Tag: syndicated

Blog Posts (613)

April 18, 2014

Genetic Testing in Torts Litigation – Justice or Injustice?

Maya Sabatello
April 18, 2014

The History of US Drug Policy Since the Cold War

One theme in HOOKED is the need to see today’s relationship between the medical profession and the pharmaceutical industry in proper historical context. When HOOKED was written, I had to struggle, as a non-historian, to try to put together an adequate historical background picture. Since then, useful books have appeared that make that task easier.

Prof. Dominique Tobbell of the University of Minnesota has contributed Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences. She makes two basic points about our struggle today to reform drug policy, in a direction that brings pharmaceutical manufacture, research, and marketing better into line with public health and public interest. The first point is that this struggle is not new; basically the same issues have recurred ever since the end of World War II. The second point is that the pharmaceutical industry has never waged this battle against what it considers burdensome government regulation on its own; it has always had allies among medical organizations and academic physicians who had a strong interest in defending the status quo.

Prof. Tobbell points out that by the mid-1960s, the drug industry had achieved an impressive enough record in fighting off government regulation that the tobacco industry turned to Pharma for advice and help. During all those years, medical practitioners were primed by the AMA to fear the bogeyman of socialized medicine, and academic physicians worried about excessive federal influence over research policies. It was easy to get these fellow travelers on board when Pharma wrapped itself in the mantle of “free enterprise” and presented a less-regulated industry to Congress and to the American public as a bulwark against communism.

In the heady postwar days, when everyone was thrilled with the tremendous advances in antibiotic, hormonal, and psychiatric therapy, the climate of ethical thought was quite different from what reigns today. For example, Prof. Tobbell describes the efforts at the University of Pennsylvania to create a training program in clinical pharmacology in 1955: “Norman Topping, the university’s vice-president in charge of medical affairs, sought to create an institutional structure that would ensure the program could be responsive to the industry’s needs. Indeed, Topping believed the new program should function, essentially, as a service unit for the drug industry.”While today such a stance would at least raise some eyebrows, apparently no one gave it a second glance in the 1950s.

Similarly, when the National Academy of Sciences formed the Drug Research Board in 1963, to help conduct the massive amount of research required to implement the new FDA amendments Congress had just passed to require that drugs be shown to be effective as well as safe, some in Congress looked askance at the inclusion of scientists with strong industry ties. The Board basically pooh-poohed any such concerns, insisting that it was a great advantage to have these scientists as part of the effort because of their inside knowledge and policy smarts. Conflict of interest—who, us?

One theme that I have addressed at some length in earlier posts—most recently:
http://brodyhooked.blogspot.com/2014/03/a-bit-of-history-louis-lasagna-and.html
--is the impact of the ideology that I prefer to call economism and others call neoliberalism on today’s Pharma policy. Prof. Tobbell was kind enough to respond to an e-mail query, since I noted that the word “neoliberalism” is virtually absent from her volume. Consistent with her thesis, she states that the anti-government-regulation, pro-free-market stance that the drug industry has adopted was present all through the 1950s and 1960s. When neoliberalism/economism entered the US political discourse in a big way in the middle to late 1970s, Pharma was happy to hitch its wagon to that rising star, just as it was happy to jump on the anticommunist bandwagon in earlier decades; but one cannot say that neoliberalism played a major formative role in Pharma’s policy or strategic thinking.

Dominique A. Tobbell, Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences. Berkeley, CA: University of California Press/Milbank Books on Health and the Public, 2012.
April 17, 2014

Yet More on Statins and the Recent Guidelines

Not to make this blog the “Statins Blog” or anything, but since I have been on a tear regarding the unfortunate ACC/AHA guidelines on cholesterol:
http://brodyhooked.blogspot.com/2013/12/more-on-cholesterol-guidelines-cochrane.html
--and since my pals at Primary Care Medical Abstracts keep feeding me more ammunition, I wanted briefly to mention two more commentaries that take aim at the guidelines (subscriptions probably required to access).

First, John Abramson, who’s been mentioned here numerous times, and his colleagues wrote in BMJabout the CTT meta-analysis, on which the new guidelines heavily relied. They challenged the rosy picture painted by the CTT by drilling down and recalculating the CTT’s own numbers. The CTT, recall, claimed that if one carefully summed the data from numerous previous clinical trials (none of which showed any reduction in all-cause mortality from taking statins for primary prevention), you could see that statins in low-risk patients save lives and prevent strokes and heart attacks.

