc.

    Where are the Jenners or Curies in MS research? Why aren't you coming up with the answers. It's all very well passing the baton to patients - unfortunately I can't stand for more that 20 mins and finding a public toilet is near impossible these days. Who will pay for us to go to the EMA?

    Every other specialism has made leaps and bounds over the lst 100 years. It's only neurology where the results hav been so poor. Perhaps there should be a payments by results system - but this would led to most MS researchers on the dole. Many are making a nice living out of this disease - NHS consultant salaries, fees from drugs companies, a merry go round of international conferences in lovely locations. Yet the blame for the situation is that us crippled up, demented humans aren't making enough noise.


    Perhaps it's time for MS researchers to reflect on why they are doing this work. For the money? For the academic kudos? Or because they want to help those struck down by a terrible disease? A focus of the latter, with a bit of well considered risk taking, will bear fruit. Ditching EAE will be a start.

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    1. "Where are the Jenners or Curies in MS research? Why aren't you coming up with the answers."
      MS is an incredibly complicated disease, more complicated than was realised even 10 years ago. If it was a simple problem, we'd have had the answer years ago. The answers are coming but it will never be quick enough, either for you or us but as someone who has worked in the field for 25 years the pace of understanding is increasing all the time.
      We researchers certainly don't do it for the money, I'm sure I could double my salary if I jumped off to pharma. The academic kudos is nice but because other people think our work is good and we are on the right track.
      As we are one of the rare MS research groups that actively engage with MSers via this blog and numerous patient meetings we certainly can't be accused of not wanting to help those suffering with MS (I also have a family member with MS).
      As for ditching EAE then if your happy that the pace of research will inevitably slow then think on. Most of the current and future drugs have come directly from EAE studies and although the model in general isn't perfect (though ours is more realistic than all the others) this will be the case for the foreseeable future. Hopefully there will come a time when we don't need animal models but that time is still some way off.

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  5. Absolutely agree with the first posters here - and with Prof G - it seems that if we want to beat MS we need to be more militant and vociferous! But as also pointed out, that is difficult when living with the practical problems of limited mobility.The numbers of people affected are a lot smaller than in the case of HIV/AIDs, but international mobilisation would swell the numbers.

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    1. wat about lobbying the at the house of commons/lords at the select committee for MS and actually getting them to do something.

      The are asking clinicians to re purpose drugs but have they created the environment and incentives for this to happen..Answer I think is no make them prove me wrong.

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    2. Hmm, you mean as an individual? I will look into it. Trouble is i am one of the lucky ones working full time with not much time outside work/travelling/domesticity. I don't really know where to begin, but will use my friend mr google to make a start.

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  6. I'll help as much as I can. Exactly what needs to be done.

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  7. Looks like a call for more research money? But where would the money be spent? Would MS researchers really start delivering results and in good time - past performance isn't a good indicator. The interferons and copaxone I now acknowledged as being mildly effective at best. Tysabri comes with the risk of PML. Alemtuzumab looks like its the real deal for early RRMS, but what about the rest of us? Would more money allow you to get neuro-protective agents to market quickly? What about repair?

    What needs to happen is the neuros start using highly effective drugs as first line therapies e.g. Alemtuzumab if it gets a licence. You would be doing it in the best interests of your patient (isn't that your job?). If enough of you started acting like this, the licensing bodies / NICE would see how powerless they were. What is the fear - medical tribunal? Accussationthat you prof G acted in the best interest of your patients as you wanted to reduce the risk of them getting more disabled!

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  8. Perhaps the teams that cracked HIV should tackle MS - there's supposed to be a viral component.

    I also think we need new blood (not you Prof G - we need more like you). I look at the various conferences and there's a gaggle of MS academics who spout the same stuff year on year (prof B, Prof E, prof T). There's equivalents in Europe and the US. They've had their day and we need energetic researchers willing to break he mood and drive things through. With the technology revolution we've seen over the last decade (MRI, processing post) the breakthroughs should have already materialised. Too many stove pipe research teams not collaborating in a way that benefits patients. Too many drugs companies making so much money from ineffective ms drugs that they have no real incentive to really try and get much better ones to market - biogen and BG12 is a classic example. The recent IL7 fraudulent research is another sign of how rotten things are.

