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by Susan F. Wood, PhD
Recently the New York Times and RHRealityCheck reported on a leaked internal proposed regulation that calls for more and different enforcement of anti-discrimination provisions for health care providers. The provisions are forms of conscience clauses that do not allow discrimination in hiring or promotion of health care workers who do not wish to perform abortion or sterilization (or indeed in the reverse, no discrimination against those who do perform abortions or sterilizations) in federally funded settings.
The draft regulation goes into detail outlining the history of the laws protecting the conscience of health providers and entities and then outlines the problem. It seems that the central concern is not discrimination against those who won’t perform abortions, but that the US Department of Health and Human Services sees a real problem with requiring health professionals (and anyone in the healthcare workforce) to be involved with contraception, even if it is part of the job. The majority of the section outlining “The Problem” concerns states that have passed laws or issued executive orders requiring pharmacies to dispense contraception, including emergency contraception, and that require hospitals to provide emergency contraception to rape victims.
From the regulation:
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.
After so many stories about tainted drugs and food, here’s some good news for a change: The FDA plans to hire hundreds of new employees to help it fulfill its responsibilities to assure the safety of food, drugs, cosmetics, and medical devices.
They’ve identified a critical need for “medical officers, consumer safety officers, chemists, nurse consultants, biologists, microbiologists, health/regulatory/general health scientists, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers” in their DC-area office as well as U.S. regional and district offices and their newly created overseas office. Here’s their complete press release:
The winners of the 92nd annual Pulitzer Prizes were announced yesterday, and reporting on veterans’ care and on drug and product safety scored top honors in the journalism category:
The Public Service prize went “to the Washington Post for the work of Dana Priest, Anne Hull and photographer Michel du Cille in exposing mistreatment of wounded veterans at Walter Reed Hospital, evoking a national outcry and producing reforms by federal officials.” The Post’s Walter Reed and Beyond website includes the original stories and slideshows, as well as reporting on the federal response.
The Investigative Reporting prize had two winners: “Walt Bogdanich and Jake Hooker of The New York Times for their stories on toxic ingredients in medicine and other everyday products imported from China, leading to crackdowns by American and Chinese officials”; and “the Chicago Tribune Staff for its exposure of faulty governmental regulation of toys, car seats and cribs, resulting in the extensive recall of hazardous products and congressional action to tighten supervision.” The New York Times doesn’t appear to have a special page dedicated to Bogdanich and Hooker’s reporting, but their initial article is here and others are listed here; the Chicago Tribune has a Kids at Risk website for its articles and resources.
Congratulations to the newspapers, reporters, and staff for their excellent work – and thanks to all of the journalists who are drawing attention to health and safety shortcomings and prompting officials to address them.
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′ “
I wrote last week about how the FDA’s mixup with Chinese factory names kept it from inspecting the Chinese facility producing the main ingredient for Baxter’s heparin; this problem came to light after the drug was implicated in four deaths. (To date, more than 400 adverse reactions have been reported.) Today, articles in the New York Times and Wall Street Journal explain what drug companies and the FDA are dealing with when they rely on Chinese production.
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:
Baxter International announced recently that it has temporarily halted production of heparin, a generic anti-clotting drug, because of four fatalities and hundreds of bad reactions potentially tied to the drug. Baxter and the FDA say they don’t know the exact cause of the bad reactions, but attention has focused on the active ingredient supplied by a Chinese facility.
This morning, Marc Kaufman reports in the Washington Post that this Chinese plant wasn’t inspected by FDA because the agency confused its name with another one:
by Susan F. Wood, PhD
It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA. The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that. Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science. The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impact of this one. Most of the press coverage has been on the call for expanded resources - which are truly needed - but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency. I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.
From the report:
by Susan F. Wood, PhD
FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures.
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 Kristen Perosino
Is FDA on the road to recovery? Will public confidence in the agency be restored?
In what is bound to be an interesting policy address (not to mention well-timed, as the recently passed FDA Amendments Act of 2007 awaits Bush’s signature), Rep. Rosa DeLauro (D-CT) is scheduled to present her vision of “The Future of the FDA” on Wednesday, October 3rd at George Washington University.
