Health News Review

It was more than 100 years ago when George Santayana wrote, “Those who cannot remember the past are condemned to repeat it.”

It was 1985 – 28 years ago – and Dr. Steven Rosenberg of the National Cancer Institute was a media darling with stories about his research on interleukin-2 for cancer.  Magazine covers, newspaper headlines, Today show appearance. Much of it hype. Newsweek put “The Search for a Cure” on its cover. An AP story included the cautionary quote: “Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston cautioned that although the research is worth pursuing, ‘I would be very reluctant to put it up in neon lights and call it a major advance.’ ”

Indeed, IL-2 has gone on to be tested in many trials. But even within a year of the 1985 splash, the news enthusiasm had dimmed.   We’re still searching for that cure.

And, 28 years later, we’re still putting immunotherapy research up in neon lights.  “Breaking Through Cancer’s Shield,” is the New York Times headline today.  Excerpt:

Still, researchers think they are seeing the start of a new era in cancer medicine.

“Amazing,” said Dr. Drew Pardoll, the immunotherapy research director at Johns Hopkins School of Medicine. This period will be viewed as an inflection point, he said, a moment in medical history when everything changed.

“A game-changer,” said Dr. Renier J. Brentjens, a leukemia specialist at Memorial Sloan-Kettering Cancer Center.

“A watershed moment,” said his colleague, Dr. Michel Sadelain. (Both say they have no financial interests in the new drugs; Dr. Pardoll says he holds patents involving some immunotherapy drugs, but not the ones mentioned in this article.)

Researchers and companies say they are only beginning to explore the new immunotherapies and develop others to attack cancers, like prostate, that seem to use different molecules to evade immune attacks. They are at the earliest stages of combining immunotherapies with other treatments in a bid to improve results.

“I want to be very careful that we do not overhype and raise patients’ expectations so high that we can never meet them,” said Dr. Alise Reicin, a vice president at Merck for research and development.

But the companies have an incentive to speed development of the drugs. They are expected to be expensive, and the demand huge. Delays of even a few months mean a huge loss of potential income.

I am struck by the similarities between the Rosenberg news coverage 28 years ago and this story today.

Cost as an obstacle:

  • Then: ”It’s clearly very novel,” said Dr. James Meir of New England Medical Center in Boston. ”The only concern I think the public should have is the incredible expense. You’re talking about tens of thousands of dollars to treat even one patient. That dwarfs the cost of any kind of conventional therapy.”
  • Now: “a high price tag — $120,000 for a course of therapy” of one approved drug.

The novelty of the approach:

  • Then: ”represents the first new kind of approach to cancer in perhaps 20 or 30 years.”
  • Now: “researchers think they are seeing the start of a new era in cancer medicine.”

Anecdotes of seemingly incredible progress in a few seriously ill people:

  • Then: “The treatments had caused tumors to regress in 11 of 25 patients with the most intractable, advanced cancers of the lung, colon, and kidney, and with melanoma, a skin malignancy.”
  • Now: “His cancer disappeared on scans and has not returned, even though he has had no treatment for a year. …Three…patients had similar responses, including one who was treated five years ago in the first study. All, with advanced disease, would have been dead by now, he said, adding, ‘I have never seen anything like this, personally.’ “

This post is not a severe criticism of the New York Times story.  It was a story about fascinating research.

It is just the call from an old health care journalist to breathe deeply.  We have been here – at these watershed moments – before.  And it wouldn’t hurt to reflect on that more openly and more directly in our news stories as we put “amazing…game-changer…watershed moment” up high in our stories.

Santayana also wrote:

The line between what is known scientifically and what has to be assumed in order to support knowledge is impossible to draw. Memory itself is an internal rumour; and when to this hearsay within the mind we add the falsified echoes that reach us from others, we have but a shifting and unseizable basis to build upon. The picture we frame of the past changes continually and grows every day less similar to the original experience which it purports to describe.”