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  9. "Would MS researchers really start delivering results and in good time - past performance isn't a good indicator."
    The past is a foreign country, they do things differently there. We need to live in the present and look to the future.

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  10. Multiple sclerosis and AIDS crisis of the early 1980s are entirely different situations and Don Giovannoni is missing the point if he believes that MSers can effectively ape the strategies deployed by HIV sufferers and their families back then.

    AIDS was a pandemic. It was like something out of a scary movie whereby a terminal contagion was spreading from person to person while a ticking clock hung in the background, counting down to finality. AIDS was a great unknown, primarily labelled as ‘gay cancer’. The gay community was extraordinary in mobilising troops and recruiting manpower. Furthermore, the gay community comprised of affluent/ prolific doctors, lawyers, journalists, politicians and powerful media players; the types of people that can get the world’s attention. MS is not in the same league.

    MS is not transmitted from person to person. It is not increasing in numbers, nor is it killing people within a very short time frame. It’s not a cinematic or ‘sexy’ disease like AIDS or cancer: it’s slow and dismissive. You can very easily ignore MS in a way you cannot with HIV because anyone can get AIDS only by transmitting it, but you can’t get MS in the same way. MS seems rather bland and boring when compared to many other diseases. That’s not a diss, it’s just the way things are. I mean, even Kanye West is rapping about Parkinson’s disease on his new album but he would never do the same with MS only because it isn’t as visceral as the former. MS is a disease we can very easily overlook and disregard.

    Don Giovannoni is committed to MS and wants everyone around him to be just as devoted, but most can’t be bothered. Most MSers can live their lives and ignore the fact they even have a disease. They can hide it and demand that others never bring it up. In that way no wonder such apathy exists in the MS community. They can create a dream world and exist in it until (and if) they start to degenerate in visible ways.

    Look Prof G, MS has had a lot of philanthropy and goodwill, only there is jack all to show for it. Harry Potter author JK Rowling donated £10 million to set up a new multiple sclerosis research clinic three years ago that has delivered jack all, while the Nancy Davis Foundation invites the toast of Hollywood to its annual Erase MS fundraising night which has also delivered jack all. The problem in the field of MS research is that too much money has been squandered and not enough tangible results delivered. I’d say that we need to stop investing in MS research and get them to think more creatively about how to do their work with less funding, which may actually harvest better results.

    The disabled community of Britain, which consists of millions, has militantly campaigned for the last three years for essential services and look how badly that’s worked out. Therefore, there is absolutely no chance of the government taking the plights of a few thousand MSers any more seriously.

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    1. Gosh, I never thought that I'd say this but hooray for Dr. Dre! What he has just said hits the nail on the head. MS is not the same type of disease as HIV and will require a very different approach to publicise it. He's right in highlighting the huge sums of money invested in MS research and how poor the results have been.

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    2. Actually you could say the same thing about cancer. Billions have been spent on it yet people still get cancer and for a number of cancers the prognosis is still bleak yet for some it isn't so has this been a waste of money? In my opinion no, though I'd like to see the money spread around to other diseases like MS more.
      Again you forget that not so long ago the technology to study these diseases was way behind what we have now. People at the time did the best with what was available and would give their eye teeth to have access to what we have now.
      The outlook for MS gets better all the time and it can only be a matter of time before the new treatments are widely available.
      If we shared Dr Dre's defeatism, we wouldn't bother doing what we do and in my opinion that would be a grave loss.
      As for Dr Dre's point that MS researchers need to think more creatively about how to do their work with less funding, well I can tell you that for many years we managed to do our research with NO funding, yet produced spectacular results.

