The challenge of new drugs

Long long ago, I had just finished my fellowship in medical oncology and moved from Boston to Denver. In the lab, I was working on an obscure enzyme that seemed to differentiate leukemia from normal cells, cystathionase. In the clinic, we had very few clinical trials, so I wrote a cold call letter to 10 different pharma companies. Only TAP Pharmaceuticals wrote back. They had developed a new drug that ultimately became Lupron, and we had the opportunity to participate in all of the trials that led to its approval. The biggest shock I had in that experience was the cost that TAP charged, although by today’s drug standards, I guess it was a bargain.

A few years later, we were asked to participate in the trials that led to approval of goserelin, or Zoladex™. My anticipation was that if approved, the costs of both drugs would drop as the companies competed for market share. It didn’t happen. There are of course many reasons, the greatest being that physicians generally didn’t worry too much about how much a drug cost….insurance or Medicare picked up the cost. Instead, the two companies competed with favors to physicians. Many urology practices made huge profits from the mark-ups in drug, and ultimately TAP paid one of the largest fines in history for unethical practices.

With the new drugs, notably abiraterone and enzalutamide, there have yet to emerge competitors that are approved. The drugs both work on the androgen stimulation axis, but via different mechanisms I have covered elsewhere. Each is incredibly expensive, around $6000/month. But beyond the above “no compete” story, I am concerned that competitors may never even reach the “podium” to provide competition (whether financial or in marketing). The reason is that prostate cancer is inherently slow and that the FDA requires survival as an endpoint. Add to this, that if a patient is on a new drug with some modest improvement in survival, this can be overwhelmed by patients going onto one of the other actives after they progress (rising psa or new lesions on scans) that will make it difficult to see the contribution to survival by “new drug”. The placebo patients will benefit equally from the new approved drugs. This may well be what happened to orteronel, (TAK 700) that was reported to have missed its survival endpoint needed for approval at last weeks ASCO GU meeting. Although I would  like to think that approval would result in lower prices for all of the new drugs, the experience described above makes me skeptical. So how about a new approval process? If a drug is clearly (and I’m not judging whether orteronel is or isn’t the equal of abiraterone here) a comparable, approve it IF the company will provide its “me too” drug to patients at a substantially reduced price. There would still be an advantage for companies to race to be “first to market” and they would enjoy the high profits of being the winner with a new category of drug. On the other hand, competitors could still expect to enter the arena and do well, perhaps competing for first place by price rather than some minor difference in side effects or similar. HOWEVER…this assumes that Medicare, physicians, and insurers would prescribe based on cost savings, something currently forbidden by Medicare but allowed in the VA administration.  And then there would be the fancy TV ads trying to convince patients one drug is better than another based on sitting in bath tubs and looking at sunsets….

7 Comments

Filed under General Prostate Cancer Issues

7 responses to “The challenge of new drugs

  1. Bob Lederer

    Depressing. Another example of our flawed system with perverse incentives. Capitalism at it’s worst. Big Pharma is about Big Profit with no regard to health care costs or outcomes.

  2. Excellent comment from Bob,”Another example of our flawed system with perverse incentives”. I think of all the PCa men who die early because they could not afford the XX-high expense of the new breakthrough drugs available to them today. This means only the “rich” can be saved?? When will our Govt. start taking care of the common man? All the breakthrough drugs discovered you and all the other researchers mean very little unless available to the majority!

  3. David

    I always check what the drug companies are getting outside of the US to get a feel for what the “real” price is. Since I’m out of the country about 6 months of the year in France I get a sense of relative pricing. My rule of thumb is that the US pays 3 times what France and Belgium do for almost all medical procedures and drugs. I have personal experience with surgeries, MRIs, emergency services, urology, dermatology and dental, including root canals and crowns. Many of the Big Parma are foreign corporations and they LOVE the USA, where they get outsized profits from Americans who pay way more than their fair share of corporate R&D budgets, not to even mention bonuses. Sadly, there does not seem to be much that Americans can do to repair this entrenched monopolistic system. We can’t even get GMOs labeled, unlike 26 other countries. But those are comments for a different forum.

  4. John Klug

    Dear Dr. Glode, You write so wonderfullysuch a gift. And you make such an enormously complicated subject seem almost understandable by us mere mortals. Thank you for everything you doJohn Klug

    From: prost8blog Reply-To: prost8blog Date: Thursday, February 6, 2014 at 11:05 PM To: John Klug Subject: [New post] The challenge of new drugs

    WordPress.com Michael Glode posted: “Long long ago, I had just finished my fellowship in medical oncology and moved from Boston to Denver. In the lab, I was working on an obscure enzyme that seemed to differentiate leukemia from normal cells, cystathionase. In the clinic, we had very few cli”

  5. jcmiller

    AS a Stage IV prostate cancer patient, i can only agree with his analysis. Ironically capitalism would dictate competition and lower prices. Greed of pharmaceutical companies and the seeming negligence of physicians to ignore prices (6k a month for a brief prolongation of life) which impact all medical costs. Both patients and physicians need to evaluate better quality of life issues!

  6. Marshall Freedman

    Agree with your comments, Mike.

  7. Pingback: Deep in the weeds. “Doc, is there anything new?” | prost8blog

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