The pharmaceutical industry has some of the deepest pockets of any industry when it comes to lobbying and pushing federal officials to license its products, as such approval can yield billions over many years. But obtaining federal approval is often slow, costly and very frustrating, both to drug makers and to sick people who are desperate for cures when legally approved prescriptions fail.
David Healy is a Professor of Psychiatry at Bangor University. He is a former Secretary of the British Association for Psychopharmacology, and author of over 175 peer reviewed articles, 200 other pieces and 20 books. Here he is in an interview
Rosenberg: In Pharmageddon, you chronicle how clinical trial oversight has gone from a hospital and university-based system to a for-profit system run by clinical research organizations or CROs.
Healy: The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core. At each juncture where they have spun off a traditional responsibility, no one has objected and so it continues.
Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?
Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate–
Rosenberg: Like Moody’s and Standard & Poor’s are funded by their clients?
Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did.
Rosenberg: Most of Pharma’s power to mislead and harm comes from such opaque and distorted data, you charge in Pharmageddon.
Healy: Without access to the raw drug data, medical professionals cannot practice responsible medicine and guidelines cannot be written. Yet Pharma, with very few exceptions, refuses to publish the data and share them with practitioners. This result is guidelines that are fictions and doctors who lack critical information they need to prescribe and treat.
Rosenberg: Pharma’s stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made Vioxx, hormone therapy and Neurontin look safe when they weren’t. Another example you give is a paper in the Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made the antidepressant Paxil look safe by hiding raw data. Then editor, Mina Dulcan, says about the missing data, which hid Paxil’s suicidal side effect in children, “I can’t control the authors. No, I don’t have regrets.”
Healy: If we were getting our drug information from the New York Times instead of medical journals, we would all be a lot safer. When theTimes reporter Jayson Blair was found to have fabricated stories, he was history. But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is herself Pharma linked. [Ed note. The COPE site says, "Liz provides writing, editing, training and consultancy services for various pharmaceutical companies (most recently Astra Zeneca, Cephalon, Cordis, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Viifor). ]
Rosenberg: Many conflicts of interest in your book, including COPE’s leadership, are structural and create a closed loop of misinformation, especially because of the money that Pharma wields. How can sunlight and transparency ever break through?
Healy: Some colleagues and I are in the process of fine-tuning a free web site that offers FDA MedWatch data with other crucial dug information but gets people affected by treatment to report in detail for perhaps the first time. The site, called RxISK.org, also helps patients file an adverse event report to US and Canadian authorities, with other countries to follow. For too long, patients, doctors and pharmacists have been isolated from each other when they encounter adverse drug events and only Pharma’s messages get out. This will help them communicate directly.
The Lawyers
The best-paid corporate lawyers are like master chess players. They are always thinking about their next series of moves to win—to protect profits. They look for accomplished scholars to help them frame new issues and arguments in many areas of law, including law professors who specialize in the First Amendment. When drug and medical device makers wanted to make a case that the federal government should let them tell medical professionals about ways their products can be used that haven’t been approved by federal regulators, they turned to Martin Redish, one of the foremost commercial speech scholars, to write a paper arguing exactly that—by citing the First Amendment privilege to disseminate information.
Martin Redish, who for decades has been widely respected as a First Amendment scholar at the Northwestern University School of Law and in August 2008 joined Sidney Austin LLP, a globally known corporate law firm, as a senior counsel. In March 2011, Redish co-authored a paper with Coleen Klasmeier, a partner in the firm's Washington office. The first footnote emphasized the paper’s importance, saying, “both authors are involved in the representation of one or more drug manufacturing company clients… in which the arguments in this article have been or could be presented to a court or prosecutorial authority, including the Department of Justice and the Food and Drug Administration.”
The paper, “Off-Label Prescription Advertising, The FDA and The First Amendment: A Study in the Values of Commercial Speech Protection,” argues that drug and medical device makers should be able to sell their products for uses not licensed by the FDA (hence the "off-label" moniker). They argue that the FDA is “unambiguously inconsistent” with approving alternative uses for drugs and devices, which ultimately harms the public. Moreover, not sharing information about other uses with medical professionals violates the company’s First Amendment commercial speech rights, Redish said, because the information they want to share is factual and true.
