4 weeks ago
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My wife Beth and I watched “Cut Poison Burn,” a film about the business of cancer. See https://medgroup.biz/cut-poison-burn.
It paints a bleak, one-sided view of FDA and big pharma and medical device companies and an active campaign against Texas-based innovator Dr. Burzynski. (A quick Internet search showed as many fierce detractors as zealous supporters.)
Today’s discussion is less about Burzynski and more about the many discussion-worthy quotes from the movie.
Jonathan W. Emord, Constitutional lawyer and author: “There’s virtually no one the FDA has to account to. Congress does an abysmal job of oversight; they might hold hearings and chastise the FDA Commissioner but there is no consequence… The courts rarely second-guess the Agency… and the American people are left helpless.”
Ralph Moss, Ph.D., author of “The Cancer Industry”: “The core problem is money… patents… who is going to control this cure or this treatment. And if it isn’t the big corporations, it just isn’t gonna happen.”
Julian Whitaker, M.D. quotes:
And this observation from the narrator:
There were too many rich stories to share here, including one about the possible efficacy of low-cost dichloroacetic acid (DCA). See https://snopes.com/politics/medical/cancercure.asp.
If you’re intrigued, give “Cut Poison Burn” a look. My library had a copy and it’s available at Amazon: https://medgroup.biz/cut-poison-burn Here’s the trailer:
What do you think?
Is cancer too profitable to cure?
Does greed inhibit or encourage medical device innovation? Or does it do both?
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A lot of you had fun clicking on last week’s video clip so, leading up to the event, I’ll show old clips we shared between speakers, like this favorite:
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Please this article. We’d all benefit from a spirited debate.
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Paul M. Stein
You are asking a question about cancer and then about medical devices. Let's hit the latter one first. I think that seeing the massive list of amazing blockbuster miracles of engineering called medical devices would convince the most ardent skeptic that medical devices work quite well at treating a myriad of chronic medical conditions. If one divides the lifespan of that device by the unit cost, you're probably talking dependable health maintenance at a dollar or two a day. Pretty good, similar to many drugs.
The thing about medical devices is that they are technological marvels that do fairly simple things. Pacemakers and neurological stimulators don't do much more than what a battery and two wires could do. The coronary stent idea probably came from the spring in a ballpoint pen. The problem with medical devices is that all the simple things were taken care of circa 2000. There really is very little new because now there are only really tough problems...like cancer, Alzheimer's, ALS, etc. These have difficult biological cures. No one has a medical device treatment for any of them.
So, then, cancer. Back in 1969, we put a man on the moon. It was an engineering marvel, but medical devices then were few and rudimentary at best. It took another 30 years to get where we finished things up in 2000. The story of the biology of cancer is even worse. Right around then, Nixon had his war on cancer that produced absolutely nothing. In the next half century, we have finally learned just a few things, but we still don't know much about an awful lot. I think it's because of that massive time frustration and monster yearly expenditures that people are looking for someone to blame and conspiracy theories then become part of that. Because cancer is that "death sentence", anyone standing in the way of any potential cure, however stupidly unscientific, like the Burzynski bullsh*t, is seen as pretty much an executioner.
The only "blame" I can see is the horrifically slow advancement of scientific understanding. Nature Reviews Drug Discovery, a monthly free publication, contains article after article discussing the latest research, knowledge, and pharmaceutical company efforts on the cancer front, as well as many other diseases. There's a ton of work going on everywhere. It's just sssslllllllllllllloooooooooooooooooooooooooww. As with much of the screaming into the night about the current state of affairs, medical, political, etc., it's usually done by the ignorant, those who know nothing about what they're screaming about. Or, those looking to either make a name for themselves or profit at the expense of others. The FDA is blameless. They can only work with what comes through their doors. When federal grant research budgets get cut and no ideas for drugs come along out of academia, and drug companies then have no idea what to work on, so no new clinical studies are done, and no nice new drugs come to the FDA, we should blame that last link in the long chain?! The screamers also don't understand the FDA's processes, or seek to hide or discredit it. The extensive data on every new drug or medical device is reviewed by a large panel of physician experts. Everyone in medicine knows their names!
Cancer is not too profitable to cure. That's insane. So many are dying of cancer, and that removes a potential patient population. Eventually, if people live long enough, everybody will get cancer. And, after they get cured, they'll get a different cancer. Imagine if, rather than dying of cancer, every person in the world could live long enough to get cured over and over and over at $10,000, $20,000, or $50,000 a pop? Don't you think that situation would make every drug company CEO in the world salivate? When any patient dies of anything, the drug companies lose a huge source of income!
