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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.
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′ “
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.
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 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 Susan F. Wood, PhD
The last week of August is full of anniversaries for me, both public and personal. On August 24, it has been one year since the partial approval of Plan B emergency contraception over-the-counter (OTC) for those over 18 years old. Two days later on August 26 is the 87th anniversary of the day that women got the right to vote, Women’s Equality Day. It also is the 2nd anniversary of the day that FDA leadership once again denied the approval of Plan B OTC despite all of the evidence and support within FDA for its approval. August 31st, just 5 days later, marks the two-year anniversary of my resignation from FDA as Assistant Commissioner for Women’s Health in response to the Aug. 26th decision.
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).
By Peter Lurie, MD, MPH, Deputy Director, Public Citizen’s Health Research Group
Dr. Lurie is a contributor to Public Citizen’s drug newsletter, available at www.worstpills.org. He will present testimony on state doctor gift disclosure laws before the Senate Special Committee on Aging on Wednesday, June 27, 2007. This article originally appeared in the May 2007 issue of Public Citizen’s Health Letter.
The life of a doctor must be tough. To judge by most of their offices, doctors are unable to afford pens, mugs, refrigerator magnets, or pads of paper. Even lunch is beyond their reach, it seems. And dinner at a fancy downtown restaurant? Fuhgeddaboutit.
Fortunately, there’s a group willing to step into the breach and supply these missing morsels and amenities. You guessed it: the pharmaceutical industry.
Despite the growing prevalence of direct-to-consumer advertising on television ($4.2 billion in 2005), the pharmaceutical industry continues to lavish the lion’s share of its advertising budget on physicians ($7.2 billion, excluding the ubiquitous free samples). After all, it is the physician who wields the power of the prescription pen.
Somehow, doctors operate under the delusion that the pharmaceutical industry is misguided enough to squander close to $20 billion on promotion annually even though, according to many doctors’ reasoning, all this largesse has no influence upon their prescribing habits. Much research suggests otherwise. When doctors were sent on expensive junkets to exotic locales, purportedly to receive objective education on a drug or disease, researchers noticed that prescribing of the sponsoring drug companies’ products went up in those doctors’ hospitals upon their return. Doctors accepting gifts from drug companies are more likely to request that their hospital add drugs to the hospital’s formulary, its list of preferred drugs.
Some people have had enough. Recently, a number of prominent medical schools, including Stanford, Yale, and the University of Pennsylvania, have sharply limited interactions between their physicians and pharmaceutical representatives. And now states are getting in on the action.
Declan Butler, Reporter updates us on the situation of the six health workers facing death in Libya. The five Bulgarian nurses and Palestinian medic were sentenced to death on the charge of deliberately infecting Libyan children with HIV, despite scientific evidence that the infections resulted from hygiene lapses and contamination of medical material. Butler reports that Libya’s Supreme Court will rule on the health workers’ appeal on July 11th and that the EU is working towards a settlement with the Libyan children’s families. He credits campaigns by scientists and others (in which Butler himself played an important role) with spurring diplomatic activity on the case, and is cautiously optimistic about a resolution. (Hat tip to Revere at Effect Measure for the link.)
Bloggers have also had their eyes on Capitol Hill this week:
- Ed Silverman at Pharmalot gives a rundown on the House Energy and Commerce Committee’s markup of the PDUFA bill on drug review and safety, while Merrill Goozner at GoozNews laments what’s missing from it. In other FDA news, The Olive Ridley Crawl gives the agency 1.5 cheers for its final rule on dietary supplements.
- Senator John Kerry blogs at Gristmill about the process of getting the energy bill through the Senate, while Matt Madia at Reg Watch warns about a damaging provision in the bill that’s gotten little attention.
- Ellen Marshall at RH Reality Check hails the House’s passage of a measure that will provide contraceptives to overseas organizations that have been denied aid because of their stance on abortion (under the Mexico City Policy, also known as the Global Gag Rule).
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 »
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.
When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allowed to negotiate with the DMV as to how the agency will use your fee? Of course not. So why is the drug industry allowed to negotiate with the FDA about how the agency will use the money it collects in fees paid for new drug applications?
We’ve written several posts already about 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. (Go here for a list of past PDUFA posts, or check out the new white paper on PDUFA here.) We and many other members of the medical and public health have raised concerns about impact of PDUFA on drug safety; Christopher Moraff summarized them neatly in a recent American Prospect article:
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.”
So, who does support the user fee system? None of the usual suspects, it turns out.
