Earlier this month, celebrity chef Paula Deen announced that she has adult-onset or type 2 diabetes, then accepted a multimillion dollar deal to promote Novo Nordisk’s type 2 diabetes drug, Victoza. Before there was Paula Deen, there was figure skater
Dorothy Hamill and actor
Wilford Brimley. Indeed, there has been a long line of celebrity spokespeople for pharmaceutical companies, and their track record thus far has been quite poor in terms of honesty, openness, and promoting the public’s health.
Middle-aged arthritis sufferers flocked to their doctors demanding Vioxx for pain relief after watching Hamill figure skate in TV ads touting the drug shortly into the new millennium. We now have
evidence that Vioxx caused as many as 140,000 extra cases of serious heart disease in the United States during the years that its maker concealed evidence of its risks, and it was withdrawn from the US market in 2004.
All right, you say, Hamill was paid to shill for a dangerous drug. But what could be wrong with Brimley telling diabetics to check their blood sugar?
There is one group of patients with type 2 diabetes, the most common form of the disease, who need to check their sugar levels frequently and who really need those cute little machines. Those are also those (apparently including Brimley) who take insulin shots. But the majority of type 2 diabetes folks take only oral medicines or use diet and exercise to regulate their blood sugar. From those ubiquitous TV ads in the late 1990s and early 2000s, however, you’d guess that scientific studies show great health advantages to religiously using home glucose monitors.
Funny thing, though. The available research shows overwhelmingly that there’s no known health benefit to home glucose monitoring for people not on insulin. A number of
large studies on improving outcomes and death rates in diabetes show consistently that tight blood sugar control is not where the action is. Rather, type 2 diabetes tends to strike through severe complications like heart attacks, strokes, kidney failure, and other diseases that basically are caused by diabetes’ effects on both large and small blood vessels. Doing things to protect yourself from those diseases—diet, exercise, stopping smoking, controlling blood pressure, and so on—improves and lengthens life in diabetics. Lowering blood sugar by itself hardly helps at all.
Don’t hold your breath waiting for highly-paid celebrity spokespersons to tell you these important medical facts on TV. And the reason they won’t is part of why the whole system of celebrities touting drugs and medical devices is unfortunate for public health. These ads don’t just sell us products. They sell us ways to think about disease. And the industry wants to be sure that the way we think about a disease is whatever way is best for pushing their sales and profits.
Physician and historian
Jeremy Greene wrote about this a few years ago. He showed how the pharmaceutical industry jumped onto the preventive medicine bandwagon to convince both doctors and the rest of us to “prescribe by the numbers”—not to ask what drugs actually lengthened life or improved quality, but simply to be happy when a lab test result, such as blood sugar or cholesterol, was high and a drug made it go lower. It turns out that it’s much easier to discover and market a drug that makes your lab values look prettier than it is to find drugs that really save lives and prevent heart attacks. But most of us simply assume that lower lab numbers mean less risk and a healthier future—a connection that medical research informs us is often missing. (A great book on this frequent lack of connection is
Overdiagnosed by W. Gilbert Welch.)
Now, at this point I have to add the usual disclaimer, and then a disclaimer on the disclaimer. The disclaimer is that you should treat your medical condition based on your doctor’s advice and not what you read on a blog or news outlet. If you have diabetes, for instance, find a physician that you trust and follow that physician’s advice, though you should also ask questions and feel free to do your own research.
But here’s disclaimer squared: when a drug or device company markets products to you with a celebrity spokesperson, you can be sure that the same marketing, probably on steroids, is going on behind the scenes in doctors’ offices and hospital corridors. When at least 84 percent of American doctors regularly rely on industry salespeople for critical information about drugs, the “prescribe by the numbers” message is
just as ingrained in their thinking as it is in the general public’s. (The celebrities that drug companies use to brainwash doctors are not the Wilford Brimleys of the world, but rather distinguished medical school faculty physicians who happily take company money to serve on their speakers’ bureaus and to push the company marketing message.)
So, bottom line: is there something especially bad about any single celebrity deciding to shill for a particular drug or medical device, like Paula Deen telling us to eat cheeseburgers and also take good care of our diabetes? Maybe yes, maybe no. Is there a problem with how these products are marketed in the United States today? Absolutely.
Howard Brody is a family physician and medical ethicist and directs the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. He maintains
a blog on the ethics of the relationship between the medical profession and the pharmaceutical industry.
