Latest Drugwonks' Blog
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.”
Remember the movie “Brazil?” It’s one of those surreal Terry Gilliam creations where up is down and down is up and Robert DeNiro stars as a subversive HVAC repairman. Anyway, it’s time to revisit the world’s largest Portuguese-speaking nation — and this time it’s not for fun. Have a look at what CMPI advisory board member Doug Bandow (of the Cato Institute) has to say.
The American Spectator
Bad Boys From Brazil
By Doug Bandow
Drugs offer incredible medical benefits. Everyone wants to take them. Drugs cost a lot to develop. No one wants to pay for them, as Brazil has demonstrated in preparing to steal several pharmaceutical patents.
The tension between access to existing medicines and creation of new ones is particularly stark in poor nations. The regular price of HIV/AIDS treatment regimens exceed per capita incomes in some countries.
Although activists routinely vilify the pharmaceutical companies, only their extensive R&D activities generate the products that keep tens of millions of people alive. Leading companies widely discount and donate their drugs in the Third World and work with charitable groups to build health infrastructure and distribute antiretrovirals.
No good deed goes unpunished, however. Even residents of rich countries don’t want to pay for life-saving medicines. Most industrialized states impose one or another set of price controls on drugs, blatantly free-riding on the scientific creativity of American firms.
Other states make even less pretense of respecting the property rights of U.S. drugmakers. Such as Brazil. Despite its manifold economic and social woes, it has the largest economy in Latin America, ranking 11th in the world. Per capita GDP runs about $8,100 — behind the U.S., but ten or more times that of the dozen poorest African states.
Yet Brasilia believes that other nations — or, more accurately, companies from other nations — owe it a medical free lunch. The government wants to save money in its health budget (what country does not?), so it expects to buy AIDS drugs at fire sale prices. Brazil backs up its demands by threatening to steal the makers’ patents.
International intellectual property rules allow use of compulsory licensing of patents, but only in public health emergencies. Brasilia, however, has never let juridical niceties stand in the way of forcing down drug prices.
IN 2001 BRAZIL BEGAN THE process of issuing a compulsory license for Viracept (nelfinavir), an AIDS drug, unless Hoffman-La Roche lowered the price. The company accepted a 40 percent cut on its already discounted price.
Two years later Brazil was back, demanding price cuts from Roche, again, as well as Bristol-Myers Squibb and Merck. To back its ultimatum, Brasilia threatened to confiscate the drug patents.
Brazil prepared a formal decree to authorize importation of “any generic medication in case of a national emergency or in the interest of public health.” Even more ominously, Health Minister Humberto Costa indicated that Brazil would provide discounted AIDS medications to its Latin American neighbors, opening the international floodgates.
Brasilia’s extortion caused the companies to slash the prices of their anti-AIDS drugs. The final cost of Merck’s STOCRIN ended up little above that in Sub-Saharan Africa.
Despite its debt problems, Brasilia was not broke. It simply wanted to save cash. Alexandre Grangeiro, coordinator of the Ministry of Health’s AIDS program, explained: “We need a price reduction now, because of our budget limitations.” Similarly, said Dr. Paulo Roberto Teixeira, Director of the Brazilian National STD/AIDS Programme: “In previous negotiations, we managed to get the prices of these drugs reduced, but now we want to lower the costs even further.”
Brazil is wielding the same weapon yet again. Only this time Brazilian officials are demanding that Abbott Laboratories, Gilead Sciences, and Merck turn over their knowledge through “voluntary licensing,” allowing Brazil, either through government operations or private manufacturers, to produce generic copies.
Brazil might be a major economic player, but why pay for what you can steal? “Even with recent price reductions that we obtained from drug producers, the total cost of retroviral drugs is growing in an unbearable way,” explained Jarbas Barbosa, a health ministry official. (Ironically, early in May Brazil rejected a $40 million U.S. grant for AIDS treatment in protest of the accompanying conditions.)
These are “negotiations” in name only, since Brasilia will accept only one result. Said Barbosa: “We’re interested in a fast negotiation. But if we’re obliged to use the compulsory licensing we will do so as a last resort.”