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  11. Dr Dre is right - HIV / Aids totally different ball game. High proportion of gay men in the entertainment business and a number of high profile deaths. Others in entertainment were keen to show support and politicians were keen to jump on the bandwagon. The victims of the disease were poor black kids in Africa and gay singers and actors - the perfect storm.

    MS is a pins an needles disease. Those in the late stages aren't seen by the general public, bar Debbie Purdy.

    We'd be better tying up with Parkinson's and Huntingtons. We've all got brains which are being shredded and the research teams can't identify the cause or come up with cures.

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    1. Some high profile MSers in the public eye; Richard Pryor, Jack Osbourne, Montel Williams, Alan Osmond, Anne Romney (wife of Mitt), William Hartnell (1st Dr Who), Clive Burr (ex drummer with Iron Maiden), Alastair Hignell (rugby player and broadcaster), Joan Didion (novelist), Bryan Forbes (actor and director), Danny Wallace (footballer), Ronnie Lane (bassist in the Faces), Stuart Henry (Radio 1 DJ), Teri Garr (actor), Michael Kamen (musician/composer), Margaret Leighton (actress), Don van Vliet (the mighty captain Beefheart, musician), Victoria Williams (musician), Clay Walker (musician), Jaqueline du Pre (musician and the first to make me aware of the disease), Benjamin Cohen (tech correspondent for Channel 4 news), Marianne Gingrich (ex-wife of the odious Newt), Lena Horne (singer), Colin Pillinger (scientist behind the Beagle 2 mission), to name but a few so I would suggest the profile is at least as high as AIDS.

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    2. Forgot (to my shame) the paralympic swimmer Stephanie Millward who visited our lab after the paralympics last year (with all her medals).

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    3. Are you kidding me MD2? Reading your list of prolific celebs made me shout out, "WHO?" I've not heard of most of them. This is what I find so confusing about the MS campaign. It's almost like the government saying there are green shoots of economic recovery and the public scratching their heads flummoxed by the statement because everything suggests there isn't. MS hardly has any profile at all. The AIDS charities are totally linked to celeb culture whereas MS remains ruled by unfashionable cake breaks and geriatric fundraising gimmicks. I thought that people with MS are primarily youngsters but the campaign face of the disease is totally old and uncool. One equates MSers as being a bunch of twee losers sat at home watching Downton Abbey box sets.

      If you are honestly claiming that MS has a disease profile as culturally potent as AIDS then you really haven't got a clue.

      Imagine if Cheryl Cole came out as an MSer or Kim Kardashian did. Imagine just how hot topic MS would become because those figures know how to entice media and glamour in the name of good causes. Think about the media coverage Angelina Jolie's preventive double mastectomy received and how it made the primetime headlines. The MS campaign needs youth and glamour, two thing you'd have thought it may already have in relation to the types of people it affects. What it doesn't need are a bunch of middle-aged lab rats telling us everything is proper irie when it is not.

      To every MSer out there reading this right now: Are you better off than you were four years ago? If you are then I owe MD2 an apology. If you're not then he has to get with the times and stop living in a bubble.

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    4. "Are you kidding me MD2? Reading your list of prolific celebs made me shout out, "WHO?" I've not heard of most of them."

      Well it seems your cultural knowledge is as blinkered as your opinions.
      Open your mind don't revel in your ignorance.

      proper irie? Can't seem to find that in my Latin lexicon.

      If you want some young peoples perspectives on MS, try here. http://shift.ms/ no doubt you'll find plenty to get aerated about there too.

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    5. MD2,

      Du Pre died at 42, Ronnie Lane died at 50, Burr died a few weeks ago at 57 (Forbes died recently but didn't have MS). Captain Beefheart died recently. The message which needs to get out is that MS kills. EDSS 10 is death due to MS. Our real hope is Jack Osborne as family has lots of money and mother is on national tv in UK and MS.

      PS thanks for all your hard work

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    6. BTW I know what proper irie means. You Jafaican or the real deal?

