The Legal Janitor

I used to think that Andy Ho was a bad journalist. Now I think he is dangerously incompetent.

In his latest opinion piece, he rails against ‘big drug firms’ and their ‘undue influence’ on regulaters like the FDA and HSA. Even more reprehensibly, he inveighs against ‘the gay lobby and Aids activists’, weaving a conspiracy theory that appears to have no other purpose other than to satisfy a personal vendetta against homosexuals.

IF YOUR doctor assures you that a new drug is safe because it is ‘FDA-approved’, take that with a pinch of salt. Once upon a time, he could have been right but, now, there is cause for concern. If he seems to be in the dark, shine some light on it for him.

The Food and Drug Administration (FDA) had long been regarded as the world’s gold standard in drug safety review.

Risk is an inescapable fact of human existence. No matter how much people may desire complete certainty, it is not humanly possible. While insurance can distribute and spread risk, and governments can tax or subsidise risk, any set of choices will ultimately face irreducible risks that must be borne by someone (Higgs: 4). It is not possible for governments to banish risk simply by fiat: Governments are not God.

Andy Ho’s fatal conceit lies in his assumption that science draws a clear and unambigious distinction between ’safe’ and ‘unsafe’. That is not true. Any drug at excessive dosage can be poisonous. Some people have fatal reactions to even the most commonly used over-the-counter drugs. What does this mean? This means that science can attempt to determine the degree and range of risk of any given drug, but the question of whether a drug is ’safe’ or ‘unsafe’ cannot be separated from the subjective condition of the consumer.

Every individual is different in their reactions and requirements to the same kind of drugs. Similarly, every person is different in their willingness to take risks. A very ill person with a 50% chance of dying can very rationally choose to take a drug with a 25% chance of serious side-effects if that drug offers the person the only chance of survival. Another person whose symptoms are not fatal might choose not to take the drug because of the side-effects. Or a person suffering from constant excruciating pain on a daily basis may choose to take a drug that increases the likelihood of stomach ulcers, while someone who is not suffering from chronic pain may choose not to.

Andy Ho thinks the question to be asked is ‘Is drug X safe?’, when the REAL question is ‘Is drug X safe for Ah Kow, Ahmad, Bala or James?’ What Andy Ho proposes, is that it is possible for a group of omniscient, all-knowing bureaucrats controlling a central government agency to determine the ‘right’ level of risk for every single person in Singapore based upon a single measure of what is ’safe’ or ‘unsafe’. Clearly, Andy Ho does not have a grip on reality.

Ever since it was found in the pockets of the huge pharmaceutical companies from 1992, critics say. An indication of how far the FDA has fallen: Even after the manufacturer, Merck, had voluntarily recalled Vioxx, the FDA would take no action on similar anti-arthritis drugs. Instead, it sat on its hands until one of its scientists turned whistle-blower during an open United States Senate hearing last November.

Andy Ho points to examples like Vioxx to substantiate his claims that the FDA did not do its job because of money from Big Pharma. But the truth is, was there really such impropriety?

In a New Yorker column, Surowiecki says:

Questions about Vioxx?s potential risks have been common since its introduction, six years ago, especially after a 2000 trial suggested that the drug increased the risk of heart disease. Merck did not hide these data, and beginning in 2002 the drug?s label included a warning about the possible cardiovascular risks.
…
The internal debates about the drug?s safety were just that?debates, with different scientists arguing for and against the drug. The simple fact that Vioxx might have risks wasn?t reason to recall it, since the drug also had an important benefit: it was less likely to cause the internal bleeding that aspirin and ibuprofen cause, and that kills thousands of people a year. And there?s no clear evidence that Merck kept selling Vioxx after it decided that the drug?s dangers outweighed its benefits.

