Primum Non Nocere

First do no harm

Dr Gary G. Kohls, a retired physician with a 40 year medical career, is a critic of what he calls the  Big Business of Medicine.

“It is often said that the real clinical trials of new drugs start when the brief pre-marketing studies — involving only hundreds or occasionally thousands of test subjects — have been approved by the FDA, for that is when millions of unsuspecting, but excited patients get their first prescriptions of the latest wannabe blockbuster drug that they saw presented so appealingly on TV.
Big Business argues that the profitability of business enterprises depends on getting new products into the marketplace quickly in order to generate profits as soon as possible. Thus, paying for thorough, independent long-term studies (especially with watchdog agency oversight) is only grudgingly accepted by the profit-driven investors on Wall Street.
In light of the current corporate reality of profit maximization (and that goes for HMOs, hospitals and most clinics, especially the for-profit kinds with their multimillionaire CEOs), we physicians should be the ones who make sure that no harm is being done because of the drugs we prescribe. Throughout history, physicians have always accepted, as a sacred trust, the duty to warn patients about the potential dangers of their treatments, and there are many. ..
...n order for a patient to give fully informed consent to a treatment option, he or she must be given thorough information about the risks, safety and efficacy of the treatment both short-term and long-term, which, in the case of most psychiatric drugs, is virtually impossible to do given the lack of long-term studies that were done prior to FDA approval and the poor post-marketing surveillance that is done. Medical malpractice suits commonly revolve around the issue of adequate informed consent.
Patients deserve to know whether or not psychotropic drugs are addicting or dependency-inducing, are capable of causing withdrawal symptoms or whether or not the patient can be sickened or intoxicated by the drugs. Patients also deserve to know about the existence alternative therapies which, in the case of mental health issues, utilize good psychotherapy and nutritionally-based, life-style alterations, approaches that are often falsely discredited by medical trade association groups like the AMA, the APA and their medical journals. The giant multinational corporations that generously fund such groups, are always looking for ways to eliminate the competition in order to achieve a near-monopoly for the sale of their substances.
The time-honored Precautionary Principle says that an ethical business, governmental agency or culture should err on the side of caution before new chemicals, technologies, procedures, services, food additives, drugs, surgical procedures, etc are introduced into the marketplace (and the environment) – and only then should they be allowed on the market when there is absolute proof that the substances are not dangerous to the environment (which includes human/animal life, the water supply, the soil and the air – i.e., our fragile planet).

So when medical industries wish to market new synthetic chemical substances that have the potential to adversely affect human or environmental health (even years or decades into the future) the Precautionary Principle requires that adequate and aggressive long-term studies (funded by agencies totally independent of those who want to profit from the substance) be undertaken and then only approved when it has been proven to be totally safe.

So, under the Precautionary Principle, regulatory agencies must be given permission to aggressively withhold the marketing approval of potentially carcinogenic, disease-producing, neurotoxic or immune system-destroying products from the environment from where they may be ingested, inhaled or otherwise absorbed into the bodies of potential victims.
Therefore, before potentially dangerous substances are allowed onto the grocery store shelves or into our pharmacies, hospitals, clinics and then, inevitably, into our bodies, the Precautionary Principle says that they should be first proven that they will do no harm, short-term or long-term.
As was documented in last week’s Duty to Warn column America has a drug-induced dementia, suicide, violence and mental ill health epidemic on its hands that should be obvious to every critical thinker that looks at the evidence. But because there are not many in the medical professions with the time (or willingness) to look at the evidence, the epidemic will surely continue to worsen because of the continued chronic use of non-curative drugs that are, in America, too often used as first-line “treatment”. Both psychiatric drug-induced brain disruption and psychiatric drug withdrawal syndromes can be mistaken for mental illnesses of unknown cause.
We can do better for our patients — and our dying planet — if we just go back to the honorable past traditions exemplified in the Hippocratic Oath and the Precautionary Principle.

From Dissident Voice

cheap drugs for sale

India - the ‘pharmacy of the world's poor’


Glivec is produced by Novartis in the treatment of chronic myeloid leukaemia (CML). Glivec as a life-saving, breakthrough drug for certain forms of cancer, The treatment cost is 130,000 rupees ($2400) a month. An Indian generic alternative is priced at cheaper 8000 to 12000 rupees a month.

The Indian Supreme court just granted a victory to the sick all over the planet when it refused the Swiss pharmaceutical giant a new patent for the tinkering it did with its anti-leukemia drug Glivec.

Novartis’ website declares: “We are committed to provide access to medicine for patients worldwide.” But how is this possible where the sick find their drugs prohibitively expensive?