Brazil’s lower house has since voted to suspend patents for AIDS drugs. At the end of June the government announced that it was going to appropriate Abbott’s Kaletra. Brasilia announced that the company had two weeks to make a counter-offer.
Understandably, the company caved, agreeing to provide ever-increasing amounts of its drug at the amount expenditure, and to yield its technology in 2015. But these concessions were like blood in the water for sharks. Brazil’s health minister, Correio Braziliense, announced that the tentative accord wasn’t enough: “The process of a compulsory license is still ongoing and breaking the patent has not been discarded as a final alternative.”
Which means Abbott will have to give more or lose its patent. Then next on the target list are Gilead Sciences and Merck, with whom Brasilia is conducting Don Corleone-like “negotiations.”
THE U.S. GOVERNMENT SHOULD punish Brazil economically — “as a last resort,” of course.
Washington generally has no duty to protect the profits of American firms that operate overseas. But in this case firms have no opt out — Brazil simply says, give us your product or we will seize it, irrespective of where you conduct business.
The consequences are potentially dire. Antiretrovirals exist only because profit-minded drugmakers have invested billions of dollars in R&D. Roberto Gouvelo, a legislator from the governing Workers’ Party, complained that one AIDS drug purchased by the government costs ten times its production cost. Unfortunately, however, industry investments must cover not only the successes, but also the failures, which are many. Even larger outlays are likely to be necessary to develop a vaccine for HIV/AIDS, as well as cures for a multitude of other serious diseases.
Should countries take new medicines whenever they want to pay less, pharmaceutical manufacturers will turn their attention to less important but less risky endeavors (most notably the “me-too” drugs routinely denounced by industry critics). It would be bad enough if Brazil stole American medicines for its domestic market. But if Brasilia begins exporting generic substitutes, it could destroy pharmaceutical innovation.
Brazil’s threats highlight another problem. By artificially driving down prices, such controls increase the gap between domestic and foreign prices, creating the perception that drugmakers are treating American consumers unfairly. That, in turn, increases pressure for so-called reimportation of the very drugs being sold under foreign price controls.
Washington should attempt to educate Brasilia. India serves as a good example: once a celebrated patent-breaker, New Delhi now sees pharmaceuticals as an emerging industry and has instituted a legal regime to protect intellectual property.
The U.S. also should indicate that Brazil’s behavior risks disqualifying it from joining any free trade system including America. The de facto theft of U.S. patents is inconsistent with open access to the American market.
Since Brasilia continues to misuse patent provisions intended to resolve a health care emergency, Washington should file a complaint before the WTO. Washington should consider direct sanctions as well.
Brazil certainly does not deserve preferential access to the U.S. market under the generalized System of Preferences (GSP) program. Brasilia’s ability to export $2.5 billion worth of goods to America duty-free already is undergoing a special review while the USTR considers the effectiveness of a Brazil’s system to combat copyright privacy. The Bush administration also should use a Special 301 investigation and penalize Brazilian exports.
Moreover, Congress should empower the U.S. Trade Representative to suspend recognition of intellectual property rights for companies headquartered in countries that violate American copyrights and patents. Retaliatory sanctions obviously should be a last resort, since a trade war is in no one’s interest. But if Brazil hopes to become a significant economic power, it should stop looking at U.S.—made pharmaceuticals as a free lunch.
If people won’t pay for their medicines, drugs won’t be created. Washington must protect the intellectual property which has created a medical boon for the entire world.
Doug Bandow is a Senior Fellow at the Cato Institute.
The American health care system is undermined, underserved, and undervalued when labeling is written more for corporate liability protection than as a valuable tool for health care providers. Today, labeling includes excessive risk information and exaggerated warnings. And this has set into motion a dangerous dynamic — labeling that does not accurately communicate to either the health care professional or the patient the conditions in which any given product can be used safely and effectively. This is nothing less than a grave menace to the public health. Labeling for liability is health care terrorism.