First Amendment law is complex. There are different legal standards for political speech and commercial speech. Redish’s argument that the FDA’s failure to allow discussion of these alternative uses is unconstitutional censorship is shrewd and parses some fine legal lines. Researchers and physicians are free to share information about off-label uses and do all the time—that’s how science works. The FDA’s prohibition is about how companies market those off-label indications, which involves profit motives.
Redish’s paper acknowledges that the FDA’s approval process is designed to weed out “quackery—fraudulent therapeutic claims,” but he says that in many treatment areas, starting with pediatrics and oncology, there is an “indisputable value of off-label uses” and “the obvious reality that manufacturers are in a unique position to provide valuable information [about] off-label uses to the medical profession.”
After citing a history of the FDA changing its mind about approved uses since the 1960s, Redish becomes indignant, noting that between 1993 and 2001, the FDA took strong steps against “materials of a lasting nature like books, audio, video tapes and software” that curbed the “free flow of information.” But “starting in 2001, the FDA at least gestured in the direction of First Amendment values, but that period of greater circumspection proved short-lived.” In other words, under the Clinton administration, the FDA cracked down. Under the Bush administration, its political appointees initially eased up. And now, under the Obama administration, the FDA is again saying no.
Redish argues that his client’s core business should have full First Amendment protection but be free from liability if something bad happens to consumers who use it. He cites a lawsuit where the conservative Washington Legal Foundation filed a brief against the FDA arguing, “that a manufacturer should be permitted to provide information about off-label uses as long as the information is accompanied by an adequate disclaimer.” He cites the FDA response, which said, “WLF’s suggestion that the manufacturer of … a dangerous product has a First Amendment right to promote it for unapproved uses, and to do so without providing adequate directions (or, in this case, any directions) for use, is breathtaking.” However, Redish calmly returns to his argument, repeating that drug companies have a First Amendment right “to give physicians information they need.”
The federal government’s effort to push junk food makers to voluntarily change the way they advertise to children and teens is one of the highest-stakes legal battles over product labeling. After a multi-year, multi-agency effort based on extensive science, the food and broadcast lobbies prompted Congress to withhold funding for this Federal Trade Commission-led effort earlier this year—despite the startling fact that many tens of millions of American youths are either overweight or obese.
One of the most aggressive advocates for media giants, which did not want to see any loss of advertising revenue, was Kathleen Sullivan, the former dean of Stanford Law School. Her brief on behalf of Viacom, the media conglomerate, against the federal Interagency Working Group on Food Marketed to Children (IWG) was dismissive of the federal effort to adopt voluntary marketing guidelines. From the start, she attacked it as one “that would limit the advertising of food and drinks directed at children and adolescents… in violation of the basic First Amendment principle that regulation of speech, including commercial speech, should be a last, not a first resort, for government action.”
The public health effort to stem childhood and teenage obesity by adopting voluntary marketing guidelines—which, as the FTC repeatedly stressed, were not requirements—was “government paternalism,” Sullivan wrote, saying it was a fiction that these were called voluntary. “The food marketing ‘guidelines’ cannot escape full First Amendment analysis merely because [they are] styled ‘voluntary.’” She noted the target of the FTC labeling effort—“breakfast cereals, snack foods, candy, dairy products, baked goods, carbonated beverages, prepared foods and meals, frozen and chilled desserts, and restaurant foods”—and said these are “definitions that sweep in many adult audience members as well.” Indeed, there is a national obesity crisis, among all ages, and yet Sullivan said, “The proposal would… have the effect of reducing the quality of original children’s programming (as well as adult programming attracting a high share of children) by diminishing or diverting the advertising revenues upon which such fully protected forms of programming depend.” Moreover, she said that, “any causal connection between advertising and childhood obesity is far too attenuated to satisfy the strong empirical showing required for restrictions on commercial speech.”
