- Politics and Social Issues»
Clinical Trials -v- Testimonies of success
Anyone who studies new claims for 'wonder drugs' and new 'cures' will swiftly understand the vast gap dividing the traditional 'white coat' scientific approach to medical matters versus the alternative treatments/health section of society.
This hub does not seek to argue who is correct and who is wrong, for each individual will already have an opinion on that issue, and like many other situations, we become entrenched in our opinions by agreeing with one position or the other.
But there are two distinct positions and they are diametrically apart.
Anyone reading my other articles will quickly see or know that I am in favour of natural alternative medicine, so I will not labour that point further.
What I do wish to do is propose a new way of dealing with new drugs, and one which I reason will lead to better and more efficient medical treatments eventually at a lower cost to the 'end user' being those of us who become afflicted by disease and sickness, and who want to get better.
Currently most clinical trials are commissioned by BigPharma (by which I mean one of the main pharmacutical companies) who seek FDA apporval for the new drugs they have produced.
These drugs, when approved, and as they are patented, will then be sold for great profit, via the public health system, at a high price, ostensibly required to cover the cost of ongoing research.
The fact remains that despite whatever BigPharma may say, they make stupendous profits for their shareholders, without fail, indeed it seems that they have increased profits during the current depression caused by the bankers.
Now profit in itself is no bad thing, we need profits to return to shareholder to generate business advancement and capitalisation, so this is not some communist rant against profit.
However your health should NOT be determined by political or financial considerations, and therefore those with vested financial or politically motivated interests are not the best people to govern what happens in health care.
- The FDA Says You Have No Right to Choose Your Food
The FDA has stated that you have no inherent right to health. You thought you had the right to choose what you eat? The FDA says you don't. They claim that there is no fundamental right to choose your food or freedom to contract for it.
From a perspective of natural health proponents, the playing field is less than level. Most people involved in natural heath and alternative health are not in it to make vast profits, indeed, they tend to be idealistic healers who are more concerned with curing sickness than selling drugs which may be approved to treat the symptoms of the disease, but will not stop the disease from afflicting you.
That is not to say there are no fraudsters selling snake oil, sick folk are just as susceptible to buying snake oil as they are to taking chemical drugs that have horrendous and even lethal side effects.
According to the Journal of the American Medical Association (JAMA) in a 1998 report, prescription drugs were found to kill over 100,000 Americans each year – that’s three times as many as are killed by automobiles—making prescription drug death the fourth leading killer after heart disease, cancer and stroke, in 1998.
- FDA sends US marshals to seize elderberry juice concentrate, deems it \'unapproved drug\'
A Kansas-based producer and distributor of elderberry juice, is the latest raid target of the US Food and Drug Administration (FDA), which recently sent US marshals to the company's winery in Mulvane to confiscate the 'unapproved drug'.
Do you think that has got better or worse?
Is this a positive reason to trust BigPharma?
There should be a better, safer way to handle healthcare.
Clinical trials for natural remedies are simply too expensive to conduct, after all, if BigPharma will not do them as they cannot make a profit, why should a small company attempt to compete?
But despite having no clinical trials, millions of people chose natural medication (and self medication) over traditional white coat medicine for the simple reason that there are stacks of testimonies that endorse cures that medical science shuns and even attempts to drive underground.
Try to find a news article where anyone has died from using natural medicine. According to a report published by the U.S. National Poison Data System, the number of people killed in 2009 across America by vitamins, minerals, amino acids or herbal supplements is exactly zero.
Private equity firm Blackstone sold its 21.8 percent stake in Southern Cross Healthcare Group, the country's biggest operator of care homes, for 169 million pounds on Thursday.
LONDON | Thu Mar 8, 2007 7:26pm GMT (Reuters)
Morgan Stanley sold 41 million Southern Cross shares on behalf of Blackstone through an accelerated bookbuilt placing.
The shares were sold for 412 pence each, and valued the company at about 770 million pounds.
Southern Cross shares jumped 80% after its initial public offering (IPO) in July 2006, when the company raised 175 million pounds from the sale of shares at 225p each.
Blackstone BG.UL owned 88% of Southern Cross prior to the IPO, but its stake fell to 48% after the flotation.
The current scandal that is happening in the UK, where Former Southern Cross owner Blackstone have come under condemnation for the way they handled the 'investment' highlights what happens when a vulnerable and essential health care situation is manipulated for profit.
