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Pharma uses press to attack cost regulations in UK

How pharma attacks cost regulations UK through corporate media

Comments below and the article are illustrative of how pharma works the media to promote their cancer treatments. 

As Prof. Ben Goldacre said, “The devil is in the details.”  In this case 3 standard practices by pharma are at the core of NICE (UK drug regulatory agency for their managed healthcare service).  All are glossed over in the pro-pharma article. Pharma does marketing studies which are designed to make to outcome of the clinical trial produce results that are better than the real-world outcome.  This is accomplished in several ways:  1) by selecting a population who will respond better to the treatment than those in the population that will be treated with a different drug.  2) In this heads-on-trial comparing to another treatment, that other treatment is administered in a way that is less than ideal to reduce its effectiveness.[1]  3) By under-reporting side effects.  4) By counting only cancer deaths rather than total deaths (in this case Kadcyla increase heart attacks and liver failure).   They then work the press to promote their cause and pressure NICE to do what isn’t in the public’s interest.  For example Roche selects a breast cancer patient to give press interviews about how she have been denied life-saving treatment by NICE (but it isn’t life-saving, only extending by 4 months).  This interview is reinforced by a patient advocacy group such as the National Cancer Association (which just so happens to receive over half it’s funding from pharma).  Finally the article does indicate how this overpriced drug will cause pain in death by its impact upon a limited budget.  Most likely Roche ghost wrote the article and distributed to the press who does makes it seem like they got it from a reporter assigned to write on Kadcyla. 

It’s all scripted tobacco (marketing) science; scripted to make NICE appear to cause great harm.  So what is left out in the scripted article:  The harm that comes from the dozens of other drugs whose cost would entail cuts in budget for essential health care.  Would the patient wish to live an extra 4 months with terminal cancer made all the worse by the Kadcyla’s liver toxicity and anemia and at the expense of a patients immobilized by arthritis and in pain while they wait years for a hip-replacement operation (assuming that was the consequence of the budget adjustment for Kadcyla).   Lives are lost because cuts will come to preventive care programs.  Nice figured that for each sick year of life the cost is $278,963.   Is one year consisting of 4 months for 3 patients dying of cancer worth that?  Second, the drug is made to seem more effective than the market trial reveals.  Compared to another treatment, patients lived 30.9 vs 25.1 months.  This duration was longer than the typical one-year survival for metastatic patents because they included in the clinical trial those who had aggressive non-metastatic breast cancer.  Third, that in the trial 43% of patients had severe toxic reaction to the drug.  Since Roche ran the trial and owns the results, Roche did not release figures on other causes of death.  So why is it approved in the US and E.U.?  It is time that we pass a law against price gouging.  The press says NICE allows patient to die because of budget constraints; but more people would die if NICE allowed Kadcyla to force budget cuts.  Price is a grievous issue in 3rd world countries, for which like with NICE pharma demands their pound of flesh.  More government in the corporate interest, and a press sides with pharma.   Pharma should be equated with Shylock.     


[1]   Common ways are select a drug for cancer that is not very effective, to administer a low dose, to administer the drug in a form that is less effective.  A couple of examples will suffice, low dose aspirin is used to show that as an anticoagulant Warfarin and Plavix are more effective.  CoQ10 is administered in the crystalline form which has only a 10% absorption rate, this was done in Parkinson trial.  To administer niacin in the day when it is effectively only at night in lowering cholesterol and free fatty acids.  Niacin has a half-life of 20-45 minutes, unlike the 14 hours of Lipitor statin.  Half-life is how long the drug will remain in the patient.

http://www.fiercepharma.com/story/nice-rejects-roches-hot-new-breast-cancer-drug-kadcyla-then-invites-negotia/2014-04-23?utm_medium=nl&utm_source=internal    

NICE rejects Roche's hot new breast cancer drug Kadcyla, then invites negotiations

Patient group says it will pressure government to pay

April 23, 2014 | By Eric Palmer

 

Let the games begin. More precisely, let the price negotiations begin, the top executive for the U.K. price watchdog suggested today after the agency nixed Roche's ($RHHBY) pioneering breast cancer drug Kadcyla as too expensive.  

This could get interesting. That is because the antibody-drug conjugate for treating HER2-positive metastatic breast cancer carries a price that the National Institute for Health and Care Excellence (NICE) doesn't want to pay but is a drug that patients and doctors very much want to use.

"A breast cancer treatment that can cost more than 90,000 [$151,000] per patient is not effective enough to justify the price the NHS is being asked to pay," NICE said in a statement.

"We had hoped that Roche would have recognized the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS," Sir Andrew Dillon, NICE chief executive, reiterated.

Roche countered, dinging the price protector by pointing out that Kadclya was the eighth consecutive treatment for advanced breast cancer to be rejected by NICE since 2011. "Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease," said Jayson Dallas, general manager of Roche Products. Roche has told Pharmafile that as a treatment until the disease progresses, trials indicated an average use of 9.6 months at a cost of around 44,310 ($74,405). 

Kadcyla, the first armed-antibody treatment for breast cancer, was only introduced into the U.K. in February, but according to a recent report, in the first 9 months since its approval in the U.S, it is being prescribed by more than 80% of oncologists. As Pharmafile points out, the antibody, trastuzumab, binds to the HER2-positive cancer cells and is believed to block signals that spur the cancer cells' growth. After the cancer cells absorb the drug, it releases the DM1 to destroy them.  And patients in the U.K. want access to it, giving Roche more leverage on price. "Kadcyla is a very impressive drug that has been shown to extend life by up to 6 months in HER2-positive secondary breast cancer patients, and with more manageable side effects than alternative drugs," Dr. Caitlin Palframan, senior policy manager for Breakthrough Breast Cancer, said in a statement today. She said that the U.K.'s approval process is not keeping up with the pace of drug development and suggested that the group would be putting pressure on the government to do something about it.

The treatment is being paid for already through the government's special Cancer Drugs Fund. It would get wider use and generate more revenues for Roche, however, if it were approved by NICE for use throughout the National Health System. NICE invited comments by May 19 and then will publish a second draft. Many companies do return with discounts, but because those negotiations and the final price are not publicized, it is never clear who caved the most on their position.

 

 

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