Latest Drugwonks' Blog
Today’s words of wisdom from Nobel Prize-winning drug researcher and United States Senator Charles Grassley, “The F.D.A. should not be slowing things down or speeding them up depending on how the wind blows.” That certainly carries a lot of weight from a man who wears a weathervane on top if his head and, during Commissioner Crawford’s confirmation vote, needed to be reminded that the FDA doesn’t have the authority to mandate label changes. The answer, my friend, is not bloviating in the wind. Rather than commenting on the prevailing winds (which certainly seems a classic case of projection) perhaps Mr. Grassley should work to increase the FDA’s budget.
I’m sorry, did somebody say that counterfeit drugs are a “red herring” of the global pharmaceutical industry? The only comment I can make is, WHO’s on first.
LONDON - Worldwide, the WHO believes counterfeits make up between 5 and 8 percent of the $550 billion of medicines sold each year. But WHO spokeswoman Daniela Bagozzi said this was based on incomplete information and the actual amount could be higher.
“It represents a huge number of people who are suffering and in some case dying,” she said. “A lot of deaths could be avoided if the drugs being taken were not substandard counterfeits.”
Here’s a thoughtful article from a doctor who’s having a hard time “donating” staff time to helping patients navigate the often difficult paperwork problems of patient assistance programs. He’s trying to do the right thing. How can we help? URL for this article:
Do we now have to start referring to “Big Generics?” As reported today,Teva agreed to buy Ivax in a $7.4 billion cash-and-stock deal that will restore the Israeli company’s No. 1 position in the market for generic medicines. Used to be that those little ‘ol generic companies were the poor country cousins of the “real” pharmaceutical companies. But it seems as though the sides are evening up and, with a big assist from Uncle Sam, “Big G” is ready to make its move to prime time. Will this move presage a more aggressive legal posture by the purveyors of off-patent in general and towards biologics in particular? Don’t bet against it. G-Wiz!
Remember that wild ad? The one that got your hackles up and made you ask your 8-year old to leave the room? Well, it’s gone goodbye — if the members of PhRMA follow #10 of the new voluntary DTC guidelines —and they’re (mostly) on record saying they will abide. As such, reminder ads are history. #10 guideline, the only one of the 15 with real teeth, is the first real move towards having responsible adults at pharmaceutical companies reign in their purposefully aggressive marketing brand folks. Good work Billy! A “perfect 10.”
PhRMA’s new voluntary guidelines for DTC advertising say a lot about what Big Pharma is ready to do — and that’s not much more than what they’re doing right now. That means being “in compliance.” That’s nice. But what they’re missing is that the problem is the status quo. Doing the wrong thing the right way is a very questionable strategy. Okay, maybe not the “wrong” thing, but not the best, most forward-looking thing. The real problem is that “long-term” thinking, relative to marketing, needs to shift from the end of the quarter to somewhat further down the pike. If not, it will end up being decided down another pike — Rockville Pike.
William Osler said “the young physician starts life with 20 drugs for each disease, and the old physician ends life with one drug for 20 diseases.” That’s a nice aphorism, but it has a deeper meaning. Dr. Osler recognized that while young physicians start their career on the cutting edge of medical science, they ultimately learn, through trial and error that the practice of medicine isn’t primarily about medicine, it’s about the patient.
Let me tell you about another famous physician, one who has influenced millions of people around the world, Dr. David Zorba, chief of neurosurgery at the renowned County Medical Hospital during the 1960s. You might remember him better if I remind you of his often-repeated mantra, Man, woman, birth, death, infinity. If we understand the need to make today a foundation for tomorrow, then infinity is a concept we should consider.
Dr. Zorba was mentor, father confessor, friend and teacher to Dr. Ben Casey, the star of the television series of the same name that ran from 1961 until 1966. In Ben Casey the limits of medicine, the ethics of physicians, and the role of medicine in society were thoughtfully examined. Dr. Zorba’s hospital functioned as a microcosm of the larger society it served. The professionals presented in Ben Casey were a tight group sworn to an oath of altruistic service. The majority of physicians in the employ of County General were not terribly inflated with self-importance. Their world was not so far removed from the world inhabited by those they helped. The problems that plagued the world outside the walls of County General could often be found within as well.
During their work at County General, Dr. Zorba and his colleagues came into contact with representatives from every level of society. Part of that contact was learning about and making judgments on certain societal issues and problems. Racial tension, drug addiction, the plight of immigrants, child abuse, and euthanasia were a few of the issues treated in Ben Casey. Medical malpractice wasn’t one of them.
How far we have come in just under half a century. Today, as in the time of doctors Zorba and Casey, physicians are often viewed as subjects of admiration. But, unlike those halcyon days at County General, physicians are more and more viewed with disdain as spendthrift by insurance providers, potentially liable by the tort bar, as in the pocket of big pharmaceutical companies by the media, and as heartless cogs in a malfunctioning health care system by our patients. Today, rather than making judgments about society, society is making judgments about us. We have moved from the leadership of Dr. Zorba to that of Dr. Phil.