She’s quite an important figure for the agency. As Chair of the House Appropriations subcommittee that funds FDA, DeLauro is influential in determining resource allocations to FDA programs. She demonstrated her clout earlier this year, for example, when FDA was rumored to cut funding for the Office of Women’s Health. DeLauro voiced her opposition and challenged Commissioner von Eschenbach to explain any such decision. FDA eventually maintained funding levels for the office after pressure from DeLauro and many women’s rights advocates. Translation: Women’s health is important to DeLauro.
The House and Senate have both passed legislation that renews the FDA’s user-fee system and enacts some important reforms. The process has been rushed because FDA is running dangerously low on funds; President Bush will need to sign the legislation today if the FDA is to avoid sending termination letters to one-fourth of its staff.
First, some background: In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA) and set up a system in which drug companies pay annual fees and fees for each prescription drug product they market, and these fees help fund the FDA’s process of reviewing new drug applications. PDUFA has to be reauthorized every five years, and advocates of drug safety and scientific integrity – including my colleagues at the Project on Scientific Knowledge and Public Policy – used the 2007 reauthorization process to push for reforms. (Go here or here for more details.) Under the current user-fee system, the FDA has devoted more resources to reviewing new drug applications and meeting new goals for review times, but its post-approval drug safety activities have suffered and some of its reviews have been rushed. Vioxx and other drugs that FDA has approved have turned out to have serious side effects and have been pulled from the market, and a 2006 Institute of Medicine report concluded that the agency needed significant reforms to improve drug safety.
Here are the important steps that the bill takes:
By Susan F. Wood, PhD
Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007″ (FDARA). And they both related to public transparency and public accountability.
The following post is by Dr. David Egilman, a familiar figure to those who have been following the case of Eli Lilly’s schizophrenia drug Zyprexa. See Alex Berenson’s New York Times articles on the case for more background, or read David Michaels’s post about Zyprexa and sequestered science. — Editor
“The Truth is Not Free”
By David Egilman
September 11, 2007
All that is needed for the forces of evil to succeed is for enough good people to remain silent.
– Edmund Burke
The consequences of silence can be devastating. My father spent WWII in a German concentration camp largely as a consequence of silence. In response to the Holocaust, which was facilitated by the silence of a nation, I have devoted much of my professional career to studying and reporting the effects of silence on public health.
Last December, I was subpoenaed for copies of internal documents that I acquired as a consulting witness in litigation against the pharmaceutical company Eli Lilly. I released all of the documents I had, which made their way to The New York Times and became the basis for four major articles. After the Times stories ran, 30 states subpoenaed documents detailing Lilly’s sales, marketing and promotional practices for Zyprexa as part of civil investigations under state consumer protection laws.
By Susan F. Wood, PhD
In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety. That study and its recommendations took on the question of how to improve our nation’s drug safety system, specifically through regulation by FDA. In her Perspective article, Dr. Smith writes:
In general, the IOM implored the agency to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error, To Err Is Human,2 has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves.
By Susan F. Wood, PhD
The Journal of Women’s Health published a special report and an editorial last month on the FDA’s Office of Women’s Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there. The special report, “The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy” identifies some of the major projects initiated by the FDA OWH, more than 100 studies costing more than $14 million over 10 years. This is a very small amount compared to NIH or to what the regulated industry funds (billions each year), but is focused on elucidating data that can help the FDA make regulatory decisions that affect the health of both women and men.
By Kristen Perosino
Congress is currently considering important legislation to improve drug and medical device safety and strengthen scientific integrity at the Food and Drug Administration (FDA). Both the House (H.R. 2900) and Senate (S. 1082) versions contain provisions that should be adopted in the final bill to better protect public health. One such provision is Title V Section 501 of the Senate bill regarding the right of FDA scientists to publish their research. This language, which amends the Federal Food, Drug, and Cosmetic Act, adds the following wording to the policy on the review and clearance of scientific articles published by FDA employees:
The Boston Globe, home town paper of Senator Ted Kennedy, Chair of the Senate Health, Environment, Labor and Pensions Committee, ran two important commentaries on the FDA this week.
First was an editorial yesterday strongly urging Congress to pass a strong FDA reform bill, including restricting financial conflicts of interests for advisory committee members.
Today the Globe ran an oped coauthored by David Michaels and me, again calling for leaders in Congress to ensure that the final bill (it is now in “conference” between the House version and the Senate version) come out as strong a bill as possible.
