GlaxoSmithKline targets arthritis in first ResearchKit study by a drug company

Posted:
in iPhone
Apple's ResearchKit was quickly adopted by clinical studies at a series of universities and hospitals, but a new iOS app focused on rheumatoid arthritis from pharmaceutical firm GlaxoSmithKline marks the first time a drug company has made use of the framework.


ResearchKit apps


According to a report by Caroline Chen for Bloomberg, Glaxo will be using ResearchKit to monitor physical symptoms and record pain and mood feedback in a rheumatoid arthritis study involving 300 participants.

ResearchKit is a framework Apple introduced early last year to help gather standardized clinical research leveraging the sensors and touch interface of iPhones. Glaxo's arthritis app includes wrist exercises that precisely monitor participants' range of motion in a standardized way.

Faster, better, stronger research



Clinical studies can cost millions of dollars due to the expenses related to finding and recruiting participants, bringing them into a facility, and paying nurses and doctors to explain the study to the participants, obtain their consent and then collect data from them over the duration of the study.

ResearchKit apps can help to reduce those costs by enabling participants to enroll themselves, presenting study details to the user, obtaining their consent and automating standardized data collection that participants can contribute from home.

ResearchKit studies can also greatly expand the number of participants that can be recruited to join a study, and accelerate the pace of its research. A cardiovascular study at Stanford attracted 10,000 participants last year, shortly after Apple announced the new initiative

Kara Dennis, a managing director at Medidata Solutions, the firm collecting and analyzing research data for Glaxo, noted that ResearchKit "has the potential to greatly improve recruitment," explaining that "one of the biggest challenges in clinical trials is that it's hard to engage patients because they might have to take time off work, they often have to travel significant distances and then they're subjected to a series of measures that can be invasive."

Last year, mobile health provider LifeMap Solutions reported high rates of consent, participation and continued engagement in ResearchKit apps, assisted in part by the ability to send out reminder notifications to participants.

Glaxo hopes to learn from its initial ResearchKit study in order to optimize the design of its app, and evaluate the use of apps in future clinical research.

Apple's health push



ResearchKit is available for free, and Apple has released the project as open source to encourage contribution of new research modules.

Apple has increasingly made health a major initiative at the company, expanding upon ResearchKit with a complementary new CareKit framework designed to facilitate apps to help guide patients through followup care.

The company continues to work with researchers and has hired prominent clinical researchers to help develop its internal health-related initiatives.

That includes a strategic extension of its IBM partnership to provide secure real-time data analytics to medical professionals, with participation from Johnson & Johnson and Medtronic. Apple also expanded support for DNA genetics results in participation with 23andMe.

Comments

  • Reply 1 of 13
    MacProMacPro Posts: 18,260member
    Slightly off topic but if like if  like me  you have severe arthritis and are on statins, try stopping the statins for a few weeks.  My arthritis vanished.
  • Reply 2 of 13
    buckalecbuckalec Posts: 192member
    A company with a soul, with meaning and acting in the greater good. Thankful to own a few shares since 1999.  Wall Street hater since 1999.
    lostkiwinolamacguy
  • Reply 3 of 13
    Rayz2016Rayz2016 Posts: 4,604member
    buckalec said:
    A company with a soul, with meaning and acting in the greater good. Thankful to own a few shares since 1999.  Wall Street hater since 1999.
    Are you talking about Apple or Glaxo?
  • Reply 4 of 13
    juxx0rjuxx0r Posts: 1member
    What a waste of effort. Why dont they just admit that arthritis is a Boron deficiency and start treating that.
  • Reply 5 of 13
    LoneStar88LoneStar88 Posts: 285member
    Well, I suppose Apple has to start somewhere with its "health" initiatives, but hopefully ACTUAL health entities dealing with nutrition, naturopathy, and homeopathy will be able to take advantage of these facilities.
  • Reply 6 of 13
    singularitysingularity Posts: 1,329member
    juxx0r said:
    What a waste of effort. Why dont they just admit that arthritis is a Boron deficiency and start treating that.
    Really, your saying that a simple deficiency once address would cure all the different types of arthritis, osteoarthritis, rheumatoid and the other 90+? Or are you simplifying just one type?
    As I know my arthritis is caused by a biomechanical issue and will soon be cured by surgery, no boron required.
    chia
  • Reply 7 of 13
    This is worth a read:

    From Wikipedia https://en.wikipedia.org/wiki/GlaxoSmithKline

    " In 2012 GSK pleaded guilty to promotion of drugs for unapproved uses, failure to report safety data, and kickbacks to physicians, in the United States and agreed to pay a $3 billion (£1.9bn) settlement the largest settlement in the country by a drug company.[9]

    2012 criminal and civil settlement

    Overview

    In July 2012 GSK pleaded guilty in the United States to criminal charges, and agreed to pay $3 billion, in what was the largest settlement until then between the Justice Department and a drug company. The $3 billion included a criminal fine of $956,814,400 and forfeiture of $43,185,600. The remaining $2 billion covered a civil settlement with the government under the False Claims Act. The investigation was launched largely on the basis of information from four whistleblowers who filed qui tam (whistleblower) lawsuits against the company under the False Claims Act.[9]

    The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses from 1998–2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia (rosiglitazone), both in violation of the Federal Food, Drug, and Cosmetic Act. Other drugs promoted for unapproved uses were two inhalers, Advair (fluticasone/salmeterol) and Flovent (fluticasone propionate), as well as Zofran (ondansetron), Imitrex (sumatriptan), Lotronex (alosetron) and Valtrex (valaciclovir).[9]

    The settlement also covered reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program, and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles ghostwritten by the company and placed by physicians in medical journals.[9] The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.[87]

    As part of the settlement GSK signed a five-year Corporate Integrity Agreement with the Department of Health and Human Services, which obliged the company to make major changes in the way it did business, including changing its compensation programmes for its sales force and executives, and to implement and maintain transparency in its research practices and publication policies.[9]It announced in 2013 that it would no longer pay doctors to promote its drugs or attend medical conferences, and that its sales staff would no longer have prescription targets.[88]

    Rosiglitazone (Avandia)

    The 2012 settlement included a criminal fine of $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone), a diabetes drug approved in 1999, and a civil settlement of $657 million for making false claims about it. The Justice Department said GSK had promoted rosiglitazone to physicians with misleading information, including that it conferred cardiovascular benefits despite an FDA-mandated label warning of cardiovascular risks.[9]

    In 1999 John Buse, a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK threatened to sue him, called his university head of department, and persuaded him to sign a retraction.[89] GSK raised questions internally about the drug's safety in 2000, and in 2002 the company ghostwrote an article in Circulation describing a GSK-funded clinical trial that suggested rosiglitazone might have a beneficial effect on cardiovascular risk.[90] From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure.[91] In April that year GSK began a six-year, open-labelrandomized trial, known as RECORD, to examine rosiglitazone and cardiovascular events.[92] Two GSK meta-analyses in 2005 and 2006 showed an increased risk of cardiovascular problems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. By December 2006 rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3 billion.[91]

    In June 2007 the New England Journal of Medicine published a meta-analysis that associated the drug with an increased risk of heart attack.[93] GSK had reportedly tried to persuade one of the authors, Steven Nissen, not to publish it, after receiving an advance copy from one of the journal's peer reviewers, a GSK consultant.[94] In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007.[95]:4[96] The FDA placed restrictions on the drug, including adding a boxed warning, but did not withdraw it.[97] (In 2013 the FDA rejected that the drug had caused excess heart attacks.)[98] A Senate Finance Committee inquiry concluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone.[95] In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.[99]

    The results of GSK's RECORD trial were published in June 2009. It confirmed an association between rosiglitazone and an increased risk of heart failure and fractures, but not of heart attack, and concluded that it "does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs."[92] Steven Nissan and Kathy Wolkski argued that the study's low event rates reduced its statistical power.[100] In September 2009 rosiglitazone was suspended in Europe.[101] The results of the RECORD study were confirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA.[102] In November that year the FDA lifted the restrictions it had placed on the drug.[103] The boxed warning about heart attack was removed; the warning about heart failure remained in place.[98]

    Paroxetine (Paxil/Seroxat)

    Main article: Study 329


    Paroxetine, known as Paxil and Seroxat

    GSK was fined for promoting Paxil/Seroxat (paroxetine) for treating depression in the under-18s, although the drug had not been approved for pediatric use.[9] Paxil had $4.97 billion worldwide sales in 2003.[104] The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression.[105] From 1998 to 2003 it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas.[9] From 2004 Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.[9]