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    7. Anonymous 5.23
      Thanks. Worryingly, Jack Osbourne seems to be falling into the clutches of the quacks. I hope I'm wrong.

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    8. PS MD and myself both had the pleasure of knowing Clive Burr. Lovely fellah, sadly missed.

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    9. Will all the Natalizumaber's and Campather's out there speak-up? We need you to tell the world that if your are treated early with effective therapies you stay well, get better and keep your jobs.

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    10. RE: "Are you better off than you were four years ago?"

      Dr Dre is right in a way because I am much worse than what I was 4 years ago. That is the depressing truth of things. How are others holding up? We should do a survey.

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    11. No way am I better off than what I was four years ago. I'm even worse than this time last year.

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    12. Me to, but I have not been on HADMTs. I suspect things would be different if I had.

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    13. There was an Annette Funicello video last fall, she was in the worst late stage of MS imaginable. It was shocking (and sad) to me and I would have thought I'd already had a more than decent MS education.

      Jack Osbourne falling into the clutches of the quacks? I'd heard he was trying stem cells.

      Montel had a fairly well publicized CCSVI procedure last year.

      Michelle Obama's father passed away of MS.

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    14. I'm much better now than I was 4 years ago. I'm thinking about to go back to work. I had to change my life, but I'm doing very well.
      I was lucky though, one of those few people who respond well to first-line DMDs and with no bad side-effects.
      We are out there.

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    15. I'm doing totally crap than what I was four years ago, thanks for asking. Four years ago I could still run around a little whilst now, no joke, I'm awaiting for the NHS to provide me with a wheelchair. I have to pay to get my bathroom adapted because adult social services are pathetically inefficient. Also, my neurologist doesn't even want me on his books anymore because I demand a strategy of how he intends to help me. I am 28 years old as well which means I have a lifetime of this type of crap ahead of me. Seriously bothers me.

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  12. Thanks for this. I agree and as a patient will help if I can.

    Practical problems I see. 1. Like gay people, many with early ms are personally better off closeted. 2. Fatigue hits hard and early. Camping out with signs takes energy. 3. Invisible disability. 'You look great! I can't believe you're sick.' The public doesn't know how bad MS is until it puts you in a wheelchair.

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  13. Another fact unknown to the public is the prevalence of the disease. When googled, I see it written as 100 to 200 per 100,000. To publicize it should be written as 1-2 per thousand people in northern Europe, North America. Everyone knows someone with MS, but even MS patients don't know who they know.

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  14. With HIV the enemy, a retrovirus, is known. Unfortunately, MS and other neuro- diseases lack in an understanding of the pathology. HAART therapy is highly effective and has direct correlation with CD4 counts and progression to AIDS. Nothing, or very little is known regarding MS progression. Cancer mortality may be relatively quick depending on stage of diagnosis unlike MS. Also, how much cancer could be prevented if society eliminated smoking, lost weight maintained an active lifestyle?. Cancer would probably be rendered a disease of the elderly. Heart disease in "third world" nations is much less prevalent than the West. Just look at the high numbers in the U.S.South's so called "cardiac belt". We need to know what we are fighting.

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  15. By the way, Ronnie Lane and the Faces were an under-rated band in the early 70's. That's why the Stones stole Ron Wood.

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  16. Wow, lots of strong opinions here. My issue with this situation is -- where does all the money go? The MS Society here in the US only invests about 16% of the money it receives on funding research. I know there are operating expenses, but when you are bringing in ~$500 million "for the cure," and only ~$70 million gets put toward actual research there is something wrong. As always, someone somewhere is making money. I own my own business, I know how it works. BTW, the Michael J. Fox Parkinsons foundation invests over 70% of the money it receives on research and the Myelin Repair Foundation over 50%. The founders of both have the disease they are working to cure, and it shows.