Read the rest of this entry »
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
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.
It looks like we’re not the only ones scrutinizing the FDA. Merrill Goozner at GoozNews takes on the agency’s prescription drug user fees, conflicted advisory committee members, and guidance for manufacturers, while Revere examines food safety and an experimental bird flu vaccine.
Also on the topic of pharmaceuticals, Abel Pharmboy at Terra Sigillata reported that the American Society of Health-System Pharmacists has developed a policy recognizing pharmacists’ right to decline to participate in therapies they find morally troubling. This set off a host of other posts: Janet Stemwedel at Adventures in Ethics and Science examined the tensions between personal conscience and professional duties and personal integrity and professional integrity, as well as the issue of dissent in professional communities. Kevin Beck at Dr. Joan Bushwell’s Chimpanzee Refuge weighed in with his own views on the matter. Abel Pharmboy summarized some of the points raised in the debate and introduced a new question, and provided the Oath of a Pharmacist and APhA Code of Pharmacist Ethics.
And, of course, there’s plenty of great blogging on topics other than the FDA and pharmacists:
By David Michaels
This is how it always works. A leading medical journal publishes a study saying a commercial product may be dangerous, perhaps even killing people. The trade association representing the manufacturers quickly attacks the study (preferably in the same news cycle), accusing the scientists of incompetence or worse.
The latest issue of the Journal of The American Medical Association (JAMA) includes a study that links that use of antioxidants (beta carotene, vitamin A, and vitamin E) with increased mortality. The issue was published today. Yesterday, the Council for Responsible Nutrition, the diet supplement industry’s trade association, issued a scathing press release, calling the study “muddled” and based on an “unsound scientific approach.”
The press release worked. The press coverage of the JAMA article included the trade association’s disparaging comments. The Washington Post quotes the Council for Responsible Nutrition’s Andrew Shao: “The message to the average consumer is: Don’t pay attention to this. This doesn’t apply to you.”
Pharmaceuticals seem to be a big topic in the blogosphere this week. Roy M. Poses MD at Health Care Renewal has more on the Zyprexa memos – which, if you haven’t been following this issue, reportedly show that manufacturer Eli Lilly suppressed information about this schizophrenia drug’s harmful side effects. Abel Pharmboy at Terra Sigillata reports on the perils of buying drugs online (and, in a post from last week, he worries about the number of people Googling DCA), and Orac at Respectful Insolence delves into the topic of experimental drug availability.
As has been the trend recently, there are also lots of interesting posts related to climate change. Gar Lipow at Gristmill examines emission trading’s mixed record; Juliane Fry at RealClimate explains the least understood component of the climate system; Joel Makower at Two Steps Forward recaps the many steps taken around climate change over the past 50 days; and Tim Lambert at Deltoid fact-checks a Wall Street Journal op-ed on global warming and DDT.
In other news …
by Susan F. Wood
Yesterday’s hearing (Feb 13, 2007) before the House Energy and Commerce Oversight and Investigations Subcommittee was amazing in several ways. What struck me was the willingness of senior FDA physician-scientists (who have recently left FDA) to speak publicly about their concerns about the ignoring of safety and efficacy data quality when there is an apparent push for approval. The specific product they were talking about is Ketek, an antibiotic that has had much written about it including on the Pumphandle. The specific issues identified have to to with the use of non-inferiority studies to assess efficacy, significant safety concerns being overlooked when Ketek was approved for conditions such as sinusitus, and the reality of serious fraud during the safety trials that was not revealed to the advisory committee. Read the rest of this entry »
by Susan F. Wood, PhD
On Wednesday Feb 21 at 3:00, the project on Scientific Knowledge and Public Policy at GWU School of Public Health and Health Services is hosting what hopefully will be a very exciting afternoon. Former Commissioners of the FDA will gather to discuss the future of FDA, bringing their experience and priorities together for an unscripted public conversation. FDA faces many challenges - some new, some old - but we need new ideas to help shape the upcoming legislative proposals that Congress will be taking up this year. Hearing from several former commissioners, including David Kessler, Jane Henney, Don Kennedy, Frank Young and hopefully Mark McClellan will bring focus to the critical functioning of FDA.
This ”Conversation with FDA Commissioners” is open to the public and the press and will be webcast the next day on Kaisernetwork.org. It will be held from 3:00-5:00 on Wednesday, Feb. 21 at the Jack Morton Auditorium, 805 21st St. NW, Washington, DC 20052. If you would like to attend rsvp to Janet at eohjip@gwumc.edu .
