Articles

The false hope of “right-to-try” metastasizes to Michigan

Nurse administers chemotherapy

Ed. note: Please read disclaimer in Dr. Gorski’s profile!

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy and I have both written about them before, and with the passage of the first such bill into law in Colorado in May, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit since the news out of Colorado, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) being introduced into the legislature in Michigan by Senator John Pappageorge and unanimously passing, almost without comment by the committee and certainly with minimal news coverage, through the first hurdle, the Michigan Senate Health Policy Committee. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.

I joke (somewhat grimly) about seeming to be opposing mom, apple pie, and the American flag (not to mention apparently also about wanting to disembowel puppies) when I discuss right-to-try bills, but there’s a reason for that. These bills tend to have not just broad bipartisan support in the legislature, because opposing such laws seems on the surface to be the equivalent of denying dying patients a last ditch chance at life, but broad support among the public because of the seemingly reasonable question, “What’s the harm?” Unfortunately, disaster can result when normal human compassion for fellow suffering humans is yoked to misinformation and misunderstanding of science (in this case how clinical trials work), who really controls drug development and regulation in the US, and the real harm that using such drugs prematurely can cause. For right-to-try, the result is perniciously popular legislation that provides lots of false hope and virtually no benefit to terminally ill patients. In the face of this, even politicians with a reasonable understanding of the science, why such laws represent nothing but false hope, and why, even if they go into effect without objection by the FDA, would be far more likely to harm patients than help them, hesitate.

Right-to-try in Colorado

Before I get to my own state, let’s look at Colorado’s right-to-try law. One thing that I feel obligated to point out again is that virtually all the recent “right-to-try” bills introduced into state legislature have been based on model legislation designed by the Goldwater Institute, a libertarian think tank whose specious and misleading arguments for such legislation I’ve discussed before and will revisit and update in this post. In her previous post on right-to-try bills, Jann Bellamy mentioned that there is “nothing like a touching anecdote to spur a politician into action,” and she’s right. That’s why the Goldwater Institute’s web page on its right-to-try initiatives is populated with heart-wrenching testimonials of mostly cancer patients arguing that, if only they had had access to experimental drugs, they might survive or of patients who died whose families tearfully argue that “if only” right to try had been in place their loved ones might not have died. In the wake of the passage of Colorado’s right-to-try law in May, anecdotes ruled, heart-wrenching anecdotes such as this one about Nick Auden, a Colorado man with stage IV melanoma who died six months before the legislation passed:

Who isn’t moved by the struggles of a father who wants to survive for his children? Who wouldn’t want to help this man? What kind of monster am I to oppose a law that would provide brave suffering patients like Nick Auden another shot at life, no matter how slim the chance? Such is the level of discourse directed at those who have the temerity to point out that right-to-try laws are a sham, false hope, and far more likely to harm terminally ill patients than help them; that is, if they have any effect whatsoever, which is unlikely. They are what I like to call placebo laws in that they make the body politic feel better but have no real effect on the underlying problem that they are meant to address. Indeed, as Jann Bellamy pointed out, a much less emotion-driven analysis of these so-called “right-to-try” bills currently before several state legislatures reveals disturbing truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

This can be seen by a simple comparison of the text of the Goldwater Institute model legislation and the final text of the Colorado right-to-try law as enacted. The Colorado law, in fact, bears a very close similarity to the Goldwater Institute model legislation. Some differences between the Goldwater Institute template and the actual Colorado law that leapt out at me included that the Colorado law:

  1. Adds a mention that the drug approval process in the US “protects future patients from premature, ineffective, and unsafe medications and treatments over the long run, but the process” (not in the Goldwater template text) and “often takes many years” (in the Goldwater text)
  2. Alters eligibility to include patients who have “been unable to participate in a clinical trial for the terminal illness within one hundred miles of the patient’s home address for the terminal illness, or not been accepted to the clinical trial within one week of completion of the clinical trial application process”
  3. States that “an insurer may deny coverage to an eligible patient from the time the eligible patient begins use of the investigational drug, biologic product, or device through a period not to exceed six months from the time the investigational drug, biologic product, or device is no longer used by the eligible patient; except that coverage may not be denied for a preexisting condition and for coverage for benefits which commenced prior to the time the eligible patient begins use of such drug, biologic product or device”

There are other differences, of course, but they’re mostly wording and Colorado-specific language about state statutes effected. I tend to interpret #1 as having been added to make it sound less as though the FDA approval process is useless, as the Goldwater text does. My guess about #2 is that it was undoubtedly added in order to exclude patients who just want experimental drugs but aren’t interested in enrolling in a clinical trial. Finally, I’m not completely sure how to interpret #3 and would welcome a lawyer’s input (particularly if it’s a health lawyer), but it sounds rather ominous in that it allows insurers to deny new coverage to a patient for a six month period from the time the patient starts use of an investigational drug, but can’t deny coverage for a preexisting condition (i.e., the condition that led the patient to be terminally ill, and any other preexisting conditions) or any benefits that commenced prior to the time the patient starts using an experimental drug or device. On the other hand, to me the language implies that insurance companies can deny coverage for any new problems that come up after the patient starts using experimental therapy, whether caused by that therapy or not. So if the patient develops a complication from the treatment, he’s out of luck. If he happens to be hit by a car, he might be out of luck. Thus, a bill that sounds compassionate appears to have a cruel, punishing twist embedded in it.

Indeed, this law is very “libertarian” in that it says that patients can try an experimental therapy that’s passed phase I trials to phase II or beyond, but anything that happens after that is all on them. (Indeed, right-to-try would allow access to a drug that’s only passed phase I, even if the phase II trial hasn’t accrued a single patient yet, as long as there’s a phase II trial open.) The doctor recommending the treatment is off the hook, no matter how bad his decision to recommend the experimental therapy was. The drug company is off the hook, no matter how many problems the drug might have. The insurance companies appear to be off the hook, complete with a potential loophole to let them refuse to cover various treatments in terminally ill patients.

At this point, I think it’s a good idea for me to remind my readers once again that that these right-to-try laws cover any drug, treatment, or experimental device that has passed phase I clinical trials. Indeed, in the video above, the reporter made a highly misleading statement when she stated that the Colorado “right-to-try” law “only applies to drugs that have been deemed safe by the FDA.” That statement is so wrong it’s not even wrong, as skeptics sometimes like to say. Just because a drug has passed phase I clinical trials does not—I repeat, does not—mean that the drug has been “deemed safe by the FDA.” Phase I trials, also known as “first in human” trials, don’t enroll very many patients. Sometimes it’s as few as 20 patients, sometimes even less. That is not enough to adequately determine safety, nor is it intended to. That’s because phase I trials are designed primarily to identify major side effects and to use a process known as dose escalation to determine what is commonly referred to as the “maximum tolerated dose” (MTD). It is utterly impossible for such a small clinical trial to adequately assess the safety of a drug. All it can do is to make sure there are no unexpected major adverse events, that the expected side effects are tolerable, and that the drug has a side effect profile that isn’t grossly more unsafe than the disease itself. Phase II and phase III trials are needed to confirm safety. That’s why the premature diffusion of unapproved drugs has the potential to increase morbidity from adverse events and even hasten death. One example is amonifide for treating breast cancer. The drug made it through phase I trials, but serious life-threatening hematologic toxicity emerged during phase II trials.

Think of phase I trials as a screening test looking for the most obvious toxicities, with phase II and III studies confirming them. Indeed, even phase III trials can’t always adequately demonstrate that a drug is safe; it’s not uncommon for less common adverse effects not to show up until post-marketing surveillance, when much larger numbers of patients receive the drug. Moreover, only 5% of all cancer drugs that enter clinical testing are ultimately approved for patient use. Among drugs tested in phase II trials, only 30% go on to phase III. So, to equate having passed phase I clinical trials with having been “deemed safe by the FDA” betrays a profound misunderstanding at the heart of the bill of what a phase I trial is and what passing it means. The potential for disaster is there.

The false hope of right-to-try metastasizes to Michigan

I’ll discuss more of what’s wrong with right-to-try laws and how misguided they are, but first I want to take look at the right-to try bills currently under consideration in the Michigan legislature. Oddly enough, I was completely unaware that a right-to-try bill had been introduced into the Michigan legislature until last week, when I got a message from a concerned person. Before that contact, as hard as it is to believe right now, I had heard absolutely nothing about these bills, but I’m a fast learner. I didn’t have much help, though, because there was very little media notice taken of the Senate hearing about this bill other than a Detroit Free Press article that I found days after the hearing and self-serving articles on John Pappageorge’s website touting mistakenly how this bill would allow “access to potentially life-saving treatments.” Either that, or I missed it because I was out of town at TAM in the days leading up to the hearing. Whatever the case, going back to look over the coverage, I found that the Freep article bought in the same compassionate but incorrect framing as was the case in the other states considering such laws:

Arlene Kalley has lived with terminal cancer for years — and with each new drug she uses to keep the disease at bay, her options dwindle.

Earlier today, the Michigan Senate’s health policy committee approved a bill that would offer Kalley and other terminally ill patients in Michigan better access to experimental medication.

It doesn’t require manufacturers to provide the drug nor does it require insurers to cover the costs. But it gives patients a “right to try,” said Sen. John Pappageorge, R-Troy, whose first wife died of cancer in 1993.

He introduced the bill earlier this year after speaking with Terry Kalley, a partner with Global Logistics Strategies in Bloomfield Hills.

And this is how the idea for introducing bill came about:

His wife, Arlene, was taking Avastin in 2011 to keep metastatic breast cancer at bay when the U.S. Food and Drug Administration yanked its approval of the drug, questioning its safety and efficacy.

Ultimately, Arlene Kalley was able to keep taking Avastin because it still was being used to treat other cancers, but the experience got the Kalleys thinking about what could happen if Arlene Kalley’s current treatment is no longer effective one day.

While I can understand why this case might have led the Kalleys to wonder about right to try, I must point out here that Avastin was a very different case than situations envisioned in right-to-try legislation. Specifically, Avastin had undergone randomized clinical trials (RCTs) beyond phase I and had already been approved for other cancers before being approved by the “fast track” approval process for advanced breast cancer. Its approval for advanced breast cancer was based on two RCTs that showed a modest increase in progression-free survival (PFS) when Avastin was added to chemotherapy, but no effect on overall survival (OS). In 2008, based on a program to “fast track” promising drugs that was developed in 1990s, the FDA gave provisional approval to Genentech to market Avastin for metastatic breast cancer with the condition that Genentech had to perform additional studies to verify the results upon which the original approval had been based. At the time, there was a great deal of argument over whether this was a wise decision, particularly given how expensive Avastin is and the lack of evidence that it improved quality of life or overall survival. Unfortunately, the results of those additional clinical trials were very disappointing to all of us who take care of breast cancer patients. The AVADO trial only found an increase in PFS of less than a month when Avastin was added to docetaxel with no increase in OS, while the RIBBON-1 trial found an improvement in PFS of 2.9 months when added to capecitabine, and 1.2 months when added to anthracycline-based chemotherapy. That’s why in July 2010 the FDA advisory committee revoked the fast track approval.

In other words, although I realize that Arlene Kalley was simply worried about what her options would be if her current treatment regimen ceases to keep her cancer in check, in a manner of speaking she is inadvertently comparing apples and oranges in a way that could lead those unfamiliar with the Avastin saga to believe that Avastin and right-to-try are related by anything other than the fact that she has done well on Avastin thus far. I bring this up because the saga of Avastin for breast cancer is relevant to right-to-try bills, but not in the manner implied. Contrary to the arguments made in favor of right-to-try laws that a single phase I trial is enough for a treatment to be deemed “safe,” even though Avastin was FDA-approved for other cancers and provisionally approved for breast cancer, in the subsequent clinical trials for advanced breast cancer there was evidence of harm due to Avastin. That harm likely accounted for why the increase in PFS did not translate into an improvement in OS. Specifically, the drug’s toxicity likely “took back” those gains in PFS. As Fran Visco of the National Breast Cancer Coalition put it, “The FDA should never have approved Avastin for breast cancer to begin with. We don’t see evidence of benefit, but we do see evidence of harm.” And that was just Avastin, not a drug with much less extensive testing, such as the experimental therapies right-to-try bills propose releasing “into the wild,” so to speak.

