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Human Genes Can No Longer Be Patented: The End of a Monopoly

 MD-FM Thursday 20 June, 2013




Sarah:
MD FM, Medical News from around the world with Peter Goodwin.

 

P1

PETER:
Hello, and with me is Sarah Maxwell. To begin with, the United Sates Supreme Court has unanimously ruled that, human genes cannot be patented

SARAH:
Yes, the Justices said: human genes, even when isolated, belong to nature. They can be “discovered” but are not “invented” so can’t be patented. In effect, this ruling ends the nearly two-decade long monopoly held by Myriad Genetics (the company at the centre of the case) over BRCA genetic testing for breast cancer. Researchers have responded that the decision will broaden the availability of BRCA testing in the United States:

Grody: The day of the ruling, literally within minutes after the announcement, two commercial laboratories in the United States, that are good labs, instantly sent out internet announcements saying they are going to start offering BRCA gene sequencing. So already we see competitors to myriad

SARAH:
That was Dr. Wayne Grody, from the UCLA School of Medicine in California.

PETER:
BRCA’s been a hot issue in the States recently since Angelina Jolie’s double mastectomy decision and I suppose this means other women, too, could more easily afford the test as competition drives prices down?

 SARAH:
Well yes. Harry Ostrer, who was involved in the Myriad litigation, told MDFM things are moving that way:

Ostrer: We do expect the cost is going to go down significantly. At least one laboratory has indicated already that it will offer the sequencing test for BRCA 1 and 2 for less than a thousand dollars. That is substantially less than what Myriad Genetics charges for their test


SARAH:
That was Dr. Harry Ostrer, from New York University. On the other side of the Atlantic, although the patent is still valid, most European labs have been offering ignoring it:

Matthijs: Technologies for sequencing a gene are available in all the laboratories and all the European labs have infringed this patent and we are all offering the test. The cost has been less than 50% of what the company charges in the US, so it fits in the healthcare system –we have reimbursement. This is an illegal practice and the patent owner could have attacked laboratories in Europe but it hasn’t happened

 
SARAH:
That was Professor Gert Matthijs, from the Center for Human Genetics in Belgium, who added that, beyond breast cancer screening, this decision should make a lot more genetic tests available, especially for rare diseases.


VIRGULE MUSICALE


P2
PETER:
In a new study, people who increased their red meat consumption by half a serving a day, over four years, greatly increased the risk of developing type-2-diabetes during the next four years

SARAH:
Yes, these are the findings, published in JAMA Internal Medicine, of the first longitudinal study to look at the association between changes in red meat consumption and diabetes. The authors collected detailed information on nearly 150,000 people and found a 48 per cent increased risk of Type 2 diabetes as compared with people who didn’t increase their meat consumption

 
PETER:
Hmm, so read meat causes an increased risk of diabetes?

 SARAH:
Well, this was an observational study, so the authors couldn’t conclude if it was a causal relationship. And, by they way, they found that reducing your meat intake has a small benefit in preventing diabetes. William Evans, who wrote an accompanying editorial, suggested it’s the fat in meat that is causing the problem:

 Evans: We know that many cuts of beef are rich in saturated fat, and it’s the consumption of saturated fat that really increases the risk of diabetes, it’s not the ‘redness’ of meat that causes the problem; there are cuts of beef that have less fat than chicken breast. Previous studies have shown that, for example, processed meat, like salami, baloney, hot dogs, they are rich in saturated fat and they impart a large increase in the risk of diabetes and heart disease. So I think the real message is to be careful about your saturated fat intake. One can choose to eat high quality proteins, cuts of beef, poultry, fish that are low in total and saturated fat.

 
SARAH:
Dr. William Evans from Duke University in North Carolina.


P3
PETER:

For children at risk of type-1 diabetes, the appearance of islet auto-antibodies can predict their likelihood of getting the disease eventually. That’s according to a study, published in JAMA, that found that most children at risk, the ones who found to have two or more such diabetes-related auto-antibodies, developed type-1 diabetes within 15 years. And the authors note that the younger the age at sero-conversion, the earlier the progression to diabetes.


