Guinea Pigs International

by Michael Patrick O'Leary

This article appeared in Lakbima News on Sunday October 24 2010.

Recent revelations that American “researchers” deliberately infected unsuspecting Guatemalans with syphilis and gonorrhoea show us what “science” can mean in the real world of medicine and pharmaceuticals.

Some time ago, I started a discussion about cholesterol and statins on a blog frequented by many medical doctors. I said that I was in favour of science and rational argument and instinctively against hippy-dippy, new-agey unsubstantiated nonsense. The problem is, science says one thing is good today, another thing is good tomorrow.

One blogging MD told me: “Alternative medicine purports to have access to ancient ‘truths’ or ‘wisdom’ that has not changed over centuries or millennia, but there is no such thing as ancient truth or wisdom.” One might retort that if something had been effective for centuries without ill-effects, why knock it?

She also said: “Doctors have had extensive, intensive and expensive training. They also keep up with the latest research and developments. They know more than the layman. In order for anyone to determine whether a treatment has merit or is a fraud, they MUST have a good working knowledge of science and statistics (or trust someone who does). Otherwise, they simply cannot accurately evaluate the alternatives.”

What does all this talk about modern medicine being more scientific than alternative medicine amount to? In an ideal world it would mean that modern remedies are superior to traditional ones because they have been subjected to rigorous scientific tests to ensure their efficacy and safety.

Does this happen?

In the US, the FDA (Food and Drug Administration) regulates about a quarter of the nation’s domestic economy, including medical treatment. The Center for Drug Evaluation and Research (CDER), is the part of the agency that regulates prescription drugs. Before a drug company can sell a drug, it must sponsor clinical trials to prove to CDER that the drug is reasonably safe and effective.

CDER’s basic requirement is simply that most new drugs need to be proved to be better than nothing. The drug trial only compares the new drug with a placebo not with existing drugs. The drug companies pay fees for each drug reviewed, so it is in the agency’s interest to review as many drugs as possible as quickly as possible. This method of funding means that the FDA/CDER sees Big Pharma rather than the pill-guzzling public as the client. In 2003, the Health and Human Services inspector general found that 18 % of CDER reviewers felt pressured by their superiors to recommend approval of drugs against their better judgment.

We patients who want to trust our doctors and those dedicated scientists labouring to improve our health might still have in our minds the fantasy that drugs are tested in hospitals and universities by saintly white-coated, Mekon-domed boffins.

Today’s reality is somewhat different. One way or another it is the pharmaceutical industry that funds testing. The old way has proved too expensive and clinical testing has been privatised and out-sourced. About 70% of clinical trials now take place in the private sector, often in the offices of private physicians or at dedicated sites. Contract research organisations (CROs), such as Parexel, Quintiles, PPD and Covance, have built themselves into corporate giants. SFBC was named one of the best small businesses in America by Forbes magazine. For ten years it was paying immigrants to be test subjects at the largest testing centre in North America in a dilapidated former Holiday Inn in Miami with a record of numerous safety and fire-code violations. There are also offshoot businesses like patient-recruitment agencies who supply the human guinea pigs.

A contract researcher does not come up with original ideas, or design research protocols, or analyse research results, or write them up for scientific publications. The pharmaceutical company does all that stuff. A contract researcher earns big bucks for few hours. A part-time contract researcher conducting four or five clinical trials a year can earn an average of $300,000 in extra income. In 2000, a full-time clinical trial site earned an average of $1.6 million.

The raw material is not research intellect or even the drugs, it is the people who are “ready-to-recruit”, in the industry jargon. Ready-to-recruits are often sick people who are also very poor. A WHO official estimates that 20,000 clinical trials are initiated each year. The guinea pig pool in the west is becoming depleted because everybody is already on some medication. ‘Treatment-naive’ subjects are easier to find in the developing world. Between 1991 and 2005 the number of clinical trials conducted in the developing world rose from 10% to 40%.

The drug companies do not encourage their Eastern European testers to come up with bad results. One physician said she had done a clinical trial on a drug that appeared dangerous. The sponsor ignored her and successfully submitted the drug for approval. The drug was later withdrawn from the market. “We never got a contract from that manufacturer again”.

Industry-sponsored trials published in medical journals consistently favour sponsors’ drugs. Negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. Thirty-seven of thirty-eight positive studies of an anti-depressant were published. Of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome.

There have been more general criticisms, some of them reported by a Parliamentary committee, of the MHRA, the UK equivalent of the FDA. As with the US system, problems arise because funding is provided by the pharmaceutical companies, which leaves much room for conflicts of interest.

Bioethicist Art Caplan is concerned that CROs are often told by pharmaceutical companies to “just get us the data on the deadline”, and “don’t get asked questions on how that’s being done.” The Association of CROs boasts that CROs conduct clinical trials 30% more quickly than the pharmaceutical companies that hire them.

In the November 2008 issue of Prospect magazine, Jim Giles wrote about Merck’s painkiller, Vioxx: “It is no surprise that marketing divisions spin results, but we expect scientists to be objective. This assumption is dangerous. The company’s scientists did not receive an edict from the board demanding a cover-up, or an e-mail suggesting the deaths of patients be ignored. The problem was that so many scientists at Merck stood to gain if Vioxx did well. When it came to judging risks, risks that in many cases were borderline and could be ascribed to other causes, they were unable to make the right call.”