Latest Drugwonks' Blog
At today’s BioCentury Summit, FDA Deputy Commissioner Scott Gottlieb issued a blunt broadside to the medical journal mandarins …
“Too much important medical information remains shielded behind strict embargo policies and too long peer-review cycles that mostly serve the interests of enterprising journal editors rather than patients.
Medical journal embargo policies are the C-Section of Journalism — you can report on something at the date, and time, of your choosing. And the medical journals such as the New England Journal of Medicine and Science are pressuring everyone, including the FDA, to release information more quickly.
They are right. Information that could influence clinical medical practice needs to be made available more quickly, and more widely, after it has gone through a deliberative scientific process that firms up its meaning and the magnitude and the veracity of its conclusions.
But why should the medical journals alone have the luxury of bottling up information behind longwinded peer review processes that can wind on for months and embargo policies that serve no useful purpose?”
Let’s see what Time Magazine has to say about that!
Senator Charles Grassley is so smart! Reading his recent statements and press releases (yes — they are hard to differentiate) you’d think he was smarter than all the career scientists at the FDA (well, except for one), the combined R&D staffs of every global pharmaceutical company, Dr. Elias Zerhouni — and now we can add to that illustrious list Dr. Andrew von Eschenbach. That being the case, and for the good of the country, maybe the senator should ask President Bush consider him to head the FDA? Then again, maybe not.
One of the reasons President Bush tapped Andy von Eschenbach to take hold of the suddenly rudderless FDA is because von Eschenbach thinks big. Now he must also think broadly. His oft-repeated (and unfairly ridiculed) challenge to make cancer a chronic disease by 2015 raised a lot of eyebrows — but it focused attention on the task at hand. His management style at the NCI challenged a lot of entrenched interests, but succeeded in making the federal government once again relevant in driving an aggressive agenda — one based on the foundation that the best kind of research is of the applied variety. A victor over cancer three-times over, von Eschenbach will now face a different kind of tripartite battle — political, bureaucratic, and scientific. He’s a known quantity at FDA, having led collaborative efforts on both NCI’s and FDA’s Critical Path efforts — rising above internecine rivalries to provide an unfortunately rare example of government agencies working together for the common good. He’s a man of energy, action and integrity. He’s a survivor. Good luck Andy.
The following is excerpted from a forthcoming article by CMPI Board of Advisory member Henry Miller …
Ideally, the nominee for FDA commissioner should be equal parts consummate manager, technocrat, and Lord High Executioner. Realistically, he must have several attributes:
Superior management skills and experience. The agency’s scope is so
sweeping — encompassing cardiac pacemakers, x-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, artificial sweeteners and fat substitutes — that a single person cannot be expected to master the body of science, medicine, pharmacology and engineering (to say nothing of the law and “regulatory science”) involved. The FDA’s own professional staff can frame the issues and options; the function of the agency head is chiefly to manage the far-flung empire, craft appropriate incentives for moving products through the pipeline more efficiently, and make the final decision on difficult policy questions. Also, the commissioner needs to be competent to perform reality checks for the senior staff. An excellent example is the agency’s oversight of food biotechnology: FDA regulators have in place a scientific and workable policy, but at UN-based negotiations on food standards, they have proposed and supported unscientific approaches to biotech foods that conflict with their own domestic policy.
Unassailable integrity and honesty. The Commissioner’s decision-making must meld law, science, medicine and regulatory precedents, in a way that maximizes the public interest. The incumbent needs to earn the respect of those who have a stake in FDA’s policies and decisions — that is, patient groups, individual consumers and drug companies — with candor, consistency and rectitude. The FDA Commissioner’s job should not be awarded as a political plum, as are cabinet posts and many ambassadorships. Politics should be banished insofar as that is possible, with the commissioner doing what is in the public interest and then taking the heat from all quarters for unpopular decisions. A corollary is that the commissioner should probably not aspire to higher political positions in government Doing the job right makes plenty of enemies.