    An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies: "It would be commercially unacceptable to include a statement that [pediatric] efficacy had not been demonstrated, as this would undermine the profile of paroxetine."[104][106] The company ghostwrote an article, published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, that misreported the results of one of its clinical trials, Study 329.[9][107] The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents."[108] The suppression of the research findings is the subject of Side Effects (2008) by Alison Bass.[109]

    For 10 years GSK marketed Paxil as non-habit forming. In 2001 35 patients filed a class-action suit alleging they had suffered withdrawal symptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming.[110] The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved.[111] In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top three antidepressants, for which dependence had been reported.[112][n 2]

    Bupropion (Wellbutrin

    The company was also fined for promoting Wellbutrin (bupropion) – approved at the time for major depressive disorder and also sold as a smoking-cessation aid, Zyban – for weight loss and the treatment of attention deficit hyperactivity disorder, sexual dysfunction and substance addiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and Continuing Medical Education programmes.[9]


  • Reply 8 of 13
    This is worth a read:

    From Wikipedia https://en.wikipedia.org/wiki/GlaxoSmithKline

    " In 2012 GSK pleaded guilty to promotion of drugs for unapproved uses, failure to report safety data, and kickbacks to physicians, in the United States and agreed to pay a $3 billion (£1.9bn) settlement the largest settlement in the country by a drug company.[9]

    2012 criminal and civil settlement

    Overview

    In July 2012 GSK pleaded guilty in the United States to criminal charges, and agreed to pay $3 billion, in what was the largest settlement until then between the Justice Department and a drug company. The $3 billion included a criminal fine of $956,814,400 and forfeiture of $43,185,600. The remaining $2 billion covered a civil settlement with the government under the False Claims Act. The investigation was launched largely on the basis of information from four whistleblowers who filed qui tam (whistleblower) lawsuits against the company under the False Claims Act.[9]

    The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses from 1998–2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia (rosiglitazone), both in violation of the Federal Food, Drug, and Cosmetic Act. Other drugs promoted for unapproved uses were two inhalers, Advair (fluticasone/salmeterol) and Flovent (fluticasone propionate), as well as Zofran (ondansetron), Imitrex (sumatriptan), Lotronex (alosetron) and Valtrex (valaciclovir).[9]

    The settlement also covered reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program, and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles ghostwritten by the company and placed by physicians in medical journals.[9] The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.[87]

    As part of the settlement GSK signed a five-year Corporate Integrity Agreement with the Department of Health and Human Services, which obliged the company to make major changes in the way it did business, including changing its compensation programmes for its sales force and executives, and to implement and maintain transparency in its research practices and publication policies.[9]It announced in 2013 that it would no longer pay doctors to promote its drugs or attend medical conferences, and that its sales staff would no longer have prescription targets.[88]

    Rosiglitazone (Avandia)

    The 2012 settlement included a criminal fine of $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone), a diabetes drug approved in 1999, and a civil settlement of $657 million for making false claims about it. The Justice Department said GSK had promoted rosiglitazone to physicians with misleading information, including that it conferred cardiovascular benefits despite an FDA-mandated label warning of cardiovascular risks.[9]

    In 1999 John Buse, a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK threatened to sue him, called his university head of department, and persuaded him to sign a retraction.[89] GSK raised questions internally about the drug's safety in 2000, and in 2002 the company ghostwrote an article in Circulation describing a GSK-funded clinical trial that suggested rosiglitazone might have a beneficial effect on cardiovascular risk.[90] From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure.[91] In April that year GSK began a six-year, open-labelrandomized trial, known as RECORD, to examine rosiglitazone and cardiovascular events.[92] Two GSK meta-analyses in 2005 and 2006 showed an increased risk of cardiovascular problems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. By December 2006 rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3 billion.[91]

    In June 2007 the New England Journal of Medicine published a meta-analysis that associated the drug with an increased risk of heart attack.[93] GSK had reportedly tried to persuade one of the authors, Steven Nissen, not to publish it, after receiving an advance copy from one of the journal's peer reviewers, a GSK consultant.[94] In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007.[95]:4[96] The FDA placed restrictions on the drug, including adding a boxed warning, but did not withdraw it.[97] (In 2013 the FDA rejected that the drug had caused excess heart attacks.)[98] A Senate Finance Committee inquiry concluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone.[95] In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.[99]