It was only when Indian firms began to make cheap copies of HIV drugs that it became possible more than a decade ago to contemplate the treatment of millions of people in impoverished countries of Africa, where the AIDS epidemic was at its worst

“This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF,” Dr. Unni Karunakara, the head of the Nobel Peace Prize-winning Médecins Sans Frontières (Doctors Without Borders)

Big Pharma - Big Profits

Tamiflu maker accused of secrecy over trial data. Scientists are set to raise serious questions about the effectiveness of Tamiflu, its side-effects and the opaque way drugs get approved for widespread use on the NHS.

Cochrane, a non-profit group dedicated to analyzing medical evidence, brings together the combined results of the world's best medical research studies, and are recognised as the gold standard in evidence-based health care. But during their two-year study into Tamiflu, researchers claimed they were hampered in their efforts to fully appraise the drug by the refusal of its manufacturer, Roche, to hand over all the raw data used to support their claims.

Professor Sir Iain Chalmers, a founder of the Cochrane Collaboration, told The Bureau of Investigative Journalism: "We have invested millions of pounds on stockpiling Tamiflu on the basis of a paper that presented the results of 12 trials, only two of which have been published. The investigation... shows Roche refused to provide data to evaluate these trials. Investigators got some data through the European Medicines Agency, but this doesn't answer all of the questions they have." He added: "It is a disgrace that Roche have not provided this data."

Tom Jefferson, the lead author of the study, said he was very concerned about the unwillingness of Roche to provide all the raw data. It is understood the European Medicines Agency that approved Tamiflu also only saw a proportion of the drugs trial results. The US Food and Drug Administration is thought not to have reviewed the largest ever trial of Tamiflu when considering it for approval.

http://www.independent.co.uk/life-style/health-and-families/health-news/tamiflu-maker-accused-of-secrecy-over-trial-data-6290699.html

SELLING CANCER

Diego Ballesteros Pino, the director of oncology at the Baja California Health Authority explains that "When a person gets a cancer diagnosis they are so hungry for life. It is human nature to not hear what the oncologists are saying and this gets even stronger when the oncologist has to tell the patient there are no longer treatments that are available for him, that they can no longer guarantee survival and that's when they start looking for hope." And that, he said, is where the alternative therapy clinics step in. "...they are definitely predatory. They're only out to make money. I see many people that come after being cheated out of their money with more advanced stages of cancer. They missed the opportunity to have the conventional medicine. Our first duty is to try to convince them to stop doing the alternative medicine and that is one of the hardest things. And some of them do get better, some of them we are able to save. Some we cannot."

Frank Cousineau, president of the Cancer Control Society believes in the efficacy of alternative cancer therapies. He says people do not need statistics, they need love. "They don't come seeking peer reviewed studies, they come for hope, because hope has been destroyed in the conventional oncology community. Too many oncologists, with a very almost cold hearted demeanor, will tell a patient that nothing can be done for them."

Professor Ian Smith at the UK's Royal Marsden Hospital. He says that while he has never seen a patient cured by alternative therapies, he accepts that the medical profession still has a lot to learn about supporting terminally ill patients who have reached the end of the road as far as conventional medicine is concerned. "It's an important criticism of us I think. We are getting it right now, much more of the sense that we have to support people all the way through and hopefully that's a way we can combat this pressure on patients to go and sell their house and sell everything and have some valueless treatment."

Some of the Tijuana clinics are offering nothing but false hope. There is little or no evidence to support their claims that their strange therapies actually work and there is plenty of evidence that vulnerable people have parted with large sums of money for no reason. ($21,000 for a two week course, a hotel down the road at your own expense and there would be the extras for treatment on return to London.). At the Hospital Santa Monica that was used to be run by an American called Kurt Donsbach a FBI investigation revealed that over an 18 month period he made $32.5m from selling treatments. Donsbach was jailed for a year after pleading guilty in a San Diego court to 13 felony charges including: impersonating a doctor, spiking his internet 'natural' supplements with dangerous and banned pharmaceuticals and falsely telling an undercover FBI agent he had a 60 per cent success rate for treating terminal cancer patients.