ATLANTA – The woman walked quietly into the busy emergency room at
Grady Memorial Hospital, Atlanta's safety net hospital for the poor and uninsured. She waited four or five hours to be seen, sitting patiently on a gurney and clutching a plastic bag.
Michael A. Schwarz, USA TODAY
Otis Brawley, professor of hematology and oncology at the Winship Cancer Institute in Atlanta, visits with patients at Grady Memorial Hospital. He is accompanied by Amanda Yassin, Pharmacy student at South University, and Brian Lingerfelt, oncology fellow at Grady Memorial Hospital.
Michael A. Schwarz, USA TODAY
Otis Brawley, professor of hematology and oncology at the Winship Cancer Institute in Atlanta, visits with patients at Grady Memorial Hospital. He is accompanied by Amanda Yassin, Pharmacy student at South University, and Brian Lingerfelt, oncology fellow at Grady Memorial Hospital.
>
Inside the bag was a moist blue towel. Wrapped inside that towel was her right breast. She was hoping it could be reattached.
Doctors in the United States don't see cancer patients like this every day. A mixture of fear, poverty and lack of paid sick leave had led her to delay cancer treatment for years. Eventually, the tumor grew so large that it cut off the blood supply, causing her right breast to die and fall off, says
Otis Brawley, chief medical officer at the
American Cancer Society, who saw the woman in the ER that morning in 2003.
In his new book, How We Do Harm: A Doctor Breaks Ranks About Being Sick in America, Brawley presents the woman's suffering as a metaphor for a rotting health system that is run, he says, "by the greedy serving the gluttonous."
Johnny Carson once said that if you want to clear your system out, sit on a piece of cheese and swallow a mouse. Many would claim that a homeopath's prescription for colonic purging would be about as helpful. In the UK activists have devised a colourful way to make their point.
The Guardian reports on a series of unusual protests outside pharmacies in the UK. On Saturday, January 30, hundreds of self-proclaimed skeptics gathered to denounce the Boots chain's hawking of homeopathic remedies, treatments that are unregulated and have little or no scientific basis. At precisely 10:23am local time protesters staged a series of mass overdoses in several cities, downing entire bottles of pills and potions to emphasize their worthlessness as medicine.
A promised sympathy demo was to have taken place in Canada, but at least according to
CanadaPharmacyNews, no one seems to have braved the cold to have at it with Canuck homeopathy.
Skeptics argue that theories behind homeopathy – which relies on the extreme dilution of animal, plant, mineral as well as synthetic substances so that remedies do not contain a molecule of the original substance – are utter nonsense. Most scientists agree that the only possible impact of such remedies is as a placebo. The
10:23 Campaign, which organized the demonstrations in Britain, has created an interesting website, with a provocative collection of
videos. Richard Dawkins is entertaining as he demolishes homeopathic theory in less than ten minutes.
As predicted, no ill effects were reported from consuming massive amounts of homeopathic remedies. Anti-homeopathy groups have targeted Boots because they believe its nationwide status as a long-established pharmacy retailer gives the public false confidence in such products. The sale of homeopathic pills and potions in drugstores – along with potato chips, candy and soft drinks – sends a mixed message.
The anti-homeopathy lobby believes that by diverting people with genuine complaints away from conventional medicine homeopaths can put lives at risk. They cite cases of patients who have been been warned away from vaccinations, given homeopathic preparations for serious diseases like malaria, or advised to stop taking medication for cardiac disease.
brief on herbal and homeopathic products, making several recommendations that generally revolved around ensuring that such preparations are regulated, that their claims of efficacy are substantiated by available clinical data, and that the safety of the Canadian public is protected.
The
Natural Health Products Regulations require all homeopathic medicines to have a licence before being sold in Canada. Licence holders are issued a product number which must appear on the label of their product. The Natural Health Products Directorate (NHPD), which is responsible for issuing product licences for all natural health products, uses evidence submitted by applicants to critically assess the safety, efficacy and quality of NHPs before approving them for sale in Canada.
In addition to a product licence, all businesses in Canada which manufacture, package, label and/or import homeopathic medicines for sale must also have a site licence as of January 1, 2006. For more information on
Canadian regulation of natural and homeopathic products, see the Health Canada website. Despite these detailed rules, Canada's pharmacies are full of products of questionable pedigree.
Caveat emptor
.
Photo credits:
flickr photo by
TW Collins
flickr photo by
ten23campaign
It isn't often that a prescription product repurposed on the street then returns to the clinic. But that's just what's happening with ketamine, sold as a generic and by Pfizer (
$PFE) under the brand names Ketalar and Ketaject (and illegally as Special K). Studies testing the injectable against depression are yielding some dramatic results, described by patients in language familiar to recreational users.