There’s a new white paper worth reading. It comes from Alberto Mingardi of the Bruno Leoni Institute in Italy and leverages the current American debate over drug importation to address some more fundamental and troubling issues — sustainability of global pharmaceutical development. Heres a sample. The full paper can be found at http://brunoleoni.servingfreedom.net/BP/
Free-riding (on drug discovery and development) by European countries does appear a markedly unsustainable course: ironically, the price controls in force in almost every development economies endangers the American exception. Pressures on the United States to take the course of socialized medicine come from many quarters and some steps in that directions have already been taken. The prospect of a “globalization” of socialized medicine emphasizes all the flaws of a situation in which Europe is content with living off the American golden eggs goose. When the fact is taken into account that in 1998 as much as 33 of the best-selling (and, therefore, most appreciated) drugs were of American origin, it is clear that the very future of an innovative healthcare industry depends on that goose. Beyond any moral issues, the danger exists that, if the United States will achieve further European-style legislative “progress,” that overstretched goose might lay her last egg.
I am proud to have served with Les Crawford at the FDA. I am prouder to consider him my friend.
The DC Council has approved legislation (which Mayor Anthony Williams has said he will sign) that would make it illegal for pharmaceutical companies to sell prescription drugs at an “excessive price” in the District of Columbia. And, of course, if companies don’t comply there is a civil penalties clause. In medical terms, the Council needs to have their collective heads examined. But their mental health isn’t the issue. The real question is, what aspects of drug pricing do pharmaceutical company’s control? Pfizer doesn’t own a chain of pharmacies. Eli Lilly doesn’t have a stake in CVS. And, in case you didn’t know, there is no such thing as MSRP (manufacturer’s suggested retail price) for prescription medicines. Here’s how it works — a drug company sells its products to a wholesaler who sells it to a pharmacy (often with multiple re-sellers and re-packagers in-between). And everyone along the supply chain marks up the price to make a profit. In fact, by the time you receive your prescription at the pharmacy, the price can be upwards of 40% over the initial price charged by the pharmaceutical company. But, since the DC Council is made up mostly of lawyers (including the genius who introduced the legislation, David Catania — a lawyer at the mega-DC firm of Akin, Gump, Strauss, Hauer, Feld) it’s not surprising they’ve chosen to focus on the deepest pockets — the pharmaceutical industry. It wouldn’t look good, after all, if their legislation forced local pharmacies (who enjoy a sizable profit on their sale of medicines) to close in Anacostia. What does “DC” stand for? Based on the current disposition of the DC City Council, it stands for “Drug Catastrophe.”
This just in …
STRASBOURG, France (AP) — Counterfeit Viagra, antibiotics and other drugs are on the rise in Europe, leading international pharmaceutical and health care experts said, blaming insufficient cross-border cooperation.
Meeting at a three-day conference organized by the Council of Europe, government officials, law enforcement officers, doctors and pharmaceutical experts from Europe and the United States called Thursday for tighter criminal legislation, better public awareness campaigns and a central point for collecting information on fake drugs.
They warned that the rise in counterfeit medicines could undermine patients’ confidence in public health care.
“It is worrying that there is no recognized central reference point in Europe entrusted with surveillance, trend analysis and policy recommendations in the field of counterfeit medicines,” said Maud de Boer-Buquicchio, deputy secretary general of the Council of Europe, the continent’s leading human rights body.
“This situation helps the counterfeiters, who can rely on international cooperation gaps in Europe,” she said. “Even when they are caught, they far too often get away with administrative fines with no deterrent effect.”
Counterfeit medicines make up approximately 10 percent of the European pharmaceutical market — up from close to zero 10 years ago — and often are supplied by international criminal rings, the World Health Organization says.
In Russia, some 20 percent of all drugs distributed are fake, while in Mexico it is 40 percent and in Nigeria as much as 80 percent, Council of Europe and WHO statistics show.
Counterfeit medicines often are packaged like the genuine product and are hard to detect. Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh.
Experts warned that purchasing health products over the Internet poses a major health risk as such drugs often have not been approved by a competent health authority.
