Tami Flu

The end may be near for the nearly two-year wrangling over the merger of two large nonprofit health plans in Pennsylvania.

With its deadline having passed for the public to submit comments on the proposed Highmark-Independence Blue Cross merger, the Pennsylvania Insurance Commissioner's office says it expects to give, or not give, its blessing by Jan. 27, 2009.

Between now and then, Pennsylvania legislators will have their chance to weigh in one final time, and the commissioner's office will review public and lawmaker comments as it considers the merger, which was first announced on March 28, 2007.

Independence, based in Philadelphia, and Highmark, based in Pittsburgh, want to combine to create a Blues plan with an estimated 8 million members and $23 billion in annual revenue.

The combined company would be the third-largest Blues plan in the country by membership.

The U.S. Justice Dept. has given the merger the go-ahead, leaving final approval to Pennsylvania Insurance Commissioner Joel Ario.

After hosting a series of hearings this summer and receiving hundreds of pages of public comment, the department cut off the official public comment period Oct. 14.

In a note submitted that day, Henry Allen, senior attorney for the American Medical Association's Private Sector Advocacy unit, argued that the merger should be blocked based on the negative impact on potential competition. The letter was written in response to a request from Ario after Allen's testimony on behalf of the AMA at the Philadelphia public hearing.

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APGaylard has won a complaint against the online BBC news service. Go and have a read, but this is the story that started his complaint:

In August, the BBC ran a story claiming that research had determined that some places in Britain were ‘happier’ than others. You can see the nature of the claims in the TV news report, “Britain’s happiest places mapped“. There was a big problem with this though: the research found no significant differences between places. The only differences were accounted for by the socio-economic status of the people.

Churnalism, which consists of rewriting press releases rather than news reporting, is common at the BBC online news pages. In fact, it is weakness that is being exploited to good effect. Mary Hicks, MD of healthcare comms shop Clew, outlines how her agency sold a story to the BBC.

She cites an example of a story that her agency successfully pitched to the site. One of the team working on GlaxoSmithKline’s Cervarix drug (a cervical cancer vaccine) spotted figures from the NHS Cancer Screening Programme showing that the numbers of women coming forward for cervical cancer screening had been falling.

This fact had been overlooked by the media so the agency used it as a news hook. The agency gathered quotes for the BBC from key spokespeople including the screening programme, gynaecologists and cervical cancer charity Jo’s Trust.

Providing spokespeople is key, says CCD Healthcare MD Justin Clark. Working in the client as part of the story using a heavyweight topic in the press, such as obesity, can create an opportunity for coverage: ‘Thesite doesn’t necessarily create an impact on sales but it does have an impact on reputation management. Clients rate the site highly because of the perceived independence of the BBC. It’s a fabulous endorsement for a client because it is seen as the truth if it appears in an article.’

It is disgraceful that the BBC are allowing themselves, and their readers, to be exploited in this way.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) have pulled the marketing authorisation for rimonabant (Acomplia) [PDF]. This isn’t much of a surprise. What is interesting in this case is the reasoning, which not only addresses safety concerns, but also concerns about effectiveness in clinical practice (as opposed to clinical trials). Effectiveness, rather than efficacy, is going to become a much more important aspect of judging the benefit and harms of drugs in future.

Following the assessment of the available information on the benefits and risks of Acomplia including data from studies completed since it was granted marketing authorisation, the CHMP confirmed at its 20-23 October meeting, that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking placebo.

The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side effects could not be adequately addressed by further risk minimisation measures.

In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period.

Also interesting is the reaction to the withdrawal from certain quarters. I suspect there isn’t much surprise in the drug safety arena, but a pressure group has expressed some reservations about the withdrawal.

Dr Colin Waine, chairman of the National Obesity Forum, said: “My patients were doing very well on it, and they will now have to stop and come off it.”

“Patient safety must be foremost, but I always thought that if you ruled out the patients with depression, you ruled out the problem with the drug.”

In the past, patient pressure has occasionally led to withdrawn drugs being re-launched, because patients argued they were willing to accept the risks for the benefits they felt they obtained from the drug. The National Obesity Forum does not appear to be a patient group, in that it seems to consist of professionals interested in obesity, rather than obese people desiring treatment for obesity. No-one doubts that obesity is a problem. However, shock horror, who do we find sponsoring the National Obesity Forum? Yes, the manufacturers of rimonabant, Sanofi-Aventis.