Researchers from the National Institute for Mental Health and from Houston's Ben Taub General Hospital have administered ketamine to severely depressed patients with almost instantaneous results, NPR reports. Yale scientists have pinpointed a potential explanation: Ketamine appears to affect glutamate in the brain, triggering new connections among brain cells.
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"I feel that something's lifted or feel that I've never been depressed in my life," was how NIMH researcher Carlos Zarate described his ketamine patients' reactions. "And it was a different experience from feeling high. This was feeling that something has been removed." One Ben Taub study patient, who believes she got ketamine, not placebo, said she went home feeling "no more fogginess, no more heaviness." Both of them reactions that
LA Weekly
deemed obvious. "Any raver could have told you this," the paper said.
Ketamine has serious potential side effects, including hallucinations during its infusion--and, not insignificantly, addiction. But unlike drugs already approved as antidepressants, the injectable appears to work quickly, a big advantage for patients in crisis. Further study is on the way; the Ben Taub researchers say that if their trial shows that ketamine outperforms a placebo, they plan to conduct a longer-term study to determine whether its effects could be long-lasting.
- see the blog
post at NPR
- get
more, also from NPR
- see the
LA Weekly
post
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About SRI: SRI International, founded as Stanford Research Institute in 1946, is a leading independent research institute. SRI conducts sponsored R&D for its government, business, and foundation clients in information and engineering technologies, pharmaceuticals and biotechnology, chemistry and materials, education, health sciences, and economics.
SRI's Policy Division (www.sri.com/policy) helps government agencies, nonprofit organizations, and commercial clients solve problems and capitalize on opportunities posed by complex issues in education, training, health, economic development, and human services. Our policy experts develop research-based solutions to problems posed by rapid social, technological, and economic changes in society. The products of our research are used to shape innovations to improve productivity and the quality of life at home, at school, and in the workplace. How to apply: Apply via our web page www.sri.com/jobs to job ID number 101376. SRI is an equal opportunity employer. www.sri.com
Requirements: Must have substantive expertise in a field such as education, special education, child development, public health, or mental health services. Requires experience and expertise in research and evaluation design, quantitative and qualitative data analysis, behavioral screening and assessment, evidence based prevention and intervention programs, and systems of care for children and youth. Outstanding writing, speaking, and project management skills and the ability to work collaboratively are required. Prefer experience and background in issues related to cultural diversity. Being bilingual in Spanish is a plus.
Ph.D. in education, special education, clinical child psychology, school psychology, child development, developmental psychology, or related field.
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About SRI: SRI International, founded as Stanford Research Institute in 1946, is a leading independent research institute. SRI conducts sponsored R&D for its government, business, and foundation clients in information and engineering technologies, pharmaceuticals and biotechnology, chemistry and materials, education, health sciences, and economics.
SRI's Policy Division (www.sri.com/policy) helps government agencies, nonprofit organizations, and commercial clients solve problems and capitalize on opportunities posed by complex issues in education, training, health, economic development, and human services. Our policy experts develop research-based solutions to problems posed by rapid social, technological, and economic changes in society. The products of our research are used to shape innovations to improve productivity and the quality of life at home, at school, and in the workplace. How to apply: Apply via our web page www.sri.com/jobs to job ID number 101377. SRI is an equal opportunity employer. www.sri.com
Requirements: Requires experience with quantitative and qualitative data analysis, instrument design, data collection, early childhood development, and early childhood programs. Must have substantive expertise in a field such as education, public health, special education, early childhood development, or human services. Outstanding writing, speaking, and project management skills and the ability to work collaboratively are required. Prefer experience and background in issues related to cultural diversity. Being bilingual in Spanish is a plus.
Ph.D. in education, early childhood education, child development, developmental psychology or related field.
1994:
I think it would be a positive thing to have women have the choice of taking the morning-after pill. I would favor having it available.
Wannabe-governor Mitt Romney in
2002:
[H]e replied yes when asked on a Planned Parenthood questionnaire, "Do you support efforts to increase access to emergency contraception?"
Gov. Mitt Romney in
July 2005:
Mr. Romney said that his veto of the bill - which would allow some pharmacists to dispense the pill without a prescription and require hospitals to offer it to rape victims - was consistent with his past statements and that he continued to support contraception.