So what do the Michigan bills SB 991 (Senate) and HB 5651 (House) propose? It’s basically very similar to the Colorado law and the Goldwater Institute boilerplate, with a couple of notable exceptions. For example, SB 991 requires:

  • A statement in the “written informed consent” for using the experimental drug that informs the patient that “the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment and that care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements.”
  • A statement in the “written informed consent” for using the experimental drug that attests that the “patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that this liability extends to the patient’s estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.”

The first of these is odd and unnecessary in that hospices tell patients up front that if they undertake curative treatment again they are no longer eligible to be in hospice while undergoing the treatment. Including such a provision in SB 991 strikes me as redundant, a duplication of law and policy that already exists for hospices. The second of these is to me quite objectionable. Not only does it put the patient on the hook for any expenses or debt that he incurs using experimental treatments, but it seems custom-made for drug companies, to make sure that they get their money for experimental therapies administered under “right-to-try,” no matter what, even letting them go after a deceased patient’s estate, something that will frequently be necessary because patients eligible for “right-to-try” by definition have a terminal illness, and the vast majority of even the most promising drugs will likely only prolong their life, not save it. Either way, both of these Michigan provisions make a bad bill even worse.

In fairness, though, there is also a provision that explicitly states that a patient’s heirs are not liable for outstanding debt related to the treatment or lack of insurance and specifies that this act “does not affect any mandatory health care coverage for participation in clinical trials under the insurance code of 1956, 1956 PA 218, MCL 500.100 to 500.8302,” which, unlike the weasely language in Colorado’s law, means that insurance companies must continue to cover all treatments not related to the experimental treatment. Also in fairness, SB 991 does add a provision to the usual Goldwater Institute boilerplate that states that “an official, employee, or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device” by adding that “counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section.” As faculty at a state institution, I would have been very worried about the part about not blocking access as a provision that might get me in trouble if I were simply to voice my medical opinion.

There was also a curious substitution resulting in a “substituted bill” for SB 991 that stops referring to “terminal illnesses” and instead refers to such illnesses as “advanced illnesses”:

(a) “Advanced illness” means a disease or medical or surgical condition with significant functional impairment that is not reversible even with administration of current federal drug administration approved and available treatments that is expected to result in death or a state of unconsciousness from which recovery is not expected. For purposes of this act only, advanced illness has the same general meaning as terminal illness has in the medical community.

For the life of me, I can’t figure out why this change was made, when the substituted bill states that for the purposes of this bill “advanced illness has the same general meaning as terminal illness has in the medical field.” I can’t help but get a sneaking suspicion, which could be wrong, that perhaps the bill’s sponsors are already thinking ahead to eventually expand eligibility for right-to-try to patients who are not terminally ill by laying the groundwork to have “advanced illness” associated with right-to-try rather than just terminal illness. I could be wrong, of course. Alternatively maybe there’s some regulatory or political reason for the substitution. Either way, the Michigan right-to-try bills are in some ways worse and in some ways not as bad as the Colorado right-to-try law. That doesn’t change how much these laws are flawed in their very conception.

The problem with right to try

I can understand the desperation of families, at least, facing the loss of a loved one to a terminal disease, be it cancer or something just as bad or even worse, such as amyotropic lateral sclerosis (ALS), more commonly known to the public as Lou Gehrig’s disease. After all, it was only five years ago that my wife and I faced the death of her mother from metastatic triple negative breast cancer, including brain metastases. Knowing, as all cancer doctors do, that it could happen to me (particularly now that I’m on the wrong side of 50), I can’t even guarantee that I wouldn’t be tempted by the siren call of right-to-try were one of these bills, or some variant thereof, to be passed into law in Michigan and I later was diagnosed with a terminal illness.

Even so, when people ask, “What’s the harm? and “How can it get worse?” I know that there is harm and it can get worse. If there’s anything worse than dying prematurely of a terminal illness, it’s accelerating your demise, suffering unnecessarily during the little time you have left, and/or emptying your bank account while doing either or both of these things. Compassion impels us to want to help terminally ill people in any way we can, but a less emotional analysis of right-to-try bills, coupled with a knowledge of the science and conduct of clinical trials reveals that these laws, as currently constituted, are almost universally a bad idea. Indeed, with such a low bar for a drug or device to qualify for right-to-try (a single phase I trial), it’s almost guaranteed that such laws are highly unlikely to help, at the cost of a not-insignificant risk of causing harm. These laws would be less odious if the bar had been raised a bit, for instance requiring that at least a phase II trial before a drug is eligible, but that’s not what any of these bills propose.

Right-to-try laws also provide false hope. For one thing, these laws rest on the faulty assumption that there are all sorts of “miracle drugs” out there that can save the lives of terminally ill patients if only the FDA would get out of the way. This assumption becomes rapidly apparent perusing the Goldwater Institute’s pages on right to try, which is packed with loaded language about the FDA and terminally ill patients, with every experimental drug apparently “potentially life-saving” and patients dying because they can’t get these drugs. Besides the greater likelihood of resulting in patient harm than help, contrary to what their advocates promise, right-to-try laws won’t deliver increased access to experimental drugs. The reason, as Jann and I have both explained at more length before, is because the federal government, through the FDA, controls drug approval, and federal law trumps state law. State right-to-try laws have no power over the FDA, and nothing states can do can compel the FDA to abide by their right-to-try laws. Moreover, drug companies are understandably reluctant to allow just anyone the use of investigational drugs still in clinical trials, because if something bad happens it could very well affect their application for approval:

However, companies and regulators alike have expressed some hesitancies about the program. For companies, expanded access means letting products out of tightly controlled and heavily monitored environments, potentially subjecting the product to incorrect use and previously-unknown adverse events, which would still need to be reported to FDA. Such incidents could potentially raise questions for regulators, thereby harming the chance of a product getting to market. Further, some companies have expressed their fears about expanded access programs robbing their clinical trials of some patients, which could reduce the statistical validity of a trial and potentially harm other patients by delaying a drug’s path to market.

Another issue is a practical one. Manufacturing a new drug for the first time is expensive, which is why, quite often, only enough is manufactured to supply approved clinical trials to be used to support an application for FDA approval. “On-demand” manufacturing would not be easy to implement, particularly if enough patients asked for the drug under right-to-try. This could be a particular problem for small biotechnology companies, which often can barely scrape together the capital to do the necessary clinical trials to support FDA approval. Given that these small biotech companies are often the most innovative and least likely to be seeking approval for “me-too” drugs, the effect of right-to-try on the pharmaceutical industry’s already weak innovation could be significant.

It’s also important to note that right-to-try laws are more about ideology than science. Proponents and supporters of right-to-try tend to use arguments very similar to those used by the “health freedom movement” that rely on questions like, “Who owns you?” and appeals to the belief that the government shouldn’t tell people how they should manage their health. For instance, the Alliance for Natural Health USA, a key “health freedom” organization that advocates relaxing laws regulating the practice of medicine, the better to let more quackery flourish, is very much in favor of a federal version of “right-to-try,” which is every bit as much a bad idea as the state right-to-try laws, given that it would actually do something. The Goldwater Institute, in an article promoting right-to-try, gives itself away by bemoaning the expansion of FDA authority in the 1960s by the Kefauver-Harris Amendments that required that the FDA not just require demonstration of safety but of efficacy as well before approving new drugs. This expansion of FDA power was in reaction to the thalidomide debacle, leading the Goldwater Institute to make the bizarre argument that because the issue with thalidomide was a safety problem, not an efficacy problem and because thalidomide was never approved in the US (mainly due to the FDA, let’s not forget), the expansion of FDA power in response to the thalidomide debacle was “unwarranted.”

Unfortunately, right-to-try bills and laws are nothing but feel-good measures that provide the illusion of actually doing something without actually doing anything substantive to help desperately ill patients, particularly given that the FDA already has an expanded access program to allow patients to use drugs outside of clinical trials. There are estimated to be 1,000 requests per year now, and it is uncommon for the FDA to deny a request for expanded access. Indeed, in FY2013, only three such requests were denied; in 2012, four; in 2011, one; and in 2010, sixteen. If, as proponents of these bills believe, expanded access programs aren’t easy enough to access, the answer is not to pass state right-to-try laws. It’s to reform the FDA’s expanded use program, something that’s occurred before and is ongoing, just as the FDA has developed a “fast-track” approval program, the same one under which Avastin was approved.

As David Kroll pointed out, true compassionate use reform will require that we as a society come to an agreement about the balance between access and scientific rigor, realizing that unapproved drugs, particularly the biologicals, such as monoclonal antibodies (which are very tricky to manufacture), are often in short supply. It doesn’t help terminally ill patients if patients demanding right-to-try put companies in a dilemma in which they either surrender some of their precious stock of investigational drug for “right-to-try” requests, thus endangering the company’s ability to conduct proper clinical trials, nor does it help patients to spend their life’s savings on investigational drugs that are unlikely to help them and could hurt them. Although their supporters are well-meaning and sincerely think they are helping the most desperate of their fellow human beings, right-to-try laws are a cruel sham perpetrated on terminally ill patients and should be opposed wherever they metastasize.

Posted in: Cancer, Pharmaceuticals, Politics and Regulation

Leave a Comment (210) ↓

210 thoughts on “The false hope of “right-to-try” metastasizes to Michigan

  1. mho says:

    ”It didn’t take long for these predictions to be realized as stem cell biotech Neuralstem announced on June 5 that it would be offering its experimental, non-FDA approved human neural stem cell therapy for ALS in Colorado. And it might do it in a for-profit manner. Further, Neuralstem CEO Richard Garr has indicated that the company will not work with the FDA for the human experiments in Colorado. It is worth pointing out that CEO Garr is also Chair of the Goldwater Institute’s Right To Try National Advisory Council.”

    http://www.ipscell.com/2014/06/neuralstem-flirting-with-stem-cell-noncompliance-in-colorado-via-right-to-try-law/

    I looked for the text of Garr’s June 5 announcement, but I couldn’t find it. Apparently he backpedaled by June 6. Quoting from his blog:

    No one is suggesting that this process take the place of the existing clinical trial process. And no company (though I can only speak for Neuralstem) will offer a drug if the FDA tells it not to. The heart of the RTT bill recognizes the contribution the FDA process makes to the determination of safety in the early stages of drug development and Neuralstem’s support of this program is based upon that recognition.”

    This sciencemag is probably interesting to read. I don’t have access to it, but a friend forwarded this
    ” ‘Any patients alive today with ALS will most likely be dead by the time we’re finished with our trials,’ says I. Richard Garr,. . . .  His company plans to take advantage of Colorado’s Right to Try law to make its unapproved treatment available to ALS patients, well ahead of any FDA decision.”
    http://www.sciencemag.org/content/344/6190/1329.

  2. Kathy says:

    I wonder how this law (if it spreads to other states) would affect Burzynski and others of his ilk? No need any longer to test for efficacy of antineoplastons – just claim “right to try” and you can use these or any woo you like after one small test to make sure they doesn’t actually poison someone.

    Put this law together with the drive to register CAM providers as PCP’s and they can channel many seriously ill or dying people into 101 varieties of woo, rather than those nasty chemical or surgical treatments for cancer, etc. They do anyway, but now their range will be extended and the money they can get for some expensive custom-made chemical (a natural chemical of course) will be so much better than for some backrubs or needles or vitamins.

    And if the patient dies you can get the costs – set by yourself without dispute from those penny-pinching insurance companies – from the estate.

    It sounds like CAM paradise.

    1. David Gorski says:

      It does make me wonder whether there is a right-to-try bill being submitted in Texas yet.

      In fairness, though, most pharmaceutical companies are appalled by these laws, whether they will say so publicly or not, because the cost of providing investigational agents for “right-to-try” is far more likely to lose them more money than they can recover by charging patients, because of potential delays and complications in obtaining FDA approval.