So when Abramson’s team went back and crunched the numbers themselves they found, for the populations included in these studies:

  • No significant difference in all-cause mortality
  • You’d have to treat 140 low risk patients for 5 years to prevent one heart attack or stroke
  • The studies overall either fail to report any adverse reactions to statins, or else report adverse reactions at a much lower rate than has been shown in independent (non-manufacturer-sponsored) studies. If the rates of adverse reactions in the independent studies are valid, it is very likely that the chance of suffering an adverse reaction from a statin is notably greater than the chance of preventing a bad outcome.
Skip now to another old acquaintance, John Ioannidis, commenting more recently in JAMA. Ioannidis addresses the new guidelines head-on and is more interested in two issues. One is the total global impact—he calculates as his title suggests that if applied across the world, the “statinization” of humankind would result in at least 1 billion folks being told they needed statins, which would be a huge impact on the health systems of those nations and would conceivably shift resources away from much more desperately needed stuff. The main issue Ioannidis focuses on is the risk calculator employed by the guideline—a calculator that’s new, and that was shown right from the get-go to have significant weaknesses, that have been since confirmed. He gives us the math to show why it’s not very reliable.

Ioannidis takes a step back then and asks the question—we’ve been in the business of trying to calculate risk of coronary artery disease for more than 30 years; so how come we still can’t get it right? He also notes that the decision on the part of the guideline writers that a 10 year risk of developing cardiovascular disease of 7.5% ought to be the cutoff for recommending statins is a completely arbitrary number, unsupported by any empirical evidence—the “right” number could be 2% or 20% for all we know.

What these commentaries have in common is that both point out how messed up the basic data are due to all the major studies being supported by the drug industry, and how serious conflicts of interest contaminate this entire enterprise.

Abramson JD, Rosenberg HG, Jewell N, Wright JM. “Should People at Low Risk for Cardiovascular Disease Take a Statin?” BMJ 347:f6123, 2013.

Ioannidis JPA. “More Than a Billion People Taking Statins? Potential Implications of the New Cardiovascular Guidelines.” JAMA 311:463-464, Feb. 5, 2014.
April 17, 2014

Summarizing the “Market Failure” Special Issue of the New England Journal

Three articles in this week’s New England Journal of Medicine all combine to illustrate “market failure” in the pharmaceutical industry. As you can guess, the editors of NEJM didn’t adopt my suggested title for their issue. (See the end if you want more explanation as to why I’m calling it that.)

First is the editorial by Drs. Hoofnagle and Sherker—
http://www.nejm.org/doi/full/10.1056/NEJMe1401508--
--that talks about what would ordinarily be considered unalloyed good news elsewhere in the issue. Hepatitis C, which up till now has been quite resistant to treatment, appears to be well controlled by a new family of antiviral medications, with a minimum of side effects. This indeed appears to be one of those all-too-rare-today “breakthroughs” in drug treatment.

So what’s not to like? As the editorialists explain, the price tag. A complete course of one of the drugs comes in at $84,000, which works out to $1000 per tablet. The authors note a collision course between newly expanded public health efforts to do a better job of detecting the additional 1.6 million Americans who have Hep C and don’t know it, so that they can get this wonderful new treatment, which then many of them will not be able to afford—or if we could provide it for them, would break the bank of what the authors delicately call an “already overburdened medical care system.”The authors work for the NIH and as dutiful government employees are apparently discouraged from saying anything bad about the pharmaceutical industry, so they offer no ideas on what might be done about this problem.

Now jump to two “Perspectives” pieces in the same issue. One is from our good friends at the Harvard-Brigham and Women’s program in Pharmacoepidemiology and Pharmacoeconomics, including Dr. Jerry Avorn:
http://www.nejm.org/doi/full/10.1056/NEJMp1400488

The P&P gang describes what has happened under a program begun by the FDA in 2007, the Risk Evaluation and Mitigation Strategy. The idea when this passed Congress was to speed the entry onto the market of useful new medications that also posed safety issues. If the company could come up with a special plan to limit the use of the drug in such a way as to lower the risk of adverse reactions, then the drug could go on the market. But the proviso added on was that this plan ought not be used as a way to stop generic products from entering the market later.

Unfortunately the amendments that passed Congress also included a monkey wrench that was virtually guaranteed to undermine this intent (assuming that Congress intended what they said, and that Pharma lobbyists did not rewrite the law in the back room). The company that developed this special safety plan for the new drug could also patent the plan.

