Category: FDA

March 28: Jessica Flanigan speaking to the HMS Division of Medical Ethics

Nir Eyal Leave a comment

Please join the HMS Division of Medical Ethics for …

 

“Why patients should have access to all drugs without a prescription”

Jessica Flanigan, PhD

Assistant Professor of Leadership Studies and Philosophy, Politics, Economics and Law

University of Richmond

Thursday, March 28, 2013; 4:00 – 5:30 PM

HMS Division of Medical Ethics

1st Floor Conference Room

641 Huntington Avenue, Boston

RSVP to DME@hms.harvard.edu

Jessica Flanigan is a philosopher whose research interests include the ethics of business and medicine, law, and public policy.  Her current research addresses the ethics of self-medication and looks at the obligations of business leaders, particularly in the pharmaceutical industry, and questions the role of public officials. She asks questions such as: Can business leaders harm consumers simply by giving them more options? Do public officials misuse their power when they prohibit potentially dangerous drugs?  She is working on a book, Liberal Medicine, which is the first sustained philosophical inquiry into the ethics of medical regulations such as premarket safety and efficacy trials and the prescription drug system.

REMINDER – Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

The Petrie-Flom Center Staff Leave a comment

A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard:

Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

May 17, 2013, 8:00AM-5:00PM

Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor)

1585 Massachusetts Ave., Cambridge, MA

Our current agenda/objectives are below the fold, and will be updated with additional detail shortly.  Please make sure to register as space is limited! 

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Xolair for Chronic Itch: Magic Bullet or Marketing Hype?

Jonathan Darrow Leave a comment

By Jonathan J. Darrow

Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb. 25, 2013, at A5).  The article noted that a Phase 3 trial (usually, the final phase before FDA approval) showed that a monthly injection of Xolair “significantly reduced hives and itchiness.” Quoting the lead author of the study, the article reported that Xolair “is the magic bullet patients have been waiting for for the last 40 years.”  Is it?

An initial concern is the large number of conflicts of interest associated with the study. An examination of the Phase 3 trial as published in the New England Journal of Medicine (NEJM), on which the New York Times article is based, reveals that the trial was “[f]unded by Genentech and Novartis,” both of which sell Xolair.  The lead author and at least one other co-author of the study have received consulting fees from one or both companies, while another of the co-authors (Karin Rosen) is the medical director for Genentech.  Conflicts of interest, however, do not necessarily mean that the drug is in fact ineffective.  To determine efficacy, one must look at the evidence.

The NEJM study reports that test subjects received either placebo or Xolair at doses of either 75 mg, 150 mg, or 300 mg.  Starting from a baseline itch-severity score of about 14, the data were as follows:

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Impact of the Sequester on Health Care: By the Numbers

kbooth Leave a comment

By: Katie Booth 

The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care sector. Read on for sequestration by the numbers…

Medicare:

  • Medicare cut by 2% ($11 billion) (not set to begin until April 1st, 2013, unlike other sequestration cuts, which are set to begin on March 1, 2013)
  • Physicians’ payments cut by 2%
  • Hospital Medicare reimbursement cut by $5.8 billion
  • Hospitals could end up with especially large cuts under the sequester because other parts of healthcare system run on longer term contracts
  • Loss of almost 500,000 health care sector jobs in the first year of the sequester according to an American Medical Association and American Hospital Association study, including job losses for 40,000 practitioners such as physicians and dentists

FDA:

  • FDA cut by 8% ($318 million)
  • FDA public funding cut by $206 million
  • FDA industry user fees cut by $112 million (for an interesting discussion of user fee cuts and the sequester, see Patrick O’Leary’s Bill of Health blog post)
  • Cuts by department (assuming 8% across-the-board cuts): $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.5 million to Devices
  • Longer drug approval process is likely
  • Layoffs and furloughs likely
  • 2,100 fewer food safety inspections

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A Fascinating Reproduction Story in the New York Times, Part II: Creating a Family with a Stranger

I. Glenn Cohen 1 Comment

About 10 days ago, the New York Times had two fascinating stories about reproduction (on back-to-back days) that I wanted to highlight and comment on. I discussed the first one here. In this post, I will take about the second story about “co-parenting” (though that term has a separate set of meanings related to divorce) through modamily.com. Modamily is a website (one among a series of such websites according to the story) that allows non-romantically affiliated people (i.e., strangers to start with) get together to produce a child and co-parent it, sort of match.com for parenting without any romantic relationship. The story centers on one couple, Ms. Hope and Mr. Williams and reports:

“Neither Ms. Hope nor Mr. Williams is interested in a romantic liaison. But they both want a child, and they’re in serious discussions about having, and raising, one together. Never mind that Mr. Williams is gay and that the two did not know of each other’s existence until last October, when they met on Modamily.com, a Web site for people looking to share parenting arrangements. Mr. Williams and Ms. Hope are among a new breed of online daters, looking not for love but rather a partner with whom to build a decidedly non-nuclear family.”

I find the convergence of assisted reproduction and web 2.0 fascinating. Here are a few thoughts: First, some sub-set of readers will say “well, what about the children” of these liasons? They will express a fear that the interests of these kids will have been set back. I have two responses: how different is this from single parent reproduction, or reproduction by couples likely to divorce? Further, as I have written about some countries’ attempts to limit the use of reproductive technologies as a single individual as well as a number of other kinds of restrictions on reproduction (see this and this and this and this). there are deep intellectual problems with these kinds of Best Interests of the Resulting Child arguments.