Gov. Mitt Romney in
September 2005:
But Romney, who describes himself as ''pro-life," said he had to veto the [emergency contraception] bill to fulfill a campaign promise not to change the state's abortion laws. Because the Massachusetts bill does not have an age restriction and Plan B sometimes causes an abortion, Romney argued, the measure undermines the state's parental consent laws.
Gov. Mitt Romney in
December 2005:
I think it's, in my personal view, it's the right thing for hospitals to provide information and access to emergency contraception to anyone who is a victim of rape.
Wannabe-president Mitt Romney in
2012:
This is a direct attack on religious liberty and will not stand in a Romney presidency.
So where does Mitt Romney stand on emergency contraception? Who the hell knows?
Men are far more likely to have the sexually transmitted human papillomavirus (HPV) in their mouths than women, the Daily Mail has reported. The Mail has outlined research into the prevalence of HPV, which is a risk factor mouth cancer and other cancers. Researchers found that HPV was more commonly found in people who engaged in all kinds of sexual activity – including vaginal, anal and oral. The Mail reports that the researchers suggest that HPV vaccination for men needs investigating to see whether it could help stop oral HPV and, potentially, oral cancer.
Mouth cancer has risen more than 20% in the past 30 years. Tobacco use and prolonged, heavy alcohol drinking are the biggest risk factors, but the presence of oral HPV is also a clear risk factor for the disease.
The latest research set out to estimate the proportion of people infected with oral HPV in the United States, and any factors associated with infection. It found that approximately 7% of the US population aged 14 to 69 years were infected with this virus, and that men were more likely to be infected than women.
This study shows a marked difference in oral HPV infection between men and women in the US, but does not necessarily reflect how many people in the UK are infected. There are many different types of HPV, and not everyone who is infected will go on to develop cancer.
HPV is known to cause cervical cancer, and a vaccine campaign for girls aims to reduce its prevalence among women, and so reduce the number of cervical cancers. It remains unclear whether vaccinating men would have an effect on the presence of oral HPV or reduce the number of cancers.
Where did the story come from?
The study was carried out by researchers from Ohio State University, the US National Cancer Institute and a US company called Information Management Services. The research was funded by Ohio State University, the US National Cancer Institute, John and Nina Cassils and the pharmaceutical company Merck. Merck is the manufacturer of Gardasil, the cervical cancer jab that targets several strains of HPV, including type 16, which is most commonly associated with oral cancer.
The study was published in the
peer-reviewed Journal of the American Medical Association.
This research was covered appropriately in the media, with the Daily Mail emphasising that the prevalence estimate was drawn from a US population, and pointing out that not all individuals infected with oral HPV will go on to develop oral cancer. The BBC was careful to point out that it is not known if the existing vaccines against HPV used for preventing cervical cancer are effective against oral HPV infection and that vaccination cannot be recommended for the primary prevention of oropharyngeal cancer.
What kind of research was this?
This was a
cross-sectional study that examined the number of people aged 14 to 69 infected with oral HPV in the United States.
Cross-sectional studies are a useful way to generate estimates of the number of cases in a population. However, they only collect information at one point in time, and cannot tell us why things are related, or how things change over time. This study provides a snapshot of the number of infections in one time period (between 2009 and 2010), but it does not attempt to link these numbers to the risk of developing oral cancer.
Background information supplied by the researchers suggests that the number of cases of oral cancer has increased over the past 30 years in several countries, and HPV has been directly implicated as the underlying cause.
What did the research involve?
Researchers recruited a sample of individuals that was intended to be representative of the US population. They conducted interviews and a physical examination. During the interview, participants provided information about:
- sociodemographic factors – such as age, sex, education, socioeconomic status, sexual orientation and marital status
- substance use – including tobacco, alcohol and marijuana
- sexual behaviour – including ever having had sex, ever having performed oral sex, age at first sex, number of sexual partners and history of sexually transmitted infection
During the physical examination samples of cells were taken from the inside of the mouth. These samples were sent to a laboratory where researchers isolated DNA from the cells to determine whether the individual was infected with oral HPV and, if so, to identify the virus type. They tested for 37 HPV types, of which 18 were ‘high-risk’ DNA types.
The researchers then analysed the data, arriving at overall estimates of the number of infections in the US population. They also conducted an analysis that accounted for sociodemographic and behavioural factors.
What were the basic results?