      1. James Peters says:

        What about off patent drugs that have been through Phase I and/or II trials but have failed to get funding for further ones?. I’m not sure how much drug companies pay for them but would doubt they give a lot for obvious reasons and if the government fail to step in then wouldn’t this be a good way forward?.

        1. WilliamLawrenceUtridge says:

          If I understand your comment, I don’t know if it applies. I don’t know if they would have been patented if they didn’t pass phase III trials. But there are trials of off-patent drugs, witness the ever-expanding uses of aspirin.

          And if a drug didn’t pass from II to III, that suggests they aren’t particularly good drugs for some reason – ineffective, or dangerous. Though it’s always possible they might have hidden uses. AZT was discovered decades before it was found to be useful as a treatment for AIDS.

  3. Jopari says:

    We can all see the blatantly misleading notion presented in this bill. But it’s so hard to sway people who have been swayed by emotional arguments rather than ones that rely on logic. The fact that this is targetted at the desperate only makes this harder.

    The government in these cases aren’t there to tell you what to do, rather what to avoid, and these are different things.

    P.s: Could someone verify that the probability of a drug passing both phase 1 and 2 is 21%? I’m not really sure about my math.

    1. KayMarie says:

      http://www.centerwatch.com/clinical-trials/overview.aspx has some general stats, with about 1/3 passing both phase I and phase II.

      I wonder if part of the problem is we science as finding answers to thing and generally people don’t realize how many failures there are to get every one right answer.

      For every one drug that gets final approval there are all those that failed not only at the human trial stage but failed along the way. Back to the just because there is an effect in a test tube doesn’t mean you can get that effect in live cells, animals or people. Each step along the way is another chance for failure.

    2. Michael says:

      http://patientnetwork.fda.gov/learn-how-drugs-devices-get-approved/drug-development-process/step-3-clinical-research

      70% from Phase I go on to Phase II

      33% from Phase II go on to Phase III

      25-30% from Phase III go on to Phase IV post marketing.

      As for what percentage of new molecular entities survive preclinical testing and enter Phase I, I do not know.

      1. David Gorski says:

        Having worked part time for a couple of years during medical school for Warner-Lambert/Parke Davis (before it got bought up by Pfizer) part time back in the 1980s, I have the impression the percentage is low. Lots of compounds are tested. Few have activity in cell culture and animal models with low enough toxicity to justify starting a phase I trial.

        Yes, I know that my revealing this tidbit will unleash the “pharma shill gambit,” even though it was nearly 30 years ago.

        1. WilliamLawrenceUtridge says:

          Probably, and probably without irony, by a Burzynski supporter.

          1. Windriven says:

            Oh, that would be ironic though the irony would likely be lost on the Burzynsiite. ;-)

        2. rork says:

          Knew it. That’s probably when they implanted the chip. Explains everything.

  4. Jopari says:

    Not to insinuate anything, but would it help if a bill was passed that limited the amount of profit made from a drug in %?

    Or would that simply mean cheaper drugs won’t be researched?

    1. TL says:

      With shrinking profit margins (from shrinking profits), the drug companies actually will research less drugs overall. It’s a problem they see over in Europe, because the drug industry is more heavily regulated there, and why so much of new drug research is started in the US and then brought over to Europe.

      I mean, there’s other issues to be had with having such large profit margins, don’t get me wrong, but drug development and manufacturing is a hugely expensive endeavor and there’s not much public funding for it. Which means that the large profits to be made in the pharmacy business is a main driver for the development of most new drugs.

    2. e canfield says:

      Not that I *know* but wouldn’t at least part of the price of a drug be in the amount of research put into it, and the difficulty in isolating or creating its compounds? The amount of time on the market probably has an effect, too. Aspirin, after all, is a very cheap drug.

  5. KayMarie says:

    I know it is an anecdote but all this right to try reminds me of the one project where I had to go over to the Clinical Research Ward of the hospital regularly.

    A cancer patient, in a trial everyone expected was likely to be pretty safe, died quite suddenly on the ward. Now it could have been anything else, may not have been the treatment, but this was one trial where the risk of death was considered from all the previous information to be really low.

    The amount of shock and devastation of the professionals working in that section of the hospital was palpable. Sure they work with a lot of ill patients, but usually death for those patients happened somewhere else at some other time. I can only imagine how that would be for a family especially if they buy into the false hope that “experimental” always means effective. Things are experimental for a reason, and part of that reason is we know there are things about the treatment we do not yet know.

    They often talk about how arrogant science types are, but while I am very clear that the things I know I do know. They are solid and clear and worth standing up for and defending. Science also show me how little of all there is to know that I do know. Open-minded does not mean you throw out the few things you do know because you know there are things you don’t know and can’t expect.

    1. Jopari says:

      I’m gonna quote Assassin’s creed here cause I liked the quote.

      “There’s a difference between having an open mind and a mind so open birds can shit in it.”

  6. Windriven says:

    “There are estimated to be 1,200 requests per year now, a number that is increasing, and it is uncommon for the FDA to deny a request for expanded access.”

    A citation would be useful here for both number of requests and number of denials.

    1. David Gorski says:

      Ask and ye shall receive. I forgot to include the link, but have now gone back and added it, along with a bit of additional text. Actually, I also noticed that the 1,200 figure was a couple of years old; it’s more like 1,000 expanded access applications per year now, but still with very few expanded access protocols and INDs turned down, generally 1-6 a year, with the exception of 2010, which appeared to be an outlier, at least in the last five years.

  7. Chris Hickie says:

    I live and practice pediatrics in Arizona, where the Goldwater Institute is headquartered. Arizonans will vote on a “right-to-try” law this November election as a ballot initiative put there by the Arizona State legislature ( http://ballotpedia.org/Arizona_Terminal_Patients'_Right_to_Try_Referendum,_Proposition_303_(2014) , see also http://www.azcentral.com/story/ejmontini/2014/05/31/right-to-try-referendum-arizona-goldwater-institute/9777457/ where Dr. Gorski is mentioned).

    Thanks for the update, David. It’s discouraging that people want to short-circuit the amazing work that’s been done battling cancer by oncologists like you. No one doubts they mean well, but they don’t grasp the harm they could be causing with these laws–both to patients and research.

    1. WilliamLawrenceUtridge says:

      Ugh.

      For example, Dr. David Gorski, a surgical oncologist and editor of the blog Science Based Medicine, said, “These (Right to Try) proposals are built on this fantasy that there are all these patients out there that are going to be saved if they could just get access to the medicine. In reality, the patients that might be helped are very few, while the number of patients who could be hurt by something like this are many.”

      He may be correct about only a “very few” patients being helped.

      But that is better than none.

      “A lot of us working on this are passionate about it because we know someone who potentially could have benefited from this sort of measure,” Riches said. “There is nothing worse than watching a loved one pass away before your eyes. If this can help just a fraction of desperate people avoid that, just a few, then it’s worth doing.”

      Because “few” isn’t despair. Few is hope.

      Way to miss the point. What if the many who aren’t helped end up dying because the drug they are taking has significant toxicities? Sure, one in ten gets to see their spouse or kid survive an extra month or six. Nine in ten watch their spouse or kid slip into a coma or have premature liver failure or dies of a clotting disorder a month or six earlier.

    2. David Gorski says:

      The ballot proposal in Arizona will, of course, almost certainly pass—likely overwhelmingly. There’s a chance of preventing the passage of right-to-try laws in a state legislature, but as a referendum a right-to-try proposal is far too easy for supporters to tug on the heartstrings with sad anecdotes of desperate patients to drum up support.

      1. Chris Hickie says:

        I haven’t seen any polling on it yet, but I’m sure anyone who comes out against it will be painted like you were by Mr. Montini in the local press. I feel this boils down to increasing scientific illiteracy in America–people have no idea how we got to where we are, and that leave them open to the quackery and woo.

        1. David Gorski says:

          I haven’t seen any polling on it yet, but I’m sure anyone who comes out against it will be painted like you were by Mr. Montini in the local press.

          Hence my rather depressing quips about being accused of opposing mom, apple pie, and the American flag while wanting to disembowel puppies…

      2. Kevin Jones says:

        Your analysis on a referendum is incorrect. It is always preferable and much cheaper to simply pass a bill through the Legislature. Keep in mind that a referendum also must FIRST pass through the Legislature and then must be approved by the voters. There are no exceptions to this.

        1. David Gorski says:

          Well, yes and no. I didn’t say anything about cheaper or easier, for one thing. I only said that it’s easier to persuade the electorate to go for a bad idea like this. It’s also easy for legislators who don’t want to take an unpopular stand just to punt and say, “Let the people decide!” rather than actually passing the law.

          1. Kevin Jones says:

            Again, you are incorrect. First, if it really was easier for legislators to “punt”, there would be dozens of issues referred to the ballot (there was only one in Arizona this year). Second, Right to Try has passed unanimously out of every state except Arizona, indicating it is actually more tenable for politicians to pass it as a bill rather than a referendum.

            1. David Gorski says:

              So why did Arizona legislators send right-to-try as a referendum for the voters rather than just passing it?

              1. Chris Hickie says:

                I still can’t get a reason why it was punted to voters instead of dealt with by those elected by the voters, but here is an interesting link of a news clip with EJ Montini who now looks extremely cachectic and not at all like I last remember seeing his picture that use to run in the upper left corner of his column (http://www.azcentral.com/story/news/politics/2014/05/13/arizonans-will-vote-right-try-drugs-measure/9026695/). This may explain why he is supporting right-to-try.

              2. David Gorski says:

                Perhaps Kevin, who was so anxious to declare me so gravely mistaken, can educate us: Why did the Arizona legislature not just pass right-to-try itself, instead of sending it to the voters as a referendum?

              3. Chris Hickie says:

                The only reasons I can come up with for this being sent to the voters are:

                1. The governor wouldn’t sign it into law if passed and the legislators didn’t feel like they had the votes to override

                2. Maybe the legislators considered it a “third rail” bill that many of them didn’t want passed but also didn’t want to be on the record as opposed to it given that there appears to be a lot of AZ voter support to it. This is shown the ballotpedia reference I gave above which notes “A poll done by Wilson, Perkins, Allen, which was cited by Chuck Warren and Tim Mooney, showed 79 percent of all voters supported the potential ballot measure before it was officially going to the ballot. The poll found 87 percent of Democrats expressed support and 64 percent strong support, while 7 percent opposed the ballot measure.” Those are pretty strong numbers–so the legislature punts to the voters and if this law turns out to be not so good, then the legislators can say “hey, you’re the ones who voted for this–not us”. FYI, when I look at the list of legislators who supported right-to-try as a ballot referendum, there are several pro-vaccine people in there. I’d like to think they could understand the risk of such a law as right-to-try.

  8. Windriven says:

    I have a certain sympathy for the motivations of the ‘right to try’ crowd, but it seems to me that there are parts of the equation that they generally ignore. Often it isn’t just the drug that is at issue but all of the costs of extra vigilance and monitoring that would be found in a clinical trial without delivering the benefit of valid clinical trial information. This would not be an issue in a society where medical resources were underutilized, but that is not the society we live in.

    There a finite number of medical professionals and resources and those resources are pretty much fully exploited. So when those resources are lavishly invested in a patient with a bleak prognosis it necessarily deprives others of access to those resources.

    I am reminded of the classic philosophy class problem of a train heading toward five people, out of earshot, and unaware of their impending doom. You can pull a switch that will divert the train onto a siding where a single person is walking and will inevitably be killed if you throw the switch. What do you do besides wish the decision wasn’t yours?

    We often speak of our rights to this and that without considering that with most rights come significant responsibilities. I suspect that I could mount a pretty good argument that a point comes at which we each have a responsibility to die. None of us likes this idea, especially when the responsibility falls on someone dear to us. But in a struggle for scarce resources how is it legitimate to invest hugely in a quixotic effort for one when it inevitably comes at the expense of some faceless group of others?

    1. rork says:

      The legitimacy may come from buying it yourself. Not sure about “lavish investment” in such cases. Eating wild-caught bluefin flown half-way round the world is ecologically idiotic, but some folks pay for it. I don’t feel I’m investing in them, though their indulgences may pick my pocket and break my leg in subtle ways. So I’m not saying you have no point, but who pays does make some difference.

