Would it be legal for a pharmaceutical co. to withhold a cancer cure?

Factual Questions
21

Well, yeah. There is a greater public interest in curing diseases than letting people make money off their creations. Now, if the pharmaceutical companies cooperate, we can do both. But, if not, then they shouldn’t be allowed to make medicine, period. I’m sure there will be someone else who would be glad to play along.

Our protections for intellectual property–whether patents, trademarks, or copyright–all exist for the betterment of society. Not because you have some inalienable right to make money off of something you created for X number of years.

We already limit drug patents more than other patents. That’s already limiting what they can do with their “intellectual property” more than others. What makes you think we couldn’t do more?

22

The Smithsonian Magazine has a good article about it. The part about Novartis being reluctant to go forward with it is on pages 4 and 5.

I should also note that they were pressed by cancer patients with an on-line petition. That’s also covered in the story.

23

20+ years of pharmaceutical development and clinical ops experience here (from tox all the way through approval). While the pharma companies DO have an interest in inflating these numbers, a new drug can easily be north of a billion dollars. The cheapest P3 (not whole development program, mind you, just P3 trial) I have ever personally seen was about $100 million, and that was for an imaging agent.

I worked on a lyophilized parenteral that had manufacturing cost of well under a dollar a vial.

Biologics can admittedly get much more expensive to manufacture.

24

Diabetes is another disease for which a cure has long been thought to be suppressed. Nope. Just like cancer, it’s proving to be a far more complex disease than anyone ever imagined, and HCPs are just as prone to it as the general population.

25

Is there any kind of liability that can arise from failing to act? Let’s say your spouse dies of cancer. And then you find out that there was a treatment that would have cured her but the company chose not to sell it.

Would you be able to argue in court that the company was partly liable for her death? And obviously it would be a class action lawsuit involving thousands of people.

If I understand the law correctly, you probably couldn’t sue the company in the United States. My understanding is that there’s no general duty to act in our civil law. The general principle seems to be that as long as you didn’t cause the situation, you’re not liable for the consequences even if you could have prevented them.

But other countries appear to have general duty to act laws. You can be held liable for just standing by while somebody was harmed if you could have reasonably prevented the harm without risking yourself.

26

O.K.

Not being “ready” to make large quantities of Gleevec is a bit different than proposing to shelve it entirely.

The point about people cured of cancer still being susceptible to other cancers is a good one. It’s not as if there’s any prospect of a curative drug magically eliminating all susceptibility to cancer in the future. And such a miracle cure would still be made to great acclaim (and profits). The market for drugs to treat chronic illnesses associated with aging in a cancer-free population would explode.

A parallel argument I’ve seen to go along with the drug-companies-suppressing-cures is the one about how oncologists resist alternative cancer remedies for fear they’d lose their jobs. Apart from the silliness of assuming that docs are incapable of going into other fields, examples abound of medical advances making previous jobs/technologies obsolete. There used to be a lot of tuberculosis sanatoriums, for example - yet the people who ran and staffed them didn’t manage to suppress effective antibiotic treatment for T.B. (which led to sanatoriums going out of business).

27

I’ve spent 20 years in and around alt medicine, and this is the first time I’ve heard that one. The explosive growth of complementary cancer treatments centers and integrative oncology departments would seem to belie it nicely, without any insight into human behavior required.

28

Legal hypothetical about duty-to-act aside, even in the OP’s scenario nobody knows that the treatment is a miracle cure until they’ve done most of the clinical testing necessary for FDA approval. Not even the evil Mustache Twirling big pharma.

At best, after many millions of dollars invested in early stage preclinical research, they’ll know (say) that the drug effectively inhibits some biochemical process that’s necessary for cancer growth, and it can kill cancer cells in a dish. But that’s a very low bar, just barely qualifying as “promising”. There are many thousands of possible treatments that have crossed

After another several million spent on late stage preclinical research, they’ll know that the drug effectively treats a few different animal models of cancer, and it is not toxic to animals or human cells in a dish. Now the drug qualifies as a pretty good candidate for clinical testing. The average success rate for “pretty good candidates” is 10%. Maybe, to be really generous, we could posit that the preclinical evidence is so positive and overwhelming that we could say that this drug has a whopping 20% or 30% chance of being a miracle cure. At this point nobody knows whether the treatment will be safe or effective for actual patients.