The UK press reported that Blackstone created the problem, Blackstone counter on their website with a rebuttal, in which they quote:
"Blackstone’s investment thesis was predicated on growth, investment in the management infrastructure of the business and on the creation of a company with a reputation for quality: a company viewed as a responsible operator by its local authority funders and its residents.
Blackstone made a positive return for its investors on this investment because it helped to create a sector leader which was successfully floated on the London Stock Exchange. After the IPO, Southern Cross’ share price nearly tripled." End Quote
Nearly tripled the share value.... so in March 2007 they sold a company at a share price which valued it at £770 million (US$1,287 million)and netted them £169 million (US$282 million) profit, and which today is worth £11.85 million (US$19.81 million) however you look at it, that is a loss for someone (those who bought the shares from Blackstone when they bailed out) of nearly 98.5% of the supposed value at IPO.
OK, fair game, people bought to make money, Blackstone's whole business is to make money and let buyer beware (and sorry if you are one of those who got caught in the trap) that's why they always state that the value of shares can also go down!
In shares, nobody makes money unless somebody loses money.
But the broader issue here is that the care of 31,000 elderly people is now in question, and the "reputation for quality......a company viewed as a responsible operator by its local authority funders and its residents." sounds hollow now, especially to the 3,000 staff that Southern Cross have said they will need to lay off.
Where is the justice in a firm that describes itself as an: alternative asset management company being allowed without restraint or future guarantee to buy a Care Home company with the expressed purpose of driving up the share price, taking a substantial profit, and then leaving it in the hands of others to sort out?
So how does this tie into clinical trials?
Having set the scene and accepted that profit, is not a bad motive, we should however concur that there are some areas of life where pure profit should not be the issue, indeed, profit should be separated from them.
Health, and health care is patently one of those areas.
I propose that rather than BigPharma controlling the drug industry, and more specifically the research and licensing of new drugs, via their chums at the FDA (were you aware that once you have worked for the FDA in a senior position, you will always find a cushy job advising a BigPharma company for a very high salary) we should adopt a new system where scientists, chemists and researchers would work developing new drugs for independent non profits who are forbidden to receive any funding directly from BigPharma, or indeed any other entity, except the government by way of grant.
The government would of course administer those grants, which could lead to vested interest pressure groups (lobbyists) ensuring that they favoured BigPharma (who have much 'invested' in controlling the market), so we would need lots of Ellen Brockovich style people on the committees of control also (i.e. whistle blower activists and people of integrity) to ensure fair play and impartiality.
We may even find members that actually put healthcare and people before profit!
These non profits would then be required to investigate and conduct clinical trials on ALL new drugs, medicines or supposed cures for anything, and report objectively concerning the efficacy of the drugs they trailed.
In this way the development and testing costs would be recovered, as the company who sold the drug would return a profit to the system as well as shareholders.
Once a new drug or natural therapy had been approved, anybody would be able to bid to hold the exclusive marketing rights on it for a given period, and the highest bidder over and above the development costs would win.
So if one BigPharma company proposed a new drug, and it was approved, then any other company could still outbid it for the marketing license, which would recoup company ones investment, and the cost of non profit development and trials.
Sales prices would be fixed by central government after analysing the development and research costs.
A fair and reasonable profit should be allowed.
In short, BigPharma should revert to being drug manufacturers, rather than the controller of the whole market place.
A proviso would need to be inserted that the winning bidder must prove effective marketing of the new product within a set time period, or the rights would be cancelled and the product would be in public domain, in order to stop BigPharma buying up successful natural cures (and there would be many I believe) and burying them in the backwoods to stop competition with their expensive chemical products.
I fully understand that commercial drug companies choose not to develop natural cures that will earn them much lower profit margins, that is the nature of business, and it is their business to make maximum profits, but in health matters, we need to focus on finding out what works best for each situation, not on what is the most profitable.
Currently the USA has the highest healthcare costs in the world, it's drugs are artificially kept at high prices and it's citizens are the least well provided for in terms of value for money. Nearly 20% of Americans have no health insurance, over 45% of bankrupcies are due to medical expenses, and the United States life expectancy ranks 42nd in the world.
In 2008 the top twenty drug companies which make up BigPharma sold almost US$500 billion of drugs, invested just under US$71 billion in research and development, and made US$110 billion profit. Between them they employed 1,342,700 employees. Which means that each employee made them about UD$64 million
This is madness.
Message to BigPharma from the natural health folk...
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- Natural medicines or chemical compounds?
In Gods plan the human body was designed to function with minimum wear and tear from birth until death without failing.