15/08/2008 by Merav.

PharmAware is forming close ties with the Drug and Therapeutics Bulletin. DTB aims to provide informed and unbiased information on medical conditions, medicines and other treatments to enable people to make informed choices. It is wholly independent of the pharmaceutical industry, Government and regulatory authorities. DTB is also free of advertising and other forms of commercial sponsorship. (To find out more information please look at http://www.dtb.org.uk/info/about.dtl)

The August 2008 issue of Drug and Therapeutics Bulletin (DTB) has two articles, the first being a drug review of both rituximab and ▼abatacept, and their role in the treatment of patients with rheumatoid arthritis. The second article reviews ▼tigecycline, a broad-spectrum antibacterial, and the first in its class, licensed for complicated skin, soft tissue and intra-abdominal infections. The issue also contains a short correction relating to our June 2008 article on Surgery for obesity in adults.

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15/08/2008 by Merav.

Several Italian researchers and clinicians have sent open letters to the media in recent weeks to protest about the removal of Nello Martini as the head of the Italian drug regulatory agency, Agenzia Italiana del Farmaco. The group say that Dr Martini was doing an exemplary job. He had kept the agency free from drug industry pressure and had managed to contain the Italian drugs bill to 13% of the country’s health expenditure. But in doing so he incurred the industry’s wrath.

The situation began with an incident earlier this year in which a member of the agency was arrested for alleged falsification of data (BMJ 2008;336:1208-9, doi: 10.1136/bmj.39591.450856.DB). That investigation is still ongoing. Dr Martini was himself accused of “causing unintentional disaster” by failing to update the safety warnings on many drugs.

BMJ 2008;337:a1276

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22/06/2008 by Merav.

Drug companies in Europe do more to make drugs available and affordable to the world’s poor countries than their counterparts in the United States or Japan, concludes a new type of assessment of company policies.

The Access to Medicines Index (www.atmindex.org), a Dutch foundation established by Wim Leereveld, a former marketing consultant to the drug industry, tries to strip away the public relations rhetoric to quantify and compare meaningful corporate contributions.

Top ranked is GlaxoSmithKline, the UK based company that has been involved in researching a range of new treatments for diseases in the developing world. It also offers “tiered” pricing to sell drugs at large discounts to low income countries.

Merck, which operates extensive drug donation programmes and is involved in researching treatments and vaccines for HIV, among other diseases, was the only US company ranked among the top seven.

BMJ 2008;336:1396 (21 June), doi:10.1136/bmj.a397, http://www.bmj.com/cgi/content/extract/336/7658/1396

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22/06/2008 by Merav.

Two research organisations based in Paris, the Institut de Recherche pour le Développement (Institute of Research for Development) and the Drugs for Neglected Diseases Initiative, have announced that they will work together to develop new candidate drugs to treat visceral leishmaniasis, Chagas’s disease, and sleeping sickness.

The collaboration will focus on the development of two types of molecules: quinolines for visceral leishmaniasis and canthin-6-one alkaloids for Chagas’s disease. Researchers working at the Institut de Recherche pour le Développement have established that these molecules have potential therapeutic activity.

BMJ 2008;336:1396-1397 (21 June), doi:10.1136/bmj.a389, http://www.bmj.com/cgi/content/extract/336/7658/1396-a

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22/06/2008 by Merav.

This week, the BMJ has a focus on the drug industry using key opinion leaders. You can read these articles at http://www.bmj.com/cgi/content/full/336/7658/1402 and even has links to interview with an ex-drug rep. Well worth a glance!

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11/05/2008 by Merav.

A group of members of European parliament with a speacial interest in breast cancer has cut its ties with a breast cancer advocacy group, Europa Donna, because of the group’s acceptance of financial support from drug companies. “We at EPGBC (European parliamentary group on breast cancer) reject further co-operation with Europa Donna because the board of the European lobby group became more and more a lobby instrument for the market interests of the big pharmaceutical companies”.

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11/05/2008 by Merav.

Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.

The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.

Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education.

