Latest Drugwonks' Blog
Huh? Jerry Avorn raises some interesting and valid arguments in his September 8th Perspective in the NEJM. But, unfortunately, he swiftly devolves into the bizarro world of Marcia Angell. In discussing FDA’s clinical measurements of “safe and effective” he posits that the public health would be better served if the agency also required, “consideration of a drugs efficacy and safety as compared with alternative therapies.” Dr. Avorn argues that such clinical evidence would make better prescribing information more readily available. But since every patient is unique, how relevant is this really? Just as there is no such thing as a “me-too” medicine (as any sober chemist will tell you), neither is there such a thing as a “me-too” patient. Patients (otherwise known as “people”) respond differently to different drugs — even drugs within the same therapeutic category. Asking FDA to recalibrate “safe and effective” to “as safe mostly but not as effective in some circumstances but somewhat more effective in others” is a poor public health course. Dr. Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital should know better. There are a lot of places that FDA belongs — but subjective intermediary between patient and doctor is not one of them.
Well, my wife prevailed upon me to see The Constant Gardener this weekend. How can I say this gently: Don’t waste your money. A new tuberculosis strain is wreaking havoc across Africa, you see, and a corrupt pharmaceutical firm has developed an effective treatment that, sadly, has the unfortunate side effect of killing many of those taking the drug. We know this because UN aid workers in Kenya, using only the most rigorous of statistical analytic tools, say so. And so the poor Africans killed by this drug are secretly buried in lime pits, while the official records of their lives are expunged. Only Soviet-style airbrushing of photos failed to have been included. Meanwhile, the starlet—-Ms. Rachel Weisz, aka Tessa Quayle in the film—-learns that the evil pharmaceutical firm, aided by some corrupt British officials, is covering up the obvious evidence of the drug’s deadly effects because fixing the formula would cost millions and take considerable time during which the firm’s competitors could create their own effective drugs that would not kill people, thus cutting into the corrupt firm’s profits, etc., etc. And this perfidy makes sense because the epidemic is likely to spread worldwide, creating a large demand for the drug, and suppression of the deadly side effects will guarantee a huge market in Asia and the West. It’s all about the money, you see.
Got that? Anyway, the evil pharmaceutical firm through its allies in Kenya arranges for the murder of the fair Tessa and her ally, a Kenyan doctor both humanitarian and seemingly the only man in the country both unpoor and uncorrupt, before they can expose the plot. After all, that is not the kind of direct-to-consumer advertising that sells medicine. And so Tessa’s loving husband Justin picks up the torch, exposes the evildoers for what they are, and then allows himself to be murdered by the same nefarious forces so that he can be together again with his beloved Tessa in heaven. Who says that Hollywood is not religious?
Well, if Big Pharma is motivated only by money, why would they expose themselves so crudely to the plaintiff’s bar in the West? After all, people would start dying in the West also; can we even imagine the sums that the juries would award in such cases? And would the FDA and the other regulatory agencies in Europe simply accept the results of such African “clinical trials?” And what about the brand name capital of the offending pharmaceutical firm? Does it not have a profit motive to protect it by marketing only drugs the benefits of which justify the downside risks?
This flick is so silly—-so Michael Moore-like in its excess and mendacity—-that the pharmaceutical industry has little to fear from it in terms of adverse p.r. It’s good thing, as Martha might put it, when those out to destroy capitalism prove themselves so crude.
Just for a minute put aside your feelings about emergency contraception and rather than thinking about Plan B, consider Plan E. That’s E like in Ephedra. During my tenure at FDA, one of the agency actions I was most proud of was the banning of dietary supplements containing Ephedra. All the scientific evidence supported the decision. Politicians and the media were laudatory. There was broad public support — especially among parents of high school athletes — some of whom had tragically died because of these dangerous snake oil supplements. I am convinced that lives were saved because of the FDA’s decision. And then, in April of this year, a federal judge in Utah — Ground Zero for the dietary supplement industry, overturned the agency’s ban. The judge’s ruling was based on the legal argument that FDA hadn’t really proven Ephedra was dangerous. Yes, that is absurd. But sometimes the law really is an ass. That’s why it’s so important that FDA decisions be based not only on sound science but also on a sound legal foundation.
