Latest Drugwonks' Blog
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.
“Pfizer Falls From Ranks of Top 10 U.S. Advertisers” announces a story in today’s Boston Globe. And it’s a pretty interesting piece about where the industy is going and why relative to direct-to-consumer advertising. Particularly intriguing was a quote from the always thoughtful John Rother of AARP, “What you have is a growing consensus that the industry has been too aggressive, particularly with drugs that have serious side effects.” While he wasn’t specific as to who was part of that growing consensus (and the story didn’t pursue the question), a crucial query should be whether or not that consensus group includes pharmaceutical brand managers. Now that would make for an interesting article.
I noticed a recent letter to the editor of The Hill from Congressman Anne M. Northup, arguing that the importation of drugs subject to foreign price controls would be consistent with both safety and patent protection. (Yes, Ms. Northup is a woman; “Congressman” is a title and not a description.) She is incorrect in both dimensions because she ignores the implications of foreign price controls on pharmaceuticals. As it would be very difficult to monitor the shipments, reverse shipments, cross shipments, and other machinations to which the legalized importation of drugs would give rise, pharmaceuticals purportedly imported from, say, Germany, in fact would carry a real risk of actual production almost anywhere. North Korea and Pakistan come to mind. And there is no need to speculate about this: The recent discovery of thousands of doses of counterfeit Lipitor in the UK is only the latest example of the fake drugs about which we know. Moreover, the foreign price controls are forced upon the pharmaceutical firms by governments threatening to confiscate patents; it is Orwellian, to say the least, for Northup and others to argue that only “patent-protected” drugs would be imported.
Northup and others argue that the importation of pharmaceuticals subject to price controls would be a manifestation of “free trade.” Please. That is analogous to an argument that the purchase of stolen merchandise from the back of a truck is “free enterprise.” It is the effort of foreign governments to use price controls to obtain free rides on the research and development costs borne by U.S. consumers that is the real problem; the importation of foreign price controls will merely reduce future cures in favor of present wealth transfers. Sadly, Northup is concerned above all with present voters.
New segmentation schema for the food pyramid: Tall. Grande. Venti.
Just saw this news item —
Statin drug may save lives of heart attack patients, according to a study of more than 170,000 patients. A study published in the American Journal of Cardiology shows that taking statin such as Pfizer Inc.’s Lipitor, the world’s best-selling prescription drug, within 24 hours of admission for a heart attack can markedly reduce the risk of early complications and of dying in the hospital.
“This is the largest study to look at whether very early use of statin therapy after (a heart attack) can influence clinical outcomes,” Dr. Gregg C. Fonarow, from the University of California Los Angeles, was quoted as saying by Reuters Health. The results do, in fact, “suggest that statins offer additional protective effects early.” The research led by Fonarow involved comparing records of more than 170,000 patients in the National Registry of Myocardial Infarction. The registry, coordinated by Genentech Inc., has collected data on more than 2.3 million heart-attack patients since 1990.
That’s certainly good news, but here’s the question — would statins be approved today under the current political environment? Unfortunately, that’s a debatable question. It’s worthwhile to remember that “back in the day,” Bob Temple saw the value of statins when the category was new and the data was spare. Temple saw the wisdom and lives were (and are) saved. FDA serves us best when it strives to both protect and advance America’s health. Imagine health care today minus statins. Imagine the dollars spent on hospitalizations. Imagine the lives lost. The wisdom of Temple is wonderful, but the FDA as Temple of Wisdom is essential. And science and politics don’t mix.
Last we heard from Minnesota Attorney General (and presumptive Democrat gubernatorial candidate) Mike Hatch, he was thumping his chest while announcing the state’s intention to sue drug companies for their attempts to keep drugs earmarked for sales in Canada in Canada. It seems Mr. Hatch took exception to drug companies telling their Canadian distributors that if they sold drugs illegally to Americans their supply would be cut off. I know, it sounds strange — a state AG suing drug companies for trying to keep foreign pharmacies from purposely breaking US law. But this is, after all, Minnesota. In any event, Mr. Hatch’s announcement got a lot of news coverage and garnered him a prominent speaking engagement in front of the Families USA national conference in Washington, DC (after me and before Senator Ted Kennedy). That was over two years ago. The news on Friday that a Federal judge dismissed the case went almost unnoticed. But the ruling says it all — “Denied as Moot.” There is sanity in the world of pharmaceutical litigation after all.
Business Week offers an insightful cover story on the promise of and impediments to smart drugs — products that target narrower subsets of a population depending on individual genetics and the specifics of the condition. The stories are fascinating reads, containing material familiar to industry insiders and hangers on but news to the public.
Embedded in the tale is the central role of profit-seeking companies, such as Switzerland’s Roche. The company bet against the best advice of its own scientific advisors and laid down $300 million in 1991 on a poker hand that indirectly led to the development of AmpliChip, a device that promises to pinpoint which drugs will help specific individuals. The stifling role of regulation is indirectly covered through a feature on FDA Deputy Commissioner Janet Woodcock, who recognizes and is addressing legitimate industry fears about narrow markets and overbroad regulation. “It isn’t that there are some bad drugs and some good drugs,” says Woodcock, in a quote that could be entered by the defense in any number of Merck’s Vioxx trials. “It’s that some drugs run into bad problems with a small subset of people.”
And, of course, unnamed naysayers and professional worriers appear, fretting that any progress may lead to increased spending on health care and life insurance denials.
“Not only is the field still immature but it is also beset with concerns about public policy and privacy. Experts fear individuals may be denied life insurance, health insurance, or even a job if they’re known to harbor genes for a debilitating illness. Also, there is a debate about whether personalized medicine will reduce or increase health-care spending. Better diagnostics would let doctors intervene more quickly, avoiding some costly procedures. But hospitals may also order more and more tests indiscriminately to cover themselves against possible lawsuits for not detecting diseases before it’s too late. And those tests can be expensive: A test for abnormalities on the BRCA1/2 genes implicated in certain breast and ovarian cancers costs $3,000 a piece.”
The possible lawsuits ought to be addressed with medical malpractice reform, not a halting of progress. As for the $3,000 price tag, ask yourself if this is too much to pay if the person in question was your husband or wife, partner, child, mom, or yourself? I’d take two just for safety, as would many others. The larger issue has to do with price controls. Although unstated, every promised advance detailed in this feature would disappear tomorrow if drugs were subject to price controls. That’s the real risk.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
