It’s popular to loathe mainstream pharmaceutical companies. Big Pharma has been accused of profiteering at the expense of the poor. Of not doing enough to find solutions to the diseases of the poor. And, when they do develop cures for the poorest, the patents are promptly stolen from them through compulsory licensing.
Some scientists are even opposed to the “power” of Big Pharma and are, like the characters in John le CarrÃ©’s Constant Gardener, working to bring down vested interests. The heights of that hubris was reached by Dr Andrew Wakefield, a British medical scientist, in 1998.
Mumps, measles and rubella are terrible diseases that have plagued humanity for generations. They are so common amongst children that they are normally abbreviated together as MMR. Parents all across the world have immunised their children using a variety of vaccines. In 1988 the UK introduced a combo-MMR drug that stopped the disease dead.
The ignorance of the free-rider
Try and grasp how awful these diseases are. They are airborne and easy to get, especially amongst groups of children. The fatality rate in un-immunised cases is 15 â€“ 25%. Mumps can cause sterility and brain damage. Measles can leave survivors with unsightly scars. Rubella causes congenital birth defects in infected pregnant mothers.
As long as the base population immunisation-rate remains at around 85% some part of the population can catch a “free ride”. Fringe groups that tell you they never get sick, even though they have never been immunised, are catching a free ride on the dedication of the rest.
In 1998 following a scientific process so ropy that it defies belief Dr Wakefield announced that the MMR vaccine causes autism in a significant number of children. Overnight panic swept the UK and parents stopped immunising their children.
In 2006 a 13-year-old boy became the first person to die of measles in the UK in 14 years. The base immunisation rate had dropped to 79%.
Dr Wakefield is accused of paying children at his son’s birthday party GBP 5 each in order to draw their blood. He gave one child a measles drug he was hoping to market in order to test the drug. His research was not authorised and he was not qualified to undertake it. Worse, he announced his results prior to any peer review.
There was so much wrong with his approach and methods that it just cries out to be stopped. If a mainstream pharmaceutical company behaved in this fashion the public would be suitably outraged.
Yet Dr Wakefield is supported by poster-bearing parents at his trial, demanding that the “truth will out”.
The self-fulfilment of hating
The question is how has it come to this point? Why do so many people prefer the doubtful benefits of quackery, and rubbish the efforts of mainstream corporations? Why do people expect that companies will cause them harm? And why are they attracted to charlatans?
It can’t just be Enron. That was an abomination. It is not the norm. If it were stock markets would not be at their highest valuations around the world. Traders would be certain that their investments would be stolen; they’d be pulling out, not pushing in.
And those self-same protestors at anti-globalisation gatherings have their pensions and lifesavings invested in those same companies they’re protesting against. Pensions are “low-beta” spread investments designed to return a stable capital gain. What could be more stable than blue-chip firms like those in pharmaceuticals, retail, industrials and mining?
It is bizarre that companies that have provided so much good for the world and extended human life by such vast quantities are treated like criminals.
Consider: life expectancy is longer than ever (in every country except the African continent) but what you can achieve during that lifetime is greater than ever too. The humble washing machine dramatically reduces time spent on chores and increases time spent on you. The same goes for microwave ovens, vacuum cleaners and industrial processes.
Ever increasing efficiency speeds up processes and lowers prices.
Certainly, there are executives who are corrupt, just as there are corrupt politicians and corrupt lawyers and corrupt human rights activists. But when you accuse the means of your salvation of killing you then you will get what you want. You will die.
If the companies making washing machines are exploiting you, do the washing by hand. If the companies selling you music are stealing from you, don’t buy any. If the drugs you take to prevent measles are causing more harm than good, don’t take them.
Your life will be shorter and considerably more drab.
The choice is yours. No-one is holding a gun to your head. Except the government when they tax the companies who sell the things you no longer want.
Dr Wakefield should be sent to prison for his actions. Can one be sent to prison for gross irresponsibility? Nope.
If more Doctors went ‘rogue male’ our country would be in the grip of every charlatan to come along brandishing a medical qualification.
Compared to many professions in the UK faith in general of surgeons, doctors etc remains high. Too many Dr Wakefields and their stock as a whole would plummet and the medical world would be viewed with the same jaundiced eye as that environment now inhabited by too many shyster lawyers.
All of mine had the MMR vaccine.