      1. Windriven says:

        @rork

        “The legitimacy may come from buying it yourself.”

        I think there is a pretty good ethical case to make that there are limits to ” ’cause I can afford it.”

        That said, you and I are in agreement, financial ability does make a difference.

  9. Tsu Dho Nimh says:

    “Among drugs tested in phase II trials, only 30% go on to phase III”

    How many don’t make it from Phase I to Phase II?

    1. Windriven says:

      Michael above quotes 70% along with a link.

    2. Windriven says:

      Sorry TsuDho, I misread your question. 30% fail to proceed to Phase II using Michael’s source.

    3. Xplodyncow says:

      Roughly three-quarters of investigational compounds in oncology move from phase 1 to phase 2, but according to this 2007 review article:

      one half of the oncology drugs that entered the expensive phase III clinical testing phase never make it to US regulatory approval.

  10. oldebabe says:

    That is exactly what a lot of old people are fighting,, i.e. the` right to try’ anything to keep a person, willing or not, alive as long as possible. Maybe it makes some sense if the person is young and would have been, otherwise, vital, to have them live longer, but how long? and at what cost? and I don’t merely mean in $.

    I definitely think this `right to try’ is a very varied, emotional, dangerous, and certainly individually personal issue, and shouldn’t become generally legalized action.

    1. weing says:

      “That is exactly what a lot of old people are fighting,, i.e. the` right to try’ anything to keep a person, willing or not, alive as long as possible.”
      Anything? Regardless of plausibility? How about human sacrifice? At least you can harvest the organs.

  11. mho says:

    And in my opinion, the patient often comes to terms with death before the families, and neither the patients or their families understand the bitter devastation created by false hope until after they’ve experienced it.

    Cudos to Rep. Juan Mendez, who voted against the Arizona referendum in committee–his local press vilified him for supporting the FDA. Shame on the UColorado Comprehensive Cancer Center for failing to stand up and oppose the bill.

  12. Yodel lady says:

    I wish these bills would define “potentially life saving.” They imply there’s a magic treatment out there which will not only stop a degenerative disease in its tracks but also magically repair all the damage the disease has done. Most of us die because one or more of our vital organs has been damaged beyond repair. I don’t see living past that point as merciful.

    I can’t recall the exact wording of the Goldwater and Colorado bills, but don’t they include a paragraph giving a person power to make the decision on behalf of a child or an adult who has signed over power of attorney? That part really gives me the creeps.

    1. David Gorski says:

      Yes they do, as I recall.

  13. Kiiri says:

    This is definitely an emotional issue, which should necessitate looking at it logically. Having recently left AZ I fully agree that as Dr. Gorski and Dr. Hickie stated that it is very likely to pass overwhelmingly. Too many people view the FDA as “too slow” and always think there is some miracle pill in the pipeline that could cure them, their parent, their child, etc. I have sympathy for these families, I can’t even think about something bad happening to my small child without starting to cry, but I do hope that if something were to happen to him or my husband (or myself) I would have courage to not grasp at false hope. Excellent article, and one that needed to be written even though as you put it your opponents will no doubt vilify you as an evil despoiler of all things American (including puppies). Thanks!

    1. Windriven says:

      “Too many people view the FDA as “too slow” and always think there is some miracle pill in the pipeline that could cure them, their parent, their child, etc.”

      I suggest that this be named the Oz Effect in honor of snake oil shill numero uno, Mehmet Oz. It is tragic when trained professionals tout ‘miracle cures’ because it fosters exactly that belief: there are magic bullets and the one that is important to me is just around the corner.

      1. Jon says:

        A lot of it’s also because of all the jokes about how slow government offices are. (Think of the DMV or the IRS.) And of course you have to have 60 votes in the Senate, which makes the federal government seem particularly slow. So the “government is slow” meme has resonance.

        1. Windriven says:

          Jon,
          I’d certainly agree with those who think FDA sometimes too slow (and nearly always too bureaucratic) but that is ultimately an administrative rather than a legislative problem. One of my disappointments with the current administration has been its willingness sometimes to accept mediocrity in high positions.

    2. mho says:

      They also buy into the idea that FDA approval is too slow because they don’t understand the process at all, or why it takes a long time to approve new drug applications, or to convene IRB’s to review the standards of the trial ,or to accrue patients, etc, etc,

      The “x number of people will die” before this drug is approved has always bothered me. If you go back in time for any event like the approval of a new medicine, there will always be someone who died before the medicine existed.
      The debate about whether a drug “exists” before its approved for marketing is the pivot point of drug regulation.

    3. KayMarie says:

      Yeah, people complain the FDA is too slow up until the point where a drug is withdrawn from the market after approval. Then they switch gears and say the approval process is either too fast or way too reckless or both.

      1. simple-touriste says:

        That proves nothing.

        1. KayMarie says:

          The statement of my opinion of the views of others regarding the FDA process was not intended as a proof.

          Do you have a different opinion of how people view the process that might be interesting, enlightening or at least amusing?

          Because I know you may see this as an attack, but, if you would respond a bit more like you want to actually communicate with othe and a bit less like a bot failing the Turin test you might get a different response from people here.

        2. WilliamLawrenceUtridge says:

          The statement “that proves nothing” is an assertion. It literally proves nothing.

  14. Jann Bellamy says:

    As this post discusses, each state has introduced its own version of “right to try.” As far as I know, no two states have the same version. This illustrates another complication. With each state having different provisions regarding eligibility, informed consent, liability (or not) of physicians and drug companies, what state employees/agents can or can’t tell patients, and so forth, this will present a regulatory nightmare for participants. My guess is that there will be race to the bottom for patients — find the state with the most liberal requirements, including doctors who will fill out the necessary paperwork to gain access to these experimental drugs, and go there. Drug manufacturers will have to hire attorneys with expertise in the law of each state enacting “right to try” laws to help them figure out what the state law allows/doesn’t allow if the company wants to participate. Instead of one federal law that applies to all, there will be potentially 50 state laws, all with different provisions. Even if two or more states pass laws worded exactly the same, there is the potential for different interpretations of the law by the courts and different administrative regulations in each state. For example, one state might have entirely different requirements than another regarding informed consent based on existing statutory and case law, even if the “right to try” statute in each state has the same provisions regarding informed consent. This could mean a totally different result even if the statutory language is the same.

    1. Windriven says:

      Do any of these bills compel drug companies to participate? I can see pharmaceutical companies not wanting to touch this with a stick.

      1. Jann Bellamy says:

        No, and I don’t think any state could constitutionally require companies to provide these drugs. You are correct that the pharmaceutical companies don’t want to participate: “”We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process, which is not in the best interest of patients and public health,” said Sascha Haverfield, vice president of scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America.” http://www.pewstates.org/projects/stateline/headlines/right-to-try-for-the-terminally-ill-85899546708

        This news story, BTW, quotes David Gorski on the subject.

      2. David Gorski says:

        None of these bills compel drug companies to participate, nor do any of them provide for payment for experimental drug. The financial burden is entirely on the patient, including his estate after he dies. Few patients will be able to afford it, and those who can could well drain their bank accounts and leave their estates liable for any additional debt after they die.

    2. WilliamLawrenceUtridge says:

      With each state having different provisions regarding eligibility, informed consent, liability (or not) of physicians and drug companies, what state employees/agents can or can’t tell patients, and so forth, this will present a regulatory nightmare for participants. My guess is that there will be race to the bottom for patients — find the state with the most liberal requirements, including doctors who will fill out the necessary paperwork to gain access to these experimental drugs, and go there.

      My bets are on a battle between New Mexico and New Hampshire (Live free or die!)

    3. Yodel lady says:

      Am I right in understanding none of these state laws actually make it legal? The FDA regulates drugs. The states can pass these laws, but it seems to me they’ll have to fund a court battle that goes all the way to the U.S. Supreme Court if they actually implement the laws.

  15. mho says:

    I just googled this. New Jersey introduced a version on June 26.
    http://www.njleg.state.nj.us/2014/Bills/A3500/3474_I1.HTM

  16. CommonSenseBoulder says:

    re: “It’s also important to note that right-to-try laws are more about ideology than science. ”

    The problem is that you seem to fail to understand that your opposition to them is more about ideology than science. I am strongly in favor personally of science based medicine and suspect I would agree with most all your bashing of quackery. The question is whether or not it is appropriate to use the force of government to get people to do things “for their own good” based on what the government thinks is their own good (rather than merely trying to educate and persuade people to do what is “for their own good” as you see it).

    The problem many people see is that if once you say the government should be trying to make decisions for people “for their own good”, the government is used to decide what is “for their own good”. That leads to various groups trying to impose their views through the political process, from the religious right to quacks who want the government to license a particular type of alternative medicine practitioner (which grants them credibility due to people’s trust in government).

    Even though I may agree with your views on science based medicine, I am aware that even the currently accepted science is in a state of constant flux (as papers are overturned) and I question the idea of setting up any entity as the final arbiter of what is “objectively” in people’s best interest,even if I might agree with it. Your desire to impose your will on others seems to stem partly from ideology,but partly from matters upon which you exhibit a religious-like faith in things which run counter to academic study.

    Your apparent hope is that the government will decide that science is the best way to determine what is people’s best interest, *and* that government will do a competent job of assessing that. Unfortunately that seems to be exhibiting a naive faith in government which is undermined by scholarly work in fields that study the actual (and theoretically expected) operation of government as opposed to wishful thinking about how it works which should lead to skepticism of your “true believer” faith in government. Nobel prizes have been awarded for things like public choice theory and regulatory capture theory which explain that it should be *expected* that special interest groups (like alternative practitioners) to have undue influence and for laws&regulations to not necessarily be steered to benefit the general public good but will instead benefit those special interest groups (as you should be aware given the licensing of quacks in various states, which somehow doesn’t seem to undermine your apparent true believer attitude towards a government approach to enforcing science).

    Once you start trying to make government the arbiter of “science”, that science will be corrupted by the political process. I’ve posted before about alternative approaches for dealing with medical issues rather than getting government involved which is merely the uncreative simplistic approach of “have a problem, hand it to government”, those who actually spend a bit more time thinking things through and considering relevant scholarly work see other options to avoid questionable faith in that approach.. Partly since this is now an old page, and since I’ve other things to do, I won’t repeat that now.

    1. n brownlee says:

      So, how do you think a person who is seriously ill but whose ailment is likely treatable is supposed to know what treatment plant to use? I mean, given the fact that the woods are full of earnest but misguided and crappy naturopaths and outright liars and venal quacks like Burzynski?

      1. CommonSenseBoulder says:

        Yes, there would be some people who get treated by quacks.. as there are now. The problem is right now we have a monopoly government entity claiming to keep us safe, without the benefits of competing entities trying to find better ways to do so. That monopoly can be unduly influenced by the very quacks we would hope to protect people from, so they license quacks instead of cautioning against them.

        Patients would pick doctors they trust, just as they do now. Right now government pretends it keeps people safe, so people aren’t wary enough of potential problems since they think “if it didn’t work, the government would stop it”, so we wind up with myriad quacks out there. Worse still, they trust some quacks since they have a government endorsement via licensing.

        Without government claiming to keep people safe, they would look to private entities that compete to do the best job of doing so. For instance there might be an SBM certification organization which certifies doctors as having passed tests indicating they practice SBM we’d approve of. Another entity might certify quacks, which is a shame, but the SBM entity on behalf of its client docs would be motivated to expose the death rates and other problems of the quacks (perhaps with dues paid by the SBM entities).

        There might be different malpractice insurers then that give different premiums depending on the certification of the doctor, and different health insurers would cover different sorts of certifications.

        1. WilliamLawrenceUtridge says:

          The problem is right now we have a monopoly government entity claiming to keep us safe, without the benefits of competing entities trying to find better ways to do so.