More importantly, Andy Ho conveniently forgets the hundreds and thousands of sufferers of chronic pain who are willing to take the risks of Vioxx in exchange for a better quality of life now. Does it make sense for the FDA to mandate the withdrawal of painkillers despite the fact that people who are fully aware of the risks wish to take that risk? To make things worse, Andy Ho advocates the FDA to take action against ’similar anti-arthritis drugs’. Where would these pain-sufferers turn to next?

Andy Ho also raises the accusations that Dr Marcia Angell, former editor in chief of The New England Journal of Medicine, make of Big Pharma, namely that scientists lose their neutrality when in the employment of these companies.

Again, the problem is Andy Ho has no idea what he is writing about. Would you trust an economist to perform open-heart surgery on you? Conversely, do you think its a good idea to let a medical doctor dictate economic policy to the state?

Richard Epstein, professor of law at University of Chicago, reviewed Dr Angell’s book, and was not impressed:

I’m a law professor, and you wouldn’t trust me to do a cancer biopsy. So be leery of physicians who tackle law, economics, marketing, and public policy with no formal training in these subjects. Angell, a pathologist, and Kassirer, an internist, aren’t writing about medicine. They are writing about complex social institutions in which it is not possible to have all good things simultaneously. You can’t get new drugs to market if you make them freely available. And you have to absorb some risk of injury to push needed drugs through the FDA process.

I believe we should also be leery of journalists who tackle law, economics, marketing and public policy with no formal training in these subjects.

But is there really a problem with accelerated approval?

Sadly, it releases new drugs well before traditional FDA clinical testing requirements would have allowed.

The other problem is Andy Ho’s contention that the FDA approves drugs ‘too quickly’. That is patent rubbish. An analysis of historical data shows that every increase in the FDA’s powers to restrict and control drugs corresponded with a decrease and delay in the number of new drugs available to consumers. That could have been redeemed if there was a corresponding increase in drug safety. Unfortunately, that did not happen.

In fact, the incentives for the FDA are structured in such a way so as to encourage consistent delay in the approval of new and valuable drugs. A simple matrix tabulating the outcomes of choices that the FDA makes clearly shows that there is a ‘systemic bias’ towards disallowing valuable drugs.

WHAT pushed the FDA off its pedestal?

In the first instance, it may be traced to pressure from the gay lobby and Aids activists.

The last and most disgusting of errors that Andy Ho makes, is when he blames ‘declining standards’ on ‘the gay lobby’ and ‘Aids activists’. Firstly he ignores the huge array of organisations, think-tanks and lobbies which oppose the existence of the FDA, excessive regulations of drugs and/or slow approval of drugs. Contrary to Andy Ho’s assertions, these organisations come from the entire range of the political spectrum. To insinuate that the reason why drugs are unsafe is because of ‘the gay lobby’ and ‘Aids activists’ is clearly unethical and unprofessional.

It is one thing to have a mistaken opinion about something. It is quite another to publish that mistaken opinion for fact. It is unconscionable when that mistake combines ignorance and personal prejudice. Is Andy Ho a poor excuse for a journalist? Is Andy Ho incompetent? Is Andy Ho a homophobic bigot?

We report, you decide.

Straights Times - Now, who is watching the drug watchdog? - Jan 23, 2005 (Full Article on page 2 of this post)

Higgs, Robert - Banning a Risky Product cannot improve any Consumer’s Welfare, with Applications to FDA Testing Requirements, Review of Austrian Economics Vol. 7 No. 2, Ludvig von Mises Institute (PDF) via Cafe Hayek - Abolish the FDA

NPR - Search for Perfect Drug Safety a Mistake (audio) (text)

Cafe Hayek - Why trust strangers with your health?

The New Yorker - Surowiecki - Don’t do the math

USAToday - For those in pain, relief trumps risks of banned painkillers

Legal Affairs - Richard Epstein - Pharma Furor via A Constrained Vision: Stop picking on pharma

FDAReview

American Enterprise Institute - The Price of Too Much Caution and American Enterprise Institute - The Burden of Staying Alive: It’s the drugs you can’t get that might kill you via A Constrained Vision: A pusillanimous FDA