Drug company’s greed risks lives of cancer patients

As I sipped my morning coffee over the paper two Sundays ago, I suddenly couldn’t believe what I was reading. The front page of the “Baltimore Sun” had a shocking headline, “How a cancer trial ended in betrayal.” While these events occurred over the past six years, the information was revealed only recently – and by accident. The details of this story, and what we’ve uncovered since is truly shocking.

Imagine if you had a rare form of skin cancer and volunteered for a drug trial to test a revolutionary product that would “probably” cure your cancer. After just 8 short weeks, the researchers told you that your cancer was virtually cured.

Now imagine it was a lie.

As reported in the Sun, that’s what happened to 22 cancer patients who were the innocent victims of a scheme to drive up the stock price of BioCryst Pharmaceuticals. The researchers’ primary motivation was getting FDA approval for their drug so their corporate stock would skyrocket. Greed replaced sound practices. Personal gain was the top priority.

To guarantee a good showing for their drug, BioCryst assigned a nurse to “help” with the study: the wife of the scientist who was running the study for the company. She was also a major stockholder and stood to make a great deal of money if the drug received FDA approval. The drug trial was conducted at the University of Alabama, and the chairman of the school’s dermatology department became a “consultant” for the drug trial.

And so began the “shell game.”

With each passing week, patients’ skin lesions were measured to determine growth or reduction. Even though it was obvious to anyone looking that most of the lesions were not disappearing or even getting better, patients were told they were being cured. Since external appearance is just one method of determining remission or cure, the cancer patients were convinced the scientists knew what they were doing and the cancer really was being cured. After all, who would know better than the experts?

At the end of the 8-week drug trial, BioCryst reported to the FDA that 59% of the patients had reduced or eliminated cancer. They’d finally found a cure!

BioCryst’s stock soared, going from $6 a share to almost $13 within a few months, and they became the darlings of Wall Street.

The drug company’s house of cards tumbled when a company researcher not privy to the plot recalculated the results of the drug trial six months after it ended. He found that only 30% of drug-treated lesions improved. The rate of cure wasn’t even close to the 59% reported to the FDA.

What’s more, those in the placebo group had results twice as good as those using the “miracle” cream!

When the real results reached the FDA, they launched an investigation. But that didn’t help the 22 cancer patients. They had wasted time – and maybe their lives – using a cream that would let their cancers flourish.

This is not a simple case of conflict of interest. It’s a case of calculated deceit, corruption, and fraud. BioCryst officials were sentenced to jail and fined (they’re appealing their convictions). That’s little comfort to the 22 people who had their hopes dashed by greedy conspirators who think that profits are more important than life.

None of this would have come to light – and the 22 cancer victims would never have known they were using a useless cream – if Dr. William Cook, BioCryst’s medical director, hadn’t been given the real results by mistake. Dr. Cook was writing a scientific article about the drug trial, and he noticed that the results reported to the FDA were not the same (or as bad) as the ones he had. When he asked for other corroborating documents, which were kept in a locked cabinet, he was mistakenly given the actual test data. Until then, no one had been provided the correct data that showed the cream was ineffective.

Even with the poor showing, BioCryst isn’t giving up on their cream. While the company’s stock sits at $6.45 today, they’re continuing to test it, although things don’t look any better. In a randomized, double-blind, placebo-controlled study conducted at the prestigious M.D. Anderson Cancer Center in Houston, the topical drug had a 28% success rate in treating skin cancer, while the placebo showed a 24% reduction in skin lesions.

The new “academic-industrial complex” that combines university resources with drug company research dollars has forever changed the face of research.

Source:
Baltimore Sun, June 24, 2001: “How a cancer trial ended in betrayal”
J Am Acad Dermatol, 44(6):940-7, 2001