In other words, Sullivan is saying "don’t blame us" and "leave our ad revenues alone."
Source
David Healy is a Professor of Psychiatry at Bangor University. He is a former Secretary of the British Association for Psychopharmacology, and author of over 175 peer reviewed articles, 200 other pieces and 20 books. Here he is in an interview
Rosenberg: In Pharmageddon, you chronicle how clinical trial oversight has gone from a hospital and university-based system to a for-profit system run by clinical research organizations or CROs.
Healy: The drug companies have outsourced all their operations from drug development and testing to clinical trials to scientific and academic writing so that they have become nothing but marketing organizations at their core. At each juncture where they have spun off a traditional responsibility, no one has objected and so it continues.
Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?
Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate–
Rosenberg: Like Moody’s and Standard & Poor’s are funded by their clients?
Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did.
Rosenberg: Most of Pharma’s power to mislead and harm comes from such opaque and distorted data, you charge in Pharmageddon.
Healy: Without access to the raw drug data, medical professionals cannot practice responsible medicine and guidelines cannot be written. Yet Pharma, with very few exceptions, refuses to publish the data and share them with practitioners. This result is guidelines that are fictions and doctors who lack critical information they need to prescribe and treat.
Rosenberg: Pharma’s stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made Vioxx, hormone therapy and Neurontin look safe when they weren’t. Another example you give is a paper in the Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made the antidepressant Paxil look safe by hiding raw data. Then editor, Mina Dulcan, says about the missing data, which hid Paxil’s suicidal side effect in children, “I can’t control the authors. No, I don’t have regrets.”
Healy: If we were getting our drug information from the New York Times instead of medical journals, we would all be a lot safer. When theTimes reporter Jayson Blair was found to have fabricated stories, he was history. But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is herself Pharma linked. [Ed note. The COPE site says, "Liz provides writing, editing, training and consultancy services for various pharmaceutical companies (most recently Astra Zeneca, Cephalon, Cordis, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Viifor). ]
Rosenberg: Many conflicts of interest in your book, including COPE’s leadership, are structural and create a closed loop of misinformation, especially because of the money that Pharma wields. How can sunlight and transparency ever break through?
Healy: Some colleagues and I are in the process of fine-tuning a free web site that offers FDA MedWatch data with other crucial dug information but gets people affected by treatment to report in detail for perhaps the first time. The site, called RxISK.org, also helps patients file an adverse event report to US and Canadian authorities, with other countries to follow. For too long, patients, doctors and pharmacists have been isolated from each other when they encounter adverse drug events and only Pharma’s messages get out. This will help them communicate directly.
The Lawyers
The best-paid corporate lawyers are like master chess players. They are always thinking about their next series of moves to win—to protect profits. They look for accomplished scholars to help them frame new issues and arguments in many areas of law, including law professors who specialize in the First Amendment. When drug and medical device makers wanted to make a case that the federal government should let them tell medical professionals about ways their products can be used that haven’t been approved by federal regulators, they turned to Martin Redish, one of the foremost commercial speech scholars, to write a paper arguing exactly that—by citing the First Amendment privilege to disseminate information.
Martin Redish, who for decades has been widely respected as a First Amendment scholar at the Northwestern University School of Law and in August 2008 joined Sidney Austin LLP, a globally known corporate law firm, as a senior counsel. In March 2011, Redish co-authored a paper with Coleen Klasmeier, a partner in the firm's Washington office. The first footnote emphasized the paper’s importance, saying, “both authors are involved in the representation of one or more drug manufacturing company clients… in which the arguments in this article have been or could be presented to a court or prosecutorial authority, including the Department of Justice and the Food and Drug Administration.”
The paper, “Off-Label Prescription Advertising, The FDA and The First Amendment: A Study in the Values of Commercial Speech Protection,” argues that drug and medical device makers should be able to sell their products for uses not licensed by the FDA (hence the "off-label" moniker). They argue that the FDA is “unambiguously inconsistent” with approving alternative uses for drugs and devices, which ultimately harms the public. Moreover, not sharing information about other uses with medical professionals violates the company’s First Amendment commercial speech rights, Redish said, because the information they want to share is factual and true.