Second, there are some interesting, fairly subtle, eugenic impulses expressed (perhaps unintentionally) by the writer of the story in the Times. The story begins by describing “A 6-foot-2 former model who loves animals, Mr. Williams is athletic, easygoing, compassionate and organized.” If I can be slightly info-mercial/Sex and the City about it, the sub-text appears to be along the lines of “Gee, ladies, wouldn’t you like a piece of that for your kids!” This is of a piece with some of the other academic work I have discussed in earlier posts on the sperm ‘donors’ chosen in reproductive technology practices and their uber-mensch characteristics. That said, as I have written elsewhere, under what circumstances such eugenic impulses are wrong as opposed to being the reproductive technology equivalent of some of what many of us do in sexual mate selection remains very much contested ground.

Third, I think the article raises interesting questions about the unbundling of romance and reproduction. One might think that in the current world of “hook-ups” among our youth, that we have already begun to decouple sex and romantic relationships, and anonymous sperm donation uncouples romance and reproduction (through non-sex), but this takes it further still. One interesting wrinkle here is the non-commodified nature of the non-intimate form of reproduction. There are no arms-length doctor and bank mediated relations between the gamete providers, rather they are trying to become intimately involved in a non-sexual way without any money involved.

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The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills

Jonathan Darrow 2 Comments

By Jonathan J. Darrow

An earlier post discussed the equivocal efficacy of Propecia (finasteride) as a baldness remedy, ending with the provocative assertion that, efficacy aside, “there is little reason for anyone ever to buy or consume Propecia (finasteride), or any doctor ever to prescribe it, since a much cheaper and identical chemical sold under the trade name Proscar (finasteride), is available.” This post continues the discussion, addressing one small component of the rising cost of healthcare—the cost of finasteride.  It explores why consumers pay as much as $240 for a bottle of Propecia (finasteride) when a $9 bottle of an equivalent, FDA-approved supply of the identical chemical is readily and legally available at nearby stores.

In the exorbitantly priced landscape of prescription drugs, there is at least one low-cost oasis: Wal*Mart.  Though some find reason to criticize the discount store, few would disapprove of the dozens of prescription medications Wal*Mart offers for an unbeatable $4 for a 30-day supply.  Cost-sensitive consumers can purchase everything from blood thinners to antidepressants to antibiotics at this price, while a 90-day supply is only $10 (and this price includes shipping to your doorstep).  A handful of drugs that cannot be sold at $4 per month sell for a still-modest $9.  For the 300 or so drugs on Wal*Mart’s list, this means there is no longer a need for $10 co-pays or snowy treks to the pharmacy in 15 degree weather.  That’s right: the Wal*Mart total price is less than most insurance company co-pays.  Finally, a major industry player seems to have put effective downward pressure on prescription drug prices.  Read More

Can the FDA Ban Cupcakes?

kbooth 6 Comments

By Katie Booth

In the spirit of Valentine’s Day, I wanted to discuss an important issue: Can the FDA ban cupcakes? While this may seem like a silly question, the Center for Science in the Public Interest (“CSPI”) has filed a petition with the FDA urging the agency to regulate the amount of sugar (including high fructose corn syrup) in soft drinks. According to the executive director of CSPI, sugar is a “slow-acting but ruthlessly efficient bioweapon” that causes “obesity, diabetes, and heart disease.”

If soft drinks are a problem, surely cupcakes are too. A twelve-ounce can of Coca-Cola contains 39 grams of sugar. A seasonally-appropriate red velvet cupcake from Sprinkles contains 45 grams of sugar—and who can eat just one? National cupcake consumption increased 52% between 2010 and 2011, and U.S. consumers ate over 770 million cupcakes last year. Sugary soft drink consumption, on the other hand, is down 23% since 1998 and 37% since 2000.

While the FDA can’t regulate sugar as a bioweapon, it probably could regulate sugar as a food additive. Under the Food, Drug, and Cosmetic Act, a food additive is “any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component or otherwise affecting the characteristics of any food.” This broad definition would include sugar. The FDA does not, however, regulate food additives that are “generally recognized as safe” (“GRAS”). Presumably the FDA considers sugar to be GRAS—for now.

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Reverse Settlements, Part 4: What Is the Baseline?

anupmalani Leave a comment

In my final post on reverse settlements I want to offer three thoughts that are more directly related to the legal question of how to treat reverse settlements under antitrust law.

First, it strikes me as odd that we scrutinize reverse settlements of Paragraph IV challenges differently than settlements of patent suits of non-drug, even non-health products.  As Einer acknowledges in his Texas Law Review piece, nearly all patent litigation affects market structure and thus both the level of competition and the amount of consumer welfare (Elhauge and Krueger 2012).  In each of those cases, because the public is not party to the litigation, settlements between patent holders and alleged infringers will – in theory and perhaps in practice – tend to hurt consumers.  (The monopoly-duopoly wedge that gives rise to the problem of reverse settlements is by no means unique to the drug market.)  Yet my patent law colleagues tell me there is no systematic review of non-drug patent settlements as is being urged of drug settlements in the FTC v. Watson case.  It seems that under the FTC view, drug patents would be treated more harshly than other patents. I am not sure why that should be the case under antitrust law.

Second, the critical question in the antitrust litigation is the baseline against which reverse settlements are judged.  Reverse settlements are only problematic under antitrust law if they extend patent duration or scope beyond some baseline.  Should that baseline be expected duration with full litigation and no settlement – as critics of reverse settlements urge – or something else?  For expected litigation to be the baseline, one has to assume that Hatch-Waxman modifies patent law and that patent duration after litigation is what is now required.  I am not sure these assumptions are appropriate.

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