“Most medical schools do not have strong conflict-of-interest policies, and this report will change that,” Mr. Restuccia said.

The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.

“We’re hoping the example set by academic medical colleges will be contagious,” Dr. Rothman said.

Drug companies spend billions wooing doctors — more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets.

So companies have for decades provided faculty and students free food and gifts, offered lucrative consulting arrangements to top-notch teachers and even ghost-wrote research papers for busy professors.

“Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception among colleagues, students, trainees and the public that practitioners are being ‘bought’ or ‘bribed’ by industry,” the report said.

A group of influential doctors decried these practices in a 2006 article in The Journal of the American Medical Association, and said that medical schools should ban them. In the article’s wake, the medical college association created a task force.

With Dr. Roy Vagelos, a former Merck chief executive, serving as the task force’s chairman and the chief executives of Pfizer, Eli Lilly, Amgen and Medtronic on the roster, some who advocate for greater restrictions on industry influence in medicine predicted that the report would be weak.

They were wrong.

In addition to the gift, food and travel bans, the report recommended that medical schools should “strongly discourage participation by their faculty in industry-sponsored speakers’ bureaus,” in which doctors are paid to promote drug and device benefits.

It recommended that schools set up centralized systems for accepting free drug samples or “alternative ways to manage pharmaceutical sample distribution that do not carry the risks to professionalism with which current practices are associated.” It suggested that schools audit independently accredited medical education seminars given by faculty “for the presence of inappropriate influence.” And it said the rules should apply to faculty even when off-duty or away from school.

Speakers’ bureaus and drug samples are pillars of the industry’s marketing operations, and many medical school professors have resisted efforts to restrict them. Only a handful of medical schools presently bar faculty members from serving on speakers’ bureaus, so if this recommendation is widely adopted, it could transform the relationship between medical school faculty and industry, and it could change substantially the way medical education is routinely delivered.

Indeed, the chief executives of Pfizer and Eli Lilly dissented from the report’s recommendation regarding speakers’ bureaus.

“We continue to believe that these types of programs, which are subject to clear regulations regarding their content, can be worthwhile educational activities,” wrote Jeffrey B. Kindler of Pfizer and Sidney Taurel of Lilly.

David Beier, an Amgen senior vice president, wrote a letter that endorsed the report’s recommendations but disagreed with some of its text “because we have a different view about the accuracy concerning representations about the motives of the participants in industry-academic interactions.”

Ken Johnson of the Pharmaceutical Research and Manufacturers of America, said his group would review the report.

“Providing physicians — and medical students — with timely, accurate information about the medicines they prescribe clearly benefits patients and advances healthcare throughout the United States,” Mr. Johnson said.

Dr. Robert J. Alpern, dean of the Yale School of Medicine, said that the university presently had no limits on participation in company speakers’ bureaus, but that because of the medical college association’s report he was thinking of taking them on.

“I don’t have a problem with doctors making $3,000 or $5,000 a year on the side,” he said, “but it’s a totally different thing when it’s $80,000.” Even more distasteful, Dr. Alpern said, is that the slides used in many of these presentations are created by drug makers, not the speakers.

“That’s like ghost-talking,” Dr. Alpern said.

Dr. Arthur S. Levine, dean of the University of Pittsburgh School of Medicine, said that when he graduated from medical school in 1964, Eli Lilly gave him his first doctor’s bag, and Roche gave him an Omega watch for being valedictorian. He still has the watch.

But this year’s graduating class of doctors at Pittsburgh will not be allowed to accept any of these gifts, and the daily pizza lunches brought by drug companies are gone, he said.

Julie Gottlieb, assistant dean of policy coordination for Johns Hopkins University School of Medicine, said Hopkins had adopted some of the association’s recommendations and was considering others.

“This report is bound to influence our deliberations,” she said.

Dr. Vagelos, formerly of Merck, said that the report’s recommendations were certain to face resistance among faculty who liked the present system.

“The outcome of this for the industry is that those companies that are strong in science will always be welcome at medical colleges and others won’t,” Dr. Vagelos said.

