Bill Clinton, Paid to Speak to Biotech Conference, Extolled $1000 Pill to Prevent “Liver Rot,” Despite Lack of Evidence that It Does

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Yves here. What won’t the Clintons do if the price tag is high enough?

By Roy Poses, MD, Clinical Associate Professor of Medicine at Brown University, and the President of FIRM – the Foundation for Integrity and Responsibility in Medicine. Cross posted from the Health Care Renewal website

In mid June, 2015, the Philadelphia Inquirer reported that former US President

Clinton was the keynote speaker at Klick Ideas Exchange, sponsored by Klick Health, a Toronto-based digital marketing agency, along with Veeva Systems and the Biotechnology Industry Organization. BIO, the Washington-based trade association, is holding its annual convention at the Pennsylvania Convention Center this week, attracting 15,000 people.

For his troubles he was apparently paid, however

his foundation did not respond to a request for information about Monday’s speaking fee. Hillary Clinton’s campaign also did not respond to a similar request. A spokeswoman for Klick Health declined to provide Clinton’s fee.

It is likely he was well paid, since his going rate is very high

disclosure forms indicated Bill Clinton received between $225,000 and $275,000 for each of eight speaches delivered between March 31 and May 14 of this year.

Clinton Endorses the Miraculous $1000 Pill

So what would a former president say to a bunch of pharmaceutical and biotechnology executives and their friends?  He chose to talk about the prices of new drugs:

Former president Bill Clinton said Monday in Philadelphia that  high prices for some medicines are hard to justify, and the biotech and pharmaceutical industries should try full explanation and disclosure to make their case.

‘Explain, explain, explain and disclose, disclose, disclose,’ Clinton said in a speech and question-and-answer session before about 200 biotech and health-care executives at the National Museum of American Jewish History. ‘Don’t expect everybody to love you, but at least they will hear your side of the story.’

Who could quarrel with more explanations and disclosures?  President Clinton did not stop there, and went on to opine about prices versus drugs’ purported value to patients, with a focus on new drugs for hepatitis C.

Clinton pointed to new hepatitis C drugs, Sovaldi and Harvoni, which are sold by Gilead Sciences for more than $80,000 for a 12-week program of treatment. Those medications often cure a disease that can cause liver disease and eventually lead to transplants or death, which are expensive, too. But the sticker price on the drug has caused a backlash by payers and patients.

Who wants to let somebody’s liver rot? Nobody,’ Clinton said. ‘Who’s got $80,000 to spend? Not many. And if you’re a small businessperson and you’re in a small pool [of employer-based insurers], are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them.’

So the implications are clearly

–  President Clinton thinks it is reasonable to charge $80,000 for a course of treatment with Sovaldi, but society needs to figure out who will pay
–  Apparently he thinks it is reasonable because without treatment, patients with hepatitis C will get “liver rot,” but the drugs will prevent that.

The Evidence Fails to Support the President

President Clinton’s preparation for this talk apparently did not include speaking with someone who had critically reviewed the best evidence from clinical studies about hepatitis C, and the effects of new drugs on it, particularly, the effects of sofosbuvir (Sovaldi.)  Neither did President Clinton read Health Care Renewal.

If he did, he would have found out starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as “cures,” at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)

–  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
–  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
–  There is no clear evidence that “sustained virologic response,” (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure.
–  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included

– a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
– an article in JAMA from the Institute for Clinical and Economic Review (1)
– a report from the Center for Evidence-Based Policy (link here)
– an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

But because, as we noted here, concerns about the lack of evidence in support of Sovaldi and its new competitors have been anechoic, it might not have been so easy for President Clinton to quickly determine if hepatits C usually causes “liver rot,” and whether Sovaldi almost always prevents “liver rot,” and hence might just be worth $1000 a pill.

Hype Wins, Logic and Reason Lose

Unfortunately, the problem is not merely that the BIO folks hired a celebrity to tell them what they wanted to hear.  President Clinton has a lot more gravitas than a Hollywood star, even given his famous equivocation about the meaning of the word “is.”

More unfortunately in this context, President Clinton is also the husband of the current front running Democratic candidate for President.  Should former Senator and Secretary of State Hilary Clinton win the election, would her health policy choices be influenced by the (probably erroneous) belief that the current extremely high prices of medical treatments, particularly new drugs, are reasonable because of their magical curative properties?  Furthermore, President Clinton is also the Founder and presumed current leader of the the Bill, Hilary and Chelsea Clinton Foundation whose goals include working “to improve global health and wellness,…”  Is this work based also based on the assumption that the astronomical prices of new drugs are justified by their miraculous powers?

