A PROPOSAL for a pilot outreach program to help veterans affected by antimalarial drugs has been rejected, with the Department of Veterans’ Affairs saying existing support services are adequate.
The decision has angered veterans who participated in controversial ADF sanctioned mefloquine and tafenoquine trials, and their families, some of whom are caring for those with mental health issues.
They now want to meet with Prime Minister Malcolm Turnbull, who has previously committed to tackling veteran suicides, an issue linked to the use of the drugs.
Lavina Salter, whose husband Chris has suffered adverse mental health after taking mefloquine during a deployment to East Timor, said the proposal rejection had left her feeling defeated.
“By their own admission, DVA has said they don’t know the full extent of the number of veterans affected by these drugs so why don’t they do something?” she said.
“We will keep trying because we can’t give up on these guys.”
The Quinoline Veterans and Families Association submitted a proposal to Veterans’ Affairs Minister Dan Tehan in December for a first-of-its-kind Veterans Outreach Program. The initial budget was $2.25 million per annum for an initial period of five years.
The program would include new research, the identification of all personnel administered mefloquine or tafenoquine during their ADF service and assist affected individuals.
QVFA co-convenor Major Stuart McCarthy, who was prescribed both mefloquine and tafenoquine by the ADF, said rejecting the program was “indefensible” because existing services were clearly not adequate.
“I can accept that Dan Tehan wouldn’t necessarily have signed up to the proposal straight away, but to come back with a blunt no and to not enter into further discussion or dialogue is unacceptable,” he said.
“We have made repeated efforts to engage with DVA and work with them to develop health outreach both for veterans and their families and that’s why we did the proposal because those needs are not being met.
“It’s really time now for the Prime Minister to provide leadership on this, because the departments of Defence and Veterans’ Affairs have completely failed.”
In a short statement, Mr Tehan told the Bulletin yesterday he believed the Federal Government was already responding to concerns about the use of mefloquine by the ADF.
“The existing services and additional support the Government has implemented are meeting the needs of the ex-service community concerned,” he said.
Parents of disabled children still fighting for compensation over swine flu vaccine
The DWP could be left with a £12m bill if it fails for a third time to overturn a ruling ordering it to pay £120,000 compensation to a 7-year-old who suffers from narcolepsy caused by the Swine Flu vaccine Pandemrix. (Photo by Jeff J Mitchell/Getty Images)
On 10 December 2009, seven-year-old John was given a vaccination called Pandemrix against the pandemic influenza A (H1N1), commonly known as Swine Flu. Four months later, following extensive hospital examination he was diagnosed with narcolepsy and cataplexy, neurological conditions that will affect him for the rest of his life.
Narcolepsy is a very rare and incurable autoimmune sleep disorder caused by the destruction of the part of the brain that produces hypocretin, a peptide that regulates sleep. Sufferers regularly experience episodes of drowsiness or excessive daytime sleepiness. Cataplexy is a condition characterised by sudden, profound muscle paralysis, the onset of which takes several seconds, and often results in the sufferer collapsing.
These conditions may also be associated with hallucinations, behavioural and mood disturbance, as well as nightmares. John, now 14, experiences all of these symptoms.
Although millions of people in the UK received Pandemrix without complications, the 2009-10 pandemic vaccine has been found to have caused an epidemic of narcolepsy in the UK and in other European countries in which it was used. About 1,500 people across Europe are thought to be affected, of which about 100 have so far been identified in the UK. John, not his real name, is one of them.
Last month, the High Court heard an appeal from the Department for Work and Pensions (DWP) against a test case decision forcing it to pay £120,000 vaccine injury compensation to John.
In January 2012 he applied to the DWP for compensation under the Vaccine Damages Payments Act 1979. The claim was initially refused on grounds of lack of a causal connection between the vaccine and John’s development of narcolepsy and cataplexy.
“What I expect of a decent, caring society is that when vaccination programmes are implemented, they come with an implicit agreement between state and citizen that ‘should’ anything go wrong, that citizen will be looked after by the rest of us.”
Matt O’Neill, Chair, Narcolepsy UK
A few months later, a medical advisor to the government’s Vaccine Damages Unit said that there was, in fact, likely to be a causal connection, but that John’s condition had improved and his level of disablement was less than 60 per cent – the threshold required to meet “severe” disability criteria for awarding compensation. He was denied payment.
On 11 February 2014, then Secretary of State for Work and Pensions Iain Duncan Smith reversed his refusal decision of two years earlier, accepting that the vaccine had caused John’s narcolepsy and cataplexy. However, Mr Duncan Smith refused to accept that John was severely disabled, and his application for payment was therefore refused.
After John appealed the decision to the First Tier Tribunal, the DWP was ordered in September 2014 to pay out as it found his narcolepsy to be severe. The DWP refused and appealed to the Upper Tribunal, arguing that only problems John had now could be taken into account and not the future impact of his condition.
It is the first time the Court of Appeal is considering a case of vaccine injury compensation under the UK statutory compensation scheme. Its decision will be binding on all future assessments of disability brought under the 1979 Act. Payments were then fixed at £10,000. Now they are £120,000 per person, so with around 100 victims seeking compensation under the Act, the DWP will be faced with a £12m bill if it loses.
Defining an individual as ’60 per cent disabled’
At Thursday’s hearing Sir Terence Etherton who, as Master of the Rolls, is the second most senior judge in England and Wales, Lord Justice Davis and Lord Justice Underhill listened to the government’s case. Adam Heppinstall, representing the Secretary of State, said the principal argument is that it was “wrong in law” for the Upper Tribunal to conclude that assessment of an individual’s disability under the statutory scheme require’s a decision maker to take into account that person’s likely future disablement in addition to his condition at the time of assessment.
“In this respect, the Upper Tribunal adopted a speculative approach, not called for by the legislation, which carries with it substantial problems and the risk of unfairness,” Mr Heppinstall said. “The Secretary of State calls for a more factual approach, in which only the present disablement can be taken into account.”
He told the court other grounds for appeal centred on how someone is assessed as “severely disabled” and that the case raises “fundamental issues” which go to the heart of how all claims under the 1979 Act should be assessed and decided by the Secretary of State.