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11/05/2008 by Merav.

The Association of American Medical Collegs suggests that all 129 member schools should prohibit pharmaceutical and devices manufacturers from providing gifts, food and travel to doctors, faculty members and students. The report says that medical schools and teaching hospitals increasingly depend on industry support for core educational missions. The report will be considered at the association’s meeting in June 2008.

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30/04/2008 by Merav.

Top-notch policy experts from around the world gathered to make formal policy recommendations about patents to Third World governments struggling with disease. Many will claim that patents allow Western drug companies to keep drug prices artificially high, and that patent-breaking is a cheap and easy way to get poor patients the drugs they need. They’re wrong on both counts.

For starters, the drugs needed in the developing world aren’t patent protected. A 2004 study published in the journal Health Affairs showed that less than 2 percent of the 319 prescription drugs on the WHO’s Model List of Essential Medicines are actually under patent.

What patients in the Third World need aren’t patent-busting bureaucrats but more roads, doctors, hospitals, nutritious food, and good sanitation. When roads are in disrepair, it can be particularly difficult to reach rural populations, where disease burden is highest. In places with no electricity, temperature-sensitive pills often go bad before anyone can benefit from them. Refrigerated Coca-Cola vans have been shipping polio vaccines to the hinterlands of Cameroon, because most roads are unmotorable. Even if roads were available and medicines were donated, they must be prescribed by qualified medical staff.

Patients will also need good drinking water and a good meal to enhance recovery from disease. However, the doctor-patient ratio is abysmally low and close to 60 percent of Africans do not have access to good sanitation and many subsist on less than a dollar a day.

Patents are actually a critical part of the solution. They protect the financial incentives that drive pharmaceutical companies to create innovative medications in the first place. It takes an average of US$800 million and 10-15 years to bring a new drug to the market. Patents ensure that pharmaceutical companies can recoup that enormous investment.

If countries start breaking patents, though, firms lose out on sales. And they’re less able to finance the development of new cures. That’s a blow to the public health efforts of all countries, rich and poor. Ghana’s health Minister told me that he fails to see how people could hold antagonistic positions against pharmaceutical companies, because in his
own words “if drugs are being made, then people must be sick somewhere – it is not for charity”.

Poor patent enforcement also gives rise to potentially harmful copycats. The generic pharmaceuticals manufactured in the developing world often don’t comply with international safety regulations. Low-quality and counterfeit drugs are common. The WHO estimates that 10 per cent of the world’s drugs are counterfeit. Patent-theft is making the problem worse.

It’s also important to realise that drug companies are not as blindly self-serving as many anti-patent groups portray them to be. Global pharmaceutical companies have worked for years with groups like the WHO and the UN Children’s Fund to lead the fight against HIV/AIDS, malaria, tuberculosis, and other diseases plaguing the developing world.

Just a few months ago, Pfizer, GlaxoSmithKline, and Merck donated $450 million in medicines to Burkina Faso, one of the poorest countries in the world. These sorts of philanthropic efforts are less likely if drug companies start struggling just to break even.

Many important steps need to be to taken to improve medical care in the Third World. Despite what the health activists are saying, stealing drug patents and stifling the creation of life-saving medicines is not one of them. It seems that a sensible route to take would be dialogue with pharmaceutical companies for differential pricing for developing world markets while making every effort to improve the well being of citizens.

Open, decentralised and transparent government, lower trade tariffs, free speech, the rule of law, relaxed business entry and exit rules, property rights, and freedom to contract and freedom from contract would be important to help poor citizens buy their own health insurance against diseases.

Author: Franklin Cudjoe is executive director of IMANI Center for Policy and Education, a think-tank located in Accra, Ghana. He spoke at the IGWG
conference in Geneva on 28-29 April, 2008. This article was first published on AFRIK.COM on Wednesday 30 April 2008 at http://en.afrik.com/article13423.html

Thanks to Reinhard Huss for sending this interesting article in.

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30/04/2008 by admin.

Update us on any news going on in the international pharm world!

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