Which brings me to Plan B. Considering the highly charged environment surrounding female reproductive issues, legal maneuvering to overturn a potential “behind the counter” decision wouldn’t be based on science, but rather on the agency’s authority to make such a split decision. And making public health decisions through litigation is not in the best interests of the public health. An action on Plan B, absent a definitive and public rule making process would, rather than making emergency contraception more widely available, very likely delay OTC availability due to prolonged and protracted legal actions. And if legal action is the most effective route, you can be sure it will be pursued.
Almost every year during Sweeps Week (when networks try to boost viewership for their annual Nielson ratings) there is a health-related horror story. This year almost every network news program, both local and national, ran stories on how FDA-approved vaccines are causing autism in previously normal, happy, healthy young children. One the one side (the side with about 95% of the airtime) are parents (mostly mothers) whose children developed autism after being vaccinated for childhood diseases. On the other side (and for only the briefest of sound bites) is a nerdy looking doctor saying that every single third-party research study over the past ten years shows absolutely no correlation between autism and childhood vaccines. Who do you think the average viewer believes? And this fear-over-facts tabloid journalism was even more effective this year than usual with the FDA on its heels over drug safety. And to prove to us, once again, that irresponsible actions often have dire unintended consequences, Governor Pataki just signed into law a bill that (effective in 2009) would prohibit children three years of age or younger from being inoculated with vaccines that contain the mercury preservative thimerosal. Another action in the growing litany of public opinion rather than hard science driving public health policy. According to the American Academy of Pediatrics, “This legislation represents very bad public health policy that is based on junk science and mass hysteria, not on the evidence of science.” The AAP continues to say that such a ban has the very real danger of scaring parents away from getting their children vaccinated. Whenever a child develops a horrible condition parents want someone to blame. But the hard truth is that bad things do happen to good people for reasons that cannot be determined. But a worse fate is to reintroduce into society childhood diseases that were the scourge of previous generations. Governor Pataki has incautiously adopted the Precautionary Principle — and put at risk the youngest generation of the Empire State.
Attention Senators Dorgan and Vitter: Here’s some info from a recent AP story that you might find interesting …
MEXICO CITY. In just eight years Farmacias Similares, or Similar Pharmacies, has grown from a single store in Mexico City to 3,329 across Mexico and is spreading throughout Central America as well as Argentina, Ecuador and Chile. A pharmacy opened in the Peruvian capital of Lima on July 29. Colombia is next. And it’s made Victor Gonzalez a rich man.
His catchy advertising — a cartoon doctor and an army of scantily clad models — has made 58-year-old Gonzalez a household name. His slogan is “The Same, Only Cheaper.”
Now the recovering alcoholic and self-professed womanizer wants to translate his popularity into a run for president, though the law is against him, as is most conventional wisdom.
Gonzalez refuses to divulge his net worth, joking in an interview, “If I tell you, they’ll come kidnap me.” But his eight companies, manufacturing, transporting or selling pharmaceuticals, generated around $400 million in sales last year. His group claims to control one-quarter of Mexico’s $9 billion drug industry.
AARP announced today it would spend $5.5 million on a campaign to get seniors signed up for Part D. Bravo. Quixotically, this is the same AARP that just spent millions of dollars on an anti-pharma, pro-foreign drug importation jihad. Will the real AARP please stand up?
A quick Google search of “Medicare” this week shows a welcome change in momentum. Stories about Secretary Leavitt and Administrator McClellan — not to mention the President — touring the nation and speaking with seniors are actually accentuating the positive. All this together with a new poll showing more seniors than ever keener than ever about the new drug benefit points to a more successful sign-up for Part D than previously thought plausible. It just goes to show that even a little strategic communications can go a long way towards helping the Medicare population do what’s in their own best self-interest. But we can’t allow a few good press clippings to make us complacent. There’s a long road ahead and we must keep our eyes on the prize.