George Peretz QC, representing John, told the court: “There is nothing ‘speculative’ about looking at the impact of that continuing disability on an 11 year old boy as he progresses into manhood, taking into account the additional opportunities and responsibilities which that transition in life brings with it.
“The Upper Tribunal adopted a speculative approach, not called for by the legislation, which carries with it substantial problems and the risk of unfairness. The Secretary of State calls for a more factual approach, in which only the present disablement can be taken into account.”
Adam Heppinstall, counsel, Secretary of State for Work and Pensions
“As the Upper Tribunal rightly pointed out, the fact that injuries such as loss of a hand are regarded as amounting to 100 per cent disablement, and that, amputation of one leg at the knee is to be regarded as 60 per cent disablement, may be useful in providing a broad framework or starting point in assessing whether John’s narcolepsy with cataplexy amounts to 60 per cent disablement.
“Such a check, for example, rules out any suggestion that 100 per cent disablement is akin to total quadriplegia or a persistent vegetative state or that 60 per cent disablement cannot be established where an individual is able to carry on a reasonable range of daily activities.”
Mr Peretz used the example of paralympian and double-amputee Oscar Pistorious, who is defined as “100 per cent disabled”, yet was still able to compete at the Olympic Games.
Sir Terence said that it was obviously an important matter – not just for John and his family, but for the 30 outstanding cases waiting on the result. The judges reserved their decision.
In a news article from Reuters (2015)- GSK CEO, Andrew Witty, discusses the multi-billion dollar market of smoking cessation therapy. E-cigarettes are making big bucks for manufacturers, however Witty claims that GSK won’t be entering the electronic cigarette market any time soon because:
“…Witty said e-cigarettes were “just too controversial” for GSK to want to get involved in at this stage, adding that “there’s not enough data,” to provide robust evidence of the products’ risks and benefits….” (see full article here)
If only Witty and GSK had thought the same before unleashing the horrible Seroxat (drug) on to the anti-depressant consumer market?
I have yet to see ‘robust’ evidence that the benefits of Seroxat (Paxil) outweigh the risks.
For a drug like GSK’s Seroxat (dogged with controversy and scandal) Witty’s claims about e-cigarettes being ‘too controversial’ are extremely ironic…
Where’s the ‘data’ on Seroxat, Witty?..
Where’s the data proving its robust safety and effectiveness?
“….Like the U.S., Italy has a national vaccine injury compensation program to give some financial support to those people who are injured by compulsory and recommended vaccinations. The Italian infant plaintiff received three doses of GlaxoSmithKline’s Infanrix Hexa, a hexavalent vaccine administered in the first year of life. These doses occurred from March to October 2006. The vaccine is to protect children from polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B. In addition to these antigens, however, the vaccine then contained thimerosal, the mercury-containing preservative, aluminum, an adjuvant, as well as other toxic ingredients. The child regressed into autism shortly after receiving the three doses. When the parents presented their claim for compensation first to the Ministry of Health, as they were required to do, the Ministry rejected it. Therefore, the family sued the Ministry in a court of general jurisdiction, an option which does not exist in the same form in the U.S…”
I’d like to think that Trump’s US attorney general will be a lot tougher, and a lot less friendly, to the the Pharmaceutical industry, than Obama’s was..
The reaction to Donald Trump’s election victory has been surprising. First, stock markets sank. Then they rose. Now at the time of writing they are falling once more. Clearly, the only thing that investors can be certain of is that uncertainty will be high over the short to medium term.
Part of the reason for this is that Trump is a known unknown. He has no long-term track record in politics and it is impossible to know exactly what policies he will pursue. In fact, there is a good chance that even he does not yet know exactly how he will seek to improve the US economy. That’s why in my view it’s a good idea to own companies which have a relatively low positive correlation with the economy. One example of this is GlaxoSmithKline (LON:GSK), which I believe will outperform a volatile wider index over the medium term.
Old Trump Vs New Trump
Perhaps the most striking part of election night was Trump’s victory speech. It was a complete contrast to the gung-ho, pumped up and bullish tone which he had struck throughout the election campaign. Trump instead talked about uniting America and being a President for all Americans, words which at the time of writing at least, seem to have placated the markets somewhat.
However, one speech does not instantly erase the policies which Trump has been shouting about in the last couple of years. His desire to protect American jobs and make trading agreements less favourable to other countries mean that the world could take a step back from an era of increasing globalisation. Similarly, his apparent admiration for Vladimir Putin could cause uncertainty in the Middle East and even in Europe, while a tougher stance on China could lead to worsening relations between the two countries.
Volatility looks here to stay
Of course, many commentators are now claiming that Trump may govern with different policies to those on which he campaigned. Whether that proves to be correct or not, in my opinion Trump’s Presidency will include significant change on taxation, spending and foreign policy. Therefore, I believe that the uncertainty seen in stock markets since the election is just the beginning of a period of highly volatile share price movements.
In the current ‘lame duck’ period, uncertainty may not rise beyond the levels seen since the election. Barack Obama is keen to ensure a smooth handover of power and Donald Trump is unlikely to make any controversial comments regarding his plan of action. After all, he can’t do anything in terms of policy-change until he becomes President in 2017.
However, beyond the point at which Donald Trump becomes President, I believe that volatility will increase significantly. His plan to reduce taxes on businesses and on individuals while at the same time increase infrastructure spending may bring rewards in terms of job creation and GDP growth. But it also means higher risk, since debt levels are likely to rise in order to fill the hole created by higher spending and lower tax receipts. This could lead to higher uncertainty regarding the US economy’s future and cause share prices to become more volatile.
A stable solution
In such volatile times, companies which offer a consistent, stable and robust outlook could become more popular among investors. That’s why I’m optimistic about GlaxoSmithKline’s future share price performance versus the wider index. Its sales and profitability are less dependent upon the performance of the wider economy than is the case for most companies. This provides GlaxoSmithKline with defensive characteristics which are further enhanced by its diverse business model.
Essentially, GlaxoSmithKline is three businesses in one. It has a consumer goods division which sells products such as Horlicks and therefore benefits from a significant amount of customer loyalty. GlaxoSmithKline also has a pharmaceuticals division and a vaccines division. It is therefore more dependent on the patent cycle than the business cycle. When combined with its consumer division’s customer loyalty, this makes GlaxoSmithKline a robust and reliable performer which could be seen as a means of diversifying away from an uncertain economic outlook.