Thus President Clinton’s apparent endorsement of the wonderful powers of Sovaldi, despite the lack of good evidence underlying them, may carry a lot of weight.

Conclusion

How distorted is health care these days.  Misinformation, even disinformation seems to dominate evidence and logic.  Concerns about health care dysfunction are suppressed by the anechoic effect.  Perhaps inspired by the generic managers who now run health care organizations, everyone seems to have become a health care expert, and so the reach of viewpoints on health care seems to be more about the celebrity of their proponents rather than their knowledge, or the logic and evidence underlying their views.

As a start, true health care reform has to somehow liberate good clinical evidence from where it has been hidden, and encourage logical discourse over marketing, public relations, hype, propaganda, and disinformation.

If only someone who knows something about health care, logic and evidence could get their views heard by ex Presidents and others who dominate our 24/7 conversation.

References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.

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32 comments

  1. human

    I’d call him the obvious, “snake oil salesman,” but Slick Willie really does suit him to a T.

  2. Praedor

    And consider how well the Clinton’s love of Big Pharma and its BIG prices dovetail with TPP and TTIP with their extortion-protection contents for Big Pharma.

    I despise Big Pharma. MOST of the costly research is NOT done by them. Most of it is done on the public dollar (via grants) at public universities by grad students and postdocs. We already paid most of the background research fees when we funded the grants. Big Pharma is merely taking another drink at the public trough. Yes, the actual process of getting a drug to market is long and costly AFTER the basic and discovery research (conducted by grad students and postdocs) but that is something to be fixed within the FDA process and NOT justification for extortion from the dying public for massive profits as fast as possible.

    Reforms are needed to reign in Big Pharma. NO claims of miracle cures without 3rd uninterested party verification. NO marketing to the public at all until a new drug proves that it is actually better than what’s already cheaply available. NO bankrupting pricing even if they stumble upon a nice new working drug. We need to put a hard profit ceiling in place like we have with insurance companies through Obamacare (what is it, 80-85% of all money in must go towards benefits rather than CEO pocketbooks?). A 15% profit ceiling seems like a nice number to start with, distributed over the span of a drug’s patent period of 20 years, hard limit, say.

    1. jrs

      At a certain point of $1000 pills (even the ones that work and are lifesaving) that insurance won’t cover (and insurance isn’t even in the wrong here, it would blow the cost of healthcare through the roof, as such a thing would destroy even state systems – seeing insurance rather than pharma and hospitals as the main villain may have been a big mistake), are people even going to see any nuance or just start saying “I don’t care anymore, it’s not worth it, why doesn’t the government fund the research all the way through to the pill itself so new medical discoveries can at least be widely available instead of strictly rationed for the super wealthy”. EVEN if there were less medicines introduced but those there were were actually readily available as opposed to just rationed to multi-millionaires it might be an improvement.

    2. digi_owl

      In essence USA quit being a industrial nation somewhere in the 80s, and instead attempts to be a rentier nation. This by renting out “knowledge” to other nations…

  3. Denis Drew

    Sovaldi: Hepatitis C can be wiped out for $300 billion (that’s a “b”) — the same amount we now pay for all other prescriptions. Cost to manufacture: one-half a billion dollars.

    Now comes: “Amgen scores a victory for PCSK9, halving cardio risks after one year” ” … new [cholesterol] drugs could eventually add as much as $150 billion to the national health-care bill.” http://www.wsj.com/articles/new-type-of-cholesterol-drug-could-prove-costly-1426817085
    http://www.fiercebiotech.com/story/amgen-scores-victory-pcsk9-halving-cardio-risks-after-one-year/2015-03-15

    The list of new breakthroughs keeps growing — we’ll all be mortgaging our homes to live:
    (6/19/25) “And they also found that azoramide greatly improved blood glucose levels in obese mice and mice with type 2 diabetes. They showed this improvement was the result of two things: better functioning of insulin-producing beta cells and greater insulin sensitivity in tissues.”
    http://www.medicalnewstoday.com/articles/295623.php

    Simple solution: government sets drug prices. If our manufacturers don’t like it we can find plenty in the poorest parts of the Third World who will be glad to have our business. Simple way to win over Congress: re-unionize the US overnight. How to re-unionize overnight: progressive states simply have to make union busting a felony (invoking federal and state [33] RICO prosecution). All very simple. All other market muscling and fixing schemes have been heavily penalized since forever. Criminalizing labor market fixing is an idea whose time is at least 100 years past due.