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Comments

Scott Merville posted on October 15, 2013 at 2:43 pm

Gary:

I appreciate the historical perspective and skepticism, but have a quibble. Or two.

This approach is no longer just a matter of research. One drug has been approved by the FDA and is in use now. When it was approved for melanoma in 2011, no drug had ever been effective against late-stage disease. And we’re not talking about just shrinking tumors or extending survival by a few weeks.

Immune checkpoint blockade has helped more than just a few anecdotal cancer cases. That 20 percent response rate cited in the Times story refers to long-term complete responses for patients with stage 4 melanoma that last for years (up to 12 years so far). That’s for patients who usually don’t live a full year with that diagnosis. I don’t recall interleukin or other immunotherapies achieving that level of impact in any metastatic cancer.

Recent research showed combining two such drugs raised that response rate to 53 percent (NEJM http://bit.ly/19PMJkD) Surely, it’s important to figure out why these drugs don’t help everyone. But 20 percent or higher rates of long-term remission in metastatic disease — that’s remarkable.

It’s always risky to say “this time it’s different.” But these drugs treat the immune system, not individual tumors, so there’s a basis for believing that it might be broadly applicable across cancers. And that seems to be the case so far in clinical trials.

I admire your dedication to scrutinizing medical news. Many thanks.

Scott Merville
MD Anderson Cancer Center PR guy

    Gary Schwitzer posted on October 15, 2013 at 3:38 pm

    Scott,

    If you appreciated my historical perspective and skepticism, then you appreciated the sole intent of my post. As I stated:

    It is just the call from an old health care journalist to breathe deeply. We have been here – at these watershed moments – before. And it wouldn’t hurt to reflect on that more openly and more directly in our news stories as we put “amazing…game-changer…watershed moment” up high in our stories.

    But since you went on to state some quibbles, I’ll quibble right back.

    You wrote:

    This approach is no longer just a matter of research. One drug has been approved by the FDA and is in use now.

    Like that is an indication that research is over? That we know all we need to know? That FDA approval is the be-all, end-all? Again, I offer history lessons called Vioxx, Baycol, Bextra, Acomplia, Xigris…..

    Gary Schwitzer
    Publisher

Alan posted on October 15, 2013 at 2:51 pm

Or in the case of HealthNewsReview: “Those who remember the past and are condemned to repeat it.” The world will never he short of snake oil salesmen, true believers, and those willing to play whack-a-mole with them. Keep up the good work!

Scott Merville posted on October 16, 2013 at 12:33 pm

Thanks Gary.
Didn’t mean to imply that research has come to an end and that all is known. There’s lots going on with additional drugs, combining therapies, etc. However, FDA approval is a landmark that separates the purely research realm from routine therapy. As with any drug, a previously unknown side effect could emerge, but that doesn’t happen all the time, either.

The fact remains that checkpoint blockade has turned back metastatic melanoma in a significant number of patients and that these have been durable responses. I can’t recall that happening in other cases of heavily hyped potential cures. Could just be a memory failure, I guess.
Regards
Scott

    Christopher McCabe posted on October 16, 2013 at 5:51 pm

    Hi Scott,

    We skeptics all hope to be proved wrong…at least I hope we do.

    That said it is important not to overstate what FDA approval represents. It is certainly a commercial landmark, but given the evidence on how ground breaking – or not – many of the new drugs fast tracked to market over the last 20 years or so have turned out to be. Variations in human biology are substantial and it is quite possible that the magnitude of response seen in some cases will turn out to be the exception. In the new world order where value in health care is an increasingly important consideration, smaller responses will struggle to justify the $120K price tag.

    Its important to realise that in the value paradigm, the $120K is not money but rather someone else’s health care. Either the budget is increased through higher premiums that crowd less affluent patients out of the system or the budget is fixed and other health care interventions are displaced impacting on other patients. The hurdle for a breakthrough is a lot higher in the value paradigm that is increasingly important; and perhaps the reporting should be correspondingly more cautious.

    Regards
    Chris