My problems with big pharma are not because of their vaccines, but rather because they’re too focused on high return drugs instead of low return/high usefulness drugs. For example, there are drugs out there (I don’t recall who has the patents) to treat diseases like malaria that have never gone anywhere because there’s no money in treating malaria. The people who have it are largely poverty-stricken (as is the case with far too many other diseases), so the big pharmaceutical companies choose to focus on drugs for impotence, heart disease, diabetes, and cancer. These drugs are certainly important, I’m not saying that they aren’t, but they treat diseases that citizens in wealthy countries are likely to get.
I’d really like to change the pharmaceutical industry paradigm. We need to figure out an effective way to equalize the importance of drugs that will save millions of lives in poverty-stricken areas with those drugs that a company could make billions off of. I’m just not sure to do it.
Brian, right now the problem is that we’ve found a better way to ensure that BigPharma won’t pay any attention to the poor majority: compulsory licensing.
Name a single company that can afford the billion dollars (what it takes to conduct all the regulatory tests on a new drug and husband it through the five year process) and then see it classified as “essential” and passed directly to some generics firm in India.
The best incentive for innovation and production has always been profit. Find a way to give profits to BigPharma and they’ll produce the goods.
The problem is that the compulsory licensing was instituted because BigPharma wasn’t doing it on their own before, and they were forced to by governments.
This is one of those areas where I’d like to see pretty much all drug development work taken out of the hands of industry and put into academic and government labs. Once the drug has been developed (the most expensive part of the process), the drug could be licensed to the pharmaceutical industry who then makes their money by marketing and selling it. This model might produce a system where lots of small companies could make a good amount of money specializing in just a few drugs sold to combat malaria, leishmaniasis, trypanosomiasis, even diseases like cholera and dysentery.
In the United States, much of the research expense is born by the government. Typical research funders include the Department of Health and Human Services and the National Institute of Health The pharmaceutical industry steps in and reaps the profits.
Since 1980, there has been an increasing discrepancy between what pharmaceutical companies say they spend on research and what the National Science Foundation says they spend. Regardless of the amount spent by research, only about one-third of research money goes toward the development of new drugs. The bulk of the money is spent on finding new ways to make more money on existing chemical cocktails.
The primary focus in the United States is “me too” drugs for profitable yet nonlethal maladies. In the United States, the healthcare industries thrives on allergy-like conditions where the patient never dies from his or her problem, but neither are they cured. Instead, they become psychological dependents in a nation accustomed to a pill for every purpose. Blitzkrieg advertising to the products drives up drug costs.
Drug companies used to be prohibited from advertising their products on TV, radio, and in newspapers in the U.S. I wonder if we could go back to those wonderful days, and whether that would help with the present problems….
So long a politicians are rented like streetwalkers, no reform will be possible.
Consider the Gates Foundation; they’re putting money into primary research on ailments not suffered by the rich but important to the poor. I think it’ll work out without having to nationalise research.
I tend to agree with Brian about most of this. But academics is not entirely without its own set of crazy politics. As Sam will likely point out, a lot of science IS driven by politics. The easiest example of this is anything to do with stem cell research.
I’m one of the guys in the trenches, begging the NIH for money, so I can’t really be unbiased about this topic. (BTW, NSF tends not to fund biomed research. They are geared more toward basic sciences. For the most part, biomed is NIH’s world).
My concerns with Big Pharma have more to do with how the research is conducted. Admittedly, they do exactly what the US government says they have to do. But they ignore and even discourage everything else. For example, if BigPharma, Inc. is working with a lab at Podunk University, they are usually testing a particular drug for a very very specific function. Lets say they are testing a drug that reduces cholesterol.
If there is additional expertise in the Podunk Lab that is outside that specific function, lets say bone metabolism, it doesn’t matter. The company doesn’t want to know about it and oftentimes won’t allow any tissue from animals which received the drug to be tested for anything outside its specified function. In essence, if the government doesn’t tell them to look, they really don’t want to know how it might effect other functions.
From the point of view of business and making money, this makes a lot of sense. If Podunk Lab found out that BigPharma’s drug increases the likelihood of osteoperosis, the stock holders and wallstreet will have a fit. If they disallow the research, what they dont’ know won’t hurt them.
Obviously, from a science and ethics standpoint, this is just nuts. This is the kind of thinking that leads to all the drug recalls we’ve been having lately. But I bet changing the government rules for testing drugs are a bitch.