Regarding greed, that's not even in any equation. You know so many terrific altruistic individuals in the medical device industry who only want to help people, and with more money, more could be helped. It's the same way in the pharmaceutical industry. While the CEO's see only dollar signs, the real people, the scientists, only see victories over diseases, and wish they could contribute.
Just my views,
Paul M. Stein, Ph. D.
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Robert Gellibolian, Ph.D
Great post Joe. Although I have not seen this film, the arguments reminded me of a similar German TV program, a couple of years ago, that featured a documentary about an alleged new cancer therapy, where the main question revolved around “What happens, when a drug promises cure but almost no profits?” The film was about a couple of scientist or physicians who claimed that methadone improves the effectiveness of anti-cancer drugs. The report portrayed methadone as a new miracle drug and conveyed the impression that the pharmaceutical industry is pulling the strings to impede its further development, because it is too cheap and would ruin their profits.
The broadcast, and much of the media hype that followed, became a case study of how a scientific issue can turn into a conspiracy theory.
There is no question in my mind that, over the past decades, the pharmaceutical industry (as a whole) has done more good that bad by developing medications and therapies that have saved if not extended the lives of our loved ones and helped to reduce the effects of debilitating disease or illness. But, as with any industry that revolve around money, in order to have heroes, there must be villains. Case in point: the recent scandal involving Martin Shkreli, with his 50-fold price increase of the life saving drug, Daraprim. Greed has always been part of human life. Sometimes the beautiful dance between science and business is disrupted when greed decides to disrespect the boundaries of science (dictated by the laws of nature), and this is where things can turn ugly in a hurry, and I believe this is where people migrate and embrace conspiracy theories. One villain can taint the waters for everyone else.
But, getting back to the question “If cancer is cured, will the industry lose sales and profits?” I do not think so. On the surface, this might seem to make sense, but it’s a logical fallacy (in my humble opinion).
Sovaldi (Gilead’s Drug for HCV) provided a near 100% cure for people that were infected with certain types of the virus. A cure mind you, not just a treatment! Competitive products could maybe cure up to 70% of those with the illness, but with significant side effects. Sovaldi was a game changer; cure rate was >90% + much less side effects + shorter treatment time. Who could ask for anything more. Competitors almost overnight halted many of the research projects for HCV (how can you compete with a cure, right?).
So, companies that develop CURES will quickly capture market share, virtually eliminating competitors and begin to reap profits selling their miracle cure. Every patient will line up to buy the miracle drug and when disease is eradicated, everyone will have made their money, and company can go out of business (a good thing), or pivot into the next chapter of its existence.
But cancer is not HCV, smallpox. We may have to grapple with the reality that cancer can never truly be cured (with exception of a few), at least for the foreseeable future. It is not simply one disease, each type is unique, similar in many respects but different in others. It develops within us and each person’s body has the potential of being susceptible to it at anytime during their life. A cure for one cancer doesn’t mean the disease will never redevelop in your body again, at least with current technology.
Although new advancements in immunotherapy show exceptionally good promise, most companies develop treatments to manage the disease. We are getting smarter in our fight with cancer, but the disease is still extremely complex.
Part of our journey is solving and curing the cancer dilemma will have to involve a change in conversation from treatment and cure to prevention. We cannot achieve true nirvana and expect to win if society continues to ignore health at its most fundamental level - from a healthy lifestyle to good eating habits. As Americans, most of us are in obsessed with food and calories, but we are not eating right, are stressed beyond limit and do not have down time. Unless this part of the conversation changes, we will forever obsess and chase after the elusive cures that may or may not be real.
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I never thought about the FDA quite that way; it’s kind of like Welfare. Sooooo…
More government control is probably not the answer. I’ve noticed that the War on Drugs has been kind of a bust.
But, I wonder if there is something in profit motive that might help, Profit being that inconvenient third side of that Greed-Government dichotomy. Any company that comes up with a cure would make some decent money, and the guys making chemo can just find something else to do. Go the way of the Buggy Whip.
On the other hand, the FDA lock-down does seem a like a huge problem. Looks like we could use something along the lines of President Trump’s Right To Try regulations, only even more life-sized. If someone has a cure, they need to have a real chance to present. If we want to add a rule to the FDA, then…
Prohibit, in any kind of peer review, any Reviewer whose industries, interests, or stock holdings might be negatively impacted were my drug or device approved.
