Wednesday, July 01, 2015

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

What were they thinking?

Former President Clinton Talkes to Pharma and Biotech Executives

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.  


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. 

ADDENDUM (2 July, 2015) - This post was republished on the Naked Capitalism blog

See also comments by Micky on the 1BoringOldMan blog.

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.


Anonymous said...

Presidents like HIT costing $billions, also, sans evidence.

Anonymous said...

You're probably getting a bunch of flak from Clintonistas.