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by David Egilman, MD, MPH
I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays’ (R-CT) comments. Christopher Shays is the last remaining Republican congressman from New England. Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.
He repeatedly stated that he “had no dog in this hunt” concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA’s actions are appropriate. It’s one thing to have no opinion; it is in another to imply that there is no reason to have opinion.
No, not V-8 the vegetable drink, but C8, the common name for ammonium perfluorooctanoate, an ingredient in Teflon and other non-stick products. Ken Ward of the Charleston Gazette reports today on the levels of perfluorooctanoic acid in the blood of about 69,000 residents living near the DuPont Co.’s Parkersburg, WV plant where C8 was manufactured. The results are posted on the West Virginia University’s Health Science’s center website. The median C8 blood-level was
“more than five times the U.S. general population.”
The highest median blood-concentration levels (i.e., 132 ppb) were found among residents who get their tap water from the Little Hocking Water Association in Ohio. Ward’s story indicates the median level in the general U.S. population is 5 ppb.
by Susan F. Wood, PhD
The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising. The bill doesn’t limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market. A moratorium was recommended by the IOM in it’s drug safety report in 2006, but was not adopted by Congress - perhaps due to arguments about first amendment rights, but perhaps due to objections by both the pharmaceutical industry and the advertising industry.
What was included is a small section requiring that all print DTC ads carry “the following statment printed in conspicuous text: ‘You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088′ “
In an 8-1 decision, the Supreme Court has ruled that medical-device manufacturers whose products secured pre-market FDA approval are immune from liability for personal injuries. So, if you’re injured by a medical device (like a drug-coated stent or prosthetic hip) that’s received this approval, you won’t be able to sue the manufacturer.
This might not be such a problem if we could have faith in FDA’s approval process. But, as reports from the Institute of Medicine and the FDA’s own Science Board have made clear, the agency lacks the resources and scientific infrastructure to do its job properly. Under such circumstances, it’s important the people be able to turn to the courts, as David Michaels explained in a post about a Texas Vioxx case:
The news is out that Merck has agreed to settle 27,000 Vioxx lawsuits for $4.85 billion. Plaintiffs who claim they or their family members suffered injury or died after taking the anti-inflammatory drug will, on average, receive just over $100,000 before legal fees and expenses, reports the New York Times’ Alex Berenson.
The Vioxx debacle is an example of how not to interpret clinical trials data. Even before the FDA approved the drug, there was extensive evidence that taking Vioxx increased the risk of a cardiovascular event. Yet the FDA approved it and an estimated 20 million Americans took the drug. As a result, between 88,000 and 140,000 people suffered heart attacks, according to an estimate by FDA scientists.
What went wrong? How did the drug get through the FDA approval system? The documents that served as the foundation for the Vioxx litigation could help the medical community understand what happened.
Before a judge signs off on the settlement, I’d like to see her press Merck and the plaintiff attorneys to release to the public all the relevant documents.
By David Michaels
Updated Below
The lead story in today’s New York Times reports something we’ve been writing about here at the Pump Handle for quite some time (here and here and here, for example): responsible corporations recognize the need for public health and environmental regulation.
In industry and after industry, corporations and trade associations are asking the Bush Administration for regulation. In some of these cases industry has realized that voluntary regulation has failed, and without mandatory regulation, consumers will reject their product. But some of the push for federal regulation is to pre-empt more stringent state or local regulation, or eliminate law suits against polluters or manufacturers of dangerous products. Read the rest of this entry »
By David Michaels
It is time for Congress to enlist the nation’s science and policy experts to help develop a federal workers’ compensation program for 9/11 rescue, recovery, and cleanup workers. The inadequacy of state worker programs led Congress to legislate special compensation programs for uranium miners, and civilian workers in nuclear weapons facilities. We did not require the families of those killed in the terrorist attacks to rely on state workers’ compensation programs. The September 11th Victim Compensation Fund (pdf) provided more than $7 billion to families of the victims. Read the rest of this entry »
By David Michaels
Tort “reformers” have long contended (with little evidence) that fear of litigation has scared off vaccine manufacturers from developing new vaccines.
It has been more than twenty years since Congress established the National Vaccine Injury Compensation Program. The program was designed to ensure that anyone injured by a vaccine would be fairly compensated, while protecting vaccine manufacturers from liability. Even with this program, the pace of new vaccine development slowed to a crawl in the 1990s. Opponents of law suits, including President George W. Bush, regularly use the industry’s inability to develop new vaccines as a rationale for limiting the ability of victims to sue.