GlaxoSmithKline is much more than just a defensive stock. Its drug pipeline holds significant promise in my view. For example, it spent £3.1 billion on R&D in 2015 and expects to generate a 13% internal rate of return (IRR) on this investment. Over the course of 2016/17, GlaxoSmithKline expects up to 20 Phase II starts and up to 10 Phase III starts. Looking further ahead, it has the potential to file up to 20 assets by 2020, which indicates that its sales could rise substantially over the medium term.
This should help to boost GlaxoSmithKline’s dividend payments. They are being frozen for the next couple of years as GlaxoSmithKline seeks to improve its cash position. Even without dividend growth in the near term, GlaxoSmithKline still has income appeal. It currently yields 5.1% versus 3.7% for the FTSE 100. This will help GlaxoSmithKline to record a positive total return should capital gains be difficult to achieve in a potentially uncertain period for global stock markets.
The US and global economies face a highly uncertain future. Although the next few weeks may prove to be a smooth transition, in 2017 I believe that the changes Donald Trump will seek to make to the US will cause share prices to become increasingly volatile. Although he may adopt a more conciliatory approach than he did during the campaign, Trump is likely to implement more radical policies than have been undertaken for a number of years. Even if they are successful in the long run, they are likely to cause investors to become increasingly risk-off in the short to medium term.
In such a situation, GlaxoSmithKline could gain in appeal. It has a well-diversified, stable business model which is not closely tied to the performance of the economy. It also has growth potential via its pipeline and offers a high yield which could appeal to defensive-minded investors. Therefore, in my opinion GlaxoSmithKline is an appealing investment following Trump’s unexpected election victory.
In a recent article, GlaxoSmithKline Chairman, Sir Philip Hampton, talked about rogue companies causing problems in British business, however he failed to mention that the company he chairs- GSK- has been one of the most rogue companies (in terms of ethical, legal, and moral transgressions) of recent times.
When you’ve read through the hundreds of examples of GSK going rogue with ethics- then perhaps read through Sir Philip’s article with your tongue firmly in your cheek, and of course with a great sense of irony and absurdity…
Rogue companies will always exist, says GSK chairman
Rogue businesses and bad bosses will always exist no matter how hard British companies and politicians work to stamp them out, according to Sir Philip Hampton, the chairman of pharmaceuticals giant GlaxoSmithKline and the former chairman of Royal Bank of Scotland.
Sir Philip, who last year published a report on corporate governance and gender diversity, told MPs that it is crucial for independent directors to be able to control domineering executives.
“In overall terms the UK structure for corporate governance is actually pretty good – it is not universally, but we always will have the Sports Directs or the Philip Greens,” Sir Philip told the Business, Energy and Industrial Strategy (BEIS) select committee.
“I don’t think there are any structures that can eliminate it, but the overall structure of governance in UK is admired pretty much globally.”
The recent scandals surrounding the collapse of BHS shortly after it was sold by Sir Philip Green and the treatment at staff at Sports Direct have shaken confidence in some of the biggest names in British business.
Sir Philip Hampton, who has been given the same award, said that business bosses should not routinely be given gongs.
“The rewards for being in business should be primarily financial, and other awards and appreciations probably should be more directed to people who are not getting financial rewards,” the GSK chairman said.
“I think to get both the financial awards and the other marks of recognition is a bit too easy. The honours system has moved away from businesspeople getting awards, and that is right.”
He also told the MPs that the best way to create more diversity in business is to set targets and deadlines, prompting the machinery of companies to act rapidly.
But he added that there may be too much focus on boards, which are dominated by non-executive directors giving only part-time service, when companies are run on a day to day basis by executives.
“Boards have made a lot of progress, but boards are overwhelmingly non-executive now in our corporate governance framework, and having more women on boards is not the same as women having proper, effective business careers,” he said.
“The bit that we’re missing is the focus on executive committees. Companies are run by their executive committees, the full-time people with the best-paid jobs who really decide most things, when a typical board member is two or three days a month, which is not the same thing. In executive committees there is still noticeable female under-representation.”
The clinical trial industry, which I work in, is in crisis.
Roughly half of clinical trials go unreported. Industry-sponsored trials are four times more likely to produce positive results than non-industry trials. And even when trials are reported, the investigators usually fail to share their study results: nearly 90 percent of trials on ClinicalTrials.gov lack results.
Failure to report clinical trial results puts patients in danger. Here’s one example of that: GlaxoSmithKline, the maker of the antidepressant Paxil, recently paid $3 billion for failing to disclose trial data showing that Paxil was not only no more effective than placebo but was also linked to increased suicide attempts among teenagers. The effectiveness of statins, the Tamiflu anti-flu medicine, antipsychotics, and other drugs have come under question due to improperly reported data. Without complete disclosure of trial results, physicians can’t make informed decisions for their patients.
A recently passed final rule from the Department of Health and Human Services now requires that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov. A complementary policy from the National Institutes of Health covers registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not covered by the final rule.
Unreported trials are subject to daily fines of $11,833. Researchers have 90 days after the rule is enacted on January 18, 2017 to comply with it. Excellent summaries of the rule have been published by the NIH and in the New England Journal of Medicine.
The final rule should help address some of the troubling trends in the clinical trial industry. It clears up ambiguous reporting requirements and explicitly requires investigators to submit clinical trial results, adverse events, and statistical methods. These are steps in the right direction that could limit the unscientific practices plaguing the trial industry.
But the final rule doesn’t go far enough, mainly because FDA lacks the staff and the political will to adequately enforce it. As STAT reported in December 2015, the FDA had never levied a single fine for clinical trial reporting violations. Representatives from the FDA cite legal complexities and lack of employees, yet critics have also pointed out the FDA is effectively on the pharmaceutical industry’s payroll. Under the Prescription Drug User Fee Act, the FDA supplements its budget by charging pharmaceutical companies drug application fees that totaled $855 million in fiscal year 2015.
The current FDA commissioner, Dr. Robert Califf, has said that the FDA will not be adding staff to enforce the final rule. That’s a mistake. How else can we expect the rule to be enforced? I work in a research group that conducts more than a dozen clinical trials and know firsthand that researchers don’t have the impetus to report their trials unless there are strong incentives to do so — like enforcement and the threat of fines.