The following day, an invitation only workshop of former FDA leaders, scientists, and legal experts will gather to discuss issues of how to improve the use of science at the FDA, the impact of resources, and independance.
With PDUFA reauthorization just around the corner, new but limited initiatives underway on drug safety, ongoing problems with food safety, and a host of other FDA issues, now is the time to get new ideas on the table. (Background on this issues is available on SKAPP’s website.) Hopefully these efforts will add to the conversation.
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).
The pharmaceutical industry was a hot topic in the blogosphere this week:
Cervantes at Stayin’ Alive advocates for a ban on direct-to-consumer pharmaceutical advertising (as opposed to the proposed legislation likely to come from the pharma industry).
Orac at Respectful Insolence has a different take on the “DCA is a miracle cancer drug Big Pharma doesn’t want you to know about” idea that’s spreading through the blogosphere.
Andrew Leonard at How the World Works knows what will make your sympathy for Big Pharma disappear.
And, of course, there were plenty of interesting posts on other topics:
Lisa Stiffler at Dateline Earth reports on the newest research on PBDEs (levels of this flame retardant in household dust correlate to levels in breast milk) and gives an update on Washington state’s proposed PBDE ban.
Jake Young at Pure Pedantry has an update on Eli Lilly’s attempts to block the online distribution of documents that show that the company tried to play down the side effects of its schizophrenia drug Zyprexa.
Mead Over at Global Health Policy commends the 22 Members of Congress who wrote to the US Trade Representative in support of Thailand’s exercise of a compulsory license for the AIDS drug Efavirenz, and provides background and analysis on this issue.
by PotomacFeverish
In the first of what may be numerous resignations, Scott Gottlieb, MD has announced that he will leave his post as Deputy Commissioner at the Food and Drug Administration. He has been at the center of the political science practiced at the FDA as noted by Time last year:
Nowhere in the federal bureaucracy is it more important to insulate government experts from the influences of politics and special interests than at the Food and Drug Administration, the agency charged with assuring the safety of everything from new vaccines and dietary supplements to animal feed and hair dye. That is why many within the department, as well as in the broader scientific community, were startled when, in July, Scott Gottlieb was named deputy commissioner for medical and scientific affairs, one of three deputies in the agency’s second-ranked post at FDA.
Today is World AIDS Day, and there’s no shortage of coverage in the blogosphere. Christy Hardin Smith at Firedoglake combines links to news stories with her own reflections, and Izzy at Unbossed remembers 1982, before they called it AIDS. Michael Bernstein and Nandini Oomman of Global Health Policy report from the World AIDS Day Event in Nairobi, and Christine Gorman of TIME’s Global Health Update links to photos and stories of people living with AIDS.
On other topics:
by Susan F. Wood
After the recent post here on KETEK, both the Wall Street Journal and Senator Grassley are on the move. The WSJ reports today on another antibiotic Cubicin which has been seeking approval for use in endocarditis and discusses the competing issues of data quality and high standards, with the push for more antibiotics, particularly in the case of serious infections without effective treatment. The case of Cubicin in some respects serves as an example of this, however Ketek does not. They both illustrate problems identified by the recent Institute of Medicine Report on drug safety.
by Susan F. Wood
Much has been written about the antibiotic drug, telithromycin, otherwise known as Ketek. It seems to combine a host of concerns all in one place (see also Matthews, AW, WSJ, May 19, 2006:B1). Critically, concerns about safety, from visual effects to fatal liver toxicity, are paired with questions about lack of relative efficacy. These very basic concerns are then confounded with problems in particular safety studies that were carried out fraudulently and the faulty data derived from it provided to the FDA. But FDA leadership/management apparently discounted these problems, did not relay this information to the advisory committee which recommended approval, and approved this new drug in 2004. This past summer more concerns were raised about studies on Ketek in children; these are no longer ongoing, but FDA has yet to take specific action on whether these studies are permissible.
In last week’s New England Journal of Medicine, David Graham points out another weakness in the approval of Ketek(NEJM, 355(21), November 23, 2006, 2260-2261). He reports on the fact that given the fraudulent safety study, FDA used adverse event data from Germany and France where Ketek is marketed. Unfortunately, Dr. Graham’s analysis points out that the data was insufficient to detect a signal for a safety problem, but “the FDA interpreted the absence of a signal of acute liver failure in the overseas data as confirmation of telithromycin’s safety when the data could not be used to identify the problem.”