So Dr. Avorn and colleagues list several cases where the drug company has sued generic competitors claiming patent infringement if the generic guys use the same safety plan, and also filing suit to stop any generic that uses a different safety plan as raising the risk level for the public unacceptably. The only sensible way to fix this problem, say the Harvard guys, is to use the same safety plan for all versions of the drug regardless of manufacturer, but to make this happen Congress would probably have to amend the 2007 act. Bottom line—a policy that was intended to allow patients access to drugs while assuring safety, that was not supposed to interfere with generics entering the market, is being used by Pharma precisely as an “evergreening” tool to prevent generic competition.

Now we come to another Perspectives article authored by Drs. Sham Mailankody and Vinay Prasad:
http://www.nejm.org/doi/full/10.1056/NEJMp1400104

They also address the cost of new drugs, in this instance for cancer. Their basic point is—there are newly developed drugs for cancer treatment that provide small but apparently real benefits, such as an average extension of life by a few months. These drugs work by mechanisms very similar to old, generic drugs. (They give the example of the new drug abiraterone, which works in much the same way as an old anti-fungal antibiotic, ketoconazole.) So the ideal scientific question now to be asked is how well these same cancer patients would do if instead of getting the very expensive new drug, they got the very cheap old drug, ketoconazole. They might do just as well, or it might be that the new drug has some advantage—until we did the study we wouldn’t know.

The kicker that Mailankody and Prasad now note is—how would this new study be paid for? No way that the drug company that’s making a mint off abiraterone is going to bankroll a study that might pull the rug out from under its golden goose. So suppose some neutral investigators try to organize the study? Well, assuming that for the very same reasons, the manufacturer won’t just give away abiraterone for free (especially knowing for what purpose it’s going to be used), the investigators would have to pay market price and buy the drug. And the authors calculate that for a study large enough to answer the question of non-inferiority of ketoconazole, the cost of the drug alone—forget the rest of the cost of the study—would be about $69 million. In other words, no study of this sort will ever be done.

These authors also work for the NIH, and so are also apparently leery of saying anything controversial, and so don’t offer any proposals for a solution to this problem.

 


OK, so we have three articles in the same issue of NEJM, all of which have the same basic theme—in the name of profits, the drug industry is working contrary to the public health and the advancement of science. This is what old-time economist Kenneth Arrow famously called the market failure of health care—it simply does not follow the laws of supply and demand. Those who continue to extol the supposedly “free” market as the right way to manage all of our affairs, pharmaceuticals and health included, have to stick their heads in the sand and pretend that market failure never happens. As this blog has shown extensively, it happens all the time.
April 17, 2014

Manslaughter conviction for ‘negligent breastfeeding’ puts other mums at risk

(The Guardian) A genetic defect may be the real culprit in the case of a woman taking painkillers whose baby died of a morphine overdose. Photograph: Yui Mok/PA On Thursday last week, a South Carolina jury convicted Stephanie Greene, a 39-year old nurse, of killing her six-week-old daughter by administering a morphine overdose in her breast […]
April 17, 2014

New Educational Primers to Accompany Anticipate and Communicate

As part of its ongoing effort to support bioethics education, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has developed and posted to Bioethics.gov a new primer to inform institutional review boards (IRBs) and their members on the ethical management of incidental and secondary findings. The Bioethics Commission designed the IRB Primer to aid IRB […]
April 16, 2014

Bias, Bias, Bias (Part I)

<p class="MsoNoSpacing">One of my areas of research focus in bioethics is known as the responsible conduct of research (RCR) (a.k.a. research integrity). Research on research integrity covers a range of different norms and practices including authorship and publication ethics, research misconduct (fabrication, falsification and plagiarism), responsible mentorship, peer review, and RCR education among others. I have written on several of these topics in our AMBI blogs.</p> <p class="MsoNoSpacing">One of the topics I am interested in chatting about today is bias in the academic setting, but even more generally in the workplace. Much about research methodology aims to reduce or eliminate bias. For example, the experimental scientific method attempts to reduce bias by having proper controls, blinding researchers, and employing statistics so that we don’t over interpret our findings. Sociologists and other qualitative researchers may declare their biases when reporting research so the reader knows where the researcher is coming from. The entire concept of declaring conflicts of interest also aim to permit others to know what potential interest(s) the researcher may have which could bias their results. Moreover, the peer review process, which academia heavily relies on, aims to reduce bias in research. Peer review is not only used in the context of evaluating research, it also evaluates academic scholars for jobs, committee memberships, awards and scholarships, and other entitlements. <a href="http://www.pnas.org/content/early/2013/08/21/1302997110.full.pdf+html">One recent study</a>done by Drs. Daniele Fanelli and John Ioannidis showed the overestimation of effect sizes in behavioral research. Here the researchers performed a meta-analysis of meta-analyses (cleverly called meta meta-analysis) and found that researchers working in the behavioral, but not biomedical, sciences tended to exaggerate effects that were not supported by the data. Most interestingly, this exaggerated effect was heightened if the research had one or more US authors. While this sort of bias in the reporting of research may at first glance seem relatively benign, it actually has significant consequences because other researchers build on the results of previously published work and accumulatively, our social policies and clinical practices are based on evidence collected from such studies. Yet bias can come in all sorts of shapes and sizes in the academic and research context, some of which I think hits more personally to individual researchers.</p> <p class="MsoNoSpacing"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
April 16, 2014