In a perfect world, the FDA would receive more funding to hire employees so it could independently enforce this policy. In the meantime, researchers can check the reporting practices of their own institutions or sign a petition to support the Alltrials campaign. Another project called OpenTrials, a collaboration between Open Knowledge International and the University of Oxford Data Lab, aims to “locate, match, and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally.” It is seeking volunteers to contribute clinical trial data.
I know from personal experience that clinical trial reporting can be tedious and seemingly unrewarding work. But the transparent exchange of scientific data is integral to evidence-based medicine and public health. While the new final rule is a step in the right direction, the public and the research community also need to support efforts like AllTrials and OpenTrials.
Chris Cai is a clinical research coordinator at Massachusetts General Hospital in Boston.
Campaigners are calling for a Europe-wide public inquiry into how a vaccine triggered devastating health sleep and brain disorders in a scandal they claim is as big as thalidomide.
Almost 1,700 people suffered narcolepsy after being vaccinated for swine flu. They are vowing to continue their fight for justice at the European Union.
The group of Europeans, including nearly 100 Britons, are calling for a public inquiry after suffering the debilitating disease which was triggered by use of the Pandemrix vaccine to treat the 2009/10 swine flu outbreak.
Narcolepsy is a rare neurological condition that affects the brain’s ability to regulate the normal sleep-wake cycle. This can lead to symptoms such as disturbed night-time sleep, excessive daytime sleepiness and cataplexy – the term given to sudden muscular weakness triggered by strong emotions such as laughter, anger and surprise. As a result, narcolepsy is often thought of as a sleep disorder, but its underlying cause means that it is better classified as a disorder of the central nervous system.
Families denied compensation
British families have been denied compensation from the Department of Work and Pensions under its compensation scheme as the Government does not recognise the condition as a “severe disability”.
Representatives of national narcolepsy groups from the UK, Ireland, Sweden, Finland, Denmark and Norway, and parents of affected children, met Vytenis Andriukaiti, EU commissioner for health and food safety, in Brussels in December.
They pressed him for recognition of the incident, and a public inquiry into lessons learnt for future pandemics. The group also called for the introduction of vaccine injury compensation standards across the EU, as there is a wide disparity in statutory vaccine injury compensation methods. They also called for clarity surrounding funding for research into treatment.
Unclear how vaccine triggered condition
While the vast majority of Pandemrix recipients had no adverse effects, there are now 1,698 adults and children across Europe registered in the EU database of adverse drug reactions who have developed narcolepsy following use of the H1N1 vaccine. While GlaxoSmithKline (GSK), the maker of Pandemrix, has acknowledged the link, and some patients and their families have been awarded compensation, how the vaccine triggered the condition is unclear.
Peter Todd, a solicitor who represents 88 injured people, compared the situation to the thalidomide scandal of the late 1950s and early 1960s. “Everybody is aware of thalidomide, but I think Pandemrix/narcolepsy is a bigger incident because the EU’s database has 1,698 people registered – and that’s a passive surveillance system,” he told i.
Similar to Thalidomide
“While there were hundreds of cases of birth defects caused by thalidomide, most cases involved shortening of one limb. I know that there were a few cases of multiple limbs shortening, but most cases were one and overall, if you weigh it up, it’s broadly comparable. Yet it doesn’t have the same public recognition.
“It’s now about seven years on from the pandemic and it did take considerable time for the epidemiology of Pandemrix and narcolepsy to become clear – the UK’s study in relation to adults and Pandemrix/narcolepsy was only published earlier this year. While the science is now settled you can’t find any clear acceptance of the incident on any EU or national government website. You can’t point to anything that amounts to official recognition. That’s why recognition from the EU is so important.”
‘Round-the-clock care for my daughter’
Narcolepsy is incurable and sufferers have a lifetime of managing the symptoms. Claire Crisp’s daughter Mathilda is one of the children affected following her swine flu vaccination. She began suffering extreme night-time sleep disturbance within two weeks of the vaccine and subsequently developed cataplexy. Within two months Mathilda, now 10, needed round-the-clock care.
“Mathilda was eventually diagnosed with narcolepsy with cataplexy,” Ms Crisp, 46, told i from the family home in California, where they felt compelled to go to seek help. “What followed was a year of battling for effective treatment whilst Mathilda continued to deteriorate.
“My husband looked for a job in California, which was not in our life plan, but we were desperate as carers, as a family, and convinced that if Mathilda didn’t get the treatment she needed, she would lose her childhood.
“Mathilda’s case was extreme, and extreme measure were needed to rescue her. I did everything I could to give her her life back. It was huge risk as we sold our home [to pay for treatment] and left our families and lives back in the UK. But I could never have lived with myself if I didn’t fight for her.”
Ms Crisp has written a book on her family’s trauma called Waking Mathilda – A Memoir of Childhood Narcolepsy, to be released this spring.
Mr Todd said: “We don’t want to undermine the vaccine or do down [its maker] GSK, but … for those that have been affected, it is quite important to have some kind of official recognition of what happened.”
Interesting story today regarding president elect- Donald Trump. Regardless of your views on Trump (mine are very mixed) he certainly does seem to be causing a stir. I have to agree with him about Big Pharma ‘Getting away with murder’ though. I have been in contact with many people harmed by Big Pharma over the last decade or more, and I have even met and spoken to people who have lost loved ones and friends to Big Pharma.
GSK’s track record on (what we could perhaps call) ‘Corporate Murder’ (or corporate manslaughter) has been well documented over the years.
I cover science and medicine, and believe this is biology’s century.
The drug industry is just wrapping up what looked like an upbeat week here at the J.P. Morgan Healthcare Conference in San Francisco, where all of the healthcare industry’s biggest executives come every year to court investors and negotiate deals. This is the where big mergers are conceived. But now every pharma and biotech executive has a lump in his throat (they’re mostly men). Because of Donald Trump.
Many pharmaceutical executives hoped that because of the Republican Party’s long-term opposition to price controls and love of free markets, a Trump presidency would involve fewer controls on drug prices than a Hillary Clinton one. But at his first press conference today, Trump made it very clear that is not the case. Here’s what he said, via NPR:
I think a lot of industries are going to be coming back. We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don’t make them here. To a large extent. And the other thing we have to do is create a new bidding procedures for the drug industry because they’re getting away with murder.
Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly. And were going to start bidding and were going to save billions of dollars over a period of time.
The “we have to get our drug industry coming back” refers to tax inversions–companies like Mylan, Allergan, and Valeant that have tax domiciles outside the U.S. but operations based here. It also seems to refer to that fact that many drugs are manufactured outside the U.S. So it might sound like a hug, but it’s not. But it’s that second part that will really hurt pharmaceutical companies: the idea that Medicare, the biggest buyer of drugs, will start negotiating drug prices. This is an idea that was popular with Bernie Sanders and Hillary Clinton. It is something drug companies have spent years fighting, because if Medicare has power to insist on a price, they will probably have to pay it.
As with most of Trump’s statements, there is no detail on how this would happen. If Medicare doesn’t have the ability to refuse to offer a medicine, it won’t really be able to lower prices much. Much of Medicare is now run by private sector insurers like Humana or Aetna, who already bid on drugs to get lower prices (this is known as Medicare Advantage). Republicans in Congress may not go along with this. Creating real government bidding on pharmaceuticals could be difficult and tiresome.
Those are details. Donald Trump doesn’t care much for details. The message here is simple and clear:
Donald Trump is going to be a populist president. Pharmaceutical companies are a popular villain. That’s it.
And there are ways Trump could use executive power to hurt drug companies that charge high prices. When Dendreon, a Seattle biotech since bought and sold by Valeant Pharmaceuticals, introduced a cancer drug that cost almost $93,000 in 2010, Medicare put it through a gauntlet called a National Coverage Determination, slowing adoption of the drug. (It flopped.) There are plenty of steps a Medicare administrator motivated by working for an angry Donald Trump could take to hurt a drug company whose price had been deemed too high.
Drug company executives have not been blithely unaware that this might happen. Some have been addressing it publicly. In December, at the Forbes Healthcare Summit, Allergan Chief Executive Brent Saunders announced an expanded patient assistance program to make sure that patients could get access to Allergan medicines for mental illness and infectious disease. He’d also pledged not to take large price increases, limiting Allergan to 10% increases no more than once a year. Here’s what he said about Trump at the time:
I worry today that the pharmaceutical industry has a very false sense of relief or security because of a Trump administration and a Republican Congress. I think we should recognize that the drug pricing issue is a populist issue. Americans are rightfully angry. The fault is not, surely, on the pharmaceutical industry’s shoulders, but we bear that because we make the drugs. We innovate the drugs, and as a result of that, whether we like it or not, or we want to try to explain it or not, we have to deal with it.
To think that President-elect Trump isn’t a populist, that he won’t jump on the next EpiPen scandal and tweet more than Hillary Clinton tweeted, or anybody else, because he’s a prolific tweeter, against any company that does something like that, you’re fooling yourself. I think perhaps the best thing that came out of this election is we have a moment in time to solve it ourselves. Maybe it’s a few months, maybe it’s several months, but we don’t have a lot of time. The next big scandal will revive the debate and probably then some because I think President-elect Trump will be more vicious, more focused on taking down or fighting whoever does something egregious again.
It turns out that Trump didn’t wait for the next egregious drug price increase. He just threw his comments into his first press conference. It doesn’t matter that Gilead Sciences cured hepatitis C, or that vaccines made by Merck and Pfizer and Sanofi keep American kids from dying of meningitis or measles. (In fact, yesterday, Trump said he was considering a commission on autism that might look at the issue of whether vaccines cause the disorder–even though it is settled.) People are mad about drug prices, and they don’t like drug companies, and that makes this a great issue for Trump.
Better yet, it could become a bipartisan issue, one of the few where Democrats will come across the aisle to support change, if anybody can figure out what change is. The pharmaceutical industry has just been thrown in a hole, handed a shovel, and told to dig itself out.
One of the key voices to listen to on this is that of Leonard Schleifer, the founder of Regeneron Pharmaceuticals, a Tarrytown, N.Y., biotechnology company. Regeneron has become a $4.7 billion (sales) company thanks largely to a drug called Eylea, which treats age-related blindness. Schleifer, who is a billionaire because of his Regeneron stake, has become a critic of his peers. Here at the J.P. Morgan meeting, he went off-script during his investor presentation and spent more time talking about drug pricing and the industry’s reputation than about his own company’s finances.
It was a line of discussion that he’d started at the Forbes Healthcare Summit. I asked a panel of pharmaceutical chief executives why the industry is so hated. After the others had answered, Schleifer was literally quivering in his seat. “If you look at the prices of drugs, they have gone up, sometimes double digits twice a year as a very efficient way of increasing profits without coupled to any innovation,” Schleifer said. “It’s ridiculous. It’s no wonder. I hate us also when I see all this stuff.”
Ian Read, the chief executive of Pfizer, disagreed. “The point I want to make is that the total cost of drugs as a percentage of healthcare has not changed in two decades,” Read says. “I don’t know whether you talk about three prices a year, two prices a year, double digits, not double digits. The cost of drugs have not changed as a percentage of healthcare in two decades, so it’s a red herring.”
Schleifer zinged back that drug companies are not “entitled to a fraction of the GDP,” but Read had a point. John Milligan, the chief executive of Gilead, had an even better one when he said, “Let’s talk about the people who are alive.” Gilead was vilified for charging $96,000 a year for Sovaldi, its hepatitis C drug. It didn’t get any credit for the fact that the drug was a cure, and arguably a cost-saving one. But here’s the reality: Schleifer and Saunders are reflecting the popular mood. The arguments Read and Milligan are making are arguments drug companies have been making for years. The pharmaceutical industry used to be one of the most respected in the country but now–maybe because of bad things it’s done, maybe because of a general anti-science sentiment, perhaps because of both–it is one of the least. And those arguments aren’t about to start working in 2017.
There’s no doubt that Trump’s statements are merely an opening salvo, a negotiating position. Things may not be as bad as they sound. It’s also almost certain that Trump and the Republican Congress will put through tax policies that will allow pharmaceutical companies to bring back many billions of dollars in off-shore cash they’ve been protecting from U.S. taxes. The industry is still launching all sorts of innovative products, and these will make money. But for the drug industry as a whole, things just got materially worse.