Take a look, I hope the Senator does!
Susan Wood is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).
This week, Congress has been wrestling with the reauthorization of the Prescription Drug User Fee Act; Merrill Goozner at GoozNews reports from Capitol Hill about the questions that FDA Acting Deputy Commissioner for Policy Randall Lutter couldn’t answer at a hearing and about the provisions that should be in the bill but aren’t. Matt Madia at Reg Watch reports that FDA drafted the bill for Congress after numerous meetings with pharmaceutical industry representatives. (Check out our past posts on PDUFA for background.) Meanwhile, Bill Miller at DeSmogBlog notes that pharmaceutical companies may profit as the world warms.
For some good news, we can turn to Angry Toxicologist, who tells us that dioxin levels in the U.K. are dropping, and Laura Lindberg at RH Reality Check, who reports that teen males have become less sexually active and much more likely to use condoms since the late 1980s (the news in the post about sex education and reproductive health services is gloomy, though).
Elsewhere:
By David Michaels
The Chinese government has apparently recognized the importance of integrity in drug regulation. According to AP:
China’s top drug regulator was sentenced to death on charges of corruption and negligence, state media said Tuesday, the latest development stemming from growing alarm over the country’s poor food-safety record. Read the rest of this entry »
This week, bloggers had plenty to say regarding the new study raising safety questions about the diabetes drug Avandia. The Olive Ridley Crawl and Merrill Goozner at GoozNews emphasize the importance of transparency around clinical trials, while Cervantes at Stayin’ Alive explains what’s wrong with using surrogate markers (as the Avandia studies used in the approval process did), and Roy M. Poses MD at Health Care Renewal explores the all-too-familiar elements of the drama.
Bloggers are also keeping an eye on Congress’s progress with the Farm Bill. Angry Toxicologist explains why we should care about this legislation, while Andrew Leonard at How the World Works alerts us to a proposed change in the Bill that could make it impossible for states or counties to prohibit farming GMOs. At Gristmill, Aimee Witteman examines the conservation section of the bill and Steph Larsen updates us on politicians’ maneuverings.
Elsewhere:
Today, the Institute of Medicine released its report Ending the Tobacco Problem: A Blueprint for the Nation. In a public briefing Richard J. Bonnie, Chair of the IOM Committee on Reducing Tobacco Use, explained that “ending the tobacco problem” means reducing tobacco use “so substantially that it is no longer a significant public health problem.”
In the U.S., tobacco use claims an estimated 440,000 lives and rings up an estimated $89 billion in health care costs every year. Worldwide, it’s responsible for five million deaths each year, making it the second major cause of death.
The reduction in U.S. smoking – tobacco use has declined by more than 50% since 1964 – is a major public health achievement, but Bonnie noted that there are still 45 million smokers and that smoking initiation rates in young adults appear to be rising. To preserve and enhance gains already made, the committee recommends strengthening existing tobacco control measures “such as excise tax increases, indoor smoking restrictions, comprehensive state-based programs, media-based prevention campaigns, school-based programs, and cessation therapies and services.” To truly end the tobacco problem, though, Bonnie explained that stronger tools are needed:
By Susan Wood
The recent study in the NEJM clearly points out that our drug safety system is in need of repair. We shouldn’t need these constant reminders, from Vioxx to Ketek and now to Avandia. Indeed FDA reform legislation is moving through Congress as we speak. But does it do what we need it to do?
The DrugWonks blog has accused those of us who are advocating for a more safety-focused FDA that is less dependent on restricted user fees of “bullying” the agency, but I only wish we were as powerful as they seem to think we are. The Senate bill, now known as S. 1082, the FDA Revitalization Act (new acronym: FDARA), unfortunately got weaker as it went through the process.