Bias, Bias, Bias (Part I)

<p class="MsoNoSpacing">One of my areas of research focus in bioethics is known as the responsible conduct of research (RCR) (a.k.a. research integrity). Research on research integrity covers a range of different norms and practices including authorship and publication ethics, research misconduct (fabrication, falsification and plagiarism), responsible mentorship, peer review, and RCR education among others. I have written on several of these topics in our AMBI blogs.</p> <p class="MsoNoSpacing">One of the topics I am interested in chatting about today is bias in the academic setting, but even more generally in the workplace. Much about research methodology aims to reduce or eliminate bias. For example, the experimental scientific method attempts to reduce bias by having proper controls, blinding researchers, and employing statistics so that we don’t over interpret our findings. Sociologists and other qualitative researchers may declare their biases when reporting research so the reader knows where the researcher is coming from. The entire concept of declaring conflicts of interest also aim to permit others to know what potential interest(s) the researcher may have which could bias their results. Moreover, the peer review process, which academia heavily relies on, aims to reduce bias in research. Peer review is not only used in the context of evaluating research, it also evaluates academic scholars for jobs, committee memberships, awards and scholarships, and other entitlements. <a href="http://www.pnas.org/content/early/2013/08/21/1302997110.full.pdf+html">One recent study</a>done by Drs. Daniele Fanelli and John Ioannidis showed the overestimation of effect sizes in behavioral research. Here the researchers performed a meta-analysis of meta-analyses (cleverly called meta meta-analysis) and found that researchers working in the behavioral, but not biomedical, sciences tended to exaggerate effects that were not supported by the data. Most interestingly, this exaggerated effect was heightened if the research had one or more US authors. While this sort of bias in the reporting of research may at first glance seem relatively benign, it actually has significant consequences because other researchers build on the results of previously published work and accumulatively, our social policies and clinical practices are based on evidence collected from such studies. Yet bias can come in all sorts of shapes and sizes in the academic and research context, some of which I think hits more personally to individual researchers.</p> <p class="MsoNoSpacing"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
April 16, 2014

Have I Officially Become an Economist Now?

In a recent Huffington Post article, I was described as a Duke University economist. I’m sure the economic community would like to make very clear that I am not one of its members. The same goes for most communities, as … Continue reading
April 16, 2014

7th Annual National Healthcare Decisions Day

IT’S HERE!  Today is the 7th Annual National Healthcare Decisions Day! 

ACTIVITIES/RESOURCES:  Even if you have your own resources, please also direct patients, residents, clients, and the public to the resources at: http://www.nhdd.org  There are free resources that people can care with loved ones throughout the country.

FREE WEBINAR TODAY: at 3:00pm eastern, please join me, Ellen Goodman and others for an NHDD webinar.  Register at:http://theconversationproject.org/

LEAD BY EXAMPLE: As always, please encourage others by your example.  Here’s a simple message you can send/post to your family and friends tomorrow:

Today is National Healthcare Decisions Day.  I have had a talk about advance care planning with my loved ones.  Have you?  Free information, forms, tools, and an incredible video are at: www.nhdd.org  Do it today.

SPREAD THE WORD FURTHER: Please share NHDD information with your members/contacts/colleagues by forwarding this email or a link to www.nhdd.org or NHDD on Facebook or Twitter or LinkedIn 

JOIN US:  If you are receiving this email second-hand (or have not previously confirmed participation), please let us know who you are by completing the short participant confirmation here:  http://www.nhdd.org/join/

DON’T FORGET THE REST OF THE YEAR:  NHDD is our rallying day, but advance care planning is important throughout the year.  Continue to use the NHDD resources and always be on the lookout for activities to make NHDD even better.   

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