Archive for July, 2007|Monthly archive page

45,000 AIDS Patients Get the Shaft from Roche Pharma

In HIV/SIDA, International Public Health, Misc. on July 27, 2007 at 3:19 pm

With everything going on with our political crises at home and abroad, not to mention the countless other chaotic happenings that smack against our already overburdened eye-balls, it’s easy to see how potentially serious and disturbing naratives can stay off the front page and our collective consciousness at large. The NY Times reported that a large Swiss drug company, Roche Pharmaceuticals, performed a massive recall of an AIDS medicine called Viracept after detecting that some shipments were contaminated with a potnentially harmful subtance. The action spread accross several countries where the drug is a cornerstone in affordable treatments for indigent patients. According to their own press release, dated June 6, the re-call is nearly 6 weeks old. So what does the first name in news have to say about this extremely late-breaking story?:

The scope of Roche’s recall is extraordinary, if not unprecedented, in the battle against the human immunodeficiency virus that causes AIDS, global health officials say. Dr. Lembit Rago, an official at the World Health Organization, said tens of thousands of people take Viracept worldwide, many of them poor people with H.I.V. in developing countries. The recall has left those patients with the painful choice of discontinuing a lifesaving medicine, or using a drug that might contain a dangerous contaminant.

….The company made the recall worldwide “in order to avoid confusion,” she [Martina Rupp, a Roche spokeswoman] said. Roche estimates that about 45,000 patients were affected by the recall.

According to the drug’s own website, the consequences of stopping treatment are serious:

When used in combination with other medication, VIRACEPT reduces how much HIV is in your blood. VIRACEPT suppresses the virus. This stops the virus from making copies of itself. With less of the virus in your blood, you’re at lower risk for life-threatening infections.

But VIRACEPT can’t work if you don’t keep enough medicine active in your blood. When you have less medicine in your system, either because you missed a dose or stopped taking it, the virus starts to make copies of itself quickly. HIV can develop resistance to HIV medicines this way. That’s why it’s so important to take all of your VIRACEPT, exactly as prescribed.

Worst of all, there are very few substitutes available, and those that are are many times more expensive, effectively rendering it useless to the people who need it. The contaminent found in the drug, ethyl mesylate, is what is known as a genotoxic, a substance that can damage DNA. Though researchers are unsure as to the level required to become dangerous to humans, realtively high levels have been shown to cause cancer in lab animals, and since it attacks genes, children are especially at risk.

As troublesome as all this sounds, what might be more disturbing is what we don’t know:

Officials at the W.H.O. in Geneva and the European Medicines Agency in London said Roche had not provided information they consider essential for safeguarding public health: which countries the tainted medicine was shipped to, the concentration of the contaminant and what the company will do for its patients.

….Roche said the recall affected “Europe and some other world regions” but has not been more specific.

This is ridiculously irresponsible, especially when compared to other recalls we’ve seen. When Firestone tires were exploding off the rims of Ford Explorers or when some Renu contact lens solution was shown to cause infection, it was plastered over every news organization and local media outlet, even the federal government got involved with Firestone. These were consumer products used by healthy people. You would think that finding dirty medicine for people with already severely impaired immune systems would engender a similar reaction, but it seems we can afford to lose 45,000 patients who are going to die anyway. How does a pharmaceutical company, or any company for that matter, get away with this kind of behavior?

An article in the International Heral Tribune gives a couple insights:

Roche announced that first-half profit rose to 4.92 billion Swiss francs, or $4.1 billion, beating analysts’ estimates. Sales climbed 15 percent to 22.8 billion francs, led by a 17 percent gain at the pharmaceutical division.

…Shares of Roche rose 6.1 francs, or 2.85 percent, to close at 220.5 francs in Zurich. They had dropped 1.9 percent this year, compared with the 4.6 percent decline in the 13-member Bloomberg Europe Pharmaceutical Index.

“Roche is the company with the strongest growth profile” in the European drug industry right now, Andreas Theisen, an analyst at WestLB, said.

Not only is it an extremely powerful and profitable drug company, but it has a lock on a potential future monopoly:

The Swiss drug maker has one of only two drugs that show promise in helping battle a bird flu pandemic. Orders for Tamiflu, originally designed to treat seasonal influenza, reached 215 million treatment courses as governments and companies from 80 countries stockpile the product.

So it now seems that we’re willing to sweep these 45,000 patients under the rug for a lock on a Bird Flu vaccine. I’m not about to play one epidemic against another, and we should absolutely take both seriously and face each with the best modern medical science has to offer. But if Roche can’t make a clean drug for a 20-year-old virus, let alone clean up the mess they make with it, my faith is thin for their go at the next plague. What happens when we find a contiminent in the Bird Flu pill? Will we be as willing, or able, to hide the recall? What will the consequences be then?

Before the contamination, Roche was doing everything that a major drug company should have been doing. They had been spending and working diligently on treatments for arthritis and cancer, Viracept was sold at a cost of around 28 cents per dose providing governments and NGOs with tools vital to their fight against AIDS. Contaminations are a fact of life in the world of manufacturing, I don’t think anyone who has made anything has done so without error. But by doing the re-call so clandestinely, with more emphasis on public relations than public health, it shows a complete lack of concern for one’s customers, let alone a callous disregard for poor AIDS patients. And what does it say about us that they will continue to earn a profit after effectively killing the population of an average American city?

To be fair, AIDS treatment on the whole has vastly improved, from 240,000 to 1.3 million patients in the last 5 years, and spending has increased in similar leaps and bounds. But many recent studies – including one delivered by our own government’s advisor, have shown that the spread of the disease continues to outpace our efforts to combat it. This demonstrates that our current prevention policies that have been dictated by religious ideology – that recommends abstinence only education and denys access to condoms and needle exchange – are ineffective. Smarter, more aggressive prevention grounded in fact and empiracle evidence is needed to increase our effectiveness. It also shows that AIDS isn’t going anywhere and it will become an even greater threat to our culture and society in the coming years. If we are to address this issue with the dedication and determination it requires, then we must be able to hold ourselves accountable for our faults as much as our successes.