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Swine flu

GOVERNMENT has changed tact on dealing with the swine flu epidemic. When the H1N1 virus first hit SA, hospitals were asked to test all patients presenting with flu-like symptoms. If they tested positive, staff were required to trace everyone with whom the victim had been in contact.

"This model for containing the epidemic simply wasn't sustainable in terms of resources," says National Institute for Communicable Diseases deputy director Lucille Blumberg. "We were overloading an already stretched diagnostic system."

The shift is in line with changes to the World Health Organisation's reporting requirements on H1N1. In July WHO said the rapid spread of the virus and rising number of cases in many countries made it difficult to confirm cases through laboratory testing. It said the outbreak was characterised by mild symptoms and most patients recovered, even without medical treatment, within a week of the onset of symptoms. The virus has spread internationally with unprecedented speed. Past flu pandemic viruses took six months to spread as widely as H1N1 has spread in six weeks. WHO added that all countries should monitor unusual events such as clusters of severe or fatal cases.

By last week, 153 cases of swine flu had been confirmed in SA. Most patients were sent home to recuperate, says Blumberg. "This really is a moderate illness compared with other outbreaks such as Avian flu."

Two drugs are used to treat swine flu: Tamiflu, produced by Roche, and Ralenza, made by GlaxoSmithKline (GSK). JP Morgan says new antiviral drugs could boost sales for GSK and Roche by US$1,8bn in rich countries and up to $1,2bn in poorer ones.

Blumberg says government has some stockpiles of Tamiflu but chose not to stockpile Ralenza, which must be inhaled and is more difficult to administer.

SA generic producer Cipla Medpro stands to benefit. It produces Oseltamivir, a generic of Tamiflu. Private healthcare facilities have been stockpiling the drug. "We expect Oseltamivir to contribute significantly to our sales this year," says Cipla Medpro CEO Jerome Smith.

Tamiflu retails for R33/capsule, Oseltamivir for about R25. A course of 10 is usually sufficient to treat swine flu. Aspen Pharmacare doesn't have a generic antiviral on the market. It was awarded a voluntary licence to produce a Tamiflu generic in 2006, but only for public-sector stockpiling in Africa to treat Avian flu. "We never exercised the right because it takes two years to complete the technology transfer required, and Avian flu was brought under control quite quickly," says Aspen senior executive Stavros Nicolaou.

Some states have asked the World Trade Organisation to be allowed to override patents on some drugs by issuing compulsory licences. Government could issue a compulsory licence for antivirals if swine flu were deemed a national emergency, says David Cochrane of intellectual property firm Spoor & Fisher. "There have been a number of applications for compulsory licences for other products, such as pesticides, in SA's high courts, but so far none has been successful," he adds.

India and Taiwan have issued compulsory licences on Tamiflu. Nicolaou says: "Though voluntary licences are a non adversarial solution to a public-health crisis, compulsory licences can discourage foreign investment."

Jacqui Pile: The Financial Mail, 30 July 2009

Sweetening the pill

WITH pharmaceutical patents worth more than US$120bn expiring between 2009 and 2011, government is looking at new ways to encourage the use of generic medicines.

Generics are drugs that are manufactured and marketed after the patent on a branded pharmaceutical expires. They are often cheaper than the original products because producers don't have to fund research and development.

Each year South Africans spend R23,5bn on medicines. The health department has introduced a number of regulations in the past few years to bring down drug costs, including limiting what drug companies can charge.

"But regulating one aspect of the market can't be done in isolation and we have to look at the entire picture," says Anban Pillay, head of the financial planning and health economics cluster at the Department of Health.

Compared with countries such as the US, where the use of generics has reached about 66% by value, SA's use is limited. The local generics industry has grown - it was worth R4,9bn in 2008 and is estimated to grow to R8,3bn by 2012 - but medical schemes and government would like to see more use of cheaper drugs.

By volume, generics make up about 80% of drugs used in the public sector and about 60% in the private sector, but in value terms this translates to about 52% of drugs in the public sector and only 29% in the private sector.

Convincing patients to use generic products is another matter. Though generic medicines are mostly cheaper than the original branded drugs, the price differential isn't enough to persuade patients to move to generics.

In the US, for example, the first generic to enter the market after a patent expires is up to 90% cheaper than the originator product, while claims data shows the weighted average differential between generics and the originator products is 32%.

On the most commonly used products, the price differential tends to be even smaller. In some cases the generics are sold at higher prices than their branded equivalents.

Pillay says it takes at least five competitors to create real competition in the market. But even that isn't a guarantee of cheaper drugs. "Contrary to what we expected, our research shows that the number of generics firms operating in a market bears little relationship to the price of generics or the level at which prices decline," says Pillay. "Increasing the number of competitors will not necessarily bring down prices."