          Really? What country do you live in? Quacks and scammers are, for all the attention they get here, a relatively tiny minority and the vast majority of the American public don’t actually use their services. I would never want to prevent people from seeking quacks, merely prevent quacks from committing crimes and prevent government funding from being spent on quacks. If the NCCAM were disbanded, then I’d be a happy man, but I wouldn’t change much else.

          1. simple-touriste says:

            You mean, there are no quack doctors selling flu shoots,
            HPV vaccines, hep B vaccines, and other useless/dangerous treatments to healthy people?

            1. WilliamLawrenceUtridge says:

              Vaccines for influenza, HPV, and hepatitis B are not quackery. Most quacks oppose their use, for a variety of spurious reasons, most related to contamination fears rather than medicine. These medicines are used on healthy people to keep them healthy.

              1. simple-touriste says:

                How are vaccines not quackery?

              2. Chris says:

                Because they work. If you have evidence to the contrary, please provide the PubMed indexed studies by reputable qualified researchers to support your claim.

              3. WilliamLawrenceUtridge says:

                Echoing Chris, because they work. Worried about smallpox lately? How about rabies? Polio? Are you continuously concerned about the impact of diptheria on the health of you or your children? What about AIDS?

                See, the reason why you worry about one of those conditions, and not the rest, is because of vaccines. They aren’t quackery.

              4. simple-touriste says:

                “Vaccines for influenza, HPV, and hepatitis B are not quackery”
                =>
                “Worried about smallpox lately?”

                You have nothing, don’t you?

              5. simba says:

                Projection at its finest.

                But yeah, the person who has absolutely no evidence to support their ideas and is frantically attempting to sling insults at their opponents is totally the one who makes sense. The people providing evidence ‘have nothing’

              6. WilliamLawrenceUtridge says:

                You have nothing, don’t you?

                You know what I don’t have? Smallpox.

              7. Chris says:

                Do I even bother asking this guy why the incidence of measles in the USA dropped 90% between 1960 and 1970? It does not seem to be the brightest of the hit and run posters.

              8. KayMarie says:

                @Chris, probably best not to ask.

                They have plenty of explanations how no vaccine in all of the history of the world has ever prevented one case of any illness ever.

                Most of which give me a migraine, or the uncontrollable giggles, or both. And giggling really isn’t fun when one has a migraine.

              9. Chris says:

                I’ve asked it several times. Many times they run away, and other times it has been very entertaining. I saved the best one:
                http://shotofprevention.com/2012/07/26/vaccine-questions-answered-the-real-simple-way/#comment-10735

              10. WilliamLawrenceUtridge says:

                Oh, I just thought of something else I don’t have – a smallpox vaccination scar, because the disease was driven extinct before I was born.

                Hooray!

              11. simba says:

                WLU- isn’t it odd, how Big Pharma didn’t make you get the smallpox vaccine anyway?

                It’s almost as if people are given vaccines for legitimate reasons.

              12. WilliamLawrenceUtridge says:

                Absolutely, for profi- I mean medicine.

                Ha, almost fooled me there into leaking the Great Pharma Conspiracy!

              13. simple-touriste says:

                “The people providing evidence ‘have nothing’”

                Which evidence?

                You are the typical worthless result of the education system.

              14. simple-touriste says:

                “They have”

                THEY

                They control minds with somethingtrails.

                They, they…

                You REALLY have ideations.

              15. WilliamLawrenceUtridge says:

                You are the typical worthless result of the education system.

                To a certain extent, yes in that my education did not include extensive discussion of cognitive biases that allow, almost force, people to refuse to admit error and place greater confidence in their opinions than they do in actual experts. But then again, I’ve spent my free time post-school learning about these things and recognizing them as errors in my reasoning. You are still a victim of them, and add a delightful layer of content-free and uncreative insults as if they butressed your case. I mean geez, you could at least make some claim of fact rather than merely asserting your correctness and insulting other people. You’re basically using a lengthier version of “nuh-uh, I’m smarter than you”. And you’re not.

    2. WilliamLawrenceUtridge says:

      Even though I may agree with your views on science based medicine, I am aware that even the currently accepted science is in a state of constant flux (as papers are overturned) and I question the idea of setting up any entity as the final arbiter of what is “objectively” in people’s best interest,even if I might agree with it.

      Straw man, as it assumes that the decision is made once and doesn’t change. Science changes as more evidence comes in. Indeed, your comment suggests some flavour of post-modernism, as if there were no way to make good decisions. There are better and worse ways to treat many illnesses, and your argument is akin to arguing that anybody should be free to try to fly their own plane their own way. Reality dictates that there is a limited number of ways you can design a heavier than air vehicle, and a limited number of ways diseases can be treated, experts are far, far, far more likely to understand those ways than amateurs, and the state has a role in vetting those experts because it’s laughable to claim that any single person can ever know enough to protect themselves from negative outcomes in all cases.

      Ugh, I hate libertarianism.

      Once you start trying to make government the arbiter of “science”, that science will be corrupted by the political process.

      Which is why you shouldn’t make government the arbiter of science. The government should be the enforcer of laws, rules, guidelines and restrictions based on science, while the science is based on the evidence (which is in turn based on government funding at least in part, a virtuous circle). Science does best when left alone to come up with best practices which are then used by government to shape behaviour.

      1. CommonSenseBoulder says:

        re: “Which is why you shouldn’t make government the arbiter of science. The government should be the enforcer of laws, rules, guidelines and restrictions based on science,”

        You seem to not grasp that you contradict yourself. If it is enforcing laws based on science, it needs to decide on what that science is. The naive fantasy some people have is that their conception of science will be determined in a reasonable fashion the way SBM advocates would like to see. The reality which should counter that naive theory is that obviously they license quacks in many states, since the “science” is being determined politically.

        As I noted, there are people who study how governments work in reality, not merely wishful thinking of the poorly informed as to how they should work. It is ironic that many that seem to pride themselves as supporting rational evidence based analysis of things seem to rebel against actually bothering to learn something about scholarly study of government operations. It is like dealing with uninformed people who push quackery that is emotionally appealing to them who don’t wish to bother learning actual science.

        re: ” Reality dictates”

        The problem is that people (even the most rational scientists) can have different assessments of what the evidence indicates reality dictates. More to the point, they can have different subjective assessments of things such as how much it is worth taking a risk when there is incomplete information.

        Unfortunately just as some religiously inclined people feel they know the ‘absolute” truth, some have the misguided view that their assessment of what is “for their own good” for others is objective absolute “truth” which they can rationalize forcing others go go along with.

        re: “Ugh, I hate libertarianism. ”

        Those who don’t wish to think rationally about public policy matters usually do since we base policy thinking on evidence and reason, not wishful thinking. Yes, we get it, you wish to impose your worldview on others through force of government and hate that anyone questions whether that is inappropriate, and rather arrogantly misguided to boot.

        Unfortunately just as most in the public who go along with quackery dismiss scientific critique out of hand, I suspect unfortunately the same is true of most pseudo-intellectuals who push government programs who don’t want to be bothered hearing about things like public choice theory. They don’t want to be asked to actually learn background material.

        I suspect part of this argument comes down to the fact that some people have a misguided view of their views of the world being the absolute truth based on a religious like faith they don’t seem to acknowledge. There are some of us who for instance call ourselves agnostics since even though we have no belief in a God, we rationally see no way to rule out certain conceptions of one as being possible, even if we think the odds are miniscule. Some others express a religious certainty about the non-existence of God and act as though certainty were possible, whereas we see that certainty as just as irrational as the certainty of believers.

        1. WilliamLawrenceUtridge says:

          The reality is generally most first-world governments do a reasonable job in large part of organizing societies. There are island ideological exceptions like climate change, but even science does pretty well under government. Generally the lives of citizens are better because of governments and private industry and personal effort will never meet all the needs of large groups of humans. A well-educated, dedicated public service makes most policies chug along nicely, irrespective the turnover and noise at the top, thankfully. Egypt knew this four thousand years ago.

          1. simple-touriste says:

            “The reality is generally most first-world governments do a reasonable job in large part of organizing societies”

            as with see with the money spent trying to prove global warming/climate change/global climate change, the money spent on useless renewables, etc.

            lol

            1. Chris says:

              I see the money spent on your education was thoroughly wasted.

              1. simple-touriste says:

                I see you are a retard.

              2. Chris says:

                Wow, a brilliant use of a word! Who knew? Dido I retard your mojo by noting your lack of substance?

              3. simple-touriste says:

                You never did anything.

                SHUT UP NOW.

              4. Chris says:

                Why? Be specific and give details.

              5. simple-touriste says:

                Go away.

                You are too dumb to use a computer.

              6. Chris says:

                Please provide the details on my intelligence and ability to use a computer. I am sorry, but I just cannot rely on the opinion of some random person who just posts short little rants. Explain exactly the errors I have committed, and how using words with more than three syllables is “dumb.”

              7. simple-touriste says:

                The details are in your inane comments on this webpage.

              8. WilliamLawrenceUtridge says:

                Obvious troll is obvious.

            2. WilliamLawrenceUtridge says:

              One doesn’t need to prove global warming, it has been amply demonstrated and is becoming increasingly precise in its predictions. The main political problem with global warming is that it is essentially a massive externality spread across nearly every human on the planet. Not one of us is directly impacted by global warming in a way we can directly perceive, yet all of us contribute to it. It’s exactly the kind of problem that requires a benevolent dictatorship ruled by my iron fist, rather than democratic states.

              Money spent on renewable energy is currently unviable. As gas gets more expensive, they will become more viable. I just hope this happens before the depletion of fossil fuels causes widespread famine.

              1. simple-touriste says:

                Yes, warmists predicted the “pause”.

                Except they didn’t.

              2. Windriven says:

                @simple minded touriste

                Is it your contention that we can push as much CO2 as we like into the atmosphere without negative impact?

                If not, then what is the appropriate limit? On what evidence do you base that number?

              3. simple-touriste says:

                No.

                All I am saying is that there is zero proof that CO2 is dangerous, and more CO2 is better for plants.

                Also, warmer is better.

              4. simple-touriste says:

                “It’s exactly the kind of problem that requires a benevolent dictatorship”

                The global climate change scam is just a way to remove freedom and have a global government.

                Except it isn’t going to happen. CO2 tax has been repelled in France and Australia, and other will follow.

              5. Jopari says:

                Way to remove freedom. *cough* go ahead, kill people, smoke in public places, fire weapons wherever you like. Some call this libertarian. I call this Anarchist.

                CO2 is harmful when it’s too much. It traps heat, the greenhouse effect, which played a part in our survival, keeping temperature relatively normal even at night, in excess leads to death of organisms which cannot cope with the change in heat, even 1°C is dangerous, as it affects weather.

                Plants use CO2 to make food, yes. When in excess they grow faster but are less nutritional. The greenhouse effect, stated above, would actually kill it.

                The reason why CO2 tax isn’t implemented is because a lot of people like you are global warming denialists.

              6. WilliamLawrenceUtridge says:

                All I am saying is that there is zero proof that CO2 is dangerous, and more CO2 is better for plants.

                Yes, that’s why they use it for euthanasia.

                Regarding plants, even assuming you are correct (which is questionable), humans aren’t plants. Now, admittedly I am completely anthrocentric here, but I think that extinction of all humans in order to favour plants is a bad thing.

                Also, warmer is better.

                Yes, that’s why you find so many living things in deserts, the hearts of stars and why dry heat sterilization isn’t a thing.

                The global climate change scam is just a way to remove freedom and have a global government.

                Oh, you’re that kind of credulous nutjob. OK, that frames things a bit. Look – in case you haven’t noticed, the “global government” is not happening and the fragile international bodies that exist are fraying, not strengthening. The WHO is having a horrible time eradicating polio because of local governments, the Kyoto Protocol was not endorsed and countries are very much not uniting under the banner of One World Order.

                Except it isn’t going to happen. CO2 tax has been repelled in France and Australia, and other will follow.

                That kinda undercuts your point, doesn’t it? Also, merely because a carbon tax has been rejected doesn’t mean anthropogenic climate change isn’t real.

                I know you think you’re a critical consumer and all, that you’re smarter than the sheeple and whatnot, but you really aren’t. You’re really just selectively ignoring evidence that contradicts your pre-existing beliefs and only attending to sources of information that you already agree with. It’s basically a circle-jerk for people who want an excuse to never have to change their mind.