It turns out, not surprisingly, that these “reformers” were wrong. With no major change in the tort law, vaccine development, according to the New York Times, is “roaring back.” Times business columnist G. Pascal Zachary writes that
By the mid-1990s, however, innovation in vaccines had virtually come to a halt. Only a handful of companies even tried to develop new ones, compared with 25 in 1955.
But fear of liability, it seems, has had little to do with the failure of manufacturers to develop new vaccines. According to Zachary
in a stunning reversal, innovators today are chasing dozens of vaccines, stimulated by some recent high-profile successes. “People see vaccines as money makers,” says Paul A. Offit, chief of the infectious diseases section at the Children’s Hospital of Philadelphia… Read the rest of this entry »
By David Michaels
Gretchen Morgenson, the terrific New York Times reporter, has a disturbing piece that describes how the toothless Consumer Products Safety Commission (CPSC) has little ability to force hazardous consumer products of the shelves of toy stores.
The focus of her report is on super powerful miniature toy magnets. They are candy colored and easily eaten by small children. Morgenson’s article is a powerful case for new legislation that gives the CPSC some real power. It is also another piece of evidence documenting how law suits serve as the de facto regulatory system, since our public health agencies don’t have adequate tools to force better corporate behavior. Read the rest of this entry »
By David Michaels
We’ve been writing for the past few months about U.S. regulatory agencies’ failure to take meaningful action on diacetyl, a toxic component of artificial butter flavor, despite having been aware of its risks since at least the start of this decade. Now, mounting evidence suggests that some flavor manufacturers have known about diacetyl’s association with severe lung disease and failed to take appropriate action for even longer - since the early 1990s, when diacetyl started killing workers in flavor plants. Disabled workers are currently suing flavor manufacturers over their failure to alert purchasers of artificial butter flavoring to the substance’s dangers.
James McNair has an important article in the Cincinnati Enquirer on the diacetyl disaster at the flavorings plant in Carthage, OH, owned by the Swiss multinational company Givaudan. Three workers at the plant have died from bronchiolitis obliterans. Evidently, the director of environmental health and safety at the plant (formerly known as Tastemaker Corp.), who was hired after the first worker death, thought the plant couldn’t be operated safely. So he was fired: Read the rest of this entry »
By David Michaels
An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies.
One recent case of such data being kept secret, which Nature reporter Jim Giles covers in an accompanying article, is Eli Lilly’s schizophrenia drug Zyprexa. David Egilman, a physician who had access to confidential documents about Zyprexa’s dangers, is being threatened with jail time for his role in the release of the papers to, among others, New York Times reporter Alex Berenson. The story Berenson broke was front page news:
A few hours ago, the Supreme Court ruled in Massachusetts vs. EPA that EPA has the authority to regulate carbon dioxide from auto emissions. (For background on the case, see this post.)
David Stout of the New York Times summarizes:
By David Michaels
Dr. David Healy is the probably the single person most responsible for identifying the link between anti-depression drugs like Zoloft and suicide risk. His work led to the FDA to require the addition of a “black box” to the label of selective serotonin reuptake inhibitors (SSRIs), warning of the increased risk for “suicidality.” A few years before the FDA instituted this policy, Dr. Healy was asked to testify about the effects of Zoloft in a lawsuit filed by the parents of Matthew Miller, a teenager who hanged himself soon after starting taking the drug for depression. Healy never took the stand. As Barry Yeoman’s important article Science in the Dock in this week’s issue of The Nation explains, the judge hearing the case refused to allow Dr. Healy to testify, ruling that his belief in the SSRI-suicide link is a “distinctly minority view.”
Dr. Healy was “Dauberted”. The same thing has happened to other respected scientists. Yeoman describes in alarming detail how the Supreme Court’s 1993 ruling in Daubert v. Merrell-Dow has had troubling consequences.
By David Michaels
The state of Pennsylvania has filed lawsuits against three drug manufacturers, claiming the firms fraudulently marketed antipsychotic drugs. According to Bloomberg News, the state alleges that Eli Lilly & Co. “hid the risks and exaggerated the benefits of its antipsychotic medication Zyprexa while persuading doctors to prescribe it for unapproved uses.” AstraZeneca and Johnson & Johnson’s Janssen Pharmaceutical are accused of doing the same for other drugs:
The defendants cost Pennsylvania’s Medicaid and drug assistance for the elderly program millions of dollars for “reimbursing for non-medically accepted indications and non- medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs, the state said in a complaint.
State law suits (Louisiana, West Virginia, Alaska and Mississippi have filed similar suits against Eli Lilly) are an important component of the ongoing saga of the anti-psychotic drugs that cost too much and are more dangerous than their manufacturers like to admit.