First Amendment law is complex. There are different legal standards for political speech and commercial speech. Redish’s argument that the FDA’s failure to allow discussion of these alternative uses is unconstitutional censorship is shrewd and parses some fine legal lines. Researchers and physicians are free to share information about off-label uses and do all the time—that’s how science works. The FDA’s prohibition is about how companies market those off-label indications, which involves profit motives.
Redish’s paper acknowledges that the FDA’s approval process is designed to weed out “quackery—fraudulent therapeutic claims,” but he says that in many treatment areas, starting with pediatrics and oncology, there is an “indisputable value of off-label uses” and “the obvious reality that manufacturers are in a unique position to provide valuable information [about] off-label uses to the medical profession.”
After citing a history of the FDA changing its mind about approved uses since the 1960s, Redish becomes indignant, noting that between 1993 and 2001, the FDA took strong steps against “materials of a lasting nature like books, audio, video tapes and software” that curbed the “free flow of information.” But “starting in 2001, the FDA at least gestured in the direction of First Amendment values, but that period of greater circumspection proved short-lived.” In other words, under the Clinton administration, the FDA cracked down. Under the Bush administration, its political appointees initially eased up. And now, under the Obama administration, the FDA is again saying no.
Redish argues that his client’s core business should have full First Amendment protection but be free from liability if something bad happens to consumers who use it. He cites a lawsuit where the conservative Washington Legal Foundation filed a brief against the FDA arguing, “that a manufacturer should be permitted to provide information about off-label uses as long as the information is accompanied by an adequate disclaimer.” He cites the FDA response, which said, “WLF’s suggestion that the manufacturer of … a dangerous product has a First Amendment right to promote it for unapproved uses, and to do so without providing adequate directions (or, in this case, any directions) for use, is breathtaking.” However, Redish calmly returns to his argument, repeating that drug companies have a First Amendment right “to give physicians information they need.”
The federal government’s effort to push junk food makers to voluntarily change the way they advertise to children and teens is one of the highest-stakes legal battles over product labeling. After a multi-year, multi-agency effort based on extensive science, the food and broadcast lobbies prompted Congress to withhold funding for this Federal Trade Commission-led effort earlier this year—despite the startling fact that many tens of millions of American youths are either overweight or obese.
One of the most aggressive advocates for media giants, which did not want to see any loss of advertising revenue, was Kathleen Sullivan, the former dean of Stanford Law School. Her brief on behalf of Viacom, the media conglomerate, against the federal Interagency Working Group on Food Marketed to Children (IWG) was dismissive of the federal effort to adopt voluntary marketing guidelines. From the start, she attacked it as one “that would limit the advertising of food and drinks directed at children and adolescents… in violation of the basic First Amendment principle that regulation of speech, including commercial speech, should be a last, not a first resort, for government action.”
The public health effort to stem childhood and teenage obesity by adopting voluntary marketing guidelines—which, as the FTC repeatedly stressed, were not requirements—was “government paternalism,” Sullivan wrote, saying it was a fiction that these were called voluntary. “The food marketing ‘guidelines’ cannot escape full First Amendment analysis merely because [they are] styled ‘voluntary.’” She noted the target of the FTC labeling effort—“breakfast cereals, snack foods, candy, dairy products, baked goods, carbonated beverages, prepared foods and meals, frozen and chilled desserts, and restaurant foods”—and said these are “definitions that sweep in many adult audience members as well.” Indeed, there is a national obesity crisis, among all ages, and yet Sullivan said, “The proposal would… have the effect of reducing the quality of original children’s programming (as well as adult programming attracting a high share of children) by diminishing or diverting the advertising revenues upon which such fully protected forms of programming depend.” Moreover, she said that, “any causal connection between advertising and childhood obesity is far too attenuated to satisfy the strong empirical showing required for restrictions on commercial speech.”
In other words, Sullivan is saying "don’t blame us" and "leave our ad revenues alone."
Source
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