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Creating Waves of Awareness

It occasionally happens that someone in the allopathic community tells the truth. It doesn't happen that often, so it's worth bookmarking for later reference. In the first article, a vice-president of Glaxo Smith Kline admits that the majority of people are not helped by the allopantic drugs they take:

The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody."

It seems that the problem of patient individuality bedevils the research protocol of allopathic medicine. Clinical trials do a good job of showing if a certain class of people is helped by a drug, but has no way of determining who within the class will be helped. And the latter, of course, is what the patient consulting a doctor is most concerned with.

In the second article, a researcher explains why there's furor over swine flu, a novel but relatively mild strain, instead of some other disease:

It's easy: They can't make money with it. With rhinoviruses, RSV and the majority of the other viruses, it's hard to make a lot of money or a career out of it. Against influenza, though, there are vaccines, and there are drugs you can sell. And that's where the big money from the pharmaceuticals industry is. It makes sure that research on influenza is published in the good journals. And that's why you have more attention being paid there, and the entire research field becomes interesting for ambitious scientists.

Much of what one gets from the mass media is either trivia, placed there for its entertainment value, or scare stories, placed by those who plan to profit from your fear.

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Comment by Debby Bruck on February 24, 2010 at 12:11am
Avandia, Heart Attacks & An Internal FDA Battle

Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports

Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports, The New York Times writes. Moreover, if every diabetic taking Avandia were given Actos instead, about 500 heart attacks and 300 cases of heart failure would be avoided each month. The pill was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be yanked (Graham said this in 2007 - look).

Some FDA officials want Avandia withdrawn because they believe a safer alternative exists, the Times adds, noting others insist studies offer contradictory info and Avandia should remain an option. GlaxoSmithKline, which makes the pill, says it studied Avandia extensively and “scientific evidence simply does not establish that Avandia increases” risk of heart attacks. The debate, which began with a meta-analysis in The New England Journal of Medicine (see here and here) is intensifying thanks to disagreement over a new clinical trial (see the FDA report on the trial here) and a Senate probe concluding Glaxo should have warned of risks earlier (press release).


In a December 2009 internal memo, FDA official Janet Woodcock, wrote “there are multiple conflicting opinions” about Avandia within the agency (see here), and she ordered an advisory committee, expected to meet this summer, to reconsider whether the drug should be sold. FDA commish Margaret Hamburg tells the Times she’ll wait for the committee recommendations but is reviewing the Senate findings, which are expected to be released on Monday. The investigation criticizes Glaxo for failing to warn patients years ago that Avandia was potentially deadly.

“Instead, GSK executives attempted to intimidate independent physicians (see here), focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” according to the report from Max Baucus, a Montana Democrat, and Chuck Grassley, an Iowa Republican, which the Times obtained.

Graham and Gelperin argued in separate internal reports that a new Glaxo study called TIDE is “unethical and exploitative” because patients given Avandia face greater risks than those given Actos, with no promise of added benefit. The trial may include patients who had heart attacks or chest pains even though foreign drug regulators warned against Avandia’s use by such patients. “The safety of the study itself cannot be assured and is not acceptable,” one report concludes.

The internal reports, which were dated October 2008 and not made public until now, were later overruled by other FDA officials, and Glaxo is currently enrolling patients in the TIDE trial, which isn’t expected to be completed until 2020, although the company is hoping to report some results to the FDA by 2014. But by 2012, the Times notes, the Avandia patent expires.

Grassley said the internal agency battle shows the FDA needs to be reorganized to give more power to safety officials over their counterparts who approve drugs and deal more directly with industry. “It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Grassley tells the Times. “The Avandia case may be the most alarming example of the problem with this setup.”

Glaxo issued a statement saying the report “draws conclusions on the safety of Avandia
(rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. In addition, the report cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia, and communicate those findings to regulators, physicians and patients.” Here is thecomplete statement.

Comment by Debby Bruck on February 24, 2010 at 12:07am
Glaxo chief: Our drugs do not work on most patients
By Steve Connor, Science Editor

A senior executive with Britain's biggest drugs company has admitted that most prescription medicines do not work on most people who take them.

Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them.

It is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public. His comments come days after it emerged that the NHS drugs bill has soared by nearly 50 per cent in three years, rising by £2.3bn a year to an annual cost to the taxpayer of £7.2bn. GSK announced last week that it had 20 or more new drugs under development that could each earn the company up to $1bn (£600m) a year.

Dr Roses, an academic geneticist from Duke University in North Carolina, spoke at a recent scientific meeting in London where he cited figures on how well different classes of drugs work in real patients.

Drugs for Alzheimer's disease work in fewer than one in three patients, whereas those for cancer are only effective in a quarter of patients. Drugs for migraines, for osteoporosis, and arthritis work in about half the patients, Dr Roses said. Most drugs work in fewer than one in two patients mainly because the recipients carry genes that interfere in some way with the medicine, he said.

"The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody."

Some industry analysts said Dr Roses's comments were reminiscent of the 1991 gaffe by Gerald Ratner, the jewellery boss, who famously said that his high street shops are successful because they sold "total crap". But others believe Dr Roses deserves credit for being honest about a little-publicised fact known to the drugs industry for many years.

"Roses is a smart guy and what he is saying will surprise the public but not his colleagues," said one industry scientist. "He is a pioneer of a new culture within the drugs business based on using genes to test for who can benefit from a particular drug."

Dr Roses has a formidable reputation in the field of "pharmacogenomics" - the application of human genetics to drug development - and his comments can be seen as an attempt to make the industry realise that its future rests on being able to target drugs to a smaller number of patients with specific genes.

The idea is to identify "responders" - people who benefit from the drug - with a simple and cheap genetic test that can be used to eliminate those non-responders who might benefit from another drug.

This goes against a marketing culture within the industry that has relied on selling as many drugs as possible to the widest number of patients - a culture that has made GSK one of the most profitable pharmaceuticals companies, but which has also meant that most of its drugs are at best useless, and even possibly dangerous, for many patients.

Dr Roses said doctors treating patients routinely applied the trial-and-error approach which says that if one drug does not work there is always another one. "I think everybody has it in their experience that multiple drugs have been used for their headache or multiple drugs have been used for their backache or whatever.

"It's in their experience, but they don't quite understand why. The reason why is because they have different susceptibilities to the effect of that drug and that's genetic," he said.

"Neither those who pay for medical care nor patients want drugs to be prescribed that do not benefit the recipient. Pharmacogenetics has the promise of removing much of the uncertainty."

Response rates

Therapeutic area: drug efficacy rate in per cent

Alzheimer's: 30
Analgesics (Cox-2): 80
Asthma: 60
Cardiac Arrythmias: 60
Depression (SSRI): 62
Diabetes: 57
Hepatits C (HCV): 47
Incontinence: 40
Migraine (acute): 52
Migraine (prophylaxis)50
Oncology: 25
Rheumatoid arthritis50
Schizophrenia: 60
Comment by Debby Bruck on July 23, 2009 at 9:24pm
Are there ratios of effectiveness on drug pamphlets that come inside the package or online within the pharmacy notes? Probably in very tiny letters.

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