      2. simple-touriste says:

        “Science changes as more evidence comes in”

        Why homosexuality is not a disease anymore, again?

        1. Windriven says:

          That was a political rather than a scientific classification.

          1. simple-touriste says:

            So now the classification is scientific?

            1. Windriven says:

              What classification do you mean? Human?

              1. simple-touriste says:

                The one where homosexuality is a disease and then it’s a non disease.

              2. Chris says:

                It was never a disease in reality. It just took political action to change some minds. Just like having a Y chromosome does not automatically make someone not understand math.

              3. simple-touriste says:

                And you are STILL not getting it.

              4. Chris says:

                Not getting what? The meaning of your short sentences that have nothing to do with the above article?

                Do provide us a scientific summary of how someone’s sexual orientation has to do with the legal issues surrounding access to medical nonsense in Michigan. Provide us citations that the LGBTQ community is promoting or restricting access to unverified treatments.

              5. simple-touriste says:

                You REALLY are stupid.

              6. Chris says:

                Then explain it all to me. Tell us exactly what the LGBTQ community has to do with the above article. Obviously you need to use lots of words and go into great detail.

              7. simple-touriste says:

                “Tell us exactly what the LGBTQ community has to do with the above article”

                YOU tell us.

              8. Chris says:

                “YOU tell us.”

                I am sorry, but it does not work that way. You brought up the LGBTQ community above, so you need to provide the reasoning of why it pertains to the above article.

                I personally think sexual orientation has no place in this discussion, but if you want to be taken seriously you need to intelligently defend your opinion.

              9. simple-touriste says:

                “I am sorry, but it does not work that way”

                I am sorry, but what you think is irrelevant.

              10. simba says:

                So are you saying you had no good reason to bring it up?
                You can’t be bothered to pretend you had one?

                Enquiring minds want to know!

                But yeah, the amusement that this is giving me aside, this is one of the classic examples where it is actually acceptable to not feed the troll. Because there is not a chance any lurkers would be convinced by their, uh, ‘arguments’.

              11. Chris says:

                Which is why I am asking you you clarify the connection between the LGBTQ community and use of untested treatments, especially in regards to the Michigan legislation. I am asking for your opinion on the subject.

                If you don’t like being asked questions, then you should learn to communicate more clearly.

              12. WilliamLawrenceUtridge says:

                And you are STILL not getting it.

                Two replies:

                1) You aren’t really saying anything, merely asserting some poorly-thought-out examples

                2) Your ongoing content-free comments suggests that the only thing we are “getting” is trolled.

        2. WilliamLawrenceUtridge says:

          Why homosexuality is not a disease anymore, again?

          Well one main reason is that there was an accumulating body of evidence showing that homosexuality was not inherently harmful to the psyche, but society’s reaction to and marginalization of homosexuality was, so massive numbers of medical professionals got together and advocated for changed based on their clinical impressions as well as the scientific evidence. It’s rather an example of how science changes as evidence comes in, and is also an example of how societies change (based on scientific and nonscientific factors). But there’s still dickish, ignorant homophobes claiming, wildly against the evidence, that homosexuality is an outright harm and inherent evil. My theory is because they’re afraid to be hit on the same way women are hit on (in this theory, men enjoy the assymetric sexual power found in conservative society that places them in a position to exploit and abuse women and take advantage of unquestioned gender power dynamics, with few consequences).

          1. simple-touriste says:

            “an accumulating body of evidence showing that homosexuality was not inherently harmful to the psyche”

            So very funny.

            You bigoted moron still don’t get it.

            1. WilliamLawrenceUtridge says:

              Your comments suggest that there is no “it” to get.

        3. Chris says:

          For the same reason all anti-miscegenation laws in the USA were repealed.

          1. simple-touriste says:

            Which as anything to do with science?

            1. Chris says:

              Did you even understand the word I used? It, along with restrictive marriage laws for homosexuals was as related to science as Nicholas Wade’s book A Troublesome Inheritance.

              1. simple-touriste says:

                Shut up and go away.

                You are too stupid to use a computer.

              2. Chris says:

                And yet, here I am. Explain the logic of if I am too dumb to use a computer, why I am able to communicate (or attempt to) with you via an internet network.

              3. simple-touriste says:

                You have been unable to read and understand what I say.

                That’s a fact everybody can see here.

              4. David Gorski says:

                Shut up and go away.

                You are too stupid to use a computer.

                simple-touriste: You are being excessively obnoxious. This is your only warning. Knock it off.

              5. simba says:

                Boring troll is boring.

                Simple-touriste is either the laziest troll in existence or just incapable of writing coherent thoughts that involve more than one sentence. Maybe they could have a point, somehow, but how would anyone see that when their sole ‘argument’ is ‘shut up’?

              6. simple-touriste says:

                @simba
                You cannot read and understand even ONE sentence.

                Moron.

              7. simple-touriste says:

                You are being excessively dense. This is your only warning. Knock it off.

              8. David Gorski says:

                simple-touriste has gone into automatic moderation. If he can keep a somewhat civil tongue in his head (metaphorically speaking given that this is a blog comment section), I’ll let his comments through. If it’s just more of the same, I’ll just ban him/her/it.

                I will say one thing: Lamest troll ever. Well, maybe not ever, but definitely the lamest troll we’ve had in a long time. Sorry it took so long to rein in him/her/it.

  17. Randy says:

    I think a terminally ill person can make the decision in whether or not acceleration, and even increased suffering, of a disease is worth even a .00001% added chance of a cure/treatment. You have no right to decide for individuals where their priorities should lie. FWIW, I generally agree with the POVs of SBM, and obviously don’t know anywhere near as much as you do, but this stance is extremely arrogant. I am 28. If you told me I could either painlessly decline for a year and die at 29 or have a 99.9% of living painfully for 6 months and a .1% chance of living a full life, I would gamble!

    1. WilliamLawrenceUtridge says:

      Part of the problem is that these drugs are portrayed, in this legislation, as miracle cures being kept out of patients’ hands. The reality is, these drugs often offer incremental benefits, if any, to pre-existing chemo. And as a skeptic, I would be far happier enrolling in a clinical trial, knowing that my death might mean someone else might benefit in the future, than indulging in the ultimately selfish decision to just hope I win the world’s least likely lottery.

      The reality is you probably don’t have that 0.1% chance, you might have a 50% chance of living an extra three months (though even that signal is pretty unlikely because it probably would have cropped up in phase II trials). Curative, targeted chemo drugs are vanishingly rare, basically nonexistent.

      1. Randy says:

        That wasn’t my point. My point was that it’s arrogant to decide for other people whether or not they consider potentially increased suffering and shorter life expectancy to be a “risk” worth taking for some possible benefit. Whether that benefit is 3 months of time or some tiny chance of a cure, only the individual should have the right to decide if it’s worth it. Saying that it’s “too risky” is my issue – many people (myself included) would not consider that to be a risk when you’re already going to die.

        1. KayMarie says:

          While I get the individual should determine their risk point of view (and that some people will always take the biggest risk in all situations) I think we really do need to make people fully aware of the risks an have procedures so people fully understand all aspects of the I’ll take any drug, do any surgery, take any risk if there is a 1 in a million chance of beating this (which may be the same chances of spontaneous remission).

          Some things might have some theoretical possibility of a hope of a benefit with very serious and devastating and common harms.

          Oddly often when people are given more options and have a deep discussion of the risks and benefits often people will choose more conservative treatment that extends the best quality of life for the longest. The do you want 6 good months with a slim chance of getting better or start 6 months of complete and total misery that will more than likely leave you disabled and damaged, with unknown chances of getting better, but it sure looked good when we gave it to mice and it didn’t kill any of the few usually healthy people who we gave it to in phase I.

          Sure you can’t protect everyone from the harm they will choose for themselves chasing some miracle that may not exist, but do we have to help them? and how much? an do you get to sue (or who pays to support you) if you end up alive but non-functioning because of something we didn’t know would happen to every 16th person who takes the treatment when we only ever tested it in 15 before you?

          We already have plenty of case studies of people who were so fearful of disease or so desperate for a cure they sought out damaging an probably un-needed treatments and ended up disabled or dead when a less is more approach may have ended up with a similar life span and preserved function.

        2. WilliamLawrenceUtridge says:

          That decision should be informed, and this legislation, by framing these drugs as potential cures, isn’t helping with that. It’s not arrogant to acknowledge that medical decision-making takes an incredible amount of background knowledge and treating everything as if it were a hail-Mary chance at a cure is bullshit.

          Patients don’t even understand the benefits of real chemotherapy, many times they don’t realize it is merely palliative. Add in the tantalizing belief and framing that these new drugs are miracle-working protocures and you’re going to be killing some number of patients early with adverse effects and toxicities.

          1. simple-touriste says:

            Yes, patients are stupid, you are enlightened, blah blah blah.

            Now, can you please stop yelling “science”?

            1. WilliamLawrenceUtridge says:

              Patients aren’t stupid, and I’m only enlightened to my inability to grasp complex topics. People think that their basic understanding of topics means they can quickly leap to the correct conclusion. This is the very essence of the Dunning-Kruger effect. I have now read sufficient popular and professional-level works on the topic to realize that I know so incredibly little about the extremely important details that there is essentially no chance of me ever mastering any topic to such a degree that I could even have an intelligent conversation with an actual expert. Which is why I delegate decision making to actual experts. The IPCC says anthropogenic climate change is occurring? I defer to them. The AMA, AAAS, EU and USDA say GMOs are harmless? I defer to them. My doctor says the best way to go is chemo and radiation? I defer to them. The only thing I am more informed in than most patients that is relevant is how much more doctors, experts and specialists actually know than I, and how I will never, ever be able to catch up. So I just shut up and trust them.

              While doctors have had their paternalism chipped away at, which is an excellent thing, they have also had their authority eroded, which is much worse. Google gives the illusion that you can become an expert quickly and easily, and that’s not how expertise works.

              People like you come along, with your cute little sound bites you’ve read on iconoclastic websites, and you think you’re enlightened. You’re not, you’ve merely fooled yourself into thinking somehow you’re smarter than all the experts. If you looked into the actual history of how homosexuality was removed from the DSM, if you looked at the counter-arguments to whatever climate change denial talking points have been fed to you, you’ll find that reality is more complex than the cute stories you believe.

              There’s a very good reason why actual experts who understand the data believe climate change is real. There are billions of reasons actually – because the individual data points lead to a theory that converges on a conclusion. The news, with its tendency to give equal weight to totally unequal players, systematically distorts your perceptions. By its very nature, which exists to sell advertising and thus prioritize controversy, ensures that you aren’t getting the real debate any more than watching Friends actually gives you a real sense of living in New York. Real New York has African Americans for instance. Even the occassional Hispanic-American!

              1. simple-touriste says:

                “There’s a very good reason why actual experts who understand the data believe climate change is real.”

                Yes: billions dollars are flowing, only if they say so.

              2. KayMarie says:

                As if oil companies have absolutely no money at all to throw at scientists?

              3. simple-touriste says:

                Yes, that’s part of the billions I just mentioned.

              4. MadisonMD says:

                Yeah that makes sense. The oil industry wants to strike the alarm so they can sell less product. I await the contorted conspirational rationale to explain why Shell Oil wants us to believe, erroneously, that burning their product is terrible for the environment.

              5. simple-touriste says:

                That’s a fact, assh0le.

              6. Harriet Hall says:

                @simple-touriste,
                If you think someone is wrong, you can explain why without resorting to offensive language.
                Please stop the insults or your comments will be deleted. Consider yourself warned.

              7. simple-touriste says:

                “@simple-touriste,
                If you think someone is wrong, you can explain why without resorting to offensive language.”

                What about the stream of attacks against me?

                You are pathetic.

              8. Harriet Hall says:

                The alleged “stream of attacks” against you have been mostly questions that you have failed to answer, and no one has used the kind of offensive language against you that you are using against others.

              9. Andrey Pavlov says:

                What about the stream of attacks against me?