Gina Darvas, the San Diego deputy district attorney, collected over 400,000 pages of evidence against him. She says: "Throughout the prosecution he remained fairly defiant and again tried to promote himself as a victim of overzealous prosecution, that the medical establishment was out to silence him for alternative medical opinions .... He said, I have a 60 per cent success rate in getting you another five years of life, and it's only going to cost you $23,000 cash up front and that’s a very powerful and persuasive incentive to someone who has maybe six months to live. It’s preying on the most vulnerable victim that could possibly be found in my view. To run a con on somebody in that situation is a terrible thing to do."

http://www.aljazeera.com/programmes/peopleandpower/2012/01/2012111152415164558.html

TCM

Western medicines are making China's ancient medical practices increasingly redundant, but their high price tag is also pushing millions further into poverty. The proportion of Chinese using Traditional Chinese Medicine in the formal medical sector fell from 25 per cent in 1991 to 14 per cent in 2004, according to a survey published in Social Science and Medicine last July. A century ago there were 800,000 practitioners of traditional medicine in China, but the numbers have steadily fallen. In 1999, the Government introduced licensing for practitioners and the number dropped to 200,000.

Western medicine comes with a Western price tag and high health costs are forcing increasing numbers of poorer workers into poverty, amounting to 2-3 per cent of the population every year. Between 1993 and 2003 costs rose six times for out-patients and four times for in-patients. Patients in hospital still check their bills daily and, if their money is running out, discharge themselves early.
China is a nation hooked on the idea that any illness can be cured with the right drugs – and the bigger the dose the better.a young man with his eyes closed, wearing a blue face mask, is also being treated with intravenous antibiotics for a cold. In the West such treatment would never be countenanced – colds are caused by viruses and antibiotics, which tackle bacteria, are regarded as rarely necessary. Moreover, intravenous administration of drugs is reserved for the most seriously ill patients.

Donald Li, a Hong Kong GP and adviser to the Shanghai government, says Chinese patients are sceptical of the value of advice given by doctors, but place great faith in the power of medicinal drugs."The belief is that there is a therapeutic value from the drug, but no value in telling me what I should do. Injections and intravenous treatment are liked. This is a culture that seeks intravenous treatment," he says.

But economics plays a part, too. Charges levied by hospitals are set deliberately low by local councils, often too low to cover the cost of the service. Hospitals have to make up the difference in the cost of drugs and diagnostic tests which are not controlled. They charge heavily for them – and encourage patients to have more. The situation is aggravated by doctors' poor rates of pay. They depend on bonuses paid by hospitals from the income generated by drugs and tests. All the incentives in the system are thus aligned, but towards the wrong objectives."There is over-diagnosis, over-treatment and bad practice," said Professor Li. "It all comes back to doctors' low salaries. If they were properly paid they wouldn't need to do these things."

Health Racism

Emergency room doctors are prescribing strong narcotics more often to patients who complain of pain, but minorities are less likely to get them than whites, a new study finds.

Even for the severe pain of kidney stones, minorities were prescribed narcotics such as oxycodone and morphine less frequently than whites. Minorities were slightly more likely than whites to get aspirin, ibuprofen and similar drugs for pain. The analysis of more than 150,000 emergency room visits over 13 years found differences in prescribing by race in both urban and rural hospitals, in all U.S. regions and for every type of pain.

Linda Simoni-Wastila of the University of Maryland, Baltimore, School of Pharmacy said the race gap finding may reveal some doctors' suspicions that minority patients could be drug abusers lying about pain to get narcotics. The irony, she said, is that blacks are the least likely group to abuse prescription drugs.

"If anybody argues they have no social biases that sway clinical practice, they have not been thoughtful about the issue or they're not being honest with themselves," said Dr. Thomas L. Fisher, an emergency room doctor at the University of Chicago Medical Center

The Drug Dealers

Drug firms are failing to make drugs affordable for the world's poor, a report by charity Oxfam suggests.

The world's biggest drug firms have done little research into diseases that affect poor people, the report said. And their overzealous protection of patents means many poor people cannot afford the drugs they need. Currently 85% of the world's population is priced out of the industry's market . Those who cannot afford drugs often pay with their lives.

Malaria claims the lives of one million people every year, while two million people die annually from TB.

Between 1999 and 2004, there were only three new drugs targeted at diseases affecting the developing world out of 163 drugs brought to market .

Yet for all its no doubt sincere bleatings for a fairness and justice , Oxfam can see no further than the continuance of the very same same capitalist system that causes these problems .

In response to the drug companies , who argue they need to charge higher prices to justify the billions of dollars they spend on research and development and that high taxes and mark-ups by pharmacists and dispensing doctors also push medicine prices higher, they point out and that in addition, their drugs and brands are often ripped off in countries with poor copyright protection , all Oxfam can do is offer the Third World as a bigger market to exploit and source for lower development costs and cheaper manufacturing. Oxfam want "prices for essential medicines need to be tiered, in line with people's ability to pay"

Surely , it must be medical needs that should determine access to medicines and not the ability to pay , no matter how the pricing system may be organised . It is this free access to all the means of life which is the demand of socialists .