VIRGULE MUSICALE


P4
PETER:
For patients with rheumatoid arthritis who weren’t responding to methotrexate therapy alone, adding two more standard disease modifying anti-rheumatic drugs was as effective as adding a biologic agent to methotrexate. That’s according to a study published in the New England Journal of Medicine

 
SARAH:
Yes, it showed that after six months of treatment, 27% of patients randomized to triple-therapy hadn’t reached the targeted clinical response. The number were the same for patients randomized to anti-tumour necrosis factor (TNF)-therapy. Blinded crossover was allowed so that all patients not responding to the initial therapy at 24 weeks could change to the other. The X-ray scores were the same at one year.

 
O’Dell-1: At the end of the day, these strategies were equivalent. So, the obvious recommendation is: when a patient is not having optimal response with methotrexate alone, they should be given a trial of triple therapy for 6 months. The major reason to make that choice is because of tremendous economic savings. And if they are not getting an adequate response on that, they should be switched to a biologic

 
SARAH:
That was Dr James O'Dell from the University of Nebraska Medical Center, in Omaha. He was speaking to us from Madrid, where he presented findings at the annual meeting for the European League Against Rheumatism. Dr. O’Dell said there were more serious adverse events among patients on anti-TNF-therapy, mainly infections, and triple therapy was associated with gastrointestinal events…so it’s checks and balances


O’Dell-2: In a patient who has a history of problematic infections, you are certainly going to favor staying with the conventional triple option as opposed to a biologic, so: clinical judgement remains very important


SARAH:
James O’Dell, from Nebraska.



VIRGULE MUSICALE



P5
PETER:
New guidelines from the European Society of Hypertension and the European Society of Cardiology were presented last week at the European congress on hypertension and cardiovascular protection in Milan

 
SARAH:
Yes and perhaps the biggest change compared to the 2007 version is the adoption of a single systolic blood pressure target for almost all patients under 80 who do not have diabetes: 140 mmHg.

 
Mancia-1: In 2007, the guidelines came up with the so-called flexible target for treatment, in other words less than 140/90 mmHg in the general hypertensive population, but less than 130/80 mmHg in individuals at high risk. Now this year the group recognizes that the evidence that is it beneficial to go below 130 is just not there. So the target blood pressure has been unified: for all patients, it’s below 140/90 mmHg

 
SARAH:
That was co-chairperson of the guidelines task force Giuseppe Mancia from Milan. He said the approach to drug therapy for hypertension has also been thoroughly revised: doctors should individualise treatment depending on the fitness of their patient; and no single drug or class is given preference.

 
Mancia-2: The beneficial effects of treatment are largely due to blood pressure lowering per se, regardless of how it is obtained. So all classes are regarded as suitable for initiation and maintenance of antihypertensive treatment. The attitude is to avoid this classification into first choice, which refers to an average patient, which hardly exists in clinical practice, and try to help physicians to tailor treatment

 
SARAH:
Professor Giuseppe Mancia from Italy.


BREVE 1 Sur fond musical

PETER:

Finally, in brief:

 

The earlier a patient gets intravenous thrombolytic treatment after having a stroke, the greater the reduction in risks of in-hospital death and intracranial haemorrhage, and the faster the rate of hospital discharge. These are the results of a study reported in JAMA with nearly 60,000 patients with acute ischemic stroke, treated with intravenous tissue plasminogen activator within four and a half hours of symptom onset.

 

And

 

BREVE 2

Prescribing an anti-retroviral to HIV-negative injecting drug users, a practice known as pre-exposure prophylaxis, cut their risk of acquiring the virus in half. And for those who did the best at regularly taking their pills: risk was reduced by three-quarters. These are the results of a randomized study, published in The Lancet, with over 2 400 volunteers randomized to receive either daily oral tenofovir or placebo.


That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then from me Peter Goodwin, goodbye!

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