One of the main challenges for generics companies is overcoming negative public perceptions about the quality of generic drugs. Though the National Health Act requires healthcare providers such as pharmacists and dispensing doctors to offer patients generic versions, it isn't happening in practice. Some have valid concerns about the safety and effectiveness of generics, specifically of antibiotic and anaesthetic drugs, and these need to be addressed.

Red tape at the Medicines Control Council (MCC), the body that approves all drugs before they can be sold in SA, hasn't helped either.

"Reduced timelines and incentives for generics companies, such as lower registration fees, would certainly play a role in improving the use of generics," acknowledges Pillay.

Pillay says while it's important that doctors and patients are educated about the safety and role of generics, it's important for generics companies to comply with labelling and advertising regulations to ensure that the industry develops a trustworthy reputation. "Poor labelling and marketing creates the impression that these products are not of the same quality as the branded products."

He says government could encourage the use of generics by stimulating competition using state tenders: "Procurement should be done using the generic, and not the originator name."

Jacqui Pile: The Financial Mail, 14 August 2009

Beware of bogus doctors

THE South African Medical Association (Sama) has warned about an increase in people masquerading as medical practitioners using fake qualifications to ply their trade. They ranged from paediatricians and neurologists to backstreet abortionists "operating under the most dismal and unhygienic circumstances imaginable", according to Sama's chairperson Professor Denise White. She said Sama had been aware for some considerable time of their existence, but there was nothing it could do about the situation other than raise awareness. White said the public should to check the qualifications and HPCSA registration of any practitioner that they might have doubts about. The HPCSA said it was concerned about the increasing number of people faking their qualifications and the "flood of advertisements" by bogus doctors claiming to be experts in abortion. Council registrar advocate Boyce Mkhize said the council had no jurisdiction over bogus doctors and anyone "masquerading" as a medical practitioner should be reported to the police as it was a criminal act to do so. Ina van der Merwe, chief executive of international background screening company Kroll, said between 15 and 18 percent of qualifications were fraudulent.

SAPA, 18 August 2009

New wonder drug began life in SA lab

THE global search for a cure for cancer has taken a giant leap forward thanks to a chance discovery made in a South African lab many years ago. Instead of killing cancer cells, using chemotherapy or radiotherapy, the new approach - called "epigenetic therapy" - is to wake up sleeping genes in those cells, which instruct them to change back to normal. A massive international clinical trial, the results of which were published in medical journal LANCET in March this year, showed that the survival rate of some cancer patients was boosted from 26%, using ordinary chemotherapy, to over 50% using "epigenetic therapy".  In May, Cape Town-born Professor Peter Jones received the US's highest cancer research award for pioneering not only the therapy, but an entire new field of science. Jones was appointed head of a US cancer dream team, and awarded a grant of R72-million. This week, Dr Carl Albrecht, head of research for the Cancer Association of South Africa and a former colleague, said Jones's work represented "the great new hope" in the war on cancer. Jones, who is director of the Norris Comprehensive Cancer Centre in California, said cancer's new frontier was born in a small laboratory in Parow, Cape Town, in the late '70s. And it happened by accident.

Wanting to see whether cancer drugs could trigger cancer in basic (as opposed to specialised) human cells, Jones instead found that an ordinary human cell which he'd treated with an obscure cancer drug known as "aza-c" was beating, like a heart. He discovered that the drug had somehow switched on genes which turned the basic cell into a muscle cell. If it could do that, Jones thought, then surely it could also switch on genes in cancerous cells to turn them back into healthy ones. Jones said "epigenetic" drugs based on aza-c had been approved in the US and Europe last year, and had since doubled the life expectancy of "tens of thousands" of mostly elderly people with certain blood cancers. LANCET reported that 358 patients in 15 countries were involved in the international trial, which found that those receiving aza-c survived an average of 9.4 months longer than those on conventional treatment, "with a two-year survival rate that was nearly doubled". Jones said the challenge for the years ahead was to wake up genes in all other kinds of cancer cells to instruct them to return to normal. Jones's drug was approved in South Africa in February. However, he warned that it had so far only proved effective in two diseases in humans: a "pre-cancer" called MDS and a kind of leukaemia called AML. The cost of a single month's treatment is R60 000 - and some medical aids will pay for the new therapy. Jones, 62, conducted his "seminal work" at Stellenbosch Medical School in the '70s. He emigrated to the US in the '80s. Last year, he received the AG Oettle prize, South Africa's highest cancer research award.