New Cancer Drug—Hope or Hype?

by Heidi Stevenson

23 June 2009

Yet again, we're hearing hype about a new drug. Here are some of the headlines:

• "Cancer: shock breakthrough" (The Independent)
• "Prostate cancer victims cured with ipilimumab" (Times Online)
• "Is Ipilimumab the Holy Grail of Prostate Cancer Treatment?" (The Progressive Puppy)
• "Medarex Surges On Successful Treatment Of Two Cancer Patients" (The Wall Street Journal on the ever-important financial result)

The only headline that's true is the last one that's focused on how much money is being made. The first three untrue headlines are the reason for it. The drug isn't yet on the market, but the news media is ecstatic because of the great promise demonstrated by Ipilimumab in treating prostate cancer. Their headlines can be summed up as, "It's a miracle!"

The way this story has been rolled out is reminiscent of similar tales in the last few years. I blew the whistle on a phony study that claimed artificial blood was effective, Unsuspecting People Die From Artificial Blood Tests. The media obediently hyped the product, but the reality was that the death rate was higher with artificial blood infusions. Herceptin, the drug heavily pushed for breast cancer using astroroots (fake grassroots) to push for its implementation in the UK, proved to be helpful in only a tiny percentage of cases. Big Pharma's history is littered with such tales.

The pharmaceutical industry has simply become masterful at creating hype around a carefully-designed image that bears little comparison with reality. Is the new Mayo Clinic prostate cancer drug another one? Though it would be wonderful if true, careful examination in conjunction with that ever-enlightening tool called Follow-the-Money-Trail would appear to document results far less stellar than presented.

Did the drug save those two men's lives?

At this point, there is little evidence to demonstrate the efficacy of ipilimumab. (I give up trying to pronounce it! Let's just call it ippy.) In a drug trial of 108 patients with inoperable prostate cancer, two patients were taken off the trial after a single dose, purportedly to allow them to have surgery because their improvement was so good. If ippy was so good and safe, why did they choose to do surgery, rather than give another dose? Or better yet, wait to see if the drug would further reduce their tumors' sizes? Those were only two of the patients; that tells us nothing of the others in the trial. This happened quite recently, so it tells us nothing of the long term survival rate.

Those points, though, are not the most egregious flaws in reporting. Both of the men involved also received hormone therapy, a treatment that is known to produce significant reductions in tumor size. In other words, nothing happened that can possibly demonstrate that ippy cured those patients.

Why pull people out of an ongoing trial?

This is a variation of the technique used to hype Herceptin. A trial was deemed to be so successful that it would have been unfair to the women who were taking placebo if they weren't also offered the drug. That destroyed any validity of the trial. Of course, that really wasn't the reason for stopping the trial. The reason was the publicity gained—and possibly also to prevent longer term results, which previous studies indicated would have demonstrated less-than-stellar effects.

Pulling people out of the trial was certainly effective in garnering enthusiasm for ippy, as seen by the recent hype. It may also be hiding long term results. The fact is that we don't know.

Follow the Money

As in so many pharmaceutical trials, money talks. That could well be the case with ippy. It is, of course, to the benefit of its manufacturers, Bristol-Myers Squibb and Medarex, to achieve good clinical results. Naturally, any financial connection they have with researchers for their drug is likely to result in favorable treatment for their products.

As it turns out, the lead researcher, Dr. Eugene Kwon, invented a product that acts as a biomarker for advanced cancer therapies. His employer, the Mayo Clinic, licensed the rights for this product to Medarex, making for a rather cozy relationship. Dr. Kwon received royalties in excess of $10,000 for this, though how much in excess is unknown. Further, Kwon and other researchers on the project co-invented a follow-up technology, and the Mayo Clinic has applied for a patent on it.

These technologies are used in treatment with ippy, so there's further financial interest in finding good results and hyping them.

Kwon has other links that tie him to pharmaceutical interests. He is a former American Cancer Society (ACS) Oncology Fellow. ACS funding sources are difficult to identify. Their website offers no information. However, their corporate ties are easy to deduce. Their history is full of actions and nonactions that were obviously because of their connections with major corporations and pharmaceuticals. For example:

• In 1992, with the National Cancer Institute, they co-launched a campaign to recruit 16,000 healthy women, who were supposedly at high risk for breast cancer, to take part in Zeneca's 5-year trial for tamoxifen. Although the drug was known to cause liver cancer in rats and virulent uterine cancer in women, the trial subjects were told that the drug was safe.
• The pesticide industry consists largely of the same corporations that sell pharmaceuticals. In 1993, the ACS publicly supported pesticide manufacturers. They belittled the idea that pesticides cause childhood cancer.
• Along with patient and doctor groups, in 1996, the ACS pressured the FDA to allow silicone breast implants, in spite of knowing that several studies demonstrated that they caused cancer in rats and that the implants were contaminated with ethylene oxide and silica, both of which are carcinogens.
• The ACS places little emphasis on cancer prevention, instead putting most of its efforts into instilling fear to push people into diagnostic tests for early detection, thus making them grist for the cancer mill of Big Pharma and modern medicine.

This is an organization with which Kwon has close ties. It appears that his entire career has been steeped in Big Pharma money.

New drug hype

The Mayo Clinic's publication, Discovery's Edge⁽¹⁾ hypes the results of the latest ippy trial, even to the point of claiming, "Both patients are free of cancer." These patients' surgeries were done just last year. The modern medical standard for claiming a patient to be free of cancer is a full five years of survival, a standard that hasn't even come close to being met in this case.

Dr. Kwon has been widely quoted as saying, "These were patients for whom there was no hope. The course of their disease has been altered in a dramatic fashion. We have a major finding which we never expected to stumble across but we have to complete our studies."

This is not how a genuine scientist, one who is interested in finding the truth, speaks—especially in light of the fact that ippy's trial history to that point had been miserable, as we'll see next.

Earlier studies of ippy

Towards the end of 2007, Bristol-Myers Squibb and Medarex were facing dismal study results from ippy studies. One of three trials had not been able to meet its goal of shrinking at least 10% of tumors. Think about that. They were hoping for nothing more than results in one out of ten patients—and didn't even meet that goal. Side effects were severe, with rashes, diarrhea, and hepatitis among them.

However, rather than give up on it, they decided to go for the gold. It seems they figured that good results on even the tiniest percentage of recipients would be okay, if those recipients were suffering from very advanced cancer. Thus was born the latest ippy trial. By the way, Dr. Kwon has been involved in these trials all along, so he would have known how to pick the patients with the best chance of success—and even then, there was a bit of game playing, since the two men whose results seem to have been so good were also given hormone treatments, which are known to shrink prostate cancer.

When looked at carefully, the hype of this so-called cancer cure can be stripped away, clarifying that the claims made don't stand up to scrutiny. Examining the behavior of the lead researcher, with his extreme enthusiasm and highly questionable actions in pulling two subjects from the study because of its seeming success in them—and only them—adds to the problematic results. Further checking shows a lead researcher and the organization he works for to be deeply in bed with pharmaceutical corporations, including the ones involved with this particular drug.

Perhaps ipilimumab will prove to be a wonder drug for cancer, but it's off to an ignoble start.