It wasn’t until 1992 that Derek fully understood what had happened to him.
His UK based mother Iris had also been injured after a myelogram and chanced upon an article about a court case on “spider’s disease” caused by myelograms.
The article in the Daily Mirror in 1992 was about how UK patients suffering arachnoiditis after an x-ray were suing drug company GlaxoSmithKline.
It was a Eureka moment for the pair.
Derek’s mother became paralysed by the dye left in her body and died on the operating table when doctors tried to ease her condition.
It was then Derek began a 25 year fight for justice for arachnoiditis victims collecting thousands of pages of official documents relating to the dye and its use worldwide.
These documents are now contained in bulging folders that line his living room and the search this year finally unearthed documents that show the TGB failed Australian patients.
In 2001 Derek began legal action against his radiologist, the hospital and the drug company but in the end the lawyers only went after the radiologist and Derek lost his case.
They told him he would not win a case against the drug company. “They talked me out of it even though 140 other Australians received an out of court settlement against the drug company.”
When Derek lost his case legal aid services across the country refused to take on any more cases.
“The government knew what they’d done and they shut it down knowing there were hundreds and thousands of cases coming behind me. They shut it down,” he said.
“There were millions of injections it would have cost billions to fix it, it was so big they just buried it,” he said.
Despite his work in amassing thousands of pages of documents that showed researchers, doctors and government regulators knew of the dangers of the dye for decades only three pieces of paper were ever used in his court case.
Derek tried and failed to stage a protest at the Sydney Olympics against the company Kodak which made the dye, Kodak was sponsoring the Olympics.
Derek blames the pain and disability he suffered as a result of the dye for the break up of his marriage and estrangement from his children.
“This dye was used in 107 countries. I believe 186,000 people were injected with Pantopaque in Australia, more when you take into account Myodil,” he says.
“The important thing is the TGB was not at the gate at the time protecting us,” he says.
“If the TGB had done their job hundreds of thousands of my fellow Australians like myself would not have been abused in this way,” Mr Morrison said.
“My life would have been very different if it did,” he says.
What Derek wants most is for the truth to be told.
“I want recognition this did happen, that the TGB truly failed us, ninety per cent of the sufferers don’t even know the link or what caused their problems,” he says.
Australians crippled and in chronic pain from dye used in toxic X-rays
Sue Dunlevy, National Health Reporter, News Corp Australia Network
December 10, 2016 11:02am
Hundreds of thousands of Australians are crippled by pain, and some are paralysed and wheelchair-bound because the nation’s medicines watchdog failed to check the safety of a dye used in spine X-rays for 42 years.
Explosive new documents reveal for the first time how the government body charged with protecting the public approved the X-ray dye Pantopaque without ever obtaining the studies that showed it was toxic to animals and humans.
“There is no evidence that any animal or clinical studies were specifically requested, submitted or evaluated as part of the approval process,” the Regulatory Services Group at the Department of Health admitted in a letter to dye victim Derek Morrison in February.
The dye called iophendylate sold under the brand name Pantopaque and Myodil contains benzene, hydrochloric and sulphuric acids and is toxic enough to eat polystyrene cups and linoleum tiles.
Medical experts who gave evidence to a 2013 parliamentary inquiry have compared the case with the harm caused by tobacco giants and asbestos company James Hardie.
The phones went into meltdown when News Corporation in 2002 revealed the terrible impact of the dyes on Australians.
Medical tests in the 1940s on 15 dogs at Rochester University in the US showed the dye killed one dog, paralysed another and left most of the animals with inflammation of their nerve roots.
Ernie Hughes, one of several importers of the dye, says he never knew the dye was toxic and says it was approved by the FDA in the United States.
“If I’d known I wouldn’t have sold it and I would have demanded that Myodil be taken off the market too,” he said.
There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.
Pantopaque was mysteriously approved by the FDA on the February 22, 1944 after previously being refused a license weeks earlier due to it being ‘too toxic’ for human use.
In 1969 an application for a licence to sell a half strength version of the dye was withdrawn after a dog study found connective tissue lesions in half the animals, three dogs died, and another became partially paralysed. Rabbit studies show it produced malformed babies with bulging eyes and malformed heads. The full strength version remained on the market.
The Health Department never checked these studies before approving the dye for use here.
Now the victims of the dye are demanding the department and the pharmaceutical companies that marketed the dye publicly admit it harmed thousands of patients.
They want their health and support costs covered, funding for research into the best way to alleviate their pain and fund a charity to support sufferers.
Their calls were backed by a parliamentary inquiry into the dye in 2013 which called on pharmaceutical company GSK to set up a charity for the victims, it has refused to do so.
“GSK considers it has acted responsibly at all times in regard to the supply of Myodil including appropriate testing and monitoring, updates to product information, fair engagement in all legal proceedings and participation in the roundtable process,” a spokeswoman for the company said.
“Taking all these points into consideration, GSK came to the view that it would not be appropriate to establish a charitable foundation,” she said.
Mr Morrison believes there has been a massive cover up by doctors, companies and governments who are ‘just waiting for us to die’.
“They couldn’t fix it, it was so big so they buried it,” he says.
Other victims have told News Corp they are furious that the medical records they need to take legal action over the dye “went missing”.
A spokesman for the Minister for Health and Aged Care, Sussan Ley, said they X-ray dyes were considered to be the best method available to diagnose serious conditions of the spine. at the time.
“We are all concerned for those who have the painful and debilitating side effects from the two medicines (Myodil and Pantopaque) which were used in patients from the 1960s until the 1970s,” he said.
“The concerns of patients who received these medications was the subject of a House of Representatives Standing Committee on Health Roundtable on Adhesive Arachnoiditis on 21 September 2012, he said.
“The committee report recommended that the sponsor of the medication, GlaxoSmithKline (GSK), should consider establishing a charitable foundation to assist sufferers of adhesive Arachnoiditis.
“I understand that GSK has compensated some patients, however, access to further assistance for other sufferers should be taken up with GSK.
“If there is any new evidence on this issue it should be brought forward and assessed,” he said..
Actress Jean Howell who co-starred with James Bond star Roger Moore in the television series The Saint was a famous victim of the dye.