    1. Denis Drew

      Today’s potential medical bankrupter — until gov sets prices — imagine if Samsung owned the sole patent for television, what they would charge:

      ‘Artificial pancreas’ holds promise for easier control of type 1 diabetes
      http://www.medicalnewstoday.com/articles/296240.php

      Got to start following Medical News Today online — endless supply of new bank breakers under current government monopoly making assembly line.

    2. Ishmael

      Okay, you really lost me there. How do we go from govt sets drug prices (by the way you seem to think that govt does things correctly and there is no corruption or cronyism there — I laughed my ass off at that assumption) to re-unionize and felony to break unions. Huhhhh! I still remember dealing with the health care plans for the teamsters in Las Vegas. The administration of the health care plans was so corrupt and riddled through with the Mafia that the federal govt was running the plans.

      By they way, one problem with dealing with the federal govt is there is no such thing as an error with the govt (even if it is on their part) it is automatically a felony.

      1. redleg

        Single payer. Best prices for consumers of medicines is by a monopsony. Single payer would do the trick.
        It also works for insurance – one buyer that represents everyone is the only way to get the absolute lowest premiums.
        Gresham’s law still can apply, of course.

    3. Gary Orton

      Denis’s $300 billion estimate for Sovaldi to treat for three million infected with HCV in the US is correct, as is his statement that this would equal the total amount spent on all other drugs in the US. Sovaldi, however, is just the canary in a drug pipeline based on unsustainable pricing policies. Spending on all specialty drugs is estimated to more than quadruple by 2020, rising from $87.1 billion in 2013 (25% of all drug spending) to $401.7 billion (50%). This is a continuation of a trend; for example, prices of cancer drugs have soared from a median monthly cost (adjusted for inflation) of $129 in the 1970s to $9,905 currently. http://shea.senate.ca.gov/sites/shea.senate.ca.gov/files/awsarepptsenhealthhearing_final2.pdf

      We need a new drug pricing policy.

  4. flora

    “Clinton Endorses the Miraculous $1000 Pill

    What a setup for an editorial cartoon: Bill as W.C.Fields in vest and bent hat hawking patent medicine.

    1. jrs

      Yea but the article is really too hard on Clinton probably. Ok imputing corruption to the Clinton’s is hardly difficult and I’m hardly saying anyone should vote for a Clinton. But beliefs that the drugs work is WIDESPREAD. This is what newspapers report about Harvoni

      http://www.latimes.com/business/hiltzik/la-fi-hiltzik-20150621-column.html#page=1

      So if belief that the drugs work is kind of what everyone (who is not a biomedical scientist or who hasn’t done serious research into the issue) believes, sure Clinton is corrupt, but maybe he’s also just as duped as anyone.

      Somehow I don’t think whether the drugs work is even the issue, of course any medical system imaginable that wasn’t 100% corrupt would want drugs that work, but is $1000 a pill justifiable for a pill that works? In my view not only no but @#$# no. And society must somehow find a way to support pharma’s $1000 pills even if they work. But even if Bill miraculously morphed for Bernie here and said “through single payer”, it wouldn’t work. Does any single payer system on earth allow drug prices to be what they are in the U.S.? I mean is there any proof that single payer could work with $1000 pills?

    2. NotTimothyGeithner

      Is there any story that exemplifies the Clinton baggage and mystique more than this?

  5. tegnost

    Reminds me of all those old timey movies where the snake oil salesman rolls into town

    1. MaroonBulldog

      Clinton talking rot: Nothing new there. Too bad he had to drag the liver into it.

  6. mass

    Hepatitis C treatment is a political football. There is rightly a scandal over how much these drugs cost (capitalism). And I suppose it could be argued that society as a whole should not bear the cost of treating 3 or 4 million people, no matter what disease they have (liberty). And certainly Bill Clinton is a shill of the first order (smarminess).

    But the idea being floated here seems to be that hepatitis C is not worth treating at all, because it’s not uniformly fatal. And that sustained viral response, which was good enough to evaluate previous treatments, is no good anymore. The citations for some of the dubious claims here are either self-referential or don’t support those claims. Many of the citations claiming insufficient research are more than a year old.

    Googling medical journals and cherry picking facts is the lowest form of blogging. Seems like we went past a lot of reasonable points right into the swamp. I can only hope that the gloomy predictions offered on NC about TPP and Grexit will turn out to be as well researched and impartially presented.

    1. Dugless

      You are correct. My wife is a hepatologist who treats many patients with hep C. She states that the evidence in the medical literature pretty much unequivocally supports SVR being equal to cure. At least if you have SVR, your mortality from hep C complications is similar to the public at large. So it may be true that this drug is unconscionably overpriced but it is not really debatable that SVR is a good thing in patients with hep C.