Website funded by educational grants from
Abbott Laboratories
Canderel
Roche
Sanofi-Aventis Ltd.
MeatandHealth.com

The National Obesity describe themselves as an independent charity. Independent is a word that I would have thought is fairly widely understood.

independent
adjective
1 free from outside control; not depending on another’s authority
2 not depending on another for livelihood or subsistence
3 not connected with another or with each other; separate

Michael Rawlins was right.

You may wish to check your pantry.
The Food Standards Agency has today issued a food alert about novelty food products from China, including chocolate-flavoured ‘willy spread’, containing melamine.

Melamine is an industrial chemical that should not be present in food. Milk products containing melamine have been at the centre of a major food incident in China.

An Agency spokesperson said: ‘This is a first. We’ve never had to put out an alert before on “willy spread” – chocolate-flavoured or otherwise. But on a serious note, if anybody has used any of the affected products they shouldn’t worry, the risk from the melamine in these products is low and it is very unlikely to be harmful.’

Remember, if you are concerned about past exposure, Paracelsus’s words, “The dose makes the poison”. Via Ben Goldacre.

How bizarre.

Someone has decided to complain to the GMC about a group of doctors involved in the decision-making process over MMR vaccine. The complainant is Bill Walsh, the author of a particularly dumb letter about the Hornig study. Sadly he is also the President of the Autism Treatment Trust, which just shows you how some of the autism community, for want of a better term, have been lead down a disastrous dead end by Wakefield and associated pseudoscientists, journalists, and, latterly, celebs.

Mr Walsh of Glasgow, Scotland, said: “I am concerned about what I believe is the absence of proper tests since 1998 when Andrew Wakefield first raised concerns about the MMR jab.

“The complaint is as rigorous as possible so it makes it so much more difficult for them to try to close it down.

“There cannot be one rule for Andrew Wakefield and another for those in powerful positions.”

The full list includes Professor Sir David Hull, Professor Michael Langman and Professor Andrew Hall of the Joint Committee on Vaccination and Immunisation. Also reported to the GMC are Professor Sir Alisdair Breckenridge, Professor Gordon Duff and Professor Colin Blakemore, all of the Medicines and Healthcare Products Regulatory Agency and Sir William Stewart, chairman of the Health Protection Agency.

The complaint said they ignored Dr Wakefield’s work, which claimed certain groups of children are damaged by the MMR jab, because of fears it would undermine the immunisation programme.

It also alleged the programme had been undermined by bad judgments and by the use of scientific studies of the general population to support the safety of the MMR jab, instead of studies of vulnerable groups as identified by Dr Wakefield.

Given only cranks are willing to promote the idea of a link between MMR vaccine and autism after all the studies (epidemological and virology) and the documented scientific failings in the initial Wakefield studies, this complaint will not get far. If it did, we would presumably witness a parade of cranks at the GMC in support of the MMR vaccine-autism link who would wilt under the weight of that most important form of evidence: facts.

However, the result is probably not what matters. Mr Welsh will be able to point to any perceived or real inaction by the GMC as an example of a powerful medical conspiracy to suppress the truth. That is the only argument left to the anti-MMR vaccine lobby. The science is lost, only the conspiracy remains.

Even at the start of this debacle, Wakefield’s work did not provide evidence which supported his claims that MMR vaccine was linked to autism. If you accepted his claims, his advice to split the vaccine was illogical. What evidence did he have that the measles vaccine was only a danger in combination with other vaccines?

What the individuals Mr Welsh is complaining about are guilty of, is balancing the risks being proposed by someone shouting his mouth off at a press conference, without any supporting evidence, against the benefits of vaccination on reducing childhood diseases. At other times the same people he is complaining have drawn attention to other legitimate safety concerns about vaccines (such as the risk of idiopathic thrombocytopenic purpura with MMR vaccine). If cui bono is the mantra, then why was this adverse effect of a vaccine accepted as legitimate?

Mr Walsh provides a valuable reminder that these people were correct in their assessment. Wakefield was not a heretic in the mold of Galileo Galilei. He was wrong. Well done to them all for not caving in to lobby group and media pressure over the past ten years, and sticking to the science. If Mr Walsh has employed the same rigour to his complaint that he applied to his recent letter on the Hornig study, we are unlikely to hear much more of this story.