This post continues a series of Bruce Willis unintended consequences posts, of which there will be two more. There is a degree of truth in all of them.
As outlined in last week’s Osama Saves Millions, Yusuf Hamied stepped in at a critical point in the unfolding global AIDS story and in offering Triple Therapy at a dollar a day decisively shifted the storyline. His company, Cipla, was an Indian pharmaceutical company dealing primarily with generic drugs.
The link between Hamied and Bill Haddad that led to Hamied’s Triple Therapy proposal was embedded in politics. The generic pharmaceutical industry in the United States was closely linked to the Democratic Party. In 1964, Haddad had stood for Congress as a Democrat with the price of drugs as his main campaign platform. He had run the Kefauver 1956 vice-presidential campaign and later Kefauver hearings on the pharmaceutical industry. He was involved in the 1960 and 1968 Kennedy campaigns.
When he approached Hamied, he was the Chair of the GPIA – the generic pharmaceutical industry association. The generic version of PhARMA. As early as 1984, he had said that if the branded industry didn’t bring drugs like AZT on the market the generic industry would – and AZT was the first drug licensed under the Orphan Drugs Act, of which Haddad was a leading instigator.
The Clinton administration efforts in the 1990s to get healthcare reform through Congress were closely tied to the fortunes of the generic pharmaceutical industry. The irony was that Republicans, not Democrats, were supposed to favor markets and dismantling monopolies as the best way to deliver better quality and cheaper products but when it comes to pharmaceuticals things often turn inside out.
Once Hamied cut the Gordian knot holding back Triple Therapy, Bill Clinton, then the former president, became the biggest promoter of Cipla and soon afterwards all Indian pharmaceutical companies, including Ranbaxy. He made many visits to India, with Indian politicians and executives apparently dazzled by their new fellowship with a political superstar.
Apparently. Pretty quickly Ranbaxy and some other companies smelt a killing. They began filing for generic approval in US and European markets for drugs about to come off patent. Not just filing but filing for first generic approval as this was worth substantially more than later approvals.
To get there first required either a very swish technical operation or fraud. Fraud was a lot easier, and cheaper and more reliable. The FDA essentially didn’t have an inspection system for Indian pharmaceutical companies. Companies didn’t have to do the experiments. They could make up the data.
There were one or two FDA operatives in the field in India and China who despite having to announce their arrival to companies beforehand and having to be escorted around plants began to raise concerns – they were fired.
What was happening came to light because of whistle-blowers within Ranbaxy, especially Dinesh Thakur.
As the evidence of problems came to light, FDA were caught in a dilemma. The Obama government had come to power and a supply of cheaper drugs was essential to proposals for healthcare reform. The findings of fraud were so egregious and the consequences of inaction for the health of patients exposed to Ranbaxy drugs so serious that doing nothing was not an option but bankrupting Ranbaxy with the kind of fines that seemed called for would be a serious blow to the Affordable Care Act. After many twists and turns, Ranbaxy ended up with a relatively small fine.
Efforts to put a proper inspection system in place for the Indian and Chinese generic companies were quietly shelved.
Bottle of Lies
The story is vividly told in Katherine Eban’s Bottle of Lies.
I keep track of books like this for any light they might shed on aspects of the history of the pharmaceutical industry. I was skeptical about the promotional blurbs, figuring this might well be another written in the branded-industry con-job, aimed at discrediting the generic industry.
If it is, its a very sophisticated one as Eban makes clear that brand name American companies are now moving their production operations to India and China where oversight is minimal to non-existent and we are likely at just as much risk from brand name products as generics as a result.
(And of course the most high profile price gougers of recent years have been generic companies like Mylan and Turing – a hedge fund in generic clothing).
Does this story make a difference to any of us. Yes it does. Pretty well every working week now I come across people with convincing stories of being given a generic drug made by a different company to their prior supplier and having a completely different response – or no response. This can be very serious in the case of a patient on a diuretic whose drug stops working.
Two decades ago if a patient switched from a branded drug to a generic, and complained there were differences, most doctors rolled their eyes to heaven and dismissed the complaint. But these problems are now being reported by people switching from one generic drug to another and are pretty gross and consistent.
Given that close to 85% of drugs used in the USA are now generics and 40% of the drugs used in Britain’s NHS are generics from India, this is not a minor issue.
Patients in the West are the lucky ones. Eban’s book makes it clear that if you are a child with a life-threatening infection in Africa, the chances are the antibiotic you are given will be a dud and you will die. A decade ago, there were concerns about Fake Medicines in Africa and elsewhere cooked up in bath-tubs but the bigger concern now is medicines from big name companies, where one batch might be okay but the next ineffective or dangerous.
This almost certainly applies to vaccines also. There are no placebo-controlled trials of vaccines. All we have are trials of adjuvant against adjuvant plus vaccine. The adjuvants are mostly compounds with an Aluminium component whose role is to trigger a more vigorous reaction to the proteins of the vaccine.
But there is another component to vaccines – fluid. The vaccine and adjuvant are dissolved in fluid. If this fluid contains a scrap of anything else, a protein, a metal, or anything, then the adjuvant can trigger a response to that also. And if any of the vaccine batches are made up in India and China then it is almost for certain, the fluid will contain other materials.
In this way even a vaccine with a clear bill of health from controlled trials could cause significant damage.
As Clinton’s story decades earlier made clear, sometimes politics requires you to execute a mentally handicapped person. Chances are Obama’s healthcare efforts may have led to the death and disablement of millions.