A gaggle of United States Senators are getting ready to introduce bills designed to change the way the FDA deals with drug safety. Can things be made better? Of course. But unless this is done carefully, there’s the real danger of turning the world’s gold standard into fools gold. A process that has evolved over time alongside important improvements in science and technology should not be subject to rash action or political maneuvering. Our system involves a careful balancing of drug benefits and risks based on the best possible scientific information that can be discovered about a drug’s safety profile. Reform? Certainly — but careful and considered reform that makes drugs safer — not hasty measures that grab headlines but do harm to the public health by slowing down the availability of new and better medicines.
The recent discussions about how to make our drug approval system better are important steps in the right direction. But we must be mindful of the fact that patients with life threatening diseases are given hope because of the advances of pharmaceutical discovery and development. Congress must support reform that makes drugs safer, but warn against those that might unintentionally slow down the flow of these new medicines, or worse, discourage the creation of some of them altogether.
Congress should embrace the following 5 key “Pillars of Safety” that are critical to reforms at the FDA:
1- Safety and Efficacy must continue to be the foundational elements of the FDA regulatory process. Safety cannot exist in a vacuum apart from efficacy.
2- Mechanisms to enhance existing structures and processes for post market safety monitoring and adverse event reporting must be explored.
3- Efforts to bring even greater efficiency and scientific expertise to the FDA’s review and monitoring processes must continue; such efforts must be done in a manner that empowers the Agency to keep pace with the rapid advancements now occurring in areas such as genomics, proteomics, and nanotechnology.
4- FDA must continue to work with industry, patient groups, physicians, hospitals, academia, and other government agencies to enhance the critical path.
5- The FDA must be sufficiently resourced in order to insure more effective pursuit of its existing mandates. Additional resources are even more essential if FDA is to successfully implement a comprehensive suite of reforms.
We should all be encouraged by FDA’s plan to allocate more than $70 million over five years to support enhanced monitoring and surveillance of risks that may be associated with drug products already on the market. However, no drug is without risk; and it always has been an unfortunate but unavoidable fact that some adverse effects may not become apparent until after a drug has been in wide or extended use. FDA must strive to minimize such adverse effects and enhance the agency’s capacity to report them, but we must also accept certain risks associated with beneficial drug products. Moreover, without new monies, every dollar the FDA shifts towards new regulations and infrastructure for safety is money taken away from programs that allow the agency to more effectively and efficiently evaluate risk and benefit together.
Finally, one of the keys to a stronger FDA and a more robust development pipeline is a clear plan for how the agency will work to modernize the medical product development process. Such a proposal has been presented in the report: “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” This document details the agency’s plan to update the tools currently used to assess the safety and efficacy of new medical products. Congress should enthusiastically support the FDA’s willingness to reach out to numerous stakeholders in an effort, “to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of product development industry-wide.”
Today’s Plan B news is that Susan Wood, the director of FDA’s Office of Women’s Health, resigned. That’s too bad, she’s a very talented professional. Not surprisingly, the media feeding frenzy is in full force. What is disappointing, however, is how a very partial media source, Ms. Magazine, has chosen to play fast and loose with the facts for political purposes — the very charge they are leveling at the FDA They represent Susan as “the top woman at the Food and Drug Administration.” Not even close to being right and, at least in my opinion, a slight to Janet Woodcock (Deputy Commissioner), Maggie Glavin (Associate Commissioner), Sheila Walcoff (Associate Commissioner) and others on par or above Dr. Wood. Susan Wood is a class act and I’m sure is embarassed by this agenda-driven hyperbole.
Recent legislation in Texas that would permit the importation of foreign drugs has hit a couple of small snags — ability, legality, and safety. Problem 1: Ability. The Texas law calls for the importation of drugs from 10 Canadian pharmacies — except that Ujjal Dosanjh, Canada’s Minister of Health has introduced enabling legislation that will allow the Government of Canada to prohibit the bulk export of prescription drugs. Problem 2: Legality. It seems that the Texas legislators who introduced the legislation didn’t really believe that the illegal importation of foreign drugs was, well, illegal. A strongly worded letter from the FDA seems to have opened their eyes. Problem 3: Big safety problems. Rather than repeat the litany of reasons why safety concerns trump political posturing, suffice it to say that just because a politician says a drug is safe, doesn’t make it safe. Yes, everything’s big in Texas. And importing drugs from outside FDA jurisdiction would be a big (dare I say “Giant”) mistake.