Now Mustache Twirling Pharma has to decide whether they want to invest tens of millions more into early stage clinical research. After Phase I trials, they’ll know that the miracle treatment doesn’t harm healthy people, but they still don’t know that it is a true “miracle cure”. The first hints that they have a “miracle cure” will be after Phase II trials, which are small scale trials in patient populations. Usually these are too small to provide definitive evidence of efficacy. However, if the drug is a “miracle cure” it’ll be pretty obvious after one of ten cancer patients in the control group has a partial remission, but ten of ten patients in the treatment group have full remissions. At last, Mustache Twirling Pharma is fairly certain (but not completely sure!) that they have a miracle cure. That they want to suppress for some unfathomable reason*. And as far as the FDA has concerned, they have not provided sufficient proof that the drug is safe and effective.

All this testing has taken the better part of a decade, so the remaining patent life is maybe 10 or 15 years.

Going back to Little Nemo’s hypothetical:

Could you sue someone for suppressing a promising but unproven treatment that perhaps has a 1% chance of actually working? A 20% chance? A 90% chance, but for a treatment that has not been officially approved by the FDA?

*Again suppression makes no economic sense at this point. The more miraculous the results in the Phase 2 trials, the cheaper the Phase 3 trial (a bigger effect means you need a smaller sample size to convincingly demonstrate the effect), and the better the justification for charging high prices.

29

I think you’re misreading the OP. It doesn’t say a company is doing research on something that might potentially cure cancer. It says “a cancer cure”. So accept the premise and figure that it’s a cure.

30

Here’s an interesting legal twist to my previous post. While under American law, you apparently can’t be held liable for doing nothing, you can be held liable if you did something to cause a situation that was preventable.

So let’s say the company in question produces a line of cancer treatments. And it takes the best one off the market in order to keep selling the less effective treatments which are more profitable.

I think you could sue the company in this situation. Not for refusing to sell the perfect treatment but for selling the other less effective treatments.

Any drug sold is going to have side effects. This is certainly true for various cancer treatments that exist. So you could sue the company for causing those side effects. Because those side effects were a consequence of you using the treatment they sold. And they could have prevented that consequence by selling you the better treatment instead.

31

OK, that’s fair, but then the economics becomes even more nonsensical. Evil Pharma does not know that their treatment is a miracle until they’ve completed nearly all clinical testing.

Why would they spend huge quantities of money developing the drug if they didn’t intend on selling it?

Why would they suppress the drug if it can be sold for huge multiples of the cost of producing it?

32

The classic example, listed above, is diabetes. I don’t have all the financials, but if we had a cure, costing (retail) $200,000/patient, I suspect it would still be more profitable to keep the patient on a lifetime supply of test strips, lancets, meters, needles, insulin, etc. I am NOT saying that this happens, but it isn’t hard to see the potential.

Cancer is actually a poor example for this question, because it doesn’t carry nearly the chronic costs (for pharma) that something like diabetes does. A diabetic can easily consume three syringes, five lancets, five test strips, .5mL insulin, and assorted other kit every day for 60 years. The first guy who kills that party will be both revered and loathed. All that said, even if Bayer or Lilly has no desire to develop a cure, someone not already in that space will.

And I have seen promising products get killed because they are believed to compete with existing assets, although that is typically because the new one is not deemed a sufficient improvement, so the public isn’t really being harmed.

As to the patent question: It is true that they expire, theoretically opening the drug to development by another co. However, the problem is that you still have the billion dollar development costs, and as soon as you launch all the generics will be able to come in cheap.

33

It’s true that a number of traditionally respected cancer treatment centers have added woo to their offerings (a case of going where the money is). But seriously, you’ve never heard the bit about greed and self-interest keeping docs from telling you about the Wonder Cures?

“If this information would be made freely available tomorrow to mainstream news, that would mean the end of the billion dollar drug industry, it would be wiped out overnight; huge institutes, million dollar research labs, universities, grants, journals, professors, experts, and cushy multimillion dollar jobs would be erased within a day.”

Wow, an overnight reckoning! (I would’ve laid money on Divine Justice** taking at least a week). :slight_smile:

http://www.thebigcancerlie.com/*

*a typical altie compilation of distortions and outright lies, including the “2%” chemotherapy success rate, most physicians allegedly refusing chemotherapy for themselves, suppressed cures and so on ad nauseum.

**the website actually uses this term in gleefully referring to the death of a physician who thwarted the success of an alt cancer cure.