The FDA certainly wasn’t the biggest newsmaker this week, but it did create some buzz in the blogosphere – mostly due to the Prescription Drug User Fee Act, or PDUFA, which is up for Congressional reauthorization. Matt Madia at Reg Watch and Merrill Goozner at GoozNews are tracking PDUFA’s progress through the Senate. Corpus Callosum has three posts on three New England Journal of Medicine editorials about PDUFA (here, here, and here). (We’ve got Susan Wood’s take on the editorials here; or, check out all our PDUFA posts here.) The Olive Ridley Crawl reports that proposed restrictions on new-drug advertising are meeting fierce resistance. Cervantes at Stayin’ Alive point to another article in NEJM, this one about the antibiotic Ketek, which the FDA approved despite safety concerns. Meanwhile, Mike the Mad Biologist looks at E. coli and the inadequacy of funding for FDA’s food inspection work.
Elsewhere in the blogosphere …
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:
By Susan Wood
Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation. The Senate will be “marking up” a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. The version of the bill that has been released is nearly 300 pages long, and so far only takes small steps toward strengthening the Kennedy-Enzi drug safety bill introduced earlier this year.
If you want to learn some of the basics linking user fees, the FDA budget and drug safety, we have just issued a white paper “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA budget, and Drug Safety Related?” This is not a position paper, but rather a brief overview of the history, legislation, connections and varying positions that are in play now as these legislative actions take place.
The first part of the current bill in the Senate is reauthorizing PDUFA for the next five years. As was written in our open letter to Congress last month, “User fees may appear to save the taxpayer money, but at an unacceptable cost to public health.”
One of the signers of this letter, Dr. Jerry Avorn, has an article today in the New England Journal of Medicine, entitled “Paying for Drug Approvals – Who’s Using Whom?” Today’s early release of three articles on FDA reform demonstrate the depth and breadth of need for change at the FDA. Former Commissioner Dr. Mark McClellan also has an article, as do Drs. Sean Hennesey and Brian Strom.
By David Michaels
The federal regulatory system is in shambles. Regulated industries call the shots and career scientists are prohibited from pushing back. With the agencies in retreat, fear of litigation has become an increasingly important mechanism for discouraging bad corporate behavior. Now, “regulation by litigation” is under attack.
Following a Bush Administration edict, a Texas judge is about to dismiss 1,000 Vioxx cases because the FDA asserts that any warning label the agency has approved — no matter how faulty or inadequate — must be considered adequate warning of danger.
Over the last few years, the Bush Administration has been quietly pushing a policy that would bar law suits from injured people if the manufacturer followed the letter of the federal agency’s regulation. It doesn’t matter if the agency succumbed (as has been the case many times recently, and certainly is true in the Vioxx case) to corporate political clout and scientific shenanigans – if the manufacturer didn’t violate a regulation, no injured party can sue.
By David Michaels
The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products, gets skewered again – this time in a piece by Christopher Moraff in the American Prospect Online. (We’ve been covering the issue here at TPH; more materials on the link between PDUFA and the drug safety crisis are also posted on DefendingScience.org).
Following hot on the heels of yesterday’s Washington Post/Bloomberg critique by Cindy Skrzycki, Moraff summarizes the shortcomings of PDUFA raised by the Institute of Medicine, the Government Accountability Office, and the letter sent by 22 experts on drug safety and regulation asking Congress not to reauthorize PDUFA:
User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug’s approval — the equivalent, according to one former chief editor of The New England Journal of Medicine, of “putting the fox in the chicken coop.”
By David Michaels
The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the drug makers for a big piece of its budget, and the money comes with lots of strings – especially ones that limit FDA’s spending on drug safety. (Here is last week post on the NY Times editorial opposing PDUFA.)
In today’s Washington Post Cindy Skrzycki’s The Regulators column has a terrific piece on the letter written by leading drug safety and policy experts asking Congress to end PDUFA. Clearly, FDA needs the money PDUFA brings in; in fact, it needs a much higher level of funding to do its job right. So we have asked Congress for a temporary reauthorization, without PDUFA’s handcuffs, until the agency can be supported with appropriated money. Read the rest of this entry »
By David Michaels
In the wake of the debacles involving Vioxx, Ketek, and other dangerous drugs that should never have been approved in the first place, Congress is about to take up reauthorization of the user fee system that funds the Food and Drug Administration’s drug review process. The system is governed by the Prescription Drug User Fee Act (PDUFA), which will expire this year. The FDA has asked Congress to reauthorize the program for five more years.
Yesterday, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking them not to reauthorize the PDUFA because, as we write “user fees may appear to save the taxpayers money, but at an unacceptable cost to public health.”
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.