    2. jrs

      With the TPP, of course anyone only has what was leaked which few have read in it’s entirety and few of them are lawyers, but there’s kind of a horse sense to it, how could an entirely secret agreement that only corporate representatives have seen but not our “representatives” or the people be good? And it’s kind of hard to believe it could.

      I’d like to believe the TPP was less bad, in the same way I’d like to believe climate change wouldn’t be so bad (but meanwhile the world burns now) so …

      But yes I’ve heard the pills work previously, but regardless $1000 pills is capitalism far beyond the point anyone should allow it period.

    3. Roy M Poses MD

      mass,

      There was not room in this post to discuss the whole literature on hepatitis C and its treatment. You might want to look at the other posts I linked to, and then the actual articles they cited. And there are plenty more articles than the ones I cited, but I was writing blog posts, not systematic review articles.

      The issue is not that “hepatitis C is not worth treating at all, because it’s not uniformly fatal.” That seems to be a straw man argument on your part.

      The issues include how people (doctors and patients) should trade off the known side effects of drugs, the possible side effects of new drugs which have not yet been discovered, versus the way less than 100% likelihood that the drugs may provide some benefit; why no one has done a long-term study to see if these expensive, heavily marketed drugs for hepatitis C actually do decrease the likelihood of severe hepatitis, cirrhosis, liver cancer, or premature death from liver disease.

      Many people, including some pretty good clinical epidemiologists/ evidence-based medicine experts, NEVER thought that SVR was good enough to evaluate treatment. Its a surrogate variable that only somewhat predicts clinical outcomes. But the FDA seems to have allowed the drug companies to rely on it in their clinical trials, and again never seems to have required long-term trials to see if these drugs improve clinical outcomes. If you know of any good clinical evidence to the contrary, please enlighten us.

      Yes, some citations claiming insufficient research are old, and I can find them going back into the 1990s. And some of the citations I provided are quite new. Yet again, the long-term trials to assess clinical outcomes have NEVER been done, even though their lack has been recognized for years.

      I will leave to others to decide who has been Googling medical journals and cherry picking facts…

  7. Gary Orton

    Bill Clinton scratches his head about who should pay the $84,000 for a course of treatment of Sovaldi. Dr. Poses wrings his hands about “misinformation, even disinformation,” about the benefits of using the drug for all hepatitis C patients. His solution: “liberate good clinical evidence from where it has been hidden, and encourage logical discourse over marketing, public relations, hype, propaganda, and disinformation.” Good luck on that without changing the perverse incentives provided drug companies by patent monopolies.

    These incentives will continue to cause inaccurate marketing and disclosure of information, including deliberate actions motivated by profit. Research conducted by Dean Baker found harm caused by such incentives from 1994 to 2008 for just five drugs (Vioxx, Avandia, Bextra, OxyContin, and Zyprexa) was $27 billion a year (in 2014 dollars), “roughly the same amount as the industry claims to have spent on research over this period.” http://www.cepr.net/publications/op-eds-columns/drug-patents-are-bad-for-your-health-the-cost-of-mismarketing

    Patent monopolies also wildly inflate prices. As Dean says, there would be much less hand-wringing if the issue was paying $900 for a course of treatment using a generic version of the drug, as is currently done in India. Alternatives to patent monopolies could provide effective drug research. Joe Stiglitz has proposed a prize system. The US, through the NIH, already spends 30 billion a year on biomedical research. It could be tripled.

  8. Herb

    I don’t understand the Clinton criticism. The drug was approved by the FDA for Hep C treatment and that’s where the blame should lie, not with Clinton. Do we really expect him to second guess the FDA before he gives a speech – in an ideal world perhaps but not in the real world.

    The drug should never have been approved given the evidence base or lack thereof.

    I hope drug effectiveness becomes an issue in the 2016 campaign though that’s a longshot.

    1. Yves Smith Post author

      Clinton has a ginormous think tank that he heads. He was perfectly capable of having someone on his large and no doubt talented staff do some poking around, but it was apparently more attractive just to take the speaking fees and not do the sort of checking you’d expect someone of his stature to do to make sure he was not taking a reputational risk.

  9. SteveLaudig

    The Final Grift.. Bill and Hill will always shill. I’m sure there’s a limerick out there but I can’t find it this morning. Is Sanders popularity a surprise? When authenticity shows up the light shines on [and through] the inauthentic.
    If Hillary wins, who protects the interns?
    cheers. Go Bernie.

  10. nat scientist

    Anyone who’s selling a “more perfect” union will make you believe that there is an American pi which can make a “more perfect” circle.

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