Now, I have no idea how to fix this. On one side, I want to keep government out of business. Business tends to be a bit more efficient at getting things done than government/academic institutions. But on the other, there has to be some balance between profits and ethics. And if academics is good at anything, it’s arguing about ethics. 🙂
Bill Gates is where Andrew Carnegie was about a century ago – trying to leave a legacy other than his unbridled greed.
Threebells, without their “unbridled greed” neither Bill Gates nor Andrew Carnegie would have ever amassed the fortunes big enough to do what they’re doing. Read my post on Atlas Shrugged.
Michael, my girlfriend is quality manager at a biotech firm. They’re busy with late-stage trials on a new product. Every day she comes home entirely enraged over the various regulatory hurdles, confusion and red-tape she has to get through.
Every single part of the test needs to be specified, any change, even in the test packaging, needs to be affirmed by layers of governing bodies. Since their test is being performed according to EU standards they have both the South African and European authorities to wade through.
I’m not surprised that companies only test what they set out to test and no more. It doesn’t matter what is possible, it matters what is allowed. An entire test, costing millions, can be scrapped if the forms weren’t filled in correctly.
In case anyone’s interested, the Center for Responsive Politics ranks the pharmaceuticals industry at No. 16 since 1990 in campaign contributions to U.S. federal candidates
I suspect that’s only for testing that goes on in the BigPharma lab. But if it gets tested in an outside, academic institution, some of that goes away. Once it gets kicked into the peer review process with publications, government regulations tend to go away. Our peers are nasty enough, trust me. 🙂
I suspect the argument against kicking it into peer review is patent laws. That’s why we all have to sign MTAs (material transfer agreements for those who don’t already know). And, maybe, animal activist groups like PETA. That’s why the lawyers get involved.
I also suspect that you’re talking about human trials. I was talking well before it gets to that stage. It’s a hell of a lot cheaper to do animal trials to work some of this stuff out.
And, in the long run, I bet it actually makes sense economically. Some of the smaller Pharma companies go out of business or get bought out when a drug gets recalled.
I have to agree with you about the paperwork, though. And, believe it or not, it’s sometimes seems like its even worse with animal work. To do my studies, I have to have approvals from the IACUC (institutional animal care and use committee), radiation safety committee, and institutional biosafety committee for each institution involved in the study. For my university alone, that’s about 25 copies of a ~20 page protocol.
That’s on top of the grants I have to write to actually get the money to do the research in the first place. (btw, funding rates are now below 10%…meaning for every proposal sent in to get funding, at least 9 others were written and not funded. And, just about no one ever gets funded on the first submission).
I cry for the trees. But I really don’t feel all that sorry for BigPharma and their paperwork nightmare. 🙂
Michael, again, it’s not about feeling sorry for BigPharma. As you point out, the process is painful. And no sane person is going to do this to themselves unless they have a really good reason.
The firm my SO works for is tiny and has few resources. They’re on human trials at present and expect it to go well, but you’d be amazed at the stupid questions that come back from the Medicines Control Council. Or, perhaps, you wouldn’t be.
The delays are killing them since they have to pay salaries and keep everyone occupied in the hope that full production on the trial can start soon. Again, how many novel drugs are stillborn because the project exceeds its budget while waiting for the regulatory process to get started?
But ask yourself why these government regulations are in place. The answer is probably complex, but I suspect a large part of it has to do with a sizable fraction of BigPharma doing things that were unethical, or ignoring data, all in the name of money. Again, this is why the lawyers are so involved with the process.
Admittedly, another part of it has to do with public misunderstanding of science. An uneducated public means politicians can get away with saying whatever they think will get them elected. Ultimately, that will drive policy. The easiest example for that is all the regulations around GMOs…but I don’t wanna get into THAT argument. 🙂
Maybe when the rules were first created they were carefully thought out but now there are departments of flannel-wearing bureaucrats whose sole job is to come up with new rules. And they do.
As for “politicians saying whatever they think will get them elected” consider my president. “HIV doesn’t cause AIDS; how can a virus cause a syndrome?” Yeah, definitely.
If Andrew Carnegie and Bill Gates had not been so greedy earlier in their lives, their generosity might not have been so necessary later in their lives.
I noticed your reference to Rand. She had a beautifully coherent philosophy, so did Marx (Karl and Groucho).
The competent do not always rise to the top, the ruthless and dishonest frequently attain those positions and maintain them through manipulation of the political system.
The system must be re-booted from time to time in order to democratize opportunity and facilitate a return to a merit based economic system.
Time for a reboot.