Associate Professor Mal McLeod from the ANU’s Research School of Chemistry says the dye iophendylate was marketed under many names including the brands Myodil and Pantopaque in Australia “it’s the same compound,” he says.
In Australia the dye was injected into patient’s spines before X-rays called myelograms for 42 years, it was withdrawn from the market in 1987 and replaced by a new water based dye.
Radiologists knew iophendylate could cause arachnoiditis but say at the time it was the only way to get a decent X-ray image.
They admit they never warned their patients the painful condition called arachnoiditis was a potential side-effect.
Experts told a parliamentary inquiry the condition causes inflammation and fusion of the nerves and membranes of the spinal cord pain and delivers burning pain “like bolts of electricity”.
Victims also suffer loss of muscle function, paraplegia, incontinence, unpleasant sensations such as ants walking on the skin or having hot water poured on one’s legs. Many patients are wheelchair-bound.
In 2000 around 140 Australian victims of the dye received compensation from drug company GlaxoSmithKline which marketed the Myodil brand of the dye.
However, many victims are unaware the dye is the cause of their health problems and those who do have been unable to get compensation cases through the courts.
Now News Corp has learned when it had a chance to check the safety of the dye in the 1970s the Therapeutic Goods Branch (TGB) of the Department of Health failed to get the studies that should have raised alarm.
The Myodil brand of the dye was first used on humans in the 1940s well before Australia had a government body that checked the safety of medicines and medical products.
However in 1966 after the thalidomide scandal the Australian Government introduced the Therapeutic Goods Bill to regulate the sale of medicines and other therapeutic goods.
This meant that in 1972 when Myodil became contaminated and a Melbourne doctor began importing a US brand of the same dye called Pantopaque it was regarded as a new product and was covered by the new medicine regulations.
A letter from the Department of Health Therapeutic Substances Branch to Epworth Hospital in June 1972 explains:
“Pantopaque is regarded as a new therapeutic substance and has not been approved for general marketing in Australia.”
The hospital was granted approval to use it in emergency cases only and as long as guidelines for experimental use were followed and chemistry and quality control data were provided.
In 1973 Nicholas Pharmaceuticals applied to the TGB for a licence to import Pantopaque into Australia.
Over the next two years various arms of the company were repeatedly asked by the TGB to supply studies on the safety and toxicology of the dye.
In February 1975 Cook Industries took over supplying the dye in Australia various Health department documents show.
The company was unable to obtain the studies from the US company Lafayette Pharmacal that marketed the dye.
Ernie Hughes the former managing director of Amyl Chemical Industries, the Australian branch of Nicholas that imported the dye and also former managing director of Cook Industries says he never knew about the studies in dogs that showed the dye was toxic.
“We only dealt with the commercial company selling Pantopaque, it had FDA approval,” he said.
There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.
He says medical practices at the time were very different to today and many radiographers as well as patients were injured by chemicals and X-ray dyes.
“Who do you go to for compensation? … you can go back in history … here were an entirely different set of things done years ago,” he says.
Despite the fact the TGB did not get the safety and toxicity studies it allowed the various companies to import over 13,500 ampoules of the dye for use in hospitals and X-ray laboratories while the marketing permit was being considered.
And in June 1975 it inexplicably gave up asking for animal studies on the dyes, crossing the word “animal studies” off its request for information from the company.
The department should have been alert to adverse events because in 1969 the US FDA demanded the US supplier of the drug include warnings on the label that adverse reactions included “severe arachnoiditis producing headache, fever, meningitis, pain in the back and extremities and elevation of the white blood count”.
In 1977 our health department was asked by the US FDA to supply details of adverse reactions after it emerged the US company had never filed adverse reaction reports as required by law.
A departmental file note in 1971 shows the TGB had received “a number” of adverse reaction reports but was “not investigating these in the laboratory at this stage as an individual approach to each of these is not possible because our background in the testing of these drugs is rather limited”.
Later, in 1978 our National Biological Standards Laboratory had complaints from 8 doctors about Pantopaque.
And in June that year a Heidelberg Hospital patient died after being administered with the x-ray dye and the adverse drug reaction report says “maybe drug casualty possible”.
Despite this the dye was finally approved for marketing in 1979 without the TGB ever obtaining the animal and human studies it asked for to prove it was safe for use in humans.
“Pantopaque was assessed for safe use in humans as part of the assessment for its marketing approval, but as mentioned to Mr Morrison this did not include specific clinical studies or animal studies,” the department told News Corp.
“The sponsor did provide a list of over 100 publications on the use of the dye as part of the evaluation. There was also knowledge of the use of the dye over many years,” the Department said.
Flinders University Emeritus Professor Michael Sage. A radiologist, says he can’t believe the TGB approved Pantopaque for use in 1979 because he was warning them at that time it caused arachnoiditis.
“It was madness to approve it in the 1970s” he says.
“I struggled to get water based dyes approved in the 1970s because I was aware of arachnoditis,” he said.
“At the same time as they were approving Pantopaque we were asking them to approved a new water based dye because of arachnoiditis,” he said.
“They should never have approved Pantopaque in the 1970s, if they approved Pantopaque in the 1970s it was without taking on board people’s concerns about arachnoiditis,’ he said.
Radiologists used the oil based dyes Myodil and Pantopaque until the 1970s because there was no alternative way to get an image of the spine, he said.
“(They) used it because there was nothing better,” he said.
The dye ceased being marketed in Australia from 1987 but many thousands of patients who suffered its adverse effects have never been compensated and many may be unaware the dye caused their symptoms.
Keith Lewin, 59, had suffered with back pain since his childhood, and claims an agent injected into his spine as a child means he will spend the rest of his life in a wheelchair
A disabled solicitor who faces the rest of his life in a wheelchair because he was inadvertently poisoned by doctors as a child is suing drugs giant GlaxoSmithKline for millions in damages, the High Court heard.
Keith Lewin, 59, suffered with back pain since his childhood but his health issues spiralled out of control in middle age and led to a devastating diagnosis in 2012.
He was told he had adhesive arachnoiditis, a rare spinal condition which causes debilitating pain and which has left Mr Lewin tetraplegic and confined to a wheelchair.
Mr Lewin, of Farington Moss, near Preston, claims that the blame lies in a procedure he underwent as a 15-year-old boy at Merseyside’s Whiston Hospital.