    The results of GSK's RECORD trial were published in June 2009. It confirmed an association between rosiglitazone and an increased risk of heart failure and fractures, but not of heart attack, and concluded that it "does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs."[92] Steven Nissan and Kathy Wolkski argued that the study's low event rates reduced its statistical power.[100] In September 2009 rosiglitazone was suspended in Europe.[101] The results of the RECORD study were confirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA.[102] In November that year the FDA lifted the restrictions it had placed on the drug.[103] The boxed warning about heart attack was removed; the warning about heart failure remained in place.[98]

    Paroxetine (Paxil/Seroxat)

    Main article: Study 329


    Paroxetine, known as Paxil and Seroxat

    GSK was fined for promoting Paxil/Seroxat (paroxetine) for treating depression in the under-18s, although the drug had not been approved for pediatric use.[9] Paxil had $4.97 billion worldwide sales in 2003.[104] The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression.[105] From 1998 to 2003 it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas.[9] From 2004 Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.[9]

    An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies: "It would be commercially unacceptable to include a statement that [pediatric] efficacy had not been demonstrated, as this would undermine the profile of paroxetine."[104][106] The company ghostwrote an article, published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, that misreported the results of one of its clinical trials, Study 329.[9][107] The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents."[108] The suppression of the research findings is the subject of Side Effects (2008) by Alison Bass.[109]

    For 10 years GSK marketed Paxil as non-habit forming. In 2001 35 patients filed a class-action suit alleging they had suffered withdrawal symptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming.[110] The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved.[111] In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top three antidepressants, for which dependence had been reported.[112][n 2]

    Bupropion (Wellbutrin

    The company was also fined for promoting Wellbutrin (bupropion) – approved at the time for major depressive disorder and also sold as a smoking-cessation aid, Zyban – for weight loss and the treatment of attention deficit hyperactivity disorder, sexual dysfunction and substance addiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and Continuing Medical Education programmes.[9]


    Who fines the FDA when they are FOS?
  • Reply 9 of 13
    crowleycrowley Posts: 5,834member
    Who fines the FDA when they are FOS?
    You can sue the FDA.
  • Reply 10 of 13
    foggyhillfoggyhill Posts: 4,767member
    Well, I suppose Apple has to start somewhere with its "health" initiatives, but hopefully ACTUAL health entities dealing with nutrition, naturopathy, and homeopathy will be able to take advantage of these facilities.
    Right... Homeopathy and Naturopathy on the same level as NUTRITION (something with actual science behind it).
    You do know what false equivalency is don't you. Look it up.

    The first two, or mostly hogwash to unproven, fracking provide the hard data on their usefulness and then make your assertion.
    BTW, naturopathy and Homeopathy is rampant with big business crap, so please spare me the big Pharma argument.
    If there is a buck to be made, big business, no matter its form, will be all over it.
    brometheusnolamacguyicoco3
  • Reply 11 of 13
    singularitysingularity Posts: 1,329member
    Well, I suppose Apple has to start somewhere with its "health" initiatives, but hopefully ACTUAL health entities dealing with nutrition, naturopathy, and homeopathy will be able to take advantage of these facilities.
    Naturopathy and homeopathy!! Are they going to dilute the Apple watch to get information¡
    If you haven't got the evidence to back it up its dangerous and just wrong in every sense.
    Might as well go back to blood letting and burning women to cure people. It's just as effective once you have taken out the placebo effect.
    brometheusicoco3
  • Reply 12 of 13
    nolamacguynolamacguy Posts: 4,758member
    Homeopathy and naturopathy are nonsense pseudoscience. proven ineffective. as useful as healing crystals. 

    https://en.m.wikipedia.org/wiki/Homeopathy

    https://en.m.wikipedia.org/wiki/Naturopathy
    edited July 2016 singularityicoco3
  • Reply 13 of 13
    icoco3icoco3 Posts: 1,459member
    They make Betnovate cream and that is the only thing that got rid of the dry skin rash I had in my arms.  It was there over 10 years and the cream knocked it right down. So, some good does come from them.

    Don't even get me going on Homeopothy...the more dilute it is, the more powerful it is.  Even to a point there are no actual molecules of the "active ingredient" left in the water mixture.  There is science involved and it does not look good for those promoting Homeopothy.
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