34

Actually I’m going to reverse my statement. The development costs of a miracle cure are already sunk, else it can’t really be described as a cure. It would be ridiculously profitable, easily selling for six-figures per treatment. If the company suppressed it, the investors would sue all the executives and replace them with someone interested in selling drugs.

Only some sort of literally insane Bond villain would develop and suppress a cure.

All those supplies are sold by a lot of different companies, right? Wouldn’t any single company prefer to make a one time profit of $200,000 per patient than a compete for a small slice of the (say) $10,000 per patient per year?

The more reasonable argument about the incentives for developing treatments for chronic diseases, rather than cures, is a long way from what the OP is talking about.

35

Oh, I’ve heard it said of:

But patient care oncologists themselves seem to be exempt from the criticism. Not sure why that is, but I just realized it when I read your other post.

A lot of alt criticism is based around Huge Corporations (as if Nature’s Way wasn’t one…), so maybe that’s it.

36

Yes, but they’d just had virtually perfect initial human trials (30 out of 31 complete remissions) but were not ready to go forward. There’s something wrong there. I’m going to go out on a limb and guess the reason for that was they were planning on cancelling the program.

They almost cancelled it before those first trials, even though in vitro testing was excellent and animal tests were generally good. I’ll let anyone interested read that part, which I did not quote. It’s on page 4 of the article I cited.

Not true about the current crop of cancer drugs, such as Gleevec. These don’t fix the underlying problem, but rather interfere with the misbehaving chemistry. The real problem with cancer is mutations in the genes. Since those aren’t fixed by the drugs, the patients are basically on the drug for the rest of their lives. Or it may become resistant to Gleevec, so they’ll have to switch to another drug that’s been developed since. Since they charge a very exorbitant amount for Gleevec, it’s now one of the top money makers for Novartis.

37

It seems one trend in drug R&D is that the early phases are increasingly being done by academic labs and spinoffs, and biotech startups rather than the large pharma companies themselves.

The small labs develop new drugs and then can be acquired by large pharma companies for larger scale clinical trials.

Forbes had this article:

Are M&A Replacing R&D In Pharma?

Also:

So the “cure for cancer” might come out of a smaller lab that can shop it around to the bigger companies.

38

Gleevec does not cure CML. It only sends it into remission, and not always. There’s a drug called Sprycel for people who failed Gleevec.

Both drugs are dreadfully expensive and can have terrible side effects. Granted, not everyone experiences those SEs, but some do, and they can be disabling.

39

And if you read my posts on it, you’ll find I never claimed it was a cure. But it was a very major advance in the treatment of CML. Previously, the only really effective treatment was a bone marrow transplant.

And there are several drugs that can replace Gleevec when CML becomes resistant. Besides Sprycel, there’s Tasigna, Bosulif, and Iclusig. Some people progress through several of them as resistances arise. At least one of these drugs were designed to overcome a specific SNP mutation that prevents Gleevec from working.

When Gleevec was first introduced, its side effects were thought mild to moderate by oncologists. But oncologists have a different idea of what serious side effects are, since they’re used to those of traditional chemotherapy.

Gleevec was the first in a class of cancer drugs that inhibit the action of enzymes called tyrosine kinases. The body uses these kinases for signaling, including signals for cell division. Mutations can cause these to be malformed so that they are stuck in the on position, at which point cancer results. While these new drugs inhibit the actions of the mutant kinases, they also may inhibit some of the non-mutant ones.

Some of the other TKIs are Nexavar(Sorafenib), Iressa(Gefitinib), and Tarceva(Erlotinib hydrochloride).

All the above drugs are horribly overpriced, of course. But that should go without saying.

40

“(Oncologists) were trained to be chemical witchdoctors and to “practice medicine” solely based on prescribing harmful drugs that ultimately undermine one’s health. They were totally brainwashed in medical school and throughout their internships and residencies at hospitals and they remain oblivious to the harm they cause. Some say we should have compassion for them because they have no choice but to “toe the line” if they want to keep their jobs.”

Oncologists are deliberately withholding the baking soda cancer cure from patients:

Of course, oncologists aren’t the only physicians suppressing alternative miracle cures. There are pathologists who post online about “quackery” at the behest of their pharma masters, to keep those lucrative cancer biopsies and resections coming in to the lab. (where’s my Bwa-ha-ha-ha smilie?)