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Thailand wins praise for AIDS vaccine trial

Thailand wins praise for AIDS vaccine trial

An experimental AIDS vaccine that appears to be the first to protect people was mired for years in controversy, and credit for its success must go to Thailand where the trial was conducted, experts said.

The trial was criticised five years ago by 22 prominent U.S. scientists who doubted it would have any effect. Washington was accused of wasting more than a $100 million by funding it.

But Thai health authorities and their U.S. partners at the National Institutes of Health and the Walter Reed Army Institute of Research pressed on with the trial involving 16,000 volunteers in a country at the forefront of the battle against HIV.

“It was a tough decision. I am glad we made it,” said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, who defied the criticism and continued the trial.

The trial vaccine was made using two failed products — Sanofi-Pasteur’s ALVAC canary pox/HIV vaccine and AIDSVAX, made by a San Francisco company called VaxGen and now owned by the non-profit Global Solutions for Infectious Disease.

Donald Burke, dean of the University of Pittsburgh’s Graduate School of Public Health, said the trial was controversial from the start and had been dismissed by prominent U.S. scientists because of the failure of previous vaccine tests.

“But given the importance of the AIDS epidemic, the decision was made to go forward regardless of these criticisms. It was a difficult choice, but a courageous choice,” said Burke, who was head of AIDS research at Walter Reed before retiring in 1997.

Burke isolated the AIDS virus taken from a young HIV-infected Thai soldier in 1989 after Thai army doctors discovered an HIV outbreak among young recruits in Chiang Mai in northern Thailand. That virus sample went on to become one of the seed viruses in the experimental vaccine, Burke said.

To their credit the Thais did a remarkable job on this,” Dr. Eric Schoomaker, the Surgeon General of the U.S. Army, told reporters. “They did remarkable job of recruiting volunteers and conducting this trial almost flawlessly.”

The $105 million trial was sponsored and paid for by the U.S. government and results showed it cut the risk of infection by 31.2 percent among 16,402 volunteers over three years.

THAI TRIUMPH

Those results mark a triumph for Thailand, a country of 67 million people where a booming sex industry had stoked fears of a major epidemic. Local authorities battled hard against a disease that threatened to spiral out of control some 20 years ago.

Experts had predicted that 4 million people would be infected by 2000 if nothing was done to slow the spread of HIV. But a massive government-led Aids education and prevention campaign in the early 1990s had an enormous effect.

HIV prevalence among injecting drug users in Thailand was as high as 30-50 percent in 1991, and 33.2 percent among female sex workers in 1994, according to UNAIDS. The number of infections has since been reduced to 20,000 annually from 140,000 in 1991.

Billboards and airwaves were bombarded with safe sex messages while health workers promoted condom use in the country’s notorious sex trade. Leading the campaign was “Mr Condom,” family planner-turned Public Health Minister, Meechai Viravaidya.

Health check-ups were made available to sex workers for free. Men were discouraged from visiting prostitutes and condom usage in Bangkok’s brothels rose from 15 percent in the early 1990s to 98 percent by 2000.

Infection rates fell and the exercise remains widely cited as a model in disease prevention among health experts — although numbers have shown signs of creeping up in the last few years among some high risk groups, such as gay and bisexual men.

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No treatment ‘not an option’ for ailing mum

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No treatment ‘not an option’ for ailing mum

Palmerston North’s Tarsh Stanton has run out of free options in her fight against cancer, and is looking for help to get to Melbourne to take part in a potentially lifesaving trial.

Within a year she has gone from being an active mother of two girls to what she describes as a steroid-puffed “blowfish”.

She’s in hospice care but determined to overcome stage four relapsed lung cancer that has spread to other organs.

She’s still working full time as ACC and non-residents co-ordinator at the MidCentral District Health Board, but chemotherapy and radiation treatment have failed to deliver on the 15 to 20 per cent chance of beating the cancer.

Only ever having had a few social puffs on cigarettes years ago, she said her cancer diagnosis came as a shock after what was either a lucky or unlucky cold.

She came home from a school camp at Whakapapa with her daughter Jazmin with an illness that became worse and made breathing difficult. Elder daughter Chelsea took her to the doctor, and the roller-coaster ride began.

Her heart beat was way too slow, and she was transferred to Wellington. She had a heart block that had to be corrected with a pacemaker last September.

X-rays showed shadows that were diagnosed as lung cancer adenosquamous non-small cell carcinoma. She was 36.

She’s had chemotherapy and radiation treatment, which has shrunk the cancer, but not stopped its spread to her other lung and bronchial tube, liver and stomach lining.

Reluctantly agreeing to be referred to the hospice team to fast track the process when she needs help with symptoms, such as the pain caused by the fluid building up between her ribs and lungs, she’s not ready to give up.