Think about it, the makers of Twinkies would probably give me a more realistic and fair review than my competitor!
Right To Try does not go nearly far enough. Allowing the inherent competition a say in my approval process is like having Rite Aid approve all new Walgreens and CVS locations! I know why the FDA picks the reviewers that they pick, but this is a process just begging for bias and shooting for stagnation!
So, use non-compete language to create one last regulation covering the approval process. One of Government’s most noble uses is when it actually regulates itself. So…
Call it, “The FDA Review Non-Compete Rule”, and, yes America, yooo ahhhr welcome!
Thanks for these, I love your questions. (I think I hit all three.) 😊
All the best,
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I got a surprising amount of feedback to me personally and privately via email, like this one:
Short response: I know this case well; will not waste time on the movie; very disappointed you put this out.
There is NOTHING preventing someone from curing cancer and making billions, regardless of patents. Competition is HUGE and rewards for superior therapy are large.
Remember, many oncologists’ family members, and friends die of cancer, including themselves. If there were a cure, THEY WOULD TAKE IT!!!!!
This is the oldest bullshit trope of alternative medicine, ever.
I am not defending the poor behaviour of drug companies or bureaucratic FDA, but this is just not logical and is colossally naive.
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And this one:
Joe, cutting to the chase, my brother has been an oncologist since 1986, after being a hematologist for X years, now Adult Bone Marrow Chief at [a well-known hospital] after being Vice Chair at [another well-known institution]. He's hardly a neophyte.
He tells me that when a patient dies, all the team suffers, it is not always a professional relationship, you care for and even love your patients, so it is not a business there.
As to the second tier, pharma, medical device, etc, his years of association with the big boys, I mean the REALLY big boys, tells him they are focused on curing this scourge, just that it has been far far more complicated and difficult than anyone could have imagined, the more we know, the more we know that we don’t know.
So throw out conspiracy theories. It's simply a bitch of a disease.
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"Mike" wrote me: Joe, if this group is going to turn into an outlet for paranoid conspiracy theories about “evil big pharma,” please remove me from your list.
Spreading nonsense such as this is a tremendous disservice to the thousands of people working tirelessly every day to make an impact in human health, across biotech, pharma, devices, and diagnostics. That’s what I thought this group was supposed to be about.
Respectfully yours, but disappointed,
To which I replied, "Michael, if you consider the body of my work in its entirety, I’m confident you’ll find much of it consistent with your preferences.
As you’ll appreciate, however, writing for tens of thousands – and pleasing everyone, with every piece – is impossible, as I learned early on my journey.
I hope you’ll stick around. I’ll understand, and not be hurt, if you choose otherwise.
In either case, you have my contact information, should you believe I or my network can be helpful for you now or in the future."
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My two cents...
There may be the occasional therapies or inventions that do get suppressed -- one would assume -- although I have yet to see proof of any single significant instance. Some are less than enthusiastically supported by the mainstream, e.g. fecal transplants, marijuana, due to no clear barriers to entry for the developers, but this is not suppression. There was never a 100 mpg carburetor or internal combustion engine that ran on water. Does dichloroacetate kill cancer cells? No doubt! It probably kills roaches, too.
My point is that FDA is not the enemy. Big pharma is not the enemy. The American Cancer Society is not the enemy. The effort cannot be left to such institutions, alone, however, simply because they do not have perfect charters to cover all possible contingencies. Capitalism is what it is: imperfect as hell, but the best we've figured out so far.
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Joe, two points... Thanks for putting out the article on Dr. Burzynski's work... It's definitely worthwhile research. I've followed Dr. B on and off for over a decade and it obviously isn't going to cure all cancers, but many of the patients in his clinicals were basically given up for dead by mainstream medicine, which had their chance and failed, so the patients in many of Dr. B's trials were in really bad shape by the time Dr. B got them, and many did survive, some long enough to have children of their own and see them have kids. Second, I don't fault capitalism, since what we have in this great country is *far* from true capitalism -- too much money influencing all levels of govt/politicians. Also, I really am suspicious of those who bad-mouth disruptive tech with vague, non-specific criticisms... that is NOT the attitude which generates novel solutions to difficult challenges!
What if we ran our National Labs, and even some univ research grants, based on the 'reward' basis... give them an incentive to SOLVE it!!! State the challenge/goal, give a number of entities $ to solve it, and the first to the finish line gets a bonus ($) to spend on their pet projects; and perhaps bonuses for the researchers. You also will accumulate over time which labs have the best minds in specific fields. -mark
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