                You are pathetic.

                We tolerate all sorts of trolls, delusionals, pro-CAM, anti-vax, and every other flavor of pseudo and anti science there is out there. The one thing that is not tolerated is a barrage of completely content free comments with nothing but personal insults.

                You can add a personal insult if you like, but that can’t be the only thing you bring to the table.

                I was going to give you a heads up but Dr. Hall already beat me to it, you’ve been that egregious.

                Honestly I’d like you to keep it up, since you have absolutely nothing worthwhile to bring here and it would be better for everyone if you were simply gone. The threshold for banning here is pretty darned high though which is why you’ve gotten away with as much as you have.

                But keep it up if you want to be banned. Think about it this way – in your deluded brain you’ll undoubtedly view it as a victory on your part so it is win-win for everyone.

              10. simple-touriste says:

                “if you looked at the counter-arguments to whatever climate change denial talking points have been fed to you”

                The only denial is denial of NO WARMING FOR 17 YEARS and denial of COMPLETE FAILURE OF MODELS.

              11. Windriven says:

                @simpleton

                “The only denial is denial of NO WARMING FOR 17 YEARS and denial of COMPLETE FAILURE OF MODELS.”

                While I am not accepting either of those assertions, I’ll ask again: do you recognize a limit to the amount of CO2 we pump into the atmosphere? If so, what is that limit and on what evidence do you base that conclusion? If not, well, have a nice day.

              12. simple-touriste says:

                “The AMA, AAAS, EU and USDA say GMOs are harmless? I defer to them.”

                I don’t.

                I listen to arguments AGAINST GMOs, and weight them.

              13. simple-touriste says:

                “I await the contorted conspirational”

                I am not your client.
                I am not your student.
                I am not your pal.
                I am not your pair.

                SHOW. SOME. RESPECT.

              14. simba says:

                Because nothing says ‘I respect you’ like repeatedly saying ‘shut up’.

                Hypocrisy at its finest.

              15. WilliamLawrenceUtridge says:

                What about the stream of attacks against me?

                Pointing out how you are wrong is not an “attack”. You may find it threatening, but that’s only because you have no response to them. As a result, you must categorize your interlocuters as enemies, “attackers” and bad people, so you are justified in not responding (or more accurately, not being able to mount a coherent, convincing, or even factual response).

        3. David Gorski says:

          Here’s the problem, as discussed in my post. The person asking for an experimental medication under “right-to-try” is not the only person in the equation. It’s a simple fact of drug development that manufacturing a new drug to pharmaceutical grade standards for the first time is expensive and often tricky, particularly for the newer “biologicals,” such as antibodies and other protein-based drugs. That’s why, most of the time, pharmaceutical companies only make up enough of the drug to supply the clinical trials needed to obtain FDA approval, plus a bit extra to cover unexpected wastage or loss.

          Patients requesting a new experimental drug under “right-to-try” would compete directly for drug with patients on clinical trials, meaning that the only ways for right-to-try to work would be for drug companies (1) to implement “on-demand” manufacture to cover the right-to-try requests and/or (2) to make up more extra drug at the time to cover possible right-to-try requests. This could be a particular problem for small biotechnology companies, which often can barely scrape together the funds from venture capitalists to do the necessary clinical trials to support FDA approval. Given that these small biotech companies are often the most innovative and least likely to be seeking approval for “me-too” drugs, the effect of right-to-try on the pharmaceutical industry’s already weak innovation could be significant if it spreads to too many states and the FDA does not intervene to say no.

          Given the incredibly small likelihood that individual patients will benefit significantly from using right-to-try medications and the not insubstantial likelihood of harm coupled with increased costs and potential slowing down of the drug development process even more, right-to-try is hard to justify.

          Here’s another issue. Given the likely large costs of right-to-try medications, which the patient and family have to bear in their entirety, only the rich or those who are willing and able to go on fundraising sprees (like patients of Stanislaw Burzynski) are likely to be able to chase even the elusive benefit of experimental drugs under “right-to-try.” Patients enrolling in clinical trials have the costs of the drug and any additional monitoring and care paid for as part of the trial. The specter of patients bankrupting themselves and draining their family’s inheritance is not unrealistic. Again, the very “libertarian” view is to say that it’s that person’s choice, but that person’s choice is not without repercussions to society, particularly (and most importantly) patients currently in clinical trials and the future patients who would benefit from the medication.

          Finally, expanded access programs already exist at the FDA, and applicants are rarely turned down if the company is willing to provide the drug. That is where the effort should go, because federal law trumps state law in this area. All the FDA has to do is to say no to a company, and right-to-try matters not at all. It’s not unreasonable to ask whether the FDA’s procedures and regulations are as patient-friendly (and doctor-friendly, given that it’s the doctor who has to fill out the forms to obtain a single patient IND under compassionate use) and to propose reforms, but state right-to-try laws are placebo laws. They make people feel as though they’ve done something, but in reality they don’t address the perceived problem and very well could make it worse through lack of effective action.

          1. simple-touriste says:

            “and applicants are rarely turned down if the company is willing to provide the drug”

            So, how could this law be a problem?

            1. Jopari says:

              Right to try laws are likely to produce unexpected ill-effects. Since phase I is no reasonable garauntee of safety. They use small amounts of people because if it is toxic, they don’t want to accidentally kill or cause harm to many people.

              Right to try laws also make the patient feel that it is legitimate to complain against drug companies who refuse to give the experimental drugs to them. Leading to less innovation for fear of the patients suing them, complaining, or after taking the drug, dying.

          2. WilliamLawrenceUtridge says:

            Given the likely large costs of right-to-try medications, which the patient and family have to bear in their entirety, only the rich or those who are willing and able to go on fundraising sprees (like patients of Stanislaw Burzynski) are likely to be able to chase even the elusive benefit of experimental drugs under “right-to-try.”

            I wonder about what kind of good could be done if this money were spent instead on clinical trials, or even basic bench research, instead of scams like this. If i develop inoperable cancer, I might wonder about fundraising to support a research chair or entity that would persist after my death with an aim of funding purely exploratory research or independent clinical trials. A much better use of money and the fleeting experience that is life.

            state right-to-try laws are placebo laws. They make people feel as though they’ve done something, but in reality they don’t address the perceived problem and very well could make it worse through lack of effective action.

            Nice one. I hope it catches on.

  18. Andy says:

    There is a lot of research suggesting that the FDA causes more harm than good (e.g., http://www.fdareview.org/). So I’m sympathetic to anything that would lessen its restrictions on drug use.

    1. simba says:

      What research?

      I’ve read the website, at best it seems to be a rather naive and idealistic view of the situation. Did they never stop to think there might be a reason people created organisations like the FDA in the first place, and why these organisations and rules occur in so many different countries?

      The situation with supplements at the moment is dismal precisely because they have less regulation than drugs: you see heavy metal contamination, they often don’t have what it says on the bottle. Suggesting that the FDA stop requiring proof of efficacy, stop requiring its regulation (allowing ‘competition’ somehow?) are just opening the doors to the kind of tragedies we saw before these regulations were passed.

      The whole thing is predicated off the assumption that clinical testing for efficacy before marketing kills people… somehow (not sure how they arrive at this conclusion except for possibly a vague idea that untested drugs are likely efficacious and reasonably safe, which is obviously untrue). But isn’t it more likely that, as is the situation with supplements now, the companies will sell whatever they please without a thought as to whether it’s efficacious? And why would most people bother to even test the efficacy (an expensive process) if they didn’t need to?

      I am open to the idea that the FDA is often toothless, may be incompetent etc. But I would strongly encourage readers of this website to go to http://www.fdareview.org, because it unwittingly makes quite a good case, for those who are familiar with the situation with supplements and the likes of Burzyinsky, for regulation of drugs. It also, notably, provides no viable alternative to the FDA which would prevent these problems. Caveat emptor, I guess.

      1. KayMarie says:

        The FDA is in that situation where if you slow the process of approval down way too much you do risk having people who could have been saved die waiting as you won’t get everyone that needs it into a clinical trial.

        On the other hand you go to fast and you risk thalidomide babies.

        Every so often I seem to remember the FDA working on either speeding up the process or slowing it down. How much is which politician had a family member on which side of the too slow/too fast issue I don’t know. I suspect that sometimes has as much effect as what is the best scientific answer we have at the moment. But there is awareness that both inaction and going too fast are dangerous.

        A lot of individuals tend to be more wedded to one side of the equation or the other. There are various reasons for that. You have a family member suffering from an illness nothing on the market is treating, you want them to approve more things faster. You have a family member maimed or dead because something that was approved got pulled from the market because to many people were hurt, you usually want them to slow things down and do more tests before letting stuff be sold.

        No matter how fast or how slow they go people will die because of their actions/inactions. If you can make everyone equally unhappy with the rate of approvals you’re probably close to the ideal rate that minimizes the deaths from both directions.

        1. simba says:

          I get that argument, and it’s a good point to make. But the website linked to is arguing that there should be NO requirements for clinical efficacy needed in order to produce and market a drug for anything, only testing for ‘safety’.

          1. KayMarie says:

            Even if you only test for safety, it still takes time. It will still be slow, there will still people dying while a drug goes through safety tests.

            Part of Phase II and Phase III is safety, even though they focus more on does it work. You won’t speed up giving the drug to hundreds or thousands of people by just dropping one or two data points. You won’t prove safety by giving it to 10-30 healthy people in a hospital setting and then proclaiming it safe for all people, either.

            Just because it doesn’t kill you, doesn’t mean it is a good idea to take it. Taking 1,000 useless things may be just as damaging as taking time to test to see if something works, if it prevents them from finding the 1,001 thing that is the only effective tool in the box because they died after only trying 523 of them.

            1. simple-touriste says:

              “Just because it doesn’t kill you, doesn’t mean it is a good idea to take it. ”

              So why not forbid vitamins/natural tonification/whatever Big Organic sells, then?

              1. Jopari says:

                Because as vitamins, they work. However, they don’t work as medicine, which is claimed. Before you ask why we don’t ban them from doing it, people have tried, and people have failed, thanks to quacks and people who, like you, think they know everything on the subject.

              2. WilliamLawrenceUtridge says:

                So why not forbid vitamins/natural tonification/whatever Big Organic sells, then?

                I think few here would want to outright forbid the sales of these products (I were, if I were dictator for life, but I’m convinced I would be a great benevolant dictator). Generally what is desired is a restriction or elimination of the authority attached to some of these products (i.e. what would be a secular equivalent of the Catholic church’s “imprimatur”) and above all an elimination of the use of public (and in some cases private, when discussing insurance companies) funds for both research and health care. And in an ideal world, a better grasp by the general public of why science is superior to other forms of knowing as-yet discovered, why “natural” isn’t “better”, and some actual scientific literacy such that people stop believing in anecdotes, irrespective their number.

                Forbidding is generally ineffective (witness prohibition and the war on drugs), particularly when you can just grow most of it. More resources are expended on unnecessary enforcement than you “save” in preventing people from accessing it. Since most natural products are simply inert, the only real harm is economic (unless someone uses the product as an outright alternative, in which case you’ve basically decided on uninformed suicide).

          2. simple-touriste says:

            “only testing for ‘safety’.”

            Not even wrong, meaningless.

            Safety is relative. No drug is absolutely safe.

            1. simba says:

              Good, go tell that to the people who wrote the fdareview.org website. I’m just quoting their position.

            2. WilliamLawrenceUtridge says:

              Not even wrong, meaningless.

              Safety is relative. No drug is absolutely safe.

              No shit Sherlock. This is recognized, anything that has a biological effect has multiple effects, this is recognized as part of toxicology and medicine in the form of “effective dose” and “lethal dose” curves, as well as the existence of phase I and II clinical trials.

              But the same could be said of anything – chiropractic causes cerebral artery dissection; acupuncture collapses lungs; hell, you can choke on homeopathic pills. It’s the risk-to-benefit ratio, in aggregate, that we are concerned with. Most SCAMs lack sufficient study to even demonstrate that there is any benefits, and often the basic science suggests that there can’t be any.