“The hospice is where you go to die, and I’m not going there,” she said.

“I’m quite relaxed. It’s not denial. I know what I’ve got, and I’m fully informed.

“I don’t like it much, but I can’t change it, and there’s no point in being sad and unfocused.”

Supported by a group of well-wishers led by her cousin Kelly Retter, Mrs Stanton has researched her options all of which cost money.

“No treatment is not an option.”

Her best hope in New Zealand is the unsubsidised drug Tarceva, which works like a sort of cling wrap encasing and constricting cancer cells, and offers a 40 per cent hope for patients who respond well. It costs about $28,000 a year.

But even more attractive is a phase II clinical trial at the Peter MacCullum Cancer Centre in Melbourne that combines Tarceva with a new biological ingredient that doesn’t even have a name yet.

Although participation is covered by drug company Roche, Mrs Stanton faces travel and accommodation costs for herself and a caregiver to travel to Melbourne for 25 appointments over two years.

Moving to Australia, where Tarceva is subsidised, is not an option.

“I’m a Kiwi. I live here, I work here, and I want to keep working. Time is precious, that’s one of the things this teaches you.

“If you only have so long to live, why would you want to spend it in Australia?”

At the moment Mrs Stanton is back in chemotherapy at Palmerston North Hospital because her cancer is too advanced to do nothing.

But once she gets the all-clear for the trial, she has to be chemo-free for a month before starting.

It’s a balancing act, as she has to be sick enough to qualify, yet well enough to tolerate the travel and treatment.

She’s hoping for Christmas in Palmerston North with husband Darren, and the girls, now aged 13 and 17, but if the trial schedule demands she be in Melbourne, she will be.

It’s a course she’s setting out on full of optimism.

“Eighty-six is my goal. It’s just a good number for sitting back in your rocking chair, drinking vodka.”

Her fundraising team is organising an October concert and a November auction to help pay for the $60,000 travel and expenses bills she’s likely to face.

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Arena weight-loss data expected to underwhelm

Arena weight-loss data expected to underwhelm

Upcoming trial results for lorcaserin, the experimental obesity drug being developed by Arena Pharmaceuticals Inc, will likely show it is about 4 percentage points more effective in promoting weight loss than a dummy pill

But that is well short of the 9.4 percent placebo-adjusted weight loss reported last week by Vivus Inc, which is developing Qnexa — a combination of phentermine and epilepsy treatment topiramate, both now sold as generics, that is designed to minimize side effects from the two drugs.

But Wall Street is not discounting the value of a viable treatment for obesity, a health-damaging condition afflicting more than one-quarter of all Americans. “Right now physicians have pretty much nothing,” said JMP Securities analyst Jason Butler.

Piper Jaffray has forecast lorcaserin sales of $3 billion in 2015.

One-year results from Vivus’ Qnexa trials sent the company’s stock up more than 70 percent on Wednesday.

“There is a lot less opportunity for that to happen with this (Arena) trial,” Butler said. “We’ve seen so much data already.”

Shares of Arena, which ended Nasdaq trading at $5.30 on Friday, closed as low as $2.26 in April and as high as $7.42 in February.

The phentermine used in Vivus’ Qnexa is a stimulant that was part of the fen-phen diet drug cocktail. Other drugs used in the cocktail, flenfluramine and dexfenfluramine, were recalled in 1997 after they were linked to heart valve damage.

SIDESTEPS HEART PROBLEMS

Lorcaserin is a serotonin activator like fenfluramine, but it is designed to selectively target only one variety of the chemical — and thereby sidestep heart-related side effects.

Earlier studies have found no heart problems associated with the drug. “There is no reason to expect anything different safety-wise,” from the new trial results expected this month, said Carol Werther, an analyst at Summer Street Research.

The company earlier this year said a large, year-long trial found that lorcaserin patients, on average, lost 5.8 percent of their body weight, while placebo patients lost 2.2 percent of their weight — a percentage point difference of 3.6 percent.

“No single agent has consistently shown a 5 percentage point difference,” said Werther.

U.S. Food and Drug Administration guidelines for obesity drugs require a 5 percent improvement in weight loss between the test drug and placebo or that the number of subjects who lose at least 5 percent of their body weight be at least 35 percent, and double the proportion in the placebo group, with a statistically significant difference between the groups.

The earlier lorcaserin trial found that 48 percent of patients on the drug lost 5 percent or more of their weight, while 20.3 percent of placebo patients achieved that goal

Dominic Behan, chief scientific officer and co-founder of Arena, said a major advantage of lorcaserin is that it is a single agent, and that doctors do not need to adjust doses for patients.

Moreover, he said lorcaserin improved cholesterol levels in patients. And data from earlier trials suggest it can be safely taken on a chronic basis, Behan said. By contrast, he said phentermine is currently approved only for short-term use.

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