There were 5,579 participants in the beginning of the study. Of these 5,501 (98.6%) were included in the analysis. The researchers found that overall:
- 6.9% of participants were infected with HPV (95%
confidence interval (CI) 5.7% to 8.3%)
- 3.7% of participants were infected with a type of HPV classified as having a high risk of causing cancer (95% CI 3.0% to 4.6%)
- 3.1% of participants were infected with a low-cancer-risk type of HPV (95% CI 2.5% to 3.9%)
- the most prevalent type of virus detected was HPV-16 (1.0%, 95% CI 0.7% to 1.3%)
When the researchers accounted for sociodemographic and behavioural factors in their analysis, they found that the following variables were independently associated with oral HPV infection:
- Age: infections peaked at two distinct age groups - in those aged 30 to 34, and again in those aged 60 to 64. This pattern was stronger for men than women.
- Sex: men had more than twice the number of infections as women (10.1% male versus 3.6% female;
prevalence ratio (PR) 2.33, 95% CI 1.66 to 3.26). When looking at the most common HPV type (HPV-16) this increased to a nearly fivefold difference (1.6% male versus 0.3% female; PR 5.41, 95% CI 2.12 to 13.83).
- Lifetime number of sexual partners: those with two or more partners had significantly more infections than those who had no sexual partners. The prevalence of infection increased with increasing numbers of lifetime partners.
- Current smoking intensity: those who smoked 10 or more cigarettes a day had significantly more infections than those who had never smoked or who no longer smoked. This association was stronger for women than for men.
Ethnicity, marital status and alcohol and marijuana use were not independently associated with oral HPV infection.
How did the researchers interpret the results?
The researchers concluded that approximately 7% of the US population between the ages of 14 and 69 were infected with oral HPV. They say that this is significantly lower than infection with genital HPV.
Conclusion
This was a relatively large cross-sectional study that estimated the number of oral HPV infections in the US among 14 to 69 year olds. These estimates cannot be directly generalised to the UK.
The researchers say that their data provide evidence that oral HPV infection is mainly sexually transmitted. This is because infection was uncommon among participants with no previous sexual partners, but was up to eight times higher among those with previous partners, and increased significantly as the number of partners increased. The researchers do point out, however, that their study did not collect information on possible non-sexual transmission methods.
While policy decisions regarding HPV infection generally focus on genital HPV among females, this research demonstrated that, at least in the US, men are more likely to be infected with oral HPV. As high-risk types of oral HPV have been shown to cause mouth cancer, this research may open up discussions on the need to address these risks. Options for reducing the risk of infection include targeting modifiable behaviours, such as smoking and sexual behaviour. Whether current vaccines against HPV can prevent oral cancer is unknown and this research does not provide any evidence as to how effective any vaccine might be.
All in all, this was a well conducted cross-sectional study that estimated the prevalence of oral HPV infections in the United States. However, it does not provide any information on the number of participants who went on to develop oral cancer. It is important to remember that there are many different types of HPV, and not everyone who is infected will go on to develop cancer. This study cannot tell us the rates of oral HPV infection in the United Kingdom, but may provide information on risk factors for infection that apply to populations outside the US.
Links To The Headlines
More men 'have oral cancer virus'. BBC News, January 27 2012
More than 16 million Americans have oral HPV. Daily Mail, January 26 2012
Links To Science
Gillison ML, Broutian T, Pickard RKL,
et al
.
Prevalence of oral HPV infection in the United States, 2009-2010. Journal of the American Medical Association. Published online January 26 2012
A DVM is required; a Board Certification is advantageous. The candidate should have five or more years’ experience in a related field and a track record of successfully implementing or investigating new technologies and adding value to the organization. S/he must have demonstrated knowledge of the pharmaceutical life cycle process with an understanding of applicable FDA or CVM regulatory requirements, and be experienced in project/program management. For additional information or to apply, contact David Burkhouse, PhD at dburkhouse@eflassociates.com or 913-234-1884.
Kader Arif, the lead Acta negotiator in the European Parliament, says Acta potentially cuts access to lifesaving generic drugs and restricts online freedom
The French MEP who resigned his position in charge of negotiating the international Anti-Counterfeiting Trade Agreement (Acta) has said it "goes too far" by potentially cutting access to lifesaving generic drugs and restricting internet freedom.
In an exclusive interview with the Guardian, Kader Arif – a member of the European parliament's international trade group, who was the lead negotiator over Acta – said that despite talks over the agreement having begun in 2007, "the European parliament, which represents the rights of the people, had no access to this mandate, neither had it information of the position defended by the commission or the demands of the other parties to the agreement".