              You’re not saying anything new or startling to this, you seem to believe you have a rather sophisticated understanding of the issues, based presumably on reading some Mercola or Adams’ rants, but your points are rather hopelessly naive and even nihilistic. You seem to be asking, perhaps implying, that if medicine can’t be perfect, SCAMs are the answer (or that we should abandon medicine). Well, you are welcome to abandon medicine (be sure to eat a lot of plants and exercise a lot, these mainstream recommendations will offset much of your resulting morbidity) but your false dilemma doesn’t mean SCAMS actually work.

    2. WilliamLawrenceUtridge says:

      I love it when Libertarians come to play. It’s the very embodiment of Dunning-Kruger distilled into a political philosophy.

      The website you link to embodies the very core point of this post – that somehow there are “miracles” being kept from the consumer. That’s not how drugs work. Drugs are extremely hard to design in a way that makes them safe and effective, because the body is poorly-evolved to use drugs. The website presents the idea that somehow drugs are “good” and “bad”, rather than presenting a wide range of effects that can be good or bad depending on your intent, often existing in overlapping capacities. It pretends that the idea is simple and research is easy, that cost-benefit ratios are simple to calculate, that occult serious effects don’t exist.

      The FDA needs more authority, power and resources, not less, and if it didn’t exist then drug companies wouldn’t bother researching any of their molecules, they would just sell them to anybody willing to buy. Do you need an example of why this is true? Look at supplements. An essentially unregulated industry that produces products in the thousands with no guarantee that the bottle contains what it says on the label and no guarantee of effectiveness. Further, existing drugs would be sold and used willy-nilly for any purpose whatsoever, as in Toberdick’s use of anti-TNFA.

      1. simple-touriste says:

        Typical retarded progressive crap.

        1. MadisonMD says:

          Wow that’s a convincing argument. I’m sold on your point of view after such a witty riposte. WLU has too much depth and inconvenient complications in his argument for it to be acceptable to us simpletons.

        2. Chris says:

          Why do you think insults are a valid way to discuss issues?

          1. simple-touriste says:

            Why don’t you ask WilliamLawrenceUtridge, retard?

            1. Chris says:

              He actually makes sense. You do not.

              1. simple-touriste says:

                No, but you are too stupid to understand what I write.

              2. Chris says:

                Evidence please.

              3. simple-touriste says:

                YOU provide evidence, moron!

              4. Jopari says:

                Your comments are devoid of any evidence, while WTU has reasoning and logic, along with evidence.

                You make absolutely massive leaps of logic, come to think of it, no, you don’t. Because you haven’t shown anyone any proof you actually think.

            2. WilliamLawrenceUtridge says:

              No, but you are too stupid to understand what I write.

              Actually, there are several possible explanations here:

              1) You could embody the soul of the brevity of wit, but we, all of us, are collectively too stupid to understand your points, in which case you are wasting your time.

              2) You could be explaining what are clear (to you) arguments so incredibly poorly that nobody else can understand them.

              3) You could be a troll.

              I’m leaning towards the third, because usually the actual zealots are over-fond of plopping down predigested talking points fed to them by shills for natural cures. I don’t quite like those kinds of threads, they tend to be boring, and repeat arguments refuted (even here) many years ago. But they’re still more interesting than your frictionless points.

      2. Andrey Pavlov says:

        Oh yes, the conservative libertarians are the most entertaining of folk. They are such caricatures of themselves it is nothing more than amusing to me to watch them flail around.

        1. David Gorski says:

          There’s a reason that the prime mover behind right-to-try laws is the Goldwater Institute. I was told by a person I met who was at the hearing in Michigan that the Goldwater Institute flew a representative in to testify. No doubt it’ll do the same thing when the Michigan right-to-try bill goes before the relevant House committee in August. Right-to-try is a libertarian dream with the weakening of federal authority over drug approval baked into its very DNA. That’s one of its purposes.

          1. simple-touriste says:

            “weakening of federal authority”

            Or suppressing it.

    3. David Gorski says:

      There is a lot of research suggesting that the FDA causes more harm than good (e.g., http://www.fdareview.org/). So I’m sympathetic to anything that would lessen its restrictions on drug use.

      Oh, wow. There’s some seriously wrong stuff on that website. For instance, they propose going to a system of “voluntary assurance” using just company reputation and non-governmental middlemen akin to how manufacturers voluntarily submit products to Underwriters’ Laboratories, for its stamp of approval and allow those injured to sue:

      http://www.fdareview.org/voluntary_assurance.shtml

      In other words, it’s proposing to go back to the way things were, pretty much, before the Pure Food and Drug Act, when traveling snake oil salesmen could peddle their wares based on their reputation and pharmaceutical companies didn’t even have to test their drugs before marketing them. We all know how well that worked out. It’s an experiment that’s been tried before—and that’s failed.

      1. simple-touriste says:

        At least people would know nobody is protecting the public against snake oil.

        Currently, the government is PROMOTING snake oil, like many vaccines, the cholesterol drugs, undiscriminated cancer screenings…

        1. Jopari says:

          I left for a brief stint looking at other articles, and the entire comments section gets hijacked.

          Have you seen any of the articles about vaccines being safe? If there’s any quackery being promoted by the government, it’s the allowance of homeopathy, non-regulation of supplements, and other non-evidence based medicine.

        2. WilliamLawrenceUtridge says:

          Currently, the government is PROMOTING snake oil, like many vaccines, the cholesterol drugs, undiscriminated cancer screenings…

          How are vaccines snake oil? They drove smallpox to extinction. Measles is only endemic in regions where people don’t vaccinate. Polio is only found in a handful of countries. What vaccine is “snake oil”? HPV sure isn’t, it prevents cervical, anal and oral cancers. Influenza is imperfect but effective within limited parameters.

          Cholesterol drugs and cancer screenings are complex questions where the NNT or NNS are quite high. The science is continually being refined, I’m not sure how your knee-jerk, single-sentence assertions accomplish your apparent purposes of winning hearts and minds.

  19. Angora Rabbit says:

    As a long-time educator, I encounter some people who truly don’t understand. Some people who find it challenging to communicate. And some who derive visceral pleasure in deliberately antagonizing others in an attempt to direct attention to themselves.

    I am requesting a ban. The conversation is derailed, and I think we’re looking at a situation that is a lovely case study from DSM-V.

    I’d call him a troll, but that would be insulting to Michiganders.

    1. Windriven says:

      I second Dr. Rabbit. This person works to be unnecessarily insulting and obnoxious. I would prefer smearing him with honey and throwing him in an ant farm. But banning would be more legal and almost as satisfying.

      Note to simple-simon: if you’re going to be insufferably offensive, bring something useful to the discussion. But just dropping by to unburden yourself of venom and bile ain’t gonna cut it.

      1. simple-touriste says:

        Where are the proofs that flu, Heb B and HPV vaccines are useful and do what they claim?

        1. WilliamLawrenceUtridge says:

          I think you mean “Hib B” there champ.

          You could try searching for these terms on SBM itself, but the Children’s Hospital of Philadelphia has a great set of pages that explores the vaccines:

          - Hib
          - HPV
          - Influenza

          For Hib specifically, here you go:

          http://cid.oxfordjournals.org/content/53/12/1230/F1.expansion.html

          But none of this really matters – you don’t care what the evidence is. If you cared about it, you would seek it out, and you would recognize that there is no real question about the effectiveness of vaccines. You’ve already made up your mind, your challenges are empty. Your goal here isn’t to inform us or even yourself, it’s to feel like you’re speaking truth to power or something. It’s basically like masturbating with your brain.

    2. simple-touriste says:

      “I am requesting a ban.”

      Typical. You cannot “tolerate” the truth.

      I am requesting you go away.

      “that is a lovely case study from DSM-V.”

      You really are a scientivist.

      1. Chris says:

        “Typical. You cannot “tolerate” the truth.”

        Which is why we asked you questions. We expected that you would answer those questions, but just you just responded with random insults.

        How old are you?

      2. Angora Rabbit says:

        Q.E.D. I love it when my hypotheses pay out.

        1. Chris says:

          :-)

          I now kind of wish I had asked him if he had any opinions about homophones.

          1. Windriven says:

            I’ve no idea what they would be, but I’m certain that he has them and that they are deeply held convictions.

            1. Chris says:

              The words that trip you up, but not your ewe. Their presence is always there. Due to their existence you do make typos.

              Beware the homophone!

              1. Windriven says:

                That’s just sad. But you know … Salt Lake City.

              2. WilliamLawrenceUtridge says:

                The article says that the concept must be explained for any language that lacks homophones.

                I have a hard time believing that there is any language out there that lacks homophones.

                I call bullshit, I think the pedagogical gap is in finding examples from the students’ languages.

      3. Jopari says:

        Requesting people who don’t support you to go away? Even though they provide evidence and you don’t. I think you’ve got the positions reversed.

        You cannot “tolerate” the truth.

        Ahahahahahaha, reminds me of Steve. So I’ll tell you what I commented on him.

        Nice, messiah.

        1. Jopari says:

          To me at least, it’s interesting to note that though the most pathetic, simple-touriste is to me the most annoying.

          1. Windriven says:

            Interestingly enough, I found him among the least annoying because his comments were entirely vacuous. I fail to understand why so many engaged her/him for so long. I would read the comments and was reminded of a homeless woman I once saw in San Francisco, her nose inches from the fence around a construction site, shrieking streams of invective at unknown parties about unknowable wrongs, real or imagined. It was, in a word, pathetic.

            I am far more concerned about rational-sounding voices distorting information, or those with medical credentials trafficking in woo. That a$$hole Oz does more damage in a 12 minute segment than simple-Simon will do in a lifetime of flailing.

            1. Jopari says:

              I suppose it’s because my intentions are selfish. I aim for an intellectual argument. Simple touriste is not only unintelligent, he’s repetitive, and because I always aim to find the reasoning and counter it if it’s wrong, I get frustrated as he has no reason.

              Repeat as many times as he comments, and I get pretty annoyed.

              I think that those who are rational are easily swayed to logic, in dr Oz’s case I believe he knows them to be wrong, and for that I don’t find him annoying, just revolting.

              1. WilliamLawrenceUtridge says:

                As someone who also enjoys arguing, may I suggest an alternative when someone like simple shows up? Start going Freudian on them and try to suss out and describe their motivations to them. Keeps me entertained.

              2. KayMarie says:

                @WLU – that reminds of a friend of mine who used to have a phone number that spelled out a dirty word.

                After a couple of minutes of Freudian analysis the obscene phone callers would hang up on her.

              3. WilliamLawrenceUtridge says:

                Like all trolls, it’s no fun if you’re not offended.

  20. simple-touriste says:

    To every progressive moron here:

    You are deluded.
    You are sheeps.
    You are the typical 911truther, only for Big Warming.
    You are the typical Natural New follower, only for Big Medicine.

    1. Jopari says:

      To the (simple-touriste)s out there.

      You are mistaken.
      You are paranoid.
      You are the face of internet trolling, only for Teen Retard.
      You are the typical anarchist, only for Huge Chaos.

      Now that that’s off my chest. Global warming is real. It is caused by excessive greehouse effect, which helps keep the planet warm, when greenhouse gasses accumulate, they will keep the planet HOT instead.

      I don’t believe Natural New, for it’s an oxymoron, besides that, what I believe is that medicine works, they are chemicals, which previously we gained from herbs, however, since herbs are unpredictable, the chemical itself is better. We don’t believe in Big medicine, we believe in science, using reason, logic and calculation to come an agreement of what is true.

      If in your paranoid mind you see a massive conspiracy, you might be right, but would you mind showing us the hypothesis and the evidence before you ‘subscribe to it’ blindly, as you say we are doing to Big pharma? After all, even an idiot has to get something right after a fashion.

      1. Jopari says:

        Disclaimer: I use the term Teen retard to ascribe the reckless anti-establishment theme that is ascribed to teens, and also the failure in thinking skills ascribed to retarded persons. However I am not intending to insult either, I have sympathy for retarded persons and teens for not all of them are so. The meaning of the terms is purely from what generally is assumed of them.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>