There, medics injected a ‘contrast agent’ called myodil into his spine so that it could be better viewed on an x-ray.
But the procedure did not reveal the source of Mr Lewin’s pain and instead led to his disability decades later, his legal team claims.
When he underwent an operation in 2013, a surgeon found the yellow oily myodil still inside his spine, the High Court heard.
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Suing myodil’s maker and supplier GlaxoSmithKline for compensation, Mr Lewin claims it should have been withdrawn for use in diagnostic procedures years before it finally was in 1988.
‘He has suffered devastating injury,’ his barrister Simeon Maskrey QC told Mr Justice Goss.
‘And its attributability is clear to him and the surgeon who discovered myodil in his spine.’
Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue over something which happened so long ago
Myodil was used as a contrast medium in imaging of the back from the 1940s, allowing medics to better identify problems around the spine.
Mr Lewin’s lawyers claim it had not been sufficiently tested and, even if it could be used, Glaxo should have warned that it must only be in the most extreme cases.
A ‘better’ warning should also have been given about the need to remove the ‘unstable and toxic’ myodil immediately after x-rays, his lawyers claim.
The drugs giant denies all of the allegations and is trying to have Mr Lewin’s case thrown out.
Glaxo barrister, Jonathan Waite QC, argues that Mr Lewin has left it far too late to sue over something which happened so long ago.
He should have suspected by 1977 that he was suffering from the condition and took action to begin a claim before 1983, he said.
Mr Maskrey told the court that the first symptoms of adhesive arachnoiditis which Mr Lewin had were in 2007 when he felt a sudden excruciating pain while out walking.
But pointing to entries in the 20-year-old Mr Lewin’s diaries back in 1977, Mr Waite said the possibility of arachnoiditis was on his mind even then.
The young man, who was still being investigated for the cause of his back pain, had written of having ‘some symptoms’ of a condition which he spelled ‘racnoiditas’, said the barrister.
That must have come from either his orthopaedic surgeon or GP and should have been the moment when he began to investigate whether he could make a claim.
That he instead left it until he had a diagnosis three decades later meant his claim was ‘time-barred’ by the Limitation Act and should automatically fail.
‘Glaxo’s case is that the information about arachnoiditis imparted to him in 1977 was what should have prompted him, as a reasonable person, to be curious enough to start investigating what the cause of this might have been,’ said Mr Waite.
But Mr Maskrey said Mr Lewin had been told of a variety of possible causes of his pain in the mid and late 1970s, of which arachnoiditis was only one.
The pain he had suffered in those days was totally different from that which led to the discovery in 2012 that he had the condition, he continued.
Mr Maskrey said the earliest time in which Mr Lewin could have begun investigating a potential claim was 2007, but that he only had ‘actual knowledge’ of potential for damages in 2012.
That meant he was in time when he launched his claim and it should continue – unless Glaxo, with its ‘vast financial reserves’, decides to settle, he said.
Mr Lewin’s arachnoiditis, which causes inflammation of the membranes which surround the spinal cord, has left him severely disabled.
He suffers from debilitating pain and is confined to a motorised wheelchair both inside and outside his home.
He has had to make extensive adaptations to his home and his partner provides care. The condition is permanent and the prognosis is said to be ‘poor’, the court heard.
In 1995, Glaxo settled – without any admission of liability in relation to myodil – 426 claims which were due to go to court.
The judge reserved his decision on Glaxo’s bid to have Mr Lewin’s claim thrown out until a later date.
Texas, other states reach $105 million agreement with pharmaceutical maker
News release | Posted Jun 4, 2014
AUSTIN – Texas Attorney General Greg Abbott and 43 other state attorneys general today secured a $105 million agreement with drug maker GlaxoSmithKline, LLC (GSK), Abbott’s office stated in a release.
The agreement resolves a multi-state investigation against GSK for “unlawfully promoting its asthma drug Advair and its antidepressant drugs Paxil and Wellbutrin,” the release stated.
Under the settlement agreement, GlaxoSmithKline must pay the state of Texas a total of $6.2 million. According to the states’ investigation, GSK violated state consumer protection law by misrepresenting the uses and qualities of Wellbutrin, Paxil and Advair. State and federal law generally prohibits pharmaceutical manufacturers from marketing their drugs for “off-label” uses that have not been approved by the U.S. Food and Drug Administration.
Among its terms, today’s judgment prohibits GlaxoSmithKline from the following actions:
Making false, misleading, or deceptive claims about any GSK product;
Promoting or distributing information describing any off-label use for a GSK product;
Representing in promotional materials that a GSK product is better, more effective, safer, or has less serious side effects than has been demonstrated by substantial evidence or substantial clinical experience;
Presenting favorable information or conclusions in promotional materials about a GSK product from a clinical study that is inadequate in design, scope, or conduct; and
Providing GSK product samples to health care professionals who would be expected to prescribe the sampled product for an “off-label” use – rather than for an FDA-approved use.
“To the benefit of patients, today’s judgment also confirms a major change in the way pharmaceutical sales teams are motivated and compensated,” the release stated. “Under the terms of today’s agreement, GlaxoSmithKline is required to continue its ‘Patients First’ program at least through March 2019.”
The “Patients First” program reduces financial incentives for sales representatives to engage in deceptive marketing, the release stated. Scientifically trained personnel must develop and approve unbiased and non-promotional responses to health care provider questions.
Oregon and Illinois led the Executive Committee, which included attorneys general from Texas, Arizona, Florida, Maryland, Pennsylvania, and Tennessee.
Additional states participating in the agreement are Alabama, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
I trust in you, O' Lord, my Savior, the One who died and rose again…. the One who brought me in and will carry me out, the Almighty waters and tides that bring us life. I come to You when there is no where else to turn, I come to You when there is. I look to You as my guiding Light, my Savior…. the One who created all I see- created my life and dreams before I knew myself~ created my talents and style before I knew the value~ I praise You and adore Your mystery. I will be strong and conquer as You would want for me. I beg of your blessings and miracles even though I am unworthy of Your power…. Yet, I trust in You~ and know You have already begun Your work. I love You. I don't know if that is a good enough word, "love"~ But I know You on a level---beyond words. Save me Lord. I will not let go of You. Hear me O' Lord. In Christ's Powerful Name Amen ~ By Brandon Heath