Arif resigned in protest on 26 January as the EU signed the treaty, saying that he wished to "denounce in the strongest manner the process that led to the signing of this agreement: no association of civil society [and] lack of transparency from the beginning".
He said that it now threatens online freedom, access to the use of generic versions of drugs for treating illnesses, and could potentially mean that someone crossing a border who has a single song or film on their computer could face criminal charges.
Asked what he thought European citizens should do, Mr Arif said: "Showing that there is interest and concern about this agreement is the best way of creating a real public debate, which was never possible until now because of the lack of transparency on this dossier. Especially if the timeframe is short, raising awareness of members of parliament will be crucial. And because Acta is a mixed agreement, it will have to be ratified both by the European parliament and by every member state of the union, so there is also an opportunity to organise debates at the national level."
He says that it is now impossible to renegotiate the agreement because the 11 key parties to it concluded their discussions on 1 October 2011: "the European commission negotiated it on behalf of the EU, on the basis of a mandate given by the member states in 2007."
That means, he says, that "at this stage one can only accept or reject the agreement – no change of the text is possible. If the right wing of the European parliament had not imposed such a tight calendar, the members of the European parliament could have drafted an interim report, which would have put conditionalities to the ratification of the agreement, by giving recommendations to the commission and member states on how to implement it. But this is no longer a feasible option."
"The title of this agreement is misleading, because it's not only about counterfeiting, it's about the violation of intellectual property rights," he told the Guardian. "There is a major difference between these two concepts."
Acta
has triggered public protests in a number of European and other countries, as well as online attacks by the hacking collective Anonymous. The US, EU member states, Australia, New Zealand, Canada, Japan and a number of other countries have signed it, although none has yet ratified it in national legislation.
The agreement would create an international framework and set of standards for a voluntary legal regime to enforce intellectual property rights across national boundaries.
Arif said one example illustrates this difference particularly well – the case of generic medicines. "Generic medicines are not counterfeited medicines; they are not the fake version of a drug; they are a generic version of a drug, produced either because the patent on the original drug has expired, or because a country has to put in place public health policies," he said.
A number of countries such as India and African nations have sought to use generic versions of drugs for infections such as HIV, which has often been resisted by pharmaceutical companies. Under Acta, Arif fears such countries would not have the same freedom to determine their own actions.
"There are international agreements,
such as the Trips agreement, which foresees this last possibility," he said. "They're particularly important for developing countries which cannot afford to pay for patented HIV drugs, for example.
"The problem with Acta is that, by focusing on the fight against violation of intellectual property rights in general, it treats a generic drug just as a counterfeited drug. This means the patent holder can stop the shipping of the drugs to a developing country, seize the cargo and even order the destruction of the drugs as a preventive measure."
He thinks that is a key flaw: "Acta also limits the flexibilities listed in the Trips agreements to support developing countries in need of generic drugs. When the question of finding the right equilibrium between protection of intellectual property rights and protection of final users is so crucial, Acta appears to be very unbalanced in favour of patent holders. This is one of the major problems with the agreement."
Internet freedoms could also be under threat if Acta is ratified in its present form, he says. "The chapter on internet is particularly worrying as some experts consider it reintroduces the concept of liability of internet providers, which is clearly excluded in the European legislation." That could make ISPs, who provide internet access, liable for users' illicit file-sharing.
Arif also expressed concern that there could be more intrusive checks at borders to fight counterfeiting.
"I see a great risk concerning checks at borders, and the agreement foresees criminal sanctions against people using counterfeited products as a commercial activity," he said.
"This is relevant for the trade of fake shoes or bags for example, but what about data downloaded from the internet? If a customs officer considers that you may set up a commercial activity just by having one movie or one song on your computer, which is true in theory, you could face criminal sanctions.
"I don't want people to have their laptops or MP3 players searched at borders, there needs to be a clearer distinction between normal citizens and counterfeiters which trade fake products as a commercial activity. Acta goes too far."
The
text of the finalised treaty (PDF) has now been made public, and the European commission has begun to try to explain how Acta would work. It has also published a document called
10 Myths about Acta, asserting that the public was informed "since the launch of the negotiations"; that it is drafted "in very flexible terms" and that "safeguards and exceptions under EU law or under the Trips agreement remain fully preserved".
It also insists that "Acta is about tackling large-scale illegal activity … there is a provision on Acta specifically exempting travellers from checks if the infringing goods are of a non-commercial nature and not part of large-scale trafficking".
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