When Thomas Edison was asked why he was so successful he responded, “Because I fail so much faster than everyone else.” Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.
In partnership, regulators, industry and academia can apply modern engineering and cutting-edge scientific knowledge to medical product manufacturing. In partnership we can improve standardization and automation of clinical research. And in partnership we can develop novel and improved clinical trial designs and analytical methods for evaluation of safety and effectiveness that can reduce costs. Currently, 50% of drugs that undergo large scale Phase 3 trials turn out to be too unsafe or not effective enough for marketing. That is not a sustainable model for the 21st century.
Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number …
* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.
* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million.
* Shifting 1/4 of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.
FDA’s critical path activities and research must complement, not compete with, what industry and other regulatory agencies in the US and around the world and are already doing.
I believe that FDA should assume an organizational role, because FDA is at the crossroads of the translational process.
FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.
FDA has the technical expertise that can draw together stakeholders, help prioritize research that is most needed, and to partner with others to conduct this research. Obviously solutions will have to come from sources with the greatest expertise. This could entail contracting with academic organizations, private industry and other global translational research groups.
FDA’s Critical Path initiative will enable innovative growth companies to better and more efficiently attack the steep hurdles facing them, allowing them to compete more effectively against the bigger, better-funded players in the market on a more level playing field. That means a real change in the risk/benefit equation for both emerging growth companies and the public health.
Consider FDA’s critical path initiative as a revised game of Shoots and Ladders. Rather than relying on a roll of the dice, FDA can be a bridge over the shoots and a guide to the ladders.
The most important tool is collaboration. Regulators must embrace stakeholders as partners in the public health process.
In the Los Angeles Times of July 25, Michael Hiltzik decried the fact that drug makers have budgeted $50 million to support one of two competing pharmaceutical pricing intitiatives (Proposition 78) that will be on the ballot at this November’s special election in California. Put very simply, Prop 78 encourages drug makers to reduce prescription prices for low-income patients voluntarilly, whereas the competing initiative, Prop 79, gives the state government almost complete control over drug prices. Mr. Hiltzik concludes his article with this invitation: “just consider how many indigent and elderly patients would be helped $50 million in discounts.”
I can’t answer the question precisely, but the answer is surely “very few.” US sales of prescription drugs run about $178 annually. About 10 percent of these sales are of generic drugs (not relevant to the question), leaving about $160 billion. Let’s say about 10 percent of US sales are in California: $16 billion. $50 million of $16 billion is a vanishingly small amount: about $1.47 for each Californian. Even if there’s a significant skewness to the distribution (as there surely is), $50 million is a tiny number. Let’s say one in ten Californians has “catastrophic” drug costs, such that they must trade off prescriptions for groceries: $50 million divided by these 3.4 million patients is still less than $15 per patient.
When looked at in perspective, $50 million is a tiny amount for this remarkably unpopular industry to invest in buying some breathing room from the relentless growth of government intervention in its affairs.
Excuse me Senator, about that bill you want a vote on that would allow imported drugs from a multitude of nations including Great Britain, this just in …
Counterfeit cholesterol drug alarm
The UK’s medicines watchdog is recalling a batch of a cholesterol-lowering drug after fake tablets were discovered. The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with Pfizer, is recalling packs of Lipitor 20mg tablets. Only those bearing the batch number 004405K1 are affected. The MHRA said patients were not at any immediate risk from the fake drugs, which should be returned to chemists. Patients will then be given new supplies of the prescription-only drug. Fake tablets can be identified because they do not come in sealed packets in which the genuine drug is provided. Tip-off Pfizer said hundreds of batch numbers were released each year, and the recall only applied to this one. There were around three million prescriptions for Lipitor issued in 2004. Seventy-three packets of counterfeit Lipitor have so far been discovered after a tip-off from customs officers in Rotterdam, Holland. It is the third time since the beginning of 2004 that fake drugs have entered the pharmaceutical supply chain in the UK. Last year, counterfeit batches of Cialis, used to treat impotence, and Reductil, used to treat obesity, were discovered. Nimo Ahmed, head of intelligence at the MHRA, said: “It is the vigilance of the MHRA that has led us to identify the counterfeit Lipitor and recall this product. “Although the quality of counterfeit medicines cannot be guaranteed, our testing of the counterfeit product indicates that there is no immediate risk to patients. If patients have any concerns about possible side-effects they should discuss them with their doctor.” Pfizer called for more effort to be made by authorities in the UK and Europe to ensure the safety of medicines Barcode Kate Lloyd, medical director of Pfizer UK, said: “Patient safety is our top concern and we are seriously alarmed at the discovery of counterfeit medicine in the UK. “Patient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross-border trade, as patients will not gain the benefits their doctor intended when selecting their medicine.” She said measures including outlawing the repackaging of original manufacturers’ medicines, supporting the introduction of tamper-resistant medicine packaging, and introducing a standardised European barcode for medicines could all help to protect medicine supplies. “We would urge any patients who have this particular batch number on their packet to follow the MHRA’s advice and return the product to where they obtained it and seek a replacement of the genuine drug.”