    If that money somehow could directly finance those looking for the cure, such as funding projects such as the Charcot Project instead of "running an organization," how much faster would we find a cure? There is plenty of money....

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    1. I don't know about the MS Society in the US but here in the UK their website shows how they spend monies donated. Last year 28% went on support, 19% on respite care, 15% on research and the same amount on fundraising. The latter point is a surprise and suggests they spend just under £5 million fund-raising !

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  17. Not sure why it is a surprise - it actually costs money to employ the professionals who run various campaigns and support the volunteers who participate in fundraising events. If you think about it, you'll see that fundraising involves a lot of work, including complying with relevant charity legislation.

    Anyone here taking part in their Challenge60 campaign to raise £250,000 in 60 days, for research?

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    1. Two things surprise me :

      Firstly that they spend as much on fund raising as they do on funding research.

      Secondly, as only half their income comes from fund-raising it suggests a very poor hit rate, £1 spent to raise £3.

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  18. First of all surely the key would be to find something that actually works. No one is shouting about wanting the current meds because most of us know they just DON'T WORK and have such nasty chronic side effects its a toss up of which is worse The MS or the possible side effects?

    Also why would anyone dare to stand up and fight for what they think after the way we have seen the CCSVI movement belittled and abused for standing up for what they know could help many?
    Banned and deleated from various walls and out cast from MS exhibitions and gatherings for what? telling of something that has helped them!
    Interesting that when some thing comes along that does work there is no need for a call to arms as people who have felt the difference are more than happy to stand up and speak out, happy to travel all over the country in freezing conditions, write to MP's and governing bodies, happy to spend time money and limited energy on a some times thankless task trying to raise awareness.

    Interesting that we are expected to jump on board and go out of our way for the drugs when it seems our leading researchers here in the UK cant even be bothered to spend a weekend looking at the facts of CCSVI, instead, happy to sit back and pluck the headlines that suit from other countries poorly executed studies.

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    1. My drug actually seems to be working quite well for me. It has few side effects. According to Prof G's slides that's true for 20% of us on first line drugs. Probably a lot more for people on second-line drugs. I'm just putting that out there for newbies who might get spooked unnecessarily.

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    2. I just wish we knew how to identify the 20% of long-term responders up front then we wouldn't have to put the other 80% through 1-2 years of smouldering MS.

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    3. I'm one of them. I am extremely thankful. I have had relapses, but recovered pretty well. I had lots of relapses before diagnosis and I didn't recover very well from those.

      4 months after starting Rebif in 2000, I had got my strength back and worked hard on my fitness. I've had to work at it ever since.
      In the years since Rebif, I've moved to another country, where I feel well. I have had to become fluent at 2 languages and I'm learning to play the violin. I can still play the piano as horribly as I could when I was a music student and I can sing big operatic arias.
      Yes, yes - it ain't over until the (not-that-fat, really..) lady sings.

      I have screwed-up knees from damage in the year before diagnosis, where during the diagnosis process (2000) the EP's showed that I had little nerve conductivity in my right leg. I'm the same now.
      So newbies who are freaked out by MS, the bad stuff may not happen.

      Yes, I feel like crap in the higher humidity of the UK, but I don't have to live there now and I've gone from being housebound to having a normal life.
      I had an MRI in 09 and another one last year and since 2000 I have 4 more lesions. So yes, I have MS, but for some reason it hasn't knocked me off my feet.
      If you are offered treatment, take it. It may work. You may get your life back on track. It may take time, but you never know.

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    4. "I just wish we knew how to identify the 20% of long-term responders up front then we wouldn't have to put the other 80% through 1-2 years of smouldering MS."

      Good point. I'm just reflecting lately on how hopeless I felt by my diagnosis. And even as I took my DMT faithfully, I didn't really believe it was going to work. And maybe it still won't. But the overall message I'm getting, even from this blog (which is my favorite source of MS info because it doesn't sugar coat anything) is that there are effective drugs that work for more and more of us all the time. Access to them is the next big challenge.

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