A study conducted by the U.S. General Accounting Office in 2004 showed that four out of 21 medicines ordered from Web sites outside the United States or Canada were fake.
“Patients using these services are at risk of receiving medicines which are counterfeit, out of date or unidentifiable for lack of proper packaging,” said Jean Parrot, President of the International Pharmaceutical Federation.
The conference, which runs through Friday, focuses on identifying ways to detect fake drugs, combating distribution and drawing up guidelines to protect the public. Representatives of the European Commission, the European Patent Office and the U.S. Food and Drug Administration were attending the meeting.
Fred Fricke, director of the Forensic Chemistry Center at the FDA, highlighted a recent case: Two former employees of pharmaceutical giant Johnson & Johnson set up their own business in India and were producing fake, non-sterile surgical mesh and distributing it to a number of hospitals in the United States.
Level-headed logic and sound advice from the editorial page of the Washington Post …
PROCEEDINGS began this week in the lawsuit filed by Frederick Humeston
of Boise, Idaho, against Merck and Co., the makers of the painkiller
Vioxx. Mr. Humeston wants compensation for the heart attack he suffered in 2001, two months after he began to take Vioxx. The facts of the case would seem to give Mr. Humeston little chance. Not only do studies of Vioxx show that the risk of heart attack is linked to use over a much longer term, but Mr. Humeston was, like many other middle-aged men, at risk of a heart attack for other reasons, too.
Unfortunately for Merck, scientific facts didn’t play much of a role in the first Vioxx trial, which ended on Aug. 19. The Texas jury in that case awarded $253.4 million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a condition Vioxx has been proven to cause. The jury, declaring that it wished to “send a message” to Merck, decided to make an enormous symbolic award anyway. Besides, said one juror afterward, the medical evidence was confusing: “We didn’t know what the heck they were talking about.” Because Texas law limits the size of jury awards, the final cost to Merck is likely to be closer to $2 million. But the precedent set by the jury is ominous. Merck is facing about 5,000 similar lawsuits. If every one of those costs the company $2 million, the total price will come to $10 billion — if, of course, a company called Merck is still around to pay it. Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label. After all, Vioxx was produced and sold legally. The drug was approved by the Food and Drug Administration, and its label did warn of coronary side effects. It is possible, even probable, that Merck was negligent in its decision to ignore early warnings of the cardiovascular risks of Vioxx. But the company has already paid a price for that negligence, in the losses it has suffered after abruptly taking Vioxx off the market. Fair compensation for the injured needn’t entail disproportionate financial
punishment as well. In the long term, using the courts to “send a message” to Merck isn’t going to help consumers. If the result is an even more cautious FDA approval system and a more cautious pharmaceutical industry, that will keep innovative drugs off the market for much longer. More people will die waiting for new treatments. The cost of producing new drugs will rise dramatically. Already, there are whole areas of medicine — women’s health during pregnancy, for example — that are made so risky by liability issues that companies may stop doing research in them. The first principle of reforming this system should be that a company that follows the FDA’s rather extensive guidelines should be protected from punitive, if not compensatory, damages. At the very least, it is time for Congress to start considering whether a model such as the one set up for children’s vaccines — in which a fund is set up to cover the
costs incurred by children harmed by vaccines — should be constructed
for all drugs.
All schizophrenics react to medicines the same way. So says the New York Times. According to the Gray Lady, “The nation is wasting billions of dollars on heavily marketed drugs that have never proved themselves in head-to-head competition against cheaper competitors.” But have these medicines proved themselves where it counts — in the bodies and biochemistries of schizophrenics? For many patients (although clearly not enough for the New York Times) a new therapeutic option often provides the chance to live their lives outside the horrible fog of schizophrenia The plain fact is that some medicines work better for some patients than for others. Some marginally so, others more significantly. One size does not fit all and nowhere is this more true than in patients suffering from severe mental illness. It’s time that the good folks at the Times editorial board stop listening to the better (Marcia) angels of their nature and reserve judgment before speaking with mental health professionals, patients and families thereof.
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.
